PRODUCTS AND SERVICES HEALTH CONTROL REGULATION

Published in the DOF on August 9, 1999

Last reform published in the DOF on 14 February 2014

On the sidelines a seal with the National Shield, which reads: United Mexican States.-Presidency of the Republic.

ERNESTO ZEDILLO PONCE DE LEÓN, President of the United Mexican States, in exercise of the power granted to me by part I of Article 89 of the Political Constitution of the United Mexican States. Article 39 of the Organic Law of the Federal Public Administration, and 60, 132, 194, fraction I, 197, 198, 200 bis, 205, 210, 212, 213, 215, 217, 269, 270, 272 to 276, 283, 286 bis, 287 and 422 of the General Health Law, I have had issue the following:

HEALTH CONTROL OF PRODUCTS AND SERVICES REGULATION

TITLE FIRST

General provisions

Single Chapter

ARTICLE 1o. The purpose of this order is to regulate, control and promote health of the process, import and export, as well as of the activities, services and establishments, related to the following products:

I. Milk, its products and derivatives;

II. Egg and its products;

III. Meat and its products;

IV. Those of fisheries and derivatives;

V. Fruit, vegetables and their derivatives;

VI. Non-alcoholic beverages, products for preparing and freezing them;

VII. Cereals, legumes, their products and botanicals;

VIII. Edible oils and fats;

IX. Cocoa, coffee, tea and its derivatives;

X. Prepared foods;

XI. Prepared foods ready for consumption;

XII. Food for infants and young children;

XIII. Condiments and dressings;

XIV. Sweeteners, their derivatives and confectionery products;

XV. Foods and non-alcoholic beverages with modifications to their composition;

XVI. Biotechnologicals;

XVII. Dietary supplements;

XVIII. Alcoholic beverages;

XIX. Tobacco;

XX. Those of perfumery, beauty, grooming and insect repellents;

XXI. Additives, and

XXII. Others which, by their nature and characteristics, are considered as foods, beverages, perfumery products, beauty or toilet or tobacco, as well as the substances associated with their process.

The packaging, packaging and irradiation of the products specified above are also subject to this Regulation.

In the same way, it is the subject of this order, the regulation, control and health promotion of the provision of the services and practices of tattoos, micropigmentations and perforations.

The products, establishments, activities and services covered by this Regulation concern those for human use and consumption, except where expressly referred to by others.

ARTICLE 2o. For the purposes of this Regulation it is understood by:

I. Health failure, irregularity in relation to the health specifications laid down in this Regulation and the applicable rules and which represent a health risk;

II. Appendix to the document which forms part of this Regulation and which contains specifications to be met by the products, activities, services and establishments covered by this Regulation;

II Bis 1. Exhibition front area, the area where the product is located, among other information, the name and the trademark of the product;

II Bis 2. Flavored beverages, products made by dissolution in water for human consumption, sugars and/or sweeteners, regardless of whether they contain other ingredients and additives, and which may or may not be carbonated;

II Bis 3. Botanas, for the products of: flour, cereal, leguminous, tubers, fecules, grains, fruit, nuts, seeds or legumes with or without shell or cuticle, pig skin, as well as nixtamalized products; which may be fried, baked, exploited, covered, extruded or roasted; whether or not added with salt, irrespective of whether they contain other food ingredients and additives;

II Bis 4. Chocolate, to a homogeneous product made from the mixture of two or more of the following ingredients: cocoa paste, cocoa butter, cocoa, added sugar or other sweetening matter, irrespective of whether other ingredients are used, such as dairy products and food additives;

III. Health status, to the situation where an establishment, product or service has been determined by health verification;

IV. Dependencies, to the dependencies of the Federal Public Administration;

IV Bis. Multiple or collective packaging, to any packaging in which two or more Prepackaged product units, equal or different, are contained, intended for sale to the consumer;

V. Label, marking, marking, marking, marking, graphic or other descriptive form that has been written, printed, stenciled, marked, embossed or in hollow, engraved, adhered, sealed or attached to the package or package of the product;

VI. Law, to the General Health Law;

VII. Batch, to the quantity of a product, produced in the same cycle, consisting of homogeneous units;

VIII. Standards, to Mexican official standards;

VIII Bis. Pre-packaging, placing of products in a package of any nature, in the absence of the consumer, which allows the quantity of product contained in it cannot be altered, unless the package is open or significantly modified;

IX. Product, to any of those referred to in Article 1. of this Regulation;

IX Bis. Products similar to chocolate, to products made from cocoa butter in which they have been wholly or partly replaced by other edible vegetable fats or, where appropriate, by their hydrogenated fractions; and they are made in special formats or mouldings whose presentation, appearance, taste or consumption are likely to be confused with the Chocolate;

X. Risk, to the likelihood that any biological, chemical or physical property that causes harm to the health of the consumer will be developed;

XI. Secretariat, to the Secretariat of Health, and

XII. Third authorised, to the person authorised by the Secretariat to deliver opinions on compliance with requirements laid down by the Secretariat itself or on the relevant rules or to carry out studies, for the purposes of formalities or health authorizations.

ARTICLE 3o. The Secretariat, in coordination with the institutions of research and higher education, both public and private, will promote the exercise of actions aimed at improving the health conditions of products, their processes and the services referred to in this Regulation.

ARTICLE 4. The Secretariat shall establish and update in the rules, in terms of the law of the matter, the classification, provisions or health specifications concerning the products, services, activities and establishments covered by this Regulation.

ARTICLE 5o. The Secretariat, within the framework of the National Health System, will carry out programs and control and health promotion campaigns, and will invite the community, producers, health professionals, and service providers to participate in these programs.

ARTICLE 6o. The popular action referred to in Article 60 of the Law, may be exercised by any person, for which it shall:

I. Report to the health authority the facts, in writing or in a verbal manner;

II. Point out the fact, act or omission that in your judgment represents a risk or causes harm to the health of the population, and

III. Provide the data to identify and locate the cause of the health risk or damage and, where appropriate, the persons involved.

When the complaint is made in a verbal manner, the health authority shall state that in writing, based on the statements of the complainant, who shall sign it, in order to proceed to the respective procedure. In no case will the anonymous complaint be processed.

The health authority shall inform the complainant of the attention it gives to the complaint.

The results of the complaint and the measures that, if any, apply the Secretariat will only be informed by a request for judicial authority.

ARTICLE 7o. The application of this Regulation shall be the responsibility of the Secretariat, as well as the governments of the federative entities in their respective fields of competence, in accordance with the coordination arrangements which, if any, are signed.

TITLE SECOND

Products

Chapter I

Health features and conditions

ARTICLE 8o. Products and substances shall be subject to the provisions of this Regulation and the corresponding rules in accordance with their characteristics.

ARTICLE 9o. The identification of the products for the purposes of this Regulation may take account of any of the following criteria:

I. Generic and, where appropriate, specific names;

II. Product Description;

III. Basic and optional ingredients, or

IV. Physical, chemical and biological characteristics, if any.

ARTICLE 10. The generic and specific names of the products shall correspond to the basic characteristics of their composition, in accordance with the relevant rules.

When by their nature, products lack generic or specific names, they shall include in the product description the name of the ingredient or ingredients that characterise them.

ARTICLE 11. Products and substances must not cause health risks or damage, with the exception of those for which the Law establishes special conditions for sanitary control.

For the purposes of the preceding paragraph, the Secretariat may analyse and issue the relevant opinion for each product, for which it may rely on expert opinion.

The opinion referred to in the preceding paragraph shall be without prejudice to the fact that, if the Secretariat is aware that a product poses a risk to health, it may prohibit its production, storage, importation, distribution or sale.

ARTICLE 12. The Secretariat shall fix the characteristics to be collected by a product for food, food supplement, biotechnological product, cosmetic treatment or any other classification, in accordance with the provisions of the Law, this Regulation and the relevant rules.

ARTICLE 13. For the purposes of sanitary control of the products and raw materials, the Secretariat may, in writing, require the persons concerned to specify the biological, chemical and physical specifications of those products, as well as the general techniques of the process, which may be corroborated by the Secretariat itself, which shall ensure the confidentiality of the data.

ARTICLE 14. Non-alcoholic foods and beverages modified in their composition shall be subject to the provisions of this Regulation and to the rules corresponding to their new characteristics, in terms of name, composition, specifications and labelling.

ARTICLE 15. The rules shall lay down the microbiological, toxicological or health-risk specifications of the products, as well as the health techniques of production to ensure such specifications and methods of sampling, testing and analysis. corresponding.

ARTICLE 16. The water used in the manufacture, mixing or conditioning of the products must be potable, except in cases where it is established, in this Regulation or in the corresponding rules, that it has to be purified, distilled or with other features.

ARTICLE 17. The materials, equipment, utensils and packaging used in the manufacture of the products covered by this Regulation shall not contain any toxic substances and shall necessarily be harmless and resistant to corrosion.

ARTICLE 18. For the purposes of this Regulation, the imitations shall be the products made with ingredients or procedures different from those used in the production of the one that he intends to imitate and whose appearance is similar to the latter.

ARTICLE 19. Imitations of food or drink shall comply with the health and labelling provisions and specifications laid down by this Regulation and the other provisions applicable to those to which they imitate, unless the Ingredients that constitute imitation have different health characteristics.

ARTICLE 20. The batches of the products shall be identified in relation to their processing date and in accordance with the other guidelines laid down in the relevant rules.

ARTICLE 21. Products that have expired expiry date shall not be imported or marketed. The Secretariat shall determine the destination of the products to be secured by written opinion.

ARTICLE 22. The composition and, where appropriate, the name of the products covered by this Regulation must comply with the ingredients, additives, processing aids and plants which, by agreement, determine the health secretary as permitted, restricted or prohibited.

The Agreement referred to in the preceding paragraph, as well as its amendments shall be published in the Official Journal of the Federation.

ARTICLE 23. Where, for the purposes of promoting or informing the consumer, inks, solvents, substances or any other means which come into contact with the products covered by this Regulation are used, the safety of such substances must be demonstrated to the appropriate health authority, when requested.

ARTICLE 24. Products whose process is carried out on the national territory and intended exclusively for export purposes shall not be subject to the provisions of this Regulation, except for those that pose a health risk.

Chapter II

Tagged

ARTICLE 25. For the purposes of labelling the products covered by this Regulation, the following general health information is considered:

I. The generic or specific name of the product;

II. The ingredient declaration;

III. The identification and address of the manufacturer, importer, packer, maquilador or national or foreign distributor, as the case may be;

IV. Instructions for their conservation, use, preparation and consumption;

V. The component (s) that may pose a medium or immediate risk to the health of consumers, whether by ingestion, application or handling of the product;

VI. The nutritional contribution;

VII. The expiration date;

VIII. The identification of the batch;

IX. The processing condition to which the product has been subjected, when the product is associated with potential risks;

X. The precautious legends, and

XI. The warning legends.

The rules for each type of product shall determine the general health information to be contained in the label or the label when, by the size of the package or package or by the conditions of the process, it cannot be display all information that is required.

In addition to the provisions of this Article, the labelling of food and non-alcoholic beverages Prepackaged, with the exception of water for human consumption, food for infants and young children, sugar-free chewing gum, pills for (a) the sugar-free breath, meal with the exception of preparations, products and raw materials intended exclusively for the use and internal consumption of institutions, and raw materials for industrial use, shall be indicated in the frontal area of display of the product:

I. The total energy content of the product expressed in kilocalories or calories. This value shall not be expressed in percentage terms of a recommended daily intake, and

II. The content of saturated fats, other fats, total sugars and sodium that are present in the product, as follows:

(a) In the case of saturated fats, other fats, and total sugars, the energy contribution of each nutrient must be expressed, indicating the percentage that each of them represents based on the values established in the following table:

Caloric input source Value for calculation

Saturated fat 200 calories

Other fat 400 calories

Total Sugars 360 Calories

(b) The sodium declaration must be expressed in milligrams, as well as the percentage that this content represents according to the reference value of 2000 milligrams;

c) Dealing with Buttons, Flavored Beverages, Chocolates, Chocolate Products and Confectionery Products, in their presentation of family packaging, the number of portions and the energy content per serving must be included present in the same, in terms of fraction I of this paragraph.

Are excluded from the provisions of the preceding paragraph, known Beverages that are considered to be of low energy content in terms of the Agreement to be issued by the Secretariat for that purpose;

(d) Multiple or collective packaging, the products of which are not individually labelled, must present the information set out in points (a), (b) and (c) of this fraction. Those multipacks or collectives whose products that make up them are individually labeled, are not required to present the information set forth in such incisors, and

e) In the case of foods and non-alcoholic beverages Prepackaged in family packages not covered by subparagraph (c) of this fraction, the information referred to in points (a) and (b) of that fraction may be included in respect of portions less than the total of the contents of the container, the energy content being expressed by container and portion, as well as the total number of portions present therein.

The Secretariat, by Agreement that is published in the Official Journal of the Federation, will establish the criteria according to which the dimensions of the front area of display will be calculated and those that must be fulfilled for to provide the information referred to in the fractions of the preceding paragraph, and to determine the reference quantities for presentations in family packages and for portion sizes, in accordance with points (c) and (e) of section II of that paragraph.

With the exception of Article 196 Bis of this Regulation, in the case of imported import products of origin, the information containing the labels shall be written in Spanish, prior to their marketing, in the terms of the corresponding standard.

ARTICLE 25 Bis. The labelling of foods and non-alcoholic beverages may include the nutritional label, where, at the request of the interested party, the Federal Commission for the Protection of Health Risks determines that the product concerned complies with the (a) the number of measures to be taken in accordance with this Article

For the purposes of the foregoing paragraph, the Secretariat shall, by means of an Agreement published in the Official Journal of the Federation, establish the numrimental flag, as well as the nutritional criteria to be taken in the account shall be taken to determine the provenance of its use and the procedure to be followed for authorisation, in which a response period of no more than three months shall be considered.

Chapter III

Transport

ARTICLE 26. The transport of food and drink must ensure that the health characteristics which make them fit for human consumption are preserved and that for no reason they may be transported in vehicles intended for the transport of pesticides, plant nutrients, toxic or dangerous substances, or grooming products with corrosive action.

ARTICLE 27. The means of transport used for the transport and distribution of the raw material or finished product must be constructed with corrosion-resistant, smooth, waterproof, non-toxic materials and which can be cleaned with facility. Vehicles must be kept permanently clean and in good condition.

Equipment installed in the means of transport referred to in the preceding paragraph shall ensure the preservation of the products and prevent the occurrence of pests.

ARTICLE 28. Perishables must be maintained at refrigeration temperatures during transportation and those requiring freezing must be kept in that state. The specific temperatures for each product type shall be set out in the relevant rules.

The doors of the cooling or freezing chambers of the vehicles must be closed before leaving the establishment and shall not be opened until they reach each of the points of destination, except for the indication of authority competent.

THIRD TITLE

Establishments

Single Chapter

ARTICLE 29. Local establishments and their premises, their premises and attachments, covered or discovered, whether fixed or mobile, are considered to be establishments in which the process of the products, activities and services referred to in this Article is carried out. Regulation.

ARTICLE 30. The establishments shall comply with the health conditions which for their operation lay down this Regulation and the corresponding rules, according to the use to which they are intended and the characteristics of the respective process.

ARTICLE 31. The establishments must have an area intended exclusively for the temporary storage of waste or offal, which must be placed in containers with a lid, duly identified and kept away from the areas of the process.

ARTICLE 32. The owners of the establishments shall apply the criteria of good hygiene practices for the prevention and control of the harmful fauna, as laid down in the relevant rules and other applicable provisions.

ARTICLE 33. The owners of the establishments shall take care of the preservation, grooming, good condition and maintenance of the same, as well as of the equipment and utensils, which shall be suitable for the activity performed or services provided.

ARTICLE 34. The clothing of personnel involved in the processing of products, in activities or in services, shall comply with the requirements laid down in the relevant rules.

ARTICLE 35. The use and management of substances that are indirectly involved in the process shall ensure the safety of the substances.

ARTICLE 36. When the process of the products requires refrigeration or freezing systems, thermometers or devices must be equipped to record the required temperature.

ARTICLE 37. In establishments engaged in the processing of products, no ingredients, raw materials or substances may exist where their use is not justified in accordance with the provisions of this Regulation and the relevant rules.

ARTICLE 38. The owners or persons responsible for the establishments intended for the processing of the products shall immediately notify the Secretariat of any health anomalies which they detect in the same or in the products which may be of potential risk. for health, and will collaborate on the necessary security measures to be implemented.

ARTICLE 39. In the establishments where the process of the products covered by this Regulation is carried out, records or logbooks must, as the case may be, be included which include at least the monitoring of the different stages of the process; the storage of the raw material; the finished product; product analysis; cleaning and disinfection programmes for the facilities and equipment, as well as for the eradication of pests. Such documents shall be made available to the Secretariat when required and within the time limits specified by the standard.

TITLE FOURTH

Milk, its products and derivatives

Chapter I

Milk Products

ARTICLE 40. For the purposes of this Regulation, the following shall be within the products and derivatives of milk:

I. Products:

a. Cream,

b. Milk sweets,

c. Butterfat,

d. Ice cream and ice cream bases,

e. Click,

f. Acidified milk,

g. Sugary condensed milk,

h. Cultivated or fermented milk,

i. Dehydrated milk,

j. Evaporated milk,

k. Pasteurized and ultrapasteurized milk,

l. Combined milk,

m. Milk recombined,

n. Reconstituted milk,

n. Rehydrated milk,

or. Butter,

p. Cheese and

q. Yogurt, Yogurt or Yoghurt, and

II. Derivatives:

a. Food grade casein or food grade caseinates,

b. Requeston and

c. Serums.

Chapter II

Milk

ARTICLE 41. Raw or bronchial milk may be used for:

I. Human consumption, when meeting the health requirements set out in this Regulation, and

II. Industrial use, under the conditions set out in the Regulation itself.

ARTICLE 42. Raw milk, after milking, must be filtered and deposited in tanks provided with cooling or cooling systems. Milk will only be allowed to remain in these conditions for up to twenty-four hours. Within this time it must be transported to the expends that are not part of the stables.

When cooling systems are not available, the raw milk must be sold within a period of no more than six hours after the order. Once this time has been exceeded, raw milk must undergo a process of industrialization with heat treatment.

ARTICLE 43. In the process of raw or bronchial milk, it cannot be:

I. Carry out any manipulation that modifies its health characteristics, except as expressly determined by the Secretariat;

II. Transport it to the expendiums, milk collection centres or pasteurizing plants, which have not submitted their operating notice to the Secretariat or to the governments of the federal entities in due time, as the case may be, and

III. Vending it outside the stables and establishments intended for this purpose.

ARTICLE 44. In the manufacture of milk products and derivatives, milk which complies with the health requirements laid down in this Title shall be used.

ARTICLE 45. It shall not be possible to sell ultra-pasteurized and sterilized milk in returnable containers.

ARTICLE 46. In all cases where the milk does not come from cows, the animal species of origin must be mentioned.

Chapter III

Winning

ARTICLE 47. Where livestock suffer from a disease which may be transmitted to man, either by contact or by milk, or where it is not transmissible, it may alter the physico-chemical characteristics of milk which render it unfit for human consumption. human consumption, the owner or the person responsible for the establishment must isolate it and inform the health authorities, in order to ensure that the health authorities, in coordination with the competent authorities, determine whether the isolation of these animals is temporary or final.

ARTICLE 48. Sites in which livestock with a disease communicable to man remain or have remained, shall be subject to compliance with health measures and other acts that are dictated by the health authorities, in coordination with the agencies. competent, on disinfection, de-infestation and other actions that are necessary for them to be judged.

ARTICLE 49. Staff who attend sick animals must change the protective clothing that has been in contact with such animals, wash and disinfect the boots and hands before handling and order the healthy livestock, as well as the clothing. contaminated before reusing it.

ARTICLE 50. The milk produced by animals affected by any disease shall not be mixed with that intended for human consumption.

Chapter IV

Ordena

ARTICLE 51. Any animal which has been subject to treatment with medicinal products must be ordered separately and its milk must not be used for human consumption until the period of disposal has elapsed, treatment and the instructions on the label thereof to ensure the excretion of such substances.

Chapter V

Establishments that process milk

ARTICLE 52. The stables must be located outside the urban and industrial areas, in terms of the applicable provisions.

ARTICLE 53. The stables shall have at least the following areas:

I. Of sorts in hygienic conditions, and

II. Isolation of animals with infectious diseases.

ARTICLE 54. The areas of the stables and the establishments which are destined for the raw or bronc milk product shall:

I. Be independent of other facilities, and

II. Show the front of the establishment a sign that says: " Exendium of raw milk or, if necessary, of the Expense of the bronc milk and the other one that clearly and ostentably point out the following:

" Hierva milk for a few minutes before consuming it. If you do not consume it immediately after you have boiled it, keep it in refrigeration. "

ARTICLE 55. The collection centres, pasteurisation plants, ultra-pasteurisation or milk sterilisation must be located in establishments separate from the stables in order to avoid contamination of the product.

ARTICLE 56. In pasteurisation, ultra-pasteurisation or sterilisation plants, at least 80 days must be kept, the temperature recording charts and the time to which the milk was submitted, which must be put to the the provision of the competent health authorities where they require them.

TITLE FIFTH

Egg and its products

Single Chapter

ARTICLE 57. For the purposes of this Regulation, the egg, its products and derivatives are classified as:

I. Fresh egg;

II. Liquid egg;

III. Liquid yolk;

IV. Clear liquid;

V. Chilled egg;

VI. Refrigerated yolk;

VII. Clear refrigerated;

VIII. Frozen liquid egg;

IX. Frozen liquid yolk;

X. Clear frozen liquid;

XI. Dehydrated egg;

XII. Dehydrated yolk, and

XIII. Clear dehydrated.

ARTICLE 58. The use, supply and supply of eggs and their products which present one or more of the following characteristics shall not be carried out:

I. That it is altered or present bad odor or taste;

II. Have the clear greenish color;

III. That it is devoid of yolk;

IV. Present fractures;

V. To present foreign bodies or parasites;

VI. That the clear is laminated and not consistent;

VII. It comes from birds whose food has been added to the colours of the so-called Sudanese;

VIII. Pesticide residues exceed the limits laid down in the relevant rules, or

IX. Whether they have been frozen or added to preservatives, with the exception of liquid egg and yolk.

ARTICLE 59. The poultry holding shall be exempt from infectious diseases of the species which affect man.

TITLE SIXTH

Meat and its products

Chapter I

Meat products

ARTICLE 60. For the purposes of this Regulation, the following are included in the meat products:

I. Cured and cooked;

II. Cured and matured;

III. Cured and emulsified cured;

IV. Chopped;

V. Salted;

VI. Dry and fried, and

VII. Other sausages.

Chapter II

Meat

ARTICLE 61. They shall not be used for human consumption, and shall be the cause of total rejection of the production line by the veterinarian:

I. Animals other than birds with fever; generalized cachexia; generalized congestion or bleeding; insufficient bleeding; anasarca; endocarditis; acute peritonitis; purulent bronchopneumonia; abscesses; multiple cysts; tumors multiple or malignant; gangrene; uremic tables; embolic hepatic abscesses; suppurative and degenerative nephritis; acute metritis; gangrenous mastitis; acute infectious arthritis; disseminated scabies; inflammation of several ganglion chains; meats Haemorrhagic meat; meat with odour which differs from normal; altered meat; meat with abnormal pigmentations, or other meat that is established in the relevant rules, as well as those that have not been inspected or have died by suffocation; and

II. Birds showing any applicable signs or lesions of the previous fraction or any of the following diseases: aspergillosis; gangrenous synovitis; Gumboro disease; nephritis nephrosis; smallpox; Newcastle disease; psittacosis; ornitosis; Marek's disease; lymphoid leucosis; salmonellosis; staphylococcosis; pulorosis; parasitosis and any other that are laid down in the relevant rules.

ARTICLE 62. Animals arriving dead or sick from: anthrax; acute salmonellosis; leucosis; septicemias; vesicular diseases; rabies; listeriosis; classical swine fever; avian fever; Newcastle disease; tuberculosis; paratuberculosis; Coccidiosis, and others indicating the competent authorities, must be slaughtered and incinerated immediately. The rejections shall be treated in accordance with the instructions of the zootechist veterinary surgeon, in accordance with the relevant standard.

ARTICLE 63. When zoonoses are presented in the area where they work, the zootechnical veterinary surgeons, irrespective of compliance with the other applicable provisions, shall give immediate notice to the nearest health authority, who shall take the driving measures, in accordance with the relevant standard.

ARTICLE 64. The Secretariat shall coordinate with the competent agencies to exchange information on proven or suspected cases of knowledge of the diseases referred to in the previous Articles, as well as other which may be of risk to human health or to the livestock population.

ARTICLE 65. No animal or part of it, which is sick or dies of any clostridiasis, may be manipulated in the area where food is processed for human consumption, and must be incinerated. All other animals which do not show signs may be slaughtered and slaughtered, with the exception of pigs, which shall be considered as suspects and shall be kept under observation.

ARTICLE 66. The viscera or part of them shall not be intended for human consumption, and shall be the cause of partial rejection, where there is:

I. The presence of parasites and their eggs;

II. The presence of abnormal coloration affecting only the organ;

III. The presence of abscesses and cysts, as well as infarcted and necrotic zones, located with or without formation of diphteroid membranes;

IV. Altering the structure or consistency of the organ;

V. The presence of bleeding, or

VI. The presence of degeneration.

ARTICLE 67. Channels, meat and viscera may not be distributed, sold or supplied for human consumption, where:

I. Come from animals that have been slaughtered in establishments that do not comply with the health requirements set out in this Regulation;

II. Are altered or added with preservative or antioxidant substances;

III. Are either frozen or stored in non-appropriate premises sanitarily;

IV. Exceed the limits of pollutants, micro-organisms and parasites which are laid down in the relevant rules;

V. Present degenerative changes;

VI. Come from dead animals for causes other than slaughter, or

VII. Come from animals used in research.

ARTICLE 68. Products and by-products of meat origin intended for human consumption must be free of the colouring matter referred to as Sudanese, red solvent 23, red toney, colour index 26100 or red DC 17 and any other colouring or additive which, in accordance with this Regulation and the applicable provisions, it should not be used for food and drink.

ARTICLE 69. As a measure of health security, the Secretariat shall determine the destination of the carcases or parts thereof, which are in the form of goods, transport and storage, where the provisions of this Title are not complied with or are not packed or are present. violated or broken.

Chapter III

Establishments where meat and meat are handled

Section first

General provisions

ARTICLE 70. The establishments which are engaged in the process of meat and viscera may only slaughter, process or expend animals or products which comply with the relevant rules and which come from traces which have given notice of operation to the Secretariat.

Section 2

Races and Abattoirs

ARTICLE 71. Animals considered fit for human consumption must be slaughtered in traces or slaughterhouses meeting the health conditions of construction, equipment and operation laid down in the relevant rules.

ARTICLE 72. One or more different domestic species may be slaughtered in the traces or slaughterhouses, always in separate areas and with their own equipment. If this is not possible, they may be sacrificed on alternate days, provided that at the end of the day's work all the furniture and equipment is washed with hot water and soap, and disinfected.

ARTICLE 73. In the establishments where the slaughter of the animals is carried out for consumption, the ante and postmortem inspection must be carried out in accordance with the requirements laid down in the relevant standard.

ARTICLE 74. Before the commencement of the post-mortem inspection, the animal health veterinarian must review the requirements laid down in the relevant rules by the local and the team.

ARTICLE 75. The cutting of the carcase, the removal of the area of slaughter or the treatment of any part of the animal may not be carried out until the end of the inspection. The contact of the channel with the work platforms, equipment and stairs shall be prevented.

ARTICLE 76. The carcases and the viscera must be identified or accommodated in such a way that the zootechist veterinary doctor can determine perfectly which channel and which viscera correspond to the same animal, for which he may stop the fishing of a channel for a detailed examination in accordance with the relevant standard.

ARTICLE 77. Trace or slaughterhouse staff who come into contact with the animals and the carcases must undergo medical examinations and laboratory tests before their recruitment and at least each year in order to detect asymptomatic carriers. intestinal bacteria, parasites, Brucella spp and other causative agents which constitute a risk of contamination.

You should not work for any communicable disease, with wounds or abscesses; also, any person affected by any gastrointestinal or parasitic disease can only be reintegrated into work when it is found. fully healthy, checking this with the appropriate laboratory tests, in accordance with the relevant standards.

Section 3

tocinery workers

ARTICLE 78. The following physically separated areas must exist in the tocinery workers, which ensure the sanitary quality of the products:

I. Reception of the raw material;

II. Separation of the different parts of the channel;

III. Frying;

IV. For obtaining lard;

V. Cooling;

VI. Garbage and garbage storage for subsequent disposal, and

VII. Of finished product.

ARTICLE 79. Refrigerators intended for the preservation of meat and products under refrigeration must be kept at a temperature not greater than 4ºC.

TITLE SEVENTH

Fishing products and their derivatives

Chapter I

Fishing products

ARTICLE 80. For the purposes of this Regulation, fishery products shall be considered to be of fresh, salt or brackish water, whether of the aquatic flora or fauna, obtained by capture or cultivation.

Chapter II

Production, extraction, and manipulation zones

ARTICLE 81. The Secretariat, in coordination with the competent agencies, shall determine the health or safety of a production or extraction area of fishery products, as well as of the water intended for the supply of these areas, according to the results of the physical, chemical, microbiological and special analyses of these waters.

ARTICLE 82. The Secretariat, in coordination with other agencies, shall carry out the evaluation of the technical and health studies for the classification of the body of water in each area in which bivalve molluscs are to be cultivated or for those used in each transplant or debug action.

ARTICLE 83. The validity of the classification of the production area shall be one year, provided that the sanitary conditions under which it was granted remain.

ARTICLE 84. In case of red tide appearance, production areas must be classified as prohibited, regardless of their previous classification.

The prohibited area classification will be in place until it is ensured that marine biotoxins are within the maximum limit set by the corresponding standards.

ARTICLE 85. They are considered as prohibited production and extraction zones, in which the water quality exceeds the maximum limits of pollutants established in the corresponding standard and therefore represent a risk to the health of the consumer, when:

I. Are contaminated with domestic, municipal, industrial, agricultural, boat, platform or other lake or sea installations;

II. Are affected by spills of materials containing toxic substances;

III. Are affected by radioactive material waste;

IV. Are affected by natural biotoxins, or

V. Are contaminated by any other source not covered by this Article.

ARTICLE 86. Water to be used for aquaculture centres and farms, as well as that for cultivation in marine waters, coastal lagoons, rivers, dams and lakes, shall not exceed the maximum, physical, chemical and specific microbiological conditions for each species to be determined in the relevant rules, without prejudice to the ecological criteria for water quality.

ARTICLE 87. The Secretariat, in coordination with other agencies, shall determine the health conditions and requirements to be met by fishing vessels, in accordance with the type of fishery for which they shall be used.

ARTICLE 88. Molluscs which are not handled live must be kept refrigerated or frozen.

ARTICLE 89. The permanence of bivalve molluscs at the premises for storage and storage shall not exceed forty-eight hours.

ARTICLE 90. Bivalve molluscs, from the time of their disconch, and gastropods and cephalopods, since their capture, must be kept at refrigeration or freezing temperatures.

ARTICLE 91. Fishing products packaged in hermetic sealing vessels shall be subjected to a commercial sterilisation process which ensures health quality, in accordance with the requirements laid down in the relevant rules.

Chapter III

Sale

ARTICLE 92. The public may not be sold or supplied to the public for fishery products which come from unsanitary areas or which have a putrid odor or those other than or other than that of the product, including odours, fuels, solvents or any derivative thereof. oil.

ARTICLE 93. An entire or sectioned fish may not be sold or supplied to the public for any of the following:

I. Pale guts with turbid mucus;

II. Blurred contours of the viscera, with variable colouring between brown and violet and the kidneys with aqueous appearance and consistency;

III. Decrease in the vitreous aspect in the musculature, with presence of enturbiation and violet coloration along the spine;

IV. Flaccid texture, such that by pressing it with the fingers, the skin does not return to its normal state;

V. Unpleasant odor with ammoniacal tendency;

VI. Removable body scales to the touch, or

VII. Spines or radio, detachable easily.

ARTICLE 94. Bivalve and gastropod molluscs may not be sold or supplied to the public for any of the following:

I. Odour other than that of the mollusc;

II. Viscose texture;

III. Opaque appearance;

IV. Open shell, or

V. Coming from an area without a sanitary or restricted classification or those where during an environmental contingency the provisions issued have not been adhered to.

ARTICLE 95. No cephalopod molluscs may be sold or supplied to the public for any of the following:

I. Odour other than that of the mollusc;

II. Split suction cups, open and separated from the body;

III. Eyes stained and opaque;

IV. Reddish-stained skin with no gloss, or

V. Detachment, to the touch, of a viscous substance.

ARTICLE 96. Crustaceans may not be sold or supplied to the public for any of the following:

I. Opaque appearance with dark spots between the joints, or

II. Muscle tissue with pasty texture.

ARTICLE 97. It shall not be possible to sell or supply to the public salted dried fish which present excessively yellow colouring or various shades of green and sepia.

ARTICLE 98. The public shall not be sold or supplied to the public with smoked fishery products with any of the following:

I. Abnormal spots or odors;

II. Water transfer by pressing with your fingers, or

III. Moulds.

TITLE EIGHTH

Fruit, vegetables and their derivatives

Single Chapter

ARTICLE 99. For the purposes of this Regulation, the following shall be included in the products and products derived from fruit and vegetables:

I. Dried fruits;

II. Dried fruit and vegetables;

III. Frozen fruit and vegetables;

IV. Preserved fruit and vegetables;

V. Crystallized fruits;

VI. Juices;

VII. Nectars;

VIII. Jellies;

IX. Jams;

X. Ates;

XI. Purées;

XII. Pulps, and

XIII. Sauces.

ARTICLE 100. Fruit and vegetables must comply with the following:

I. Be in good storage conditions, devoid of abnormal external moisture and no odours or strange taste;

II. Be free from eggs, larvae, insects, worms, molluscs or parts or excreta of any of them;

III. Be free of foreign material attached to the surface, and

IV. Do not exceed the maximum residue limit for pesticides, toxic substances and micro-organisms to be laid down in the relevant rules.

TITLE NINTH

Non-alcoholic beverages, products for preparing and freezing them

Single Chapter

ARTICLE 101. For the purposes of this Regulation, in the case of non-alcoholic beverages, products for the preparation and freezing of non-alcoholic beverages shall include the following:

I. Packaged water;

II. Non-alcoholic flavored beverages;

II. Bis. Caffeine-added drinks, understood to be those that contain more than 20 milligrams of caffeine per 100 millilitres of product;

III. Frozen from the above;

IV. Powder, and

V. Syrup.

ARTICLE 102. Non-alcoholic beverages and products to be prepared shall not exceed the limits of foreign matter laid down in the relevant rules.

ARTICLE 103. Waters packaged for human consumption and establishments where they are processed, irrespective of their origin or treatment to which they are submitted, must comply with the health specifications of drinking water and other provisions at least which, where appropriate, determines the Secretariat.

ARTICLE 104. Mineral water shall not exceed the limit of radionuclides laid down in the relevant standard.

ARTICLE 105. In the case of non-alcoholic flavoured beverages, products for the preparation and freezing thereof may be used for additives and processing aids provided for in the Agreement referred to in Article 22 of this Regulation.

ARTICLE 106. Sports drinks may contain the class and quantity of electrolytes to be established in the relevant rules.

ARTICLE 107. Repealed.

ARTICLE 108. In frozen products for non-alcoholic beverages, no:

I. Place ice directly on the products during processing or preservation;

II. Allow the production of products without packaging or wrappers that protect and identify them, as the case may be;

III. Re-freeze products that have left the factory, and

IV. Employ conservatives.

ARTICLE 109. The drinking or ground ice must be protected from contamination, for which it must be handled in containers that avoid contact with the floor.

ARTICLE 110. Containers used for cooling packaged beverages must be printed with the printed caption: "This ice is not for human consumption".

ARTICLE 111. Ice factories must be located in establishments or separate areas of other facilities.

In the case of establishments which for the production of products intended for human consumption require drinking ice, they may have an ice factory attached to them, provided that the requirements are met. health.

The rooms of workers, employees or any other person shall not have direct access to the factory or direct areas of production.

TITLE TENTH

Cereals, legumes, and their products

Single Chapter

ARTICLE 112. For the purposes of this Regulation, in cereals, legumes and their products the following shall be included:

I. Cereals:

a. Prepared flours and flours,

b. Pastes,

c. Prepared foods based on cereals,

d. Panification products, and

e. Tortillas;

II. Starch;

III. Botanas, and

IV. Legumes and their products.

ARTICLE 113. The procedures used to obtain the products covered by this Title must be carried out under conditions of hygiene which ensure their quality of health and which are within the specifications laid down in the corresponding rules.

ARTICLE 114. In the manufacture of pastes, no excess of the same shall be used which are dirty, altered, infested, contaminated or have foreign matter.

ARTICLE 115. In the manufacture of stuffed pastes, the reuse of pastes may not be carried out.

ARTICLE 116. All products referred to in this Title shall be stored in the health conditions laid down in the applicable provisions.

TITLE TENTH FIRST

edible oils and fats

Chapter I

Edible Oils

ARTICLE 117. Edible oils by their origin are classified as:

I. Vegetable oil, and

II. Animal oil.

ARTICLE 118. Edible vegetable oils may be added with the additives laid down in the Agreement referred to in Article 22 of this Regulation.

ARTICLE 119. The oil of animal origin may be extracted only from species determined by the Secretariat. The health specifications shall be laid down in the relevant rules.

Chapter II

Grocery grasses

ARTICLE 120. For the purposes of this Regulation, the following shall be included in edible fats:

I. Lard;

II. Edible sebum;

III. First juices or oil stock;

IV. Vegetable butter;

V. Mixed or composite fat or butter, and

VI. Margarine or oleomargarine.

ARTICLE 121. The vegetable butter shall be produced only from edible vegetable oils identified by the Secretariat in the relevant list.

ARTICLE 122. Margarine or oleomargarine may be added with the additives and processing aids provided for in the Agreement referred to in Article 22 of this Regulation.

ARTICLE 123. For the production of margarines or oleomargarines, no fat and mineral oils may be used.

TENTH SECOND TITLE

Cacao, coffee, tea and its derivatives

Chapter I

General provisions

ARTICLE 124. In the manufacture of the products (sic) of cocoa, coffee, tea and its derivatives, products altered or attacked by pests, with a strange taste, may not be used with residues of pesticides or chemical substances outside the limits laid down in this Regulation. the relevant rules.

Chapter II

Cacao and coffee

ARTICLE 125. For the purposes of this Regulation, the following products and derivatives of cocoa and coffee are included:

I. Cocoa:

a. Husked toast, and

b. Paste or liqueur;

II. Cocoa derivatives:

a. Cake,

b. Lard,

c. Cocoa or its mixtures and

d. Chocolates, and

III. Coffee:

a. Crude or green,

b. Toast,

c. Soluble and

d. Blends with coffee.

ARTICLE 126. The Agreement referred to in Article 22 of this Regulation shall provide for food additives which may be used in the manufacture of coffee products, coffee substitutes and cocoa derivatives.

ARTICLE 127. Roasted coffee and soluble coffee may be combined with each other and added from milk powder, spices and other ingredients which are set out in the relevant rules.

Chapter II

Tea or infusions

ARTICLE 128. Where the Secretariat is aware, based on scientific research results, that a herb or mixtures thereof show signs of toxic or cumulative effects or any other health risk, it shall not permit its importation and prevent its processing, storage, distribution and sale, and shall implement the necessary security measures.

You must also proceed immediately to include them in the corresponding list, which will be published in the Official Journal of the Federation.

ARTICLE 129. Mixtures of plants or parts thereof shall be permitted, provided they do not pose health risks.

ARTICLE 130. Both on the label and on the information with which the products referred to in this chapter are placed on the market, no information is to be presented which confuses, exaggerates or deceive as to its effects, composition, origin and other properties of the product. product, nor should it contain rehabilitatory or therapeutic indications.

ARTICLE 131. In the label of the products referred to in this Chapter, names shall not be used for the purpose of clearly or thinly expressing indications in relation to diseases, symptoms or syndromes, or to recall anatomical or physiological phenomena.

ARTICLE 132. The label of the teas or infusions to be drawn up with the plants or parts thereof which the Secretariat determines by means of the corresponding lists, shall include the following warning: "Attention: Not to be consumed during pregnancy."

THIRD THIRD TITLE

Prepared or semi-prepared foods

Single Chapter

ARTICLE 133. Prepared or semi-prepared foods shall not exceed the maximum limits laid down in this Regulation and in the relevant rules for pathogenic micro-organisms, microbial toxins, microbial inhibitors, toxic substances and other which are set out in the relevant rules.

ARTICLE 134. The ingredients used for the preparation of prepared or semi-prepared foods shall not exceed the limits of foreign matter laid down in the relevant rules.

ARTICLE 135. The use of additives and processing aids in the caldos or consomes shall be subject to the provisions of the Agreement referred to in Article 22 of this Regulation.

ARTICLE 136. Packaged prepared or semi-prepared foods to be subjected to heat treatment shall be commercially sterile.

TENTH TITLE

Food for infants and young children

Chapter I

General provisions

ARTICLE 137. In the preparation of food for infants and young children, the following should be observed:

I. The ingredients must be clean, safe and fit for child consumption;

II. The additives and processing aids to be used are those laid down in the Agreement referred to in Article 22 of this Regulation, and

III. Nitrites, glutamates and artificial sweeteners may not be used in the manufacture of these products.

ARTICLE 138. The products covered by this Title must not contain residues of hormones, antibiotics or pharmacologically active substances.

ARTICLE 139. The products and their ingredients for the feeding of infants and young children shall not be subjected to ionizing radiation.

Chapter II

Infant formulas

ARTICLE 140. For the purposes of this Regulation, the following shall be included in the infant formula:

I. Milk formula, where at least 90% of the protein is derived from milk or whey, and

II. Non-dairy formula, where the product does not contain milk or any of its derivatives. In this case it must be stated on the label, in an express way: "It does not contain milk", "No milk derivatives", or equivalent legend.

ARTICLE 141. Infant formulae and follow-on formulae shall be nutrimentally appropriate to promote normal growth and the development of those who consume them.

ARTICLE 142. The preparation of infant formulae may be used for food additives and food processing aids to be laid down in the Agreement referred to in Article 22 of this Regulation.

ARTICLE 143. Infant formulae must form free suspensions of particles or coarse clumps.

ARTICLE 144. The specifications shall be laid down in the relevant rules to which the formulae for the continuation of the products relating to this Title shall be attached.

ARTICLE 145. The Secretariat shall establish programmes to promote breastfeeding.

ARTICLE 146. In medical care units, the use of food products that replace breast milk may not be promoted unless the child's or mother's health requires it.

ARTICLE 147. Only endowments of infant formula may be provided for use in clinical research where the respective protocols are duly sanctioned by the research commission of the establishment providing services of medical care and authorised by the Secretariat in terms of the applicable provisions.

Chapter III

Packaged foods and processed cereal-based foods

ARTICLE 148. Food packaged for infants and young children may be prepared with any food accepted by the Secretariat as suitable for human consumption and appropriate for such products, including spices.

ARTICLE 149. The products covered by this Chapter shall not be used as preservatives.

ARTICLE 150. All procedures for the preparation and desiccation of the food referred to in this Chapter must be carried out in such a way that the loss of nutrients in the products is minimal, and the quantities of these products are guaranteed. on the label.

ARTICLE 151. Food packaged to be delivered directly, must be subjected to heat treatment before or after being packaged in hermetically sealed containers and commercially sterile.

FIFTH TITLE

Condiments and dressings

Single Chapter

ARTICLE 152. For the purposes of this Regulation, the following conditions fall within the conditions:

I. Salt;

II. Vinegar, and

III. Spices.

ARTICLE 153. The salt for direct human consumption in any of its classifications shall be iodine or fluorourated iodide, under the conditions and in the quantities laid down in this Regulation and the corresponding standard.

ARTICLE 154. The exception of fluorourse salt which is intended for the food and iodine industry only when the iodine interferes in the quality of the products to be produced with it.

ARTICLE 155. In ground spices, additives and processing aids may be used which are laid down in the Agreement referred to in Article 22 of this Regulation.

ARTICLE 156. Spices shall be subjected to a treatment which abates the microbial flora, up to the limits laid down in the relevant rules.

ARTICLE 157. The producer, packer and distributor of the products referred to in this Title shall have a record of physico-chemical analysis of the salt and the control of the number of the production batch, which must be available to the authority. health. Such registration shall be kept for as long as it establishes the relevant standard and shall be at the disposal of the health authority when required.

SIXTH TITLE

Sweeteners, their derivatives, and confectionery products

Single Chapter

ARTICLE 158. For the purposes of this Regulation, the following shall be included in natural sweeteners and confectionery products:

I. Natural sweeteners:

a. Sugar or sucrose,

b. Invert sugar,

c. Fructose, levulose or fruit sugar,

d. Glucose of maize in solution or powder,

e. Cane syrup or cane sugar syrup,

f. Glucose syrup, fructose and starch syrup,

g. Lactose or milk sugar,

h. Molasses,

i. Melado,

j. Honey or honey bee,

k. Honey from maguey,

l. Honey of maize and

m. Piloncillo or panela, and

II. Confectionery products:

a. Candy,

b. Chewing gums,

c. Confites,

d. Tablets,

e. Gelatins and gums and

f. Traditional sweets.

ARTICLE 159. The Secretariat shall, in coordination with other competent agencies, lay down in the relevant rules the maximum permissible limits for pesticide residues in plants used as raw material for the products covered by this Regulation. chapter.

TENTH SEVENTH TITLE

Non-alcoholic foods and beverages with modifications to their composition

Single Chapter

ARTICLE 160. Non-alcoholic foods and beverages, in accordance with the modifications made, are classified as:

I. Restored;

II. With less content or removal of any nutrients such as sodium, lipids, gluten, sugars and other substances to be established in the relevant rules, and

III. Added vitamins, minerals, proteins and other nutrients, as set out in the relevant rules.

ARTICLE 161. Only food and non-alcoholic beverages may be incorporated in our food, where:

I. The added nutrient is stable under the daily conditions of storage, distribution and use, and

II. The nutrient is assimilated by the consumer, and the addition is nutrimentally justified based on the population's deficiencies.

No nutrients may be added to unprocessed or fresh food.

ARTICLE 162. The products to which substances with a recognised pharmacological action are incorporated or those to which, on the basis of their composition, therapeutic, preventive or rehabilitation properties are attributed to them and provide greater quantities of nutrients The provisions of the Law and the regulation on health supplies shall be considered as medicinal products or herbal remedies, and shall therefore be subject to the provisions applicable to such products.

In addition, products that modify cellular structures must be subject to the applicable provisions.

ARTICLE 163. The labels of non-alcoholic foods and beverages with changes in their composition shall include the information and the precautionary legends set out in the relevant rules.

EIGHTH TITLE

Biotechnology products

Single Chapter

ARTICLE 164. The biotechnological products which are subject to the health control of this Regulation are food, ingredients, additives or raw materials for direct or indirect use or consumption, resulting in or in the process of intervention. bodies or part of them and which have undergone any genetic manipulation.

It is understood by genetic manipulation to the transfer and intentional recombination of specific genetic information from one organism to another, that to do so use fusion or hybridization of cells that naturally does not occur, introduction direct or indirect of the heritable material and any other technique which, for the same purposes, could be applied in the future.

ARTICLE 165. Those responsible for the process of the products referred to in the previous Article shall submit to the Secretariat the technical information of the results of studies that support their safety and stability. The placing on the market of such products shall be subject to the assessment made of the information requested and, where appropriate, also to the results of the sampling carried out by the Secretariat.

ARTICLE 166. The labels of the products referred to in this Title shall contain information about their characteristics and the risk they pose to health, in accordance with the provisions laid down and specified by the Secretariat for the case.

ARTICLE 167. The rules shall establish, as appropriate, the health guidelines or specifications for the activities, establishments, products and services relating to this title.

NINTH TITLE

Food supplements

Single Chapter

ARTICLE 168. Dietary supplements may consist of carbohydrates, proteins, amino acids, fatty acids, metabolites, plants, herbs, algae, traditional dehydrated foods or other foods established by the Secretariat, be presented in a form In isolation or in combination, whether added or not, of vitamins or minerals and their consumption must not present a health risk.

In the preparation of dietary supplements, additives and processing aids may be used to be established in the Agreement referred to in Article 22 of this Regulation.

ARTICLE 169. Food supplements must not contain in their ingredients substances such as procaine, ephedrine, yohimbine, germanium, animal or human hormones, plants which are not permitted for infusions or tea, or any other pharmacological substance recognized or that represents health risk.

In the case of containing poorly known substances which may present a risk or harm to the health, the process and import of the products covered by this Title shall be subject to the scientific evidence of such substances. Secretariat the safety of the same.

ARTICLE 170. The raw material for food supplements, in particular dehydrated plants, must be subjected to treatments, controls or procedures which abate the microbial flora accompanying it and the physical or chemical residues which may damage the health.

ARTICLE 171. The products to which substances with a recognised pharmacological action are incorporated or those to which therapeutic, preventive or rehabilitative properties are attributed to them, may not be placed on the territory of the territory national, unless they comply with the provisions applicable to health inputs.

ARTICLE 172. The Secretariat may request the following information:

I. Description of the product, in which it is noted:

a. Name of each ingredient, scientific name in the case of plants and monograph for those non-common substances and

b. Quantitative formula;

II. Mode of employment, and

III. Sample of the original label and information with which it is marketed.

ARTICLE 173. On the label and on the information with which the food supplements are placed on the market, no information shall be submitted which confuses, exaggerates or deceive as to its composition, origin, effects and other properties of the product, or preventive, rehabilitation or therapeutic indications.

ARTICLE 174. The labelling and information on the market of food supplements shall not be used for designations, figures and declarations relating to diseases, symptoms, syndromes, anatomical data, physiological phenomena or legends. which claim that the product covers only the individual's nutritional requirements or that it can replace some food.

TITLE TWENTIETH

Alcoholic beverages

Single Chapter

ARTICLE 175. For the purposes of this Regulation, the following shall be included in alcoholic beverages:

I. Fermented beverages;

II. Distilled beverages;

III. Spirits, and

IV. Prepared alcoholic beverages and cocktails.

ARTICLE 176. For the purposes of this Regulation, alcoholic beverages, by their alcoholic content, are classified as:

I. Of low alcoholic content, beverages with an alcoholic strength of 2% and up to 6% by volume;

II. Of medium alcoholic content, beverages with an alcoholic strength of 6,1% and up to 20% by volume, and

III. Of high alcoholic content, beverages with an alcoholic strength of 20.1% and up to 55% by volume.

ARTICLE 177. The preparation, conditioning, packaging, transport, distribution, storage, distribution, supply or import of alcoholic beverages in envelopes or bags of any material, in volumes less than one litre, shall not be prepared.

ARTICLE 178. In the sale of alcoholic beverages packaged or in a natural state, mixed, prepared, added or put up, for consumption within the establishments, official identification shall be required where the physical appearance of the The majority of the age group is not clear. If it is not submitted, the products cannot be sold or supplied.

ARTICLE 179. No alcoholic beverages may be sold by automatic machines. No presentations of a volume of less than 180 ml may be expended, in places other than establishments supplying alcoholic beverages, in the natural state, mixed, prepared, added or put up, for consumption within of the same.

For promotional purposes, the presentations referred to in the preceding paragraph may only be marketed in packages for collection, whether multiple or collective, or when they are part of craft presentations for the purposes of ornate, or individually in airport stores.

TITLE TWENTY first

Tobacco

TITLE TWENTY SECOND

perfumery, beauty, and grooming products

Chapter I

Perfumery and beauty products

ARTICLE 187. For the purposes of this Regulation, the following are included in perfumery and beauty products:

I. Products intended to change the odour of the human body:

a. Antiperspirant,

b. Deodorant and

c. Perfume;

II. Products or preparations for external use, intended to preserve, improve or modify personal appearance:

1. For the hair:

a. Conditioner,

b. Alaciator,

c. Decolorant,

d. Rinse,

e. Fixer,

f. Product for permanent,

g. Dye and

h. Hair treatment;

2. For facial or body use:

a. Oil,

b. Self-tanking,

c. Solar blocker,

d. Tanner,

e. Cream,

f. Corrector,

g. Depilatory,

h. Defusing,

i. Epillatory,

j. Gel,

k. Lotion,

l. Makeup,

m. Eye makeup,

n. Mask,

n. Product for lips,

or. Sunscreen or sunscreen and

p. Blush and

3. For hands and nails:

a. For nail care,

b. For hand cleaning,

c. Cuticle remover and

d. Remove or remove enamel;

III. Products or preparations intended for the grooming of persons:

a. Shampoo (Shampoo),

b. Dermolimpiator,

c. Toilet soap,

d. For the bath: salts and bubbles,

e. Preparations for before and after shaving and

f. Cleansing wipes, and

IV. Other products:

a. Adhesive for eyelashes and a post-tip.

ARTICLE 188. Manufacturers of perfumery and beauty products are responsible for the health quality of the products they produce.

ARTICLE 189. The narcotic and psychotropic substances contained in Articles 234 and 245 of the Law, drugs, pharmaceutical preparations and those set out in the corresponding lists may not be used in the preparation of the products of this chapter.

ARTICLE 190. To check that perfumery and beauty products do not cause harm to health, the following tests must be carried out:

I. Dermal primary irritation index for:

a. Conditioners, rinses, capillaries and fixers,

b. Decolorants, temporary dyes and progressive dyes,

c. Depilatories,

d. Deodorants and antiperspirants,

e. Soaps, shampoos (shampoos) for children,

f. Toilet soaps, dermollopers, shampoo (shampoo) and bath products,

g. Lotions, oils, creams, makeup and correctors,

h. Children's lotions, oils and creams,

i. Masks or mascara, eyeliners, shadows, adhesive for eyelashes and eye contour creams,

j. Perfumes, colonies and extracts,

k. Powders and talks for children and adults,

l. Preparations for before and after shaving,

m. Products for lips and blushes,

n. Hand cleaning products,

n. Sunscreens or filters and sunscreens, tasters and self-tellers,

or. Cuticle removers, hardeners, prolongators, repairers and adhesives for post-shacks and

p. Permanent dyes, products for permanent and alaciators;

II. Awareness rate for:

a. Decolorants, temporary dyes and progressive dyes,

b. Depilatories,

c. Deodorants and antiperspirants,

d. Soaps and shampoos (shampoos) for children,

e. Lipsticks and blushes,

f. Children's lotions, oils and creams,

g. Perfumes, colonies and extracts (photosensitisation),

h. Preparations for before and after shaving,

i. Sunscreens, suntasters, self-tellers (photosensitisation) and solar blockers and

j. Permanent dyes, products for permanent and alaciators, and

III. Eye irritation index:

a. Soaps, shampoos (shampoos) for children,

b. Toilet soaps, dermollopers, shampoos and bath products, and bath

c. Masks or mascara, eyeliners, shadows, adhesive for eyelashes, eye contour creams, and dismakeup.

ARTICLE 191. Hypoallergenic perfumery and beauty products must be pre-tested for biological sensitisation tests to check their hypoallergenicity condition.

ARTICLE 192. Microbiological checks shall be carried out in the manufacture of the following products:

I. Skin products: creams, cream lotions, talcos and powders, makeup, lip pencils, tellers, self-tellers, protectors or filters and sunscreens;

II. Eye area products: shadows, eyeliners, mascara, or mask for eyelashes and demakeup, and

III. Children's products: talcos, powders, oils, creams and cream lotions.

ARTICLE 193. The following shall not be sold in bulk: dyes, permanent products, alaciators, decolorants, depilatories and beauty treatment products containing as active substances: vitamins, proteins, lecithin, hydroquinone, liposomes and other which are set out in the relevant rules.

ARTICLE 194. The bulk sale of the products referred to in this Chapter shall be carried out in hermetically sealed packages, in order to prevent contamination and, for dispatch to the public, clean containers must be used and the use of utensils perfectly washed for each product.

ARTICLE 195. Cosmetic treatment products shall comply with the provisions laid down in the relevant rules for each of them.

ARTICLE 196. The lists of ingredients, additives, processing aids and plants permitted, restricted or prohibited for the formulation of the products referred to in this Title may also be amended at the request of any interested party, which shall provide the Secretariat with the following information, as appropriate:

I. Generic name and best known synonym, if it is a chemical, or genus and species, if it is a product derived from a plant or animal;

II. Where appropriate, condensed and structural chemical formula, if known;

III. Justification for their function in the product;

IV. Oral acute DL50, primary dermal irritation, eye irritation and sensitisation, if any;

V. Analytical methods for determining their identity, concentration and contaminants;

VI. Products in which their employment is proposed and, where appropriate, maximum concentration limits to be used, and

VII. For the case of denominations: the qualitative composition, physicochemical properties, processing process, final product presentation, use, function and effects, if any.

ARTICLE 196 Bis. The information contained in the label of the products covered by this Title shall appear in Spanish, with the exception of the list of ingredients which may be declared with the International Nomenclature of Cosmetic Ingredients (INCI).

The precautionary legends associated with ingredients that according to the provisions that the Secretariat issues represent health risks, must be written in Spanish, including the name of these ingredients.

When the ingredients have been declared in accordance with the International Nomenclature of Cosmetic Ingredients (INCI), the precautious legends referred to in the preceding paragraph must also include that name.

Chapter II

grooming products

ARTICLE 197. The toiletries which are subject to the health check of this Regulation are those substances or mixtures of these substances which are used directly or indirectly, irrespective of their physical state, in the cleaning, washing and hygiene of objects, textile surfaces and fibres and which are intended to release or remove dirt and stains; provide a certain aroma or remove odours; impart a glossy finish to objects and surfaces; modify and condition the texture or any other characteristic of the fabrics; unclogging the sanitary ducts of the sewage and stormwater and other water for similar purposes as determined by the Secretariat.

ARTICLE 198. The rules shall lay down the provisions and specifications concerning the safety of use of the packaging of the products referred to in this Chapter.

Packaging containing grooming products, in addition to complying with the provisions of this Regulation, must allow for the easy discharge of the product and, where appropriate, a device to prevent leakage, splashing and spills.

Chapter III

Insect Repelants

ARTICLE 199. Insect repellents intended for human use and containing active ingredients other than those laid down in the agreement of the Health Secretary published in the Official Journal of the Federation shall be subject to testing Primary dermal irritation and sensitisation, as well as toxicological tests to determine the acute oral DL50 and dermal DL50 or other tests requested by the Secretariat in accordance with the prior assessment carried out. The results of such tests shall be made available to the Secretariat when required.

TITLE TWENTY THIRD

Additives

Single Chapter

ARTICLE 200. Repealed

ARTICLE 201. The additives must:

I. Use only in the amount necessary to obtain the desired effect;

II. Do not exceed the permitted limits in the Agreement referred to in Article 22 of this Regulation, and

III. Be free, if any, of decomposition, rot and other alterations that make them unfit for human consumption.

ARTICLE 202. The use of the additives and the processing aids, as well as the quantity to be used, shall be subject to the provisions laid down in this Regulation and to those laid down in the Agreement referred to in Article 22 of this Regulation. Regulation.

The warning legends which, if applicable, should be used for the products containing these additives shall be laid down in the relevant rules.

ARTICLE 203. Additives may not be used when the following requirements are not met:

I. That they are harmless when used to the permitted level of use;

II. That they serve a useful function and are not used to hide health quality defects;

III. To obtain an effect that can be achieved by using only good manufacturing practices, and

IV. It has an analytical method that effectively controls its use or justifies the inapplicability of it.

ARTICLE 204. The colours referred to as Sudanese, red solvent 23, red toney, colour index 26100 or red DC 17, or any other colouring not permitted in food and drink, may not be used in accordance with the respective list.

ARTICLE 205. Where the Federal Commission for the Protection of Health Risks is aware, based on recognised scientific research, that an additive shows confirmed evidence of carcinogenic, teratogenic, mutagenic or other effects Health risk, shall not permit its importation, prohibit the manufacture, storage and sale, shall apply the corresponding security measures and shall propose the modifications corresponding to the Agreement referred to in Article 22 of this Agreement. Regulation.

ARTICLE 206. All additives must be properly packaged and labelled. The packaging must protect the products from any contamination. The labels shall contain the legends set out in this Regulation and the relevant rules.

ARTICLE 207. Packaging materials that have substances that can migrate to products, without putting the health of the consumer at risk, are considered as indirect additives.

ARTICLE 208. The lists of permitted, prohibited or restricted additives contained in the Agreement referred to in Article 22 of this Regulation may be amended at the request of any interested party provided that it provides the following information:

I. The generic name and the best known synonym, if it is a chemical, or the genus and species, if it is a product derived from a plant or animal;

II. Where appropriate, the condensed and structural chemical formula, if known;

III. The justification for its technological function;

IV. Toxicological studies of national or foreign origin, in the short and long term in which the DL50 is included in laboratory mammals and the acceptable daily intake to assess their safety, especially in relation to cancer and their teratogenic effects, if applicable;

V. Analytical methods to determine their identity, purity and contaminants, and

VI. The products in which their employment and proportion are proposed, in such a way that the safety margins are not exceeded, in order to determine whether their use represents a risk to the health of the consumer.

The modification of the lists of permitted, prohibited or restricted additives contained in the Agreement referred to in Article 22 of this Regulation may also be carried out at the request of any interested party, when provide for approval to the Secretariat of the evaluations and approvals of the Joint FAO/WHO Expert Committee on Food Additives, the Codex Alimentarius, the European Union or the United States of America.

ARTICLE 208 Bis. Those additives and processing aids which have been evaluated and approved by the Secretariat may be used immediately, as long as the Agreement referred to in Article 22 of this Regulation is updated, provided that the said additives are not substances are disseminated on the electronic page of the Federal Commission for the Protection of Health Risks. The update of the said Agreement shall be carried out every six months.

20TH TITLE

Packaging and packaging products

Single Chapter

ARTICLE 209. The products, in accordance with their characteristics, may have the packaging necessary to ensure their integrity and safety.

ARTICLE 210. The classification of packaging and the physical, chemical and toxicity characteristics for each type of packaging material, in addition to that provided for in this Regulation, shall be specified in the relevant rules.

The Secretariat shall determine, by means of an Agreement published in the Official Journal of the Federation, the criteria according to which a package, by reason of the quantity of product it contains, may be considered as a family member.

ARTICLE 211. The substances used, where appropriate, for the internal coating of food packaging, non-alcoholic beverages, alcoholic beverages and perfumery and beauty products, shall meet the following requirements:

I. To be perfectly adhered to the surfaces in which they are applied and not to be detached, broken or incorporated in some form to the content, under normal conditions of use;

II. Be insoluble or inactive with respect to the components of the content;

III. Not be toxic;

IV. To be completely free from the volatile compounds used for dissolution and application;

V. Do not contain heavy metals;

VI. Prevent corrosion of the container, and

VII. Do not alter, where appropriate, the acidity or alkalinity of the product.

ARTICLE 212. In the production of packaging, reused, recycled or non-considered material may be used only when it is ensured that the packaging obtained is harmless.

ARTICLE 213. The packaging of the products shall prevent leakage which may cause damage to the health and, where appropriate, the chemical or microbiological contamination of the product.

ARTICLE 214. Packaging for food, non-alcoholic beverages, spirits or perfumery and beauty products, which have contained medicinal products, grooming products, pesticides, plant nutrients or toxic or dangerous substances, may not be used.

TWENTIETH TITLE

Irradiation of products

Single Chapter

ARTICLE 215. Ionising radiation may only be used in products, raw materials and additives when they meet a technological need or when it contributes to achieving one of the following food hygiene objectives:

I. Decontaminate;

II. Sterilize;

III. Deflate;

IV. Delay maturation;

V. Prevent sprouts or germination;

VI. Extend conservation time, and

VII. Give quarantine treatment.

ARTICLE 216. Ionising radiation must not be applied to conceal incorrect working practices or to conceal alterations in the products. In no case shall it apply to foods for infants and young children.

ARTICLE 217. The irradiation of products, raw materials and additives shall be in accordance with the type and size of the energy source, with the characteristics of the irradiator, with the nature and conditions of the product, in accordance with the rules laid down in the rules corresponding.

ARTICLE 218. The irradiation doses of products, raw materials and additives, as well as their purpose, shall be established in the relevant standard.

ARTICLE 219. The levels of radiation used in the treatment of products, raw materials and additives shall not produce harmful substances to health in primary packaging, which lead to contamination of the product.

ARTICLE 220. Irradiated foods shall not be subjected to repeated irradiation, except those of low moisture content such as cereals, legumes and dehydrated foods, among others.

ARTICLE 221. Products, raw materials and irradiated additives are not considered to be subjected to repeated irradiation when:

I. The final product and the raw materials that make up the final product are irradiated for different purposes and at levels less than or equal to the doses laid down in the relevant rules;

II. The irradiation of the final product is 5% lower than that applied to its ingredients, and

III. The total dose of ionising radiation required to achieve the desired effect is applied to products in fractionated mode with a specific technological end.

ARTICLE 222. Treatment with ionising radiation to products, raw materials and additives shall only be carried out in establishments which comply with the requirements laid down in the applicable provisions and at least with the following:

I. Have in-house laboratories that are responsible for carrying out the process quality control and dosimetry tests;

II. Have the necessary infrastructure to ensure that the products are handled, packaged and stored correctly and at the appropriate temperature, in accordance with the case in question;

III. Hold the international food irradiation symbol in a visible place;

IV. Provide mask workers with dust and clothing including overalls, cofia or cap, protection lenses, gloves and boots in those establishments where they are irradiated in bulk products that release powders, as well as monitor that use when they are on them, and

V. Carry out the ongoing systematic internal monitoring of all the operations carried out and keep the relevant records, in particular those concerning the dosimetry.

ARTICLE 223. The labels of finished products, raw materials, additives and other inputs which have been irradiated and which are intended for direct human consumption or use shall bear the following legend: "Irradiated product" and the international irradiation symbol corresponding, in contrasting colours, and in the same proportion as the name of the product.

The health information to be provided by the label shall be laid down in the relevant rules where raw materials, additives or other inputs irradiated to a product that are not subjected to subsequent irradiation are incorporated.

ARTICLE 224. The shipping documents for the products, raw materials and additives irradiated from import, packaged or in bulk, as well as those transported in containers, must clearly indicate that they are irradiated products, as well as the total dose the average irradiation and the prior health permit for import or import health advice, as appropriate.

In the shipping documents, in addition to the above mentioned in the preceding paragraph, the Secretariat shall be given the appropriate information to identify the installation in which the product has been irradiated, which must be licensed official issued by the competent authorities.

TITLE TWENTY-FIFTH BIS

Tattoos, Micropigmentations, and Drillings

Single Chapter

Article 224 Bis 1. Tattooists, micropigmentators and drillers, for the provision of their services, shall have a health control card, which shall be valid for two years from the date of their issue.

Article 224 Bis 2. The application to obtain the health control card, as referred to in the previous Article, must be submitted in the format approved by the Secretariat and published in the Official Journal of the Federation, which must indicate, at least, the name of the procedure, the full name and address of the tattoo, piercing or micropigmentator, the address of the establishment and the time of care.

The request will be accompanied by the following documents:

I. Manual of procedures, which should indicate the following:

a) The techniques of tattoos, micropigmentations or perforations to offer;

b) Detailed description of each procedure you will use for the provision of your services; and

c) The material and equipment that you will use in the delivery of your services.

II. Curriculum vitae of the applicant containing his/her general data, studies and work experience, related to the procedures to be performed;

III. Documentation to verify that the applicant has knowledge on first aid and mastery of hygiene and asepsy techniques;

IV. Proof of vaccination against tetanus and hepatitis B;

V. Two child-sized photographs, and

VI. Proof of payment of rights, in terms of the Federal Law of Rights.

The Secretariat shall resolve requests for health control cards for tattooists, micropigmentators and drillers within 40 working days after the application has been submitted.

Article 224 Bis 3. Tattoos, micropigmentators or drillers, prior to the completion of the tattoo, micropigmentations or perforations procedures, shall apply to the user a questionnaire, in accordance with the model approved by the Secretariat and published in the Official Journal of the Federation, in order to verify that its health is optimal.

Article 224 Bis 4. Prior to the execution of a tattoo, micropigmentation or perforation, the tattooists, micropigmenters or drillers, will provide users with clear, complete and precise information regarding the procedure. Once the relevant information has been received, the users will express their consent by signing the respective letter of acceptance, in accordance with the model issued by the health authority and published in the Official Journal of the Federation, which contain the following aspects:

I. The risks involved in the procedures of tattoos, micropigmentations or perforations;

II. The irreversibility of the tattoo or micropigmentation to be performed and, where appropriate, the possibility of reducing the perceptibility thereof, through medical procedures performed by specialized professional staff, and

III. Care to be taken after the procedure to be performed.

Article 224 Bis 5. The procedures of tattoos, micropigmentations or perforations, in children under eighteen years of age, can only be performed in the following cases:

I. Where the written authorisation of one of the persons exercising the parental authority or of his or her guardian is provided, subject to verification of that nature, and

II. Where, at the time of the conduct of the procedure, they are accompanied by one of their parents or their guardian, prior to the accreditation of such a character.

The authorization referred to in section I of this Article must be recorded in writing, in accordance with the model approved by the Secretariat and published in the Official Journal of the Federation, and must be annexed to the questionnaire refers to Article 224 Bis 3 of this Regulation.

The authorization must be accompanied by a copy of the official document certifying the relationship of parentage or the exercise of the parental authority or guardianship with the child, as appropriate. The documentation referred to must be kept in storage for a period of two years.

Article 224 Bis 6. It is prohibited to perform tattoo procedures, micropigmentations and perforations in people who are under the influence of alcohol or some drugs, or who are not in full enjoyment of their mental faculties.

Article 224 Bis 7. Jewelry, needles, knives, punches or other cutting-edge material used in the procedures of tattoos, micropigmentations or perforations must be disposable and used only once.

Any utensil, equipment or instrument which may be reused and which is different from those mentioned in the preceding paragraph, must be sterilized and stored prior to its use, under conditions which maintain that status.

It is prohibited to use pistols to drill, or any other equipment, that because of its inability to be sterilized or disinfected, in all its parts, constitutes a risk of disease transmission.

Article 224 Bis 8. In the case of perforations, sterile implantation or biocompatible surgical materials shall be used. In the case of tattoos, the inks must be biocompatible with the human body and maintained in their original packages. In micropigmentations the pigments must be harmless and insoluble.

Article 224 Bis 9. Tattooists, micropigmentators and drillers may only use topical anaesthetics to reduce pain from lacerations, burns, implants, scarifications or any other such technique.

Article 224 Bis 10. Tattoos, micropigmentators or drillers, when performing a tattoo, micropigmentation or perforation procedure, must prevent the transmission of infectious diseases and microbiological contamination, for which they must, by less, use the following material:

I. Tattoo, micropigmentation or drilling equipment, new or properly sterilized;

II. Gloves for surgical use;

III. Covers the mouth of disposable material;

IV. Disinfectants;

V. Autoclave or sterilizer;

VI. Running water, and

VII. Other materials and equipment that enable you to maintain the necessary hygiene and aseptic levels.

Article 224 Bis 11. The handling of hazardous waste generated in the procedures of tattoos, micropigmentations and perforations shall be carried out in accordance with the applicable legal provisions.

Article 224 Bis 12. The tattooist, micropigmenter or driller must keep a record of the users of his/her services in a bound and foliated book, in which he/she must establish the personal information and the data of the official identification of who received the service, and in the case of minors, of those who exercise the parental authority or guardian, as well as a description of the service provided.

Article 224 Bis 13. The practice of tattoos, perforations and micropigmentations shall be carried out in accordance with the manual of procedures referred to in Article 224 Bis 2 of this Regulation.

Article 224 Bis 14. The health control card referred to in Article 224 Bis 1 of this Regulation may be extended for periods of two years.

The request for the extension of the health control card must be submitted no later than fifteen working days before the expiration of the health control card.

The extension request must be accompanied by the following documents:

I. Original of the proof of payment of rights, in terms of the Federal Law of Rights, and

II. Simple copy of the health control card from which the extension is requested.

The Secretariat will resolve the request for the extension of the health control card, within 15 working days from the time the application was submitted.

Article 224 Bis 15. The Secretariat may at any time revoke the corresponding health check card, the tattooists, micropigmenters and drillers, in accordance with the provisions of Chapter II of Title Tenth of the Law.

Article 224 Bis 16. Failure to comply with the provisions laid down in this Chapter shall be punishable in accordance with the provisions of the Law, Chapter III of Title Twenty-seventh of this Regulation and the other applicable provisions.

20TH TITLE

Authorizations, Warnings, and Certificates

Chapter I

Common Provisions

ARTICLE 225. Where this Regulation does not specify an express time limit for resolving an application, the Secretariat shall have 40 days to that effect.

In all cases, the time limits shall be counted from the day following the receipt of the duly requested requests.

ARTICLE 226. The Secretariat may require, in writing, additional or missing information within a time limit which shall be equal to one third of the period granted for the purpose of resolving the application, where the latter is of a two-thirds administrative nature. parts, where it is of a technical nature.

In the event that the time limits set forth in the preceding paragraph elapse without any request for information, the Secretariat may not deny authorization for lack of information.

ARTICLE 227. The time limits shall be suspended when the Secretariat requires the applicant, in an express and written form, documents, clarifications or missing information, and shall resume the day after the individual has failed to comply with the requirement. In the event that the requirement in the term that the effect is granted is not de-drowned, the application shall be as unfiled.

ARTICLE 228. The health authorizations granted in the terms of this Regulation may be reviewed by the Secretariat at any time, in accordance with the requirements of the Law and this order.

When of the review made, the Secretariat determines that the holder must comply with any provision established in the Law or in this Regulation, must notify the person concerned to be, within a period of not more than 15 days (i) the right of the person to whom he is entitled. On the expiry of that period, whether or not there is an expression of the person concerned, the authority shall determine what is appropriate in accordance with the Law.

ARTICLE 229. The formalities referred to in this Title shall be initiated using the formats authorised and published in the Official Journal of the Federation. These formats shall specify the data, requirements and documents that the applicant, in each case, must provide, comply with and accompany.

ARTICLE 229 Bis. The formalities for the import and export of the products referred to in this Regulation may be submitted by electronic means.

Applicants who opt for electronic means in the proceedings referred to in the preceding paragraph shall submit the same information and documentation as they do under this Regulation and other applicable legal provisions requires the corresponding processing. Such information and documentation shall be submitted by such electronic means.

The procedures performed by electronic means will be substantial and will be resolved by the same means, so the notifications made to the applicant regarding the requirements, actions, resolutions, exhibition, conservation or submission of authorisations or documents to be submitted by the competent authority to the competent authority and, in general, any administrative act resulting from such formalities, shall be verified by electronic means, in accordance with the legal provisions applicable.

ARTICLE 230. With the exception of services provided by tattooists, micropigmentators and drillers; in the products, services, establishments and activities covered by this Regulation, the health control card referred to in the Article 377 of the Law.

Chapter II

Permissions

ARTICLE 231. In the case of pre-import health permits, the Secretariat shall have five days to resolve the applications, and two days in the case of amendments thereto.

In the event of modifications, after the expiry of the period without the authority having issued a resolution, the resolution shall be approved and, at the request of the applicant, the Secretariat shall extend in writing the respective constancy, to more take the business day following the submission of the request.

ARTICLE 232. Where products are imported, the Secretariat may determine that they are subject to one of the following assumptions:

I. Import without restriction, the importer enters into national territory the corresponding merchandise and has it according to his interests;

II. Sampling and release, the importer enters the goods into national territory, takes it to the final destination and notifies the health authority to carry out the corresponding sampling. Immediately thereafter it has agreed with its interests;

III. Sampling and insurance, the importer enters the goods into national territory, takes it to its final destination and notifies the health authority to carry out the sampling and insurance, and will not be able to dispose of it until the authority health count with the lab results and issue the corresponding resolution, or

IV. The importer notifies the local health authority about the entry of the goods in order to ensure that it is final destination and, if this is the case, the importer notifies the local health authority of the goods. notify the local health authority for the withdrawal of the safety measure at the final destination and, if sampling has been carried out, the importer shall dispose of the goods until the authority has issued the relevant decision on the basis of the results of laboratory analysis.

ARTICLE 233. In the case of the cases referred to in fractions II to IV of the previous Article, the Secretariat shall have two working days, counted from the notification made by the importer that the products reached their destination, for the taking of samples or application of security measures, and three days, from the receipt of the results of the analyses, to issue the resolution. The importer may place the products on the market after sampling, provided that no safety measure has been applied, in which case it shall be carried out in accordance with Article 414 of the Law.

In the same act of sampling the importer shall receive them, in order to carry out their analysis by an authorised third party or, where appropriate, in a private laboratory accredited and approved in the terms of the legislation on metrology and standardisation and will deliver to the Secretariat the results of the analyses.

ARTICLE 234. The Secretariat may grant the prior health permit for the importation of raw materials or products to establishments which, in accordance with the applicable provisions, are not required to present a working notice, provided that the applicant demonstrates that are for donation, personal consumption, for scientific research purposes or laboratory tests.

The validity of the prior import permit shall be determined by the health authority according to the type and risk of the product, as well as any health alerts that may exist.

Importers shall retain prior import health permits at least for one year and shall be obliged to display them to the health authority when required.

ARTICLE 235. Products or raw materials which require prior medical import permits, and are introduced into the country without such permission, shall be deemed to be interned. The Secretariat shall apply the relevant security and sanctions measures and shall inform the competent authority of this fact.

ARTICLE 236. Imports of products the use or consumption of which has been prohibited for health reasons in their country of origin or provenance or on the recommendation of specialised international bodies shall not be authorised.

ARTICLE 237. In the case of a national or international health alert, the Secretariat shall take the necessary measures to prevent the importation of products, raw materials and other ingredients that are involved in their preparation and which may cause harm to health. Those measures shall be published in the Official Journal of the Federation.

ARTICLE 238. Where a product or raw material is intended to be returned to the country which has not been accepted by the country of destination, the exporter and, where appropriate, the manufacturer shall apply for prior medical import permit, in the words of the Law, this Regulation and other applicable provisions.

The health authority will determine the final destination of the products after evaluating their health status, through the documentation they request and the analyses they carry out, by accredited and approved persons in the terms of the legislation on metrology and standardisation or by authorised third parties.

If the decision is that the product is suitable for consumption, the Secretariat shall ensure, in particular in the case of perishables, that at the time of its disposal the product is maintained in microbiological conditions, parasitological, physical, chemical and sensory appropriate for human consumption. The storage and loss costs incurred during the time required for the opinion and, where appropriate, the destruction shall be borne by the exporter or manufacturer who has applied for the re-entry of the products into the country.

Chapter III

Notices

ARTICLE 239. Where the owner or the person responsible for an establishment who is obliged to submit an operating notice allows the products to be manufactured, in whole or in part, by a third person, he or she must update the particulars of that notice, within the thirty days following the start of the external manufacturing process for the products.

The owners or persons responsible for the establishments involved in the external manufacturing referred to in the preceding paragraph shall submit an operating notice or update thereof within 30 days of the date of the notification. start of manufacture.

ARTICLE 240. The import health notices and the health certificates of the country of origin shall be submitted only once a year for each of the products subject to an import health warning, and shall be valid for all shipments to be carried out. within the period in question. In case the Secretariat identifies anomalies in the health condition or identity, as the case may be, it may again require the submission of the relevant notice or certificate.

Chapter IV

Certificates

ARTICLE 241. In support of export, the Secretariat may issue, inter alia, certificates for the export of free sales, product analysis or compliance with good health practices.

The Secretariat will resolve requests within the following deadlines:

I. Three days in the case of certificates for free export. If the certificate is required to be issued in a special format, the time limit shall be ten days;

II. Five days from the delivery of the results of the laboratory tests, in the case of certificates for export of product analysis, and

III. Five days on the assumption of export certificates of good health practices.

When modifications are requested to the certificates the Secretariat will resolve within a maximum of two days.

ARTICLE 242. If the exporter requests that a verification visit be carried out in order to certify the health quality of its products and raw materials for export purposes, it shall submit a request to the Secretariat, which shall have a period of time. of 15 days to carry out such a visit.

Chapter V

Authorized Third Parties

ARTICLE 243. The Secretariat shall periodically publish calls for the authorisation of third parties referred to in Article 391 a of the Law.

For the purpose of knowing technically about applications for the granting of third-party authorizations, the Secretariat will form technical committees composed of experts in the specific fields, representatives of chambers and associations and, where appropriate, of the accreditation entities.

ARTICLE 244. To operate as an authorized third party you will need to comply with the following:

I. Submit a request for the legal capacity of the applicant;

II. Demonstrate that the applicant has the technical, material, human and financial capacity, as well as the facilities, equipment and technology to carry out the tests, studies, verifications and other activities necessary to issue the opinions;

III. Having the standard operating procedures that ensure the quality of the performance of their tasks;

IV. Not be subject to direct influence by any manufacturer, merchant or commercial moral person of the processes and products to be evaluated;

V. Present your product and service proposals to rule, as well as describe the services you intend to provide and the procedures to use, and

VI. Submit proof of payment of corresponding rights.

ARTICLE 245. The Secretariat shall carry out the verification visits and, in conjunction with the committee referred to in Article 243 of this Regulation, shall carry out the evaluations which shall be carried out by the Secretariat. necessary to rule if the requirements referred to in the previous Article are met.

If the opinion issued by the Secretariat is not favorable, the applicant shall be granted a period of up to one hundred and eighty calendar days from the date of notification to correct the detected anomalies. That period may be extended for a single period, for a single occasion, where the applicant justifies the need for this before the end of the period indicated.

In case the applicant fails to correct the anomalies detected within the given time limit, the procedure will be considered abandoned and the application will be rejected.

ARTICLE 246. The Secretariat shall authorize third parties to comply with the requirements and procedures to be established for the purpose and may, at any time, carry out verification visits to verify that the conditions under which the corresponding authorization are met by these.

ARTICLE 247. If the conditions referred to in the previous Article do not persist, or the applicable legal provisions are not complied with, the Secretariat shall prevent the person concerned to remedy the anomalies found and give him a period of up to one hundred and eighty days to correct them. Where they involve a health risk, the Secretariat may temporarily or partially suspend the activities for which the authorisation was granted.

The failure to comply with the corrections indicated by the Secretariat, within the time allowed, will be the cause of suspension of the authorization granted. In this case, the Secretariat will grant you a new period of ninety days to correct the irregularities. Failure to comply in time and in the manner indicated by the Secretariat will revoke the authorization.

ARTICLE 248. The Secretariat shall publish regularly in the Official Journal of the Federation, the list of authorised third parties, as well as suspensions and revocations.

ARTICLE 249. Authorised third parties shall:

I. Comply with the regulations applicable to the acts or acts in which they are involved;

II. To provide services on non-discriminatory terms and to observe other provisions in the field of economic competition;

III. Avoid the existence of conflicts of interest that may affect their performances and be excused when they exist;

IV. To inform the Secretariat immediately of any irregularities in its relationship with clients, the performance of their functions or breaches identified in the processes or products it evaluates;

V. Provide the Secretariat with reports on the opinions and technical recommendations it issues;

VI. Report regularly to the Secretariat on the services it provides;

VII. Assist the Secretariat when requested to do so;

VIII. Allow the verification of their activities and provide the Secretariat with free access to its facilities, as well as provide the information required to it, and

IX. Respect the confidentiality and intellectual and industrial property rights derived from the documentation and information provided by the applicants.

ARTICLE 250. The results of the tests carried out by the approved third parties shall be recorded in an opinion to be signed, under their responsibility, by the person empowered to do so. Such opinions shall be valid before the Secretariat in accordance with the functions authorized to the third party.

ARTICLE 251. The Secretariat shall safeguard and ensure the confidentiality of the documentation and information provided by the authorised third parties, in accordance with the applicable provisions.

ARTICLE 252. Where the authorized third party has complied with the terms, conditions and obligations established by the Secretariat, during the time allowed for the authorization, the validity of the authorization may be extended for a period similar to the one granted initially, for which it shall submit a request one month before its expiry.

TITLE TWENTY-SEVENTH

Verification, Security Measures, and Sanctions

Chapter I

Verification

ARTICLE 253. Verification visits shall be carried out in accordance with the procedure laid down in the Law and shall be:

I. Get health conditions information:

a. From the establishment,

b. Of the process,

c. Of the equipment, machinery, utensils and instruments with which the process is performed,

d. Of the products, raw materials, additives and packaging material and packaging, used in the manufacture of the same,

e. Of the personnel involved in the process of the products,

f. Of the process conditions that determine the health quality of the product,

g. Systems to ensure the health quality of products and services and

h. Of the transport of the products, where required;

II. Identify health deficiencies and failures;

III. Take samples, if any;

IV. Apply or release health security measures, and

V. Conduct orientation, instruction and education activities of a health nature.

ARTICLE 254. It is for the health authority to verify that the establishments are conditioned for the use to which they are intended, in accordance with the characteristics of the process of the products, taking into account the provisions of this Regulation and the rules corresponding.

ARTICLE 255. The allocation of the establishment or place to carry out the verification visit shall be determined by any of the following mechanisms:

I. By random selection;

II. By contingency or health alert;

III. By programmes determined by the health authority, in which case it shall be expressly stated in the relevant order of business;

IV. By denunciation of third parties, in the terms of Article 6o. of this Regulation;

V. At the request of the owner, and

VI. As a follow-up to an administrative procedure initiated by the health authority.

ARTICLE 256. The verification visit order, among other requirements, must include the telephone number of the health authority issuing it so that the owner, in charge, responsible for the establishment or the place, or who stores the visit, can to make inquiries, complaints and complaints and, where appropriate, confirm the origin of the act of verification.

In the event that the information obtained by telephone does not match that of the order of business, the owner, responsible or responsible for the establishment will be able to deny the realization of the visit, which must be established in the verification.

If the owner, in charge or who stores the visit, is missing the truth, with respect to the data provided by the telephone information system, the sanctions will be secured.

ARTICLE 257. The verification record shall include the circumstances of the diligence referred to in Article 401 of the Act and shall contain at least the following:

I. The legal accreditation of the verifier to perform the function;

II. The description of the health conditions of the establishment or place, equipment, personnel, raw materials, processes and products;

III. The report, based on a specific verification guide for industrial, commercial or service rotation;

IV. The description and qualification of observed health failures or deficiencies;

V. The sampling, if any, and

VI. The manifestation of what is entitled to it to the owner, responsible, manager or occupant of the establishment or place.

ARTICLE 258. Following the verification procedure, the health authority shall assess compliance with the provisions applicable to the products, services, activities and establishments referred to in this Regulation and shall notify in writing the The outcome of the opinion, in terms of Article 430 of the Law.

In the notification referred to in the preceding paragraph, the health authority may request the person responsible to submit in writing, within a period of not more than five days, the form and time in which it shall comply with the measures dictated by the health authority.

If the individual does not submit the reference document within the time limit, the health authority shall take the appropriate measures.

Chapter II

Security measures

ARTICLE 259. If the health conditions of the establishment, raw materials, process, procedure or product represent an important health risk or lack the essential requirements laid down in the Law and other applicable provisions, the They shall take immediate safety measures, with the approval or consent of the health authority from which they are dependent. In this case it can be awarded by telephone and identified by a key.

The security measure imposed must be ratified, amended or revoked within a period not exceeding five days from the appearance of the person concerned.

ARTICLE 260. The competent health authorities may order the application of the security measures referred to in Article 404 of the Law, when in the areas, installations, equipment or manufacturing process the identity, purity, and conservation are affected. or manufacture of the products, as well as for non-compliance with good practice and, in general, where the provisions of the Law, this Regulation and other applicable provisions which entail a serious health risk are infringed.

Chapter III

Sanctions

ARTICLE 261. The health authority shall sanction the person in breach of the provisions of this Regulation, without prejudice to the penalties applicable to them when they constitute a crime.

For the purposes of Article 418 (II) of the Act, the following assumptions shall be determined by the seriousness of the infringement:

I. Which results in some danger;

II. To allow or give rise to some risk;

III. That it goes indirectly to the detriment of the health condition or consumption habits;

IV. That any action or omission is performed without the health authorizations indicated by the applicable provisions;

V. That the action or omission involves health risk during the development of activities or services, the processing of the products or the operation of the establishments, and

VI. That any action or omission is performed without the approval of the health authority.

Any biological, chemical or physical agent that has the potential to cause adverse health effects is understood to be at risk.

ARTICLE 262. In cases where the infringer acts with intent or bad faith, the offence shall be aggravated, without prejudice to the penalties that correspond to them when they constitute a crime.

ARTICLE 263. A fine of up to a thousand days of general minimum wage, in force in the economic zone concerned, shall be punishable by infringement of the provisions of Articles 25, VI, 39, 46 and 52 of this Regulation, as well as I. 4.5, I. 4.6, III.6.6.1., III.6.6.3., III.6.6.., first paragraph, III.7.2.2., III.7.2.3., V. 13. First paragraph, V. 32., VI.46., VI.60., VI.61., VI.62., VIII.26., IX.7.1., IX.8., IX.9.1., X.3.1., X.3.2., X.3.3., X.3.2., X.6., X.7.1., X.12.1., X.12.2., X.12.3., X.13.1., X.13.3., X.19, XIV.6.1., XIV.10.1. and XV.4. of the appendix.

ARTICLE 264. A fine of one thousand to four thousand days of general minimum wage, in force in the economic zone concerned, shall be punishable by infringement of the provisions of Articles 25, fractions III and IX, 32, 43, fraction III, 45, 54, fraction I, 56, 72, 77, first paragraph, 79, 111, 113, 116, 134, 147, 161, last paragraph, 194 and 234, last paragraph, of this Regulation, as well as I. 4.1., I. 4.4., III.2.1., III.2.3., III.2.4., III.3.1., III.3.2., III.3.3., III.4.1., III.4.2., III.5.2., III.6.5., III.6.6., first paragraph, V. 7., V. 9., V. 19., V. 24., V. 27., V. 28., V. 29., V. 30., V. 31., V. 33., V. 36., V. 38., VI.12., VI.13., VI.16., VI.17., VI.18., VI.31., VI.32., VI.33.2., VI.33.3., VI.33.4., VI.33.5, VI.33.6., VI.33.7., VI.3., VI.3., VI.34., VI.3., VI.36., VI.3., VI.3., VI.40., VI.41., VI.43., VI.45., VI.49., VI.50., VI.51., VI.54., VI.55., VI.56., VI.57., VI.59., VIII.2., VIII.3., VIII.4. Second paragraph, VIII.34., IX.4., IX.6., X.18., first paragraph, XIV.6.2., XV.6., XXI.6., XXII.3. and XXII.4. of the appendix.

ARTICLE 265. A fine of four thousand to six thousand days of the general minimum wage in force in the economic zone concerned shall be imposed, the infringement of the provisions of Articles 10, 16, 17, 21, 25, fractions I, II, IV, V, VIII, X and XI, 26, 28, 35, 36, 37, 38, 42, 43, fractions I and II, 44, 48, 49, 50, 51, 53, 54, fraction II, 55, 58, 59, 61, 62, 63, 65, 66, 67, 68, 71, 73, 75, 76, 77, second paragraph, 84, 86, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 103, 108, 109, 110, 114, 115, 121, 123, 124, 129, 130, 131, 132, 133, 136, 137, 138, 139, 140, 141, 142, 143, 146, 149, 150, 151, 153, 154, 155, 156, 157, 161, 162, 163, 187, 188, 192, 193, 211, 212, 213, 214, 235, 238, 239, 249 and 250 of this Regulation, as well as I. 4.2., I. 4.3. II.1., II.2., III.4.3., III.4.7., III.4.10., III.4.10., III.4.12., III.4.13., III.4.15., III.4.16., III.4.17., III.5.1., III.6.6.2., III.6.6.4., III.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6.6. III.7.2.7., III.7.2.8., III.10.1., III.10.2., III.10.3., V. 5., V. 6., V. 8., V. 12., V. 13, second paragraph, V. 14., V. 15., V. 16., V. 20., V. 21., V. 22., V. 23., V. 35., V. 37., VI.2., VI.3., VI.6., VI.7., VI.8., VI.9., VI.11., VI.15., VI.21., VI.22., VI.23., VI.24., VI.25., VI.26., VI.27., VI.28., VI.29., VI.30., VI.3., VI.37.2., VI.37.5., VI.38., VI.48., VI.52., VI.53., VII.2., VII.3., VIII.5., VIII.6., VIII.7., VIII9., VIII.12., VIII.13., VIII.14., VIII.15., VIII.16., VIII.17., VIII.18. VIII.19., VIII.21., VIII.22., VIII.23., VIII.24., VIII.25., VIII.29., VIII.30., VIII.33., VIII.35., IX.2., IX.3., IX.5., IX.7.2., IX.7.3., IX.8.2., IX.8.3., IX.9.2., X.3.3., X.3.3., X.3.7., X.3.8., X.9., X.11., X.12.4., X.12.5., X.12.6., X.12.7., X.12.8., X.13.2., X.14., X.15., X.16., X.17., X.18.1., X.18.2., XI.7., XI.8., XI.9., XI.11., XI.13., XI.14., XI.15., XII.2., XII.3., XII.4., XII.8., XII.9., XII.10., XII.11., XII.12., XII.13., XIV.2., XIV.5., XIV.6.2., XIV.7., XIV.8., XIV.10.2., XIV.11., XV.2., XV.3., XV.5., XV.8., XV.9. and XXII.2. of the appendix.

ARTICLE 266. A fine of six thousand to ten thousand days of general minimum wage, in force in the economic zone concerned, shall be punishable by infringement of the provisions of Articles 12, 22, first paragraph, 23, 25, fraction VII, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 189, 201, 204, 206, 215, 216, 217, 218, 219, 220, 221, 222, 223 and 224 of this Regulation, as well as XVII.1., XVII.2., XVII.3., XVII.4., XVIII.1., XIX.1., XIX.2., XXI.2., XXI.4., XXI.7. and XXIII.3. of the appendix.

ARTICLE 267. The health authorities shall, on the basis of the results of the verification or information provided by the persons concerned, lay down the health measures to correct any irregularities detected, notifying the person concerned and giving an appropriate period of time for its completion, which may be up to 30 calendar days, which may be extended by an equal period of time at the request of the person concerned, provided that he proves that he is correcting the anomalies.

ARTICLE 268. Infringements not provided for in this Chapter shall be punishable by fines of up to ten thousand days of general minimum wage in the economic zone concerned.

TRANSIENT

FIRST. This Regulation shall enter into force on the following 90 days following its publication in the Official Journal of the Federation, except for the provisions set out below, which shall enter into force within the time limits indicated, the entry into force of this instrument:

I. At six months, Articles 20, 110, 173, 174 and 181 of this Regulation, as well as II.1., II.2., III.4.7., III.4.17.3., III.5.11.2., XVII.1., XVII.3., XVII.4., XVIII.1., XIX.2., XX.5., XX.6., XXI.6., XXII.3. of the appendix, and

II. At twelve months, Article 182.

SECOND. Articles 2 (a), (iii), (a) to (q) and (t), IV (b); 36; 45; 47; 48; 49; 54; 60; 65; 80; 119, fractions I, II, III, IV, VI, VII, VIII and XI; 149, fraction I, points (a), (b), (e), (f) and (g); 167, fractions I, II, III, VII, VIII and IX; 1271; 1276; 1277; 1283; 1284; 1288; 1289; 1292; 1293 and 1294; Chapter II of Title Third, and Titles Fourth, Fifth, Sixth, Seventh, Eighth, Ninth, Tenth, First, 12th, 13th, 14th, 15th, Sixteenth, 17th, 19th, 20th and 21st of the General Law Regulation Health in Matter of Health Control of Activities, Establishments, Products and Services, published in the Official Journal of the Federation on January 18, 1988.

Also, the regulations of Restaurants, Cafes, Fondas, Loncheries, Torteria, Taquerias, Comedor's Service in the House of Guests, Refrigerators, Ostioneries, Salons of Tea and other similar establishments and Sanitary Control are opened. of the Nixtamal Molinos, Masa and Tortillas Expendios in the Federal District and Federal Territories, published in the Official Journal of the Federation on February 8 and 17, 1962, respectively.

THIRD. The administrative provisions in force shall continue to apply, until such time as others are issued, except in so far as they are contrary to this Regulation.

FOURTH. In the case of administrative acts and procedures relating to the matter of this Regulation, which have been initiated or initiated before it enters into force, the person concerned may decide to continue to apply the rules in force in accordance with the procedure in force. during their initiation or by the application of this Regulation.

QUINTO. The products, activities, services and establishments covered by this Regulation shall be subject to the specifications laid down in the Appendix to that Regulation, which shall be repealed on the same dates as the official rules of the Regulation enter into force. (s) for each subject matter.

Given at the Federal Executive Branch, in Mexico City, Federal District, at the twenty-nine days of the month of July of a thousand nine hundred and ninety-nine.-Ernesto Zedillo Ponce de León.-Heading.-The Secretary of Health, Juan Ramon de la Fuente.-Rubrica.

APPENDIX TO THE HEALTH CONTROL OF PRODUCTS AND SERVICES REGULATION.

I. Establishments.

I. 1. The establishments must be provided with drinking water, in sufficient quantity and pressure to meet the needs of the persons in them and must have excreta disposal services connected to the network of (a) the provisions of Article 1 (1) of Regulation (European) No No 1 of the European Union and of the European Union; For health purposes, non-drinking water intake must be identified by means of a marking to be established: "Non-drinking water, not drinking water", or other equivalent.

When the establishment has air conditioning systems, in which there is contact with water, the water must be potable.

I. 2. Establishments where food or beverages are handled must have facilities for hand washing, cleaning and disinfection of utensils and work equipment, constructed of materials resistant to corrosion and capable of easily be cleaned. Such installations shall have at least water, liquid soap, disposable towels and disinfectant substances.

I. 3. The establishments shall have a system of discharges of waste water and stormwater. Drainage pipes, registers and temporary storage tanks shall be maintained in good condition of preservation, maintenance and operation, in terms of the applicable provisions.

I. 4. The establishments covered must meet the following requirements:

I. 4.1. The construction elements exposed to the exterior will be resistant to the environment and the harmful fauna;

I. 4.2. The warehouses, where appropriate, shall ensure the proper conservation and management of the products in separate areas by product type, in order to avoid contamination, adulteration or alteration;

I. 4.3. Drinking water tanks shall be covered with harmless impermeable material, with smooth inner surfaces, fitted with lids and with protective systems to prevent contamination or water disturbance;

I. 4.4. The areas of office, dining room, health services, reception, production, distribution, laboratory or any other area requiring the process must be separated;

I. 4.5. Be provided with sufficient lighting, either natural or artificial, appropriate to the nature of the work, as well as adequate ventilation for continuous air renewal and to avoid excessive heat, steam condensation and accumulation. powder, and

I. 4.6. The finishes of walls, floors and ceilings, within the areas of manufacture, operation and storage, must be waterproof and easy to clean and disinfect.

II. Tagged.

II.1. Where several establishments are involved in the manufacture, manufacture, preparation, mixing, packaging or packaging of a product, the following shall be indicated on the label: 'Made for ...' or an equivalent, in addition to complying with the specifications indicating the relevant rules.

II.2. Finished products containing ethyl alcohol or alcoholic beverages in quantities less than 2% by volume must include the following legend on the main exhibition surface of the label: " This product contains % of alcohol. Not recommended for children. "

III. Milk, its products and derivatives.

III.1. For the purposes of this paragraph, it is understood by:

III.1.1. Cream:

a. Cream, to the food in which most milk fat has been collected, either by rest or by centrifugation, subjected to pasteurisation, ultra-pasteurisation, sterilisation or any other treatment that ensures its safety;

III.1.2. Components:

a. Food grade casein, to the product obtained from the coagulation of the proteins of the uncreamed pasteurized milk, by the action of coagulant agents of milk, whether of biological origin (enzymes and cultures of lactic bacteria) or chemicals (acids); the curd thus obtained is subjected to the processes of washing with drinking water, pasteurization and dehydration,

b. Food grade caseinate, to the product obtained by solubilisation of the food grade casein rehydrated or fresh, by the action of neutralising agents, subjected to pasteurisation, dehydrated or not and

c. Butterfat, to the fat obtained from milk, which is characterized by having a high content of fatty acids;

III.1.3. Milk-based sweets, products made by heat treatment of milk and sweeteners, which may be added as additives for food and optional ingredients;

III.1.4. Ice cream:

a. Ice cream, to the food made by freezing, with agitation of a pasteurized mixture consisting of a combination of dairy ingredients, which may contain permitted vegetable fats, fruits, egg, its derivatives and food additives and

b. Mixtures or bases for ice-cream, products containing the necessary ingredients, so as to freeze them, give a final product which conforms to the composition of the ice cream, as the case may be, which may be presented in liquid, concentrated or powder;

III.1.5. Vegetable cream, to the food obtained from the emulsions of edible fats or vegetable oils in milk or milk solids and food additives, subject to pasteurisation, ultra-pasteurisation or sterilisation with similar characteristics to the cream of milk;

III.1.6. Milks:

a. Milk, natural secretion of the mammary glands of healthy cows or any other animal species, excluding colostrum,

b. Flavored milk, to which it has a characteristic flavour provided by concentrates, natural or artificial savored, with or without sweeteners and other food additives,

c. Dehydrated milk, which results from the removal of water from milk,

d. Sterilized milk, to which it has been subjected to a temperature-time ratio that ensures its commercial sterility,

e. Combined milk, to that made from own or non-milk ingredients and drinking water in the quantities necessary to adjust the product to the composition, sensory and health specifications of the milk,

f. Recombined milk, to the product made from the milk's own ingredients, such as casein, fat and whey; drinking water or vegetable fat in the quantities necessary to adjust the product to the composition specifications and Milk sensory,

g. Reconstituted milk, which is obtained from skimmed milk powder, butterfat or vegetable fat and water and

h. Rehydrated milk, which is obtained by the addition of drinking water to dehydrated milk;

III.1.7. Fermented and acidified milks:

a. The product obtained by treatment with lactic bacteria of pasteurised milk, fresh, clean and healthy, whole, partly skim or skim, with butterfat,

b. Acidified milk, obtained by acidification of whole milk, partially skim or skim, pasteurised, which can be rehydrated and added with acidulant agents,

c. Milk grown or fermented, to that obtained by acidification of whole or dehydrated milk, pasteurised, partly uncreamed, semi-creamed or uncreamed due to the action of live lactic bacteria and

d. Yoghurt, yogurt or yoghurt, to the product obtained by fermentation of whole, partially skim or skim, pasteurized, standardized milk produced by crops of the viable lactic bacteria Lactobacillus bulgaricus and Streptococcus termophyllus, whether or not added;

III.1.8 Establishments:

a. Order area, to the specific area where the milk is extracted, inside or outside the stable,

b. Milk collection centre, to the establishment where milk from different production areas is collected and

c. Stable, to the covered establishment in which the animal species intended for the production of milk is housed, for care, feeding and ordering;

III.1.9. Mantequillas:

a. Butter, to the fat product obtained from pasteurised milk from cow, goat or sheep or the mixture thereof, whether or not added to salt,

b. Cheese whey butter, to the fat matter which comes from pasteurised whey of cheese, without addition of other fat and

c. Buttermilk, to the liquid product that is separated during the removal of the fat from the cream or in the manufacture of the butter, subjected to pasteurisation process and which can be dehydrated;

III.1.10. Processes:

a. Standardization of milk, adjustment of fat content and non-fatty solids to a certain proportion of the components of the milk,

b. Homogenization of the milk, to the subdivision of the fat contained in the milk in small cells that allow its distribution through the entire volume of the milk,

c. Pasteurization, thermal treatment, generally performed at temperature up to 100 °C, which is applied for the destruction of pathogenic microorganisms and the inactivation of enzymes of some liquid foods and

d. Ultra-pasteurization, thermal treatment performed at a temperature greater than 100 °C, is applied for the destruction of microorganisms and the inactivation of enzymes of some liquid foods, and

III.1.11. Cheeses:

a. Cheese, to the product made from the standardized milk curd of cow or other animal species, with or without the addition of cream, obtained by the coagulation of casein with rennet, lactic germs, appropriate enzymes, edible organic acids, with or without further processing by heating, drained, pressed or not, with or without the addition of ripening ferments, special moulds, flux salts and optional edible ingredients. Can be fresh, matured or processed,

b. Whey cheese, to the product obtained from whey of pasteurised milk cheese from cow, goat or sheep, by heating in acid medium to encourage the formation of the curd, which is room, drained and moulds with or without the addition of cream,

c. Processed cheese, to the product obtained from the mixture of the matured, melted and emulsified cheeses, to which ingredients and spices may be added,

d. Matured cheese, to the product of hard, semi-finished or soft paste, with or without bark; subjected to a ripening process by the addition of microorganisms, moulds or bacteria under controlled conditions of time, temperature and humidity to cause in they are biochemical and physical changes that are characteristic of the different denominations of these products and

e. Whey, the liquid product that is separated from the curd after the coagulation of the milk proteins subjected to pasteurisation and which may or may not be dehydrated.

III.2. Establishments processing milk.

III.2.1. The owners or managers of establishments engaged in the production or production of milk shall have a daily relationship which must be kept for as long as the relevant standard is laid down and shall be available to them. competent health authorities, where they so require. That relationship shall contain the following:

III.2.1.1. The time of the average order and quantity produced per day;

III.2.1.2. The average daily of the volume of milk received in the milk collection center, as well as the pointing of its location, owner's name and delivery time at the plant;

III.2.1.3. The time of pasteurisation, ultra-pasteurisation or sterilisation and packaging, and

III.2.1.4 The identification of the production batch of the packaged milk and the date of expiry assigned.

III.2.2. The stables must comply with the requirements of this Regulation, irrespective of whether they are intended for the production of milk from animal species other than cows.

III.2.3. The collection centres, in addition to complying with the provisions of this Regulation for establishments, shall have:

III.2.3.1. Storage area of the milk with cooling, which may be clarified, and

III.2.3.2. Warehouse.

III.2.4. Pasteurisation, ultra-pasteurisation or sterilisation plants, in addition to complying with the arrangements for establishments identified in this Regulation, shall have the following areas:

III.2.4.1. Receipt and emptying of raw milk;

III.2.4.2. Storage of raw milk;

III.2.4.3. Clarification and, where appropriate, pasteurisation, ultra-pasteurisation or sterilisation, homogenisation, deodorisation and packaging;

III.2.4.4. Storage of pasteurized, ultrapasteurized or sterilized milk packaged, and

III.2.4.5. Laboratory for chemical physical analysis and bacteriological examinations.

III.2.5. Detergents and germicides used in the washing and disinfection of the utensils and equipment involved in the milk process and whose surfaces are brought into contact with it must be permitted in this Regulation and in the rules corresponding.

III.3. Sorts.

III.3.1. The following conditions will be observed in the order area:

III.3.1.1. The livestock must be clean during the order;

III.3.1.2. The udders must be washed, disinfected and dried immediately before the order and when the nipples must be sealed;

III.3.1.3. Before the order of each animal, the first three extractions of milk must be obtained from each of the nipples, this milk must be collected in a special container and inuse, and

III.3.1.4. The place of the order must be clean and provided with a channel with decline to receive the manure and urine of the cows while they are ordered. The manure must be continuously removed and collected at a site away from the site of the order.

III.3.2. Computers shall comply with the following requirements:

III.3.2.1. Do not have wounds or skin infections;

III.3.2.2. Have clean and cut to the nails of the hands;

III.3.2.3. Do not have infectious diseases;

III.3.2.4. Wash hands with soap and water, for which they will use brush and rinse with water containing some disinfectant solution, before ordering;

III.3.2.5. Stay clean throughout the process, and

III.3.2.6. Wear gowns, light-colored caps and clean rubber boots.

III.3.3. The mechanical order shall be subject to the following requirements:

III.3.3.1. The millers shall be washed, disinfected and rinsed with sufficient drinking water prior to ordering;

III.3.3.2. Hooves shall be washed, disinfected and rinsed with sufficient drinking water before the order of each animal;

III.3.3.3. The hooves must not be in contact with the floor, and

III.3.3.4. The millers, tubes, connections and hooves must be washed and disinfected after each order and shall be allowed to drain in appropriate places.

III.4. Milk.

III.4.1. The transport of raw milk for human consumption from the stables to the premises of the stables, to the collection centres or to the pasteurizers, as well as that which is intended for the production of milk products and products, shall only be carried out in containers or thermotanks of design and sanitary material, previously washed and disinfected.

III.4.2. Raw or bronzed milk, packaged pasteurised milk, fresh cheeses and creams may not be sold on the public road when they are not kept in refrigeration.

III.4.3. Packaging for milk, its products and derivatives must be of any material which allows the preservation of the product under conditions suitable for human consumption, to be perfectly clean and disinfected at the time of use and to allow for the hermetic closure that prevents contamination, alteration or adulteration.

III.4.4. Milk intended for direct human consumption and used as raw material in processes for the production of products or products derived therefrom shall comply with the following characteristics:

III.4.4.1. Come from clean, healthy animals;

III.4.4.2. Be pure, clean and free of antiseptic, conservative and neutralizing materials;

III.4.4.3. Being of characteristic colour, odour and flavour corresponding to a hygienic order;

III.4.4.4. Do not clot by boiling;

III.4.4.5. Do not contain blood or pus;

III.4.4.6. Present alcohol test at 68% negative;

III.4.4.7. Present test to the inhibitors, negative;

III.4.4.8. Present evidence to the saccharocnta, negative;

III.4.4.9. Have a density at 15.5ºC, not less than 1,031;

III.4.4.10. Have an index of refraction at 20ºC, not less than 37 and not greater than 39, by the copper sulphate method;

III.4.4.11. Have a freezing point not greater than 0,0,530 and not less than 0,0,550 with the Horvet cryocodend;

III.4.4.12. Present acidity with a limit of not less than 1,3 and not more than 1,7 g/l, expressed as lactic acid;

III.4.4.13. Have chlorides whose limits are not less than 0,8 g/l and not more than 1 g/l, expressed as chlorine by the Volhard method;

III.4.4.14. Have only the fat proper to the milk, from the milking;

III.4.4.15. Have proteins with a minimum of 30 g/l, own milk;

III.4.4.16. Contain lactose, between 43 g/l and 50 g/l by the Wiley polarimetric method or by the Fehling method;

III.4.4.17. Have non-fatty solids of milk (SNG), not less than 83 g/l and not more than 89 g/l, and

III.4.4.18. To be subjected to pasteurisation or to inform the consumer about the need to submit it to a boiling process, prior to ingestion.

III.4.5. Milk for human consumption is classified by the heat treatment to which it is submitted in:

III.4.5.1. Pasteurized;

III.4.5.2. Ultra-pasteurized;

III.4.5.3. Sterilized, and

III.4.5.4. Boiled.

III.4.6. Ultra-pasteurised milk may be flavoured, flavoured and sweetened with the savored, flavouring and sweeteners permitted in this Regulation and in the relevant rules.

III.4.7. Ultra-pasteurised milk, the fat content of which is less than or equal to 16 g/l, shall be added to 670 µ g retinol (2 000 IU vitamin A) per litre.

III.4.8. Ultra-pasteurised or sterilised milks, which are hermetically packaged, must be commercially sterile.

III.4.9. Milk which complies with the requirements for milk intended for direct human consumption must be used in the preparation of the milk of flavours and the final composition shall correspond to the requirements laid down by the Secretariat in the relevant standard.

III.4.10. Products and products derived from packaged milk for transport must be packed in conditions that prevent the deterioration of the packaging and the contamination of the products.

III.4.11. The sugar content used in the sugary condensed milk must be sufficient to prevent its deterioration.

III.4.12. The sweetened condensed milk shall be free of pathogenic micro-organisms and shall not contain more than 10 000 CFU/g of aerobic mesophilic bacteria.

III.4.13. Dried milk must not exceed the following microbiological limits: Staphylococcus aureus coagulase positive, negative per gram; Salmonella absent in 25 grams; maximum aerobic mesophilic bacteria 10 000 CFU/g, and total coliforms NMP maximum 20 /g.

III.4.14. Dried milk may be used for:

III.4.14.1. Rehydration for direct human consumption, and

III.4.14.2. For the food industry.

III.4.15. Dehydrated milk must be packaged in containers of impermeable material which protects it from moisture, avoids contamination and ensures its preservation, and cannot be sold in bulk to the public.

III.4.16. Rehydration of milk for direct human consumption shall be carried out in accordance with the following:

III.4.16.1. The refund must be made with drinking water;

III.4.16.2. Milk must be pasteurised or ultra-pasteurised and packaged immediately;

III.4.16.3. The phosphatase test, once the milk is packaged, must be negative if it is pasteurized;

III.4.16.4. The milk shall be free of pathogenic micro-organisms and its account for aerobic mesophilic bacteria shall not be greater than 5 000 CFU/ml, and

III.4.16.5. Milk shall be stored, distributed and sold under refrigeration conditions at an appropriate temperature to maintain the corresponding health characteristics.

III.4.17. The labelling of the packaging of pasteurised, ultrapasteurised, evaporated, sugary condensed, dehydrated, combined, reconstituted or recombined milk packaging shall include the following:

III.4.17.1. Name, as set out in the relevant standard;

III.4.17.2. Declaration of ingredients in order of quantitative predominance, except in the case of pasteurised or ultra-pasteurised milk without flavour;

III.4.17.3. Vitamin A content expressed in µ g retinol equivalents per litre or per serving, except in whole milk and sugary condensed milk;

III.4.17.4. Expiration date, with letter or number, as follows:

a. Pasteurized milk: day, month and year and

b. Ultra-pasteurised milk: month and year;

III.4.17.5. Identification of the lot, and

III.4.17.6. The following conservation legends, depending on:

a. Pasteurized milk: "Stay in refrigeration" or "Keep in refrigeration", or an equivalent,

b. Ultra-pasteurised, evaporated and condensed milk: 'Keep in cool and dry place', 'Do not require refrigeration as long as the packaging', or equivalent legends and

c. Dehydrated milk: "Stay well covered, rather cool and dry," or an equivalent.

III.5. Cheeses.

III.5.1. The milk used in the manufacture of cheese shall be pasteurised or free of tuberculosis and brucellosis, for which process control systems are applied and which demonstrate by microbiological, physico-chemical and Sensorial which is suitable for human consumption, without prejudice to other applicable provisions.

III.5.2. The cheese to be sold in bulk shall be kept in sanitary form and protected from dust and contaminants.

III.5.3. Cheeses may be covered with waxes prepared with or without colour or others which protect them from contamination.

III.5.4. Processed cheese bearing a name corresponding to a matured cheese of a single variety and designation of origin shall contain in the mixture not less than 60% of this cheese and the rest of other cheeses.

III.5.5. Cheese may be made from:

III.5.5.1. Whole milk;

III.5.5.2. Partially uncreamed milk;

III.5.5.3. Semi-skimmed milk;

III.5.5.4. Skim milk;

III.5.5.5. Cream, and

III.5.5.6. Double cream.

In the name of the cheese the class of milk used must be highlighted, according to its animal origin.

III.5.6. The cheese may be matured and for its consistency, it shall be classified as hard, semi-solid or soft.

III.5.7. The cheese based on the material used, its components, its processing and place of origin may be considered as original, genuine and type.

III.5.8. The specific name of the cheese, whether national or foreign, by its preparation and composition technique shall be in accordance with the relevant rules.

III.5.9. In the manufacture of cheeses, the following products may not be used:

III.5.9.1.Non-proprietary fats from the milk used;

III.5.9.2. Starch, and

III.5.9.3. Herbs or other milk products, other than those laid down in this Regulation and the applicable standards.

III.5.10. The following ingredients may be used in the preparation of fresh, aged and processed cheeses:

III.5.10.1. Spices, condiments, (including chilies) (Capsicum annum L. sp) and thermally processed adobo;

III.5.10.2. Heat-processed vegetables, fruits, meat and shellfish, in quantity not greater than 10%, and

III.5.10.3. Mixture of two or more of the above ingredients in quantity not greater than 10%.

III.5.11. The labelling of the cheeses shall be:

III.5.11.1. The indication of the type of milk and the animal origin of the milk, and

III.5.11.2. The minimum percentage of butterfat, protein, and maximum moisture.

III.5.12. The cheese serum according to its preparation is classified as sweet serum or acid serum, it may or may not be demineralized.

III.6. Stay.

III.6.1. The butter must not contain less than 80% milk fat and not more than 16% moisture.

III.6.2. The cheese whey butter shall not contain less than 80% milk fat and not more than 16% moisture.

III.6.3. The following ingredients may be used in the manufacture of mantequillas:

III.6.3.1. Buttermilk of cheese and butterfat anhydrous;

III.6.3.2. Salt, in quantity not greater than 3% in the case of salted butter;

III.6.3.3. Lactic cultures of Streptococcus lactis, Streptococcus cremoris, Streptococcus diacetylactis, Streptococcus heterofermentatives and Leuconostoc sp, and

III.6.3.4. Spices, condiments and other ingredients permitted in this Regulation and in the relevant rules.

III.6.4. The labelling of butter and whey butter shall contain the following:

III.6.4.1. The indication of whether it is serum, if any, and

III.6.4.2. The species or animal species from which the leches are used in their manufacture.

III.6.5. The butter and whey butter for sale to the public must be protected against contamination with wrappers, packaging or packaging.

III.6.6. The buttermilk may be sold for human consumption, packaged in the same way as milk or dried milk, as appropriate.

The labels of the buttermilk containers must contain the following data:

III.6.6.1. The name of the product according to its classification;

III.6.6.2. The indication that the product is pasteurized;

III.6.6.3. The non-fatty solids content of the milk;

III.6.6.4. The expiration date, and

III.6.6.5. The identification of the batch.

III.6.7. The butterfat must not contain less than 99,3% milk fat and not more than 0,5% moisture. The final product shall not contain more than 10 CFU/g of total coliform organisms and a maximum of 20 CFU/g of moulds and yeasts.

III.6.8. In the manufacture of anhydrous butyric fat, any combination of propyl, octyl and dodecyl gallates with hydroxyanisole butyl (BHA) or hydroxytoluene butyl (BHT) or both, in amounts not greater than 0,02%, may be used as antioxidants. provided that the galatos do not exceed the amount of 0,01%.

III.7. Cream.

III.7.1. The cream is classified into:

III.7.1.1. Cream, which contains 30% milk fat;

III.7.1.2. Extra fat cream, which does not contain less than 35% milk fat;

III.7.1.3. Cultivated cream, the acidity of which is derived solely from the presence of lactic acid cultures, with a content not less than 30% fat and a minimum acidity of 0,5% expressed as lactic acid;

III.7.1.4. Acidified cream, which is obtained by adding acidulant agents, which may or may not contain crops of lactic bacteria, and whose fat and acidity content must correspond to that of the cultivated cream;

III.7.1.5. Half cream, which does not contain less than 20% milk fat;

III.7.1.6. Light cream or light cream for coffee, which does not contain less than 14% milk fat;

III.7.1.7. Pastry cream, to which sugar has been added and which must not contain less than 20% milk fat;

III.7.1.8. Cream to beat, which does not contain less than 30% milk fat;

III.7.1.9. Extra fat cream to beat, which does not contain less than 35% milk fat, emulsifiers and thickeners, and

III.7.1.10. Sweet cream of butter powder, the one obtained by dehydration of the sweet butter whey concentrate, which must not contain less than 7% butterfat, not less than 30% protein, and not more than 4% moisture.

III.7.2. The labelling of the creams should bear the following:

III.7.2.1. The indication that the product is pasteurised, ultra-pasteurised or sterilised;

III.7.2.2. The species or species of animals from which it originates;

III.7.2.3. The minimum percentage of fat contained in the milk used;

III.7.2.4. In the case of pasteurized cream, the legend: 'Keep in refrigeration' or 'Keep in refrigeration', or an equivalent;

III.7.2.5. For creams subjected to commercial sterilisation, the legend: "Does not require refrigeration as long as the packaging", or other equivalent is not opened;

III.7.2.6. In the case of dehydrated creams, the legend: "Stay in cool and dry place";

III.7.2.7. Expiration date, and

III.7.2.8. Identification of the lot.

III.8. Yogurt, yogurt, or yoghurt.

III.8.1. Products containing the same as one of its ingredients may not be referred to as yogurt, but may be included as part of their name. These products may or may not be heat-treated.

III.8.2. The labelling of the packages of yogurts shall contain the following:

III.8.2.1. The kind of milk used in the production of milk: whole, partially uncreamed or uncreamed, and

III.8.2.2. The percentage of milk fat it contains.

III.9. Ice cream.

III.9.1. The ice cream is classified into:

III.9.1.1. Cream ice cream;

III.9.1.2. Milk ice cream, and

III.9.1.3. Sorbet.

III.9.2. Ice-cream and sorbets must comply with the following specifications:

Categories Components

Minimum Percentage I II III

Milk fat 7.0 2.0 1.0

Non-fatty solids 7.0 9.0 1.0

Total solids 26.0 25.0 15.0

III.9.3. The volume of air which is incorporated into ice-cream or sorbets must be adjusted to the ratio of dividing the volume of the product expressed in litres, between the mass of the product, expressed in kilograms, which must not be more than 2 and may be equal to 2,2 if the total solids of these products are greater than 30%.

III.9.4. Ice-cream and sorbets shall not weigh less than 475 g/l.

III.9.5. The labelling of the ice-cream must bear the following:

III.9.5.1. The name, and

III.9.5.2. The percentage of fat and its origin.

III.10. Components.

III.10.1. Food grade caseins and caseinates shall not exceed the following microbiological limits: aerobic mesophilic bacteria 10 000 CFU/g thermophilic micro-organisms 5 000 CFU/g moulds and yeasts 50 CFU/g faecal coliforms negative/g; Staphylococcus aureus positive coagulase negative/g, and Salmonella negative in 25 g.

III.10.2. Caseins and food grade caseinates shall be packaged for sale, and their labelling shall contain the following:

III.10.2.1. The indication that the product was obtained from pasteurized milk;

III.10.2.2. The expiration date, and

III.10.2.3. The identification of the batch.

III.10.3. In the preparation of food grade caseins, both acidic and lactic or those obtained by enzymes, the following may be used:

III.10.3.1. For acid: food grade acids as co-adjuvants; lactic acid, citric acid, acetic acid, hydrochloric acid, sulphuric acid, allowed in necessary quantity;

III.10.3.2. For lactic acid: crops of lactic bacteria allowed in needed quantity, and

III.10.3.3. For those obtained with enzymes: renin or renin, enzymatic preparations of Bacillus cereus, Mucor miehei var. Conney and Emerson allowed in required quantity.

IV. Egg and its products.

IV.1. For the purposes of this paragraph, it is understood by:

IV.1.1. Clear dehydrated, to the product obtained from the fresh egg to which the yolk and water have been removed;

IV.1.2. Clear liquid, to the product obtained from the fresh egg, to which the yolk has been separated and subjected to pasteurisation;

IV.1.3. Egg, the product of the ovulation of the hen (Gallus domesticus) and other animal species which are accepted for human consumption, which has been cleaned and, which has been observed in the light or by the ovoscope, appears completely clear and without shadows;

IV.1.4. Dried egg, the product obtained from the egg, without shell, pasteurised, and which has been removed from the water;

IV.1.5. Liquid egg, product obtained from the egg without shell and subjected to pasteurisation;

IV.1.6. Fresh egg, to the product that has no more than 24 hours of ovado;

IV.1.7. Chilled egg, to the product that immediately after ovado is stored and maintained in refrigeration chambers;

IV.1.8. Dried yolk, to the product obtained from the pasteurized egg yolk and to which the water has been partially or totally removed, and

IV.1.9. Liquid yolk, to the product obtained from the fresh egg, without shell, to which the clear and subjected to the pasteurization process has been eliminated.

V. Meat and its products.

V. 1. For the purposes of this paragraph, it is understood by:

V. 1.1. Meat and by-products:

a. Carcass, to the body of the animal devoid of skin, bristles or feathers, head, legs and viscera,

b. Meat, to the structure consisting of striated muscle fibre, whether or not accompanied by connective tissue such as bone, fat, lymphatic and blood vessels, as well as nerve fibres of the animal species considered fit for human consumption,

c. By-product of meat origin, to the tissue other than meat which includes the viscera, blood and skin of the species considered fit for human consumption and

d. Viscera, to the organs contained in the thoracic, abdominal, pelviana, cranial and oral cavities of the species of animals considered fit for human consumption;

V. 1.2. Meat inspection:

a. Antertem inspection, to the procedure by which a zootechist veterinary doctor checks the animals inside the stay to decide whether they are clinically healthy for slaughter and

b. Post-mortem inspection, to the procedure by which the animal health veterinarian examines the carcases and the viscera of the animals slaughtered to decide whether or not they are fit for human consumption;

V. 1.3. Rejections:

a. Partial rejection, separation of animals, carcases, meat, viscera or their parts and meat products or parts thereof, which present pathological alterations or undesirable characteristics in a localized manner, so that the parties which do not present such alteration can be exploited,

b. Total rejection, separation of animals, carcases, meat, viscera or their parts and meat products which are not fit for human consumption and

c. Suspect, animal, carcase, meat, viscera, and meat product or parts thereof which may present a health risk and require health inspection by the veterinary doctor or diagnostic tests to define its destination final;

V. 1.4. Establishments:

a. Meat packer, to the establishment intended for the process of meat products,

b. The invention relates to a method for the separation of the different portions of the pig carcase, with or without the production of meat derivatives, for the production of fritures and the production of lard and

production of pork and pork.

c. Trace or slaughterhouse, to the establishment dedicated to the slaughter and slaughter of animals under humanitarian conditions, as well as, where appropriate, to their industrialization, and

V. 1.5. Meat products and derivatives:

a. Cooked meat product, in the form of meat from animals considered fit for human consumption, subjected to heat treatment until a minimum temperature of 68 °C is reached in its thermal centre,

b. Cured meat product, in the form of meat from animals considered fit for human consumption, subject to the action of the curing agents,

c. Cured and cooked meat product, in the form of meat from animals considered fit for human consumption, subjected to the action of the curing agents and to a heat treatment until reaching a minimum temperature of 68 °C in its centre thermal,

d. Meat product cured, emulsified and cooked, in the form of meat, viscera and by-products of animals considered fit for human consumption, which has been subjected to the action of curing agents, mixed with water, ice and other additives for use food and ingredients until a homogeneous and stable dispersion is achieved, as well as a thermal treatment until reaching a minimum temperature of 68 °C in its thermal center. Can be embedded in natural or synthetic gut,

e. Cured and matured meat product, prepared with defined cuts of animals considered fit for human consumption, subjected to the action of curing agents and matured for a certain period of time,

f. Salted meat product, in the form of meat of animals considered fit for human consumption, which is dried by the action of the salt and

g. Meat product chopped, in the form of meat from animals considered fit for human consumption, which has been cut or chopped to pieces not less than 2 mm and whether or not subjected to the action of curing agents.

V. 2. Only persons who are not members of the slaughter facility, carcases of carcases and the cleaning of the viscera may be brought in by the owner or in charge of the authorisation.

V. 3. Pens of sick animals, suspected or not intended for human consumption, must first be disinfected with soap and water and subsequently with disinfectants such as: creoline or muriatic acid. The entry shall not be permitted before the residues of such disinfectants have been removed.

V. 4. The animal health veterinarian shall, in accordance with the relevant standard, request the laboratory investigation which it considers necessary to determine the final destination of the animals arriving sick.

V. 5. The anthemic inspection shall not be the sole criterion for considering an animal as fit for human consumption, even if it may be for the destruction of an animal.

V. 6. The anormortem inspection may be sufficient to decide the final destination of the carcase and by-products. This inspection must be carried out within the poultrymeat and shall be divided into the animals into three groups, which shall be housed in separate pens, in accordance with the following criteria:

V. 6.1. Suitable animals are clinically healthy animals, which must be slaughtered in normal killing rooms and undergo post-mortem inspection in the areas where the food is made for human consumption;

V. 6.2. Sick or suspected animals are those with clinical signs, such as claudication, dyspnoea, gastrointestinal disorders, which may be treated and, once healthy, all or part of the animal may be recovered for human consumption. The responsible animal health veterinarian shall determine the time at which they must be slaughtered to remove the medicinal products from the tissues. Animals killed in this yard must be considered as retained or rejected, and

V. 6.3. Rejected animals, are those kept in confinement, for presenting (sic) clinical signs of diseases that are a health risk or that are notifiable disease spreaders.

Within the clinical signs referred to in point V. 6.3., the following are found: extreme emaciation, watery watery diarrhoea, pyrexia, vesicles and ulcers in snout and interdigital spaces, nerve disorders, dyspnoea intense inspiratory and expiratory, massive involvement of the respiratory system, generalized increase of the lymph nodes; in addition, icteric animals and others considered by the zootechist veterinary physician.

V. 7. Animals introduced into the slaughter areas must be slaughtered immediately, and the fish must be carried out with the suspended animal. In no case should you contact the floor, for which there will be a network of air rails.

V. 8. The operations of insensitization, bleeding, desolation and eviscerate, as well as the scalding, paring, scraping and chamusing of pigs, should not be carried out in areas close to other cleaner operations.

Scaling tanks must be emptied and filled with drinking water daily.

V. 9. The carcase and the viscera shall be reviewed at the post-mortem inspection and the zootechnical and toxicological examinations shall be carried out by the animal health veterinarian.

Post-mortem inspection should include visual inspection, palpation, and incision, as well as taking into account the odor in certain cases.

In all mammalian species the head should be checked; lungs; heart; liver; stomach; intestines; spleen; uterus; kidney; mammary gland; testes; the following lymph nodes: submaxillary, prepectoral, pre-scapular, lumbar, crural, iliac, supramamary, renal, as well as other ganglion organs and groups.

The lack of any of these organs will result in the animal being unable to target for human consumption.

V. 10. Once the results of the anthortem and postmortem inspections have been obtained, the final opinion may be given on the destination of the products in which the total or partial rejection of the products shall be indicated.

V. 11. Where infectious diseases are determined during the post-mortem inspection, all equipment which has come into contact with the carcase or the viscera must be disinfected immediately with 5% sodium hydroxide solutions, or any other suitable disinfectant.

V. 12. The carcases of animals from other traces must be inspected in order to determine their final destination.

V. 13. The use of suspended hoses for the final washing of channels after evisceration should only be allowed, provided that it does not cause splashes to the rest of the channels.

The channels must be washed immediately after the post-mortem inspection and before entering the refrigerator.

V. 14. Birds for human consumption shall be free from deformations, wounds, lacerations or any other form affecting their integrity.

V. 15. The handling carried out in birds must be carried out with hygiene and without altering the health characteristics. In order to avoid microbiological contamination, only the following may be performed:

V. 15.1. Sacrifice and bleeding. It will be ensured that in the slaughter the birds of the birds are empty, for which they must not be fed during the twelve hours before the sacrifice. The bleeding must be complete;

V. 15.2. Escalations. It must be done after the bleeding and will be immersed in the bird in a climbing tank;

V. 15.3. Evisceration. The viscera, the residues of blood or foreign matter shall be removed and the bird shall be washed externally with drinking water, in accordance with the relevant standard, and

V. 15.4. Cut. The body of the bird shall be divided into halves, quarters or pieces and the neck, tuses and wings shall be separated.

V. 16. The postmortem inspection of the birds must include the head, esophagus, buche, proventricle, molleja, duodenum, ileocecal valve, liver, factory bag and canal.

V. 17. The rejected products must be removed without crossing the slaughter lines and a route which leads them directly to the storage area of the products shall be used.

V. 18. In the promotion and descent of the channels to the sanitary transport, it shall be avoided that they come into contact with the floor or any other polluting surface.

V. 19. Transport vehicles must be washed on a daily basis inside and outside and no detritus must be accumulated. Such vehicles shall be washed first with hot or pressure water, followed by the application of a disinfectant such as sodium hypochlorite or iodine solutions, and rinsed as many times as necessary for the disposal of waste.

V. 20. Meat and products which have been rejected shall not be transported in the same vehicle unless the contact between them is avoided by the use of properly identified closed containers as laid down in the relevant rules.

V. 21. The inspection processes of the anthemortem, eviscerated, postmortem and refrigerated inspection must be carried out in accordance with the following times:

V. 21.1. Antertem inspection: maximum 24 hours before slaughter;

V. 21.2. Eviscerate: after slaughter and immediately after the scale, cut or plucked;

V. 21.3. Post-mortem inspection: immediately after the eviscerate, and

V. 21.4. Refrigerated: immediately after post-mortem inspection.

The channels must be covered with a clean blanket when entering the refrigerator and must remain in this refrigerator of sixteen to twenty-four hours at a temperature of 4ºC, in accordance with the corresponding standard.

V. 22. Bags of polyethylene or other permitted material, used for packaging or packing meat, viscera or other edible parts in the trace, shall bear the name and location of the trace and, in the case of non-frozen products, the date of killing.

V. 23. Evisceration should be performed at most thirty minutes after bleeding.

Measures should be taken to prevent contamination of the canal by intestinal content.

In evisceration, the esophagus and rectum must be previously linked to avoid contaminating the meats.

V. 24. The handling of meat and viscera in the meat packers must be carried out on tables of waterproof material and stainless steel.

V. 25. The movement of the meat as raw or industrialized material inside the establishment must be carried out in containers of sanitary material.

V. 26. The food products listed below shall be processed in the manufacture of all the following:

V. 26.1. The butter, which is the product resulting from the melting of the fat of the pig;

V. 26.2. The chicharron, which is the product that results from the frying that is made from the skin of the pig, and

V. 26.3. Fried or fried meats, which are the products that result from frying the pork and its viscera and, if necessary, pressing them.

V. 27. The melting of fats, as well as the weaning of carcases of slaughtered animals, may be carried out in the packing of cold meat, provided that it is in separate areas from those intended for processing and packaging.

V. 28. The following areas must exist in the establishments dedicated to obtaining lard:

V. 28.1. The one intended for the separation of fat from the different portions of the animal, and

V. 28.2. The melting of the fats proper for the manufacture of the product.

If the meat of the pigs is kept in the establishment, they must be kept in properly conditioned refrigerators.

V. 29. The areas of establishments dedicated to obtaining lard must have the conditions laid down for the workers.

V. 30. The areas of fritures and greases must be fitted with a suitable installation of masonry ovens, iron paila provided with draught or other modern method for the manufacture of butter and fritures.

The butter must be cooled in places specially designed for this purpose and the laying in open areas cannot be carried out.

V. 31. The meat and viscera products shall have at least the following furniture and utensils, which must be washed daily:

V. 31.1. Refrigeration units with sufficient capacity for all meat and viscera to remain hung or in suitable washable containers; in no case shall such food be in contact with the floor or the walls and the hangers shall be be of iron or of any material that is established in the relevant rules;

V. 31.2. Refrigerated display cases with sufficient capacity to store meat and viscera;

V. 31.3. Smooth and waterproof material cover counter;

V. 31.4. Surface for cutting of non-wood meat;

V. 31.5. Containers for garbage, bones, tallow, among others, in sufficient numbers, in accordance with the requirements of the stipend; these containers may only be filled to the point where the lids may be closed;

V. 31.6. Furniture where cleaning accessories may be placed, separate from the material used to wrap goods, and

V. 31.7. Containers for waste of impermeable material, which must not come into direct contact with the meat or viscera.

The windows of these items must be protected by mosquito cloth.

V. 32. In both the expendium and the refrigeration unit, the corners must not form angles and there shall be no accumulation of detritus in the first of them.

The walls, floors and ceilings must be painted white, with oil paint; the furniture may be of this color or steel color, other may not be used.

V. 33. In order to expend viscera, legs and lard, these must be kept in containers of sanitary material and kept in separate refrigeration units of the meat.

V. 34. In the case of beef and veal products, pork and raw chicken meat, cold meat and dairy products may be placed on the market provided that they are packaged and comply with the following:

V. 34.1. The products must be packaged and marketed in the same way. No pig or poultry can be kept in a canal, cut or sold in bulk;

V. 34.2. The products shall be displayed in refrigeration units, which must be unique for each product type;

V. 34.3. The staff shall be kept clean, with their hair collected, the nails trimmed, no moustache and no ornaments on the ears, neck and hands, with a turban or a white quartz, without visible or visible stains or dirt, and

V. 34.4. The staff who handle the food, after going to the bathroom and at every job interruption, must wash their hands with soap and water and dry with disposable towels.

V. 35. The transport of viscera shall, in addition to the requirements laid down in the relevant rules, be carried out in containers of plastic or stainless steel with easy cleaning that can be closed.

Viscera and by-products should not touch the floor or walls.

V. 36. Meat products may not contain:

V. 36.1. Lymph nodes and glandular tissue, with the exception of salivary glands, or

V. 36.2. Larynx, trachea, esophagus, lung, uterus, spleen, pancreas, or testicles.

V. 37. Salted meat products shall comply with the following specifications:

V. 37.1. 100 CFU/g; moulds and yeasts

V. 37.2. Staphylococcus aureus coagulase positive, 1000 CFU/g, and

V. 37.3. Salmonella spp. 25 g of sample shall be negative.

V. 38. Where the smoking of the products is carried out with wood smoke, it shall be of non-resinous hard wood and in a natural state without prior treatment, except for the manufacture of wood.

V. 39. In establishments where meat and meat products are processed, the Secretariat may, at any time, order any repairs it deems necessary and the removal of furniture and supplies which are not in the appropriate sanitary conditions.

VI. Fishery products and their derivatives.

VI.1. For the purposes of this paragraph, it is understood by:

VI.1.1. Production areas:

a. Approved area, to the area of bivalve molluscs production, in which the sanitary study, monitoring and surveillance indicate that there are no marine biotoxins, contamination by fecal matter, pathogenic microorganisms and toxic substances or noxious,

b. Area approved conditionally, to the area of bivalve molluscs production that is subject to intermittent microbial contamination, but is in a position to meet the requirements of the approved area in a predictable period of time, for its opening or closing. The health authority shall determine the areas under these conditions,

c. Restricted area to the area of production where bivalve molluscs may be harvested or extracted only when permitted by the health authority and where they have undergone a controlled purification process, i.e. where the levels of faecal contamination, pathogenic micro-organisms, toxic or harmful substances are within the permitted limits. The temporary closure or opening of this area will be determined by the health authority,

d. Distribution, to the activity by which the products are moved from the zones and production centers to the sales establishments and

e. Areas of production and extraction of fishery products, to bodies of water that do not exceed the limits of established pollutants, with capacity for the development of aquatic flora and fauna organisms;

VI.1.2. Fishery products:

a. Chilled fresh fish and shellfish, to the various edible species, obtained by fishing or cultivation, subjected to refrigeration or dill and, where appropriate, peeling, evisceration, unchunching or other cleaning operations,

b. Fishery products, to the resources of the aquatic flora and fauna, are fish, crustaceans, molluscs, echinoderms or other animals and plants whose natural means of life, temporary or permanent, is water,

c. Product of frozen fishery, to which it has been subjected to the action of the cold, until reaching in the thermal center a temperature not exceeding -18ºC,

d. Fresh-chilled fishery product, to which it has been subjected to the action of the cold until reaching in the thermal centre a temperature of 0 to 4 °C and

e. Product of glase-fishing, to which it is covered with a thin protective layer of ice from drinking water;

VI.1.3. Processed fishery products:

a. Sausages of fishery products, to the mixture of one or more species of meat of fish or shellfish milled with food ingredients and additives, with which natural or melted guts of synthetic material are stuffed and subjected to a treatment thermal or ripening and cooling for preservation,

b. Fishmeal, to the product obtained from the whole fish or its parts, which are used, cooked, pressed, dried and ground with or without the addition of soluble and insoluble solids recovered from the liquid phase,

c. Pasta of fishery products, to the product resulting from the milling of the meat of one or more fish or shellfish species, mixed with food ingredients and additives, moulded in various forms, packaged and subjected to treatment thermal for storage,

d. Product of the smoked fishery, to the previously brated to the direct or indirect action of the smoke generated by the combustion of non-resinous and treated wood, in order to dehydrate it partially, and to give it a taste to smoke,

e. Product of dehydrated fishing, to which after fishing or catch the water has been removed,

f. Product of the pressed fishing, to which after fishing or catching, after evisceration, is cured with salt and pressed,

g. Product of dried fishing, to which after fishing or catch is subjected to a process for the disposal of water, prior to scalding and evisceration, salted or not and

h. Product of the salted fishery, to which after fishing or catching is mixed with edible salt in bulk form or brine to keep it, and

VI.1.4. Salt processes:

a. Wet salt, to the procedure by which the product is mixed with edible salt without removing the exudates that are formed by dissolving the salt in the muscle tissue,

b. Dried salted, to the procedure by which the product is mixed with edible salt so that the resulting exudation is constantly drained and

c. Brine, to the immersion of the product in a solution of water and salt.

VI.2. The extraction and handling of bivalve molluscs shall be subject to the following:

VI.2.1. They will be extracted from approved areas, conditionally approved, or restricted areas under health surveillance;

VI.2.2. They shall be healthy and clean, otherwise they must undergo a purification process, and shall be in tanks or floaters for this purpose;

VI.2.3. They shall be washed with clean sea water from approved area or with drinking water with sufficient pressure;

VI.2.4. They shall be stored in rafts or floats where appropriate, provided that the quality of the water is acceptable and that the salinity is sufficient;

VI.2.5. They shall be stored carefully, in order to avoid abrasions, in bodegas with sufficient ventilation and free from harmful or domestic fauna, and

VI.2.6. They shall be washed, in the case of thermal separation of the shell, with drinking water and handled quickly, for immediate refrigeration or freezing.

VI.3. For the purification of bivalve molluscs, the following shall be observed:

VI.3.1. The quantity of water they receive must be clean, continuous and sufficient for the volume of organisms to be cleaned, which must not exceed the capacity of the purification centre or area;

VI.3.2. The operation of the purification system shall allow live bivalve molluscs to be re-fed by filtration, remove the polluting residues and be kept alive under appropriate conditions after prior purification to the packaging, storage and transport prior to placing on the market, and

VI.3.3. The batches of organisms shall not be mixed; if so, they must be of the same species and come from the same production area or from different areas having the same health classification.

VI.4. Fresh fish must comply with the following characteristics:

VI.4.1. The scales will be well attached to each other and tightly attached to the skin;

VI.4.2. The skin will be moist, well attached to the underlying tissues;

VI.4.3. The mucus, in the species that possess it, will be watery and transparent;

VI.4.4. The eyes will occupy the entire orbital cavity, they will be transparent, bright and outgoing. The iris must not be stained with red (sufusion);

VI.4.5. The operations shall be rigid and provide resistance to their opening;

VI.4.6. The gills will be colored from the red to intense red, moist and bright, with characteristic smell and soft;

VI.4.7. The abdomen will be terse, without external difference with the ventral line; the cut, the tissues must offer resistance; with the anal pore closed; the viscera of vivid and well differentiated colors; the bright interior walls; the blood vessels full and resistant to digital pressure; and with characteristic and soft odour, and

VI.4.8. The muscles will show elasticity marked, firmly attached to the bones and not detached from them when exerting digital pressure; with the characteristic natural color, the first cut; and with its own color with a bright cutting surface.

VI.5. The flow of products shall be continuous, without delay, or intermediate storage, or thawing and freezing during a process line in order to maintain health quality, in accordance with the characteristics of the product and the process, as well as your health risk.

VI.6. The dead crustaceans shall have the following characteristics:

VI.6.1. The exoskeleton will be slightly wet, bright and consistent;

VI.6.2. The body will be rigid;

VI.6.3. The stubs will be resilient and firm, and

VI.6.4. The smell will be the own of each species.

VI.7. Live crustaceans shall have the following characteristics:

VI.7.1. The shell will be wet and bright, and

VI.7.2. The mobility shall be presented at the lowest excitation.

VI.8. Fresh cephalopod molluscs shall have the following characteristics:

VI.8.1. The skin shall be smooth and wet, without bloodstained or strange spots to the species;

VI.8.2. The muscles must present consistency and elasticity;

VI.8.3. The colour shall be the characteristic of each species, and

VI.8.4. The smell will be the characteristic.

VI.9. Live bivalve molluscs and live gastropods must come from catching areas which have health certification or approval and comply with the following characteristics:

VI.9.1. Have closed valves. When they are open, they must be closed when they are gently hit. In the interior of the valves there must be crystal clear water. Bivalve molluscs, submerged in warm water, shall leave their shell;

VI.9.2. Present the characteristic odour;

VI.9.3. Count on wet muscles, well attached to the valves and look spongy, light-Cinderella in the oysters and yellowish in the mussels, and

VI.9.4. Present reactions to stimuli and heartbeat.

VI.10. Vessels shall be equipped, in accordance with the distance of the catching areas and characteristics of the species, with means of conservation such as: ice, mechanical refrigeration or freezing under sanitary conditions.

VI.11. Fishing vessels, with a capacity exceeding five tonnes, which are fitted with a cooling system, must submit the product at a temperature of no more than 4 °C and shall not be in operation for more than 25 days.

When you have a freezing system, it must provide the product with a maximum temperature of -18 °C.

VI.12. Fishing vessels with a capacity of more than five tonnes shall have a hold meeting the following requirements:

VI.12.1. Be thermally insulated;

VI.12.2. Being interiorly coated with glass, plastic or other hygienic material with a smooth surface and resistant to corrosion;

VI.12.3. Be divided into compartments to store the product under sanitary conditions;

VI.12.4. Having ice sheets of such thickness that ensure the preservation of the product and the maximum height shall be that which prevents the deterioration of the product in the lower layer;

VI.12.5. Have a drainage system that allows for deicing and is regularly drained, and

VI.12.6. Present conditions of ventilation, cleaning, disinfection and other requirements to avoid physical damage and contamination of the product.

VI.13. In fishing vessels with a capacity of up to five tonnes which do not have a hold, the product must be stowed for storage in containers with sufficient ice. This type of vessel may not carry out fishing operations for periods of more than 24 hours.

VI.14. Fishing vessels with a capacity of more than five tonnes shall have a system of supply of clean drinking water or clean seawater.

In addition, they must have a complete and efficient disinfection system in the necessary places, in order to facilitate the thorough and effective washing and sanitation of the areas of product confinement and general cleaning of the product. ship, before exiting the port and after unloading.

VI.15. Vessels, parts and equipment used in the extraction, before and after each fishing operation, shall be washed with running water and shall be free of fish, shellfish or fragments thereof, as well as other susceptible organic matter decomposition that can contaminate the product.

VI.16. All equipment used for washing, handling, transporting, cooling and storing fishery products on board vessels shall be constructed with unalterable and non-toxic material that allows easy cleaning and disinfection.

VI.17. The equipment for washing and transporting fishery products shall be constructed with stainless material and designed to prevent the product from suffering bruising and other damage.

VI.18. The cover and all your equipment, immediately after unloading the catch, must be washed with hose, brushed, thoroughly cleaned with suitable cleaning products, disinfected and rinsed.

VI.19. When sea or well water is used, as an auxiliary cleaning element, it must be supplied by means other than drinking water and its ducts must be painted with different colours for identification.

VI.20. Containers of multiple service, equipment and utensils used in the handling, storage or transport of fishery products shall be washed, disinfected and finally rinsed with drinking water after each day of the day. job.

VI.21. Detergents and disinfectants used for cleaning the equipment must be properly labelled and protected.

They must also be used exclusively for the purpose of use and are used with sufficient caution in order to avoid contamination or alteration of fishery products.

VI.22. The product caught, when unloaded on the cover, must be handled in such a way that it does not hit, damage or contaminate.

VI.23. At the time it is feasible, after the catch, the product must be washed and, where appropriate, the viscera may be removed, wacky or unenciled, preventing the waste from being in contact with the products intended for human consumption.

The product must be placed with enough ice until it is delivered for processing.

VI.24. The product, once free of viscera, head or shell, must be washed with clean running water; in the case of fish, this must be done until the bleeding ceases.

VI.25. The abdominal cavity of the fish, free of viscera, must be filled with ice and covered with ice.

Ice that has been previously used for some other purpose should not be used to cool the product.

VI.26. Viscera, as well as waste intended for animal consumption or non-food industrial use, must be preserved to prevent their decomposition and to separate them from human consumption.

VI.27. Products which have not undergone prior treatment on board shall be subjected to their classification and washing, depending on the species; where appropriate, the removal of viscera, wacky or disconch may also be carried out and shall be placed in containers. clean and stored in refrigeration or freezing chambers.

VI.28. In order for the product not to be damaged, to contaminate or to undergo heating by action of the solar radiation, the manual discharge must be carried out in clean containers, and it cannot be launched from the cellar to the cover, to the platform of the dock or to the means of transport.

VI.29. All appropriate precautions shall be taken to ensure that fishing vessels evacuate human and other waste in such a way that they do not constitute a danger to public health and hygiene, in accordance with the applicable provisions.

VI.30. The springs and other landing sites shall be kept clean and drain for the drain.

VI.31. No plywood or joints and other laminated structures may be used on tables and surfaces intended for cutting and filtering of fishery products.

VI.32. The industrialization of the fishery by-products shall be carried out in conditioned and separate areas from those in which products are developed for human consumption.

VI.33. Industrial fishing establishments shall comply with the following health requirements:

VI.33.1. Be equipped with drinking water and drainage;

VI.33.2. Have floors of impermeable material and resistant to attack of organic salts, acids and waste, with decline towards drainage;

VI.33.3. Have adequate sanitation systems or, at least, with a water intake to perform the toilet of each hundred and fifty square meters of surface, in the areas of reception of raw material and process;

VI.33.4. Have a specific area for cleaning and disinfection of equipment;

VI.33.5. Have perfectly flattened and painted walls, with oil paint or similar material, which may be fully or partially covered with sanitary material;

VI.33.6. Having protected windows with wire cloth and doors with automatic closing and air or polyvinyl curtains;

VI.33.7. Having roofs constructed of sanitary material;

VI.33.8. Have lighting with sufficient natural and artificial light, and

VI.33.9. Have ventilation in such a way as to avoid excessive heat, condensation of steam, unpleasant odours, dust, smoke and pollution.

VI.34. The mandims, boots and coisies to be used by the employees of the establishments of receipt, packaging, packaging and marketing of the fishery products shall be washed and dried after each shift.

VI.35. Industrial establishments intended for the processing of fishery products for human consumption shall, as appropriate, have the following sections:

VI.35.1. For the reception, sorting, preparation and storage of raw materials, separately;

VI.35.2. Storage of food ingredients and additives;

VI.35.3. Manufacture of the product;

VI.35.4. Packaging, labeling and packaging;

VI.35.5. Storage of finished products;

VI.35.6. Washing equipment and utensils;

VI.35.7. Of solid waste;

VI.35.8. Fourth of machines;

VI.35.9. Storage of materials, and

VI.35.10. Water treatment.

VI.36. Containers intended to store brine for the salt of the product must be of corrosion resistant material and in a manner that allows them to be emptied and cleaned completely.

VI.37. Equipment used for heat treatment, refrigeration, freezing and storage shall be equipped with devices for the control and recording of operation parameters and shall comply with the following:

VI.37.1. The location shall ensure the cleanliness, maintenance and inspection of the same;

VI.37.2. The refrigeration equipment must be equipped with thermal and relative humidity control, which shall be read, recorded and dated at least 3 times a day;

VI.37.3. The smoked oven must be constructed with insulating materials, with smooth inner surface and coated with material to facilitate the cleaning of the walls with steam and hot water.

VI.37.4. The equipment used for cooking must be constructed in such a way as to provide a constant and sufficient supply of heat in order to ensure that all products receive the same treatment in terms of time and temperature;

VI.37.5. Freezing and cold storage facilities shall be of sufficient volume for the intended production and shall be equipped with automatic temperature control and recording devices, which shall be -18 °C at least, and

VI.37.6. The records of the operation parameters will be preserved for one year.

VI.38. Where the raw material for the production of fishery products is to be stored for several days, it must be kept in refrigeration or freezing, and shall be entered in the relevant book of the establishment, inter alia, of the following data:

VI.38.1. Date of receipt;

VI.38.2. Species;

VI.38.3. Tonnage;

VI.38.4. Average temperature at the time of receipt, and

VI.38.5. Average daily temperature.

The log book will be available to the competent health authorities when required.

VI.39. In the preparation of the raw material, the following actions shall be included:

VI.39.1. Inspection and classification;

VI.39.2. Washing;

VI.39.3. Debugging products;

VI.39.4. Thawed;

VI.39.5. Flaky, disengaged, wacky, eviscerated or unvenerated;

VI.39.6. Storage, and

VI.39.7. The necessary to remove foreign matter and non-edible parts.

VI.40. For the cooking of the crustaceans, drinking water or clean seawater must be used, the degree of which must not exceed 3% in sodium chloride.

VI.41. Crustaceans, after cooking, must be packaged and immediately chilled, frozen or added to the ice.

VI.42. The ice to be used to preserve the raw material must be made with drinking water that meets the health requirements laid down in the relevant standards.

VI.43. Frozen non-packaged products, immediately after freezing, shall be glaseated or packaged to protect against dehydration and oxidation during their stay in the cold store.

VI.44. When the icing is required, the water temperature to be used shall be less than 5 °C.

VI.45. The brine shall be at a concentration of at least 18% and in sufficient quantity to cover the whole product.

VI.46. Pressed fishery products, as a finished product, must not exceed 45% moisture and 8% fat. When exceeding the limits indicated, the product must be smoked or dried when it is intended for human consumption.

VI.47. Fishery products must be canned with the vacuum needed to prevent vessels from abombing because of high temperatures or low pressures during their transport, storage or marketing.

VI.48. The heat treatment or sterilisation of the canned goods must be started immediately or before an hour after the closure.

VI.49. In the preparation of fishmeal, in addition to fish, usable parts of molluscs, crustaceans or other aquatic species, intended for human consumption, may be used which must comply with the established health requirements. for such products.

VI.50. The packing area of the establishments engaged in the refrigeration and freezing of fishery products shall be maintained at a maximum temperature of 15 °C.

VI.51. Packaging designed to be reused must be sanitized before being reused.

VI.52. The raw material for pastes and sausages shall be derived from fishery products that comply with the applicable health requirements.

VI.53. Pastes and sausages of fishery products which have not been heat-treated after packaging must be kept in refrigeration at 4 °C.

VI.54. Vehicles intended for the transport of fishery products shall comply with the following:

VI.54.1. Be in good working and clean up;

VI.54.2. Having insulated chambers thermally and coated with hygienic material;

VI.54.3. Have a cooling or freezing system, as the case may be;

VI.54.4. Have temperature indicators inside the box outside the vehicle;

VI.54.5. Have a system for the drainage of thawing water;

VI.54.6. Count, in the case of open-box vehicles, with an impermeable canvas, which shall be kept clean and cover the entire load;

VI.54.7. Present the inner surface of the smooth vehicle box and non-porous and corrosion resistant material for fresh or frozen products;

VI.54.8. Place, during the bulk transport, of fresh fishery products, alternating layers of crushed ice up to a maximum height of one meter; the first and last layers shall be of ice;

VI.54.9. Carry out the transport of bivalve molluscs, washed and refrigerated at a temperature between 1 °C and 4 °C, and

VI.54.10. Avoid transporting any products that may lead to cross-contamination, in case they transport fresh or frozen fishery products. Only fish meal or fish oil may be transported together with other products when they are packaged.

VI.55. In vehicles, the storage chamber, the containers used for the stowage and other surfaces which are in contact with the product must be washed with drinking water and disinfected before and after each trip.

VI.56. For the transport of fishery products such as pickling, pastes, sausages, smoked and limited storage time, vehicles with refrigeration shall be used.

To transport dehydrated, dried, salted and canned products, they must be properly stretched and protected from heat and moisture.

VI.57. The transport of fresh-shied fishery products, with a maximum duration of five hours, may be carried out on vehicles without a cooling chamber with a closed box and covered with sanitary quality material.

VI.58. The transport of fishery products shall be carried out in clean and covered containers.

VI.59. Commercial establishments must have areas of:

VI.59.1. Receipt;

VI.59.2. Classification and Inspection;

VI.59.3. Cleaning and filtering;

VI.59.4. Ice tank, cold storage or warehouse for refrigerated or frozen product, as appropriate;

VI.59.5. Sales display;

VI.59.6. Landfill connected to the drain, and

VI.59.7. Tank with hermetic lid for product waste.

VI.60. The walls shall be coated with light-coloured, washable waterproof material, at least 1,8 m in height; the remainder shall be painted with light-coloured washable material.

VI.61. Fishery products, fresh or frozen, intended for human consumption, shall have the purchase and sale document to verify their origin and health quality.

VI.62. Fishery products which are presented for display and sale to the public shall be placed in masonry counters or any other harmless, resistant material with smooth, waterproof and light-coloured surface, allowing for easy access to the products. toilet, with the inclination necessary to allow the draining of the melting water. If the display and sale are made in trays, these must be of harmless plastic material or other anti-corrosive material that is easy to clean and disinfect.

VII. Fruit, vegetables and their derivatives.

VII.1. For the purposes of this paragraph, it is understood by:

VII.1.1. Fruit and vegetables:

a. Fruit, to the fleshy product of the fertilisation of the plants which may contain seeds,

b. Fresh fruit, to the product that is consumed in a natural state, of adequate maturity, healthy, clean and that preserves its sensory properties and

c. Vegetables, flowers, leaves, stems, tubers, roots, rhizomes and some fruits of various edible vegetables, as well as different species of healthy and clean edible fungi;

VII.1.2. Fruit and vegetables product:

a. Fruit or vegetable sweets, products such as casings, jellies or marmalades, obtained by cooking pulps or fruit or vegetable juices with sweeteners, whether or not added to food

,

b. Crystallized fruit, whole product or parts that have been submerged in sugary syrups, whether or not subjected to heat treatment with subsequent cooling, until a crystalline consistency is achieved,

c. Frozen fruit and vegetables, products which may be whole, cut, cut, peeled and disinfected, whether or not subjected to heat treatment and subsequent freezing,

d. Dried fruit and vegetables, fresh, healthy and clean products, whole or divided, with appropriate maturity, to which they have been partially or totally removed from water by natural or artificial methods,

e. Dried fruit, to the product that once matured presents a degree of dehydration that allows its conservation, in which the seed is the edible part,

f. Fruit or vegetable paste, to the product obtained by milling or sifting, subject to concentration,

g. Preserved product, to the product hermetically packaged and subjected to a heat treatment, in such a way that it does not alter or pose any danger to the health of the consumer, under appropriate storage conditions for a period of time extended,

h. Fruit and vegetable pulps, products which have been boned, ground or sifted, subjected to heat treatment until their concentration, whether or not added to optional ingredients and food additives,

i. Pure, to the product obtained by milling or sifting of fruit or vegetable, whether or not subjected to heat treatment and

j. Sauce, to the product containing mixtures of vegetables or legumes, condiments and spices, diluted or concentrated, added or not of food additives;

VII.1.3. Juices and nectars:

a. Concentrated fruit juice or vegetable juice, to the product which has been removed from its water content by physical processes and which may be frozen or aseptically packaged,

b. Concentrate juice, to the product obtained by adding purified water to a concentrated juice to obtain a similar product in terms of concentration and sensory characteristics of the juice of the fruit or vegetable in question,

c. Fruit juice or vegetable juice, to the product obtained by the extraction of the undiluted endocarp and the materials of the ripe, healthy and clean fruit or vegetables, to which the pulp, partially or wholly, may be removed by appropriate processes.

d. Dried fruit juice or vegetable juice, to the product referred to in the previous paragraph, to which the water has been removed and

e. Nectar, to the product produced with fruit pulp and juice, added to drinking water, sugars, acidulants, natural aromas and antioxidants, and

VII.1.4. Process:

a. Commercial sterilization, the heat treatment applied to the product for the destruction of all viable microorganisms of importance in public health and those capable of reproducing in the food under normal conditions of storage and distribution, without the cooling condition.

VII.2. Repealed.

VII.3. Concentrated, dehydrated and concentrated juices of concentrates must not exceed the limits of the pollutants laid down for the juices.

VII.4. Repealed

VII.5. Repealed.

VII.6. Fruit juice or vegetable juice may be concentrated and then reconstituted with drinking water or purified, as appropriate, to preserve the essential composition and quality factors of the fruit or vegetable juice.

VII.7. The vegetable juice may be conditioned.

VII.8. Repealed.

VII.9. For the juices, sucrose, glucose, fructose or corn syrup may be used to adjust the brix/acidity ratio, in accordance with the requirements laid down in the relevant rules.

VII.10. Sucrose, glucose, fructose or starch syrup may be used in fruit nectars in a quantity not exceeding 20%.

VIII. Non-alcoholic beverages, packaged water, products for preparing and freezing them.

VIII.1. For the purposes of this paragraph, it is understood by:

VIII.1.1. Packaged water, to water of any origin which for its placing on the market is presented to the consumer in closed containers and which must be suitable for direct or indirect human consumption:

a. Natural mineral water, spring water or well of natural origin, whose composition, flow stability or temperature are constant, taking into account the cycles of natural fluctuations, characterized by the content of certain mineral salts, as well as by the presence of trace elements and other characteristics such as temperature and radioactivity (at source of origin), packaged as it arises from the source, without any chemical treatment, and which may or may not be carbonated,

b. Mineralized water, purified water that has been added to salts, and which may or may not be carbonated,

c. Drinking water, water whose use and consumption does not cause harmful effects to humans and

d. Purified water, to water that has undergone physico-chemical treatment, to make it fit for human consumption;

VIII.1.2. Non-alcoholic flavoured beverages:

a. Flavoured drinks, products produced by dissolution in treated drinking water, mineral water or milk, sweetening matter and sater, whether or not added to juices or fruit pulp, concentrates or extracts, and other additives for food, and which may or may not be carbonated,

b. Sports drink, to the product produced by the dissolution of mineral salts, sweeteners or other ingredients in order to replenish the water, energy and electrolytes lost by the human body during the exercise and

c. Powder for the preparation of non-alcoholic beverages, the product with or without sugars or synthetic sweeteners, whether or not added to juice, milk and food additives, and

VIII.1.3. Frozen products:

a. Frozen non-alcoholic beverages, to the product produced with drinking water to which juice or fruit pulp, sweeteners and other food additives are added with or without air incorporation and which can be moulded or packed,

b. Drinking ice, to the product obtained by freezing or crystallizing drinking water and

c. Snow, frozen product of non-alcoholic beverages, with juice or fruit pulp, with air intake.

VIII.2. Establishments intended for the manufacture of drinking ice, in addition to complying with the requirements laid down in this Regulation, shall have:

VIII.2.1. Filling and freezing area, in which the following shall be observed:

a. The moulds for freezing the water must be of non-oxidizable material and of sanitary design that allows easy washing and disinfection. The moulds must be fitted with lids of the same non-oxidizable material, and must be washed and disinfected,

b. The filling of the moulds must be made through fixed tubing,

c. The brine tanks must maintain a level that prevents contamination of the drinking water contained in the moulds,

d. Equipment for the treatment of water, chlorinators, sand filters, gravel and activated carbon, or others that are required for specific cases, shall be maintained in good working order to ensure water potability,

e. Freezing tanks containing brine shall maintain a level that prevents contamination of the drinking water contained in the moulds and

f. The access platforms to the freezing tanks shall be smooth and of impermeable material, with one slope towards the drain and one edge on each side;

VIII.2.2. Cutting and packing area, in which the following shall be observed:

a. The part of the cutting and packaging equipment which is brought into contact with the ice must be of non-oxidizable material, and must be washed and disinfected at the beginning of the operations and

b. The packaging may be manual and should avoid contact of the ice with the staff responsible for this operation, and

VIII.2.3. Cold ice storage chambers, which must:

a. Count with cooling system that maintains the freezing temperature of the ice,

b. Be provided with the recording and temperature control devices for the purposes of the preceding paragraph and

c. Count with insulator in good condition and stops to protect the walls of the hits that can produce the ice bars.

The filling and freezing, cutting and packing areas, as well as the cold ice storage chambers, must be independent, if any, of the chemical and ice pack stores, the machines, the maintenance lubricants, the loading area, the laboratory, the administrative offices, the health care units and the dressing rooms.

VIII.3. In the access to the filling and freezing areas, cutting and packing, as well as in cold ice-keeping chambers, there must be tappetes that will contain a disinfectant solution. The staff who work in these areas, before entering the areas, must disinfect their boots on these mats.

The access of people outside of the activity in those areas will not be allowed.

VIII.4. Non-alcoholic beverages, as a final product, may be pasteurised before or after packaging and contain up to 0,5% by volume at 20 °C of ethyl alcohol from the savored.

Non-alcoholic beverages for sale or supply to the public must be protected with sealed-off containers to prevent contamination.

VIII.5. Natural mineral water shall be colourless, with the characteristic odour and flavour of the natural source, and shall not exceed the following limits:

MAXIMO (mg/l)

VIII.5.1.             Copper 1;

VIII.5.2.             Manganese 2;

VIII.5.3.             Zinc 5;

VIII.5.4.             Borato 30 calculated

as H3BO3;

VIII.5.5.             Matter 3 calculated

organic as O2

consumed;

VIII.5.6.             Arsenic 0,05;

VIII.5.7.             Barium 1;

VIII.5.8.             Cadmium 0,01;

VIII.5.9.             Chrome 0,05;

VIII.5.10.           Lead 0.05;

VIII.5.11.           Silver 0.05;

VIII.5.12.           Mercury 0.001;

VIII.5.13.           Selenium 0.01;

VIII.5.14.           Calculated fluoride 2,0

as F;

VIII.5.15.           Nitrate 45 calculated

as NO3;

VIII.5.16.           Calculated 0,05 sulphide

like H2S, and

VIII.5.17.           Sulfate 400.

VIII.6. Natural mineral water shall not contain pathogenic micro-organisms, microbial toxins, antibiotics, hormones, medicinal products and toxic substances which are a risk to the health of the consumer or cause alteration or decomposition of the It shall also not exceed the following microbial limits:

VIII.6.1.             Mesophilic 100 CFU/ml;

aerobes

VIII.6. 2.             Moulds and 25 CFU/ml, and

yeasts

VIII.6. 3.             Escherichia coli Negativo.

VIII.7. The The carbonation of the packaged water must be carried out on a food grade carbon dioxide (minimum purity 99,8%), free of nitrous acid, sulphuric acid, sulphur dioxide and other impurities, its carbon monoxide content must not be more than 0,2% by volume and the gas pressure must not be greater than 5 atmospheres at 15,5 °C.

VIII.8. Non-alcoholic flavored beverages, in accordance with their juice content, are classified as follows:

VIII.8.1. Taste drinks, and

VIII.8.2. Drinks from, followed by the name of the fruit.

VIII.9. Non-alcoholic flavored beverages shall not exceed the limit of contaminants for drinking water. In the case of drinks containing fruit, they must not exceed the limits of the pollutants corresponding to the proportion of the juice used.

VIII.10. Non-alcoholic flavoured beverages shall not contain pathogenic micro-organisms or exceed the following limits:

Micro-organisms Drinks drinks not

carbonated carbonates

MAXIMO aerobes

MAXIMO

VIII.10.1.           Mesophilic 25 CFU/ml 50 CFU/ml;

aerobes

VIII.10.2.           Negative Negative Coliforms;

totals

VIII.10.3.           Moulds 10 CFU/ml 25 CFU/ml, and

VIII.10.4.           Yeasts 10 CFU/ml 25 CFU/ml.

VIII.11. Repealed.

VIII.12. Repealed.

VIII.13. Repealed.

VIII.14. Repealed.

VIII.15. Repealed.

VIII.15.1. Repealed.

VIII.15.2. Repealed.

VIII.15.3. Repealed.

VIII.15.4. Repealed.

VIII.16. Repealed.

VIII.17. Repealed.

VIII.18. Repealed.

VIII.19. Repealed.

VIII.20. Citrus fruit flavour drinks shall contain essential oil of the corresponding fruit.

VIII.21. Sports drinks shall contain the ingredients and additives for foods laid down for non-alcoholic beverages, except for synthetic sweeteners, which may be used only for the purpose of supplement the product's sweetness.

VIII.22. The microbiological specifications of the added drinks of nutrients shall correspond to those laid down in Article VIII.10. of this Appendix.

VIII.23. Low-calorie drinks, low-calorie drinks and non-calorie drinks will need to meet the microbiological specifications set for non-alcoholic flavoured drinks.

VIII.24. Products for the preparation of non-alcoholic beverages shall not contain pathogenic micro-organisms. The maximum tolerance for aerobic mesophilic shall be 5000 CFU/g and yeasts and moulds of 100 CFU/g.

VIII.25. Repealed.

VIII.26. Powders for preparing beverages shall not exceed 4% of moisture.

VIII.27. On frozen non-alcoholic beverages, no preservatives may be used.

VIII.28. Frozen non-alcoholic beverages shall not contain pathogenic micro-organisms. The maximum tolerance for aerobic mesophilic shall be 1000 CFU/g, and yeasts and moulds 25 CFU/g.

VIII.29. The drinking ice must be made with overwater (maximum residual free chlorine 1.0 mg/l).

VIII.30. The bacteriological tests of the drinking ice must be carried out weekly and the residual free chlorine determinations once a day, at least.

VIII.31. The disinfection of the water freezing moulds must be carried out with a free chlorine solution at a concentration of 50 mg/l.

VIII.32. The tappetes in the access of the filling and freezing areas shall contain a free chlorine solution at a concentration of 500 mg/l.

VIII.33. The handling of the bar ice during all stages of the process must be done in a hygienic manner.

VIII.34. Vehicles intended for the transport of drinking ice must be used only for this purpose and, where appropriate, must have a hielera-type box; they must also be kept clean and in good condition.

VIII.35. The labelling of the products shall, as appropriate, bear the following:

VIII.35.1. For frozen non-alcoholic beverages, the legend: "For the protection of your health, you must wash your hands and the container of this product before consuming it", and

VIII.35.2. For non-alcoholic beverages with changes in their composition, as set out in this Regulation and the corresponding rules.

IX. Cereals, legumes, their products and botanicals.

IX.1. For the purposes of this paragraph, it is understood by:

IX.1.1. Cereals, legumes and tubers:

a. Rice, to the mature, whole, healthy and clean grain of the genus Oriza sativa, L.,

b. Oats, whole grain, mature, healthy and clean from the genus Avena sativa, L.,

c. Cereal, to the edible grains of certain plants belonging to the family of single-cotyledon grasses, such as wheat, maize, rice, oats, rye and barley,

d. Legume, to the plant of the family of the same name, the fruit of which is presented in pods, and from which the seeds are separated,

e. Maize, to the mature, whole, healthy and dry grain of the genus Zea, L.; species mays and others,

f. Nixtamalized corn or nixtamal corn, healthy and clean corn that has been cooked with water, in the presence of calcium hydroxide, in adequate proportion according to the characteristics of the maize used,

g. Wheat, to the mature, whole, healthy and dry grain of the genus Triticum, L.; of the species vulgare, compactum and durum and

h. Tuber, to the plant product from the roots of some plants;

IX.1.2. Flours and their products:

a. Germ, to the residue of the milling of the cereals formed by the embryo and spit it out,

b. Wheat flour or flour, to the product obtained from the milling of the grain of ripe, whole or broken wheat, clean, healthy and dry of the genus Triticum L. of the species vulgare, compactum and durum or mixtures thereof, in which much of the bran and germen and the rest is crushed to obtain a proper grain of fineness,

c. Rice flour, to the product resulting from the milling of the rice grain; mature, clean, whole or broken, healthy and dry of the genus Oriza sativa, L; white or slightly yellowish, which can be presented with or without pericarp, without glumas and polished,

d. Oat flour, to the product resulting from the milling of the grain of oats; mature, clean, whole, healthy and dry of the genus Avena sativa, L; and which is also free from its cellulosic wraps,

e. Rye flour, to the product resulting from the milling of the rye grain; mature, clean, whole, healthy and dry, of the genus Secale cereale; without cellulosic wraps,

f. Bean flour, to the product precooked, crushed, dehydrated and ground, obtained from the seeds of the plant belonging to the genus Phaseolus vulgaris L.,

g. Maize flour, to the product resulting from the wet or dry milling of maize grains, ripe, clean, healthy and dry of the genus Zea, L.; species mays and others,

h. Nixtamalized corn flour, to the dehydrated product obtained from the milling of nixtamalized corn grains,

i. Soybean meal, to the product obtained from the milling of the seeds of the plant belonging to the genus and species Glycine max,

j. Defatted soybean meal, to the product obtained from milling or breaking of soya bean seeds, uncascarated and subjected to the extraction of the oil, by the use of solvents and with the elimination thereof,

k. Integral flour, to the product obtained from the milling of the grain which preserves its shell and other components,

l. Integral soy flour, to the product obtained from the milling of the bean seeds of soy with peel and preserving its fat,

m. Prepared flour, to the product made from cereals and legumes, added to other ingredients and food additives, to prepare doughnuts, hot cakes, churros, tamales, tortillas and pastels, among others,

n. Bran, savior, cema or acemite, to the residue of the milling of the wheat integrated by the grain shell, mixed with a small portion of flour,

or. Semolina, to the bulk granule product obtained from the milling of wheat free from tegumentos and germen and

p. Semolina, to the small granule product obtained from milling wheat;

IX.1.3. Protein concentrates:

a. Soy protein concentrate, to the product obtained from soybean seeds, from which most of the oil and non-protein water-soluble components have been removed and must contain no less than 70% protein,

b. Gluten, to the proteins found in wheat, triticals, rye, barley and oats and

c. Protein isolated from soy, to the product obtained from the fraction of the soy seed, free of the non-protein contents; and which must contain at least 90% protein;

IX.1.4. Breadmaking products:

a. Biscuit, to the product made primarily by a mixture of flour, fats or edible oils and water, whether or not added to sugars, other optional ingredients and food additives, subject to kneading and further processing thermal, which gives rise to a very varied presentation product, characterized by its low water content,

b. White bread, to the product which results from baking a mass obtained from fermented flour per action of leudant, edible water and salt, conditioners and improvers of mass, added or not of edible oils and fats, milk, other ingredients and food additives,

c. Whole flour bread, to the product resulting from the bread-making of the dough fermented by the action of yeasts, prepared with wheat flour, flour of whole grain or leguminous, drinking water, edible salt, sugars, fats edible, other food ingredients and additives,

d. Sweet bread, to the bread-making product consisting of flour, water, egg, sugars, edible fats or oils or hydrogenated oils, yeasts, whether or not added to food additives, fruit in any of its presentations, salt and milk, kneading, fermented, moulded and baked into the oven or by frying in edible fats or oils,

e. Black bread, to the breadmaking product obtained from the mixture of wheat flour and rye, which can be acidic and added to spices and food additives,

f. Cake or panty, to the product which is beaten and baked, prepared with flour of cereals or legumes, sugars, fats or oils, leudant and salt; whether or not added to egg and milk, whipped cream, fruit or other optional ingredients and additives for food,

g. Pay, to the product made with cereal flour or ground cookie, sugars, water and salt, with or without leudant, edible fats or oils, fruit, pastry cream, optional ingredients and food additives; moulded in the form of bark for contain a sweet or salty filling, which can be covered, baked, fried or frozen and

h. Bread-making products, obtained from mixtures of grain flour or whole or leguminous flour, drinking water, fermented or not containing edible salt, butter, margarine, edible oils hydrogenated or not, leudant, baking powder, spices and other optional ingredients such as, sugars, honey, fruit, juices or other similar edible products, may or may not be used for food; subject to baking, cooking or frying; with or without filling or with cover, can be kept at room temperature, in cooling or freezing, as the case may be;

IX.1.5. Tortillas:

a. Wheat flour tortilla, to the product under cooking made from wheat flour, edible fats or oils, leudant, edible salt and food additives and

b. Corn tortilla, to the product under cooking, made from the mass or flour of nixtamalized maize and water;

IX.1.6. Starches:

a. Starch, to the starch extracted from the grains, seeds or tubers of the plants; which may be added as dyes or flavorings and

b. Product for the preparation of atole, in the form of starch or cereal flour, whether or not added to sours and dyes;

IX.1.7. Pastes:

a. Flour paste for botanicals, to the product obtained from the mechanical kneading of a mixture of cereal flour, leguminous or tubers, drinking water and other ingredients, whether or not added

food additives

b. Soup for soup, the product obtained by mechanical kneading of wheat flour or meal or semolina or mixtures thereof and drinking water, whether or not added to gluten and egg and, where appropriate, colouring matter and other ingredients;

IX.1.8. Prepared foods based on cereals, edible seeds, flour or mixtures thereof, products made from grains of cereals or other grains and edible seeds, healthy, clean and of good quality, whole or parts thereof (flours), prepared by physical processes, suitable for consumption directly or after cooking, whether or not added to food additives and other optional ingredients; they may be prepared by processes such as: inflated, laminated, coating, roasting, extruding or other and

IX.1.9. Botanas:

a. Botanicals, products made from flour, seeds, tubers, cereals, grains and healthy and clean fruits, which may be fried, baked and exploited or roasted and added with salt, other ingredients and food additives and

b. Seed for bottles, to the part of the edible fruit of the plants or trees, clean, healthy, with or without shell or cuticle, fried, roasted or baked, added or not of other ingredients or additives for food.

IX.2. Cooked defatted soybean meal shall comply with the following microbiological specifications:

IX.2.1. Aerobic mesophilic 50 000 CFU/g maximum, and

IX.2.2. Mohos100 CFU/g maximum.

IX.3. The pastes must comply with the following microbiological specifications:

IX.3.1. Maximum UFC/g Mohos100;

IX.3.2. Maximum CFU/g CFU/g;

IX.3.3. Escherichia coli < 3 NMP/g, and

IX.3.4. Salmonellanegative in 25g.

IX.4. Pastes filled for storage must be protected with appropriate packaging and those that have not undergone any drying process must be kept in freezing or refrigeration until before cooking for consumption.

IX.5. On the labelling of stuffed pastes, the expiry date must be indicated. In the case of non-dehydrated stuffed pastes, the following must be added: "Stay in refrigeration" or "Stay frozen", as the case may be.

IX.6. Tubers used in the manufacture of botanicals must be healthy, washed, peeled or not, clean and, where appropriate, sliced and fried with edible vegetable oil.

IX.7. Products made from flour paste shall comply with the following specifications:

IX.7.1. Physicochemical:

MAXIMO

a. Acidity as citric acid,

if applicable, and 1% and

b. Peroxide index, only

for fried flour pastes.                 70 meq/kg

IX.7.2. Pollutants:

a. Aflatoxins 15 µ g/kg, and

IX.7.3. Microbiological:

a. They must not contain pathogenic micro-organisms.

IX.8. Seeds made from seeds shall comply with the following specifications:

IX.8.1. Physicochemical:

MAXIMO

a. Dry seed moisture 7.0%,

b. Moisture in dry chestnuts 8.5%,

c. Moisture in dry chickpeas 11.0%,

d. Moisture in dry beans 12.0%,

e. Acidity as citric acid,

in your case 1.0% and

f. Peroxide index 70 meq/kg;

IX.8.2. Pollutants:

a. Aflatoxins 15 µ g/kg,

b. Arsenic (As) 0,2 mg/kg,

c. Lead (Pb) 0,5 mg/kg and

d. Mercury (Hg) 0,01 mg/kg, and

IX.8.3. Microbiological:

a. They must not contain pathogenic micro-organisms.

IX.9. Fried botanicals made from tubers must comply with the following specifications:

IX.9.1. Maximum peroxido70 meq/kg index, and

IX.9.2. They must not contain pathogenic micro-organisms.

X. Edible oils and fats.

X.1. For the purposes of this paragraph, oils and fats are defined as:

X.1.1. Edible oil, to the product obtained from agricultural products or animal species, suitable for human consumption, which has undergone extraction and, where appropriate, refining, washing, deodorizing, bleaching, hibernation or wintering, when determined by the Secretariat;

X.1.2. Mixed or composite fat or butter, to the product produced by mixing edible fats or vegetable oils with animal fats or edible sebos;

X.1.3. Lard, to the fat separated from the fatty, fresh, clean and healthy tissues of the pig (Suis scrofa) subjected to heat treatment;

X.1.4. Vegetable butter, to the product obtained by partial hydrogenation of edible vegetable oils, or by mixing of non-hydrogenated edible vegetable oils and hydrogenated edible vegetable oils or by interesterification of oils edible vegetable oils or edible vegetable oils;

X.1.5. First juice or oil stock, to the product obtained from melting by mild heating the fresh fat of the heart, membranes, kidneys and mesentery of bovine animals;

X.1.6. Edible tallow, to animal fat from the fresh, clean and healthy fatty tissues of bovine, ovine and equine animals, and

X.1.7. Margarine or oleomargarine, to the product produced by the stabilized emulsion of vegetable oils and oils or edible animals, partially hydrogenated or not, incorporated with water or milk, whey or milk solids, as well as ingredients optional and food additives.

X.2. Edible vegetable oils may be extracted by expression or with one or more of the following solvents:

X.2.1. Saturated acyclic hydrocarbons, in which chains of 5 to 8 carbon atoms predominate;

X.2.2. Cyclic hydrocarbons, in which cyclohexane predominates, and

X.2.3. Ethyl alcohol and isopropyl alcohol.

X.3. Edible oils must comply with the following specifications:

X.3.1. Present maximum humidity of 0,05%;

X.3.2. Present free acidity expressed as oleic acid, maximum 0,05%;

X.3.3. Present a peroxide index, not greater than 2 meq oxygen/kg;

X.3.4. Be free of extraneous or rancid odours or flavours;

X.3.5. Do not contain more than 1,5 mg/kg iron;

X.3.6. Do not contain more than 0,1 mg/kg of copper;

X.3.7. Do not contain more than 0,1 mg/kg lead, and

X.3.8. Do not contain more than 0,1 mg/kg of arsenic.

X.4. Repealed.

X.4.1. Tocopherols 0.03%;

X.4.2. Propyl gallate 0,01%;

X.4.3. Octyl and gallate galate

of dodecyl alone or mixed 0.01%

X.4.4. Thiodipropionic acid

and its esters 0.01%;

X.4.5. Butyl hydroxyanisole (BHA) 0,01%;

X.4.6. Hydroxytoluene butyl (BHT) 0,02%;

X.4.7. Citric acid or acid

phosphoric 0.005%;

X.4.8. Terbutil Hydroquinone

(TBHQ) 0.02%;

X.4.9. Almitate and ascorbilyl stearate 0.02% alone or mixed, and

X.4.10. Mixture of the galatos referred to in this Article with BHA and BHT, in a proportion not greater than 0,02% provided that the galatos do not exceed 0,01% established, and

X.5. The limits of the content of erucic acid and glucosinolates of the seeds of the species Brassica napus, L. O; Brassica campestris, L. O; and Brassica tournefortii shall be laid down in the relevant standard.

X.6. The edible tallow used as raw material for the manufacture of mixed or composite butter shall comply with the following specifications:

X.6.1. The peroxide index shall not be greater than 16 meq of oxygen/kg of fat, and

X.6.2. The acid index must not be greater than 2.5 mg of KOH/g fat.

X.7. In the first stock or oil stock used as raw material for the manufacture of mixed butter, the peroxide index must not exceed 10 meq of oxygen/kg of fat.

X.8. The labelling of edible oils of natural origin shall contain the following information:

X.8.1. The name of the product to be indicated in any of the following ways:

a. In the case of a mixture of two or more oils: "edible vegetable oil",

b. Where the oil comes from a single source, the common name of the seed or oil fruit from which it comes shall be specified, which shall be preceded by the following: "Pure edible oil"; and

X.8.2. The percentage of the antioxidants that are used.

X.9. The lard and the sebum must comply with the following sanitary provisions:

X.9.1. Come from animals that do not suffer from diseases that disable them for consumption as food;

X.9.2. Come from animals slaughtered in establishments that meet the established health requirements, and

X.9.3. Do not contain, in the case of edible tallow, fat from anatomical regions that present open wounds, or abscesses or tumors.

X.10. Compound fats shall be made from:

X.10.1. Edible oils of vegetable origin, hydrogenated or not, and

X.10.2. Animal edible fats and oils complying with the health requirements and specifications laid down by the Secretariat.

X.11. In the manufacture of vegetable butter and edible fats, emulsifiers of the mono or diglyceride type may be added.

X.12. The plant butter must comply with the following specifications:

X.12.1. Have a melting point of less than 50ºC;

X.12.2. Present humidity of not more than 0,05%;

X.12.3. Have free acidity less than 0,5%, expressed as oleic acid;

X.12.4. Do not contain more than 1,5 mg/kg iron;

X.12.5. Do not contain more than 0,1 mg/kg of copper;

X.12.6. Do not contain more than 0,1 mg/kg lead;

X.12.7. Do not contain more than 0,1 mg/kg of arsenic, and

X.12.8. Do not contain more than 0,1 mg/kg nickel.

X.13. Mixed or composite fats or butters must comply with the following specifications:

X.13.1. Present a free acidity of less than 1%, expressed as oleic acid;

X.13.2. Do not exceed the limits of heavy metals, laid down for plant butter, and

X.13.3. Present a peroxide rate of 1.5 meq oxygen/kg fat, maximum.

X.14. The labels of edible fats and butter must include the percentage and function of the additives used in their preparation.

X.15. 6 670 µ g of retinol (20 000 IU of Vitamin A) per kilogram shall be added to margarines or table oleomarins and margarines modified in their composition.

X.16. Repealed.

X.17. Margarines or oleomargarines must comply with the following microbiological specifications:

X.17.1. Do not contain pathogenic micro-organisms;

X.17.2. Aerobic mesophilic 500 CFU/g maximum;

X.17.3. Total coliforms 10 CFU/g;

X.17.4. 1 g negative Escherichia coli;

X.17.5. Moulds and yeasts 10 CFU/g, and

X.17.6. Negative monocytogenes listeria in 20 g.

X.18. Margarine or oleomargarine must be sold in a paper wrap for fining or other impermeable material, in which, in addition to the mandatory legends, the following labels must be indicated on their labels:

X.18.1. The content of Vitamin A expressed in µ g retinol equivalents per 100 g of finished product, and

X.18.2. The caption: "Keep in cooling."

X.19. Edible oils and fats which are reused in the frying industry shall be subject to the following:

X.19.1. Do not present unpleasant taste and smell, dark colour, foam or sediment;

X.19.2. Present a free acidity of less than 2,5% in fat and less than 2,0% in oil, expressed as oleic acid;

X.19.3. Have polar compounds not greater than 25%;

X.19.4. Have oxidized fatty acids insoluble in petroleum ether less than 1%, and

X.19.5. Have dimeric and polymeric triglycerides less than 16%.

XI. Cocoa, coffee, tea and its derivatives.

XI.1. For the purposes of this paragraph, it is understood by:

XI.1.1. Cocoa and its derivatives:

a. Cocoa, whole grain, healthy and clean, extracted from the ripe mazorcas of the trees of the species Theobroma cacao, of the family of the sterculaceae,

b. Unhusked roasted cocoa, to the grain of dried, clean, healthy and roasted cacao, to which they have been stripped of the shell, tegumentos, embryos and other impurities,

c. Cocoa, to the product obtained by the spraying of the cocoa cake, to which part of the cocoa butter has been extracted,

d. Chocolate, to the product obtained by the homogeneous mixture of variable quantities of cocoa paste, or cocoa butter, or cocoa with sugars or other sweeteners, optional ingredients and food additives,

e. Cocoa butter, to the product obtained by pressure from the cocoa paste,

f. Cocoa paste or liqueur, to the product obtained from the ground of husked roasted cocoa, practically without germ and without removing or adding any of its constituents and

g. Cocoa cake, to the product obtained by pressure from the cocoa paste, after partial extraction of the cocoa butter;

XI.1.2. Coffee and its derivatives:

a. Coffee, to the product obtained from the seeds of different species of the genus Coffea, from the family of Rubiaceas,

b. Raw or green coffee, to the healthy and clean coffee bean that has been desiccated and uncascarated to remove the exterior tegumentos and which can be decaffeinated,

c. Soluble coffee, to the product obtained by dehydration of the roasted coffee infusion and

d. Roasted coffee, to the grain of raw or green coffee, healthy and clean that has been subjected to a heat treatment, being able to be decaffeinated;

XI.1.3. Tea or infusion, to the product obtained from parts of plants which are harmless, clean, healthy, ground or not, in good condition, properly treated by infusion or by decoction in water, the infusion of which is intended for human consumption, and

XI.1.4. Sweet of vegetable fat with chocolate taste, the product containing the components of the chocolate and the cocoa butter has been replaced with other edible vegetable fat.

XI.2. The cocoa beans, according to the treatment to which they are subjected, may be:

XI.2.1. Cocoa in grain washed, dried and unfermented, and

XI.2.2. Fermented grain cocoa.

XI.3. The cocoa, in accordance with its cocoa butter content, must comply with the following:

XI.3.1. Cocoa of low fat content, with a minimum of 8% and a maximum of 13,9% of cocoa butter;

XI.3.2. Cocoa of medium fat content, with a minimum of 14% and a maximum of 19,9% of cocoa butter, and

XI.3.3. High-fat cocoa, with a minimum of 20% cocoa butter.

XI.4. Chocolate products may be added with:

XI.4.1. Whole milk, partially uncreamed, semi-skimmed or powdered;

XI.4.2. Vanilla, cinnamon or other natural savors;

XI.4.3. Vanillin and ethylvanillin or other artificial synthetic savors;

XI.4.4. Sodium chloride;

XI.4.5. Coffee;

XI.4.6. Honey;

XI.4.7. Extract from Malta;

XI.4.8. Cereals;

XI.4.9. Spices, and

XI.4.10. Butter.

XI.5. Chocolate and chocolate with milk may be added with preserved fruit such as cherries or other fruits; with oil seeds such as almonds, hazelnuts, pine nuts; with pašitas and others, which must be clean and healthy, in quantity not less than 8% for such characteristics to be displayed on the label.

XI.6. Chocolate-flavoured vegetable fat sweets shall be such as to be such as to be followed by the name of the variety of chocolate in question.

XI.7. Cocoa, coffee and its derivatives must not contain Salmonella in 25 g or other pathogenic micro-organisms and parasites.

XI.8. Cocoa, cocoa and chocolate butter must not exceed the maximum limits of the following pollutants:

Contaminant Manteca Cocoas Chocolate

of cocoa

Maximum Maximum Maximum

Arsenic (As) 0.5 mg/kg 1.0 mg/kg 0.5 mg/kg

Copper (Cu) 15.0 mg/kg 30,0 mg/kg 15.0 mg/kg

Lead (Pb) 1.0 mg/kg 2.0 mg/kg 1.0 mg/kg

XI.9. Cocoa, chocolate, coffee and its varieties must not contain more than 20 µ g/kg of aflatoxins.

XI.10. The manufacture of filled chocolates allows the use of ethyl alcohol.

XI.11. Where the products and derivatives of cocoa contain ethyl alcohol or alcoholic beverages in quantities less than 2% by volume in the finished product, the specific name must include the alcoholic ingredient used and the corresponding warning legends.

XI.12. The percentage of sugar in the finished product must be indicated on the labelling of the coffee mixed with sugar.

XI.13. The tea or infusion must comply with the following microbiological specifications:

XI.13.1. Mesophilic 1 X 106 CFU/g;

XI.13.2. Bacillus cereus 1 X 102 CFU/g;

XI.13.3. Escherichia coli Maximo 1 X 104 NMP/g;

XI.13.4.Salmonella and

Shigella absent/25 g, and

XI.13.5. Maximum 1 X 104 CFU/g moulds and yeasts.

XI.14. The products must not contain chemical and biological contaminants that may endanger the health of the consumer.

XI.15. The labelling of the tea or infusion must comply with the following:

XI.15.1. The common and botanical name shall be indicated, with the indication of the genus and species. In the case of mixtures, each of the botanical species shall be indicated, and

XI.15.2. No texts referring to therapeutic, preventive or rehabilitative effects shall be included.

XII. Prepared or semi-prepared foods.

XII.1. For the purposes of this paragraph, it is understood by:

XII.1.1. Prepared foods:

a. Prepared or semi-prepared food, the product consisting of various ingredients and condiments, which may or may not contain food additives, whether or not subjected to heat treatment, the identity of which corresponds to a specific culinary specialty; and which is semi-prepared or fully prepared for consumption and

b. Prepared food ready for consumption, which is subjected to a mechanical process such as minced or mixed, physicochemical as wet or dry heat, frying, cooling or freezing for consumption;

XII.1.2. Caldos or consomes:

a. Prawn broth or consort, to the food prepared from fresh or dried shrimp or its extract, cooked in drinking water and seasoned with spices, condiments, with or without additives for food and which may be dehydrated or in paste,

b. Chicken broth or consign, to the food prepared from chicken or chicken meat or its extracts, cooked in drinking water and seasoned with spices and condiments, with or without food additives, and which may be dehydrated or in paste and

c. Broth or const of beef, to the food prepared from fresh or dehydrated meat or its extract, cooked in drinking water and seasoned with spices and condiments with or without food additives, and which may be dehydrated or in paste;

XII.1.3. Soups:

a. Condensed or concentrated soup, to which part of the water has been removed by thermal process and which by composition must be diluted for consumption,

b. Cream soup, to the product obtained from the mixture of vegetables or tubers, added with drinking water, milk and other ingredients, spices and food additives and

c. Soup prepared with a mixture of dehydrated ingredients, to the product made from dried or dried ingredients of animal or vegetable origin, with or without the addition of farinaceous materials, sodium chloride, spices or condiments, with or without additives for food;

XII.1.4. Mole, to varieties of food products of colour and variable appearance, according to their composition, containing as basic ingredients dried or fresh chillies, water, edible oils or fats, flours, fecules, starches, salt and other spices and perfectly homogenised and ground conditions, which are presented in liquid form, paste or powder, and

XII.1.5. Stuffed pasta, to the product that results from filling the fresh pasta, with some food prepared.

XII2. The refrigeration of prepared or semi-prepared foods shall be carried out to reach and maintain a maximum temperature of 7 °C.

XII.3. The freezing of prepared or semi-prepared foods shall be carried out by the process either quickly or slowly, up to a temperature of -18 °C. Once the products are frozen they must be stored at a maximum temperature of -18 °C.

XII.4. Prepared or semi-prepared foods preserved by freezing must be ensured that they maintain their sensory characteristics, nutritional input and health quality, up to the time of their sale.

XII.5. Broths or consomes, soups, stews and moles are prepared or semi-prepared foods.

XII.6. The soups, in accordance with their composition and preparation, are classified in:

XII.6.1. Cream soup;

XII.6.2. Condensed or concentrated soup, and

XII.6.3. Mixture of dehydrated ingredients to prepare soup.

XII.7. Prepared or semi-prepared foods are classified as:

XII.7.1. Condensates;

XII.7.2. Concentrates;

XII.7.3. Dehydrated;

XII.7.4. Refrigerated, and

XII.7.5. Frozen.

XII.8. Dried caldos or consomes shall not exceed the following microbiological limits:

MAXIMO

XII.8.1. Aerobic mesophilic 500 000 CFU/g;

XII.8.2. Total coliforms 100 CFU/g

XII.8.3. Staphylococcus aureus 100 CFU/g, and

XII.8.4. Salmonella spp. in 25g.

XII.9. In soups containing ingredients which have been treated with sulphur dioxide (SO2) or other sulphurant substances, the residual quantity in the product ready for consumption shall not exceed 20mg/l as SO2.

XII.10. The mixture of dehydrated ingredients to prepare dehydrated soup shall not contain more than 1000 CFU/g of Staphylococcus aureus.

XII.11. Repealed.

XII.12. Moles and their varieties shall not exceed the following microbiological limits:

PRODUCT PRODUCT

COOKED CRUDE

CFU/g CFU/g

XII.12.1.            Mesophilic 1 000 000 100 000;

aerobes

XII.12.2.            Moulds 2 500 1 000;

XII.12.3.            5 000 2 500 yeasts, and

XII.12.4.            Negative Salmonella Negative Bacteria

spp. in 25g enteropathogens.

XII.13. The labelling of prepared or semi-prepared foods shall bear:

XII.13.1. In the case of refrigerated products, the legend: "Keep or stay in refrigeration", and the expiration date, and

XII.13.2. In the case of frozen products, the legends: "Stay in freezing at -18ºC" and

"Once defrosted is ready for consumption, it must not be frozen again."

XIII. Food for infants and young children.

XIII.1. For the purposes of this paragraph, it is understood by:

XIII.1.1 Infants and young children:

a. Infants, children not older than twelve months and

b. Children of young age, over 12 months of age and up to forty-eight months of age; the infant is included over one year to one year eleven months, and to preschool, aged two to four years;

XIII.1.2. Food for infants and young children:

a. Cereal-based foods for infants and young children, the product made from cereals added or not from other ingredients, intended to supplement the nutritional status of infants and young children, such as cereals added milk, cooked cereal flours and biscuits, among others and

b. Packaged foods for infants and young children, products that are used from the normal period of ablation of infants or young children to full and balanced feeding; are prepared to be administered directly or dehydrated to be reconstituted by dilution in water, milk or juice;

XIII.1.3. Formulas:

a. Follow-on formulae to products made from cows ' milk or other animals or with other constituents of animal or vegetable origin intended to be used to supplement or supplement the breast milk in the ablation diet for infants from the sixth month, when they are fed with breast milk or from the age of four months when they are fed with infant formula, or, when the weight of the infant is greater than 6 kg, as well as for children of young age and

b. Infant formula, to the products based on cow's milk or other mammals or other edible components of plant or animal origin, including fish, which are considered appropriate for the feeding of infants, and

XIII.1.4. Prepared cereals, food from healthy cereals, clean and free of teguments, added not less than 20% of milk solids, whether or not subjected to heat treatment, whether or not added to the product back for consumption.

XIII.2. The ingredients which may be added to processed cereal-based foods for infants and young children are as follows:

XIII.2.1. Protein concentrates or other high protein content ingredients suitable for consumption by infants and young children. Essential amino acids can be added to improve the quality of proteins, but only in the quantities necessary for that purpose and in natural forms L of amino acids;

XIII.2.2. Salt (sodium chloride);

XIII.2.3. Milk and milk products;

XIII.2.4. Eggs;

XIII.2.5. Meat;

XIII.2.6. Fats and oils;

XIII.2.7. Fruit and vegetables;

XIII.2.8. Sugars;

XIII.2.9. Malta;

XIII.2.10. Honey;

XIII.2.11. Honey of maize;

XIII.2.12. Cocoa and its products, only in products to be consumed after nine months of age and at the maximum dose of 5 %m/m dry;

XIII.2.13. Potatoes;

XIII.2.14. Starches, including those modified with enzymes and those treated by physical means, and

XIII.2.15. Vitamins, minerals and other nutrients, which may only be added in the quantities to be laid down in the relevant rules.

XIV. Seasonings and dressings.

XIV.1. For the purposes of this paragraph, it is understood by:

XIV.1.1. Dressings:

a. Dressing, to the product prepared for seasoning food, prepared with edible vegetable oil, egg, acidifying like vinegar or lemon, sugars, spices, condiments and other ingredients, which can be liquid, homogenized or in phases multiple,

b. Mayonnaise dressing, to the mixture of mayonnaise with cooked starch, salt, edible vegetable oil, egg and its derivatives, sweeteners, mustard, paprika and any other species, extract or essential oil thereof, with the exception of turmeric and the like saffron,

c. Mayonnaise, to the emulsified, creamy-looking product, made from edible vegetable oil, egg yolk and vinegar, whether or not added to lemon juice, salt, sweeteners, spices, condiments and food additives, except saffron, turmeric and thickeners and

d. Prepared mustard or yellow prepared mustard, to the food product of a more or less fluid pasty consistency of yellow colour, prepared with the flour of clean, healthy, dry and ripe mustard seed, vinegar or grape must of white wine or wine red, edible salt, sugar, turmeric and spices;

XIV.1.2. Condiments and spices:

a. Condiment, to the product of natural origin that serves to impart better flavor to the food,

b. Spice, plant or parts thereof containing aromatic, sapid or exciting substances which are used to make or improve the aroma or taste of food and drink and

c. Seasoning, condiment or mixture of these, whether or not accompanied by other ingredients that complements, gives or intensifies the taste of food;

XIV.1.3. Salt, to the product consisting basically of sodium chloride, which comes exclusively from natural sources; it is presented in the form of colourless, water-soluble and characteristic flavour crystals, which can be refined or not and

XIV.1.4. Vinegar, to the product obtained by acetic fermentation of the wine, beer, juice of healthy and ripe fruits, cereals, potable alcohol, syrup or sugars.

XIV.2. Vinegar may only be flavoured with spices and coloured with caramel.

XIV.3. Vinegar may be clarified with bentonite, land of infusoriums, land of lebrija, albumin or gelatin, which do not yield foreign substances.

XIV.4. In the milling of spices it will not be possible:

XIV.4.1. Use altered or adulterated spices;

XIV.4.2. Add any other ingredients or substances other than those permitted to prevent the agglomeration of the salt, in terms of the corresponding rules, or

XIV.4.3. Extract from spices, whole or ground, their active substances, when intended for direct human consumption.

XIV.5. On the labels of the packaging of the spices, the part of the plant where they come from should be pointed out.

XIV.6. Mayonnaise must comply with the following specifications:

XIV.6.1. Physicochemical:

a. Ethereal extract 65% minimum,

b. Protein 1% minimum,

c. Phosphorus pentoxide

per 100g of product 60 to 80mg,

d. Total acidity as

acetic acid 0.25% to 0.55% and

e. PH 4.0 maximum, and

XIV.6.2. Microbiological:

a. Aerobic mesophilic 3 000 CFU/g,

b. Total coliforms 10 CFU/g,

c. Moulds 20 CFU/g,

d. Yeasts 50 CFU/g,

e. Escherichia coli Negativa/g,

f. Staphylococcus aureus Negativa/g and

g. Salmonella spp. in 25g.

XIV.7. Repealed.

XIV.8. The microbiological specifications for mayonnaise dressings shall correspond to those indicated for the mayonnaise.

XIV.9. Repealed.

XIV.10. The prepared mustard or yellow prepared mustard must comply with the following specifications:

XIV.10.1. Physicochemical:

a. Total solids 16.5% minimum and

b. Acid acidity

acetic 4.0% maximum, and

XIV.10.2. Microbiological:

a. Aerobic mesophilic 3000 CFU/g,

b. Moulds and yeasts 20 CFU/g and

c. Salmonella spp. in 25g.

XIV.11. In the preparation of prepared mustard or yellow prepared mustard, no artificial colours, acetic acid or pyrolenous acid may be used.

XIV.12. Repealed.

XV. Sweeteners, their derivatives and confectionery products.

XV.1. For the purposes of this paragraph, it is understood by:

XV.1.1. Sugars:

a. Sugar or sucrose, to the product extracted from the sugar cane Saccharum officinarum, L. O of the sugar beet Beta vulgaris, L. Variety rapa,

b. Crystallized or cane sugar, to the product obtained from the crystallization of the sugar, presenting in the form of large and transparent prismatic crystals,

c. White standard sugar, purified and crystallized raw sugar,

d. Glass sugar, to refined or standard sugar which has been finely ground, with or without the addition of anti-caking agents,

e. Invert sugar, to the product obtained by the hydrolysis of sucrose; consisting of a mixture of glucose, fructose, sucrose, which may be present in solution, anhydrous or with a crystallization water molecule,

f. Chewing sugar, to the crystallised product, consisting essentially of sucrose, obtained by centrifuging a mixture of honey and sugar crystals, without removing the film which covers them after centrifugation,

g. Refined sugar, to the product consisting essentially of bright white sucrose crystals, with a purity of 99,5% and having undergone a refining process and

h. Lactose, to sugar from the whey of milk which is present in crystals or in powder, odourless and completely soluble in water;

XV.1.2. Sweeteners:

a. Sweetener, to the product whose predominant composition is constituted by natural sugars,

b. Syrup, to the product produced with drinking water, with a concentration of sugars in sufficient quantity to achieve the desired consistency and which has undergone heat treatment to ensure its preservation,

c. Honey of bee, to natural sweetener, obtained from nectar of flowers or exudations of plants that the bees Apis mellifera and other species collect, transform and combine with own specific substances, storing it in the honeycomb and

d. Honey of maguey, to the product that is presented as a dense liquid, of a slightly ambarino, sweet taste, obtained by partial evaporation of the concentrated, unfermented water, and

XV.1.3. Confectionery products:

a. Caramel, to the product made by cooking a mixture of sugar, glucose, or other sweeteners and water, added to other ingredients and additives for food, with or without filling,

b. Sweet imitation of marzipan, a product made with a mixture of sugar or other sweetening matter, peanut or other roasted and ground nuts, except almonds and food ingredients and additives,

c. Edible gelatin or grenetin, to the product obtained by acidic or alkaline hydrolysis of the collagen material of bones, skins or cartilage,

d. Prepared gelatine or jelly, to the product made from drinking water or pasteurised milk, gelatin or edible grade grenetine added from sugars or other sweeteners; and which may be added to food additives,

e. Chewing gum, to the product made from natural gums or synthetic gums, polymers and copolymers, added to other ingredients and food additives,

f. Ingredient for chewing gum base, substance or mixture of substances, of natural or synthetic origin, coagulated or concentrated, in addition to a softener or plasticizer, antioxidant and, where appropriate, a polymerisation controller,

g. Marshmallow, to the aerated product made by cooking sugar, glucose or other sweeteners and water, added of aerated agents, gelling agents and food ingredients and additives,

h. Mazapan, to the product made by cooking and moulding a mixture of sweet almonds and glucose or other sweeteners,

i. Peladilla, to the product made with almonds covered by one or more uniform layers of sugar or other sweeteners, which may be added to other ingredients and food additives,

j. Powder for the preparation of flavour gelatine, to the product made with a mixture of sugar, gelatin or grenetin, without edible grade taste, added to natural or artificial flavour and colouring matter,

k. Powder for the preparation of imitation gelatin, to the product made with a mixture of sugar, sodium alginate, carrageñins, gelled gum or combination of permitted gums, natural dyes and dyes and other food additives,

l. Powder for the preparation of a style or an imitation of flan, to the product obtained from the mixture of sugar, vegetable gums, with or without starch, natural and artificial sours and colours,

m. Confectionery products, to the products of sweet taste, varied texture, that inside its main components is found the sugar or other sweeteners, and may contain additional ingredients and additives for food and

n. Turron, to the prepared product, whose mass contains water, sugars, honey, egg white or gelatin, is made with almonds and added or not of fresh or candied fruits.

XV.2. In the manufacture of confectionery products, the use of anhydrous ethyl alcohol is permitted in a quantity not exceeding 1 ,99 %m/m in the finished product.

XV.3. Mononitrobenzene or other toxic substances may not be used during the extraction of honey from bee.

XV.4. Packaging that has been used for other products may not be used in the packaging of honey.

XV.5. Bee and maguey honey must not contain pathogenic micro-organisms.

XV.6. The syrups must undergo heat treatment for preservation.

XV.7. Repealed.

XV.8. Syrups must not contain moulds, pathogenic micro-organisms, or parasites.

XV.9. The powder for preparing flavour gelatine shall comply with the following microbiological specifications:

MAXIMO

XV.9.1. Total coliforms 10 000 CFU/g;

XV.9.2. 100 CFU/g; moulds and yeasts

XV.9.3. Staphylococcus aureus Negativo, and

XV.9.4. Salmonella spp. in 25g.

XV.10. Repealed.

XVI. Foods and non-alcoholic beverages with modifications to their composition.

XVI.1. For the purposes of this paragraph, it is understood by:

XVI.1.1. Non-alcoholic foods and beverages with modifications in their composition, those to which one or more of their nutrients are reduced, eliminated or added, such as carbohydrates, proteins, lipids, vitamins, minerals or fibres Dietary,

XVI.1.2. Added product, which has been added to it, whether or not they are normally contained in the product,

XVI.1.3. Product with less content or removal of nutrients, products to which the content of one or more nutrients has been reduced or removed in relation to its original concentration, and

XVI.1.4. Restored products, those that have been added to one or more of the nutrients that have been lost during processing, in a concentration equal to that contained in the original food.

XVII. Dietary supplements.

XVII.1. The quantity of vitamins and minerals in these products shall not exceed, per day, the following limits:

XVII.1.1. Vitamins:

DOSIS

Vitamin A/Retinol 1000 µ g

Ac. Folic 400 µ g

Beta Carotene 15 mg

Biotin 300 µ g

Vit. B1/Tiamine 15 mg

Vit. B2/Riboflavin 18 mg

Vit. B3/Niacin 25 mg

Vit. B5/Ac.Pantothenic 20 mg

Vit. B6/Piridoxin 10 mg

Vit. B12/Cianocobalamin 12 µ g

Vit. C/Ac. Ascorbic 300mg

Vit. D 10 µ g

Vit. E/d-a -tocopherol 200mg

Vit. K 30 µ g

XVII.1.2. Minerals:

DOSIS

Calcium 1200mg

Copper 3 mg

Chromium 200 µ g

Fluor 1 mg

Phosphorus 1200mg

Iron 20 mg

Magnesium 500 mg

Manganese 7.5 mg

Molybdenum 250 µ g

Selenium 100 µ g

Iodine 200 µ g

Zinc 20 mg

XVII.2. Dietary supplements must not contain chemical and biological contaminants that may endanger the health of the consumer.

XVII.3. The label of the products referred to in this paragraph shall include:

XVII.3.1. The generic and product-specific naming;

XVII.3.2. The list of full ingredients and in order of quantitative predominance; in products which include in their formulation herbs, whether or not they are mixtures, must be included both the usual or common name, and the corresponding botanical name, signalling gender and species;

XVII.3.3. The component (s) that may pose a medium or immediate risk to the health of consumers;

XVII.3.4. The nutrition declaration;

XVII.3.5. The name and address of the manufacturer or importer, packer, maquilador and national or foreign distributor, as the case may be;

XVII.3.6. Instructions for their conservation, use, preparation and consumption;

XVII.3.7. The identification of the batch;

XVII.3.8. The legend of warning set forth in Article 216 of the Law, as well as the legend: "The consumption of this product is the responsibility of the person who recommends it and who uses it", which must be in capital letters, with the same type of letter as the information contained in the information surface, in clear characters, easily legible, in bold bold and contrasting colours with the background, in accordance with the following:

a. Area of the minimum Height surface of the

information on cm2 typeface in mm

Up to 20.9 0.5

21 to 40.9 0.8

41 to 160.9 2

Greater than 161 3,

b. Around the legends there must be an information free space of at least once the size of the letter and

c. When the legends are presented one after the other, the free space around both must be at least once the size of the letter, and

XVII.3.9. The expiration date.

XVII.4. The nutrient declaration referred to in the preceding paragraph shall include at least the following:

a. Product

Per 100g or ml. per serving

Energy content _________________ kcal

Proteins _________________ g

Fats (lipids) _________________ g

Carbohydrates

(carbohydrates) _________________ g

Sodium _________________ g

Specific Content

of each of the vitamins

and minerals containing * _________________mg or µ g

* Vitamins and minerals may be declared in international units, provided that, in brackets, the quantity in units of the General System of Units of Measures is indicated,

b. Any other nutrient or component that is included or highlighted in the label, attachment or advertising information and

c. In the case of fats, all or none of the following, according to the type of product:

polyunsaturated fat ________g; monounsaturated fat ________g; saturated fat _______g; cholesterol ______mg.

XVIII. Alcoholic beverages.

XVIII.1. The labelling of the products referred to in this paragraph shall bear the legend precauthorship as laid down in the Law, in contrasting colour with the background, in condensed helvetic letter, in clear and easily readable, according to the following table:

MINIMUM HEIGHT VOLUME

OF THE TYPE

OF LETTER

From 0 To 50 Ml 1.5mm

50.1 to 190 ml 2.0mm

From 190.1 to 500 ml 2.5mm

500,1 up to 1000 ml 3.0mm

From 1000,1 to 4000 ml 5.0mm

Over 4000 ml 7.0mm

Around the legend there must be a free space of at least 3 mm.

The precautious legend may also appear in the stopper or in the skirt of the square bracket, provided that it is visible and not covered by any type of seal, doorbell or envelope that prevents the consumer from reading the complete legend, with the same characteristics as indicated for the labelling in the previous fractions.

In the packings and packing cartons, with the exception of the presentations referred to in the second paragraph of Article 179 of this Regulation, the legend shall additionally be held at the top and side faces, in characters not less than 4 mm.

The labels may contain the classification indicated in Article 176 of this Regulation, which, when used, shall appear as stated in that Article and shall not be used for promotional purposes, or for advertising of the products. The texts of the precautious legends may not be modified or used superlatives relating to the classification.

XX. Perfumery, beauty and grooming products.

XX.1. For the purposes of this paragraph, it is understood by:

XX.1.1. Perfumery and beauty products for facial or body use:

a. Oil, the purpose of which is to keep the skin surface clean, hydrated and flexible, consisting of one or more oils of animal, vegetable or mineral origin,

b. Adhesive for eyelashes and prostizas, to the product consisting basically of latex or compounds derived therefrom in an organic solvent,

c. Antiperspirant, to the product containing substances with slightly astringent action, which tends to reduce the size of skin pores and to limit the passage of moisture in local areas of the body,

d. Bubble bath, to the body cleaning product that provides abundant foam at low concentrations of detergents,

e. Corrector, to the product similar to facial or body application makeup, which is used to cover or hide the eyes, small spots and imperfections of the skin,

f. Facial or body cream, to the unctuous preparation of skin application, which is used as a vehicle of harmless substances with diverse action that benefit the skin,

g. Cosmetics, perfumery and beauty products that through suitable technical means can modify the natural odor of the body and maintain and perfect its aesthetics,

h. Depilatory, to the product with substances that when applied on the skin removes the surface hair without injuring it,

i. Dermolimpiator, to the product consisting of synthetic surfactants, which may be added with soap, flavouring or other additives,

j. Deodorant, to the product containing one or more ingredients that suppress or diminish the malodor of perspiration, prevent their development or effect both actions,

k. Epillatory, to the mixture of waxes and resins that, previously melted, are applied on the skin and, once cooled, is removed to extract the hair along with its bulb and hair papilla to delay its appearance,

l. Toilet soap, to the product that regardless of its physical state, is obtained, either by the saponification of fats and oils of natural origin, by the neutralization of fatty acids or by the mixture of substances, and that can contain perfume and other additives of natural or synthetic origin, which confer on it some cosmetic property, the physical, chemical or physicochemical action of which facilitates the cleansing and hygiene of the skin,

m. Facial or body lotion, to the liquid product that may contain alcohol and other ingredients that determine your specific action, such as moisturizing, softening, astringent, refreshing, cleaning or defusing, among others,

n. Make-up, to the skin application product, which is used to cover small imperfections, give a specific skin tone or avoid excessive brightness, and which is made up of a mixture of dyes and a vehicle,

n. Eye makeup, to the product, whatever your presentation, that applies in the area around the eyes to improve your appearance,

or. Mask, the facial application product for a given time, a presentation and a diverse composition that is used to clean, soften, moisturize, astringir, condition the skin or for other beneficial actions on it,

p. Perfume, cologne and extracts, to the mixture of aromatic products of natural or synthetic origin, generally diluted in alcohol and other inert vehicles to be applied to the skin,

q. Cosmetic treatment product, the perfumery and beauty product that attempts to mitigate or prevent deficiencies or alterations in the functioning of the skin or which modifies the structure of the skin,

r. Preparations for before and after shaving, consisting of surfactants and cooling substances, in a vehicle that determines their presentation and which is used to reblender the hair and to condition the skin,

s. Product for the care of nails, to the mixture of resins in organic solvents, which may contain pigments and other additives or hardening substances which are applied on the nail in order to form a film to prevent its cracking, imparting color, shine, repair, improve appearance, thickened or eliminate frailty, or thickening it,

t. Product for the cleaning of the hands, consisting of aliphatic solvents, kerosene and oils, among others, which can be added as emollients to improve the application properties and prevent the loss of skin fat and which is used no need to wash them with soap and water,

u. Product for lips, consisting basically of a vehicle such as waxes, oils, fats or other innocuous, which can be added to colours and which according to its composition can impart colour, gloss or protection to the lips,

v. Perfumery and beauty products, intended for application directly to the skin, its attachments and fannies, the purpose of which is to beautify, improve the appearance and preserve the cleanliness and pulchitude of the people,

w. Hypoallergenic perfumery and beauty products, which do not cause adverse reaction to the skin of sensitive individuals,

x. Cuticle remover, to the product used to reblender the cuticle, facilitating its removal,

y. Removal or removal of enamel, the product consisting of organic solvents which may contain small amounts of lipids to counteract the drying action of such solvents,

z. Blush, to the product consisting of a mixture of colours and a vehicle which is applied to the cheeks to impart colour of a given tonality,

aa. Salts for the bath, mixtures of soluble salts, perfume and dyes formulated, in most cases, to soften the water and

bb. Talc, to the powder mixture, which has a hygienic purpose, which absorbs moisture, fat or sweating of the skin, with or without additives and optional ingredients;

XX.1.2. Grooming products:

a. Starch or sizing, to the substance or mixture of substances that serves to increase the rigidity of the fabrics or to facilitate ironing,

b. Flavouring of the environment, the substance or mixture of substances that mask odours and impart aroma to the environment,

c. Bleach, the substance or mixture of substances which, by physical, chemical or physico-chemical action, impart greater whiteness and may open up the fabrics,

d. Disinfectant, to the substance or mixture of substances that remove or decrease the development of microorganisms from the surfaces where they are applied,

e. Desmanchador, to the substance or mixture of substances that clean or remove stains from the surface where they are applied,

f. Deodorant of the environment, the substance or mixture of substances that prevents or masks the odours of the environment,

g. Detergent, to the mixture of substances whose function is to reduce the surface tension of the water, which exerts a humectant, emulsifying and dispersing action, and facilitates the removal of dirt, stains and fats, which can be added to other ingredients and additives,

h. Soap, to the product that regardless of its physical state is obtained, either by the saponification of fats and oils, by the neutralization of fatty acids or by the mixture of substances, and that can contain perfume and other additives of origin natural or synthetic, and whose physical, chemical or physicochemical action facilitates cleanliness and hygiene,

i. Cleanser, substance or mixture of substances which, by means of physical action, chemistry or a combination of both, facilitates the release of dirt particles and

j. Remover, to the mixture of substances with solvent properties which, by means of their physical or physico-chemical action, facilitates the release of soils;

XX.1.3. Insect repellent for human use, the inoculum product which, when it comes into contact with insects, either directly or through a gaseous phase, is scared away by avoiding the bite, and which can be applied directly to the skin or to the skin. clothing;

XX.1.4. Sunscreens and sunscreens:

a. Self-tanning, to the product that produces a temporary pigmentation similar to the tanning by effects of the ultraviolet rays coming from the sun, but without the action of ultraviolet rays to intervene,

b. Sun blocker, to the product that is applied to the skin producing a continuous layer whose purpose is to prevent the passage of the solar radiations,

c. Tanner, to the product that accelerates the pigmentation of the skin, by effect of the sun rays, mixed or not, added or not of sun filters and

d. Sunscreen or sunscreen, to the product containing one or more solar filters on a vehicle that determines its presentation and which applies to the skin, and produces a film to prevent or reduce the harmful effects of solar radiation or Assist with skin tanning without any adverse effects on the skin;

XX.1.5. Hair perfumery and beauty products:

a. Conditioner, to the product that is used to protect the hair, restore the hair sheath, fill cracks, smoothen or attach cuticle scales and leaves it bright, natural appearance and easily manageable,

b. Alaciator, to the product used to partially or totally decrease the wavy hair waver,

c. Shampoo or shampoo, to the product that is used to remove from the skin, hair and body, excess fat and accumulated particles,

d. Decolorant, to the product consisting of substances having the function of producing hair pigment degradation,

e. Rinse, to the product that is used after the shampoo or shampoo, to neutralize the electrical charges of the surfactants contained therein, in order to leave the hair easily manageable,

f. Fixative, to the product used to preserve the hair in place or to model it, preventing the hair from taking a different position than the desired one,

g. Gel, colloid in which the dispersed phase is combined with the continuous phase, forming a mass of gelatinous consistency used as a vehicle in beauty products,

h. Product for permanent, to the mixture of substances that wavy the hair, modifying it chemically in its keratinous structure,

i. Dye, to the product, whatever its presentation, that imparts color to the hair or resets its original color, with an aesthetic purpose; according to its formula, can deposit the color on the surface of the hair without penetrating into it and disappear to the wash it, or wash it, which is made with low molecular weight direct dyes that gradually disappear and the one in which colourless substances are used which are transformed into coloured hair as a result of chemical reactions diverse that penetrate into the same to impart color in a more permanent way and

j. Treatment or hair lotion, to the product that remains in the skin of the skin, helps the beautification and improvement of the hair, modifying its greasy or dry characteristics, and

XX.1.6. Other:

a. Natural essential oils and their mixtures, to volatile products, whether concentrated or not, of oily consistency, extracted from plants, of which they constitute the olorous or sapid principle, which may be mixed and added as flavourings natural and

b. Cleaning wipes, to small canvases of cotton fabric, of cellulose or of any other inert material impregnated with liquid preparations with cleaning properties.

XX.2. The microbiological limits for perfumery and beauty products shall not exceed the following:

XX.2.1. Aerobic micro-organisms:

a. Not more than 500 CFU/g or ml in children's products and for application in the eye area, and

b. Not more than 1 000 CFU/g or ml for other products, and

XX.2.2. Moulds and yeasts not more than 100 CFU/g or ml,

XX.2.3. Negative Escherichia coli/g or ml,

XX.2.4. Salmonella spp. in 25 g or ml,

XX.2.5. Pseudomonas spp./g or ml and

XX.2.6. Staphylococcus aureus negative/g or ml.

XX.3. One or more preservatives may be included in the production of perfumery and beauty products to inhibit the development of micro-organisms harmful to health.

XX.4. The Secretariat may ask manufacturers of cosmetic treatment products for the following information:

XX.4.1. Description of the product, in which it is noted:

a. Name of each ingredient, scientific name, in the case of plants, monograph for non-common substances and the technological justification for their use and

b. Quantitative formula;

XX.4.2. Mode of employment, and

XX.4.3. Sample of the original label and advertising material.

XX.5. The labelling of the perfumery and beauty products sold in bulk shall be such as:

XX.5.1. The generic and specific naming;

XX.5.2. The name and address of the manufacturer, and

XX.5.3. The manufacturing batch number.

XX.6. The labelling of insect repellents used on the skin or on clothing shall contain:

XX.6.1. Legends that refer to the following aspects:

a. "Don't be left within reach of children,"

b. "Don't apply near the eyes"

c. "In case of any reaction to the product, discontinue use" and

d. "In case of accidental ingestion, get medical help";

XX.6.2. The percentage of active ingredient in the ingredient declaration, and

XX.6.3. The minimum application distance, as well as the indication that for its facial use it shall be applied with the hands, in the case of the aerosol-packed products.

XXI. Additives.

XXI.1. For the purposes of this paragraph, it is understood by:

XXI.1.1. Additives:

a. Repealed.

b. Repealed.

c. Repealed.

d. Repealed.

e. Repealed.

f. Repealed.

g. Repealed.

h. Repealed.

i. Repealed.

j. Repealed.

k. Repealed.

l. Repealed.

m. Repealed.

n. Repealed.

n. Repealed.

or. Repealed.

p. Repealed.

q. Repealed.

r. Repealed.

s. Repealed.

t. Repealed.

u. Lacquer, to the product prepared by the suspension or precipitation of some artificial dye, on an insoluble compound,

v. Repealed.

w. Oxidant, to the substance or mixture of substances which by oxidation process conditions or maintains certain characteristics in some ingredients of the products; which can also be used as bleach and

x. Pigment, to the substance that has the property of being insoluble in hydrophilic and lipophilic media and that has the property of imparting color to the medium containing it by the dispersion it has in it, elaborated from the fixation of a color natural or synthetic on a substrate permitted or obtained from a mineral source and which has subsequently been subjected to safety-proof tests which allow its use in food and perfumery, beauty and grooming products or in any part thereof and that, directly or through its reaction with other substances it is able to impart the color that characterizes;

XXI.1.2. Concentrates:

a. Artificial concentrate, to the product containing artificial aromatic substances, which may be added to natural aromatic substances, fruit juices and additives,

b. Artificial concentrate with fruit juices, to the product corresponding to the composition of the artificial concentrates, but containing at least 50% of the juice or pulp of the fruit or the equivalent quantity of the fruit or juice concentrated,

c. Essential oil concentrate with fruit juice, essential oil containing not less than 50% of the juice or pulp of the corresponding fruit or its equivalent of the concentrated juice, may be added of additives with the exception of substances artificial synthetic aromatics,

d. Fruit concentrate, to the product containing 90% of the juice or pulp of the corresponding fruit or of the equivalent of the pulp or juice concentrate, which may be added to colouring, emulsifying or other additives, with the exception of substances Artificial aromatics,

e. Non-natural concentrate of essential oils, to the product obtained from natural essential oils, which may be added to fruit juices and other additives, with the exception of artificial aromatic substances and

XXI.1.3. Oils, essences and extracts:

a. Natural essential oil and its mixtures, to the volatile product, whether concentrated or not, of oily consistency, extracted from the plants, of which it is the olorous or sapid principle, which can be mixed and added to natural flavourings,

b. Artificial base, to the product obtained by mixtures of artificial aromatic substances, may contain essential oils and up to 10% ethyl alcohol, propylene glycol and other diluents,

c. Artificial essence, to the product obtained by dilution of the artificial bases in ethyl alcohol, propylene glycol, lactose or other appropriate diluent, or by direct preparation from its components,

d. Natural essence, to the product obtained by dilution of the natural essential oils in ethyl alcohol, propylene glycol or other diluent and

e. Extract and extract, aromatic or savored, to the product obtained from the plants by maceration, percolation, distillation or other procedures to extract the main savors and flavourings;

XXI.1.4. Repealed.

XXI.1.5. Adjuvants:

a. Processing aid, to the substance or matter, excluding appliances, utensils and additives, which is not consumed as a food ingredient by itself, and is intentionally used in the manufacture of raw materials, foodstuffs or their ingredients, to achieve some technological purpose during treatment or processing, which may result in the unintended, but unavoidable, presence of residues or derivatives of the final product and

b. Colour adjuvant, to the substance used to intensify, retain or develop colour.

XXI.2. Additives in general shall not exceed the maximum limit of pollutants as follows:

XXI.2.1. Arsenic not more than 3mg/kg;

XXI.2.2. Heavy metals, not more than 40mg/kg, and

XXI.2.3. Lead, not more than 10 mg/kg.

XXI.3. They are considered as natural organic dyes, products that impart their own color, either alone or mixed with others.

XXI.4. The colours may be mixed with each other in order to obtain certain chromatic shades, provided they do not constitute a health risk.

XXI.5. It may be added to the mixture of dyes, vehicles or harmless excipients, such as sodium chloride, sugars, dextrin, edible oils and fats, glycerin, propylene glycol, drinking water and sodium hydroxide.

XXI.6. For the sale of synthetic organic dyes, organic minerals, minerals and lacquers, the manufacturer shall supply the buyer, its analysis with purity, specifications and limits of contaminants.

XXI.7. The labelling of additives shall provide the following information:

XXI.7.1. The additives used as raw materials shall indicate the generic name, the chemical name and the common name, in addition to the specifications required;

XXI.7.2. Non-colouring additives shall indicate:

a. The quantity and mode of employment,

b. The name and technological function of each of the additives, in the case of several additives,

c. The percentage and function of the preservatives, antioxidants or any other limiting substance they contain and

d. The power declaration, in case they have it;

XXI.7.3. In the case of flavouring and flavouring additives, the name of each sater or flavouring is not required, but only the name, in accordance with the relevant classification;

XXI.7.4. In the case of permitted natural organic colorants, they must declare the name as set out in the relevant list;

XXI.7.5. In pure colouring additives for products, the name of the synthetic organic dye or artificial dye and the concentration of the pure dye shall be indicated;

XXI.7.6. If this is a mixture of the colours indicated in the previous paragraph, the colour tone, the sum of the concentrations of the colorants as a percentage, as well as the excipients used must be shown.

XXI.7.7. In the case of a colouring lacquer, the concentration of the colouring lacquer and the corresponding concentration of the pure dye must appear, and

XXI.7.8. In the case of products containing a mixture of synthetic organic colouring agents or artificial colours, the name of the colouring agent shall be indicated in the list of ingredients, the percentage of the sum of the colour lakes and the percentage of the sum of pure dyes of the lacquers.

XXII. Packaging and packaging of products.

XXII.1. For the purposes of this paragraph, it is understood by:

XXII.1.1. Primary packaging, to which it contains the product and which comes into contact with it; which aims to protect and preserve its physical, chemical and microbiological integrity, and

XXII.1.2. Secondary pack, to which it contains the primary package.

XXII.2. The packaging of products for human consumption must not give up harmful substances to health.

XXII.3. Wood may not be used as primary packaging material for food.

XXII.4. Packaging of products which have been irradiated must not have been damaged or altered to make them unfit for use.

XXIII. Product irradiation.

XXIII.1. For the purposes of this paragraph, Gray (Gy) is defined as the unit of measure of the amount of energy absorbed by a product and is equivalent to 1j; of energy per kg of irradiated product.

XXIII.2. Ionising radiation applicable to products, raw materials and additives must come from the following sources:

XXIII.2.1. Gamma rays, from sealed sources containing the isotope Cobalt 60 (Co-60) or the isotope Cesium 137 (Cs-137);

XXIII.2.2. Electron beam generated by an electron accelerator at energy levels not exceeding 10 million electron volts (10 Mev), and

XXIII.2.3. X-ray, generated by machines that work at 5 million electron-volts (5 Mev), or lower.

XXIII.3. The records referred to in Article 222 (V) of this Regulation shall be kept for a period of five years, which shall be provided to the health authority where it so requires in writing.

Such records should contain the following:

XXIII.3.1. The name of the treated products;

XXIII.3.2. The amount of irradiated product;

XXIII.3.3. The data of the physical or moral person who delivered the products for their irradiation process;

XXIII.3.4. The identification lot;

XXIII.3.5. The operation logbook;

XXIII.3.6. The source of radiation;

XXIII.3.7. The calibration of the source;

XXIII.3.8. Dosimetry;

XXIII.3.9. The distribution of the dose in the product, and

XXIII.3.10. The date of irradiation.