The so-called "Machinery Directive" has undergone significant developments since the adoption of Council Directive 89 /392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery. Directives 91 /368/EEC and 93 /44/EEC extended their scope and Directive 93 /68/EC amended certain "horizontal" aspects resulting from the updating of the general rules of the so-called "New Approach" established by Council Resolution of 7 May 1985 on a new approach to harmonization and standardization. All this had their correspondence in the Royal Decrees 1435/1992 of 27 November and 56/1995 of 20 January.

In order to facilitate the reading of the Community texts, the European Commission addressed the task of recasting in one only all those who will deal with the same subject. Thus, in the case of the machinery directive, Directive 98 /37/EC was drawn up, as a result of the four cited above. Since the directives only oblige the Member States in terms of the results, a new royal decree was not deemed necessary to transpose Directive 98 /37/EC, as this did not imply any variation in the framework of rights and obligations previously established.

However, Directive 98 /79/EC of 27 October on 'in vitro' diagnostic medical devices has again, by means of Article 21, amended the scope of Directive 98 /37/EC.

The principles of the "New Approach" and how to translate them into a horizontal instrument applicable to all the directives adopted within that framework have been discussed for some time. However, the European Commission and the Member States considered that the completion of these discussions could not be expected, given the complexity of the machinery directive, the evolution of other directives and the experience gained in dealing with problems arising from the previous text, added to the demand to define more specifically the scope of the existing directive and the concepts relating to its implementation, as well as to improve other elements of the directive, all of which was of such a magnitude that it required the drafting of a new text, although it was trying to keep the previous structure, to facilitate the transition between the two.

Directive 2006 /42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95 /16/EC is the result of that decision. It was published in the Official Journal of the European Union of 9 June 2006, stating on 29 June 2008 as the deadline for Member States to adopt the internal provisions necessary to accommodate their provisions and on 29 December 2009, from which they are to be effectively implemented.

Consequently, this royal decree is intended to transpose the provisions of that directive into Spanish domestic law.

The Spanish Constitution, as well as the Act of Accession to the European Economic Community (today the European Union) established the two main basic legal supports that underpin the subsequent normative development in our country, within which, as it could not be otherwise, is the economic activity and, in particular, the regulations regarding the safety of facilities and products.

Thus, Law 21/1992, of July 16, of Industry, established the new legal framework in which industrial activity is unravels. The purpose of this law, as set out in Article 2 thereof, is industrial safety and, in turn, the purpose of this law is, in accordance with Article 9, "the prevention and limitation of risks, as well as the protection against accidents and accidents capable of causing damage to persons, flora, fauna, property or the environment, arising from industrial activity or from the use, operation and maintenance of installations or equipment and the production, use or consumption, storage or disposal of industrial products".

This royal decree therefore has its foundation in the aforementioned Industry Law.

The harmonised application of Directive 2006 /42/EC requires that, as equivalent to the provisions of this Royal Decree, any other decree issued with the same objective by the other Member States, and third parties which maintain agreements in this regard with the European Union, as well as the direct references made to the said Directive in documents implementing it, be regarded as equivalent, since it is not possible to require references to each and every one of the Member States ' provisions in documents from manufacturers, notified bodies or in the harmonised standards.

Since the directive is addressed to the Member States, some of its forecasts cannot be reflected in the internal text but, where appropriate, as a particular adaptation to the Community system. In addition, as regards the obligations of manufacturers, the rules must be exactly those set out in the directive.

In the field of theoretical application of the Directive there are machines-fully corresponding to the definition of 'machine' which makes the directive-covered by other directives which are considered to be more specific, which is why it was estimated that as clear a border as possible should be drawn. So, for example:

(a) Agricultural and forestry tractors are primarily governed by Directive 2003 /37/EC (which is incorporated into Spanish legislation by Order CTE/2780/2003 of 8 October), although it was considered that this does not deal with all the hazards to which the machinery directive is concerned. For this reason, a transitional solution was agreed to no longer apply the requirements of the machinery directive as they were covered by tractors, which would be the only one relevant in the future.

(b) Motor vehicles and their trailers are covered by Directive 70 /156/EEC, with their modifications and the vehicles of 2 and 3 wheels by Directive 2002 /24/EC (both transposed by Royal Decree 2028/1986 of 6 June 1986 and their amendments) but those Directives only concern the conditions required for vehicles to circulate. As a result, the exclusion of vehicles does not apply to machines which are mounted on them.

c) Many of the machines are operated by their connection to the low voltage power grid, which is why Directive 73 /23/EEC (so called Low Tension), as amended by Directive 93 /68/EEC (Royal Decree 7/1988 of 8 January 1988, concerning the safety requirements of electrical equipment intended for use in certain voltage limits, as amended by Royal Decree 154/1995 of 3 February 1995) applies to them. However, it was considered appropriate to deal particularly with a number of machines in sectors traditionally covered by this Directive, excluding them from the machinery directive, and the only one to be implemented, rather than both, will be the low-voltage directive.

(d) It was considered that the lifts with speed not exceeding 15 centimetres per second, currently subject to Directive 95 /16/EC (Royal Decree 1314/1997 of 1 August, laying down detailed rules for the implementation of the Directive of the European Parliament and of the Council 95 /16/EC on lifts, as amended by Royal Decree 57/2005 of 21 January 2005), were subject to requirements which were too demanding, and have therefore been removed from the Directive to include them in the new machinery directive, but without forgetting to reinforce the requirements of this Directive in order to bring them into line with those requirements. apparatus. At the same time, an accuracy of the "cabin" concept has been made in Directive 95 /16/EC, which becomes known as the "passenger compartment" in order to avoid discussions on the definition of the lift itself. All this, through the express amendment of that directive.

e) Fixed appliances, which are used during construction works for buildings for the lifting of persons, with or without loads, but not intended to work on them, were still subject to the national regulations of the Member States, because they are excluded from both the machinery directive and the one of lifts (in Spain, in particular, they are currently regulated by the Regulation of Lifting Appliances for Works, adopted by Order of 23 May 1977). With the inclusion of these devices in the new machinery directive, the harmonization of this type of products is carried out, which also benefit from free intra-Community trade.

(f) Finally, arms, including firearms, are subject to Directive 91 /477/EEC and therefore continue to be excluded from the machinery directive. On the other hand, it has not been considered appropriate for portable explosive-charging machines and other portable impact machines designed solely for industrial or technical purposes to maintain this situation, for the fact that they are subject to the Convention for the reciprocal recognition of the handfuls of portable firearms tests, Regulation of the International Permanent Commission (CIP) and Annex I and II of 1 July 1969, ratified by Spain by means of an instrument of ratification of 22 January 1973, since it is only signed by a few States and has limited requirements. In the light of the international commitments of the signatory States of the Convention, a transitional period of 5 years is granted to accommodate the new situation.

On the other hand, where other provisions which apply Community directives and which cover the dangers detailed in Annex I to this royal decree are in force or are in force for certain machines, these specific provisions shall apply only.

In another order of things, Directive 2006 /42/EC refers both to the placing on the market of machinery and to the placing on the market of machinery, and therefore also applies to those manufactured for its own use.

Member States retain their right to lay down the requirements they deem necessary to ensure the protection of persons, provided that this does not entail modifications of the machinery in a way already covered by the Directive.

Generally speaking, the use of machines is regulated by another Community Directive (Directive 89 /655/EEC, and its amendments, on minimum conditions for the use by workers in the work of the work equipment, applied in Spain by Royal Decree 1215/1997 of 18 July 1997 and its amendments in the field of the Law on the Prevention of Occupational Risks), together with other more specific provisions, such as the supplementary technical instructions MIE-AEM 2 and MIE-AEM 4 of the Regulation on Elevation and Maintenance, relating to detachable tower-cranes for self-propelled works and cranes, respectively.

In order to be able to benefit from the effects of the directive, machinery must comply-with the principles of "integration of safety in design and manufacturing"-to be met-the so-called "essential safety and health requirements" which ensure the safety of the machinery, taking into account the state of the art at the time of manufacture and the technical and economic imperatives, and be the subject of a correct installation and maintenance. The essential safety and health requirements should be applied with discernment, as some are of general scope, and others are aimed, in addition, at certain types of machinery or hazards. All this in the framework of certain procedures for the assessment of conformity, provided for in the light of the importance of the risks involved in the use of machinery. The following caveats are provided:

(a) "quasi-machines", a concept introduced to enable certain mechanical assemblies to be able, by means of a specific procedure, to benefit equally from free movement, even if the requirements of the Directive do not apply in full.

(b) The machines offered at fairs, exhibitions and similar events, where the machines are not required to comply with the requirements of the Directive, but it is necessary to inform the interested parties accordingly and of the impossibility of acquiring such machines under such conditions.

Directive 2006 /42/EC indicates that the design and manufacture of machinery carried out in accordance with the relevant harmonised standards laid down by the European standardisation bodies are in conformity with the relevant essential requirements, from the time of publication of the references of those standards in the Official Journal of the European Union, which makes it easier for manufacturers to comply with their obligations and is also useful for their control. For information purposes, the publication of their equivalent Spanish standards is set out in the "Official State Gazette" by the Ministry responsible for industrial safety. In any case, the rules always keep their status as voluntary.

Since the CE marking, as the external sign of conformity of the machinery with the Directive, is the only mark guaranteeing such conformity, the prohibition of any marking which may mislead third parties on the meaning of the CE marking, on its logo or on both at the same time, is hereby established. In order to avoid any confusion between the CE marking which may appear on certain components and the CE marking corresponding to the machine, the latter marking is determined to be affixed together with the name of the manufacturer or his authorised representative.

The full responsibility for the conformity of the machines is conferred on the manufacturers of the machines, without prior control by the public administrations. As a counter-position, market surveillance is essential, and it also guarantees the correct and uniform application of the directives, and the directive therefore strengthens the mechanisms for the Member States, which are responsible for the directive, to carry it out harmoniously, taking into account the guidelines drawn up by the European Commission.

In the context of this market surveillance, restrictive measures are imposed on the marketing of certain machinery, which do not comply with the provisions of the Directive, including the withdrawal from the market. The directive sets out safeguard mechanisms which the Member States must observe in order to achieve this in a common Community framework. The Community control action may be directed against specific non-compliances of certain machines, against certain general types of machinery whose technology is considered inappropriate in order to achieve the required level of safety or against harmonised standards where they do not satisfy the requirements they claim to cover.

It is for the Member States, as determined by the Treaty establishing the European Community (TEC) and expressly stated in the Directive, to ensure in their territory the safety and health of persons, in particular workers and consumers, as well as, where appropriate, domestic animals and property, in particular in the light of the risks arising from the use of machinery. A system of effective, proportionate and dissuasive sanctions should be envisaged.

To do so, the violations of the provisions of this royal decree will be classified and sanctioned in accordance with the provisions of Title V of Law 21/1992, of July 16, of Industry.

In addition to possible sanctions, other restrictive measures on the marketing or use could be adopted by the competent administration in order to preserve security. In any event, the addressees of any decision taken pursuant to this royal decree shall be aware of the reasons which led to the adoption of that decision and the resources available to them, in accordance with the legislation in force.

The leading industrial safety management body of the Ministry of Industry, Tourism and Trade is responsible for the development of a non-binding guide, as aid to the various actors concerned for the best understanding of the regulatory requirements.

This regulation is of a basic regulation and contains forecasts of an exclusive and markedly technical nature, so the Law is not an ideal instrument for its establishment and its approval is justified by means of a royal decree.

The project of this royal decree has been consulted to the autonomous communities, as well as to entities related to the sector, known and considered to be more representative, in accordance with the provisions of article 24.1.c) of Law 50/1997 of 27 November of the Government. This royal decree has also been the subject of a report by the Council for the Coordination of Industrial Security, as provided for in Article 2 (d) of Royal Decree 251/1997 of 21 February.

In its virtue, on the proposal of the Ministers of Industry, Tourism and Trade, and of Labor and Immigration, with the prior approval of the Minister of Public Administrations, in agreement with the Council of State, after deliberation of the Council of Ministers at its meeting of October 10, 2008,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object and scope of application.

1. The purpose of this royal decree is to lay down the requirements relating to the placing on the market and putting into service of machinery, in order to ensure the safety of machinery and its free movement, in accordance with the obligations laid down in Directive 2006 /42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95 /16/EC.

2. This royal decree will apply to the following products:

a) The machines.

b) The interchangeable equipment.

c) The security components.

d) The lifting accessories.

e) The chains, cables, and cinches.

f) The removable mechanical transmission devices.

g) Quasi machines.

3. Without prejudice to the above paragraph, this royal decree shall not apply to the following products:

(a) Safety components intended to be used as spare parts to replace identical components, and supplied by the manufacturer of the original machine.

b) Specific equipment for fairs and amusement parks.

(c) machines specially designed or put into service for nuclear purposes and whose faults may cause a radioactivity emission.

d) Arms, including firearms.

e) The following means of transport:

1. Agricultural and forestry tractors for the risks covered by Directive 2003 /37/EC, transposed by Order CTE/2780/2003 of 8 October, excluding machinery installed in such vehicles.

2. Motor vehicles and their trailers covered by Council Directive 70 /156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers, and their amendments, transposed by Royal Decree No 2028/86 of 6 June 1986 and their amendments, with the exception of machinery installed in such vehicles.

3. The vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 on the type-approval of two-or three-wheel motor vehicles, and their amendments, transposed by Royal Decree 2028/1986 of 6 June 1986 and their amendments, with the exception of machinery installed in such vehicles.

4. º Motor vehicles intended exclusively for competition, and

5. The means of transport by air, by water or by railway networks, excluding machines installed in such means of transport.

(f) Maritime vessels and mobile offshore units, as well as machines installed on board such vessels and/or units.

g) Machines specially designed and manufactured for military or police purposes.

h) Machines specially designed and manufactured for the purpose of research for temporary use in laboratories.

i) Lifts for mine shafts.

j) Machines intended to raise or transport actors during artistic representations.

(k) Electrical and electronic products which are included in the following areas, in so far as they are covered by Council Directive 73 /23/EEC of 19 February 1973 on the approximation of the laws of the Member States relating to electrical equipment intended for use with certain voltage limits, and their amendments, transposed by Royal Decree 7/1988 of 8 January 1988 and their amendments:

1. Household Appliances for domestic use.

2. Audiovisual Equipment.

3. Information Technology Equipment.

4. Office Current Machines.

5. Connection and low voltage control devices.

6. ° Electric motors.

l) The following high voltage electrical equipment:

1. Connection and command devices.

2.

Article 2. Definitions.

1. For the purposes of this royal decree, the term 'machinery' shall apply in general to the products referred to in points (a) to (f) of Article 1 (2).

2. The following definitions shall also apply:

a) "Machine":

A set of components or components linked to each other, of which at least one is movable, associated for a given application, provided or intended to be provided with a system of actuation other than human or animal force, applied directly.

Set as the one indicated in the first hyphen, which is missing only the elements of connection to the power and motion sources.

Set as indicated in the first and second indents, prepared for installation which can only be operated upon installation on a means of transport or installed in a building or a structure.

A set of machines such as those set out in the first, second and third indents or quasi-machines referred to in point (g) of this Article 2.2, which, in order to achieve the same result, are arranged and operated to operate as a single machine.

A set of components or components linked to each other, of which at least one is mobile, associated with raising loads and whose sole source of energy is the human force directly employed.

(b) "interchangeable equipment" means a device which, after putting into service a machine or a tractor, is coupled by the operator itself to that machine or tractor to modify its function or to provide a new function, provided that this equipment is not a tool.

c) "Security Component": Component:

To serve a security function,

to be marketed separately,

whose failure and/or malfunction endanger the safety of people, and

which is not necessary for the operation of the machine or which, for the operation of the machine, can be replaced by normal components.

In Annex V to this Royal Decree, an indicative list of safety components may be updated in accordance with the decisions taken by the European Commission as provided for in Article 8 (1) (a) of Directive 2006 /42/EC.

(d) "Lifting accessory" means a component or equipment which is not an integral part of the lifting machine, which allows the loading, between the machine and the load, to be carried out, or on the load itself, or which is intended to be an integral part of the load and to be placed on the market separately.

Sings and their components shall also be considered as lifting accessories.

(e) "Chains, cables and cinches": Chains, cables and cinches designed and made for lifting as part of lifting machines or lifting accessories.

(f) "Removable Mechanical Transmission Device" means a removable component intended for the power transmission between a self-propelled machine or a tractor and a receiving machine joining the first fixed support. When marketed with the stub it should be considered as a single product.

g) "quasi-machine": A set that constitutes almost a machine, but which cannot be performed on its own by a particular application.

A drive system is a quasi-machine.

The quasi-machine is intended only to be incorporated into, or assembled with, other machines, or other quasi-machines or equipment, to form a machine to which this royal decree applies.

(h) "Marketing" means the first making available in the European Community, by payment or free of charge, of a machine or quasi-machine, with a view to its distribution or use.

i) "Manufacturer" means a natural or legal person who designs and/or manufactures a machine or quasi-machine covered by this royal decree and who is responsible for the conformity of that machine or quasi-machine with this royal decree, with a view to its marketing, under its own name or its own brand, or for its own use. In the absence of a manufacturer in the right sense, any natural or legal person who places a machine or a machine covered by this royal decree shall be considered a manufacturer.

(j) "authorised representative" means a natural or legal person established in the European Community who has received a written mandate from the manufacturer to fulfil on his behalf all or part of the obligations and formalities relating to this royal decree.

k) "Puesta en servicio": First use, according to its intended use, in the European Community, of a machine covered by this royal decree.

l) "Harmonised standard": Technical specification, of a non-compulsory nature, adopted by a standardisation body, namely the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), in the framework of a mandate from the Commission granted in accordance with the procedures laid down in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the rules concerning the services of the information society, transposed into Spanish law by Royal Decree 1337/1999, of 31 July.

Article 3. Specific regulatory provisions.

Where, for a machine, the hazards listed in Annex I to this royal decree are covered in whole or in part more specifically by other provisions implementing Community directives, this royal decree shall not apply or cease to apply to that machinery in respect of such hazards, as from the entry into force of those provisions.

Article 4. Market surveillance.

1. The competent bodies of the Autonomous Communities shall take all necessary measures to ensure that machinery can be placed on the market and/or put into service only if they comply with all the relevant provisions of this royal decree and do not endanger the safety or health of persons or, where appropriate, domestic animals or property, where they are properly installed and maintained and used in accordance with their intended use or under reasonably foreseeable conditions.

2. They shall take all appropriate measures to ensure that such machines can be marketed only if they comply with the relevant provisions of this royal decree.

3. The competent authorities of the Autonomous Communities shall establish or appoint the competent authorities to check the conformity of machinery and thus use machines with the provisions of paragraphs 1 and 2, with the definition of their missions, organisation and powers. These administrations shall communicate all these data-and any subsequent amendments-to the Ministry of Industry, Tourism and Trade (or ministerial department which may replace it in their duties), in order to enable, by means of the established procedure, the information thereof to the European Commission and to the other Member States.

CHAPTER II

Marketing and commissioning

Article 5. Placing on the market and putting into service.

1. The manufacturer or his authorised representative, before placing on the market or putting into service a machine, shall:

(a) Ensure that it complies with the relevant essential health and safety requirements set out in Annex I.

(b) Ensure that the technical file referred to in Part A of Annex VII is available.

c) Facilitate in particular the necessary information, as is the case with the instructions.

(d) Carry out the appropriate conformity assessment procedures in accordance with Article 12.

e) Compose the EC declaration of conformity, in accordance with Annex II, Part 1, Section A, and ensure that this declaration is attached to the machine.

(f) Place the CE marking, in accordance with Article 16.

2. The manufacturer or his authorised representative must ensure, before marketing a quasi-machine, that the procedure referred to in Article 13 has been completed.

3. For the purposes of the procedures referred to in Article 12, the manufacturer or his authorised representative must have the necessary means, or have access to them, to ensure the conformity of the machinery with the essential health and safety requirements set out in Annex I.

4. Where machinery is the subject of other provisions which apply Community directives relating to other aspects and which provide for the affixing of the CE marking, this marking shall indicate that the machinery also complies with the provisions of those provisions.

However, if one or more of those provisions allow the manufacturer or his authorised representative to choose, during a transitional period, the system to be applied, the CE marking shall only indicate conformity with the requirements of the directives applied by the manufacturer or his authorised representative. The EC declaration of conformity shall contain the references of the directives applied, as published in the Official Journal of the European Union.

Article 6. Free movement.

1. The placing on the market and/or putting into service in the Spanish territory of the machines that comply with this royal decree may not be prohibited, limited or hindered.

2. The placing on the market of such a machine shall not be prohibited, limited or impeded when, by means of the incorporation declaration referred to in Section B of Part 1 of Annex II, the manufacturer or his authorised representative declares that the latter is intended to be incorporated into a machine or assembled with other machines to form a machine.

3. At fairs, exhibitions, demonstrations and similar events, machines or machines which do not fully comply with the provisions of this royal decree may be presented, provided that there is a visible sign indicating such a circumstance and that such machines may not be available before they are put into conformity.

In addition, appropriate security measures must be taken to ensure the protection of persons in the demonstrations of such machines or non-conforming machines.

Article 7. Presumption of conformity and harmonised standards.

1. Machinery bearing the CE marking and accompanied by the EC declaration of conformity, the contents of which are set out in Section A of Part 1 of Annex II, shall be deemed to comply with the provisions of this royal decree.

2. A machine manufactured in accordance with a harmonised standard, the reference of which has been published in the Official Journal of the European Union, shall be considered in accordance with the essential health and safety requirements covered by that harmonised standard.

3. The Spanish rules which transpose the harmonised standards referred to in the previous paragraph shall be published, for information purposes, in the 'Official Gazette of the State'.

CHAPTER III

Particular measures

Article 8. Special measures.

The competent industrial safety authority of the Ministry of Industry, Tourism and Trade shall take appropriate measures to comply with the implementing measures provided for in Article 8 of Directive 2006 /42/EC, which are adopted by the European Commission, concerning:

(a) The update of the indicative list of safety components set out in Annex V, referred to in Article 2.2.c) of this royal decree.

(b) The restriction on the placing on the market of the machinery referred to in Article 9 below.

Article 9. Special measures for potentially dangerous machinery.

1. Where, in accordance with the procedure laid down in Article 10 of Directive 2006 /42/EC, the European Commission considers that a harmonised standard does not fully satisfy the essential health and safety requirements laid down in Annex I to that standard, as required by Article 10 of Directive 2006 /42/EC, and in order to ensure, at Community level, a high level of protection of the health and safety of persons, the competent bodies of the Autonomous Communities shall take the necessary measures to ensure that the standards are met. prohibit or restrict the placing on the market of machinery whose technical characteristics present a risk due to the defects of the standard, or for such machines to be subjected to special conditions.

2. Where, as a result of a safeguard clause lodged by a Member State, pursuant to Article 11 of Directive 2006 /42/EC, the European Commission considers that a measure adopted by that Member State is justified, at its request, and in order to ensure, at Community level, a high level of protection of the health and safety of persons, the competent bodies of the Autonomous Communities shall take appropriate measures to prohibit or restrict the placing on the market of machinery which, by virtue of its technical characteristics, presents the same risks, or for such machines to be subjected to special conditions.

3. Where appropriate, the General Administration of the State may, by means of the established procedure, request the European Commission to examine the need for the adoption of the measures referred to in paragraphs 1 and 2.

Article 10. The procedure for challenging a harmonised standard.

1. Where the competent authority of the autonomous community, on its own initiative or at the request of the person concerned, considers that a harmonised standard does not fully satisfy the essential health and safety requirements for which it is concerned, and which are included in Annex I to this royal decree, it shall inform the competent authority of the Ministry of Industry, Tourism and Trade.

2. The competent authority of the Ministry of Industry, Tourism and Trade in accordance with the procedure referred to in Article 10 of Directive 2006 /42/EC, shall use the Committee established by Directive 98 /34/EC, by means of the established channel, giving its reasons, in order to enable the European Commission, in accordance with the opinion of that Committee, to take the decision-as the case may be-to publish, to publish, to publish with restrictions, to maintain, to maintain with restrictions or to withdraw the reference of the harmonised standard in question in the Official Journal of the European Union.

Article 11. Safeguard clause.

1. Where the competent authority of the autonomous community, on its own initiative or at the request of a person concerned, finds that a machine covered by this royal decree, provided with the CE marking, accompanied by the EC declaration of conformity and used in accordance with its intended use or under reasonably foreseeable conditions, may endanger the health and safety of persons and, where appropriate, domestic animals or property, it shall take all necessary measures to remove such machinery from the market, prohibit its placing on the market and/or its placing in service or limit its free movement.

2. In order to achieve a Community effect, the General Administration of the State shall, by means of the established procedure, immediately inform the European Commission and the other Member States of such measures and indicate the reasons for its decision, in particular if the non-conformity is:

(a) That the essential requirements referred to in point (a) of Article 5 (1) are not met

(b) to the incorrect application of the harmonised standards referred to in Article 7 (2) and/or

(c) to a defect in the harmonised standards referred to in Article 7 (2).

3. Where the measures provided for in paragraph 1 of this Article are based on a defect in the harmonized standards, the procedure for the challenge laid down in Article 10 of this royal decree shall be initiated.

4. As a result of the decision taken by the European Commission in respect of the clause, the competent authority of the Autonomous Community shall take appropriate measures to comply with the clause. In the case of safeguard clauses lodged by other Member States, which the Commission would have considered justified, the corresponding measures may also be applied to identical machines which will be found on the Spanish market.

5. Where a machine does not comply with the CE marking, the competent authority of the Autonomous Community shall take the appropriate measures against which it has affixed such marking and shall inform the General Administration of the State in order to inform the European Commission thereof.

CHAPTER IV

CE marking and compliance assessment

Article 12. Procedures for the assessment of the conformity of machinery.

1. In order to certify the conformity of a machine with the provisions of this royal decree, the manufacturer or his authorised representative shall apply one of the conformity assessment procedures described in paragraphs 2, 3 and 4.

2. Where the machinery is not listed in Annex IV, the manufacturer or his authorised representative shall apply the conformity assessment procedure with internal control for the manufacture of the machinery provided for in Annex VIII.

3. Where the machine is listed in Annex IV and has been manufactured in accordance with the harmonised standards referred to in Article 7 (2), and provided that those standards cover all the relevant essential health and safety requirements, the manufacturer or his authorised representative shall apply one of the following procedures:

(a) The conformity assessment procedure by means of internal control of the manufacture of the machine described in Annex VIII,

(b) the EC type-examination procedure described in Annex IX, plus the internal manufacturing control procedure of the machine, as described in Annex VIII, paragraph 3, or

(c) the total quality assurance procedure described in Annex X.

4. Where the machine is listed in Annex IV and has not been manufactured in accordance with the harmonised standards referred to in Article 7 (2) or has been manufactured in accordance with those standards only in part, or if the harmonised standards do not cover all the relevant essential health and safety requirements, or if there are no harmonised standards for the machinery in question, the manufacturer or his authorised representative shall apply one of the following procedures:

(a) The EC type-examination procedure described in Annex IX, plus the internal manufacturing control procedure of the machine, as described in Annex VIII, paragraph 3, or

(b) the total quality assurance procedure described in Annex X.

Article 13. Method for the quasi-machines.

1. The manufacturer of a quasi-machine or his authorised representative must ensure, prior to placing on the market, why:

(a) The relevant technical documentation as described in Annex VII, Part B, be drawn up

(b) the assembly instructions set out in Annex VI are drawn up, and

(c) the incorporation declaration described in Annex II, Part 1, Section B, has been drawn up.

2. The mounting instructions and the incorporation declaration must accompany the machine until it is incorporated into the final machine and thus become part of the technical file of the machine.

Article 14. Notified bodies.

1. The General Administration of the State shall, by means of the established procedure, notify the European Commission and the other Member States of the Spanish bodies designated to carry out the conformity assessment with a view to the marketing referred to in Article 12 (3) and (4), specifying the specific procedures for the assessment of conformity, the categories of machinery for which those bodies have been designated and the identification numbers which the Commission has previously assigned them, as well as any subsequent amendment.

2. The Spanish notified bodies shall have the character of control bodies referred to in Chapter I of Title III of Law 21/1992 of 16 July 1992, of Industry, which shall be authorized by the competent organ of the Autonomous Community where such bodies initiate their activities or radiate their facilities, applying the procedures laid down in that Law, and must meet the minimum criteria set out in Annex XI to this royal decree, as well as the other requirements laid down in the aforementioned Law and regulations for development that apply to them.

The control bodies which satisfy the assessment criteria laid down in the relevant harmonised standards, the references of which are published in the Official Journal of the European Union, shall be presumed to comply with the criteria set out in Annex XI.

3. The competent bodies of the Autonomous Communities which grant the authorisations of the control bodies shall forward copies thereof to the Ministry of Industry, Tourism and Trade expressly indicating the procedures and categories of machinery referred to in paragraph 1 above, for the purposes of dissemination and eventual communication to the other competent public administrations, as well as to the European Commission and the other Member States.

4. The Ministry of Industry, Tourism and Trade shall publish in the "Official State Gazette" and on the Ministry's website, for information, the list of bodies notified by the Member States of the European Union, indicating their identification numbers and the tasks assigned to them, and shall update it regularly.

5. Where a Spanish notified body finds that a manufacturer does not comply with or no longer complies with the relevant requirements of this royal decree, or that it should not have issued an EC type-examination certificate or approved a quality assurance system, that body, taking into account the principle of proportionality, shall suspend or withdraw the certificate issued or the approval, or impose limitations, giving detailed reasons for its decision, unless the manufacturer, by means of appropriate corrective measures, ensures compliance with those requirements.

In accordance with the provisions of Article 16.2 of Law 21/1992 of 16 July 1992 on Industry, the person concerned may express his disagreement with the body and, in the event of disagreement, with the competent authority of the Autonomous Community. The competent body shall require the body to have the background and to carry out the checks which correspond to the person concerned in the manner provided for in Law 30/1992 of 26 November 1992, of the Legal System of Public Administrations and of the Common Administrative Procedure, in order to resolve within the period prescribed for that purpose and, failing that, within three months whether or not the inspection carried out by the body is correct. As long as there is no revocation of the negative certification by the Administration, the person concerned may not request the same control of another notified body.

The agency shall also inform the competent authority of the Autonomous Community, in accordance with Article 4 of this royal decree, in the event that it suspends or withdraws the certificate or approval or imposes limitations or requires intervention by the competent authority. The General Administration of the State shall inform the other Member States and the Commission without delay.

6. The Spanish notified bodies shall be obliged to participate directly or by delegation in other exchanges of experience which the European Commission organises between the authorities responsible for the appointment, notification and supervision of the notified bodies in each Member State, and the notified bodies themselves, in order to coordinate the uniform application of Directive 2006 /42/EC, as well as in the forums of notified bodies organised at Community level.

7. The competent authority of the Autonomous Community which has authorised a body shall immediately withdraw its authorisation and inform the Ministry of Industry, Tourism and Trade when it finds:

(a) That the body no longer meets the criteria set out in Annex XI, or,

b) that the body seriously fails to fulfil its responsibilities.

The General Administration of the State shall, by means of the established procedure, immediately inform the European Commission and the other Member States thereof.

Article 15. Installation and use of machines.

The provisions of this royal decree shall be without prejudice to the power of the Administration to, in compliance with Community law, lay down the conditions deemed necessary to ensure the protection of persons and, in particular, workers, when using machines, provided that this does not entail the modification of such machines in a manner not indicated in this royal decree.

Article 16. CE marking.

1. The CE conformity marking shall be composed of the initials 'EC' in accordance with the model set out in Annex III.

2. The CE marking shall be affixed to the machine in a visible, legible and indelible manner in accordance with Annex III.

3. It shall be prohibited to fix on the machines marked, signs and inscriptions which may mislead third parties in relation to the meaning of the CE marking, with its logo, or both at the same time. Any other marking may be affixed to the machinery, provided that it does not affect the visibility, legibility or significance of the CE marking.

Article 17. Non-compliant marking.

1. It shall be considered non-compliant:

(a) The fixing of the CE marking under this royal decree on products outside the scope specified in Article 1.

(b) The absence of CE marking and/or the absence of the EC declaration of conformity for a machine.

(c) The fixation on a machine of a marking, other than the CE marking, and prohibited pursuant to Article 16 (3).

2. Where the competent authority of the Autonomous Community finds that a marking does not comply with the relevant provisions of this royal decree, the manufacturer or his authorised representative shall have the obligation to bring the product into conformity and to end the infringement under the conditions laid down by that Administration.

3. Where non-conformity persists, the competent authority of the Autonomous Community shall take all necessary measures to restrict or prohibit the placing on the market of the product concerned or to withdraw it from the market in accordance with the procedure laid down in Article 11.

CHAPTER V

Operating Principles

Article 18. Confidentiality.

1. Without prejudice to existing legislation on confidentiality, the competent authorities shall ensure that all parties and persons affected by the application of this royal decree are required to treat as confidential the information obtained in the execution of their mission. More specifically, business, professional and commercial secrets will be treated confidentially except if their dissemination is considered essential to protect the health and safety of people.

2. The provisions of paragraph 1 shall not affect the obligations of the competent authorities and the notified bodies in relation to the reciprocal exchange of information and the dissemination of alerts.

3. Any decision taken by the Member States and by the Commission pursuant to Articles 9 and 11 of this royal decree shall be made public.

Article 19. Cooperation between Member States.

1. The competent authorities referred to in Article 4 (3) shall cooperate with each other, with those of the other Member States and with the European Commission, through the mechanisms established, and shall transmit the information necessary to enable the uniform application of Directive 2006 /42/EC in the European Union.

2. The competent authorities responsible for market surveillance, through the mechanisms established, shall be involved in exchanges of experience between Member States organised by the European Commission in order to coordinate the uniform application of the Directive.

Article 20. Dissemination of information.

The Ministry of Industry, Tourism and Trade shall take appropriate measures to ensure that appropriate information concerning the implementation of Directive 2006 /42/EC can be made available, in particular by inserting it into the relevant website.

CHAPTER VI

Sanctioning Regime

Article 21. Infringements and sanctions.

The violations of the provisions of this royal decree will be classified and sanctioned in accordance with the provisions of Title V of Law 21/1992, of July 16, of Industry.

Additional disposition first. Resources.

Any decision of the public authorities adopted pursuant to this royal decree that would impose a restriction on the marketing and/or putting into service of a product included in the scope of application of Article 1, will be motivated precisely and will be communicated in the form legally established to the interested party, indicating to him the resources coming and the deadlines to interpose them, according to the provisions of Law 30/1992, of 26 November, of Legal Regime of the Public Administrations and of the Common Administrative Procedure.

Additional provision second. Technical guide.

The management body responsible for industrial safety in the Ministry of Industry, Tourism and Commerce will develop and keep up to date a non-binding technical guide for the practical application of the forecasts of this royal decree, which will be able to establish clarifications to concepts of a general nature included in it.

First transient disposition. Update of notified bodies.

The bodies that would have been notified for the implementation of the royal decrees 1435/1992, of 27 November, and 56/1995, of January 20, will have to update their authorizations, adjusting them to what is established in this royal decree, provided that they coincide with the procedures, and types of machines of the latter.

Where the body requests authorisation for new procedures or types of machinery, the general procedure referred to in Article 14 shall be followed.

Second transient disposition. Machinery operated with explosive charge.

Until 29 June 2011, the placing on the market and the putting into service of portable, explosive-laden, other portable impact-fixing machines which are in conformity with the Convention for the reciprocal recognition of the handfuls of portable firearms tests, Regulation of the Standing International Commission (CIP) and Annex I and II of 1 July 1969, ratified by Spain by means of an instrument of ratification of 22 January 1973, shall be authorised.

Single repeal provision. Regulatory repeal.

Will be repealed with effect from 29 December 2009:

(a) Royal Decree 1435/1992 of 27 November 1992 laying down detailed rules for the application of Council Directive 89 /392/EEC on the approximation of the laws of the Member States relating to machinery.

(b) Royal Decree 56/1995 of 20 January 1995 amending Royal Decree 1435/1992 of 27 November 1992 on the detailed rules for the application of Council Directive 89 /392/EEC on machinery.

c) Regulation of lifting apparatus for works, approved by Order of 23 May 1977.

Final disposition first. Amendment of Royal Decree 1314/1997 of 1 August laying down detailed rules for the application of the Directive of the European Parliament and of the Council 95 /16/EC on lifts.

Royal Decree 1314/1997 of 1 August, laying down detailed rules for the application of the Directive of the European Parliament and of the Council 95 /16/EC on lifts, as amended by Royal Decree 57/2005 of 21 January 2005, is hereby amended as follows:

One. In Article 1, paragraph 3 is replaced by the following:

" 3. This royal decree will not apply to:

Lifting devices whose speed is not greater than 0,15 m/s,

construction site lifts,

cable facilities, including funicular facilities,

elevators specially designed and manufactured for military or police purposes,

lifting appliances from which jobs can be performed,

the mine shaft lifts,

lifting apparatus intended to move actors during artistic representations, lifting apparatus installed in means of transport,

lifting apparatus attached to a machine and intended exclusively for access to workstations, including maintenance and inspection points of the machinery,

the rack trains,

the escalators and mechanical corridors. "

Two. In Article 2, paragraph 1 is replaced by the following:

" 1. 'Elevator' means any lifting apparatus which serves defined levels, with a passenger compartment moving along rigid guides and the inclination of which is more than 15 degrees above the horizontal inclination for transport:

From people, people, and objects,

only of objects if the compartment is accessible, that is, if a person can enter the room without difficulty, and if it is provided with actuation organs located within the compartment or within the reach of a person located within it.

Lifting devices that move along a fixed path, even if not determined by rigid guides, will be considered elevators pertaining to the scope of this royal decree.

"Room" means the part of the lift in which persons or objects are situated in order to be elevated or lowered. "

Three. In Annex I, point 1.2 is replaced by the following:

" 1.2 Room.

The passenger compartment of each lift will be a cabin. This cabin must be designed and constructed in such a way that its space and strength correspond to the maximum number of persons and the nominal lift load fixed by the installer.

When the lift is intended for the transport of persons and its dimensions permit, the cabin shall be designed and constructed so that, by its structural characteristics, it does not hinder or impede access to or use by persons with disabilities, and allows any adaptation to facilitate its use by such persons. "

Final disposition second. Competence title.

This royal decree constitutes a regulatory standard of industrial safety, which is dictated by the provisions of article 149.1.13 of the Spanish Constitution, which attributes to the State exclusive competence on the basis and coordination of the general planning of economic activity.

Final disposition third. Incorporation of European Community law and references to repealed directives.

1. This royal decree incorporates into Spanish law Directive 2006 /42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95 /16/EC of the European Parliament and of the Council. Consequently, any reference to this royal decree must be understood in the context of what is indicated in that directive. They shall also be regarded as equivalent to the provisions of this royal decree any other given with the same objective by the other Member States, and third States which maintain agreements in this regard with the European Union, as well as the direct references made to the said Directive in documents implementing it.

2. References to Directive 98 /37/EC made, including until 28 December 2009 in any form of documentation implementing it, shall be construed as references to Directive 2006 /42/EC, in accordance with the correlation table set out in Annex XII.

Final disposition fourth. Entry into force.

This royal decree will enter into force on 29 December 2009, except for Article 14, which regulates the procedure for the authorisation and notification of Spanish control bodies for the application of certification procedures, which will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on October 10, 2008.

JOHN CARLOS R.

The First Vice President of the Government

and Minister of the Presidency,

MARIA TERESA FERNANDEZ DE LA VEGA SANZ

ANNEX I

Essential health and safety requirements for the design and manufacture of machines

General principles

1. The manufacturer of a machine, or his authorised representative, shall ensure that a risk assessment is carried out in order to determine the safety and health requirements applied to the machinery. The machine shall be designed and constructed taking into account the results of the risk assessment.

By an iterative risk assessment and reduction process, the manufacturer or his authorised representative must:

Determine the limits of the machine, including the intended use and its reasonably foreseeable misuse,

Identify the hazards that the machine can generate and the corresponding hazardous situations,

Estimate risks, taking into account the severity of potential injury or damage to health and the likelihood of occurrence,

To assess the risks, in order to determine whether a reduction of the risks is required, in accordance with the objective of Directive 2006 /42/EC,

Eliminate hazards or reduce the risks arising from such hazards by implementing preventive measures, in accordance with the order of priority set out in point 1.1.2 (b).

2. The obligations laid down by the essential health and safety requirements shall apply only when the machinery in question, used under the conditions laid down by the manufacturer or his authorised representative, or in foreseeable abnormal situations, presents the relevant hazard. In any event, the principles of security integration referred to in point 1.1.2 and the marking obligations of the machines and instructions referred to in points 1.7.3 and 1.7.4 respectively shall always apply.

3. The essential health and safety requirements set out in this Annex are mandatory. However, it is possible that, in view of the state of the art, the objectives laid down by those requirements cannot be achieved. In such a case, the machine shall, as far as possible, be designed and constructed to approach such objectives.

4. This Annex consists of several parts. The first one has a general scope and applies to all types of machines. The other parts relate to certain types of more specific hazards. However, it is essential to study the whole of this Annex in order to ensure that all relevant essential requirements are met. When designing a machine, the requirements of the general part and the requirements of one or more of the other parts of the Annex shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these general principles.

1. Essential health and safety requirements

1.1 Generalities.

1.1.1 Definitions. For the purposes of this Annex,

following definitions shall apply:

a) "Danger": Source of possible injury or damage to health.

(b) "Dangerous Zone" means any area within and/or around a machine in which the presence of a person poses a risk to their safety or health.

c) "Exposed Person": Any person who is, entirely or partly, in a dangerous area.

d) "Operator": Person or persons in charge of installing, handling, regulating, maintaining, cleaning, repairing or moving a machine.

e) "Risk": Combination of the probability and severity of an injury or damage to health that may occur in a hazardous situation.

f) "Stub": Machine element used specifically to provide protection by means of a physical barrier.

g) "Protective device": Device (other than a stub) that reduces the risk, by itself or associated with a stub.

h) "Planned usage": Machine use according to the information provided in the instructions for use.

i) "Reasonably Foreseeable Misuse": The use of the machine in a manner not proposed in the instructions for use, but which may result from easily predictable human behaviour.

1.1.2 Security Integration Principles:

(a) Machines should be designed and manufactured in such a way as to be suitable for their function and to be capable of handling, regulating and maintaining without risk to persons when such operations are carried out under the conditions laid down, but also taking into account any reasonably foreseeable misuse.

The measures to be taken must be aimed at eliminating any risk during the foreseeable life of the machine, including the stages of transport, assembly, dismantling, removal of service and scrapping.

(b) By opting for the most appropriate solutions, the manufacturer or his authorised representative shall apply the following principles, in the order indicated:

Remove or reduce risks as far as possible (design and manufacture of the inherently secure machine),

Adopt protective measures that are necessary against risks that cannot be removed,

Inform users about residual risks due to the incomplete effectiveness of the preventive measures taken, indicate whether special training is required and to indicate whether it is necessary to provide some individual protective equipment.

(c) When designing and manufacturing a machine and when drafting the instruction manual, the manufacturer or his authorised representative shall provide for not only the intended use of the machinery but also any reasonably foreseeable misuse.

Machines should be designed and manufactured in such a way that their use is avoided in an incorrect manner, when this could generate a risk. Where appropriate, in the instruction manual, the user must be pointed to the ways in which, by experience, they can be presented in which a machine must not be used.

(d) Machines should be designed and manufactured in the light of any inconvenience the operator may suffer from the necessary or foreseeable use of an individual protective equipment.

e) The machines must be delivered with all the special equipment and accessories that are essential to ensure that they can be safely regulated, maintained and used.

1.1.3 Materials and Products. -Materials that have been used to manufacture the machine, or products that have been used or created during use, shall not cause safety or health risks to persons.

Especially when fluids are used, the machine will be designed and manufactured to avoid the risks caused by filling, utilization, recovery and evacuation.

1.1.4 Lighting. The machine shall be supplied with a built-in lighting, adapted to operations, in cases where, despite the presence of an ambient lighting of a normal value, the absence of such a device could create a risk.

The machine must be designed and manufactured in such a way that no annoying shadow areas, annoying bedazzles, or hazardous strobe effects occur on the mobile elements due to the lighting.

The internal organs to be inspected and adjusted frequently, as well as the maintenance areas, shall be fitted with the appropriate lighting devices.

1.1.5 Design of the machine with a view to its maintenance. -Machine or each of its different elements:

You must be able to safely manipulate and transport.

It will be packed or designed so that it can be stored without risk or deterioration.

During the transport of the machine or its elements, no unflestive displacements or hazards due to instability shall be possible if the machine or its elements are handled according to the instruction manual.

When the mass, size or shape of the machine or its different elements do not allow for manual displacement, the machine or each of its different elements shall:

Carry accessories that make it possible for a lift to be taken, or

Be designed in such a way as to provide it with such accessories, or

Have such a way that normal lifting means can be easily adapted.

When the machine or one of its elements is manually transported, it must:

Be easily scrollable, or

Take means of apprehension with which you can safely move.

Specific measures shall be established with regard to the handling of tools and/or parts of machines, however light they may be, which may be dangerous.

1.1.6 Ergonomics. -Under the conditions laid down for use, the operator's physical and mental stress, fatigue and stress must be reduced to the minimum possible, taking into account ergonomie principles such as:

Adapt to the morphological, strength and resistance differences of the operators.

Provide sufficient space for the movements of the various parts of the operator's body,

Avoid a machine-determined work rate.

Prevent surveillance from requiring a prolonged concentration.

Adapt the man-machine interface to the predictable characteristics of the operators.

1.1.7 Command posts. The command post must be designed and constructed in such a way as to avoid any risk due to the exhaust gases and/or the lack of oxygen.

If the machine is intended to be used in a hazardous environment, present risks to the health and safety of the operator, or if the machine itself originates a dangerous environment, adequate means must be provided for the operator to have good working conditions and be protected against any foreseeable danger.

Whenever appropriate, the command post shall have an appropriate cab designed, constructed and/or equipped to meet the above requirements. The exit must allow for a quick evacuation.

In addition, if applicable, an emergency exit must be provided in a direction other than normal departure.

1.1.8 Seats. -Where appropriate and the working conditions permit, the working position forming an integral part of the machinery must be designed for the installation of seats.

If the operator is expected to be seated during operation and the command post is an integral part of the machine, the machine must have a seat.

The operator's seat will guarantee the stability of your position. In addition, the seat and the distance between the seat and the actuating organs shall be capable of being adapted to the operator.

If the machine is subject to vibration, the seat must be designed and constructed in such a way that the vibrations transmitted to the operator are reduced to the minimum reasonably possible. The seat anchorage shall withstand all the stresses to which it may be subjected. If there is no ground below the operator's feet, the operator must have anti-slip footrest.

1.2 Command Systems.

1.2.1 Security and reliability of command systems. -Command systems should be designed and manufactured in such a way as to avoid any dangerous situation. In particular, they should be designed and manufactured in a way:

To resist expected efforts of operation and external influences.

That a failure on the material support or the logical support of the command system does not cause dangerous situations.

That errors that affect the logic of the command system do not cause dangerous situations.

That a reasonably foreseeable human error during operation does not cause dangerous situations.

Special attention should be paid to the following aspects:

That the machine does not start up in a bad way.

Do not vary the machine parameters in an uncontrolled way, when such variation can result in dangerous situations.

That the machine stop is not prevented if that order has already been given.

That the fall or projection of any movable element of the machine or of any piece held by it cannot be produced.

Do not prevent the automatic or manual stop of the mobile elements, whatever these are.

That the protection devices remain fully operational or issue a stop order.

That the parts of the security control system are applied consistently to the whole set of machines and/or quasi-machines.

In the case of radio control, an automatic stop must occur when the correct control signals are not received, including the loss of communication.

1.2.2 Drive organs. -Drive organs:

They will be clearly visible and identifiable by pictograms when appropriate.

They will be placed in such a way that they can be safely operated, without hesitation or loss of time and unambiguously.

They shall be designed in such a way that the movement of the actuation organ is consistent with the ordered effect.

They shall be placed outside the hazardous areas except, if necessary, certain actuation organs, such as an emergency stop or a learning console.

They will be positioned so that the action of actuates them does not carry additional risks.

They will be designed or protected in such a way that the desired effect, when it can carry a danger, can only be achieved through deliberate action.

They will be manufactured in such a way as to resist foreseeable efforts; special attention will be given to emergency stop devices that may be subject to major efforts.

When a drive body is designed and designed to perform several different actions, i.e. when its action is not unique, the ordered action must be clearly displayed and, if necessary, require confirmation.

The actuation organs will have a configuration such that their layout, travel and resistant effort are compatible with the ordered action, taking into account the ergonomic principles.

The machine must be equipped with the indicator devices that are necessary to enable it to operate safely. From the command post, the operator must be able to read the indications of those devices.

From each command post, the operator must be in a position to ensure that no one is in the hazardous areas, or the command system must be designed and constructed in such a way as to prevent the start up while there is someone in the hazardous area.

If none of these possibilities can be applied, a sound and/or visual warning signal must be produced before the machine is launched. The exposed persons must have sufficient time to leave the hazardous area or to prevent the machinery being put in place.

If necessary, the machine must have the means to be controlled only from command posts located in one or more predetermined areas or sites.

When there are several control posts, the control system must be designed in such a way that the use of one of them prevents the use of the other, except for the emergency stop and stop devices.

When the machine has several control posts, each of them must be equipped with all the necessary actuation organs without the operators being disturbed or endangering each other.

1.2.3 Puesta en gait. -the operation of a machine must be carried out only by means of voluntary action on an operating organ provided for this purpose.

This requirement will also apply:

To start up again after a stop, whatever the cause of the stop.

To the order of a major modification of the operating conditions.

However, starting up again after a stop or the modification of the operating conditions may be carried out by a voluntary action on a device other than the drive provided for this purpose, provided that this does not lead to a dangerous situation.

In the case of automatic operation of a machine, start-up, start-up after a stop or modification of operating conditions may occur without intervention if this does not lead to a dangerous situation.

When the machine has several operating organs for start-up and operators can therefore put themselves in danger, additional devices must be available to eliminate such risks. If, for safety reasons, it is necessary for the start-up and/or the stop to be carried out in accordance with a particular sequence, there shall be devices to ensure that those operations are carried out in the correct order.

1.2.4 Parada.

1.2.4.1 Normal stop. -Machines shall be fitted with an operating organ which allows for their complete stop in safe conditions.

Each workstation shall be fitted with an operating organ that allows the entire or part of the machine functions to be stopped, depending on the hazards, in such a way that the machine is in a safe position.

The stop order of the machine will take precedence over the commissioning orders.

Once the machine or its hazardous functions have been stopped, the power supply of the affected actuators shall be interrupted.

1.2.4.2 Operational Parada. -When for operational reasons a stop order is required that does not interrupt the power supply of the actuators, the stopping conditions shall be monitored and maintained.

1.2.4.3 Emergency stop. -Machines shall be fitted with one or more emergency stop devices by means of which dangerous situations which may occur imminently or which are occurring may be avoided.

Are excluded from this obligation:

The machines in which the emergency stop device cannot reduce the risk, either because it does not reduce the time to obtain the normal stop or because it does not allow the individual measures to be taken to deal with the risk.

Portable machines and/or hand-guided machines.

The device must:

Having clearly identifiable, highly visible and rapidly accessible drive organs.

Cause the dangerous process to stop in the shortest possible time, without creating new risks.

Eventually, trigger or allow certain protection moves to be triggered.

When the emergency stop device is no longer actuated once the stop order has been given, this order must be maintained by locking the emergency stop device until the lock is expressly deactivated; the device must not be locked without generating a stop order; it will only be possible to unlock the device by appropriate action and this unlock must not start the machine again, but only allow it to be rebooted.

The emergency stop function must be available and operational at all times, regardless of how it works.

Emergency stop devices must be used to support other protective measures and not to replace them.

1.2.4.4 Machine sets. -In the case of machines or machinery elements designed to operate together, they must be designed and constructed in such a way that the stopping devices, including emergency stop devices, can stop not only the machinery but also all related equipment if the fact that they continue to operate could constitute a hazard.

1.2.5 Selection of control or operating modes. The selected mode of control or operation shall take precedence over all other modes of control or operation, with the exception of the emergency stop.

If the machine has been designed and manufactured so that it can be used according to various control or operating modes that require different protection measures and/or working procedures, it will carry a selector mode of command or operation interlocking in each position. Each of the selector positions must be clearly identifiable and must correspond to a single mode of control or operation.

The selector may be replaced by other means of selection with which the use of certain functions of the machine may be limited to certain categories of operators.

If, in certain operations, the machine is to be able to operate with a displaced or removed guard or with a neutralized protective device, the control or operating mode selector shall at the same time:

Deactivate all other modes of command or operation.

Authorize the operation of the hazardous functions only by means of actuation organs that require a sustained operation.

Authorize the operation of dangerous functions only under reduced risk conditions and avoiding any danger arising from a succession of sequences.

Prevent any hazardous function from working by voluntary or involuntary action on the machine's sensors.

If these four conditions cannot be met simultaneously, the command or operating mode selector will activate other preventive measures designed and manufactured to ensure a safe intervention zone.

In addition, from the setting position, the operator must be able to control the operation of the elements on which it is acting.

1.2.6 Power power failure. -The interruption, the reset after an interruption or the variation, in the sense that it is, of the power supply of the machine will not cause dangerous situations.

Special attention should be paid to the following aspects:

That the machine does not start up in a bad way.

Do not vary the machine parameters in an uncontrolled way, when such variation can result in dangerous situations.

That the machine stop is not prevented if the order has already been given.

That the fall or projection of any movable element of the machine or of any piece held by it cannot be produced.

Do not prevent the automatic or manual stop of the mobile elements, whatever these are.

That the protection devices remain fully operational or issue a stop order.

1.3 Protection measures against mechanical hazards.

1.3.1 Risk of loss of stability. -machinery, as well as its elements and equipment, must be sufficiently stable to prevent the overturning, fall or uncontrolled movements during transport, assembly, disassembly and any other action related to the machinery.

If the machine's own shape or the intended installation does not allow sufficient stability to be ensured, appropriate means of attachment must be provided, which shall be indicated in the instruction manual.

1.3.2 Risk of breakage in service. -Both the parts of the machine and the joints between them will have to be able to resist the requests to which they are subjected during the use.

The materials used shall have sufficient resistance, adapted to the characteristics of the environment of use provided by the manufacturer or his authorised representative, in particular with regard to the phenomena of fatigue, ageing, corrosion and abrasion.

The instruction manual should indicate the types and frequency of inspections and maintenance required for safety reasons. Where appropriate, it shall indicate the parts which may be worn and the criteria for replacement.

If, in spite of the measures taken, a risk of bursting or breakage persists, the affected elements shall be mounted, disposed and/or provided with protection so that any fragment is retained, thereby avoiding dangerous situations.

Rigid or flexible conduits for which fluid circulates, especially at high pressure, will have to be able to withstand the intended internal and external requests; they will be solidly subject and/or provided with protection to ensure that there are no risks in the event of a break.

In case of automatic advancement of the material to be worked towards the tool, the following conditions must be given in order to avoid risks to the persons:

When the tool and part come into contact, the tool will need to have reached its normal working conditions.

At the time the start-up and/or the tool stop (voluntarily or accidentally) occurs, the movement of the tool and the movement of the tool must be coordinated.

1.3.3 Risks due to falling and projecting objects. -precautions should be taken to avoid falls or projections of objects that may present a risk.

1.3.4 Risks due to surfaces, edges or angles. -the elements of the machine which are accessible shall not, to the extent permitted by their function, present any sharp edges or angles or rough surfaces likely to cause injury.

1.3.5 Risks due to the combined machines. -When the machine is intended to be able to carry out several different operations in which the piece is to be taken with the hands between operation and operation (combined machine), it must be designed and constructed so that each element can be used separately without the remaining elements constituting a risk to the exposed persons.

To this end, each of the elements, if lacking protection, must be able to be put in place or stopped individually.

1.3.6 Risks related to variations in operating conditions. -In the case of operations under different conditions of use, the machinery must be designed and constructed in such a way that the choice and adjustment of these conditions can be carried out safely and reliably.

1.3.7 Risks related to mobile elements. -Mobile elements of the machine must be designed and manufactured in order to avoid the risks of contact which may cause accidents or, where the risks remain, they shall be fitted with guards or protective devices.

All necessary measures must be taken to avoid the unexpected blocking of the moving elements involved in the work. In case the possibility of blocking the equipment in spite of the measures taken, the necessary protective devices and tools must be provided, where appropriate, to enable the equipment to be safely unlocked.

The instruction manual and, if possible, an indication entered on the machine, should mention these specific protection devices and how to use them.

1.3.8 Choice of protection against risks caused by mobile elements. -guards or protective devices designed to protect against the risks due to the movable elements shall be chosen on the basis of the existing risk. The following indications must be used to make the choice.

1.3.8.1 Mobile Transmission Elements. -guards designed to protect people from the hazards caused by the mobile transmission elements shall be:

Fixed guards as indicated in paragraph 1.4.2.1, or

Locks movable with interlock as indicated in paragraph 1.4.2.2.

This latest solution will be used if frequent interventions are foreseen.

1.3.8.2 Mobile elements involved in the work: Guards or protective devices designed to protect people against the risks caused by the mobile elements involved in the work will be:

Fixed guards as indicated in paragraph 1.4.2.1, or

Locking movable guards as indicated in paragraph 1.4.2.2, or

Protective devices as specified in paragraph 1.4.3, or

A combination of the above.

However, when certain moving elements directly involved in the work cannot be made completely inaccessible during operation due to operations requiring operator intervention, those elements shall be provided with:

Fixed or lockable locks that prevent access to parts of items that are not used for the job, and

Adjustable guards as referred to in paragraph 1.4.2.3 that restrict access to the parts of the mobile elements to which they need to be accessed.

1.3.9 Risks due to unintended movements. -Where an element of a machine has been stopped, the drift from the stopping position, for any reason other than the action on the actuating organs, shall be prevented or shall be such that no danger arises.

1.4 Features to be collected by the guards and protection devices.

1.4.1 General requirements. -guards and protective devices:

They will be robust manufacturing.

They should remain solidly in their position.

They will not cause additional hazards.

They will not be able to be easily mocked or nullified.

They must be located at an appropriate distance from the hazardous area.

The observation of the production process should be restricted as little as possible.

They must allow the necessary interventions for the placement and/or replacement of the tools, as well as for the maintenance work, limiting the access exclusively to the area where the work is to be carried out and, if possible, without dismantling the guard or neutralise the protective device.

In addition, the guards must, as far as possible, protect against the projection or fall of materials or objects and against the emissions generated by the machine.

1.4.2 Specific requirements for guards.

1.4.2.1 Fixed guards. The fixing of fixed guards shall be ensured by systems which can only be opened or dismantled by means of tools.

The fixing systems must remain attached to the guards or the machine when the guards are removed.

As far as possible, the guards will not be able to remain in their position if they lack their means of attachment.

1.4.2.2 Mobile with locking device. -Mobile guards with locking device:

Whenever this is possible, they will be attached to the machine when they are opened

They should be designed and manufactured so that they can only be regulated through voluntary action.

Mobile guards with interlocking devices will be associated with a locking device so that:

Prevent dangerous machine functions from being put in place while the guards are not closed, and

Generate a stop order when they are no longer closed.

Where it is possible for an operator to reach the hazardous area before the risk posed by the dangerous functions of the machine has ceased, the mobile guards shall be associated, in addition to a locking device, to a locking device which:

Prevent dangerous machine functions from being put in place while the stub is not locked and locked, and

Keep the stub closed and locked until the risk of damage to the dangerous functions of the machine ceases.

Mobile guards with locking devices must be designed in such a way that the absence or failure of one of its components prevents the operation from being started or causes the dangerous functions of the machine to stop.

1.4.2.3 Regulable Respects that restrict access. -Regulable safeguards that restrict access to parts of the mobile elements strictly necessary for the job:

You must be able to regulate manually or automatically, depending on the type of work to be performed.

They should be able to be easily regulated without tools.

1.4.3 Specific requirements for protection devices. -Protection devices shall be designed and incorporated into the control system in such a way that:

It is impossible for mobile elements to start working while the operator can contact them.

No person can come into contact with the moving items while in motion.

The absence or failure of one of its components will prevent start-up or stop the mobile elements from being stopped.

Protection devices can only be regulated by voluntary action.

1.5 Risks due to other hazards.

1.5.1 Electrical energy. -If the machine is powered by electric power, it must be designed, manufactured and equipped in such a way that all hazards of electrical origin can be avoided or avoided.

The safety objectives set out in Directive 73 /23/EEC (incorporated into the Spanish legal order by Royal Decree 7/1998 of 8 January 1998) will apply to machines. However, the obligations relating to the conformity assessment and the placing on the market and/or putting into service of a machine with regard to the hazards caused by electrical energy shall be regulated exclusively by Directive 2006 /42/EC, which is transposed by this Royal Decree.

1.5.2 Static electricity. -machinery must be designed and manufactured to prevent or restrict the appearance of electrostatic charges that may be dangerous and/or have the means to be able to evacuate them.

1.5.3 Energy other than electric. -If the machine is fed with energy sources other than the electric one, it must be designed, manufactured and equipped to prevent all possible risks linked to these sources of energy.

1.5.4 Mount errors. -Errors which may be committed in the assembly or replacement of certain parts which may cause risks must be made impossible by the design and manufacture of such parts or, failing that, by indications appearing in the parts themselves and/or in their respective cartres. The same indications shall be shown on the moving elements and/or their respective cards when, in order to avoid a risk, the meaning of the movement must be known.

Where appropriate, the instruction manual should include additional information on these risks.

When a faulty connection can cause risks, any erroneous connection must be made impossible by the design itself or, failing that, by indications appearing in the elements to be connected or, where appropriate, in the means of connection.

1.5.5 Extreme temperatures. -Measures shall be taken to avoid any risk of injury from contact or proximity to parts or materials at high or very low temperatures.

The measures necessary to prevent or protect against the risk of hot or very cold materials shall also be taken into account.

1.5.6 Fire. -machinery must be designed and manufactured in such a way as to avoid any risk of fire or overheating caused by the machine itself or by gases, liquids, powders, vapours and other substances produced or used by the machine.

1.5.7 Explosion. -machinery must be designed and constructed in such a way as to avoid any risk of explosion caused by the machinery itself or by gases, liquids, powders, vapours and other substances produced or used by the machinery.

As regards the risks of explosion due to the use of the machinery in a potentially explosive atmosphere, the machinery must comply with the provisions transposing the specific Community directives.

1.5.8 Noise. -machinery must be designed and constructed in such a way that the risks resulting from the emission of the air noise produced are reduced to the lowest possible level, taking into account the technical progress and the availability of means of noise reduction, especially at source.

The level of noise emitted may be assessed by reference to the comparative emission data of similar machines.

1.5.9 Vibrations. -machinery must be designed and constructed in such a way that the risks resulting from the vibrations which it produces are reduced to the lowest possible level, taking into account the technical progress and the availability of means of reducing the vibrations, especially in its source.

The level of vibration produced may be assessed by reference to the comparative emission data of similar machines.

1.5.10 Radiations. -Non-desired radiations of the machine should be removed or reduced to levels that do not adversely affect people.

Any functional ionizing radiation emitted by the machine shall be limited to the minimum level necessary to ensure the correct operation of the machine during its installation, operation and cleaning.

Where there is a risk, the necessary protective measures shall be taken.

Any functional non-ionising radiation emitted during installation, operation and cleaning shall be limited to levels that do not adversely affect persons.

1.5.11 External radiations. The machine must be designed and constructed in such a way that external radiation does not disturb its operation.

1.5.12 Laser radiations. -If laser equipment is used, the following standards must be taken into account:

The laser equipment of the machines must be designed and manufactured in such a way as to avoid any inadvertent radiation.

The laser equipment of the machines shall have protection in such a way that they do not impair the health or the radiation, nor the radiation produced by reflection or diffusion, nor the secondary radiation.

Optical equipment for the observation or adjustment of laser equipment of machines must be such that they do not give rise to any risk to health due to laser radiation.

1.5.13 Emissions of hazardous materials and substances. The machine must be designed and manufactured in such a way that the risks of inhalation, ingestion, contact with the skin, eyes and mucous membranes, and penetration of the skin, materials and dangerous substances produced by it, can be avoided.

When it is impossible to remove this hazard, the machine shall be equipped so that hazardous materials and substances can be confined, evacuated, precipitated by water spraying, filtered or treated by another equally effective method.

If the process is not completely closed during the normal operation of the machine, the containment and/or evacuation devices shall be located in such a way as to produce a maximum effect.

1.5.14 Risk of being locked in a machine. -machinery must be designed, manufactured or equipped with means to prevent a person from being locked in it or, if this is not possible, to allow him to ask for help.

1.5.15 Risk of slipping, tripping or falling. -Parts of the machine on which persons are intended to be moved or parked must be designed and constructed in such a way as to prevent such persons from slipping, falling or falling on or outside those parts.

Where appropriate, these parts shall be equipped with fixed handles that allow users to maintain stability.

1.5.16 Rays. -Machines requiring protection against the effects of lightning during their use must be equipped with a system which allows the resulting electrical charge to be brought to the ground.

1.6 Maintenance.

1.6.1 Machine maintenance. -The adjustment and maintenance points shall be located outside the hazardous areas. The operations of adjustment, maintenance, repair, cleaning and the intervention on the machine must be carried out with the machine stop.

If at least one of the above conditions cannot be met for technical reasons, measures shall be taken to ensure that such operations can be carried out safely (see, in particular, point 1.2.5).

For automated machines and, where appropriate, for other machines, a connection device should be provided to enable a breakdown diagnosis equipment to be mounted.

The elements of an automated machine that are to be replaced frequently must be able to be dismantled and reassembled easily and safely. Access to these elements should enable these tasks to be carried out with the necessary technical means following a previously defined modus operandi.

1.6.2 Access to jobs or intervention points. -Machine must be designed and manufactured with means of access that allow to arrive with complete safety to all the areas in which it is necessary to intervene during its operation, adjustment and maintenance.

1.6.3 Separation of energy sources. -The machine shall be equipped with devices which allow to isolate it from each of its energy sources. Such devices shall be clearly identifiable. They should be able to be blocked if they were able to put people in danger again. The devices must also be able to be blocked when the operator is unable to verify, from all positions to which he has access, the permanence of such separation.

In the case of machines that can be plugged into a power outlet, the disconnect of the plug shall be sufficient, provided that the operator can check, from all positions to which he has access, the permanence of such disconnection.

The residual energy or stored in the circuit of the machine after its isolation must be able to be dissipated normally without risk to the people.

Notwithstanding the requirement of the preceding paragraphs, some circuits may remain connected to their source of energy to enable, for example, the maintenance of parts, the protection of information, the lighting of the internal parts, etc. In this case, special measures must be taken to ensure the safety of operators.

1.6.4 Operator Intervention. -Machines should be designed, manufactured and equipped in such a way as to limit the operators ' causes of intervention. Provided that the operator's intervention cannot be avoided, the operator must be able to operate easily and safely.

1.6.5 Cleaning of the inner parts. -machinery must be designed and constructed in such a way that it is possible to clean up the inner parts which have contained dangerous substances or preparations without penetrating them; likewise, if it is necessary to unblock them, the operation must be capable of being carried out from the outside. If it is impossible to avoid having to penetrate the machine, the machine must be designed and manufactured in such a way that it is possible to carry out the cleaning with complete safety.

1.7 Information.

1.7.1 Informations and warnings about the machine. -Information and warnings about the machine should preferably be provided in the form of easily understandable pictograms or symbols. Any verbal or written information or warning shall be expressed, when the machine is marketed and/or put into service in Spain, at least in Spanish, accompanied, if requested, by the versions in other official languages of the Community which are understood by the operators.

1.7.1.1 Information and information devices. -Information necessary for the handling of a machine must be without ambiguities and be easy to understand. It shall not be excessive to the extent that it constitutes an overload for the operator.

Display screens or any other interactive media between the operator and the machine must be easy to understand and use.

1.7.1.2 Warning devices. -Where the health and safety of persons may be in danger of defective operation of a machine operating without surveillance, the machinery must be equipped in such a way as to warn it by means of an appropriate sound or light signal.

If the machine carries warning devices, these devices will not be ambiguous and will be easily perceived. Measures shall be taken to enable the operator to verify whether these warning devices are still effective.

The requirements of the specific Community directives on colours and safety signals will apply.

1.7.2 Warning of residual risks. -If, in spite of the inherently safe design measures, the protective measures and the accompanying preventive measures, there are risks, the necessary warning signs, including warning devices, must be placed.

1.7.3 Marking of machines. -Each machine shall bear, in a visible, legible and indelible manner, at least the following particulars:

The social reason and the full address of the manufacturer and, where applicable, his authorised representative.

The designation of the machine.

The CE marking (see Annex III).

The designation of the string or model.

The serial number, if any.

The year of manufacture, that is, the year in which the manufacturing process ends.

It is forbidden to indicate an earlier or later date on the machine when the CE marking is applied.

In addition, the machine designed and manufactured for use in a potentially explosive atmosphere must bear the corresponding marking.

Depending on the type of machine, the machine must also bear all the information that is essential for safe use. Those indications shall comply with the requirements laid down in paragraph 1.7.1.

When an element of the machine is to be handled during use, by means of lifting, its mass must be inscribed in a legible, durable and unambiguous manner.

1.7.4 Manual of instructions. -When marketed and/or put into service in Spain, each machine must be accompanied by an instruction manual, at least in Spanish. This manual will be an "original manual" or a "translation of the original manual"; in the latter case, the translation will be accompanied by an "original manual".

However, the instructions for maintenance to be provided to specialised personnel authorised by the manufacturer or his authorised representative may be supplied in one of the languages of the European Community comprising such specialised personnel.

The instruction manual will be written according to the principles listed below.

1.7.4.1 General guidelines for the instruction manual:

(a) The instruction manual shall be drawn up in one or more of the official languages of the European Community.

The words "Original manual" shall be shown in the language version or versions checked by the manufacturer or by his authorised representative.

(b) Where there is no "Original Manual" in Spanish, the manufacturer or his authorised representative, or the person responsible for the introduction of the machine in the language area concerned, shall provide a translation at least in Spanish. Translations shall include the words 'Translation of the original manual'.

c) The contents of the instruction manual should not only cover the intended use of the machine but also take into account its reasonably foreseeable misuse.

(d) In the case of machines intended for non-professional users, the level of general training and the acumen which can reasonably be expected from such users shall be taken into account in the drafting and presentation of the instruction manual.

1.7.4.2 Instructions Manual Content: Each instruction manual will contain at least, where appropriate, the following information:

(a) The social reason and full address of the manufacturer and his authorised representative.

(b) The designation of the machine, as indicated on the machine itself, with the exception of the serial number (see point 1.7.3).

(c) The EC declaration of conformity or a document setting out the content of that declaration and in which the particulars of the machine are not required to include the serial number and the signature.

d) A general description of the machine.

e) The drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machine, as well as to check its correct operation.

f) A description of the jobs that operators can occupy.

g) A description of the intended use of the machine.

h) warnings regarding the ways in which a machine should not be used which, by experience, can be presented.

i) Instructions for assembly, installation and connection, including drawings, diagrams and means of attachment and the designation of the chassis or installation in which the machine is to be mounted.

(j) Instructions relating to installation and assembly, aimed at reducing noise and vibration.

(k) The instructions concerning the putting into service and use of the machinery and, if necessary, the instructions concerning the training of the operators.

(l) Information on residual risks that exist despite the inherently safe design measures, protection measures and accompanying preventive measures.

m) Instructions on the preventive measures to be taken by the user, including, where appropriate, the individual protective equipment to be provided.

n) The basic features of the tools that can be attached to the machine.

(o) The conditions under which the machines meet the stability requirement during their use, transport, assembly, disassembly, out-of-service situation, test or foreseeable breakdown situation.

(p) Instructions for the operation of transport, maintenance and storage to be carried out with complete safety, indicating the mass of the machinery and its various components when, on a regular basis, they are to be transported separately.

q) The operational mode to be followed in the event of an accident or breakdown; if a lock is likely to occur, the operational mode to be followed to achieve the unblocking of the equipment with complete security.

r) The description of the adjustment and maintenance operations to be performed by the user, as well as the preventive maintenance measures to be complied with.

s) Instructions designed to allow the setting and maintenance to be performed with complete safety, including preventive measures to be taken during such operations.

t) The characteristics of the spare parts to be used, when they affect the health and safety of the operators.

u) The following indications on the airborne noise emitted:

The level of noise pressure of the A-weighted emission pressure at the workstations, when it exceeds 70 dB (A); if this level is less than or equal to 70 dB (A), this fact must be mentioned.

The maximum value of the weighted instantaneous sound pressure C in the workstations, when it exceeds 63 Pa (130 dB relative to 20 µ Pa).

The machine-issued A-weighted sound power level, if the A-weighted emission sound pressure level exceeds, in the workstations, 80 dB (A).

These values will actually be measured in the machine considered, or will be established from measurements made on a technically comparable machine and representative of the machine to be manufactured.

When the machine is of very large dimensions, the indication of the weighted sound power level A may be replaced by the indication of the weighted emission sound pressure levels A at specified places around the machine.

When harmonised standards are not applied, the acoustic data shall be measured using the measurement code that is best suited to the machine. When the noise emission values are indicated, the uncertainty associated with the noise emission values shall be specified. The operating conditions of the machine shall be described during the measurement and the methods used for the measurement.

When the job (s) are not defined or cannot be defined, the measurement of the weighted sound pressure level A shall be carried out at 1 m from the surface of the machine and at a height of 1,6 metres above the ground or the access platform. The position and value of the maximum sound pressure shall be indicated.

Where there are specific Community Directives providing for other requirements for measuring the sound pressure level or the sound power level, these Directives shall apply and the corresponding requirements of this point shall not apply.

v) Where the machine is likely to emit non-ionising radiation which may cause damage to persons, in particular to persons carrying active or inactive implantable medical devices, information on radiation emitted for the operator and exposed persons.

1.7.4.3 Advertising information. -Advertising information describing the machine shall not contradict the instruction manual as regards the health and safety aspects. The advertising information describing the operating characteristics of the machine shall contain the same information as the instruction manual on emissions.

2. Additional essential health and safety requirements for certain categories of machines

Machines intended for the food, cosmetics or pharmaceutical industry, portable machines and/or hand-guided machines, portable fasteners and other portable impact machines, and machines for working wood and materials of similar physical characteristics shall be responsible for all the essential safety and health requirements described in this Chapter, in accordance with the provisions of point 4 of the General Principles.

2.1 Machines for the food, cosmetics or pharmaceutical industry.

2.1.1 Generalities. -Machines intended to be used with foodstuffs, cosmetics or pharmaceuticals should be designed and manufactured in such a way as to avoid the risks of infection, disease and contagion.

The following requirements must be observed:

(a) Materials which enter or are intended to come into contact with foodstuffs, cosmetics or pharmaceuticals must comply with the specific rules of application. The machine must be designed and constructed in such a way that such materials can be cleaned before each use; when this is not possible, disposable elements will be used.

(b) All surfaces in contact with foodstuffs, cosmetics or pharmaceuticals other than surfaces of disposable elements:

They will be smooth and will have neither rugosities nor cavities that can host organic matter. The same principle applies to junctions between two surfaces,

must be designed and manufactured in such a way as to minimize the projections, flanges, and relocations of the assemblies,

must be able to be easily cleaned and disinfected, where necessary, after removal from those parts which are easily removable. The curves of the internal surfaces shall be of sufficient radius to enable a complete cleaning.

c) liquids, gases and aerosols from foodstuffs, cosmetics or pharmaceuticals, and cleaning, disinfection and rinsing products must be able to be completely removed from the machine (if possible, in a "cleaning" position).

d) The machine must be designed and manufactured in such a way that any infiltration of substances, any accumulation of organic matter or penetration of living beings and, in particular, insects, in areas that cannot be cleaned, can be avoided.

e) The machine must be designed and manufactured in such a way that ancillary products which represent a health hazard, including lubricants used, cannot come into contact with foodstuffs, cosmetics or pharmaceuticals. If necessary, the machine must be designed and constructed in such a way that the permanent compliance with this condition can be checked.

2.1.2 Manual of instructions. -In the instruction manual of the machines intended to be used with foodstuffs, cosmetics or pharmaceuticals, the products and methods of cleaning, disinfection and rinsing should be indicated, not only for the easily accessible parts but also for the parts whose access is impossible or has been discouraged.

2.2 Portable machines and hand-guided machines.

2.2.1 Generalities. -Portable machines and/or hand-guided machines:

According to the type, they will have a sufficient size support surface and will have the sufficient means of apprehension and fastening correctly sized, arranged so that the stability of the machine can be guaranteed under the intended operating conditions,

except if this is technically impossible or if there is an independent operating organ, in the event that the means of apprehension cannot be released in total safety, they shall be equipped with start-up and/or stop-drive organs arranged in such a way that the operator does not have to release the means of apprehension to actuate them,

shall not present any risks of start-up or continue to operate after the operator has released the means of apprehension. Equivalent measures should be taken if this requirement was not technically feasible,

will allow, if necessary, visual observation of the hazardous area and the action of the tool in the material being worked.

The power of the portable machines must be designed and manufactured in such a way that it is easy to start and stop.

2.2.1.1 Manual of instructions. -In the instruction manual the following shall be indicated on the vibrations transmitted by the portable machines and the hand-guided machines:

The total value of the vibrations to which the hand-arm system is exposed, when they exceed 2.5 m/s². When this value does not exceed 2.5 m/s², this fact must be mentioned,

the uncertainty of the measurement.

These values will actually be measured in the machine considered, or will be established from measurements made on a technically comparable machine and representative of the machine to be manufactured.

When harmonised standards are not applied, vibration data should be measured using the measurement code that is best suited to the machine.

The operating conditions of the machine shall be described during measurement, as well as the methods used for the measurement, or the reference to the harmonised standard applied.

2.2.2 Portable attachment machines and other portable impact machines.

2.2.2.1 Generalities. -Portable attachment machines and other portable impact machines should be designed and manufactured in such a way that:

Power is transmitted to the element that suffers the impact by means of an intermediate element in solidarity with the machine,

a validation device will prevent impact while the machine is not in the right position with appropriate pressure in the base material,

inadvertent commissioning is prevented; if necessary, in order for an impact to be triggered the timely sequence of actions on the validation device and the drive organ shall be required,

during maintenance or in case of a hit, accidental commissioning is prevented,

load and unload operations can be performed easily and with total security.

If necessary, the machine may be equipped with guards against splinters, and the manufacturer of the machine must provide the appropriate guards.

2.2.2.2 Manual of instructions. -In the instruction manual you must give the necessary information regarding:

interchangeable accessories and equipment that can be used with the machine,

appropriate fixing elements or other elements to be subjected to the impact to be used with the machine,

where appropriate, the appropriate cartridges to be used.

2.3 Machines for working wood and materials with similar physical characteristics. -Machines for working wood and materials with similar physical characteristics shall meet the following requirements:

(a) The machine must be designed, manufactured or equipped so that the part to be worked can be placed and guided with total safety; when the part is taken with the hand on a working table, the latter must ensure sufficient stability during the work and must not be disturbed by the displacement of the part.

(b) Where the machine can be used under conditions which cause a risk of projection of the parts to be worked or parts thereof, it must be designed, constructed or equipped in such a way as to prevent such a projection or, if this is not possible, so that the projection does not produce risks for the operator and/or the exposed persons.

(c) When there is a risk of contact with the tool while it is slowing, the machine shall be equipped with automatic brake so that the tool stops in a sufficiently short time.

d) When the tool is integrated into a machine that is not fully automated, the machine must be designed and constructed in such a way that the risk of an injury is eliminated or reduced.

3. Additional essential health and safety requirements to neutralise hazards due to the mobility of machines

Machines which present hazards due to their mobility shall be responsible for all the essential safety and health requirements described in this Chapter (see point 4 of the General Principles).

3.1 Generalities.

3.1.1 Definitions.

a) "Machine presenting hazards due to its mobility":

Machine whose operation requires either mobility during work, whether it is a continuous or semi-continuous displacement in a succession of fixed working points, or

machine whose operation is carried out without displacement but which may be provided with means to move it more easily from one place to another.

b) "Driver": operator responsible for the displacement of a machine. The driver may either go on the machine or on foot with the machine or guide the machine by means of remote control.

3.2 Jobs.

3.2.1 Driving position. -visibility from the driving position shall allow the driver to manipulate the machine and its tools, under foreseeable conditions of use, with total safety for himself and for exposed persons. If necessary, appropriate devices should be provided to remedy the hazards due to the lack of direct visibility.

On-board machines must be designed and constructed in such a way that, from driving positions, there is no risk of the driver being inadvertently in contact with the wheels or the chains.

The driving position of the driver on board must be designed and constructed in such a way that it can be fitted with a cab, provided that this does not increase the risk and whenever the dimensions permit. The cab must have a place to lay the instructions necessary for the driver.

3.2.2 Seats. -Where there is a risk that the operators or other persons transporting the machinery are crushed between elements of the machinery and the ground in the event that the machine is flying or turns, in particular as regards the machinery fitted with the protective structures referred to in paragraphs 3.4.3 and 3.4.4, its seats must be designed or equipped with a restraint device which keeps the persons in their seats, without restricting the movement necessary for the operations or movements with regard to the structure due to the suspension of the seats. Such holding devices shall not be fitted if they increase the risk.

3.2.3 Posts for other people. -If the conditions of use require other persons other than the driver to be transported occasionally or regularly by the machine, or to work on the machine, adequate posts must be provided such that such transport or work does not entail any risk.

The second and third paragraphs of point 3.2.1 shall also apply to posts intended for other persons other than the driver.

3.3 Command Systems. -If necessary, the means shall be provided to prevent the unauthorized use of the organs of actuation.

In the case of remote control, each control unit must clearly indicate the machine intended to be operated from that unit.

The remote control system should be designed and manufactured to affect only:

To the machine in question,

to the functions in question.

The remote controlled machine must be designed and constructed in such a way that it responds only to the signals of the intended command units.

3.3.1 Actuation organs. -From the driving position, the driver must be able to operate all the operating organs necessary for the operation of the machinery, except for functions which can only be carried out in total safety using drive organs located elsewhere. These functions include, in particular, those which other operators are responsible for apart from the driver, or for which the driver must leave the driving position in order to monitor them in total safety.

When there are pedals, they must be designed, manufactured and arranged so that they can be operated with complete safety by the driver, with a minimum risk of incorrect actuation. The pedals must present a non-slip surface and be easy to clean.

When your drive can pose risks, especially dangerous movements, the operating organs of the machine, except those with predetermined positions, must return to a neutral position as soon as the operator releases them.

In the case of wheeled machines, the steering mechanism must be designed and constructed in such a way as to reduce the force of the sudden movements of the steering wheel or the steering lever as a result of shocks on the steering wheels.

Any differential locking organ must be designed and arranged so as to allow the differential to be unlocked when the machine is in motion.

The sixth paragraph of point 1.2.2, concerning sound and/or visual warning signs, shall apply only in the case of reverse gear.

3.3.2 Puesta in March/offset. -The movement of a self-driving machine with a driver on board may only be carried out if the driver is in his/her command post.

When, for the purposes of operation, a machine is equipped with devices that protrude from its normal gauge (e.g. stabilizers, arms, etc.), the driver must have the means to enable him to verify with ease, before moving it, that the devices are in a position that allows for a safe movement.

This same requirement applies to all other elements that, in order to make a safe offset possible, must occupy a defined position, locked if necessary.

When this does not cause other risks, the displacement of the machine must be subject to the safe position of the aforementioned elements.

The machine must not be able to move involuntarily when the engine is running.

3.3.3 Offset function. -Without prejudice to the mandatory rules for road traffic, motor vehicles and their trailers must comply with the requirements for deceleration, stopping, braking and immobilisation which ensure safety in all the intended conditions of operation, load, speed, ground state and slopes.

The driver must be able to slow down and stop a self-driving machine through a main device.

To the extent required by security, and in the event of failure of the main device, or when there is no energy required to actuate this device, an emergency device must exist, with a fully independent and easily accessible operating organ, which allows the machine to decrelate and stop.

To the extent required by security, a parking device must exist to keep the machine stationary. The device may be integrated into one of the devices referred to in the second subparagraph, provided that it is a purely mechanical device.

A remote controlled machine must have devices to obtain the automatic and immediate stop of the machine and to prevent potentially dangerous operation in the following situations:

If the driver loses control,

if the machine receives a stop signal,

when a failure is detected in a part of the security system,

when a validation token has not been detected for a specified time.

Point 1.2.4 does not apply to the offset function.

3.3.4 Displacement of machines with driver on foot. -In the case of self-driving machines with a driver on foot, displacements can only be produced if the driver is holding the corresponding drive. In particular, the machinery must not be able to move when the engine is running.

The control systems of the driver-on-foot machines must be designed in such a way as to minimise the risks due to the unexpected displacement of the machine towards the driver, in particular the risks of:

Crush,

injuries due to rotating tools.

The speed of displacement of the machine must be compatible with the speed of a driver on foot.

In the case of machines to which a rotary tool may be attached, it shall be impossible to actuate the rotating tool while the reverse is activated, unless the displacement of the machine is the result of the movement of the tool. In the latter case, the reverse gear shall be such that it does not represent any danger to the driver.

3.3.5 Command circuit failure. -Where there is a failure in the power of the servo-steering, the power must not be prevented from running the machine for the time necessary to stop it.

3.4. Protective measures against mechanical hazards.

3.4.1 Unintended Movements. -machinery must be designed, manufactured and, where appropriate, mounted on its mobile support so that, during its displacement, the uncontrolled oscillations of its centre of gravity do not affect its stability or make excessive efforts to its structure.

3.4.2 Mobile transmission elements. By way of derogation from point 1.3.8.1, in the case of engines, mobile guards which prevent access to the movable elements of the engine compartment may not be fitted with interlocking devices, provided that their opening requires the use either of a tool or a key, or the actuation of an organ located in the driving position, provided that the latter is located in a fully enclosed cabin and fitted with a lock to prevent access to unauthorised persons.

3.4.3 Risk of tipping or spinning. -Where, in a self-driving machine with a driver, operators or other persons on board, there is a risk of circling or tipping, the machinery must be fitted with an appropriate protective structure, unless this increases the risk.

Such a structure should be such that, in case of spinning or turning, it ensures the persons on board an adequate limit volume of deformation.

In order to verify that the structure complies with the requirement laid down in the second subparagraph, the manufacturer or his authorised representative shall carry out or carry out appropriate tests for each type of structure.

3.4.4 Fall of objects. -Where, in a self-driving machine with a driver, operators or other persons on board, there is a risk of falling objects or materials, such a machine must be designed and constructed in such a way as to take account of that risk and be provided, if the size permits, of an appropriate protective structure.

This structure should be such that, in the event of falling objects or materials, it ensures that people on board an adequate volume of deformation.

In order to verify that the structure complies with the requirement laid down in the second subparagraph, the manufacturer or his authorised representative shall carry out or carry out appropriate tests for each type of structure.

3.4.5 Media. -The handholds and steps must be designed, constructed and installed so that the operators can use them instinctively without actuating the actuation organs to facilitate access.

3.4.6 Trailer devices. -Any machinery used for towing or towing must be equipped with towing or coupling devices designed, manufactured and arranged so as to be easy and secure for coupling and uncoupling, and that accidental uncoupling may not occur while the machine is being used.

As long as the load of the lance so requires, these machines must be fitted with a support with a support surface adapted to the load and to the ground.

3.4.7 Power transmission between the automotive machine (or the tractor) and the receiving machine. -removable mechanical transmission devices which attach a self-driving machine (or a tractor) to the first fixed support of a receiving machine must be designed and constructed in such a way that any part in motion during its operation has protection, along its entire length.

On the side of the machine or the tractor, the power-taking to which the removable mechanical transmission device is engaged must be provided with protection, either by means of a guard fixed and attached to the self-driving machine (or to the tractor), either by means of any other device providing equivalent protection.

This stub must be able to be opened to access the removable drive device. Once the stub is installed, sufficient space should be left to prevent the drag tree from deteriorating during the movement of the machine (or tractor).

On the receiving machine, the receiving tree must be housed in a protective crankcase attached to the machine.

Only torque limiters or free wheels are allowed to be installed on the side of the hook with the receiving machine. In this case it is appropriate to indicate in the removable mechanical transmission device the sense of the assembly.

Any receiving machine whose operation requires a removable mechanical transmission device which the one to a self-driving machine (or to a tractor) must have a coupling system of the removable mechanical transmission device so that, when the machine is disengaged, the removable mechanical transmission device and its guard do not deteriorate when it comes into contact with the ground or an element of the machine.

The exterior elements of the shield must be designed, manufactured and arranged so that they cannot be rotated with the removable mechanical transmission device. The shield must cover the transmission to the extremities of the inner jaws, in the case of simple cardan joints and, at least, to the centre of the outer joint (s), in the case of large angle cardan joints.

When the means of access to the jobs close to the removable mechanical transmission device are provided, they must be designed and constructed in such a way as to prevent the transmission tree guards from being used as a step, unless they have been designed and manufactured for this purpose.

3.5 Protective measures against other hazards.

3.5.1 Accumulator Battery. -The battery compartment must be designed and constructed in such a way as to prevent the projection of the electrolyte on the operator in the event that the machine turns or turns, and that the accumulation of vapours in the places occupied by the operators is avoided.

The machine must be designed and manufactured so that the battery can be disconnected by means of an easy-to-access device installed for the purpose.

3.5.2 Fire. -depending on the risks envisaged by the manufacturer, and when its dimensions so permit, the machine must:

Allow installation of easily accessible extinguishers, or

to be provided with extinction systems that are part of the machine.

3.5.3 Emissions of hazardous substances. -The second and third subparagraphs of paragraph 1.5.13 shall not apply when the main function of the machine is the spraying of products. However, the operator must be protected against the risk of exposure to such dangerous emissions.

3.6 Information and indications.

3.6.1 Labels, signs and warnings. -Each machine must have signs and/or plates with the instructions regarding the use, adjustment and maintenance, provided that this is necessary in order to guarantee the health and safety of the persons. They must be chosen, designed and made in a way that is clearly visible and durable.

Without prejudice to the provisions of road traffic rules, machinery with a driver on board shall have the following equipment:

An acoustic signalling device that allows people to be alerted,

an appropriate light-signalling system for the intended conditions of use; this latter requirement shall not apply to machines exclusively intended for underground work and devoid of electrical energy,

if necessary, there must be an appropriate connection between the trailer and the machine for the operation of the signals.

Remote controlled machines which, under normal conditions of use, present a risk of shock or crushing for persons must be equipped with adequate means to signal their movements or means to protect persons from such risks. This should also be the case for machines whose use involves the systematic repetition of forward and backward movements on the same axis, and the driver of which has no direct view of the area behind the machine.

The machine must be manufactured so that inadvertent deactivation of warning and signaling devices cannot occur. Provided that this is essential for safety reasons, such devices must be equipped with systems which enable the correct operation to be controlled and any failure of the operator to be known to the operator.

In the case of machines whose movements, or those of their tools, are particularly dangerous, an inscription must be placed on the machine that prohibits approaching the machine during the work; the inscriptions must be legible from a sufficient distance to ensure the safety of the people who are going to work in their proximity.

3.6.2 Marking. -Each machine must bear the following indications in a legible and indelible manner:

The rated power expressed in kilowatts (kW),

the mass in the most usual configuration in kilograms (kg),

and, if applicable:

The maximum traction effort provided on the traction hook in newtons (N),

the maximum expected vertical stress on the traction hook in newtons (N).

3.6.3 Manual of instructions.

3.6.3.1 Vibrations. -In the instruction manual the following will be indicated about the vibrations that the machine transmits to the hand-arm system or to the entire body:

The total value of the vibrations to which the hand-arm system is exposed, when they exceed 2.5 m/s². When this value does not exceed 2.5 m/s², this fact should be mentioned,

the highest mean square value of the weighted acceleration to which the entire body is exposed, when this value exceeds 0,5 m/s². When this value does not exceed 0.5 m/s², this fact should be mentioned,

the uncertainty of the measurement.

These values will actually be measured in the machine considered, or will be established from measurements made on a technically comparable machine and representative of the machine to be manufactured.

When harmonised standards are not applied, vibrations should be measured using the measurement code that best suits the machine.

The operating conditions of the machine must be described during the measurement, as well as the measurement codes used for the measurement.

3.6.3.2 Multiple uses. -The manual of instructions for the machines which allow several uses, depending on the equipment applied, and the manual of instructions for the interchangeable equipment must include the information necessary to mount and use with total security the base machine and the interchangeable equipment that can be mounted on it.

4. Additional essential health and safety requirements to neutralise the hazards arising from lifting operations

Machines that present hazards due to lifting operations must meet all the relevant essential health and safety requirements described in this Chapter in accordance with the provisions of point 4 of the General Principles.

4.1 Generalities.

4.1.1 Definitions.

a) "Lifting operation": an operation of displacement of unit loads formed by objects and/or persons in need, at a given time, a change of level.

(b) "Guided load" means a load whose displacement is carried out in its entirety along rigid or flexible guides, the position of which is determined by fixed points.

(c) "Use Coefficient" means an arithmetic relationship between the load that an item can bear, guaranteed by the manufacturer or its authorised representative, and the maximum load of use marked on the item.

(d) "Test Coefficient" means the arithmetic ratio between the load used to perform the static or dynamic tests of a lifting machine or of a lifting accessory and the maximum load of use marked on the lifting machine or lift fitting, respectively.

(e) "Static test" means a test consisting of the inspection of a lifting machine or an elevation fitting, and then applying a force corresponding to the maximum use load multiplied by the appropriate static test coefficient and, after removing the load, reinspecting the machine or lifting accessory in order to verify that no damage has occurred.

(f) "Dynamic test" means a test which consists in operating the lifting machine in all its possible configurations with the maximum use charge multiplied by the appropriate dynamic test coefficient in view of the dynamic behaviour of the lifting machine in order to verify its proper functioning.

g) "Room": part of the machine where the persons and/or objects are located in order to be elevated.

4.1.2 Protection measures against mechanical hazards.

4.1.2.1 Risks due to lack of stability. The machine must be designed and constructed in such a way that the stability required in paragraph 1.3.1. is maintained both in service and off-duty, including all stages of transport, assembly and disassembly, during the foreseeable failures of an element and also during the tests carried out in accordance with the instruction manual. To this end, the manufacturer or his authorised representative shall use the appropriate verification methods.

4.1.2.2 Machine that circulates by guides or running tracks. -The machine must be equipped with devices that act on the guides or tracks, in order to avoid the derailments.

If, in spite of such devices, there is still a risk of derailment or of failure of the guiding or rolling elements, devices must be provided to prevent the fall of equipment, elements or load or the dump of the machine.

4.1.2.3 Mechanical resistance. -machinery, lifting accessories and their components must be able to withstand the efforts to which they are subjected during operation and, where appropriate, where they do not work, under the intended installation and operating conditions and in all relevant configurations, taking into account, where appropriate, the effects produced by the atmospheric factors and by the forces exerted by the persons. This requirement must also be met during transport, assembly and dismantling.

The machine and lifting accessories must be designed and constructed in such a way as to avoid any failure due to fatigue or wear due to the intended use.

The materials used must be chosen taking into account the work environment provided, with particular attention to corrosion, abrasion, shock, extreme temperatures, fatigue, fragility and ageing.

The machine and lifting accessories must be designed and constructed in such a way that they can withstand without permanent deformation or visible defect the overloads due to static tests. Resistance calculations should take into account the value of the selected static test coefficient in such a way as to ensure an adequate level of safety; this coefficient shall, as a general rule, have the following values:

a) Machines moved by human strength and lifting accessories: 1,5;

b) other machines: 1.25.

The machine must be designed and constructed in such a way that it does not fail the dynamic tests performed with the maximum load of utilization multiplied by the dynamic test coefficient. This dynamic test coefficient shall be selected in such a way as to ensure an adequate level of safety; as a general rule, this coefficient shall be equal to 1,1. Such tests shall, as a general rule, be carried out at the nominal speeds envisaged. In case the machine control system allows for several simultaneous movements, the tests must be carried out under the most unfavourable conditions, as a general rule combining the movements.

4.1.2.4. Pulleys, drums, rollers, cables and chains. -The pulleys, drums and rollers must have diameters compatible with the dimensions of the cables or the chains with which they may be equipped.

Drums and rollers must be designed, manufactured and installed so that the cables or chains with which they are equipped can be wound without leaving the intended site.

The cables used directly to lift or support the load must not bring any splicing except for the ends. However, the splices shall be tolerated in those installations intended, by design, to be regularly modified in accordance with the requirements for use.

The coefficient of use of the assembly formed by the cable and its terminations shall be selected in such a way as to ensure an adequate level of safety; as a general rule, this coefficient shall be equal to 5.

The coefficient of use of the lift chains must be selected in such a way as to ensure an adequate level of safety; as a general rule, this coefficient shall be equal to 4.

In order to verify that an appropriate coefficient of use has been achieved, the manufacturer or his authorised representative must carry out or make appropriate tests for each type of chain and cable used directly to raise the load and for each type of cable termination.

4.1.2.5 Lifting accessories and their elements. -lifting accessories and their components must be sized for a number of operating cycles according to the intended life span of the same, under the operating conditions specified for the application in question, taking into account the fatigue and ageing phenomena.

In addition:

(a) The coefficient of use of the combinations formed by the cable and the termination must be selected in such a way as to ensure an adequate level of safety; as a general rule, this coefficient shall be equal to 5. The cables must not carry any splice or loop except at their ends.

(b) When using the chain of welded links, they must be of the type of short links. The coefficient of use of the chains must be selected in such a way as to ensure an adequate level of safety; as a general rule, this coefficient shall be equal to 4.

(c) The coefficient of use of textile fibre cables or clamps shall depend on the material, the manufacturing process, the dimensions and their use. This coefficient must be selected in such a way as to guarantee an adequate level of safety; as a general rule, it will be equal to 7 as long as the materials used are of excellent quality and that the manufacturing process is appropriate for the intended use. Otherwise the ratio shall be higher as a general rule in order to provide an equivalent level of safety. The textile fibre ropes or clamps shall not bear any splice, tie or link except at the end of the sling or in the closure of an endless sling.

(d) The coefficient of use of all metallic elements of a sling, or used with a sling, must be selected in such a way as to ensure an adequate level of safety; as a general rule, this coefficient shall be equal to 4.

e) The maximum use load of a multiple thread sling must be determined taking into account the coefficient of utilization of the weakest yarn, the number of threads and a reduction factor that will depend on the slingling configuration.

(f) In order to verify that an appropriate coefficient of use has been achieved, the manufacturer or his authorised representative must carry out or carry out the appropriate tests for each type of element referred to in points (a), (b), (c) and (d).

4.1.2.6 Control of movements. -The actuation organs to control the movements must act in such a way that the machine in which they are installed remains in security situation.

(a) The machine must be designed, manufactured or equipped with devices in such a way as to maintain the amplitude of the movements of its elements within the prescribed limits. The action of these devices shall, where appropriate, be preceded by a warning.

(b) Where several fixed machines or rails can be simultaneously developed in the same place, with collision risks, such machines must be designed and constructed in such a way that they can be equipped with systems to avoid these risks.

(c) The machine must be designed and constructed in such a way that the loads cannot be slid in a dangerous way or fall unexpectedly in free fall, even in the case of partial or total failure of the power supply or the operator ceasing to operate the machine.

(d) Under normal operating conditions, it shall not be possible for the load descent to depend exclusively on a friction brake, except on the machines whose function requires the operation to be performed in that manner.

e) The prension organs must be designed and manufactured so that the loads cannot be inadvertently dropped.

4.1.2.7 Movement of loads during maintenance. -The control position of the machinery must be so located as to allow the maximum monitoring of the trajectory of the moving elements, in order to avoid possible shocks with persons, materials or other machines which may function simultaneously and which may constitute a hazard.

Guided load machines should be designed and constructed in such a way as to avoid personal injuries due to the movement of the load, the compartment or the counterweights, if they exist.

4.1.2.8 Machines to communicate fixed landings.

4.1.2.8.1 Room displacements. -The displacement of the passenger compartment of a machine that communicates fixed landings must be guided by rigid means towards the landings and in the same. The scissor systems are also considered as rigid guided.

4.1.2.8.2 Access to the carrier. -When persons have access to the passenger compartment, the machine must be designed and constructed in such a way that the carrier remains static during access, in particular during loading and unloading.

The machine must be designed and constructed in such a way that the level difference between the passenger compartment and the landing is not a risk of tripping.

4.1.2.8.3 Risks due to contact with the moving compartment. -Where necessary to comply with the requirement set out in the second paragraph of paragraph 4.1.2.7, the volume of travel must be inaccessible during normal operation.

When, during inspection or maintenance, there is a risk that persons located below or above the passenger compartment are crushed between this and any fixed element, sufficient free space should be allowed either by physical shelters or by mechanical means of locking the displacement of the passenger compartment.

4.1.2.8.4 Risks of falling cargo out of the passenger compartment. -Where there is a risk of load falling outside the passenger compartment, the machinery must be designed and constructed in such a way as to avoid such risk.

4.1.2.8.5 Fill-in. -The risks due to the contact of persons located in the landings with the moving compartment or other moving parts should be avoided.

When there is a risk that people will fall within the volume of travel when the carrier is not present in the landings, guards must be installed to avoid this risk. These guards must not be opened in the direction of the volume. They must be fitted with a locking and locking device controlled by the position of the passenger compartment, which prevents:

Hazardous movements in the room while the guards are not closed and locked,

the dangerous opening of a guard until the compartment has stopped in the corresponding landing.

4.1.3 Aptitude for use. -Where lifting machines or lifting accessories are placed on the market or put into service for the first time, the manufacturer or his authorised representative shall ensure, by taking or making appropriate action, that lifting machines or lifting accessories which are ready for use-handbooks or motorbikes-can fulfil their intended functions in total safety.

The static and dynamic tests referred to in paragraph 4.1.2.3. must be carried out on all lifting machines ready for service.

When the machine cannot be mounted on the premises of the manufacturer or on the premises of its authorised representative, appropriate measures must be taken at the place of use. In other cases, the measures may be taken either at the premises of the manufacturer or at the place of use.

4.2. Requirements for machines moved by an energy other than human strength.

4.2.1 Control of movements. -The actuation organs for controlling the movements of the machine or its equipment must be operated. However, for movements, partial or total, which do not present any risk of shock to the load or the machine, these organs may be replaced by actuating organs which allow automatic stops in pre-selected positions without the operator maintaining the action on the actuation organ.

4.2.2 Load Control. -Machines with a maximum use of 1 000 kg or less, or whose time of overturning is at least 40 000 Nm, must be equipped with devices which warn the driver and prevent dangerous movements in case:

Overload, exceeding the maximum utilization load or peak utilization time due to excess load,

to exceed the dump time.

4.2.3 Cable-guided installations. -Carrier cables, tractors or tractor-holders must be used either by means of a counterbalance or by means of a device to permanently control the voltage.

4.3. Information and markings.

4.3.1 Chains, cables and cinches. -Each chain length, cable or lift cinch which is not part of a set must bear a mark or, where this is not possible, a plate or ring which is immovable with the name and address of the manufacturer or his authorised representative and the identification of the corresponding certification.

The above certification must contain at least the following information:

(a) The name and address of the manufacturer and, where applicable, his authorised representative.

b) A description of the string or cable, including:

Its nominal dimensions,

your manufacturing,

the material used in its manufacture, and

any special metallurgical treatment to which the material has been subjected.

c) The test method used.

d) The maximum usage load to be supported by the string or string. Depending on the intended applications, a range of values may be indicated.

4.3.2 Lift Accessories. -Lift accessories must bear the following indications:

Identification of the material when this information is needed for use security,

the maximum usage load.

In the case of lifting accessories the marking of which is physically impossible, the particulars referred to in the first subparagraph must appear on a plate or other equivalent means and be firmly attached to the fitting.

The indications must be legible and placed in a place where they cannot disappear due to wear and tear or endanger the strength of the accessory.

4.3.3 Lifting machines. -The maximum use load must be marked prominently on the machine. This marking must be legible, indelible and uncoded.

When the maximum use load depends on the machine configuration, each command post must bear a load plate including, preferably in the form of a diagram or a frame, the maximum allowable load for each configuration.

Machines designed exclusively for the lifting of objects, equipped with a passenger compartment that allows people to access, must bear a clear and indelible warning that prohibits the lifting of persons.

Such an indication must be visible in each of the sites for which access is possible.

4.4 Manual of instructions.

4.4.1 Lift Accessories. -Each lifting accessory or each consignment of commercially indivisible lifting accessories must be accompanied by an instruction booklet including at least the following particulars:

a) The intended use.

(b) The employment limits (in particular for lifting accessories such as magnetic or vacuum suction cups which cannot be fully satisfied with the requirements of paragraph 4.1.2.6 (e)).

c) The instructions for mounting, using, and maintaining.

d) The static test coefficient used.

4.4.2. Lifting machines. -The lifting machine must be accompanied by an instruction manual indicating the following:

a) The technical characteristics of the machine and in particular:

The maximum use load and, where applicable, a copy of the load plate or load box described in paragraph 4.3.3, second paragraph,

the reactions on the supports or on the anchorages and, where appropriate, the characteristics of the tracks,

if applicable, the definition and means of installation of the lastres;

b) The contents of the machine history book, if not supplied with the machine.

c) The usage tips, in particular to remedy the lack of direct view of the load by the operator.

(d) Where appropriate, a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representative.

e) For machines which have not been mounted on the manufacturer's premises in their configuration of use, the instructions necessary to carry out the measurements referred to in point 4.1.3 before their first entry into service.

5. Additional essential health and safety requirements for machines intended for underground work

Machines intended for underground work must meet all the essential health and safety requirements described in this Chapter, in accordance with the provisions of point 4 of the General Principles.

5.1 Risks due to lack of stability. -Self-displaceable bras must be designed and constructed in such a way that they maintain a given direction during their displacement and that they cannot slide before the pressure, neither during the pressure nor after the decompression. They must have anchor points for the head plates of the individual hydraulic struts.

5.2 Circulation. -Self-displaceable bras should allow people to circulate without difficulty.

5.3 Drive organs. -The actuation organs for acceleration and braking of the displacement of the mobile machines on rails must be actuated with the hands. However, the validation devices may be operated with the foot.

The drive organs of the self-displaceable bras must be designed, manufactured and arranged so that, during the displacement operations, the operators are protected by an already placed hold. The actuation organs must be protected against any involuntary actuation.

5.4 Parada. -Self-driving machines on rails intended for use in underground work must be fitted with a validation device acting on the control circuit of the displacement of the machine, so that the displacement is stopped if the driver stops controlling the displacement.

5.5 Fire. The second indent of point 3.5.2 is compulsory for machines with highly flammable parts.

The braking system of machines for underground work must be designed and constructed in such a way that it does not produce sparks or cause fires.

Internal combustion engine engines for underground work must be equipped exclusively with engines using a low-voltage steam fuel and which cannot produce sparks of electrical origin.

5.6 exhaust emissions. -exhaust emissions from internal combustion engines should not be evacuated upwards.

6. Additional essential health and safety requirements for machines presenting particular hazards due to the lifting of persons

Machines that present hazards due to the elevation of persons should respond to all relevant essential health and safety requirements, as described in this Chapter, in accordance with the provisions of point 4 of the General Principles.

6.1 Generalities.

6.1.1 Mechanical resistance. -The compartment, including all hatches, must be designed and constructed in such a way as to provide the space and present the resistance corresponding to the maximum number of persons authorised in that compartment and the maximum use.

The coefficients of use of the components defined in points 4.1.2.4 and 4.1.2.5 are not sufficient for machines intended for the lifting of persons and, as a general rule, must be doubled. Machines designed for the lifting of persons or persons and objects must be equipped with a system of suspension or support of the passenger compartment, designed and constructed in such a way as to ensure an adequate level of overall safety and to prevent the risk of falling in the passenger compartment.

When cables or chains are used to suspend the passenger compartment, as a general rule, at least two separate cables or chains are required, each of which must have its own anchorage system.

6.1.2 Load control for machines moved by a different energy of human strength. -The requirements of paragraph 4.2.2 shall apply regardless of the maximum use load and the time of the rollover, unless the manufacturer can demonstrate that there is no risk of overloading or overturning.

6.2 Drive organs. -When the safety requirements do not impose other solutions, the passenger compartment must be designed and constructed as a general rule so that the persons within it have the means to control the movements of rise, descent and, where appropriate, other movements of the passenger compartment.

Such actuation organs should prevail over any other operating organ of the same movements, except for emergency stop devices.

The drive organs to control these movements must be operated, except when the housing itself is completely closed.

6.3. Risks for people who are in the room.

6.3.1 Risks due to the movements of the passenger compartment. -Machines for the elevation of persons must be designed, manufactured or equipped so that the accelerations and/or decelerations of the compartment do not create risks for the people.

6.3.2 Risks of fall outside the passenger compartment. -The compartment may not be inclined to the point of creating a risk of the occupants falling, even during the movement of the machine and the passenger compartment.

When the passenger compartment is planned as a job, it must be necessary to ensure stability and prevent dangerous movements.

If the measures referred to in paragraph 1.5.15 are not sufficient, the habitacles must be equipped with adequate anchorage points, in sufficient numbers, for the number of persons authorised in the passenger compartment.

The anchor points must be sufficiently resistant for the use of individual protective equipment against vertical falls.

When there is a hatch on the floor, or on the roof, or side doors, they must be designed and constructed to prevent their unexpected opening and must be opened in the opposite direction to the risk of falling in the event of an unexpected opening.

6.3.3 Risks due to falling objects over the passenger compartment. -Where there is a risk of falling objects on the passenger compartment with danger to persons, the passenger compartment must have a protective roof.

6.4. Machines that communicate fixed landings.

6.4.1 Risks for people who are in, or about, the living room. -The compartment must be designed and constructed in such a way as to avoid the risks due to the contact of persons and/or objects located in, or on, the compartment with any fixed or movable element. Where necessary to comply with this requirement, the passenger compartment itself must be completely closed with doors fitted with a locking device which prevents the dangerous movements of the passenger compartment unless the doors are closed. When there is a risk of falling outside the passenger compartment, the doors must remain closed if the passenger compartment stops between two landings.

The machines must be designed, manufactured and, if necessary, equipped with devices in such a way as to prevent uncontrolled displacement of rise or descent of the passenger compartment. These devices must be able to stop the passenger compartment with its maximum use load and the maximum foreseeable speed.

Stop action should not cause a hazardous deceleration for occupants, regardless of the load conditions.

6.4.2 Actuation organs located in the rells. -The actuation organs, except those provided for emergency, located in the rells must not initiate the movement of the passenger compartment when:

The actuation organs of the compartment are being actuated,

the carrier is not in a landing.

6.4.3 Access to the passenger compartment. -The guards in the landings and in the passenger compartment must be designed and manufactured in such a way as to guarantee a safe transit to and from the room, taking into account the foreseeable range of objects and people to raise.

6.5 Marked. -The carrier must carry the information necessary to ensure security, including:

The number of people authorized in the room,

the maximum usage load.

ANNEX II

Statements

1. Content

A. EC declaration of conformity of machinery

This declaration and its translations must be drawn up under the same conditions as the instruction manual (see Annex I, paragraph 1.7.4.1, points (a) and (b)), either on a machine or handwritten in capital letters.

This statement refers only to machines in the state in which they are marketed, excluding any added elements and/or operations that the end user performs later.

The EC declaration of conformity shall consist of the following elements:

1) Social reason and full address of the manufacturer and, where applicable, his authorised representative.

2) Name and address of the person empowered to collect the technical file, who must be established in the Community.

3) Description and identification of the machine including generic name, function, model, type, serial number and commercial denomination.

4) A paragraph expressly stating that the machine complies with all applicable provisions of Directive 2006 /42/EC and, where applicable, a similar paragraph to declare that the machine complies with other relevant Community directives and/or provisions. These references shall be those of the texts published in the Official Journal of the European Union.

5) Where appropriate, name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX, and the number of the EC type-examination certificate.

6) Where appropriate, name, address and identification number of the notified body which approved the total quality assurance system referred to in Annex X.

7. Where appropriate, reference to the harmonised standards referred to in Article 7 (2) which have been used.

8) Where appropriate, the reference to other standards and technical specifications that have been used.

9) Place and date of the declaration.

10) Identification and signature of the person empowered to write this declaration on behalf of the manufacturer or his authorised representative.

B. Declaration of incorporation of a quasi-machine

This declaration and its translations must be drawn up under the same conditions as the instruction manual (see Annex I, paragraph 1.7.4.1, points (a) and (b)), either on a machine or handwritten in capital letters.

The incorporation declaration will consist of the following elements:

1) Social reason and full address of the manufacturer of the quasi-machine and, where appropriate, his authorised representative.

2) Name and address of the person empowered to collect the relevant technical documentation, who shall be established in the Community.

3) Description and identification of the quasi-machine, including: generic name, function, model, type, serial number and commercial denomination.

4. A paragraph specifying the essential safety and health requirements that have been applied and complied with, that the relevant technical documentation has been developed in accordance with Annex VII, Part B, and, where appropriate, a declaration of the conformity of the quasi-machine with other relevant Community Directives. These references shall be those of the texts published in the Official Journal of the European Union.

5) The commitment to transmit, in response to a duly motivated request from the national authorities, the relevant information relating to the quasi-machine. This commitment shall include the modalities of transmission and shall not prejudice the intellectual property rights of the manufacturer of the quasi-machine.

6) If applicable, a declaration that the quasi-machine shall not be put into service while the final machine in which it is to be incorporated has not been declared in accordance with the provisions of Directive 2006 /42/EC.

7) Place and date of the declaration.

8) Identification and signature of the person empowered to write this declaration on behalf of the manufacturer or his authorised representative.

2. Custody

The manufacturer of the machine or his authorised representative shall keep the original of the EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery.

The manufacturer of the quasi-machine or its authorised representative shall keep the original of the incorporation declaration for a period of at least 10 years from the last date of manufacture of the quasi-machine.

ANNEX III

CE Marking

The CE conformity marking shall be composed of the initials "CE" designed as follows:

In case of reducing or increasing the size of the CE marking, the proportions of this logo must be respected.

The different elements of the CE marking must have appreciably the same vertical dimension, which may not be less than 5 mm. Exceptions to the minimum size are permitted in the case of small machines.

The CE marking shall be affixed to the name of the manufacturer or his authorised representative by the same technique.

Where the total quality assurance procedure referred to in point (c) of Article 12 (3) and point (b) of Article 12 (4) has been applied, the identification number of the notified body shall be indicated after the CE marking.

ANNEX IV

Categories of machines to which one of the procedures referred to in Article 12 (3) and (4) shall apply

1 Circular saws (one or more sheets) for working wood and materials of similar physical characteristics, or for cutting meat and materials of similar physical characteristics, of the following types:

1.1 Sierras with one or more fixed sheets during the cutting process, with fixed table or bench, with manual advance of the piece or with removable advance device.

1.2 Sierras with one or more fixed sheets during the cutting process, with table-easel or reciprocating movement cart, manual displacement.

1.3 Sierras with one or more fixed sheets during the cutting process, with integrated advance device of the pieces to be serrar, loading and/or manual unloading.

1.4 Sierras with one or more mobile sheets during the cutting process, with motorized tool displacement, loading and/or manual unloading.

2. Brush with manual advance to work the wood.

3. Rubbers of a face with integrated advance device, manual loading and/or unloading, for working the wood.

4. Manual loading and/or unloading tape saws for working the wood and materials of similar physical characteristics, or for cutting meat and materials of similar physical characteristics, of the following types:

4.1 Sierras with one or more fixed sheets during the cutting process, with table or bench for the piece, fixed or alternative movement.

4.2 Sierras with one or more sheets mounted on an alternative movement cart.

5. Combined machines of the types mentioned in points 1 to 4 and 7, for working wood and materials of similar physical characteristics.

6. Multi-axis spigners with manual advancement to work the wood.

7. Vertical spindle tuft with manual advancement for working wood and materials of similar physical characteristics.

8. Portable chain saws to work the wood.

9. Presses, including folding machines, for working in cold, loading and/or manual unloading metals, the working elements of which may have a course of more than 6 mm and a speed of more than 30 mm/s.

10. Machines for moulding plastics by injection or compression of manual loading or unloading.

11. Machines for moulding rubber by injection or compression of manual loading or unloading.

12. Machines for underground jobs, of the following types:

12.1 Locomotives and vagones-brake.

12.2 Self-displaceable hydraulic holds.

13. Manual load household waste collection buckets and compression mechanism.

14. Removable mechanical transmission devices, including their guards.

15. Guards for removable mechanical transmission devices.

16. Lifting platforms for vehicles.

17. Lifting apparatus for persons, persons and materials, with a danger of a vertical fall exceeding 3 metres.

18. Portable machines for fixing, explosive charging and other portable impact machines.

19. Protective devices designed to detect the presence of persons.

20. Motorised mobile guards with locking devices designed to be used as a protective measure on the machines referred to in points 9, 10 and 11.

21. Logical blocks for performing security functions.

22. Dump protection structures (ROPS).

23. Object drop protection structures (FOPS).

ANNEX V

Indicative list of safety components referred to in Article 2 (c)

1. Guards for removable mechanical transmission devices.

2. Protective devices designed to detect the presence of persons.

3. Motorised mobile guards with interlocking devices designed for use as a protective measure on the machines referred to in points 9, 10 and 11 of Annex IV.

4. Logical blocks for performing security functions on machines.

5. Valves with additional means for detecting faults and used for controlling the dangerous movements of the machines.

6. Systems for the extraction of emissions from machines.

7. Guards and protective devices intended to protect people against mobile elements involved in the process on the machine.

8. Device for controlling the load and control of movements in lifting machines.

9. Systems to keep people in their seats.

10. Emergency stop devices.

11. Discharge systems to prevent the generation of potentially dangerous electrostatic charges.

12. Energy limiters and discharge devices referred to in Annex I, points 1.5.7, 3.4.7 and 4.1.2.6.

13. Systems and devices for reducing noise and vibration emission.

14. Dump protection structures (ROPS).

15. Object drop protection structures (FOPS).

16. Two-handed control devices.

17. Components for machines designed for the lifting and/or descent of persons between different landings, including the following list:

a) Lock devices from the doors of the landings.

b) Devices to prevent the fall or uncontrolled upward movements of the cabin.

c) Devices to limit excess speed. (d) Energy accumulation buffers:

Non-linear character, or

With recoil damping.

e) Energy dissipation dampers.

f) Protective devices mounted on the cylinders of the power hydraulic circuits, when used as devices to prevent the fall. (g) Electrical protection devices in the form of safety switches containing electronic components.

ANNEX VI

Instructions for mounting a quasi-machine

The instructions for mounting a quasi-machine will contain the indications to be met in order to make the correct assembly possible on the final machine so that safety and health are not compromised.

They must be drawn up in an official Community language accepted by the manufacturer of the machinery in which this machine is to be incorporated, or by his authorised representative.

ANNEX VII

A. Technical file of the machines

This part describes the procedure for drawing up a technical file. The technical file shall demonstrate the conformity of the machinery with the requirements of Directive 2006 /42/EC, which transpose this royal decree. It shall cover, as far as is necessary for this assessment, the design, manufacture and operation of the machinery. The technical file shall be drawn up in one or more of the official languages of the European Community, with the exception of the machine instructions manual, to which the particular requirements referred to in Annex I, paragraph 1.7.4.1 apply.

1. The technical file shall consist of the following elements:

a) An integrated manufacturing case by:

A general description of the machine.

The machine assembly plane and the planes of the control circuits, as well as the relevant descriptions and explanations necessary to understand the operation of the machine.

Detailed and complete drawings, accompanied by any calculation notes, test results, certificates, etc., to verify the conformity of the machine with the essential health and safety requirements.

The documentation for risk assessment, which shows the procedure followed, including:

i. A list of the essential health and safety requirements that apply to the machine, and

ii. the description of the preventive measures applied to eliminate the identified hazards or to reduce the risks and, where appropriate, the indication of the residual risks associated with the machinery.

The standards and other technical specifications used, with an indication of the essential safety and health requirements covered by those standards.

Any technical report that reflects the results of the tests performed by the manufacturer, by a body chosen by the manufacturer or his authorised representative.

A copy of the machine instruction manual.

If applicable, declaration of incorporation of the quasi-machines included and the corresponding instructions for the assembly of these.

Where appropriate, copies of the EC declaration of conformity of the machinery or other products incorporated into the machinery.

A copy of the EC declaration of conformity.

(b) In the case of serial manufacturing, the internal provisions to be applied in order to maintain the conformity of the machinery with the Directive.

The manufacturer must submit the components or accessories, or the machine in its entirety, to the necessary studies and tests to determine whether, by design or manufacture, the machine can be mounted and put into service in safety conditions. The technical file shall include the relevant reports and results.

2. The technical file referred to in point 1 shall be at the disposal of the competent authorities for at least 10 years from the date of manufacture of the machinery or, in the case of serial manufacture, from the last unit produced.

The technical file will not necessarily have to remain in the territory of the European Community, nor will it exist permanently in a material form. However, the person indicated in the EC declaration of conformity must be able to bring it together and have it available in a time compatible with its complexity.

The technical file shall not include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery, unless the knowledge of the sub-assemblies is essential to verify compliance with the essential safety and health requirements.

3. Failure to submit the technical file in response to a duly reasoned request from the competent national authorities may be sufficient reason to doubt the conformity of the machinery concerned with the essential safety and health requirements.

B. Relevant technical documentation of quasi-machines

This part describes the procedure for preparing the relevant technical documentation. The documentation must show what health and safety requirements have been applied and complied with. It shall cover the design, manufacture and operation of the quasi-machine to the extent necessary to assess its conformity with the essential health and safety requirements applied. The documentation shall be drawn up in one or more of the official languages of the Community.

Consist of the following elements:

a) An integrated manufacturing case by:

The assembly plane of the quasi-machine and the planes of the control circuits.

Detailed and complete drawings, accompanied by any calculation notes, test results, certificates, etc., to verify the conformity of the quasi-machine with the essential safety and health requirements applied.

The documentation for risk assessment, which shows the procedure followed, including:

i. A list of the essential health and safety requirements that have been applied and met,

ii. The description of the preventive measures applied to eliminate the identified hazards or to reduce the risks and, where appropriate, the indication of the residual risks,

iii. The standards and other technical specifications used, with an indication of the essential safety and health requirements covered by those standards,

iv. Any technical report reflecting the results of the tests carried out by the manufacturer, by a body chosen by the manufacturer or his authorised representative, and

v. A copy of the instructions for mounting the quasi-machine;

(b) In the case of serial manufacture, the internal provisions to be applied in order to maintain the conformity of the quasi-machines with the essential health and safety requirements applied.

The manufacturer must submit the components or accessories, or the quasi-machine, to the necessary studies and tests to determine whether, by design or manufacture, the quasi-machine can be mounted and used in safety conditions. The technical file shall include the relevant reports and results.

The relevant technical documentation shall be available for at least 10 years from the date of manufacture of the quasi-machine, or in the case of serial manufacture, of the last unit produced, and shall be submitted to the competent authorities at the request of the latter. It will not necessarily have to remain in the territory of the European Community or exist permanently in a material form. The person indicated in the declaration of incorporation shall be able to bring it together and submit it to the competent authority.

The failure to present the relevant technical documentation in response to a duly reasoned request from the competent authorities may be sufficient reason to doubt the conformity of the quasi-machines with the essential safety and health requirements applied and declared.

ANNEX VIII

Assessment of compliance by internal control of machine manufacturing

1. This Annex describes the procedure by which the manufacturer or his authorised representative, who fulfils the obligations laid down in points 2 and 3, ensures and declares that the machine in question complies with the relevant requirements of Directive 2006 /42/EC, which transpose this royal decree.

2. For each representative type of the series concerned, the manufacturer or his authorised representative shall draw up the technical file referred to in Part A of Annex VII.

3. The manufacturer shall take the necessary steps to ensure that the manufacturing process is carried out in such a way as to ensure that the machinery manufactured with the technical file referred to in Part A of Annex VII and with the requirements of the Directive is satisfied.

ANNEX IX

EC type examination

The EC type-examination is the procedure by which a notified body checks and certifies that a model representative of a machine referred to in Annex IV (hereinafter referred to as 'type') complies with the provisions of Directive 2006 /42/EC, which transpose this royal decree.

1. The manufacturer or his authorised representative shall draw up, for each type, the technical file referred to in Part A of Annex VII.

2. For each type, the application for the EC type-examination shall be submitted by the manufacturer or his authorised representative to a notified body of his choice. The request will include:

Name and address of the manufacturer and, if applicable, of his authorised representative,

A written declaration specifying that the same application has not been submitted to any other notified body,

The technical file.

In addition, the applicant shall make a sample of the type available to the notified body. The notified body may request further samples if the testing programme so requires.

3. The notified body shall:

3.1 Examine the technical file, verify that the type has been manufactured in accordance with it and determine the elements that have been designed in accordance with the relevant provisions of the standards referred to in Article 7 (2) and the elements whose design is not based on those standards.

3.2 To carry out or carry out appropriate inspections, measurements and tests to determine whether the solutions adopted comply with the essential safety and health requirements of Annex I where the standards referred to in Article 7 (2) have not been applied.

3.3 To carry out or carry out appropriate inspections, measurements and tests to check whether, in the case of the use of the harmonised standards referred to in Article 7 (2), they have actually been applied.

3.4 Agree with the applicant on the place where the verification of the type has been manufactured in accordance with the technical file examined and the necessary inspections, measurements and tests.

4. If the type complies with the provisions of the Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall contain the name and address of the manufacturer and, where appropriate, his authorised representative, the data necessary for the identification of the approved type, the conclusions of the examination and the conditions to which his/her expedition may be subject.

The manufacturer and the notified body shall retain, for a period of 15 years from the date of issue of the certificate, a copy of the certificate, the technical file and all relevant documentation.

5. Where the type does not comply with the provisions of the Directive, the notified body shall refuse the applicant for the issue of the EC type-examination certificate and shall give detailed reasons for its refusal. It shall inform the applicant, the other notified bodies and the competent authority which has authorised it. An appeal procedure must be provided.

6. The applicant shall inform the notified body in possession of the technical file relating to the EC type-examination certificate on all modifications made to the approved type. The notified body shall examine these amendments and shall confirm the validity of the existing EC type-examination certificate or draw up a new one where the modifications may compromise the conformity of the type with the essential health and safety requirements or with the intended conditions of use.

7. The European Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates. On request, the Commission and the Member States may obtain a copy of the technical file and the results of the examinations carried out by the notified body.

8. The files and correspondence relating to EC-type examination procedures shall be drawn up in the official Community language or languages of the Member State in which the notified body is established or in any other official language of the European Community accepted by the notified body.

9. Validity of the EC type-examination certificate:

9.1 The notified body shall have a constant responsibility to ensure that the EC type-examination certificate remains valid. It shall inform the manufacturer of any changes of importance which have consequences for the validity of the certificate. The notified body shall withdraw the certificates which are no longer valid.

9.2 The manufacturer of the machine in question shall have a constant responsibility to ensure that the machine is in conformity with the state of the corresponding technique.

9.3 The manufacturer shall ask the notified body for the review, every five years, of the validity of the EC type-examination certificate.

If the notified body considers that the certificate is still valid taking into account the state of the art, it will renew the certificate for five more years.

The manufacturer and the notified body shall keep a copy of the certificate, the technical file and all documents relating to the case for a period of 15 years from the date of issue of the certificate.

9.4 If the validity of the EC type-examination certificate is not renewed, the manufacturer shall interrupt the placing on the market of the machine in question.

ANNEX X

Total Quality Assurance

This Annex describes the conformity assessment of a machine referred to in Annex IV manufactured in accordance with a total quality assurance system and the procedure by which a notified body evaluates and approves the quality system and monitors its application.

1. The manufacturer shall apply an approved quality system for the design, manufacture, final inspection and testing as specified in point 2, and shall be subject to the control referred to in point 3.

2. Quality system.

2.1 The manufacturer or his authorised representative shall submit an application for the assessment of his quality system to a notified body of his choice.

The request will include:

The name and address of the manufacturer and, if applicable, of his authorized representative,

The locations of design, manufacture, inspection, testing and storage of the machines,

The technical file described in Annex VII, Part A, for a model of each category of machines listed in Annex IV that it provides for manufacturing,

The documentation on the quality system,

A written statement specifying that the same application has not been submitted to any other notified body.

2.2 The quality system will ensure the conformity of the machines with Directive 2006 /42/EC, transposed by this royal decree. All the elements, requirements and precepts adopted by the manufacturer must appear in a systematic and rational documentation in the form of written measurements, procedures and instructions. The documentation of the quality system shall allow for the uniform interpretation of the procedural and quality measures, such as programmes, plans, manuals and quality records.

In particular, such documentation will include an appropriate description of:

Quality objectives, organization chart and responsibilities of management personnel and their authority as regards the design and quality of the machines,

The technical specifications of the design, including the rules to be applied and, where the standards referred to in Article 7 (2) are not fully applied, the means to be used to ensure compliance with the relevant essential health and safety requirements.

The techniques of control and verification of the design, processes and systematic activities to be used during the design of the machines,

The corresponding manufacturing, quality assurance and quality assurance techniques to be used, as well as the systematic processes and actions to be followed,

The inspections and tests to be carried out before, during and after manufacturing and their frequency,

Quality records, such as inspection reports and test and calibration data, and reports on the qualification of affected personnel,

The desired means to verify the achievement of the quality and design of the machine, as well as the efficient operation of the quality system.

2.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in point 2.2.

The elements of the quality system that comply with the relevant harmonised standard shall be considered to be in conformity with the relevant requirements referred to in point 2.2.

The team of auditors will have at least one member who has experience in evaluating the technology of the machines. The assessment procedure shall include an inspection visit to the manufacturer's premises.

During the assessment, the audit team shall review the technical file referred to in the third indent of the second paragraph of point 2.1 to ensure that it complies with the relevant safety and health requirements.

The decision shall be notified to the manufacturer or his authorised representative. The notification shall include the conclusions of the examination and the reasoned decision on the assessment of the system. An appeal procedure must be provided.

2.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in such a way as to continue to be appropriate and effective.

The manufacturer or his authorised representative shall keep the notified body that has approved the quality system informed of any changes to the quality system he plans to carry out.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements set out in point 2.2 or if a new assessment is required.

The notified body shall notify the manufacturer of its decision. The notification shall include the conclusions of the examination and the reasoned decision on the assessment of the system.

3. Surveillance under the responsibility of the notified body

3.1 The aim of monitoring is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

3.2 The manufacturer shall authorise the notified body to have access, for inspection purposes, to its design, manufacturing, inspection, testing and storage facilities and shall provide it with all the necessary information, in particular:

The documentation for the quality system,

The quality records foreseen in the part of the quality system dedicated to the design, such as the results of the analyses, calculations, tests, etc. ,

The quality records foreseen in the part of the quality system dedicated to manufacturing such as inspection reports and test data, calibration data, reports on the qualification of the affected staff, etc.

3.3 The notified body shall carry out regular audits to ensure that the manufacturer maintains and applies the quality system; it shall provide an audit report to the manufacturer. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

3.4 In addition, the notified body may carry out unannounced inspection visits to the manufacturer. The need for such additional visits and their frequency shall be determined on the basis of a monitoring system of visits managed by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The results of previous inspection visits,

The need to ensure the follow-up of corrective measures, where appropriate, the special conditions for the approval of the system, the significant changes in the organisation of the manufacturing process, the measurements or the techniques.

For these visits, the notified body may, if necessary, carry out or carry out tests to verify the proper functioning of the quality system. That body shall provide the manufacturer with an inspection report and, where tests have been carried out, a test report.

4. The manufacturer or his authorised representative shall have at the disposal of the competent authorities for 10 years from the last date of manufacture:

The documentation referred to in point 2.1,

The notified body's decisions and reports referred to in point 2.4, third and fourth paragraphs, and points 3.3 and 3.4.

ANNEX XI

Minimum criteria to be considered for notification of organisms

1. The body, its director and the personnel responsible for carrying out the verification operations may not be the designer, the manufacturer, the supplier, the installer of the machines they control, or the authorised representative of one of these persons. They may not intervene directly or as authorised representatives in the design, manufacture, marketing or maintenance of such machines. This does not preclude the possibility of an exchange of technical information between the manufacturer and the body.

2. The body and its staff shall carry out the verification operations with the greatest possible professional integrity and the greatest possible technical competence, and shall be free from any pressure or coercion, in particular economic order, which may influence their judgment or the results of the inspection, particularly those arising from persons or groups of persons interested in the results of the verifications.

3. The body shall count, for each category of machinery for which it is notified, with personnel having the technical expertise and sufficient and appropriate experience to carry out the conformity assessment. It shall have the necessary means to carry out in an appropriate manner the technical and administrative tasks relating to the execution of the verifications; it shall also have access to the material necessary for the exceptional verifications.

4. The staff responsible for the checks must have:

Good technical and professional training,

A satisfactory knowledge of the provisions relating to the testing and a sufficient practice of such tests, The aptitude required to draw up the certificates, minutes and reports attesting to the conduct of the tests.

5. The impartiality of the staff responsible for control must be ensured. The remuneration of such staff shall not depend on the number of tests performed or on the result of such tests.

6. The body must take out civil liability insurance unless such liability is covered by the State in the form determined, or the Administration itself is responsible for conducting the tests directly.

7. The staff of the body shall be obliged to keep the professional secrecy in respect of all the information to which it has access in the performance of its duties under Directive 2006 /42/EC, which has been transposed by this royal decree, except in respect of the competent authority.

8. Notified bodies shall participate in the coordination activities. They shall also take part directly or through representation in European standardisation, or shall ensure that they are kept abreast of the situation of the relevant standards.

9. In the event of termination of the activities of a notified body, the files of its clients must be referred to another body or made available to the Autonomous Community which has authorised it.

ANNEX XII

Correlation table (1)

Directive 98 /37/EC

Annex I, Section 3.6.3, point (b)

Directive 2006 /42/EC
Article 1, paragraph 1	Article 1, paragraph 1.
Article 1, paragraph 2, letter a)	Article 2, letters a), and b).
Article 1, paragraph 2, letter b)	Article 2, letter c).
Article 1, paragraph 3	Article 1, paragraph 2.
Article 1, paragraph 4	Article 3.
Article 1, paragraph 5	-
Article 2, paragraph 1	Article 4, paragraph 1.
Article 2, paragraph 2	Article 15.
Article 2, paragraph 3	Article 6, paragraph 3.
Article 3	Article 5 (1) (a).
Article 4, paragraph 1	Article 6, paragraph 1.
Article 4, paragraph 2, first paragraph	Article 6, paragraph 2.
Article 4, paragraph 2, second paragraph	-
Article 4, paragraph 3	-
Article 5, paragraph 1, first paragraph	Article 7, paragraph 1.
Article 5, paragraph 1, second paragraph	-
Article 5, paragraph 2, first paragraph	Article 7, paragraphs 2 and 3.
Article 5, paragraph 2, last paragraph	-
Article 5, paragraph 3	Article 7, paragraph 4.
Article 6, paragraph 1	Article 10.
Article 6, paragraph 2	Article 22.
Article 7, paragraph 1	Article 11, paragraphs 1 and 2.
Article 7, paragraph 2	Article 11, paragraphs 3 and 4,.
Article 7, paragraph 3	Article 11, paragraph 4.
Article 7, paragraph 4	Article 11, paragraph 5.
Article 8, paragraph 1, first paragraph	Article 5, paragraph 1, point (e), and Article 12, paragraph 1.
Article 8, paragraph 1, second paragraph	Article 5 (1) (f).
Article 8, paragraph 2, letter a)	Article 12, paragraph 2.
Article 8 (2) (b)	Article 12, paragraph 4.
Article 8, paragraph 2, letter c)	Article 12, paragraph 3.
Article 8, paragraph 3	-
Article 8, paragraph 4	-
Article 8, paragraph 5	-
Article 8, paragraph 6	Article 5, paragraph 4.
Article 8, paragraph 7	-
Article 8, paragraph 8	-
Article 9, paragraph 1, first paragraph	Article 14, paragraph 1.
Article 9, paragraph 1, second paragraph	Article 14, paragraph 4.
Article 9, paragraph 2	Article 14, paragraphs 3 and 5.
Article 9, paragraph 3	Article 14, paragraph 8.
Article 10, paragraphs 1 to 3	Article 16, paragraphs 1 to 3.
Article 10, paragraph 4	Article 17.
Article 11	Article 20.
Article 12	Article 21.
Article 13, paragraph 1	Article 26, paragraph 2.
Article 13, paragraph 2	-
Article 14	-
Article 15	Article 28.
Article 16	Article 29.
Annex I, preliminary observation 1	Annex I, General principles, point 2.
Annex I, preliminary observation 2	Annex I, General principles, point 3.
Annex I, preliminary observation 3	Annex I, General principles, point 4.
Annex I, point 1	Annex I, point 1.
Annex I, point 1.1	Annex I, paragraph 1.1.
Annex I, paragraph 1.1.1	Annex I, paragraph 1.1.1.
Annex I, paragraph 1.1.2	Annex I, paragraph 1.1.2.
Annex I, paragraph 1.1.2, point (d)	Annex I, paragraph 1.1.6.
Annex I, paragraph 1.1.3	Annex I, paragraph 1.1.3.
Annex I, point 1.1.4	Annex I, paragraph 1.1.4.
Annex I, point 1.1.5	Annex I, paragraph 1.1.5.
Annex I, point 1.2	Annex I, paragraph 1.2.
Annex I, paragraph 1.2.1	Annex I, paragraph 1.2.1.
Annex I, paragraph 1.2.2	Annex I, paragraph 1.2.2.
Annex I, paragraph 1.2.3	Annex I, paragraph 1.2.3.
Annex I, paragraph 1.2.4	Annex I, paragraph 1.2.4.
Annex I, Section 1.2.4, first to third paragraphs	Annex I, paragraph 1.2.4.1.
Annex I, paragraph 1.2.4, paragraphs fourth to sixth	Annex I, paragraph 1.2.4.3.
Annex I, paragraph 1.2.4, seventh paragraph	Annex I, paragraph 1.2.4.4.
Annex I, paragraph 1.2.5	Annex I, paragraph 1.2.5.
Annex I, paragraph 1.2.6	Annex I, paragraph 1.2.6.
Annex I, point 1.2.7	Annex I, paragraph 1.2.1.
Annex I, point 1.2.8	Annex I, paragraph 1.1.6.
Annex I, point 1.3	Annex I, point 1.3.
Annex I, paragraph 1.3.1	Annex I, paragraph 1.3.1.
Annex I, paragraph 1.3.2	Annex I, paragraph 1.3.2.
Annex I, point 1.3.3	Annex I, paragraph 1.3.3.
Annex I, point 1.3.4	Annex I, paragraph 1.3.4.
Annex I, point 1.3.5	Annex I, paragraph 1.3.5.
Annex I, paragraph 1.3.6	Annex I, paragraph 1.3.6.
Annex I, paragraph 1.3.7	Annex I, paragraph 1.3.7.
Annex I, paragraph 1.3.8	Annex I, paragraph 1.3.8.
Annex I, paragraph 1.3.8, A	Annex I, paragraph 1.3.8.1.
Annex I, paragraph 1.3.8, B	Annex I, paragraph 1.3.8.2.
Annex I, point 1.4	Annex I, point 1.4.
Annex I, paragraph 1.4.1	Annex I, paragraph 1.4.1.
Annex I, paragraph 1.4.2	Annex I, paragraph 1.4.2.
Annex I, point 1.4.2.1	Annex I, paragraph 1.4.2.1.
Annex I, point 1.4.2.2	Annex I, paragraph 1.4.2.2.
Annex I, paragraph 1.4.2.3	Annex I, paragraph 1.4.2.3.
Annex I, paragraph 1.4.3	Annex I, paragraph 1.4.3.
Annex I, point 1.5	Annex I, point 1.5.
Annex I, paragraph 1.5.1	Annex I, paragraph 1.5.1.
Annex I, paragraph 1.5.2	Annex I, paragraph 1.5.2.
Annex I, paragraph 1.5.3	Annex I, paragraph 1.5.3.
Annex I, paragraph 1.5.4	Annex I, paragraph 1.5.4.
Annex I, point 1.5.5	Annex I, paragraph 1.5.5.
Annex I, paragraph 1.5.6	Annex I, paragraph 1.5.6.
Annex I, paragraph 1.5.7	Annex I, paragraph 1.5.7.
Annex I, paragraph 1.5.8	Annex I, paragraph 1.5.8.
Annex I, point 1.5.9	Annex I, paragraph 1.5.9.
Annex I, paragraph 1.5.10	Annex I, paragraph 1.5.10.
Annex I, paragraph 1.5.11	Annex I, paragraph 1.5.11.
Annex I, paragraph 1.5.12	Annex I, paragraph 1.5.12.
Annex I, paragraph 1.5.13	Annex I, paragraph 1.5.13.
Annex I, paragraph 1.5.14	Annex I, paragraph 1.5.14.
Annex I, paragraph 1.5.15	Annex I, paragraph 1.5.15.
Annex I, point 1.6.	Annex I, point 1.6.
Annex I, paragraph 1.6.1	Annex I, paragraph 1.6.1.
Annex I, paragraph 1.6.2	Annex I, paragraph 1.6.2.
Annex I, paragraph 1.6.3	Annex I, paragraph 1.6.3.
Annex I, paragraph 1.6.4	Annex I, paragraph 1.6.4.
Annex I, paragraph 1.6.5	Annex I, paragraph 1.6.5.
Annex I, point 1.7	Annex I, paragraph 1.7.
Annex I, paragraph 1.7.0	Annex I, paragraph 1.7.1.1.
Annex I, paragraph 1.7.1	Annex I, paragraph 1.7.1.2.
Annex I, paragraph 1.7.2	Annex I, paragraph 1.7.2.
Annex I, paragraph 1.7.3	Annex I, paragraph 1.7.3.
Annex I, paragraph 1.7.4	Annex I, paragraph 1.7.4.
Annex I, paragraph 1.7.4, letters b) and h)	Annex I, paragraph 1.7.4.1.
Annex I, paragraph 1.7.4, points (a), (c), and (e) to (g)	Annex I, paragraph 1.7.4.2.
Annex I, Section 1.7.4, point (d)	Annex I, paragraph 1.7.4.3.
Annex I, point 2	Annex I, point 2.
Annex I, point 2.1	Annex I, paragraph 2.1.
Annex I, paragraph 2.1, part first	Annex I, paragraph 2.1.1.
Annex I, paragraph 2.1, part second	Annex I, paragraph 2.1.2.
Annex I, point 2.2	Annex I, paragraph 2.2.
Annex I, paragraph 2.2, part first	Annex I, paragraph 2.2.1.
Annex I, paragraph 2.2, part second	Annex I, paragraph 2.2.1.1.
Annex I, paragraph 2.3	Annex I, paragraph 2.3.
Annex I, point 3	Annex I, point 3.
Annex I, point 3.1	Annex I, paragraph 3.1.
Annex I, paragraph 3.1.1	Annex I, paragraph 3.1.1.
Annex I, paragraph 3.1.2	Annex I, paragraph 1.1.4.
Annex I, paragraph 3.1.3	Annex I, paragraph 1.1.5.
Annex I, paragraph 3.2	Annex I, paragraph 3.2.
Annex I, point 3.2.1	Annex I, points 1.1.7 and 3.2.1.
Annex I, paragraph 3.2.2	Annex I, points 1.1.8 and 3.2.2.
Annex I, paragraph 3.2.3	Annex I, paragraph 3.2.3.
Annex I, point 3.3	Annex I, point 3.3.
Annex I, paragraph 3.3.1	Annex I, paragraph 3.3.1.
Annex I, paragraph 3.3.2	Annex I, paragraph 3.3.2.
Annex I, paragraph 3.3.3	Annex I, paragraph 3.3.3.
Annex I, point 3.3.4	Annex I, paragraph 3.3.4.
Annex I, point 3.3.5	Annex I, paragraph 3.3.5.
Annex I, point 3.4	Annex I, point 3.4.
Annex I, paragraph 3.4.1, first paragraph	Annex I, paragraph 1.3.9.
Annex I, paragraph 3.4.1, second paragraph	Annex I, paragraph 3.4.1.
Annex I, paragraph 3.4.2	Annex I, paragraph 1.3.2.
Annex I, paragraph 3.4.3	Annex I, paragraph 3.4.3.
Annex I, point 3.4.4	Annex I, paragraph 3.4.4.
Annex I, paragraph 3.4.5	Annex I, paragraph 3.4.5.
Annex I, point 3.4.6	Annex I, paragraph 3.4.6.
Annex I, paragraph 3.4.7	Annex I, paragraph 3.4.7.
Annex I, paragraph 3.4.8	Annex I, paragraph 3.4.2.
Annex I, point 3.5	Annex I, point 3.5.
Annex I, paragraph 3.5.1	Annex I, paragraph 3.5.1.
Annex I, paragraph 3.5.2	Annex I, paragraph 3.5.2.
Annex I, paragraph 3.5.3	Annex I, paragraph 3.5.3.
Annex I, point 3.6	Annex I, point 3.6.
Annex I, paragraph 3.6.1	Annex I, paragraph 3.6.1.
Annex I, paragraph 3.6.2	Annex I, paragraph 3.6.2.
Annex I, paragraph 3.6.3	Annex I, paragraph 3.6.3.
Annex I, paragraph 3.6.3, letter a)	Annex I, paragraph 3.6.3.1.
Annex I, paragraph 3.6.3.2.
Annex I, point 4	Annex I, point 4.
Annex I, point 4.1	Annex I, paragraph 4.1.
Annex I, paragraph 4.1.1	Annex I, paragraph 4.1.1.
Annex I, paragraph 4.1.2	Annex I, paragraph 4.1.2.
Annex I, paragraph 4.1.2.1	Annex I, paragraph 4.1.2.1.
Annex I, paragraph 4.1.2.2	Annex I, paragraph 4.1.2.2.
Annex I, paragraph 4.1.2.3	Annex I, paragraph 4.1.2.3.
Annex I, paragraph 4.1.2.4	Annex I, paragraph 4.1.2.4.
Annex I, paragraph 4.1.2.5	Annex I, paragraph 4.1.2.5.
Annex I, paragraph 4.1.2.6	Annex I, paragraph 4.1.2.6.
Annex I, paragraph 4.1.2.7	Annex I, paragraph 4.1.2.7.
Annex I, paragraph 4.1.2.8	Annex I, paragraph 1.5.16.
Annex I, point 4.2	Annex I, paragraph 4.2.
Annex I, paragraph 4.2.1	-
I, paragraph 4.2.1.1	Annex I, paragraph 1.1.7.
Annex I, Section 4.2.1.2	Annex I, paragraph 1.1.8.
Annex I, Section 4.2.1.3	Annex I, Section 4.2.1.
Annex I, Section 4.2.1.4	Annex I, paragraph 4.2.2.
Annex I, paragraph 4.2.2	Annex I, paragraph 4.2.3.
Annex I, paragraph 4.2.3	Annex I, points 4.1.2.7 and 4.1.2.8.2.
Annex I, paragraph 4.2.4	Annex I, paragraph 4.1.3.
Annex I, point 4.3	Annex I, paragraph 4.3.
Annex I, paragraph 4.3.1	Annex I, paragraph 4.3.1.
Annex I, paragraph 4.3.2	Annex I, paragraph 4.3.2.
Annex I, paragraph 4.3.3	Annex I, paragraph 4.3.3.
Annex I, point 4.4	Annex I, point 4.4.
Annex I, paragraph 4.4.1	Annex I, paragraph 4.4.1.
Annex I, paragraph 4.4.2	Annex I, paragraph 4.4.2.
Annex I, point 5	Annex I, point 5.
Annex I, point 5.1	Annex I, point 5.1.
Annex I, point 5.2	Annex I, paragraph 5.2.
Annex I, point 5.3	-
I, point 5.4	Annex I, paragraph 5.3.
Annex I, point 5.5	Annex I, point 5.4.
Annex I, point 5.6	Annex I, point 5.5.
Annex I, point 5.7	Annex I, paragraph 5.6.
Annex I, point 6	Annex I, point 6.
Annex I, point 6.1	Annex I, paragraph 6.1.
Annex I, paragraph 6.1.1	Annex I, paragraph 4.1.1, point (g).
Annex I, paragraph 6.1.2	Annex I, paragraph 6.1.1.
Annex I, paragraph 6.1.3	Annex I, paragraph 6.1.2.
Annex I, point 6.2	Annex I, paragraph 6.2.
Annex I, paragraph 6.2.1	Annex I, paragraph 6.2.
Annex I, paragraph 6.2.2	Annex I, paragraph 6.2.
Annex I, paragraph 6.2.3	Annex I, paragraph 6.3.1.
Annex I, point 6.3	Annex I, paragraph 6.3.2.
Annex I, paragraph 6.3.1	Annex I, paragraph 6.3.2, third paragraph.
Annex I, paragraph 6.3.2	Annex I, paragraph 6.3.2, fourth paragraph.
Annex I, paragraph 6.3.3	Annex I, paragraph 6.3.2, first paragraph.
Annex I, paragraph 6.4.1	Annex I, points 4.1.2.1, 4.1.2.3, and 6.1.1.
Annex I, paragraph 6.4.2	Annex I, paragraph 6.3.1.
Annex I, point 6.5	Annex I, point 6.5.
Annex II, Parts A, and B	Annex II, Part 1, Section A.
Annex II, part C	-
Annex III	Annex III.
Annex IV, Part A, point 1 (1.1. to 1.4)	Annex IV, point 1 (1.1. to 1.4).
Annex IV, Part A, point 2	Annex IV, point 2.
Annex IV, Part A, point 3	Annex IV, point 3.
Annex IV, Part A, point 4	Annex IV, point 4 (4.1 and 4.2).
Annex IV, Part A, point 5	Annex IV, point 5.
Annex IV, Part A, point 6	Annex IV, point 6.
Annex IV, Part A, point 7	Annex IV, point 7.
Annex IV, Part A, point 8	Annex IV, paragraph 8.
Annex IV, Part A, point 9	Annex IV, point 9.
Annex IV, Part A, point 10	Annex IV, point 10.
Annex IV, Part A, point 11	Annex IV, paragraph 11.
Annex IV, Part A, point 12 (first and second indents)	Annex IV, point 12 (12.1 and 12.2).
Annex IV, Part A, point 12 (third indent)	-
Annex IV, Part A, point 13	Annex IV, point 13.
Annex IV, Part A, point 14, Part One	Annex IV, paragraph 15.
Annex IV, Part A, point 14, Part Two	Annex IV, paragraph 14.
Annex IV, Part A, point 15	Annex IV, paragraph 16.
Annex IV, Part A, point 16	Annex IV, paragraph 17.
Annex IV, Part A, point 17	-
Annex IV, Part B, point 1	Annex IV, point 19.
Annex IV, Part B, point 2	Annex IV, point 21.
Annex IV, Part B, point 3	Annex IV, paragraph 20.
Annex IV, Part B, point 4	Annex IV, paragraph 22.
Annex IV, Part B, point 5	Annex IV, paragraph 23.
Annex V, point 1	-
Annex V, point 2	-
Annex V, paragraph 3, first paragraph, point (a)	Annex VII, Part A, point 1, first paragraph, point (a).
Annex V, paragraph 3, first paragraph, point (b)	Annex VII, Part A, point 1, first paragraph, point (b).
Annex V, paragraph 3, second paragraph	Annex VII, Part A, point 1, second paragraph.
Annex V, paragraph 3, third paragraph	Annex VII, Part A, point 3.
Annex V, point 4 (a)	Annex VII, Part A, paragraph 2, second and third paragraphs.
Annex V, point 4, point (b)	Annex VII, Part A, point 2, first paragraph.
Annex V, point 4, letter c)	Annex VII, part A, Introduction.
Annex VI, point 1	Annex IX, Introduction.
Annex VI, point 2	Annex IX, points 1 and 2.
Annex VI, point 3	Annex IX, point 3.
Annex VI, paragraph 4, first paragraph	Annex IX, paragraph 4, first paragraph.
Annex VI, paragraph 4, second paragraph	Annex IX, point 7.
Annex VI, point 5	Annex IX, point 6.
Annex VI, point 6, first sentence	Annex IX, point 5.
Annex VI, point 6, second and third sentences	Article 14, paragraph 6.
Annex VI, point 7	Annex IX, paragraph 8.
Annex VII, point 1	Annex XI, point 1.
Annex VII, point 2	Annex XI, point 2.
Annex VII, point 3	Annex XI, point 3.
Annex VII, point 4	Annex XI, point 4.
Annex VII, point 5	Annex XI, point 5.
Annex VII, point 6	Annex XI, point 6.
Annex VII, point 7	Annex XI, point 7.
Annex VIII	-
Annex IX	-

(1) This table shows the correlation between the parts of Directive 98 /37/EC and those of Directive 2006 /42/EC dealing with the same subject. On the contrary, the content of the correlative parts does not necessarily have to be identical.