Considerations on COM(2021)202 - Machinery products - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2021)202 - Machinery products. |
|---|---|
| document | COM(2021)202  |
| date | June 14, 2023 |
(2) The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Union economy. The social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installation and maintenance.
(3) Experience with the application of Directive 2006/42/EC has shown inadequacies and inconsistencies in the product coverage and conformity assessment procedures. It is therefore necessary to improve, simplify and adapt the provisions set out in that Directive to the needs of the market and provide clear rules in relation to the framework within which machinery products may be made available on the market.
(4) Since the rules setting out the requirements for machinery products, in particular the essential health and safety requirements and the conformity assessment procedures, need to be of uniform application for all operators across the Union, and not give room for divergent implementation by Member States, Directive 2006/42/EC should be replaced by a regulation.
OJ C […], […], p. […].
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery,
and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
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(5) Member States are responsible for protecting, on their territory, the health and safety of persons, in particular workers and consumers and, where appropriate, domestic animals and property, notably in relation to the risks arising out of the use of machinery. For the avoidance of doubt, domestic animals should be considered to include farm animals.
(6) Regulation (EC) No 765/2008 of the European Parliament3 lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. That Regulation should be applicable to machinery products covered by this Regulation in order to ensure that those products, which are benefiting from the free movement of goods within the Union, fulfil requirements providing a high level of protection of public interests such as the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment.
(7) Regulation (EC) No 2019/1020 of the European Parliament and of the Council4 sets out rules on market surveillance and control of products entering the Union market. That Regulation already applies to machinery, since Directive 2006/42/EC is listed in its Annex I.
(8) Decision No 768/2008/EC of the European Parliament and of the Council5 lays down common principles and reference provisions intended to apply across sectoral legislation. In order to ensure consistency with other sectoral product legislation, it is appropriate to align certain provisions of this Regulation to that Decision, in so far as sectoral specificities do not require a different solution. Therefore, certain definitions, the general obligations of economic operators, the rules on presumption of conformity, the rules on EU declaration of conformity, the rules on CE marking, the requirements for conformity assessment bodies, the rules on notification procedures and conformity assessment procedures and the rules on procedures to deal with machinery products presenting a risk should be adapted to the reference provisions laid down in that Decision.
(9) This Regulation should cover machinery products which are new to the Union market when placed on the market, i.e. either new machinery products made by a manufacturer established in the Union or machinery products, whether new or secondhand, imported from a third country.
(10) Where there is a possibility that the machinery products will be used by a consumer, that is to say, a non-professional operator, the manufacturer should take account of the fact that the consumer does not have the same knowledge and experience with handling machinery products in the design and construction of the products. The same
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out
the requirements for accreditation and market surveillance relating to the marketing of products and
repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No
765/2008 and (EU) No 305/2011 (OJ L169, 25.6.2019, p. 1.)
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218,
13.08.2008, p. 82).
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applies where a machinery product is normally used to provide a service to a
consumer.
(11) Recently, more advanced machines, which are less dependent on human operators, have been introduced on the market. These machines, known as collaborative robots or cobots, are working on defined tasks and in structured environments, yet they can learn to perform new actions in this context and become more autonomous. Further refinements to machines, already in place or to be expected, include real-time processing of information, problem solving, mobility, sensor systems, learning, adaptability, and capability of operating in unstructured environments (e.g. construction sites). The Commission Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics6, states that the emergence of new digital technologies, like artificial intelligence, the Internet of things and robotics, raises new challenges in terms of product safety. The report concludes that the current product safety legislation, including Directive 2006/42/EC, contains a number of gaps in this respect that need to be addressed. Thus, this Regulation should cover the safety risks stemming from new digital technologies.
(12) In order to ensure protection of the health and safety of persons, domestic animals, property and, where applicable, the environment, this Regulation should apply to all forms of supply of machinery products, including distance selling as referred to in Article 6 of Regulation (EU) 2019/1020.
(13) In order to ensure legal certainty for all users, the scope of this Regulation should be set out in a clear manner and the concepts relating to its application should be defined as precisely as possible.
(14) In order to avoid legislating twice the same product, is appropriate to exclude from the scope of this Regulation weapons, including firearms that are subject to Directive (EU) 2017/853 of the European Parliament and of the Council7.
(15) Since the purpose of this Regulation is to address the risks stemming from the machinery function and not the transport of goods or persons, it should not apply to vehicles which only objective is the mere transport of goods or persons on road, by air, on water or on rail networks, regardless of the speed limits. However, machinery mounted on such vehicles or mobile machinery intended for facilitating works such as in construction sites or warehouses e.g. dumpers and forklifts, have a machinery function and should therefore be covered by this Regulation. Since agricultural and forestry vehicles and two- or three-wheel vehicles and quadricycles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, fall within the scope of Regulation (EU) No 167/2013 of the European Parliament and of the Council8 and Regulation (EU) No 168/2013 of the
Report from the Commission to the European parliament, the Council and the European economic and
social committee on the safety and liability implications of Artificial Intelligence, the Internet of Things
and robotics (COM/2020/64 final)..
Directive (EU) 2017/853 of the European Parliament and of the Council of 17 May 2017 amending
Council Directive 91/477/EEC on control of the acquisition and possession of weapons (OJ L 137,
24.5.2017, p.22).
Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the
approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).
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European Parliament and of the Council9 respectively, they should be excluded from the scope of this Regulation.
(16) Household appliances intended for domestic use which are not electrically operated furniture, audio and video equipment, information technology equipment, office machinery, low-voltage switchgear and control gear and electronic motors fall within the scope of Directive 2014/35/EU of the European Parliament and of the Council10 and should therefore be excluded from the scope of this Regulation. Some of those products are progressively incorporating Wi-Fi functions, e.g. washing machines, and are therefore covered by Directive 2014/53/EU of the European Parliament and of the Council11as radio equipment. Those products should also be excluded from the scope of this Regulation.
(17) The evolution of the machinery sector has resulted in the growing use of digital means and software plays a more and more important role in the machinery design. Consequently, the definition of machinery should be adapted. In this respect, machinery missing only the upload of a software intended for the specific application of the machinery should fall under the definition of machinery and not under the definition of partly completed machinery. Furthermore, the definition of safety components should cover not only physical devices but also digital devices. In order to take into account the increasing use of software as a safety component, software that performs a safety function and is placed independently on the market should be considered a safety component.
(18) Partly completed machinery is a machinery product which must undergo further construction in order to be able to perform its specific application, i.e. the well-defined operations for which the machinery product is designed. It is not necessary that all requirements of this Regulation apply to partly completed machinery but in order to ensure the safety of the machinery product as a whole, it is nevertheless important that the free movement of such partly completed machinery be guaranteed by means of a specific procedure.
(19) Where machinery products pose risks that are addressed by the essential health and safety requirements set out in this Regulation but are also wholly or partly covered by other more specific Union legislation, this Regulation should not apply to the extent that those risks are covered by that other Union legislation. In other cases, machinery products may pose risks that are not covered by the essential health and safety requirements set out in this Regulation. For example, machinery products incorporating a Wi-Fi function or an artificial intelligence system may pose risks not addressed by the essential health and safety requirements set out in this Regulation, as this Regulation does not deal with risks specific to such systems. For artificial
Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 35). Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
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intelligence systems, the specific Union legislation on artificial intelligence should apply, since it contains specific safety requirements for high-risk artificial intelligence systems. In order to avoid incoherence with regard to the type of conformity assessment and to avoid introducing requirements to perform two conformity assessments, those specific safety requirements should however be checked as part of the conformity assessment procedure set out in this Regulation. The essential health and safety requirements set out in this Regulation should in any case be applied in order to ensure, where applicable, the safe integration of the artificial intelligence system into the overall machinery, so as not to compromise the safety of the machinery product as a whole.
(20) For trade fairs, exhibitions and similar events, it should be possible to exhibit machinery products which do not meet the requirements of this Regulation, since this would not pose any safety risk. However, for the sake of transparency, interested parties should be properly informed that the machinery products are not compliant and cannot be purchased.
(21) The evolution of the state of the art in the machinery sector has an impact on the classification of high-risk machinery products. In view of properly reflecting all high-risk machinery products, criteria should be established for the assessment by the Commission of which machinery products should be included in the list of high risk machinery products.
(22) Other risks related to new digital technologies are those provoked by malicious third parties that have an impact on the safety of machinery products. In this respect, manufacturers should be required to adopt proportionate measures which are limited to the protection of the safety of the machinery product. This does not preclude the application to machinery products of other Union legislation specifically addressing cybersecurity aspects.
(23) In order to ensure that machinery products, when placed on the market or put into service, do not entail health and safety risks for persons or domestic animals and do not cause harm to property and, where applicable, the environment, essential health and safety requirements should be set out which have to be met in order for the machinery products to be allowed on the market. Machinery products should comply with the essential health and safety requirements when placed on the market or put into service. Where such machinery products are subsequently modified, by physical or digital means, in a way that is not foreseen by the manufacturer and that may imply that it no longer meets the relevant essential health and safety requirements, the modification should be considered as substantial. For example, users may upload software in a machinery product that is not foreseen by the manufacturer and that may generate new risks. In order to ensure the compliance of such a machinery product with the relevant essential health and safety requirements, the person that carries out the substantial modification should be required to perform a new conformity assessment before placing the modified machinery product on the market or putting it into service. That requirement should only apply with respect to the modified part of the machinery product, provided that the modification does not affect the machinery product as a whole. In order to avoid an unnecessary and disproportionate burden, the person carrying out the substantial modification should not be required to repeat tests and produce new documentation in relation to aspects of the machinery product that are not impacted by the modification. It should be up to the person who carries out the substantial modification to demonstrate that the modification does not have an impact on the machinery product as a whole.
(24) In the machinery sector, around 98 % of the companies are small or medium sized enterprises (SMEs). In order to reduce the regulatory burden on SMEs, notified bodies should adapt the fees for conformity assessments and reduce them proportionately to the specific interests and needs of SMEs.
(25) Economic operators should be responsible for the compliance of machinery products with the requirements of this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as the health and safety of persons, where appropriate, domestic animals and property and, where applicable, the environment, as well as the fair competition on the Union market.
(26) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market only machinery products, which are in conformity with this Regulation. This Regulation should provide a clear and proportionate distribution of obligations, which correspond to the role of each economic operator in the supply and distribution chain.
(27) In order to facilitate communication between economic operators, market surveillance authorities and users, Member States should encourage economic operators to include a website address in addition to the postal address.
(28) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.
(29) The manufacturer or the manufacturer’s authorised representative should also ensure that a risk assessment is carried out for the machinery product, which the manufacturer wishes to place on the market. For this purpose, the manufacturer should determine which of the essential health and safety requirements that are applicable to the machinery product and in respect of which measures must be taken to address the risks that the machinery product may present. Where the machinery product integrates an artificial intelligence system, the risks identified during the risk assessment should include those risks that may appear during the machinery product’s lifecycle due to an intended evolution of its behaviour to operate with varying levels of autonomy. In this respect, where the machinery product integrates an artificial intelligence system, the risk assessment for the machinery product should consider the risk assessment for that artificial intelligence system that has been carried out pursuant to Regulation (EU) .../... of the European Parliament and of the Council+.
(30) The safety of the integral machinery product relies on the dependencies and interactions between its components and partly completed machinery and individual machinery that participate in a coordinated assembly of a machinery system. Therefore, manufacturers should be required to assess all those interactions in the risk assessment. The risk assessment should also address future updates or developments of a software installed in the machinery product, which are foreseen when the machinery product is placed on the market.
(31) It is essential that, before drawing up the EU declaration of conformity, the manufacturer or the manufacturer’s authorised representative established in the Union
OJ: Please insert in the text the number of the Regulation contained in document
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prepares a technical construction file, which they should be required to make available to national authorities or notified bodies on request. Detailed plans of subassemblies used for the manufacture of the machinery product should only be required as part of the technical construction file where knowledge of such plans is essential for assessing conformity with the essential health and safety requirements set out in this Regulation.
(32) It is necessary to ensure that machinery products from third countries entering the Union market comply with the requirements of this Regulation and do not pose a risk to the health and safety of persons, where appropriate, domestic animals and property and, where applicable, the environment, and in particular, that appropriate conformity assessment procedures have been carried out by manufacturers with regard to such machinery products. Provision should therefore be made for importers to ensure that machinery products that they place on the market comply with the requirements of this Regulation and do not pose a risk to the health and safety of persons, where appropriate, domestic animals and property and, where applicable, the environment. For the same reason, provision should also be made for importers to ensure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the competent national authorities.
(33) As the distributor makes machinery products available on the market after they have been placed on the market by the manufacturer or the importer, the distributor should act with due care to ensure that his or her handling of the machinery product does not adversely affect its compliance with the requirements set out in this Regulation.
(34) When placing machinery products on the market, the importer should indicate on the machinery product his or her name, registered trade name or registered trade mark and the postal address at which he or she can be contacted. Exceptions should be provided for in cases where the size or nature of the machinery product does not allow it. This includes cases where the importer would have to open the packaging to put his or her name and address on the machinery product.
(35) In view of ensuring the health and safety of the users of the machinery product, economic operators should ensure that all relevant documentation, such as the user's instructions, whilst containing precise and comprehensible information, is easily understandable, takes into account technological developments and changes to end-user behaviour, and is as up to date as possible. When machinery products are made available on the market in packages containing multiple units, the instructions and information should accompany the smallest commercially available unit.
(36) Any economic operator who either places a machinery product on the market under his or her own name or trademark or modifies a machinery product in such a way that compliance with the requirements of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
(37) Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the machinery product concerned.
(38) Ensuring traceability of machinery products throughout the whole supply chain enables a simpler and more efficient market surveillance. The economic operators
should therefore be required to keep the information on their transactions of machinery products for a certain period of time. However, that obligation should be proportionate to the role of each economic operator in the supply chain and the economic operators should not be required to update information that they have not produced.
(39) This Regulation should be limited to setting out the essential health and safety requirements, supplemented by a number of more specific requirements for certain categories of machinery products. In order to facilitate the assessment of conformity with those health and safety requirements it is necessary to provide for a presumption of conformity for machinery which is in conformity with harmonised standards that are developed and which references are published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council12 for the purpose of expressing detailed technical specifications of those requirements.
(40) In the absence of relevant harmonised standards, the Commission should be able to establish technical specifications for the essential health and safety requirements. Recourse to technical specifications should be used as a fall back solution to facilitate the manufacturer’s obligation to comply with the health and safety requirements, for instance when the standardisation process is blocked due to a lack of consensus between stakeholders or there are undue delays in the establishment of a harmonised standard. Such delays could for example occur when the required quality is not reached.
(41) Compliance with harmonised standards and with technical specifications established by the Commission should be voluntary. Alternative technical solutions should therefore be acceptable where compliance of the machinery with the relevant essential health and safety requirements is demonstrated in the technical file.
(42) The essential health and safety requirements should be satisfied in order to ensure that the machinery product is safe. Those requirements should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements.
(43) In view of addressing the risks stemming from malicious third party actions that have an impact on the safety of machinery products, this Regulation should include essential health and safety requirements for which a presumption of conformity may be given to the appropriate extent by a certificate or statement of conformity issued under a relevant cybersecurity scheme adopted pursuant to and in accordance with Article 54(3) of Regulation (EU) 2019/881 of the European Parliament and of the
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Council13.
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC(52), 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
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(44) Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not satisfy or entirely satisfy the requirements of this Regulation.
(45) The list of high-risk machinery in Annex I to Directive 2006/42/EC is so far based on the risk emanating from the intended use or any reasonably foreseeable misuse of that machinery. Nevertheless, the machinery sector embraces new ways of designing and constructing machinery products that may imply high risks, regardless of such intended use or any reasonably foreseeable misuse. For example, software ensuring safety functions of machinery based on artificial intelligence, embedded or not in the machinery product, should be classified as a high-risk machinery product due to the characteristics of artificial intelligence such as data dependency, opacity, autonomy and connectivity, which might increase very much the probability and severity of harm and seriously affect the safety of the machinery product. Furthermore, the market for software ensuring safety functions of machinery products based on artificial intelligence is so far very small, which results in a lack of experience and data. Therefore, the conformity assessment of software ensuring safety functions based on artificial intelligence should be carried out by a third party.
(46) Manufacturers should draw up an EU declaration of conformity to provide information on the conformity of machinery products with this Regulation. Manufacturers may also be required to draw up an EU declaration of conformity by other Union legislation. To ensure effective access to information for market surveillance purposes, a single EU declaration of conformity should be drawn up in respect of all Union acts. In order to reduce the administrative burden on economic operators, it should be possible for that single EU declaration of conformity to be a dossier made up of relevant individual declarations of conformity.
(47) The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. The general principles governing the CE marking are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking on machinery products should be laid down in this Regulation.
(48) The CE marking should be the only marking, which guarantees that machinery products comply with the requirements of this Regulation. Member States should therefore take appropriate action as regards other markings which are likely to mislead third parties as to the meaning or the form of the CE marking.
(49) In order to enable economic operators to demonstrate and the competent authorities to ensure that machinery made available on the market is in conformity with the essential health and safety requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules.
(50) Manufacturers should be responsible for certifying the conformity of their machinery products with this Regulation. Nevertheless, for certain types of machinery products that have a higher risk factor, a stricter certification procedure requiring participation of a notified body should be required.
(51) It is essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.
(52) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in this Regulation.
(53) In order to ensure a consistent level of quality in the performance of conformity assessment of machinery products, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.
(54) The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.
(55) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.
(56) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the machinery to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified, and the monitoring of bodies already notified, cover also activities carried out by subcontractors and subsidiaries.
(57) Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.
(58) In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.
(59) Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Union legislation. It is therefore appropriate to put in place a
legal framework within which market surveillance can be carried out in an appropriate
manner.
(60) Member States should take all appropriate measures to ensure that machinery products covered by this Regulation may be placed on the market only if, when properly installed and used for its intended purpose, or under conditions of use which can be reasonably foreseen, it does not endanger the health or safety of persons, and, where appropriate, domestic animals and property and, where applicable, the environment. Machinery products covered by this Regulation should be considered as non-compliant with the essential health and safety requirements laid down in this Regulation only under conditions of use, which could result from lawful and readily predictable human behaviour.
(61) In the context of market surveillance, a clear distinction should be established between the disputing of a harmonised standard conferring a presumption of conformity on machinery products and the safeguard clause relating to machinery products.
(62) Directive 2006/42/EC already provides for a safeguard procedure, which is necessary to allow for the possibility of contesting the conformity of machinery products. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States.
(63) The existing safeguard procedure should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to machinery products posing a risk to the health or safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment. It should allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such machinery products.
(64) Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.
(65) In order to take into account technical progress and knowledge or new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the list of high-risk machinery products and the indicative list of safety components. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(66) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission establishing technical specifications for the essential health and safety requirements, requesting the notifying Member State to take the necessary corrective measures in respect of a notified body that does not meet the requirements for its notification and establishing whether a national measure in respect of compliant machinery which a Member State finds to
pose a risk to health and safety of persons is justified. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council14.
(67) The Commission should adopt immediately applicable implementing acts determining whether a national measure taken in respect of compliant machinery products that poses a risk is justified or not where, in duly justified cases relating to the protection of the health or safety of persons, imperative grounds of urgency so require.
(68) In line with established practice, the committee set up by this Regulation can play a useful role in examining matters concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
(69) When matters relating to this Regulation, other than its implementation or infringements, are being examined in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and, where appropriate, an invitation to attend such meetings.
(70) The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant machinery products are justified or not.
(71) The traceability of machinery data required for the technical file and for market surveillance purposes, must comply with confidentiality rules to protect manufacturers.
(72) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.
(73) Since the objective of this Regulation, namely to ensure that machinery products placed on the market fulfils the requirements providing for a high level of protection of health and safety of persons, and, where appropriate, domestic animals and property and, where applicable, the environment, while guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States, but can rather, by reason of the need for harmonisation , be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(74) Council Directive 73/361/EEC15 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the certification and
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Council Directive 73/361/EEC of 19 November 1973 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the certification and marking of wire-ropes, chains and hooks (OJ L 335, 5.12.1973, p. 51–55).
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marking of wire-ropes, chains and hooks should be repealed as Directive 2006/42/EC took over its scope by including lifting accessories and chains and ropes.
(75) Directive 2006/42/EC has been amended several times. Since further substantial amendments are needed, and in order to ensure a uniform implementation of the rules on machinery products throughout the Union, Directive 2006/42/EC should be repealed.
(76) It is necessary to provide for sufficient time for economic operators to comply with their obligations under this Regulation, and for Member States to set up the administrative infrastructure necessary for its application. The application of this Regulation should therefore be deferred.