Legal provisions of 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 |
Contents
CHAPTER - I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation lays down requirements for the design and construction of machinery products to allow the making available on the market or putting into service of machinery products, and establishes rules on the free movement of machinery products in the Union.
Article 2
Scope
(1) This Regulation applies to the following machinery products
(a) machinery;
(b) interchangeable equipment;
(c) safety components;
(d) lifting accessories;
(e) chains, ropes, slings and webbing;
(f) removable mechanical transmission devices;
(g)
partly completed machinery.
(2) This Regulation does not apply to:
(a) safety components that are intended to be used as spare parts to replace identical components and are supplied by the manufacturer of the original machinery product;
(b) specific equipment for use in fairgrounds or amusement parks;
(c)
(d) weapons, including firearms;
machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
(e) (f)
(g)
(h)
(i) (j)
(k) (l) (m)
(n)
vehicles which have as their only objective the transport of goods or persons by road, air, water or rail except for machinery mounted on those vehicles;
two- or three-wheel vehicles and quadricycles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that fall within the scope of application of Regulation (EU) No 168/2013;
agricultural and forestry vehicles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that fall within the scope of application of Regulation (EU) No 167/2013;
seagoing vessels and mobile offshore units and machinery installed on board such vessels or units;
machinery specially designed and constructed for military or police purposes;
machinery specially designed and constructed for research purposes for temporary use in laboratories;
mine winding gear;
machinery intended to move performers during artistic performances;
the following electrical and electronic products, insofar as they fall within the scope of application of Directive 2014/35/EU or Directive 2014/53/EU :
(i) household appliances intended for domestic use which are not
electrically operated furniture;
(ii) audio and video equipment;
(iii) information technology equipment;
(iv) office machinery;
(v) low-voltage switchgear and control gear;
(vi) electric motors;
the following high-voltage electrical products:
(i) switch gear and control gear;
(ii)
transformers.
Article 3
For (1)
the purposes of this
Definitions
Regulation, the following definitions shall apply:
‘machinery’ means:
(a) an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application;
(b) an assembly referred to in point (a), missing only the components to connect it on site or to sources of energy and motion;
(c) an assembly referred to points (a) and (b), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure;
(d) assemblies of machinery referred to in points (a), (b), (c) or partly completed machinery referred to in point (7) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;
(e) an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
(f) an assembly as referred to in points (a), (b), (c), (d) and (e) missing only the upload of a software intended for its specific application.
(2) ‘interchangeable equipment’ means a device which, after the putting into service of a machinery product, is assembled with that machinery product by the operator himself in order to change its function or attribute to it a new function, in so far as that equipment is not a tool;
(3) ‘safety component’ means a physical or digital component, including software, of machinery which serves to fulfil a safety function and which is independently placed on the market, the failure or malfunction of which endangers the safety of persons but which is not necessary in order for the machinery to function or may be substituted by normal components in order for the machinery to function;
(4) ‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market, including slings and their components;
(5) ‘chains’ means chains designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
(6) ‘ropes’ means ropes designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
(7) ‘slings’ means slings designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
(8) ‘webbing’ means webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
(9) ‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing;
(10) ‘partly completed machinery’ means an assembly which is machinery but for the fact that it cannot in itself function so as to perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming a machinery product;
(11) ‘making available on the market’ means any supply of a machinery product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(12) ‘placing on the market’ means the first making available of a machinery product on the Union market;
(13) ‘putting into service’ means the first use, for its intended purpose, in the Union, of a machinery product;
(14) ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;
(15) ‘artificial intelligence system’ means an artificial intelligence system as defined in Article 3(1) of Regulation (EU) .../... of the European Parliament and of the Council+
(16) ‘substantial modification’ means a modification of a machinery product, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen by the manufacturer and as a result of which the compliance of the machinery product with the relevant essential health and safety requirements may be affected;
(17) ‘manufacturer’ means any natural or legal person who manufactures machinery products or who has machinery products designed or manufactured, and markets those machinery products under his or her name or trademark or who designs and constructs machinery products for his or her own use;
(18) ‘instructions for use’ means the information provided by the manufacturer when the machinery product is placed on the market or put into service to inform the user of the machinery product of the intended purpose and the proper use of that machinery product as well as information on any precautions to be taken when using or installing the machinery product, including information on the safety aspects;
(19) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his or her behalf in relation to specified tasks;
(20) ‘importer’ means any natural or legal person established within the Union who places machinery products from a third country on the Union market;
(21) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes machinery products available on the market;
(22) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
(23) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by machinery products;
(24) ‘harmonised standard’ means a harmonised standard as defined in Article 2(1), point (c) of Regulation (EU) No 1025/2012;
(25) ‘CE marking’ means a marking by which the manufacturer indicates that a machinery product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
OJ: Please insert in the text the number of the Regulation contained in document … and insert the number, date, title and OJ reference of that Regulation in the footnote."
+
(26) ‘accreditation’ means accreditation as defined in Article 2, point (10) of Regulation (EC) No 765/2008;
(27) ‘national accreditation body’ means a national accreditation body as defined in Article 2(11) of Regulation (EC) No 765/2008;
(28) ‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to machinery products have been fulfilled;
(29) ‘conformity assessment body’ means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;
(30) ‘notified body’ means a conformity assessment body notified in accordance with Article 26 of this Regulation;
(31) ‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point (4) of Regulation (EU) 2019/1020;
(32) ‘recall’ means any measure aimed at achieving the return of a machinery product that has already been made available to the end-user;
(33) ‘withdrawal’ means any measure aimed at preventing a machinery product in the supply chain from being made available on the market.
Article 4
Free movement
1. Member States shall not impede, for reasons relating to the aspects covered by this Regulation, the making available on the market or the putting into service of machinery products which comply with this Regulation.
2. At trade fairs, exhibitions and demonstrations or similar events, Member States shall not prevent the display of a machinery product which does not comply with this Regulation, provided that a visible sign clearly indicates that it does not comply with this Regulation and will not be available on the market until it has been brought into conformity.
During demonstrations, adequate measures shall be taken to ensure the protection of persons.
Article 5
High-risk machinery products
1. High-risk machinery products listed in Annex I shall be subject to a specific conformity assessment procedure, as referred to in Article 21(2).
2. The Commission is empowered to adopt delegated acts in accordance with Article 45 to amend Annex I in view of technical progress and knowledge or new scientific evidence by including in the list of high-risk machinery products a new machinery product or withdrawing an existing machinery product from that list, pursuant to the criteria laid down in paragraphs 3 and 4.
3. A machinery product shall be included in the list of high-risk machinery products in Annex I if it poses a risk to human health taking into account its design and intended
4.
5.
purpose. A machinery product shall be withdrawn from the list of high-risk machinery products in Annex I if it no longer poses such risk. The risk posed by a certain machinery product shall be established based on the combination of the probability of occurrence of harm and the severity of that harm.
In determining the probability and severity of harm, the following shall be taken into account:
(a) (b) (c)
(d)
(e)
(f)
the degree to which each affected person would be impacted by the harm;
the number of persons potentially affected;
the degree to which potentially affected parties are dependent on the outcome produced by the machinery product;
the degree to which potentially affected parties are in a position vis-à-vis the user of the machinery product;
vulnerable
the degree of reversibility of the harm produced by the machinery product;
the degree to which the machinery product has been used for a specific purpose;
(g) indications of harm that have been caused in the past by machinery products which have been used for a specific purpose.
The Commission shall thoroughly assess the criteria laid down in paragraph 3 on the basis of available information. In particular the following information shall be communicated to the Commission by the Member States when it becomes available to them in connection with market surveillance or as a result of the concerns referred to in the fifth paragraph:
(a) (b) (c) (d)
an assessment of the risks as referred to in paragraph 3; a cost-effectiveness analysis;
a machinery accident analysis;
statistics on accidents caused by the machinery product for the preceding four years based, in particular information obtained from the Information and Communication System for Market Surveillance (ICSMS) information, safeguard clauses, Rapid Alert System (RAPEX) and the Machinery Administrative Cooperation Group reporting.
A Member State which has concerns about a machinery product being listed or not listed in Annex I shall immediately inform the Commission of its concerns and provide reasons in support thereof.
Article 6
Safety components
1. An indicative list of safety components is set out in Annex II.
2. The Commission is empowered to adopt delegated acts in accordance with Article 45 to amend Annex II in view of technical progress and knowledge or new scientific evidence by including a new safety component in the indicative list of safety components or withdrawing an existing safety component from that list.
3. The Commission shall thoroughly assess the risks that require the inclusion of a new safety component in the list of safety components in Annex II or a withdrawal of a safety component from that list.
4. A Member State which has concerns about a safety component being listed or not listed in Annex II shall immediately inform the Commission of its concerns and provide reasons in support thereof.
Article 7
Requirements for machinery products
Machinery products shall only be made available on the market or put into service if, where properly installed and maintained and used for their intended purpose or under conditions which can reasonably be foreseen, they meet the essential health and safety requirements set out in Annex III.
Article 8
Specific Union harmonisation legislation
Where, for a certain machinery product, the risks addressed by the essential health and safety requirements set out in Annex III are wholly or partly covered by other more specific Union harmonisation legislation, this Regulation shall not apply to that machinery product to the extent that that specific Union legislation covers such risks.
Article 9
Regulation (EU) .../... of the European Parliament and of the Council+
Where machinery products contain an artificial intelligence system, to which the essential health and safety requirements of Regulation (EU) …/… apply, this Regulation shall, in relation to that artificial intelligence system, only apply with regard to its safe integration into the overall machinery, so as not to compromise the safety of the machinery product as a whole.
OJ: Please insert in the text the number of the Regulation contained in document
+
CHAPTER I - I
OBLIGATIONS OF ECONOMIC OPERATORS
Article 10
Obligations of manufacturers
1. When placing a machinery product on the market, manufacturers shall ensure that it has been designed and constructed in accordance with the essential health and safety requirements set out in Annex III.
2. Before placing a machinery product on the market, manufacturers shall draw up the technical documentation referred to in Annex IV (‘technical documentation’) and carry out the relevant conformity assessment procedures referred to in Article 21 or Article 22 or have them carried out.
Where compliance of the machinery product with the essential health and safety requirements laid down in Annex III has been demonstrated by that conformity assessment procedure, manufacturers shall draw up the EU declaration of conformity in accordance with Article 18 and affix the CE marking in accordance with Article 20, except for partially completed machinery.
3. Manufacturers shall keep the technical documentation and the EU declaration of conformity, where relevant, at the disposal of the market surveillance authorities for ten years after the machinery product has been placed on the market. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from the competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential health and safety requirements set out in Annex III.
4. Manufacturers shall ensure that procedures are in place for machinery products that are part of a series production to remain in conformity with this Regulation. Changes in the production process or in the design or characteristics of the machinery product and changes in the harmonised standards or the technical specifications referred to in Article 17 by reference to which the conformity of the machinery product is declared or by application of which its conformity is verified shall be adequately taken into account.
When deemed appropriate with regard to the risks presented by machinery products, manufacturers shall, to protect the health and safety of end-users, carry out sample testing of machinery products made available on the market or put into service, investigate, and, if necessary, keep a register of complaints, of non-conforming machinery products and machinery product recalls, and shall keep distributors informed of any such monitoring.
5. Manufacturers shall ensure that the machinery products which they place on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the machinery product does not allow it, that the required information is provided on the packaging or in a document accompanying the machinery product.
6. Manufacturers shall indicate their name, registered trade name or registered trade mark, the postal address and the email address at which they can be contacted on the
machinery product or, where that is not possible, on its packaging or in a document accompanying the machinery product. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
7. Manufacturers shall ensure that the machinery products are accompanied by the instructions and information set out in section 1.7 of Annex III in a language which can be easily understood by end-users, as determined by the Member State concerned. Such instructions and information shall be clear, understandable, intelligible and legible.
8. Manufacturers shall either provide the EU declaration of conformity with the machinery product or include in the instructions and information set out in section 1.7 of Annex III the internet address at which the EU declaration of conformity can be accessed.
9. Manufacturers who consider or have reason to believe that a machinery product, which they have placed on the market or put into service is not in conformity with the essential health and safety requirements set out in Annex III shall immediately take the corrective measures necessary to bring that machinery product into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the machinery product presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the machinery product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the machinery product with the essential health and safety requirements set out in Annex III, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any measures taken to eliminate the risks posed by the machinery product, which they have placed on the market or put into service.
Article 11
Authorised representatives
1. A manufacturer may, by a written mandate, appoint an authorised representative.
The obligations laid down in Article 10(1) and the obligation to draw up the technical documentation shall not form part of the authorised representative's mandate.
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a) keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for ten years after the machinery product has been placed on the market;
(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the machinery product;
(c) cooperate with the competent national authorities, at their request, on any measures taken to eliminate the risks posed by a machinery product covered by the authorised representative's mandate.
Article 12
Obligations of importers
1. Importers shall only place on the market machinery products that comply with the essential health and safety requirements set out in Annex III.
2. Before placing a machinery product on the market, importers shall ensure that the appropriate conformity assessment procedures referred to in Article 21 or Article 22 have been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the machinery product bears the CE marking referred to in Article 19 and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 10(5) and (6).
Where an importer considers or has reason to believe that a machinery product is not in conformity with the essential health and safety requirements set out in Annex III, the importer shall not place it on the market until it has been brought into conformity. Furthermore, where the machinery product poses a risk to the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
3. Importers shall indicate their name, registered trade name or registered trade mark, the postal address and the email address at which they can be contacted on the machinery product or, where that is not possible, on its packaging or in a document accompanying the machinery product. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
4. Importers shall ensure that the machinery product is accompanied by the instructions and information set out in section 1.7 of Annex III in a language which can be easily understood by end-users, as determined by the Member State concerned.
5. Importers shall ensure that, while the machinery product is under their responsibility, storage or transport conditions do not jeopardise its conformity with the essential health and safety requirements set out in Annex III.
6. When deemed appropriate with regard to the risks to the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment, presented by a machinery product, importers shall carry out sample testing of machinery products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming machinery products and machinery products recalls, and shall keep distributors informed of any such monitoring.
7. Importers who consider or have reason to believe that a machinery product, which they have placed on the market, is not in conformity with the essential health and safety requirements set out in Annex III shall immediately take the corrective measures necessary to bring that machinery product into conformity, to withdraw it or recall it, as appropriate. Furthermore, where the machinery product poses a risk to
the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment, importers shall immediately inform the competent national authorities of the Member States in which they made the machinery product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
8. Importers shall, for ten years after the machinery product has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential health and safety requirements set out in Annex III.
9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the machinery product with the essential health and safety requirements set out in Annex III in a language that can be easily understood by that authority. They shall cooperate with that authority, at its request, on any measures taken to eliminate the risks to the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment posed by a machinery product, which they have placed on the market.
Article 13
Obligations of distributors
1. When making a machinery product available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
2. Before making a machinery product available on the market, distributors shall verify that:
(a) the machinery product bears the CE marking;
(b) the machinery product is accompanied by the required documents and by the instructions and information set out in section 1.7 of Annex III in a language which can be easily understood by end-users in the Member State in which the machinery product is to be made available on the market;
(c) the manufacturer and the importer have complied with the requirements set out in Article 10(5) and (6) and Article 12(3) respectively.
3. Where a distributor considers or has reason to believe that a machinery product is not in conformity with the essential health and safety requirements set out in Annex III, the distributor shall not make the machinery product available on the market until it has been brought into conformity. Furthermore, where the machinery product poses a risk to the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment, the distributor shall inform the manufacturer and the market surveillance authorities to that effect.
4. Distributors shall ensure that, while a machinery product is under their responsibility, storage or transport conditions do not jeopardise its conformity with the essential
health and safety requirements set out in Annex III.
5. Distributors who consider or have reason to believe that a machinery product, which they have made available on the market, is not in conformity with the essential health and safety requirements set out in Annex III shall make sure that the corrective measures necessary to bring that machinery product into conformity, to withdraw it or recall it, as appropriate, are taken. Furthermore, where the machinery product poses a risk to the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment, distributors shall immediately inform the competent national authorities of the Member States in which they have made the machinery product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
6. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the machinery product with the essential health and safety requirements set out in Annex III in a language that can be easily understood by that authority. They shall cooperate with that authority, at its request, on any measures taken to eliminate the risks to the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment, posed by a machinery product, which they have made available on the market.
Article 14
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 10 where that importer or distributor places a machinery product on the market under his or her name or trademark or carries out a substantial modification of a machinery product that has already been placed on the market or put into service.
Article 15
Other cases in which obligations of manufacturers apply
A natural or legal person, other than the manufacturer, the importer or the distributor, that carries out a substantial modification of the machinery product shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 10 for the part of the machinery product that is affected by the modification or, if the substantial modification has an impact on the safety of the machinery product as a whole, for the entire machinery product.
Article 16
Identification of economic operators
1. Economic operators shall, on request, identify the following to the market
surveillance authorities:
(a) any economic operator who has supplied them with a machinery product;
(b) any economic operator to whom they have supplied a machinery product.
2. Economic operators shall be able to present the information referred to in paragraph
1 for ten years after they have been supplied with the machinery product and for ten years after they have supplied the machinery product.
CHAPTER II - I
CONFORMITY OF THE MACHINERY
Article 17
Presumption of conformity of machinery products
1. A machinery product which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III covered by those standards or parts thereof.
2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the essential health and safety requirements set out in Annex III.
3. The Commission is empowered to adopt implementing acts establishing technical specifications for the essential health and safety requirements set out in Annex III where the following conditions have been fulfilled:
(a) no reference to harmonised standards covering the relevant essential health and safety requirements is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;
(b) the Commission has requested one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements and there are undue delays in the standardisation procedure or the request has not been accepted by any of the European standardisation organisations.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3).
4. A machinery product which is in conformity with the technical specifications or parts thereof shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III covered by those technical specifications or parts thereof.
5. Machinery products that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme adopted in accordance with Regulation (EU) 2019/881 and the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III, sections 1.1.9 and 1.2.1, as regards protection against corruption and safety and reliability of control systems in so far as those requirements are covered by the cybersecurity certificate or statement of conformity or parts thereof.
Article 18
EU declaration of conformity
1. The EU declaration of conformity shall state that the fulfilment of the applicable essential health and safety requirements set out in Annex III has been demonstrated.
2. The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the relevant modules set out in Annexes VI, VII, VIII and IX and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the machinery product is placed on the market or is made available on the market.
3. Where a machinery product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the machinery product with the requirements laid down in this Regulation.
Article 19
General principles of the CE marking
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 20
Rules for affixing the CE marking
1. The CE marking shall be affixed visibly, legibly and indelibly to the machinery product. Where that is not possible or not warranted on account of the nature of the machinery product, it shall be affixed to the packaging and to the documents accompanying the machinery product.
2. The CE marking shall be affixed before the machinery product is placed on the market.
3. For a machinery product in the conformity assessment of which a notified body participates in accordance with Annex IX, the CE marking shall be followed by the identification number of that notified body.
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or the manufacturer’s authorised representative.
4. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating a special risk or
use.
5. Member States shall build upon existing mechanisms to ensure correct application of
the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
CHAPTER I - V
CONFORMITY ASSESSMENT
Article 21
Conformity assessment procedures for machinery products except partly completed
machinery
1. In order to certify the conformity of a machinery product with this Regulation, the manufacturer or its authorised representative and the person who has carried out a substantial modification to the machinery product, shall apply one of the procedures for assessment of conformity referred to in paragraphs 2 and 3.
2. Where the machinery product is a high-risk machinery product listed in Annex I, the manufacturer or the manufacturer’s authorised representative and the person who has carried out a substantial modification to the machinery product shall apply one of the following procedures:
(a) EU type-examination procedure (module B) provided for in Annex VII, followed by conformity to type based on internal production control (module C) set out in Annex VIII;
(b) Conformity based on full quality assurance (module H) set out in Annex IX.
3. Where the machinery product is not a high-risk machinery product listed in Annex I, the manufacturer or the manufacturer’s authorised representative and the person who has made a substantial modification to the machinery product shall apply the internal production control procedure (module A) set out in Annex VI.
4. Notified bodies shall take into account the specific interests and needs of small and medium sized enterprises when setting the fees for conformity assessment and reduce those fees proportionately to their specific interests and needs.
Article 22
Conformity assessment procedures for partly completed machinery
1. The manufacturer of partly completed machinery or the manufacturer’s authorised
representative shall, before placing partly completed machinery on the market, ensure that the following documents are drawn up:
(a) the relevant technical documentation that satisfies the requirements laid down in Annex IV, part B;
(b) assembly instructions that satisfy the requirements laid down in Annex X;
(c) the EU declaration of incorporation that has the model structure set out in Annex V.
2. Where relevant, the manufacturer of partly completed machinery or the
manufacturer’s authorised representative shall make available to the competent national authority upon its request the source code or programmed logic included in the technical documentation referred to in paragraph 1, point (a), , provided that it is needed in order for that authority to be able to check compliance with the essential health and safety requirements set out in Annex III. The assembly instructions referred to in paragraphs 1, point (b), and the declaration of incorporation referred to in paragraph 1, point (c), shall accompany the partly completed machinery until it is incorporated into the final machinery product and shall afterwards form part of the technical file for that machinery product.
Article 23
Protection of persons during installation and use of machinery products
Member States may lay down requirements to ensure that persons, including workers, are protected when installing and using machinery products, provided that such rules do not allow for modification of a machinery product in a way that is not compatible with this Regulation.
CHAPTER - V
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 24
Notification
Member States shall notify the Commission and the other Member States of conformity assessment bodies authorised to carry out conformity assessments in accordance with this Regulation.
Article 25
Notifying authorities
1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 32.
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body, which is not a governmental entity that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 26. In addition, that body shall have arrangements to cover liabilities arising out of its activities.
4. The notifying authority shall take full responsibility for the tasks performed by the
body referred to in paragraph 3.
Article 26
Requirements relating to notifying authorities
1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.
2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment of the machinery product.
4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis.
5. A notifying authority shall safeguard the confidentiality of the information it obtains.
6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
Article 27
Information obligation on notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.
The Commission shall make that information publicly available.
Article 28
Requirements relating to notified bodies
1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.
2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.
3. A conformity assessment body shall be a third-party body independent of the organisation or the machinery product it assesses.
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacture, provision, assembly, use or maintenance of machinery products which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a conformity assessment body.
4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of a machinery product, that they assess, nor the representative of any of those parties. This shall not preclude the use of a machinery product that is necessary for the operations of the conformity assessment body or the use of a machinery product for personal purposes.
A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, installation, use or maintenance of machinery products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
A conformity assessment body shall ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.
5. A conformity assessment body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence its judgement or the results of its conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.
6. A conformity assessment body shall be capable of carrying out all the conformity assessment activities mentioned in Annexes VII, VIII and IX and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
At all times, and for each conformity assessment procedure and each kind of a machinery product for which it has been notified, a conformity assessment body shall have at its disposal the necessary:
(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;
(b)
(c) (d)
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures;
appropriate policies and procedures to distinguish between activities that it carries out as a notified body and other activities;
procedures for the performance of conformity assessment activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the machinery technology in question and the mass or serial nature of the production process.
A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
7. The personnel responsible for carrying out conformity assessment tasks shall have
the following:
(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
(b) (c)
(d)
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
appropriate knowledge and understanding of the essential health and safety requirements set out in Annex III, of the applicable harmonised standards referred to in Article 17, and of the relevant provisions of Union harmonisation legislation and of national legislation;
the ability to draw up certificates, records and reports demonstrating that conformity assessments have been carried out.
8. The impartiality of a conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment activities shall be guaranteed.
The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessment activities shall not depend on the number of conformity assessments carried out or on the results of those assessments.
9. A conformity assessment body shall take out liability insurance unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.
10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment activities in accordance with Annexes VII, VIII and IX, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights, intellectual property rights and trade secrets shall be protected.
11. A conformity assessment body shall participate in, or ensure that its personnel responsible for carrying out the conformity assessment activities are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 40 and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Article 29
Presumption of conformity of notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 28 in so far as the applicable harmonised standards cover those requirements.
Article 30
Subsidiaries of and subcontracting by notified bodies
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 28 and shall inform the notifying authority accordingly.
2. A notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever those are established.
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
4. A notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes VII, VIII and IX.
Article 31
Application for notification
1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.
2. The application for notification shall be accompanied by a description of the conformity assessment activities, of the conformity assessment procedures set out in Annexes VII, VIII and IX and of the kind of machinery product for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 28.
3. Where the conformity assessment body concerned cannot provide an accreditation certificate as referred to in paragraph 2, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 28.
Article 32
Notification procedure
1. A notifying authority shall notify only conformity assessment bodies which have satisfied the requirements laid down in Article 28.
2. The notifying authority shall send a notification to the Commission and the other Member States of each conformity assessment body referred to in paragraph 1, using the electronic notification tool developed and managed by the Commission.
3. The notification referred to in paragraph 2 shall include the following:
(a) full details of the conformity assessment activities to be performed;
(b) an indication of the conformity assessment module or modules and the kinds of machinery products concerned;
(c)
the relevant attestation of competence.
4. Where a notification is not based on an accreditation certificate referred to in Article 31(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 28.
5. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of the validation of the notification where it includes an accreditation certificate referred to in Article 31(2), or within two months of the notification where it includes documentary evidence referred to in Article 31(3).
Only such a body shall be considered a notified body for the purposes of this Regulation.
6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification referred to in paragraph 2.
Article 33
Identification numbers and lists of notified bodies
1. The Commission shall assign an identification number to a notified body.
It shall assign a single such number even where the body is notified under several Union acts.
2. The Commission shall make publicly available the list of notified bodies including the identification numbers that have been assigned to them and the conformity assessment activities for which they have been notified.
The Commission shall ensure that the list is kept up to date.
Article 34
Changes to notifications
1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 28, or that it is failing to fulfil its obligations as set out in Article 35 the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
Article 35
Challenge of the competence of notified bodies
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.
2. The notifying authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying authority to take the necessary corrective measures, including the withdrawal of the notification if necessary.
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 46(2).
Article 36
Operational obligations of notified bodies
1. A notified body shall carry out conformity assessments in accordance with the conformity assessment procedures set out in Annexes VII, VIII and IX.
2. A notified body shall perform its activities in a proportionate manner, avoiding unnecessary burdens for economic operators, and taking due account of the size of an undertaking, the sector in which the undertaking operates, the structure of the undertaking, the degree of complexity of the machinery technology in question and the mass or serial nature of the production process.
In so doing, the notified body shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the machinery product with the requirements of this Regulation.
3. Where a notified body finds that the essential health and safety requirements set out in Annex III, or the harmonised standards referred to in Article 17, or other technical specifications have not been met by a manufacturer, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity or adopt an approval decision
4. Where, in the course of the monitoring of conformity following the issuance of a certificate of conformity or the adoption of an approval decision, a notified body finds that a machinery product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate of conformity or the approval decision, if necessary.
5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates of conformity or approval decisions, as appropriate.
Article 37
Appeals against decisions of notified bodies
A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.
Article 38
Information obligation on notified bodies
1. A notified body shall inform the notifying authority of the following:
(a) any refusal, restriction, suspension or withdrawal of a certificate of conformity or approval decision;
(b) any circumstances affecting the scope of, or the conditions for, its notification;
(c) (d)
any request for information which it has received from market surveillance authorities regarding its conformity assessment activities;
on request, any conformity assessment activities performed within the scope of its notification and any other activity performed, including cross-border activities and subcontracting.
2. A notified body shall provide other notified bodies carrying out similar conformity
assessment activities covering the same kinds of machinery product with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Article 39
Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
Article 40
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between notified bodies are put in place and properly operated in the form of a sectoral group of notified bodies.
A notified body shall participate in the work of that group, directly or by means of designated representatives.
CHAPTER V - I
UNION MARKET SURVEILLANCE, CONTROL OF MACHINERY PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
Article 41
Procedure at national level for dealing with machinery products presenting a risk
1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a machinery product covered by this Regulation presents a risk to the health or safety of persons, and, where appropriate, domestic animals or to property and, where applicable, the environment, they shall carry out an evaluation in relation to the machinery product concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the machinery product does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the machinery product into compliance with those requirements, to withdraw the machinery product from the market, or to recall it within a reasonable period which is commensurate with the nature of the risk referred to in the first subparagraph.
The market surveillance authorities shall inform the relevant notified body accordingly.
2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the machinery products concerned that the economic operator has made available on the market throughout the Union.
4. Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, second subparagraph, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the machinery product being made available on their national market, to withdraw the machinery product from that market or to recall it.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
5. The information referred to in paragraph 4, second subparagraph, shall include all available details, in particular the data necessary for the identification of the non-compliant machinery product, the origin of that machinery product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:
(a) failure of the machinery product to meet the requirements relating to the essential health and safety requirements set out in Annex III;
(b) shortcomings in the harmonised standards referred to in Article 17(1);
(c) shortcomings in the technical specifications referred to in Article 17(4).
6. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the machinery product concerned, and, in the event of disagreement with the adopted national measure, of their objections.
7. Where, within three months of receipt of the information referred to in paragraph 4, second subparagraph, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the machinery product from the market, are taken in respect of the machinery product concerned without delay.
Article 42
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 41(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not.
The Commission shall address its decision to all Member States and shall without delay communicate it to them and to the relevant economic operator or operators.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 46(3).
2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant machinery product is withdrawn from their market, and shall inform the Commission accordingly.
If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.
3. Where the national measure is considered justified and the non-compliance of the machinery product is attributed to shortcomings in the harmonised standards or technical specifications referred to in Article 41(5), points (b) and (c), of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Article 43
Compliant machinery products which present a risk
1. Where, having carried out an evaluation under Article 41(1), a Member State finds
that although a machinery product is in compliance with the essential health and safety requirements set out in Annex III, it poses a risk to the health and safety of persons and, where appropriate, domestic animals or to property and, where
applicable, the environment, it shall require the relevant economic operator to take all appropriate measures to ensure that the machinery product concerned, when placed on the market, no longer presents that risk, to withdraw the machinery product from the market or to recall it within a reasonable period which is commensurate with the nature of the risk.
2. The economic operator shall ensure that corrective action is taken in respect of all the machinery products concerned that the economic operator has made available on the market throughout the Union.
3. The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the machinery product concerned, the origin and the supply chain of the machinery product, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not and, where necessary, order appropriate measures.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 46(3).
On duly justified imperative grounds of urgency relating to the protection of the health and safety of persons, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 46(4).
5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator or operators.
Article 44
Formal non-compliance
1. Without prejudice to Article 41, where a Member State makes one of the following
findings with regard to a machinery product, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 20 of this Regulation;
(b) the CE marking has not been affixed;
(c) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 20(3) or has not been affixed;
(d) the EU declaration of conformity has not been drawn up or has not been drawn up correctly;
(e) the technical documentation is either not available or not complete;
(f) the information referred to in Article 10(6) or Article 12(3) is absent, false or incomplete;
(g) any other administrative requirement provided for in Article 10 or Article 12 is not fulfilled.
2. Where the non-compliance referred to in paragraph 1 persists, the Member State
concerned shall take all appropriate measures to restrict or prohibit the machinery product being made available on the market or ensure that it is recalled or withdrawn from the market.
CHAPTER VI - I
DELEGATED POWERS AND COMMITTEE PROCEDURE
Article 45
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Articles 5(2) and 6(2) shall be conferred on the Commission for a period of five years from … [the date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
4. The delegation of powers referred to in Articles 5(2) and 6(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Articles 5(2) and 6(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 46
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
5. The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by any other Union legislation.
The committee may furthermore examine any other matter 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.
CHAPTER VII - I
CONFIDENTIALITY AND PENALTIES
Article 47
Confidentiality
1. All parties shall respect the confidentiality of the following information and data
obtained in carrying out their tasks in accordance with this Regulation:
(a) personal data;
(b)
commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights, unless disclosure is in the public interest.
2. Without prejudice to paragraph 1, information exchanged on a confidential basis between the competent national authorities and between competent national authorities and the Commission shall not be disclosed without the prior agreement of the originating competent national authority.
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to the exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
4. The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Article 48
Penalties
1. Member States shall lay down the rules on penalties applicable to infringements by economic operators of this Regulation and shall take all measures necessary to ensure that they are enforced. The penalties provided for shall be effective, proportionate and dissuasive and may include criminal penalties for serious infringements.
2. Member States shall notify those rules and those measures to the Commission by … [24 months after the date of entry into force of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.
CHAPTER I - X
TRANSITIONAL AND FINAL PROVISIONS
Article 49
Repeals
1. Directive 73/361/EEC is repealed.
References to the repealed Directive 73/361/EEC shall be construed as references to this Regulation.
2. Directive 2006/42/EC is repealed with effect from … [30 months after the date of entry into force of this Regulation].
References to the repealed Directive 2006/42/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XI.
Article 50
Transitional provisions
1. Member States shall not until … [42 months after the date of entry into force of this Regulation] impede the making available on the market of machinery which was placed on the market in conformity with Directive 2006/42/EC before … [the date of entry into force of this Regulation]. However, Chapter VI of this Regulation shall apply mutatis mutandis to such machinery instead of Article 11 of that Directive, including machinery for which a procedure has already been initiated under Article 11 of Directive 2006/42/EC as from … [the date of entry into force of this Regulation].
2. EC type-examination certificates and approval decisions issued in accordance with Article 14 of Directive 2006/42/EC shall remain valid until … [42 months after the date of entry into force of this Regulation], unless they expire before that date.
Article 51
Evaluation and review
1. By … [54 months after the date of entry into force of this Regulation] and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The reports shall be made public.
2. Taking account of technical progress and practical experience gained in Member States as indicated in Article 5, the Commission shall in its report include an evaluation on the following aspects of this Regulation:
(a) the essential health and safety requirements set out in Annex III;
(b) the conformity assessment procedure applicable to high-risk machinery products listed in Annex I.
Where appropriate, the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this Regulation.
Article 52
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from … [30 months after the date of entry into force of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.