89 Amendments of Maria-Manuel LEITÃO-MARQUES related to 2021/0105(COD)
Amendment 101 #
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on machinery products (Text with EEA relevance)
Amendment 103 #
Proposal for a regulation
Recital 10
Recital 10
(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 and consider the safety impact. The same applies where a machinery product is normally used to provide a service to a consumer. While consumers do not necessarily purchase machinery products, machinery products are still being used by them.
Amendment 104 #
Proposal for a regulation
Recital 15
Recital 15
(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 or domestic animals, it should noteither apply to vehicles which only objective is the mere transport of goods, or persondomestic animals on road, by air, on water or on rail networks, regardless of the speed limits, nor to vehicles which have as their only objective the transport of persons by air, water or rail. 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. Equally, non-type-approved, off-road and competition vehicles, as well as e-bikes, e- scooters and similar means of transport should 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 ofare approved according to Regulation (EU) No 167/2013 of the European Parliament and of the Council19 and Regulation (EU) No 168/2013 of the European Parliament and of the Council20 respectively, they should be excluded from the scope of this Regulation. __________________ 19 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). 20 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).
Amendment 108 #
Proposal for a regulation
Recital 16
Recital 16
(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 Council21 and should therefore be excluded from the scope of this Regulation, except for the mechanical safety of appliances, where applicable. 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 Council22 as radio equipment. Those products should also be excluded from the scope of this Regulation. __________________ 21 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). 22 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).
Amendment 109 #
Proposal for a regulation
Recital 17
Recital 17
(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 if the safe use of this machinery does not depend on this software. 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.
Amendment 112 #
Proposal for a regulation
Recital 24
Recital 24
(24) In the machinery sector, around 98 % of the companies are small or medium sized enterprises (SMEs). In order to reduce the regulatoavoid unnecessary burdens on SMEs, notified bodies should simplify and facilitate procedures and adapt the fees for conformity assessments and reduce them proportionately to the specific interests and needs of SMEs.
Amendment 114 #
Proposal for a regulation
Recital 29
Recital 29
(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 lifecyclestimated lifetime 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 Council23 . __________________ 23 + OJ: Please insert in the text the number of the Regulation contained in document ….
Amendment 117 #
Proposal for a regulation
Recital 31
Recital 31
(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 prepares a technical construction fileprepares a technical documentation as referred to in Annex IV, 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 filedocumentation where knowledge of such plans is essential for assessing conformity with the essential health and safety requirements set out in this Regulation.
Amendment 125 #
Proposal for a regulation
Recital 46 a (new)
Recital 46 a (new)
Amendment 127 #
Proposal for a regulation
Recital 50
Recital 50
(50) Manufacturers should be responsible for certifying the conformity assessment of their machinery products withas specified by 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.
Amendment 128 #
Proposal for a regulation
Recital 56
Recital 56
(56) Conformity assessment bodies frequently subcontract parts of their activitietasks 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 activitietasks carried out by subcontractors and subsidiaries.
Amendment 137 #
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(ga) specific equipment for use in fairgrounds or amusement parks;
Amendment 139 #
Proposal for a regulation
Article 2 – paragraph 1 – point g b (new)
Article 2 – paragraph 1 – point g b (new)
(gb) vehicles which have as their objective the transport of goods or persons by road, not falling within the scope of application of Regulation (EU) No 168/2013;
Amendment 140 #
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
Amendment 145 #
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) vehicles which have as their only objective the transport of goods, or persondomestic animals by road, air, water or rail except for machinery mounted on those vehicles; vehicles which have as their only objective the transport persons by air, water or rail except for machinery mounted on those vehicles;
Amendment 147 #
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) 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 168/2013are approved according to Regulation (EU) No 168/2013 except for machinery mounted on those vehicles;
Amendment 152 #
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) 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 167/2013are approved according to Regulation (EU) No 167/2013, except for machinery mounted on those vehicles;
Amendment 156 #
Proposal for a regulation
Article 2 – paragraph 2 – point g a (new)
Article 2 – paragraph 2 – point g a (new)
(ga) motor vehicles and their trailers as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that are approved according to Regulation (EU) No 2018/858, except for machinery mounted on those vehicles;
Amendment 157 #
Proposal for a regulation
Article 2 – paragraph 2 – point g b (new)
Article 2 – paragraph 2 – point g b (new)
(gb) motor vehicles exclusively intended for competition;
Amendment 160 #
Proposal for a regulation
Article 2 – paragraph 2 – point m – point i
Article 2 – paragraph 2 – point m – point i
(i) household appliances intended for domestic use which are not electrically operated furniture, except for their mechanical safety;
Amendment 162 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point d
Article 3 – paragraph 1 – point 1 – point d
(d) assemblies of machinery referred to in points (a), (b), (c) or partly completed machinery referred to in point (710) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;
Amendment 165 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point f
Article 3 – paragraph 1 – point 1 – point f
(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, if the safe use does not depend on this software.
Amendment 166 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(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 or herself in order to change its function or attribute to it a new function, in so far as that equipment is not a tool;
Amendment 169 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘safety component’ means a physical or digital component, including software, of a machinery product, except partly completed 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;
Amendment 171 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12
Article 3 – paragraph 1 – point 12
(12) ‘placinged on the market’ means the first making available of a machinery product on the Union market;
Amendment 173 #
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘putting into service’ means the first use, for its intended purpose, in the Union, of a machinery product, excluding partly completed machinery;
Amendment 179 #
Proposal for a regulation
Article 3 – paragraph 1 – point 16
Article 3 – paragraph 1 – point 16
(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 whicha risk assessment the compliance of the machinery product with the relevant essential health and safety requirements may beis affected, excluding repair and maintenance works;
Amendment 180 #
Proposal for a regulation
Article 3 – paragraph 1 – point 17
Article 3 – paragraph 1 – point 17
(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 constructuses machinery products for his or her own upurposes;
Amendment 183 #
Proposal for a regulation
Article 3 – paragraph 1 – point 18
Article 3 – paragraph 1 – point 18
(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;
Amendment 184 #
Proposal for a regulation
Article 3 – paragraph 1 – point 19
Article 3 – paragraph 1 – point 19
(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 with regard to the manufacturer’s obligations under the requirements of this Regulation;
Amendment 185 #
Proposal for a regulation
Article 3 – paragraph 1 – point 25
Article 3 – paragraph 1 – point 25
(25) ‘CE marking’ means a marking by which the manufacturer indicates that a machinery product, excluding partly completed machinery, is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
Amendment 188 #
Proposal for a regulation
Article 3 – paragraph 1 – point 29
Article 3 – paragraph 1 – point 29
(29) ‘conformity assessment body’ means a body that performs conformity assessment activitietasks, including calibration, testing, certification and inspection;
Amendment 189 #
Proposal for a regulation
Article 3 – paragraph 1 – point 29 a (new)
Article 3 – paragraph 1 – point 29 a (new)
(29a) ‘technical documentation’ means all the elements referred to in Annex IV for the machinery products under this Regulation;
Amendment 190 #
Proposal for a regulation
Article 3 – paragraph 1 – point 30
Article 3 – paragraph 1 – point 30
(30) ‘notified body’ means a conformity assessment body notified in accordance with Article 265 of this Regulation;
Amendment 197 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. The Commission is empowered to adopt delegated acts in accordance with Article 45 to amend Annex I, after consulting the stakeholders concerned, 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.
Amendment 202 #
Proposal for a regulation
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
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 purpose and foreseeable use. 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.
Amendment 205 #
Proposal for a regulation
Article 5 – paragraph 4 – point d
Article 5 – paragraph 4 – point d
(d) 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 and the European Injury Database (EU IDB).
Amendment 214 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. When placing a machinery product is placed 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.
Amendment 216 #
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 1
Article 10 – paragraph 2 – subparagraph 1
Before placing a machinery product is placed 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.
Amendment 217 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Manufacturers shall keep the technical documentation and the EU declaration of conformity electronically, 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.
Amendment 219 #
Proposal for a regulation
Article 10 – paragraph 6
Article 10 – paragraph 6
6. Manufacturers shall indicate their name, registered trade name or registered trade mark, the postal address and the email address, web address, email address and telephone number 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.
Amendment 220 #
Proposal for a regulation
Article 10 – paragraph 7
Article 10 – paragraph 7
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 and accessible for persons with disabilities in accordance with requirements of Directive (EU) 2019/882 (European Accessibility Act), as determined by the Member State concerned. Such instructions and information shall be clear, understandable, intelligible and legible.
Amendment 223 #
Proposal for a regulation
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The authorised representative shall have the appropriate financial and organisational means to perform the tasks specified in the mandate. The authorised representative shall provide a copy of the mandate to the competent authority, upon request, in a Union language determined by the competent authority. The mandate shall allow the authorised representative to do at least the following:
Amendment 224 #
Proposal for a regulation
Article 11 – paragraph 2 – point a
Article 11 – paragraph 2 – point a
(a) keep the EU declaration of conformity and the technical documentation electronically at the disposal of the national market surveillance authorities for ten years after the machinery product has been placed on the market;
Amendment 225 #
Proposal for a regulation
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(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. It could be either in paper or electronic form;
Amendment 226 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1
Article 12 – paragraph 2 – subparagraph 1
Before placing a machinery product is placed 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).
Amendment 227 #
Proposal for a regulation
Article 12 – paragraph 3
Article 12 – paragraph 3
3. Importers shall indicate their name, registered trade name or registered trade mark, the postal address and the email address, web address, email address and the telephone number 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.
Amendment 228 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
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 and accessible for persons with disabilities in accordance with requirements of Directive (EU) 2019/882 (European Accessibility Act), as determined by the Member State concerned.
Amendment 229 #
Proposal for a regulation
Article 12 – paragraph 8
Article 12 – paragraph 8
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 electronically 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.
Amendment 251 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The EU declaration of conformity must be able to be filled electronically and 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.
Amendment 255 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. In order to certifydetermine 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.
Amendment 265 #
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
Amendment 271 #
Proposal for a regulation
Article 25 – paragraph 3
Article 25 – paragraph 3
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 activitietasks.
Amendment 272 #
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activitietasks.
Amendment 273 #
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. A notifying authority shall not offer or provide any activitietasks that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis.
Amendment 276 #
Proposal for a regulation
Article 28 – paragraph 4 – subparagraph 1
Article 28 – paragraph 4 – subparagraph 1
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, importer, distributor, installer, purchaser, owner, user or maintainer of a machinery product, that they assess, nor the authorised 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.
Amendment 277 #
Proposal for a regulation
Article 28 – paragraph 4 – subparagraph 2
Article 28 – paragraph 4 – subparagraph 2
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, import, distribution, manufacture, marketing, installation, use or maintenance of machinery products, or represent the parties engaged in those activitietasks. They shall not engage in any activitytask that may conflict with their independence of judgement or integrity in relation to conformity assessment activitietasks for which they are notified. This shall in particular apply to consultancy services.
Amendment 278 #
Proposal for a regulation
Article 28 – paragraph 4 – subparagraph 3
Article 28 – paragraph 4 – subparagraph 3
A conformity assessment body shall ensure that the activitietasks of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activitietasks.
Amendment 279 #
Proposal for a regulation
Article 28 – paragraph 4 – subparagraph 3 a (new)
Article 28 – paragraph 4 – subparagraph 3 a (new)
The conformity assessment body shall ensure rotation between the responsible personnel carrying out the conformity assessment tasks.
Amendment 280 #
Proposal for a regulation
Article 28 – paragraph 5
Article 28 – paragraph 5
5. A conformity assessment body and its personnel shall carry out the conformity assessment activitietasks 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 activitietasks, especially as regards persons or groups of persons with an interest in the results of those activitietasks.
Amendment 281 #
Proposal for a regulation
Article 28 – paragraph 6 – subparagraph 1
Article 28 – paragraph 6 – subparagraph 1
A conformity assessment body shall be capable of carrying out all the conformity assessment activitietasks 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.
Amendment 282 #
Proposal for a regulation
Article 28 – paragraph 6 – subparagraph 2 – point a
Article 28 – paragraph 6 – subparagraph 2 – point a
(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activitietasks;
Amendment 283 #
Proposal for a regulation
Article 28 – paragraph 6 – subparagraph 2 – point c
Article 28 – paragraph 6 – subparagraph 2 – point c
(c) appropriate policies and procedures to distinguish between activitietasks that it carries out as a notified body and other activitietasks;
Amendment 284 #
Proposal for a regulation
Article 28 – paragraph 6 – subparagraph 2 – point d
Article 28 – paragraph 6 – subparagraph 2 – point d
(d) procedures for the performance of conformity assessment activitietasks 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.
Amendment 285 #
Proposal for a regulation
Article 28 – paragraph 6 – subparagraph 3
Article 28 – paragraph 6 – subparagraph 3
A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activitietasks in an appropriate manner and shall have access to all necessary equipment or facilities.
Amendment 286 #
Proposal for a regulation
Article 28 – paragraph 7 – point a
Article 28 – paragraph 7 – point a
(a) sound technical and vocational training covering all the conformity assessment activitietasks in relation to which the conformity assessment body has been notified;
Amendment 287 #
Proposal for a regulation
Article 28 – paragraph 8 – subparagraph 1
Article 28 – paragraph 8 – subparagraph 1
The impartiality of a conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment activitietasks shall be guaranteed.
Amendment 288 #
Proposal for a regulation
Article 28 – paragraph 8 – subparagraph 2
Article 28 – paragraph 8 – subparagraph 2
The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessment activitietasks shall not depend on the number of conformity assessments carried out or on the results of those assessments.
Amendment 289 #
Proposal for a regulation
Article 28 – paragraph 10
Article 28 – paragraph 10
10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment activitietasks in accordance with Annexes VII, VIII and IX, except in relation to the competent authorities of the Member State in which its activitietasks are carried out. Proprietary rights, intellectual property rights and trade secrets shall be protected.
Amendment 290 #
Proposal for a regulation
Article 28 – paragraph 11
Article 28 – paragraph 11
11. A conformity assessment body shall participate in, or ensure that its personnel responsible for carrying out the conformity assessment activitietasks are informed of, the relevant standardisation activitietasks and the activitietasks 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.
Amendment 291 #
Proposal for a regulation
Article 30 – paragraph 3
Article 30 – paragraph 3
3. ActivitieTasks may be subcontracted or carried out by a subsidiary only with the agreement of the client.
Amendment 292 #
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The application for notification shall be accompanied by a description of the conformity assessment activitietasks, 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.
Amendment 293 #
Proposal for a regulation
Article 32 – paragraph 3 – point a
Article 32 – paragraph 3 – point a
(a) full details of the conformity assessment activitietasks to be performed;
Amendment 294 #
Proposal for a regulation
Article 32 – paragraph 5 – subparagraph 1
Article 32 – paragraph 5 – subparagraph 1
The conformity assessment body concerned may perform the activitietasks 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).
Amendment 295 #
Proposal for a regulation
Article 33 – paragraph 2 – subparagraph 1
Article 33 – paragraph 2 – subparagraph 1
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 activitietasks for which they have been notified.
Amendment 296 #
Proposal for a regulation
Article 36 – paragraph 2 – subparagraph 1
Article 36 – paragraph 2 – subparagraph 1
A notified body shall perform its activitietasks 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.
Amendment 297 #
Proposal for a regulation
Article 38 – paragraph 1 – point c
Article 38 – paragraph 1 – point c
(c) any request for information which it has received from market surveillance authorities regarding its conformity assessment activitietasks;
Amendment 298 #
Proposal for a regulation
Article 38 – paragraph 1 – point d
Article 38 – paragraph 1 – point d
(d) on request, any conformity assessment activitietasks performed within the scope of its notification and any other activitytask performed, including cross-border activitietasks and subcontracting.
Amendment 299 #
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. A notified body shall provide other notified bodies carrying out similar conformity assessment activitietasks covering the same kinds of machinery product with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Amendment 325 #
Proposal for a regulation
Annex I – point 25 a (new)
Annex I – point 25 a (new)
25a. Escalators and moving walks.
Amendment 327 #
Proposal for a regulation
Annex I – point 25 b (new)
Annex I – point 25 b (new)
25b. Cranes with a load moment >150 kNm.
Amendment 328 #
Proposal for a regulation
Annex I – point 25 c (new)
Annex I – point 25 c (new)
25c. Palletisers, depalletisers, pallet wrapping machines.
Amendment 336 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.2 – point a
Annex III – Part 1 – point 1.1 – point 1.1.2 – point a
(a) A machinery product shall be designed and constructed so that it is fit for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen butreasonably foreseeable conditions of use also taking into account any reasonably foreseeable misuse thereof. The aim of protective measures shall be to eliminate any risk throughout the foreseeable lifetime of the machinery product including the phases of transport, assembly, dismantling, disabling and scrapping.
Amendment 343 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.2 – point e a (new)
Annex III – Part 1 – point 1.1 – point 1.1.2 – point e a (new)
(ea) The manufacturer shall inform the user about vulnerabilities that might arise and provide remedial measures.
Amendment 390 #
Proposal for a regulation
Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 4 – point c
Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 4 – point c
(c) be presented in a format that makes it is possible for the end user to download the instructions throughout the lifetime of the product and save them on an electronic device so that he or she can access them at all times, in particular during a breakdown of the machine. This requirement also applies to a machinery product where the instruction manual is embedded in the software of the machinery product. General principles for the drafting of instructions
Amendment 403 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 1
Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 1
Where there is a risk that operators or other persons transported by the machinery may be crushed between parts of the machinery and the surroundings should the machinery roll or tip over, in particular for machinery equipped with a protective structure referred to in section 3.4.3 or 3.4.4, the machinery shall be designed or equipped with a restraint system so as to keep the persons in their seats or in the protective structure, without restricting movements necessary for operations or movements relative to the structure caused by the suspension of the seats. Such restraint systems shall be designed according to ergonomic principles. Such restraint systems or provision shall not be fitted if they increase the risk.
Amendment 405 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2
Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2
Amendment 429 #
Proposal for a regulation
Annex III – Part 6 – point 6.2 – paragraph 3
Annex III – Part 6 – point 6.2 – paragraph 3
The control devices for the movements referred to in the first paragraph shall be of the hold-to-run type except where the carrier is completely enclosed. If there is no risk of persons or objects on the carrier colliding or falling and no other risks due to the upward and downward movements of the carrier, including in case of power failure and rescue, control devices authorising automatic stops at preselected positions may be used instead of hold-to- run type control devices
Amendment 435 #
Proposal for a regulation
Annex VII – point 5 – paragraph 1
Annex VII – point 5 – paragraph 1
The notified body shall draw up an evaluation report that records the activitietasks undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, as mentioned in Article 32, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.