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1、July 2023 Ref. Eurogip-182/EISBN 979-10-97358-58-7Machinery:from the Directiveto the new Regulation, what changes?1st edition, July 2023Pierre Belingard, EUROGIP Stefano Boy, ETUIeurogip.fretui.orgMachinery: From the Directive to the new Regulation, what changes?Machinery: From the Directive to the
2、new Regulation, what changes? - Eurogip-182/E - 07/20237PUBLISHERSEUROGIP51, avenue des Gobelins 75013 ParisFrance https:/eurogip.fr/European Trade Union Institute (ETUI)Bd du Jardin Botanique 201000 Brussels Belgium https:/etui.org/Director of the publicationRaphal Haeflinger DirectorAuthorsPierre
3、Belingard belingardeurogip.frISBN979-10-97358-58-7ParisRef. Eurogip-182/E July 2023Stefano Boy sboyetui.orgTable of contentsChapter I GENERAL PROVISIONS.9Article 1 Subject matter .9Article 2 Scope .9Article 3 Definitions .12Article 4 Free movement .18Article 5 Protection of persons during installati
4、on or use of machinery or related products .18Article 6 Categories of machinery and related products listed in Annex I subject to relevantconformity assessment procedures .19Article 7 Safety components .23Article 8 Essential health and safety requirements for products within the scope of thisRegulat
5、ion .24Article 9 Specific Union harmonisation legislation .24Chapter II OBLIGATIONS OF ECONOMIC OPERATORS .25Article 10 Obligations of manufacturers of machinery and related products .25Article 11 Obligations of manufacturers of partly completed machinery .30Article 12 Authorised representatives .34
6、Article 13 Obligations of importers of machinery and related products .34Article 14 Obligations of importers of partly completed machinery .37Article 15 Obligations of distributors of machinery and related product .39Article 16 Obligations of distributors of partly completed machinery .40Article 17
7、Cases in which obligations of manufacturers apply to importers and distributors .42Article 18 Other cases in which obligations of manufacturers apply .42Article 19 Identification of economic operators .43Chapter III CONFORMITY OF PRODUCTS WITHIN THE SCOPE OF THIS REGULATION44Article 20 Presumption o
8、f conformity of products within the scope of this Regulation .44Article 21 EU declaration of conformity of machinery and related products .46Article 22 EU declaration of incorporation of partly completed machinery .47Article 23 General principles of the CE marking .48Article 24 Rules for affixing th
9、e CE marking to machinery and related products .48Chapter IV CONFORMITY ASSESSMENT .50Article 25 Conformity assessment procedures for machinery and related products .50Chapter V NOTIFICATION OF CONFORMITY ASSESSMENT BODIES .52Article 26 Notification .52Article 27 Notifying authorities .52Article 28
10、Requirements relating to notifying authorities .53Article 29 Information obligation on notifying authorities .54Article 30 Requirements relating to notified bodies .54Article 31 Presumption of conformity of notified bodies .58Article 32 Use of subcontractors and subsidiaries by notified bodies .58Ar
11、ticle 33 Application for notification .58Article 34 Notification procedure .59Article 35 Identification numbers and lists of notified bodies .60Article 36 Changes to notifications .61Article 37 Challenge of the competence of notified bodies .61Article 38 Operational obligations of notified bodies .6
12、2Article 39 Appeals against decisions of notified bodies .63Article 40 Information obligation on notified bodies .63Article 41 Exchange of experience .64Article 42 Coordination of notified bodies .65Chapter VI UNION MARKET SURVEILLANCE AND UNION SAFEGUARD PROCEDURES .65Article 43 Procedure at nation
13、al level for dealing with machinery products presenting a risk .65Article 44 Union safeguard procedure .68Article 45 Compliant products within the scope of this Regulation which present a risk .69Article 46 Formal non-compliance .71Chapter VII DELEGATED POWERS AND COMMITTEE PROCEDURE .73Article 47 E
14、xercise of the delegation .73Article 48 Committee procedure .74Chapter VIII CONFIDENTIALITY AND PENALTIES .75Article 49 Confidentiality .75Article 50 Penalties .76Chapter IX TRANSITIONAL AND FINAL PROVISIONS .78Article 51 Repeals .78Article 52 Transitional provisions .79Article 53 Evaluation and rev
15、iew .80Article 54 Entry into force and application .81ANNEX I Categories of machinery or related products to which one of the procedures referred to inarticle 25 (2) and (3) shall be applied .82ANNEX II Indicative list of safety components .85ANNEX III Essential health and safety requirements relati
16、ng to the design and constructionof machinery or related products .87ANNEX IV Technical documentation .174ANNEX V EU declaration of conformity and EU declaration of incorporation .180ANNEX VI Internal production control (Module A) .185ANNEX VII EU type-examination (Module B) .187ANNEX VIII Conformit
17、y to type based on internal production control (Module C) .195ANNEX IX Conformity based on full quality assurance (Module H) .197ANNEX X Conformity based on unit verification (module G) .204ANNEX XI Assembly instructions for partly completed machinery .207Additional content: Scope of application of
18、regulation and specific Union harmonisation legislation(Article 2 & 9) .210Additional content: Schematic representation of Article 6.211Additional content: Schematic representation of assessment procedures (Article 10 & 11) .213Additional content: Milestones .214Created in 1991 within the French Soc
19、ial Security system, EUROGIP is an observatory and resource centre on issues relating to accidents at work and occupational diseases at international level.EUROGIPs mission is to analyse international, and particularly European, developments in the field of insurance and prevention of occupational i
20、njuries, but also to put forward the point of view of the French occupational injury insurance on these issues to the relevant Community bodies and national organizations.It carries out various activities:- Comparative surveys on occupational risks in Europe- Projects of Community interest- Informat
21、ion sharing and communication: monthly newsletter (Eurogip infos), publication of survey reports and thematic notes, organization of events, social networks (Twitter, LinkedIn), etc.- Secretariat of the coordination of notified bodies for the regulatory certification of personal protective equipment
22、 and machinery (delegation of the French Ministries of Labour and Agriculture)- Coordination of the network of 70 experts from the French occupational health and safety insurance scheme, chosen for their technical skills, who participate in European and international standardization work in the fiel
23、d of occupational health and safety.EUROGIP was set up in the form of a public interest grouping between the French National Health Insurance Fund (CNAM) and the National Research and Safety Institute for the Prevention of Occupational Injuries (INRS).The European Trade Union Institute is the indepe
24、ndent research and training centre of the European Trade Union Confederation (ETUC). It uses its expertise to promote the interests of workers at European level and to strengthen the social dimension of the European Union.The ETUI is composed of two Departments: A Research Department, which includes
25、 three units (Europeanisation of Industrial Relations; Economic, Social and Employment Policies; Working Conditions, Health and Safety) and an Education Department.The ETUI conducts studies on socio-economic and industrial relations issues and monitors European policy developments of strategic impor
26、tance to the world of work. It builds bridges between academia, the research community and the trade union movement in order to encourage independent research on topics of key importance to the world of work.The ETUI encourages training, education and learning activities. It provides the ETUC and it
27、saffiliates with programmes and exchanges that strengthen the European trade union identity.The ETUI provides technical assistance in the field of health and safety to achieve a high level of protection at work for workers throughout Europe.A foresight unit is responsible for studying the long- term
28、 challenges for the European trade union movement and its implications for the functioning of the Institute.The ETUI is an international non-profit association under Belgian law, employing a staff of about 70 people from all over Europe. It receives financial support from the European Union.PrefaceM
29、arian SchaapmanETUIRaphal Haeflinger EUROGIP“At ETUI, we are convinced that European legislation should be subject to constant public debate so that the degree of accountability, transparency and competence of the European Institutions can be measured at any time.At EUROGIP, our task is among others to improve understanding of the decisions and actions implemented at Community level regarding health and safety at work.Thus, this work would not have been possible without the joint contr