L_2023165EN.01000101.xml
https://eur-lex.europa.eu/eli/reg/2023/1230/oj/eng
EU Machinery Regulation 2023/1230, applying 20 January 2027. Annex I Part A item 5 pulls machine-learning safety components into mandatory third-party conformity assessment — the open question about whether this is a market
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41−Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (Text with EEA relevance)
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43−Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (Text with EEA relevance)
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45−Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (Text with EEA relevance)
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47−PE/6/2023/REV/1
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49−OJ L 165, 29.6.2023, pp. 1–102
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52−In force: This act has been changed. Current consolidated version:
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1+L_2023165EN.01000101.xml
2+
3+29.6.2023
4+
5+EN
6+
7+Official Journal of the European Union
8+
9+L 165/1
10+
11+REGULATION (EU) 2023/1230 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
12+
13+of 14 June 2023
14+
15+on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC
16+
17+(Text with EEA relevance)
18+
19+THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
20+
21+Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
22+
23+Having regard to the proposal from the European Commission,
24+
25+After transmission of the draft legislative act to the national parliaments,
26+
27+Having regard to the opinion of the European Economic and Social Committee ( 1 ) ,
28+
29+Acting in accordance with the ordinary legislative procedure ( 2 ) ,
30+
31+Whereas:
32+
33+(1)
34+
35+Directive 2006/42/EC of the European Parliament and of the Council ( 3 ) was adopted in the context of establishing the internal market, in order to harmonise health and safety requirements for machinery in all Member States and to remove obstacles to trade in machinery between Member States.
36+
37+(2)
38+
39+The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Union economy. The social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installation and maintenance.
40+
41+(3)
42+
43+Experience with the application of Directive 2006/42/EC has shown inadequacies and inconsistencies in the product coverage and conformity assessment procedures. It is therefore necessary to improve, simplify and adapt the provisions set out in that Directive to the needs of the market and provide clear rules in relation to the framework within which products within the scope of this Regulation may…
44+
45+(4)
46+
47+Since the rules setting out the requirements for products within the scope of this Regulation, in particular the essential health and safety requirements and the conformity assessment procedures, need to be of uniform application for all operators across the Union, and not give room for divergent implementation by Member States, Directive 2006/42/EC should be replaced by a regulation.
48+
49+(5)
50+
51+Member States are responsible for protecting, on their territory, the health and safety of persons, in particular workers and consumers, and, where appropriate, domestic animals and property, and, where applicable, for protecting the environment, notably in relation to the risks arising out of the intended use or any reasonably foreseeable misuse of machinery or related products. For the avoidance…
52+
53+(6)
54+
55+Regulation (EC) No 765/2008 of the European Parliament and of the Council ( 4 ) lays down rules on the accreditation of conformity assessment bodies, and the general principles of the CE marking. That Regulation should be applicable to products within the scope of this Regulation in order to ensure that those products, which are benefiting from the free movement of goods within the Union, fulfil …
56+
57+(7)
58+
59+Regulation (EU) 2019/1020 of the European Parliament and of the Council ( 5 ) sets out rules on market surveillance and control of products entering the Union market. As Directive 2006/42/EC is listed in Annex I of Regulation (EU) 2019/1020, that Regulation already applies to products within the scope of this Regulation. However, Regulation (EU) 2019/1020 applies to products within the scope of t…
60+
61+(8)
62+
63+Regulation (EU) 2019/1020 lays down the tasks of economic operators regarding products subject to certain Union harmonisation legislation. It also provides that such products are to be placed on the market only if there is an economic operator established in the Union who is responsible for those tasks. That Union harmonisation legislation includes Directive 2006/42/EC. As a result, products withi…
64+
65+(9)
66+
67+Decision No 768/2008/EC of the European Parliament and of the Council ( 6 ) lays down common principles and reference provisions intended to apply across sectoral legislation. In order to ensure consistency with other sectoral product legislation, it is appropriate to align certain provisions of this Regulation to that Decision, insofar as sectoral specificities do not require a different solutio…
68+
69+(10)
70+
71+This Regulation should cover products which are new to the Union market when placed on the market, and are either new products made by a manufacturer established in the Union or products, whether new or second-hand, imported from a third country.
72+
73+(11)
74+
75+Where there is a possibility that machinery or related products will be used by a consumer, that is to say, a non-professional user, the manufacturer should take account of the fact that the consumer does not have the same knowledge of and experience in handling machinery or related products in the design and construction of the products. The same applies where the machinery or related product is …
76+
77+(12)
78+
79+Recently, more advanced machinery, which is less dependent on human operators, has been introduced on the market. Such machinery is working on defined tasks and in structured environments, yet it can learn to perform new actions in this context and become more autonomous. Further refinements to machinery, already in place or to be expected, include real-time processing of information, problem solv…
80+
81+(13)
82+
83+In order to ensure protection of the health and safety of persons, and, where appropriate, domestic animals and property, and, where applicable, of the environment, this Regulation should apply to all forms of supply of products within the scope of this Regulation, including distance selling as referred to in Regulation (EU) 2019/1020.
84+
85+(14)
86+
87+In order to ensure legal certainty, the scope of this Regulation should be set out in a clear manner and the concepts relating to its application should be defined as precisely as possible.
88+
89+(15)
90+
91+In order to ensure that the scope of this Regulation is sufficiently clear, a distinction should be made between machinery, related products and partly completed machinery. Moreover, related products should be understood as comprising interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices, which are all products w…
92+
93+(16)
94+
95+In order to avoid legislating twice on the same product, it is appropriate to exclude from the scope of this Regulation weapons, including firearms, that are subject to Directive (EU) 2021/555 of the European Parliament and of the Council ( 7 ) .
96+
97+(17)
98+
99+The purpose of this Regulation is to address the risks stemming from machinery function and not from the transport of goods, persons or animals. Consequently, this Regulation should not apply to means of transport by air, on water and on rail networks although it should still apply to the machinery mounted on those means of transport. Means of transport by road that are not yet covered by a specif…
100+
101+(18)
102+
103+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 electric motors fall within the scope of Directive 2014/35/EU of the European Parliament and of the Council ( 11 ) and should therefore be excluded from the scope of this Regulation.…
104+
105+(19)
106+
107+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 machinery design. Consequently, the definition of machinery should be adapted. In this respect, machinery missing only the upload of software intended for the specific application foreseen by the manufacturer, and which is the subject of the conformity assessm…
108+
109+(20)
110+
111+Considering their critical protective function, certain components included in the indicative list of safety components in Annex II should also be subject to specific conformity assessment procedures and included in Annex I.
112+
113+(21)
114+
115+Partly completed machinery is a product within the scope of this Regulation which needs to undergo further construction in order to be able to perform its specific application, namely the well-defined operations for which the product is designed. It is not necessary that all requirements of this Regulation apply to partly completed machinery but, in order to ensure the safety of the product as a w…
116+
117+(22)
118+
119+Where products within the scope of this Regulation present risks that are addressed by the essential health and safety requirements set out in this Regulation but which are also wholly or partly covered by more specific Union harmonisation legislation than this Regulation, this Regulation should not apply to the extent that those risks are covered by that other Union legislation. In other cases, p…
120+
121+(23)
122+
123+For trade fairs, exhibitions and demonstrations or similar events, it should be possible to display products within the scope of this Regulation which do not meet the requirements of this Regulation, since this would not present any safety risk. However, for the sake of transparency, interested parties should be properly informed that the products within the scope of this Regulation are not compli…
124+
125+(24)
126+
127+The evolution of the state of the art in the machinery sector has an impact on the classification of categories of machinery or related products listed in Annex I. With a view to properly reflecting any categories of machinery or related products presenting a higher risk factor, criteria should be established for the assessment of categories of products which should be included in the list of cate…
128+
129+(25)
130+
131+Other risks related to new digital technologies are those provoked by malicious third parties that have an impact on the safety of products within the scope of this Regulation. In this respect, manufacturers should be required to adopt proportionate measures which are limited to the protection of the safety of the product within the scope of this Regulation. This does not preclude the application …
132+
133+(26)
134+
135+In order to ensure that machinery or related products, when placed on the market or put into service, do not entail health and safety risks for persons or domestic animals and do not cause harm to property, and, where applicable, to the environment, essential health and safety requirements should be set out which have to be met in order for the machinery or related products to be allowed on the ma…
136+
137+(27)
138+
139+In the machinery sector, approximately 98 % of companies are small or medium sized enterprises (SMEs). In order to reduce the regulatory burden on SMEs, it is important that notified bodies consider adapting the fees for conformity assessment and reducing them proportionately to the specific interests and needs of SMEs.
140+
141+(28)
142+
143+Economic operators should be responsible for the compliance of products within the scope of this Regulation with the requirements of this Regulation in relation to their respective roles in the supply chain so as to ensure a high level of protection of public interests, such as the protection of the health and safety of persons, in particular consumers and professional users, and, where appropriat…
144+
145+(29)
146+
147+All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market only products within the scope of this Regulation, which are in conformity with this Regulation. This Regulation should provide a clear and proportionate distribution of obligations, which correspond to the role of each economic operator in the s…
148+
149+(30)
150+
151+In order to facilitate communication between economic operators, market surveillance authorities and users, manufacturers and importers should indicate a website, email address or other digital contact in addition to the postal address.
152+
153+(31)
154+
155+The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.
156+
157+(32)
158+
159+The manufacturer should also ensure that a risk assessment is carried out for the product within the scope of this Regulation, which the manufacturer wishes to place on the market or put into service. In this context, the manufacturer should determine which essential health and safety requirements are applicable to the product within the scope of this Regulation and which measures need to be taken…
160+
161+(33)
162+
163+The safety of the entire machinery or related product relies on the dependencies and interactions between its components, including partly completed machinery, and, if relevant, with other machinery or related products that participate in a coordinated assembly of a machinery system, which can also result in an assembly of machinery. Therefore, manufacturers should be required to assess all those …
164+
165+(34)
166+
167+It is essential that, before drawing up the EU declaration of conformity or the EU declaration of incorporation, the manufacturer prepare technical documentation. The manufacturer should be required to make that technical documentation available to national authorities on request or to notified bodies in the context of the relevant conformity assessment procedure. Detailed plans of subassemblies u…
168+
169+(35)
170+
171+A person who manufactures machinery or related products for his or her own use is considered as to be a manufacturer and should be required to fulfil all the related obligations. In that case, the machinery or related product is not placed on the market, since it is not made available by the manufacturer to another person but is used by the manufacturer itself. However, such machinery needs to com…
172+
173+(36)
174+
175+It is necessary to ensure that products within the scope of this Regulation from third countries entering the Union market comply with the requirements of this Regulation and do not present a risk to the health and safety of persons, in particular consumers and professional users, and, where appropriate, to domestic animals and property, and, where applicable, to the environment, and in particular…
176+
177+(37)
178+
179+When placing products within the scope of this Regulation on the market, importers should indicate on those products their respective names, registered trade names or registered trade marks, postal addresses, websites, email addresses or other digital contacts at which they can be contacted. Exceptions should be provided for in cases where the size or nature of the product does not allow it. This …
180+
181+(38)
182+
183+As the distributor makes products within the scope of this Regulation available on the market after they have been placed on the market by the manufacturer or the importer, the distributor should act with due care to ensure that its handling of the product within the scope of this Regulation does not adversely affect its compliance with the requirements set out in this Regulation.
184+
185+(39)
186+
187+With a view to ensuring the health and safety of the users of products within the scope of this Regulation, economic operators should ensure that all relevant documentation, such as the instructions for use, while containing precise and comprehensible information, is easily understandable and available in a language which can be easily understood by users, as determined by the Member State concern…
188+
189+(40)
190+
191+Instructions and other relevant documentation may be provided in a digital printable format. However, the manufacturer should ensure that distributors can provide, at the request of the user at the time of the purchase, the instructions for use in a paper format free of charge. The manufacturer should also consider providing the contact details where the user can request the instructions to be dis…
192+
193+(41)
194+
195+Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the product within the scope of this Regulation concerned.
196+
197+(42)
198+
199+Any economic operator who either places a product within the scope of this Regulation on the market under its own name or trademark or modifies a product within the scope of this Regulation in such a way that compliance with the requirements of this Regulation might be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
200+