第6条 関連する適合性評価手続の対象となる附属書Iに掲げる機械及び関連製品の区分

1. Machinery and related products that fall within the categories listed in Annex I, Part A, shall be subject to the specific conformity assessment procedures referred to in Article 25(2), and machinery and related products that fall within the categories listed in Annex I, Part B shall be subject to the specific conformity assessment procedures referred to in Article 25(3).

2. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex I, after consulting the stakeholders concerned, in the light of technical progress, advances in knowledge or new scientific evidence by adding to the list of categories of machinery and related products in Annex I a new category of machinery or related products, withdrawing an existing category of machinery or related products from that list or moving a category of machinery or related products from one Part of Annex I to another Part of that Annex, in accordance with the criteria and the procedures laid down in paragraphs 4, 5 and 7 of this Article.

3. Before adopting a delegated act, the Commission shall seek the views of experts in the relevant expert group in accordance with Article 47(4).

4. The Commission shall assess the seriousness of the inherent potential risk presented by a category of machinery or related product for the purpose of determining whether to add that category of machinery or related product to Annex I or to withdraw that category of machinery or related product from Annex I. That assessment 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 criteria shall, where relevant, be taken into account:

(a)the nature of the hazard inherent to the function of the category of machinery or related product, taking into account the intended use and any reasonably foreseeable misuse;

(b)the severity of harm which a person would suffer, including the degree of reversibility of that harm;

(c)the number of persons potentially affected by the harm;

(d)the frequency and the duration of the exposure to the hazard that a person would be exposed to in the course of the intended use or any reasonably foreseeable misuse of the category of machinery or related product;

(e)the possibilities of avoiding or limiting harm;

(f)in the case of safety components, the likelihood of serious consequences for the safety of the persons exposed to harm in the event of their failure.

5. When conducting the assessment referred in paragraph 4, the Commission shall consider the following elements:

(a)indications of harm that have been caused in the past by machinery or related products which have been used for their intended use or following any reasonably foreseeable misuse;

(b)information about safety defects detected in the course of market surveillance, and material possibly available in the information systems administered by the Commission;

(c)information about known accidents and serious ‘close calls’, including the characteristics of those accidents or ‘close calls’;

(d)data on accidents or damage to health caused by the machinery or related product for at least the preceding four years. In particular, information obtained, inter alia, from the Information and Communication System on Market Surveillance (ICSMS), safeguard clauses, Safety Gate Rapid Alert System, the European Injury Database (EU-IDB), Eurostat’s European Statistics on Accidents at Work (ESAW) and the Machinery Administrative Cooperation Group (AdCo).

In addition to points (a) to (d) of this paragraph, the Commission shall take into account any other information available that is relevant to the assessment referred to in paragraph 4.

6. The data and information referred to in paragraph 5, points (a) to (d), shall be provided by Member States in accordance with paragraph 9.

7. A category of machinery or related product shall be included in Annex I, Part A, if, according to the assessment referred to in paragraph 4, and taking into account the available information, including the data referred to in paragraph 5, it presents a serious inherent potential risk, and one or more of the following conditions is fulfilled:

(a)there is a lack of harmonised standards or common specifications covering the relevant essential health and safety requirements;

(b)residual risks exist, including those which, according to the manufacturer, could be reduced by particular training or personal protective equipment, and the data and information referred to in paragraph 5, demonstrate the recurrence of similar serious or fatal accidents or damage to health in connection with those residual risks;

(c)data and information exist which according to the Commission demonstrate recurring wrongful application of the relevant harmonised standards or common specifications and for which the market surveillance activities that were carried out have not led to major improvements of the market situation, in a reasonable period;

(d)there is a degree of uncertainty in the existing risk assessment methods related to new categories of machinery or technologies.

Any other category of machinery or related product that, according to that assessment, presents a serious inherent potential risk but does not fulfil one or more of the conditions in points (a) to (d) shall be included in Annex I, Part B.

8. A Member State which has concerns about a category of machinery or related product being listed or not in Annex I shall immediately inform the Commission of those concerns and provide reasons in support thereof.

The Commission shall conduct the assessment referred to in paragraph 4 immediately after being informed by a Member State.

After making that assessment, the Commission may initiate the procedure laid down in paragraph 2.

9. By 20 July 2025, and every five years thereafter, Member States shall provide the data and information referred to in paragraph 5, including information to the effect that none of the events referred to in paragraph 5 has occurred, for every category of machinery or related products which is included in Annex I or which is not included in Annex I where that non-inclusion is a cause of concern for the Member State.

10. The Commission shall adopt implementing acts setting out and, where necessary in the light of technological and market development, updating a template concerning the collection by Member States of the data and the information referred to in paragraph 5, points (a) to (d).

When adopting those implementing acts, the Commission shall issue guidance to Member States on the collection and transmission of comparable, high-quality data and information.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

The first such implementing act shall be adopted not later than 20 July 2024.

11. If necessary after the Commission report referred to in Article 53(3), the Commission shall adopt delegated acts in accordance with Article 47 to supplement paragraph 5 of this Article by specifying the obligations of Member States to provide data and information required pursuant to this Article through the establishment of a common methodology concerning the data and information to be collected, including the methods for their collection and compilation, and the procedures for their transmission, as well as the relevant definitions, in order to ensure that sufficient and comparable data is available for the Commission to carry out the assessment referred to in paragraph 4.