Activities of Stefania ZAMBELLI related to 2021/0105(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on machinery products
Amendments (11)
Amendment 22 #
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 thoseappropriate guidelines should be drawn up, in order to properly assess the possible further risks that may appear during the machinery product’s lifecycle 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 guidelines establishing the risk assessment procedures for the machinery, including the AI, should also take into account the risk assessment for(and the machinery product should consider the risk assessmentrelated terminology and risk levels) for thate 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 32 #
Proposal for a regulation
Recital 45 a (new)
Recital 45 a (new)
(45a) Nevertheless, the provisions laid down in Articles 5(1) and 21(2) of this Regulation should be applied only to AI systems capable of self-determination and evolving during normal operation. By contrast, they should not be applied to conventional software that is not capable of learning or evolving and is programmed solely to make machinery products perform certain automated functions.
Amendment 41 #
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) agricultural and forestry vehicletractors, 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, except for the machinery products installed on those vehicles;
Amendment 42 #
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 itsthe specific application planned by the manufacturer and which is the subject of the procedure assessing the conformity of the machinery product.
Amendment 44 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
Amendment 49 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
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 and applies only to artificial intelligence systems with self- determining behaviour or logic which are capable of evolving during normal operation, so as not to compromise the safety of the machinery product as a whole.
Amendment 50 #
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
Amendment 52 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
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.
Amendment 54 #
Proposal for a regulation
Annex I – point 24
Annex I – point 24
24. SThe safety component of the AI- system software ensuring safety functions, including AI systems.
Amendment 57 #
Proposal for a regulation
Annex I – point 25
Annex I – point 25
Amendment 60 #
Proposal for a regulation
Annex II – point 18
Annex II – point 18
18. SAI-system software ensuring safety functions, including AI systems.