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8 Amendments of Françoise GROSSETÊTE related to 2017/0353(COD)

Amendment 41 #
Proposal for a regulation
Recital 5
(5) This Regulation should cover products that are subject to Directive 2001/95/EC or the Union harmonisation legislation listed in the Annex. The legislation listed in the Annex should cover all Union harmonisation legislation concerning manufactured products other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. This will ensure a uniform framework for market surveillance of those products at Union level. Several instruments of Union harmonisation legislation on products need to be amended in consequence, in particular to remove references to certain provisions of Regulation (EC) No 765/2008. If new Union harmonisation legislation is adopted in the future, it will be for that legislation to provide whether this Regulation is also to apply to that legislation.
2018/05/25
Committee: ENVI
Amendment 46 #
Proposal for a regulation
Recital 14
(14) A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this purpose, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers, distributors and the market surveillance authorities is a key element allowing immediate intervention and corrective action in relation to the product. It is important that there should be a contact person established in the Union so that market surveillance authorities have someone to whom questions can be addressed regarding a product’s compliance with Union harmonisation legislation. The person responsible for providing such compliance information should be the manufacturer, or the importer or an authorised representative of that manufacturer, an importer when the manufacturer is not established in the EU and does not have another authorised representative, or if there is no manufacturer or importer established in the EU, or another person designated by the manufacturer for this purpose, for example another economic operator. The role of a person responsible for compliance information established in the Union is essential for providing market surveillance authorities with an interlocutor established in the Union, and for performing specific tasks in a timely manner to ensure that the products comply with the requirements of Union harmonisation legislation, for the benefit of consumers, workers and businesses within the Union. The provisions in this Regulation requiring there to be a person established in the Union responsible for compliance information should not apply where specific requirements set out in certain legal instruments on products achieve the same result in effect, namely Article 4 of Regulation (EC) No 1223/2009, Article 15 of Regulation (EU) 2017/745 and Article 15 of Regulation 2017/746.
2018/05/25
Committee: ENVI
Amendment 48 #
Proposal for a regulation
Recital 18
(18) Market surveillance activities should be thorough and effective, to ensure that Union harmonisation legislation on products is applied correctly. Given that controls may represent a burden for economic operators, market surveillance authorities should organise and conduct inspection activities, taking their interests into account and limiting the said burden to what is necessary for the performance of efficient and effective controls. Furthermore, market surveillance activities should be performed with the same level of care by the competent authorities of the Member State irrespective of whether non- compliance of the given product is relevant on the territory of that Member State or is likely to have an impact on the market of another Member State. Uniform conditions could be envisaged for inspection activities carried out by the market surveillance authorities when a product presents a known or emerging risk.
2018/05/25
Committee: ENVI
Amendment 63 #
Proposal for a regulation
Article 2 – paragraph 1
1. This Regulation applies to all products that are subject to Directive 2001/95/EC or the Union harmonisation legislation set out in the Annex to this Regulation (‘Union harmonisation legislation’).
2018/05/25
Committee: ENVI
Amendment 73 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15
(15) ‘sSerious risk’ means any serious risk, including a serious risk where the effects are not immediate, requiring rapid intervention by the market surveillance authorities; any product that does not meet an essential condition set out in the harmonisation legislation, or any product that does not meet the general product safety criteria based on Directive 2001/95/EC;
2018/05/25
Committee: ENVI
Amendment 76 #
Proposal for a regulation
Article 3 – paragraph 1 – point 22 a (new)
(22a) ‘distinct models’ means all products with different characteristics, even when those differences are minor or even non-existent.
2018/05/25
Committee: ENVI
Amendment 88 #
Proposal for a regulation
Article 4 – paragraph 3 – point b
(b) further to a reasoned request from a market surveillance authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the product in an official Union language determined by the Member State concerned, and to show significant differences in the characteristics of its distinct models as defined in Article 3(22)(a);
2018/05/25
Committee: ENVI
Amendment 165 #
Proposal for a regulation
Article 25 – paragraph 3
3. Products deemed to be non- compliantunsafe on the basis of a decision of a market surveillance authority in one Member State, shall be presumed to be non-compliantunsafe by market surveillance authorities in another Member State, unless economic operators can provide evidence to the contrary.
2018/05/25
Committee: ENVI