32 Amendments of Cristian-Silviu BUŞOI related to 2017/0353(COD)
Amendment 64 #
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation shall appliesy to all products that are subject to Directive2001/95/EC or the Union harmonisation legislation set out in the Annex to this Regulation (‘Union harmonisation legislation’).
Amendment 72 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
(15) ‘serious risk’ means any serious risk, including a serious riskrisk requiring rapid intervention and follow-up, including cases where the effects aremay not be immediate, requiring rapid intervention by the market surveillance authorities; any product that does not meet an essential requirement defined in the harmonisation legislation, as well as any product that does not meet the general safety requirement as defined in the mandate given by the Commission to the standardisation organisation shall be considered as presenting a serious risk; any product subject to an emergency decision based on Article 13 of Directive 2001/95/CE shall be considered as a product posing a serious risk;
Amendment 77 #
Proposal for a regulation
Article 4 – paragraph 1 – point a – introductory part
Article 4 – paragraph 1 – point a – introductory part
(a) the manufacturer, or its establauthorished in the Union or there is at least one of the following in place with respect to the product:representative, is established in the Union;
Amendment 80 #
Proposal for a regulation
Article 4 – paragraph 1 – point a – point i
Article 4 – paragraph 1 – point a – point i
(i) (b) an importer, when the manufacturer is not established in the Union and there is no authorised representative;
Amendment 82 #
Proposal for a regulation
Article 4 – paragraph 1 – point a – point ii
Article 4 – paragraph 1 – point a – point ii
(ii) (c) in case there is no manufacturers or importer established in the Union, a natural or legal person established in the Union who has a written mandate from the manufacturer designating him as a person responsible for compliance and performing the tasks listed in paragraph 3 and requiring him to perform those tasks on the manufacturer’s behalf;
Amendment 85 #
Proposal for a regulation
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) (d) the identity and contact details of the manufacturer, importer or other person meeting the requirements of points (a to c) are publicly available in accordance with paragraph 4 and are indicated or identifiable in accordance with paragraph 5.
Amendment 86 #
Proposal for a regulation
Article 4 – paragraph 3 – point b
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 demonstrate the existence of different essential characteristics between its distinct models as defined in point 22a of Article 3;
Amendment 90 #
Proposal for a regulation
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
(c) cooperating with the market surveillance authorities, at their request, on any action taken to eliminate or, if that is not possible, mnd take immediate action to remedy the case of a product presenting a risk or the case of a product being non-compliant with the requirements set out in Union harmonisation legislation or harmonised standards applicable to the product in question, at their own initigate tive or when risks posed by the product.equired to do so by the market surveillance authorities;
Amendment 94 #
Proposal for a regulation
Article 4 – paragraph 3 – point c a (new)
Article 4 – paragraph 3 – point c a (new)
(c a) when considering or having reason to believe that a product in question present a risk or is not in conformity with the applicable Union harmonisation legislation or harmonised standard, immediately inform the manufacturer and, where applicable, other economic operators;
Amendment 97 #
Proposal for a regulation
Article 4 – paragraph 5 a (new)
Article 4 – paragraph 5 a (new)
5 a. The manufacturer, importer and any other person meeting the requirements of point (a) of paragraph 1 of this Article, shall make available to the public and to other economic operators by any appropriate means, lists of their product models, accompanied by a picture, in particular for products that are or have been the subject of a decision by the Commission under Article 13 of Directive 2001/95/CE and for products that are the subject of widespread distribution.
Amendment 103 #
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 1
Article 8 – paragraph 1 – subparagraph 1
Market surveillance authorities may enter into memoranda of understanding with custom authorities, port and airport authorities, businesses or organisations representing businesses or end-users for the carrying out, or financing, of joint activities aimed at identifying non- compliance or promoting compliance in specific geographical areas or with respect to specific categories of products. The market surveillance authority shall provide a draft memorandum to the Commission at least 2 months before its adoption and a report on its implementation every year from the date of its adoption. The Commission shall provide an opinion to the market surveillance authorities on the draft memorandum and the implementation report.
Amendment 130 #
Proposal for a regulation
Article 12 – paragraph 5 a (new)
Article 12 – paragraph 5 a (new)
5 a. To settle any disputes arising out of a divergent risk assessment among the authorities of the Member States, the economic operators and the conformity assessment bodies the Commission may, of its own initiative or at the request of a surveillance authority, have a risk assessment carried out by a reference laboratory of the European Union referred to in Article 28, which shall be binding on all of the stakeholders.
Amendment 135 #
Proposal for a regulation
Article 13 – paragraph 2 – point b
Article 13 – paragraph 2 – point b
(b) the areas identified as a priority for the enforcement of Union harmonisation legislation;. Member States shall consider products that are or have been subject to an emergency decision based on Article 13 of Directive 2001/95/EC as priority areas.
Amendment 140 #
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation should cover products that are subject to the Directive 2001/95/EC on General Product Safety 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.
Amendment 152 #
Proposal for a regulation
Recital 14
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 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 interlocutorits authorised representative, an importer when the manufacturer is not established in the Union, and for performing specific tasks in a timely manner to ensure that the products comply with the requithere is no other authorised repremsents of Union harmonisation legislationative, 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.– in case there is no manufacturers or importer established in the Union - another person designated by the manufacturer for this purpose, for example another economic operator. (…)
Amendment 163 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. At the request of an applicant authority or the Commission or any other stakeholders bringing due evidence of non-compliance, the requested authority shall without delay take all necessary enforcement measures using the powers conferred on it under this Regulation in order to bring an instance of non- compliance to an end. In case the requested authority would not take action, the Commission could itself take all necessary enforcement measures.
Amendment 166 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Market surveillance authorities shall treat as a matter of priority products declared free for circulation by an authorised economic operator as set out in Article 38(2) of Regulation (EU) No 952/2013, the release of products which isare suspended in accordance with Article 28(1) of this Regulation equally for all economic operators.
Amendment 171 #
Proposal for a regulation
Article 35
Article 35
Amendment 183 #
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation shall appliesy to all products that are subject to Directive2001/95/EC on General Product Safety or the Union harmonisation legislation set out in the Annex to this Regulation (‘Union harmonisation legislation’).
Amendment 195 #
Proposal for a regulation
Article 3 – paragraph 1 – point 22 a (new)
Article 3 – paragraph 1 – point 22 a (new)
(22a) ‘distinct models’ means models of products that are considered to be distinct as presenting different essential characteristics from one another, and that may have an impact on their safety.
Amendment 215 #
Proposal for a regulation
Article 4 – paragraph 3 – point b
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 demonstrate the existence of different essential characteristics between its models within the meaning of the definition given in point (22a) of Article 3 of this Regulation;
Amendment 216 #
Proposal for a regulation
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
(c) cooperating with the market surveillance authorities, at their request, on any action taken to eliminate or, if that is not possible, mnd take immediate action to remedy the case of a product presenting a risk or the case of a product being non-compliant with the requirements set out in Union harmonisation legislation or harmonised standards applicable to the product in question, at their own initigate tive or when risks posed by the product.equired to do so by the market surveillance authorities;
Amendment 219 #
Proposal for a regulation
Article 4 – paragraph 3 – point c a (new)
Article 4 – paragraph 3 – point c a (new)
(ca) when considering or having reason to believe that a product in question present a risk or is not in conformity with the applicable Union harmonisation legislation or harmonised standard, immediately inform the manufacturer and, where applicable, other economic operators;
Amendment 227 #
Proposal for a regulation
Article 4 – paragraph 5 a (new)
Article 4 – paragraph 5 a (new)
5a. The manufacturer, importer and the other person meeting the requirements of point (a) should make available to the public and other economic operators by any appropriate means, lists of their product models, accompanied by a picture, in particular for products that are or have been the subject of a decision by the Commission under Article13 of the Directive 2001/95/CE on General product safety and for products that are the subject of widespread distribution.
Amendment 230 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Obligations of distributors 1. Before making a product available on the market distributors shall verify that the manufacturer and the importer have complied with the requirements set out in the applicable harmonisation legislation, harmonised standard or the directive on General Product Safety. 2. Distributors who consider or have reason to believe that a product which they have made available on the market is not compliant shall make sure that the corrective action necessary to bring that product into conformity is taken, while withdrawing or recalling the non- compliant products. Furthermore, distributors shall immediately inform the manufacturer or importer, as applicable as well as market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.
Amendment 315 #
Proposal for a regulation
Article 12 – paragraph 3 – subparagraph 1 – point b
Article 12 – paragraph 3 – subparagraph 1 – point b
(b) the product does not conform to applicable requirements under Union harmonisation legislation. or under the General Product Safety Directive and associated safety standards, the references of which have been published in the Official Journal of the EU.
Amendment 318 #
Proposal for a regulation
Article 12 – paragraph 3 – subparagraph 1 – point b a (new)
Article 12 – paragraph 3 – subparagraph 1 – point b a (new)
(ba) the product is recognized as non- compliant by any judicial or administrative court in the EU.
Amendment 339 #
Proposal for a regulation
Article 12 – paragraph 5 a (new)
Article 12 – paragraph 5 a (new)
Amendment 344 #
Proposal for a regulation
Article 13 – paragraph 2 – point b
Article 13 – paragraph 2 – point b
(b) the areas identified as a priority for the enforcement of Union harmonisation legislation;. Member States shall consider products that are or have been subject to an emergency decision based on Article 13 of Directive 2001/95/EC as priority areas.
Amendment 455 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. At the request of an applicant authority or the Commission or any other stakeholders bringing the evidence of non-compliance, the requested authority shall without delay take all necessary enforcement measures using the powers conferred on it under this Regulation in order to bring an instance of non- compliance to an end. In case the requested authority would not take action, the Commission could itself take all necessary enforcement measures.
Amendment 461 #
Proposal for a regulation
Article 25 – paragraph 3
Article 25 – paragraph 3
3. Products deemed to be non- compliant on the basis of a decision ofunsafe by a market surveillance authority i, based on none Member Stat-compliance, shall be presumed to be non-compliant byunsafe by another market surveillance authorities in another Member Statey, unless economic operators can provide evidence tof the contrary.
Amendment 530 #
Proposal for a regulation
Article 35
Article 35