58 Amendments of Sirpa PIETIKÄINEN related to 2017/0353(COD)
Amendment 42 #
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation should cover products that are subject to the 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.
Amendment 45 #
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, wholesalers, retailers 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, orauthorised representative, an importer when the manufacturer is not established in the Union and there is no other authorised representative, or - in the 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. 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.
Amendment 65 #
Proposal for a regulation
Article 2 – paragraph 1
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’).
Amendment 66 #
Proposal for a regulation
Article 2 – paragraph 1
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’).
Amendment 71 #
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 75 #
Proposal for a regulation
Article 3 – paragraph 1 – point 22 a (new)
Article 3 – paragraph 1 – point 22 a (new)
(22 a) ‘distinct models’ means models of products that are considered to be distinct due to different essential characteristics that may have an impact on their safety.
Amendment 78 #
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 79 #
Proposal for a regulation
Article 4 – paragraph 1 – point a – point i
Article 4 – paragraph 1 – point a – point i
(i) an importer, when the manufacturer is not established in the Union and there is no authorised representative;
Amendment 83 #
Proposal for a regulation
Article 4 – paragraph 1 – point a – point ii
Article 4 – paragraph 1 – point a – point ii
(ii) 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 performing the tasks listed in paragraph 3 and requiring him to perform those tasks on the manufacturer’s behalf;
Amendment 87 #
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 between its distinct models as defined in point 22a of Article 3;
Amendment 89 #
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, mitigate tnd 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 initiative or when risks posed by the product.equired to do so by the market surveillance authorities;
Amendment 92 #
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 taketo take action to eliminate or, if that is not possible, mitigate the risks posed by the product.
Amendment 93 #
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 98 #
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 take all reasonable steps to ensure that the manufacturer and the importer have complied with the requirements set out in the applicable harmonisation legislation, harmonised standards or the Directive 2001/95/EC. 2. Further to a reasoned request from a market surveillance authority, the person responsible for compliance information shall provide 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 104 #
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.
Amendment 106 #
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 1 a (new)
Article 8 – paragraph 1 – subparagraph 1 a (new)
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 128 #
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 Directive 2001/95/EC.
Amendment 130 #
Proposal for a regulation
Recital 1
Recital 1
(1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that products are fully compliant with the EU law and fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, protection of consumers, protection of the environment and public security, similarly to requirements governing similar products produced within the EU Single Market. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union market for goods can thrive. Rules are therefore necessary to ensure this enforcement throughout the internal market, including on products entering the Union from third countries.
Amendment 131 #
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 132 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Each Member State shall draw up a national market surveillance strategy, as a minimum, every 3 years. The strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and enforcement of Union harmonisation legislation within the territory of the Member State and shall include all sectors and stages of the product supply chain, including imports and digital supply chains. In establishing their national market surveillance strategies, the Member States shall consult stakeholders and make their comments available to the general public.
Amendment 135 #
Proposal for a regulation
Recital 3
Recital 3
(3) Currently, the implementation of surveillance to guarantee compliance is insufficient. The framework for market surveillance should be strengthened in order to reach the set objectives, with a view to further improving compliance with and enforcement of Union harmonisation legislation on products. Surveillance of compliance should go beyond monitoring of safety of a product, and cover other EU standards such as labour, health and environmental standards.
Amendment 136 #
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 Directive2001/95/EC as priority areas;
Amendment 136 #
Proposal for a regulation
Recital 3
Recital 3
(3) Currently, the implementation of surveillance to guarantee compliance is insufficient. The framework for market surveillance should be strengthened in order to reach the set objectives, with a view to further improving compliance with and enforcement of Union harmonisation legislation on products. Surveillance of compliance should go beyond monitoring of safety of a product, and cover other EU standards such as labour, health and environmental standards.
Amendment 138 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Member States shall communicate their national market surveillance strategy through the system referred to under Article 34, and shall make it available to the general public.
Amendment 141 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Responsibility for compliance with the EU standards lies with the importer. For this end, self-monitoring and control of importers should be strengthened and the system for self-monitoring developed. This should be done by strengthening the liability for self-monitoring of the importer, who should be required to conduct an independent third party audit. The liability for compliance would also be held by the independent third party auditor regarding the accuracy of the audit.
Amendment 142 #
Proposal for a regulation
Recital 9
Recital 9
(9) Responsibility for enforcing Union harmonisation legislation should lie with the Member States, whose market surveillance authorities should be required to ensure that the legislation is fully complied with. The Member States should, therefore, establish harmonised systematic approaches, including effective, proportionate and dissuasive penalties, to ensure effectiveness of market surveillance and other enforcement activities. In case of serious and recurrent breaches of compliance should be followed by sanctions, corresponding to 5% of the turnover of an entity.
Amendment 146 #
Proposal for a regulation
Recital 12
Recital 12
(12) Modern supply chains encompass a wide variety of economic operators who should all be subject to enforcement of Union harmonisation legislation, while taking due consideration of their respective role in the supply chain, and the extent to which they contribute to the making available of products on the Union market. Products, which seek to enter the Union market should be held to the same production standards as those which are produced and sold within the EU. Therefore, it is necessary to apply this Regulation to economic operators that are directly concerned by Regulation (EC) No 273/2004 of the European Parliament and of the Council31 , Regulation (EC) No 1907/2006 of the European Parliament and of the Council32 , Regulation (EC) No 1272/2008 of the European Parliament and of the Council33 , Regulation (EC) No 1222/2009 of the European Parliament and of the Council34 , Regulation (EC) No 1223/2009, Regulation (EU) 2016/424 of the European Parliament and of the Council35 , Regulation (EU) 2016/425 of the European Parliament and of the Council36 , Regulation (EU) 2016/426 of the European Parliament and of the Council37 and Regulation (EU) 2017/1369 of the European Parliament and of the Council38 , Regulation (EU) 2017/745 and Regulation (EU) 2017/746, and in Directive 2006/42/EC of the European Parliament and of the Council39 , Directive 2006/66/EC of the European Parliament and of the Council40 , Directive 2009/48/EC of the European Parliament and of the Council41 , Directive 2010/35/EU of the European Parliament and of the Council42 , Directive 2013/29/EU of the European Parliament and of the Council43 , Directive 2013/53/EU of the European Parliament and of the Council44 , Directive 2014/28/EU of the European Parliament and of the Council45 , Directive 2014/29/EU of the European Parliament and of the Council46 , Directive 2014/30/EU of the European Parliament and of the Council47 , Directive 2014/31/EU of the European Parliament and of the Council48 , Directive 2014/32/EU of the European Parliament and of the Council49 , Directive 2014/33/EU of the European Parliament and of the Council50 , Directive 2014/34/EU of the European Parliament and of the Council51 , Directive 2014/35/EU of the European Parliament and of the Council52 , Directive 2014/68/EU of the European Parliament and of the Council53 , and Directive 2014/90/EU of the European Parliament and of the Council54 . _________________ 31 Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47, 18.2.2004, p. 1). 32 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 33 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). 34 Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46). 35 Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1). 36 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51). 37 Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99). 38 Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1). 39 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157, 9.6.2006, p. 24). 40 Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1). 41 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys ( OJ L 170, 30.6.2009, p. 1–37). 42 Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36 ( OJ L 165, 30.6.2010, p. 1–18). 43 Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (recast) (OJ L 178, 28.6.2013, p. 27). 44 Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90). 45 Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (recast) (OJ L 96, 29.3.2014, p. 1). 46 Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45). 47 Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) (OJ L 96, 29.3.2014, p. 79). 48 Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non- automatic weighing instruments (OJ L 96, 29.3.2014, p. 107). 49 Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast) (OJ L 96, 29.3.2014, p. 149). 50 Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251). 51 Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast) (OJ L 96, 29.3.2014, p. 309). 52 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357). 53 Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164). 54 Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).
Amendment 147 #
Proposal for a regulation
Recital 12
Recital 12
(12) Modern supply chains encompass a wide variety of economic operators who should all be subject to enforcement of Union harmonisation legislation, while taking due consideration of their respective role in the supply chain, and the extent to which they contribute to the making available of products on the Union market. Products, which seek to enter the Union market should be held to the same production standards as those which are produced and sold within the EU. Therefore, it is necessary to apply this Regulation to economic operators that are directly concerned by Regulation (EC) No 273/2004 of the European Parliament and of the Council31 , Regulation (EC) No 1907/2006 of the European Parliament and of the Council32 , Regulation (EC) No 1272/2008 of the European Parliament and of the Council33 , Regulation (EC) No 1222/2009 of the European Parliament and of the Council34 , Regulation (EC) No 1223/2009, Regulation (EU) 2016/424 of the European Parliament and of the Council35 , Regulation (EU) 2016/425 of the European Parliament and of the Council36 , Regulation (EU) 2016/426 of the European Parliament and of the Council37 and Regulation (EU) 2017/1369 of the European Parliament and of the Council38 , Regulation (EU) 2017/745 and Regulation (EU) 2017/746, and in Directive 2006/42/EC of the European Parliament and of the Council39 , Directive 2006/66/EC of the European Parliament and of the Council40 , Directive 2009/48/EC of the European Parliament and of the Council41 , Directive 2010/35/EU of the European Parliament and of the Council42 , Directive 2013/29/EU of the European Parliament and of the Council43 , Directive 2013/53/EU of the European Parliament and of the Council44 , Directive 2014/28/EU of the European Parliament and of the Council45 , Directive 2014/29/EU of the European Parliament and of the Council46 , Directive 2014/30/EU of the European Parliament and of the Council47 , Directive 2014/31/EU of the European Parliament and of the Council48 , Directive 2014/32/EU of the European Parliament and of the Council49 , Directive 2014/33/EU of the European Parliament and of the Council50 , Directive 2014/34/EU of the European Parliament and of the Council51 , Directive 2014/35/EU of the European Parliament and of the Council52 , Directive 2014/68/EU of the European Parliament and of the Council53 , and Directive 2014/90/EU of the European Parliament and of the Council54 . _________________ 31 Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47, 18.2.2004, p. 1). 32 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 33 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). 34 Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46). 35 Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1). 36 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51). 37 Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99). 38 Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1). 39 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157, 9.6.2006, p. 24). 40 Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1). 41 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys ( OJ L 170, 30.6.2009, p. 1–37). 42 Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36 ( OJ L 165, 30.6.2010, p. 1–18). 43 Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (recast) (OJ L 178, 28.6.2013, p. 27). 44 Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90). 45 Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (recast) (OJ L 96, 29.3.2014, p. 1). 46 Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45). 47 Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) (OJ L 96, 29.3.2014, p. 79). 48 Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non- automatic weighing instruments (OJ L 96, 29.3.2014, p. 107). 49 Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast) (OJ L 96, 29.3.2014, p. 149). 50 Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251). 51 Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast) (OJ L 96, 29.3.2014, p. 309). 52 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357). 53 Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164). 54 Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).
Amendment 148 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Within the internal market, there is an increasing number of products in circulation which have begun to put constraints on public resources and limit the possibility of increasing public market surveillance on an adequate scale. This could be alleviated by complementary and innovative market-based solutions to provide for more effective market surveillance on a larger scale such as independent third party auditing of quality control systems and products.
Amendment 158 #
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Severe and recurrent breaches of compliance should be followed by adequate sanctions. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic operators from exploiting gaps in the enforcement system by relocating to Member States whose market surveillance authorities are not equipped to tackle unlawful practices. In particular, the powers should ensure that information and evidence can be exchanged between competent authorities so that enforcement can be undertaken equally in all Member States.
Amendment 159 #
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Severe and recurrent breaches of compliance should be followed by adequate sanctions. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic operators from exploiting gaps in the enforcement system by relocating to Member States whose market surveillance authorities are not equipped to tackle unlawful practices. In particular, the powers should ensure that information and evidence can be exchanged between competent authorities so that enforcement can be undertaken equally in all Member States.
Amendment 161 #
Proposal for a regulation
Article 20 – paragraph 4 a (new)
Article 20 – paragraph 4 a (new)
4 a. Market surveillance authorities shall take due account of the test, results, analysis and conclusions of the Union testing facilities to adopt appropriate market surveillance measures.
Amendment 164 #
Proposal for a regulation
Article 25 – paragraph 3
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-compliantillegal by market surveillance authorities in another Member State, unless economic operators can provide evidence to the contrary.
Amendment 165 #
Proposal for a regulation
Recital 27
Recital 27
(27) Market surveillance authorities act in the interest of economic operators, end- users, and of the general public, to ensure that public interests established by Union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement action, and that compliance with such legislation is ensured across the supply chain through appropriate controls. Consequently, market surveillance authorities should account to economic operators, end-users and the general public for the efficiency and effectiveness of the activities they perform. They should provide access to information concerning the organisation and performance of their activities, including controls, and regularly publish information on activities performed and the results of such activities. They should also, subject to certain conditions, be entitled to publish or to make available information about the compliance record of individual economic operators based on the outcome of market surveillance controls, particularly in the case of economic operators that have been found to have repeated breaches in compliance with Union harmonisation legislation.
Amendment 166 #
Proposal for a regulation
Recital 27
Recital 27
(27) Market surveillance authorities act in the interest of economic operators, end- users, and of the general public, to ensure that public interests established by Union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement action, and that compliance with such legislation is ensured across the supply chain through appropriate controls. Consequently, market surveillance authorities should account to economic operators, end-users and the general public for the efficiency and effectiveness of the activities they perform. They should provide access to information concerning the organisation and performance of their activities, including controls, and regularly publish information on activities performed and the results of such activities. They should also, subject to certain conditions, be entitled to publish or to make available information about the compliance record of individual economic operators based on the outcome of market surveillance controls, particularly in the case of economic operators that have been found to have repeated breaches in compliance with Union harmonisation legislation.
Amendment 167 #
Proposal for a regulation
Recital 38
Recital 38
(38) An effective way to ensure that unsafe or non-compliant products are not placed on the Union market would be to detect such products before they are released for free circulation. Customs authorities, as authorities in charge of the control on products entering the customs territory of the Union, enjoy a complete overview of trade flows across the external borders, and should therefore be required to carry out adequate controls on a risk assessment basis, to contribute to a safer market place, which ensures a high level of human health, consumer and environmental protection. A uniform enforcement of Union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of information between market surveillance and customs authorities. These authorities should receive well in advance from the market surveillance authorities all the necessary information concerning non- compliant products or information on economic operators where a higher risk of non- compliance has been identified. In turn, customs authorities should inform the market surveillance authorities in a timely manner of the release of products for free circulation, and the results of controls, where such information is relevant for the enforcement of Union harmonisation legislation on products. Furthermore, where the Commission becomes aware of a serious risk posed by an imported product, it should inform the Member States about those risks in order to ensure coordinated and more effective compliance and enforcement controls at the first points of entry to the Union.
Amendment 168 #
Proposal for a regulation
Recital 38
Recital 38
(38) An effective way to ensure that unsafe or non-compliant products are not placed on the Union market would be to detect such products before they are released for free circulation. Customs authorities, as authorities in charge of the control on products entering the customs territory of the Union, enjoy a complete overview of trade flows across the external borders, and should therefore be required to carry out adequate controls on a risk assessment basis, to contribute to a safer market place, which ensures a high level of human health, consumer and environmental protection. A uniform enforcement of Union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of information between market surveillance and customs authorities. These authorities should receive well in advance from the market surveillance authorities all the necessary information concerning non- compliant products or information on economic operators where a higher risk of non- compliance has been identified. In turn, customs authorities should inform the market surveillance authorities in a timely manner of the release of products for free circulation, and the results of controls, where such information is relevant for the enforcement of Union harmonisation legislation on products. Furthermore, where the Commission becomes aware of a serious risk posed by an imported product, it should inform the Member States about those risks in order to ensure coordinated and more effective compliance and enforcement controls at the first points of entry to the Union.
Amendment 169 #
Proposal for a regulation
Recital 39
Recital 39
(39) In order to support customs and market surveillance authorities in carrying out tasks related to controls on products entering the customs territory of the Union, a more favourable treatment should be granted for products declared for free circulation by an authorised economic operator, as defined in Article 38(2) of Regulation (EU) No 952/2013, pending the establishment of the procedure for the exchange of information on the status of the authorised economic operators and their record of compliance relawith the Union harmonisation law, related to including but not limited to product safety. Such an approach should allow a more targeted control, on a risk basis, of products released for free circulation.
Amendment 170 #
Proposal for a regulation
Recital 39
Recital 39
(39) In order to support customs and market surveillance authorities in carrying out tasks related to controls on products entering the customs territory of the Union, a more favourable treatment should be granted for products declared for free circulation by an authorised economic operator, as defined in Article 38(2) of Regulation (EU) No 952/2013, pending the establishment of the procedure for the exchange of information on the status of the authorised economic operators and their record of compliance relawith the Union harmonisation law, related to including but not limited to product safety. Such an approach should allow a more targeted control, on a risk basis, of products released for free circulation.
Amendment 282 #
Proposal for a regulation
Article 10 – paragraph 2 – point b a (new)
Article 10 – paragraph 2 – point b a (new)
(ba) procedures for monitoring any harm to the persons in general involved in the manufacturing of the product, health and safety conditions in the workplace, consumer protection, the environment and public security as well as other public interests, which are suspected of having been caused by such products;
Amendment 283 #
Proposal for a regulation
Article 10 – paragraph 2 – point b a (new)
Article 10 – paragraph 2 – point b a (new)
Amendment 306 #
Proposal for a regulation
Article 12 – paragraph 2 – point a – point i
Article 12 – paragraph 2 – point a – point i
(i) the product, such as the number of products on the market and any hazards associated with that product, which have the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security;
Amendment 307 #
Proposal for a regulation
Article 12 – paragraph 2 – point a – point i
Article 12 – paragraph 2 – point a – point i
(i) the product, such as the number of products on the market and any hazards associated with that product, which have the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security;
Amendment 316 #
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, including EU standards on labour laws and environmental protection.
Amendment 397 #
Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory controls on the basis of a representative sample. The market surveillance by authorities shall be combined with self-check systems by importer, verified by an independent third party auditor.
Amendment 417 #
Proposal for a regulation
Article 18 – title
Article 18 – title
18 Products presenting a serious risk or a breach of the Union harmonisation law
Amendment 418 #
Proposal for a regulation
Article 18 – title
Article 18 – title
Products presenting a serious risk or a breach of the Union harmonisation law
Amendment 419 #
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Market surveillance authorities shall take measures to recall or withdraw products which present a serious risk to consumers, environment or the persons involved in the manufacturing of the product, or to prohibit the making available of themsuch products on the market. They shall inform the Commission of such measures without delay, in accordance with Article 19.
Amendment 422 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The decision whether or not a product presents a serious riskbreach of the Union harmonisation law, including a serious risk to consumer, the environment, or the persons involved in the manufacturing of the product, shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk.
Amendment 423 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The decision whether or not a product presents a serious riskbreach of the Union harmonisation law, including a serious risk to consumer, the environment, or the persons involved in the manufacturing of the product, shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk.
Amendment 471 #
Proposal for a regulation
Article 26 – paragraph 2 a (new)
Article 26 – paragraph 2 a (new)
2a. An importer bears a responsibility for a self-monitoring the compliance of a product entering the Union market. Such compliance shall be subject to a mandatory independent third party audit. Liability for control check is held by the importer and the liability for verifying the control check is held by the independent third party auditor.
Amendment 498 #
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
A product released for free circulation in accordance with point (a) shall not be deemed to be in compliance with Union harmonisation legislation merely by reason of having been released for free circulation. The product released for free circulation needs to be compliant with general EU standards applicable to similar products produced within the EU Single Market, including but not limited to safety.
Amendment 499 #
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
A product released for free circulation in accordance with point (a) shall not be deemed to be in compliance with Union harmonisation legislation merely by reason of having been released for free circulation. The product released for free circulation needs to be compliant with general EU standards applicable to similar products produced within the EU Single Market, including but not limited to safety.
Amendment 501 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. Market surveillance authorities and the customs authorities shall exchange information on the status of the authorised economic operators and their record of compliance related to product safetywith the Union harmonisation legislation, related to but not limited to product safety, including with general EUs standards such as the environment and labour laws.
Amendment 503 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. Market surveillance authorities and the customs authorities shall exchange information on the status of the authorised economic operators and their record of compliance related to product safetywith the Union harmonisation legislation, related to but not limited to product safety, including with general EU standards such as the environment and labour laws.
Amendment 550 #
Proposal for a regulation
Article 61 – paragraph 2 – point b
Article 61 – paragraph 2 – point b
(b) the nature, gravity and duration of the non-compliance taking into account the harm caused to end-users as well as the environment, labour force involved in the manufacturing and animals where relevant;
Amendment 555 #
Proposal for a regulation
Article 61 – paragraph 3
Article 61 – paragraph 3
3. The penalties may be increased where the economic operator has previously committed a similar infringement and may include criminal penalties for serious infringements of Union harmonisation legislation. A penalty of 5 % of the turnover of an entity should be considered in such cases.
Amendment 562 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
The report shall assess whether this Regulation achieved its objectives, in particular with regard to reducing the number of non-compliant products on the Union market, ensuring effective and efficient enforcement of Union harmonisation legislation within the Union, improving cooperation between competent authorities and strengthening the controls on products entering the Union market, whilst taking into account the impact on business and in particular on small and medium-sized enterprises. In addition, the evaluation should also assess the effectiveness of the market surveillance activities that receive Union financing in the light of the requirements of Union policies and legislation, as well as explore and propose new market-based solutions that could effectively complement the market surveillance actions that are currently being carried out, and shall include, but not be limited to, exploring the potential of compulsory independent third party auditing schemes.