41 Amendments of Christel SCHALDEMOSE related to 2017/0353(COD)
Amendment 44 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7 a) Special attention should be given to Internet of Things (IoT) and the increasing number of Artificial Intelligence (AI) enabled devices, taking into account that consumers are increasingly using connected devices in their daily lives without knowing the security threats these devices can represent and the remote risks that exist. The Union regulatory framework should therefore address these issues to ensure a better protection of consumers.
Amendment 56 #
Proposal for a regulation
Recital 36 a (new)
Recital 36 a (new)
(36 a) The level of penalties applicable to infringements of the provisions of this Regulation that impose obligations on economic operators and to infringements of provisions of any Union and Member States’ legislation on products that impose obligations on economic operators should be stepped up in order to efficiently deter the placement of non-compliant products on the market.
Amendment 74 #
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 risk where the effects are not immediate, requiring rapid intervention by the market surveillance authorities, in accordance with the precautionary principle;
Amendment 100 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, manufacturers including those from third countries, or importers, shall make the declaration publicly available on their website or, in the absence of a website, by any other means that allows the declaration to be readily accessed by the general public in the Union free of charge.
Amendment 107 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. A market surveillance authority may use any information resulting from activities carried out or financed by other parties to a memorandum of understanding entered into by it under paragraph 1 as part of any investigation undertaken by it into non-compliance, but only if the activity in question was carried out independently, impartially and without bias. Information on how products have been tested and the results of such tests shall be made publicly available.
Amendment 114 #
Proposal for a regulation
Article 10 – paragraph 2 – point d a (new)
Article 10 – paragraph 2 – point d a (new)
(d a) procedures for collecting and exploring scientific and technical knowledge concerning safety issues, impacting in particular health and environmental protection.
Amendment 122 #
Proposal for a regulation
Article 12 – paragraph 2 – introductory part
Article 12 – paragraph 2 – introductory part
2. Market surveillance authorities shall perform controls as part of their activities set out in paragraph 1, on a risk- based approach, taking into account the precautionary principle and, as a minimum, the following factors:
Amendment 127 #
Proposal for a regulation
Article 12 – paragraph 3 – subparagraph 1 – point a a (new)
Article 12 – paragraph 3 – subparagraph 1 – point a a (new)
(a a) the product is liable to pollute or endanger the environment;
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 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 137 #
Proposal for a regulation
Article 13 – paragraph 2 – point f a (new)
Article 13 – paragraph 2 – point f a (new)
(f a) an assessment of new risks for consumers related to products which can connect to the internet and endanger consumers security;
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 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 150 #
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
5. Market surveillance authorities shall exercise their powers in accordance with the precautionary principle and the principle of proportionality.
Amendment 153 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The decision whether or not a product presents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and, the likelihood of its occurrence and the precautionary principle. 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 156 #
Proposal for a regulation
Article 20 – paragraph 4 – point e a (new)
Article 20 – paragraph 4 – point e a (new)
(e a) act as a knowledge hub on risks and emerging risks for consumers and the environment stemming from harmful chemicals;
Amendment 157 #
Proposal for a regulation
Article 20 – paragraph 4 – point e b (new)
Article 20 – paragraph 4 – point e b (new)
(e b) act as a knowledge hub on new risks for consumers related to products which can connect to the internet;
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 162 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. Market surveillance authorities mayshall charge economic operators administrative fees in relation to instances of non- compliance by that economic operator in order to enable the authorities to recover the costs of their activities with respect to these instances of non- compliance. Those costs may include the costs of carrying out testing for the purposes of a risk assessment, the costs of taking measures in accordance with Article 30(1) and (2) and the costs of their activities relating to products that are found to be non- compliant and subject to corrective action prior to their release for free circulation.
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 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
Article 33 – paragraph 1 – point a b (new)
Article 33 – paragraph 1 – point a b (new)
(a b) to define a common testing methodology in order to ensure there is uniformity in the controls carried out by Member States;
Amendment 169 #
Proposal for a regulation
Article 33 – paragraph 1 – point f
Article 33 – paragraph 1 – point f
(f) to organise cooperation and facilitate the effective and regular exchange of information and best practices between market surveillance authoritieMember States as well as between market surveillance authorities, and between Member States and relevant stakeholders;
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
Article 33 – paragraph 1 – point m a (new)
Article 33 – paragraph 1 – point m a (new)
(m a) to set up procedures for the provision of a pan-European database for the collection of data regarding accidents, harm or damages caused to the health, safety and/or security of end-users or to the environment, and to make the information provided in that database readily accessible to all relevant stakeholders;
Amendment 175 #
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, to the environment, to social and economic interests;
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 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 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 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 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 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.