Consumer Product Safety and Market Surveillance package

Transcription

1 Consumer Product Safety and Market Surveillance package POSITION PAPER Date: 21 June 2013 Ilya Bruggeman Adviser on Internal Market and Consumer Affairs T: bruggeman@eurocommerce.be Julien Bouyeron Project assistant on Internal Market and Consumer Affairs T : bouyeron@eurocommerce.be Emilie Prouzet Director for European Affairs, FCD EuroCommerce issue leader for the Product Safety and Market Surveillance package T : prouzet@fecd.eu TABLE OF CONTENTS

2 INTRODUCTION... 3 CONSUMER PRODUCT SAFETY REGULATION Distributors Authorised representatives Isolated cases Risk assessment Mandatory origin labelling Technical Documentation Traceability and delegated acts Confidentiality importers... 7 MARKET SURVEILLANCE OF PRODUCTS REGULATION Better application of the principle of mutual recognition Risk and serious risk Serious risk and operators actions Non-compliance Release of product blocked at customs Fees Consumer complaint information Entry into force Standards Rapex and update ANNEX I: Amendments for CPSR ANNEX II: Amendments for MSPR of 23

3 INTRODUCTION Consumer confidence is a key priority for retailers and wholesalers. To secure this confidence, consumer product safety is paramount. EuroCommerce is supportive of the Commission s goals to ensure a high level of product safety for consumers throughout Europe and to achieve the smooth functioning of the single market for goods. Any legislation on product safety and market surveillance should fulfill the following three missions: 1. define the role of each operator in a clear and proportionate manner; 2. streamline the system for more efficiency; 3. reinforce cooperation between actors. In this respect, EuroCommerce welcomes the proposed Consumer Product Safety Regulation (CPSR) and the Market Surveillance of Product Regulation (MSPR) and supports its aim to streamline EU legislation for product safety. By providing a common framework for all nonfood products and clear responsibilities for every private and public operator, the Commission will increase legal certainty. We, as economic operators, welcome this: it will enable us to further strengthen safety mechanisms. Combined with consistent, fair and effective enforcement, this will help achieve the goal of placing only safe products on the market. It is crucial that the revised Blue Guide on the implementation of EU product rules foreseen at the end of 2013 as well as the GPSD Guidelines and the Rapex Guidelines are consistent with the Product Safety package. EuroCommerce supports the Commission s intention to distribute clear and proportionate obligations to economic operators in relation to their respective role in the supply chain (e.g. recitals 15 & 16, CPSR). Clarifying the responsibility in accordance with their sphere of influence on the one hand and strengthening their cooperation on the other will improve product safety and consumer protection. EuroCommerce supports the inclusion of a pan-european accident and injury database 1. EuroCommerce does not think it is necessary to include the precautionary principle in the market surveillance regulation. It is already implicitly covered by measures such as emerging risks. In article 114 (3) of the Treaty on the Functioning of the European Union, the precautionary principle is for use by the legislator only in the face of scientific uncertainty. This interpretation has been explicitly confirmed by the EC Communication on the precautionary principle 2. We kindly ask you to take the following comments into account when drafting your report on this important consumer safety and internal market dossier COM/2000/0001final: =en 3 of 23

4 CONSUMER PRODUCT SAFETY REGULATION 1. Distributors To evaluate a risky product and to know where it has been marketed, you need to be able to identify the responsible person of this product and to obtain the technical documentation. Retailers may assume different responsibilities (manufacturer, importer and distributor) because of the wide range of different products in store. In our distributor role, one of our main responsibilities is to ensure that elements enabling the identification of the responsible person is affixed on the product/packaging. Clearly identifying the elements to be checked by distributors before they made available a product on the market will help us to streamline our product control for more efficiency. Next to that, it should be clarified that distributor cannot verify the veracity of these elements but only the presence 3. Otherwise, distributors will need to have access to the technical documentation of the product to check the conformity of these elements with the results of the test reports or other confidential information which could lead to many problems with suppliers 4. Annex I: proposal for an amendment 1 2. Authorised representatives EuroCommerce backs the Commission s decision to introduce an obligation for all operators to exchange information about their monitoring of risky products. This obligation should also apply to the authorised representative to guarantee consistency of obligations amongst economic operators. As they have to act on behalf of the manufacturer it is also important that the authorised representative can draw up technical documentation. This will make it easier for MSAs to have quick access to the necessary information. Annex I: proposal for an amendment 2 3. Isolated cases The guidelines accompanying the General Product Safety Directive (GPSD) states that situations exist which, while safety issues may arise in relation to a product, do not require any verification, monitoring or action by the authorities and do not provide information useful for risk assessment or consumer protection 5. This situation may arise when there is solid evidence that only a small number of products that are deemed risky have been managed, the so-called isolated cases. 3 These purpose has been confirmed by the Commission in its guidelines in the Toy safety Directive which was the first directive aligned with the NLF: distributors only have to verify that the address is present Page Within the safety package and in line with the NLF, only the person who places a product on the market (manufacturer and importer) has to keep the technical documentation. 5 Guidelines for the Notification of Dangerous Products to the Competent Authorities of the Member States by producers and distributors in accordance with Article 5(3) of Directive 2001/95/EC, Chapter of 23

5 Nonetheless, the CPSR provides that distributors do not have to notify if the manufacturer, importer or distributor can demonstrate that the risk has been fully controlled and cannot any more endanger the health and safety of persons. (Art.13.1(b)). This wording provides for total control of risk which is impossible to achieve as it is acknowledged by the Commission itself 6. Due to its relevance as a general principle of the product safety regime, the provision on isolated cases should be generally applicable (i.e. applicable for all products, harmonised and non-harmonised). This can be achieved by moving the provision to chapter 1 of the CPSR. Annex I: proposal for an amendment 3 4. Risk assessment Distinction between CPSR and MSPR It should be noted first that the subject matters set out in the CPSR, i.e. safety (Art.1) and the MSPR, i.e. to safeguard at a high level, the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security and other public interests (Art.1) are very different. It means that the assessment required from economic operators under the CPSR will not cover the same risks as the MSAs risk assessment under the MSPR. EuroCommerce calls for clarification how these provisions will be enforced. Methodology needs to be determined Regarding the risk assessment for non-harmonised product, EuroCommerce believes that the methodology (e.g. how many products in one sample?) and format (how detailed should the sample testing be?) lack certainty. With the help of business representatives, the Commission needs to come up with clear guidelines to define what a risk assessment and in particular a sample testing exactly to prevent legal uncertainty and distortion of competition. This calls for clarification from the Commission in both the Blue Guide 7 that is being revised and the Action 5 of the Multiannual Action Plan 8 on a EU general risk assessment methodology for products. 5. Mandatory origin labelling EuroCommerce strongly rejects the inclusion of mandatory origin labelling in article 7 9 and ask for deletion of it. Mandatory origin labelling as proposed in article 7 will not enhance the traceability of products and therefore does not contribute towards reaching the goal of this package, i.e. consumer product safety (recital 21). Instead, the traceability of products is guaranteed by articles 14 ( Identification of economic operators ) and article 8.6 and 8.7 ( Obligations of manufacturers ). Furthermore, the introduction of a mandatory origin labelling based on non-preferential rules of origin has the potential to mislead both consumers and Market Surveillance Authorities, as in many cases it does not refer to the place where a given product was manufactured. 6 The table 4 of the Commission Decision of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System on the risk level from the combination of the severity of injury and probability lists the different degrees of risks: serious risk, high risk, medium risk and low risk but does not mention no risk. (p.64) The Commission Communication on 20 actions for safer and compliant products for Europe: a multiannual action plan for the surveillance of products in the EU makes part of the Product Safety package. 9 This position does not reflect the opinion of the EuroCommerce member Confcommercio-Imprese per l Italia (The Italian Confederation of Entreprises, Professional Occupation and Self-Employment). 5 of 23

6 For the good understanding of the traceability obligations it should be clarified that the common basis for all products placed/made available on the market, the following obligations apply: the obligation to indicate the name and address at which the manufacturer and/or importer can be contacted on the product; the obligation to indicate an element allowing the identification of the product (type, batch or serial number, ); the obligation to identify the operator who has supplied and to whom it has supplied combined with the obligation to keep this information for 10 years (Art.14). Annex I: proposal amendment 4 For further information, please consult EuroCommerce s position paper on Origin Labelling on 6. Technical Documentation Making available the Technical Documentation As MSAs must identify a risk on the product before sending any request to the concerned economic operator, they should link this request to the risk and therefore ask for the specific information related to this risk. Besides, this would enhance consistency with the NLF 10 and the Directives that have been aligned with it such as the Toy Safety Directive 11. Annex I: proposal for amendment 5 Keeping the Technical documentation With regards to the amount of time manufacturers and importers should keep this technical information, EuroCommerce is concerned that the 10 year-period does not reflect the business realities without contributing whatsoever to traceability. Indeed, an important number of consumer products have a life cycle shorter than 10 years (e.g. socks). Economic operators should not be obliged to keep technical information of a product whose life cycle is already over. Annex I: proposal for amendment 6 Translating the technical documentation Concerning translation of technical documentation, it is important to stress that today when operators are required to make available to MSAs any documentation, they send its English version to the authorities which is common practice. This situation is working very well and it must remain so. Indeed, giving the MSAs the power to demand from economic operators that this documentation is sent to them in any other language than English will simply result in more red tape and costs whereas the daily practice is efficient. Plus, only the manufacturer could be liable for the translation of the technical documentation of their own product. Annex I: proposal for amendment 7 10 Articles R4.9 and R2.9 of Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC 11 Articles 5.3 and 4.9 of Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys 6 of 23

7 Sending the Technical Documentation in electronic form When a number of MSAs are asking for technical documentation at the same time, operators find themselves in a difficult position as they have only one copy of it. Therefore, to facilitate communication between the operators and the MSAs, the possibility for each economic operator in possession of the technical documentation (manufacturer, importer and authorised representative) to send it in electronic form should be introduced in the CPSR 12. Annex I: proposal for amendment 8 7. Traceability and delegated acts With regards to the power of the Commission to establish traceability systems for specific product or categories of products, it should be noted that first the Commission is already working on traceability through the Working Group on Traceability in order to determine the key elements of such a system. Before engaging in new actions, EuroCommerce would like to evaluate the working group s results. Second, EuroCommerce questions the efficiency of having numerous traceability systems with diverging rules as this will undermine operators capacity to trace products. For this reason, before requiring the economic operator to establish or adhere any system of traceability, the Commission should at least consult the business representatives as they are the ones who have expertise and are aware of trends of innovation. Annex I: proposal for amendment 9 8. Confidentiality importers The obligation for non-eu manufacturers to mark the products with their name and address of contact raises confidentiality issues for importers. If non-eu-manufacturers are required to put their name and address on the product, this name and address would be known to the importer s competitors and business customers with the consequence that they could bypass this particular importer in the future and source directly from the non-eu-manufacturer. This requirement will not hinder safety mechanisms as the only operator who gathers all the necessary documentation to take corrective action in case of risky product is the one who places the product on the market, i.e. in that case the importer. Annex I: proposal for an amendment This is all the more relevant as the European Parliament and the Council recently reached a deal on the EU customs code that is currently being revised to keep pace with IT developments. This text states that all EU customs transaction information exchanged by the authorities and economic operators should be electronic by 2020 at the latest, save in exceptional cases. Aligning communication procedures provided in different EU pieces of legislation appears even more necessary against this background. 7 of 23

8 MARKET SURVEILLANCE OF PRODUCTS REGULATION 9. Better application of the principle of mutual recognition The Commission s decision to set up a European Market Surveillance Forum (EMSF) and to better take into account the reports by operators and MSAs is a step in the right direction. This will strengthen their quality and help establish trust between them as well as to guarantee better application of the principle of mutual recognition. Next to that, a conformity assessment body within the meaning of Regulation 765/2008 is an organization, a laboratory that benefits from the accreditation issued by a European national accreditation body. A number of laboratories located on the site of production have received this accreditation. It should so be possible to present their report and to ensure they are considered by the authorities. Annex II: proposal for amendment 11 Annex II: proposal for amendment 12 Annex II: proposal for amendment 13 Annex II: proposal for amendment Risk and serious risk Only products presenting a serious risk should be notified to the Commission through RAPEX, as stipulated in Article 22.2 of the current EU Regulation 765/2008 on the market surveillance of products. It is important to distinguish the various levels of risks and to process them more adequately. Rapex should continue to be reserved for cases involving a serious risk, requiring immediate action. All other cases should be dealt with through Information Communication System for Market Surveillance (ICSMS). Annex II: proposal for amendment Serious risk and operators actions It is especially important to react quickly in cases where a product presents a serious risk. In this situation, the cooperation with economic operators is more than ever necessary to restrict the risk and identify all the products placed/made available on the market in order to take the appropriate corrective action. That is why we hold on to the current system set up by the Rapex Guideline 13 which allows the operator to react before the MSAs takes action. In case of serious risk, the economic operator should be able to take corrective action such as the ones specifically mentioned in Article 9.4(c) and (d) within a short period of time. Therefore, MSAs must have the capacity to take the necessary measures where an operator cannot be identified or is unwilling to do so e.g. a rogue trader or one that decides to let the authorities act rather than act himself. 13 When there is a serious risk companies are required to inform the authority(ies) immediately and in no case later than three days after they have obtained notifiable information. Guidelines for the notification of dangerous consumer products to the competent authorities of the member states by producers and distributors in accordance with article 5(3) of directive 2001/95/EC, p.18 8 of 23

9 Annex II: proposal for amendment Non-compliance Cases of formal non-compliance (such as the wrong size of the CE marking) should not, as such, give sufficient reason to believe that the product may present a risk. Such an approach is not only disproportionate but, more importantly, dilutes the concept of risk. It also sends the wrong signal to MSAs who might concentrate their efforts on detecting formal non-compliance/issues rather than focus on material safety/non-compliance problems. Therefore, we strongly urge the Commission to take over the concept of the NLF (Article R34 of Decision 768/2008), to treat the case of formal non-conformities separately, and to delete any reference to risk. Annex II: proposal for amendment 17 Annex II: proposal for amendment Release of product blocked at customs The MSPR provides that in the event of a suspension of release of a product by customs authorities, MSAs have the possibility to request them to continue this suspension for an indefinite duration without justification (Art.15.1). This provision might lead to unjustified and very costly consequences for businesses which can have their compliant products blocked at customs for months, even years with the risk that these products suffer significant damage. Secondly, EuroCommerce proposes to the time of suspension must be reasonable as explained in the Blue Guide on Product Rules. Annex II: proposal for amendment 19 Annex II: proposal for amendment Fees EuroCommerce considers safety a very important public good and this key responsibility of the competent authorities should be financed by public means and not by the private sector. This will guarantee the independence of the official controls and will create an incentive for the competent authorities to further enhance the effectiveness and efficiency of their control system. In the case that fees are possible they should only be imposed on non-compliant operators, they should be proportionate in relation to the traders size and they should not exceed the actual costs being made by the MSA. It is important that actions delivered by MSAs are accurate, of high quality and are performed in an efficient manner. Annex II: proposal for amendment Consumer complaint information The MSPR provides consumers with the possibility to submit complaints relating to product safety (Art.6.5(a)) to the Market Surveillance Authorities. While EuroCommerce does not oppose this, it should be made clear that: this information will not be made public; each complaint it contains is carefully verified in order to avoid exaggerated claims; the database is updated on a regular basis to withdraw complaints about products which no longer present a risk following the manufacturer s intervention; when relevant, MSA should consult the economic operator concerned before any corrective action is taken by them in order to provide them with background information that could help them take the right decision. 9 of 23

10 EuroCommerce is also concerned about the way MSA will use this information. More clarity is needed here. Annex II: proposal for amendment Entry into force The MSPR states that the Regulation shall apply from 1 January 2015 (Art.36). This will leave too little time for economic operators to adjust to the new requirements laid out in the Regulation. Economic operator will have to carry out a risk analysis of each product, affix information on it, draw technical documentation, etc. The transitional period has to be sufficient for economic operators to adapt to the changes (Recital 31, CPSR). Therefore, it has to begin once this methodology has been adopted. Annex II: proposal for amendment Standards EuroCommerce questions the effective implementation of standards for products. Indeed, operators are often faced with many grey areas for products. Standards may be outdated and their strict application by accredited laboratories may restrict innovation. Besides, their acquisition is very expensive and if there is more than one language on the same product, it is necessary to acquire the norms in all languages available in order to guarantee their conformity. In cases where norms are not translated into the language of the country where the product is marketed, it is necessary to contact a translation agency. As economic operators do not resort to the same translation agency, different information can appear on the product. If standards have to take an important role, the Commission or the standardisation organisations should make available translation of markings and warnings in all EU languages to operators and Member States for free. Finally, business operators face many difficulties with contradictory test reports on the same batch number. This could apply for example during official controls (counter-expertise). Eurocommerce would like to draw the Parliament s attention to the expertise of laboratories/bodies in non-eu Member States but as well in Europe as they are far from the production area. 18. Rapex and update It happens that information (batch number, distributor or Member State concerned, ) in Rapex is obsolete. Rather than submitting a business application on the product that has been already notified, it could be more efficient and less burdensome to simply update it. For these reasons, the Commission should introduce the possibility to update information listed in Rapex. Annex II: proposal for amendment of 23

11 ANNEX I: Amendments for CPSR Proposal for Amendment 1 Article 11.2 (CPSR) Obligations of distributors Article 11.2 (CPSR) Obligations of distributors 2. 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 Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable. 2. Before making a product available on the market, distributors shall verify that the product bears the markings set out in Articles 8(6), (7) and 10(3) and is accompanied with the elements set out in Articles 8(8) and 10 (4). Proposal for Amendment 2 Article 9.1 (CPSR) Authorised representatives Article 9.1 (CPSR) Authorised representatives 1. A manufacturer may, by a written mandate, appoint an authorised representative. 1. A manufacturer may, by a written mandate, appoint an authorised representative. The obligations laid down in Article 8(1) and (4) shall not form part of the authorised representative's mandate. The obligations laid down in Article 8(1) shall not form part of the authorised representative's mandate. Article 9.3 (new) 3. Depending on their mandate and proportionate to the possible risks of a product, authorised representatives shall, to protect the health and safety of consumers, carry out sample testing of products made available on the market, investigate complaints and keep a register of complaints, nonconforming products and product recalls, and shall keep distributors informed of any such monitoring. Proposal for Amendment 3 CHAPTER III Control of products within the Union Article 13 (CPSR) CHAPTER I General Provision (new) Article 8 (CPSR) 11 of 23

12 Article 13 Exemption from certain obligations of manufacturers, importers and distributors 1. Obligation to inform the market surveillance authorities in accordance with Article 8(9), Article 10(2) and (7) and Article 11(3) and (5) shall not apply where the following conditions are fulfilled: Article 13 Exemption from certain obligations of manufacturers, importers and distributors 1. Obligation to inform the market surveillance authorities in accordance with Article 8(9), Article 10(2) and (7) and Article 11(3) and (5) shall not apply where the following conditions are fulfilled: (a) only a limited number of well-identified products are not safe; (a) only a limited number of wellidentified products are not safe; (b) (c) the manufacturer, importer or distributor can demonstrate that the risk has been fully controlled and cannot any more endanger the health and safety of persons;; the cause of the risk of the product is such that knowledge of it does not represent useful information for the authorities or the public. 2. The Commission may by means of implementing acts determine the situations which meet the conditions of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19(3). 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 determining the products, categories or groups of products for which, due to their low level of risk, the information referred to in Article 8(7) and Article 10(3) does not need to be indicated on the product itself. (b) (c) the manufacturer, importer or distributor can demonstrate that the risk has been effectively; the cause of the risk of the product is such that knowledge of it does not represent useful information for the authorities or the public. 2. The Commission may by means of implementing acts determine the situations which meet the conditions of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19(3). 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 determining the products, categories or groups of products for which, due to their low level of risk, the information referred to in Article 8(7) and Article 10(3) does not need to be indicated on the product itself. Proposal for Amendment 4 Article 7 (CPSR) Indication of the origin 1. Manufacturers and importers shall 12 of 23

13 ensure that products bear an indication of the country of origin of the product or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product. deleted 2. For the purpose of determination of the country of origin within the meaning of paragraph 1, non-preferential origin rules set out in Articles 23 to 25 of Council Regulation (EEC) No 2913/92 establishing a Community Customs Code shall apply. 3. Where the country of origin determined in accordance with paragraph 2 is a Member State of the Union, manufacturers and importers may refer to the Union or to a particular Member State. Proposal for Amendment 5 Article 8.5 (CPSR) Obligations of manufacturers Article 8.5 (CPSR) Obligations of manufacturers 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request. 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it or part of it available to the market surveillance authorities, upon reasoned request. Article 10.8 (CPSR) Obligations of importers Article 10.8 (CPSR) Obligations of importers 8. Importers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request. Article 8.1 (MSPR) General obligations of economic operators 8. Importers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it or part of it available to the market surveillance authorities, upon reasoned request. Article 8.1 (MSPR) General obligations of economic operators 1. On request, economic operators and, where applicable, conformity assessment 1. On reasoned request, economic operators and, where applicable, conformity 13 of 23

14 bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them. assessment bodies, shall make available to market surveillance authorities only the necessary documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them. Proposal for Amendment 6 Article 8.5 (CPSR) Obligations of manufacturers Article 8.5 (CPSR) Obligations of manufacturers 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request. 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market or for the whole life cycle of the product when shorter than 10 years, the technical documentation and make it available to the market surveillance authorities, upon request. Article 10.8 (CPSR) Obligations of importers Article 10.8 (CPSR) Obligations of importers 8. Importers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request. 8. Importers shall keep, for a period of ten years after the product has been placed on the market or for the whole life cycle of the product when shorter than 10 years, the technical documentation and make it available to the market surveillance authorities, upon request. Proposal for Amendment 7 Article 8.1 (CPSR) General obligations of economic operators Article 8.1 (CPSR) General obligations of economic operators 1. On request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them. 1. On request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood. Proposal for Amendment 8 14 of 23

15 Article 8.5 (CPSR) Manufacturers Article 8.5 (CPSR) Manufacturers 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request. 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities whether in electronic form or not, upon request. Article 10.8 (CPSR) Obligations of importers Article 10.8 (CPSR) Obligations of importers 8. Importers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request. Article 8.1 (MSPR) General obligations of economic operators 8. Importers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities whether in electronic form or not, upon request. Article 8.1 (MSPR) General obligations of economic operators 1. On request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them. 1. On request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, whether in electronic form or not, in a language which can be easily understood by them. Article 15.1 (CPSR) Traceability of products Proposal for Amendment 9 Article 15.1 (CPSR) Traceability of products 1. For certain products, categories or groups of products which, due to their specific characteristics or specific conditions of distribution or usage, susceptible to bear a serious risk to health and safety of persons, the Commission may require economic operators who place and make available those products on the market to establish or adhere to a system of traceability. 1. For certain products, categories or groups of products which, due to their specific characteristics or specific conditions of distribution or usage, susceptible to bear a serious risk to health and safety of persons, the Commission may require economic operators who place and make available those products on the market, after consulting all affected business representatives, to establish or adhere to a system of traceability. 15 of 23

16 Article 8.7 (CPSR) Obligations of manufacturers Proposal for amendment 10 Article 8.7 (CPSR) Obligations of manufacturers 7. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. 7. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. For a product from a third country that is placed on the Union market, instead of the obligation set out in Article 8 (7) sentence 1 and sentence 2, the obligation of the importer set out in Article 10 (3) sentence 1 applies. 16 of 23

17 ANNEX II: Amendments for MSPR Proposal for amendment 11 Article 13 (MSPR) Risk Assessment Article 13 (MSPR) Risk Assessment 1. In the context of the risk assessment, market surveillance authorities shall take into account the extent to which the product complies with the following: 2. In the context of the risk assessment, market surveillance authorities shall take into account the extent to which the product complies with the following: (a) any requirements laid down in or pursuant to Union harmonisation legislation that apply to the product and relate to the potential risk under consideration, taking full account of test reports or certificates attesting conformity and issued by a conformity assessment body; (a) any requirements laid down in or pursuant to Union harmonisation legislation that apply to the product and relate to the potential risk under consideration, taking full account of test reports or certificates attesting conformity and issued by a conformity assessment body including non EU conformity assessment bodies. Proposal for amendment 12 Article 21 (MSPR) Information and communication system for market surveillance Article 21 (MSPR) Information and communication system for market surveillance [ ] [ ] 3. Market surveillance authorities shall recognise the validity and make use of test reports prepared by or for their counterparts in other Member States and entered into ICSMS. 3. Market surveillance authorities shall recognise the validity and make use of test reports prepared by or for their counterparts in other Member States and entered into ICSMS. 4. Market surveillance authorities shall take into considerations any test reports or risk assessment prepared by an EU or NON EU accredited laboratories. Proposal for amendment of 23

18 Article 27 (MSPR) Tasks of the EMSF Article 27 (MSPR) Tasks of the EMSF The EMSF shall have the following tasks: The EMSF shall have the following tasks: [ ] [ ] (i) to ensure the easy access, retrieval and sharing of product safety information collected by market surveillance authorities, including information on complaints, accidents, injury reports and investigation and test results; (i) to ensure the easy access, retrieval and sharing of product safety information collected by market surveillance authorities, including information on complaints, accidents, injury reports and investigation and test results issued by an economic operator or EU and non EU accredited laboratories or authorities including the authorities of other Member States; Proposal for amendment 14 Article 28 (MSPR) European Union reference laboratories Article 28 (MSPR) European Union reference laboratories 1. Within the area of their designation, Union reference laboratories shall where appropriate have the following tasks: 3. Within the area of their designation, Union reference laboratories shall where appropriate have the following tasks: (a) carrying out product testing in relation to market surveillance activities and investigations; (a) carrying out product testing in relation to market surveillance activities and investigations; (b) contributing to the resolution of disputes between the authorities of Member States, economic operators and conformity assessment bodies; (b) contributing to the resolution of disputes between the authorities of Member States, economic operators and conformity assessment bodies; (c) providing independent technical or scientific advice to the Commission and the Member States; (c) providing independent technical or scientific advice to the Commission and the Member States; (d) developing new techniques and methods of analysis; (d) developing new techniques and methods of analysis; (e) disseminating information and providing training. (e) disseminating information and providing training. (f) ensure a better coordination between accredited laboratories including the accredited laboratories of non EU Member 18 of 23

19 State. Proposal for amendment 15 Article 19 (MSPR) Union Rapid Information Exchange System RAPEX Article 19 (MSPR) Union Rapid Information Exchange System RAPEX 1. The Commission shall maintain the system for rapid exchange of information (RAPEX). Member States shall use RAPEX for exchanging information about products presenting a risk in accordance with this Regulation. 1. The Commission shall maintain the system for rapid exchange of information (RAPEX). Member States shall use RAPEX for exchanging information about products presenting a serious risk in accordance with this Regulation. Proposal for amendment 16 Article 10.4 (MSPR) Measures taken by Market Surveillance Authorities Article 10.4 (MSPR) Measures taken by Market Surveillance Authorities 4. Where market surveillance authorities consider that a product presents a serious risk, they shall take all necessary measures and may do so without first requiring the economic operator to take corrective action pursuant to Article 9(3) and without giving the operator the opportunity to be heard beforehand. In such cases the economic operator shall be heard as soon as practicable. 4. Where market surveillance authorities consider that a product presents a serious risk and the economic operator cannot be identified or is unwilling to take the necessary measures, they shall take all necessary measures and may do so without first requiring the economic operator to take corrective action pursuant to Article 9(3) and without giving the operator the opportunity to be heard beforehand. In such cases the economic operator shall be heard as soon as practicable. Proposal for amendment 17 Article 9.2 (MSPR) Products presenting a risk Article 9.2 (MSPR) Formal non-compliance 2. In relation to a product that is subject to Union harmonisation legislation, formal non-compliance with that legislation shall give market surveillance authorities sufficient reason to believe that the product may present a risk in any of the following cases: 2 Without prejudice to Article 9 (1), where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the conformity marking has been affixed in violation of Article 30 of 19 of 23

20 (a) the CE marking or other markings required by Union harmonisation legislation have not been affixed or have been affixed incorrectly; regulation 765/2008 related to the CE-marking; (b) the conformity marking has not been affixed; (b) the EU declaration of conformity, where required, has not been drawn up or has been drawn up incorrectly; (c) the EC declaration of conformity has not been drawn up; (d) the EC declaration of conformity has not been drawn up correctly; (c) the technical documentation is incomplete or unavailable; (d) the required labelling or instructions for use are incomplete or missing. Regardless whether the risk assessment shows that the product in fact presents a risk, market surveillance authorities shall require the economic operator to rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities shall ensure that the product is withdrawn or recalled. (e) technical documentation is either not available or not complete. (new) 3. Where the non-compliance referred to in paragraph 2 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market. 4. Without prejudice [ ] Proposal for amendment 18 Article 14 (3) checks and suspension of release Article 14 (3) checks and suspension of release Subject to Article 17, the authorities in charge of external border controls shall suspend release of a product for free circulation on the Union market when, in the course of the checks referred to in paragraph 1, they have reason to believe that the product may present a risk. Subject to Article 17, the authorities in charge of external border controls shall suspend release of a product for free circulation on the Union market when, in the course of the checks referred to in paragraph 1, they have reason to believe that the product may present a risk. In relation to a product which must comply with Union harmonisation legislation when it is released for free circulation, formal noncompliance with that legislation shall give the authorities of Member States sufficient reason to believe that the product may present a risk in any of the following cases: (a) is not accompanied by the Where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the conformity marking has been affixed in violation of Article 30 of regulation 765/2008 related to the 20 of 23

21 documentation required by the legislation; (b) is not marked or labelled in accordance with that legislation; (c) bears a CE marking or other marking required by Union harmonisation legislation which has been affixed in a false or misleading manner. CE-marking; (b) the conformity marking has not been affixed; (c) the EC declaration of conformity has not been drawn up; (d) the EC declaration of conformity has not been drawn up correctly; (e) technical documentation is either not available or not complete Proposal for amendment 19 Article 15.1 Release 1. A product the release of which has been suspended by the authorities in charge of external border controls pursuant to Article 14 shall be released if, within three working days of the suspension of release, those authorities have not been requested by the market surveillance authorities to continue the suspension or they have been informed by the market surveillance authorities that the product does not present a risk, and provided that all the other requirements and formalities pertaining to such release have been fulfilled. EuroCommerce amendment Article 15.1 Release 1. A product the release of which has been suspended by the authorities in charge of external border controls pursuant to Article 14 shall be released if, within three working days of the suspension of release, those authorities have not been requested by the market surveillance authorities to continue the suspension for a reasonable time or they have been informed by the market surveillance authorities that the product does not present a risk, and provided that all the other requirements and formalities pertaining to such release have been fulfilled. Proposal for amendment 20 Article 16.1 (MSPR) Refusal to release 2. Where the market surveillance authorities conclude that a product does present a risk, they shall instruct the authorities in charge of external border controls not to release the product for free circulation and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document: Product presents a risk release for free circulation not authorised Regulation (EU) No XXX/XXXX. Article 16.1 (MSPR) Refusal to release 2. Where the market surveillance authorities prove that a product does present a risk, they shall instruct the authorities in charge of external border controls not to release the product for free circulation and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document: Product presents a risk release for free circulation not authorised Regulation (EU) No XXX/XXXX. 21 of 23

22 Article 10.8 (MSPR) Measures taken by market surveillance authorities 6. Market surveillance authorities may charge fees which wholly or partly cover the costs of their activities, including testing carried out for the risk assessment, where they take measures in accordance with paragraph 1. Article 10.8 (MSPR) Measures taken by market surveillance authorities 6. Authorities in charge of external border controls may charge fees which partly cover the costs of their activities in accordance with paragraph 1. Proposal for amendment 21 Recital 34 (MSPR) (34) Market surveillance should be financed at least in part by fees charged to economic operators where they are required by market surveillance authorities to take corrective action or where those authorities are obliged to take action themselves. Recital 34 (MSPR) (34) Market surveillance should be financed by public authorities who are able to charge proportionate fees to the economic operator where it has had to undertake a necessary action because the economic operator has been unwilling or unable to do so. Proposal for amendment 22 Article 6.5(a) General obligations of market surveillance authorities 5. Market surveillance authorities shall: (a) provide consumers and other interested parties with the opportunity to submit complaints on issues relating to product safety, market surveillance activities and risks arising in connection with products and follow up those complaints as appropriate; Article 6.5(a) General obligations of market surveillance authorities 5. Market surveillance authorities shall: (a) provide consumers and other interested parties with the opportunity to submit complaints on issues relating to product safety, market surveillance activities and risks arising in connection with products and follow up those complaints as appropriate. The complaint information shall not be made public and shall be updated on a regular basis; Proposal for amendment 23 Article 36 (MSPR) Entry into force This Regulation shall enter into force on [insert date - the same day as Regulation Article 36 (MSPR) Entry into force This Regulation shall enter into force on [insert date - the same day as Regulation 22 of 23