Enforcement of SVHC. Sibylle Wursthorn Ministry of the Environment, Climate protection and Energy Sector Baden-Württemberg (Germany)

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1 Enforcement of SVHC Sibylle Wursthorn Ministry of the Environment, Climate protection and Energy Sector Baden-Württemberg (Germany) CLEPA Material Regulation Event 2018 Stuttgart,

2 Content enforcement and compliance information on safe use of articles complex objects enforcement projects

3 Legal basis SVHC (substances of very high concern) Article 33 REACH regulation Any supplier of an article containing a substance (meeting the criteria in Article 57 and identified in accordance with Article 59(1)) in a concentration above 0,1 % weight by weight (w/w) - shall provide sufficient information, available to the supplier, to allow safe use of the article including - as a minimum, the name of that substance. Article 33 (1): the recipient of the article Article 33 (2): on request by a consumer within 45 days of receipt of the request. Candidate list substances (CL substances)/ SVHC:

4 Ruling of the European Court of Justice at Article 33 of Regulation No 1907/2006 must be interpreted as meaning that it is for the supplier of a product one or more constituent articles of which contain(s) a substance of very high concern identified in accordance with Article 59(1) of that regulation in a concentration above 0.1% weight by weight of that article, to inform the recipient and, on request, the consumer, of the presence of that substance by providing them, as a minimum, with the name of the substance in question. reference to supplied article

5 ECHA Guidance on requirements for substances in articles Implementation of the judgements` content in ECHA guidance (June 2017, Version 4.0) chapter Communication of information down the supply chain The substance concentration threshold of 0.1% (w/w) applies to every article supplied. This threshold applies to each article of an object made up of more than one article, which were joined or assembled together (complex object). reference to supplied article concept of compex objects

6 Compliance checks Requirements (1) supplier have to fulfil information duties in case an article contains CL substances above the threshold value, information duty is triggered by the presence of the substance, does not depend on the knowledge of the supplier, relevant for establishing of compliance: if the correct information is passed on to the enforcement authorities Guidance on requirements for substances in articles (June 2017, Version 4.0) The communication obligations arise from the presence of the Candidate List substance in the article. These obligations apply regardless of whether or not the supplier is aware of the presence of the substances. Therefore, it is in the interests of the supplier to seek information on the presence of Candidate List substances. (chapter 3.2.1)

7 Compliance checks Requirements (2) enforcement authorities expect from the company substantive and documented evidence on presence/absence of CL substances in articles (Article 36 of REACH!) in order to ensure compliance : information (also lacking of information) from supplier should - be critically questioned - as a consequence of this: an obligation to determine information could be derived an obligation to determine information could be: contractual arrangement, request by the supplier Guidance on requirements for substances in articles (June 2017, Version 4.0) The communication obligations arise from the presence of the Candidate List substance in the article. These obligations apply regardless of whether or not the supplier is aware of the presence of the substances. Therefore, it is in the interests of the supplier to seek information on the presence of Candidate List substances. (chapter 3.2.1)

8 Compliance checks Requirements (2) Guidance on requirements for substances in articles (June 2017, Version 4.0) Where the information received or available is not sufficient to check compliance and comply with REACH, producers, importers and other suppliers of articles should consider obtaining the necessary information by pro-active requests in the supply chain. (chapter 5.1.3) The confirmation of the presence of Candidate List substances in the articles could be done by requesting information up in the supply chain and evaluating the information provided by suppliers (Appendix 5)

9 sanctioning measures in DE: any non-compliance with Article 33 of REACH can be imposed with a fine: => fine up to in case of intentional breach or gross negligence - provide information not, not correctly, not completely, not in the described manner or not on time, administrative discretion of the authority: take into account compliance efforts of the responsible company active efforts of the supplier relevant e.g. for pursuing non-compliance with a fine in case of sanctioning measures enforcement authorities consider e.g.: accusation/ (gravity of) culpability / the endeavour for compliance of the company reach /relevance/ consequences/ severity of the non-compliance

10 Guidance and Ruling from the ECJ: content of information on safe use Coverage of relevant safe use informationen of articles : Ruling from the ECJ: The duty to provide information is aimed indirectly at allowing those operators and consumers to make a supply choice in full knowledge of the properties of the products, including those of articles forming part of their composition. (paragraph 78). Guidance on requirements for substances in articles (June 2017, Version 4.0), chapter by exposure/ risk based considerations the supplier of an article must consider all the life-cycle stages during use of the article, also recycling and disposal of the articles as well as foreseeable misuse of articles, in particular, by consumers on a case-by-case basis

11 Notification obligation currently low number of notifications received by ECHA Exemptions from notification obligation - exemption based on exclusion of exposure all exposure routes at all life cycle stages have to be considered (service life of the article and waste stage) demonstrate no CL substance does come into contact with humans/ environment. - exemption for substances already registered for that use The substance is the same as the substance already registered; The use is the same as the use described in a registration of the substance, i.e. the registration refers to the use in the article. => Guidance: information of ECHA s dissemination portal will normally not be sufficient enhanced clarity for enforcement: Is such a detailed information/ documentation of the dutyholder available? Are relevant aspects considered? (Art. 36 REACH)

12 complex objects complex product : term in the Ruling of the ECJ when it is assembled or joined with other objects in order to form with them a complex product => does not cease to be an article Guidance on requirements for substances in articles (June 2017, Version 4.0) - complex object article F, e.g. fastener mixture M, e.g. adhesive, solder

13 complex objects In Guidance on requirements for substances in articles (June 2017, Version 4.0) - complex object mixture M, e.g. adhesive, solder supplier of articles is required to communicate information: Candidate List substance X in article A Candidate List substance Y in article B Candidate List substance Z in complex object D

14 Enforcement Projects legal interpretation of ECJ is enforced in individual cases and in enforcement campaigns several enforcement campaigns in several MS, e.g. experiences in DE (BW): high non-compliance rates with 30% ECHA-Forum: pilot project in 2017/ 2018

15 ECHA-Forum pilot project (I) (*) Scope check compliance with notification and communication obligations on substances in articles Timelines Inspections: Oct June 2018 Target groups Companies: all types of suppliers of articles (including e-commerce), but focussing more on producers and importers of articles Articles consumers articles where CL substances are likely to be found that contains CL substances with potential for exposure (*) see Webinar Communicating about substances in articles - what you need to know, (10/2017)

16 ECHA-Forum pilot project (II) Target articles - examples Consumer products Electrical products Building, interior articles Others Target Candidate List substances examples Brominated flame retardants Phosphorous flame retardants Short-chain chloroparaffins Phthalates Aprotic polar solvents Perfluorinated substances Phenolic benzotriazoles Other Candidate List substances

17 ECHA-Forum pilot project (III) Inspections also on site inspections methodology/ questionnaire taking samples chemical Analyses of CL substances

18 REACH Review 2018 Summary COM: REACH enables citizens to ask companies whether the articles they supply contain SVHCs, but this provision has had limited use. Where it is used, companies struggle with its implementation.

19 Thank you! Sibylle Wursthorn Ministry of the Environment, Climate protection and Energy Sector Baden-Württemberg (Germany) Tel: /