Fédération des entreprises du commerce et de la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison (FMB) v Ministre de l’écologie, du développement durable et de lʼénergie.
Date: 2015-09-10
25. It is apparent from those observations that FCD and FMB and the Commission are asking the Court to rule on the compatibility of the Notice of 8 June 2011 with EU law. It is settled case-law, however, that it is not for the Court, in the context of a reference for a preliminary ruling under Article 267 TFEU, to give a ruling on the compatibility of provisions of national law with EU law or to interpret national legislative or regulatory provisions (see, to that effect, inter alia, judgment in Vueling Airlines , C‑487/12, EU:C:2014:2232, paragraph 26 and the case-law cited). The Court has jurisdiction to give the national court full guidance on the interpretation of EU law in order to enable it to determine the issue of compatibility for the purposes of the case before it (judgment in Transportes Urbanos y Servicios Generales , C‑118/08, EU:C:2010:39, paragraph 23 and the case-law cited).
28. It is true that Article 77(2) of the REACH Regulation confers on the Secretariat of the ECHA the task, inter alia, of ‘providing technical and scientific guidance and tools where appropriate for the operation [of that regulation] in particular ... technical and scientific guidance for the application of Article 7 by producers and importers of articles’ and ‘preparing explanatory information on [that regulation] for other stakeholders’. Given the legislature’s intention, a document such as the ECHA Guidance document may be one of the factors to be taken into consideration in interpreting the REACH Regulation. However, despite the scientific and technical nature of the aspects relating to the chemical substances regulated by the REACH Regulation, a document of that nature remains purely explanatory. The interpretation it gives of that regulation’s provisions is of no legislative effect whatsoever. It is a document drawn up by the ECHA and is not among the legal acts of the European Union referred to in Article 288 TFEU; accordingly it cannot be of a legally binding nature (see, by analogy, judgment in Chemische Fabrik Kreussler , C‑308/11, EU:C:2 012:548, paragraph 23).
31. Before examining the provisions the interpretation of which has been sought by the referring court, it must be remembered that it is apparent from Article 1(1) of the REACH Regulation that it aims to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.
32. To that end, the REACH Regulation introduces an integrated system for monitoring chemical substances, including registration, evaluation and authorisation, together with possible restrictions on their use. The cardinal principles governing those aspects were presented by the Commission in the introduction to its regulation proposal in COM(2003) 644 final of 29 October 2003, which describes ‘the REACH system’ as comprising, first of all, registration, which requires ‘industry to obtain relevant information on their substances and to use that data to manage them safely’, next, ‘[e]valuation[, which] provides confidence that industry is meeting its obligations’ and authorisation for substances of very high concern whose ‘[r]isks associated with uses … are adequately controlled, … if the socio-economic benefits outweigh the risks and there are no suitable alternative substitute substances or technologies …’. Lastly, ‘[t]he restrictions procedure provides a safety net to manage risks that have not been adequately addressed by another part of the REACH system’.
33. supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market;
...
35. recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers;
...’
7. Article 6 of the REACH Regulation, entitled ‘General obligation to register substances on their own or in mixtures’, provides in paragraph 1:
‘Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more mixture(s), in quantities of one tonne or more per year shall submit a registration to the Agency.’
8. Article 7 of that regulation, entitled ‘Registration and notification of substances in articles’, is worded as follows:
‘1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:
(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.
A submission for registration shall be accompanied by the fee required in accordance with Title IX.
2. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met:
(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
(b) the substance is present in those articles above a concentration of 0.1% weight by weight (w/w).
3. Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.
...
6. Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use.
...’
9. Article 10 of that regulation lists the information to be submitted for general registration purposes.
10. According to Article 33 of the REACH Regulation, entitled ‘Duty to communicate information on substances in articles’:
‘1. 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 the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
2. On request by a consumer 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 the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
The relevant information shall be provided, free of charge, within 45 days of receipt of the request.’
11. Article 55 of that regulation, entitled ‘Aim of authorisation and considerations for substitution’, provides:
‘The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.’
12. Article 57 of that regulation, entitled ‘Substances to be included in Annex XIV’, provides:
‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:
(a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to 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 2008 L 353, p. 1)];
(b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation … No 1272/2008;
(c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation … No 1272/2008;
(d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII [to] this Regulation;
(e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII [to] this Regulation;
(f) substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.’
13. Article 59 of that regulation provides for a procedure for the identification of substances referred to in Article 57.
14. Article 77 of the REACH Regulation, entitled ‘Tasks’, provides:
‘1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of this Regulation.
2. The Secretariat shall undertake the following tasks:
...
(g) providing technical and scientific guidance and tools where providing technical and scientific guidance and tools where appropriate for the operation of this Regulation in particular to assist the development of chemical safety reports (in accordance with Article 14, Article 31(1) and Article 37(4)) and application of Article 10(a)(viii), Article 11(3) and Article 19(2) by industry and especially by SMEs; and technical and scientific guidance for the application of Article 7 by producers and importers of articles;
(h) providing technical and scientific guidance on the operation of this Regulation for Member State competent authorities and providing support to the helpdesks established by Member States under Title XIII;
(i) providing guidance to stakeholders including Member State competent authorities on communication to the public of information on the risks and safe use of substances, on their own, in mixtures or in articles;
...
(k) preparing explanatory information on this Regulation for other stakeholders;
...
(m) keeping a Manual of Decisions and Opinions based on conclusions from the Member State Committee regarding interpretation and implementation of this Regulation;
...’
Commission Note of 4 February 2011
15. Document CA/26/2011 of the European Commission dated 4 February 2011, entitled ‘Update of Commission opinion — Substances in articles’, addressed to the competent national authorities, states that: ‘… the Commission has come to the conclusion that objects which at a certain step in their life-cycle meet the definition of article under REACH cease to be individual articles and become components once they are assembled into another article. For this reason, the obligations in Article 7(2) and 33 apply only with respect to such assembled article, and not with respect to its individual components’.
ECHA Guidance document
16. The ‘Guidance on requirements for substances in articles’, published by the European Chemicals Agency (ECHA) on 1 April 2011 (‘the ECHA Guidance document’), contains information in chapter 4 for determining the concentration of a substance of very high concern included on the candidate list in articles with different components.
17. Section 4.4. of the ECHA Guidance document, entitled ‘Determination of the concentration of a [substance of very high concern] included on the candidate list in articles with different components’, is worded as follows:
‘A [substance of very high concern] on the candidate list may be contained in different concentrations in different components of the same article, e.g. one concentration in the chassis of a laptop and another concentration in the transformer. For obligations according to Article 7(2) and 33 to apply, the concentration of this [substance of very high concern] has to exceed 0.1% (w/w) in the entire article as identified according to chapter 2. In order to check this condition firstly it needs to be known for each component whether it contains above 0.1% (w/w) of the SVHC or not (if not yet available, this information can be obtained by different means as described in chapter 5).’
French law
18. According to the Notice of 8 June 2011:
‘With reference to the publication of 1 April 2011 on the site of the [ECHA] (http://guidance.echa.europa.eu/docs/guidance_document/articles_en.pdf) … of the revised guide concerning the application of the REACH Regulation to substances contained in articles and more precisely to the executive director’s memorandum attached to that guide which indicates that it was not the subject of consensus among all the Member States of the European Union/European Economic Area, by means of this notice the French authorities inform economic operators of the interpretation adopted in France for the purpose of the application of Articles 7.2 and 33 of the REACH Regulation.
They state that the concept of “article” is to be understood as each object meeting the definition of “article” as provided for in REACH, that is to say, each object “which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition” (Article 3.3). Thus, an article may be composed of one or several objects which meet the definition of “article”, and the provisions laid down in Articles 7.2 and 33 are therefore to apply to each of them.
...
It is on the basis of those factors that the French authorities will apply Articles 7.2 and 33. Control measures will gradually be implemented to verify compliance with those provisions, using an approach which is pragmatic and proportionate to the health and environmental matters at stake.’
The dispute in the main proceedings and the question referred for a preliminary ruling
19. By application of 5 December 2011, FCD and FMB brought proceedings before the Conseil d’État (Council of State, acting in a judicial capacity) against the Notice of 8 June 2011. They argued that that notice was based on an interpretation of the concept of article which does not adhere to either the Commission Note of 4 February 2011 or the ECHA Guidance document. The Conseil d’État considers that the answer to the pleas in law put forward by FCD and FMB turns on the question whether, in the case of an article made up of more than one component, each coming within the definition of article laid down in the REACH Regulation, the obligations arising under Articles 7(2) and 33 of that regulation apply only in respect of the assembled article or in respect of each of those components.
20. It is on that basis that the Conseil d’État decided to stay proceedings and to refer the following question to the Court for a preliminary ruling:
‘Where an “article” within the meaning of [the REACH Regulation] is composed of several elements which themselves meet the definition of “article” given by the regulation, are the obligations resulting from Article 7(2) and Article 33 of the regulation to apply only with regard to the assembled article or with regard to each of the elements which meets the definition of “article”?’
Preliminary observations
The subject-matter of the present proceedings
21. FCD and FMB submit that the dispute in the main proceedings has arisen from the diverging interpretation of the REACH Regulation adopted by the French Republic in the Notice of 8 June 2011. Following the publication of that notice, the Commission looked into whether there was a possible infringement by the French Republic. At the end of its analysis, on 21 June 2012 the Commission sent a letter of formal notice to the French Republic in the procedure 2012/2109.
22. In July 2013, the French, Belgian, Danish, German, Swedish and Norwegian Governments published a guide for suppliers of articles. That guide indicates that the same piece of information about the presence of substances on the candidate list for authorisation must be provided, irrespective of whether that article is sold separately or as part of an article assembled from more than one article. The guide states (note 3, p. 6) that the co-authoring States and the Republic of Austria do not accept the interpretation of that regulation given by the ECHA in its guide.
23. FCD and FMB take the view that the interpretation contained in the Notice of 8 June 2011 is clearly contrary to the one put forward as early as 2007 by the Commission and the ECHA. The rules introduced in the REACH Regulation need to be defined and implemented at EU level. That regulation specifically entrusted the Commission and the ECHA with the mission of acting to implement effectively the provisions it introduces. FCD and FMB observe in that regard that Article 77 of the REACH Regulation provides expressly that the ECHA may provide technical and scientific guidance to producers and importers of articles for the application of Article 7 of that regulation and draw up explanatory information about the article for interested parties. The French authorities’ divergent interpretation hinders the uniform implementation of the REACH Regulation and undermines legal certainty as well as the proper functioning of the internal market and fair competition between economic operators.
24. The Commission submits that the divergences in the interpretation and application of the REACH Regulation by the French Republic and certain other Member States jeopardise the indivisibility of the EU legal order and undermine the principles of legal certainty and of the protection of legitimate expectations, as well as the proper functioning of the internal market. The Commission observes that Article 33 of the REACH Regulation effects an exhaustive harmonisation at EU level of the obligation to provide information on the substances contained in articles. If the French authorities wish to depart from that provision, they must provide proof of the existence of valid grounds relating to the protection of public health and/or the environment, as required under Article 114(4) to (9) TFEU.
25. It is apparent from those observations that FCD and FMB and the Commission are asking the Court to rule on the compatibility of the Notice of 8 June 2011 with EU law. It is settled case-law, however, that it is not for the Court, in the context of a reference for a preliminary ruling under Article 267 TFEU, to give a ruling on the compatibility of provisions of national law with EU law or to interpret national legislative or regulatory provisions (see, to that effect, inter alia, judgment in Vueling Airlines , C‑487/12, EU:C:2014:2232, paragraph 26 and the case-law cited). The Court has jurisdiction to give the national court full guidance on the interpretation of EU law in order to enable it to determine the issue of compatibility for the purposes of the case before it (judgment in Transportes Urbanos y Servicios Generales , C‑118/08, EU:C:2010:39, paragraph 23 and the case-law cited).
26. In the present case, the Court is being called on not to rule on the compatibility of national law with EU law, but to provide the referring court with guidance as to the interpretation of the REACH Regulation, in order to enable it to determine whether EU law requires it to disapply national rules governing the interpretation of that regulation. The question before the Court is therefore not whether, in adopting the Notice of 8 June 2011, the French authorities infringed their obligations under EU law.
27. Moreover, the fact that the interpretation the REACH Regulation given by the French authorities in the Notice of 8 June 2011 is contrary to the one adopted by the ECHA in its Guidance document of 1 April 2011 and the one issued by the Commission to the Member States once in 2007 and then a second time in 2011, is not relevant for the purposes of the present proceedings under Article 267 TFEU.
28. It is true that Article 77(2) of the REACH Regulation confers on the Secretariat of the ECHA the task, inter alia, of ‘providing technical and scientific guidance and tools where appropriate for the operation [of that regulation] in particular ... technical and scientific guidance for the application of Article 7 by producers and importers of articles’ and ‘preparing explanatory information on [that regulation] for other stakeholders’. Given the legislature’s intention, a document such as the ECHA Guidance document may be one of the factors to be taken into consideration in interpreting the REACH Regulation. However, despite the scientific and technical nature of the aspects relating to the chemical substances regulated by the REACH Regulation, a document of that nature remains purely explanatory. The interpretation it gives of that regulation’s provisions is of no legislative effect whatsoever. It is a document drawn up by the ECHA and is not among the legal acts of the European Union referred to in Article 288 TFEU; accordingly it cannot be of a legally binding nature (see, by analogy, judgment in Chemische Fabrik Kreussler , C‑308/11, EU:C:2 012:548, paragraph 23).
29. That lack of legally binding nature is, moreover, set out expressly in a preliminary section in the ECHA Guidance document, entitled ‘Legal notice’, which states that ‘the text of the REACH Regulation constitutes the sole authentic legal reference; the information contained in the present document has no legal value’ and that ‘[ECHA] declines all liability in respect of content’. It is also apparent from a ‘Note to reader’ that the guidance document ‘has not been fully supported by the national authorities of the Member States ... consulted at the final consultation stage [and that] consequently, undertakings may encounter divergent implementation practices with regards to some of the aspects of this document’.
30. Against that background, it is for the Court, as part of the judicial cooperation established by Article 267 TFEU, to respond to the request for a preliminary ruling in order to ensure a uniform interpretation and application of the relevant provisions of the REACH Regulation.
The REACH Regulation
31. Before examining the provisions the interpretation of which has been sought by the referring court, it must be remembered that it is apparent from Article 1(1) of the REACH Regulation that it aims to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.
32. To that end, the REACH Regulation introduces an integrated system for monitoring chemical substances, including registration, evaluation and authorisation, together with possible restrictions on their use. The cardinal principles governing those aspects were presented by the Commission in the introduction to its regulation proposal in COM(2003) 644 final of 29 October 2003, which describes ‘the REACH system’ as comprising, first of all, registration, which requires ‘industry to obtain relevant information on their substances and to use that data to manage them safely’, next, ‘[e]valuation[, which] provides confidence that industry is meeting its obligations’ and authorisation for substances of very high concern whose ‘[r]isks associated with uses … are adequately controlled, … if the socio-economic benefits outweigh the risks and there are no suitable alternative substitute substances or technologies …’. Lastly, ‘[t]he restrictions procedure provides a safety net to manage risks that have not been adequately addressed by another part of the REACH system’.
33. In accordance with those objectives, the REACH Regulation places the responsibility for the analysis of chemical substances with industry, instituting, for that purpose, a number of information-related mechanisms aimed at contributing, all along the supply chain, to the identification of their dangerous properties and risk management in order to ensure that human health and the environment are not adversely affected.
52. That does not necessarily mean, however, that the articles used in that production process thereby cease to be articles. It should be noted in that regard that Article 2(2) of the REACH Regulation provides that ‘[w]aste as defined in [Directive 2006/12] is not a substance or article within the meaning of Article 3 [of that regulation]’. It follows that an object meeting the criteria laid down in Article 2(2) of that same regulation ceases to be an ‘article’ for the purposes of the REACH Regulation when it becomes waste as defined in EU law (judgment in Commune de Mesquer , C‑188/07, EU:C:2008:359, paragraph 40). Apart from that provision, the REACH Regulation does not contain any provision under which an object meeting the definition of article within the meaning of Article 3(3) thereof is liable subsequently to cease being an article.