62010TO0346_EN
Parties
Grounds
Operative part
Parties
In Case T‑346/10,
Borax Europe Ltd,
established in London (United Kingdom), represented by K. Nordlander, lawyer, and H. Pearson, Solicitor,
applicant,
v
European Chemicals Agency (ECHA),
represented by M. Heikkilä and W. Broere, acting as Agents, and by J. Stuyck and A.‑M. Vandromme, lawyers,
defendant,
supported by
European Commission,
represented by P. Oliver and E. Manhaeve, acting as Agents, and by K. Sawyer, Barrister,
intervener,
APPLICATION for annulment of the decision of the ECHA, published on 18 June 2010, identifying boric acid (EC No 233-139-2) and disodium tetraborate, anhydrous (EC No 215-540-4) as substances meeting the criteria referred to in Article 57 of 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 2006 L 396, p. 1), and including those substances in the candidate list for eventual inclusion in Annex XIV to Regulation No 1907/2006, in accordance with Article 59 of that regulation,
THE GENERAL COURT (Seventh Chamber),
composed of A. Dittrich (Rapporteur), President, I. Wiszniewska-Białecka and M. Prek, Judges,
Registrar: E. Coulon,
makes the following
Order
Grounds
Background to the dispute
1. The applicant, Borax Europe Ltd, is a company governed by English law. It is engaged in the importation and sale in the European Union of boric acid (EC No 233-139-2) and disodium tetraborate, anhydrous (EC No 215-540-4) (collectively, ‘the borates’), which are supplied to it by a company governed by American law.
2. Uses of the borates include, in particular, glass and insulation fibre glass. The borates are also used in detergents and cleaning products as well as in wood preservatives.
3. The borates were included in Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ, English Special Edition 1967, p. 234) by Commission Directive 2008/58/EC of 21 August 2008 amending, for the purpose of its adaptation to technical progress, for the 30th time, Directive 67/548 (OJ 2008 L 246, p. 1), which entered into force on 5 October 2008. As a result of that inclusion, the borates were classified as toxic for reproduction category 2.
4. With the entry into force on 20 January 2009 of 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), Annex I to Directive 67/548 was repealed and its content, as applicable prior to amendment by Directive 2008/58, was transferred to Part 3 of Annex VI to Regulation No 1272/2008. There was, therefore, no reference to the borates in Annex VI to Regulation No 1272/2008 at the time when that regulation entered into force.
5. With the entry into force on 25 September 2009 of Commission Regulation (EC) No 790/2009 of 10 August 2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation No 1272/2008 (OJ 2009 L 235, p. 1), the classification of the borates as toxic for reproduction category 2 was referred to in Part 3 of Annex VI to Regulation No 1272/2008. According to Article 2(2) and (3) of Regulation No 790/2009, that classification applied from 1 December 2010, but could be applied before that date.
6. On 8 March 2010, the Federal Republic of Germany and the Republic of Slovenia submitted to the European Chemicals Agency (ECHA) a dossier which they had prepared concerning the identification of boric acid as a substance meeting the criteria referred to in Article 57(c) of 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 2006 L 396, p. 1), amended subsequently by, inter alia, Regulation No 1272/2008, in which they referred to the classification of boric acid as toxic for reproduction category 2 in Part 3 of Annex VI to Regulation No 1272/2008.
7. On the same day, the Kingdom of Denmark submitted to the ECHA a dossier which it had prepared concerning the identification of disodium tetraborate, anhydrous as a substance meeting the criteria referred to in Article 57(c) of Regulation No 1907/2006, and referring to the classification of disodium tetraborate, anhydrous as toxic for reproduction category 2 in Part 3 of Annex VI to Regulation No 1272/2008.
8. Subsequently, the ECHA published notices on its website inviting interested parties to submit comments on the dossiers prepared in relation to the borates. After receiving comments on the dossiers concerned, including from the European Borates Association, of which the applicant is a member, the ECHA referred those dossiers to its Member State Committee. On 9 June 2010 that committee reached unanimous agreement on the identification of the borates as substances of very high concern meeting the criteria set out in Article 57(c) of Regulation No 1907/2006.
9. On 18 June 2010, the list of substances in the candidate list for eventual inclusion in Annex XIV to Regulation No 1907/2006 (‘the candidate list’) including the borates was published on the ECHA’s website.
Procedure and forms of order sought by the parties
10. By application lodged at the Registry of the Court on 18 August 2010, the applicant brought an action for annulment of the decision of the ECHA, published on 18 June 2010, identifying the borates as substances meeting the criteria referred to in Article 57 of Regulation No 1907/2006 and including those substances in the candidate list in accordance with Article 59 of that regulation (‘the contested decision’).
11. By letter registered at the Registry of the Court on 10 December 2010, the European Commission applied for leave to intervene in the present proceedings in support of the form of order sought by the ECHA. After hearing the main parties, the President of the Seventh Chamber of the General Court granted leave to intervene, by order of 12 January 2011.
12. By separate document lodged at the Registry of the Court on 14 December 2010, the ECHA raised an objection of inadmissibility under Article 114(1) of the Rules of Procedure of the General Court. The applicant lodged its observations concerning the plea of inadmissibility on 31 January 2011.
13. By application lodged at the Registry of the Court on 31 January 2011, the applicant submitted an application for confidential treatment of its written statements vis-à-vis the intervener. That application has not been challenged.
14. By document lodged at the Registry of the Court on 18 February 2011, the Commission waived its right to lodge a statement in intervention on the question of admissibility alone.
15. In its application the applicant claims that the Court should:
– declare the action admissible;
– annul the contested decision in so far as it identifies the borates as substances meeting the criteria set out in Article 57(c) of Regulation No 1907/2006 and adds them to the candidate list;
– order the ECHA to pay the costs.
16. In its objection of inadmissibility the ECHA contends that the Court should:
– declare the action inadmissible;
– order the applicant to pay the costs.
17. In its observations on the plea of inadmissibility, the applicant claims that the Court should:
– reject the plea of inadmissibility;
– declare the action admissible;
– order the ECHA to produce a copy of the contested decision;
– annul the contested decision in so far as it identifies the borates as substances meeting the criteria set out in Article 57(c) of Regulation No 1907/2006 and adds them to the candidate list.
Law
18. Under Article 114(1) and (4) of the Rules of Procedure, if a party so requests, the Court may make a decision on a plea of admissibility without ruling on the substance of the case. In accordance with Article 114(3), unless the Court otherwise decides, the remainder of the proceedings is to be oral. The Court finds that, in the present case, it has sufficient information from the case‑file not to open the oral procedure.
19. In support of the form of order sought, the ECHA raises two pleas of inadmissibility, alleging that there is a lack of direct concern to the applicant and that the contested decision, which is not a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU, is not of individual concern to the applicant.
Plea of inadmissibility alleging a lack of direct concern to the applicant
20. Under the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.
21. In the present case, it is common ground that the contested decision was not addressed to the applicant; it is not, therefore, an act addressed to that person. That being the case, in accordance with the fourth paragraph of Article 263 TFEU, the applicant may institute proceedings for annulment of that act only if it is of direct concern to the applicant.
22. With regard to direct concern, it has consistently been held that that condition requires, first, that the measure complained of directly affect the legal situation of the individual and, second, that it leave no discretion to the addressees of that measure, who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from European Union rules without the application of other intermediate rules (Case C‑386/96 P Dreyfus
v Commission
[1998] ECR I‑2309, paragraph 43; Case C‑486/01 P Front national
v Parliament
[2004] ECR I‑6289, paragraph 34; and Joined Cases C‑445/07 P and C‑455/07 P Commission
v Ente per le Ville vesuviane
and Ente per le Ville vesuviane
v Commission
[2009] ECR I‑7993, paragraph 45).
23. In the first place, the applicant submits that the contested decision is of direct concern to it, in that its legal situation is affected by the obligation arising from that decision to provide a safety data sheet or to update it, pursuant to Article 31 of Regulation No 1907/2006. It must be observed that, according to Article 31(1)(a), (b) and (c) of that regulation, the suppliers of a substance must provide the recipient of that substance with a safety data sheet where the substance meets the criteria for classification as dangerous in accordance with Directive 67/548, where the substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII to that regulation, or where the substance is included in the list established in accordance with Article 59(1) of Regulation No 1907/2006 for reasons other than those previously referred to. Article 31(9)(a) of Regulation No 1907/2006 provides in that regard that suppliers must update that safety data sheet without delay as soon as new information which may affect the risk management measures, or new information on hazards becomes available.
24. First, as regards the alleged obligation to provide a safety data sheet pursuant to Article 31(1)(c) of Regulation No 1907/2006, it must be noted that the borates were included in the candidate list on the ground that they met the criteria, under Article 57(c) of that regulation, for classification as toxic for reproduction category 2, in accordance with Directive 67/548. Since such a case is expressly referred to in Article 31(1)(a) of Regulation No 1907/2006, it is not within the scope of Article 31(1)(c), which only concerns cases where a substance is included in the candidate list for reasons other than those referred to in Article 31(1)(a) and (b). Therefore, the applicant was not obliged, following the contested decision, to provide a safety data sheet pursuant to Article 31(1)(c) of Regulation No 1907/2006.
25. Second, as regards the obligation allegedly arising under Article 31(9)(a) of Regulation No 1907/2006 to update the safety data sheet, the Court must consider whether the identification in the contested decision of the borates as substances of very high concern as a result of the procedure referred to in Article 59 of Regulation No 1907/2006 constitutes new information within the meaning of Article 31(9)(a) of Regulation No 1907/2006 capable of triggering the obligation referred to in that provision, namely the updating of the safety data sheet, with the result that the contested decision directly affects the legal situation of the applicant.
26. As regards the safety data sheet, Article 31(1) of Regulation No 1907/2006 provides that it must be compiled in accordance with Annex II to that regulation. According to that annex, which contains a guide to the compilation of safety data sheets, the sheets must provide a mechanism for transmitting appropriate safety information on classified substances down the supply chain to the immediate downstream user(s). The purpose of Annex II is to ensure consistency and accuracy in the content of each of the mandatory headings listed in Article 31(6) of Regulation No 1907/2006, so that the resulting safety data sheets will enable users to take the necessary measur es relating to protection of human health and safety at the workplace, and protection of the environment.
27. The identification of the borates as substances of very high concern as a result of the procedure referred to in Article 59 of Regulation No 1907/2006 could constitute new information in relation to headings 2 (hazards identification) and 15 (regulatory information) of Article 31(6) of that regulation.
28. With regard to heading 2 (hazards identification), according to section 2 of Annex II to Regulation No 1907/2006, the classification of a substance which arises from application of the classification rules in Directive 67/548 must be given under that heading. The hazards a substance presents to man and the environment must be indicated clearly and briefly.
29. In the present case, the identification of the borates as substances of very high concern as a result of the procedure referred to in Article 59 of Regulation No 1907/2006 does not concern the classification of those substances in accordance with Directive 67/548. The identification was made on the basis that, under Article 57(c) of Regulation No 1907/2006, the borates met the criteria for classification as toxic for reproduction category 2 in accordance with Directive 67/548. However, the fact that the borates meet those criteria was already established in Annex I to Directive 67/548, as amended by Directive 2008/58, and subsequently in Part 3 of Annex VI to Regulation No 1272/2008, as amended by Regulation No 790/2009 (see paragraphs 3 to 5 above). In accordance with Article 59(3) of Regulation No 1907/2006, the Member States concerned referred in the dossiers they submitted to the ECHA on 8 March 2010 to the inclusion of the borates in Part 3 of Annex VI to Regulation No 1272/2008 (see paragraphs 6 and 7 above).
30. It is true that when the contested decision was published on 18 June 2010, the applicant was not bound by a mandatory classification of the borates. With the entry into force on 20 January 2009 of Regulation No 1272/2008, Annex I to Directive 67/548 which included the borates was repealed, and the obligation to classify the borates in accordance with the harmonised classification defined in Part 3 of Annex VI to Regulation No 1272/2008, as amended by Regulation No 790/2009, did not apply since Article 2(2) of Regulation No 790/2009 specified 1 December 2010 as the starting date in that regard.
31. However, the hazards which had resulted in the classification of the borates had been legally defined to the requisite legal standard at the time of publication of the contested decision. It was clear to all interested parties that those hazards had not disappeared merely because Annex I to Directive 67/548 had been deleted and its content had to be transferred to Part 3 of Annex VI to Regulation No 1272/2008. Moreover, with the entry into force of Regulation No 790/2009 on 25 September 2009, the classification of the borates as toxic for reproduction category 2 was referred to in Part 3 of Annex VI to Regulation No 1272/2008. The fact that that classification was not mandatory before 1 December 2010 does not affect the validity of the finding that the classification criteria were met as soon as Regulation No 790/2009 entered into force. Article 2(2) of Regulation No 790/2009 merely defers until 1 December 2010 the legal obligations arising from that classification under Regulation No 1272/2008, as amended by Regulation No 790/2009. That conclusion is supported by the fact that it is clear from Article 2(3) of Regulation No 790/2009 that the harmonised classification in Part 3 of Annex VI to Regulation No 1272/2008, as amended by Regulation No 790/2009, could be applied before 1 December 2010.
32. It follows that the identification of the borates as substances of very high concern did not contain new information on the hazardous properties of those substances but represented the outcome of the identification procedure referred to in Article 59 of Regulation No 1907/2006. The contested decision did not therefore produce any new information on hazards identification within the meaning of heading 2 of Article 31(6) of Regulation No 1907/2006.
33. With regard to heading 15 (regulatory information) of Article 31(6) of Regulation No 1907/2006, it must be noted that, according to section 15 of Annex II to that regulation, if the substance covered by the safety data sheet is the subject of specific provisions in relation to protection of man or the environment at European Union level, such as authorisations given under Title VII of the regulation or restrictions imposed under Title VIII, those provisions must, as far as is possible, be stated.
34. In that regard, first, it must be observed that, although the identification of a substance as a substance of very high concern as a result of the procedure referred to in Article 59 of Regulation No 1907/2006 can trigger information obligations on the part of economic operators, that does not have the effect of making the substance in question fall within a particular regime and thus of making it the subject of specific provisions. On the contrary, such identification has no impact on the placing on the market and use of the substance.
35. Second, as regards the authorisation procedure provided for in Title VII of Regulation No 1907/2006 and the restrictions imposed under Title VIII, the only examples listed in section 15 of Annex II to that regulation as being caught by that provision are the authorisations given and the restrictions. Since the identification of a substance as a substance of very high concern as a result of the procedure referred to in Article 59 of Regulation No 1907/2006 does not relate to the restrictions imposed under Title VIII of that regulation but is part of the authorisation procedure provided for under Title VII, the reference to the restrictions in section 15 of Annex II to Regulation No 1907/2006 does not support the proposition that such identification falls under heading 15 of Article 31(6) of that regulation.
36. As regards the authorisations given, it is apparent from Title VII of Regulation No 1907/2006 that these are the authorisations granted in accordance with Article 60 of that regulation, which are part of a subsequent stage of the authorisation procedure (Articles 60 to 64 of Regulation No 1907/2006). They may be requested from the ECHA pursuant to Article 62(1) of that regulation for one or several uses of a substance which it is prohibited to place on the market because of its inclusion in Annex XIV to that regulation. However, it must be noted that, with regard to the authorisation procedure provided for in Title VII of Regulation No 1907/2006, identification of a substance as a substance of very high concern as a result of the procedure referred to in Article 59 of that regulation was not expressly mentioned by the legislature in section 15 of Annex II to that regulation. It is true that the reference to authorisations given under Title VII of that regulation is provided by way of example only, but the fact remains that that is the only reference relating to the authorisation procedure under Title VII of Regulation No 1907/2006. While it cannot be ruled out that heading 15 of the safety data sheet is affected by other specific provisions in relation to protection of man or the environment at European Union level, so far as the authorisation procedure provided for under Title VII of Regulation No 1907/2006 is concerned, that consideration would also indicate that authorisations alone fall under that heading. That conclusion is supported by the fact that Article 31(9)(b) of that regulation provides that the safety data sheet must be updated once an authorisation has been granted or refused.
37. It follows that the identification of a substance as a substance of very high concern as a result of the procedure referred to in Article 59 of Regulation No 1907/2006 does not have the effect of making a substance the subject of specific provisions in relation to protection of man or the environment at European Union level within the meaning of section 15 of Annex II to that regulation.
38. In light of the foregoing, the identification of the borates as substances of very high concern as a result of the procedure referred to in Article 59 of Regulation No 1907/2006 did not amount to new information capable of affecting the risk management measures, or new information on hazards within the meaning of Article 31(9)(a) of Regulation No 1907/2006, and therefore the applicant was not obliged to update the safety data sheet. Consequently, the contested decision does not directly affect the legal situation of the applicant on the basis of the obligation provided for by that provision.
39. In the second place, as regards the applicant’s argument that the contested decision is of direct concern to it in that its legal situation is affected by the obligations arising under Article 7(2) and (3) and Article 33 of Regulation No 1907/2006, it must be noted that those provisions contain information obligations on producers, importers and suppliers of articles, as defined in Article 3(4), (11) and (33) of that regulation.
40. In accordance with Article 7(2) of that regulation, any producer or importer of articles must notify the ECHA if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if (i) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, and if (ii) the substance is present in those articles above a concentration of 0.1% weight by weight (w/w). Where Article 7(2) of Regulation No 1907/2006 does not apply, Article 7(3) provides that the producer or importer must supply appropriate instructions to the recipient of the article. According to Article 7(7) of Regulation No 1907/2006, from 1 June 2011 Article 7(2) and (3) of that regulation is to apply six months after a substance has been identified in accordance with Article 59(1).
41. Under Article 33(1) of Regulation No 1907/2006, 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) must 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. According to Article 33(2) of Regulation No 1907/2006, that supplier is subject to the same obligation vis-à-vis a consumer, on request by that consumer. The relevant information must be provided, free of charge, within 45 days of receipt of the request.
42. It is common ground that the applicant does not have the status of a producer or importer of articles, nor is it a supplier of an article within the meaning of Article 3(4), (11) and (33) of Regulation No 1907/2006. It is engaged in the importation and sale of the borates. The obligations laid down under Article 7(2) and (3) and Article 33 of that regulation clearly cover directly therefore only the applicant’s customers in so far as those customers are producers or importers of articles or suppliers of an article.
43. Nevertheless, referring to the judgment in Case C‑125/06 P Commission
v Infront WM
[2008] ECR I‑1451, paragraph 52, the applicant maintains that it is directly affected by the contested decision since that decision affects the manner in which its customers can produce or supply articles incorporating the borates by imposing strict information requirements upon them that are enforceable before the national courts by means of criminal and civil sanctions.
44. In that regard, it must be noted that while, in Commission v Infront WM, cited in paragraph 43, the rights at issue were subject to a certain number of legal restrictions as a result of the act at issue, this is not the case here with regard to the borates. The information requirements to which the applicant’s customers are subject, as laid down under Articles 7 and 33 of Regulation No 1907/2006 and which arise from the contested decision, do not entail new limits or restrictions in respect of the borates. It is true that producers or importers of articles and suppliers of an article must provide information if a substance is identified as a substance of very high concern in accordance with Article 59 of Regulation No 1907/2006, and if the conditions of Articles 7 and 33 of that regulation are met. However, those information requirements do not have the effect of limiting or restricting the placing on the market and use of the substances at issue, and thus of affecting the legal situation of the supplier of that substance. Furthermore, the applicant has not claimed that any information obligations on the part of its customers that may arise under Articles 7 and 33 of Regulation No 1907/2006 necessarily presuppose that it must provide information to those customers in order for them to be able to fulfil their obligations.
45. It follows that the obligations laid down under Article 7(2) and (3) and Article 33 of Regulation No 1907/2006 do not lead to the conclusion that the contested decision directly affects the legal situation of the applicant.
46. In the third place, as regards the applicant’s argument that the contested decision is of direct concern to it in that that decision affects its material situation, it must be noted that the mere fact that a measure may exercise an influence on an applicant’s material situation cannot suffice to allow him to be regarded as directly concerned. Only the existence of specific circumstances may enable a person subject to European Union law and claiming that the measure affects his position on the market to bring proceedings under the fourth paragraph of Article 263 TFEU (Joined Cases 10/68 and 18/68 Eridania and Others
v Commission
[1969] ECR 459, paragraph 7, and order in Case T‑189/97 Comité d’entreprise de la Société française de production and Others
v Commission
[1998] ECR II‑335, paragraph 48). In the present case, the applicant has merely claimed that its customers would stop using the borates; it has thus failed to prove the existence of those specific circumstances.
47. In light of the foregoing, it must be held that the contested decision does not directly affect the legal situation of the applicant. Since the first criterion of direct effect has not been met, the contested decision is not of direct concern to the applicant.
48. Therefore, the present plea of inadmissibility must be upheld and the action dismissed as inadmissible, and there is no need to consider the other plea of inadmissibility raised by the ECHA.
Request for measures of inquiry
49. By way of measure of inquiry in accordance with Article 66(1) of the Rules of Procedure, the applicant requests the Court to order the ECHA to produce a copy of the contested decision.
50. However, as is apparent from all of the foregoing, the Court is in a position to rule on the action without ordering measures of inquiry. Furthermore, since the contested decision has been published on the ECHA’s website and produced by the applicant in an annex to the application, this request is irrelevant.
51. The applicant’s request for a measure of inquiry must therefore be refused, and the action dismissed in its entirety.
Costs
52. Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Furthermore, under Article 87(4), the institutions which have intervened in the proceedings are to bear their own costs.
53. Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those of the ECHA, as applied for by the ECHA. The Commission shall bear its own costs.
Operative part
On those grounds,
THE GENERAL COURT (Seventh Chamber)
hereby orders:
1. The action is dismissed as inadmissible.
2. Borax Europe Ltd shall bear its own costs and pay those incurred by the European Chemicals Agency (ECHA).
3. The European Commission shall bear its own costs.
Luxembourg, 21 September 2011.