Orders nº T-1/10 R of The General Court, March 26, 2010

• Resolution Date: March 26, 2010
• Issuing Organization: The General Court
• Decision Number: T-1/10 R

In Case T‑1/10 R,

SNF SAS, established in Andrézieux-Bouthéon (France), represented by K. Van Maldegem and R. Cana, lawyers, and P. Sellar, Solicitor,

applicant,

v

European Chemicals Agency (ECHA), represented by M. Heikkila and W. Broere, acting as Agents,

defendant,

APPLICATION for suspension of operation of the decision identifying acrylamide as a substance of very high concern which is stated to have been adopted by the European Chemicals Agency (ECHA) on 7 December 2009 pursuant to Article 59 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),

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

Legal context

1 On 18 December 2006, the European Parliament and the Council adopted Regulation (EC) No 1907/2006 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), subsequently amended, in particular, by 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 (OJ 2008 L 353, p. 1) (‘Regulation No 1907/2006’).

2 The legislature thereby established a regime concerning the registration, evaluation, authorisation and restriction of chemicals (‘REACH’), the purpose of which is, in particular, to ensure a high level of protection of human health and the environment as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. Article 3(1) of Regulation No 1907/2006 defines ‘substance’ as ‘a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition’.

3 More specifically, one of the fundamental objectives of REACH is to ensure that ‘substances of very high concern’ are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available.

4 Regulation No 1907/2006 thus lays down, in Title VII, an authorisation procedure the aim of which is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern will be properly controlled and that these substances will progressively be replaced by suitable alternative substances or technologies where these are economically and technically viable (Article 55 of Regulation No 1907/2006). The authorisation procedure applies to all substances fulfilling the criteria referred to in Article 57 of the regulation. Under that provision, among the substances that may be included in Annex XIV to the regulation are substances meeting the criteria for classification as carcinogenic or mutagenic in accordance with 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), as amended in particular by Commission Directive 2004/73/EC (OJ 2004 L 152, p. 1) and by Regulation No 1272/2008.

5 The first stage of the authorisation procedure consists in identifying the substances that meet the criteria referred to in Article 57 of Regulation No 1907/2006 and establishing a list of substances identified for eventual inclusion in Annex XIV to the regulation (‘the candidate list of substances’). Article 59 lays down a multi-step procedure for this purpose.

6 The identification procedure can be begun on the initiative of a Member State, which may prepare a dossier for substances which in its opinion are of very high concern and forward the dossier to ECHA (Article 59(3) of Regulation No 1907/2006). Next, ECHA makes the dossier available to all the Member States and publishes on its website a notice inviting all interested parties to submit comments to it (Article 59(2) to (4) of the regulation). If ECHA receives such comments, it refers the dossier to the Member State Committee and, if that committee reaches a unanimous agreement on the identification of a substance, ECHA includes the substance in the candidate list of substances (Article 59(7) and (8) of the regulation). Finally, ECHA is to publish and update the candidate list of substances without delay after a decision on inclusion of a substance has been taken (Article 59(10) of the regulation).

7 Following the inclusion of a substance in the candidate list of substances, the economic operators concerned, in particular producers, importers and suppliers of the substance, are subject to information obligations, in accordance with Article 7(2) and (4), Article 31(1)(c), Article 31(3)(b) and Articles 33 and 34 of Regulation No 1907/2006.

8 The second stage of the authorisation procedure consists in the inclusion, in order of priority, of candidate substances in Annex XIV to Regulation No 1907/2006, that is to say, in the list of substances subject to authorisation. For this purpose, as is apparent from Article 58 of the regulation, the Commission takes its decision in accordance with the procedure referred to in Article 133(4) of the regulation, upon a recommendation from ECHA, the latter taking into account the opinion of the Member State Committee and comments submitted by interested parties. Inclusion of a substance in Annex XIV triggers a prohibition on placing it on the market after a date set for that purpose, unless an authorisation is granted; however, certain uses or categories of uses may be exempted from the authorisation requirement.

9 The third stage of the authorisation procedure consists in examination of the applications for authorisation that have been made by manufacturers, importers or users for one or several uses of a substance included in Annex XIV to Regulation No 1907/2006 (Articles 60 to 64 of the regulation). Article 64 lays down a multi-step procedure for this purpose. The procedure provides, in particular, for an opinion to be obtained from ECHA’s Committee for Risk Assessment and from its Committee for Socio-economic Analysis. Ultimately, a final decision granting or refusing the authorisation is taken in accordance with the procedure referred to in Article 133(3) of the regulation.

10 Article 2(8)(b) of Regulation No 1907/2006 provides, however, for a derogation regarding the field of application of the authorisation procedure envisaged in Title VII of the regulation. It expressly states that ‘on-site isolated intermediates and transported isolated intermediates’ are exempted from Title VII. According to Article 3(15) of the regulation, ‘intermediate’ means ‘a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance’, while Article 3(15)(a), (b) and (c) define the terms ‘non-isolated intermediate’, ‘on-site isolated intermediate’ and ‘transported isolated intermediate’.

11 With a view to ensuring effective management of the technical, scientific and administrative aspects of Regulation No 1907/2006 at European Union level, an independent central entity was created, namely the European Chemicals Agency (ECHA) (Articles 75 to 111 of the regulation and recital 15 in its preamble).

Background to the dispute

12 The applicant, SNF SAS, has as its principal activity the manufacture of acrylamide and of acrylamide-based polymers (‘polyacrylamides’). It is part of the SPCM SA group of companies which has more than 30 subsidiaries and operations in more than 140 countries around the world. The group has manufacturing sites in France, the United States, China and South Korea. It has, with 40% of world capacity, the largest capacity for the manufacture of polyacrylamides, which are mainly used in water treatment (both for drinking water and wastewater), paper manufacturing, textile printing and mineral extraction and processing.

13 On 25 August 2009, a Member State, namely the Netherlands, forwarded to ECHA a dossier which it had prepared for identification of acrylamide as a substance meeting the criteria mentioned in Article 57(a) and (b) of Regulation No 1907/2006; it referred to the classification of acrylamide as carcinogenic and mutagenic in Annex I to Directive 67/548 and Part 3 of Annex VI to Regulation No 1272/2008. On 31 August 2009, ECHA published on its website a notice inviting interested parties to submit comments on the dossier prepared for acrylamide. On the same day it also invited the competent authorities of the other Member States to submit comments in this regard.

14 After receiving comments on the dossier in question and the responses of the Member State concerned to those comments, ECHA referred the dossier to the Member State Committee, which, on 27 November 1999, reached unanimous agreement on the identification of acrylamide as a substance of very high concern, on the ground that it met the criteria referred to in Article 57(a) and (b) of Regulation No 1907/2006.

15 On 7 December 2009, ECHA issued a press release announcing, first, that the Member...