Commission Regulation (EU) No 253/2011 of 15 March 2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XIII Text with EEA relevance

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1907/2006 of 18 December 2006 of the European Parliament and of the Council 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 (1), and in particular Article 131 thereof,

Whereas:

(1) Regulation (EC) No 1907/2006 provides that substances which are persistent, bioaccumulative and toxic (PBT) as well as substances which are very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII may be included in Annex XIV in accordance with the procedure laid down in Article 58. Furthermore, Regulation (EC) No 1907/2006 establishes registration obligations of Union manufacturers or importers of substances on their own, in mixtures or articles, where, as part of the chemical safety assessment in accordance with Annex I, registrants have to do a PBT and vPvB assessment comprising, as a first step, a comparison with the criteria in Annex XIII to that Regulation.

(2) Article 138(5) of Regulation No 1907/2006 requires the Commission to review Annex XIII by 1 December 2008, in order to assess the adequacy of the criteria for identifying substances which are PBT or vPvB, with a view to proposing an amendment to it, if appropriate.

(3) Experience at international level shows that substances with characteristics rendering them persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, present a very high concern. For that reason, the Commission has taken existing experience in the identification of these substances into account in the review of Annex XIII with a view to ensuring a high level of protection for human health and the environment.

(4) The review carried out by the Commission pursuant to Article 138(5) of Regulation No 1907/2006 has revealed that there is a need to amend Annex XIII to that Regulation.

(5) Experience shows that, for the adequate identification of PBT and vPvB substances, all relevant information should be used in an integrated manner and applying a weight-of-evidence approach by comparing the information to the criteria set out in Section 1 of Annex XIII.

(6) A weight-of-evidence determination is particularly relevant in cases where the application of the criteria set out in Section 1 of Annex XIII to the available information is not straightforward.

(7) Accordingly, for the PBT and vPvB assessment of a substance in the framework of registration, registrants should consider all the information that is contained in the technical dossier.

(8) In cases where the technical dossier contains, for one or more endpoints, only limited information as required in Annexes VII and VIII to Regulation (EC) No 1907/2006, the available data may not allow to reach a definitive conclusion on the PBT or vPvB properties. In such cases, the relevant information available in the technical dossier should be used for screening for P, B, or T properties.

(9) In order to avoid unnecessary studies, only in cases where the screening assessment indicates a possible P, B, or T property, or a vP or vB property, the registrant should develop additional information or propose additional testing to conclude its PBT and vPvB assessment, unless the registrant implements or recommends sufficient risk management measures or operational conditions. For the same reason, registrants should not be required to develop additional information or propose additional testing if there is no indication of the P or B properties from the screening.

(10) Since substances can have one or more constituents with PBT or vPvB properties, or can transform or degrade into products with such properties, the identification should also take account of the PBT/vPvB-properties of such constituents and transformation and/or degradation products.

(11) Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

Article 1

Annex XIII to Regulation (EC) No 1907/2006 is replaced by the text set out in the Annex to this Regulation.

Article 2

Article 3

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 March 2011.

For the Commission The President José Manuel BARROSO

(1) OJ L 396, 30.12.2006, p. 1.