(1)

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 (2) harmonises the provisions and criteria for the classification and labelling of substances, mixtures and certain specific articles within the Community, taking into account the classification criteria and labelling rules of the Globally Harmonised System of Classification and Labelling of Chemicals.

(2)

Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (3) and Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (4) were amended several times. Directives 67/548/EEC and 1999/45/EC will be replaced over a transitional period according to which substances must be classified, labelled and packaged according to Regulation (EC) No 1272/2008 from 1 December 2010 and mixtures from 1 June 2015, although from 1 December 2010 until 1 June 2015 classification of substances according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008 is required. Both Directives will be repealed in full by Regulation (EC) No 1272/2008 with effect from 1 June 2015.

(3)

Annex I to Regulation (EC) No 1907/2006 should be amended to adapt it to the criteria for classification and other relevant provisions laid down in Regulation (EC) No 1272/2008.

(4)

Article 58(1) of Regulation (EC) No 1272/2008 modifies Article 14(4) of Regulation (EC) No 1907/2006 to adapt it to the classification criteria in Regulation (EC) No 1272/2008. This also has consequences for Annex I to Regulation (EC) No 1907/2006, which was not amended by Regulation (EC) No 1272/2008. It is therefore necessary to adapt Annex I to Regulation (EC) No 1907/2006 to the new text in its Article 14(4).

(5)

Regulation (EC) No 1272/2008 introduces substantive changes in terminology compared to those used in Directive 67/548/EEC. Annex I to Regulation (EC) No 1907/2006 was not amended by Regulation (EC) No 1272/2008 and should be updated to reflect these changes and ensure consistency throughout.

(6)

Furthermore, references to Directive 67/548/EEC should be replaced by appropriate references to Regulation (EC) No 1272/2008.

(7)

In accordance with Regulation (EC) No 1907/2006, registrations including chemical safety reports will have been submitted by the date of application of this Regulation. Changes in classification criteria and other relevant provisions resulting from Regulation (EC) No 1272/2008 apply to substances from 1 December 2010, in accordance with the second paragraph of Article 62 of that Regulation. In order to ensure a smooth transition for the updating of registrations, a transitional period should be provided.

(8)

Annex I to Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(9)

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

1.

point 0.6 is replaced by the following:

‘0.6.   Steps of a chemical safety assessment

2.

point 1.0.1 is replaced by the following:

3.

point 1.0.2 is replaced by the following:

4.

point 1.1.3 is replaced by the following:

5.

points 1.3.1 and 1.3.2 are replaced by the following:

6.

the second sentence of point 1.4.1 is replaced by the following:

‘For some hazard classes, especially germ cell mutagenicity and carcinogenicity, the available information may not enable a toxicological threshold, and therefore a DNEL, to be established.’;

7.

point 2.1 is replaced by the following:

8.

point 2.2 is replaced by the following:

9.

point 2.5 is replaced by the following:

10.

point 3.0.1 is replaced by the following:

11.

points 3.2.1 and 3.2.2 are replaced by the following:

12.

points 4.1 and 4.2 are replaced by the following:

‘4.1.   Step 1: Comparison with the criteria

This part of the PBT and vPvB assessment shall entail the comparison of the available information with the criteria given in Section 1 of Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. The assessment shall be conducted in accordance with the provisions laid down in the introductory part of Annex XIII as well as Sections 2 and 3 of that Annex.

4.2.   Step 2: Emission Characterisation

If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance.’;

13.

Part B of the table in Section 7 is amended as follows: