S.I. No. 272/2008 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 2008

GIVEN under my Official Seal,

15 July 2008

MARY COUGHLAN,

Minister for Enterprise, Trade and Employment.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation).

These Regulations amend the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 2003 ( S.I. No. 116 of 2003 ) as last previously amended by the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations 2006 ( S.I. No. 25 of 2006 ).

The Regulations transpose Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency.

The Regulations, inter alia, replace Regulations 5, 6, and 7 (relating to Competent Authority, Placing on the Market and Testing and assessment of properties of substances, respectively) and revoke Regulations 10 to 18, 24, 25 and 27 of and Schedules 6, 8 and 9 to the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 2003 relating to Full Notification, Reduced Notification for substances placed on the market in quantities of less than one tonne per annum, Substances Notified at least 10 years previously, Notification of Polymers, Pre-marketing Notification Period, Exemptions from the notification requirements, Follow up Information, Re-notification of the same substance and avoidance of duplicate testing in vertebrate animals, Confidentiality of data, Safety Data Sheet, Supply of Substances, Fees Payable by Notifier, Annex VIIA, Annex VIIB, Annex VIIC, Annex VIID and Annex VIII: Information required for the Technical dossier, Obligatory Headings for Safety Data Sheets and Fees Payable by Notifier, respectively. The matters covered by the revoked provisions, (other than Regulations 25 and 27 and Schedules 6 and 9 which are consequential amendments) are now provided for directly in the REACH Regulation (EC) No. 1907/2006.

The definitions of “Annex V”, “Annex VII.A”, “Annex VII.B”, “Annex VII.C”, “Annex VII.D”. “Annex VIII”, “notification”, “polymer”, “process-orientated research and development” and “scientific research and development” are deleted from the 2003 Regulations.

References in the 2003 Regulations to Annexes VII A, VII B, VII C, VII D and VIII of Council Directive 67/548/EEC shall be construed as references to the corresponding Annexes VI, VII, VIII, IX, X and XI of the REACH Regulation.

Schedule 5 to the 2003 Regulations (Annex VI of Directive 67/548/EEC as amended) is replaced in full by the provisions set out in the Schedule to these Regulations for ease of reference. The relevant changes incorporated in the latest text of Schedule 5 are the substitution, in accordance with Article 13(2) of Regulation (EC) No. 1907/2006 and Commission Regulation (EC) No. 440/2008, of—

• “(a) the words “Commission Regulation (EC) No. 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)” for “Annex V” and “Annex V to this Directive” in each place where they occur;

• (b) in section 1.6.1, for point (a) the following:

• “(a) as regards substances for which information specified in Annexes VI, VII and VIII of Regulation (EC) No. 1907/2006 is required, most of the necessary data for classification and labelling appear in the base set. This classification and labelling must be reviewed, if necessary, when further information is available (Annexes IX and X of Regulation (EC) No. 1907/2006):”;

  • (c) in section 5.1, for the second paragraph the following:

  “The criteria set out below follow directly from the test methods set out in Commission Regulation (EC) No. 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in so far as they are mentioned. The test methods required for the base set referred to in Annexes VII and VIII of Regulation (EC) No. 1907/2006 are limited and the information derived from them may be insufficient for an appropriate classification. Classification may require additional data derived from Annexes IX or X of Regulation (EC) No. 1907/2006 or other equivalent studies. Furthermore, classified substances may be subject to review in the light of other new data.”

  and

  • (d) in section 5.2.1.2 for the second sentence in the second paragraph the following:

  “Such additional scientific evidence should normally be based on the studies required by Annex IX of Regulation (EC) No. 1907/2006, or studies of equivalent value and could include,”.

Footnotes