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27.April 2009 - 00:00

Directive 2009/2/EC and CLP Regulation (EC) No 1272/2008

Commission Directive 2009/2/EC(1) of 15 January 2009 amending, for the purpose of its adaptation to technical progress, for the 31st time, Council Directive 67/548/EEC(2) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances is creating an unreasonable amount of uncertainty for Member States, economic actors and trading partners of the EU.

Can the Commission answer the following:

1. Does Directive 2009/2/EC have any legal effect? Bearing in mind that Annex I of Directive 67/548/EEC has been deleted and that the classifications in Directive 2009/2/EC are not included in Part 3 of Annex VI of Regulation (EC) No 1272/2008(3), what is the status of the classifications contained in Directive 2009/2/EC?

2. Are Member States to implement Directive 2009/2/EC by 1 June 2009 as provided for in the Directive’s Article 2?

3. Has Directive 2009/2/EC been assessed for its impact on developing countries as recommended by the better regulation strategy? And if so, can the Commission provide the evidence?

4. Will the first ATP to Regulation (EC) No 1272/2008 be prepared and adopted in full compliance with the procedures and criteria set out in Regulation (EC) No 1272/2008? Will an impact assessment be carried out?

5. Has the Commission taken any measures to minimise possible negative effects for economic actors and trading partners of the EU resulting from the uncertainties related to Directive 2009/2/EC? And if so, what?

(1) OJ L 11, 16.1.2009, p. 6.

(2) OJ 196, 16.8.1967, p. 1.

(3) OJ L 353, 31.12.2008, p. 1.

27 April 2009

Answer given by Mr Dimas on behalf of the Commission

Directive 2009/2/EC(1) amended Annex I to Directive 67/548/EEC(2) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances by introducing new and updated harmonised classifications. However, Annex I to Directive 67/548/EEC was deleted by Article 55(11) of Regulation (EC) No 1272/2008(3) on classification, labelling and packaging of substances and mixtures as of its entry into force on 20 January 2009. This means that Directive 2009/2/EC and the harmonised classifications contained therein are not in force.

As a consequence, there is no need for Member States to implement Directive 2009/2/EC. The Commission has prepared a proposal for a first adaptation to technical progress (‘ATP’) to Regulation (EC) No 1272/2008 with a view to transferring the harmonised classifications contained in Directives 2008/58/EC(4) and 2009/2/EC into Annex VI to this regulation. This ATP takes the form of a Regulation and will therefore be directly applicable throughout the EU.

Directive 2009/2/EC required dangerous substances to be properly labelled and packaged. Information on the dangers of the substance and the precautions to be taken are transmitted by means of warning labels containing standard symbols and phrases. All substances and mixtures placed on the EU market, whether produced within the EU or imported, are subject to the same classification and labelling requirements based on the same criteria.

Directive 2009/2/EC was to harmonise the classification of the substances in the annex with the aim of ensuring the functioning of the internal market on the basis of the best available scientific information. As the classification of substances in itself does not imply restrictions on their use, the Commission considered the impact of the 30th and 31st ATP on trade as minimal. The proposal for the 31st ATP, including the classification of the Nickel compounds, was notified to the World Trade Organisation (WTO) Technical barriers to trade (TBT) Committee in September 2008 to give WTO members the opportunity to submit comments within the standard 60-day deadline.

A discussion in the TBT Committee took place in November 2008, preceded by an expert meeting providing further possibility for third countries to specify and substantiate their concerns. Various bilateral meetings also took place. The Commission has asked industry and WTO members to substantiate their arguments on the negative impact on trade. To date, we have not received any information on this, except for some speculation about possible consequences this classification could entail under REACH(5) and other Community legislation.

The first ATP to Regulation (EC) No 1272/2008 was prepared in full compliance with the provisions, procedures and criteria set out in Regulation (EC) No 1272/2008. No impact assessment was carried out on the 1st ATP to Regulation (EC) No 1272/2008.

The Commission does not consider it necessary to take any measures to minimise possible negative effects for economic actors and trading partners of the EU resulting from the uncertainties related to Directive 2009/2/EC. As explained above, no such uncertainty exists

(1) Commission Directive 2009/2/EC of 15 January 2009 amending, for the purpose of its adaptation to technical progress, for the 31st time, Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ L 11, 16.1.2009.

(2) 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 196, 16.8.1967.

(3) Regulation (EC) No 1272/2008 of the 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 L 353, 31.12.2008.

(4) Commission Directive 2008/58/EC of 21 August 2008 amending, for the purpose of its adaptation to technical progress, for the 30th time, Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ L 246, 15.9.2008.

(5) Regulation (EC) No 1907/2006 of the 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 L 396, 30.12.2006.

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