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Classification, Labelling, and Packaging

As was seen in the previous section, the classification of chemical substances tends to have very significant implications for how they are regulated. And that labelling can be an important instrument for enabling safe handling of chemicals is obvious. What is now the EU has had rules on classification, labelling, and packaging of chemical substances since the 1960s. The core piece of legislation has been Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances, in more recent years supplemented by Directive 1999/45/ EC concerning classification, packaging and labelling of dangerous preparations.33 However, as of 31 May 2015 these have both been replaced by Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (‘the CLP Regulation’).34 This has been made primarily to adapt EU rules to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), developed within the United Nations to facilitate international trade while protecting human health and the environment.

The CLP Regulation has replaced Title XI of REACH on classification and labelling inventorying and effected changes to other parts of REACH as well. The CLP [1] [2]

Regulation is even more extensive than REACH and occupies, including annexes, more than 2,000 pages. It is also in large parts quite detailed and technical.

The purpose of the CLP Regulation, which is based on an article corresponding to the current Article 114 TFEU, is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures, and articles. This is done primarily by harmonising the criteria for classification of substances and mixtures as well as the rules on labelling and packaging for hazardous substances and mixtures. Manufacturers, importers, and downstream users are required to classify substances and mixtures placed on the market in accordance with Title II of the Regulation.^ Where a substance or mixture is classified as hazardous, suppliers must ensure that it is labelled and packaged in accordance with Titles III and IV, before placing it on the market. Also substances not placed on the market must be classified if they are subject to registration or notification under REACH. Substances subject to harmonised classification and labelling, through an entry in Part 3 of Annex VI, shall be classified in accordance with that entry.

The Regulation also establishes a list of substances with their harmonised classifications and labelling elements at EU level (Part 3 of Annex VI) and a classification and labelling inventory of substances. Substances and mixtures that do not comply with the CLP Regulation may not be placed on the market.

Exempted from the scope of the CLP Regulation are, inter alia, radioactive substances within the scope of certain Euratom rules and substances and mixtures for scientific research and development that are not placed on the market, provided they are used under controlled conditions in accordance with EU workplace and environmental legislation. (Arts 1, 3, and 4.)

A substance or mixture classified as hazardous and contained in packaging must be labelled in accordance with the provisions in Title III. Requirements on packaging containing hazardous substances or mixtures are laid down in Title IV. Title V is dedicated to harmonisation of classification and labelling of substances and the classification and labelling inventory.

  • [1] The Court of Justice has made clear that the EU principle of proportionality is not applicablewith respect to more stringent protective measures of domestic law adopted by virtue of Art 193TFEU and going beyond the minimum requirements laid down by a secondary EU law. Case C-6/03, DeponiezweckverbandEiterkopfe ECLI:EU:C:2005:222, paras 61—63. Since they are not subject tocore principles of EU law, such national measures can hardly be part of EU environment legislation.
  • [2] [1999] OJ L 200/1. 34 [2008] OJ L 353/1.
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