Consultation Periods Open on Proposals to Harmonize Classification and Labeling of Four Substances under the EU's CLP Regulation

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EU CLP Regulation:

Public consultation periods have opened on propoosals to harmonize the classification and labeling of four substances under the EU Regulation on Classification, Labelling and Packaging of Substances and Mixtures (the so-called “CLP Regulation,” (EC) No 1272/2008). The CLP Regulation implements the UN’s Globally Harmonized System of Classification and Labeling of Chemicals (“GHS“). The substances are:  2-Ethoxyethanol (CAS No. 203-804-4); Reaction mass of 2,4,4-Trimethylpent-1-ene and 2,4,4-Trimethylpent-2-ene (CAS No. 246-690-9); Vinyl acetate (CAS No. 203.545-4); and Indoxacarb and Indoxacarb (enantiomeric reaction mass S:R 75:25 (Indoxocarb CAS No. 173584-44-6).   Copies of the proposals, and other details such as the deadlines for submitting comments, are available on the website of the European Chemicals Agency (“ECHA”).

If a proposal is accepted, the substance would be added to the list of harmonised classifications in Annex VI, part 3 of the CLP Regulation.  Thereafter, all manufacturers, importers and users of the substance in the EU would need to abide by the new harmonised classification and labelling.  Persons potentially affected may be interested in submitting comments.

Background on CLP Regulation and Harmonization

The so-called CLP Regulation entered into force on January 20, 2009.   The regulation will gradually replace the Dangerous Substances Directive (67/548/EEC) and Dangerous Preparations Directive (1999/45/EC).  Both directives will be repealed by June 1, 2015. 

Under the Regulation, individual EU Member States (“Competent Authorities” or “CAs”) and industry may propose harmonization of the classification and labelling of substances.  The decision on a particular classification for a substance or mixture is usually made by the supplier (“self-classification”).  However, in certain cases the decision on the classification of a substance is made at the Community level, which is then called “harmonized classification.”  A harmonized classification must be applied by default by the suppliers of the respective substance.

Hamonized classification and labeling may be approved:

  • when the substance is either:

    • carcinogenic;

    • mutagenic;

    • toxic for reproduction; and/or

    • a respiratory sensitiser;

  • when the substance is an active substance in a biocidal or plant protection products; or

  • when there is a need to harmonize a classification at EU level, as supported by a justification demonstrating the need for such action.

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Check back periodically for future postings on CLP developments.