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CLP

Annex VI to CLP

Where can I find the updated version of Table 3.1 of Annex VI to CLP?

The European Commission issues Adaptations to Technical Progress (ATPs) to the CLP Regulation, which provide updates to the harmonised classification and labelling in Table 3.1 of Annex VI to CLP. The updated version of this table is included in the Classification and Labelling Inventory managed by ECHA. 

ECHA has prepared an unofficial excel table containing all updates to the harmonised classification and labelling in Table 3.1 of Annex VI to CLP (http://echa.europa.eu/information-on-chemicals/annex-vi-to-clp).

The table should be used for informative purposes only as it could contain inconsistencies with the legally-binding entries in Annex VI to CLP as published in the Official Journal of the European Union (http://echa.europa.eu/regulations/clp/legislation).

What should you do where you have to use a harmonised classification which is marked as minimum classification in Table 3.1 of Annex VI to CLP?

In order to take full account of the work and experience accumulated under DSD, all previously harmonised DSD substance classifications were translated into harmonised CLP classifications. For substances with harmonised classifications for the hazard classes acute toxicity and STOT (repeated exposure), minimum classifications were assigned. These minimum classifications take account of the fact that the exact translation of the DSD criteria into the CLP criteria was not possible, based on the lack of available data.

 

Manufacturers or importers must apply at least this minimum classification (marked with an asterisk), but must classify in a more severe hazard category when they have further information, e.g. in the form of an LD50 value, which shows that a more severe category is more appropriate. 

Can a manufacturer, importer or downstream user submit to the Agency a proposal to introduce additional harmonised classification and labelling elements to an existing entry in Part 3 of Annex VI?

Yes. A manufacturer, importer or downstream user can submit a proposal to introduce additional harmonised classification and labelling elements to an entry in Part 3 of Annex VI to CLP directly to the Agency. A condition for submitting such a proposal is that the additional harmonised classification and labelling elements concern a hazard class or differentiation not yet covered by the harmonised classification of the substance in Part 3 of Annex VI. The procedure is described in Article 37(2) of CLP.

Where a change to the existing harmonised classification and labelling elements of a substance in Part 3 of Annex VI to CLP is proposed, the manufacturer, importer or downstream user must submit the proposal to a competent authority of a Member State in which the substance is placed on the market (Article 37(6)).

When a manufacturer, importer or downstream user has new information which may lead to a change of the existing harmonised classification and labelling of substances regulated under the Biocidal Products Regulation (EU) 528/2012 (the BPR) or under Regulation (EC) No 1107/2009 on plant protection products (the PPPR), they must act according to Article 37(6) CLP.

As harmonised classifications in Annex VI are binding for the endpoints covered in the entry (except the minimum classifications (section 1.2 in Annex VI to CLP) indicated by the reference * in Table 3.1), it is not possible to use a different classification and labelling from a harmonised one until an ATP amending it has been published. 

If a substance is subject to harmonised classification, do I have to classify it for the hazards which are not covered by the entry in Part 3 of Annex VI?

Yes, you do. A substance, which is listed on Annex VI, must be classified in accordance with the entry in Part 3 of Annex VI. Furthermore, the manufacturer, importer or downstream user of such a substance has to carry out a self-classification in accordance with Title II for those hazard classes or differentiations where no harmonised classification is contained in the entry in Part 3 of Annex VI. For example, a substance may have a harmonised classification for acute oral toxicity, but not for acute dermal toxicity. This means that a supplier would have to explore, using the information available, whether the classification criteria for acute dermal toxicity are fulfilled, and classify accordingly. For harmonised classifications referring to the aquatic hazard classification acute or chronic category 1 where no M-factor appears on Annex VI, the classifier must set an M-factor.

Self-classification may entail new testing for those physical hazards where no harmonised classification exists and where, pursuant to CLP Article 8(2), adequate and reliable information is not available.

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