Regulation (EC) No 1272/2008 of the European 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 (Text with EEA relevance)
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This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling.
The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier.
For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.
A dossier for harmonised classification and labelling shall contain the following:
Proposal
The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed.
Justification for the proposed harmonised classification and labelling
A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006.
Justification for other effects at Community level
For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC.
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