Part 2 / DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING
PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING
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:
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Proposal
The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed;
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Proposal
The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed;
Proposal
The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed;
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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.
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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 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.
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Justification for the proposed grouping of substances for the purpose of harmonised classification and labelling
Where a harmonised classification and labelling proposal is made for a group of substances, the dossier shall include a scientific justification.
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Justification for the proposed grouping of substances for the purpose of harmonised classification and labelling
Where a harmonised classification and labelling proposal is made for a group of substances, the dossier shall include a scientific justification.
Justification for the proposed grouping of substances for the purpose of harmonised classification and labelling
Where a harmonised classification and labelling proposal is made for a group of substances, the dossier shall include a scientific justification.
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Justification for other effects at Community level
For effects other than carcinogenity, mutagenicity, reprotoxicity, endocrine disruption for human health and the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile, and respiratory sensitisation, a justification that there is a need for action demonstrated at Union level shall be provided. This shall not apply for an active substance within the meaning of Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012.
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Justification for other effects at Community level
For effects other than carcinogenity, mutagenicity, reprotoxicity, endocrine disruption for human health and the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile, and respiratory sensitisation, a justification that there is a need for action demonstrated at Union level shall be provided. This shall not apply for an active substance within the meaning of Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012.
Justification for other effects at Community level
For effects other than carcinogenity, mutagenicity, reprotoxicity, endocrine disruption for human health and the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile, and respiratory sensitisation, a justification that there is a need for action demonstrated at Union level shall be provided. This shall not apply for an active substance within the meaning of Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012.