1.3.: Step 3: Classification and Labelling

1.3.1. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified. Where applicable, Specific Concentration limits resulting from the application of Article 10 of Regulation (EC) No 1272/2008 and Articles 4 to 7 of Directive 1999/45/EC shall be presented and, if they are not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified.

The assessment should always include a statement as to whether the substance fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B.

1.3.2. If the information is inadequate to decide whether a substance should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.