Article 2Amendments to Directive 92/85/EEC
Annex I to Directive 92/85/EEC is amended as follows:
- (1)
Section A is amended as follows:
- (a)
point 2 is replaced by the following:
‘2.Biological agents
Biological agents of risk groups 2, 3 and 4 within the meaning of points 2, 3 and 4 of second paragraph of Article 2 of Directive 2000/54/EC of the European Parliament and of the Council14, in so far as it is known that such agents or the therapeutic measures necessitated by them endanger the health of pregnant women and the unborn child, and in so far as they do not yet appear in Annex II.’; - (b)
point 3 is amended as follows:
- (i)
point (a) is replaced by the following:
- ‘(a)substances and mixtures which meet the criteria for classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council15 in one or more of the following hazard classes and hazard categories with one or more of the following hazard statements, in so far as they do not yet appear in Annex II;
germ cell mutagenicity, category 1A, 1B or 2 (H340, H341);
carcinogenicity, category 1A, 1B or 2 (H350, H350i, H351);
reproductive toxicity, category 1A, 1B or 2 or the additional category for effects on or via lactation (H360, H360D, H360FD, H360Fd, H360Df, H361, H361d, H361fd, H362);
specific target organ toxicity after single exposure, category 1 or 2 (H370, H371).’;
- ‘(a)
- (ii)
point (b) is replaced by the following:
- ‘(b)chemical agents in Annex I to Directive 2004/37/EC of the European Parliament and of the Council16;’
- ‘(b)
- (i)
- (a)
- (2)
Section B is replaced by the following:
‘B.Processes
Industrial processes listed in Annex I to Directive 2004/37/EC.’