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Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (repealed)
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For substances which produce such effects, the concentration limits laid down in Table VI, expressed as a weight/weight percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:
Carcinogenic categories 1 and 2: | T; R45 or R49 |
Carcinogenic category 3: | Xn; R40 |
Mutagenic categories 1 and 2: | T; R46 |
Mutagenic category 3: | Xn; [F1R68] |
Toxic for reproduction fertility categories 1 and 2: | T; R60 |
Toxic for reproduction development categories 1 and 2: | T; R61 |
Toxic for reproduction fertility category 3: | Xn; R62 |
Toxic for reproduction development category 3: | Xn; R63 |
a In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.] | ||
Classification of the substance | Classification of the preparation | |
---|---|---|
Categories 1 and 2 | Category 3 | |
Carcinogenic substances of category 1 or 2 with R45 or R49 | Concentration ≥ 0,1 % carcinogenic R45, R49 obligatory as appropriate | |
Carcinogenic substances of category 3 with R40 | Concentration ≥ 1 % carcinogenic R40 obligatory ( unless already assigned R45 a ) | |
Mutagenic substances of category 1 or 2 with R46 | Concentration ≥ 0,1 % mutagenic R46 obligatory | |
Mutagenic substances of category 3 with R68 | Concentration ≥ 1 % mutagenic R68 obligatory ( unless already assigned R46 ) | |
Substances ‘ toxic for reproduction ’ of category 1 or 2 with R60 (fertility) | Concentration ≥ 0,5 % toxic for reproduction (fertility) R60 obligatory | |
Substances ‘ toxic for reproduction ’ of category 3 with R62 (fertility) | Concentration ≥ 5 % toxic for reproduction (fertility) R62 obligatory ( unless already assigned R60 ) | |
Substances ‘ toxic for reproduction ’ of category 1 or 2 with R61 (development) | Concentration ≥ 0,5 % toxic for reproduction (development) R61 obligatory | |
Substances ‘ toxic for reproduction ’ of category 3 with R63 (development) | Concentration ≥ 5 % toxic for reproduction (development) R63 obligatory ( unless already assigned R61 ) |
Textual Amendments
F2 Substituted by Commission Directive 2006/8/EC of 23 January 2006 amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (Text with EEA relevance).
For gases which produce such effects, the concentration limits laid down in Table VI A, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:
Carcinogenic categories 1 and 2: | T; R45 or R49 |
Carcinogenic category 3: | Xn; R40 |
Mutagenic categories 1 and 2: | T; R46 |
Mutagenic category 3: | Xn; [F1R68] |
Toxic for reproduction fertility categories 1 and 2: | T; R60 |
Toxic for reproduction development categories 1 and 2: | T; R61 |
Toxic for reproduction fertility category 3: | Xn; R62 |
Toxic for reproduction development category 3: | Xn; R63 |
a In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.] | ||
Classification of the substance | Classification of the preparation | |
---|---|---|
Categories 1 and 2 | Category 3 | |
Carcinogenic substances of category 1 or 2 with R45 or R49 | Concentration ≥ 0,1 % carcinogenic R45, R49 obligatory as appropriate | |
Carcinogenic substances of category 3 with R40 | Concentration ≥ 1 % carcinogenic R40 obligatory ( unless already assigned R45 a ) | |
Mutagenic substances of category 1 or 2 with R46 | Concentration ≥ 0,1 % mutagenic R46 obligatory | |
Mutagenic substances of category 3 with R68 | Concentration ≥ 1 % mutagenic R68 obligatory ( unless already assigned R46 ) | |
Substances ‘ toxic for reproduction ’ of category 1 or 2 with R60 (fertility) | Concentration ≥ 0,2 % toxic for reproduction (fertility) R60 obligatory | |
Substances ‘ toxic for reproduction ’ of category 3 with R62 (fertility) | Concentration ≥ 1 % toxic for reproduction (fertility) R62 obligatory ( unless already assigned R60 ) | |
Substances ‘ toxic for reproduction ’ of category 1 or 2 with R61 (development) | Concentration ≥ 0,2 % toxic for reproduction (development) R61 obligatory | |
Substances ‘ toxic for reproduction ’ of category 3 with R63 (development) | Concentration ≥ 1 % toxic for reproduction (development) R63 obligatory ( unless already assigned R61 ) |
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