Eightieth Commission Directive 95/34/EC of 10 July 1995 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

18th COMMISSION DIRECTIVE 95/34/EC of 10 July 1995 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 94/32/EC (2), and in particular Article 8 (2) thereof,
After consultation of the Scientific Committee on Cosmetology,
Whereas furocoumarines are recognized to be photomutagenic and photocarcinogenic; whereas the Scientific Committee on Cosmetology has not been able to conclude from the available scientific, technical and epidemiological data that the association of protective filters with furocoumarines would guarantee the safety of sun protection and bronzing products containing furocoumarines above a minimum level; whereas, in order to protect public health, it is therefore necessary to limit furocoumarines to less than 1 mg/kg in these products;
Whereas 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette), is recognized to be a potent photoallergen; whereas, on the basis of recent scientific research, use of this substance in cosmetic products poses a risk to human health; whereas it is therefore necessary to prohibit its use;
Whereas toxicological evaluation of Diisobutyl-phenoxy-ethoxy-ethyldimethylbenyl-ammonium chloride (Benzethonium), shows that this ingredient is toxic to a significant degree; whereas the safety margin for human health, when this ingredient is used in cosmetic products, is inadequate; whereas it is therefore necessary to prohibit its use;
Whereas cells, tissues or products of human origin are liable to transmit the Creutzfelt-Jakob disease, human spongiform encephalopathy, and certain virus diseases; whereas it is therefore necessary, given the current state of scientific knowledge, to prohibit their use in cosmetic products;
Whereas recent toxicological studies of 3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein*); show a net clastogenic effect in vitro; whereas the safety margin is low, especially where children are concerned; whereas it is therefore necessary to prohibit its use;
Whereas, on the basis of the latest scientific and technical research, 2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester may be used as ultraviolet filter in cosmetic products;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector,