An extended consequence of the 7th amendment
The 7th amendment of the European Directive n° 76/768/EEC – directive 2003/15/EC of the 27th February 2003 - bans the use in cosmetics of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1, 2 or 3 under annex I to Council Directive 67/548/EEC.
However, it allows the use of substances classified in category 3, if evaluated and found acceptable by SCCP.
Recently, the Commission Directive 2005/80/EC of 21 November 2005 was published in order to amend annexes II and III to Directive 76/768/EEC accordingly.
In its Opinion of September 2001, confirmed by Opinion of 21 June 2005, SCCP considered that “if a carcinogenic, mutagen or a substance toxic to reproduction is present in a cosmetic product from its presence in a natural ingredient, as an impurity or because it is formed during the manufacture, it must be demonstrated that the product does not pose a threat to the health of the consumer”.
Although initial provisions targeted only CMR substances intentionally added to cosmetic products, the SCCP Opinion and the precautionary principle lead the cosmetic industry to require all information to the possible presence of all CMR substances in botanical ingredients.
With the view to enable ingredients manufacturers to reply accurately, Unitis conducts with 3 European Experts a large study on the possible presence of CMR in living botanicals that has been extended to all dangerous substances listed in the directive 67/548/EEC.