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Pharmacosmetech show 2022
Thursday, July 12, 2012SCCS

SCCS: 3 new opinions open to comments

©CosmeticOBS-L'Observatoire des Cosmétiques

The opinions of the SCCS, released during the 15th Plenary session, held on June 26 and 27, are numerous. In the today list:  N-nitrosodiethanolamine, benzisothiazolinone and kojic acid.

Reading time
~ 3 minutes

N-nitrosodiethanolamine (NDELA) et N-nitrosodimethylamine (NDMA)

Theses nitrosamines may be present as contaminants in a number of products including food (such as certain beverages), tobacco products, rubber products and cosmetics.

NDELA and NDMA are classified as category 1B carcinogens. Cosmetic products containing nitrosamines including NDELA are banned under the Cosmetics Directive and its annex III refers to the limit of 50 μg/kg for nitrosamines. Furthermore, limit values for nitrosamines and nitrosatable substances in toys were established in the new Toys Safety Directive; they enter into force on 20 July 2013.

However, not all authorities agreed to the classification of the risk as “serious”. SCCS releases today a line of argument on the topic of exposure levels to these substances, adding in its conclusion that the end classification will come as a risk management decision.

For further information
• See the full text of the Opinion on NDELA in cosmetic products (SCCS, 2012)

Benzisothiazolinone

Benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and therefore cannot be used as preservative. The industry has requested the inclusion of benzisothiazolinone in Annex VI in order to allow its use in cosmetic products.

The SCCS considers benzisothiazolinone safe for use as a …

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