Newly banned ingredients under the EU Cosmetics Regulation

This summer the Commission adopted Regulation 2019/831, amending Annexes II, III and V of the Regulation (EC) No 1223/2009 (Cosmetics Regulation).

What are the amendments to Annex II?

The new Regulation introduces 226 new ingredients and replaces one entry in Annex II of the Cosmetics Regulation. These ingredients are considered as banned for use in cosmetic products as of the date of entry into force of the new Regulation, namely the 12th of June 2019.

The newly banned ingredients were already classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 (CLP Regulation). With the current Regulation the Commission aims at implementing uniformly the prohibition of CMR substances within the internal market, to ensure legal certainty with regards to competent authorities and cosmetic manufacturers and to ensure high level of human health. Notable examples of ingredients which were added to Annex II are Octamethylcyclotetrasiloxane (also known as D4), Quaternium-15 and Formaldehyde.

What are the amendments to Annexes III and V?

The amendment to Annex III concerns the ingredients:

· Hydrogen Peroxide, which will now be allowed for use, under certain conditions, in oral products and in product intended for the eyelashes.

· Trimethylbenzoyl diphenylphosphine oxide, which can be used up to 5% in artificial nail systems for professional use

· Furfural, which can be used with maximum concentration of 0.001%.

The amendment to Annex V concerns the ingredient Polyaminopropyl biguanide, which can be used up to 0.1% as long as there is no risk that the end user might inhale the ingredient.

Additionally, the ingredients which were previously in Annex III or V and are now in Annex II were deleted from the former annexes.

Efrosina Zhivkova

Expert Consultant at RA Department

July 22, 2019

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