New amendments to the Cosmetics Regulation

The Commission adopted Regulation 2018/885 and Regulation 2018/978 during the summer of 2018, amending Annexes VI and II and III of the Regulation (EC) No 1223/2009 (Cosmetics Regulation) respectively.

What are the amendments to Annex VI?

The amendment to Annex VI concerns the nano version of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (MBBT). MBBT is allowed for use in cosmetic products as UV-filter with maximum concentration of 10%. The use of MBBT (nano) was, up until this amendment, not regulated.

From July 2018 and following the opinion of the Scientific Committee on Consumer Safety (SCCS) from 25 March 2015, the Commission had authorized the use of MBBT (nano) as UV-filter in cosmetic products at a maximum concentration of 10%, except in applications that may lead to the exposure of the end-user’s lungs to the ingredient by inhalation. The Annex also mentions certain characteristics which the nanomaterial must possess to be considered as safe for use.

What are the amendments to Annexes II and III?

The second amendment is with regards to flower extracts and oils from the ingredients Tagetes erecta, Tagetes minuta and Tagetes patula, which are widely used in fragrances.

In light of various SCCS opinions, the following changes were introduced:

  • The flower oil and extract of Tagetes erecta were added as entries to Annex II and from 1 May 2019 cosmetic products containing the substance shall not be placed on the Union market. From 1 August 2019 cosmetic products containing the substance shall not be made available on the Union market.
  • The flower oil and extract of Tagetes minuta and Tagetes patula are allowed for use under Annex III in leave-on products up to 0.001% and in rinse-off products up to 0.1%, except for sunscreen products and products marketed for exposure to natural/artificial UV light. The same dates as the abovementioned must be respected with regards to compliance.

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As a professional EU Responsible Person Center, Obelis specializes in the European Regulatory framework and will continue to keep track of the latest developments of the European Regulations in order to provide our clients with the best and most up-to-date information.

If you wish to ensure that your products comply with the EU Cosmetics Regulation, please contact us!

Efrosina Zhivkova

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