Omnibus Regulation 2019

EU Cosmetics Regulation: State of play of the current regulatory developments

Several important cosmetic ingredients are currently in the process of being regulated by the EU Commission and the biggest uncertainty now concerns the timeline for enforcement and implementation of these new risk management measures.

Biorius informed you about several ongoing issues and made assumptions on when these amendments of the EU Cosmetics Regulation would get published. The fact is that most of these regulatory developments take more time than expected and, with this information letter, Biorius would like to report the state of play of these current regulatory developments and explain why they have been delayed.

The processing of ongoing dossiers has been slowed considerably or even put on hold by the EU Commission due to important organizational changes. These changes occurred coincidentally at several levels of governance and can be summarized as follows:

Political changes at the EU Commission

Following the European elections of May 22-25, 2014, a new EU Parliament took shape and a new Commission was appointed. Jean-Claude Juncker, confirmed by the Parliament on July 15th, 2014 is the new President of the EU Commission since November 1st, 2014.

The new EU Commission nominated by Juncker is much more political than Manuel Barroso’s college of Commissioners, has a different structure and clearly targets different priorities. While the EU Commission isrelatively flat in itsstructure (with the President and as many Commissioners as they are EU Member States, all with the same hierarchical level), Juncker’s Commission is composed of the President, the first Vice-President, the High Representative, five Vice-Presidents (also called super Commissioners) and twenty Commissioners.

Changes in the organizational chart

It is also noteworthy that the responsibility for the management of Health Technology and Cosmetics moved from DG SANCO (B2 Unit) to DG GROWTH (D4 Unit) in Juncker’s Commission. High-level staff has been completely reshuffled and the previous Chief of the Health Technology and Cosmetics unit Sabine Lecrenier is now replaced by Salvatore d’Acunto.

Changes in the unit staff

Almost as important as the points outlined above, the staff of the Health Technology and Cosmetics unit has been partly replaced for various reasons over the last few months and the new staff has still a relatively limited experience of the ongoing dossiers.


What does it mean in terms of practical consequences for the current regulatory developments? It would be speculative for Biorius to calculate a new date for the publication of each ongoing dossier. However, it can at least be reported that the amendment on fragrance allergens is expected to be enforced around February 2016 (instead of May-June 2015!). This piece of information comes directly from IFRA and an information letter giving more details on this topic will be published soon.

Furthermore, Biorius received many questions on Zinc Oxide as the current regulatory development aiming to add this ingredient to Annex VI (positive list of UV filters) of the EU Cosmetics Regulation is eagerly awaited by cosmetics manufacturers. Based on the recent SCCS Scientific Opinions on this topic and the exchange between the EU Commission, the Industry and
the EU Member States, Biorius can safely conclude that this addition to the annex will come one day even though there is no certainty on the date. Challenged by the Industry on the definition of “sprayable products”, the SCCS revised its latest Opinion on December 16th, 2014 to confirm that zinc oxide is safe for use in all products including in sprayable products at the exclusion of cosmetics dispensed by the use of propellant gas, which generates respirable airborne particles. It seems that everything is now clear from a scientific perspective and the amendment should now
get formally validated by the EU Commission.

Any questions?


  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

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