Omnibus Regulation 2019

The case of Peanut oil and Hydrolyzed Wheat Protein

Follow-up: New Legal Requirements for Peanut Oil and Hydrolyzed Wheat Protein

December 5th, 2017

On December 4 th , 2017, the EU Commission published a new amendment to the EU Cosmetics Regulation (EU No 2017/2228) related to Peanut Oil (plus its extracts and derivatives) and Hydrolyzed Wheat Protein. The use of these two ingredients will not be restricted butspecific purity criteria will be implemented to reduce the risk of anaphylactic shock when consumers are exposed to cosmetics. The regulatory proposal highlighted in above was accepted as such.

This new amendment to the EU Cosmetics Regulation will enter into force on December 25 th, 2017 and the transitional period has been validated as follows:

  • From September 25 th, 2018 (~9 months from now) only cosmetic products which comply with this Regulation shall be placed on the Union market.
  • From December 25 th, 2018 (~12 months from now) only cosmetic products which comply with this Regulation shall be made available on the Union market.

Any questions?

Peanut Oil / Hydrolyzed Wheat Protein Currently under Public Consultation

April 18th, 2016

The EU Commission published new public consultations to evaluate the feasibility of two regulatory proposals and determine their socio-economic impact on the industry and the market. Both public consultations will end on July 1 st , 2016 and you are welcome to voice your concerns in case you have robust arguments to share.

The first public consultation relates to the addition of Peanut Oil and Hydrolyzed Wheat Protein to Annex III of the EU Cosmetics Regulation. In order to reduce the incidence of type I allergies to these ingredients, the EU Commission proposes to enforce the purity criteria reported below:

Name of the ingredient CAS Purity criteria
Peanut oil, extracts and derivatives 8002-03-7, 68425-36-5, 68440-49-3, 93572-05-5, 61789-57-9, 73138-79-1 0.5 ppm of peanut protein
Hydrolized wheat protein 94350-06-8, 222400-28-4, 70084-87-6, 100209-50-5 Maximum molecular weight average of the peptides in hydrolysates: 3,5 kDa

This amendment of the EU Cosmetics Regulation would come with a transition period of 9 months for placing compliant products on the market and 12 months for withdrawing non-compliant products from the market..

Author

  • Christophe Brault-Chevalier is the Scientific & Regulatory Affairs Director at Biorius, bringing over 20 years of experience in the cosmetics industry. He has previously held positions at International Flavors & Fragrances Inc. (IFF) and LVMH, further enhancing his expertise in the field.

    View all posts Scientific & Regulatory Affairs Director @ BIORIUS