Subject: Publication of the ‘Omnibus Regulation’ – Update of IL-044 and IL-045
Article 15 of the European Cosmetics Regulation regulates the use of CMR substances in cosmetic products. In principle, the use of CMR substances is prohibited in the EU although exemptions remain possible under specific conditions. The regulatory procedure implies the publication of an amendment to Annex II (prohibited substances) before a ban takes effect. Annex III (restricted substances) and Annex V (preservatives) may also have to be adapted if an exemption is granted.
The long-awaited Regulation EU No 2019/831 (so-called ‘Omnibus Regulation’) has been adopted on May 22nd and explicitly prohibits the use of 227 substances. Furthermore, it further restricts the use of four others. Most of the banned substances were not used in cosmetic products anyway and are reported in this regulation to adapt the European Cosmetics Regulation to the new classifications of the CLP Regulation (EC No 1272/2008). Only the substances reported below have a documented usage in cosmetic products:
Cosmetic ingredients prohibited (addition to Annex II):
The non-intentional presence of Cyclotetrasiloxane will be tolerated. Indeed Cyclotetrasiloxane is a common impurity stemming from the manufacturing process of other silicones such as Cyclopentasiloxane or Dimethicone. The trace level not to exceed can be determined as follows:
- Maximum 0.1% in rinse-off products because of the REACH Restriction (see IL-051) limiting the presence of D4, D5 and D6 in wash-off products at 0.1%, whatever their source and function, from January 31st, 2020.
- Maximum 0.3% in leave-on products because exceeding this concentration can hardly be considered as unavoidable in Good Manufacturing Practices.
Cosmetic ingredients further restricted (addition to Annex III):
The use of Trimethylbenzoyl diphenylphosphine oxide will only be permitted for the application of artificial nail systems. Beyond the concentration limit, the following warnings will have to be listed on the product labels:
- For professional use only
- Avoid skin contact
- Read directions for use carefully
Cosmetic ingredients further restricted (addition to Annex V):
However, the use of Polyaminopropyl Biguanide is prohibited in applications that may lead to exposure of the end-user’s lungs by inhalation (aerosols, sprays if the size of droplets are below 10 ?M, loose powders, etc.).
This regulation will be enforced on June 11th, 2019. As previously communicated, no transition period will be granted and the legal requirements will therefore start to apply at the enforcement date of the regulation.
We hope that this letter will be of help and stay at your disposal for any questions related to this topic. Should you have any question, please, feel free to contact your dedicated Account Manager.
Dr. Fred Lebreux