Titanium dioxide CMR form exemption conditions
On May 28, 2021, the Official Journal of the European Union announced the amendment of the European Commission (EU) No. 2021/850, mainly regarding the CMR substances determined in the authorization regulation (EU) No. 2020/217, and the EU Cosmetics Regulation (EC) No 1223/2009 Appendices II, III, IV and VI are amended to deal with regulatory provisions for substances such as titanium dioxide and salicylic acid.
Titanium dioxide and its nanoforms, currently regulated by Article 143 of Annex IV and Article 27/27a of Annex VI of the EU Cosmetics Regulation, can be used as a colorant or sunscreen. Authorization Regulation (EU) No. 2020/217 identifies titanium dioxide powder with a particle content of 1% and above with an aerodynamic diameter of ≤10 microns as a Category 2 inhalation carcinogen, to be regulated as required by the EU CLP Regulation from 1 October 2021 .
According to Article 15 of the EU Cosmetics Regulations, Class 2 CMR substances can be exempted from ban if they are safe to use in cosmetics after being assessed by the EU Consumer Safety Scientific Committee SCCS. On October 6, 2020, the SCCS issued a scientific opinion on the use of titanium dioxide in cosmetics with inhalable exposure (SCCS/1617/20). In the conclusion of the opinion, the SCCS stated that titanium dioxide powder with a particle content of 1% and above with an aerodynamic diameter of ≤10 microns is used at a concentration of 25% for facial loose powder products and 1.4% for hair aerosol spray-type products. , are safe for ordinary consumers; and for professionals, the safe concentration of hair aerosol spray products is 1.1%.
Based on the above opinions of SCCS, the EU has decided to authorize titanium dioxide powder with a particle content of 1% or more with aerodynamic diameter ≤10 microns to be used as restricted substances in cosmetics, colorants for cosmetics and sunscreens. Therefore, Annex III, Article 143 of Annex IV, Article 27 of Annex VI of the EU Cosmetics Regulations are revised as follows, and will be implemented from October 1, 2021.
The following clauses have been added to Annex III of the EU Cosmetics Regulations
Editor's Note: The reference number in the table below is x. The content is updated according to Article 143 of Appendix IV and Article 27 of Appendix VI. The reference number here should be 321, so this modification is made for reading. The specifics are subject to the official update later.
Clause 143 of Annex IV of the EU Cosmetics Regulation is replaced by the following clause
Clause 27 of Annex VI of the EU Cosmetics Regulation is replaced by the following clauses
When used for non-preservative purposes, salicylic acid is regulated by Article 98 of Annex III of the EU Cosmetics Regulation. In 2019, the European Commission (EU) Amendment No. 2019/1966 updated this clause with new restrictions (read more), effective from 1 May 2020. However, this revised clause does not fully cover the safe use scenarios in the conclusions of the SCCS opinion on the safety of salicylic acid (SCCS/1601/18, learn more). Based on this, the European Commission decided to expand the use of salicylic acid in cosmetics and authorize it to be used in body lotions, eye shadows, mascaras, eyeliners, lipsticks and deodorant roll-on products, and to amend Clause 98 of Annex III of the EU Cosmetics Regulations. Effective from June 17, 2021, the details are as follows.
Clause 98 of Annex III of the EU Cosmetics Regulation is replaced by the following clauses
Include new CMR substances on the list of banned substances
With the exception of titanium dioxide, none of the other substances identified as CMR substances by Authorization Regulation (EU) 2020/217 are exempted from use in cosmetic products. Therefore, the European Commission has decided to add substances not included in the list of prohibited substances in cosmetics to the supervision of Annex II of the EU Cosmetics Regulations, which will be implemented from October 1, 2021. The specific substances are as follows.
Editor's Note: The reference number column in the table below in the original text is all 'x'. It is recommended to pay attention to the recent official update, and it should be corrected and the corresponding serial number will be determined.