Request a Demo
On Oct. 14, 2021, European Union consulted on the revised use conditions for Benzophenone-3 and Octocrylene in the List of UV Filters Allowed in Cosmetic Products of Regulation (EC) No 1223/2009 and the new threshold for labelling formaldehyde releasers on the finished cosmetic products containing substances in the List of Preservatives Allowed in Cosmetic Products. The final date for comments about the revisions is December 13, 2021.
1. Benzophenone-3 (CAS Number: 131-57-7)1
Revised Conditions | Current Conditions | |
Product type, body parts | a) Face products, hand products, and lip products, excluding propellant and pump spray products b) Body products, including propellant and pump spray products c) Other products | / |
Maximum concentration in ready use preparation | a) 6% b) 2.2% c) 0.5% | 6% |
Other | For a) and b): Not more than 0.5% to protect product formulation a) If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 5.5%. b) If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 1.7%. | Not more than 0.5% to protect product formulation |
Wordings of conditions of use and warnings | For a) and b): Contains Benzophenone-3 | Contains Benzophenone-3 |
2. Octocrylene (CAS Number: 6197-30-4)1
Revised Conditions | Current Conditions | |
Product type, body parts | a) Propellant spray products b) Other products | / |
Maximum concentration in ready use preparation | a) 9% b) 10% | 10% (as acid) |
3. Threshold for Labelling Formaldehyde Releasers 2
According to the Preamble of the Annex V (List of Preservatives Allowed in Cosmetic Products) to Regulation (EC) No 1223/2009, all finished products containing substances in the List and which release formaldehyde must be labelled with the warning “contains formaldehyde” where the concentration of formaldehyde in the finished product exceeds 0.05%. Taking into account the advice of the Scientific Committee on Consumer Safety (SCCS), European Union is now proposing to lower the current threshold for labelling formaldehyde releasers from 0.05% to 0.001% in order to further protect consumers sensitised to formaldehyde.
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
