EU Updates Annexes V and VI to the Cosmetics Regulation

by Percefoni Doufou-Shafiq, Ph.D., senior regulatory specialist, Supply Chain team, UL Solutions 

On July 7, 2022, and July 8, 2022, respectively, the EU Commission published Regulation (EU) 2022/1176, amending the Cosmetics Regulation (EU)1223/2009 by updating Annex VI (UV filters allowed in cosmetic products) and Regulation (EU) 2022/1181, updating the preamble of Annex V to the Regulation (preservatives allowed in cosmetic products). 

The amendment of Annex VI regarding substances benzophenone-3 (CAS No 131-57-7) and octocrylene (CAS No 6197-30-4) is based on the safety assessment findings performed by the Scientific Committee for Consumer Safety (SCCS). Stakeholders requested this assessment because available data indicated potential endocrine disrupting properties for these two substances. The SCCS concluded that benzophenone-3 and octocrylene are not safe for consumers as UV filters up to the current maximum concentration of 6% in sunscreen products, either in the form of body cream, sunscreen propellant spray or pump spray. 

The SCCS advised that benzophenone-3 is safe to use by consumers as a UV filter, in maximum concentrations of 6% in face cream, hand cream and lipsticks (excluding propellants and pump sprays) and 2.2% in body creams, propellants and pump sprays. If benzophenone-3 is used in the same product at 0.5% for formulation protection, concentrations of the substance in the product should be adjusted accordingly to not exceed the maximum allowed concentrations.

For octocrylene, the SCCS concluded that the substance is safe as a UV filter at a maximum concentration of 10% in cosmetic products when used individually or for combined use with sunscreen cream or lotion, sunscreen pump spray, face cream, hand cream and lipstick. For combined use with propellant sprays, the concentration should not exceed 9% when the other products used in combination contain 10% octocrylene.

The amendment is applicable from July 27, 2022, with an allowed transition period until Jan. 28, 2023, for new products and July 28, 2023, for existing products in order for the industry to adjust to the new requirements.

Regulation (EU) 2022/1181 amended the preamble to Annex V regarding the labeling requirements for products containing formaldehyde (Cas No 50-00-0), from formaldehyde-releasing substances. The amendment is based on the safety assessment findings of the Scientific Committee for Consumer Safety (SCCS). 

Formaldehyde, classified as a carcinogen (Category 1B) and skin sensitizer (Category 1), is prohibited from use in cosmetic products. There are, however, preservative substances listed in Annex V of the Cosmetics Regulation that release formaldehyde, and cosmetic products with a concentration of released formaldehyde exceeding 0.05% should include a warning ‘’Contains formaldehyde’’ on the label.

The SCCS advised that the threshold concentration of 0.05% for triggering the warning on the label did not adequately protect consumers sensitized to formaldehyde. Therefore, it concluded that the threshold over which the warning "Releases Formaldehyde" is printed on the label should be decreased to 0.001%, regardless of whether the finished product contains one or more formaldehyde-releasing substances.

The amendment is applicable from July 28, 2022, but given the number of cosmetic products that can be affected by the new requirement, a transition period of 24 and 48 months for new and existing products has been set, respectively, in order to allow the industry to adapt to the new labeling and formulation requirements.

UL Solutions ChemADVISOR^® Regulatory Database is being updated to reflect the changes.

Sources

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
Amendment (EU) 2022/1176
Amendment (EU) 2022/1181