REGULATORY – DOES YOUR SUNSCREEN CONTAIN OCTOCRYLENE AND/OR BENZOPHENONE 3?

On 7 July 2022, Regulation (EU) 2022/1176 was published amending Regulation (EC) 1223/2009 regarding the use of two UV filters used on cosmetics, Benzophenone-3 and Octocrylene.

Both substances are considered of concern for the human health for their potential endocrine-disrupting properties. For this reason, the SCCS published two opinions, SCCS/1625/20 and SCCS/1627/21. After reviewing these Opinions, the European Commission amended Annex VI to Regulation 1223/2009 entries 4 for Benzophenone-3 and 10 for Octocrylene.

The new entries of Annex VI are the following:

Annex VI/4: Benzophenone-3:

  1. a) Face products, hand products and lip products, excluding propellant and pump spray products. Maximum concentration in ready use preparation is 6%.
  2. b) Body products, including propellant and pump spray products. Maximum concentration in ready use preparation is 2%.
  3. c) Other products. Maximum concentration in ready use preparation is 5%.

Furthermore, for a) If used at 0.5% to protect formulation, the levels used as UV filter must not exceed 5.5%. For b) If used to protect product formulation, the levels used as UV filter must not exceed 1.7%.

For a) and b) the warning “Contains Benzophenone-3” must be declared on the label unless the concentration is 0.5% or less and when it is used only for product protection purposes.

Annex V/10: Octocrylene:

  1. a) Propellant spray products. Maximum concentration in ready use preparation is 9%.
  2. b) Other products. Maximum concentration in ready use preparation is10%.

The Regulation went into force on 28 July 2022. The limit date to comply with the restrictions set out in Regulation (EC) No 1223/2009 is 28 July 2023.

Therefore, few days remaining to comply with the new restrictions!

SHAPYPRO can help you review your formulas and comply with the European Regulation.

Contact us for further information:

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