GLOBAL REGULATIONS
49
EU Cosmetic Regulations amendments – an update
Martin Perry - Advanced Development and Safety Laboratories
In the July 2022 edition of Personal Care Global, I reviewed changes to the European Cosmetics Regulation (EC) No 1223/2009, the European Union’s notifications to the World Trade Organisation of its intention to prohibit the use or certain nanomaterials and the Scientific Committee on Consumer Safety (SCCS) opinions on ingredients which may have endocrine properties. This article follows on from that article and
looks at more recent amendments to Regulation (EC) 1223/2009 and at future changes to this regulation. It then looks at the United Kingdom’s cosmetic regulation and the changes that have been made to it since the country left the European Union.
Commission Regulation (EU) 2022/1176 Benzophenone-3 and Octocrylene are both UV filters listed in Annex VI (entries 4 and 10 respectively). The SCCS was asked to review the safety of both as they had been identified as potential endocrine disruptors. The SCCS concluded in their March 2021 opinion that Benzophenone-3 is not safe for use as a UV filter at up to 6% in sunscreen products when used in body cream, sunscreen propellant spray or pump spray.1 However, they did say that Benzophenone-3
is safe up to a maximum concentration of 6% in face cream, hand cream, and lipsticks, 2.2% in body creams, propellent sprays and pump sprays and 0.5% when used to protect the product. Commission Regulation (EU) 2022/1176 adopts this opinion and amends the entry in the EU cosmetic regulation. Products containing Benzophenone-3 must be labelled with the warning “Contains Benzophenone-3” unless the concentration is 0.5% or lower and it is being used with the sole purpose of protecting the product. The SCCS reviewed the safety of Octocrylene
and concluded that it was safe as a UV filter in cosmetic products at up to 10% when used individually.2
The SCCS concluded that
Octocrylene is safe for a combined use of sunscreen cream or lotion, sunscreen pump spray, face cream, hand cream and lipstick at a concentration up to 10%, but that the use of Octocrylene in propellent spray products is only safe at a maximum concentration of 9% when used in combination with face cream, hand cream or lipstick containing 10% Octocrylene. Commission Regulation (EU) 2022/1176 adopts
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this opinion and amends the entry for Octocrylene in the EU cosmetic regulation restricting the use of Octocrylene to 9% in propellant spray products and 10% in all other products. For products containing Benzophenone-3
and Octocrylene that no longer comply with the EU cosmetic regulation following its amendment could be placed on the EU market until 28 January 2023 but have to be off the market by 27 July 2023.
Commission Regulation (EU) 2022/1181 Commission Regulation (EU) 2022/1181 relates solely to the labelling of products that contain formaldehyde-releasing preservatives. Formaldehyde is classified as carcinogenic category 1B and a skin sensitizer by Regulation (EC) 1272/2008 (CLP regulation) and is prohibited for use in cosmetic products in the EU. Products containing formaldehyde-releasing
preservatives have to be labelled with the phrase “contains formaldehyde” when the concentration of formaldehyde in the finished product exceeds 0.05%. The SCCS in their May 2021 report concluded that the threshold for using the phrase “contains formaldehyde” of 0.05% (500 ppm) does not sufficiently protect the consumer from sensitization to formaldehyde and that the threshold
for using the phrase should be lowered to 0.001% (10 ppm),3
and should apply to the
total formaldehyde released irrespective of whether the product contains one or more formaldehyde-releasing substances. Commission Regulation (EU) 2022/1181
requires that all cosmetic products containing formaldehyde-releasing substances listed in Annex V be labelled with the warning “releases formaldehyde” when the total concentration of formaldehyde exceeds 0.001% (10 ppm) irrespective of whether the finished product contains one or more formaldehyde-releasing substances. Cosmetic products containing formaldehyde-releasing substances which comply with the EU cosmetic regulation on 30 July 2022 may be placed on the EU market until 31 July 2024 and may remain on the market until 31 July 2026.
Commission Regulation (EU) 2022/1531 Article 15 of regulation (EC) 1223/2009 requires that substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) category 1A, 1B or 2 by Regulation (EC) 1272/2008 are prohibited from use in cosmetic products unless the criteria set down in article 15 are met. The European Commission has decided to prohibit the use of 14 substances that were classified as CMR by Delegated
July 2023 PERSONAL CARE
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