50 GLOBAL REGULATIONS
Regulation (EU) 2021/849. These will be added to Annex II (entries 1681 to 1694). The European Commission also has decided
to restrict the use of the fragrance ingredient Methyl Salicylate which has been classified as CMR 2 by Delegated Regulation (EU) 2021/849 and to include it in Annex III (entry 324). For substances classified as CMR 2, article 15 of regulation (EC) 1223/2009 requires that the SCCS evaluates its safety. The SCCS, in their opinion of 26-27 October
2021, considered Methyl Salicylate to be safe when used with restrictions. The European Commission has adopted
the SCCS opinion and restricted the maximum concentration of Methyl Salicylate in cosmetic products as follows: 0.06% in leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic based fragrances) and leave-on hair products (except spray/aerosol products); 0.05% in face makeup (except lip products, eye makeup and makeup remover; 0.002% in eye makeup and makeup remover; 0.009% in leave- on hair products (spray/aerosol ); 0.003% in deodorant spray/aerosol; 0.04% in body lotion spray/aerosol; 0.06% in rinse-off skin products (except hand wash) and rinse-off hair products; 0.6% in hand wash; 0.6% in hydroalcoholic based fragrances; 0.03% in lip products; 2.52% in toothpaste; 0.1% in mouthwash intended for children aged six to ten; 0.6% in mouthwash intended for children above ten years of age and adults; and 0.65% in mouth spray. Methyl Salicylate should not be used in
products for children under six except for toothpaste. In addition, Commission Regulation (EU) 2022/1531 corrects the entries in regulation (EC) 1223/2009 for Sodium Hydroxymethylglycinate.
Commission Regulation (EU) 2022/2195 Butylated Hydroxytoluene (BHT) has been identified as a potential endocrine disruptor. The SCCS was asked to consider whether BHT was safe to use in cosmetic products and concluded that it poses a potential risk to human health when the concentration exceeds 0.001% in mouthwash, 0.1% in toothpaste and 0.8% in other leave-on and rinse-off products.4 Commission Regulation (EU) 2022/2195 adopts the SCCS opinion and adds BHT to Annex III (entry 325). The SCCS was asked if Acid Yellow 3 was
safe to be used in non-oxidative hair colouring products and concluded that it was providing the on head concentration does not exceed 0.5%.5
Acid Yellow 3 has been added to Annex
III (entry 326). For BHT and Acid Yellow 3, cosmetic
products not complying with this amendment to the cosmetic regulation must be placed on the EU market before 1 July 2023 and must be off the market before 1 January 2024. Homosalate is a UV filter listed in Annex
VI (entry 3). In light of Homosalate being a potential endocrine disruptor the SCCS was asked to consider whether Homosalate is safe as a UV filter in cosmetic products up to a maximum concentration of 10 %. They concluded that it was safe in cosmetic products up to a maximum concentration of 0.5%.6 Following this opinion, the cosmetic industry
submitted a revised margin of safety calculation to support the safe use of Homosalate. The SCCS concluded that Homosalate is safe at up to 7.34% in face cream and pump spray products,7
but not when combined with the use
in all cosmetic products at 0.5%. Commission Regulation (EU)
2022/2195 adopts the SCCS opinion and restricts its use to 7.34% in face products with the exception of propellent face products. Products containing Homosalate that do not comply with this amendment to the cosmetic regulation must be placed on the market before 1 January 2025 and must be off the EU market before 1 July 2025. Bis-(Diethylaminohydroxybenzoyl Benzoyl)
Piperazine is a UV filter that has not previously been regulated by the EU cosmetic regulation (EC) 1223/2009. The SCCS in September 2014 concluded that it was safe to use in non-nano form (micronized or non-micronised, with a median particle size distribution of 134 nm or larger) at a concentration of up to 10%.8 In September 2020, the industry submitted additional information supporting its use in nano form. The SCCS concluded in October 2021 that its use in nano form as a UV filter in dermally applied cosmetic products up to a maximum concentration of 10% is safe providing the minimum purity is equal to or above 97% and median particle size in term of particle number is equal to or greater than 50 nm.9 The combined use of nano and non-nano
forms should not exceed 10%. The SCCS does not recommend its use in products which could lead to it being inhaled into the lungs. Commission Regulation (EU) 2022/2195 adopts this opinion and adds Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine in its non-nano and nano forms to Annex VI (entries 33 and 34 respectively). The nano form is not permitted to be used in applications that might lead to the end user’s lungs being exposed to it by inhalation. Commission Regulation (EU) 2022/2195 also
corrects the entry for Resorcinol (Annex III entry 22) by deleting the do not use on eyebrows restriction.
Nanomaterials On 23 May 2023, the European Commission notified the World Trade Organisation of its intention to prohibit the use of the following nano materials and to add them to Annex II of Regulation (EC)1223/2009: Styrene/ Acrylates Copolymer (nano), Sodium Styrene/ Acrylates Copolymer (nano), Copper (nano), Colloidal Copper (nano), Colloidal Silver (nano), Gold (nano), Colloiodal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano), Acetyl Heptapeptide-9 Colloidal Gold (nano), Platinum (nano), Colloidal Platinum (nano), Acetyl Tetrapeptide-17 Colloidal Platinum. Following the SCCS opinion that
Hydroxyapatite (nano) is safe when used at concentrations up to 10% in toothpaste and up to 0.465% in mouthwash,10
the European
Commission intends to restrict its use to these concentrations and to add it to Annex III. Only nanomaterials composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9 will be permitted to be used in cosmetic products in the EU. The particles must not be coated or surface
modified. They must not be used in applications that may lead to exposure of the end-user’s
PERSONAL CARE July 2023
www.personalcaremagazine.com
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