The EU publishes Regulation amending annexes impacting 9 cosmetic ingredients
On 3rd April 2024, the EU Commission published in the Official Journal of the EU the regulation amending the Annexes to the EU Cosmetic Products Regulation (CPR) with 9 cosmetic ingredients as detailed below:
Annex II inclusions and therefore banned in cosmetics:
- 4-methylbenzylidene camphor (UV filter) is not permitted to be placed on the market from 1st May 2025 and is not permitted to be available on the market from 1st May 2026
Annex III inclusions and therefore restricted in cosmetics:
- Alpha Arbutin - maximum concentration of 2% in face cream and 0.5% in body lotions. Hydroquinone levels shall remain as low as possible in formulations containing alpha- arbutin and shall not be higher than the unavoidable trace level. The ‘placing on the market’ deadline is 1st February 2025; the ‘making available’ deadline is 1st November 2025.
- Arbutin - maximum concentration of 7% in face cream.Hydroquinone levels shall remain as low as possible in formulations containing arbutin and shall not be higher than the unavoidable trace level. The ‘placing on the market’ deadline is 1st February 2025; the ‘making available’ deadline is 1st November 2025.
- Daidzein - maximum concentration of 0.02%. The ‘placing on the market’ deadline is 1st February 2025 and the ‘making available’ deadline is 1st November 2025.
- Genistein - maximum concentration of 0.007%. The ‘placing on the market’ deadline is 1st February 2025 and the ‘making available’ deadline is 1st November 2025.
- Kojic acid - maximum concentration of 1% in face and hand products. The ‘placing on the market’ deadline is 1st February 2025 and the ‘making available’ deadline is 1st November 2025.
- Retinol, Retinyl Acetate & Retinyl Palmitate - maximum concentration of 0.05% retinol equivalent in body lotions and maximum concentration of 0.3% retinol equivalent in other leave-on and rinse-off products. Cosmetic products containing these substances must also be labelled with the warning ‘Contains Vitamin A. Consider your daily intake before use.’ The ‘placing on the market’ deadline is 1st November 2025 and the ‘making available’ deadline is 1st May 2027.
Annex V of permitted preservatives amendments
- Triclocarban - permitted for use in all cosmetic products except mouthwash which has a maximum concentration of 0.2%. Purity criteria: 3,3',4,4'-tetrachloroazobenzene ≤ 1 ppm, 3,3',4,4'-tetrachloroazoxybenzene ≤ 1 ppm. Triclocarban cannot be used in toothpaste intended for children under 6 years of age. If a toothpaste contains triclocarban it must have the following warning ‘Not to be used for children under 6 years of age’.
- Triclosan - maximum concentration of 0.3% when used in in toothpastes, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders and blemish concealers, nail products for cleaning the fingernails and toenails before the application of artificial nail systems. Triclosan cannot be used in toothpaste intended for children under 3 years of age. If a toothpaste contains triclocarban it must have the following warning ‘Not to be used for children under 3 years of age’.
The ‘placing on the market’ deadline is 31st December 2024 and the ‘making available’ deadline is 31st October 2025 for both Triclocarban and Triclosan
The UK publishes an Update to the Annexes of the UK Cosmetics Regulation
On 3rd April 2024, the Office for Product Safety and Standards (OPSS) published a Statutory Instrument updating Annex III of the UK Cosmetics Regulation. Annex III contains substances which are restricted in cosmetic products.
The amendment restricts the use of butylated hydroxytoluene (BHT) in cosmetic products in the following use conditions:
- Toothpaste - maximum concentration of 0.1%
- Mouthwash - maximum concentration of 0.001%
- Leave-on oral care products - maximum concentration of 0.001%
- Other leave-on and rinse-off products - maximum concentration of 0.8%
The ‘placing on the market’ deadline is 24th February 2025 and the ‘making available’ (off-shelf) deadline is 24th June 2025.
Australia AICIS Amends Categorisation, Reporting, and Record-keeping Requirements for Industrial Chemicals
On 21st & 27th March 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced the amendments to the Industrial Chemical (General) Rules 2019 and the Industrial Chemicals Categorization Guidelines.
In Australia, chemical introductions must be completed before the chemicals are manufactured in or imported to Australia. They are divided into five categories:
- Listed introductions - Chemicals listed on the Australia Inventory of Industrial Chemicals (AIIC) and whose introduction is within the terms of the listing (if any)
- Exempted introductions - Chemical with very low risk
- Reported Introductions - Chemical with low risk
- Assessed Introductions - Chemical with medium to high risk
- Commercial Evaluation Authorisations - Chemicals whose commercial potential must be determined before introduction, and the commercial evaluation authorisation is needed
The amendments to the Rules are mainly on the introduction categorisation, reporting, and record-keeping. They include:
- Records replace some written undertakings, making compliance easier for introducers (manufacturers or importers) who find it difficult to obtain undertakings from chemical identity holders.
- International Nomenclature of Cosmetic Ingredients (INCI) names are accepted for the following three types of exempted/reported introductions, if the introducer does not know the CAS or IUPAC (International Union of Pure and Applied Chemistry) name.
- Chemicals imported and subsequently exported
- Research and development
- The highest indicative risk is at a low level, which means reported introductions apply to this type
3. The chemical introduction categorisation criteria are expanded for:
- Domestic soap makers
- Introducers of chemicals in flavour and fragrance blends
- Introducers of hazardous chemicals where introduction and use are controlled.
4. Criteria and/or reporting requirements are enhanced for health and environmental protection, as an effort to prevent persistent organic pollutants (POPs) from being categorised as exempted or reported introductions.
Key changes to the Guidelines include:
- Requirements are more detailed for checking hazardous esters and salts of chemicals on the “List of Chemicals with High Hazards for Categorization
- Highly hazardous chemicals are added to the List based on an AICIS assessment or evaluation
- Options are expanded for introducers to demonstrate the absence of skin irritation and skin sensitisation.
- More models are provided for in silico predictions; a test guideline is added for ready biodegradability.
The amendments are expected to reduce the challenges for chemical introducers in meeting their regulatory obligations, and strengthen the protection of human health and the environment from hazardous chemicals. The scheduled effective date of the amendments is 24th April 2024.
