China Looking To Implement Six-month Transition Period for Submission of Cosmetic Safety Assessment Report
The regulatory authorities are developing and aiming to promptly publish optimization measures and technical guidance documents pertaining to cosmetic safety assessment. Regarding the submission of a full version of safety assessment reports, a six-month transition period is under consideration. Registrants and notifiers of cosmetic products that have already started safety assessments before May 1, 2024, will be allowed to submit a simplified version of the report within a specified timeframe.
EU updates the Cosmetic Products Regulation 1223/2009 annexes for 13 Nanomaterials in Cosmetics
On 15th March 2024 the EU Commission published in its Official Journal regulation 2024/858 on nanomaterials.
The below nanomaterials are added to Annex II of the EU Cosmetic Products Regulation (CPR) and therefore banned for use in cosmetics:
- Styrene/Acrylates copolymer (nano), Sodium Styrene/Acrylates copolymer (nano)
- Copper (nano), Colloidal Copper (nano)
- Colloidal silver (nano)
- Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano), Acetyl heptapeptide-9 Colloidal gold (nano)
- Platinum (nano), Colloidal Platinum (nano), Acetyl tetrapeptide-17 Colloidal Platinum (nano)
Hydroxyapatite (nano) is added to Annex III of the EU CPR and therefore restricted for use in specific condition:
- Toothpaste max 10%
- Mouthwashes max 0.465%
- The ingredient shall not be used in applications that may lead to exposure of the end- user’s lungs by inhalation.
- Only nanomaterials having the following characteristics are allowed: 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; the particles are not coated or surface modified.
The manufacturing deadline is 1 February 2025. The sales deadline is 1 November 2025. After this date, no cosmetic products containing the above banned ingredients can be present on the EU market and any cosmetics containing Hydroxyapatite (nano) must be in compliance with its new Annex III restriction outlined above.
The full Regulatory text can be found here - https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202400858
Canada - Additional Comment Period for Cosmetic Ingredient Hotlist Review
Following the consultation on proposed updates to the Cosmetic Ingredient Hotlist last year, Health Canada is making additional information available for certain ingredients included in the consultation, to provide a more comprehensive overview of the risk factors considered during the development of the proposed Hotlist conditions.
Stakeholders can provide additional comments on the conditions proposed in the consultation for these ingredients:
- Thioglycolic acid esters
- Retinoic acid precursors (Retinal and Retinol and its esters)
- Mixed cresols and derivatives (p-, m- and o-Cresol)
- Aluminium chlorohydrate and its associated complexes
- Peroxide and peroxide-generating compounds and Benzoyl Peroxide
The additional comment period for these specific ingredients is open until 7 June 2024. Companies can submit any comments or additional data concerning these ingredients by email or in writing to:
Hotlist Coordinator
Cosmetics Program
Consumer and Hazardous Products Safety Directorate
Health Canada
269 Laurier Ave West
Address Locator: 4908A
Ottawa ON K1A 0K9
Email: cosmetics@hc-sc.gc.ca
EU Finalises Opinion on Hexyl Salicylate
On 11 March 2024, the Scientific Committee on Consumer Safety (SCCS) published its final opinion on hexyl salicylate in cosmetic products. The SCCS concluded that hexyl salicylate is safe when used up to the maximum concentrations as shown below:
Hydroalcoholic-based fragrances - 2%
All Rinse-off products - 0.5%
All Leave on products - 0.3%
Oral care (toothpaste and mouthwash) - 0.001%
The opinion can be found here - https://health.ec.europa.eu/publications/hexyl-salicylate-casec-no-6259-76-3228-408-6_en
