Government is intending to update the technical annexes to Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, and Schedule 2 to the Toys (Safety) Regulations 2011. These changes entail either a reduction in the permitted level or prohibition of specific chemicals.
These chemicals can be grouped into three categories:
- Chemicals assessed by the Scientific Advisory Group on the Chemical Safety of non-food and non-medicinal consumer products (SAG-CS)
- Chemicals classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) under GB Classification, Labelling and Packaging (CLP) Regulations
- Fragrance allergens
Below is a summary of the proposed amendments to the Toys and Cosmetic Regulations as relating to the groups mentioned above.
SAG-CS advice and government decisions
The SAG -CS has recently concluded assessment on the risk to human health regarding:
- Deoxyarbutin used in cosmetics
- Salicylic Acid used in cosmetics
- Formaldehyde used in toys
- Aniline used in toys
- Aluminium used in toys
The conclusions of these assessments have been published:
The Government has considered the advice of SAG-CS regarding the above chemicals in these opinions and used this to inform decisions regarding restrictions of these chemicals in products, which are set out below:
- amend Annex 2 to the Cosmetic Regulation to prohibit the use of deoxyarbutin
- amend Annex 3 to the Cosmetic Regulation to permit the use of salicylic acid for uses other than as a preservative at 0.5% in body lotion, eye shadow, mascara, eyeliner, lipstick, and roll-on deodorant applications
- amend Appendix C to Schedule 2 of the Toys (Safety) Regulations 2009 to introduce specific (lower) limits for aniline and formaldehyde for toys intended for use by children under 36 months old or other toys intended to be placed in the mouth
- amend point 13 of Annex 2 to the Toys Regulations to reduce the permitted migration limits for aluminium
Chemicals classified as CMRs
Under the Cosmetic Regulations, substances classified as CMR of category 1A, 1B or 2 under the GB CLP Regulation must not be present in cosmetic products unless the substance is included in any of Annexes 3 to 6. To be included in Annexes 3 to 6 various conditions must be met. As of 1 October 2021 and 1 March 2022, there is a set of chemicals that has been classified as CMRs (PDF, 151 KB, 2 pages). The conditions for including them in Annex 3 to 6 have not been met. Therefore, these substances will be added to Annex 2 (prohibited substances) and where they are currently present in Annexes 3 to 6, they will be removed.
Fragrance allergens
Three chemicals (methyl heptine carbonate, atranol and chloratranol) have recently been included in the EU list of allergens which are prohibited for the use in toys. Currently in the UK atranol and chloratranol have already been prohibited and methyl heptane carbonate has been restricted to 0,01% for cosmetic products.
The fragrances in question are also used in some toys including fingerpaints and modelling clay, where the exposure routes to the fragrances will be similar to those from cosmetics. We will therefore be amending the UK Toys Regulations to prohibit the uses of these chemicals in toys.
Timeline
Our intention is that products containing CMR substances and fragrance allergens will not be able to be placed on the market on or after 15 October 2022, however a transitional provision will allow them to be made available until 15 December 2022, after which any supply will be unlawful.
Our intention is that products containing the chemicals SAG-CS has assessed (as listed above) will not be able to be placed on the market on or after 15 December 2022, however a transitional provision will allow them to be made available until 15 March 2023, after which any supply will be unlawful.
