OPSS Publishes Planned Changes to Toys and Cosmetics Regulations
OPSS Publishes Planned Changes to Toys and Cosmetics Regulations - Published on Product Compliance Manager - May 31, 2022
This is the publication as it was announced by the OPSS on May 30, 2022.
Do you have applied standards to prove compliance in regard to one or more of the mentioned regulations? We recommend you to check the new list of standards to see if any of the standards you applied have been updated. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.
These guidances will assist your understanding of the regulations and they include obligations for manufacturers, their authorised representatives, importers and distributors.
The Office for Product Safety and Standards (OPSS) announced its intention
- to update the technical annexes to Regulation (EC) No 1223/2009 on Cosmetic Products, 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. Between 1 October 2021 and 1 March 2022, there is a set of chemicals that has been classified as CMRs (PDF, 150 KB, 2 pages). These substances will be added to Annex 2 (prohibited substances) where the conditions for including them in Annex 3 to 6 have not been met.
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.
|Chemicals||Non-compliant products cannot be placed on the market after|
|Fragrance Allergens – Atranol, Chloroatranol and Methyl heptine carbonate||15 October 2022|
|Chemicals assessed by SAG-CS – Aluminium, Formaldehyde, and aniline||15 December 2022|
|Chemicals||Non-compliant products cannot be placed on the market after||Products already placed on the market can be made available until|
|CMRs||15 October 2022||15 December 2022|
|Chemicals assessed by SAG-CS – Salicylic Acid and deoxyarbutin|
OPSS Publishes Planned Changes to Toys and Cosmetics Regulations - Links and Downloads
- List of Harmonized Standards for Quality Management Systems, Sterilisation and the Application of Risk Management to Medical Devices Has Been Updated