Updates to the EU and UK annexes, including BHT, resorcinol, acid yellow 3…

1) Updates to the Annexes of the EU Cosmetics Regulation Notified to WTO:

Following changes are being proposed in the latest draft:

Annex III:

a) Butylated hydroxytoluene (BHT) is restricted for use in cosmetic products at

  • 0,001% in mouthwashes
  • 0,1% in toothpastes
  • 0,8% in other leave-on and rinse-off products

b) Acid yellow 3 is restricted for use in non-oxidative hair dye products at 0,5% (entry 82 of Annex IV still applies if the ingredient is used as a colorant)

c) Entry 22 for resorcinol is corrected in column i(a) by changing the last sentence from “Do not use to dye eyelashes or eyebrows.” to “Do not use to dye eyelashes.”

The transition period for BHT and acid yellow 3 is 6 months from entry into force for placing on the market, and 12 months from entry into force for making available on the market (off-shelf).

Annex VI:

a) Homosalate is allowed for use at 7,34% in face products, with the exception of propellent spray products. The transition period is of 24 months from entry into force for placing on the market, and 30 months from entry into force for making available on the market (off-shelf).


b) Bis-(diethylaminohydroxybenzoyl benzoyl) piperazine is included for use as a UV filter in cosmetic products at 10%, both in the non-nano and nano forms. The nanoform is only allowed for purity ≥ 97 %, median particle size D50 (50 % of the number below this diameter) ≥ 50 nm of number size distribution.  Furthermore, the nano form cannot be used in applications that may lead to exposure of the end user’s lungs by inhalation.  In case of combined use of both the non-nano and nano forms, the sum concentration shall not exceed 10%.

More information can be found here.

 

2) Updates to the Annexes of the UK Cosmetics Regulation Notified to WTO can be found at this link.

 

3) SCCS Mandate for Sodium Bromothymol Blue (C186):

New SCCS opinion is being prepared for hair dye Sodium Bromothymol Blue (C186).

4) 18TH ATP to CLP Published

It includes the following ingredients:

 

  • Benzophenone: carcinogenic 1B
  • Theophylline: reprotoxic 1B
  • Melamine: carcinogenic 2
  • Margosa (azadirachta indica) extract: Reprotoxic 2
  • Trimethylolpropane triacrylate: carcinogenic 2
  • Pentetic acid: reprotoxic 1B
  • Pentasodium pentetate: reprotoxic 1B

As these ingredients were not defended by industry, the EU Commission will include these substances in Annex II (prohibited substances) of the EU Cosmetic Products Regulation via the sixth CMR Omnibus Regulation.  The making available (off-shelf) deadline for products containing these substances will be 23 November 2023, as per the deadline from the 18th ATP to CLP.