EU to Revise the Ingredient Lists in Cosmetics Regulation: 2 Newly Restricted Ingredients and 2 Newly Permitted UV Filters

The EU drew up a draft Commission Regulation to amend the ingredient lists in Regulation (EC) No 1223/2009 on Cosmetic Products. The amendments include: 1) Adding 2 restricted ingredients 2) Adding 2 permitted UV filters 3) Revising the use requirements for 1 UV filter

On April 12, 2022, the EU introduced new amendments to cosmetic ingredients in Regulation (EC) No 1223/2009 in a draft Commission Regulation notified to the WTO. The draft regulation is made based on the latest scientific opinions from the Scientific Committee on Consumer Safety, and is open for comment until June 11, 2022. The details of the amendments are shown as follows (the text in red indicates changes to the previous regulations):

1. Restricted ingredients: two added

Substance Identification				Restrictions
Chemical Name / INN	Name of Common Ingredients Glossary	CAS No.	EC No.	Product Type, Body Parts	Maximum Concentration in Ready for Use Preparation
2,6-Di-Tert-Butyl-4-Methylphenol	Butylated Hydroxytoluene	128-37-0	204-881-4	a) Mouthwash b) Toothpaste c) Other leave-on and rinse-off products	a) 0.001 % b) 0.1 % c) 0.8 %
1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts*	Acid Yellow 3 / CI 47005	8004-92-0	305-897-5	Non-oxidative hair dye products	0.5 %
Notes: * For use as a colorant, see Annex IV List of Colorants Allowed in Cosmetic Products, entry No. 82.

2. Permitted UV filters: one revised and two added

Status	Substance Identification				Restrictions
Status	Chemical Name/INN	Name of Common Ingredients Glossary	CAS No	EC No	Product Type, Body Parts	Max. Concentration in Ready for Use Preparation	Other
Revision	Benzoic acid, 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester / Homosalate	Homosalate	118-56-9	204-260-8	Face products with the exception of propellent spray products	7.34 %	/
Addition	1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone	Bis-(Diethylaminohyd-roxybenzoyl Benzoyl) Piperazine / HAA299	919803-06-8	485-100-6		10 %*	/
Addition	1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone	Bis-(Diethylaminohyd-roxybenzoyl Benzoyl) Piperazine (nano) / HAA299 (nano)	919803-06-8	485-100-6		10 %*	Only nanomaterials having the following characteristics are allowed: - Purity≥97 % - Median particle size D50 (50 % of the number below this diameter): ≥50 nm of number size distribution. Not to be used in applications that may lead to exposure of the end user's lungs by inhalation.
Notes: * In case of combined use of Bis-(Diethylaminohyd-roxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohyd-roxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10 %.

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