UK to Revise the Ingredient Lists in Cosmetic Regulations: Skin Whitening Agent Deoxyarbutin and 38 CMRs Banned

The UK introduced amendments to the list of prohibited and restricted ingredients in cosmetics, involving skin whitening agent deoxyarbutin, fragrance ingredient lilial, salicylic acid, zinc pyrithione, 38 CMRs, etc.

On April 13, 2022, the United Kingdom notified the WTO of a draft regulation aiming at amending the technical annexes of the retained EU legislation Regulation (EC) No 1223/2009 to prohibit or restrict the use of cosmetic ingredients following advice from the Scientific Advisory Group on Chemical Safety. ¹

Detailed amendments to the UK Cosmetic Regulations are as follows (The text in red indicates revisions to the previous regulations. Strikethrough indicates removal from the previous regulations.): ²

1. Prohibit the use of deoxyarbutin and 38 carcinogenic, mutagenic, or reprotoxic substances (CMRs) by adding them to Annex II list of prohibited substances in cosmetics.

Entry No.

Chemical Name

Effective Date

1645

4-[(tetrahydro-2H-pyran-2-yl)oxy]phenol (Deoxyarbutin, Tetrahydropyranyloxy Phenol)

(CAS No. 53936-56-4)

Dec. 15, 2022

1646-1680

Cobalt (CAS No. 7440-48-4),

Metaldehyde (ISO); 2,4,6,8-tetramethyl- 1,3,5,7- tetraoxacyclooctane (CAS No. 108-62-),

Methylmercuric chloride (CAS No. 115-09-3),

Benzo[rst]pentaphene (CAS No. 189-55-9),

Diisohexyl phthalate (CAS No. 71850-09-4),

2-methylimidazole (CAS No. 693-98-1),

…

(See the full list here)

Oct. 15, 2022

2. Remove lilial and zinc pyrithione from Annex III list of restricted substances in cosmetics, modify the exceptions for water-soluble zinc salts, and add the product types and concentration limits for salicylic acid for uses other than as a preservative.

Status	Entry No.	Substance Identification	Restrictions		Effective Date
Status	Entry No.	Substance Identification	Product type, body parts	Maximum concentration in ready for use preparation	Effective Date
Deletion	83	Butylphenyl methylpropional (fragrance ingredient BMHCA, “lilial”) CAS No. 80-54-6	/	/	Oct. 15, 2022
Deletion	101	Zinc Pyrithione CAS No. 13463-41-7	Leave-on hair products	0.1%	Oct. 15, 2022
Supplementation	98	Salicylic Acid CAS No. 69-72-7	(a) Rinse-off hair products (b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant (c) Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant	(a) 3.0 % (b) 2.0 % (c) 0.5 %	Dec. 15, 2022
Revision	24	Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and Pyrithione zinc (Annex II, entry 1670)	/	/	Oct. 15, 2022

3. Remove zinc pyrithione from Annex V list of permitted preservatives in cosmetics, and add a note to the permitted preservative sodium hydroxymethylamino acetate.

Status	Entry No.	Substance Identification	Conditions			Effective Date
			Product type, body parts	Maximum concentration in ready for use preparation	Other
Deletion	8	Zinc Pyrithione CAS No. 13463-41-7	Hair products	1.0%	Only in rinse-off products Not to be used in oral products	Oct. 15, 2022
			Other products	0.5%
Supplementation	51	Sodium hydroxymethylamino acetate CAS No. 70161-44-3	/	0.5%	Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0.1 % w/w

It is worth noting that cosmetics containing deoxyarbutin or salicylic acid (not complying with the new restriction) shall not be placed on the market from December 15, 2022, and not be made available on the market from March 15, 2023. For cosmetics containing other revised ingredients, the placing on the market deadline is expected to be October 15, 2022, and the off-shelf deadline is expected to be December 15, 2022.

ChemLinked Upcoming Webinar on UK Cosmetic Compliance

The UK has implemented an independent regulatory framework for cosmetics since it officially left the European Union in 2021. The content of the UK Cosmetics Regulation generally continues that of the EU cosmetics regulation EC 1223/2009, but there are indeed some changes. To help cosmetic companies better understand UK’s post-Brexit cosmetic regulations and how they differ from EU regulations, ChemLinked will team up with the UK's Cosmetic Toiletry & Perfumery Association (CTPA) to host a webinar on May 19, highlighting the changes after almost a year and a half of the entry into force of the UK Cosmetics Regulation, as well as practical considerations on product compliance. Welcome to register here.