EU Proposes Cosmetics Regulation Amendment: 15 CMR Substances to Be Banned and Annexes III-V to Be Revised
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On May 21, 2025, the European Union notified the WTO (G/TBT/N/EU/1140) of its proposal to amend the EU Cosmetics Regulation (EC) No 1223/2009. The amendment seeks to add 15 substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) to Annex II (List of Prohibited Substances). It also proposes updates to Annex III (List of Restricted Substances), Annex IV (List of Permitted Colorants), and Annex V (List of Permitted Preservatives). The regulation will take effect 20 days after its publication in the Official Journal of the European Union and will apply from May 1, 2026.

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Regulatory Interpretation

This amendment primarily concerns CMR substances classified as Category 1A, 1B, or 2 under Regulation (EU) 2024/2564. In September 2024, the European Commission published Commission Delegated Regulation (EU) 2024/2564 of June 19, 2024, which amends the Classification, Labelling and Packaging (CLP) Regulation. The amendment mainly updates the harmonized classification and labelling list in Part 3 of Annex VI to the CLP Regulation, covering substances such as Sodium Perborate (CAS No. 7632-04-4) and Silver (CAS No. 7440-22-4). This amendment will enter into force on May 1, 2026.

Proposed Amendments

(1) Annex II is amended as follows:

(a) Entry 1397 is replaced by the following:

Reference
number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

1397

Perboric acid (H3BO2(O2)), monosodium salt trihydrate [1];

13517-20-9 [1]

239-172-9 [1]

Perboric acid, sodium salt, tetrahydrate [2];

37244-98-7 [2]

234-390-0 [2]

Perboric acid (HBO(O2)), sodium salt, tetrahydrate [3];

10486-00-7 [3]

- [3]

Sodium peroxoborate, hexahydrate [4];

- [4]

- [4]

Sodium perborate [5];

15120-21-5 [5]

239-172-9 [5]

Sodium peroxometaborate; sodium peroxoborate [6];

7632-04-4/

10332-33-9/

10486-00-7 [6]

231-556-4 [6]

Perboric acid, sodium salt [7];

11138-47-9 [7]

234-390-0 [7]

Perboric acid, sodium salt, monohydrate [8];

12040-72-1 [8]

234-390-0 [8]

Perboric acid (HBO(O2)), sodium salt, monohydrate [9];

10332-33-9 [9]

- [9]

(b) Entries 1398 and 1399 are deleted;

(c) Entry 1727 is replaced by the following:

Reference 
number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

1727

Silver (nano) [1 nm < particle diameter≤100 nm];

Silver (massive) [particle diameter≥1 mm]

7440-22-4

231-131-3

(d) The following entries are added:

Reference 
number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

Replace with the next consecutive number

Multi-walled Carbon Tubes (synthetic graphite in tubular shape) with a geometric tube diameter range≥30 nm to < 3 µm and a length≥5 µm and aspect ratio > 3:1, including Multi-Walled Carbon Nanotubes, MWC(N)T

-

-

reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol

-

-

Acetone oxime

127-06-0

204-820-1

2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one

119344-86-4

438-340-0

2,3-epoxypropyl neodecanoate

26761-45-5

247-979-2

Benthiavalicarb-isopropyl (ISO); isopropyl [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate

177406-68-7

-

7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

2386-87-0

219-207-4

Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

52556-42-0

258-004-5

Replace with the next consecutive number

1,4-dichloro-2-nitrobenzene

89-61-2

201-923-3

Replace with the next consecutive number

Fenpropidin (ISO);

(R,S)-1-[3-(4-tertbutylphenyl)-2-methylpropyl]piperidine

67306-00-7

-

Replace with the next consecutive number

N,N'-methylenediacrylamide

110-26-9

203-750-9

Replace with the next consecutive number

tert-butyl 2-ethylperoxyhexanoate

3006-82-4

221-110-7

Replace with the next consecutive number

Trimethyl borate

121-43-7

204-468-9

Replace with the next consecutive number

S-metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide; (RaSa)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl]acetamide

[contains 80-100% 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide and 0-20% 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2R)-1-methoxypropan-2-yl]acetamide]

87392-12-9

-

Replace with the next consecutive number

Pyraclostrobin (ISO); methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate

175013-18-0

-

(2) In Annex III, the following entries are added:

Reference number

Substance identification

Restrictions

Wording of conditions of use and warnings

Chemical Name /INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type
Body parts

Maximum concentration in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

Replace with the next consecutive number

Silver (powder)

[100 nm < particle diameter < 1 mm]

Silver

7440-22-4

231-131-3

(a) Toothpaste

(b) Mouthwash

For (a) and (b): 0.05 %

  

Replace with the next consecutive number

Hexyl 2-hydroxybenzoate

Hexyl Salicylate

6259-76-3

228-408-6

(a) Hydroalcoholic-based fragrances

(b) All rinse-off products (except shower gel, hand wash, hair conditioner and shampoo intended for children below 3 years of age)

(c) All leave-on products (except hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm and fragrance products intended for children below 3 years of age)

(d) Toothpaste

(e) Mouthwash

(f) Shower gel, hand wash, shampoo, hair conditioner, body, face and hand (skin) care products, lipstick/lip balm and fragrance products intended for children below 3 years of age

(a) 2 %

(b) 0.5 %

(c) 0.3 %

(d) 0.001 %

(e) 0.001 %

(f) 0.1 %

Not to be used in preparations for children under 3 years of age, with the exception of (d) “Toothpaste and (f).

(e) Not to be used for children under 3 years of age

(3) In Annex IV, entry 142 is replaced by the following:

Reference
number

Substance identification

Conditions

Wording of conditions of use and warnings

Chemical name

Colour index Number/Name of Common Ingredients Glossary

CAS
number

EC
number

Colour

Product type
Body parts

Maximum concentration in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

j

142

Silver (powder)

[100 nm < particle diameter< 1 mm]

Silver

7440-22-4

231-131-3

White

(a) Lip products

(b) Eye shadow

For (a) and

(b): 0.2 %

  

(4) In Annex V, entry 7 is replaced by the following:

Reference
number

Substance identification

Conditions

Wording of conditions of use and warnings

Chemical name/INN

Name of common

ingredients glossary

CAS
number

EC
number

Product type
Body parts

Maximumconcentration in
ready for use
preparation

Other

a

b

c

d

e

f

g

h

i

7

Biphenyl-2-ol; 2- phenylphenol; 2-hydroxybiphenyl

o-Phenylphenol

Sodium o-

90-43-7

132-27-4

201-993-5

205-055-6

(a) Rinse-off products

(b) Leave-on products

(a) 0.2 % (as phenol

(b) 0.15 % (as phenol)

When o-Phenylphenol and Sodium o-Phenylphenate are used together, the combined concentration (as phenol) shall not exceed 0.2 % in rinse-off and 0.15 % in leave-on products.

Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products.

Avoid contact with eyes

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Further Information

https://members.wto.org/crnattachments/2025/tbt/EEC/25_03493_00_e.pdf

https://members.wto.org/crnattachments/2025/tbt/EEC/25_03493_01_e.pdf

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