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    EU Proposes Cosmetics Regulation Amendment: 15 CMR Substances to Be Banned and Annexes III-V to Be Revised

    from CIRS by

    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.

    EU,Cosmetic,Amendment,CMR,Ingredient,Ban,Revise

    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

    About CIRS

    The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

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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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