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

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]

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

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

-

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

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 %

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