Commission Regulation (EU) 2026/78 of 12 January 2026 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction

Article 1

Annexes II, III, IV and V to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 1 May 2026.

ANNEX

ANNEX
Annexes II, III, IV and V to Regulation (EC) No 1223/2009 are amended as follows:
(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 (H 3 BO 2 (O 2 )), 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(O 2 )), 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(O 2 )), sodium salt, monohydrate [9]
10332-33-9 [9]
— [9]
Trimethyl borate
121-43-7 [10]
204-468-9 [10]’
(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
‘1752
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
—
—
1753
reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol
—
—
1754
Acetone oxime
127-06-0
204-820-1
1755
2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one
119344-86-4
438-340-0
1756
2,3-epoxypropyl neodecanoate
26761-45-5
247-979-2
1757
Benthiavalicarb-isopropyl (ISO); isopropyl [( S )-1-{[( R )-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate
177406-68-7
—
1758
7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate
2386-87-0
219-207-4
1759
Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
52556-42-0
258-004-5
1760
1,4-dichloro-2-nitrobenzene
89-61-2
201-923-3
1761
Fenpropidin (ISO); ( R , S )-1-[3-(4-tert-butylphenyl)-2-methylpropyl]piperidine
67306-00-7
—
1762
N,N’ -methylenediacrylamide
110-26-9
203-750-9
1763
tert -butyl 2-ethylperoxyhexanoate
3006-82-4
221-110-7
1764
Trimethyl borate
121-43-7
204-468-9
1765
S -metolachlor (ISO); 2-chloro- N -(2-ethyl-6-methylphenyl)- N -[(2 S )-1-methoxypropan-2-yl]acetamide; ( R
a
S
a )-2-chloro- N -(6-ethyl- o -tolyl)- N -[(1 S )-2-methoxy-1-methylethyl]acetamide [contains 80-100 % 2-chloro- N -(2-ethyl-6-methylphenyl)- N -[(2 S )-1-methoxypropan-2-yl]acetamide and 0-20 % 2-chloro- N -(2-ethyl-6-methylphenyl)- N -[(2 R )-1-methoxypropan-2-yl]acetamide]
87392-12-9
—
1766
Pyraclostrobin (ISO); methyl N -(2-{[1-(4-chlorophenyl)-1 H -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
‘379
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 %
380
Hexyl 2-hydroxybenzoate
Hexyl Salicylate
6259-76-3
228-408-6
(a)
Hydroalcoholic-based fragrances (except hydroalcoholic-based fragrances intended for children below 3 years of age)
(b)
All rinse-off products (except shower gel/bath products, 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/bath products, 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).’
(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]
77820
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
Maximum concentration in ready for use preparation
Other
a
b
c
d
e
f
g
h
i
‘7
Biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl
Sodium 2-biphenylate
o-Phenylphenol
Sodium o-Phenylphenate
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’

Commission Regulation (EU) 2026/78 of 12 January 2026 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction

Schedules & Appendices

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