cosmetics-restricted-subs

Cosmetic Products Regulation, Annex III - Restricted Substances

EU. Restricted Substances: Annex III, Regulation 1223/2009/EC on Cosmetic Products, as amended by Regulation (EU) 2023/1545, OJ L 188, 27 July 2023

This list contains substances whose use in cosmetic products in the European Union is banned, except under certain conditions as indicated in Annex III. The list specifies the field of application or use, maximum allowable concentration limits in finished products, and any additional limitations.

Last updated 24 svibnja 2024. Database contains 770 unique substances/entries.
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Restrictions  
204-317-7
119-36-8
324
Toothpaste
2.52 %
Not to be used in preparations for children under 6 years of age, with the exception of Toothpaste
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
Details
204-317-7
119-36-8
324
Mouth spray
0.65 %
Not to be used in preparations for children under 6 years of age, with the exception of Toothpaste
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
Details
204-317-7
119-36-8
324
Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave on hair products (except spray/aerosol products)
0.06 %
Not to be used in preparations for children under 6 years of age, with the exception of Toothpaste
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
Details
204-317-7
119-36-8
324
Rinse-off skin products (except hand wash) and rinse-off hair products
0.06 %
Not to be used in preparations for children under 6 years of age, with the exception of Toothpaste
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
Details
204-317-7
119-36-8
324
Hydroalcoholic-based fragrances
0.6 %
Not to be used in preparations for children under 6 years of age, with the exception of Toothpaste
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
Details
204-317-7
119-36-8
324
Mouthwash intended for children aged 6–10 years
0.1 %
Not to be used in preparations for children under 6 years of age, with the exception of Toothpaste
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
Details
204-317-7
119-36-8
324
Mouthwash intended for children above 10 years of age and adults
0.6 %
Not to be used in preparations for children under 6 years of age, with the exception of Toothpaste
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
Details
201-642-6
85-91-6
323
Leave-on products
0.1 %
Not to be used in sunscreen products and products marketed for exposure to natural or artificial UV light
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
Details
201-642-6
85-91-6
323
Rinse-off products
0.2 %
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
Details
203-909-2
111-80-8
173
Oral products
Details
203-909-2
111-80-8
173
Cosmetic products other than oral products
0.002 %
When present in combination with methyl heptine carbonate, the combined level in the finished product shall not exceed 0.01% (of which methyl octine carbonate shall not be more than 0.002%)
Details
203-836-6
111-12-6
89
Cosmetic products other than oral products
0.01 %
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
When present in combination with methyl octine carbonate, the combined level in the finished product shall not exceed 0.01 % (of which methyl octine carbonate shall not be more than 0.002 %)
Details
203-836-6
111-12-6
89
Oral products
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: 0.001% in leave-on products and 0.01 % in rinse-off products
Details
-
-
9
General use hair dye substance in oxidative hair dye products
5 %
For general use
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base
Details
-
-
9
Professional use hair dye substance in oxidative hair dye products
5 %
For professional use only
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base
Details
-
-
9
Professional use hair dye substance in oxidative hair dye products
5 %
For professional use only
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base
Details
-
-
9
General use hair dye substance in oxidative hair dye products
5 %
For general use
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base
Details
-
-
271
Hair dye substance in non-oxidative hair dye products
2 %
Details
-
-
61
All cosmetic products
0.5 %
Not to be used with nitrosating systems- Minimum purity: 99 %
Maximum secondary amine content: 0,5 % (applies to raw materials)
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
Details
-
-
61
All cosmetic products
0.5 %
Not to be used with nitrosating systems- Minimum purity: 99 %
Maximum secondary amine content: 0,5 % (applies to raw materials)
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
Details
-
-
38
Oral products
0.15 %
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15 %
Details
FLUORGELB 2
443-760-2
10442-83-8
261
Hair dye substance in oxidative hair dye products
2.5 %
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2.5 %
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg /kg
Keep in nitrite-free containers
Details
FLUORGELB 2
443-760-2
10442-83-8
261
Hair dye substance in non-oxidative hair dye products
2.5 %
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg /kg
Keep in nitrite-free containers
Details
This substance is identified by SDA Substance Name: C12-C18 alkyl benzyl dimethyl ammonium chloride and SDA Reporting Number: 16-052-00.
269-919-4
68391-01-5
65
Rinse-off hair (head) products
3 %
In the final products the concentrations of benzalkonium chloride, bromide and saccharinate with an alkyl chain of C14, or less must not exceed 0.1% (as benzalkonium chloride)
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
Details
-
-
8
Professional use hair dye substance in oxidative hair dye products
3 %
For professional use only
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3 % calculated as free base
Details

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