Cosmetic Requirement Updates: EU controls the use of Vitamin A and Alpha-Arbutin and Arbutin, and Substances with endocrine disrupting properties in Cosmetic Products
2024.04.23
On April 3, 2024, the European Commission approved an amendment to Regulation (EC) No. 1223/2009, which aims to regulate the use of Vitamin A, Alpha-Arbutin, Arbutin, and certain substances with potential endocrine disrupting properties in cosmetic products. This amendment, known as Regulation (EU) 2024/996, will come into effect on April 24, 2024. However, the industry will be given a transition period to implement some of the new measures.
Following substances are covered in this amendment,
- ‘Retinol’, ‘Retinyl Acetate’ and ‘Retinyl Palmitate’
- ‘Alpha-Arbutin’ and ‘Arbutin’
- ‘4-Methylbenzylidene Camphor’ (4-MBC)
- ‘Genistein’ and ‘Daidzein’
- ‘Kojic Acid’
- ‘Triclosan’
- Triclocarban’
'Retinol', 'Retinyl Acetate', and 'Retinyl Palmitate' in cosmetics
One of the key changes introduced by the amendment is the restriction on the use of 'Retinol', 'Retinyl Acetate', and 'Retinyl Palmitate'. These ingredients are commonly used as skin conditioning agents in cosmetic products but were not previously regulated under Regulation (EC) No. 1223/2009.
The decision to restrict their use comes in response to the findings of the Scientific Committee for Consumer Safety, which identified potential risks to human health associated with the use of Vitamin A at certain levels or above.
What is the new requirement?
In response to the Opinion (SCCS/1639/21 Final version, 24-25 October 2022) by Scientific Committee for Consumer Safety, under the new regulation, these substances will be included in Annex III.
- The maximum concentration of 'Retinol', 'Retinyl Acetate', and 'Retinyl Palmitate' in body lotions is restricted to 0.05% (RE).
- Other leave-on and rinse-off products will have a maximum limit of 0.3% (RE) for these ingredients.
- Cosmetic products with these ingredients must include a warning statement on the label regarding the daily intake of Vitamin A from other sources like food and supplements.
How does EU implement the requirement?
- From May 1, 2025, cosmetic products that do not comply with the new requirements should not be placed in the EU market.
- From May 1, 2026, non-compliant cosmetic products should not be marketed within the EU.
| 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 |
| 376 | (2E,4E,6E,8E)-3,7-dimethyl- 9-(2,6,6-trimethylcyclohexen- 1-yl)nona-2,4,6,8-tetraen- 1-ol | Retinol | 11103-57-4/ 68-26-8 | 234-328-2/ 200-683-7 | (a) Body lotion (b) Other leave-on and rinse-off products | (a) 0.05% Retinol Equivalent (b) 0.3% RE | For any cosmetic product containing Retinol, Retinyl Acetate or Retinyl Palmitate the following labelling is obligatory: ‘Contains Vitamin A. Consider your daily intake before use.’ | |
| [(2E,4E,6E,8E)-3,7-dimethyl- 9-(2,6,6-trimethylcyclohexen- 1-yl)nona-2,4,6,8-tetraenyl] acetate | Retinyl Acetate | 127-47-9 | 204-844-2 | |||||
| [(2E,4E,6E,8E)-3,7-dimethyl- 9-(2,6,6-trimethylcyclohexen- 1-yl)nona-2,4,6,8-tetraenyl] hexadecanoate | Retinyl Palmitate | 79-81-2 | 201-228-5 | |||||
‘Alpha-Arbutin’ and ‘Arbutin’
‘Alpha-Arbutin’ and ‘Arbutin’ are commonly used as skin bleaching and skin conditioning agents in cosmetic products. They are not regulated under Regulation (EC) No. 1223/2009 (as of consolidated version 04/04/2024).
What is the new requirement?
In response to the Opinion (SCCS/1642/22 Final version, 31 January 2023) by Scientific Committee for Consumer Safety on the use of Alpha-Arbutin and Arbutin and the level of Hydroquinone in cosmetic products, in this amendment, these substances will be included in Annex III.
- Alpha-Arbutin in face creams will be restricted to a maximum concentration of 2%.
- Alpha-Arbutin in body lotions will be restricted to a maximum concentration of 0.5%.
- Arbutin in face creams will be restricted to a maximum concentration of 7%.
- Hydroquinone in cosmetic products with Alpha-Arbutin and Arbutin should be kept as low as possible and not exceed trace levels.
How does EU implement the requirement?
- From 1 February 2025, cosmetic products that do not fulfil the new requirement should not be placed in EU.
- From 1 November 2025, cosmetic products that do not fulfil the new requirement should not be marketed in EU.
| 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 |
| 377 | 4-Hydroxyphenyl-alpha-D- glucopyranosid | Alpha-Arbutin | 84380-01-8 | 617-561-8 | (a) Face cream (b) Body lotion |
(a) 2% (b) 0.5% |
Hydroquinone levels shall remain as low as possible in formulations containing alpha- Arbutin and shall not be higher than the unavoidable trace level. | |
| 378 | 4-Hydroxyphenyl-beta-D- glucopyranoside | Arbutin | 497-76-7 | 207-850-3 | Face cream | 7% | ||
‘4-Methylbenzylidene Camphor’
4-Methylbenzylidene Camphor (4-MBC) is currently allowed to use as a UV-filter with a maximum concentration of 4% in cosmetic products.
What is the new requirement?
From Opinion (SCCS/1640/21 Final version, 29 April 2022) by Scientific Committee for Consumer Safety, 4-Methylbenzylidene Camphor is a possible endocrine disruptor. Therefore, in this amendment,
- The amendment prohibits the use of 4-Methylbenzylidene Camphor is prohibited as a UV-filter in cosmetic products.
- 4-Methylbenzylidene Camphor will be completely prohibited for all uses in cosmetic products.
How does EU implement the requirement?
- From 1 May 2025, cosmetic products that do not fulfil the new requirement should not be placed in EU.
- From 1 May 2026, cosmetic products that do not fulfil the new requirement should not be marketed in EU.
| Reference number | Substance identification | Remark | ||
| Chemical name/INN | CAS number | EC number | ||
| a | b | c | d | |
| ‘1730 | 3-(4'-methylbenzylidene)-camphor [INCI: 4-Methylbenzylidene Camphor] | 36861-47-9/38102-62-4 | 253-242-6/- | Prohibited |
Remark: Entry 18 of Annex VI will be deleted from 1 May 2025.
‘Genistein’ and ‘Daidzein’
‘Genistein’ and ‘Daidzein’ are commonly used as skin conditioning agents, protecting agents and antioxidants in cosmetic products. They are not regulated under Regulation (EC) No. 1223/2009 (as of consolidated version 04/04/2024).
What is the new requirement?
In response to the Opinion (SCCS/1641/22 Final version, 11 October 2022) by Scientific Committee for Consumer Safety, in this amendment, these substances will be included in Annex III.
- Genistein will be restricted to a maximum concentration of 0.007%.
- Daidzein will be restricted to a maximum concentration of 0.02%.
How does EU implement the requirement?
- From 1 February 2025, cosmetic products that do not fulfil the new requirement should not be placed in EU.
- From 1 November 2025, cosmetic products that do not fulfil the new requirement should not be marketed in EU.
|
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
|
|
‘373
|
Genisteol; 4',5,7-Trihydroxyisoflavone; 5,7-dihydroxy- 3-(4-hydroxyphenyl)- 4-benzopyrone
|
Genistein
|
446-72-0
|
207-174-9
|
0.007%
|
|
||
|
374
|
Daidzeol; 4',7-Dihydroxyisoflavone; 7-hydroxy- 3-(4-hydroxyphenyl)- 4-benzopyrone
|
Daidzein
|
486-66-8
|
207-635-4
|
|
0.002%
|
||
‘Kojic Acid’
‘Kojic Acid’ is commonly used as a skin lightening agent, whitening agent or a depigmenting agent, and it is not regulated under Regulation (EC) No. 1223/2009 (as of consolidated version 04/04/2024).
What is the new requirement?
In response to the Opinion (SCCS/1637/21 Final version & Corrigendum, 15-16 March 2022 and 10 June 2022) by Scientific Committee for Consumer Safety concluding a potential risk to human health associated with the use of Kojic Acid at certain level or above, in this amendment, Kojic acid will be included in Annex III.
- Kojic Acid will be restricted to a maximum concentration of 1%.
- The restriction applies specifically to Kojic Acid's use as a skin lightening agent in face and hand products.
How does EU implement the requirement?
- From 1 February 2025, cosmetic products that do not fulfil the new requirement should not be placed in EU.
- From 1 November 2025, cosmetic products that do not fulfil the new requirement should not be marketed in EU.
|
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
|
|
375
|
5-Hydroxy-2-(hydroxymethyl)- 4H-pyrane-4-one
|
Kojic Acid
|
501-30-4
|
207-922-4
|
Face and hand products
|
1%
|
|
|
‘Triclosan’
‘Triclosan’ is currently allowed to use as a preservative in cosmetic products with a maximum limit of 0.3% in toothpastes, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders and blemish concealer, and in nail products for cleaning the fingernails and toenails before the application of artificial nail systems, as well as 0.2% in mouthwashes, under Regulation (EC) No. 1223/2009 (as of consolidated version 04/04/2024).
What is the new requirement?
In response to the Opinion (SCCS/1643/22, Final version 24-25 October 2022) by Scientific Committee for Consumer Safety, the restriction in Annex V to the use of Triclosan will be updated.
- Triclosan is not allowed in mouthwash and toothpaste for children under 3 years old.
- Triclosan is still allowed in toothpaste, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders, blemish concealer, and nail products (for cleaning the fingernails and toenails before the application of artificial nail systems) at a maximum concentration of 0.3%.
- Toothpaste containing triclosan will require a warning statement on the product label.
How does EU implement the requirement?
- For cosmetic products that do not fulfil the new requirements but comply with the conditions as applicable on 23 April 2024, they could be placed on the market until 31 December 2024.
- For those products have been placed on the market before 31 December 2024, they are allowed to market in EU until 31 October 2025.
| 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 |
| 25 | 5-Chloro-2- (2,4- dichlorophenoxy) phenol (*) | Triclosan | 3380-34-5 | 222-182-2 | Toothpastes; Hand soaps; Body soaps/Shower gels; Deodorants (non-spray); Face powders and blemish concealers; Nail products for cleaning the fingernails and toenails before the application of artificial nail systems; | 0.3% | Not to be used in toothpaste intended for children under 3 years of age. | For toothpaste containing Triclosan the following labelling is obligatory: ‘Not to be used for children under 3 years of age’. |
‘Triclocarban’
‘Triclocarban’ is currently allowed to use as a preservative with a maximum concentration of 0.2% in cosmetic products, and with a maximum concentration of 1.5% when it is used with purposes other than inhibiting the development of micro-organisms in rinse-off products, under Regulation (EC) No. 1223/2009 (as of consolidated version 04/04/2024).
What is the new requirement?
In response to the Opinion (SCCS/1643/22, Final version 24-25 October 2022) by Scientific Committee for Consumer Safety, in this amendment, the restriction in Annex V to the use of Triclocarbon will be updated.
- Triclocarban will not be allowed in mouthwash.
- It can be used as a preservative in cosmetic products at a maximum level of 0.2% in cosmetic product.
- If used for purposes other than as a preservative, it can be used at a maximum level of 1.5% in cosmetic products.
- Triclocarban is not allowed in toothpaste for children under 6 years old.
- Similar to Triclosan, a warning statement on the product label for toothpaste is necessary.
How does EU implement the requirement?
- For cosmetic products that do not fulfil the new requirements but comply with the conditions as applicable on 23 April 2024, they could be placed on the market until 31 December 2024.
- For those products have been placed on the market before 31 December 2024, they are allowed to market in EU until 31 October 2025.
| 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 |
| ‘23 | 1-(4-Chlorophenyl)- 3-(3,4-dichlorophenyl) urea | Triclocarban | 101-20-2 | 202-924-1 | All cosmetic products, with the exception of mouthwash | 0.2% | Purity criteria: 3,3',4,4'- Tetrachloroazobenzene ≤ 1 ppm 3,3',4,4'- Tetrachloroazoxybenzene ≤ 1 ppm Not to be used in toothpaste intended for children under 6 years of age. | For toothpaste containing Triclocarbonthe following labelling is obligatory: ‘Not to be used for children under 3 years of age’. |
(*) For uses other than preservatives, see Annex III, No. 100.
Source:
See More Blog
