Version · Cosmetics Regulation
Version in force
Made by Regulation (EU) 2022/1531 32022R1531 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2022/2195 32022R2195 on EUR-Lex (external, EUR-Lex)
Version 33 of 41 recorded for Cosmetics Regulation.
In force , . First seen by emendrix on , when it first read this version; that is not a legal date.
4 changes in this version
Consolidated versions 02009R1223-20221006 → 02009R1223-20221217. v1 is the previous version, v2 this one.
What changed
Annex II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS, Modified§
No explanation shipped — the difference between the two versions lies beyond the characters this stage can show, so no explanation was requested.
Each CAS and EC number in these tables links to its own page, which lists every entry that prints it across the acts this record holds.
14 entries added, 1 amended, 0 removed.
3 rows carry no key and are not compared.
14 entries added
| Identifiers | Reference number | Substance identification | ||
|---|---|---|---|---|
| Chemical name/INN | CAS number | EC number | ||
| a | b | c | d | |
| Reference number 1681CAS 116-14-3EC 204-126-9 | 1681 | Tetrafluoroethylene | 116-14-3 | 204-126-9 |
| Reference number 1682CAS 119-47-1EC 204-327-1 | 1682 | 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol;[DBMC] | 119-47-1 | 204-327-1 |
| Reference number 1683CAS 688046-61-9EC 692-456-8 | 1683 | (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone | 688046-61-9 | 692-456-8 |
| Reference number 1684CAS 1101132-67-5EC 701-225-3 | 1684 | (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate | 1101132-67-5 | 701-225-3 |
| Reference number 1685CAS 35575-96-3EC 252-626-0 | 1685 | Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate | 35575-96-3 | 252-626-0 |
| Reference number 1686CAS 1453-58-3EC 215-925-7 | 1686 | 3-methylpyrazole | 1453-58-3 | 215-925-7 |
| Reference number 1687CAS 1228284-64-7EC 817-852-1 | 1687 | N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen | 1228284-64-7 | 817-852-1 |
| Reference number 1688CAS 874967-67-6EC 688-331-2 | 1688 | N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane | 874967-67-6 | 688-331-2 |
| Reference number 1689CAS 108-10-1EC 203-550-1 | 1689 | 4-methylpentan-2-one; isobutyl methyl ketone (MIBK) | 108-10-1 | 203-550-1 |
| Reference number 1690CAS 110488-70-5EC 404-200-2 | 1690 | Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine | 110488-70-5 | 404-200-2 |
| Reference number 1691CAS 114311-32-9EC 601-305-7 | 1691 | Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid | 114311-32-9 | 601-305-7 |
| Reference number 1692CAS 153719-23-4EC 428-650-4 | 1692 | Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine | 153719-23-4 | 428-650-4 |
| Reference number 1693CAS 138182-18-0 | 1693 | Triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol | 138182-18-0 | - |
| Reference number 1694CAS 13684-56-5EC 237-198-5 | 1694 | Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate | 13684-56-5 | 237-198-5 |
1 entry amended
| Identifiers | Version | Reference number | Substance identification | ||
|---|---|---|---|---|---|
| Chemical name/INN | CAS number | EC number | |||
| a | b | c | d | ||
| Reference number 1680CAS 80-43-3EC 201-279-3 | Before | 1680 | Bis(α,α-dimethylbenzyl) peroxide | 201-279-3 | |
| After | 1680 | Bis(α,α-dimethylbenzyl) peroxide | 80-43-3 | 201-279-3 | |
Text from EUR-Lex, before and after
Previous version, in force 6 October 2022 02009R1223-20221006 → this version, in force 17 December 2022 02009R1223-20221217
ANNEX II
LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS
OJ L 159, 29.6.1996, p. 1Modified INNM-name.OJ L 273, 10.10.2002, p. 1.for the individual ingredient see reference number 364 in Annex II.for the individual ingredient see reference number 413 in Annex II.From 23 … 17,007 unchanged words … (ISO); isopropyl [(2S)-3- methyl-1-{[1-(4- methylphenyl)ethyl] amino}-1-oxobutan-2- yl]carbamate 140923-17-7 -
1676 Dichlorodioctylstannane 3542-36-7 222-583-2
1677 Mesotrione (ISO); 2-[4-(methylsulfonyl)- 2-nitrobenzoyl]-1,3- cyclohexanedione 104206-82-8 -
1678 Hymexazol (ISO); 3-hydroxy-5-methylisoxazole 10004-44-1 233-000-6
1679 Imiprothrin (ISO); reaction mass of: [2,4- dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-trans-chrysanthemate 72963-72-5 428-790-6
1680 Bis(α,α-dimethylbenzyl) peroxide 80-43-3; 80-43-3 201-279-31681 Tetrafluoroethylene 116-14-3 204-126-9
1682 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol;[DBMC] 119-47-1 204-327-1
1683 (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone 688046-61-9 692-456-8
1684 (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate 1101132-67-5 701-225-3
1685 Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate 35575-96-3 252-626-0
1686 3-methylpyrazole 1453-58-3 215-925-7
1687 N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen 1228284-64-7 817-852-1
1688 N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane 874967-67-6 688-331-2
1689 4-methylpentan-2-one; isobutyl methyl ketone (MIBK) 108-10-1 203-550-1
1690 Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine 110488-70-5 404-200-2
1691 Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid 114311-32-9 601-305-7
1692 Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine 153719-23-4 428-650-4
1693 Triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol 138182-18-0 -
1694 Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate 13684-56-5 237-198-5
Annex III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN, Modified§
dates added to the text: 2023-07-01, 2024-01-01
Explanation, written by a model and checked against the cited text
The list of introductory footnotes/explanatory statements gained two new market-restriction statements referencing 1 July 2023 and 1 January 2024 dates, one concerning a substance generally and one specifically concerning non-oxidative hair dye products.
A new footnote cross-referencing Annex IV, entry No 82 for use as a colorant was also added.
Within entry 22, the eyelash-colouring restriction wording changed from prohibiting use to dye eyelashes or eyebrows to prohibiting use to dye eyelashes only.
Cited: Annex III, v2 (external, EUR-Lex) · Annex III, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
3 entries added, 1 amended, 0 removed.
4 rows carry no key and are not compared.
3 entries added
| Identifiers | 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 | |
| Reference number 324CAS 119-36-8EC 204-317-7 | 324 | Methyl 2-hydroxybenzoate | Methyl Salicylate | 119-36-8 | 204-317-7 | (a) 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) | (a) 0,06 % | Not to be used in preparations for children under 6 years of age, with the exception of (k) Toothpaste | |
| (b) Face makeup (except lip products, eye makeup and makeup remover) | (b) 0,05 % | ||||||||
| (c) Eye makeup and makeup remover | (c) 0,002 % | ||||||||
| (d) Leave-on hair products (spray/aerosol) | (d) 0,009 % | ||||||||
| (e) Deodorant spray/aerosol | (e) 0,003 % | ||||||||
| (f) Body lotion spray/aerosol | (f) 0,04 % | ||||||||
| (g) Rinse-off skin products (except hand wash) and rinse-off hair products | (g) 0,06 % | ||||||||
| (h) Hand wash | (h) 0,6 % | ||||||||
| (i) Hydroalcoholic-based fragrances | (i) 0,6 % | ||||||||
| (j) Lip products | (j) 0,03 % | ||||||||
| (k) Toothpaste | (k) 2,52 % | ||||||||
| (l) Mouthwash intended for children aged 6–10 years | (l) 0,1 % | ||||||||
| (m) Mouthwash intended for children above 10 years of age and adults | (m) 0,6 % | ||||||||
| (n) Mouth spray | (n) 0,65 % | ||||||||
| Reference number 325CAS 128-37-0EC 204-881-4 | 325 | 2,6-Di-Tert-Butyl-4-Methylphenol | Butylated Hydroxytoluene | 128-37-0 | 204-881-4 | a) Mouthwash b) Toothpaste c) Other leave-on and rinse-off products | a) 0,001 % b) 0,1 % c) 0,8 % | ||
| Reference number 326CAS 8004-92-0EC 305-897-5 | 326 | 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts (CI 47005) , | Acid Yellow 3 | 8004-92-0 | 305-897-5 | Non-oxidative hair dye products | 0,5 % | ||
1 entry amended
| Identifiers | Version | 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 | ||
| Reference number 22CAS 108-46-3EC 203-585-2 | Before | 22 | 1,3-benzenediol | Resorcinol | 108-46-3 | 203-585-2 | (a) Hair dye substance in oxidative hair dye products | For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 1,25 % | (a) To be printed on the label:
The mixing ratio.
Hair colorants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary black henna tattoos may increase your risk of allergy.
Do not colour your hair if:
you have a rash on your face or sensitive, irritated and damaged scalp,
you have ever experienced any reaction after colouring your hair,
you have experienced a reaction to a temporary black henna tattoo in the past.
Contains resorcinol.
Rinse hair well after application.
Rinse eyes immediately if product comes into contact with them.
Do not use to dye | |
| (b) Products intended for colouring eyelashes | (b) For professional use only. | (b) To be printed on the label: The mixing ratio. For professional use only. Contains resorcinol. This product can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. Rinse eyes immediately if product comes into contact with them. | ||||||||
| (c) Hair lotions and shampoos | (c) 0,5 % | (c) Contains resorcinol. | ||||||||
| After | 22 | 1,3-benzenediol | Resorcinol | 108-46-3 | 203-585-2 | (a) Hair dye substance in oxidative hair dye products | For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 1,25 % | (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. Contains resorcinol. Rinse hair well after application. Rinse eyes immediately if product comes into contact with them. Do not use to dye eyelashes. | ||
| (b) Products intended for colouring eyelashes | (b) For professional use only. | (b) To be printed on the label: The mixing ratio. For professional use only. Contains resorcinol. This product can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. Rinse eyes immediately if product comes into contact with them. | ||||||||
| (c) Hair lotions and shampoos | (c) 0,5 % | (c) Contains resorcinol. | ||||||||
Text from EUR-Lex, before and after
Previous version, in force 6 October 2022 02009R1223-20221006 → this version, in force 17 December 2022 02009R1223-20221217
compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere
ANNEX III
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.
… 31 unchanged lines …
From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market. From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.
From 26 January 2022 hair dye and self-tanning products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 22 April 2022 hair dye and self-tanning products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 21 August 2022 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 21 November 2022 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 1 July 2023 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 1 July 2023 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be made available on the Union market.
For use as a colorant, see Annex IV, entry No 82.
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
… 300 unchanged lines …
Contains resorcinol.
Rinse hair well after application.
Rinse eyes immediately if product comes into contact with them.
Do not use to dye eyelashes or eyebrows. Do not use to dye eyelashes.
(b) Products intended for colouring eyelashes (b) For professional use only. (b) To be printed on the label:
The mixing ratio.
For professional use only.
… 1,611 unchanged lines …
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers324 Methyl 2-hydroxybenzoate Methyl Salicylate 119-36-8 204-317-7 (a) 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) (a) 0,06 % Not to be used in preparations for children under 6 years of age, with the exception of (k) Toothpaste (b) Face makeup (except lip products, eye makeup and makeup remover) (b) 0,05 %
(c) Eye makeup and makeup remover (c) 0,002 %
(d) Leave-on hair products (spray/aerosol) (d) 0,009 %
(e) Deodorant spray/aerosol (e) 0,003 %
(f) Body lotion spray/aerosol (f) 0,04 %
(g) Rinse-off skin products (except hand wash) and rinse-off hair products (g) 0,06 %
(h) Hand wash (h) 0,6 %
(i) Hydroalcoholic-based fragrances (i) 0,6 %
(j) Lip products (j) 0,03 %
(k) Toothpaste (k) 2,52 %
(l) Mouthwash intended for children aged 6–10 years (l) 0,1 %
(m) Mouthwash intended for children above 10 years of age and adults (m) 0,6 %
(n) Mouth spray (n) 0,65 %
325 2,6-Di-Tert-Butyl-4-Methylphenol
Butylated Hydroxytoluene 128-37-0 204-881-4 a) Mouthwash
b) Toothpaste
c) Other leave-on and rinse-off products a) 0,001 %
b) 0,1 %
c) 0,8 % 326 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts (CI 47005)
,
Acid Yellow 3 8004-92-0 305-897-5 Non-oxidative hair dye products 0,5 %
Annex V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS, Modified§
Not in every listWhat this means
Found in the text, but not every source lists it — the text comparison found this change; the EU's own amendment metadata does not list it. The source that does not name it is the EU's own amendment metadata. Both are shown; neither is overruled.
Explanation, written by a model and checked against the cited text
The two texts are identical apart from a minor spacing change in entry 51, where the substance name "Sodium N-(hydroxymethyl)glycinate" has an added space before "glycinate" in the later version.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
0 entries added, 1 amended, 0 removed (1 of the amended differs only in spacing, dash forms or accents).
1 entry amended
1 entry differs only in spacing, dash forms or accents
| Identifiers | Version | 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 | ||
| Reference number 51CAS 70161-44-3EC 274-357-8 | Before | 51 | Sodium | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | 0,5 % | Not to be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w | ||
| After | 51 | Sodium N-(hydroxymethyl) glycinate | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | 0,5 % | Not to be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w | |||
Text from EUR-Lex, before and after
Previous version, in force 6 October 2022 02009R1223-20221006 → this version, in force 17 December 2022 02009R1223-20221217
ANNEX V
LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
Preamble
1. For the purposes of this list:
Salts is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.
Esters is taken to … 1,627 unchanged words … to be used in aerosols (sprays) Contains glutaral
49 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane 7-Ethylbicyclooxazolidine 7747-35-5 231-810-4 0,3 % Not to be used in oral products and in products applied on mucous membranes 50 3-(p-Chlorophenoxy)-propane-1,2 diol Chlorphenesin 104-29-0 203-192-6 0,3 % 51 Sodium N-(hydroxymethyl)glycinate N-(hydroxymethyl) glycinate Sodium Hydroxymethylglycinate 70161-44-3 274-357-8 0,5 % Not to be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w 52 Silver chloride deposited on titanium dioxide Silver chloride 7783-90-6 232-033-3 0,004 % (as AgCl) 20 % AgCl (w/w) on TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products 53 Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride Benzethonium Chloride 121-54-0 204-479-9 (a) Rinse-off products
(b) Leave-on products other than oral products 0,1 % 54 Benzalkonium chloride, bromide and saccharinate
Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate 8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9 264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1 0,1 % (as benzalkonium chloride) Avoid contact with eyes
55 Methanol, (phenylmethoxy-) Benzylhemiformal 14548-60-8 238-588-8 Rinse-off products 0,15 % 56 3-Iodo-2-propynylbutylcarbamate Iodopropynyl butylcarbamate 55406-53-6 259-627-5 (a) Rinse-off products
(b) Leave-on products
(c) Deo-dorants/anti-perspirants (a) 0,02 %
(b) 0,01 %,
(c) 0,0075 % Not to be used in oral and lip products
(a) Not to be used in products for children under 3 years of age, except in bath products/shower gels and shampoo
(b) Not to be used in body lotion and body cream
(b) and (c) Not to be used in products for children under 3 years of age (a) Not to be used for children under 3 years of age
(b) and (c) Not to be used for children under 3 years of age
57 2-Methyl-2H-isothiazol-3-one Methylisothiazolinone
2682-20-4 220-239-6 Rinse-off products 0,0015 % 58 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride
Ethyl Lauroyl Arginate HCl 60372-77-2 434-630-6 (a) Mouthwashes (a) 0,15 % (a) Not to be used in preparations for children under 10 years of age (a) Not to be used for children under 10 years of age
(b) Other products (b) 0,4 % (b) Not to be used in lip products, oral products (other than mouthwashes), and spray products
59 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate Citric acid (and) Silver citrate — 460-890-5 0,2 %, corresponding to 0,0024 % of silver Not to be used in oral products and eye products 60 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one Hydroxyethoxyphenyl Butanone 569646-79-3 933-435-8 0,7 %
Annex VI LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS, Modified§
dates added to the text: 2025-01-01, 2025-07-01
Explanation, written by a model and checked against the cited text
The introductory notes for Annex VI gained a new phase-out passage stating that from 1 January 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market, and that from 1 July 2025 such non-complying products shall not be made available on the Union market, along with a new sentence limiting the combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form to 10 %.
Entry 3 (Homosalate) had its product type and body parts column changed from an unrestricted listing to face products with the exception of propellant spray products, and its maximum concentration changed from 10 % to 7,34 %.
Two new entries, 33 and 34, were added for Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form, each with identification data, a 10 % maximum concentration, and for the nano form additional conditions on purity, particle size, and a restriction against inhalation exposure.
Cited: Annex VI, v2 (external, EUR-Lex) · Annex VI, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
2 entries added, 1 amended, 0 removed.
2 entries added
| Identifiers | Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
|---|---|---|---|---|---|---|---|---|---|
| Chemical name/INN/XAN | 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 | |
| Reference number 33CAS 919803-06-8EC 485-100-6 | 33 | 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone | Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine | 919803-06-8 | 485-100-6 | 10 % | |||
| Reference number 34CAS 919803-06-8EC 485-100-6 | 34 | 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone | Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano) | 919803-06-8 | 485-100-6 | 10 % | Only nanomaterials having the following characteristics are allowed: Purity ≥ 97 % Median particle size D50 (50 % of the number below this diameter): ≥ 50 nm of number size distribution. Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation. | ||
1 entry amended
| Identifiers | Version | Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Chemical name/INN/XAN | 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 | ||
| Reference number 3CAS 118-56-9EC 204-260-8 | Before | 3 | Benzoic acid, | Homosalate | 118-56-9 | 204-260-8 | ||||
| After | 3 | Benzoic acid, 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester/Homosalate | Homosalate | 118-56-9 | 204-260-8 | Face products with the exception of propellent spray products | 7,34 % | |||
Text from EUR-Lex, before and after
Previous version, in force 6 October 2022 02009R1223-20221006 → this version, in force 17 December 2022 02009R1223-20221217
ANNEX VI
LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS
Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.
For use as a colorant, see Annex IV, No 143.
In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.
In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.
In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g.
However, cosmetic products containing that substance and complying with the restrictions set out in Regulation (EC) No 1223/2009 as applicable on 27 July 2022 may be placed on the Union market until 28 January 2023 and be made available on the Union market until 28 July 2023.
Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.
From 1 January 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 July 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.
In case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10 %.
Reference number Substance identification Conditions Wording of conditions of use and warnings
Chemical name/INN/XAN 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
1 2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfate Camphor Benzalkonium Methosulfate 52793-97-2 258-190-8 6 % 3 Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester/Homosalate Homosalate 118-56-9 204-260-8 10 Face products with the exception of propellent spray products 7,34 % 4 2-Hydroxy-4-methoxy-benzophenone/Oxybenzone
Benzophenone-3 131-57-7 205-031-5 a) Face products, hand products, and lip products, excluding propellant and pump spray products
b) Body products, including propellant and pump spray products
c) Other products a) 6 %
b) 2,2 %
c) 0,5 % For a) and b) … 876 unchanged words … (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate 1419401-88-9 700-860-3 3 % Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation
Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers 33 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine 919803-06-8 485-100-6 10 %
34 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano) 919803-06-8 485-100-6 10 %
Only nanomaterials having the following characteristics are allowed:
Purity ≥ 97 %
Median particle size D50 (50 % of the number below this diameter): ≥ 50 nm of number size distribution.
Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.
The full entry is committed at eu/32009R1223/CHANGELOG.md.