On 28 April 2026, the European Commission issued Regulation (EU) 2026/909, which amends and updates the usage rules for multiple cosmetic ingredients, including benzyl salicylate, triphenyl phosphate, ammonium silver zinc aluminium silicate, aluminium, water-soluble zinc salts, acetylated vetiver oil, citral, HC Blue No 18, HC Red No 18, HC Yellow No 16, hydroxypropyl‑p‑phenylenediamine and its dihydrochloride, as well as DHHB. This regulation revises Annexes II, III, IV and V of the EU Cosmetics Regulation (EC) No 1223/2009.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. CIRS has summarized and sorted out the key contents of this regulatory revision, and provided an in-depth interpretation of the relevant substances for your reference.
Substance Interpretation and Regulatory Revisions
1. Triphenyl Phosphate
Interpretation: Triphenyl Phosphate is not regulated under Regulation (EC) No 1223/2009 but is used in cosmetic products as a plasticiser to soften, or make supple, various synthetic polymers.
The SCCS concluded in its opinion of SCCS/1656/23 (26 October 2023) that Benzyl Salicylate is safe for use in cosmetic products up to the maximum concentrations provided in the submissions by industry. Considering the SCCS opinion, it can be concluded that there is a potential risk to human health arising from the use of Benzyl Salicylate in cosmetic products when the concentration of that substance exceeds certain levels. In its opinion of SCCS/1664/24 (25 July 2024), the SCCS could not conclude on the safety of Triphenyl Phosphate because the information provided was insufficient to fully evaluate and exclude potential genotoxicity. Considering the SCCS opinion, it can be concluded that there is a potential risk to human health arising from the use of that substance in cosmetic products.
Revised Content: Therefore, Triphenyl Phosphate should be added to the list of substances prohibited in cosmetic products in Annex II to Regulation (EC) No 1223/2009. The following entry is added in Annex II:
| Reference number | Substance identification | ||
| Chemical name/INN | CAS number | EC number | |
| a | b | c | d |
| 1752 | Triphenyl Phosphate (*) | 115-86-6 | 204-112-2 |
(*) From 1 January 2027 cosmetic products containing Triphenyl Phosphate and not complying with the restrictions shall not be placed on the Union market. From 1 July 2028 cosmetic products containing Triphenyl Phosphate and not complying with the restrictions shall not be made available on the Union market.
2. Benzyl Salicylate
Interpretation: Benzyl Salicylate (CAS No 118-58-1) is listed under entry 75 of Annex III to Regulation (EC) No 1223/2009.
Revised Content: Therefore, Benzyl Salicylate is allowed for use as a fragrance allergen in cosmetic products subject to a requirement to inform consumers about its presence when its concentration exceeds 0,001 % in leave-on and 0,01 % in rinse-off products. Entry 75 of Annex III is replaced as follows:
| 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 |
| 75 |
2-hydroxyben zoic acid phenylmethyl ester (**) |
Benzyl Salicylate |
118-58-1 |
204-292-9 |
(a) Fragrance products (hydroalcoholic and non-hydroalcoholic, spray and non- spray) |
(a) 4 % |
The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds: - 0,001 % in leave-on products - 0,01 % in rinse- off products. |
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(b) Rinse-off skin and hair products (except shower gel/ bath products) |
(b) 0,5 % |
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(c) Shower gel/bath products |
(c) 1,3 % |
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(d) Leave-on skin and hair products (non- spray/non-aerosol) (except body lotion) |
(d) 0,5 % |
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(e) Leave-on hair products (spray/ aerosol) |
(e) 0,5 % |
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(f) Body lotion |
(f) 0,7 % |
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(g) Face make-up and make-up remover products |
(g) 0,2 % |
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(h) Oral products |
(h) 0,004 % |
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(i) Deodorant products (spray/ aerosol) |
(i) 0,91 % |
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(**) From 1 January 2027 cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 1 July 2028 cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.
3. Aluminium and Aluminium-containing Ingredients
Interpretation: Aluminium and aluminium-containing ingredients are used in a variety of cosmetic products with different functions. Currently, different aluminium-containing ingredients are listed in Regulation (EC) No 1223/2009 entries 34, 50, 189, 190 and 192 of Annex III; in entries 117, 118, 119, 121, 131 and 150 of Annex IV, and entry 27a of Annex VI. On 27 March 2024, the SCCS adopted an opinion (SCCS/1662/23), concluding that aluminium and aluminium-containing ingredients can be considered safe under specific conditions of use.
Revised Content: Without prejudice to the restrictions and conditions already provided for in Annexes III, IV and VI to Regulation (EC) No 1223/2009, the aluminium concentration limits indicated for non-spray and sprayable cosmetic product categories in the SCCS opinion should be reflected in Annex III to that Regulation. The following entry is added in Annex III:
| 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 |
| 379 | Aluminium- containing ingredients with the exception of those listed in entries 34, 50, 189, 190 and 192 of Annex III, in entries 117, 118, 119, 121, 131, 150 of Annex IV, in entry 61 in Annex V, and entry 27a of Annex VI. (**) |
(a) Non-aerosol antiperspirants or deodorants | (a) 7,73 % (as Al) | For (q): Not to be used in sunscreen products that may lead to exposure of the end user’s lungs by inhalation. | For (r): Keep powder away from children’s nose and mouth | |||
| (b) Aerosol antiperspirants or deodorants | (b) 3,24 % (as Al) | |||||||
| (c) Toothpaste | (c) 3,18 % (as Al) | |||||||
| (d) Lip products | (d) 14,62 % (as Al) | |||||||
| (e) Body and face rinse-off products | (e) 0,89 % (as Al) | |||||||
| (f) Bar soap | (f) 4 % (As AI) | |||||||
| (g) Hair rinse-off products | (g) 7,14 % (as Al) | |||||||
| (h) Hair leave-on products that may lead to the exposure of the end user’s lungs by inhalation | (h) 0,15 % (as Al) | |||||||
| (i) All other hair leave-on products | (i) 6,7 % (as Al) | |||||||
| (j) Make-up products (except lip products, eye liner products, eye shadow, nail varnish and mascara) | (j) 23 % (as Al) | |||||||
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(k) Eye liner products |
(k) 15,76 % (as Al) | |||||||
| (l) Eye shadow | (l) 43,31 % (as Al) | |||||||
| (m) Nail varnish | (m) 3,61 % (as Al) | |||||||
| (n) Mascara | (n) 3,13 % (As Al) | |||||||
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(o) Face leave-on products (except make-up products, eye liner products, eye shadow and mascara) |
(o) 10,59 % (as Al) | |||||||
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(p) Hand leave-on products |
(p) 0,86 % (as Al) | |||||||
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(q) Other leave-on skin products (except non- aerosol antiperspirants or deodorants, aerosol antiperspirants or deodorants, face leave-on products, hand leave-on products and talcum powder |
(q) 3,81 % (as Al) | |||||||
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(r) Talcum powder |
(r) 2,0 % (as Al) | |||||||
(**) From 1 January 2027 cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 1 July 2028 cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.
4. Water-soluble Zinc Salts
Interpretation: Water-soluble zinc salts has been included in Annex III of Regulation (EC) No 1223/2009 with entry 24 which restricts the use of zinc acetate, zinc chloride, zinc gluconate, and zinc glutamate up to a maximum concentration of 1 % (as zinc) in all cosmetic products.
On 26 October 2023, the SCCS adopted an opinion (SCCS/1657/23), concluding that water-soluble zinc salts covering zinc acetate (CAS No 557-34-6), zinc chloride (CAS No 7646-85-7), zinc gluconate (CAS No 4468-02-4), zinc citrate (CAS No 546-46-3), and zinc sulphate, zinc sulphate monohydrate, zinc sulphate heptahydrate (CAS No 7733-02-0/ 7446-19-7/7446-20-0) can be considered safe when used in toothpaste in concentrations up to 1 % (as zinc) with the exception of children below 1 year of age where that concentration should not exceed 0,72 % (as zinc). In addition, the SCCS concluded that water-soluble zinc salts can be considered safe when used in mouthwash in concentrations up to 0,1 % (as zinc) across all age groups above 6 years.
Revised Content: In view of the SCCS opinion, it can be concluded that there is a potential risk to human health arising from the use of water-soluble zinc salts in oral products when the concentration of those substances exceeds certain levels. Therefore, the use of water-soluble zinc salts should be restricted to the maximum concentrations proposed by the SCCS. Entry 24 of Annex III is replaced as follows:
| 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 |
| 24 | Water-soluble zinc salts with the exception of zinc | Zinc Acetate | 557-34-6/ 5970-45-6 | 209-170-2/- | (a) Toothpaste intended for users above 1 year of age | (a) 1 % (as zinc | ||
| 4- hydroxy- benzene sulphonate (entry 25 of Annex III) (**) | Zinc Chloride | 7646-85-7 | 231-592-0 | (b) Toothpaste intended for children between 6 months and 1 year of age | (b) 0,72 % (as zinc) | |||
| Zinc Gluconate | 4468-02-4 | 224-736-9 | ||||||
| Zinc Glutamate | 1949-15-1 | - | ||||||
| Zinc Citrate | 546-46-3 | 208-901-2 | (c) Mouthwash intended for users above 6 years of age | (c) 0,1 % (as zinc) | ||||
| Zinc Sulphate | 7733-02-0/ 7446-19-7/ 7446-20-0 | 231-793-3 | (d) Other products | (d) 1 % (as zinc) | ||||
(**) From 1 January 2027 cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 1 July 2028 cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.
5. Acetylated Vetiver Oil
Interpretation: Acetylated vetiver oil (CAS No 84082-84-8) is not regulated under Regulation (EC) No 1223/2009 but is used as a fragrance in various types of cosmetic products. The SCCS concluded in its opinion (SCCS/1599/18) that Acetylated vetiver oil can be considered safe as a fragrance ingredient when used with 1 % alpha-tocopherol in cosmetic leave-on and rinse-off cosmetic products at the concentrations proposed by the industry. In addition, in its opinion (SCCS/1663/24), the SCCS concluded that Acetylated vetiver oil can also be considered safe when used in sprayable products that may lead to inhalation exposure.
Revised Content: In view of the SCCS opinions, it can be concluded that there is a potential risk to human health arising from the use of Acetylated vetiver oil in cosmetic products when the concentration of that substance exceeds certain levels. Therefore, the use of acetylated vetiver oil in cosmetic products should be restricted to the maximum concentrations proposed by the SCCS. Entry 380 is added in Annex III:
| 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 |
| 380 | Vetiveria zizanioides, ext., acetylated (**) Oils, vetiver, acetylated (**) | Acetylated Vetiveria Zizanioides Root Extract; Acetylated Vetiveria Zizanioides Root Oil | 84082-84-8/ 68917-34-0 | 282-031-1/- | (a) Fragrance products (hydroalcoholic and non- hydroalcoholic, spray and non- spray) | (a) 0,9 % | For (a)-(e): stabilised with 1 % alpha- tocopherol (applies to raw materials). | |
| (b) Deodorant | (b) 0,05 % | |||||||
| (c) Make-up products | (c) 0,05 % | |||||||
| (d) Leave-on products (except (a), (b) and (c)) | (d) 0,1 % | |||||||
| (e) Rinse-off products | (e) 0,2 % | |||||||
(**) From 1 January 2027 cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 1 July 2028 cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.
6. Citral
Interpretation: Citral (CAS No 5392-40-5) is listed under entry 70 of Annex III to Regulation (EC) No 1223/2009. It is allowed for use as a fragrance allergen in cosmetic products subject to a requirement to inform consumers about its presence when its concentration exceeds 0,001 % in leave-on and 0,01 % in rinse-off products.
On 29 July 2024, the SCCS adopted an opinion (SCCS/1666/24), concluding that Citral can be considered safe in relation to the induction of sensitisation at the concentrations proposed by the industry.
Revised Content: In view of the SCCS opinion, there is a potential risk to human health arising from the use of Citral in cosmetic products when the concentration of that substance exceeds certain levels. Therefore, the use of that substance in cosmetic products should be restricted to the maximum concentrations proposed by the SCCS. Entry 70 of Annex III is replaced as follows:
| Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
| Chemica lname/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 |
| 70 |
3,7-Dimethy l-2,6-octadienal (**) (E)-3,7- dimethylocta-2,6- dienal (***) (Z)-3,7- dimethylocta-2,6- dienal (***)
|
Citral | 5392-40-5 | 226-394-6 | (a) Lip make-up products, lipstick, lip salves | (a) 0,11 % |
The presence of the substance or substances shall be indicated as ‘Citral’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds: -0,001 % in leave-on products -0,01 % in rinse- off products. |
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| Geranial | 141-27-5 | 205-476-5 | (b) Deodorants and antiperspirants | (b) 0,032 % | ||||
| Neral |
106-26-3 |
203-379-2 |
(c) Eye products, face make-up and make-up remover | (c) 0,65 % | ||||
| (d) Fragrance products (hydroalcoholic and non-hydroalcoholic, spray and non- spray) | (d) 0,6 % | |||||||
| (e) Leave-on skin products (except lip products, deodorants and antiperspirants, fragrance products, eye products, face make-up and make-up remover) and nail products | (e) 0,15 % | |||||||
| (f) Oral products | (f) 0,35 % | |||||||
| (g) Hair leave-on products | (g) 1,2 % | |||||||
| (h) Skin and hair rinse- off products | (h) 1,2 % | |||||||
| (i) Leave-on products for the anogenital area (baby wipes and intimate wipes) | (i) 0,063 % |
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(**) From 1 January 2027 cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 1 July 2028 cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.
(***) From 1 January 2027 cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 1 August 2028 cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.
7. HC Blue No 18
Interpretation: HC Blue No 18 (CAS No 1166834-57-6/852356-91-3), is currently not regulated under Regulation (EC) No 1223/2009, and is used as a substance in oxidative and non-oxidative hair dye products. The SCCS concluded in their scientific advice of SCCS/1653/23 (27 April 2023) that HC Blue No 18 is safe when used in such products at on-head concentrations of up to 0,35 %.
Revised Content: In light of the SCCS scientific advice, it can be concluded that there is a potential risk to human health arising from the use of HC Blue No 18 in oxidative and non-oxidative hair dye products when the concentration of that substance exceeds a certain level. Therefore, the use of that substance in those products should be restricted to a maximum concentration of 0,35 %. Entry 381is added in Annex III as follows:
| 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 |
| 381 | 3-[(E)-(3-chloro- 4-hydroxyphenyl) diazenyl]-2,l- benzisothiazole- 5-sulfonamide | HC Blue No 18 | 1166834-57-6/ 852356-91-3 | -/- | (a) Hair dye substance in oxidative hair dye products | (b) 0,35 % | For (a): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,35 %. | For (a): To be printed on the label: The mixing ratio. “Hair colourants 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”. |
| (b) Hair dye substance in non-oxidative hair dye product | ||||||||
8. HC Yellow No 16
Interpretation: HC Yellow No 16 (CAS No 1184721-10-5) is currently not regulated under Regulation (EC) No 1223/2009, and is used as a substance in oxidative and non-oxidative hair dye products. The SCCS concluded in scientific advice of SCCS/1670/24 (25 October 2024) that HC Yellow No 16 is safe when used in such products at on-head concentrations of up to 1 % in oxidative and up to 1,5 % in non-oxidative hair dye products.
Revised Content: According to SCCS scientific advice, there is a potential risk to human health arising from the use of HC Yellow No 16 in oxidative and non-oxidative hair dye products when the concentration of that substance exceeds a certain level. Therefore, the use of that substance in non-oxidative and oxidative hair dye products should be restricted to a maximum concentration of 1,5 % and 1 % respectively. Entry 383 is added in Annex III as follows:
| 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 |
| 383 | 2-chloro- 4-[(1E)-(1-methyl-1H-pyrazol-5-yl)diazenyl]-phenol | HC Yellow No 16 | 1184721- 10-5 | - | (a) Hair dye substance in oxidative hair dye products | (b) 1,5 % | For (a): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1 %. | For (a): To be printed on the label: The mixing ratio. “Hair colourants 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”.reaction to a temporary ‘black henna’ tattoo in the past”. |
| (b) Hair dye substance in non-oxidative hair dye products | ||||||||
9. HC Red No 18
Interpretation: HC Red No 18 (CAS No 1444596-49-9) is currently not regulated under Regulation (EC) No 1223/2009, and is used as a substance in oxidative and non-oxidative hair dye products.Tthe SCCS concluded in their scientific advice of SCCS/1673/24 (22 January 2025)that HC Red No 18 is safe when used in such products at on-head concentrations of up to 1,5 % in oxidative and up to 0,5 % in non-oxidative hair dye products.
Revised Content: In light of the SCCS scientific advice, it can be concluded that there is a potential risk to human health arising from the use of HC Red No 18 in oxidative and non-oxidative hair dye products when the concentration exceeds a certain level. Therefore, the use of that substance in oxidative and non-oxidative hair dye products should be restricted to a maximum concentration of 1,5 % and 0,5 % respectively. Entry 384 has been added in Annex III as follows:
| Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
| Chemica lname/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body part | Maximum concentration in ready for use preparation | Other | ||
| 384 | 2-chloro- 4-[(1E)-(1-methyl-1H-pyrazol-5-yl)diazenyl]-phenol | HC Yellow No 16 | 1184721- 10-5 | - | (a) Hair dye substance in oxidative hair dye products | (b) 1,5 % | For (a): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1 %. | For (a): To be printed on the label: The mixing ratio. “Hair colourants 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”.reaction to a temporary ‘black henna’ tattoo in the past”. |
| (b) Hair dye substance in non-oxidative hair dye products | ||||||||
10. Hydroxypropyl-p-phenylenediamine and Hydroxypropyl-p-phenylenediamine 2HCl
Interpretation: Hydroxypropyl-p-phenylenediamine and Hydroxypropyl-p-phenylenediamine 2HCl (CAS No 73793-79-0 and 1928659-47-5) is currently not regulated under Regulation (EC) No 1223/2009, and is used as a substance in oxidative hair dye products. The SCCS concluded in its opinion of 28 February 2024 ( SCCS/1659/23)that those substances are safe when used in such products at on-head concentrations of up to 2 %.
Revised Content: In light of the SCCS opinion, there is a potential risk to human health arising from the use of Hydroxypropyl-p-phenylenediamine and Hydroxypropyl-p-phenylenediamine 2HCl in oxidative hair dye products when the concentration of that substance exceeds a certain level. Therefore, the use of those substances in those products should be restricted to a maximum concentration of 2 %. Entry 382 has been added in Annex III as follows:
| 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 |
| 382 | 3-(2,5-diaminophenyl)propan-1-ol and 3-(2,5-diamino phenyl) propan- 1-ol dihydrochloride salt | Hydroxypropyl-p- phenylenediamine and Hydroxypropyl- p- phenylenedia mine 2HCl |
73793-79-0 1928659-47-5 |
827-723-1 - |
Hair dye substance in oxidative hair dye products | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 %. | To be printed on the label: The mixing ratio. “Hair colourants 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”. | |
11. Ammonium Silver Zinc Aluminium Silicate
Interpretation: Ammonium Silver Zinc Aluminium Silicate (CAS No 130328-20-0) has been classified as ‘Toxic for Reproduction of Category 2’ by Commission Regulation (EU) 2017/776. Pursuant to Article 15(1) of Regulation (EC) No 1223/2009, Ammonium Silver Zinc Aluminium Silicate is listed as a prohibited substance in cosmetic products. The SCCS concluded that Ammonium Silver Zinc Aluminium Silicate is safe up to a maximum concentration of 1 % in spray deodorant and powder foundation, provided that the silver content in silver zinc zeolite does not exceed 2,5 %.
Revised Content: Considering the SCCS opinion, Ammonium Silver Zinc Aluminium Silicate should be deleted from the list of prohibited substances in cosmetic products in Annex II to Regulation (EC) No 1223/2009 and should be added to the list of preservatives allowed in cosmetic products in Annex V to that Regulation. Therefore, in Annex V, entry 61 is added:
| 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 |
| 61 | Silver zinc zeolite | Ammonium Silver Zinc Aluminium Silicate | 130328-20-0 | 603-404-0 |
(a) Deodorant spray (b) Powder foundation |
(a) and (b) 1 % | For (a) and (b) the silver content in Ammonium Silver Zinc Aluminium Silicate must not exceed 2,5 %. | |
Furthermore, entry 1597 in Annex II is replaced by the following:
| Reference number | Substance identification | ||
| Chemical name/INN | CAS number | EC number | |
| a | b | c | d |
| 1597 | Silver zinc zeolite with the exception of silver zinc zeolite under the conditions set out in entry 61 in Annex V | 130328-20-0 | 603-404-0 |
12. Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB)
Interpretation: Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) (CAS/EC No 302776-68-7/ 443-860-76), is listed in entry 28 of Annex VI to Regulation (EC) No 1223/2009 and is therefore allowed for use as a UV filter in cosmetic products.
The SCCS concluded in their scientific advice of SCCS/1678/25 (14 February 2025) that the trace level of 260 ppm is safe as an unavoidable trace impurity in DHHB. The SCCS has also noted in its scientific advice the available information showing that the levels of DnHexP in DHHB can be lowered to 1 ppm. Therefore, the SCCS is of the opinion that this trace level of 1 ppm should be the target for the maximal level of DnHexP as an unavoidable trace impurity in DHHB. Given the increased cost of production of DHHB with a trace level of 1 ppm of DnHexP, in particular for small and medium-sized companies, and consequently the higher cost of sunscreens products containing DHHB for consumers, the Commission and Member States have agreed that the level of 10 ppm can be accepted as safe for DnHexP in DHHB.
Revised Content: In light of the SCCS scientific advice, there is a potential risk to human health arising from the contaminant DnHexP in the UV filter DHHB when the concentration of that contaminant exceeds a certain level. Therefore, the maximal level of DnHexP as an unavoidable trace impurity in DHHB should be restricted to 10 ppm, taking into account the economic impact on manufacturers of sunscreen product. In Annex VI, entry 28 is replaced by the following:
| 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 |
| 28 | Benzoic acid, 2-[4-(diethylamino)- 2- hydroxybenzoyl]- , hexyl ester (****) | Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) | 302776-68-7 | 443-860-6 | 10 % | Di-n-hexyl phthalate (DnHexP) as an unavoidable trace impurity in DHHB must not exceed 10 ppm. | ||
(****) From 1 January 2027 cosmetic products containing ‘Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyl ester’ and not complying with the conditions shall not be placed on the Union market. From 1 July 2028 cosmetic products containing ‘Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyl ester’ and not complying with the conditions shall not be made available on the Union market.
CIRS Reminder
It is recommended that cosmetic enterprises timely follow up on the latest amendments to the EU cosmetics regulations, and comprehensively sort out the list of controlled substances. Enterprises shall conduct targeted formula and ingredients self-inspections, and strictly comply with the updated prohibition and restriction requirements specified in Annexes II, III, IV and V of the EU Cosmetics Regulation.Meanwhile, enterprises should make rational use of the transition period, optimize product formulas in advance, improve raw material control and compliance documents, and keep track of subsequent EU regulatory updates.This will ensure the compliance of products marketed in the EU and effectively prevent risks such as product removal, recall and trade non-compliance.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- EU Cosmetic Product Formula and Label Review
- EU Cosmetic Responsible Person
- Product Information File (PIF)
- EU Cosmetic Safety Assessment (CPSR)
Further Information:
European Commission issued Regulation (EU) 2026/909
