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We’re facing a lot of changes in cosmetic law. Commission Regulation (EU) 2026/909 of 27 April 2026 introduces changes to the use of Benzyl Salicylate, Citral, Triphenyl Phosphate, Ammonium Silver Zinc Aluminum Silicate, aluminum, water-soluble zinc salts, acetylated vetiver oil, HC Blue No. 18, HC Red No. 18, HC Yellow No. 16, Hydroxypropyl-p-phenylenediamine and its dihydrochloride salt, and DHHB. This post will be quite long, so sit back and enjoy a cup of coffee or tea 😊


Changes to the use of 2 allergens – Benzyl Salicylate and Citral

Benzyl Salicylate and Citral are well-known fragrance ingredients in cosmetics that were previously regulated as standard allergens. They are included in Annex III of Regulation 1223/2009, requiring consumers to be informed of their presence when concentrations exceed 0.001% in leave-on products and 0.01% in rinse-off products. From now, additional restrictions on the use of these substances will apply.

Concerns have been raised regarding benzyl salicylate’s potential endocrine-disrupting properties. Therefore, it was assessed by the SCCS, which established safe levels for its use in specific cosmetics. Entry 75 in Annex III will therefore be amended, adding the following product categories with maximum permissible concentrations of Benzyl Salicylate:

  • a) Fragrance products (hydroalcoholic and non-hydroalcoholic, spray and non-spray) – C max. = 4%;
  • b) Rinse-off skin and hair products (except shower gel/bath products) – C max. = 0.5%;
  • c) Shower gel/bath products – C max. = 1.3%;
  • d) Leave-on skin and hair products (nonspray/non-aerosol) (except body lotion) – C max. = 0.5%;
  • e) Leave-on hair products (sprays/aerosols) – C max. = 0.5%;
  • f) Body lotion – C max. = 0.7%;
  • g) Face make-up and make-up remover products – C max. = 0.2%;
  • h) Oral products – C max. = 0.004%;
  • i) Deodorant products (spray/aerosol) – C max. = 0.91%.

Citral (item 70, Annex III) has been subject to additional restrictions on use due to its relatively high sensitization potential. Therefore, regulations have been added for this substance regarding its use in such cosmetics as:

  • a) Lip makeup products, lipsticks, lip balms – C max. =0.11%;
  • b) Deodorants and antiperspirants – C max. =0.032%;
  • c) Eye products, face make-up, and make-up remover – C max. =0.65%;
  • d) Fragrance products (hydroalcoholic and non-hydroalcoholic, spray and nonspray) – C max. = 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 product – C max. =0.15%;
  • f) Oral products – C max. =0.35%;
  • g) Leave-on hair products – C max. =1.2%;
  • h) Skin and hair rinse-off products – C max. =1.2%;
  • i) Leave-on products for the anogenital area (baby wipes and intimate wipes) – C max. =0.063%.

Triphenyl Phosphate as a new prohibited substance

Triphenyl Phosphate was previously not regulated by cosmetics law and it was used as a plasticizer to soften or elasticize synthetic polymers. Due to its endocrine-disrupting properties, as well as insufficient safety information and potential genotoxicity, the SCCS issued a negative opinion for this ingredient. Triphenyl Phosphate will therefore be added to the list of prohibited substances (Annex II, entry 1752).


Changes in the Use of Ammonium Silver Zinc Aluminum Silicate

Silver zinc zeolite (INCI: Ammonium Silver Zinc Aluminum Silicate) is listed as a prohibited substance in cosmetic products (entry 1597, Annex II) due to its classification as a “reproductive toxicant category 2.”

However, the cosmetics industry has taken defensive measures to ensure the safe use of silver zinc zeolite as a preservative in cosmetic products, as the number of available cosmetic preservatives is drastically decreasing. The SCCS has confirmed that this substance is safe at a maximum concentration of 1% in spray deodorants and powder foundations, provided that the silver content of the silver zinc zeolite does not exceed 2.5%.

Therefore, Ammonium Silver Zinc Aluminum Silicate will be added to the list of preservatives permitted in cosmetic products (Annex V, entry 61), where it can be used at a maximum concentration of 1% in:

  • a) Spray deodorants,
  • b) Powder foundations.

Additional restrictions include the requirement for the silver content in Ammonium Silver Zinc Aluminum Silicate, which cannot exceed 2.5%. So, we have a small success, as we have obtained a new preservative 🙂

In turn, entry 1597, Annex II, will read: Silver zinc zeolite with the exception of silver zinc zeolite under the conditions set out in entry 61 in Annex V.


Aluminum and aluminum-containing ingredients

The time has also come for new regulations on the use of aluminum and its compounds in cosmetics. They perform a variety of functions in cosmetics, from antiperspirants and rheology modifiers to colourants. Currently, Regulation 1223/2009 already lists various aluminum-containing ingredients: in entries 34, 50, 189, 190, and 192 of Annex III; entries 117, 118, 119, 121, 131, and 150 of Annex IV; and entry 27a of Annex VI.

The new entry will be entry 379 in Annex III: 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 V. The following categories of cosmetics have been identified in which aluminum-containing substances may be used:

  • a) Non-aerosol antiperspirants or deodorants – C max. =7.73% (as Al)
  • b) Aerosol antiperspirants or deodorant – C max. =3.24% (as Al)
  • c) Toothpaste – C max. =3.18% (as Al)
  • d) Lip products – C max. = 14.62 % (as Al)
  • e) Body and face rinse-off products – C max. =0.89 % (as Al)
  • f) Bar soap – C max. =4 % (as Al)
  • g) Rinse-off hair products – C max. =7.14 % (as Al)
  • h) Leave-on hair products that may lead to exposure of the end user’s lungs by inhalation – C max. =0.15 % (as Al)
  • i) All other leave-on hair products – C max. =6.7 % (as Al)
  • j) Make-up products (except lip products, eye liner products, eye shadow, nail varnish and mascara)– C max. =23 % (as Al)
  • k) Eye liner products – C max. =15.76 % (as Al)
  • l) Eye shadow – C max. =43.31 % (as Al)
  • m) Nail varnish – C max. =3.61 % (as Al)
  • n) Mascara – C max. =3.13 % (as Al)
  • o) Face leave-on products (except make-up products, eye liner products, eye shadow and mascara)- C max. =10.59 % (as Al)
  • p) Hand leave-on products – C max. =0.86 % (as Al)
  • 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) – C max. =3.81% (as Al), with an additional requirement:Not to be used in sunscreen products that may lead to exposure of the end user’s lungs by inhalation.
  • r) Talcum powder – C max. = 2.0% (as Al), plus a warning requirement on the packaging: “Keep powder away from children’s nose and mouth”.

Whew, that’s a lot of requirements, right?


Water-soluble zinc salts

The next substances to undergo changes in their conditions of use are water-soluble zinc salts. Currently, entry 24 of Annex III covers them, which restricts the use of zinc acetate, zinc chloride, zinc gluconate, and zinc glutamate to a maximum concentration of 1% (as zinc) in all cosmetic products.

Concerns about the use of zinc salts in oral products have been raised, the SCCS has reviewed them. In the light of the SCCS opinion, the use of water-soluble zinc salts in oral hygiene products poses a potential risk to human health if the concentration of these substances exceeds certain levels. Therefore, entry 24, Annex III, has been amended, where:

– in addition to the existing zinc acetate, zinc chloride, zinc gluconate, and zinc glutamate, zinc citrate and zinc sulphate have been added,

– instead of the permissible concentration of 1% in all cosmetics, the following possible cosmetic categories and maximum concentrations have been added:

  • a) Toothpaste intended for users over 1 year of age – C max. =1% (calculated as zinc),
  • b) Toothpaste intended for children between 6 months and 1 year of age – C max. =0,72% (calculated as zinc),
  • c) Mouthwash intended for users above 6 years of age – C max. =0.1% (calculated as zinc),
  • d) Other products – C max. =1% (calculated as zinc).

Acetylated Vetiver Oil

Acetylated vetiver oil is used as a fragrance ingredient and has not been regulated until now. Due to the concerns about its high allergenic potential, the SCCS issued an opinion on it and determined the need to introduce restrictions on its use in cosmetics.

Therefore, the ingredients with INCI names: Acetylated Vetiveria Zizanioides Root Extract, Acetylated Vetiveria Zizanioides Root Oil will be included in position 380 of Annex III. Their use restrictions will be as follows:

  • a) Fragrance products (hydroalcoholic and nonhydroalcoholic, spray and nonspray) – C max. =0.9%;
  • b) Deodorant – C max. =0.05%;
  • c) Make-up products – C max. =0.05%;
  • d) Leave-on products (except a), b), and c)) – C max. =0.1%;
  • e) Rinse-off products – C max. = 0.2%.

An additional requirement is that raw materials containing acetylated vetiver oil must be stabilized with 1% alpha-tocopherol.


New hair colourants

The regulation, specifically Annex III, will also include new hair colourants. These include:

  • • HC Blue No. 18,
  • • Hydroxypropyl-p-phenylenediamine,
  • • Hydroxypropyl-p-phenylenediamine 2HCl,
  • • HC Yellow No. 16,
  • • HC Red No. 18.

These hair colourants were not previously regulated by the Cosmetics Regulation. They will now be listed in entries 381 (HC Blue No. 18), 382 (Hydroxypropyl-p-phenylenediamine, Hydroxypropyl-p-phenylenediamine 2HCl), 383 (HC Yellow No. 16), and 384 (HC Red No. 18). All dyes will be permitted in oxidative and non-oxidative hair dyes (except for item 382 – oxidative dyes only) with the conditions and warnings on the packaging specific to hair dyes.

The maximum permissible concentrations that will apply are:

  • 0.35% (oxidative and non-oxidative dyes) for HC Blue No. 18,
  • 2% (oxidative dyes) for Hydroxypropyl-p-phenylenediamine and Hydroxypropyl-p-phenylenediamine 2HCl,
  • • 1% for oxidative dyes and 1.5% for non-oxidative dyes for HC Yellow No. 16,
  • • 1.5% for oxidative dyes and 0.5% for non-oxidative dyes for HC Red No. 18.

Additional purity requirements for DHHB UV filter

DHHB (Diethylamino Hydroxybenzoyl Hexyl Benzoate) is a UV-filter regulated by Annex VI, entry 28.

Concerns have been raised about the contamination of this ingredient with di-n-hexyl phthalate (DnHexP), which occurs as an unavoidable trace impurity. The Commission and Member States have agreed on a level of 10 ppm as acceptable for the amount of DnHexP in DHHB.

A new raw material purity requirement will therefore be added to entry 28 of Annex VI: “Di-n-hexyl phthalate (DnHexP) as an unavoidable trace impurity in DHHB must not exceed 10 ppm.”


Summary

I’m glad you made it to the end. Additional conditions for the use of two common allergens: benzyl salicylate and citral, a ban on the use of triphenyl phosphate, a zeolite containing silver and zinc as a new preservative, changes in the use of aluminum compounds, water-soluble zinc salts, and acetylated vetiver oil, all the way to new hair dyes and purity requirements for the DHHB filter – these are the changes introduced by this single regulation.

How much time do we have for all these changes? The regulation will enter into force on May 18, 2026! Fortunately, it provides for additional transition periods for: triphenyl phosphate, water-soluble zinc salts, citral, benzyl salicylate, aluminum, acetylated vetiver oil, and DHHB. These deadlines include January 1, 2027 for placing on the market and July 1, 2028 for making available on the market.

Finally, I’m attaching the link to the regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600909

Citral, aluminum, new hair colourants, and other news in cosmetic law Read More »

We started the new year with a legislative bang! 😉 We have a new, freshly published – on January 12, 2026 – Commission Regulation (EU) 2026/78, the so-called Omnibus VIII on CMR substances. What changes does this legislation bring to the cosmetics industry? I invite you to read it.


Changes in the use of Silver

Silver has been recently particularly analysed for its safety in cosmetics. This substance, with a particle diameter of:

1) equal to or larger than 1 mm (silver massive),
2) larger than 100 nm and smaller than 1 mm (silver powder),
3) larger than 1 nm and smaller than or equal to 100 nm (silver nano)

has been finally classified as a CMR category 2 (reproductive toxicity).

Currently, silver is listed in the entry 142 of Annex IV to Regulation (EC) No. 1223/2009 as an permitted colourant (CI 77820), while its colloidal nanoform (1–100 nm) is prohibited in cosmetic products (entry 1727 in Annex II).

Current changes to the use of silver in cosmetics include:

Entry 1727, Annex II (prohibited substances): In addition to nano-colloidal silver (Colloidal Silver (nano)), Silver (massive) [particle diameter ≥ 1 mm] will be added, and for nano-colloidal silver, the appropriate particle sizes will be included: Silver (nano) [1 nm < particle diameter ≤ 100 nm],

New entry 379, Annex III (permitted substances with restrictions): Silver (powder) [100 nm < particle diameter < 1 mm] will be permitted in toothpastes and mouthwashes, at a maximum concentration of 0.05%.

Entry 142, Annex IV (permitted colourants): Permitted silver sizes, product types, and permitted concentrations will be specified, i.e.: Silver (powder) [100 nm < particle diameter < 1 mm] permitted for use in: lip products and eye shadows at a maximum concentration of 0.2%.


Changes in the use of hexyl salicylate

Hexyl salicylate (INCI: Hexyl Salicylate) is primarily used as a fragrance in cosmetics (providing a floral-fruity scent). It was not previously regulated by Regulation 1223/2009. Due to its classification as CMR 2 (reproductive toxicity) and the SCCS opinion, Hexyl Salicylate will be added to the list of substances subject to restrictions on use in cosmetics.

This ingredient will therefore occupy position 380 in Annex III, where it will be permitted in the following products:

a) Hydroalcoholic-based fragrances (except hydroalcoholic-based fragrances intended for children below 3 years of age); max. concentration = 2%;

b) All rinse-off products (except shower gel/bath products, hand wash, hair conditioner, and shampoo intended for children below 3 years of age); max. concentration = 0.5%;

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); max. concentration = 0.3%;

d) Toothpaste; max. concentration = 0.001%;

e) Mouthwash; max. concentration = 0.001%;


f) Shower gel/bath products, hand wash, shampoo, hair conditioner, body, face, and hand (skin) care products, lipstick/lip balm, and fragranced products intended for children below 3 years of age; max. concentration = 0.1%.

Furthermore, hexyl salicylate will not be allowed to be used in products for children under 3 years of age, with the exception of item d) “toothpaste” and item f).


Changes in the use of o-phenylphenol

Another change concerns the substance biphenyl-2-ol (INCI: o-Phenylphenol), which has also been classified as a CMR substance category 2 (carcinogen category 2). O-Phenylphenol is now listed in entry 7 of Annex V to the Cosmetics Regulation as a preservative permitted in rinse-off and leave-on products at maximum permitted concentrations of 0.2% and 0.15% (expressed as phenol), respectively, provided that eye contact is avoided.

The SCCS concluded in its opinion of October 25, 2024, that o-Phenylphenol and its derivative, Sodium o-Phenylphenate, can be considered safe under certain conditions of use in cosmetic products. Therefore, entry 7 of Annex V will be amended as follows:

– next to o-Phenylphenol, its sodium salt, Sodium o-Phenylphenate, will be added,

– the condition of use will be added: 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,

– and a further condition: 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.

The permitted products and concentrations for these preservatives will remain unchanged.


New Prohibited Substances

In addition to the above changes, a number of new ingredients will be added to the list of prohibited substances, including: acetone oxime, trimethyl borate, fenpropidin, and 2,3-epoxypropyl neodecanoate. Furthermore, perboric acid and its salts have been consolidated into a single group, meaning entries 1397, 1398, and 1399 have been combined into a single entry – 1397. Annex II will now contain 1766 entries.


Summary

There are therefore many changes to the Cosmetics Regulation. For more details, I encourage you to read the text of the new regulation https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600078

It is worth noting that the regulation will enter into force on February 2, 2026, but will apply from May 1, 2026. Are you ready for new changes?

New regulations for silver, hexyl salicylate, and o-phenylphenol Read More »

Some time has passed since the last entry. But that does not mean that cosmetic law has come to a standstill. A new Commission Regulation (EU) of 12 May 2025 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 has just appeared. It introduces further banned substances to Annex II.


What will be banned?

The list of ingredients banned in cosmetics will include 21 new substances with carcinogenic, mutagenic or toxic to reproduction effects. This means that we will now have not 1730 but as many as 1751 substances banned for use in cosmetics.

For the cosmetics industry, the most important bans are on the use of:

Dimethyltolylamine – the substance has not been regulated by law so far,

Trimethylbenzoyl Diphenylphosphine Oxide (TPO) – currently covered by Annex III, item 311, permitted for use in a maximum concentration of 5% in products intended for nail modeling and styling, for professional use only.

These substances were of particular importance in applications in nail polishes for hybrid manicure. Dimethyltolylamine serves as a polymerization accelerator, and TPO is a photoinitiator in the processes of curing pigmented coatings curable with UV radiation. Currently, Dimethyltolylamine has been classified as carcinogenic, and TPO – as a substance harmful to reproduction. Hence their use is prohibited.

The regulation will be applied from September 1 this year. This means that from 1 September 2025, cosmetics containing the indicated substances will not be allowed to be placed on the market or made available on the market.


Summary

Today’s concise entry talks about the introduction of new substances prohibited in cosmetic products. Among them, the ban on the use of Dimethyltolylamine and Trimethylbenzoyl Diphenylphosphine Oxide, which are very important for the hybrid varnish industry, deserves special attention. For more details, I refer you to the regulation on the website: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202500877

More banned substances Read More »

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