Publication of the 22nd Adaptation to Technical Progress amending the annexes of the CLP regulation EU 1272/2008
October 2024 - Publication of the 22nd Adaptation to Technical Progress amending the annexes of the CLP regulation EU 1272/2008
On September 30th, 2024, the Regulation EU 2024/2564, a.k.a. the 22nd Adaptation to Technical Progress (ATP) amending the CLP regulation, has been published in the Official Journal of the European Union.
This regulation introduces harmonized hazard classifications for a new batch of chemical ingredients. The date of application is May 1st 2026.
7 of those entries are used in cosmetics and have been classified as CMRs. They are listed in the annex at the end of this page. These ingredients will be banned, except for the 3 ones defended by the industry and for which a favorable SCCS opinion has been issued:
- HEXYL SALICYLATE – The SCCS has given its favorable opinion at the requested concentrations for adults (SCCS/1658/23) and children under 3 years old (SCCS/1668/24 under finalization):
| Product type | Maximum concentration (% w/w) |
|---|---|
| Hydroalcoholic-based fragrances | 2 |
| All Rinse-off products | 0.5 |
| All Leave-on products | 0.3 |
| Oral care (toothpaste and mouthwash) | 0.001 |
| Products for children under 3 y/o: Shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm, fragrance products | 0.1 |
| Products for children under 3 y/o: Toothpaste | 0.001 |
- O’PHENYLPHENOL – The SCCS gives a favorable preliminary opinion (SCCS/1669/24 under finalization):
| Product type | Maximum concentration (% w/w) |
|---|---|
| Rinse-off products | 0.2 |
| Leave-on products | 0.15 |
Moreover, O-Phenylphenol and Sodium o-Phenylphenate, when used together, should not exceed the maximum concentration 0.15 % in leave-on cosmetic products.
O-Phenylphenol and Sodium o-Phenylphenate, when used together, should not exceed the maximum concentration 0.2 % in rinse-off cosmetic products.
- SILVER (micron-sized) – Only a few uses have been considered safe by the SCCS (SCCS/1665/24):
| Product type | Maximum concentration (% w/w) |
|---|---|
| Lip balm | 0.2 |
| Toothpaste | 0.05 |
| Mouthwash | 0.05 |
An Omnibus regulation is expected to add the bans and the restrictions above mentioned in the cosmetic regulation (see Annex for details).
The application deadline for the bans and restrictions in cosmetics will be the same as the enforcement date of these new classifications: May 1st 2026.
Non-compliant products on the EU market after that date will have to be withdrawn.
We hope that this letter will be of help and stay at your disposal for any questions related to this topic. Should you have any question, please, feel free to contact your dedicated Customer Relationship Manager.
ANNEX
List of chemicals used in cosmetics that have been classified CMR by the ATP 22.
| Chemical name | INCI name | Cas No | CMR Classification | Restriction/Ban in cosmetics |
|---|---|---|---|---|
| silver massive: [particle diameter ≥ 1 mm] | SILVER | 7440-22-4 | Repr. 2 | Ban |
| silver powder: [particle diameter > 100 nm < 1 mm] | CI 77820; COLLOIDAL SILVER; SILVER | 7440-22-4 | Repr. 2 | Restriction: see above |
| silver nano: [particle diameter > 1 nm ≤ 100 nm | CI 77820; COLLOIDAL SILVER; SILVER | 7440-22-4 | Repr. 2 | Ban (already banned via Omnibus nano regulation) |
| Hexyl Salicylate | HEXYL SALICYLATE | 6259-76-3 | Repr. 2 | Restriction (see above) |
| biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl | O’PHENYLPHENOL | 90-43-7 | Carc. 2 | Restriction (see above) |
| N ,N’-methylenediacrylamide | N,N’-METHYLENEBISACRYLAMIDE | 110-26-9 | Muta. 1B | Ban |
| tert-butyl 2-ethylperoxyhexanoate | 3006-82-4 | Repr. 1B | Ban |
Get in Touch
Need a piece of advice, a quotation or answers to your questions?
Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!
As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmeticproducts in various markets:
-
First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries -
50 regulatory experts, toxicologists, pharmacists, and chemists to serve you. -
A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more! -
A best-in-class IT tool, free of charge, and saving a lot of your time. -
More than 1,500 international clients have already chosen Biorius! -
We evaluated more than 100,000 products and have always successfully managed compliance over 15 years of existence
Get in Touch
"*" indicates required fields
Authors
