Regulation (EU) 2026/78: What changes for cosmetic products from 1 May 2026

Another amendment, and a quick one

The Serbian rulebook on cosmetic products was amended in March 2026. A month earlier, the European Commission had published Regulation (EU) 2026/78, a new wave of amendments that has not yet appeared in Serbian law.

The regulation applies from 1 May 2026. For Serbian cosmetics exporters, that deadline is not abstract.

Serious exporters prepared in advance. The regulatory process in the EU runs for months before formal adoption. Anyone who follows the work of the scientific committees and the Commission’s proposals is not surprised. The aim of this article is not to raise alarm. It is an overview of the concrete changes and a reminder that the same changes are still waiting to be implemented in the Serbian rulebook.

The basis: the 22nd ATP to the CLP Regulation

Regulation (EU) 2026/78 implements the new CMR classifications from Delegated Regulation (EU) 2024/2564, which is the 22nd adaptation to technical progress (ATP) of the CLP Regulation. Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR categories 1A, 1B and 2) as a rule may not be used in cosmetic products. An exception is possible only on the basis of a positive opinion of the Scientific Committee on Consumer Safety (SCCS) and under strictly prescribed conditions.

The regulation amends Annexes II, III, IV and V of Regulation (EC) No 1223/2009.

Annex II: new prohibitions

Around fifteen substances newly classified in the CMR categories have been added to the list of substances prohibited in cosmetic products. Among them are

trimethyl borate,
tert-butyl-2-ethylperoxyhexanoate and
N,N’-methylenediacrylamide.

There is no transitional period for these substances. Products containing them may not be on the EU market from 1 May 2026.

In addition, the existing entries 1397, 1398 and 1399 for perboric acid and its salts have been consolidated into a single entry for clarity and legal certainty. In substance, the prohibition remains unchanged.

Silver (CAS No 7440-22-4) has been classified as a CMR substance of category 2. Its treatment in the regulation depends on particle size:

Nano form (diameter 1 nm to 100 nm) and coarse form / massive (diameter 1 mm and above): prohibited; entry 1727 in Annex II is extended to cover both forms.
Micron-sized powder / silver powder (diameter between 100 nm and 1 mm): not prohibited, but subject to restrictions (see Annex III and Annex IV).

Annex III: restrictions and conditions

Silver (micron-sized powder) is permitted for use as a preservative in toothpastes and mouthwashes, at a concentration of up to 0.05% in the finished product. As a colourant, it keeps its authorisation in Annex IV (CI 77820), but only for lip products and eye shadow, at a concentration of up to 0.2%.

Hexyl Salicylate (hexyl 2-hydroxybenzoate, CAS No 6259-76-3), which until now was not regulated in EU cosmetics law, is classified as CMR category 2 and is added to Annex III as entry 380. Differentiated limits apply by product category:

Alcohol-based perfumes (excluding products for children under 3 years): up to 2%
Rinse-off products: up to 0.5%
Other leave-on products: up to 0.3%
Toothpastes and mouthwashes: up to 0.001%
Products for children under 3 years: prohibited, with certain exceptions

This level of granularity calls for a review of formulations by category, not just a check against a single general limit.

Annex V: the preservative o-Phenylphenol

Entry 7 in Annex V, which regulates o-Phenylphenol as a preservative, is supplemented with its sodium salt, sodium o-phenylphenate. Both forms are permitted as preservatives at a maximum concentration of 0.2% in rinse-off products and 0.15% in leave-on products, expressed as phenol.

When they are used together, combined limits apply.

Prohibitions have also been added for products that involve inhalation exposure and for oral products.

What this means for Serbian exporters

Serbian cosmetics companies that place products on the EU market have the same regulatory obligations as companies based in the EU. Compliance with Regulation (EU) 2026/78 is not an option that waits for transposition into Serbian law; the obligations apply from 1 May 2026, regardless of where the company is registered.

Serious exporters prepared for this in advance. The period from formal adoption to the start of application is too short for any substantial operational changes.

Conclusion

Regulation (EU) 2026/78 is not a dramatic change to cosmetics regulation. It is a routine step of alignment with the new CMR classifications from the CLP Regulation. Anyone who follows EU regulation is not surprised.

The Serbian rulebook on cosmetic products has not yet taken over these changes. Serbian transposition of EU cosmetics regulation follows its established pace, and these provisions are waiting for the next alignment cycle. The pattern is familiar: whatever happens in the EU arrives here too.

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This blog post is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed chemical adviser or a lawyer specialising in chemical regulation.