Amendments to the Rulebook on Cosmetic Products: what "Official Gazette of RS" No. 25/2026 brings

The amendments to the Rulebook on Cosmetic Products were published in “Official Gazette of RS” No. 25/2026 and concern:

Annex 2 (prohibited substances),
Annex 3 (substances subject to restrictions),
Annex 5 (preservatives) and
Annex 6 (UV filters).

The amendments are part of aligning Serbian legislation with EU Regulation 1223/2009 on cosmetic products and its 2024 amendments.

Until this amendment, the applicable consolidated basis was the 2019 Rulebook with its 2022 and 2023 amendments. Annex 3 ended with entry No. 326. The amendment expands this annex to 378 entries, and Annexes 2, 5 and 6 are also amended.

Before reviewing the specific substantive changes, it is necessary to point out two systemic problems that run through this regulation.

A note on deadlines and an error in the wording

Problem 1 – retroactive deadlines and shifted dates

Serbia implements amendments to EU cosmetics legislation with a certain time lag. Rulebook 25/2026 was published in March 2026, but it contains dates that originate from EU legislation adopted during 2024. Those dates were entered into the Serbian regulation with a shift, but in some cases, even with that shift, they had already passed before the rulebook was published.

As an illustration: EU legislation for retinol prohibited placing non-compliant products on the market from February 1, 2025, and making them available on the market from November 1, 2025. The Serbian rulebook shifts both deadlines. The ban on placing on the market moves to November 1, 2025 (+9 months), and the ban on making available to May 1, 2027 (+18 months). The result is that the ban on placing on the market, despite the shift, takes effect 4 months before the rulebook was published.

The same type of problem exists for homosalate in Annex 6 and for some entries in Annex 2.

Problem 2 – an error in the wording of the footnotes for entries 372–378

Annex 3 distinguishes in substance between prohibited substances (Annex 2) and substances that are permitted under certain conditions (Annex 3). For substances in Annex 3, any ban on placing or making available on the market should apply exclusively to non-compliant products. These are products that do not meet the prescribed conditions of use.

EU legislation for the substances in entries 372–378 explicitly states:

“cosmetic products containing that substance and not complying with the conditions shall not be placed on the market.”.

The Serbian text of the footnote for the same entries omits this qualifier. The wording:

“products containing this substance shall not be placed on the market” –

as written, prohibits all products containing that substance. This applies regardless of whether the products meet the prescribed conditions or not.

By contrast, entries 327–371 (fragrance allergens) correctly contain the wording “which do not comply with the restrictions”, so this error is not systemic but limited to entries 372–378.

It is not clear whether there is a general provision in the text of the rulebook that would correct this interpretation. A logical argument that can be used is that the substances in Annex 3 are by definition not prohibited, so any ban must imply non-compliant products. However, that is an interpretation, not what the text explicitly says. For all situations in which the relevant products are already on the market or are being planned, consulting the competent authority is recommended.

Formal changes to the main text of the rulebook

In addition to the changes in the annexes, Rulebook 25/2026 also amends the normative text itself.

Article 5, which defined the alternative Serbian documentation route – the “Documentation with product information” – has been deleted in its entirety. In practice, this alternative already ceased to apply on April 11, 2023 under the transitional provisions of Article 18 of the 2019 Rulebook. With the deletion of Article 5, the documentation framework now relies exclusively on the Product Information File from Article 4, which corresponds to the EU model.

In addition, Article 4 has been supplemented to specify that the Product Information File must be “readily accessible to the sanitary inspector, in electronic or other format at the address indicated on the product.” Article 17, which governs claims about cosmetic products, has been aligned with the deletion of Article 5 – the obligation for claims to be compliant now refers exclusively to the Product Information File.

Practical conclusion: the Product Information File under the Article 4 model is nothing new for those who have followed implementation since 2022. For those who may have been late with the transition, it is clear that the alternative route no longer exists.

Annex 2 – prohibited substances: new entries 1725–1751

Until this amendment, Annex 2 contained 1724 entries. 27 new ones are added.

Nanomaterials (entries 1725–1729)

The use of the following nanomaterials is prohibited: Styrene/Acrylates Copolymer (nano), copper (nano), silver (nano), gold (nano) and platinum (nano). For products placed on the Serbian market by February 1, 2025, it is prescribed that they may remain on the market until the date this rulebook enters into force. Since these entries are in Annex 2, the list of prohibited substances, the wording “containing this substance” is correct here: there are no conditions under which use would be permitted.

4-Methylbenzylidene Camphor (entry 1730)

This substance, until now permitted as a UV filter in Annex 6 (up to 4%), moves to the list of prohibited substances. It is prescribed that from May 1, 2025 it may not be placed on the Serbian market, and from May 1, 2026 it may not be on the market. Both dates preceded the publication of the rulebook – see the note on retroactive deadlines.

Other new entries (1731–1751)

Entries 1731–1751 cover various substances with the note: “applies from September 1, 2025.” This date also preceded the publication of the rulebook.

Annex 3 – substances subject to restrictions: entries 327–378

Fragrance allergens (entries 327–371)

This group of 45 new entries concerns fragrance substances and essential oils for which mandatory listing in the INCI ingredient list is prescribed when the concentration exceeds 0.001% in leave-on products, or 0.01% in rinse-off products. Covered substances include Citral, Limonene, Linalool, Eugenol, Geraniol, Linalyl Acetate, Menthol, Carvone, Vanillin, Benzyl Alcohol, Santalol, as well as essential oils such as Lavandula angustifolia, Mentha piperita, Rosa rugosa and Cinnamomum zeylanicum.

For these entries the footnotes are correctly worded: “cosmetic products containing this substance and which do not comply with the restrictions may be placed on the market until July 31, 2026, and made available on the market until July 31, 2028.” Compliant products are not affected by this transitional deadline.

This is a relevant set of new obligations for anyone who formulates perfumed cosmetic products or uses essential oils – both for documentation and for updating labels.

New active cosmetic ingredients (entries 372–378)

These seven new entries introduce restrictions for active ingredients widely used in the skin care segment. The note on the wording of the footnotes described in the introductory section applies to all of them.

Hydroxyapatite (nano) (No. 372) – Permitted for use in toothpastes up to 10% and mouthwashes up to 0.465%, with prescribed technical characteristics of the nanoparticles.

Genistein (No. 373) – A soy phytoestrogen, maximum concentration 0.007%.

Daidzein (No. 374) – A soy phytoestrogen, maximum concentration 0.02%.

Kojic acid (No. 375) – Permitted exclusively in face and hand creams, up to 1%.

Retinol, Retinyl acetate, Retinyl palmitate (No. 376) – Body lotions up to 0.05% retinol equivalent (RE); other leave-on and rinse-off products up to 0.3% RE. Mandatory statement on the label: “Contains vitamin A. Consider your daily intake of vitamin A before use.”

The footnote to this entry contains both problems described in the introductory note: the qualifier “which do not comply with the restrictions” is omitted, and the deadline for the ban on placing on the market (November 1, 2025) passed before the rulebook was published, while the deadline for the ban on making available on the market (May 1, 2027) has not yet arrived.

Alpha-Arbutin (No. 377) – Face creams up to 2%, body lotions up to 0.5%. The level of hydroquinone must remain as low as possible and must not exceed the unavoidable presence in traces.

Arbutin (No. 378) – Face creams up to 7%. The same note on hydroquinone.

For entries 372–375, 377 and 378 the footnote reads: products containing this substance placed on the Serbian market by February 1, 2025 may remain on the market until the date this rulebook enters into force. The same qualifier is omitted here – the footnote does not say “which do not comply with the restrictions” but “containing this substance”, which as written also covers compliant products.

Annex 5 – preservatives: two changes

Formaldehyde and formaldehyde-releasing substances

The previous rule required the warning “contains formaldehyde” when the concentration exceeds 0.05%. That rule still applies to products already on the market, until July 31, 2026.

From July 31, 2026 a new provision applies: the warning “releases formaldehyde” is mandatory when the total concentration of formaldehyde that can be released from the finished product exceeds 0.001% (10 ppm), regardless of the number of substances that release it. This is a significantly stricter threshold than the previous 0.05%.

The July 31, 2026 deadline is concrete and applicable. If you formulate products containing formaldehyde-releasing preservatives – DMDM Hydantoin, Imidazolidinyl Urea, Diazolidinyl Urea, Sodium Hydroxymethylglycinate and others – a review of concentrations and updating of labels are necessary before that date.

Triclocarban (No. 23)

New restrictions for this antimicrobial substance:

must not be used in mouth rinse products
must not be used in toothpastes for children under 6 years of age
mandatory statement: “Not to be used for children under 6 years of age”

Annex 6 – UV filters: two changes

Homosalate (No. 3)

The previous limit of 10% for all cosmetic products is replaced by new conditions: the maximum concentration is 7.34%, and use is permitted exclusively in face products, except those in spray form.

The deadlines prescribed with this change (January 1, 2025 and July 1, 2025) preceded the publication of the rulebook – the note on retroactive deadlines from the introductory section applies.

Benzophenone-3 (No. 4)

The previous limit of 6% for all categories is replaced by a differentiated system:

face, hand and lip products (except aerosols and sprays): up to 6%
body products, including aerosols and sprays: up to 2.2%
other products: up to 0.5%

For the first two categories, up to 0.5% may be used exclusively to protect the formulation, outside this limit as a UV filter.

Annex 9 – a formal change

The content of Annex 9, which defines microbiological criteria, remains unchanged. The only change is an update of the referenced standard: instead of EN ISO 17516:2014, SRPS EN ISO 17516:2015 is cited.

What to check

The only deadline that is unambiguously applicable and has not yet passed is July 31, 2026 – the new labelling rules for formaldehyde-releasing substances. This deadline should be treated as a concrete compliance deadline.

For the fragrance allergens in Annex 3 (entries 327–371), the compliance deadline for new placings on the market is July 31, 2026, and for stock July 31, 2028.

For all of entries 372–378 – the new active cosmetic ingredients, including kojic acid, the arbutins, genistein, daidzein, hydroxyapatite and retinol – the situation is regulatorily ambiguous because of the errors in the wording of the footnotes and the retroactive deadlines. Direct consultation with the competent authority is recommended before making business decisions related to these substances.

Conclusion

The amendments to the Rulebook on Cosmetic Products published in “Official Gazette of RS” No. 25/2026 bring concrete new obligations: 27 new prohibited substances, 52 new entries in Annex 3 including fragrance allergens and active cosmetic ingredients, and changes for preservatives and UV filters.

What is specific about this regulation is the combination of two problems: some of the deadlines passed before publication, and the footnotes for entries 372–378 omitted the key qualifier that distinguishes compliant from non-compliant products. In the most extreme interpretation, this opens the possibility that even compliant products containing these substances are treated as subject to the ban. For those situations, consulting the competent authority is not an option – it is the only safe route.

The amendments to the Rulebook on Cosmetic Products affect everyone who places cosmetic products on the Serbian market and require a systematic review of documentation, formulations and labels.

Exporters operating on the EU market had to adapt to these changes during the past year, when the deadlines from the parent EU legislation arrived, so they will have no additional activities if they also placed the same formulations on the Serbian market.

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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.