The EU Cosmetics Regulation is rapidly evolving, driven by scientific progress, updated SCCS opinions, and increasing demands for transparency.
The Regulation (EC) No 1223/2009 remains the cornerstone of this framework, setting out strict requirements for safety, labeling, notification, and ingredient control. However, the European Commission has recently introduced significant updates that directly affect cosmetic manufacturers, laboratories, and responsible persons.
These amendments—based on new Scientific Committee on Consumer Safety (SCCS) opinions and the alignment with the CLP Regulation (EC) No 1272/2008)—introduce new prohibitions, restrictions, and conditions of use.
This article outlines the key regulatory updates, their technical implications for the cosmetics industry, and the strategies required to ensure compliance, while highlighting the importance of regulatory transparency through platforms such as COSMILE Europe.
Updates To The EU Cosmetics Regulation
The European Commission’s proposal includes a comprehensive amendment to the Annexes of Regulation (EC) No 1223/2009, expected to enter into force in the first quarter of 2026.
These changes reflect the EU’s commitment to the precautionary principle and to continuously updating the scientific basis underpinning the safe use of cosmetic ingredients.
EU Cosmetics Regulation: Annex II Banned Ingredients
Key substances added to Annex II (prohibited ingredients) include:
- Silver Zinc Zeolite, except when authorized as a preservative (Annex V).
- Triphenyl Phosphate.
Both are banned due to their adverse toxicological profile, linked to endocrine-disrupting potential and chronic toxicity. Their prohibition requires immediate reformulation for products previously using them as antimicrobials or plasticizers.
Restricted Substances in the EU Cosmetics Regulation (Annex III)
The amendment also introduces new restrictions for ingredients commonly used in fragrance, hair color, and personal care products:
- Acetylated Vetiver Oil (Vetiveria zizanioides).
- Aluminum compounds.
- Benzyl Salicylate, Citral, Geranial, and Neral.
- Hair colorants: HC Blue 18, HC Yellow 16, HC Red 18.
- Hydroxypropyl-p-phenylenediamine and its dihydrochloride salt.
- Water-soluble zinc salts.
These updates stem from new evidence on allergenicity, systemic toxicity, and environmental persistence, requiring immediate raw material reviews and supplier communication.
Preservatives in the EU Cosmetics Regulation (Annex V)
A new preservative has been introduced:
- Ammonium Silver Zinc Aluminum Silicate, subject to strict purity and concentration criteria.
This inclusion reflects the Commission’s direction toward authorizing only ingredients supported by robust analytical data and traceability along the supply chain.
UV Filters Under the EU Cosmetics Regulation (Annex VI)
The UV filter DHHB (Diethylamino Hydroxybenzoyl Hexyl Benzoate)—widely used in sunscreens—has been reassessed due to the potential contamination by DnHexP during synthesis.
The SCCS established a maximum limit of 0.026% (260 ppm) for this impurity, provided that DHHB concentration does not exceed 10% in the finished product.
This decision reinforces the growing importance of purity and impurity control as part of cosmetic ingredient safety assessment.
Regulation (EU) 2025/877 – Omnibus VII
In parallel, the Omnibus VII Regulation (EU) 2025/877 further expands the list of substances banned from cosmetics under CLP classification.
More than 20 substances classified as CMR (carcinogenic, mutagenic, or toxic for reproduction) have been added to Annex II, with direct application from 1 September 2025—no transition period.
This means that non-compliant products must be withdrawn immediately from the EU market.
The Case Of TPO
One of the most impactful changes is the prohibition of Trimethylbenzoyl Diphenylphosphine Oxide (TPO), a common photoinitiator in UV-cured nail products.
Moving TPO from Annex III (restricted) to Annex II (prohibited) effectively bans its use in the EU cosmetics market, posing major challenges for manufacturers of gel nail systems and UV-curable formulations.
Recent SCCS Opinions
The Scientific Committee on Consumer Safety (SCCS) remains the scientific authority responsible for evaluating the safety of cosmetic ingredients in the EU. Two recent opinions stand out for their relevance:
Tea Tree Oil (Melaleuca alternifolia)
The SCCS considers Tea Tree Oil (TTO) safe only within specific limits:
- 2.0% in shampoos.
- 1.0% in facial cleansers or shower gels.
- 0.1% in facial creams.
Furthermore, only oils compliant with ISO 4730:2017 are allowed, and aerosol products are excluded due to inhalation risks.
This position aims to balance the demand for natural ingredients with the need to prevent exposure to volatile components and potential Repr. 1B classifications.
UV Filter DHHB And Impurity Control
As noted earlier, the SCCS emphasized the importance of controlling impurities such as DnHexP in DHHB, setting precise analytical limits.
This trend highlights the growing role of advanced instrumental analysis in ensuring ingredient compliance.
Modern techniques—such as X-ray fluorescence (XRF), used in the S2 PUMA system implemented by SHAPYPRO—illustrate how analytical technology is enabling the cosmetics industry to meet increasingly stringent regulatory standards.
EU Cosmetics Regulation: Technical Implications
These regulatory changes demand a comprehensive review of manufacturing and compliance processes:
- Accelerated reformulation: replacing banned ingredients and adapting concentrations before enforcement deadlines.
- Updated toxicological assessments: revising Cosmetic Product Safety Reports (CPSR) to reflect new concentration limits and impurity controls.
- Supplier management: verifying documentation, raw material purity, and conformity with international standards.
- Labeling updates: ensuring accurate information on allergens, warnings, and ingredient lists.
Transparency And Access To Ingredient Information: The Role Of COSMILE Europe
In an increasingly complex regulatory environment, transparency and access to scientific data have become essential for compliance and consumer confidence.
The COSMILE Europe platform, launched by Cosmetics Europe, is a landmark initiative providing verified information on over 30,000 cosmetic ingredients.
It offers a reliable, science-based source of data on ingredient functions, safety, and regulatory status—accessible to both professionals and consumers.
By linking regulatory knowledge and digital transparency, COSMILE Europe strengthens the connection between science and consumer trust, supporting an industry that values clarity, responsibility, and evidence-based communication.
Compliance And Regulatory Monitoring Strategies
Given the frequency of regulatory updates, companies must adopt a proactive compliance strategy built on continuous monitoring and technical adaptability.
Key recommendations:
- Audit product portfolios to identify affected ingredients and formulations.
- Strengthen supplier collaboration to secure documentation on purity, traceability, and CLP compliance.
- Update CPNP notifications according to new limits and ingredient classifications.
- Implement a regulatory watch system—ideally supported by specialized consultancy—to anticipate and respond to future amendments.
Conclusion
The ongoing evolution of European cosmetics regulation highlights a clear direction: greater safety, transparency, and scientific accountability.
The recent updates to Regulation (EC) No 1223/2009, the latest SCCS opinions, and initiatives like COSMILE Europe confirm the EU’s commitment to a responsible, evidence-driven cosmetics industry.
For manufacturers, this means not only meeting new compliance requirements but also strengthening consumer confidence through rigorous quality control and transparent communication.
At SHAPYPRO, we help laboratories and brands interpret and implement these updates through regulatory consultancy, safety assessments, and proficiency testing programs designed to ensure analytical accuracy and long-term compliance.