An ingredient in our cosmetic has been banned or restricted

The Cosmetics Regulation, Regulation (EC) No 1223/2009, controls ingredients through its annexes. Article 14(1) says a cosmetic product shall not contain prohibited substances listed in Annex II, restricted substances used outside the conditions in Annex III, and colorants, preservatives and UV filters other than those allowed in Annexes IV, V and VI under their conditions. Article 15 adds that substances classified as carcinogenic, mutagenic or toxic for reproduction under Part 3 of Annex VI to the CLP Regulation are prohibited, with narrow exceptions for category 2 substances found safe by the Scientific Committee on Consumer Safety (SCCS), and stricter conditions for category 1A and 1B substances.^[1]

The annexes are not fixed. Where there is a potential risk to human health that needs a Union-wide answer, the Commission may amend Annexes II to VI after consulting the SCCS (Article 31(1)). The consolidated text of 18 May 2026 lists more than fifty amending acts. Each one has its own date. Regulation (EU) 2025/877, for example, added the substances classified as CMR by Delegated Regulation (EU) 2024/197 to Annex II (entries 1731 to 1751), deleted the Annex III entry for Trimethylbenzoyl Diphenylphosphine Oxide used in artificial nail systems, entered into force on 2 June 2025 and applies from 1 September 2025, the date from which those classifications apply (Article 2, recitals 4 and 11). It has no sell-through period. A Commission proposal of 8 July 2025, COM(2025) 531, would set a deadline for derogation requests and transition periods of 12 months for placing on the market and 24 months for products already available after a CMR ban. On 4 October 2026 it is a proposal, not law.^[1][2][3]

The duty to follow these changes lies with the responsible person. Under Article 5(1), the responsible person ensures compliance with Articles 14 and 15, among others. Under Article 5(2), a responsible person who has reason to believe a product placed on the market does not conform must immediately take the corrective measures needed to bring it into conformity, withdraw it or recall it, and, where it presents a risk to human health, inform the competent authorities of the Member States where it was made available and of the Member State where the product information file is readily accessible.^[1]

A reformulation is not finished when the new formula works. The product information file must be kept for each product, contain the safety report and be updated as necessary, and it is kept for ten years after the last batch was placed on the market (Article 11).^[1]

Distributors have their own duty. They must act with due care, and if they have reason to believe a product does not conform, they must not make it available until it has been brought into conformity (Article 6(3)). Competent authorities can require the responsible person to take corrective action within a set time limit when the substance restrictions are breached (Article 25(1)(f)), and can require the same of distributors (Article 26).^[1]