The essentials
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products entered into application on 11 July 2013. It replaced the previous Cosmetics Directive 76/768/EEC and harmonized cosmetic safety rules across all EU and EEA Member States. Unlike a directive, a regulation has direct legal effect: it applies as written, without national transposition (European Commission, Cosmetics Regulation portal, accessed 2026-05-29).
Perfume falls under the regulation as a cosmetic product. Every fine fragrance sold in the EU must satisfy the same chain of obligations: a documented safety assessment by a qualified expert, a complete Product Information File, notification through the Cosmetic Products Notification Portal (CPNP), and labeling that meets the Article 19 requirements. These obligations apply to every brand, niche or mainstream, that places product on an EU market.
The regulation also bans animal testing for cosmetic purposes. The testing ban on finished products entered force in 2004; the testing ban on ingredients and the marketing ban on cosmetics tested on animals reached full application on 11 March 2013. Since that date, no cosmetic product or ingredient tested on animals after the relevant deadline can be placed on the EU market, regardless of where the testing occurred (European Commission, animal testing ban summary, accessed 2026-05-29).
Scope and direct legal effect
The regulation covers every product intended to be placed in contact with the external parts of the human body, the teeth, or the mucous membranes of the oral cavity, with a view to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odors. Perfume sits squarely within this definition.
Because it is a regulation rather than a directive, it does not need to be turned into national law by each EU country. The text applies in identical form across the twenty-seven Member States. Member State authorities, such as the ANSM in France, the BfArM in Germany, and the FAMHP in Belgium, enforce it through market surveillance and post-market controls.
Safety assessment and the product file
Before any cosmetic product is placed on the EU market, a qualified safety assessor must produce a Cosmetic Product Safety Report under Annex I of the regulation. The assessor must hold a recognized qualification in pharmacy, toxicology, medicine, or a related discipline. The report covers ingredient-by-ingredient toxicology, exposure modelling, microbiological stability, and the conclusion that the product is safe for its intended use.
The brand owner, designated as the Responsible Person, holds the Product Information File for ten years after the last batch enters the market. The file must be available to national authorities on request and includes the safety report, the formula, the manufacturing process, the stability data, and proof of any claims made on the packaging.
Annexes II and III: prohibited and restricted
Annex II lists substances prohibited in cosmetics. It contains several materials historically used in perfumery that have been removed for safety or environmental reasons, including certain musk ketones, nitromusks, and specific furocoumarin-bearing extracts at concentrations above the allowed thresholds.
Annex III lists substances restricted, with conditions and concentration limits. This is where most direct rules on fragrance materials live, including the labeling thresholds for the regulated allergens and the upper limits for materials such as hydroxyisohexyl 3-cyclohexene carboxaldehyde and lilial (BMHCA), now prohibited following SCCS opinions. Annexes IV, V, and VI cover colorants, preservatives, and UV filters, which apply less directly to fine fragrance.
Fragrance allergens and the 2023 revision
From 2003, EU rules required 26 fragrance allergens to be listed by name on cosmetic labels when present above 0.001% in leave-on products or 0.01% in rinse-off products. This list, which included linalool, limonene, geraniol, eugenol, coumarin, and oakmoss extract, became the visible signature of EU labeling on every fine fragrance carton.
On 26 July 2023, the European Commission published Regulation (EU) 2023/1545, which expanded the list to roughly 80 allergens. New entries include several materials common in modern perfumery, such as menthol, vanillin, and acetyl cedrene. The transition periods run to 31 July 2026 for placing new products on the market and 31 July 2028 for products already in the supply chain (European Commission, Regulation 2023/1545, accessed 2026-05-29).
How it differs from IFRA Standards
The EU Cosmetics Regulation is law; IFRA Standards are private industry rules. A perfume compliant with IFRA can still violate the EU regulation if its label does not list the regulated allergens. A perfume compliant with the EU regulation can technically use materials prohibited by IFRA, provided no Annex II ban applies, but in practice IFRA-member suppliers will not sell those materials for such use, so the question rarely arises.
The two systems often share scientific input through the Scientific Committee on Consumer Safety (SCCS), which relies extensively on RIFM data when assessing fragrance materials. The result is increasing alignment, but the legal force remains different: only the EU regulation can be enforced by national authorities with fines, recalls, and market withdrawal.
Sources
- European Commission, Regulation (EC) No 1223/2009 on cosmetic products, consolidated text and Annexes I through VI. Accessed 2026-05-29.
- European Commission, Regulation (EU) 2023/1545 expanding the fragrance allergen labeling list, July 2023 publication. Accessed 2026-05-29.
- Scientific Committee on Consumer Safety, opinions on fragrance allergens, lilial, hydroxyisohexyl 3-cyclohexene carboxaldehyde. Accessed 2026-05-29.
- Cosmetics Europe, industry guidance on the Product Information File and Responsible Person obligations. Accessed 2026-05-29.