New fragrance regulation in cosmetics

What was previously regulated?

The following was previously regulated: Based on the SCCNFP Opinion on Fragrance Ingredients (1999): The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers: Opinion concerning Fragrance Allergy in Consumers. A Review of the Problem. Analysis of the Need for appropriate Consumer Information and Identification of Consumer Allergens, adopted 8 December 1999. SCCNFP/0017/98 Final 1999.

In 2003, 26 allergenic fragrances were included in Annex III of the Cosmetics Regulation, with a declaration obligation from a quantity of

• 0.01 % for rinse-off/wash-off products and
• 0.001 % for products that remain on the skin/hair.

The fragrance and flavouring substances and their starting materials are indicated with the terms "perfume" or "flavouring". The presence of substances required to be listed under the column "Others" in Annex III shall also be indicated in the list of ingredients in addition to the terms perfume or flavouring.

* Methyl 2-octynoate, No. 89: 0.01% (when used alone), when used with Methyl Octine: together 0.01% (Methyl Octine not more than 0.002%)
** Applies to all products except oral care products

In a further statement from SCCS/1459/11(334 pages), other fragrances were scrutinised:

From studies conducted on population groups, it can be estimated that the frequency of contact allergies to fragrance ingredients in the total population in Europe is 1-3%. A contact allergy cannot be cured, which means that sensitised persons may experience symptoms such as itching, skin inflammation and blisters every time they come into contact with the allergy trigger - even in low concentrations.

The studies since the SCCNFP statement on fragrance allergies in consumers confirm that the fragrance allergens identified by the SCCNFP in 1999 are still relevant fragrance allergens for consumers due to their exposure to cosmetic products. A review of the clinical and experimental data published since then shows that many more fragrances have been shown to be allergenic in humans. Based on clinical experience alone, 82 substances can be categorised as established contact allergens in humans: 54 individual chemicals and 28 natural extracts.

This means that

• The 26 original allergenic fragrances remain relevant, 2 of which have been banned (included in Annex II):
  • The fragrance "hydroxyisohexyl 3-cyclohexene carboxaldehyde" was banned due to its sensitising properties. Since 23 August 2021, this substance has been banned and may no longer be made available. (Regulation (EU) No. 2017/1410) - > Annex II/ No. 1380
  • "Butylphenyl methylpropional" will be banned from 1 March 2022 due to its classification as CMR (reprotoxic) (Regulation (EU) No. 2021/1902) -> Annex II/No. 1666

Amending Regulation (EU) 2023/1545

Further contact allergens must be brought to the attention of the consumer:

• 82 substances are classified as established contact allergens in humans: 54 individual chemicals and 28 natural extracts

Substances that can change chemically or precursors must be treated in the same way as allergens

• Prehaptens: limonene, linalool, linalyl acetate, alpha-terpine geraniol... (through oxidation or hydrolysis)
• Prohaptens (through metabolic transformation): Cinnamyl alcohol, eugenol, isoeugenol and isoeugenol acetate

Labelling of the new allergenic fragrances

Manufacturers are granted a transitional period of three or five years to change the information on cosmetic products.

• For all new products (placing on the market): 3 years (31 July 2026)
• For all products already on the market (making available on the market): 5 years (31 July 2028)

Digital-only labelling is currently not permitted; the ingredients must be labelled directly on the cosmetic product.

Practical tips

(Examples from Cosmetics Europe Guidelines on the "Fragrance Allergens" Requirements, see references)

Positioning of the substances in the ingredient list

• Either at the position corresponding to the respective concentration
  • In any case, if a substance is added as an ingredient with more than 1%
  • After all other ingredients at the end of the list of ingredients (below 1% in any order)
• In the case of a natural substance with variable compositions:
  • worst-case assessment  to determine whether the allergen exceeds the declaration threshold
  • Substance from different sources (e.g. citral), then the contents of the different sources must be added together and stated accordingly in the list of ingredients
• If the substance is intentionally added as an ingredient (and not declared as a perfume or flavouring):
  • must also be declared for levels below the declaration threshold

Names of the allergens

• If a fragrance subject to labelling is a component of another fragrance subject to labelling (e.g. an essential oil):
  • if the concentration thresholds for labelling are exceeded, both substances may also have to be labelled.

Example: Linalool from lavender oil

• Lavendula Hybrida Oil: 1.3% (> as declaration threshold)
  • Of which 45% linalool = 0.585% linalool (> as declaration threshold)
  • Both lavandula oil/extract (= group name) and linalool must be declared

Group name - individual name

• Name of the allergen
  • Stand alone - names: One allergen = one substance = one INCI name; the substance must then be entered in the list of ingredients as in column c
  • Group names: indicated in column h: if the sum of the substances within a group exceeds the declaration threshold, the group name must be used. The group name then appears in column h

References and helpful documents on the new fragrance regulation:
Amending Regulation (EU) 2023/1545
Cosmetics Europe (2023): Guidelines on the "Fragrance Allergens" Requirements
German translation from IKW