Q.01

Which fragrance allergens must be listed on cosmetic labels?

Answer: In the EU, every fragrance substance whose Annex III entry under Regulation (EC) No 1223/2009 says so must be named in the ingredient list, alongside "parfum" or "aroma", once its concentration exceeds 0,001 % in leave-on or 0,01 % in rinse-off products. The current consolidated Annex III has 81 such entries [1][2]. Canada follows the EU list directly. Great Britain's text still has 25 entries. US federal rules let fragrance be declared simply as "fragrance".

EU (Regulation (EC) No 1223/2009)

  • Legal basis. Article 19(1)(g) says perfume and aromatic compositions "shall be referred to by the terms 'parfum' or 'aroma'". It also says substances that the "Other" column of Annex III requires to be mentioned "shall be indicated in the list of ingredients in addition to" those terms [1].
  • How the list grew. Before Regulation (EU) 2023/1545 there were 24 individually labelled allergens (entries 45 and 67 to 92) [3]. The SCCS then identified 56 more [4], and 2023/1545 added them at the same thresholds [5].
  • What the list covers:
    • The original 24, for example linalool, limonene, citronellol, geraniol, coumarin, eugenol, hexyl cinnamal, benzyl alcohol and the oak moss and treemoss extracts.
    • New single substances, for example menthol, vanillin, camphor, linalyl acetate, terpineol, pinene, benzaldehyde, beta-caryophyllene and the rose ketones.
    • Essential oils and extracts, for example lavender, peppermint, ylang ylang, bergamot, lemon peel, clove, eucalyptus, rose and jasmine.
  • Prescribed label names. Some grouped entries fix the name that must appear in the ingredient list. Examples are "Citral" [6], "Rose Flower Oil/Extract" [7], "Rose Ketones" [8] and "Lemongrass Oil" [9].
  • Transition dates. Under Annex III footnotes (38) and (40), products that do not meet the new restrictions could be placed on the market until 31 July 2026 and made available until 31 July 2028. For footnote (38) entries, this also requires that the products meet the rules that applied on 15 August 2023 [10]. So as of today, products newly placed on the EU market must carry the expanded labelling. Stock already on the market may be sold until 31 July 2028.
  • Small products. For soap, bath balls and other small products where a label, tag, tape, card or leaflet is impossible, the ingredient information "shall appear on a notice in immediate proximity to the container" [11].

Great Britain. Article 19 has the same parfum/aroma rule [12]. However, the GB Annex III attaches the labelling condition to only 25 entries:

  • Entry 45 [13].
  • Entries 67 and 69 to 92, except 83. This includes entry 79, hydroxyisohexyl 3-cyclohexene carboxaldehyde [14].

None of the 2023/1545 additions appear in the GB text. Entry 79 does not appear in the current EU labelling list.

Canada. Section 21.4 of the Cosmetic Regulations defines "fragrance allergen" by reference to EU Annex III "as amended from time to time". Such an allergen "must be listed" above 0.01 % in rinse-off or 0.001 % in leave-on products. Each one becomes mandatory only from the later of the date the EU amendment comes into force and the EU date for making products available [15].

United States. Under 21 CFR, "fragrance or flavor may be listed as fragrance or flavor" [16]. I found no requirement to label individual fragrance allergens in 21 CFR Parts 700-740.

The panel document lists all 81 EU entries, with reference number, labelling name (marked where the name is prescribed), CAS numbers and transition footnote, each cited.

Approach: I searched the consolidated EU Cosmetics Regulation and amending Regulation (EU) 2023/1545, the GB assimilated Cosmetics Regulation, Canada's Cosmetic Regulations and 21 CFR Parts 700-740. I did not check US state laws or any FDA allergen rulemaking under MoCRA.

Q.02