Fragrance Allergens
MoCRA: This information is applicable to: All Cosmetic Manufacturers
Under the new MoCRA requirements, you will need to identify any fragrance allergens in the ingredient declaration for any cosmetic product.1 However, it probably won’t go fully into effect until sometime after June, 2026.
What fragrance allergens must be identified?
The list hasn’t been created or published.
MoCRA says that the FDA should consider any existing international, State and local requirements for allergen disclosures when they are proposing regulations.2 Currently, Canada, Europe, UK, India, New Zealand, and S. Korea have rules that require fragrance allergens to be are disclosed – and most of them use the same list of substances. They require disclosure if the fragrance allergen substance is present at more than 0.01% in rinse off products or 0.001% in leave on products. (See table at the end of this article.)
It’s likely that the US list of fragrance allergens will include all or most of those same substances. The thresholds are likely to be the same as well.
However, in December 2024 the FDA updated the rule agenda 3 and said they will consider an alternative labeling requirement, such as a more general allergen statement. That might mean the individual fragrance allergens will not be specified by the FDA and/or that they won’t need to be individually listed on the label.
When will it go into effect?
The FDA had until June 29, 2024 to create the proposed list, but they didn’t make the deadline. Then they extended to October 2024, which they also didn’t meet.
As of December 2024, the timeline for the proposed rule is January 2025.
Once the proposed rule is issued, they originally had six months after the comment period closes to issue the final list. In the final rule there will some time allowed to get your labels updated before the regulation takes effect (usually a year).
However, in December 2024 they stated that they would consider an earlier compliance date for making the required labeling changes.4
What should you do now?
The requirement to identify fragrance allergens in your cosmetic ingredient declarations is still several years out. However, we already know what fragrance allergens have been identified by other countries. You can use that list to figure out if they are in your products and at what amounts.
Your fragrance or essential oil provider should be able to provide you with the name(s) and percentage of any fragrance allergen substances in the fragrance/essential oils you purchase.
For essential oils you can also check the Natural Complex Substances list published by International Fragrance Association (IFRA). You’ll have to do some math to figure out the amount of any substances in the essential oil(s). Luckily, you won’t have to figure out the exact amount of the substance in your product, just whether it is more that 0.01% for rinse off products or 0.001% for leave on products.
Internationally Regulated Fragrance Allergens
Fragrance Allergen | Source | Plant Sources |
Alpha-Isomethyl Ionone | Synthetic | n/a |
Amy cinnamal | Synthetic | n/a |
Amyl cinnamyl alcohol | Synthetic | n/a |
Anisyl (Anise) alcohol | Synthetic or Natural | Honey, Anise, Tomatoes, Tahiti Vanilla |
Benzyl alcohol | Synthetic or Natural | Peru Balsam, Tolu Balsam, Jasmin, Apricot, Almond, Apple, Asparagus, Banana, Black Currant, Blackberry |
Benzyl benzoate | Synthetic or Natural | Peru Balsam, Tolu Balsam, Jasmin, Ylang-Ylang |
Benzyl cinnamate | Synthetic or Natural | Peru Balsam, Tolu Balsam, Copahu |
Benzyl salicylate | Synthetic or Natural | Propolis |
Butylphenyl methyl propional | Synthetic | n/a |
Cinnamal | Synthetic or Natural | Cinnamon, Hyacinth , Patchouli, Nutmeg |
Cinnamyl alcohol | Synthetic or Natural | Hyacinth |
Citral | Synthetic or Natural | Lemon, Orange Peel, Eucalyptus, Grapefruit, Orange, Celeris, Apricot, Blackcurrant, Grape, Kiwi, Mango, Ginger, Melon, Plum, Raspberry, Rose |
Citronellol | Synthetic or Natural | Lemongrass, Ceylon, Apple, Apricot, Cassis, Blackberry, Blueberry, Orange, Passion Fruit, Peach, Rose |
Coumarin | Synthetic or Natural | Woodruff, Flouves, Sweet clover, Angelique, Berce |
Eugenol | Synthetic or Natural | Clove, Allspice, Bay (Myrcia acris), Avens, Ceylon Cinnamon, Laurel, Cistus, Labdanifere, Basil Sassafras, Basil Java, Cassia, Sweet Flag, Carnation, Boldo, Cascarille, Galangal, Bay Leaves, Nutmeg, Pale Rose, Ylang-Ylang, Marjoram, Calamus, Camphor, Lemongrass, Patchouli |
Farnesol | Synthetic or Natural | Rose, Neroli, Ylang-Ylang, Lime, Tolu Balsam |
Geraniol | Synthetic or Natural | Rose oil, Orange, Palmarosa, Verbena, Neroli, Lemongrass, Hyssop, Laurel, Lavender, Mandarine, Melissa, Myrtle, Apple, Apricot, Black Cranberries, Blackcurrant, Blackberry, Coriander, Ginger, Nutmeg, Thyme, Geranium, Rose, Palmarosa, Ylang-Ylang |
Hexyl Cinnamal (Cinnamaldehyde) | Synthetic | n/a |
Hydroxycitronellal | Synthetic | n/a |
Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (Hydroxy-methylpentyl-cyclohexenecarbox aldehyde) | Synthetic | n/a |
Hydroxycitronellal | Synthetic | n/a |
Isoeugenol | Synthetic or Natural | Citronella, Essential Oils of Ceylon, Essential Oils of Ylang-ylang |
d-Limonene | Synthetic or Natural | Lemon, Dill, Common Juniper, Orange, Verbena, Neroli, Niaouli, Melaleuca, Lemon Balsam, Peppermint, Nutmeg, Myrrh, Angelique, Aspic, Badiane, Bergamot, Mandarin, Bigaradier, Caraway, Celery, Lavender, Lime |
Linalool | Synthetic or Natural | Lavender, Pine, Laurel, Sour Orange, Marjoram, Peppermint, Lemon, Orange, Ylang Ylang, Verbena, Myrtle, Neroli, Coriander, Geranium, Lime, Lemon Balsam, Nutmeg, Lemongrass, Basil, Bergamot, Rosewood, Banana, Blackberry, Bean, Blueberry, Apple, Apricot, Artichoke, Thyme, Rose, Palmarosa |
Methyl 2-Octynoate | Synthetic | n/a |
Oakmoss Extract | Natural | Oak moss extract |
Tree moss extract | Natural | Tree moss extract |
1 21 USC 364e(b)
2 Ibid.
3 Fall 2024 Unified Agenda of Regulatyory and Deregulatory Actions, Rule 0910-AI90 https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202410&RIN=0910-AI90
4 Ibid.