81 allergens in cosmetics: the European Commission has tripled the number of fragrance allergens that must be listed on the label.
The new Regulation (EU) 2023/1545, amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards
concerning the labelling of fragrance allergens in cosmetic products, defines fragrances as «organic compounds with characteristic, generally pleasant odours, which are widely used in perfumes and other scented cosmetic products, but also in many other products, such as detergents, fabric softeners and other household products».
Fragrances are usually derived from natural extracts and enable us to create perfumery products, as well as to enhance the olfactory experience of other cosmetics and/or other categories of hygiene products (such as biocides or chemical products). As we are well aware, many people are allergic to pollen, certain types of fruit or nuts, and even aromatic herbs. And whilst they retain many of the properties of the original, fragrances also have the same allergenic potential as their natural counterparts.
Or to put it another way: a person who suffers from allergic reactions – the main ones being skin sensitisation and the onset of allergic contact dermatitis – let’s take, for example, the lemon, and it is likely to be the same for the citronella, which is the fragrance extracted from lemons. And knowing which fragrances have been used in the manufacture of a cosmetic product can help you avoid these allergic reactions.
Fragrance allergens: the history of labelling and the origins of the regulations
In 1999, as a result of scientific innovation and collaboration between European national authorities, it was decided to establish a system enabling EU Member States to notify one another of the fragrances used in the manufacture of cosmetic products. And although the criteria for such notification have varied over time, from its inception until last July, one constant had remained, even following the publication of the Regulation (EC) No 1223/2009 on Cosmetic Products. The fact is, we were able to identify a list of 26 allergens that must be declared for cosmetics manufacturers.
This original list from 26 fragrances used in perfumery and cosmetics included the following substances or compounds, which had to be duly listed on the labelling of the cosmetic product:
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- Alpha-Isomethyl Ionone
- Aniseed spirit
- Amyl cinnamal
- Amylcinnamyl alcohol
- Benzyl alcohol
- Benzyl benzoate
- Benzyl cinnamate
- Benzyl salicylate
- Butylphenyl methylpropional (also known as Lilial)
- Cinnamal
- Cinnamyl alcohol
- Citral
- Citronellol
- Coumarin
- Eugenol
- Evernia Prunastri Extract
- Evernia furfuracea extract
- Farnesol
- Geraniol
- Hexyl Cinnamal.
- Hydroxycitronellal
- Hydroxyisohexyl 3-cyclohexene carboxaldehyde. (Also known as Lyral)
- Isoeugenol
- Liminene
- Linalool
- Methyl 2-octynoate.
This is how the list of allergens worked until last July 2023: in order to place a cosmetic product on the market, the manufacturer was required to include on the label, amongst the ingredients, a short list specifying which of these 26 allergens the product contained (provided that their concentration did not exceed 0.01% in rinse-off products and 0.001% in leave-on cosmetic products).
In order to establish these minimum concentrations to be reported, the European Commission has taken into account the how long the fragrance might linger on our bodies, as well as the minimum quantity they are able to produce unwanted adverse reactions. In fact, it is understood that a cosmetic product containing any of these 26 fragrances in a concentration of less than 0.01% and 0.001% – in rinse-out and leave-in products, respectively –, there is no need to report them, as the risk of an allergic reaction is likely to be quite low.
What do consumers need to know about fragrance allergens?
A recommendation regarding fragrances with allergenic potential: As consumers, we must assume that a cosmetic product may contain undeclared fragrances (as their concentration has been deemed too low), unless the labelling specifically states that it is a “hypoallergenic” or “allergen-free”, a ‘’claim' reserved solely for those products that have been designed with the aim of reducing their allergenic potential.
After all, providing information on fragrance allergens on the label is necessary to ensure that the end consumer has sufficient information to identify those substances. And it is assumed that A reasonably well-informed consumer will be able, where appropriate, to avoid purchasing an item if one of the fragrances it contains causes an allergic reaction.
In this regard, the Regulation (EU) 2023/1545 It does not involve many changes to the way things work: there are still some fragrances in cosmetics that are considered allergens that must be declared and that, if we want to use it in the formulation For a cosmetic product, we must to state this on their labelling. The fact is that, essentially, the main change introduced by these new Regulationsor is it the extension to 81 fragrance allergens subject to notification.
For the publication of the Regulation (EU) 2023/1545, The previous list of allergens subject to mandatory labelling has been updated with information gathered by the Scientific Committee on Consumer Safety (SCCS), a body under the European Commission and whose remit includes research into the safety of cosmetic products and ingredients.
In accordance with the SCCS’s recommendations, in the RRegulation (EU) 2023/1545, amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the labelling of fragrance allergens in cosmetic products 55 substances used as fragrances in cosmetics – which previously did not need to be declared – have been included, bringing the total number of allergens subject to mandatory declaration to 81.
What are the new fragrance allergens that will need to be declared from now on?
In addition to the 26 allergens already included in the original list, the new list published in the RRegulation (EU) 2023/1545, amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the labelling of fragrance allergens in cosmetic products includes:
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- Acetyl Cedrene
- Amyl salicylate
- Benzaldehyde
- Camphor
- Beta-caryophyllene
- Carvone
- Dimethyl / Phenethyl Acetate
- Hexadecanolactone
- Hexamethylindanopyran
- Linalyl
- Menthol
- Trimethylcyclopentenylmethylisopentenol
- Salicylaldehyde
- Santalol
- Sclareol
- Terpineol
- Tetramethyl acetyloctahydronaphthalenes
- Trimethylbenzenepropanol
- Vanillin
- Cananga odorata
- Cinnamomum Cassia Leaf Oil
- Cinnamomum zeylanicum bark oil
- Citrus Aurantium Amara Flower Oil / Citrus Aurantium Dulcis Flower Oil
- Citrus Aurantium Amara Peel Oil / Citrus Aurantium Dulcis Peel Oil / Citrus Sinensis Peel Oil
- Citrus Aurantium Bergamia Peel Oil
- Citrus Limon Peel Oil
- Cymbopogon schoenanthus oil / Cymbopogon flexuosus oil
- Eucalyptus globulus leaf oil / Eucalyptus globulus leaf and twig oil
- Eugenia caryophyllus leaf oil / Eugenia caryophyllus flower oil / Eugenia caryophyllus stem
- Oil / Eugenia Caryophyllus Bud oil
- Jasminum Grandiflorum Flower Extract / Jasminum Officinale Oil / Jasminum Officinale Flower Extract
- Juniperus virginiana oil / Juniperus virginiana wood oil
- Laurus Nobilis Leaf Oil
- Lavandula Hybrida Oil / Lavandula Hybrida Extract / Lavandula Hybrida Flower Extract
- Lavandula Intermedia Flower/Leaf/Stem Extract / Lavandula Intermedia Flower/Leaf/Stem Oil / Lavandula Intermedia Oil
- Lavandula Angustifolia Oil / Lavandula Angustifolia Flower/Leaf/Stem Extract
- Peppermint Oil
- Mentha Viridis Leaf Oil
- Narcissus Poeticus Extract / Narcissus Pseudonarcissus Flower Extract / Narcissus Jonquilla Extract / Narcissus Tazetta Extract
- Pelargonium graveolens flower oil
- Pogostemon Cablin Oil
- Rosa Damascena Flower Oil / Rosa Damascena Flower Extract
- Rosa Alba Flower Oil / Rosa Alba Flower Extract
- Rosehip Flower Oil
- Rosa Centifolia Flower Oil / Rosa Centifolia Flower Extract
- Rosa Gallica Flower Oil
- Rosa Moschata Flower Oil
- Rosa Rugosa Flower Oil
- Santalum Album Oil
- Eugenyl acetate
- Geranyl Acetate
- Isoeugenyl Acetate
- Pinenes
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When will the changes come into force? Will it be necessary to declare up to 81 allergens in cosmetics?
The RRegulation (EU) 2023/1545, amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the labelling of fragrance allergens in cosmetic products came into force 15 days after its publication.
The date set by the European Commission for there to be 81 allergens that must be declared on labels is the second quarter of 2023. However, as is obviously the case with all regulations published in the eurozone, companies cannot be required to make the changes overnight, nor can they be forced to withdraw all existing products from the market that do not comply with the new regulations. Therefore, a period of 3 years (until 2026), that the European Commission considers that this is sufficient to enable cosmetics companies to redesign and adapt the labelling of cosmetic products in accordance with the new cosmetic allergens.
Finally, with regard to the products that were already on the market in accordance with the previous labelling rules, but which do not comply with the new Regulation (EU) 2023/1545, the deadline proposed by the European Commission for withdrawing them from the market is 2028.
