What is an allergen?

Although the word “allergen” doesn’t appear in the EU Cosmetic Regulation, the 26 substances listed in Annex III of the Regulation are known for their allergenic potential and are under the regulatory framework because of it. An allergen is commonly defined as “any substance, often a protein, that induces an allergy”.

The paragraph 49 of Regulation 1223/2009 of the Preamble states: “A number of substances have been identified by the SCCS as likely to cause allergic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them. In order to ensure that consumers are adequately informed, the presence of these substances should be mentioned in the list of ingredients and consumers’ attention should be drawn to the presence of these ingredients. This information should improve the diagnosis of contact allergies among consumers and should enable them to avoid the use of cosmetic products which they do not tolerate. For substances which are likely to cause allergy to a significant part of the population, other restrictive measures such as a ban or a restriction of concentration should be considered.”

Usually, allergens that have the most allergenic potential are contained in fragrances. In this optic, the Scientific Committee on Consumer Safety (SCCS) has published a factsheet where they explain that 1 to 3% of the European population have an allergy due to fragrance ingredients. In this opinion, the SCCS goes beyond the actual Regulation, and has identified 30 individual chemicals in addition to the 26 natural extracts listed by the Cosmetics Regulation. An update is expected for 2016-2017, and over 90 substances would then be regulated more strictly.

What is the aim of the restriction of certain fragrance?

The objective is to protect consumers that are subject to allergies by providing enough information at the time of purchase of the product. The consumer should know right away if the cosmetic does contain allergens in order to avoid intolerance symptoms.

The information should be clear and easily accessible to the consumer and to the medical profession. Labeling must be used (mandatory requirements), but some dematerialized digital means should also be used, i.e. providing allergen information to your website.

Means of communication to the consumer must be practical, easily manageable by the industry and able to absorb and adapt to additional regulatory requirements on the long-run

COSMED, the French trade association, offers a hybrid approach:

• Labeling of the current 26 allergens on the product
• Pictogram on the label to refer to a web link which includes the exhaustive information: presence of other allergens, condition of use and prevention.

The list of the 26 allergenic substances

To test fragrance allergies, two commons tests are usually conducted:

Fragrance Mix 1:

1. 1% Amyl Cinnamal
2. 1% Cinnamal Alcohol
3. 1% Eugeniol
4. 1% Geraniol
5. 1% Hydroxycitronellal
6. 1% Isoeugenol
7. 1% Oak Moss
8. 5% Sorbitan Sesquioleate

Fragrance Mix 2:

1. 10% Alpha-Hexyl-Cinnamaldehyde
2. 5% Farnesol
3. 5% Coumarine
4. 2,5 % Lyral
5. 2% Citral
6. 1% Citronellol

You may also prevent the allergy risks by:

• Induction: Sensitization of people who were not allergic before
• Elicitation: when sensitized people have a clinical reaction after being in contact again with an allergen

What if my product contains allergenic substances?

If one of the 26 substances listed above is present in your finished formula, you have to comply with the labeling requirements of the European Regulation. You must comply with the following rules:

The allergenic substances must appear on the label if:

• The concentration is higher than 0.01% in a rinse-off product, e.g. a shampoo.
• The concentration is higher than 0.001% in a leave-on product, e.g. a night cream.

Note: If an allergen is contained in different ingredient of your product, you have to add up all the concentration to verify the threshold and label your product in accordance with the rule above.

In addition to these specific requirements you must comply with all the requirements set up by the Cosmetics Regulation, especially labeling requirements.

For more info you can take a look at our Expert Advice on cosmetic claims and our article about cosmetic labelling differences between US and EU.

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