Allergens in Cosmetics

Cosmetic products can cause allergic reactions in some people. Allergy is not the same thing as irritation. A product can be a dermal irritant and not cause an allergy, and vice versa. Many people suffer from allergies and anyone at any age can develop allergies. Allergic reactions are the immune system's overreaction to substances that might otherwise be harmless. An allergen can cause the immune system to release chemicals, such as antibodies, that result in allergy symptoms. Many people are familiar with seasonal allergies caused by the pollen of flowering plants or with food allergies. Allergic reactions to cosmetics often appear as red, itchy rashes – or contact dermatitis.

Common allergens fall into five classes, they are:

• natural rubber: latex;
• preservatives: methylisothiazolinone (MIT), methylchloroisothizolinone (CMIT), ingredients that release formaldehyde (bronopol, 5-bromo-5-nitro-1,3-dioxane, diazolidinyl urea, DMDM hydantoin, imidazolidinyl urea, sodium hydroxymethylglycinate, quaternium-15);
• dyes: chemicals used in hair dyes and black henna tattoos (p-phenylenediamine PPD and coal-tar);
• metals: nickel and gold;
• fragrances.

More than 80 allergenic substances that a cosmetic product may contain and must be described on the labeling:

The term “fragrance allergens” is a misnomer used to refer to contact allergens that are often present in fragrance compositions. The European regulation (EC) 2023/1545 itself uses the term “fragrance allergens”. Since no definition is given to this term in the regulation, its use in the regulatory context could lead someone to think that the new labeling requirements only apply if the source of the allergen is in a fragrance mixture, which is not correct. . The presence of more than 80 allergens (i.e. substances within the scope of entries 45, 46, 67, 69 to 78, 80 to 82, 84 to 92, 109, 114, 122, 124, 131, 133, 154,157,175,196 , 324 and 327 to 371) must be labeled regardless of its origin.

An allergen may be present in a cosmetic product due to:

1. Its presence in the fragrance or aroma mixture, whether added directly or as part of a natural complex substance (e.g. essential oil, botanical extract);
2. Its presence as a constituent of a natural complex substance (NCS) (e.g. essential oil, botanical extract);
3. Its presence as an impurity or contaminant;
4. A combination of two or more of the above (not contributed as a cosmetic ingredient);
5. Its intentional addition as a cosmetic ingredient (i.e., not as a fragrance or mixture of scents);
6. Combination of one or more of the above.

In the regulation there are two regulatory approaches to allergen designation in Annex III, which are referred to in the document as “individual” and “grouped”.

The individual allergen entry approach is the usual regulatory approach used in the past for the 24 allergens: i.e. one allergen = one substance = 1 Glossary/INCI name.

The allergen pooled entry approach is a new regulatory approach that was developed to address the issue of lengthening ingredient lists that would make labeling too long and complicated and therefore unfriendly to the consumer (especially for allergy sufferers). During the decision-making process, the industry's overall goal was to provide consumers with simple information. For grouped allergens, the allergic person only needs to know whether the group of those substances with the same cross-sensitizing property is present (> LT). Therefore, instead of forcing the allergic person to memorize the entire list of substances belonging to the same cross-sensitization group, only one name for each group should be memorized by the allergic consumers concerned. These are the so-called 'Group Names' (GN), which in the legislation are provided in column h. All GN are recognized INCI names.

Below is an example of a grouped allergen entry. The characteristics of this entry are as follows:

• The scope of the entry covers all substances with the same cross-sensitizing property (broad scope of column b).
• Mandatory allergen labeling is triggered if the sum of the concentrations of substances covered by the same entry exceeds the limit of 0.001 % in leave-on products or 0.01 % in rinse-off products (referred to as 'Limit Labeling' or 'LT' when throughout this document);
• The name on the label to be used to identify the allergen (group name) is specified in column h (not c, as for independent allergen entries).

In this case, if a leave-in product contains 0.0008 % of flower oil Citrus aurantium amaranth and 0.002 % of flower oil Citrus aurantium dulcis, their sum exceeds the LT for unrinsed products. Therefore, the two allergens must be labeled using the GN 'Citrus aurantium flower oil'. If the company also wishes to add the SN'Citrus aurantium amara flower oil' It is 'Citrus aurantium dulcis flower oil' As additional information, this is possible, but not required.

Click on the link below to access Annex III with the list of allergens:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1545

References:

Guidelines on the 'Fragrance Allergens' Requirements, Cosmetic Europe, published 11/07/2023. https://cosmeticseurope.eu/files/7516/9893/4117/FINAL_Fragrance_allergens_guide_02_11_2023.pdf

Commission Regulation (EU) 2023/1545 of 26 July 2023. Amending Regulation (EC) Nº 1223/2009 of the European Parliament and of the Council as Regards Labeling of Fragrance Allergens in Cosmetic Products. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1545.

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