Annex 3 extended allergen declaration

In the Annex 3 Allergen Declaration, Annex 3 is extended from 26 to over 80 declarable allergens in accordance with SCCS/1459/11 and Regulation (EU) 2023/1545.

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What does this mean for us and our customers?

Certain substances have been shown to be a significant cause of allergic reactions in consumers who are sensitive to fragrances. To ensure that such consumers are adequately informed, the presence of these substances should be indicated on the list of ingredients.

The purpose of this additional labeling is to inform sensitive individuals who have been tested and know which ingredients to avoid.

Currently, 26 “fragrance allergens” must be included in the list of ingredients, even if they are components of a perfume, a flavoring or a complex ingredient. Labeling is mandatory if the substance is present in the cosmetic product above certain threshold concentrations, which are different for leave-on and rinse-off products. The new regulation extends this list to over 80 allergens.

FRIKE Internal is a specially created task force that is now working hard on this issue, as around 1,000 raw materials are affected and now need to be examined. Examples of affected raw materials include perfume oils, extracts, tinctures and essential oils. Affected customers will be informed of any changes and adjustments in good time.

Transition periods and deadlines are as per publication in the Official Journal of July 27, 2023.

The date of entry into force of the new regulation was August 16, 2023, but there is a transitional period until July 31, 2026 for placing on the market (production or import into the EU). The transitional period for making products available on the market (sale and withdrawal of products) runs until July 31, 2028. The detailed implementation and guidelines for the law are currently being discussed. The FRIKE GROUP is monitoring this and has simultaneously begun implementing the extended allergen list in the internal computer system.

What other effects will this have?

The extension of the list of allergens will lead to new challenges in regulation and implementation. Consumers with allergies will have to remember many new and complicated names for one and the same type of allergen. At the same time, there will be space problems on labels due to the very long list of ingredients.

Ronnie Heusser, Head of Sales Business Unit Care
«Looking for advice or a quote? I’m your point of contact, from the initial idea to the finished product.»
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