New draft published by the European Commission. More than 80 allergens to be declared.

16/09/2022

New draft published by the European Commission with more than 80 substances

Yesterday, 15^th September 2022, the European Commission notified the WTO of a new amendment to the Cosmetic Regulation. The publication is amending Regulation (EC) No 1223/2009 of the European Parliament and the Council as regards labelling of fragrance allergens in cosmetic products.

The draft measure proposes additional fragrance allergens must be individually labelled on the package of a cosmetic product if their concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products. It further introduces some updates and simplifications in the names of those substances. It will be all done through amendments of Annex III to Regulation (EC) No 1223/2009.

What are these substances?

Fragrance substances are organic compounds with characteristic, usually pleasant, odours. They are widely used in perfumes and other perfumed cosmetic products, but also in many other products such as detergents, fabric softeners and other household products.

These substances are linked to contact allergy, which is a life-long, altered specific reactivity in the human immune system. Different measures aim to protect the whole population from acquiring fragrance allergies (primary prevention) and to protect sensitised individuals from developing allergy symptoms (secondary prevention).

Which risk do they have? What we can do to minimise it?

In accordance with Cosmetics Regulation (EC) No 1223/2009, a cosmetic product is to be made available on the Union market only where a list of ingredients is indicated on its packaging. Furthermore, it is specified that perfume and aromatic compositions and their raw material are to be referred to by the terms ‘parfum’ or ‘aroma’ in the list of ingredients and complemented by substances the mention of which is required under the column ‘Other’ in Annex III to that Regulation.

Currently, 25 fragrance allergens listed in entries 67 to 92 of Annex III to Regulation (EC) No 1223/2009 are to be mentioned in the list of ingredients (individually labelled), along with the INCI name of the fragrance, “parfum” grouping the rest of substances the fragrance has.

In response to the request of the Commission for an update of the list of individually labelled fragrance allergens, the Scientific Committee on Consumer Safety (SCCS) adopted an opinion at its plenary meeting on 26-27 June 2012, confirming the fragrance allergens listed on Annex III to Regulation (EC) No 1223/2009 are still relevant, but the SCCS identified 56 additional fragrance allergens, which have clearly caused allergies in humans and which have currently no requirement of individual labelling.

Measures adopted by the European Commission

With the aim to protect the safety of the European consumers, an obligation to individually label those new fragrance allergens will be introduced in Annex III to Regulation (EC) No 1223/2009, when their concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products.

For reasons of consistency and clarity, also for completeness, certain existing entries for fragrance allergens will be updated, by aligning common names of the substances to those of the latest version of the Common Ingredients Glossary referred to in Article 33 of that Regulation, and by grouping similar substances in one entry. It is also necessary to update certain existing entries for fragrance allergens by adding isomers and by complementing and amending the respective CAS and EC numbers.

What has to be done now?

As the updated list of fragrance allergens is likely to result in entries in Annex III to Regulation (EC) 1223/2009 combining existing and new restrictions, economic operators should be allowed a reasonable period of time to adapt to them by making the adjustments to product formulations and containers that are necessary to ensure that only cosmetic products complying with the new requirements are placed on the market.

This gives the cosmetic companies and fragrance manufacturers a period of 3 years after the date of entry into force of this Regulation to place cosmetic products containing those substances and not complying with the restrictions on the Union market. Also, the companies and manufacturers should also be allowed a reasonable period of time to withdraw from the market cosmetic products which do not comply with the new requirements, a period of 5 years after the date of entry into force of this Regulation will be allowed.

The list of substances to be declared as allergens will grow to more than 80 individual substances, and the INCI names will be placed on the ingredient list of the cosmetic products when their concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products.

This draft lists 56 new entries that will be added and amended in Annex III of Regulation 1223/2009, and from now on, these substances and their derivatives must be taken into account.

If you need an exhaustive list of the substances, do not hesitate to contact us, we will be glad to help.

Brief summary. Dates and actions to take.

The draft of the amendment published will be open to comments 60 days from the notification and, when all comments will be revised, the European Commission will publish the amendment, presumably in the first half of 2023.

This period of time will enable the cosmetic companies and fragrance manufacturers to update the documents of the cosmetic products, along with the labelling of cosmetic products. A new allergen certificate will be needed, listing all the substances included in the amendment and their concentrations, to be able to calculate if the substances need to be declared on the ingredient list of the different cosmetic products.

The expected dates and periods are:

The draft is open to comments during the next 60 days.
The European Commission will publish the amendment first quarter of 2023.
The amendment will come into force 20 days after its publication in the Official Journey of the European Commission.
3-year period to be able to place into the EU market cosmetic products not in compliance with the published regulation. This will allow companies to revise the documents and labels of their products.
5-year period to remove from the shelves of the EU market cosmetic products not in compliance with the published regulation. This will allow companies to get rid of the stock and place revised products.

Please contact us if you need any advice about your products. The Cosmeservice team is at your disposal, if you wish to get more information about this subject feel free to contact us at info@cosmeservice.com.

For other updates and news please visit http://www.cosmeservice.com.

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