What are fragrance allergens?
Some substances present in fragrances may cause a skin or respiratory allergy. The present public consultation covers only skin (also called: contact) allergens. Both synthetic chemicals and substances of natural origin may be skin allergens.
How many people have a skin allergy to fragrances? What are the symptoms?
It is estimated that between 1-3% of the population in Europe has a skin allergy to fragrances. The most frequent symptoms include irritation, swelling and rash, but they may develop into a chronic condition (eczema). An allergic reaction to a substance depends on many factors, including the genetic predisposition, age and intensity of exposure to this substance.
Why the Commission asked the Scientific Committee on Consumer Safety (SCCS) to issue an opinion on fragrance allergens?
The Cosmetics Regulation includes a list of substances which are forbidden in cosmetic products (Annex II to the Cosmetics Regulation) and a list of substances which are allowed, but subject to restrictions (Annex III). Some of the substances in Annex II and III are fragrance allergens.
There is a need for a regular review of those lists. As the last update on fragrance allergens was done in 2003 (including additional substances to Annex III), the Commission’s services requested the SCCS to review this issue and in July 2012 the Committee issued its opinion.
What were the findings of the SCCS opinion on fragrance allergens?
The most important findings of the SCCS were the following:
- Three allergens (HICC, atranol and chloroatranol) were considered not safe,
- The consumer should be made aware of the presence of additional allergens in the cosmetic product,
- 12 single chemicals and 8 natural extracts were identified as substances of special concern, based on the number of persons with positive patch test results. It was suggested that the 12 chemicals, also when present in natural extracts, should be subject to concentration limits in the cosmetic product.
How are these findings translated into proposed changes of the Cosmetics Regulation?
The Commission’s services propose in the public consultation that:
- The three substances which were found to be unsafe should be banned from cosmetic products,
- Additional allergens should be subject to the obligation of individual labelling on the package of a cosmetic product. In other words, they have to be mentioned in the list of ingredients, in addition to the words ‘parfum’ or ‘aroma’. Because of the widespread use of fragrances it may be very difficult to avoid them all. It is therefore important to avoid those to which a person is already sensitised
Further scientific work is needed to define safe concentration limits of chemicals of special concern.
How does the process of changing the Annexes to the Cosmetics Regulation look like? What will be the next steps?
The opinion was released by the Scientific Committee in June 2012. It was followed by informal consultations with the industry, consumer organisations, healthcare professionals and the Member States of the EU. The next step is to launch a public consultation. Taking the consultations into account, the proposed changes to the Cosmetics Regulation in the form of an implementing act will be subject to a vote by the Member States in the standing Committee on Cosmetics. Once the measures are approved by the Member States, the European Parliament and the Council will have three months to exercise their right of scrutiny. If the proposal is not opposed the formal adoption of those changes is expected at the end of 2014/beginning 2015.
Is the Commission going to ban specific perfumes?
The Commission’s services are not proposing to ban any perfume. What we propose is that three strong fragrance allergens which were found unsafe should be banned. If they are in a perfume, this perfume should be reformulated so that the banned allergen is replaced with another substance.
Is it possible to avoid fragrance allergies by not using cosmetics including perfumes?
Fragrances are used for various types of cosmetics such as perfumes, creams and deodorants. While it may be very difficult to avoid all fragrances, it is important to avoid those to which a person is already sensitised. That is why the obligation of specifying allergens on the package of a cosmetic product is so important.
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