Public consultation on fragrance allergens in the framework of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products
Any interested parties, including authorities of the Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumers associations.
Period of consultation: From 13.2.2014 to 14.5.2014
Regulation (EC) No. 1223/2009 on cosmetic products ('Cosmetics Regulation')provides that perfume, aromatic compositions and their raw materials shall be referred to in the list of ingredients on the packaging as 'parfum' or 'aroma'. However, 26 fragrance allergens listed in Annex III of the Cosmetics Regulation shall be mentioned in the list of ingredients in addition to the term 'parfum' or 'aroma', if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. Moreover, Annex II lists substances which are prohibited in cosmetic products, including some fragrance allergens.
In June 2012, the Scientific Committee on Consumer Safety ('SCCS') adopted a new opinion on fragrance allergens in cosmetic products. The opinion covered contact allergens (respiratory allergens were excluded).
In that opinion the SCCS:
1) Updated the list of fragrance allergens that the consumer should be made aware of when they are present in cosmetic products, while confirming that the 26 fragrance allergens currently regulated for individual labelling are still of concern.
The SCCS also indicated that substances known to be transformed, through air oxidation (prehaptens) or/and bioactivation (prohaptens), into allergens which are more potent than the parent substance should be treated as equivalent to those allergens.
2) Identified, among fragrance allergens established in humans, 12 chemicals and 8 natural extracts of special concern as each of them gave rise to at least 100 reported cases of contact sensitisation. For these substances, a maximum limit of concentration in the cosmetic product should be fixed. In addition, the consumer should be informed of their presence in the cosmetic product.
3) Indicated that three fragrance allergens: 3 and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC), atranol and chloroatranol (the two latter being components of oak moss and tree moss extracts) should not be present in cosmetics.
Following the 2012 opinion of the SCCS, the Member States and other stakeholders were consulted at the meetings of the Standing Committee on Cosmetic Products and of the Working Group organised throughout 2013. The Commission's services took their views into account in drafting the present document.
In view of the SCCS opinion, there are several areas in which further scientific work is needed. One of them is the refinement of the dermal sensitization Quantitative Risk Assessment ('QRA'), which would allow for more precise determination of concentration limits for fragrance allergens and thus better protection of non-sensitised consumers against allergies. The industry is currently working on the issue in the framework of the IDEA project and the Commission is regularly informed on the progress of this scientific work.
In addition, in the areas where the SCCS opinion already provides sufficient basis, the Commission's services propose to amend the Cosmetics Regulation in order to ensure adequate consumer information and to protect the consumer against the strongest allergens.
Proposed modifications to the Cosmetics Regulation
The services of the European Commission propose to:1) Amend Annex III to the Cosmetics Regulation ('List of substances which cosmetic products must not contain except subject to the restrictions laid down') to submit additional contact allergens to the obligation of individual labelling, in addition to the 26 allergens already listed in Annex III. The allergens concerned, some of them derivatives of the same substance, would be those with the strongest scientific evidence, i.e. contact allergens established in humans as well as pre-haptens/pro-haptens which may be activated into them. For each of them, a requirement would be included in the column 'Other' of Annex III to indicate the presence of the substance in the list of ingredients, in addition to the terms 'parfum' or 'aroma', when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
The proposed transitional period for listing these fragrance allergens on the packaging of the cosmetic products placed on the market is three years after the entry into force of the measure.
2) Amend Annex II to the Cosmetics Regulation ('List of substances prohibited in cosmetic products') to include HICC, atranol and chloroatranol.
The proposed transitional period for making available on the marketproducts containing atranol and chloroatranol is two years, which means that two years after the entry into force of the amendment such products shall no longer be placed on the market and shall be withdrawn.
For HICC, the proposed transitional period is two years after the entry into force of the measure for placing products containing this substance on the market and five years for their withdrawal.
The proposed changes to Annex II and Annex III of the Cosmetics Regulation may be found in the Annex of this document.
The Commission's services would like to invite any interested parties, including authorities of the Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumers associations, to submit their comments on the proposed measures and on their possible economic impact.
With relation to the economic impact, the information/comments should refer, inter alia, to the following topics:
- feasibility of the proposed changes,
- competitiveness, markets and trade,
- direct and indirect costs imposed on business, including SMEs,
- innovation and research,
- specific regions, sectors or workers,
- third countries and international relations,
- macroeconomic environment.
How to submit your contribution
Any comments should be sent with the reference: 'Fragrance allergens - Public Consultation' by post or e-mail by 14th May 2014 at the latest to:
Directorate General Health and Consumers
Unit B/2, Health Technology and Cosmetics,
Office DM24 02/082
A summary of this public consultation is available, in all EU languages.
 OJ L 342, 22.12.2009, p. 59.
 Article 19 (1) (g), indent 2 of the Cosmetics Regulation.
 See Column 'Other' of Annex III.
 SCCS/1459/11; click here.
 The amendments will enter into force on the twentieth day following that of their publication in the Official Journal of the European Union.
 '”Making available on the market” means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge' (Article 2(1) (g) of the Cosmetics Regulation).
 The rule from Article 17 of the Cosmetics Regulation according to which the non-intended presence of small quantities of prohibited substances stemming from impurities of natural ingredients which are technically unavoidable is permitted, if the product is safe, shall apply.
 '”Placing on the market” means the first making available of a cosmetic product on the Community market' (Article 2(1) (h) of the Cosmetics Regulation). The concept of placing on the market refers to each individual product, not a type of product, and whether it was manufactured as an individual unit or in series ('Guide on the implementation of the Directives Based on the New Approach and the Global Approach', p. 18,) click here
 '”Withdrawal” means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain' (Article 2(1) (q) of the Cosmetics Regulation).