The European Commission has recommended amending the Cosmetics Regulation to ban three fragrance allergens and add others to a list of substances that must be identified on product labeling, according to a proposal released Feb. 13.

The proposal could lead to costly reformulations and relabeling for fragrance products and cosmetic products containing fragrance sold in Europe.

“[We] are concerned that the extension of the current labelling of allergens may not improve the level of information for consumers already sensitized, nor enable future enhancements.” – IFRA President Pierre Sivac

The EC issued its proposal based on a June 2012 opinion on the matter adopted by the Scientific Committee for Consumer Safety and input from informal consultations with industry, consumer organizations, healthcare professionals and Member States. SCCS examined the safety of fragrance allergens at the request of the EC, which is committed to regular updates on the issue.

In line with SCCS’s recommendations, the EC suggests amending the Cosmetics Regulation to prohibit use of three allergens the advisory group found to be unsafe – atranol and chloratranol, which are components of oak moss extract and tree moss extract, respectively, and hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC), which has been the most frequently reported chemical linked to fragrance allergy.

Moreover, the EC recommends expanding a list of 26 fragrance allergens in the Cosmetics Regulation that must be labeled specifically on product packaging – as opposed to with a generic “fragrance” citation – if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. SCCS advocated for such a move and identified a number of candidates in its opinion.

“Ingredient listing of individual fragrance allergens has been shown to be an important tool to enable consumers with an identified allergy to reduce/avoid relevant exposures. Moreover, ingredient listing is also of great importance to ensure that an adequate diagnosis of fragrance contact allergy can be made without undue delay,” SCCS says.

According to an EC memo on the fragrance allergen consultation, between 1% and 3% of Europe’s population has a fragrance skin allergy. Symptoms of the allergy include skin irritation, swelling and rash, which can develop into a chronic condition such as eczema. Allergic reactions are attributed to genetics, age and “intensity of exposure to the substance.”

Of the already listed 26 fragrance allergens, SCCS’s opinion called out 12 chemicals and eight natural extracts “of special concern” that have each been linked to more than 100 reported incidences of skin sensitization, including limonene, linalool, geraniol, citral, coumarin, cinnamal, eugenol, isoeugenol, farnesol, cinnamyl alcohol, lyral and hydroxycitronellal.

SCCS recommended that concentrations of those substances be restricted to 0.01% of finished products.

The EC’s proposal does not go that far. Instead, the EC advises “further scientific work” to determine safe concentration limits for the allergens of special concern.

The EC’s stance on the special-concern allergens likely reflects industry’s influence. The International Fragrance Association said in December 2012 that the “blanket approach” proposed in SCCS’s opinion would limit each of the 12 materials to concentrations so low that it “renders them useless olfactively,” and noted that the move could have significant economic consequences Also see "IFRA Works To Block Legislation Limiting Fragrance Ingredients" - HBW Insight, 10 December, 2012..

Industry has been pushing its Quantitative Risk Assessment approach to fragrance sensitization as the optimal strategy for determining consumer exposure to fragrance materials and minimizing allergy risks. In the consultation document the EC notes that “refinement of the dermal-sensitization Quantitative Risk Assessment … would allow for more precise determination of concentration limits for fragrance allergens and thus better protection of non-sensitized consumers against allergies.”

The commission adds that industry is working on advancing the methodology in the context of the International Dialogue on the Evaluation of Allergens (IDEA), a stakeholder group comprising regulators, dermatologists, industry experts and academics, launched in 2013.

IFRA expressed optimism in a same-day release regarding the EC’s openness to the QRA system.

Public comments on the EC’s proposal will be accepted through May 14. After considering the comments, the EC will issue an “implementing act” to amend the Cosmetics Regulation that will be voted on by Member States. After Member State approval, the European Parliament and Council will have three months “to exercise their right of scrutiny.” If the proposal is not opposed by those bodies, it will be formally adopted at the end of 2014 or the beginning of 2015, according to the EC.

Firms would have three years from when the amendment is adopted to list newly recognized fragrance allergens on cosmetic product packaging, and would have two years to remove products containing atranol and chloroatranol from the market.

Reportedly, atranol, or oak moss extract, is a component of the iconic Chanel No. 5 fragrance. If the proposal is adopted as is, the scent would be subject to reformulation.

For products containing HICC, firms could continue using the ingredient for two years after the amendment goes into force. All products containing the ingredient would need to be withdrawn from the market within five years.

IFRA Questions Labeling Component

The International Fragrance Association says it welcomes the EC’s proposal and notes that its “measures are relevant and will be effective.”

However, the trade group expresses unease with provisions regarding allergen labeling on products.

“[We] are concerned that the extension of the current labelling of allergens may not improve the level of information for consumers already sensitized, nor enable future enhancements,” IFRA President Pierre Sivac says in a Feb. 13 release. “The current proposals, we feel, could be more effective by combining meaningful labelling and additional information through a website.”

Despite the disagreement regarding labeling, “consumers can be confident that their health will be protected and that they can continue to enjoy safe, innovative products,” IFRA says.

The trade group notes that it will continue working on the science of fragrance allergens and promoting movement toward international risk-assessment harmonization as part of IDEA.

“The past years demonstrated that there is a need for better and common understanding, assessment and management of fragrance allergens,” Sivac says. “This program is designed to significantly improve the risk-assessment methodologies and identify appropriate risk-management measures.”

EC Proposes Tighter Regulation Of Fragrance Allergens, Ban On Three

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