Important regulatory development focusing on fragrance allergens
The European Commission and the trade associations (IFRA, Cosmetics Europe, UEAPME, etc.) worked for years on this future piece of legislation and its adoption is expected to take place in February 2016 although there is no certainty about the exact date.
The European Cosmetics Regulation provides that perfume and aromatic compositions as well as their raw materials shall be referred to, in the list of ingredients, by the word ‘parfum’ or ‘aroma’.
However, since 2005 the presence in the cosmetic product of 26 fragrance allergens must be specifically indicated in the list of ingredients, in addition to the terms ‘parfum’ or ‘aroma’, when their concentration exceeds 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinseoff products.
In 2012, the Scientific Committee on Consumer Safety (SCCS) issued a Scientific Opinion (SCCS/1459/11) to update this list of fragrance allergens. This Opinion, regarded by the Fragrance and Cosmetic Industries as particularly tough, recommended that the EU Commission:
- Increases the number of fragrance allergens to label from 26 to 127.
- Restricts the use of 11 fragrance allergens of specific concern at 100 ppm in the finished product (including their contribution from natural extracts).
- Prohibits the use of Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC, also called Lyral) and chloro(atranol) (making the use of Oak moss and Tree moss virtually impossible).
IFRA (the International Fragrance Association) and Cosmetics Europe raised strong concerns about the direct transposition of this Scientific Opinion into the regulation and conveyed with success their joint position to the EU Commission. After several years of negotiation, the EU Commission released a regulatory proposal. This document contains the requirements that follow:
- 82 fragrance allergens* will have to be labelled (instead of 26) and the threshold for labeling will remain 10 ppm for leave-on products and 100 ppm for rinse-off products. Given the important numbers of allergens to label and the limited space on cosmetic products packaging, the EU Commission considers the possibility to label the fragrance allergens online via a dedicated website maintained by the cosmetics manufacturer. The transition periods for implementing this new requirement would be between three and six years from the moment when the amendment gets enforced.
- Then, 11 fragrance allergens of specific concerns will get restricted according to a specific risk assessment tool called Dermal Sensitization Quantitative Risk Assessment (QRA). The maximum use levels are not yet known but could be relatively similar to what is reported in the IFRA Standards and will differ depending on the product category.
- Finally, HICC will get prohibited but the transition period should be relatively comfortable (2 years for placing new products on the market containing HICC and 5 years for the products already placed on the market). Regarding Oak moss and Tree moss, the EU Commission agreed that these two natural extracts could continue to be used provided that their content of atranol and chloroatranol remains as low as technically feasible (a few ppb in the finished product) which is in line with the IFRA Standards already in place.
The next steps
Due to organizational issues at the EU Commission level, the regulatory process got considerably delayed. The publication of this amendment to the Cosmetics Regulation (initially expected to occur in May-June 2015) has been postponed to February 2016.
*82 fragrance allergens to be labelled
(DAMASCENONE) ROSE KETONE-4, (DL)-LIMONENE, 3-METHYL-5-(2,2,3-TRIMETHYL-3-CYCLOPENTENYL)PENT-4-EN-2-OL, 6 METHYL COUMARIN, ACETYLCEDRENE, alpha-DAMASCONE (TMCHB), alpha-ISOMETHYL IONONE, alpha-PINENE and beta-PINENE, alpha-SANTALOL and betaSANTALOL, alpha-TERPINEOL, AMYL CINNAMAL, AMYL CINNAMYL ALCOHOL, AMYL SALICYLATE, ANISE ALCOHOL, BENZALDEHYDE, BENZYL ALCOHOL, BENZYL BENZOATE, BENZYL CINNAMATE, BENZYL SALICYLATE, beta-CARYOPHYLLENE, BUTYLPHENYL METHYLPROPIONAL (Lilial®), CAMPHOR, CANANGA ODORATA and Ylang-ylang oil, CARVONE, CEDRUS ATLANTICA BARK OIL, CINNAMAL, “CINNAMOMUM CASSIA LEAF OILCINNAMOMUM ZEYLANICUM BARK OIL”, CINNAMYL ALCOHOL, cis-beta-DAMASCONE, CITRAL, CITRONELLOL, CITRUS AURANTIUM AMARA FLOWER / PEEL OIL, CITRUS BERGAMIA PEEL OIL EXPRESSED, CITRUS LIMONUM PEEL OIL EXPRESSED, CITRUS SINENSIS (syn.: AURANTIUM DULCIS) PEEL OIL EXPRESSED, COUMARIN, CYMBOPOGON CITRATUS / SCHOENANTHUS OILS, delta-DAMASCONE, DIMETHYLBENZYL CARBINYL ACETATE (DMBCA), EUCALYPTUS SPP. LEAF OIL, EUGENIA CARYOPHYLLUS LEAF / FLOWER OIL, EUGENOL, EVERNIA FURFURACEA LICHEN EXTRACT, EVERNIA PRUNASTRI, FARNESOL, GERANIOL, HEXADECANOLACTONE, HEXAMETHYLINDANOPYRAN, HEXYL CINNAMAL, HYDROXYCITRONELLAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (HICC), ISOEUGENOL, JASMINUM GRANDIFLORUM / OFFICINALE , JUNIPERUS VIRGINIANA, LAURUS NOBILIS, LAVANDULA HYBRIDA, LAVANDULA OFFICINALIS, LINALOOL, LINALYL ACETATE, MENTHA PIPERITA, MENTHA SPICATA, MENTHOL, METHYL 2-OCTYNOATE, METHYL SALICYLATE, MYROXYLON PEREIRAE, NARCISSUS SPP., PELARGONIUM GRAVEOLENS, Pinus mugo,
POGOSTEMON CABLIN, PROPYLIDENE PHTHALIDE, ROSE FLOWER OIL (ROSA SPP.), SALICYLALDEHYDE, SANTALUM ALBUM, SCLAREOL, TERPINEOL (mixture of isomers), Terpinolene, TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES, trans-ANETHOLE, TRIMETHYLBENZENEPROPANOL (Majantol), TURPENTINE (oil), VANILLIN, Verbena absolute (Lippia citriodora Kunth.).
*11 restricted fragrance allergens
Cinnamal, Cinnamyl alcohol, Citral, Coumarin, Eugenol, Farnesol, Geraniol, Hydroxycitronellal, Isoeugenol, Limonene (oxidized), Linalool (oxidized).