A list of 26 substances that have to be identified on products to inform consumers was established in 1999.

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1 page 1/9 Source document: Perfume Allergies SCCS (212) Summary & Details: GreenFacts Context - More than 2,5 fragrance ingredients are used in perfumes and perfumed consumer goods such as cosmetics, detergents, fabric softeners and other household products. to give them a specific, usually pleasant smell. They can sometimes cause skin irritations or allergic reactions. A list of 26 substances that have to be identified on products to inform consumers was established in Is this list sufficient, or is it necessary for additional fragrance ingredients be added to the list? Introduction...2 What kind of skin problems are known to be caused by fragrance ingredients?...2 How can fragrance substance become skin allergens?...2 What fragrance substances can be classified as skin allergens?...3 How is the general public exposed to fragrance allergens?...3 What are the gaps in the current knowledge about perfume allergies?...3 Conclusion : are the current European regulations on fragrance allergens adequate?...4 The answers to these questions are a faithful summary of the scientific opinion produced in 212 by Scientific Committee on Consumer Safety (SCCS): "Opinion on Fragrance allergens in cosmetic products" The full publication is available at: and at: This PDF Document is the Level 1 of a GreenFacts Co-Publication. GreenFacts Co-Publications are published in several languages as questions and answers, in a copyrighted user-friendly Three-Level Structure of increasing detail: Each question is answered in Level 1 with a short summary. These answers are developed in more detail in Level 2. Level 3 consists of the Source document, the internationally recognised scientific opinion which is faithfully summarised in Level 2 and further in Level 1. All GreenFacts Co-Publications are available at: and at:

2 page 2/9 1. Introduction Fragrance substances can be derived from natural sources or chemical synthesis. They are organic compounds with a characteristic, usually pleasant smell, which are used in perfumes and perfumed consumer goods such as cosmetics, detergents, fabric softeners and other household products. Fragrances provide the consumer with a desired fresh smell or mask unpleasant odours. Fragrance substances are also used in aromatherapy and are sometimes present in herbal products. Fragrance ingredients are found in cosmetics and other consumer products. Source: Lilieks 2. What kind of skin problems are known to be caused by fragrance ingredients? The most common problems observed with fragrance ingredients, either through use of a perfume or a fragranced consumer product, are skin allergies and skin irritations. Many people complain about intolerance or rashes to perfumes or perfumed products. However, the majority of complaints commonly described as skin rash are believed to be irritant reactions and not skin allergies. A key difference is that allergic reactions typically occur with a delay of about one day after using the perfume or cosmetic product, while irritant reactions develop immediately after use. Skin rashes can be caused by fragrance ingredients, but are usually not allergic reactions. Source: James Heilman Skin allergy to fragrance ingredients occurs when an individuals skin has been exposed to a certain minimum dose of a fragrance allergen. For example through regular use of a fragranced cosmetic product. Once an allergy has developed, it is a life-long condition. The symptoms are redness, swelling and vesicles that are commonly described as skin rash and may occur upon re-exposure to the fragrance allergen in question. Skin allergies to fragrance ingredients are most commonly caused by fragranced cosmetic products and frequently involve the skin of the face, hands or armpits. Fragrances in perfumes and cosmetic products may also cause irritant reactions. However, skin irritant reactions cannot necessarily be attributed alone to the fragrance ingredients contained in the product. This effect also depends on the irritation potential of the other ingredients and their levels in the cosmetic product. 3. How can fragrance substance become skin allergens? To cause a skin allergy, a certain minimum amount of the fragrance substance must penetrate the skin and attach to a skin protein. Only once the fragrance substance is attached to a skin protein can it provoke a cascade of events in our immune system which ultimately ends in allergy symptoms. Whilst there are fragrance substances that directly bind to skin proteins, we also know that there are other types of fragrance substances which have to be chemically transformed before they can bind to skin proteins. This transformation occurs on the skin, for example in the presence of air or sunlight, or under the skin after reacting with skin enzymes ( bio-activation ). Such transformation processes may turn a non- or weakly- allergenic substances into potent skin allergens.

3 page 3/9 4. What fragrance substances can be classified as skin allergens? Depending on the quality of the available information and the strength of the evidence, dermatologists and other scientists distinguish between established (in humans or animals), likely, or possible contact allergens. In their evaluations, they consider information available on the fragrance substance from human studies (for example clinical or epidemiological studies), data from experimental animal studies or chemical structure information that, based on historical experience with similar type of chemicals, suggest the potential of a fragrance substance to cause skin allergies. Following their review and data evaluation, the Scientific Committee on Consumer Safety identified a total of 54 individual fragrance substances and 28 natural extracts (essential oils) as established contact allergens in humans. The scientific committee also considered 18 individual chemicals and 1 natural extract as established contact allergens in animals, 26 individual chemicals categorised as likely contact allergens and 35 individual chemicals plus 13 natural extracts categorised as possible contact allergens. Category Number of individual fragrences Number of natural extracts Lists of substances Conclusion concerning labelling of consumer products Established in humans substances (13.1 [see Annex 2, p. 6] ) Labelling recommended (see conclusion) Established in animals substances (13.2 [see Annex 1, p. 5] ) Labelling recommended (see conclusion) Likely Substances (13.3 [see Annex 4, p. 9] ) Labelling recommended (see conclusion) Possible substances (13.4 [see Annex 3, p. 8] ) - (For the 127 established and likely contact allergens labelling of consumer products that contain them is recommended) 5. How is the general public exposed to fragrance allergens? The general public is exposed to fragrance substances via their use in perfumes and perfumed consumer products such as cosmetics detergents, fabric softeners and other household products. In the latter product types, fragrances may be used to provide the consumer with a fresh smell or to mask unpleasant odours from raw materials. Fragrance substances are also used in aromatherapy and may be present in herbal products. Fragrances or perfumes are complex mixtures which may contain up to several hundreds of different fragrance ingredients. Special databases list more than 2,5 fragrance ingredients that are used for perfuming consumer products. 6. What are the gaps in the current knowledge about perfume allergies? Although science has progressed in recent years, gaps in knowledge remain regarding; which specific fragrance substances cause allergies in humans, to what extent susceptible population groups run a greater risk of developing allergies compared to the rest of the population, what exposure levels can be considered to be safe for the general population and susceptible groups and how consumers are using perfumed cosmetic products as well as how much and how often.

4 page 4/9 A better understanding of these aspects will improve the risk assessment of fragranced products containing fragrance allergens and allow better risk management of the products. 7. Conclusion : are the current European regulations on fragrance allergens adequate? In 1999, a set of 26 fragrance allergens with a well-recognised potential to cause allergy had been ifentified, for which information should be provided to consumers about their presence in cosmetic products. On this basis, the Cosmetics directive required that the presence any of these 26 substances be indicated in the list of ingredients when its concentration exceeds,1 % in leave-on products and,1 % in rinse-off products. These limits had been set in a pragmatic administrative decision in the absence of known thresholds for these allergens. Such labelling allows patients who are allergic to one or more of these 26 fragrance chemicals to avoid products containing them. The Scientific Committee on Consumer Safety now identified more than 1 additional individual substances and natural extracts as established contact allergens or likely contact allergens by combination of evidence. In its conclusions, the scientific committee recommends that the consumer be made aware of the presence of all known and likely fragrance allergens in cosmetic products and not only the 26 currently listed. While a general safe exposure level that would apply to all individual fragrance allergens can still not be established, it is considered that a level of.1% of a fragrance allergen in a cosmetic product (refered to in the Cosmetics directive) could be tolerated by most consumers with contact allergy to the respective fragrance allergen. This maximum allowable level does not, however, preclude that the most sensitive segment of the population may develop a skin allergy upon exposure. Hence, having a maximum allowable product level does not remove the necessity for providing information to the consumer concerning the presence of the fragrance substance in cosmetics.

5 page 5/9 Annex Annex 1: Table 13-2: Fragrance substances categorised as established contact allergens in animals. INCI name (or, if exists, perfuming name according to CosIng) Human evidence: see text EC 3 value (min; %) Allyl phenoxyacetate p-tert. -Butyldihydrocinnamaldehyde CYCLAMEN ALDEHYDE Dibenzyl ether ,3-DIHYDRO-2,2,6-TRIMETHYLBENZALDEHYDE trans-2-hexenal Hexylidene cyclopenta HEXYL SALICYLATE p-isobutyl-α-methyl hydrocinnamaldehdye Isocyclocitral α-methyl cinnamic aldehyde METHYLENEDIOXYPHENYL METHYLPROPANAL METHYLUNDECANAL Methoxy-4-methylphenol Methoxy-α-methyl benzenpropanal METHYL OCTINE CARBONATE Perillaldehyde p-mentha-1,8-dien-7-al PHENYLACETALDEHYDE Natural extracts Jasminum Sambac Flower CERA / Extract / Water Source: SCCS, Opinion on Fragrance allergens in cosmetic products [see consumer_safety/docs/sccs_o_12.pdf], pages 19-11

6 page 6/9 Annex 2: Table 13-1: Established contact allergens in humans. INCI name (or, if exists, perfuming name according to CosIng) Human evidence: see text ACETYLCEDRENE AMYL CINNAMAL* AMYL CINNAMYL ALCOHOL* AMYL SALICYLATE trans-anethole ANISE ALCOHOL* BENZALDEHYDE BENZYL ALCOHOL* BENZYL BENZOATE* BENZYL CINNAMATE* BENZYL SALICYLATE* BUTYLPHENYL METHYLPROPIONAL * CAMPHOR beta-caryophyllene (ox.) CARVONE CINNAMAL* CINNAMYL ALCOHOL* CITRAL* CITRONELLOL* COUMARIN* (DAMASCENONE ) ROSE KETONE-4 alpha-damascone (TMCHB) cis-beta-damascone delta-damascone DIMETHYLBENZYL CARBINYL ACETATE (DMBCA) EUGENOL* FARNESOL* GERANIOL* HEXADECANOLACTONE HEXAMETHYLINDANOPYRAN HEXYL CINNAMAL* HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (HICC)* HYDROXYCITRONELLAL* ISOEUGENOL* alpha-isomethyl IONONE* (DL)-LIMONENE* LINALOOL* LINALYL ACETATE MENTHOL 6-METHYL COUMARIN METHYL 2-OCTYNOATE* METHYL SALICYLATE 3-METHYL-5-(2,2,3-TRIMETHYL-3- CYCLOPENTENYL)PENT-4-EN-2-OL alpha-pinene and beta-pinene PROPYLIDENE PHTHALIDE SALICYLALDEHYDE / / / / / / / / / and , resp (r.t.) (r.t.) Non-ox.:, ox.: (r.t.) (r.t.) - (r.t.) (non-ox.); (ox.) (non-ox.) (ox.) (non-ox.) (ox.) (r.t.) (r.t.)

7 page 7/9 INCI name (or, if exists, perfuming name according to CosIng) Human evidence: see text alpha-santalol and beta-santalol SCLAREOL TERPINEOL (mixture of isomers) alpha-terpineol Terpinolene TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES TRIMETHYL-BENZENEPROPANOL (Majantol) VANILLIN Natural extracts CANANGA ODORATA and Ylang-ylang oil CEDRUS ATLANTICA BARK OIL CINNAMOMUM CASSIA LEAF OIL CINNAMOMUM ZEYLANICUM BARK OIL CITRUS AURANTIUM AMARA FLOWER / PEEL OIL CITRUS BERGAMIA PEEL OIL EXPRESSED CITRUS LIMONUM PEEL OIL EXPRESSED CITRUS SINENSIS (syn.: AURANTIUM DULCIS) PEEL OIL EXPRESSED CYMBOPOGON CITRATUS / SCHOENANTHUS OILS EUCALYPTUS SPP. LEAF OIL EUGENIA CARYOPHYLLUS LEAF / FLOWER OIL EVERNIA FURFURACEA EXTRACT* EVERNIA PRUNASTRI EXTRACT* JASMINUM GRANDIFLORUM / OFFICINALE JUNIPERUS VIRGINIANA LAURUS NOBILIS LAVANDULA HYBRIDA LAVANDULA OFFICINALIS MENTHA PIPERITA MENTHA SPICATA MYROXYLON PEREIRAE NARCISSUS SPP. PELARGONIUM GRAVEOLENS PINUS MUGO/PUMILA POGOSTEMON CABLIN ROSE FLOWER OIL (ROSA SPP.) SANTALUM ALBUM TURPENTINE (oil) VERBENA ABSOLUTE and , resp / / / / ; ; ; ; ; ; ; ; ; ; ; ; ; ; diverse ; / ; Diverse ; ; ; (r.t.) (r.t.) (r.t.) Source: SCCS, Opinion on Fragrance allergens in cosmetic products [see consumer_safety/docs/sccs_o_12.pdf], pages 16-19

8 page 8/9 Annex 3: Table 13-4: Fragrance substances categorised as possible contact allergens. Opinion on fragrance allergens in cosmetic products INCI name (or, if exists, perfuming name according to CosIng) Human evidence: see text EC 3 value (min; %) SAR CYCLOHEXYL ACETATE ETHYLENE DODECANEDIOATE HYDROXYCITRONELLOL METHOXYTRIMETHYLHEPTANO L METHYL p-anisate METHYL DIHYDROJASMONATE PHENETHYL ALCOHOL PHENYLPROPANOL AMYLCYCLOPENTANONE BENZYL ACETATE ETHYLIDENEOCTAHYDRO-5,8-METHANO-2H-BENZO-1-PYRAN α,4,5,6,7,7α-HEXAHYDRO-4,7-METHANO-1H-INDEN-5(OR 6)-YL ACETATE alpha-ionone beta-ionone METHYL IONONE (mixture of isomers) TERPINEOL ACETATE (Isomer mixture) alpha-terpinyl ACETATE CITRONELLYL NITRILE alpha-cyclohexylidene BENZENEACETONITRILE DECANAL DIHYDROMYRCENOL ,7-DIMETHYL-1,6-NONADIEN-3-OL ETHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-2-BUTEN-1-OL GERANYL ACETATE HEXAHYDRO-METHANOINDENYL PROPIONATE IONONE isomeric mixture ISOBERGAMATE METHYL DECENOL TRICYCLODECENYL PROPIONATE OXACYCLOHEXADECENONE VERDYL ACETATE / trans-beta-damascone gamma-damascone Citronellal Phenethyl salicylate Natural extracts ACORUS CALAMUS ROOT OIL CEDRUS DEODARA WOOD OIL CITRUS AURANTIUM AMARA LEAF OIL CITRUS TANGERINA CYMBOPOGON NARDUS / WINTERIANUS HERB OIL ; ILLICIUM VERUM FRUIT OIL LAVANDULA SPICA LITSEA CUBEBA

9 page 9/9 INCI name (or, if exists, perfuming name according to CosIng) Human evidence: see text EC 3 value (min; %) SAR PELARGONIUM ROSEUM SALVIA spp. Diverse TAGETES PATULA THYMUS spp VETIVERIA ZIZANOIDES ; Source: SCCS, Opinion on Fragrance allergens in cosmetic products [see consumer_safety/docs/sccs_o_12.pdf], pages Annex 4: Table 13-3: Fragrance substances categorised as likely contact allergens by combination of evidence. INCI name (or, if exists, perfuming name according to CosIng) Human evidence: see text EC 3 value (min; %) SAR AMBRETTOLIDE CARVACROL Citrus paradisi R43 n.a. CUMINALDEHYDE CYCLOPENTADECANONE trans-trans-delta-damascone ,4-dimethyl-3-cyclohexen-1-carboxaldehyde R43 DIMETHYLTETRAHYDRO BENZALDEHYDE ETHYL VANILLIN HELIOTROPINE ISOAMYL SALICYLATE ISOLONGIFOLENEKETONE Longifolene R43 Mentha arvensis R43 n.a. METHOXYCITRONELLAL METHYL CINNAMATE METHYLIONANTHEME METHYL-alpha-IONONE MYRCENE MYRTENOL NEROL Nerolidol (isomer not specified) NOPYL ACETATE PHYTOL RHODINOL trans-rose KETONE ! Substances/natural mixtures were classified as R43, according to the submission by IFRA. The evidence on which this classification was based was not available to the SCCS, so the validity of classification cannot be assessed. Nevertheless, the four substances/substance mixtures should be treated as likely contact allergens. n.a.: not applicable (natural mixture) Source: SCCS, Opinion on Fragrance allergens in cosmetic products [see consumer_safety/docs/sccs_o_12.pdf], pages