http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm 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 1999. Is this list sufficient, or is it necessary for additional fragrance ingredients be added to the list? 1. 2. 3. 4. 5. 6. 7. 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: http://copublications.greenfacts.org/en/perfume-allergies/ and at: http://ec.europa.eu/health/opinions/en/perfume-allergies/ 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: http://copublications.greenfacts.org/ and at: http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm
http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm 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.
http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm 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 54 28 82 substances (13.1 [see Annex 2, p. 6] ) Labelling recommended (see conclusion) Established in animals 18 1 19 substances (13.2 [see Annex 1, p. 5] ) Labelling recommended (see conclusion) Likely 26 26 Substances (13.3 [see Annex 4, p. 9] ) Labelling recommended (see conclusion) Possible 35 13 48 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.
http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm 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.
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 7493-74-5 3.1 p-tert. -Butyldihydrocinnamaldehyde 18127-1- 4.3 CYCLAMEN ALDEHYDE 13-95-7 22 Dibenzyl ether 13-5-4 6.3 2,3-DIHYDRO-2,2,6-TRIMETHYLBENZALDEHYDE 116-26-7 7.5 trans-2-hexenal 6728-26-3 2.6 2-Hexylidene cyclopenta 17373-89-6 2.4 HEXYL SALICYLATE 6259-76-3.18 p-isobutyl-α-methyl hydrocinnamaldehdye 6658-48-6 9.5 Isocyclocitral 1335-66-6 7.3 α-methyl cinnamic aldehyde 11-39-3 4.5 METHYLENEDIOXYPHENYL METHYLPROPANAL 125-17- 16.4 METHYLUNDECANAL 11-41-8 1 2-Methoxy-4-methylphenol 93-51-6 5.8 4-Methoxy-α-methyl benzenpropanal 5462-6-6 23.6 METHYL OCTINE CARBONATE 111-8-8 2.5 Perillaldehyde p-mentha-1,8-dien-7-al 2111-75-3 8.1 PHENYLACETALDEHYDE 122-78-1 3 Natural extracts Jasminum Sambac Flower CERA / Extract / Water 9177-14-8 35.4 Source: SCCS, Opinion on Fragrance allergens in cosmetic products [see http://ec.europa.eu/health/scientific_committees/ consumer_safety/docs/sccs_o_12.pdf], pages 19-11
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 32388-55-9 122-4-7 11-85-9 25-8- 418-23-8 15-13-5 1-52-7 1-51-6 12-51-4 13-41-3 118-58-1 8-54-6 76-22-2 / 464-49-3 87-44-5 99-49- / 6485-4-1 / 2244-16-8 14-55-2 14-54-1 5392-4-5 16-22-9 / 1117-61-9 / 754-51-4 91-64-5 23696-85-7 4352-87-5 / 23726-94-5 23726-92-3 57378-68-4 151-5-3 97-53- 462-84- 16-24-1 19-29-5 1222-5-5 11-86- 3196-4-4 / 51414-25-6 17-75-5 97-54-1 127-51-5 138-86-3 78-7-6 115-95-7 149-4-6 / 89-78-1 / 2216-51-5 92-48-8 111-12-6 119-36-8 6781-2-1 8-56-8 and 127-91-3, resp. 17369-59-4 9-2-8 (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.)
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 115-71-9 and 77-42-9, resp. 515-3-7 8-41-7 1482-56-1 / 98-55-5 586-62-9 54464-57-2 / 54464-59-4 / 68155-66-8 / 68155-67-9 13694-68-4 121-33-5 83863-3-3; 86-81-3 9221-55-3; 8-27-9 87-8-5 84649-98-9 816-38-4; 72968-5-4 89957-91-5 84929-31-7 97766-3-8; 828-48-6 89998-14-1; 87-2-1; 89998-16-3 9252-7-; 8-48-4 8-34-8 928-67-4 928-68-5 84776-64-7; 945-94-6; 822-96-6 8-27-9; 8585-41-2 82-41-3; 87-48-5; 8463-73-6 91722-69-9 84776-65-8 86-9-4; 8482-7-2 84696-51-5 87--9; diverse 982-51-2; 8-46-2 982-72-7 / 97676-5-6 814-9-3; 84238-39-1 Diverse 84787-7-2; 86-87-9 86-64-2; 95-9-7; 852-14- 824-12-2 (r.t.) (r.t.) (r.t.) Source: SCCS, Opinion on Fragrance allergens in cosmetic products [see http://ec.europa.eu/health/scientific_committees/ consumer_safety/docs/sccs_o_12.pdf], pages 16-19
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 622-45-7 ETHYLENE DODECANEDIOATE 54982-83-1 HYDROXYCITRONELLOL 17-74-4 METHOXYTRIMETHYLHEPTANO L 4189-92- METHYL p-anisate 121-98-2 METHYL DIHYDROJASMONATE 24851-98-7 PHENETHYL ALCOHOL 6-12-8 PHENYLPROPANOL 122-97-4 AMYLCYCLOPENTANONE 4819-67-4 BENZYL ACETATE 14-11-4 6-ETHYLIDENEOCTAHYDRO-5,8-METHANO-2H-BENZO-1-PYRAN 93939-86-7 3α,4,5,6,7,7α-HEXAHYDRO-4,7-METHANO-1H-INDEN-5(OR 6)-YL ACETATE 5483-99-8 alpha-ionone 127-41-3 beta-ionone 79-77-6 METHYL IONONE (mixture of isomers) 1335-46-2 TERPINEOL ACETATE (Isomer mixture) 87-35- alpha-terpinyl ACETATE 8-26-2 CITRONELLYL NITRILE 51566-62-2 alpha-cyclohexylidene BENZENEACETONITRILE 1461-98- DECANAL 112-31-2 DIHYDROMYRCENOL 18479-58-8 3,7-DIMETHYL-1,6-NONADIEN-3-OL 1339-55-6 2-ETHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-2-BUTEN-1-OL 28219-61-6 GERANYL ACETATE 15-87-3 HEXAHYDRO-METHANOINDENYL PROPIONATE 68912-13- IONONE isomeric mixture 813-9-9 ISOBERGAMATE 68683-2-5 METHYL DECENOL 81782-77-6 TRICYCLODECENYL PROPIONATE 17511-6-3 OXACYCLOHEXADECENONE 3492-57-3 VERDYL ACETATE 25-83-6/ 5413-6-5 trans-beta-damascone 23726-91-2 gamma-damascone 3587-49-1 Citronellal 16-23- Phenethyl salicylate 87-22-9 Natural extracts ACORUS CALAMUS ROOT OIL 84775-39-3 CEDRUS DEODARA WOOD OIL 91771-47- CITRUS AURANTIUM AMARA LEAF OIL 72968-5-4 CITRUS TANGERINA 223748-44-5 CYMBOPOGON NARDUS / WINTERIANUS HERB OIL 89998-15-2; 91771-61-8 ILLICIUM VERUM FRUIT OIL 8465-59-9 LAVANDULA SPICA 97722-12-8 LITSEA CUBEBA 963-59-5
page 9/9 INCI name (or, if exists, perfuming name according to CosIng) Human evidence: see text EC 3 value (min; %) SAR PELARGONIUM ROSEUM 982-55-6 SALVIA spp. Diverse TAGETES PATULA 91722-29-1 THYMUS spp. 84929-51-1 VETIVERIA ZIZANOIDES 816-96-4; 84238-29-9 Source: SCCS, Opinion on Fragrance allergens in cosmetic products [see http://ec.europa.eu/health/scientific_committees/ consumer_safety/docs/sccs_o_12.pdf], pages 111-113 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 7779-5-2 CARVACROL 499-75-2 Citrus paradisi 816-2-4 R43 n.a. CUMINALDEHYDE 122-3-2 CYCLOPENTADECANONE 52-72-7 trans-trans-delta-damascone 7148-82-3 2,4-dimethyl-3-cyclohexen-1-carboxaldehyde 6839-49-6 R43 DIMETHYLTETRAHYDRO BENZALDEHYDE 68737-61-1 ETHYL VANILLIN 121-32-4 HELIOTROPINE 12-57- ISOAMYL SALICYLATE 87-2-7 ISOLONGIFOLENEKETONE 3347-62-4 Longifolene 475-2-7 R43 Mentha arvensis 68917-18- R43 n.a. METHOXYCITRONELLAL 3613-3-7 METHYL CINNAMATE 13-26-4 METHYLIONANTHEME 55599-63-8 5-METHYL-alpha-IONONE 79-69-6 MYRCENE 123-35-3 MYRTENOL 515--4 NEROL 16-25-2 Nerolidol (isomer not specified) 7212-44-4 NOPYL ACETATE 128-51-8 PHYTOL 15-86-7 RHODINOL 6812-78-8 trans-rose KETONE-5 39872-57-6! 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 http://ec.europa.eu/health/scientific_committees/ consumer_safety/docs/sccs_o_12.pdf], pages 11-111