New Restrictions Proposed for Fragrance Chemicals By Stephen and Gina Antczak, authors of Cosmetics Unmasked In recent years there has been much talk about the increasing number of allergies caused by fragrance chemicals in cosmetics and toiletries but as yet there is no legislation to control the use of natural or artificial fragrances. The European Union (EU) Commission now plans to plug this gap in the law. Under current legislation there are no restrictions on the quantities or combinations of fragrance chemicals that may be used in cosmetics. When fragrance chemicals are added, the law requires only that the label on a cosmetic or toiletry includes the word 'Parfum' in the EU or 'Fragrance' in the USA. There are no requirements to name individual fragrance chemicals in the list of ingredients. This is because a typical perfume contains a mixture of a large number of fragrance chemicals, often between 50 and 100 and it would be impossible to list them all on a small label. This creates a problem for people who are sensitive or allergic to a particular fragrance chemical. Buying cosmetics becomes a lottery for them because they can never know if the offending chemical has been used in a product or not. All of this is set to change. The EU Commission has asked the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) to make recommendations on for the control of fragrance chemical used in cosmetics. The SCCNFP responded with three lists: A list of 24 chemicals that are most frequently reported as contact allergens A list of 36 fragrance chemicals that should be banned from cosmetics A list of 78 chemicals (in 28 families) that should be restricted. The exact form of the restriction has not been finalised yet but it is possible that these chemicals could be individually listed in the ingredients and the amounts that can be used will be limited. It is interesting to note that many of these chemicals are natural plant extracts or were originally obtained from plants but are more easily and cheaply made by artificial means. List of fragrance chemicals most frequently reported as contact allergens. Issued 8 December 1999. Amyl cinnamal Amylcinnamyl alcohol (May cross react with amyl cinnamal) Benzyl alcohol Benzyl salicylate Cinnamyl alcohol Cinnamal Citral Coumarin Eugenol Geraniol Hydroxycitronellal Hydroxymethylpentylcyclohexenecarboxaldehyde Isoeugenol Anisyl alcohol Benzyl benzoate Benzyl cinnamate Citronellol Farnesol Hexylcinnamaldehyde (Used as a positive control substance in animal sensitization tests.) Lilial (2-(4-tert-butylbenzyl)propionaldehyde) d-Limonene (Oxidization products are strong sensitisers. Mostly reported as an occupational allergen.) Linalool Methyl heptine carbonate g-Methylionone (3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one) List of fragrance chemicals which must not form part of cosmetic products. Issued 3 May 2000. Alantroot (Inula helenium) essential oils and derivatives e.g. concrete and absolute. Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. Allylisothiocyanate Should not be used as or in fragrance ingredients. The recommendation is based on the absence of reports on the use of this material as fragrance ingredient and/or inadequate evaluation of potential adverse effects resulting from its use in fragrances. Benzyl cyanide Should not be used as or in fragrance ingredients. The recommendation is based on the absence of reports on the use of this material as fragrance ingredient and/or inadequate evaluation of potential adverse effects resulting from its use in fragrances. p-tert-Butylphenol Prohibited. Should not be used as a fragrance ingredient based on published literature on its sensitization and depigmentation properties. Chenopodium oil Should not be used as or in fragrance ingredients. The recommendation is based on the absence of reports on the use of this material as fragrance ingredient and/or inadequate evaluation of potential adverse effects resulting from its use in fragrances. Cyclamen alcohol Prohibited. Should not be used as a fragrance ingredient as such. Diethyl maleate Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. Dihydrocoumarin Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. 2,4-Dihydroxy-3-methylbenzaldehyde Prohibited. Should not be used as a fragrance ingredient based on the sensitizing potential of this material . 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) Should not be used as or in fragrance ingredients. The recommendation is based on the absence of reports on the use of this material as fragrance ingredient and/or inadequate evaluation of potential adverse effects resulting from its use in fragrances. 4,6-Dimethyl-8-tert-butylcoumarin Prohibited. Should not be used as a fragrance ingredient based on its potential for inducing photoallergic reactions. Dimethyl citraconate Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. 7,11-Dimethyl-4,6,10-dodecatrien-3-one Prohibited. Should not be used as a fragrance ingredient. 6,10-Dimethyl-3,5,9-undecatrien-2-one Prohibited. Should not be used as a fragrance ingredient. Diphenylamine Should not be used as or in fragrance ingredients. The recommendation is based on the absence of reports on the use of this material as fragrance ingredient and/or inadequate evaluation of potential adverse effects resulting from its use in fragrances. Ethyl acrylate Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential and its classification as a carcinogen. Fig leaf, fresh and preparations (Ficus carica) Prohibited. Should not be used as a fragrance ingredient based on the sensitizing and extreme phototoxic potential. trans-2-Heptenal Prohibited. Should not be used as a fragrance ingredient based on test results showing the sensitizing potential of this material. trans-2-Hexenal diethyl acetal Prohibited. Should not be used as a fragrance ingredient based on test results showing the sensitizing potential of this material. trans-2-Hexenal dimethyl acetal Prohibited. Should not be used as a fragrance ingredient based on test results showing the sensitizing potential of this material. Hydroabietyl alcohol Prohibited. Should not be used as a fragrance ingredient in cosmetic products based on its weak sensitizing potential. Hydroquinone monoethyl ether Prohibited Should not be used as a fragrance ingredient based on the depigmenting effect of this material. 6-Isopropyl-2-decahydronaphthalenol Prohibited. Should not be used as a fragrance ingredient based on the sensitizing potential of this material. 7-Methoxycoumarin Prohibited. Should not be used as a fragrance ingredient based on its potential of inducing allergic and photoallergic reactions. 4-Methoxyphenol Prohibited. Should not be used as a fragrance ingredient based on its depigmenting effect. 4-(p-Methoxyphenyl)-3-butene-2-one Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. 1-(p-Methoxyphenyl)-1-penten-3-one Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. Methyl trans-2-butenoate Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. 6-Methylcoumarin Prohibited. Should not be used as a fragrance ingredient based on its potential for producing photoallergic reactions. 7-Methylcoumarin Prohibited. Should not be used as a fragrance ingredient based on its potential for inducing photoallergic reactions. 5-Methyl-2,3-hexanedione Prohibited. Should not be used as a fragrance ingredient based on test results on its sensitizing potential. Musk ambrette Prohibited. Musk ambrette should not be used as a fragrance ingredient based on photosensitivity, neurotoxic effects and on accumulated evidence that musk ambrette can penetrate human skin and is only slowly excreted. 2-Pentylidenecyclohexanone Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. 4-Phenyl-3-buten-2-one Prohibited. Should not be used as a fragrance ingredient based on findings on the sensitizing potential of this material and on its sensitizing effects on guinea pigs and humans. 3,6,10-Trimethyl-3,5,9-undecatrien-2-one Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. Verbena ( Lippia citriodora Kunth.) essential oils and derivatives e.g. concrete and absolute. Prohibited. Should not be used as a fragrance ingredient based on its sensitizing potential. Note that this has been included in the following list which allows it to be used subject to certain restrictions. List of fragrance chemicals that may be used subject to certain restrictions. Issued 25 September 2001. Essential oils and isolates derived from the pine trees (Pinacea family), including Pinus and Abies genera, should only be used when the level of peroxides is kept to the lowest practicable level, for instance by adding antioxidants at the time of production. Such products should have a peroxide value of less than 10 millimoles peroxide per litre. Based on the published literature mentioning sensitizing properties when containing peroxides. These extracts are: Abies alba oil from cones (Abies Alba Mill.) Abies alba oil from needles (Abies Alba Mill.) Abies sachalinensis oil Fir balsam (Abies balsamea (L.) Mill) Fir needle oil (Abies sibirica) Fir needle oil, Canadian (Abies balsamea) Pine needle, dwarf, oil (Pinus mugo turra var. pumilio (Haenke) Zenari) Pine needle oil (Abies spp.) Scots Pine oil (Pinus sylvestris L.) Pinus nigra oil Turpentine gum (Pinus spp.) Turpentine oil Turpentine oil rectified Turpentine, steam distilled (Pinus spp.) Acetyl hexamethyl indan For applications on areas of skin exposed to sun, excluding bath preparations, soaps and other rinse-off products, limit use to 2%in the finished cosmetic product. Based on the phototoxic potential showing no effects at 10% in human photo-toxicity tests. Esters of Allyl Alcohol. Use only when the level of free allyl alcohol in the ester is less than 0.1%. Based on the delayed irritant potential of allyl alcohol. These esters include: Allyl butyrate Allyl cinnamate Allyl cyclohexaneacetate Allyl cyclohexanepropionate Allyl heptanoate Allyl hexanoate Allyl isovalerate Allyl octanoate Allyl phenoxyacetate Allyl phenylacetate Allyl 3,5,5-trimethylhexanoate Allyl heptine carbonate Should not be used such that the level in the finished cosmetic products exceeds 0.002 %. Based on test results showing the absence of sensitizing reactions for allyl heptine carbonate at low concentrations in a test on humans. This material should not be used in combination with any other 2-alkynoic acid ester (e.g. methyl heptine carbonate). Amylcyclopentenone Should not be used such that the level in the finished cosmetic product exceeds 0.1 %. Based on test results showing sensitization at 10% and no sensitization at 1 %. Natural extracts containing furocoumarin-like substances. These may be used in cosmetic products, provided that the total concentration of furocoumarin-like substances in the finished cosmetic product do not exceed 1ppm. These extracts include: Angelica root oil (Angelica archangelica L.) Bergamot oil Grapefruit oil, expressed (Citrus paradisi Macf.) Lemon oil Lemon oil, cold pressed, Calif ornia type Lemon oil, cold pressed, desert type Lime oil, cold pressed, Mexican Lime oil, expressed Lime oil expressed rectified Orange peel oil, bitter (Citrus aurantium L.) Rue oil (Ruta graveolens L.) Extracts and distillates of Peru balsam (the exudation from Myroxylon pereirae (Royle) Klotzsch). These should not be used such that the total level exceeds 0.4% in cosmetic products. Based on a wide variety of test results on the sensitizing potential of Peru balsam and its derivatives. These are: Balsam oil, Peru (Myroxylon pereirae Klotzsch) Balsam absolute, Peru Balsam anhydrol, Peru p-tert-Butyldihydrocinnamaldehyde Should not be used such that the level in the finished cosmetic product exceeds 0.6%. Based on test results showing sensitizing potential and no sensitization reactions when tested at 6%. Substances containing Cinnamic aldehyde. The concentration of Cinnamic aldehyde in the finished cosmetic product should not exceed 0.1%. These substances are: Cinnamal Cinnamic aldehyde-methylanthranilate (Schiff base) Natural extracts containing Cinnamic aldehyde. The prime allergen is Cinnamic aldehyde. The concentration of Cinnamic aldehyde in the finished cosmetic product should not exceed 0.1%. These extracts are: Cassia oil Cinnamon bark oil Cinnamyl alcohol Should not be used such that the level in finished cosmetic products exceeds 0.8%. Based on test results showing sensitizing potential. Cumin oil For applications on areas of skin exposed to sun, excluding bath preparations, soaps and other wash-off products, limit cumin oil to 0.4% in the finished cosmetic product. Based on the photo-toxicity of cumin oil, the observed no-effect level of 25% on the skin of the hairless mouse and on the no-effect level of 5% in tests with humans. Damascones and related compounds. These should not be used as fragrance ingredients such that the total level in finished cosmetic products exceeds 0.02%, individually or in combination. Based on test data showing sensitizing potential for these materials and on evidence of cross-reactivity. These chemicals are: cis-alpha-Damascone trans-beta-Damascone Isodamascone 1-(2,6,6-Trimethylcyclohexa-1,3-dienyl)-2-buten-1-one 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one 1-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one 1-(2,6,6-Trimethyl-2-cydohexen-1-yl)-2-buten-l-one trans-Hexen-2-al Should not be used such that the level in finished cosmetic products exceeds 0.002%. Based on test results of RIFM showing sensitization reactions at 0.2% and no sensitization reactions when tested at 0.02%. Hydroxycitronellal Should not be used such that the level in finished cosmetic products exceeds 1.0%. Based on a review of a large number of animal and human test data. Isoeugenol Should not be used such that the level in finished cosmetic products exceeds 0.02%. Based on test results showing sensitizing potential. Limonene and natural products containing substantial amounts of it. These should only be used when the level of peroxides is kept to the lowest practical level, for instance by adding antioxidants at the time of production. Such products should have a peroxide value of less than 20 millimoles peroxide per litre. These include: d-Limonene l-Limonene dl-Limonene (racemic) p-Mentha-1,8-dien-7-al Should not be used such that the level in finished cosmetic products exceeds 0.1%. Based on test results showing sensitization. Menthadiene-7-methyl formate Should not be used such that the level in finished cosmetic products exceeds 0.1 %. Based on tests showing sensitization. Methoxy dicyclopentadiene carboxaldehyde Should not be used such that the level in finished cosmetic products exceeds 0.5%. Based on test results showing sensitization potential. Methyl N-methylanthranilate For applications on areas of the skin exposed to sunlight, excluding bath preparations, soaps and other wash-off products, limit to 10 % in the finished cosmetic product. Based on the phototoxic potential and on the observed no-effect level of approximately 2 mg/cm2 of the hairless mouse. 3-Methyl-2(3)-nonenenitrile Should not be used such that the level in finished cosmetic products exceeds 0.2%. Based on test results showing sensitization. Methyl octine carbonate and Methyl heptine carbonate When used alone the level in finished cosmetic products of Methyl octine carbonate should not exceed 0.002%. When used alone level in the finished cosmetic products of Methyl heptine carbonate should not exceed 0.01%. When present in combination, the combined level in the finished product should not exceed 0.01% of which methyl heptine carbonate should not be more than 0.002% Extracts of Oakmoss and Treemoss. These should not be used such that the level in finished cosmetic products exceeds 0.1%. The maximum concentration of Oakmoss and Treemoss in combination in the finished cosmetic product should not exceed 0.1%. The allergenic fractions in these species have not been fully elucidated nor has the relative contribution of the allergenic fractions between the species. These ingredients are: Oakmoss absolute (Evernia spp.) Oakmoss resinoid (Evernia spp.) Treemoss absolute (Usnea spp.) Treemoss concrete (Usnea spp.) Treemoss resinold (Usnea spp.) 1-Octen-3-yl acetate Should not be used such that the level in finished cosmetic products exceeds 0.3%. Based on test results showing sensitizing potential. 3-Propylidenephthalide Should not be used such that the level in finished cosmetic products exceeds 0.01 %. Based on test results showing sensitization potential. 2,4,6-Trimethyl-3-cyclohexene-1-methanol Should not be used such that the level in finished cosmetic products exceeds 0.5%. Based on test results showing sensitization potential. Verbena absolute Verbena absolute obtained from Lippia citriodora Kunth should not be used such that the level in finished cosmetic products exceeds 0.2%. Based on test results showing sensitization. Back to the top © Gina & Steve Antczak, 2001 This page was last updated, 2 January 2002 CosmeticsUnmasked.Com