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Survey and risk assessment of chemical substances in deodorants 2 Market survey and product sampling
2.1 Market surveyThe following strategy was adopted to ascertain a realistic overview of the deodorants sold on the Danish market: - Contact to The Association of Danish Cosmetics Toiletries Soap and Detergent Industries (SPT) to get an overview of deodorants on the Danish market and the most sold deodorants, - An overview of deodorants on the Danish Market via the internet, - An overview of deodorants on the Danish market by visiting big supermarkets and some special perfume shops, - Written/telephone contact to Danish manufacturers/importers/distributors of deodorants as well as to deodorants responsible persons in big supermarkets to get information on most sold deodorants, - Contact to Information Centre for Environment and Health to get relevant information on the deodorants, which were included in their survey. SPT and Information Centre for Environment and Health informed that all information was on their respective home pages. There was no information on the most sold deodorants on the Danish market on these webpages (5). However at the SPT’s homepage (5), information was given on the most sold brands of perfumes (both for men and women) based on turnover in Danish Kroner. SPT recommended a contact to its members to get more information. The Information Centre for Environment and Health suggested that the expensive deodorants (international brands with relatively high price) should also be included in the present survey. Google search on ”deodorant” revealed over six million pages with deodorants, of which approximately 53.000 pages with Danish addresses. The impression from going through the first 200 pages was that the most deodorant manufacturers, both Danish and international, advertise their products through the internet and also inform about the quality and property of the respective products. In some cases the ingredient list was also given, for example 14 variants of Axe deodorant with different composition. The internet search also revealed that the same products can be bought through several different addresses, but some specific products were available only through specified shops. The addresses of Danish deodorant dealers on the internet are described in Table 1. The list is not exhaustive as only 200 of the 53000 pages were reviewed. A number of retail shops were visited to get an overview of deodorants on the Danish market. Thus several supermarkets, special perfume shops, clothing- sport articles shops were visited. All of the shops visited were in the greater Copenhagen area and in Roskilde County. Several shop owners/administrators were requested to give information on the most sold products in their respective shops, but in most cases such information was not given. Table 1: Internet addresses for the shopping of deodorants in Denmark (found in the first 200 of the 53000 web pages in Google search) Twenty nine manufacturers and importers/distributors of deodorants in Denmark, whose products were estimated to cover a major part of deodorant market in Denmark, and six big supermarkets/magazines were contacted in writing or by phone to get information on the most sold deodorants and the number of units sold per year in Denmark. The administrators in three retail shops provided information about the names of the most sold deodorants in their shops. Five manufactures/importers of deodorants also informed about the most sold brand of their respective products as well as the numbers of individual products sold per year. Furthermore, two manufacturers of deodorants formulated products only for specific dealers. Three cosmetic importers had no deodorants in their assortment. According to the information received, approximately 2000-175000 units/year of individual deodorants of different brands were sold in Denmark in 2006. All information received is treated confidentially at NERI. The information received is used only for the present study and has not been forwarded to anyone else. Cosmetic products including deodorants are also sold via shops in airports, at ferries and also through travel agencies. The customers in the airports and at ferries can be Danes as well as of other nationalities. Therefore, sale of deodorants in these shops has not been considered in the present study, which is focused on the deodorants on the Danish market. One of the travel agencies in Denmark was contacted, in writing, to get information on the most sold deodorant via its shop, but no answer was received. In the present investigation, information on the most sold deodorants via membership of various cosmetic clubs (post-order cosmetic dealers) is not requested and internet dealers of deodorants are not contacted, as it was considered a minor part of deodorants sold in Denmark. 2.2 LegislationCosmetic products including deodorants marketed in Denmark/EU should comply with the EU Cosmetic Directive/Danish Statutory Order on Cosmetic Products (4). The Cosmetic Directive requires labelling of cosmetic products among others full declaration of ingredients. This also means that content of all ingredients in deodorants should be declared on these products, according to § 25 of the Danish Satutory Order concerning labelling of cosmetic products. Furthermore, according to § 33 of the Danish Satutory Order the manufacturer in EU or the responsible for marketing should also be identified on the label, so that Member State authorties, for example DEPA, have easy access to information concerning ingredients and risk assessment of the products. This project is focussed on fragrance substances and preservatives, which should only be used in deodorant formulation under the restrictions laid down in Annex III and Annex VVI respectively. The requirements concerning contents of other ingredients according to the Cosmetic Directive should also be met, obviously. Deodorants should be labelled with the 26 named fragrance substances if there concentration in the products is over 10 ppm. Furthermore, the products should be labelled “contains perfume (or aroma)”, if it contains other than the 26 named fragrance substances, or less than 10 ppm of these 26 substances. Maximum permitted concentration of triclosan, which is analysed in the selected products in this study, in cosmetic products, and thus, in deodorants is 0.3% (w/w). 2.3 Sampling of products and control of labellingTo control the labelling of the deodorants as well as to get an impression of a reliable pattern of the exposure of Danish population by deodorant ingredients, sampling of deodorants was performed on the basis of: - information received on the number of sold units of different brands of deodorants, - the most popular deodorants (number of units sold) according to the salesmen in various shops/supermarkets visited - the most sold men and women perfumes according to SPT’s homepage The deodorants purchased for the present survey are described in Annex 1. All products are bought in retail-outlets/magazines in the greater Copenhagen area or in Roskilde in the period 18-22 May 2006. All-in-all 97 deodorants were bought, so that most brands were included in the study, which included all types of deodorants (55 sprays and 42 deo roll-on, cream deo and deostick) both for men and women. Identification of the purchased products, information of manufacturers/importers/dealers and labelling of contents on the products are described in Annex 1. Labelling of all products was checked for the conformity of the declaration of ingredients with the guidance in the Cosmetic Directive, and it was also checked that the manufacturers/importers of the products were clearly identified. Names of some substances in the ingredient lists (in italics) were not in agreement with the corresponding names in the Danish Statutory Order on Cosmetic Products: anisyl alcohol/anise alcohol, hexyl cinnamicaldehyde/hexyl cinnamal, hydroxymethypentyl cyclohexenecarboxaldehyde/hydroxyisohexyl 3-cyclohexene carboxaldhyde, 3-methyl-4-(2,6,6-2-cyclohexen-1-yl)-3-butene-2-one/alpha-isomethylionone and 2-(4-ter-butylbenzyl)-propionaldehyd/butylphenyl methylpropional. A possible explanation for this is that the names of the respective substances in the Danish Statutory Order are not INCI names. Furthermore, labelling of ”limonene” can be interpreted as the products contain ”d-limonene”, as one of the 26 regulated fragrance substances. Nine of the sampled products were not declared to contain perfume, but only eight of these were explicitly labelled as perfume free. Seventeen of the sampled products were labelled with “perfume”, without mentioning any specific fragrance substance. This indicates that these products either did not contain any of the 26 regulated fragrance substances, or the concentrations of these 26 fragrance substances in the products were less than the concentration (10 ppm) required for obligatory labelling according to the Cosmetic Directive. The distribution of the individual 26 fragrance substances/extracts, whose content should be declared according to the Cosmetic Directive, in the 88 perfume containing products, is described in Table 2. The frequency of labeled essential oils, which could be sources of some of the 26 fragrance substances, is not included in the Table 2. Besides the 26 regulated fragrance substances, two other fragrance ingredients were labelled on the sampled deodorants: bisbolol in 4 products and triethyl citrate in 4 products. Among the 26 fragrance substances, most commonly used in the formulation of perfume containing deodorants was citronellol (65.9%), followed by linalool (53.4 %), d-limonene (53.4 %), geraniol (48.9 %), butylphenyl methyl propional (48.9 %), alpha isomethylionone (46.6 %), benzyl salicylate (39.8 %), hydroxyisohexyl 3-cyclohexene carboxaldehyd (32.3 %), coumarin (32.3 %), hydroxycitronellal (27.3 %), eugenol (27.3 %), citral (26.1 %) and benzyl benzoate (25 %). The remaining 13 of the 26 fragrance substances were used in less than 25% of the deodorants (Table 2). Comparison of the declared contents of fragrance substances in the sampled deodorants with the content of selected fragrance substances in deodorants on the European market, in an earlier study (6) may indicate that the use of strong fragrance allergens in deodorants is decreasing. The two studies, however, cannot be directly compared, as only a subsample of the deodorants were analysed chemically in the present study. Table 2. Fragrance substances labelled on the 88 perfume containing deodorants*
INCI (Inventory of Ingredients, Official Journal of the European Union) is used, except for the substances with no INCI name *17 products were labelled to contain perfume without mentioning any specific fragrance substance. The declared content of preservatives/antimicrobials in the deodorants is described in Table 3. Only about 40% of the deodorants contained the permitted preservatives. It is therefore possible that one or more of the other ingredients in the remaining products functions as preservative/antimicrobial. For example, ethanol which is used as solvent in the formulation of deodorants is a well know antimicrobial substance, and the fragrance substance benzyl alcohol can also be used as a preservative according to the Cosmetic Directive. In general, 0-3 preservatives/antimicrobial substances were present in the sampled deodorants, except in the product No. 306, which contained 5 different preservatives. The most commonly used preservative/antimicrobial substance in the deodorants was triclosan (in 15 % of the products), followed by parabens (in 9 % of the products) and phenoxyethanol (in 7 % of the products). Other preservatives (Table 3) were present in 1-2 % of the sampled products. Triclosan was present only in the products of upper price category. Table 3. Preservative/antimicrobial labelling on the purchased deodorants.
2.4 Selection of products for analysisProducts for the analyses as well as risk assessment of fragrance substances and preservatives/antimicrobial substances were selected in cooperation with DEPA. Fifteen of the products labelled to contain triclosan (Table 3), were selected for the determination of triclosan. Only few products contained other permitted preservatives/antimicrobial substances, and therefore, risk assessment of additional fragrance substances than planned was prioritised, instead of analysis and risk assessment of an additional preservative. Fragrance substances were selected in such a way that these were potent allergens and/or frequently involved in skin allergy, and a dose-response study in allergic persons, with the deodorants containing these substances, had been performed earlier. Isoeugenol, hydroxycitronellal and hydroxyisohexyl-3-cyclohexene carboxaldehyde (HICC) were prioritised, because these are among the most frequent allergenic fragrance substances and dose-response studies using deodorants containing these fragrance substances on persons allergic to these fragrance substances have been performed (7-10). Moreover cinnamyl alcohol was selected, because it metabolises in the skin to cinnamal, one of most allergenic fragrance substances, which itself was found only in one of the products in this study. Finally, it was decided to include farnesol to get an overview of the content of farnesol in deodorants, as this substance can also be used as antimicrobial in addition to its function as fragrance substance. For the analysis of the content of 26 regulated fragrance substances, 23 deodorants were selected in a way, so that these were among the most sold products and at least two of the fragrance substances selected for risk assessment were declared on the respective ingredient lists. Furthermore, all products containing isoeugenol and/or cinnamyl alcohol were selected for the analysis. Determination of the contents of evernia prunastri extract (oakmoss) and evernia furfuracea extract (treemoss) (among the 26 fragrance substances) is omitted, as a suitable method for the determination of these substances is not yet available. Thus, only 24 of the 26 fragrance substances were analysed in the selected samples.
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