Idiomas:
The SCCS opinion states:
5. PRODUCTION, USE AND FATE OF TRICLOSAN
Triclosan is a broad spectrum antimicrobial used as an antiseptic, disinfectant or preservative in clinical settings, various consumer products including cosmetics, household cleaning products, plastic materials, toys, paints, etc. It is also incorporated on the surface of medical devices, plastic materials, textiles, kitchen utensils, etc., from which it might slowly leach for a long period of time during their use, to perform its biocidal action. A detailed list of products containing triclosan is provided by the US Environmental Protection Agency (EPA) (McMahon et al. 2008) and by the Environmental Working Group, a US NGO (www.ewg.org/node/26752
). According to EU Biocide Directive 1998/8/EC, triclosan is used in product types 1 (human hygiene), 2 (private and public health area), 3 (veterinary hygiene), 7 (film preservative) and 9 (fibre, leather, rubber and polymerised materials preservative). According to the information provided by COLIPA, the quantity of triclosan used within the EU reached approximately 450 tons (as 100% active) in the year 2006. Dye et al. (2007) estimated triclosan production in the EU to be 10-1,000 tonnes per year. It is not clear whether the above information on use or production of triclosan includes the amounts of triclosan which may be imported in the EU or exported from the EU via finished products, such as medical devices, toys, textiles, etc. In the EU, about 85% of the total volume of triclosan is used in personal care products, compared to 5% for textiles and 10% for plastics and food contact materials (usage data reported by COLIPA in 2007).
The Danish EPA performed a survey of the use of triclosan in Denmark for the period 2000-2005 (Borling et al. 2005). This survey showed that the amount of triclosan in products on the Danish market had decreased from approx. 3.9 to 1.8 tonnes (54%) in the period 2000-2004. Cosmetics were the largest contributor to the amount of triclosan on the Danish market (99% of the total reported amount in the survey). However, this might not be representative for the whole EU, as similar data for comparison is not available for the EU as a whole or for any of its Member States.
Source & ©: SCCS, 
The SCCS opinion states:
5.1. Triclosan in cosmetics
Triclosan was listed in 1986 in the European Community Cosmetics Directive (76/768/EEC) for use as a preservative in cosmetic products at concentrations up to 0.3%. The recent risk assessment performed by the EU Scientific Committee on Consumer Products (SCCP) concluded that, although its use at a maximum concentration of 0.3% in toothpastes, hand soaps, body soaps/shower gels and deodorant sticks was considered safe on a toxicological point of view in individual products, the magnitude of the aggregate exposure to triclosan from all cosmetic products is not safe. Any additional use of triclosan in face powders and blemish concealers at this concentration was also considered safe, but the use of triclosan in other leave-on products (e.g. body lotions) and in mouthwashes was not considered safe for the consumer due to the resulting high exposures2. Inhalation exposure to triclosan from spray products (e.g. deodorants) was not assessed.
In a Danish EPA survey (Borling et al. 2005), the highest amount of triclosan in cosmetics was found in products for dental hygiene, including toothpaste. In this group, the amount had decreased by 37% during 2000-2004. Deodorants were the group of cosmetics with the greatest decrease in amount of triclosan (79%). A recent Danish EPA survey revealed that 15% of the most commonly sold deodorants in the Danish market contained <0.3% triclosan (Rastogi et al. 2007).
Triclosan being non-ionic, it can be formulated in conventional dentifrices. However, it does not bind to the oral surfaces for more than a few hours, and therefore does not deliver a sustained level of anti-plaque activity. To increase uptake and retention of triclosan by oral surfaces for the improvement of plaque control and gingival health, triclosan/polyvinylmethyl ether maleic acid copolymer and triclosan/zinc citrate and triclosan/calcium carbonate dentifrice are used (Williams 1998, Davies et al. 2004, Brading et al. 2004, Davies 2007).
Source & ©: SCCS,
The SCCS opinion states:
5.2. Triclosan in healthcare and medical devices
Triclosan has been effectively used clinically to eradicate micro-organisms such as methicillin-resistant Staphylococcus aureus (MRSA) (Brady et al. 1990; Cookson et al. 1991; Webster et al. 1994; Zafar et al. 1995), notably with the recommendation to use 2% triclosan bath. Triclosan is employed as surgical scrubs, and it is widely used in hand washing (Boyce and Pittet 2002) and as a body wash to eradicate MRSA from carriers prior to surgery (Wilcox et al. 2003).
Triclosan is used in a number of medical devices, for example ureteral stents (Knudsen et al. 2005), surgical sutures (Ford et al. 2005; Justinger et al. 2009) and might be considered to prevent graft infection (Cakmak et al. 2009). Bojar et al. (2009) did not observe a difference in colonisation between triclosan-coated sutures and regular multifilament suture, although their work concerned five bacteria and is only based on the determination of the zone of inhibition. In ureteral stents, triclosan has been shown to inhibit the growth of common bacterial uropathogens and to reduce the incidence of urinary-tract infections and, potentially, catheter encrustation (Chew et al. 2006, Cadieux et al. 2009). Wignall et al. (2008) have recently demonstrated synergistic effects of triclosan and relevant antibiotics on clinical isolates comprising seven uropathogenic species, and they support the use of the triclosan-eluting stent when necessary, along with standard antibiotic therapy in treating complicated patients. In some further developments, the use of triclosan in urinary Foley catheter was suggested since triclosan successfully inhibited the growth of Proteus mirabilis and controlled encrustation and blockage of the catheter (Stickler et al. 2003, Williams and Stickler 2008). Recently, Darouiche et al. (2009) demonstrated synergistic, broad-spectrum and durable antimicrobial activity of the catheters coated with a combination of triclosan and DispersinB, an anti-biofilm enzyme that inhibits and disperses biofilms (Kaplan et al. 2004, Itoh et al. 2005).
Source & ©: SCCS,
The SCCS opinion states:
5.3. Triclosan in household and other consumer products
The broad-spectrum antimicrobial activity of triclosan has led to its incorporation in an extended range of product formulations intended for home use such as liquid soaps, detergents, chopping boards, children’s toys, carpets and food storage containers (Bhargava and Leonard 1996, McBain et al. 2003, Yazdankhah et al. 2006, Gilbert et al. 2007). A detailed list of consumer products containing triclosan is provided by the US Environmental Protection Agency (EPA) (McMahon et al. 2008) and by the US NGOs "Environmental Working Group" (www.ewg.org/node/26752
) and "Beyond Pesticides" (www.beyondpesticides.org/antibacterial/products.htm ). An increasing number of clothing articles are treated with biocides. Triclosan is one of the finishing agents for the production of such textiles (Orhan et al. 2009).The fabrics finished with triclosan are treated with cross-linking agents to provide durable antibacterial properties. On the basis of the available information, 17 products from the Danish retail market were analysed for the content of some selected antibacterial compounds: triclosan, dichlorophen, Kathon 893, hexachlorophen, triclocarban and Kathon CG. Five of the products were found to contain 0.0007% - 0.0195% triclosan (Rastogi et al. 2003).
Aiello et al. (2007), in the first systematic review assessing the benefit of soaps containing triclosan, evaluated 27 studies published between 1980 and 2006. One of the key findings is that soaps that contained less than 1% triclosan showed no benefit from non-antimicrobial soaps (the EU limit is 0.3%). Studies that used soap containing > 1% triclosan showed a significant reduction in bacterial levels on hand, often after multiple applications. The apparent lack of relationship between the use of soap containing triclosan and reduction in infectious illness was difficult to ascertain in the absence of identification of the biological agents responsible for the illness symptoms. Two recent US studies (Fischler et al. 2007, Fuls et al. 2008) demonstrated that hand washing with antimicrobial soap containing triclosan (0.46%) reduced bacterial load and transfer of bacteria from hands, compared to handwashing with a non-antimicrobial soap.
Source & ©: SCCS,
The SCCS opinion states:
5.4. Triclosan in food and feed
5.4.1.Triclosan in food production
Triclosan was evaluated by the Scientific Committee on Food (SCF 2000) and the European Food Safety Authority (EFSA 2004) for use in food contact materials and classified in SCF List 33 with a restriction of 5 mg/kg of food. The evaluation was referred to the use of triclosan as surface biocide i.e. as substance intended to inhibit the growth of bacteria on the surface but which is not intended to have an antimicrobial effect on the food itself. Potential uses beyond household articles like cutting boards, kitchen utensils and food storage containers exist (e.g. conveyor belts, machinery, work surfaces and transport containers used in food processing). However, in April 2009 the petitioner has withdrawn the application for these uses. According to a March 2010 Commission Decision4 triclosan shall not be included in the positive list of additives to Directive 2002/72/EC and cannot be used in the manufacture of plastics intended to come into contact with food.
In Germany, the use of triclosan in food contact plastics is banned since September 2009. BfR supports the ban on triclosan in food contact materials (BfR Opinion N°. 031/2009, 12 June 2009).
Triclosan has been identified in drinking water in certain places (Stackelberg et al. 2004, Boyd et al. 2003). Kantiani et al. (2008) found methyl triclosan (12 μg/L) in one of the 22 drinking water samples from Barcelona.
5.4.2. Triclosan as disinfectant in food and feed production
Triclosan is not notified in the framework of the European regulations on biocides (Directive 98/8/EC) for use as disinfectant in food and feed production.
5.4.3. Triclosan as food preservative
Triclosan is not approved as food preservative in Europe. Food preservatives are regulated by Directive 95/2/EC on food additives other than colours and sweeteners. In Annex III of this Directive on the permitted preservatives and restrictions for their use, triclosan is not listed. As a result, the use of triclosan in so-called “active food contact materials and articles” is not allowed. Regarding substances released from such materials in order to extend the shelf-life of food, the Regulation (EC) 1935/2004 on food contact materials refers to the authorisations applicable to their use in foods.
5.4.4. Triclosan in animal husbandry
Triclosan is notified in the framework of the European regulations on biocides (Directive 98/8/EC) for use in veterinary hygiene biocidal products.
5.4.5. Triclosan as feed preservative
According to Regulation (EC) 1831/2003 on additives for use in animal nutrition the use of triclosan as preservative in feed is not authorised. The substance is not listed in the corresponding Community Register of Feed Additives (2004/C 50/01).
Source & ©: SCCS,
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