The European Commission has announced that 2,4,4’-trichloro-2’-hydroxydiphenyl ether (triclosan) has been removed from its provisional list at the request of the Swiss-based company that manufactures the chemical.
The notification, listed in the Official Journal of the European Union, said Ciba had taken the decision to withdraw its application as it “does not consider the use of the substance in plastics intended to come into contact with food appropriate any more”.
The Journal added that as the substance may have already been used in the production of food contact plastics, a transition period would be introduced to allow a staggered phase out.
“Plastic materials and articles manufactured with 2,4,4’-trichloro- 2’-hydroxydiphenyl ether and placed on the market before 1 November 2010, may continue to be marketed until 1 November 2011, subject to national law”, said the document published on March 19.
Triclosan is an antibacterial substance that has traditionally been used in cosmetics but also in textiles and various food packing plastics. It had been included as part of the EC Provisional List of Additives used in plastics for food contact materials (FCM).
In 2004, the European Food Safety Authority (EFSA) authorised the use of triclosan in packaging, provided the substance did not migrate into food at more than 5 mg per kg of food.
Strategic decision
Ciba, a subsidiary of chemical giant BASF, last year told FoodProductionDaily.com that it had withdrawn the application for triclosan so it could focus sales of the antimicrobial ingredient in the personal hygiene, health care and medical device sectors instead.
“This is a strategic business decision made to focus Ciba’s resources in the areas of greatest customer value, and in markets where the proven safety and efficacy of triclosan is most clearly valued by our customers and supported by market demand”, said the company in a statement in August 2009.
But at least one national food safety authority had expressed concern over the use of triclosan as a food contact material. In June 2009, Germany’s Federal Institute for Risk Assessment, BfR, raised several concerns about the substance saying “consumers may already be at risk from the wide-spread use of triclosan in cosmetics”. The body recommended the substance be banned in Germany.
Tests on triclosan had revealed problems with the margin of exposure – defined as the highest level of a substance which has no effect in animal experiments and the amount deemed to be safe for humans, said BfR. A value of 100 is deemed safe, with the higher the ratio the lower the risk of adverse health effects, it said. However, the safety body told FoodProductionDaily.com that results from a safety assessment by the Scientific Committee on Consumer Products (SCCP) showed values of 45 and 32 had been found in some cosmetic products.
It said: “As a consequence of the migration of triclosan from plastic materials to food, consumers ingested additional amounts of the biocide. Hence BfR is of the opinion that further exposure routes should be avoided and triclosan should not be approved as a food additive.”
To read the full decision, click on the following link