Disagreement over why food packing additive application withdrawn

By Rory Harrington

- Last updated on GMT

Related tags European commission

Moves to include the chemical triclosan on a European list of additives that could be authorised for use in food contact materials have been abandoned by the Swiss-based manufacturer of the substance.

But the reasons for its removal remain unclear; triclosan producer Ciba said it has withdrawn the application on strategic grounds, while the German risk assessment authority, BfR, claimed safety concerns it raised over the chemical convinced the European Commission (EC) to recommend its exclusion from the so-called provisional list.

Provisional list

Triclosan is an antibacterial substance that has traditionally been used in cosmetics but also in textiles and various food packing plastics. It is currently part of the EC Provisional List of Additives used in plastics for food contact materials (FCM). From 1 January 2010 the register of additives relating to FCMs will become a positive list to the exclusion of all others. The provisional list is comprised of substances for which a dossier had been submitted by 2006 and that were already on the market. These materials can continue to be used in line with national legislation of individual EC members after the beginning of 2010 until a decision on their inclusion into or exclusion from the positive list has been made via an opinion by the European Food Safety Authority (EFSA).

Strategic decision

Ciba, which has recently been taken-over by chemical giant BASF, said it had withdrawn its application for triclosan’s inclusion on the provisional list so it could focus sales of the antimicrobial ingredient in the personal hygiene, health care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 sent to FoodProductionDaily.com.

The EC confirmed it had received notification from the company and would seek to de-list the chemical. It was likely this process would be completed by the end of this year, said a commission official.

Margins of exposure

But Germany’s Federal Institute for Risk Assessment, BfR, said its report delivered in June questioning the safety of triclosan had swayed the EC’s working group not to approve the chemical for inclusion on the list. The 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 has 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.”

The organisation said that triclosan was often present in very low concentrations and was used despite failing to offer “any hygiene advantages that could not be achieved with conventional cleaning agents”.

“For that reason BfR is of the opinion that the use of triclosan should be reduced to the absolutely necessary minimum,”​ said the organisation.

The EC said it believed authorities in Italy and Denmark had also not authorised the substance.

Company backs triclosan

But Ciba has defended the safety of the chemical.

“Ciba stands behind the safety and efficacy of triclosan in the approved personal hygiene, medical device and health care applications. Triclosan is supported by an extensive database of safety research.”

Related topics Regulation & Safety