Triclosan (2,4,4’-trichloro-2’hydroxydiphenyl ether) is an anti-microbial agent added to some food packaging, which is marketed by Microban International and Microban Europe, the applicants in this case before the EU General Court (ECG).
In March 2010 the EC adopted Decision 2010/169/EU concerning the non-inclusion of triclosan on a positive EU list of additives that may be used in the manufacture of “plastic materials and articles” intended to come into contact with foodstuffs.
Triclosan has traditionally been used in cosmetics but also textiles and various food packaging plastics, and had been authorised for use in food packaging by the European Food Safety Authority (EFSA) in 2005 subject to a migration limit of 5mg per kg of food.
Blanket marketing ban
The ECG explained there was no longer a valid application for the inclusion of triclosan on the additive list in March 2010, after Swiss firm Ciba (a subsidiary of chemical giant BASF that makes the chemical) withdrew its application for triclosan’s use in food packaging manufacture in April 2009.
To quote the ECG’s judgement: “As there was no longer a valid application for the authorisation of the use of triclosan as an additive … the EC concluded that the substance should not be included in Annex III to Directive 2002/72, which contains the positive list.”
The EC stated that the substance should, therefore, also be removed from the provisional list of allowed additives, subject to a transitional period – to allow a staggered phase-out of the chemical – during which articles containing triclosan could continue to be marketed by Member States.
But Microban contested several EC articles, one of which stated that Triclosan should not be included in Annex III under the 2002 directive.
Another stated: “Plastic materials and articles manufactured with triclosan and placed on the market before November 1 2010, may continue to be marketed until November 1 2011, subject to national law.”
But in a hearing on September 27, Microban called for the EC’s decision to remove triclosan from the annex to be overturned.
The EC argued that the action was inadmissible because, in legal terms, it was “not of individual concern to the applicants”, since they were not the addressees of the contested decision.
Past safety controversy
But the ECG noted that the effect of an effective marketing ban on triclosan-based products was obvious, and directly affected the applicants’ legal position.
“As was made clear at the hearing, the applicants buy triclosan and use it to manufacture a product with antimicrobial and antibacterial properties, which is then sold on for use in the manufacture of plastic materials and articles intended to come into contact with foodstuffs.”
Moreover, human health protection under Directive 2002/72 was no basis for the EC's non-inclusion of triclosan on the positive list, said the ECG, since neither the Scientific Committee for Food (in 2000) nor EFSA (in 2005) objected to the marketing of chemical.
However, in June 2009 Germany’s Federal Institute for Risk Assessment (BfR) raised concerns about the use of triclosan in cosmetics and recommended that the substance be banned in Germany.
In August 2009 the BfR said its own safety report on triclosan had swayed the relevant EC working group not to include the chemical on the provisional list.
But summing up, the ECG said the EC had infringed Regulation No. 1935/2004 and Directive 2002/72, “in adopting a decision not to include an additive solely on the basis of the withdrawal of the initial application for inclusion of triclosan on the positive list”.
There was no legal basis for such a move, the court said, and as such it annulled the EC’s decision to strike triclosan off the EU’s permitted additive list, and ordered the body to pay costs.