Triclosan Marketing Ban Overturned by European General Court
In a case of first impression that involves the popular antimicrobial triclosan, the European General Court (the Court), a part of the European Union (EU) Court of Justice, decided that the European Commission (EC) may not remove an additive from the Union (positive) list based solely on the initial petitioner's withdrawing its application for the substance. Instead, the Court held that such a decision must be based upon a proper risk assessment related to the safety of that substance. The case is Microban International Ltd and Microban (Europe Ltd) vs. European Commission, Case T-262/10.
The matter arose when Ciba Inc., the company that petitioned to include triclosan on the positive list of additives for plastic food-contact materials, withdrew its application. Triclosan had been listed (by its chemical identity, 2,4,4'-trichloro-2'-hydroxydiphenyl ether) since 2008 on the provisional list of additives that are not yet authorized at the EU level but nonetheless may be used subject to the laws of the individual EU Member States. Ciba initially submitted an application in 1998 to list triclosan as a permitted additive in plastics. Upon review, the Scientific Committee on Food (SCF) issued an opinion concluding that triclosan was suitable for use as an additive for food-contact plastics, although no acceptable daily intake (ADI) or tolerable daily intake (TDI) was established. SCF's successor, the European Food Safety Authority (EFSA), confirmed the view of SCF in a separate opinion that was published in 2004. Triclosan was added to the provisional list of additives in 2008.
In 2009, Ciba informed the EC that it intended to withdraw its petition for triclosan for use as an additive in plastic food-contact articles. The Commission took the view that, since there was no longer a valid application for the inclusion of triclosan on the positive list of additives, the substance should be removed from the provisional list of additives. The Commission's Decision 2010/169/EU in this regard provided for a transitional period during which triclosan could continue to be authorized by the Member States. Plastic materials and articles manufactured using the additive that were placed on the market before November 1, 2010 could remain on the market until November 1, 2011.
The Commission's decision meant that the petitioners, which manufacture antibacterial and antimicrobial additives including triclosan and market the additives for use in food-contact materials and articles throughout the EU, no longer had a legal basis to market the triclosan additive; therefore, petitioners filed the lawsuit claiming that the Commission improperly withdrew the authorization for the additive on the provisional list.
After finding that the petitioners had proper standing to bring their case, the Court overruled the Commission's decision to remove triclosan from the provisional list. In rendering its decision, the Commission cited Article 11(3) of the EU Framework Regulation. The Court noted that this provision relates only to the authorization of new substances. Because the Commission's decision to withdraw triclosan from the provisional list actually resulted in a prohibition on marketing of the additive, the Court found Article 11(3) was not the appropriate legal justification for the decision.
The Court went on to address the plaintiffs' second claim that the Commission breached procedural rules by not providing interested parties an opportunity to object to the withdrawal of the clearance. The Court pointed out that triclosan had been evaluated by SCF in 2000 and EFSA in 2004 and that no objection was raised to the marketing of triclosan in the EU in either of these scientific opinions. The Court held that the Commission could remove a substance only following a risk management decision or if an applicant refuses to cooperate with EFSA during the course of its safety evaluation. Given that neither of these scenarios arose in the case of triclosan, and that EFSA in fact already had conducted its evaluation of triclosan and deemed it suitable for food packaging use, the Court held that the Commission's decision was improper.
The Court ruled that triclosan was wrongly excluded from the positive list of additives and annulled the Commission's decision to remove triclosan from the list of permitted additives. The practical effect is that triclosan remains on the positive list (as a provisionally listed substance), and may continue to be used as an additive in plastic food-contact materials and articles subject to Member State law.