EU Regulatory Status Quaternary Ammonium Compounds

28 June2012

EU regulatory status Quaternary Ammonium Compounds

In recent weeksanissue regarding the presenceof quaternary ammonium compounds (QAC) on fruit and vegetables has emerged and led to a great number of enquiries from the membership. This note aims to clarify the EU regulatory status.

Labs have detected the following QACs in several fruits and vegetables mainly originating from third countries but also from Europe: Didecyl Dimethyl Ammonium Chloride (DDAC) and Alkyl Dimethyl Benzalkonium Chloride (ADBAC). These compounds are mainly used as biocides (disinfectant/cleaning agent) but in some countries also as pesticides (foliar spray, dip application), in certain cases they are also used as co-formulants. On 1 June the first public notification was made by the Danish authorities on Kenyan beans (notification 2012.0756). We expect an increased focus on these substances by the food safety authorities in the coming weeks.

The regulatory status with regard to residues is clear as Regulation (EC) No 396/2005 EU provides the default MRLs of 0,01 ppm for both DDAC and the QAC-family in general. The MRL covers residues caused by pesticides and biocides. As such, fruit and vegetables containing residue levels above 0,01 ppm may not be placed on the market.

The use of QACs as pesticide on fruit and vegetables (and food products in general) in the EU is forbidden. Whilst DDAC is authorized at EU-level (Reg (EU) NO 540/2011), its use is strictly limited to indoor uses on ornamental plants.Even if a request for an import tolerance covering a dip application on citrus fruit has been filed, the lack of toxicological data suggests this process may take considerable time (+/- 2 years).

The use of QACs as biocide in the EU is authorized, even if both ADBAC and DDAC have not been officially included in the EU positive list (Directive 98/8/EC). Indeed Article 16 provides a derogation allowing the placing on the market of products containing existing substances, whilst they are being evaluated under the review programme for existing active substances (List of existing active substances under evaluation).Applications have been filed for several ADBAC-types and DDAC, all of these cover the use as food and feed areas disinfectant.

The use of QACs as co-formulants in pesticides, biocides, biostimulants, … is presently not regulated at EU-level, even if the new EU pesticide legislation will include a review of certain co-formulants. The use of such products according to the label may however not lead to MRL-exceedances.

We'd appreciate an assessment of the use of QACs in your supply chain, if possible with resulting residue levels. Any information would be of great help to decide whether regulatory steps need to be taken and if so, to assess the feasibility of different options in order to remedy the situation in the near future.

Toxicological information is available in the registration reports from the US Environmental Protection Agency: ADBAC, DDAC.

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