Technical Bulletin: Quaternary Ammonium Compounds Update

The European Commission have proposed to re-set the temporary MRLs for DDAC and BAC to 0.1mg/kg. This proposal will be voted upon by the EU Standing Committee on 12-13th June 2014.

Within the quality controls performed by food business operators and PriF pesticide surveillance programme, residues of didecyldimethylammonium chloride (DDAC) and benzalkonium chloride (BAC) were identified which exceeded the permitted legal limit of 0.01 mg/kg (default MRL established in Article 18(1)(b) of Regulation (E)C No 396/2005).

The source of DDAC and BAC residues in food is not conclusive but is probably linked to the use of these substances in biocidal products and cleaning agents. Since DDAC and BAC were used as pesticides in the past, they fall under the provisions of Regulation (EC) No 396/2005. In 2012 the European Commission and Member States agreed on an enforcement level of 0.5 mg/kg as a proportionate risk management measure on a temporary basis. At the same time a monitoring programme within the EU was set up to enable a better understanding of the source and the magnitude of DDAC and BAC residues in food.

Based on the results of the monitoring data generated by EU Member States, European Commission derived a proposal to set a temporary MRL at the level of 0.1 mg/kg. EFSA was requested to assess in the framework of Article 43 of Regulation (EC) No 396/2005 whether these proposed temporary MRLs for DDAC and BAC are sufficiently protective for consumers.

For the dietary risk assessment EFSA used the ADI and ARfD values derived by the German Bundesinstitut fur Risikobewertung (BfR).

  • ADI for both DDAC and BAC: 0.1 mg/kg bw per day,
  • ARfD for both compounds: 0.1 mg/kg bw

These values are considered as ‘indicative’, since no full toxicological dossiers are available for the compounds. It is noted that in the framework of a previously submitted MRL application an indicative ARfD of 0.61 mg/kg was derived for DDAC.

Based on the analytical data available for DDAC, with the exception of oranges, no long term consumer intakes were identified. A potential acute consumer risk was identified with oranges which showed 132.6% of the tentative ArfD.

No acute consumer risk was identified with BAC.

Conclusion

The European Commission have proposed to re-set the temporary MRLs for DDAC and BAC to 0.1mg/kg. This proposal will be voted upon by the EU Standing Committee on 12-13th June 2014. However, due to the limited information available, the risk assessments for DDAC and BAC are affected by a high degree of uncertainty, in particular related to the lack of detailed information on the toxicological studies, other possible sources of exposure which may contribute to the overall consumer exposure and the lack of information on the nature and magnitude of residues in processed products.

For further information, please contact Scientific Analysis Laboratories on 01954 782791 or npatel@salltd.co.uk
May 2014