23.10.2014 Official Journal of the European Union L 304/43 COMMISSION REGULATION (EU) No 1119/2014 of 16 October 2014 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benzalkonium chloride and didecyldimethylammo- nium chloride in or on certain products (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (*), and in particular Article 14(1)(a) and Article 16(1)(a) thereof, Whereas: (1)  Up to now, no specific maximum residue levels (MRLs) have been set for benzalkonium chloride (BAC) and dide- cyldimethylammonium chloride (DDAC) and those substances have not been included in Annex IV to Regulation (EC) No 396/2005. (2)  BAC is not an approved active substance in plant protection products under Regulation (EC) No 1107/2009 of the European Parliament and of the Council (3). DDAC was approved as an active substance in plant protection products for use on ornamental crops, but all authorisations for plant protection products containing DDAC have been revoked following the withdrawal of the approval (). Both substances are used as biocides for disinfec- tion. That use may lead to detectable residues in food. (3)  The Commission received information from Member States and business operators showing the presence of BAC and DDAC in or on certain products leading to higher residues than the default MRL of 0,01 mg/kg laid down in Regulation (EC) No 396/2005. (4)  The European Food Safety Authority, hereinafter ‘the Authority’, collected monitoring data in 2012 and 2013 to investigate the presence of residues of BAC and DDAC in food. Those data were generated by Member States and food business operators and showed that those substances are present at levels that vary depending on the source and product, but that the levels frequently exceed the default MRL of 0,01 mg/kg. These findings provide evidence of the unavoidable presence of BAC and DDAC in or on certain products. (5)  The Authority provided a technical report on the statistical evaluation of the collected data (*). It assessed whether the temporary MRLs proposed by the Commission services sufficiently protect consumers as regards their possible exposure to residues due to the use in biocidal products and gave a reasoned opinion on the proposed MRLs (). It forwarded the report and the opinion to the Commission and the Member States and made them available to the public. (6)  The Authority concluded in its reasoned opinion that while the risk assessment is affected by a high degree of uncertainties due to the limited information available, the proposed temporary MRLs are expected to sufficiently protect consumers. The Authority took into account the health assessments performed by the German () OJL70,16.3.2005, p. 1. (*) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). (®) Commission Implementing Regulation (EU) No 175/2013 of 27 February 2013 amending Implementing Regulation (EU) No 540/2011 as regards the withdrawal of the approval of the active substance didecyldimethylammonium chloride (O] L 56, 28.2.2013, p. 4). (*) European Food Safety Authority; Evaluation of monitoring data on residues of didecyldimethylammonium chloride (DDAC) and benzalkonium chloride (BAC). EFSA supporting publication 2013:EN-483, 30 pp. (°) European Food Safety Authority; Reasoned opinion on the dietary risk assessment for proposed temporary maximum residue levels (MRLs) of didecyldimethylammonium chloride (DDAC) and benzalkonium chloride (BAC). EFSA Journal 2014;12(4):3675, 23 pp.