L 320/18 Official Journal of the European Union 3.12.2011 COMMISSION REGULATION (EU) No 1259/2011 of 2 December 2011 amending Regulation (EC) No 1881/2006 as regards maximum levels for dioxins, dioxin-like PCBs and non dioxin-like PCBs in foodstuffs (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food ('), and in particular Article 2(3) thereof, Whereas: (1) (") ¢ Commission  Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (?) sets maximum levels for dioxins and dioxin-like PCBs in a range of foodstuffs. Dioxins belong to a group of 75 polychlorinated dibenzo-p-dioxin (PCDD) congeners and 135 polychlor- inated dibenzofuran (PCDF) congeners, of which 17 are of toxicological concern. Polychlorinated biphenyls (PCBs) are a group of 209 different congeners which can be divided into two groups according to their toxi- cological properties: 12 congeners exhibit toxicological properties similar to dioxins and are therefore often referred to as ‘dioxin-like PCBs’ (DL-PCB). The other PCBs do not exhibit dioxin-like toxicity but have a different toxicological profile and are referred to as ‘non dioxin-like PCB’ (NDL-PCB). Each congener of dioxins or DL-PCBs exhibits a different level of toxicity. In order to be able to sum up the toxicity of these different congeners, the concept of toxic equivalency factors (TEFs) was introduced to facilitate risk assessment and regulatory control. As a result the analytical results relating to all the individual dioxin and dioxin-like PCB congeners of toxicological concern are expressed in terms of a quantifiable unit, namely the TCDD toxic equivalent (TEQ). The World Health Organisation (WHO) held an expert workshop on 28 to 30 June 2005 concerning the TEF values, agreed by WHO in 1998. A number of TEF values were changed, notably for PCBs, octachlorinated congeners and pentachlorinated furans. The data on the effect of the new TEF values and the recent occurrence are compiled in the European Food Safety Authority’s 37, 13.2.1993, p. 1. oJ L 0] L 364, 20.12.2006, p. 5. ®) (%) EFSA  Journal 2010; efsajournal/doc/1385.pdf (EFSA) scientific report ‘Results of the monitoring of dioxin levels in food and feed’ (}). Therefore, it is appro- priate to review the maximum levels of PCBs taking into account these new data. The Scientific Panel on Contaminants in the Food Chain of the EFSA on a request from the Commission has adopted an opinion on the presence of NDL-PCBs in feed and food (¥). The sum of the six marker or indicator PCBs (PCB 28, 52,101, 138, 153 and 180) comprises about half of the amount of total NDL-PCB present in feed and food. That sum is considered as an appropriate marker for occurrence and human exposure to NDL-PCB and therefore should be set as a maximum level. Maximum levels have been established taking into account recent occurrence data compiled in the EFSA scientific report Results of the monitoring of non dioxin-like PCBs in food and feed’ (°). Although it is possible to achieve lower limits of quantification (LOQ), it can be observed that a considerable number of labora- tories apply an LOQ of 1 pglkg fat or even 2 pgjkg fat. Expressing the analytical result as an upperbound level would result in some cases in a level close to the maximum level if very strict maximum levels would be established, even if no PCBs have been quantified. It was also acknowledged that for certain food categories the data were not very extensive. Therefore, it would be appropriate to review the maximum levels in 3 years time, based upon a more extensive database obtained with a method of analysis with sufficient sensitivity for quantifying low levels. Derogations have been granted to Finland and Sweden to place on the market fish originating in the Baltic region and intended for consumption in their territory with dioxin levels higher than the maximum levels established for dioxins and the sum of dioxins and DL-PCBs in fish. Those Member States have fulfilled the conditions as regards the provision of information to consumers on dietary recommendations. Every year they communicate to the Commission the results of their monitoring of the levels of dioxins in fish from the Baltic region and the measures to reduce human exposure to dioxins from the Baltic region. 8(3):1385, http:/[www.efsa.europa.eufen| () EFSA Journal (2005) 284, p. 1, http://[www.efsa.europa.cufen/ efsajournal/doc/284.pdf (°) EFSA  Journal 2010; efsajournal/doc/1701.pdf 8(7):1701,  http:/[www.efsa.europa.eufen|