3.12.2011 Official Journal of the European Union L 32015 COMMISSION REGULATION (EU) No 1258/2011 of 2 December 2011 amending Regulation (EC) No 18812006 as regards maximum levels for nitrates 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 () ) L 37, 13.2.1993, p. 6 Commission  Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (?) sets maximum levels for nitrates in certain leafy vegetables. In some cases, despite developments in good agricultural practice, the maximum levels are exceeded and therefore a temporary derogation was granted to certain Member States for the placing on the market of certain leafy vegetables, grown and intended for consumption in their territory with nitrate levels higher than the estab- lished maximum levels. Since the application of the maximum levels of nitrates in lettuce and spinach, many investigations have been performed on the factors involved in the presence of nitrates in lettuce and spinach and on the measures to be taken to reduce the presence of nitrates in lettuce and spinach as much as possible. Despite the progress achieved in the good agricultural practice to reduce the presence of nitrates in lettuce and spinach and a strict application of this good agricultural practice, it is not possible to achieve in a consistent way nitrate levels in lettuce and fresh spinach below the current maximum levels in certain regions of the Union. The reason is that the climate and in particular the light conditions are the main determinant factor in the presence of nitrates in lettuce and spinach. These climate conditions cannot be managed or changed by the producer. To provide an up-to-date scientific basis for the longer- term strategy for managing the risk arising from nitrates in vegetables, a scientific risk assessment by the European Food Safety Authority (EFSA), taking into account new information, was needed. Such assessment had to take into account any relevant considerations on risks and benefits, for example, weighing the possible negative impact of nitrate versus the possible positive effects of eating vegetables, such as antioxidant activities or other 1. L 364, 20.12.2006, p. 5. properties that might in some way counteract or provide a balance to the risks arising from nitrates and the resulting nitroso-compounds. On request of the Commission, the Panel on Contaminants in the Food Chain (the Panel) adopted on 10 April 2008 a Scientific opinion on nitrate in vegetables (). The Panel compared the risk and benefits of exposure to nitrate from vegetables. Overall, the estimated exposures to nitrate from vegetables are unlikely to result in appreciable health risks, therefore, the recognised beneficial effects of consumption of vegetables prevail. The Panel recognised that there are occasional circumstances (e.g. unfavourable localfhome production conditions) for vegetables which constitute a large part of the diet, or individuals with a diet high in vegetables such as rucola which need to be assessed on a case-by-case basis. Following discussion on appropriate measures and concerns expressed as regards possible risks for infants and young children following acute dietary intake exposure, the Commission asked EFSA for a comple- mentary scientific statement on nitrates in vegetables, whereby the possible risks for infants and young children related to the presence of nitrates in fresh vegetables are assessed in more detail, also considering the acute dietary intake, taking into account recent occurrence data on the presence of nitrates in vegetables, more detailed consumption data of vegetables by infants and young children and the possibility of the estab- lishment of slightly higher than the current maximum levels for nitrates in leafy vegetables. The Panel adopted on 1 December 2010 a Statement on possible public health risks for infants and young children from the presence of nitrates in leafy vegetables (). In that statement the Panel concluded that exposure to nitrate at the current or envisaged maximum levels in spinach cooked from fresh spinach is unlikely to be a health concern, although a risk for some infants eating more than one spinach meal per day cannot be excluded. EFSA noted that it did not take into account possible changes of the nitrate content due to processing of the food commodities, such as washing, peeling and/or cooking, as this could not be considered due to lack of (}) Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission to perform a scientific risk assessment on nitrate in vegetables, EFSA Journal (2008), Journal No 689, p. 1. http://www.efsa.europa.cufen/scdocs/doc/689.pdf (*) EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on possible health risks for infants and young children from the presence of nitrates in leafy vegetables. EFSA Journal 2010; 8(12):1935. doi:10.2903/j.efsa.2010.1935. hittp:// www.efsa.europa.eufen/scdocs/doc/1935.pdf