Draft Commission Regulation amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the food additives nitrites (E 249-250) and nitrates (E 251-252) (Text with EEA relevance). Language(s): English. Number of pages: 49
The text revises the conditions of use and the EU specifications of the authorised food additives potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251) and potassium nitrate (E 252). Nitrites and nitrates are food additives authorised in the European Union used as a preservative to secure, in conjunction with other factors, the microbiological safety of foods. At the same time, the presence of nitrites and nitrates in foods can give rise to the formation of nitrosamines some of which are carcinogenic. The European Food Safety Authority (EFSA) in its 2017 scientific opinions re-evaluating the safety of nitrites and nitrates as food additives concluded that their respective Acceptable Daily Intake values (ADIs) were not exceeded from food additive uses; however the ADIs would be exceeded if all sources of dietary exposure were to be considered together. In addition, EFSA considered that there was some concern for the overall exposure to nitrosamines present in food, which was also confirmed by the recent scientific opinion on the risks to public health related to the presence of nitrosamines in food (2023).
Following the EFSA re-evaluation of nitrites and nitrates as food additives, it is appropriate to reduce the maximum amounts of nitrites and nitrates that may be added to foods to keep the level of nitrosamines potentially formed due to that use as low as possible, while ensuring microbiological safety. It is also appropriate to amend the specifications and lower the existing maximum permitted limits for lead, mercury and arsenic in nitrites and nitrates additives. In order to allow for a smooth transition, the text lays down transitional periods for food business operators to adapt to the new more stringent conditions of use and specifications.