Fishery products: changes to levels for nitrates

13 OCTOBER 2023

The Commission published a Regulation (EU) 2023/2108 amending Annex II to Regulation (EC) No 1333/2008 and the Annex to Commission Regulation (EU) No 231/2012 as regards food additives nitrites (E 249-250) and nitrates (E 251-252). Potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251) and potassium nitrate (E 252) are substances authorised in accordance with Annex II of Regulation (EC) No 1333/2008. They have been used for many decades as a preservative to secure, in conjunction with other factors, the preservation and microbiological safety of fish products, and to contribute to their characteristic organoleptic properties. However, at the same time, it is recognised that the presence of nitrites and nitrates in foods can give rise to the formation of nitrosamines, some of which are carcinogenic. Therefore, there is a need to minimise the risk of formation of nitrosamines through the presence of nitrites and nitrates in foods, on the one hand, and maintain their protective effects against the multiplication of bacteria, in particular of C. botulinum, responsible for botulism, on the other hand.

EFSA concluded that there are risks to public health related to the presence of nitrosamines in food on 28 March 2023, and that the Margin of Exposure for carcinogenic nitrosamines occurring in food is highly likely to be less than 10 000 at the high exposure for all age groups, which may indicate a health concern. Given the re-evaluation of nitrites and nitrates as food additives by EFSA, it is also appropriate to lower the existing maximum limits for the presence of lead, mercury and arsenic in nitrites (E 249 and E 250) and nitrates (E 251 and E 252), laid down in the Union specifications.

Category 09.2 (Processed fish and fishery products including molluscs and crustaceans) is amended as follows:

the entry for E 251–252 (Nitrates) is replaced by the following:
‘E 251–252 Nitrates, 500,   only pickled herring and sprat Period of application: until 9 October 2025
E 251–252 Nitrates, 270, (XA) (XD),  only pickled herring and sprat Period of application: from 9 October 2025’;

(ii) the following footnotes are added:

‘(XA): The maximum amount that may be added during the manufacturing expressed as NO3 ion.

(XD): The maximum residual amount from all sources for the product ready for marketing throughout the shelf-life of the product shall not exceed 45 mg/kg expressed as NO2 ion.’.

‘E 249 potassium nitrite’, the specification ‘Purity’ is replaced by the following:
‘Purity
Loss on drying Not more than 3 % (4 hours, over silica gel)
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg’;
 
  ‘E 250 sodium nitrite’, the specification ‘Purity’ is replaced by the following:
‘Purity
Loss on drying Not more than 0,25 % (4 hours, over silica gel)
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg’;
  ‘E 251 sodium nitrate’, part ‘(i) solid sodium nitrate’, the specification ‘Purity’ is replaced by the following:
‘Purity
Loss on drying Not more than 2 % (105 °C, 4 hours)
Nitrites Not more than 30 mg/kg expressed as NaNO2
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg’;
  ‘E 251 sodium nitrate’, part ‘(ii) liquid sodium nitrate’, the specification ‘Purity’ is replaced by the following:
‘Purity
Free nitric acid Not more than 0,01 %
Nitrites Not more than 10 mg/kg expressed as NaNO2
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg’;
   
  ‘E 252 potassium nitrate’, the specification ‘Purity’ is replaced by the following:
‘Purity
Loss on drying Not more than 1 % (105 °C, 4 hours)
Nitrites Not more than 20 mg/kg expressed as KNO2
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg’.

Foods not complying with the provisions laid down in Annex I applicable from the respective date indicated therein that have been lawfully placed on the market before the respective date of application may continue to be marketed until their date of minimum durability or ‘use-by’ date.

The food additives potassium nitrite (E 249) and/or sodium nitrite (E 250) and/or sodium nitrate (E 251) and/or potassium nitrate (E 252) that have been lawfully placed on the market before 29 October 2023 and that do not comply with the maximum limits for lead, mercury and arsenic laid down in Annex II applicable from 29 October 2023 may be added to food in accordance with Annexes II and III of Regulation (EC) No 1333/2008 until 29 April 2024.

Foods containing the food additives potassium nitrite (E 249) and/or sodium nitrite (E 250) and/or sodium nitrate (E 251) and/or potassium nitrate (E 252) that have been lawfully placed on the market before 29 October 2023 and that do not comply with the maximum limits for lead, mercury and arsenic laid down in Annex II applicable from 29 October 2023 may continue to be placed on the market until 29 April 2024 and may continue to be marketed until their date of minimum durability or ‘use-by date’.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union (published 09.10.2023).

More information: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202302108

Contact: ksaari@frucom.eu

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