(1)

Nitrofurans and their metabolites are antimicrobial agents which are prohibited for use in food of animal origin in the Union and therefore nitrofurans are listed in Table 2 of the Annex to Commission Regulation (EU) No 37/2010 (2) on prohibited substances, for which maximum residue limits cannot be established.

(2)

Commission Regulation (EU) 2019/1871 (3) established reference points for action (‘RPA’) for certain non-allowed pharmacologically active substances present in food of animal origin, for which no maximum residue limits have been laid down. From 28 November 2022, a reference point of action of 0,5 μg/kg shall be applied for nitrofurans and their metabolites.

(3)

Based on the opinion of the European Food Safety Authority (4), semicarbazide (‘SEM’), a metabolite of the nitrofuran nitrofurazone, can be present in food either as a metabolite occurring due to illegal treatment with nitrofurazone or as a metabolite produced during food processing, arising from the use of disinfecting agents or from reactions of various food components. Therefore, the presence of SEM cannot be considered as an unequivocal marker of abuse of nitrofurazone during animal products production.

(4)

Based on data provided by industry and available occurrence data (5), higher levels of SEM can be found in gelatine, collagen hydrolysate, hydrolysed cartilage products, spray dried blood products, whey and milk protein concentrates, caseinates and milk powder as a result of high temperature processing, even when no treatment with nitrofurans has been applied to those processed products.

(5)

Therefore, as an exception, the RPA for SEM should not be applied for gelatine, collagen hydrolysate, hydrolysed cartilage products, spray dried blood products, whey and milk protein concentrates, caseinates and milk powder unless other nitrofurans or their metabolites are found together with SEM in those processed products.

(6)

Infants and young children are vulnerable group of consumers. Bearing in mind that their diet consists in particular of milk-powdered food, that exemption should not apply to infant formulae and follow-on formulae.

(7)

In order to enable the Commission to establish specific regulatory measures as regards the presence of SEM in gelatine, collagen hydrolysate, hydrolysed cartilage products, spray dried blood products, whey and milk protein concentrates, caseinates and milk powder, food business operators and other interested parties should provide within a defined time period necessary data and information on investigations on the parameters and factors in the processing steps resulting in the formation of SEM during processing in those processed products. Food business operators should also take measures to reduce the presence of SEM in these products at levels as low as reasonably achievable. In the absence of those data and information, the exemption can no longer be maintained.

(8)

Regulation (EU) 2019/1871 should be amended accordingly.

(9)

The reference point of action at level 0,5 μg/kg for nitrofurans and their metabolites applies as from 28 November 2022. In order to avoid unnecessary withdrawals from the market of the processed products concerned with SEM content at the level above the RPA because of wrong assumption of illegal use of nitrofurans, it is necessary to apply the exemption retroactively from the same date.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,