Commission Regulation (EU) 2023/411 of 23 February 2023 amending Regulation (EU) 2019/1871 as regards the application of reference points for action for nitrofurans and their metabolites (Text with EEA relevance)

• CELEX: Regulation (EU) 2023/411
• Articles: 3

Article 1

The Annex to Regulation (EU) 2019/1871 is amended in accordance with the Annex to this Regulation.

Article 2

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

It shall apply from 28 November 2022.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Regulation (EU) 2019/1871 is replaced by the following:

‘ANNEX

Reference points for action (RPA)

Substance

RPA

(μg/kg)

Other provisions

Chloramphenicol

0,15

Malachite green

0,5

0,5 μg/kg for the sum of malachite green and leucomalachite green

Nitrofurans and their metabolites

0,5  ( 1 )

( 2 )

0,5 μg/kg for each of the metabolites of furazolidone (AOZ or 3-amino-2-oxazolidinone), furaltadone (AMOZ or 3-amino-5-methylmorpholino-2-oxazolidinone), nitrofurantoin (AHD or 1-aminohydantoin), nitrofurazone (SEM or semicarbazide) and nifursol (DNSH or 3,5-dinitrosalicylic acid hydrazide)

( 1 )   Due to the natural occurrence of SEM in crayfish at levels above the RPA, only levels of AOZ, AMOZ, AHD and DNSH above the RPA are a clear indication of the illegal use of nitrofurans and their metabolites. The RPA of 0,5 μg/kg for SEM in crayfish shall only be applied when the illegal use of nitrofurazone or SEM on crayfish has been established, i.e. at least one of the other nitrofuran metabolites has been detected.

( 2 )   Due to the occurrence of SEM at levels above the RPA as the consequence of processing in gelatine, collagen hydrolysate, hydrolysed cartilage products, spray dried blood products, whey and milk protein concentrates, caseinates and milk powder (excluding infant formulae and follow-on formulae) only levels of AOZ, AMOZ, AHD and DNSH above the RPA are a clear indication of the illegal use of nitrofurans and their metabolites. The RPA of 0,5 μg/kg for SEM in gelatine, collagen hydrolysate, hydrolysed cartilage products, spray dried blood products, whey and milk protein concentrates, caseinates and milk powder (excluding infant formulae and follow-on formulae) shall only be applied, when the illegal use of nitrofurazone or SEM has been established, i.e. at least one of the other nitrofuran metabolites has been detected.

Food business operators and other interested parties shall communicate by 1 March 2024 to the Commission the results of investigations on the parameters and factors in the processing steps resulting in the formation of SEM in gelatine, collagen hydrolysate, hydrolysed cartilage products, spray dried blood products, whey and milk protein concentrates, caseinates and milk powder (excluding infant formulae and follow-on formulae) during processing. They shall also communicate the measures taken to ensure that the levels of SEM in these products are kept as low as reasonably achievable. In the absence of satisfactory data and information, measures shall be taken to end this exemption.’