COMMI SSION REGUL ATION (EU) 2023/411 
of 23 Febr uary 2023
amending Regulation (EU) 2019/1871 as regards the application of reference points for action for 
nitrofurans and their metabolites 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down 
Community procedures for the establishment of residue limits of phar macologically active substances in foodstuffs of 
animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in 
particular Article 18 thereof,
Whereas:
(1) Nitrofurans and their metabolites are antimicrobial agents which are prohibited for use in food of animal origin in 
the Union and theref ore nitrofurans are listed in Table 2 of the Annex to Commission Regulation (EU) 
No 37/2010 (2)on prohibit ed substances, for which maximum residue limits cannot be established.
(2) Commission Regulation (EU) 2019/1871 (3)established referen ce points for action (‘RPA’) for certain non-allowe d 
phar macologically active substances present in food of animal origin, for whic h 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 Author ity(4), semicarbazide (‘SEM’), a metabolite of the nitrofuran 
nitrofurazone, can be present in food either as a metabolite occur ring due to illegal treatment with nitrofurazone or 
as a metabolite produced during food processing, arising from the use of disinf ecting agents or from reactions of 
various food compo nents. Theref ore, the presence of SEM cannot be considered as an unequivocal mark er of abuse 
of nitrofurazone during animal products production.
(4) Based on data provid ed by industr y and available occur rence data (5), higher levels of SEM can be found in gelatine, 
collagen hydrolysate , hydrolysed cartilage products, spra y dried blood products, whey and milk protein 
concentrat es, 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) Theref ore, as an excep tion, the RPA for SEM should not be applied for gelatine, collagen hydrolysat e, hydrolysed 
cartilage products, spra y dried blood products, whe y and milk protein concentrat es, caseinat es and milk powder 
unless other nitrofurans or their metabolites are found together with SEM in those processed products.
(1)OJ L 152, 16.6.2009, p. 11.
(2)Commission Regulation (EU) No 37/2010 of 22 December 2009 on phar macologically active substances and their classif ication 
regar ding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
(3)Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed phar macologically 
active substances present in food of animal origin and repealing Decision 2005/34/EC (OJ L 289, 8.11.2019, p. 41).
(4)EFSA (European Food Safety Autho rity), O’Keeffe M, Christodoulidou A and Nebbia C, 2021. Scientific repor t on the presence of 
nitrofurans and their metabolites in gelatine. EFSA Journal 2021;19(10):6881, 22 pp, https://doi.org/10.2903/j.efsa.2021.6881 .
(5)Richard H. Stadler et al. 2015. Why semicarbazide (SEM) is not an appropr iate marker for the usag e of nitrofurazone on agricultural 
animals. Food Additives & Contaminants: Part A, Vol. 32, No 11, p. 1842–1850, http://dx.doi.org/10.1080/ 
19440049.2015.1086028EN Offi cial Jour nal of the European Union L 59/8 24.2.2023  (6) Infants and young children are vulnerable group of consumers. Bear ing in mind that their diet consists in particular 
of milk -powdered food, that exem ption should not apply to infant formulae and follow-on formulae.
(7) In order to enable the Commission to establish specific regulatory measures as regar ds the presence of SEM in 
gelatine, collagen hydrolysate , hydrolysed cartilage products, spra y dried blood products, whe y and milk protein 
concentrat es, caseinat es and milk powder , food business operators and other interest ed parties should provide 
within a defined time period necessar y data and information on inve stigations on the parameters and factors in the 
processing steps resulting in the formation of SEM during processing in those processed products. Food business 
operat ors should also take measures to reduce the presence of SEM in these products at levels as low as reasonably 
achi evable. In the absence of those data and information, the exem ption can no long er be maintained.
(8) Regulation (EU) 2019/1871 should be amended according ly.
(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 unnecessar y withdra wals from the market of the processed products concer ned with SEM 
conte nt at the level abov e the RPA because of wrong assum ption of illegal use of nitrofurans, it is necessar y to apply 
the exem ption retroactively from the same date.
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
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 followi ng that of its publication in the Official Journal of the 
European Union.
It shall apply from 28 November 2022 .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 Febr uary 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 24.2.2023 L 59/9  ANNEX 
The Annex to Regulation (EU) 2019/1871 is replaced by the following:
‘ANNEX
Refe rence points for action (RPA) 
SubstanceRPA
(μg/kg)Other provisions
Chloramphe nicol 0,15
Malac hite green 0,5 0,5 μg/kg for the sum of malachi te green and leucomalachit e 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-o xazolidinone), furaltadone (AMOZ or 3-amino- 
5-methyl mor pholino-2-o xazolidinone), nitrofurantoi n (AHD or 
1-aminohydan toin), nitrofurazone (SEM or semicarbazide) and 
nifursol (DNSH or 3,5-dinitrosalicylic acid hydrazide )
(1)Due to the natural occur rence 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 detect ed.
(2)Due to the occur rence of SEM at levels above the RPA as the consequence of processing in gelatine, collagen hydrolysate, hydrolysed 
cartilage products, spra y dried blood products, whey and milk prot ein 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 cartilag e products, 
spra y dried blood products, whey and milk prot ein concentrates, caseinates and milk pow der (excl uding 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 detect ed.
Food business operat ors and other interes ted parties shall communicate by 1 March 2024 to the Commission the results of 
investig ations on the paramet ers and factors in the processing steps resulting in the formation of SEM in gelatine, collag en hydrolysat e, 
hydrolysed cartilage products, spra y dried blood products, whey and milk prot ein concentrates, caseinates and milk powder (excluding 
infant formulae and follo w-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 satisfact ory data and information, measures shall 
be taken to end this exem ption.’EN Offi cial Jour nal of the European Union L 59/10 24.2.2023