COMMI SSION REGUL ATION (EU) 2019/1871 
of 7 November 2019 
on reference points for action for non-allo wed phar macologically activ e subst ances present in food 
of animal origin and repealing Decision 2005/34/EC 
(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 Articles 18, 19(3) and 24(4) thereof, 
Whereas: 
(1) Where necessar y for the purpose of official controls of food of animal origin, the Commission may establish 
referen ce values (‘refe rence points for action’) for residues of phar macologically active substances in food of animal 
origin, for which no maximum residue limit has been laid down. Reference points for action should apply to food 
of animal origin impor ted from third countr ies and to food of animal origin produced in the Union. 
(2) Following a request from the Commission, the EFSA Panel on Contaminants in the Food Chain (EFSA CONT AM 
Panel) has adopt ed guidance on methodological principles and scientifi c methods to be taken into account when 
assessing the safety of reference points for action (‘EFSA guidance’) (2). EFSA guidance descr ibes a process for 
assessing whether the analytical concentration of a phar macologically active substance, which can be deter mined by 
official control laboratories using a validated analytical method, is low enough to adequate ly prot ect human health. 
(3) EFSA guidance further specifi es situations, in whic h a substance-specifi c risk assessment should be under taken by 
EFSA in accordance with Regulation (EC) No 470/2009. In particular , in order to ensure an adequat e level of health 
prote ction, substance-specific risk assessments should be performed for phar macologically active substances, whic h 
cause blood dyscrasias (aplastic anaemia) or allergy (excluding skin sensitisation) or whic h are high poten cy 
carcinog ens or inorg anic substances. 
(4) Methodological principles and scientific methods for assessing the safety of reference points for action should 
theref ore be adopt ed. 
(5) Commission Decision 2002/657/EC (3) lays down the minimum required performa nce limits of analytical methods 
used for detecting a limite d number of substances, for whic h the use is not allowed, or is specifi cally prohibited in 
the Union. Those minimum required performa nce limits correspond to the average limit above whic h the detection 
of a substance or its residues can be considered as methodologically meaningful. The minimum required 
performa nce limits apply to the matr ixes specifi ed in Annex II to that Decision. 
(1)OJ L 152, 16.6.2009, p. 11. 
(2)Updated guidance on methodological principles and scientif ic methods to be taken into account when establishing Reference Points for 
Action (RPAs) for non-allowed phar macologically active substances present in food of animal origin. EFSA Journal 2018;16(7):5332. 
(3)Commission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC concer ning the perfor mance of 
analytical methods and the interpretation of results (OJ L 221, 17.8.2002, p. 8). EN Offi cial Jour nal of the European Union 8.11.2019                                                                                                                                         L 289/41   (6) Pursuant to Commission Decision 2005/34/EC (4), the minimum required performa nce limits laid down in Decision 
2002/657/EC are to be used as reference points for action irrespective of the food matr ix tested for food of animal 
origin, imported from third countr ies. Food of animal origin, containing residues of a phar macologically active 
substance in a concentration at or abov e the referen ce point for action, is to be considered not to compl y with 
Union legislation, while food of animal origin containing concentrations below the reference points for action are 
not to be prohibit ed from entering the food chain. However , the setting of reference points for action should in no 
way serve as a pretext for condoning the illegal use of prohibit ed or non-allowed substances. Theref ore any residues 
of those substances in food of animal origin should be considered undesirable. The reference points for action laid 
down in Decision 2005/34/EC have been based solely on analytical considerations, taking into account the lowest 
residue concentration, whic h can be detected and conf irmed with a validated analytical method, without 
consideration of the toxic poten tial of the substances in question. 
(7) For chloramphenicol, malach ite green and nitrofuran metabolites reference points for action have been laid down in 
Decision 2005/34/EC. For these substances, however , EFSA concluded that followi ng EFSA guidance instead of the 
standard risk assessment methodology a substance-specific risk assessment was needed. Theref ore, follo wing the 
request of the Commission, the EFSA CONT AM Panel adop ted scientifi c opinions on chloram phenicol in food and 
feed (5), on nitrofurans and their metabolite s in food (6) and on malachit e green in food (7). 
(8) It is theref ore appropr iate to lay down referen ce points for action for these substances, which take into account both 
the analytical considerations and the toxic pote ntial of these substances. In view of the uncer tainties, which EFSA 
identif ied in its risk assessments for chloramph enicol and the nitrofuran metabolites , the sensitivity of analytical 
methods should be improved, in order to enable enforcement of the lowe st possible concentrations. 
(9) Detection of residues of prohibit ed or non-allowe d substances, even below established reference points for action, 
could be a signal of misuse of such substances. In such cases Regulation (EC) No 470/2009 requires Member States 
and, as appropr iate, the Commission, to take follo w-up measures. To this end, information should be available to 
the Member States and the Commission through the Rapid Aler t Syste m for Food and Feed (8). 
(10) In order to allow official laboratori es to adap t their methods to the updated reference points for action for 
chloramphenicol, malachi te green and nitrofuran metabolit es, a period of three years should be allowed to elapse 
before these lowered reference points for action become applicable. 
(11) As this Regulation takes over the provisions of Decision 2005/34/EC, updat es and further expands them, for reasons 
of legal certainty Decision 2005/34/EC should be repealed. 
(12) 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 
Scope 
This Regulation lays down: 
(a) rules for the establishment of reference points for action for residues of phar macologically actives substances, for whic h 
no maximum residue limit has been laid down in accordance with Regulation (EC) No 470/2009; 
(4)Commission Decision 2005/34/EC of 11 Januar y 2005 laying down harmonised standards for the testing for certain residues in 
products of animal origin impo rted from third countr ies (OJ L 16, 20.1.2005, p. 61). 
(5)EFSA CONT AM Panel (EFSA Panel on Contaminants in the Food Chain), 2014. Scientific Opinion on Chloramphen icol in food and 
feed . EFSA Journal 2014;12(11):3907, 145 pp. doi:10.2903/j.efsa.2014.3907. 
(6)EFSA CONT AM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. Scientific Opinion on nitrofurans and their metabolites 
in food. EFSA Journal 2015;13(6):4140, 217 pp. doi:10.2903/j.efsa.2015.4140. 
(7)EFSA CONT AM Panel (EFSA Panel on Contaminants in the Food Chain), 2016. Scientific Opinion on malachit e green in food. EFSA 
Journal 2016;14(7):4530, 80 pp. doi:10.2903/j.efsa.2016.4530. 
(8)Commission Regulation (EU) No 16/2011 of 10 Januar y 2011, laying down implementing measures for the Rap id alert system for 
food and feed (OJ L 6, 11.1.2011, p. 7). EN Offi cial Jour nal of the European Union L 289/42                                                                                                                                         8.11.2019   (b) methodological principles and scientific methods for the risk assessment of the safety of reference points for action; 
(c) reference points for action for residues from certain phar macologically active substances for whic h no maximum 
residue limit has been laid down in accordance with Regulation (EC) No 470/2009; 
(d) specifi c rules on action to be taken in the case of a conf irmed presence of a residue of a prohibited or non-allowe d 
substance at levels above, equal to or below the reference point for action. 
Article 2 
Rules for the establishment of reference points for action 
Reference points for action shall be set at the lowest level which can analytically be achi eved by the official control 
laboratories, designate d in accordance with Article 37 of Regulation (EU) 2017/625 of the European Parliament and of the 
Council (9). 
Reference points for action shall be regularly reviewed to ensure that they correspond to the lowe st levels, which are 
achi evable, taking into account the most recent scientifi c developments. 
When setting or reviewing reference points for action, the Commission shall consult the relevant European Reference 
Laboratori es on the analytical capabilities of National Reference Laboratories and official laboratori es, as regar ds the lowe st 
residue concentration, which can be identified with an analytical method, validat ed in accordance with the requirements of 
Decision 2002/657/EC. 
Article 3 
Methodological principles and scientif ic methods of risk assessment 
1. The risk assessment applied for the assessment of the safety of reference points for action shall take into account: 
(a) the toxic poten tial and phar macological activity of the substance; 
(b) intake of the residue via food. 
2. For the purpose of deter mining the toxic poten tial and phar macological activity of the substance, the followi ng 
toxicological screening values shall be applied: 
(a) for Group I substances, corresponding to non-allowe d phar macologically active substances for which there is direct 
evidence of genoto xicity or for whic h there is an alert for genot oxicity (from structure activity relationships or read 
across) or for which there is a lack of information on genot oxicity , and hence genoto xicity cannot be excl uded 0,0025 
μg/kg body weight (b.w .) per day; 
(b) for Group II substances, corresponding to non-allowe d phar macologically active substances with phar macological 
activity on the nervous system or the reproductive system , or that are corticoids 0,0042 µg/kg b.w. per day; 
(c) for Group III substances, corresponding to non-allo wed phar macologically active substances with anti-infecti ous, anti- 
inflammatory and antiparasitic effect and other phar macologically active agents 0,22 µg/kg b.w. per day. 
3. The relevant food intake shall be determined based on food consump tion figures, food consump tion patter ns and the 
occur rence of the substance in diffe rent food commodities. 
(9)Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official 
activities perfor med to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant 
prot ection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 
1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council 
Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 
2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, 
Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 
92/438/EEC (Offic ial Controls Regulation) (OJ L 95, 7.4.2017, p. 1). EN Offi cial Jour nal of the European Union 8.11.2019                                                                                                                                         L 289/43   4. The safety of reference points for action shall be assessed, by verifying whether the toxicological screening value, 
divided by the relevant food intak e, is higher than or equal to the analytical capability of the official control laboratories, in 
which case the safety of the reference point for action at the analytical capability level is guaranteed. 
Article 4 
Subst ance-specif ic risk assessment 
1. A request shall be addressed to EFSA for a substance-specifi c risk assessment as to whether referen ce points for action 
are adequate to prote ct human health, in particular for substances: 
(a) that cause blood dyscrasias or allergy (excluding skin sensitisation); 
(b) that are high potency carcinog ens; 
(c) for whic h genoto xicity cannot be excluded, if there is exper imental or other evidence that the use of the toxicological 
screening value of 0,0025 μg/kg b.w. per day may not be adequat ely health protective. 
2. The Commission shall, where appropr iate, submit a request to EFSA for a substance-specifi c risk assessment as to 
whether a referen ce point for action is adequate to protect human health, where application of the method laid down in 
Article 3(4) indicates that the toxicological screening value, divided by the relevant food intak e, is lower than the analytical 
capability of the offici al control laborat ories, and that there is little or no possibility of signif icant impro vement in the 
analytical capability within a shor t to medium time frame. 
3. Where the substance specific risk assessment is inconclusive, due to uncer tainties regarding certain aspects of the 
toxicological or exposure assessment, and no guarant ees are available on whether the lowest analytically achievable 
concentration is suffic iently safe for consumers, the European and National Reference Laboratori es shall endeav our to 
imp rove the sensitivity of analytical methods in order to be able to enforce lower concentrations and the referen ce points 
for action shall be set at levels which are low enough to stimulate improvement of the lowe st achi evable levels. 
Article 5 
Enforcement of reference points for action 
For the purpose of control in food of animal origin of some residues of substances, whose use is prohibit ed or not allowe d 
in the Union, the reference points for action, laid down in the Annex, shall apply irrespective of the food matr ix tested. 
Food of animal origin, containing residues of a phar macologically active substance in a concentration at or abov e the 
referen ce point for action, shall be considered not to compl y with Union legislation and shall not enter the food chain. 
Food of animal origin containing residues of a phar macologically active substance in a concentration at a level below the 
referen ce point for action shall not be prohibited from entering the food chain. 
Article 6 
Informa tion exchange and investigations in case of conf irmed presence of a prohibited or non-allo wed subst ance 
Where the results of official controls, including analytical tests, identify residues of prohibit ed or non-allo wed substances at 
levels abov e, equal to or below the reference points for action, the compet ent author ity shall carry out the investigations 
refer red to in Articles 137(2) or (3) of Regulation (EU) 2017/625 and Articles 13, 16(2), 17 and 22 to 24 of Directive 
96/23/EC (10), to deter mine whether there has been illegal treatment with a prohibited or non-allo wed phar macologically 
active substance. 
(10)Council Directive 96/23/EC of 29 Apr il 1996 on measures to monitor certain substances and residues thereof in live animals and 
animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 
23.5.1996, p. 10). EN Offi cial Jour nal of the European Union L 289/44                                                                                                                                         8.11.2019   In the event of established non-comp liance, the compet ent author ity shall take one or more actions refer red to in Article 
138 of Regulation (EU) 2017/625 and Articles 15(3), 17 and 23 to 25 of Directive 96/23/EC. 
The compet ent author ity shall retain a record of the find ings. Where the results of official controls, including analytical tests 
on foods of animal origin from the same operat or, show a recur rent patt ern pointing to suspicion of non-compliance 
relat ed to one or several prohibit ed or non-allowed substances from a particular origin, the compe tent author ity shall 
inform the Commission and the other Member States in the Standing Committee on Plants, Animals, Food and Feed. 
Where the recur rent patter n concer ns imported food, the Commission shall bring this to the attenti on of the compet ent 
author ity of the countr y or countr ies of origin. 
Member State s shall repor t the results of official controls, including analytical tests, showi ng confir med presence of a 
prohibit ed or non-allo wed substance at levels abov e or equal to the reference points for action through the Rapid Aler t 
System for Food and Feed. 
Article 7 
Repeal of Decision 2005/34/EC 
Decision 2005/34/EC is repealed. 
Article 8 
Application of the reference points for action 
The reference points for action, set out in the Annex to this Regulation shall apply from 28 November 2022. 
Until the date laid down in the first paragraph the minimum required performa nce limits for chloramp henicol, nitrofuran 
metabolites and the sum of malachi te green and leucomalachit e green, included in Annex II to Decision 2002/657/EC, 
shall apply as reference points for action for food of animal origin impor ted from third countr ies and for food of animal 
origin produced in the Union. 
Article 9 
Entr y into force 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 7 November 2019.  
For the Commission 
The President 
Jean-Claude JUNCKER     EN Offi cial Jour nal of the European Union 8.11.2019                                                                                                                                         L 289/45   ANNEX 
Refe rence points for action (RPA)                                                                
Substance RPA 
(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 leucomalachi te green 
Nitrofurans and their metabo­
lites 0,5 (1) 0,5 µg/kg for each of the metabolites of furazolidone (AOZ or 3-amino-2- 
oxazolidinone), furaltadone (AMOZ or 3-amino-5-methylmor pholino-2- 
oxazolidinone), nitrofurant oin (AHD or 1-aminohydant oin), 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 on crayfish has been established.   EN Offi cial Jour nal of the European Union L 289/46                                                                                                                                         8.11.2019