EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10413/2015 
(POOL/E2/2015/10413/10413 -EN.doc)  
D061419/02  
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
on reference points for action for non -allowed pharmacologically active substances 
present in food of animal origin and repealing Decision 2005/34/EC  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
on reference points for action for non -allowed pharmacologically active substances 
present in food of animal origin and repealing Decision 2005/34/EC  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard 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 pharmacologically active substances in foodstuffs of animal origin, repealing 
Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the Eur opean 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament 
and of the Council1, and in particular Articles 18, 19(3) and 24(4) thereof,  
Whereas:  
(1) Where necessary for the purpose of official controls of food of animal orig in, the 
Commission may establish reference values (‘reference points for action’) for residues 
of pharmacologically 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 imported from third countries and to food of animal origin 
produced in the U nion. 
(2) Following a  request from the Commission, the EFSA Panel on Contaminants in the 
Food Chain ( EFSA CONTAM Panel) has adopted guidance on methodological 
principles and scientific methods to be taken into account when assessing the safety of 
reference points for action  (‘EFSA guidance’)2. EFSA  guidance describes a process 
for assessing whether the analytical concentration of a  pharmacologically active 
subst ance, which can be determined by official control laboratories using a validated 
analytical method, is low enough to adequately protect human health.  
(3) EFSA guidance further specifies situations, in which a substance -specific risk 
assessment should be undert aken by EFSA  in accordance with Regulation (EC) 
No 470/2009 . In particular, in order to ensure an adequate level of health protection, 
substance -specific risk assessments should be performed for pharmacologically active 
substances, which caus e blood dyscrasias (aplastic an aemia ) or allergy (excluding skin 
sensitisation) or which are high potency carcinogens or inorganic substances . 
(4) Methodological principles and scientific methods for assessing the safety of reference 
points for action should therefore  be adopted.  
                                                 
1 OJ L 152, 16.6.2009, p. 11.  
2 Updated g uidance on methodological principles and scientific methods to be taken into account when 
establishing Reference Points for Action (RPAs) for non -allowed pharmacologically active substances 
present in food of animal origin. EFSA Journal 201 8;16(7):5332 .  
EN 2  EN (5) Commission Decision 2002/657/EC3 lays down the minimum req uired performance 
limits  of analytical methods used for detecting a limited number of substances, for 
which the use is not allowed , or is specifically prohibited in the Union. Those 
minimum req uired performance limits  correspond to the average limit above which the 
detection of a substance or its residues can be considered as methodologically 
meaningful. The minimum req uired performance limits  apply to the matrixe s specified 
in Annex II  to that D ecision.  
(6) Pursuant to Commission Decision 2005/34/EC4, the minimum req uired performance 
limits  laid down in Decision 2002/657/EC are to be used as reference points for action 
irrespective of the food matrix tested for food of animal origin , import ed from third 
countries. Food of animal origin, containing residues of a pharmacologically active 
substance in a concentration at or above the reference point for action, is to be 
considered not to comply with Union legislation, while food of animal origin  
containing concentrations below the reference points for action are not to be prohibited 
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 prohibited or  
unauthorised substances. Therefore 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, which can be detected and confirmed with a 
validated analytical method, without consideration of the toxic potential of the 
substances in question.  
(7) For chloramphenicol,  malachite green and nitrofuran metabolites reference points for 
action have been laid  down in Decision 2005/34/EC. For these substances , however , 
EFSA  concluded that following  EFSA guidance instead of the standard risk 
assessment methodology a substance -specific risk assessment was needed. Therefore,  
following the request of the Commission, the EFSA CONTAM Panel adopted 
scientific opinions on chloramphenicol in food and feed5, on nitrofurans and their 
metabolites in food6 and on malachite green in food7. 
(8) It is therefore appropriate to lay down referen ce points for action for these substances, 
which take into account both the analytical considerations and the toxic potential of 
these substances. In view of the uncertainties, which EFSA identified in its risk 
assessments for chloramphenicol and the nitro furan metabolites, the sensitivity of 
analytical methods  should be improved , in order to enable enforcement of the lowest  
possible concentrations.  
                                                 
3 Commission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC 
concerning the performance of analytical methods and the interpretation of results  (OJ L 221, 
17.8.2002, p.  8). 
4 Commission Decision 2005/ 34/EC of 11 January 2005 laying down harmonised standards for the 
testing for certain residues in products of animal origin imported from third countries (OJ L 16, 
20.1.2005, p. 61).  
5 EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2014. Scientific Opinion on 
Chloramphenicol in food and feed. EFSA Journal 2014;12(11):3907, 145 pp. 
doi:10.2903/j.efsa.20 14.3907 . 
6 EFSA CONTAM 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 CONTAMPanel (EFSA Panel on Contaminants in the Food Chain), 2016. Scientific  Opinion on  
malachite green in food. EFSA Journal 2016;14(7):4530, 80 pp. doi:10.2903/j.efsa.2016.4530 .  
EN 3  EN (9) Detection of residues of prohibited or non -allowed 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 appropriate, the 
Commission, to take follow -up measures. To this end, information shoul d be available 
to the Member States and the Commission through the Rapid Alert System for Food 
and Feed8.  
(10) In order to allow official laboratories to adapt their methods to the updated reference 
points for action for chloramphenicol, malachite green and ni trofuran metabolites, 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, updates and 
further expands them, for reason s of legal certainty Decision 2005/34/EC should be 
repealed.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Scope  
This Regu lation lays down:  
(a) rules for the establishment of reference points for action for residues of 
pharmacologically actives substances, for which no maximum residue limit has been 
laid down in accordance with Regulation (EC) No 470/2009 ; 
(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 pharmacologically active 
substances for which no maximum residue limit has been laid down in a ccordance 
with Regulation (EC) No  470/2009;  
(d) specific rules on action to be taken in the case of a confirmed presen ce of a residue of 
a prohibited or non -allowed 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 achieved 
by the official control laboratories , designated in accordance with Article 37 of Regulation 
(EU) 2017/62 5 of the European Parliament and of the Council9. 
                                                 
8 Commission Regulation (EU) No 16/201 of 10 January 2011, laying down implementing measures for 
the Ra pid alert system for food and feed  (OJ L 6, 11.1.2011 , p. 7). 
9 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on 
animal health and welfare, plant health and plant protection 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)  
EN 4  EN Reference points for  action shall be regularly reviewed to ensure that they correspond to the 
lowest levels, which are achievable, taking into account  the most recent scientific 
developments.   
When setting or reviewing reference points for action, the Commission shall consult the 
relevant European Reference Laboratories on the  analytical capabilities of National Reference 
Laboratories and official laboratories, as regards the lowest residue conc entration, which can 
be identified with an analytical method, validated in accordance with the requirements of 
Decision 2002/657/EC.  
Article 3  
Methodological principles and scientific methods of risk assessment  
1. The risk assessment applied for the assess ment of the safety of reference points for 
action shall take into account:  
(a) the toxic potential and pharmacological activity of the substance;  
(b) food intake.  
2. For the purpose of determining the toxic potential and pharmacological activity of 
the sub stance, the following toxicological screening values shall be applied:  
(a) for Group I substances, corresponding to  non-allowed pharmacologically 
active substances for which there is direct evidence of genotoxicity or for 
which there is an alert for genoto xicity (from structural activity relationships or 
read across) or for which there is a lack of information on genotoxicity, and 
hence g enotoxicity cannot be excluded 0,0025 μg/kg body weight (b.w.) per 
day; 
(b) for Group II substances, corresponding to  non-allowed pharmacologically 
active substances with pharmacological 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-allowed pharmacologically 
active substances with anti -infectious, anti -inflammatory and antiparasitic 
effect and other pharmacologically active agents 0,22 µg/kg b.w. per day . 
3. Food intake shall be determined based on food consumption figures,  food 
consumption pattern s and the oc currence of the substance in  different food 
commodities.  
4. The safety of reference points for action shall be assessed , by verifying whether the 
toxicological screening value, divided by the relevant food intake, is higher than or 
equal to the analytical capa bility 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  
Substance -specific risk assessment  
1. A request shall be addressed to EFSA for a substance -specific risk assessment as to 
whether reference point s for action are  adequate to protect human health , in 
particular for substances : 
                                                                                                                                                         
No 854/2004 and (EC) No 882/2004 of the E uropean 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  (OJ L 95, 7.4.2017, p. 1 ).   
EN 5  EN (a) that cause blood dyscrasias or allergy  (excluding skin sensitisation);  
(b) that are  high potency carcinogens ; 
(c) for which genotoxicity cannot be excluded, if there is experimental or other 
evidence that the use of the toxicological screening value of 0,0025 μg/kg b.w. 
per day may not be adequately health protective.  
2. The Commission shall, where appropriate, submi t a request to EFSA for a substance -
specific risk assessment as to whether a reference  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 intake, 
is lower than the analytical capability of the official control laboratories, and that 
there is little or no possibility of significant improvement in the analytical capability 
within a short to medium time frame.  
3. Where the substance specific risk assessment is inconclusive, due to uncertainties 
regarding certain aspects of the toxicological or exposure assessment, and no 
guarantees are available on whether the lowest analytically achievable concentration 
is sufficiently saf e for consumers , the European and National Reference Laboratories 
shall endeavour to improve the sensitivity of analytical  methods in order to be able to 
enforce lower concentration s and the r eference points for action  shall be set at levels 
which are low enough to stimulate improvement of the lowest achievable 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 prohibited or not allowed  in the Union, the reference points for action,  laid down in the 
Annex , shall apply irrespective of the food matrix tested.   
Food of animal origin, containing residues of a pharmacologically active substance in a 
concentration at or above the reference point  for action , shall be considered not to comply 
with Union legislation and shall not enter the food chain . Food of animal origin containing 
residues of a pharmacologically active substance in a concentration at a level below the 
reference point for action shall not be p rohibited from entering the food chain.  
Article 6  
Information exchange and investigations in case of confirmed presence of a prohibited or 
non-allowed substance  
Where the results of official controls, including analytical tests , identify residues of prohibited 
or non -allowed substances at levels above, equal to  or below the reference points for action, 
the competent authority shall carry out the investigations referred 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/EC10, 
to determine whether there has been illegal treatment with  a prohibited or non -allowed  
pharmac ologically active substance.  
In the event of established non -compliance, the competent authority shall take one or more 
actions referred to in Article 138 of Regulation (EU) 2017/625  and Articles 15(3), 17 and 23 
to 25 of Directive 96/23/EC .  
                                                 
10 Council Directive 96/23/EC of 29 April 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, 26.5.1996, p. 10).   
EN 6  EN The competent authority shall retain a rec ord of the findings. Where the results of official 
controls, including analytical tests on foods of animal origin from the same operator, show a 
recurrent pattern pointing to suspicion of non -compliance related to one or several prohibited 
or non -allowed s ubstances from a particular origin, the competent authority shall inform the 
Commission and the other Member States in the Standing Committee on Plants, Animals, 
Food and Feed.   
Where the recurrent pattern concerns imported food, the  Commission shall bring  this to the 
attention of the competent authority of the country or countries of origin.  
Member States shall report the results of official controls, including analytical tests , showing 
confirmed presence of a  prohibited or non -allowed substance  at levels  above or  equal to the 
reference point s for action through the Rapid Alert 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  [3 
years after entry into force of this Regulation ].  
Until the date laid down in the first paragraph the minimum required performance limits for 
choramphenicol, nitrofuran metabolites and the sum of malachite green and leucomalachite 
green, included in Annex II to Decision 2002/657/EC , shall apply as reference points for 
action for food of animal origin imported from third countries and for food of animal origin 
produced in the U nion. 
Artic le 9 
Entry into force  
This Regulation shall enter into force on the twentieth day following 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,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER