EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2021/12796 CIS 
(POOL/G5/2021/12796/12796 -EN 
CIS.docx)  
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of 
the Council as regards maximum levels and action thresholds for arsenic, cadmium, 
lead, nickel, rye ergot, delta -9-tetrahydrocannabinol, endosulfan, heptachlor, 
hexachlorbe nzene, hexachlorohexane, dioxins and PCBs, Datura sp., certain 
coccidiostats and histomonostats and p -phenetidine in animal feed    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Directive 2002/32/EC of the European Parliament and of the Council1 establishes maximum 
levels and action thresholds  for undesirable substances in feed to ensure a high level of human 
health, animal health and protection of the environment and to not adversely affect livestock 
production. Products intended for animal feed may enter the Union, be put into circulation 
and/or used in the Union only if they are sound, genuine and of merchantable quality and 
therefore when correctly used do not represent any danger to human health, animal health or 
to the environment or do not adversely affect livestock production. In particu lar products 
intended for animal feed are deemed not to be in conformity if the level of undesirable 
substances does not comply with the maximum levels established by the Directive.  
Taking into account the experience in implementation of the Directive and  the outcome of 
scientific opinions from the European Food Safety Authority (EFSA) an update of the 
Annexes to Directive 2002/32/EC is needed.  
The changes to the Annexes to the Directive relates to  
– the establishment of maximum levels for nickel, Δ9-tetrahydrocannabinol ( Δ9-
THC) and p -phenetidine ; 
– changes to certain maximum levels for arsenic, cadmium, lead, rye ergot, 
endosulfan, heptachlor, hexachlorobenzene, hexachlorocyclohexane, dioxins 
and dioxin -like PCBs, Datura  seeds ; 
– changes to the section on authorised feed additives in feed for non-target 
animal species  following unavoidable carry -over following changes in the 
conditions of authorisation of certain feed additives ; 
– changes to certain action levels for dioxins and PCBs . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The draft Delegated Regulation has been discussed during meetings of the Commission 
Expert Group on Animal Nutrition (E03698), representing the competent authorities of all 
Member States and private stakeholders, the last one on  4 October 2023, and is largely 
supported by those experts.  
Before adopting this Delegated Regulation, the Commission conducted public consultations in  
an open and transparent way in accordance with the procedures laid down in the 
Interinstitutional Agreem ent of 13 April 2016 between the European Parliament, the Council 
of the European Union and the European Commission on Better Law -Making2. 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
In accordance with Article 8(1) of Directive 2002/32/EC, the Commission is empowered to 
adopt delegated acts to adapt Annexes I and II to Directive 2002/32/EC to the scientific and 
technical developments.   
 
1 Directive 2002/32/EC of the E uropean Parliament and of the Council of 7 May 2002 on undesirable 
substances in animal feed (OJ L 140, 30.5.2002, p.10)  
2 OJ L 123, 12.5.2016, p. 1.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of 
the Council as regards maximum levels and action thresholds for arsenic, cadmium, 
lead, nickel, rye ergot, delta -9-tetrahydrocannabinol, endosulfan, heptachlor, 
hexachlorbe nzene, hexachlorohexane, dioxins and PCBs, Datura sp., certain 
coccidiostats and histomonostats and p -phenetidine in animal feed  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having  regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 
May 2002 on undesirable substances in animal feed3, and in particular Article 8(1) thereof,  
Whereas:  
(1) Directive 2002/32/EC establishes maximum levels and action thresholds in Annex I 
and Annex II , respective ly, for undesirable substances in feed , in order  to ensure a 
high level of human health, animal health and protection of the environment and to not 
adversely affect livestock production. The Annexes to that Directive should be 
updated , taking into account scientific and technical developments.  
(2) According to  scientific  data from competent authorities and feed business operators 
concerned , the current maximum level  for total arsenic in fish , other aquatic animals 
and products derived thereof  and in complementary feed for fish  (including 
Crustacea ) is not achie vable  in all production conditions  despite applying good 
practices to reduce the presence of arsenic in these feeds.  Varying levels of arsenic are 
observed in the marine environment, resulting in different levels of contamination of 
marine organisms used f or the production of feed materials.  It is therefore appropriate 
to increase the maximum level for total arsenic in these feeds to a level that is assessed 
to be as low as reasonabl y achievable , taking into account the available scientific data. 
Such increase  of the maximum level  does not adversely affect human health, animal 
health or the protection of the environment,  as the maximum level for total arsenic in 
complete feed and the maximum level for inorganic arsenic, the toxic form of arsenic, 
in the  concerned feeds remain unchanged.  
(3) Scientific  information  shows that  certain seaweed species not yet provided for in  
Directive 2002/32/EC contain high levels of inorganic arsenic . Those  species  should 
therefore  be subject to  control for the level of inorga nic arsenic.  
(4) The name of certain trace elements, i.e. cupric sulphate pentahydrate, cupric 
carbonate, ferrous carbonate, cupric oxide, manganous oxide and ferrous carbonate has 
changed and it is appropriate to update these.  
 
3 OJ L 140, 30.5.2002, p.10     
EN 3  EN (5) According to scientific d ata fr om concerned feed business operators , the general 
maximum level of 10 mg/kg for cadmium in feed additives belonging to the functional 
group of compounds of trace elements is not consistently achievable for the trace 
element copper (I) oxide in all producti on conditions despite applying good practices 
to reduce the presence of cadmium in copper (I) oxide. It is therefore appropriate to 
increase the maximum level for cadmium in copper (I) oxide  to a level that is assessed 
to be as low as reasonabl y achievable , taking into account the available scientific data.  
[. Such  increase  of the maximum level  does not adversely affect the  human health , 
animal health or the protection of the environment,  as the maximum level laid down 
for cadmium in complete fe ed remains unchanged.  
(6) According to scientific d ata from competent authorities , the current maximum level 
for lead in game meat for use in pet food is not consistently achievable in all 
production conditions despite applying good practices. It is therefore appropriate to 
increase the maximum level for lead in game meat for use in pet food  to a level that is 
assessed to be as low as reasonabl y achievable , taking into account the available 
scientific data.  Such  increase of the maximum level does not adversely  affect the 
animal health as the maximum level laid down for lead in complete feed for pet 
animals remains unchanged.  
(7) On 31 March 2015, t he European Food Safety Authority (‘the Authority’) adopted a 
scientific opinion as regards  the presence of nickel in feed4. It concluded that any 
adverse impact on animal health of nickel via feed is unlikely, but that the contribution 
of food of animal origin  to human dietary exposure to nickel should not be 
underestimated. Following Commissi on Recommendation (EU) 2016/11105, the 
Authority assessed in May 2019 the occurrence data of nickel in feed and on animal 
exposure6. In the framework of that assessment, certain  feed materials were identified 
to contain significant levels of nickel as th e consequence of the use of nickel as 
catalyst in hydrogenation processes . As low levels of nickel can be ensured by 
applying good practices, it is appropriate to establish a maximum level of nickel for 
these feed materials  to a level that is assessed to b e as low as reasonabl y achievable , 
taking into account the application of good practices.  
(8)  According to the Authority, t he presence of ergot alkaloids in feed might be of animal 
health concern7. It is possible b y applying good practices, including sorting 
techniques , to lower the level of rye ergot in unground cereals .  Therefore, it is 
appropriate to lower the maximum levels of rye ergot in feed materials and compound 
feed containing unground cereals to the level that is  assessed to be as low as 
reasonably  achievable by the application of good practices.  
 
4 EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. S cientific Opinion on 
the risks to animal and public health and the environment related to the presence of nickel in feed. 
EFSA Journal 2015;13(4):4074, 76 pp. https://doi.org/10.2903/j.efsa.2015.4074   
5 Commission Recommendation (EU) 2016/1110 of 28 June 2016 on the monitoring of the presence of 
nickel in feed (OJ L 183, 8.7.2016, p. 68)  
6 EFSA (European Food Safety Authority), Arcella D, Gergelova P, Innocenti ML , Lopez -Gálvez G and 
Steinkellner H, 2019. Occurrence data of nickel in feed and animal exposure  assessment. EFSA Journal 
2019;17(6):5754, 34 pp. https://doi.org/10.2903/j.efsa.2019.5754   
7 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Ergot alkaloids in 
food and feed. EFSA Journal  2012;10(7):2798. (158 pp. )   https://doi.org/10.2903/j.efsa.2012.2798    
EN 4  EN (9) Certain feed materials derived from hemp are listed in the catalogue of feed materials8.   
Already in 2011, the Authority concluded that the use in feed of hemp -derived feed 
materials sh ould be restricted  or prohibited  due to the presence of Δ9 -
tetrahydrocannabinol (Δ9 -THC)9 to ensure a high level of human health protection . 
Maximum levels for Δ9 -THC for certain hemp -derived products intended for human 
consumption are established by Commission Regulation (EU) 20 23/91510. As these 
maximum levels are achievable by applying good practices r egardless  of whether these 
hemp -derived products are destined for food or feed, it is appropriate to establish 
corresponding maximum levels for relevant feed materials and complete feed.  
(10) Taking into account the conclusions in opinions  of the Authority , the presence  of 
endosulfan11, heptachlor12, hexachlorobenzene13 and gamma -hexachlorocyclohexane14 
in feed is of possible health concern and the presence of these substances should be as 
low as reasonably achievable. Recent data on occurrence of these substances in fee d 
provides evidence that lower levels than the current maximum levels are reasonably 
achievable. Therefore , it is appropriate to lower certain maximum levels for these 
substances and to align them with the maximum residue levels established by 
Regulation ( EC) No 396/2005  of the European Parliament and of the Council15. 
(11) According to the Authority, the presence of dioxins and dioxin -like PCBs in feed and 
food is of health concern16. Maximum levels of those substances are expressed as 
Toxic Equivalent Quantities (TEQ). The Authority concluded that the current 
WHO 2005-Toxic Equivalent Factors (TEFs) used for the calculation of the TEQ values 
should be re -evaluated to take into account new toxicity data. The World Health 
Organisation has re -evaluated the TEFs in 2022 and  the publication of new TEF 
values is envisaged in 2023 and should be the basis for a comprehensive review of the 
maximum and action levels for dioxins and dioxin -like PCBs in feed. Pending this 
comprehensi ve review, taking into account the health concern and scientific data from 
recent years available in the EFSA database on the occurrence of dioxins and dioxin -
 
8 Commission Regulation (EU) No 68/2013 of 16  January 2013 on the Catalogue of feed materials (OJ L 
29, 30.1.2013, p. 1 ) 
9 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP);  Scientific 
Opinion on the safety of hemp ( Cannabis genus) for use as animal feed.  EFSA Journal 2011;9(3):2011.  
41pp. https://doi.org/10.2903/j.efsa.2011.2011   
10 Commission Regulation (EU) 2023/915 of 25  April 2023 on maximum levels for certain contaminants 
in food and repealing Regulation (EC) No  1881/2006 (OJ L 119, 5.5.2023, p. 103) . 
11 Opinion of the Scientific Panel o n Contaminants in the Food Chain on a request from the Commission 
related to endosulfan as undesirable substance in animal feed. The EFSA Journal (2005) 234, 1 -31. 
https://doi.org/10.2903/j.efsa.2005.234   
12 Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the Commission 
related to heptachlor as undesirable substance in animal feed. The EFSA Journal (200 7) 478, 1-48. 
https://doi.org/10.2903/j.efsa.2007.478   
13 Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the Commission 
related to hexachlorobenzene  as undesirable substance in animal feed. The EFSA Journal (200 6) 402, 1-
49. https://doi.org/10.2903/j.efsa.2006.402   
14 Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the Commission 
related to gamma -hexachloro cyclo hexane (𝛾-HCH) and other hexachlorocyclohexanes as undesirable 
substance in animal feed. The EFSA Journal (200 5) 250, 1-39. https://doi.org/10.2903/j.efsa.2005.250   
15 Regulation (EC) No 396/2005 of the European  Parliament and of the Council of 23  February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending 
Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1)  
16 EFSA CONTAM Panel (EFSA Panel on Contaminant s in the Food Chain), Scientific Opinion on the 
risk for animal and human health related to the presence of dioxins and  dioxin -like PCBs in feed and 
food. EFSA Journal 2018;16(11):5333, 331 pp.  https ://doi.org/10.2903/j.efsa.2018.5333    
EN 5  EN like PCBs in certain feeds which provide evidence that lower levels than the current 
maximum leve ls are reasonably achievable by applying good practices . Therefore,  it is 
appropriate to lower the maximum and action levels in these  feeds  to the levels 
assessed to be as low as reasonably achievable by good practices.  
(12) As the harmful botanical impurities  have generally the same moisture content as the 
feed in which they are present, it is appropriate for the harmful botanical impurities to 
express the maximum level relative to the feed without correction for moisture 
content.  
(13) In an opinion on tropane alka loids (from Datura  sp.) in animal feed17, the Authority  
indicated that it cannot be excluded that feed contamination with Datura  sp. at the 
current maximum level would cause adverse health effects in pigs . By applying good 
agricultural pract ices and, if ne cessary, cleaning the harvested cereals whereby the  
Datura  sp. seeds are sorted out before processing , lower levels than the current 
maximum levels are achievable.  It is therefore appropriate to lower the maximum 
level of Datura sp. as a harmful botanical impurity in feed  to a level that is reasonably 
achievable by applying good agricultur al practices and if necessary sorting that 
ensures that feed containing a quantity of Datura  sp. at the maximum level does not 
result in adverse health effects in pigs    
(14) As regards coccidiostats and histomonostats, transfer from one production lot to 
another may occur when such substances are used as authorised feed additives. Such 
transfer may resu lt in the contamination of feed subsequently produced by the 
presence of technically unavoidable traces of such substances, referred to as 
unavoidable carry -over or cross -contamination, in feed  for non -target animal species . 
Taking into account the applica tion of good manufacturing practices, maximum levels 
of unavoidable carry -over of coccidiostats or histomonostats in feed for non -target 
animal species are established following the as low as reasonably achievable principle. 
For the purpose of enabling the  feed manufacturer to manage unavoidable carry -over, 
a carry -over rate of 3 % of the authorised maximum content is considered acceptable 
as regards feed for less sensitive non -target animal species while a carry -over rate of 1 
% of the authorised maximum c ontent is considered acceptable for feed intended to 
sensitive non -target animal species and feed used for the period before slaughter. The 
carry -over rate of 1 % is also considered acceptable for cross -contamination of other 
feed for target species to whi ch no coccidiostats or histomonostats are added, and as 
regards feed for non -target animal species for ‘continuous food -producing animals’, 
such as dairy cows or laying hens, where there is evidence of transfer from feed to 
food of animal origin.  As the co nditions of authorisation of the feed additive s 
diclazuril, lasalocid sodium, nicarbazin , robenidine hydrochloride  and salinomycin 
sodium, these changes should be reflected in the provisions related to maximum levels 
of unavoidable carry -over of authorised  feed additives in feed  for non -target animal 
species in accordance with the proposed carry -over rates.  
(15) Given that maduram icin ammonium alpha is no longer authorised as feed additive in 
the U nion,  the entry related to that feed additive should be deleted  from Annex I  to 
Directive 2002/32/EC .  
 
17 Scien tific Opinion of the Panel o n Contaminants in the Food Chain on tropane alkaloids (from Datura 
sp.) as undesirable substance in animal feed.  The EFSA Journal (200 8) 691, 1-55.  
https://doi.org/10.2903/j.efsa.2008.691    
EN 6  EN (16) In its opinion of 27 January 2022  on ethoxyquin18, the Authority could not conclude 
on the safety of that additive at any level , considering that the additive contains p -
phenetidine, a recognised possible mutagen which remains as an impurity in the 
additive.  Commission Implementing Regulation (EU) 2022/137519 denied  the 
authorisation of ethox yquin (E324) as a feed additive.  Therefore, the use of 
ethoxyquin in feed is no longer allowed in the Union, including in feed entering the 
Union from third countries.  Given that ethoxyquin with significant levels of p -
phenetidine as impurity is still aut horised and used in certain third countries , and cross 
contamination cannot be excluded, a maximum level of p -phenetidine  at the limit of 
quantification should be established for all feed  to ensure a high level of animal and 
public health protection . 
(17) To enable feed business operators to prepare for the new rules introduced by this 
Regulation, it is appropriate to provide for transitional measures.  
 
(18) Directive 2002/32/EC should be amended accordingly,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendments t o Directive 2002/32/EC  
 
Annexes I and II to Directive 2002/32/EC are amended, respectively, in accordance with 
Annexes I and II to this Regulation . 
 
Article 2  
Transitional measure s  
Feed containing Arsenic, cadmium, lead, nickel, rye ergot, delta -9-tetrahydrocannabinol, 
endosulfan, heptachlor, hexachlorbenzene, hexachlorohexane, dioxins and PCBs, Datura sp.,  
p-phenetidine , diclazuril, lasalocid sodium, nicarbazin, robenidine hydrochloride  and 
salinomycin sodium listed in the Annex  to this Regulation , lawfully produced before [OP 
please insert the date of entry into force] , may continue to be placed on the market until [3 
months after the date of entry into force] and may be used until [6 months after the date of 
entry into force]  
 
18 EFSA FEEDAP Panel (EFSA Panel on Additives, Products or Substances used in  Animal Feed), 
Scientific Opinion on the safety and efficacy of a feed additive consi sting of  ethoxyquin (6 -ethoxy -1,2-
dihydro -2,2,4 -trimethylquinoline) for all animal species (FEFANA asbl).  EFSA  Journal 
2022;20(3):7166. 44 pp.  https://doi.org/10.2903/j.efsa.2022.7166   
19 Commission I mplementing Regulation (EU) 2022/1375 of 5  August 2022 concerning the denial of 
authorisation of ethoxyquin as a feed additive belonging to the functional group of antioxidants and 
repealing Implementing Regulation (EU) 2017/962 (OJ L 206, 8.8.2022, p. 39)  
  
EN 7  EN By way of derogation from the first paragraph, point (1 0) of Annex I shall apply as from 1 
July 2025.  
Article 3 
Entry into force  
 
This Regula tion 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 Comm ission  
 The President  
 Ursula VON DER LEYEN