Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: administrative formalities, animal feedingstuffs, biocide, bovine spongiform encephalopathy, food additive, food inspection, food safety, genetically modified organism, market approval, pesticide residue, plant health product, veterinary inspection

EN 

  EN 

   EUROPEAN COMMISSION  Strasbourg, 16.12.2025  COM(2025) 1030 final/3 2025/0410 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements {SWD(2025) 1030 final}  
 
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The proposal is part of the cross-cutting legislative simplification package  announced in the 
European  Commission’s  Vision  for  Agriculture  and  Food1.  The  aim  of  the  package  is  to 
reduce  unnecessary  regulatory  burdens  while  maintaining  high  standards  for  food  and  feed 
safety, and for the protection of human and animal health, and the environment. The proposal 
responds to repeated requests from stakeholders and EU Member States for faster and clearer 
regulatory procedures.  

This  initiative aims  at  simplifying and streamlining certain  requirements  and procedures  for 
products  used  in  the  production  of  food  and  feed  identified  as  particularly  burdensome  by 
industry  and  authorities.  These  provisions  would  benefit  from  regulatory  streamlining  and 
modernisation, which would make the respective legislation more efficient and cost-effective 
for industry and Member States authorities, while at  the same time ensuring  a high  level  of 
protection of human and animal health and the environment. More specifically, this initiative 
is  aiming  at  simplification  of  certain  provisions  and  procedures  and  ensure  a  better 
implementation of the following acts: 

Regulation (EC) No 1107/20092: In line with the announcement in the Vision for Agriculture 
and Food, it is necessary to accelerate access to the market for new biocontrol substances and 
products containing them in order to increase their availability to European farmers with the 
objective to support the shift towards more sustainable plant protection practices and reduce 
the use of more hazardous chemical plant protection products.  

Biocontrol  substances  (such  as  micro-organisms,  semiochemicals  (pheromones),  plant 
extracts) are more sustainable alternatives to chemical active substances. However, the range 
of pests that those already approved today can control and the number of crops on which they 
are  allowed  to  be  used  is  relatively  limited.  Prospective  applicants  for  the  approval  of  new 
biocontrol substances and for product authorisations on a wider range of crops complain that 
the  capacity  and  expertise  in  Member  States  to  conduct  the  necessary  risk  assessments  is 
insufficient and that the time-to-market is too long. The Commission has already taken steps 
to  facilitate  placing  on  the  market  of  biocontrol  substances.  For  instance,  updated  data 
requirements3,4  and  uniform  principles5  for  micro-organisms  were  adopted  in  2022  to  make 
them more fit-for-purpose, and a Single Market Enforcement Taskforce (SMET) project6 was 
developed  to  address  delays  in  the  authorisation  of  biocontrol  products  by  Member  States 
through  sharing  of  good  practices  and  solutions  for  more  efficiency  and  less  burden. 
However,  the  measures  taken  are  not  yet  sufficient.  Therefore,  this  legislative  proposal 

1 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping 
together  an  attractive  farming  and  agri-food  sector  for  future  generations,  COM/2025/75,  https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075  

2 
Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21  October  2009 
concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC 
and 91/414/EEC (OJ L 309, 24.11.2009, pp. 1–50, http://data.europa.eu/eli/reg/2009/1107/oj ) 
3 
4 
5 
6 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02013R0283-20221121  
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02013R0284-20221121  
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011R0546-20221121  
https://ec.europa.eu/internal_market/smet/projects/biosolutions/index_en.htm  

EN 

1 

  EN 

 
 
contains several targeted amendments to Regulation (EC) No 1107/2009 to accelerate market 
access for biocontrol substances and products containing them.  

Several  stakeholders  have submitted comments  in  the  call  for  evidence  of  the  Biotech 
Act8 (14 May 2025 - 11 June 2025) asking, among other things, to streamline the regulatory 
process for biocontrol products and to have a clear definition for this group of substances to 
delineate the scope of substances benefitting from  the simplification efforts proposed in  the 
amended Regulation (EC) No 1107/2009. Their input is also included and considered in the 
proposed provisions. 

Several Member States, in particular smaller ones, have also signalled that applicants for the 
authorisation of products containing biocontrol substances and low-risk active substances do 
not  submit  applications  in  their  territories  considering  the  limited  market  potential  versus 
costs  and  delays  related  to  the  need  to  obtain  authorisations  in  the  different  zones  to  which 
Member  States  are  assigned  in  accordance  with  Annex  I  to  Regulation  (EC)  No  1107/2009 
and due to difficulties and delays in mutual recognition procedures. Therefore, it is proposed 
to  reinforce  the  mutual  recognition  procedure  for  plant  protection  products  containing  only 
biocontrol  or  low-risk  active  substances  by  providing  for  tacit  agreement  in  case  the 
concerned Member State does not decide on the mutual recognition procedure in the 120-day 
period.  

Article  67(1)  of  Regulation  (EC)  No  1107/2009  requires  that  professional  users  of  plant 
protection products keep, for at least three years, records of the plant protection products they 
use, containing the name of the product, the time and the dose of application, the area and the 
crop where the plant protection product was used in order to raise the protection of human and 
animal  health  and  the  environment  by  ensuring  the  traceability  and  potential  exposure,  to 
increase the efficiency of monitoring and control and to reduce the costs of monitoring water 
quality.  Considering  that  such  information  is  less  relevant  for  plant  protection  products 
containing  biocontrol  substances,  and  in  order  to  reduce  the  administrative  burden  for 
farmers,  the  obligation  to  keep  records  should  not  apply  to  plant  protection  products 
containing only biocontrol substances.  

Furthermore, experience with the implementation of Regulation (EC) No 1107/2009 and the 
findings  of  the  Report  on  the  REFIT  revaluation  of  the  pesticides  legislation7  as  well  as 
suggestions  by  Member  States  and  stakeholders  have  shown  that  amending  certain  other 
provisions in the Regulation can increase clarity, address concerns about continued ability of 
farmers  to  produce  crops  to  ensure  food  security,  and  significantly  reduce  administrative 
burdens for authorities and stakeholders without lowering the level of protection of human or 
animal health or the environment.  

The  REFIT  evaluation  of  Regulation  (EC)  No  1107/2009  showed  that  the  most  significant 
burdens for companies and Member States relate to the procedures for approval and renewal 
of approval of active substances and for authorisation and renewal of authorisation for plant 
protection products. In particular, due to lack of resources in the Member States’ competent 
authorities,  in  most  cases,  regulatory  deadlines  for  completing  administrative  procedures 
cannot be respected 8, causing negative impacts for farmers and industry. The workshop Zonal 
Authorisation Procedure – Improvements and Developments (ZAPID) held in 20239 intended 

7 
https://food.ec.europa.eu/plants/pesticides/refit_en  
8 
Report  on  the  compliance  with  the  legal  deadlines  set  out  in  the  Regulation  (EC)  No  1107/2009 
concerning the authorisation of plant protection products reported by Member States and Norway for the years 
2017,  2018,  2019  and  2020,  https://food.ec.europa.eu/system/files/2022-09/pesticides_ppp_report_ms-
survey_regulatory-procedures-timing_2017-20_0.pdf  
9 
https://food.ec.europa.eu/document/download/21e6b162-ac20-4d3c-aefb-
a9084888f515_en?filename=pesticides_auth-ppp_workshop_20231205_sum.pdf  

EN 

2 

  EN 

 
 
to  address  these  delays  by  considering  different  options  for  increasing  efficiency  in  the 
assessment  of  applications  for  product  authorisations.  One  of  the  findings  of  the  workshop 
was that Member States dedicate significant resources to the systematic renewal of approvals 
of active substances followed by the renewals of authorisations of plant protection products, 
as these are time-limited and would expire if no applications for renewal were submitted and 
assessed. As a consequence, approvals of new active substances and first-time authorisations 
of plant protection products containing new active substances are often even more delayed or 
potential  applicants  find  no  Member  State  who  is  able  to  take  on  the  role  as  rapporteur  or 
reference Member State.  

These  delays  prevent  a  transition  towards  more  sustainable  active  substances  and  plant 
protection  products.  Therefore,  resources  in  the  Member  States  dedicated  to  renewal 
procedures  should  be  made  available  for  the  assessment  of  applications  for  new  active 
substances  and  products.  Considering  that  most  approved  active  substances  have  gone 
through  at  least  one  renewal  process  and  that  new  active  substances  are  expected  to  have 
better  toxicological  and  ecotoxicological  properties,  it  is  proposed  that  approvals  of  active 
substances become unlimited in duration, except for active substances that are candidates for 
substitution and those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these 
have  properties  that  are  of  concern  with  regards  to  human  or  animal  health  or  the 
environment.  Nevertheless,  in  order  to  maintain  a  high  level  of  protection  of  human  and 
animal health and the environment, it will still be possible to set time limits for approvals if 
found appropriate in light of the outcome of the risk assessment In addition, the Commission, 
taking  into  account  requests  from  Member  States,  may  identify  active  substances  with 
unlimited  approval  for  which  a  full  renewal  procedure  will  be  carried  out  or  identify  active 
substances with unlimited or limited approval periods for targeted reassessment. In addition, 
the  possibility  for  ad-hoc  reviews  already  foreseen  in  Article  21  of  Regulation  (EC)  No 
1107/2009 is maintained. Such an approach will lead to a more efficient use of resources as 
Member  States  and  the  European  Food  Safety  Authority  (‘the  Authority’)  would  be  able  to 
dedicate available resources to those active substances for which there is a justification for re-
evaluation and to the assessment of applications for the approval of new active substances and 
for the authorisation of plant protection products containing these substances. 

Article  22  of  Regulation  (EC)  No  1107/2009  sets  out  criteria  to  identify  low-risk  active 
substances, referring to hazard-based criteria for the substance set out in point 5 of Annex II 
and risk-based criteria for the plant protection products containing them set out in Article 47. 
Implementation  of  these  provisions  has  proven  difficult  in  practice  as  at  the  time  of  the 
approval  or  renewal  of  approval  of  active  substances  it  is  generally  not  known  whether  the 
criteria  related  to  products  in  Article  47  can  be  fulfilled  or  not.  The  criteria  are  therefore 
simplified to only refer to the intrinsic properties of the active substance. Furthermore, there 
have been cases where an active substance could not be approved as low-risk because certain 
elements related to the criteria could not be fully clarified during the approval or renewal of 
approval procedure, while further information showing that these are fulfilled was generated 
later. However, there is currently no possibility in Regulation (EC) No 1107/2009 to apply for 
a  change  of  the  status  of  an  approved  active  substance  to  low-risk.  Such  a  possibility  is, 
therefore, introduced. 

Article  4(7)  of  Regulation  (EC)  No  1107/2009  provides  for  a  derogation  to  allow  for  the 
approval  of  active  substances  not  meeting  the  approval  criteria  in  Article  4  and  Annex  II 
where  it  is  necessary  to  do  so  because  of  a  serious  danger  to  plant  health  which  cannot  be 
contained  by  other  available  means  including  chemical  and  non-chemical  methods  with 
comparable  costs  and  efficacy,  except  for  active  substances  having  particularly  hazardous 
properties.  In  such  cases,  all  measures  to  reduce  exposure  to  the  active  substance  must  be 

EN 

3 

  EN 

 
taken and consumer safety must be safeguarded. Member States authorising plant protection 
products containing such active substances must draw up a phasing-out plan and submit it to 
the  Commission.  However,  experience  has  shown  that  the  drafting  of  this  provision  is  not 
clear  as  regards  its  scope  and  should  be  improved  to  clarify  for  which  substances  such  a 
derogation  is  possible.  Furthermore,  the  obligation  on  Member  States  authorising  plant 
protection  products  containing  such  active  substances  to  draw  up  a  phasing-out  plan  is 
disproportionate when considering that approvals under this provision are in any case limited 
to  five  years.  This  obligation  is,  therefore,  removed  and  the  scope  of  Article  4(7)  is  further 
clarified. 

Following  the  non-renewal  of  the  approval  of  an  active  substance,  Member  States  must 
withdraw all authorisations of products containing the active substance and farmers must stop 
using  these  products.  In  such  situations,  Member  States  need  time  to  enact  withdrawals  of 
product authorisations and in order to avoid creation of waste and give time to farmers to find 
alternatives, Article 20(2) foresees the possibility in certain cases to provide for grace periods 
not  exceeding  maximum  deadlines  for  placing  on  the  market  and  use  of  existing  stocks  of 
plant protection products for which authorisations must be withdrawn. Currently Article 20(2) 
does not cover situations where the reasons for the renewal are related to protection of health 
or the environment but there are no immediate concerns for human health or animal health or 
the environment. However, also in these situations it would be preferable that the Regulation 
not renewing the approval of an active substance provides for maximum grace periods that the 
Member States may set under Article 46 in order to enable farmers to find alternatives. 

Additionally, the maximum length of graces periods specified in the current Article 20(2), i.e. 
6 months for sale and distribution and a further 1 year for disposal, storage and use of existing 
stocks, might not be sufficient for farmers to get access to suitable alternatives in cases where 
reasonable alternatives do not currently exist. Doubling the maximum overall length of grace 
periods  to  3  years  would  allow  for  alternative  plant  protection  products  to  be  authorised  in 
such  cases,  if  necessary,  thus  preventing  losses  of  revenue  for  farmers  and  ensuring  food 
security for consumers. 
A  survey10  conducted  by  the  Authority  has  shown  that  the  competent  authorities  of  many 
Member  States  lack  technical  or  scientific  expertise  to  complete  their  tasks  as  rapporteur 
Member States withing the periods foreseen in  Regulation  (EC) No 1107/2009.  This  causes 
significant  delays  in  delivering  and  updating  draft  assessment  reports  for  applications  for 
approval  or  renewal  of  approval  of  active  substances,  safeners  or  synergists.  Therefore,  the 
proposal provides for the possibility for rapporteur Member States to ask the European Food 
Safety  Authority  (‘the  Authority’)  for  support  during  the  preparation  of  a  draft  assessment 
report  for  an  application  for  approval  or  renewal  of  approval,  the  assessment  of  additional 
information required during the peer review process and when updating the draft assessment 
report after its initial submission.  

The requirement for Member States to consider ‘current scientific and technical knowledge’ 
in the context of product authorisations has led to some confusion and divergent interpretation 
of  what  constitutes  such  current  knowledge  –  in  particular,  if  applications  for  product 
authorisations (or mutual recognition thereof) are submitted several years after an approval or 
renewal  of  approval  of  an  active  substance.  This  has  led  to  divergent  risk  assessment 
outcomes among Member States and unequal access to plant protection products for farmers 
depending on the Member State of their establishment. Article 36(3) is, therefore, clarified to 
allow  for  harmonised  assessment  of  the  latest  scientific  and  technical  knowledge  while 
ensuring any specific needs for further assessment of active substances are followed up. 

10 

33rd Pesticide Steering Network meeting | the Authority 

EN 

4 

  EN 

 
 
It  has  been  observed  that  applicants  have  obtained  product  authorisations  in  a  reference 
Member  State  having  set  lower  fees  than  others  in  order  to  afterwards  apply  for  mutual 
recognition  of  these  authorisations  in  other  Member  States,  without,  however,  placing  the 
plant  protection  products  concerned  on  the  market  in  the  reference  Member  State  having 
granted  the  first  authorisation.  As  a  consequence,  farmers  in  that  Member  States  have  no 
access to the plant protection products concerned despite the existing authorisation. In order 
to  prevent  abuse  of  the  mutual  recognition  system  and  circumvention  of  higher  fees, 
application  for  mutual  recognition  of  a  product  authorisation  shall  only  be  possible,  if  the 
product  for  which  authorisation  by  mutual  recognition  is  sought  is  actually  placed  on  the 
market in the reference Member State. Furthermore, where companies decide to only apply in 
certain Member States for authorisation of a plant protection product but not in others, Article 
40  is  amended  so  that  it  is  easier  for  official  or  scientific  bodies  involved  in  agricultural 
activities or professional agricultural organisations to apply for mutual recognition of product 
authorisations  in  those  other  Member  States  so  that  farmers  situated  there  can  also  have 
access to the product concerned. Additionally, the administrative burden for such applicants 
and  also  for  applicants  for  the  extension  of  authorisations  of  products  for  minor  uses  is 
reduced by removing the obligation under Article 42 to provide certain documents as part of 
the  application,  as  these  can  be  obtained  directly  from  the  reference  Member  State  having 
granted the authorisation for which mutual recognition or extension is sought. Lastly, in order 
to accelerate access to plant protection products that contain only biocontrol or low-risk active 
substances,  it is  clarified that if Member States do not  take a decision on an application for 
authorisation of a product authorised by the reference Member State in the zonal system or by 
mutual  recognition  of  an  authorisation  granted  by  another  Member  State,  the  authorisation 
shall be deemed as having been granted.  

Article  51  of  Regulation  (EC)  No  1107/2009  has  set  out  specific  provisions  to  facilitate 
obtaining  authorisations  of  plant  protection  products  for  minor  uses.  However,  in  practice, 
some of the conditions haven proven too restrictive i.e. that extension of an authorisation must 
be in the public interest or that mutual recognition of an authorisation from another Member 
State is only possible if that authorisation is also for a minor use. Therefore, these restrictions 
should be removed. Furthermore, the application of Article 51 varies significantly depending 
on the Member States. A report of the European Minor Use Coordination Facility from 202211 
stressed the lack of harmonisation and difficulties to make available plant protection products 
for  minor  crops,  which,  although  occupying  a  lower  production  acreage  in  the  Union 
compared  to  major  crops,  may  be  high  value  crops  and  are  important  for  the  environment, 
farmers,  producers,  and  consumers.  Therefore,  transparency  and  sharing  of  best  practices 
should be increased to achieve more equal access to plant protection products for minor users 
by  all  farmers  independent  of  the  Member  State  of  establishment.  For  the  same  purpose 
Article 51 is amended to provide for a possibility for the Commission to adopt implementing 
acts harmonising the procedures for granting extensions of authorisations for minor uses and 
for authorisations by mutual recognition. 
Furthermore, Regulation (EU) 2016/203112 aims at preventing the establishment or spreading 
of pests that would have  unacceptable economic, environmental or social impacts  on Union 
territory  including  EU  agricultural  production.  The  availability  of  plant  protection  product 
authorised  uses  to  apply  the  provisions  of  Regulation  (EU)  2016/2031  is  essential  and 

11 
https://minoruses.eu/media/files/resources/MUCF_MU_Survey_2022_Compiled_Information_final.pdf 
12 
Regulation  (EU)  2016/2031  of  the  European  Parliament  of  the  Council  of  26  October  2016  on 
protective  measures  against  pests  of  plants,  amending  Regulations  (EU)  No  228/2013,  (EU)  No  652/2014  and 
(EU)  No  1143/2014  of  the  European  Parliament  and  of  the  Council  and  repealing  Council  Directives 
69/464/EEC,  74/647/EEC,  93/85/EEC,  98/57/EC,  2000/29/EC,  2006/91/EC  and  2007/33/EC  (OJ  L  317, 
23.11.2016, pp. 4–104, ELI: http://data.europa.eu/eli/reg/2016/2031/oj). 

EN 

5 

  EN 

 
 
Member States have repeatedly mentioned difficulties in this regard. Also, the Authority has 
indicated repeatedly in the relevant pest risk assessments that not being able to prevent such 
establishment or spreading of pests would lead to a higher use of plant protection products in 
the medium or long term. Administrative simplifications like a one-zone approach (instead of 
three zones), and a prioritisation of applications for this kind of purposes would increase the 
timely  availability  of  plant  protection  product  uses  and  ensure  the  possibility  to  apply  the 
provisions of Regulation (EU) 2016/2031.  

Regulation (EC) No 1107/2009  contains specific provisions for the use of  basic substances, 
which are defined as active substances that have primary uses for other  purposes than plant 
protection  but  are  nevertheless  useful  for  farmers  for  protecting  plants  against  pests.  Most 
approved  basic  substances  are  biocontrol  but  not  all.    Following  their  approval  under 
Regulation  (EC)  No  1107/2009,  they  can  be  directly  used  by  farmers  without  obtaining 
national authorisations by Member States. However, in practice, certain provisions related to 
basic  substances  have  proven  to  be  unclear  and  hinder  their  availability  to  farmers,  in 
particular the prohibition that they cannot be substances of concern, cannot be placed on the 
market as plant protection products or that there must be a primary use for purposes other than 
plant  protection.  The  ambiguity  of  some  of  the  current  legal  provisions  on  basic  substances 
led  to  disharmonised  implementation  across  the  EU,  as  became  evident  in  a  workshop  with 
Member  States  organised  in  2024.  Therefore,  the  relevant  provisions  are  amended  and 
clarified so that in addition to use, the placing on the market of approved basic substances for 
plant  protection  purposes  does  not  require  an  authorisation  by  Member  States  to  allow  for 
easier access to basic substances by farmers in a suitable form and with clear instructions for 
use.  

Experience  has  shown  that  Member  States  have  developed  different  interpretations  of  the 
provisions related to the placing on the market and use of seeds treated with plant protection 
products  in  Regulation  (EC)  No  1107/2009.  In  particular,  divergent  views  on  whether  the 
sowing  of  treated  seeds  constitutes  a  use  of  plant  protection  products  has  created  confusion 
amongst producers of treated seeds, farmers and competent authorities. Additionally, Member 
States  have  different  interpretations  as  to  whether  the  provision  on  treated  seeds  cover  also 
other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of 
clarity creates barriers for the free circulation of treated seeds and plant reproductive materials 
and has created disparity between the Member States as regards imports of seeds treated with 
active  substances  not  approved  for  use  in  the  EU  and  their  sowing.  Therefore,  the  relevant 
provisions are clarified,  in  order to  increase harmonisation among  Member  States.  It  is  also 
clarified  that  machinery  used  for  the  sowing  of  treated  seeds  is  not  to  be  regarded  as 
pesticides application equipment in the meaning of Directive 2009/128/EC on the sustainable 
use  of  pesticides  on  order  not  to  create  additional  burden  for  the  farmers.  The  clarification 
would not create additional burden for the seed treatment industry as treated seeds themselves 
are still not to be considered a plant protection product.  

The provisions in Regulation (EC) No 1107/2009 related to the protection of data in test and 
study  reports  used  in  regulatory  procedures  for  the  approval  of  active  substances  and 
authorisation  of  plant  protection  products  had  been  significantly  amended  compared  to  the 
ones  under  the  repealed  Directive  91/414/EEC13.  Experience  has  shown  that  the  current 
patched  territorial  scope  under  Regulation  (EC)  No  1107/2009  (Member  State  per  Member 
State) creates barriers to the entry to the market of new suppliers of plant protection products 
and unequal distribution and different costs of plant protection products depending on the size 
of  the  Member  State’s  market,  thus  creating  unfair  competition  between  plant  protection 

13 
the market (OJ L 230, 19.8.1991, pp. 1–32, ELI: http://data.europa.eu/eli/dir/1991/414/oj) 

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on 

EN 

6 

  EN 

 
 
product manufacturers and farmers. Furthermore, the current data protection regime is highly 
complex  and  lacks  transparency  in  terms  of  when  data  protection  for  a  given  test  or  study 
report  expires  in  the  different  Member  States,  in  particular  for  studies  or  tests  used  for 
renewals  of  approvals  or  review  of  authorisations.  The  relevant  provisions  are  therefore 
amended to install Union-wide territorial scope of data protection and the same length of data 
protection periods for a given test or study report across the Union to increase transparency 
and facilitate market  access  for alternative suppliers and to  increase the availability of plant 
protection  products  at  comparable  costs  to  farmers  independent  from  the  Member  States 
where they are established.  

Lastly, transitional provisions are established in order to provide legal certainty in procedures 
for applications for approval or renewal of active substances including basic substances, or for 
the authorisation of plant protection products that are ongoing at the time of entry into force 
of this Regulation and to ensure a smooth transition from the current provisions in Regulation 
(EC) No 1107/2009 to the amended provisions.  
Regulation (EC) No 396/200514: Regulation (EC) No 396/2005 on maximum residue levels 
(MRLs) of pesticides allows the setting and maintaining of import tolerances and alignment 
with Codex standards for residues of pesticides not approved in the EU if they pose no risk to 
consumers. This currently may also include a number of substances with particularly severe 
hazards that prevent their approval in the EU under Regulation (EC) No 1107/2009, but for 
which it is nevertheless possible to establish safe maximum residue levels in food.  

In  the  Vision  for  Agriculture  and  Food,  the  Commission  announced  to  pursue  a  stronger 
alignment  of  production  standards  applied  to  imported  products,  notably  on  pesticides. 
Therefore, it announced to establish a principle that the most hazardous pesticides banned in 
the EU for health and environmental reasons are not allowed back to the EU through imported 
products.  To  advance  on  this,  the  Commission  has  launched  in  November  2025  a  study  to 
prepare an impact assessment that will consider the impacts on the EU’s competitive position 
and  the  international  implications  and,  if  appropriate,  the  Commission  will  propose 
amendments  to  the  applicable  legal  framework.  In  the  meantime  Regulation  (EC)  No 
396/2005 should already be amended to provide that, for substances that are not approved in 
the  Union  and  that  have  certain  particularly  hazardous  properties,  MRLs  that  have  been  set 
based on good agricultural practices in third countries or Codex maximum limits may be set at 
the  limit  of  quantification  (technical  zero)  if  considered  appropriate  in  the  light  of  the 
outcome of an impact assessment. 

Based  on  the  scientific  criteria  listed  in  Regulation  (EC)  No  1107/200915,  this  includes 
substances  with  mutagenic,  carcinogenic, or  reprotoxic  properties  as  well  as  endocrine 
disruptors that may cause adverse effects in humans. Therefore, no level of exposure should 
be allowed in order to ensure a high level of protection for consumers in the Union. 

In  addition,  this  includes  substances  that  are  persistent  organic  pollutants  (POP),  persistent, 
bioaccumulative  and  toxic  (PBT)  substances,  and  very  persistent  and  very  bioaccumulative 
(vPvB) substances, as well as substances with endocrine disrupting properties that may cause 
adverse  effect  in  non-target  organisms.  The  adverse  effects  of  these  substances  are  directly 

14 
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, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj) 
15 
points  3.6.2  to  3.6.5,  3.7.1  to  3.7.3,  and  3.8.2  of  Annex  II  to  Regulation  (EC)  No  1107/2009  of  the 
European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products 
on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009. 

EN 

7 

  EN 

 
 
linked  to  their  intrinsic  properties.  Persistent  substances,  by  their  very  nature,  resist 
degradation, resulting in prolonged presence in the environment. Their accumulation poses a 
significant  threat  to  ecosystems,  endangering  biodiversity,  agricultural  production  and  food 
security.  Endocrine  disruptors,  similarly,  interfere  with  the  hormonal  systems  of  living 
organisms,  causing  detrimental  effects  not  only  to  individual  species  but  also  to  entire 
ecosystems. Therefore, these substances create environmental concerns of a global nature that 
have a connexion with the territory of the Union. Not allowing residues of these substances in 
food  in  the  Union  aligns  with  international  efforts  to  combat  pollution  and  supports  global 
initiatives aimed at sustainable development and biodiversity conservation16. 

In addition, the definition of the term “import tolerance” in Article 3(2)(g) of Regulation (EC) 
No  396/2005  is  often  misunderstood.  Therefore,  it  should  be  repealed  and  replaced  by  a 
reference to good agricultural practice in a third country. The definition of good agricultural 
practice in Article 3(2)(a) should be adapted accordingly. 

Article 49(2) of Regulation (EC) No 396/2005 allows for the continued marketing of products 
that  were  placed  on  the  market  prior  to  the  applicability  of  new  Maximum  Residue  Levels 
(MRLs), provided they complied with the MRLs in force at the time of their placing on the 
market  or  placing  into  storage  after  production.  However,  this  provision  is  currently  not 
applied across the board. In such cases, newly established lower MRLs are also enforced for 
products  already  available  on  the  market  from  the  date  of  applicability  of  the  new  MRLs, 
regardless of the specificities of each case. In such circumstances, the products are withdrawn 
from the market and destroyed. This situation frequently arises when MRLs, which have been 
stable  and  deemed  safe  over  extended  periods,  undergo  reassessment  based  on  revised  data 
requirements and/or updated exposure assessment models. 

The impossibility to allow, as a matter of principle, for continued marketing of products that 
are compliant with earlier applicable MRLs has particularly impacted products with long shelf 
lives,  some  of  them  with  high  economic  value,  such  as  wine,  hops,  oils,  and  berries  while 
others being  key in  human and animal  nutrition,  such as cereals,  pulses and rice, which not 
only  causes  economic  losses  to  producers  but  also  creates  food  waste,  which  is  undesirable 
and  incompatible  with  the  Union’s  objective  to  reduce  food  loss  and  waste.  Therefore,  the 
Commission  proposes  a  more  proportionate  approach  to  allow  continued  marketing  of 
products that were compliant with MRLs applicable at the time of production, even after new 
lower MRLs are implemented, depending on the circumstances of each specific case.  

Article 16 of Regulation (EC) No 396/2005 provides for a procedure for setting MRLs based 
on monitoring data instead of the standard requirement of having supporting residue trials. It 
is used for substances that have not been approved for use in plant protection products in the 
Union  for  a  long  time  and  may  now  be  regarded  as  contaminants,  for  minor  dietary 
components like herbal infusions and honey, and for other particular scenarios where residues 
persistently  remain  in  plants  long  after  their  last  application.  At  present,  MRLs  established 
through monitoring data are not granted on a permanent basis and must be reviewed within a 
specified  timeframe  not  exceeding  ten  years.  Although  regular  reviews  are  justified  for 
substances  for  which  it  can  be  expected  that  the  levels  of  the  residues  concerned  might 
evolve, for substances that have not been approved for several decades and are now deemed 
as  contaminants  due  to  their  persistence  in  the  environment  and  for  which  stable  residue 
recorded  over  many  years,  such  as  DDT,  dieldrin,  aldrin, 
levels  have  been 

16 
Biological Diversity, https://www.cbd.int/ 

Stockholm Convention on Persistent Organic Pollutants (POPs),  https://www.pops.int/; Convention on 

EN 

8 

  EN 

 
 
hexachlorobenzene, or mercury, a mandatory review after ten years appears disproportionate 
when considering the costs involved. 

There is an existing inconsistency between the terminology employed in Regulation (EC) No 
396/2005  and  that  used  within  international  standards  for  laboratory  analysis  to  decide 
whether residues in food commodities can be quantified or not. Regulation (EC) No 396/2005 
uses the term “limit of determination (LOD)”, whereas the appropriate analytical terminology 
is “limit of quantification (LOQ)”. Both terms refer to the same concept: the lowest residue 
concentration that can be quantified and reported through routine monitoring using validated 
control  methods.  However,  within  international  laboratory  analysis  standards,  "LOD"  also 
serves as the abbreviation for "limit of detection," a distinct limit that is lower than the limit 
of  determination/limit  of  quantification.  This  discrepancy  concerning  the  abbreviation 
“LOD,”  leads  to  legal  uncertainty  among  food  business  operators  and  laboratories,  as  they 
often misinterpret these abbreviations. Therefore, it is proposed to use only the term “limit of 
quantification (LOQ)”. 

Regulation (EU) No 528/2012: The completion of the review programme of existing biocidal 
active  substances  set  out  in  Article  89  of Regulation  (EU)  No  528/2012  suffers  from  major 
delays. Initiated on 14 May 2000 under Directive 98/8/EC17, and planned to be completed by 
14  May  2010,  the  review  programme  had  to  be  extended  a  first  time  in  2009  until  14  May 
201418, a second time in  2013 until  31 December 202419, and  recently a third time until 31 
December 203020. 

The  vast  majority  of  the  competent  authorities  in  the  Member  States  have  not  met  the  time 
limits  for  submitting  the  assessment  reports  for  applications  for  approval  of  existing  active 
substances to the European Chemicals Agency (ECHA). The main reasons for the delays, as 
identified  in  the  Commission  implementation  report  submitted  to  the  Council  and  the 
European Parliament in June 202121, are: i) the lack of resources in Member States competent 
authorities;  ii)  quality  of  the  original  applications  and  delays  by  applicants  in  submitting 
additional data; iii) complex technical questions on specific dossiers that need to be resolved 
first;  iv)  evolution  of  technical  guidance;  and  v)  the  adoption  of  new  scientific  criteria  for 
determining  endocrine disrupting properties22, which triggered the need for further data  and 

L 

of 

of 

pp. 

(OJ 

123, 

biocidal 

products 

24.4.1998, 

the  market 

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
1–63, 

17 
on 
biocidal 
placing 
ELI: http://data.europa.eu/eli/dir/1998/8/oj) 
18 
Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 amending 
Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain 
time periods (OJ L 262, 6.10.2009, p. 40, ELI: http://data.europa.eu/eli/dir/2009/107/oj). 
19 
Commission Delegated Regulation (EU) No 736/2013 of 17 May 2013 amending Regulation (EU) No 
528/2012  of  the  European  Parliament  and  of  the  Council  as  regards  the  duration  of  the  work  programme  for 
examination 
25, 
active 
existing 
ELI: http://data.europa.eu/eli/reg_del/2013/736/oj). 
20 
Commission Delegated Regulation (EU) 2024/1398 of 14 March 2024 amending Regulation (EU) No 
528/2012  of  the  European  Parliament  and  of  the  Council  as  regards  a  further  extension of  the  duration  of  the 
work  programme  for  the  systematic  examination  of  all  existing  biocidal  active  substances  (OJ  L,  2024/1398, 
22.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1398/oj ). 
21 
https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1623326515401&uri=CELEX%3A52021DC0287    and  the  Staff  Working  Document, 
which  presents  detailed  evidence  for  the  findings  outlined  in  the  report,    is  available  here:  https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021SC0128&qid=1623670527414 
22 
Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific  criteria 
for  the  determination  of  endocrine-disrupting  properties  pursuant  to  Regulation  (EU)  No  528/2012  of  the 
European 
ELI: 
Council 
http://data.europa.eu/eli/reg_del/2017/2100/oj). 

The  Commission  Report 

17.11.2017, 

Parliament 

substances 

31.7.2013, 

available 

link: 

204, 

301, 

(OJ 

this 

and 

(OJ 

1, 

p. 

p. 

at 

is 

L 

L 

EN 

9 

  EN 

 
 
 
assessments.  That  implementation  report  also  announced  that,  instead  of  a  second 
implementation report, an evaluation of the Regulation (EU) No 528/2012 will start in 2025 
with the aim of analysing the fitness of the regulatory system set out in the Regulation. While 
any fundamental changes to Regulation (EU) No 528/2012 should await the outcome of that 
evaluation, a few targeted amendments should be enacted sooner to increase the efficiency of 
its implementation.  

Since  2015,  the  Commission  has  held  regular  discussions  with  experts  from  the  Member 
States  at  the meetings of the Commission expert group ‘Competent  Authorities for Biocidal 
Products  (Regulation  (EU) No 528/2012)’ (the ‘CA meetings’)23, including also  stakeholder 
representatives  as  observers,  and  agreements  were  reached  on  a  number  of  actions24  to 
accelerate the delivery of assessment reports for existing active substances. ECHA organised 
workshops  and  adopted  an  action  plan  on  active  substances25.  In  2023,  the  Commission 
launched a call for expression of interest26 by Member States to obtain financial grants to help 
them  achieving  progress  in  the  implementation  of  Regulation  (EU)  No  528/2012.  Nine 
Member  States  have  successfully  applied  for  this  grant  for  biocidal  products  for  a  total  of 
around 6.8 million euros. 

Despite  these  actions,  on  1  September  2025,  only  51%  of  the  work  programme  of  existing 
active  substance  was  completed,  which  means  that  the  safety  of  many  active  substances 
contained  in  biocidal  products  placed  on  the  market  in  the  Member  States  under  the 
transitional  provisions  foreseen  in  the  Regulation  (EU)  No  528/2012  has  not  yet  been 
established.  On  the  other  hand,  as  the  approvals  of  active  substances  are  limited  in  time, 
renewal  procedures  for  a  number  of  active  substances  evaluated  and  approved  earlier  are 
already  ongoing  (for  some  already  for  the  second  time),  with  each  procedure  binding 
resources  in  the  competent  authorities  that  are,  as  a  consequence,  not  available  for  the 
completion of the pending assessments of existing active substances not yet approved.  

In order to give higher priority to the completion of the review programme of existing active 
substances  not  yet  assessed  and  enable  Member  States  to  dedicate  their  resources  to  the 
related tasks, it is appropriate to set an unlimited duration of the approval of active substances, 
except  for  active  substances  that  are  approved  although  they  meet  the  exclusion  criteria  set 
out in Article 5(1) of the Regulation (EU) No 528/2012 or the substitution criteria set out in 
Article  10  as  these  have  properties  that  are  of  concern  to  human  or  animal  health  or  the 
environment.  Nevertheless,  in  order  to  maintain  a  high  level  of  protection  of  human  and 
animal health and the environment, it will still be possible to set time-limits for approvals if 
found appropriate in the light of the outcome of the risk assessment prior to a decision on an 
approval.  

The  approval  of  active  substances  already  approved  should  be  converted  into  unlimited 
approvals  following  these  new  rules,  except  for  active  substances  identified  as  meeting  the 
exclusion  criteria  set  out  in  Article  5(1)  of  the  Regulation  (EU)  No  528/2012  or  the 

23 
Register Code E03125 (Register of Commission expert groups and other similar entities).  
24 
Letters  sent  in  2015  and  2021  to  responsible  Ministers  in  all  Member  States  to  express  her  concerns 
about  the  delays  in  implementing  the  Biocidal  Products  Regulation  (active  substances  assessments,  product 
authorisations),  and  called  on  Member  States  to  take  action,  including  allocating  sufficient  resources;  CA 
documents of CA-March18-Doc.5.1a - Final - Actions for AS review programme.pdf, CA-Dec23-Doc.5.4 - Final 
- Extension of RP beyond 2024.doc  
25 
CA-Feb20-Doc.5.2 - Final - AS Action Plan.doc 
26 
Contributing  to  more  sustainable  and  circular  food  production  systems  by  boosting  Member  States’ 
capacities  to  evaluate  and  remove  from  the  market  unsafe  pesticides  and  biocides  –  SMP-FOOD-2022-
BIOCIDES-PESTICIDES-IBA 

EN 

10 

  EN 

 
 
substitution  criteria  set  out  in  Article  10,  substances  for  which  the  renewal  examination 
already  started  (on-going  evaluation),  and    substances  for  which  no  application  for  renewal 
was  submitted  on  time.    In  addition,  the  possibility  is  foreseen  that  the  Commission 
periodically  selects  a  number  of  active  substances  for  which  a  renewal  procedure  would  be 
triggered, while also maintaining the existing possibility to initiate early reviews pursuant to 
Article 15 of Regulation (EU) No 528/2012.   

Regulation  (EU)  No  528/2012  provides  in  Chapter  VIII  that,  as  an  alternative  to  national 
authorisations  of  biocidal  products  and  mutual  recognition  procedures,  and  when  certain 
conditions  are  fulfilled,  companies  can  obtain  a  Union  authorisation  for  biocidal  products 
granted by the Commission and valid under the same terms and conditions in the Union. The 
requirement  for  publication  in  the  EU  Official  Journal  of  the  Commission  Implementing 
Regulation  granting  a  Union  authorisation  including  the  Summary  of  the  Products 
Characteristics in all official languages has proven to be cumbersome, leading to delays, and 
without  added  value  considering  that  the  decision  is  also  disseminated  on  the  ECHA 
website27. Therefore, it is proposed to simplify the publication of taking into account the way 
in  other  similar  regulatory 
authorisation  decisions  are  adopted  and  disseminated 
frameworks28.  More  concretely,  the  individual  decisions  will  take  the  form  of  Commission 
Implementing  Decisions  notified  only  to  the  applicants,  and  summaries  of  those  Decisions 
should be published in the EU Official Journal. 

Regulation  (EC)  No  1829/200329:  The  use  of  fermentation30  processes  using  genetically 
modified  micro-organisms  (‘GMMs’)  to  manufacture  products  is  of  growing  importance  in 
the food and feed sectors and in the bioeconomy at large. The Commission has committed to 
strengthen  the  competitiveness  of  these  sectors  with  different  initiatives,  including  its 
Communication of March 2024 on  Building  the future with nature: Boosting Biotechnology 
and Biomanufacturing in the EU31, a Strategy for European Life Sciences in February 202532.  

The European food and feed fermentation sector has voiced concerns about uncertainty of the 
legal  status  of  food  and  feed  fermentation  products  manufactured  using  GMMs,  due  to 
unclarity as regards the scope of Regulation (EC) No 1829/2003 on genetically modified food 
and  feed.  This  concerns  cases  where  the  GMM  is  used  in  the  production  process  but  is 
removed  from  the  fermentation  product,  although  residues  of  the  genetically  modified 
production strain may be present in the food or feed.  

Regulation  (EC) No 1829/2003  sets  out  the rules for the  placing  on the  market  of food and 
feed  containing,  consisting  of  or  produced  from  genetically  modified  organisms  (GMOs). 
Recital  16  of  that  Regulation  clarifies  that  the  Regulation  does  not  apply  to  food  and  feed 
produced ‘with’ a GMO and specifies that food and feed which is manufactured with the help 
of a genetically modified processing aid is excluded from its scope.  

27 
https://www.echa.europa.eu/information-on-chemicals/biocidal-products 
28 
For  instance,  authorisation  decisions  of  substances  adopted  under  REACH  Regulation  (EC)  No 
1906/2007, or authorisation decision of medicines for human or veterinary use adopted under  Regulation (EC) 
No 726/2004  
29 
on 
http://data.europa.eu/eli/reg/2003/1829/oj  
30 

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
ELI: 

Fermentation is a process in which micro-organisms such as bacteria, fungi, yeasts and micro-algae are 
used to preserve and/or transform raw materials into products, e.g. food and feed. 
COM(2024) 137 final. 
COM(2025) 525 final 

genetically  modified 

18.10.2003, 

feed, 

food 

268, 

p.1, 

and 

OJ 

L 

31 
32 

EN 

11 

  EN 

 
 
However,  uncertainties  remain  as  to  whether  the  presence  of  residues  of  the  genetically 
modified production strain in the food or feed render the latter ‘produced from a GMO’ and 
therefore  subject  to  Regulation  (EC)  No  1829/2003.  In  that  regard,  the  detection  by 
enforcement authorities  of minute amounts of DNA fragments in  food and feed products  in 
recent  years  due  to  the  use  of  increasingly  sensitive  analytical  methods  has  aggravated  the 
situation,  raising  more  frequently  questions  on  the  legal  framework  applicable  to  those 
products,  which  led  to  different  enforcement  practices  by  national  authorities,  including  the 
withdrawal  of  products  from  the  market  in  some  cases.  In  turn,  this  has  created  legal 
uncertainty for food and feed business operators as to the legal framework applicable to their 
products.  Therefore,  it  is  necessary  to  clarify  the  legal  status  of  food  and  feed  products 
manufactured using GMMs as production strains and not containing the GMM used to obtain 
them but potentially containing residues thereof. 

In order to safeguard the smooth functioning of the internal market as regards food and feed 
products obtained with GMMs and to ensure legal certainty for operators, the legal status of 
such  products  is  clarified  by  making  explicit  that  the  definition  of  food  and  feed  ‘produced 
from  GMOs’  does  not  cover  food  and  feed  products  obtained  using  GMMs  as  production 
strains where there is no presence in those products of those GMMs and any residues thereof 
are limited to non-viable cells, are minimized through reasonable attempts to remove them in 
accordance with good manufacturing practice and have no technological effect on the food or 
the feed. While the specific process  and the level  of removal or minimization of non-viable 
cells that is reasonably achievable without negatively affecting the quality of the food or feed 
may  vary  depending  on  the  production  strain  used,  and  the  type  of  food  or  feed  product 
obtained  with  it,  the  removal  or  minimization  of  non-viable  cells  of  the  GMM  should  be 
carried  out  in  accordance  with  good  manufacturing  practices  used  in  conventional  food  and 
feed products to minimize the presence of residues. 

It  should  be  underlined  that  the  assessment  of  any  risks  of  those  food  and  feed  products 
relating to the GMMs used during their production process and to any residues thereof is to be 
carried  out  under  the  relevant  food  and  feed  legislation  for  the  specific  product  (e.g. 
Regulation (EC) No 1831/2003 on additives for use in animal nutrition, Regulation (EC) No 
1332/2008 on food enzymes33, Regulation (EC) No 1333/2008 on food additives, Regulation 
(EC) No 1334/2008 on flavourings34, Regulation (EU) 2015/2283 on novel foods35).  

In  order  to  be  consistent  with  the  overall  applicable  framework  on  GMOs,  it  should  be 
ensured that the same rules apply to animal and plant cells, regardless of whether they are in 
culture,  not  in  culture  or  embedded  in  the  complete  organisms.  Therefore,  the  reference  to 
GMMs in the definition of ‘produced from GMOs’ should cover only micro-organisms in the 
biological sense and exclude animal and plant cells in culture. 

33 

34 

35 

Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on 
food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, 
Directive  2000/13/EC,  Council  Directive  2001/112/EC  and  Regulation  (EC)  No  258/97,  OJ  L  354, 
31.12.2008, p. 7. 
Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on 
flavourings  and  certain  food  ingredients  with  flavouring  properties  for  use  in  and  on  foods  and 
amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 
and Directive 2000/13/EC, OJ L 354, 31.12.2008, p. 34 
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council 
and  repealing  Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  and 
Commission Regulation (EC) No 1852/2001, OJ L 327, 11.12.2015, p. 1 

EN 

12 

  EN 

 
 
 
 
Regulation  (EC)  No  1831/2003:  Regulation  (EC)  No  1831/2003  on  additives  for  use  in 
animal nutrition36 was the subject of an evaluation that was published on 28 February 202437, 
which  confirmed  that  the  legislation  continues  to  meet  its  core  objectives:  ensuring  a  high 
level  of  protection  of  human  and  animal  health  and  the  environment,  safeguarding  users’ 
interests, and supporting the effective functioning of the internal market. At the same time, the 
evaluation  identified  several  provisions  whose  implementation  creates  some  complexity  or 
administrative  burden,  without  corresponding  safety  benefits.  These  issues  primarily  affect 
feed business operators, especially SMEs, but also the Member States, the Authority and the 
Commission,  who  are  required  to  process  and  handle  applications  for  authorisation  of  feed 
additives. Three main areas for simplification or clarification emerged in particular from the 
evaluation  and  subsequent  stakeholder  feedback:  renewal  of  authorisations,  modification  of 
existing authorisations and labelling requirements. The 10-year renewal obligation is seen as 
too resource-intensive for both operators and authorities, and as a too short period to justify 
investment  costs,  while  resources  could  rather  be  allocated  to  the  development  of  new  and 
innovative  products.  Concerning  the  modification  of  existing  authorisations,  some  of  the 
current procedures are too burdensome, for example when changing an authorisation-holder, 
or could be improved in terms of clarity and coherence. As to the labelling requirements, the 
current  obligation  for  physical  labels  on  additives  and  premixtures  does  not  reflect  the 
potential of digital tools for non-safety information and is not fully coherent with the labelling 
rules for feed materials and compound feed.  

Those findings were largely confirmed in the feedback received from business stakeholders, 
but  also  from  several  public  authorities,  in  the  context  of  the  Call  for  Evidence  published 
ahead of this proposal. 

The  proposed  amendments  target  these  specific  provisions  to  simplify  procedures,  reduce 
administrative burden and costs, and improve legal clarity. They do not alter the fundamental 
objectives of the Regulation. Safeguards such as the possibility to modify, suspend or revoke 
authorisations at any time remain in place, and are even strengthened, ensuring that food and 
feed safety standards are not compromised. The objective of the proposed simplification and 
clarification measures is to achieve improved efficiency of the additives’ authorisation system 
and  thereby  increased  competitiveness  of  EU  feed  businesses,  including  SMEs,  positive 
effects on investments and the development and availability of new innovative feed additives 
in the Union. 

Regulation  (EC)  No  852/2004  and  Regulation  (EC)  No  853/2004:  Regulation  (EC)  No 
852/200438  and  Regulation  (EC)  No  853/200439  of  the  European  Parliament  and  of  the 
Council  provide  for  a  specific  notification  procedure  to  be  followed  by  Member  States 
wishing to adopt national measures adapting the requirements laid down in Annexes II and III 
to  those  regulations  respectively.  These  requirements  concern  the  production  of  traditional 
products, regions with geographical constraints and measures in relation with structure, layout 
and equipment. However, those regulations also provide for the possibility for the competent 

in 

use 

animal 

nutrition 

additives 

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
29,  ELI: 

36 
for 
on 
http://data.europa.eu/eli/reg/2003/1831/oj) 
37 
38 
hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/852/oj ) 
39 
down  specific  hygiene 
http://data.europa.eu/eli/reg/2004/853/oj ) 

SWD(2024) 46 final  
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the 

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying 
(OJ  L  139,  30.4.2004,  p.  55,  ELI: 

food  of  animal  origin 

18.10.2003, 

(OJ  L 

rules 

268, 

for 

p. 

EN 

13 

  EN 

 
 
authorities of Member States to authorise certain activities or certain production procedures, 
which must then be notified to the Commission and the other Member States in accordance 
with  Directive  (EU) 2015/153540.  The  proposal  aims  at  simplifying  the  procedure  of 
notifications of national measures by requiring the use of a unique notification procedure, that 
provided for in Directive (EU) 2015/1535. This simplification of procedures would be highly 
beneficial to subsidiarity and the adoption of national measures adapting Union requirements 
to local needs, where necessary. The procedure in Directive (EU) 2015/1535 is simpler, and 
more efficient in terms of transparency, translation and time management, since all Member 
States have access to the TRIS database.   

Regulation (EC) No 1099/200941: As regards animal welfare at the time of killing, Member 
State competent authorities are currently required to submit annual reports to the Commission 
on  depopulation  operations  carried  out  the  previous  year,  in  addition  to  the  annual  reports 
submitted under the Regulation (EU) 2017/62542. Given its limited completeness and lack of 
comparability, the information provided has proven to be of limited value, when compared to 
the administrative burden of preparing the report. In addition, Member states’ annual reports 
under  the  Official  Controls  Regulation  cover  official  controls  on  the  Regulation  on  the 
welfare  of  animals  at  the  time  of  killing  including  its  provisions  concerning  depopulation 
operations,  and  are  sufficient  to  verify  compliance  with  Regulation  (EC)  No  1099/2009. 
Withdrawing  the  obligation  to  submit  a  specific  annual  reports  on  depopulation  operations, 
will  reduce  the  administrative  burden  on  Member  State  competent  authorities  and  the 
Commission. 

Regulation (EC) No 999/2001: Regulation (EC) No 999/200143 on transmissible spongiform 
encephalopathies  (TSEs)  was  adopted 
the  bovine  spongiform 
encephalopathy  (BSE)  epidemic  through  a  strict  precautionary  framework.  Since  then,  and 
although it is not possible to conclude that BSE is absent or has completely disappeared from 
the  EU  territory,  the  epidemiological  situation  has  improved,  with  most  Member  States 
recognised as having negligible risk. 

to  address 

in  2001 

Moreover,  the  rules  are  misaligned  with  the  World  Organisation  for  Animal  Health's 
(WOAH)standard, revised in 202344 and with recent scientific opinion on the BSE risk posed 
by ruminant collagen and gelatine derived from bones of the Authority published in 202445. In 

Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time 

40 
Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 maying 
down  a  procedure  for  the  provision  of  information  in  the  fields  of  technical  regulations  and  of  rules  on 
Information Society services (OJ L 214, 17.9.2015, p.1,  ELI: http://data.europa.eu/eli/dir/2015/1535/oj) 
41 
of killing (OJ L 303, 18.11.2009, pp. 1–30, ELI: http://data.europa.eu/eli/reg/2009/1099/oj) 
42 
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) 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 (Official Controls Regulation) (OJ L 95, 7.4.2017, 
pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj). 
43 
Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying 
down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ 
L 147, 31.5.2001, pp. 1–40, ELI: http://data.europa.eu/eli/reg/2001/999/oj) 
44 
revised-standard-on-bse/  
45 

WOAH  revised  standards  adopted  in  2023,  https://www.woah.org/en/article/woah-members-adopt-a-

https://www.efsa.europa.eu/en/efsajournal/pub/8883  

EN 

14 

  EN 

 
 
this context, certain  elements  of the  current  rules  should be reviewed and updated to  reflect 
this  evolution  and  to  ensure  they  remain  proportionate  to  the  current  level  of  risk  for  that 
disease in the Union. 

The  objective  of  this  proposal  is  to  modernise  Regulation  (EC)  No  999/2001  by  revising 
certain Articles, so that to ensure that the control measures of that disease can be updated in a 
swift  and  proportionate  manner  to  remove  certain  existing  unnecessary  regulatory  and 
operational burdens for authorities and operators, and remain science-based and aligned with 
international standards, while continuing to guarantee a high level of protection of public and 
animal health. 

In  order  to  achieve  this,  the  proposal  empowers  the  Commission  to  adopt  delegated  acts  in 
accordance  with  Article  290  of  the  Treaty  on  the  Functioning  of  the  European  Union.  This 
empowerment allows the Commission to amend the annexes of Regulation (EC) No 999/2001 
and  to  supplement  certain  provisions  concerning  surveillance,  specified  risk  material  and 
products of animal origin. Such delegation ensures timely alignment with evolving scientific 
knowledge,  international  standards  and  the  epidemiological  situation,  while  ensuring  the 
rights of scrutiny of the European Parliament and the Council. 
Regulation  (EU)  2017/625:  Article  50(3)  of  Regulation  (EU)  2017/62546  provides  that 
consignments entering the Union and presented for official controls at the border control posts 
(BCPs),  cannot  be  split  until  the  required  controls  have  been  completed  on  the  entire 
consignment.  It  implies  that  BCPs  are  not  allowed  to  release  the  compliant  part  of  a 
consignment if another part still needs further checks, such as laboratory testing.  

This  requirement  is  particularly  detrimental  to  the  plant  health  sector  where  phytosanitary 
certificates can cover consignments consisting of multiple batches of various plants and plant 
products,  for  which  each  individual  batch  require  different  type  of  controls  and  analyses  of 
varying duration. In the case of perishable products with a limited shelf life, these delays can 
sometimes  lead  to  spoilage  or  even  complete  loss  of  products  that  are  not  subjected  to  any 
laboratory  analysis.  Member  States  and  stakeholders  have  called  for  some  flexibility  in  this 
area,  to  avoid  unnecessary  delays  and  heavy  financial  consequences  for  the  operators. 
Introducing  an  option  of  partial  clearance  for  consignments  of  plants  and  plant  products 
would  solve  this  issue.  In  addition,  this  will  not  compromise  the  level  of  phytosanitary 
protection  of  the  Union  territory  as  it  will  not  impact  the  quality  and  accuracy  of  official 
controls. 

Therefore, it is considered appropriate to amend Article 50(3) of Regulation (EU) 2017/625 to 
allow the competent authorities of the BCPs to split consignments of plant and plant products 
before completing the official controls on the entirety of the consignment, in order to release 
the parts for which official controls have already been finalised. 

46 
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) 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 (Official Controls Regulation) (OJ L 95, 7.4.2017, 
pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj) 

EN 

15 

  EN 

 
 
Article  93(3)  and  Article  100(2)  of  Regulation  (EU)  2017/625  provide  that  EU  reference 
laboratories and national reference laboratories have to include all the methods of laboratory 
analysis,  test  or  diagnosis  within  their  accreditation  scope.  This  requirement  created 
significant challenges for reference laboratories which are expected to seek accreditation for a 
very large number of contaminants, pests, methods and matrices in areas such as plant health, 
food contact materials, feed additives and food additives, food enzymes and flavourings. The 
accreditation is a complex and costly process for laboratories which poses a heavy burden in 
terms  of  time  and  resources  on  reference  laboratories.  This  problem  has  been  repeatedly 
flagged  by  the  Member  States  and  by  EU  reference  laboratories  which  underline  that  the 
current framework does not sufficiently take into account operational realities.  

In order to reduce accreditation and human resources costs for EU reference laboratories and 
national  reference  laboratories  without  affecting  the  reliability  of  the  analysis  results  it  is 
appropriate to allow under certain conditions to designate them even if they are not accredited 
for all laboratory methods. 

Article  37(4),  point  (e),  Article  93(3),  point  (a)  and  Article  100(2)  of  Regulation  (EU) 
2017/625 provides that official laboratories, EU reference and national reference laboratories 
should  operate  and  be  accredited  in  accordance  with  the  EN  ISO/IEC  17025  standard. 
Nevertheless,  certain  biological  food  safety  hazards  could  be  analysed  in  laboratories 
accredited by both the EN ISO/IEC 17025 and another similar laboratory standard such as, the 
ISO 15189.  

In order to avoid duplication of accreditation, reduce costs and increase effectiveness of the 
competent  authorities  of  the  Member  States  to  analyse  samples  for  certain  biological  food 
safety hazards it is appropriate to allow for laboratories to be accredited by similar laboratory 
standards other than EN ISO/IEC 17025. 

•  Consistency with existing policy provisions in the policy area 

The proposal is part of a package of measures concerning simplification, aiming at reducing 
administrative burden and costs for industries. 

•  Consistency with other Union policies 

This  initiative  contributes  to  simplification  and  reduction  of  regulatory  burdens  for  the 
agrifood  sector,  as  announced  in  the  Vision  on Agriculture  and  Food  while  maintaining  the 
high standards of protection for the human, animal health and the environment. 

2. 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

•  Legal basis 

Article  43(2),  Article  114,  Article  168(4)(b)  and  Article  192(1)  of  the  Treaty  on  the 
Functioning of the European Union (TFEU). 

•  Subsidiarity (for non-exclusive competence)  

The  proposed  amendments  are  adopted  at  EU  level  as  the  Regulations  concerned  were 
adopted at EU level  [before and the intended objectives, therefore, could  not be  sufficiently 
achieved  at  Member  State  level.  To  solve  the  same  problems,  one  action  at  EU  level  was 
considered  less  costly  and  more  efficient  than  national  measures  in  27  Member  States. 
Accordingly, amendments to these Regulations need to be made at EU level.] 

EN 

16 

  EN 

 
•  Proportionality 

The initiative does not go beyond what is necessary to achieve the objectives of simplification 
and burden reduction without lowering the protection of human health and environment. 

•  Choice of the instrument 

This proposal for revision is a legislative proposal, as the relevant Regulations to be amended 
were adopted by co-decision/ ordinary legislative procedure. 

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

•  Ex-post evaluations/fitness checks of existing legislation 

This  proposal  is  accompanied  by  a  Commission  staff  working  document  that  includes  a 
detailed  overview  of  the  positive  impacts  of  the  proposed  amendments  of  the  relevant 
provisions of food and feed safety legislation, based on existing data and information gathered 
during the Call for evidence and the previous analyses. 

•  Stakeholder consultations 

The  Commission  ran  a  proportionate,  targeted  consultation  to  calibrate  the  proposed 
measures,  drawing  on  ongoing  exchanges  with  Member  States  and  stakeholders,  recent 
evaluations  (in  particular  on  the  pesticides  legislation  and  the  feed  additives  regulation).  In 
addition,  the  Commission  organised  a  targeted  Implementation  Dialogue  on  the  biocidal 
products regulation in July 2025. A Call for Evidence ran from 16 September to 14 October 
2025, which gathered 6,440 responses overall. Nearly 6,000 came from citizens, mostly due 
through  semi-automated  campaigns,  318  from  businesses  and  their  associations,  52  public 
authorities, 107 from civil society, and 16 from academia. All these stakeholders shared 319 
position papers with detailed, technical input. The evidence informed the problem definition, 
prioritisation of options, and safeguards.  

On plant protection products, the most directly affected stakeholders backed faster access to 
effective  tools,  especially  biocontrol,  while  warning  that  biologicals  are  not  like-for-like 
replacements  and  that  farmers  need  workable,  affordable  options.  Many  cited  delays, 
complexity and costs in substance renewal and product authorisations, and asked for clearer, 
risk-based selection for full renewals, firm timelines and better mutual recognition/minor uses 
extensions.  Non-governmental  organisation  (NGOs)  and  citizens,  however,  voiced  strong 
concerns about the overall direction of simplification, fearing it could weaken safeguards for 
health, biodiversity  and water protection. They called for maintaining  or even strengthening 
the  high  level  of  precaution  under  the  plant  protection  products  legislation,  phasing  down 
pesticide  use,  limiting  derogations,  and  avoiding  any  reduction  in  oversight  of  active 
substances  or  authorisations.  Views  on  aerial  spraying  of  plant  protection  products  were 
similarly  split:  businesses  favour  enabling  use  under  harmonised  risk-management  rules 
(precision,  drift  reduction,  operator  safety),  while  NGOs,  citizens  and  some  Member  States 
warned of potential exposure and drift risks, calling for strict limitations near sensitive sites 
and  robust  enforcement.  On  MRLs,  many  supported  clarifications  and  fair  transitional 
measures to avoid food waste and economic losses, whereas NGOs and some farmer groups 
urged a more precautionary stance, i.e. tighter controls on import tolerances for substances not 
approved in the Union and continued prioritisation of consumer health over trade facilitation.  

EN 

17 

  EN 

 
For  biocidal  products,  relevant  industry  stakeholders  and  several  Member  States  prioritised  
completing  the  review  programme  and  simplifying  renewals;  most  business  inputs  opposed 
the 2025 end date already set in the legislation for the protection of data submitted for existing 
active  substances  still  in  the  review  programme,  referring  to  their  concerns  that  other 
companies would benefit from free access to data, and to investment risks, though a minority 
warned  extensions  could  dampen  competition.  NGOs  and  citizens  expressed  concern  that 
streamlining  could  be  perceived  as  deregulation  and  stressed  that  any  adjustments  must  not 
reduce scrutiny of high-risk biocidal products or delay the evaluation of endocrine disruptors 
and should rather await the results of the full evaluation of Regulation (EU) No 528/2012.   

Authorities  and  industry  sought  legal  clarity  on  fermentation  products  obtained  by  using 
GMMs  as  a  production  strain  to  harmonise  the  interpretation  of  Regulation  (EC)  No 
1829/2003 and its enforcement, while NGOs insisted such products should be remain covered 
by  GMO  rules,  with  mandatory  risk  assessment,  traceability  and  labelling  as  genetically 
modified food and feed to ensure consumer choice.  

Feed  additives  business  stakeholders  largely  supported  streamlining,  unlimited  in  time 
authorisations,  and  wider  use  of  digital  labelling,  whereas  NGOs  and  several  public 
authorities  called  for  vigilance  to  ensure  safety  and  transparency  of  sustainability  claims. 
Member  States  welcomed  simpler  hygiene  notifications;  several  requested  rationalising 
animal-welfare  depopulation  reporting.  Stakeholder  input  also  shows  broad  support  for 
aligning BSE measures with WOAH standards, provided that risk-based updates do not dilute 
surveillance.  On  official  controls,  operators  and  authorities  backed  partial  clearance  of 
laboratory-accreditation 
consignments  with  harmonised  procedures  and  proportionate 
flexibilities limited in scope.  

Overall,  stakeholders  favoured  risk-proportionate  simplification  that  preserves  high  health, 
environmental  and  consumer  protection,  underpinned  by  transparency,  independent  science, 
and strong enforcement. 

•  Collection and use of expertise 

Different suggestions for clarifying certain provisions of food and feed safety legislation and 
removing the excessive administrative burden stemming from these provisions have emerged 
through stakeholders’ proposals for simplification. Furthermore, in  response and the follow-
up  of  the  Call  of  evidence  mentioned  above,  the  Commission  received  more  than  6000 
detailed  position  papers  from  stakeholders,  providing  additional  suggestions,  data  and  costs 
estimates. 

•  Impact assessment 

The  proposed  simplification  measures  are  highly  technical  in  nature.  There  are  no  viable 
alternatives  to  achieve  the  objectives,  and  the  proposed  measures  do  not  alter  core  policy 
objectives  or  introduce  significant  new  obligations.  For  these  reasons,  a  full  impact 
assessment  would  not  bring  added  value.  Instead,  the  proposal  is  accompanied  by  an 
analytical staff working document. The document clearly explains the proposed measures and 
present  the underlying evidence, analysis and stakeholders’ views, as well  as estimating  the 
potential cost savings. 

On  the  basis  of  the  information  available,  it  is  expected  that  the  amendments  would  entail 
significant  cost  savings  for  industry  and  for  authorities.  Most  measures,  e.g.  on  biocontrol 
plant protection products, biocides, feed additives, would start yielding benefits quickly, while 

EN 

18 

  EN 

 
the broader plant protection  products  framework  simplification, requiring  structural  changes 
to  renewal,  will have a longer transition.  From 2027, business  cost  savings are estimated  at 
€335,6 million annually, rising by a further €93 million per year from 2029 as plant protection 
products simplifications take effect. In this mandate, the ten measures are expected to deliver 
at least €1 billion in 2027–2029, with an additional €2.1 billion in the next mandate.  

Public authorities would also gain substantially: administrative costs are projected to fall by € 
661  million  annually  and  in  total,  this  amounts  to  an  estimated  €  4.6  billion  reduction  in 
administrative costs over 2027–2034. 

•  Regulatory fitness and simplification 

This proposal is part of the commitment of the Commission to lighten the regulatory burden 
for people, businesses and administrations in the EU to boost prosperity and resilience of the 
Union  The  proposal  is  therefore  aiming  at  simplifying  provisions  of  food  and  feed  safety 
legislation,  reducing  unnecessary  burdens  and  costs  for  businesses  and  authorities,  without 
undermining the protection of human and animal health and the environment. 

•  Fundamental rights 

The proposal respects the fundamental rights enshrined in the Charter of Fundamental Rights 
of  the  European  Union  and  adheres  to  the  principles  recognised  therein.  The  reduction  of 
administrative burden on companies should lead to societal gains in terms of wealth creation, 
employment and innovation. At the same time, the proposal will not undermine the objective 
of ensuring a high level of protection of human health and of the environment. 

4. 

BUDGETARY IMPLICATIONS 

The  proposed  initiative  is  expected  to  result  in  an  increase  of  EUR  15,073  million  in  the 
subsidy  paid  by  the  Commission  to  the  Authority  for  the  period  2028–2034.  Without 
prejudice to the negotiations on the next MFF, the additional appropriations allocated to the 
agency from 2028 onwards will be compensated via redeployments from programmes under 
the same heading as the agency under the 2028-2034 MFF. 

5. 

OTHER ELEMENTS 

•  Implementation plans and monitoring, evaluation and reporting arrangements 

The Commission will monitor the implementation and application of the new provisions and 
compliance  with  them.  Furthermore,  the  Regulations  to  be  amended  by  this  proposal  are 
subject  to  regular  evaluation  of  their  efficiency,  effectiveness  in  reaching  their  objectives, 
relevance,  coherence  and  value  added  in  accordance  with  better  regulation  principles.  This 
proposal does not require an implementation plan. 

•  Detailed explanation of the specific provisions of the proposal 

•  Regulation (EC) No 1107/2009 

This  legislative  proposal  contains  several  targeted  amendments  to  Regulation  (EC)  No 
1107/2009  to  accelerate  market  access  for  biocontrol  substances  and  products  containing 
them, including a clear definition of them under Articles 2 and 3, prioritising the approval and 
authorisation  procedures  for  such  substances  and  products  under  Articles  11  and  37,  giving 
the  possibility  to  Member  States  to  grant  provisional  authorisations  for  plant  protection 
products  containing  new  biocontrol  substances  for  which  the  approval  procedure  is  still 

EN 

19 

  EN 

 
ongoing  under  Article  30,  and  allowing  the  Authority  to  take  on  the  tasks  of  a  rapporteur 
Member  State  for  the  initial  risk  assessment  of  an  application  for  approval  in  order  to 
compensate  for  the  lack  of  capacity  in  some  Member  States  under  Article  7.  Additional 
resources  for  the  Authority  are  proposed  to  take  on  these  new  tasks  as  indicated  in  the 
Legislative  Financial  Fiche.  As  many  biocontrol  substances  may  also  have  plant  growth 
stimulation functions, a clearer borderline between biocontrol substances and biostimulants is 
needed to increase legal certainty for companies and a smoother enforcement by authorities. 

In  order  to  reduce  these  difficulties  and  ensure  a  more  equal  access  to  biocontrol  products 
across all Member States, Articles 3 and 33 are amended so that all Member States are to be 
considered to be in one zone for applications for authorisation for such products. Considering 
that  plant  protection  products  containing  only  biocontrol  substances  or  low-risk  active 
substances  are  not  expected  to  pose  different  levels  of  risk  in  different  Member  States,  the 
provisions  on  zonal  authorisation  in  Article  37  and  mutual  recognition  under  Article  42  are 
reinforced  so  that  authorisations  for  such  products  granted  by  one  Member  States  are 
recognised by tacit agreement if decisions on applications for  zonal authorisation or mutual 
recognition  are  not  adopted  within  the  prescribed  deadline.  The  obligation  to  keep  records 
under  Article  67  shall  not  apply  to  plant  protection  products  containing  only  biocontrol 
substances in order to reduce administrative burdens on farmers using these products. 

Considering  that  most  approved  active  substances  have  gone  through  at  least  one  renewal 
process already and that new active substances are expected to have better toxicological and 
ecotoxicological  properties,  Article  5  is  to  be  amended  so  that  the  approval  of  active 
substances  becomes  unlimited  in  time,  except  for  active  substances  that  are  candidates  for 
substitution and those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these 
have properties that are of concern with regard to human or animal health or the environment, 
and  for  active  substances  for  which  it  has  been  decided  to  set  time  limits  for  approvals  if 
found  appropriate  in  the  light  of  the  outcome  of  the  risk  assessment  prior  to  a  decision  on 
approval.  A new Article 27a is  inserted  making the approval  period of all active substances 
approved  at  the  time  of  the  entry  into  force  of  this  regulation  unlimited,  with  certain 
exceptions. Article 18 is amended and a new Article 18a is created to allow the Commission, 
taking into account requests from Member States, to identify active substances with unlimited 
approval for which a full renewal procedure will be carried out or identify active substances 
with  unlimited  or  limited  approval  periods  for  targeted  reassessment.  In  addition,  the 
possibility  for  ad-hoc  reviews  already  foreseen  in  Article  21  of  Regulation  (EC)  No 
1107/2009 is maintained. Article 32 is amended in order to maintain the limited duration for 
authorisations  of  plant  protection  products  containing  active  substances  with  unlimited 
approval. Articles 43 and 44 are amended to further specify provisions related to the renewals 
and reviews  of authorisations of plant protection products containing  active substances with 
unlimited approval.    

Article  19  is  also  amended  to  allow  for  the  adoption  of  implementing  rules  setting  out  the 
provisions necessary for the implementation of a targeted reassessment procedure (in addition 
to the renewal procedure which already exists). 

Article  4(7)  is  amended  to  clarify  for  which  substances  the  derogation  can  be  used  and  to 
waive  the  obligation  on the  Member  States  authorising  plant  protection products  containing 
active substances approved under Article 4(7) to draw up a phasing-out plan.  

The criteria for identifying low-risk active substances in Article 22 are simplified to only refer 
to the intrinsic properties of the active substance and Article 7 is amended so that it is possible 
to apply for a change of the status of an approved active substance to low-risk. 

EN 

20 

  EN 

 
Article  20(2)  is  amended  to  allow  for  the  setting  of  grace  periods  when  the  approval  of  an 
active  substance  is  not  renewed  except  for  cases  where  there  are  immediate  and  serious 
concerns for human or animal health or the environment. Article 46 is amended to align the 
maximum  grace  period  that  the  Member  States  can  set  in  case  of  withdrawals  of 
authorisations with the one set under Article 20(2). The maximum grace period under Article 
20(2) and Article 46 is increased to a maximum of one year for the sale and the distribution 
and an additional maximum of two years for the disposal, storage, and use of existing stocks 
of  the  plant  protection  products  concerned,  for  cases  where  reasonable  alternatives  do  not 
exist. 

Article  11  is  amended  in  order  to  provide  the  possibility  for  the  Member  States  to  ask  for 
support  from  the  Authority  during  the  preparation  of  the  draft  assessment  report  for  an 
application for approval or renewal of approval, for the assessment of additional information 
required during the peer review process and for updating the draft assessment report after its 
initial submission.  

Article 36(3) is amended in order to clarify that the last assessment conducted at EU level for 
an  active  substance  shall  be  taken  into  account  by  the  Member  States  when  they  assess  the 
‘current scientific and technical knowledge’ for the substance. However, if they consider that 
an update is of that assessment is justified they shall submit a request to the Commission for 
harmonised  assessment  of  the  current  scientific  and  technical  knowledge  concerning  the 
active substance. 

Article 40 and Article 42 are amended in order to facilitate the mutual recognition process, in 
particular  in  case  of  applications  submitted  by  official  or  scientific  bodies  involved  in 
agricultural activities or professional agricultural organisations or application for minor uses 
extensions. Article 51 is also amended in order to further facilitate minor uses extensions.  

Article 3, point 17, and Article 37 are amended providing for a one-zone approach (instead of 
three  zones),  and  a  prioritisation  of  applications  for  the  purposes  of  Regulation  (EU) 
2016/2031. 

Articles 23 and 28 are amended and a new Article 23 a is inserted in order to clarify the status 
of  the  basic  substances,  the  approval  criteria  and  to  allow  for  their  marketing  so  that  the 
farmers and non-professional users in the EU have equal access to these substances.  

Article 49 is clarified by providing explicitly that the sowing of treated seeds constitutes a use 
of  plant  protection  products  and  by  broadening  its  scope  to  plant  reproductive  material  in 
general and not only treated seeds. 

Article 59 is amended to provide for EU-wide territorial scope of the data protection and to 
simplify its application by Member States and applicants. 

Article  68  is  deleted  as  the  reports  of  the  Member  States  on  the  official  controls  of  plant 
protection  products  are  already  included  in  the  annual  reports  under  Article  113(1)  of 
Regulation (EU) 2017/625. 

Article  2  of  the  draft  Regulation  is  introduced  containing  transitional  provisions  to  provide 
legal certainty in procedures for applications for approval or renewal of active substances or 
for  the  authorisation  of  plant  protection  products  that  are  ongoing  at  the  time  of  entry  into 
force of this Regulation and to ensure a smooth transition from the current provisions under 
Regulation (EC) No 1107/2009 to the new ones. It is clarified also that the data protection of 

EN 

21 

  EN 

 
test or study reports which started under the old rules will continue but only for the Member 
States where it was granted while for the rest of the Member States the new rules will apply to 
the same test and study report. Transitional provision on the basic substance is also included 
providing  that  all  approved  basic  substances  could  be  used  and  placed  on  the  market 
notwithstanding whether they were approved also as regular active substances under the old 
regime  where  the  placing  on  the  market  as  a  plant  protection  product  in  a  Member  State 
prevented the use of basic substance for the same use in that Member State. 

•  Regulation (EC) No 396/2005 

Article  3(2)  is  amended  to  clarify  in  point  (a)  that  ‘good  agricultural  practice  (GAP)’  can 
relate to a use in the EU or in  a third country. As a consequence, the definition of the term 
“import tolerance” in point (g) is no longer needed and can be removed and in Article 6(4) the 
term “import tolerances” is replaced by “setting an MRL based on a GAP implemented in a 
third country”. Article 14(2)(e) is amended to set out that for substances that are not approved 
in  the  Union  and  that  have  certain  particularly  hazardous  properties,  MRLs  that  were  set 
based on good agricultural practices in third countries or Codex maximum limits may be set at 
the  limit  of  quantification  (technical  zero)  if  considered  appropriate  in  the  light  of  the 
outcome of an impact assessment. . 

Article 3(2)f is amended so that the term ‘Limit of determination (LOD)’ is replaced with the 
term  ‘Limit  of  quantification  (LOQ)’  in  order  to  align  the  terminology  to  the  one  used  in 
international  standards  for  laboratory  analysis.  Article  10(1)b)  and  31(1)(b)  are  amended 
accordingly to replace the abbreviation ‘LOD’ with ‘LOQ’.  

New  paragraphs  are  added  to  Article  14  and  Article  18  that  provide  for  the  possibility  to 
establish transitional measures allowing the placing or remaining on the market in the Union 
of  products  that  were  compliant  with  the  MRLs  applicable  at  the  time  their  placing  on  the 
market or at the time of their placing into storage after production in order to avoid the need 
for market withdrawal and food waste. 

Article  15(1)  and  Article  16  are  amended  so  that  MRLs  based  on  monitoring  data  are  no 
longer  temporary,  but  permanent.  For  substances  that  have  not  been  approved  for  several 
decades and are now deemed as contaminants due to their persistence in the environment and 
for which stable residue levels have been recorded over many years, such as DDT or mercury, 
a mandatory review after ten years is  disproportionate when considering the costs involved. 
At the same time Article 43 is modified so that the MRLs can be reviewed at any time based 
on new scientific and technical knowledge which ensures that the MRLs based on monitoring 
data still could be reviewed, if necessary.  

•  Regulation (EU) No 528/2012 

In order to give higher priority to the completion of the review programme of existing active 
substances, Article 4(1), Article 9 and Article 12(3) are amended to provide for an unlimited 
duration  of  the  approval  of  biocidal  active  substances,  except  for  active  substances  that  are 
approved although they meet the exclusion criteria set out in Article 5(1) of Regulation (EU) 
No 528/2012 or the substitution criteria set out in Article 10 as these have properties that are 
of concern to human or animal health or the environment. The time limits for approvals can 
also  be  imposed  on  case-by-case  basis,  in  the  light  of  the  outcome  of  the  risk  assessment, 
prior to a decision on an approval. The approval of active substances already approved will be 
converted  into  unlimited  approvals  following  these  new  rules,  except  for  active  substances 
identified  as  meeting  the  exclusion  criteria  set  out  in  Article  5(1)  of  Regulation  (EU)  No 

EN 

22 

  EN 

 
528/2012  or  the  substitution  criteria  set  out  in  Article  10,  active  substances  for  which  the 
renewal  examination  already  started  for  which  the  renewal  evaluation  will  continue  or  the 
approval will expire when no application was submitted by the deadline (new Article 15a). 

Article 13(1) is modified to specify that the renewal process is relevant for active substances 
with  specified  expiry  dates  of  approval.  In  order  to  maintain  a  high  level  of  protection  of 
human and animal health and the environment, a new Article 14a is added so that it provides 
the  possibility  for  the  Commission  to  select  a  number  of  active  substances  for  which  a 
renewal procedure would be triggered. Selection criteria for active substances subject to that 
procedure can include, among others, relevant new or updated data requirements or guidance 
documents,  indications  of  safety  concerns  for  human  or  animal  health  or  the  environment, 
new  scientific  or  technical  knowledge  and  available  monitoring  data,  and  may  take  into 
account requests from Member States. 

Articles  44  and  46  are  amended  so  that  the  individual  decisions  on  Union  authorisation  no 
longer take the form of Commission Implementing Regulations, published at the EU Official 
Journal, but the form of Commission Implementing Decisions only notified to the applicants. 
Thus,  only  summaries  of  these  Decisions  will  be  published  at  the  EU  Official  Journal  for 
transparency  which  will  reduce  the  time  period  necessary  for  the  translation  and  publishing 
and simplify the process. 

•  Regulation (EC) No 1829/2003  

Article 2, point 10, of Regulation (EC) No 1829/2003 is amended to clarify that the definition 
of food and feed ‘produced from GMOs’ does not cover food and feed products obtained with 
GMMs used as production strains.  

•  Regulation (EC) No 1831/2003 

Paragraph 8 of Article 9 is amended in order to  provide that authorisations granted for feed 
additives  are  valid  for  an  unlimited  period  of  time,  and  no  longer  for  a period  of  ten  years. 
This amendment aligns with the principle of unlimited authorisation period applicable in other 
sectors  such  as  food  additives,  which  provide  for  mechanisms  allowing  a  supervision  and 
possible  review  of  existing  authorisations  in  order  to  ensure  the  safety  of  the  products 
concerned.  The  paragraph  specifies  that  such  authorisation  is  valid  without  prejudice  to 
Article 13, which allows to modify, suspend or revoke any authorisation at any time where the 
safety or efficacy conditions for authorisation are no longer met. A new paragraph 8b is added 
to  provide  for  a  derogation  to  the  unlimited  authorisation  period  as  regards  additives 
belonging  to  the  category  of  coccidiostats  and  histomonostats,  the  authorisation  of  which 
remaining  valid  for  ten  years  due  to  their  higher  safety  risk  profile  in  relation  to  their 
antimicrobial nature. 

Alternative  measures  to  the  option  of  authorisations  valid  for  an  unlimited  period  of  time, 
such as longer authorisation periods for some or all feed additives or different  authorisation 
periods according to the type of additives, were not considered as satisfactory due to a lack of 
objective criteria to differentiate between additives’ categories or functional groups in terms 
of safety or efficacy or due to the risk of absence of applicants for the renewal of non-holder 
specific authorisations. 

Article  14  concerning  the  renewal  of  authorisations  is  amended  to  reduce  its  scope  to 
additives belonging to the category of coccidiostats and histomonostats, as a consequence of 
the provisions laid down in Article 9(8) and (8b). 

EN 

23 

  EN 

 
A new Article 9a is introduced to clarify that authorisations of feed additives already granted 
before the entry into force of the new rules (this proposed Regulation) are deemed unlimited 
in time, except those concerning: (i) feed additives belonging to the category of coccidiostats 
and  histomonostats,  (ii)  urgent  authorisations  granted  under  Article  15  and  concerning 
authorisations  for  which  no  application  for  renewal  has  been  submitted  on  time  before  the 
entry into force of the new rules (this proposed Regulation) or for which such application has 
been submitted but subsequently withdrawn, and (iv) authorisations for which an application 
for renewal  has  been submitted in  accordance with Article 14 before  the entry into force of 
the  new  rules  (this  proposed  Regulation)  and  for  which  no  decision  has  been  taken  by  that 
date. 

In  addition,  a  new  Article  14a  is  introduced  to  provide  legal  certainty  regarding  pending 
procedures concerning applications for renewal of authorisation that have been submitted in 
accordance  with  Article  14  as  applicable  before  the  entry  into  force  of  the  new  rules  (this 
proposed  Regulation)  and  for  which  no  decision  has  been  taken  by  that  date,  which  must 
continue  to  be  treated  under  the  previous  rules.  However,  it  is  clarified  that  the  renewed 
authorisation will be valid for an unlimited period of time in accordance with the new Article 
9(8). 

Paragraph 1 of Article 13 concerns cases where the Authority adopts an opinion on whether 
an authorisation still meets the conditions set out by Regulation (EC) No 1831/2003 either on 
its  own  initiative  or  upon  request  from  a  Member  State  or  from  the  Commission.  The 
paragraph is amended to further specify that, in order to prepare its opinion, the Authority has 
to  take  into  account  scientific  and  technological  developments  and  may  request  relevant 
information and data from the person who was the applicant for the authorisation concerned, 
or,  where  applicable,  from  the  holder  of  that  authorisation.  In  addition,  considering  that  the 
the Authority’s opinion is not triggered by the submission of an application for modification 
of an authorisation, the Authority will still have the possibility, in accordance with Articles 32 
and 33 of Regulation (EC) No 178/2002, to commission any scientific studies and to collect 
any data that would be needed to perform a proper assessment. 

Paragraph  3  of  Article  13  concerns  cases  where  an  application  for  modification  of  an 
authorisation  is  submitted  by  the  holder  of  that  authorisation.  A  paragraph  3a  is  added  to 
provide  that  where  a  modification  of  the  name  of  the  authorisation-holder  is  requested,  a 
notification must be sent to the Commission, accompanied by the relevant data, and that the 
Community Register of Feed Additives is to be adapted accordingly. This aims to avoid the 
need  to  adopt  a  formal  regulation  concerning  such  administrative  modification,  while  the 
name  of  the  authorisation-holder  will  continue  to  be  publicly  accessible  through  the 
Community  Register  of  Feed  Additives,  instead  of  being  included  in  the  terms  of  the 
authorisation regulation. As a consequence, Article 9(6) and (8) are amended to provide that 
the  name  of  the  authorisation-holder  is  included  in  the  Register  of  feed  additives  and  no 
longer in the regulation granting the authorisation. In addition, Article 2 is amended to include 
the definition of ‘holder of the authorisation’ as the natural or legal person mentioned as such 
in  the  Community  Register  of  Feed  Additives  in  relation  to  the  authorisation  concerned. 
Article 3(3) is amended as well to remove the mention of the holder of the authorisation in the 
Regulation granting the authorisation. 

Furthermore, a new paragraph 8a is added in Article 9 to provide for the possibility to amend 
the  Regulations  granting  authorisations  adopted  before  the  date  of  entry  into  force  of  this 
Regulation,  and  which  included  the  name  of  the  holder  of  the  authorisation,  with  a  view  to 
including  such  name  in  the  Community  Register  of  Feed  Additives  instead  of  in  those 

EN 

24 

  EN 

 
Regulations. In order to ensure uniform conditions for the implementation of Regulation (EC) 
No  1831/2003  regarding  such  amendment  to  Regulations  granting  authorisations  adopted 
before  the  date  of  entry  into  force  of  this  Regulation,  implementing  powers  should  be 
conferred  on  the  Commission  in  accordance  with  Regulation  (EU)  No  182/2011  of  the 
European Parliament and of the Council47. 

A new paragraph 4 is added in Article 13 to provide for the possibility for any interested party 
to  submit  an  application  for  modification  of  an  authorisation  for  which  there  is  no  specific 
holder, i.e. for the additives belonging to  the current  categories of technological,  sensory or 
nutritional additives. The requested modification should aim at extending the specifications or 
conditions included in the existing authorisation, due to its ‘generic’, i.e. non-holder specific, 
nature. This new explicit possibility clarifies and simplifies the procedures applicable where 
requests  are  submitted  to  the  Commission  in  view  of  adapting  the  terms  of  existing  non-
holder  specific  authorisations,  avoiding  the  re-submission  of  full  applications  for  new 
authorisations, mirroring the procedure in force for holder-specific authorisations, and will be 
all the more relevant under the new proposed regime of authorisations for an unlimited period 
of time. 

A new paragraph 5 is  added in  Article 13 to  allow the  adaptation  of existing authorisations 
with  regard  specifically  to  the  methods  of  analysis  included  therein,  to  take  into  account 
scientific  and  technological  developments  and  in  the  absence  of  procedure  for  renewal  of 
authorisations,  which  could  include  such  adaptation.  The  proposed  procedure  allows  the 
Community  Reference  Laboratory  to  submit  a  new  evaluation  report  to  be  verified  by  the 
Authority before the adoption by the Commission of a regulation on the modification of the 
authorisation. 

Finally, in order to ensure uniform conditions for the implementation of Regulation (EC) No 
1831/2003  regarding  the  modification  of  authorisations,  implementing  powers  should  be 
conferred  on  the  Commission  in  accordance  with  Regulation  (EU)  No  182/2011  of  the 
European Parliament and of the Council. Furthermore, the possibility to adopt any appropriate 
measures  in  accordance  with  Articles  53  and  54  of  Regulation  (EC)  No  178/2002  of  the 
European Parliament and of the Council48 should continue to apply. 

Paragraph 1 of Article 16 is amended to clarify the feed business operators’ responsibility for 
the labelling particulars, in line with the provisions of Regulation (EC) No 767/2009 for the 
labelling  of  feed.  Paragraph  2  also  introduces  a  distinction  between  physical  and  digital 
labelling of feed additives and premixtures. While this provision basically requires labelling 
to be made on a label attached to the packaging or container, it is proposed to provide for a 
derogation  to  that  principle  by  allowing  digital  labelling  for  certain  non-safety  related 
information. This derogation concerns information referred to in points (b) (name and address 
of  the  person  responsible  for  the  labelling  particulars),  (d)  (approval  number,  where 
applicable, of the establishment manufacturing or placing the product on the market) and (g) 
(batch reference number and date of manufacture) of paragraph 2.  

47 Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011  laying 
down  the  rules  and  general  principles  concerning  mechanisms  for  control  by  Member  States  of  the 
Commission’s 
13, 
exercise 
ELI:  http://data.europa.eu/eli/reg/2011/182/oj). 

implementing 

28.2.2011, 

powers 

(OJ 

55, 

of 

p. 

L 

48 

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority  and  laying  down  procedures  in  matters  of  food  safety  (OJ  L  31,  1.2.2002,  p.  1,  ELI:  
http://data.europa.eu/eli/reg/2002/178/oj). 

EN 

25 

  EN 

 
 
 
A new paragraph 7 is added in Article 16 to set out basic and clear conditions for the labelling 
of  information  by  digital  means:  information  to  be  made  available  on  a  physical  label  to  a 
competent  authority  upon  request;  information  to  be  easily  and  directly  accessible,  free  of 
charge and information to be made available for a period of two years from the date of placing 
on the market. 

A new paragraph 9 is added in Article 16 to empower the Commission to adopt delegated acts 
to supplement Regulation (EC) No 1831/2003 by establishing rules to enhance and facilitate 
digital labelling. Those rules may relate to the nature of the information concerned, including 
information referred to in paragraphs 2, 4 or 5 of Article 16, and the type of digital means that 
may be used. However, safety-critical and essential-use information, such as that included in 
the  authorisation,  must  remain  on  a  physical  label.  The  aim  is  to  expand  digital  labelling 
possibilities  in  the  future  to  take  into  account  technological  developments  and  to  provide 
operators with greater flexibility, while preserving the core objective of ensuring safe use of 
feed additives. Article 21a concerning the exercise of the delegation needs to be amended in 
order to refer to the new empowerment granted to the Commission. 

In  order  to  take  into  account  the  expansion  of  the  possible  labelling  means,  Article  2(2)  is 
amended  by  adding  a  definition  for  the  concepts  of  ‘labelling’  and  ‘label’,  in  line  with  the 
corresponding definitions laid down in Regulation (EC) No 767/2009 which sets out labelling 
rules concerning feed materials and compound feed. 

•  Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004 
Article  13  of  Regulation  (EC)  No  852/200449  and  Article  10  of  Regulation  (EC)  No 
853/200450 are amended in order to replace the specific notification procedure by the general 
notification procedure under Directive (EU) 2015/1535 of the European Parliament and of the 
Council51, as it is  simpler, and  more efficient in  terms of transparency, translation  and time 
management.  

•  Regulation (EC) No 1099/2009 

Member State competent authorities are currently required by Regulation (EC) No 1099/2009 
to  submit  annual  reports  to  the  Commission  on  depopulation  operations  carried  out  the 
previous  year,  in  addition  to  the  annual  reports  submitted  under  the  Official  Controls 
Regulation.  Given  its  limited  completeness  and  lack  of  comparability,  the  information 
provided has proven to  be of limited value, when compared  to  the  administrative burden of 
preparing  the  report.  In  addition,  Member  states  annual  reports  under  the  Official  Controls 
Regulation cover official controls on the Regulation on the welfare of animals at the time of 
killing,  including  its  provisions  concerning  depopulation  operations,  and  are  sufficient  to 
verify  compliance  with  Regulation  (EC)  No  1099/2009.  By  withdrawing  the  obligation  in 
Article 18, paragraph 4 of Regulation (EC) No 1099/2009 to submit a specific annual report 
on  depopulation  operations,  this  omnibus  will  reduce  the  administrative  burden  on  Member 
State competent authorities and the Commission 

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the 

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying 
(OJ  L  139,  30.4.2004,  p.  55,  ELI: 

49 
hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/852/oj ) 
50 
down  specific  hygiene 
http://data.europa.eu/eli/reg/2004/853/oj ) 
51 
Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 maying 
down  a  procedure  for  the  provision  of  information  in  the  fields  of  technical  regulations  and  of  rules  on 
Information Society services (OJ L 214, 17.9.2015, p.1) ELI: http://data.europa.eu/eli/dir/2015/1535/oj 

food  of  animal  origin 

rules 

for 

EN 

26 

  EN 

 
 
•  Regulation (EC) No 999/2001 

The  proposal  introduces  targeted  amendments  to  Regulation  (EC)  No  999/2001  to  ensure 
timely alignment with evolving scientific evidence and international standards. 

Articles  5,  6,  8  and  16  are  amended  to  provide  technical  adaptations  empowering  the 
Commission to adopt delegated acts to amend the list of rapid tests, surveillance requirements 
and the list of specified risk material. This ensures proportionate and risk-based monitoring, 
flexible  adaptation  of  subpopulations  and  age  categories,  and  alignment  with  World 
Organisation for Animal Health standards. 

In  addition,  in  Article 16 restrictions on gelatine and collagen  derived  from  ruminant  bones 
are removed, in line with the 2023 WOAH standards and the 2024 Authority opinion.  

In  Article  23  and  new  Article  23b  revision  refer  to  the  removal  of  the  previous  comitology 
procedures  by  empowerment  of  the  Commission  to  adopt  delegated  acts  to  amend  annexes 
to  epidemiological  developments,  scientific 
and  supplement  provisions 
knowledge, international standards and the Authority opinions, while ensuring scrutiny by the 
European  Parliament  and  the  Council.  These  changes  modernise  the  framework,  simplify 
procedures,  and  allow  proportionate,  science-based  and  internationally  coherent  control 
measures for transmissible spongiform encephalopathies 

in  response 

•  Regulation (EU) 2017/625 

Article 50(3) of Regulation (EU) 2017/625 is amended to allow the competent authorities of 
the border control posts to split consignments of plant and plant products before completing 
the official controls on the entirety of the consignment, in order to release the parts for which 
official controls have been finalised while other parts still need further controls. This measure 
will  ensure  that  official  controls  are  carried  out  at  border  control  posts  without  causing 
unnecessary  delay  or  financial  loss  for  the  operators  of  the  plant  sector,  and  without 
compromising the level of phytosanitary protection of the Union territory. 

Articles  41,  93,  100  and  144  of  Regulation  (EU)  2017/625  are  amended  so  that  the 
Commission is empowered to adopt delegated acts to supplement Regulation (EU) 2017/625 
concerning the cases where, and the conditions under which, laboratories may be designated 
as  official  laboratories,  national  reference  laboratories  and  EU  reference  laboratories,  while 
not  operating  and  being  accredited  in  accordance  with  standards  EN  ISO/IEC  17025  and/or 
not  being  accredited  for  all  the  methods  they  use  for  official  controls  or  other  official 
activities. 

EN 

27 

  EN 

 
2025/0410 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) 
No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 
1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and 
strengthening of food and feed safety requirements 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 43(2), Article 114, Article 168(4)(b) and Article 192(1) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 

Having regard to the opinion of the European Economic and Social Committee,  

Having regard to the opinion of the Committee of the Regions,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

In its Communication A Vision for Agriculture and Food52, the European Commission 
announced  a  cross-cutting  simplification  package  aimed  at  reducing  unnecessary 
regulatory burdens while maintaining high standards for food and feed safety, human 
and animal health, and environmental protection. 

Ten legal acts in the area of food and feed safety are amended by this Food and Feed 
Simplification  Regulation  in  order  to  address  certain  requirements  and  procedures 
which  are  particularly  burdensome  for  the  industry  and  the  competent  authorities  of 
the  Member  States.  The  targeted  amendments  aim  at  rendering  the  food  and  feed 
legislation  more  efficient  and  cost-effective  for  the  industry,  reduce  burdens  on  the 
industry and authorities, while at the same time ensuring a high level of protection of 
human and animal health and of the environment.  
Regulation  (EC)  No  1107/200953  sets  out  the  regulatory  procedure  for  approval  of 
active substances and authorisation of plant protection products in the Union.  

In  order  to  decrease  farmers’  dependency  on  plant  protection  products  containing 
chemical active substances and in line with the announcements in the Communication 
A  Vision  for  Agriculture  and  Food,  the  accessibility  and  availability  of  sustainable 

52 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping 
together  an  attractive  farming  and  agri-food  sector  for  future  generations,  COM/2025/75,  https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 
53 
Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21  October  2009 
concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC 
and 91/414/EEC (OJ L 309, 24.11.2009, pp. 1–50, http://data.europa.eu/eli/reg/2009/1107/oj ) 

EN 

28 

  EN 

 
 
(5) 

(6) 

(7) 

(8) 

(9) 

plant  protection  products,  including  plant  protection  products  containing  biocontrol 
substances, needs to increase.  

In  order  to  facilitate  faster  market  access  for  biocontrol  substances  and  products 
containing them, biocontrol substances need to be more clearly defined and identified 
under Regulation (EC) No 1107/2009.  A definition for biocontrol substances should 
include  micro-organisms,  inorganic  substances  as  occurring  in  nature,  with  the 
exception  of  heavy  metals  and  their  salts,  or  substances  of  biological  origin  or 
produced synthetically that are functionally identical  and structurally similar to  them 
such  as  semiochemicals,  biological  macromolecules  or  molecules  comprised  of 
components  thereof,  as  well  as  substances,  including  of  unknown  and  variable 
composition,  originating  from  living  organisms  or  derived  by  biological  processes 
(e.g. extracts from plant products, metabolites produced by micro-organisms).  

As  many  biocontrol  substances  may  also  have  plant  growth  stimulation  functions,  a 
clearer borderline should be set with regard to fertilising products, in particular plant 
biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available 
on  the  market  of  EU  fertilising  products54.  Thus,  the  scope  of  Regulation  (EC)  No 
1107/2009 should be clarified to exclude substances which influence positively the life 
processes  of  crops,  as  those  substances  qualify  as  plant  biostimulants  from  a  plant 
physiological  perspective.  Substances  interfering  with  life  processes  of  plants  and 
controlling  the  growth  of  the  plants  or  parts  of  them,  should  remain  in  the  scope  of 
Regulation (EC) No 1107/2009. 

For  the  same  purpose,  the  evaluation  of  applications  for  approval  of  such  active 
substances  and  for  the  authorisation  of  plant  protection  products  containing  them 
should  be  given  priority  to  ensure  timely  crop  protection  from  existing  pests  and 
diseases.  

The  risk  assessment  of  biocontrol  substances  requires  specific  technical  knowledge, 
and  some  Member  States  do  not  have  enough  experts  specialised  in  this  type  of 
assessment.  As  a  result,  some  applicants  for  approval  of  biocontrol  substances  face 
difficulties in finding a rapporteur Member State. In order to increase capacity for the 
assessment of new biocontrol substances, it should be possible for the European Food 
Safety Authority (“the Authority”) to assume the role of the rapporteur Member State 
for the assessment of applications for approval and the Authority’s resources should be 
increased  accordingly.  The  Authority  should  put  in  place  appropriate  safeguards  to 
ensure independence of the subsequent peer review and to avoid any possible conflict 
of interests for the experts involved at the different stages of the assessment.  

To accelerate the accessibility and availability to farmers of plant protection products 
containing  new  biocontrol  substances,  Member  States  should  have  the  possibility  to 
grant  provisional  authorisations  for  such  products  as  soon  as  the  draft  assessment 
report for an application for approval has been delivered concluding that the substance 
can  be  approved.  When  the  new  biocontrol  substance  is  approved,  and  in  order  to 
avoid unnecessary administrative procedures, it should be possible to transform such 
provisional authorisations into regular authorisations without the need of reassessment 
unless the conditions set out in the approval require an amendment of the conditions 
set out in the provisional authorisations.  

54 

Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down 
rules on the making available on the market of EU fertilising products and amending Regulations (EC) 
No  1069/2009  and 
(EC)  No  2003/2003, 
(EC)  No  1107/2009  and  repealing  Regulation 
PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj.  

EN 

29 

  EN 

 
 
(10)  To reduce burdens on applicants and Member States and to facilitate the availability of 
plant  protection  products  containing  only  biocontrol  substances  or  low-risk  active 
substances,  the  Union  should  be  considered  as  one  zone  for  applications  for  the 
authorisation  of  such  products.  Considering  also  that  plant  protection  products 
containing only biocontrol substances are not expected to pose different levels of risk 
in  different  Member  States,  mutual  recognition  of  authorisations  for  such  products 
granted by one Member States should be considered as granted by tacit agreement if 
decisions on applications for mutual recognition are not adopted within the prescribed 
deadline.  

(11)  Article  67(1)  of  Regulation  (EC)  No  1107/2009  requires  that  professional  users  of 
plant  protection  products  shall,  for  at  least  three  years,  keep  records  of  the  plant 
protection products they use, containing the name of the product, the time and the dose 
of  application,  the  area  and  the  crop  where  the  plant  protection  product  was  used  in 
order  to  raise  the  protection  of  human  and  animal  health  and  the  environment  by 
ensuring  the  traceability  and  potential  exposure,  to  increase  the  efficiency  of 
monitoring  and  control  and  to  reduce  the  costs  of  monitoring  water  quality. 
Considering  that  such  information  is  less  relevant  for  plant  protection  products 
containing biocontrol substances, and to reduce the administrative burden for farmers, 
the obligation to keep records should not apply to plant protection products containing 
only biocontrol substances. 

(12)  Article  22  of  Regulation  (EC)  No  1107/2009  sets  out  criteria  to  identify  low-risk 
active substances, referring to hazard-based criteria for the substance set out in point 5 
of Annex II to that Regulation and risk-based criteria for the plant protection products 
containing  them  set  out  in  its  Article  47.  Implementation  of  these  provisions  has 
proven  difficult  in  practice  as,  at  the  time  of  the  approval  or  renewal  of  approval  of 
active substances, it is generally not known whether the criteria related to products in 
Article 47  can be fulfilled or not.  The  criteria should  therefore be simplified to  only 
refer to intrinsic properties of the active substance. Furthermore, there have been cases 
where an active substance could not be approved as low-risk because certain elements 
related  to  the  criteria  could  not  be  fully  clarified  during  the  approval  or  renewal  of 
approval  procedure,  while  further  information  generated  later  showed  that  these  are 
fulfilled. To address such situation, he possibility to apply for a change of the status of 
an approved active substance to low-risk should be introduced. 

(13)  The  provisions  related  to  basic  substances  in  Regulation  (EC)  No  1107/2009  have 
proven to be unclear, which has led to disharmonised implementation across Member 
States  and  hinders  the  availability  of  those  substances  to  farmers.  Therefore,  a  clear 
definition  of  basic  substance  should  be  included  in  Article  3.  specifying  that  basic 
substances  include  foodstuff  as  defined  under  Article  2  of  Regulation  (EC)  No 
178/2002  as  well  as  substances  for  which  any  relevant  evaluations,  carried  out  in 
accordance  with  other  Union  legislation  regulating  the  use  of  that  substance  for 
purposes other than for a plant protection product, show that the substance has neither 
an  immediate  or  delayed  harmful  effect  on  human  or  animal  health  nor  an 
unacceptable effect on the environment. 

(14)  Separate  provisions  for  the  approval  criteria  for  basic  substances  and  the  application 
procedure should be set out, as well as more specific labelling requirements to better 
inform users about the conditions of use. It should also be clarified that in addition to 
use,  the  placing  on  the  market  of  approved  basic  substances  for  plant  protection 
purposes does not require an authorisation by Member States to allow for easier access 
to  basic  substances  by  farmers  in  a  suitable  form.  Transitional  provisions  should  be 

EN 

30 

  EN 

 
added  so  that  all  basic  substances  that  are  approved  at  the  moment  of  the  entry  into 
force  of  this  Regulation  could  be  placed  on  the  market  in  the  Union,  without  any 
restrictions  stemming  from  the  superseded  rules,  ensuring  level-playing  field  for  all 
users in all Member States.  

In order to support a transition towards more sustainable active substances and plant 
protection  products,  resources  in  the  Member  States  currently  dedicated  to  renewal 
procedures should be made available for the assessment of applications for new active 
substances  and  products.  Therefore,  approvals  for  active  substances  should  become 
unlimited  in  time,  except  for  active  substances  that  are  candidates  for  substitution, 
those  approved  under  Article  4(7)  of  Regulation  (EC)  No  1107/2009  as  these  have 
properties that are of concern to human or animal health or the environment and those 
approved for a limited period for reasons linked to the results of the risk assessment. It 
should still be possible to set time limits for approvals if found appropriate in the light 
of  the  outcome  of  the  risk  assessment  conducted  prior  to  a  decision  on  an  approval. 
The  Commission  should  also  be  able  to  identify  active  substances  with  unlimited 
approval  for  which  a  full  renewal  procedure  should  be  carried  out  or  identify  active 
substances  with  unlimited  or  limited  approval  periods  for  targeted  reassessment. 
Identification  of  active  substances  should  be  based  on  multiple  criteria  and  requests 
from  Member  States.  In  addition,  the  possibility  for  ad-hoc  reviews  of  active 
substances  at  any  time  as  already  foreseen  in  Article  21  of  Regulation  (EC)  No 
1107/2009 should be maintained. 

(15) 

In the interest of predictability, efficiency, consistency and transparency, rules setting 
out the provisions necessary for the implementation of targeted reassessments should 
also be created. 

(16)  Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for 
the approval of active substances not meeting the approval criteria laid down in Article 
4  and  Annex  II  where  it  is  necessary  to  do  so  because  of  a  serious  danger  to  plant 
health which cannot be contained by other reasonable means including  chemical and 
non-chemical  methods  with  comparable  costs,  availability  and  efficacy,  except  for 
active substances having particularly hazardous properties. Experience has shown that 
it is necessary to clarify the scope of the criteria for which such derogation is possible. 
A harmonised derogation in certain cases where a serious danger to plant health which 
cannot  be  contained  by  other  reasonable  means  would  reduce  the  administrative 
burden for Member States authorising plant protection products containing such active 
substances  under  Article  53  and  will  contribute  to  reducing  disparity  for  access  to 
plant  protection  products  containing  the  substances  concerned  between  the  farmers 
located  in  different  Member  States.  It  should  also  be  possible  that  in  addition  to  the 
information included in an application for approval or renewal of approval of an active 
substance any other information provided in the course of the approval procedure may 
also be taken into account when considering the possibility to grant the derogation.  

(17) 

In order to support Member States lacking sufficient technical or scientific expertise to 
complete  their  tasks  as  rapporteur  Member  States  within  the  periods  foreseen  in 
Regulation (EC) No 1107/2009, it should be possible for rapporteur Member States to 
ask  the  Authority  for  support  when  preparing  the  draft  assessment  report  for  an 
application  for  approval  or  renewal  of  approval,  assessing  additional  information 
required during an evaluation and updating the draft assessment report after its initial 
submission.  The  Authority  should  put  in  place  appropriate  safeguards  to  ensure 
independence  of  the  subsequent  peer  review  and  to  avoid  any  possible  conflict  of 
interests for the experts involved at the different stages of the assessment. 

EN 

31 

  EN 

 
(18)  Following the non-renewal of approval of an active substance, Member States are to 
withdraw  all  authorisations  of  plant  protection  products  containing  that  active 
substance  and  farmers  are  to  stop  using  those  products.  In  such  situations,  Member 
States need time to enact withdrawals of product authorisations and existing stocks of 
products become waste unless grace periods are foreseen to  allow for placing on the 
market and use of such stocks. In addition, farmers need time to find alternatives for 
the  no-longer  authorised  products.  Article  20  of  Regulation  (EC)  No  1107/2009 
provides the possibility in certain cases the Commission to set maximum grace periods 
for placing  on the market  and use of  existing  stocks of plant protection  products  for 
which  authorisations  are  to  be  withdrawn.  However,  the  conditions  set  in  Article  20 
for when such maximum  grace periods  can be  granted should be amended to  clarify 
that the setting of a maximum grace period for distribution and use of existing stocks 
of plant protection products for which authorisations have to be withdrawn is possible 
in general, except for cases where there are immediate and serious concerns for human 
or  animal  health  or  the  environment  and  to  clarify  the  link  with  Article  46. 
Additionally,  the  time  limit  for  grace  periods  of  18  months  is  insufficient  in  cases 
where  there  are  no  alternative  plant  protection  products  available  on  the  market  in 
particular Member State at the time of withdrawal of the authorisations. Therefore, the 
maximum duration of grace periods that Member States may set should be increased 
to a total period of 3 years in such cases so that it allows the Member States enough 
time to have alternative plant protection products authorised and to allow the farmers 
to  adapt  their  crop  protection  solutions.  For  the  same  reasons,  the  grace  periods  in 
which  the  Member  States  may  grant  under  Article  46  following  withdrawals  or 
amendments  of  authorisations  should  be  aligned  with  the  maximum  possible  under 
Article 20. 

(19)  The  requirement  for  Member  States  to  consider  current  scientific  and  technical 
knowledge  relevant  for  the  active  substance  in  the  context  of  product  authorisations 
has  led  to  some  confusion  and  divergent  interpretation  among  Member  State, 
diverging  outcomes  of  risk  assessments,  and,  as  a  consequence,  unequal  access  to 
plant  protection  products  for  farmers  depending  on  the  Member  State  of  their 
establishment.  It  is  therefore  necessary  to  clarify  that  the  Member  States  should 
normally rely on in the latest active substance assessments at Union level, while also 
acknowledging  that  updates  may  be  needed  and  in  such  cases  the  Member  States 
should  notify  the  Commission  so  that  the  scientific  and  technical  knowledge  is 
assessed in a harmonised way.  

(20)  Regulation  (EU)  2016/203155  aims  at  preventing  the  establishment  or  spreading  of 
pests that would have unacceptable economic, environmental or social impacts on the 
Union territory including impacts on agricultural production. The timely availability of 
authorised  plant  protection  product  uses  is  essential  to  apply  the  provisions  of  this 
Regulation. Member States have repeatedly mentioned difficulties in this regard and, 
therefore, the timely availability of authorised plant protection product uses across all 
Member States to prevent the entry into, and spread within, the Union, of pests listed 
in  accordance  with  Articles  5(2),  30(1),  32(3),  37(2)  of  Regulation  (EU)  2016/2031 
should be facilitated.  

55 
Regulation  (EU)  2016/2031  of  the  European  Parliament  of  the  Council  of  26  October  2016  on 
protective  measures  against  pests  of  plants,  amending  Regulations  (EU)  No  228/2013,  (EU)  No  652/2014  and 
(EU)  No  1143/2014  of  the  European  Parliament  and  of  the  Council  and  repealing  Council  Directives 
69/464/EEC,  74/647/EEC,  93/85/EEC,  98/57/EC,  2000/29/EC,  2006/91/EC  and  2007/33/EC  (OJ  L  317, 
23.11.2016, pp. 4–104, ELI: http://data.europa.eu/eli/reg/2016/2031/oj). 

EN 

32 

  EN 

 
 
 
(21) 

In  order  to  prevent  abuse  of  the  mutual  recognition  system  in  the  light  of  divergent 
fees  set  by  the  Member  States  for  obtaining  authorisations  for  plant  protection 
products, applications for mutual recognition of a product authorisation should only be 
possible  if  the  product  for  which  authorisation  by  mutual  recognition  is  sought  is 
actually  placed  on  the  market  in  the  reference  Member  State.  Furthermore,  in  cases 
where companies decide to only apply for authorisation of a plant protection product 
in  certain  Member  States  but  not  in  others,  it  should  be  made  easier  for  official  or 
scientific  bodies  involved  in  agricultural  activities  or  professional  agricultural 
organisations to apply for mutual recognition of product authorisations in these other 
Member  States  by  lifting  the  obligation  to  obtain  the  consent  of  the  authorisation 
holder.  Moreover,  the  administrative  burden  for  such  applicants,  as  well  as    for 
applicants  for  the  extension  of  authorisations  of  products  for  minor  uses,  should  be 
reduced  by  removing  the  obligation  to  provide,  as  part  of  the  applications,  certain 
documents   which can be obtained directly from the reference Member State having 
granted the authorisation for which mutual recognition or extension is sought. 

(22)  Divergent  views  among  Member  States  on  whether  the  sowing  of  treated  seeds 
constitutes a use of plant protection products has created confusion amongst producers 
of  treated  seeds,  farmers  and  competent  authorities.  Additionally,  there  are  different 
interpretations as  to  whether the provision  on treated seeds  cover also  other types of 
plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity 
creates  barriers  for  the  free  circulation  of  treated  seeds  and  plant  reproductive 
materials  and  at  the  same  time  has  created  disparity  between  the  Member  States  as 
regards  imports  of  seeds  treated  with  active  substances  not  approved  for  use  in  the 
Union and their sowing. Therefore, the relevant provisions should be clarified, in order 
to  increase  harmonisation  among  Member  States.  The  measures  would  not  create 
additional burden for the seed treatment industry as treated seeds themselves are still 
not  to  be  considered  a  plant  protection  product.  The  administrative  burden  for  the 
farmers  should  be  limited  thus  specific  derogation  for  the  machinery  used  for  the 
sowing of treated seeds should be provided so that it is not to be regarded as pesticides 
application  equipment  within  the  meaning  of  Directive  2009/128/EC56  on  the 
sustainable use of pesticides. 

(23)  Some  of  the  conditions  for  obtaining  authorisations  for  plant  protection  products  for 
minor uses set out in Article 51 of Regulation (EC) No 1107/2009 haven proven to be 
too  restrictive  and  should  be  removed  in  order  to  make  more  products  available  to 
farmers.  Furthermore,  the  implementation  of  that  Article  varies  significantly  across 
Member States. Therefore, the transparency should be improved, and the Commission 
should  be  empowered  to  adopt  implementing  acts  harmonising  the  procedures  for 
granting extensions of authorisations for minor uses and for authorisations by mutual 
recognition  in  order  to  achieve  more  harmonised  availability  of  plant  protection 
products for minor uses. 

(24)  Experience has shown that the provisions in Regulation (EC) No 1107/2009 related to 
the protection of data in test and study reports submitted for the authorisation of plant 
protection products are complex and create barriers to market entry for new suppliers 
of  plant  protection  products  and  unequal  distribution  and  different  costs  of  plant 
protection products depending on the size of the Member States, thus creating unfair 
farmers. 
competition  between  plant  protection  product  manufacturers  and 

56 
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing 
a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, pp. 71–
86, ELI: http://data.europa.eu/eli/dir/2009/128/oj) 

EN 

33 

  EN 

 
 
Furthermore,  the  data  protection  regime  lacks  transparency  in  terms  of  when  data 
protection  for  a  given  test  or  study  report  expires  in  the  different  Member  States,  in 
particular  for  studies  or  tests  used  for  renewals  of  approvals  or  extensions  of 
authorisations for minor uses. The relevant provisions should therefore be amended to 
set  the  same  data  protection  period  for  a  given  study  or  test  across  the  Union  to 
increase transparency and facilitate market access for alternative suppliers to increase 
the  availability  of  plant  protection  products  at  comparable  costs  to  farmers 
independent from the Member States where they are established.  

(25)  The obligation of the Member States under Article 68 to transmit to the Commission 
reports on the official controls on the enforcement of Regulation (EC) No 1107/2009 
has already been superseded by the obligation to transmit annual reports under Article 
113(1)  of  Regulation  (EU)  2017/625.  Thus  Article  68  should  be  deleted  in  order  to 
avoid confusion and unnecessary administrative burden for the Member States. 

(26)  Transitional  provisions  are  necessary  in  order  to  ensure  a  smooth  transition  for  the 
pending  approval  and  renewal  procedures  for  active  substances  used  in  plant 
protection products, so that they are completed under the current rules but the approval 
period  is  granted  under  the  new  rules.  A  transitional  provision  is  also  necessary  in 
order to ensure that a test or study report whose data protection started under the old 
rules does not get double protection in the same Member State under the new EU wide 
rules. It is further clarified that all basic substances approved at the entry into force of 
this Regulation could be placed on the market independent of their approval as regular 
active substances in order to ensure equal treatment and fair competition for all basic 
substances and for all farmers independent from the Member State they are based.  

(27)  Regulation  (EC)  No  396/200557  sets  the  procedure  for  defining  maximum  residue 
levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the 
Vision  for  Agriculture  and  Food,  the  Commission  announced  it  would  pursue  a 
stronger  alignment  of  production  standards  applied  to  imported  products,  notably  on 
pesticides  and  establish  the  principle,  in  compliance  with  the  EU‘s  international 
obligations,  that  the  most  hazardous  pesticides  banned  in  the  EU  for  health  and 
environmental  reasons  should  not  be  allowed  back  to  the  EU  through  imported 
products.  To  advance  on  this,  the  Commission  has  launched  in  November  2025  a 
study  to  prepare  an  impact  assessment  that  will  consider  the  impacts  on  the  EU’s 
competitive  position  and  the  international  implications  and,  if  appropriate,  propose 
amendments  to  the legal framework.  In the meantime  Regulation  (EC)  No 396/2005 
should already be amended to provide that, for substances that are not approved in the 
Union  and  that  have  certain  particularly  hazardous  properties,  MRLs  that  have  been 
set  based on good agricultural  practices in  third  countries  or Codex maximum limits 
may be set at the limit of quantification (technical zero). 

(28)  This  concerns  substances  with  mutagenic,  carcinogenic, or  reprotoxic  properties  as 
well as endocrine disruptors that may cause adverse effects in humans. Therefore, no 
level  of  residues  leading  to  exposure  of  consumers  should  be  allowed  in  order  to 
ensure a high level of protection for consumers in the Union. 

(29) 

In  addition,  this  concerns  substances  that  are  persistent  organic  pollutants  (POP), 
persistent, bioaccumulative and toxic (PBT) substances, and very persistent and very 
bioaccumulative  (vPvB)  substances,  as  well  as  substances  with  endocrine  disrupting 

57 
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, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) 

EN 

34 

  EN 

 
 
properties  that  may  cause  adverse  effect  in  non-target  organisms.  Persistent 
substances, by their very nature, resist degradation, resulting in prolonged presence in 
the  environment.  Their  accumulation  poses  a  significant  threat  to  ecosystems, 
endangering  biodiversity,  agricultural  production  and  food  security.  Endocrine 
disruptors, similarly, interfere with the hormonal systems of living organisms, causing 
detrimental effects not only to individual species, including migratory species, but also 
to  entire  ecosystems  across  national  boundaries.  Therefore,  these  substances  create 
environmental concerns of a global nature that have a connection with the territory of 
the Union. Not allowing residues of these substances in food in the Union aligns with 
international  efforts  to  combat  pollution  and  supports  global  initiatives  aimed  at 
sustainable development and biodiversity conservation58. 

(30)  Where an appropriate evaluation  by the Authority of the hazardous properties  of the 
substance  under  Regulation  (EC)  No  1107/2009  is  not  available,  the  Commission 
should  ask  the  Authority  for  an  evaluation  under  Article  43  of  Regulation  (EC)  No 
396/2005.  Furthermore, 
is  often  misunderstood. 
Therefore,  the  term  “import  tolerance”  should  be  repealed  and  it  should  be  clarified 
that the definition of good agricultural practice applies equally to the Union and to a 
third country for the setting of MRLs. 

term  “import  tolerance” 

the 

(31)  When  lowering  MRLs  under  Regulation  (EC)  No  396/2005,  a  reasonable  period 
should  be  allowed  to  elapse  before  the  new  MRLs  become  applicable,  in  order  to 
permit Member States, third countries and food business operators to adapt themselves 
to  the  new  requirements.  It  is  recognised  that  fresh  products,  being  perishable,  are 
typically sold and consumed prior to the date of applicability of new MRLs. However, 
products with extended shelf lives, often processed, may still be on the market when 
the  new  lower  MRLs  become  effective.  To  ensure  legal  certainty  and  to  prevent 
unnecessary  economic  losses  for  farmers  and  food  business  operators,  as  well  as  to 
prevent  food  waste,  it  is  deemed  proportionate  that  products  lawfully  placed  on  the 
market in the Union before the applicable date of the new measure, and compliant with 
the  MRLs  valid  at  the  time  of  their  placing  on  the  market  in  the  Union,  should  be 
permitted to remain on the market unless food safety is compromised. 

(32)  Article  16  to  Regulation  (EC)  No  396/2005  sets  out  the  procedure  for  establishing 
temporary MRLs based on monitoring data, with a mandatory review scheduled within 
a  specified  time  frame,  not  exceeding  ten  years.  However,  certain  MRLs  based  on 
monitoring data pertain to active substances that have not been approved in the Union 
for  several  decades,  and  for  which  residue  levels  have  remained  stable  over  time. 
Reviewing such temporary MRLs every ten years imposes an unnecessary burden on 
Member States, food business operators,  and the Authority the Authority in terms of 
data  generation  and  analysis.  Given  that  MRLs  can  be  reviewed  at  any  time  under 
Article  43  of  Regulation  (EC)  No  396/2005,  it  is  appropriate  to  foresee  the 
establishment of MRLs based on monitoring data on a permanent basis. 

(33)  The terms ‘limit of determination (LOD)’ used in Regulation (EEC) No 396/2005 and 
‘limit  of  quantification  (LOQ)’  used  in  international  standards  of  laboratory  analysis 
have the same meaning. However, the acronym ‘LOD’ may be confused with ‘limit of 
detection’  which  has  a  different  meaning.  For  clarity  and  to  avoid  confusion  among 
food business operators and laboratories, it is appropriate to align Regulation (EC) No 
396/2005 with the recognised international terminology. 

58 

Stockholm Convention on Persistent Organic Pollutants (POPs),  https://www.pops.int/; Convention on 
Biological Diversity, https://www.cbd.int/ 

EN 

35 

  EN 

 
 
(34)  Regulation (EU) No 528/201259 sets out the procedures for approval of biocidal active 
substances and authorisation and making available on the market and use of biocidal 
products.  The  completion  of  the  review  programme  of  existing  biocidal  active 
substances set out in Article 89 of that Regulation is significantly delayed. In order to 
ensure that Member States can dedicate their resources to the completion of the review 
programme,  it  is  appropriate  to  set  an  unlimited  duration  for  the  approval  of  active 
substances,  except  for  active  substances  meeting  exclusion  or  substitution  criteria 
under  Articles  5(1)  or  10  of  that  Regulation  as  those  have  properties  that  are  of 
concern  to  human  or  animal  health  or  the  environment,  and  except  for  active 
substances for which time limits of approvals are considered necessary in the light of 
the outcome of the risk assessment conducted prior to a decision on an approval. The 
approval  of  active  substances  already  approved  should  be  converted  into  unlimited 
approvals following these new rules, except for active substances identified as meeting 
exclusion  or  substitution  criteria  under  Articles  5(1)  or  10  of  that  Regulation,  active 
substances  for  which  the  renewal  examination  already  started  for  which  the  renewal 
evaluation  should  continue  or  for  which  the  approval  should  expire  when  no 
application  for  renewal  was  submitted  by  the  deadline.  A  possibility  should  be 
foreseen that the Commission periodically selects a number of active substances based 
on  specific  criteria  for  which  a  renewal  procedure  should  be  triggered,  while  also 
maintaining  the  possibility  to  initiate  early  reviews  pursuant  to  Article  15  of 
Regulation (EU) No 528/2012. Criteria for the selection of active substances subject to 
the  renewal  procedure  should  include,  among  others,  relevant  new  or  updated  data 
requirements  or  guidance  documents,  indications  of  safety  concerns  for  human  or 
animal health or the environment, new scientific or technical knowledge and available 
monitoring data, and might take into account requests from Member States. 

(35)  To simplify and accelerate the procedure for adoption and publication of the decisions 
on  applications  for  Union  authorisation  of  biocidal  products  submitted  pursuant  to 
Chapter  VIII  of  Regulation  (EU)  No  528/2012,  the  individual  decisions  should  no 
longer  take  the  form  of  Commission  Implementing  Regulations  and  be  published  at 
the  EU  Official  Journal,  but  should  take  the  form  of  Commission  Implementing 
Decisions  to  be  notified  to  the  applicants,  and  only  summaries  of  those  Decisions 
should be published at the EU Official Journal for transparency. 

(36)  Regulation (EC) No 1829/2003 covers food and feed produced ‘from’ a GMO but not 
food  and  feed  produced  ‘with’  a  GMO.  In  this  regard,  Recital  16  of  that  Regulation 
recalls that the Regulation does not apply to processing aids, or to food and feed which 
are manufactured with the help of a genetically modified processing aid. However, the 
scope of Regulation  (EC) No 1829/2003 as  regards food and feed products  obtained 
using genetically modified micro-organisms (GMMs) as production strains is unclear 
given  that,  on  the  one  hand,  Recital  16  of  that  Regulation  also  states  that  the 
determining  criterion  between  food  and  feed  produced  ‘from’  or  ‘with’  a  GMO  is 
whether  material  derived  from  the  genetically  modified  source  material  is  present  in 
the food or in the feed and, on the other hand, the definition of ‘processing aid’ in EU 
food  and  feed  law  allows,  under  certain  conditions,  for  the  presence  in  the  final 
product  of  residues  of  the  substance  or  its  derivatives.  Furthermore,  the  increasing 
sensitivity of detection methods has the consequence that food and feed that have been 
considered  free  from  residues  of  GMMs  and  have  been  placed  on  the  market  as 

59 
Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  of  22  May  2012 
concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, 
ELI: http://data.europa.eu/eli/reg/2012/528/oj)  

EN 

36 

  EN 

 
 
conventional products for many years may at some point be considered as containing 
such residues. 

(37)  Therefore,  to  ensure  the  good  functioning  of  the  internal  market  and  provide  legal 
certainty to food and feed business operators, food and feed products obtained using a 
GMM  as  production  strain  and  from  which  the  GMM  has  been  removed  should  not 
fall within the scope of Regulation (EC) No 1829/2003 even if residues of the GMM 
are present in the food or feed, provided that they are limited to non-viable cells, that 
the  presence  thereof  is  minimized  through  reasonable  attempts  to  remove  them  and 
have no technological effect on the final food or feed. In particular, in order to ensure 
that reasonable attempts to remove residues have been made, it should be required that 
they have been carried out in accordance with good manufacturing practices as those 
used in similar food and feed products to minimize the presence of residues.  

(38)  The  reference  to  GMMs  in  the  definition  of  ‘produced  from  GMOs’  should  refer  to 
GMMs  as  defined  in  Directive 2009/41/EC  of  the  European  Parliament  and  the 
Council of 6 May 2009,60  with  the exclusion of  animal  and plant  cells in  culture.  In 
order to be consistent with the overall applicable framework on GMOs, it  should be 
ensured that the same rules apply to animal and plant cells, regardless of whether they 
are  in  culture,  not  in  culture  or  embedded  in  the  complete  organisms.  The  specific 
provisions  should  therefore  cover  only  micro-organisms  in  the  biological  sense, 
including the taxonomic groups Archaea and Bacteria, the unicellular species and life 
stages  of  Protozoa,  Chromista  and  Fungi,  as  well  as  filamentous  fungi  and  viruses, 
while excluding animal and plant cells in culture. 

(39)  Regulation (EC) No 1831/200361 sets out the grounds and procedures for authorisation 
of  feed  additives  in  the  Union.  It  provides  that  authorisations  of  feed  additives  are 
valid  for  ten  years  and  are  renewable  for  ten-year  periods  upon  submission  of  an 
application  in  due  time.  This  renewal  requirement  has  proved  to  generate  high 
administrative  and  regulatory  burden  and  financial  costs  for  businesses,  in  particular 
SMEs, but also for the Authority, the Member States and the Commission involved in 
the  renewal  procedure.  In  addition,  the  implementation  of  Regulation  (EC)  No 
1831/2003 has so far led to only very few withdrawals or denials of authorisation for 
safety reasons, in particular on the occasion of the renewal of authorisations. In order 
to  avoid  unnecessary  administrative  and  financial  burdens,  and  thereby  making 
available  resources  to  research,  product  development  and  market  expansion,  the 
authorisation  of  feed  additives  should  be  granted  for  an  unlimited  period  of  time, 
except  for  additives  belonging  to  the  category  of  coccidiostats  and  histomonostats 
which should remain under the ten-year authorisation regime due to their antimicrobial 
nature and their derived higher risk profile.  

(40)  Alternative  measures  to  the  option  of  authorisations  valid  for  an  unlimited  period  of 
time,  such  as  longer  authorisation  periods  for  some  or  all  feed  additives  or  different 
authorisation  periods  according  to  the  type  of  additives,  were  not  considered  as 
satisfactory  due  to  a  lack  of  objective  criteria  to  differentiate  between  additives’ 
categories  or  functional  groups  in  terms  of  safety  or  efficacy  or  due  to  the  risk  of 
absence of applicants for the renewal of non-holder specific authorisations. 

60 

61 

EN 

Directive 2009/41/EC of the European Parliament and of the Council of 6 May  2009 on the contained 
use of genetically modified micro-organisms (Recast) (Text with EEA relevance); OJ L 125, 21.5.2009, 
pp. 75–97 
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on 
(OJ  L  268,  18.10.2003,  p.  29,  ELI: 
for  use 
http://data.europa.eu/eli/reg/2003/1831/oj). 

animal  nutrition 

additives 

in 

37 

  EN 

 
 
(41)  Modifications, suspensions or revocations of existing authorisations should continue to 
be  adopted  anytime  where  such  authorisations  no  longer  meet  the  safety  or  efficacy 
conditions set out in Regulation (EC) No 1831/2003, taking into account scientific and 
technological  developments.  The  high  safety  level  of  protection  pursued  by  the 
Regulation  should  continue  to  be  ensured,  considering  in  particular  the  supervision 
and  monitoring  requirements  on  holders  of  authorisations,  including  implementation 
of  post-market  monitoring  required  in  authorisations  granted  before  this  Regulation, 
the Authority’s possible scientific reassessment of authorisations on its own initiative 
or on Member States’ or Commission’s request or upon submission of applications for 
modification of authorisations or for the authorisation of new uses of feed additives. In 
view  of  a  scientific  reassessment  of  authorisations,  the  Authority’s  powers  should 
include  possible  requests  of  information  to  applicants  and  authorisation-holders  and 
the accomplishment of any relevant tasks provided by Regulation (EC) No 178/2002 
of  the  European  Parliament  and  of  the  Council62,  such  as  data  collection, 
commissioning of scientific studies and use of information identified from monitoring 
of  emerging  risks.  The  application  of  these  safeguards  should  ensure  that  the 
authorisation of feed additives for an unlimited period of time does not pose a risk to 
safety. Article 9 and Article 14 of Regulation (EC) No 1831/2003 should therefore be 
amended accordingly. 

(42) 

In order to provide legal certainty and to ensure a smooth transition to the new rules, it 
should  be  clarified  that  authorisations  of  feed  additives  already  granted  before  the 
entry into force of this Regulation, and which are still in force, are deemed unlimited 
in  time,  except  for  additives  belonging  to  the  category  of  coccidiostats  and 
histomonostats,  urgent  authorisations  granted  under  Article  15,  authorisations  for 
which  no  application  for  renewal  has  been  submitted  on  time  before  the  entry  into 
force  of  the  new  rules  or  for  which  such  application  has  been  submitted  but 
subsequently  withdrawn,  and  authorisations  for  which  an  application  for  renewal  of 
authorisation has been submitted before the entry into force of the new rules and for 
which no decision has been taken by that date.  

(43)  Applications for renewal of authorisation submitted before the date of entry into force 
of the present Regulation and for which no decision on that renewal has been taken yet 
at that date, should continue to be treated in accordance with the rules set out in Article 
14 as applicable at the time of their submission. However, authorisations renewed after 
the entry into force of this Regulation should be valid for an unlimited period of time. 
Furthermore, the new rule of authorisation for an unlimited period of time should not 
affect  the  processing  of  existing  procedures  concerning  applications  submitted 
pursuant to Article 10(2) of Regulation (EC) No 1831/2003. 

(44)  The  implementation  of  the  procedures  for  modification  of  authorisation  of  feed 
additives,  as  laid  down  in  Regulation  (EC)  No  1831/2003,  are  in  some  cases  too 
burdensome  or  could  be  improved  in  terms  of  clarity  and  coherence.  In  particular, 
requests  for  modification  of  the  holder  of  an  authorisation  should  be  handled  as  an 
administrative  change  and  addressed  in  the  Community  Register  of  Feed  Additives, 
rather  than  be  included  in  the  terms  of  the  Regulation  granting  the  authorisation.  In 
order  to  ensure  uniform  conditions  for  the  implementation  of  Regulation  (EC)  No 
1831/2003,  implementing  powers  should  be  conferred  on  the  Commission  to  amend 

62 

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority  and  laying  down  procedures  in  matters  of  food  safety  (OJ  L  31,  1.2.2002,  p.  1, 
ELI:  http://data.europa.eu/eli/reg/2002/178/oj). 

EN 

38 

  EN 

 
 
Regulations  granting  an  authorisation  adopted  before  the  entry  into  force  of  this 
Regulation, and which include the name of the holder of the authorisation, to remove 
such name from those Regulations and include it in the Community Register of Feed 
Additives  instead.  Those  powers  should  be  exercised  in  accordance  with  Regulation 
(EU) No 182/2011 of the European Parliament and of the Council63. 

(45) 

In addition, it would be appropriate to allow interested parties to submit an application 
to  modify  a  non-holder  specific  authorisation,  as  it  is  already  provided  for  holder-
specific  authorisations,  with  a  view  to  possibly  expanding  the  specifications  or 
conditions  included  in  that  authorisation.  The  current  absence  of  such  procedure 
requires operators wishing to modify a non-holder specific authorisation to resubmit a 
full application for a new authorisation, which generates unnecessary burden.   

(46)  Furthermore,  due  to  the  new  unlimited  authorisation  regime,  it  is  appropriate  to 
establish a specific procedure to modify authorisations in order to adapt the methods 
of analysis concerning feed additives to scientific and technological developments, on 
the basis of a report of the Community reference laboratory.  

(47)  Finally,  in  order  to  ensure  uniform  conditions  for  the  implementation  of  Regulation 
(EC)  No  1831/2003  regarding  the  modification  of  authorisations,  implementing 
powers should be conferred on the Commission. Those powers should be exercised in 
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the 
Council. Articles 2, 3, 9 and 13 of Regulation (EC) No 1831/2003 should therefore be 
amended accordingly. 

(48)  Regulation  (EC)  No  1831/2003  lays  down  the  labelling  requirements  applicable  to 
feed  additives  and  premixtures  and  requires  displaying  extensive  information  on  a 
label in a physical form attached to the packaging or the container. In order to take into 
account the broader labelling means allowed in Regulation (EC) No 767/2009 of the 
European Parliament and of the Council64 for feed materials and compound feed, the 
development  of new, digital,  communication means, and to  allow more flexibility in 
the labelling practices and to reduce burden associated with the printing and update of 
physical  labels  by  the  operators,  labelling  by  digital  means  should  be  permitted  for 
certain  non-safety  related  information  under  certain  conditions  of  accessibility  and 
reliability. For the purpose of ensuring the safe use of feed additives, all safety-critical 
and  essential  use  information,  which  is  in  particular  included  in  the  authorisation, 
should  however  remain  mandatory  on  the  physical  label.  Accordingly,  a  distinction 
should be made in the context of the requirements for feed additives and premixtures 
between the concepts of ‘labelling’ and of ‘label’, which should  be properly defined 
in line with the corresponding definitions laid down in Regulation (EC) No 767/2009 
in order to ensure consistency. In addition, clarification should be brought concerning 
the  labelling  responsibility,  in  line  with  the  provisions  of  Regulation  (EC)  No 
767/2009  regarding  feed  labelling.    Article  2  and  Article  16  of  Regulation  (EC)  No 
1831/2003 should therefore be amended accordingly. 

63 

64 

Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011 
 control  by  Member 
laying down the rules and general principles concerning mechanisms for 
States  of  the  Commission’s  exercise  of  implementing  powers  (OJ  L  55,  28.2.2011,  p.  13, 
ELI:  http://data.europa.eu/eli/reg/2011/182/oj). 
Regulation (EC) No  767/2009 of the European Parliament and of the  Council of 13 July 2009 on the 
placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 
1831/2003 and repealing Council Directive  79/373/EEC, Commission Directive 80/511/EEC, Council 
Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 
2004/217/EC (OJ L 229, 1.9.2009, p. 1, ELI:  http://data.europa.eu/eli/reg/2009/767/oj). 

EN 

39 

  EN 

 
 
(49) 

In order to keep Regulation (EC) No 1831/2003 in line with technical progress and the 
digitalisation of the society, the power to adopt acts in accordance with Article 290 of 
the  Treaty  on  the  Functioning  of  the  European  Union  should  be  delegated  to  the 
Commission  in  respect  of  supplementing  the  Regulation  by  establishing  rules  to 
enhance and facilitate labelling of feed additives and premixtures by the use of digital 
means. Those rules  may relate to  the nature of the information concerned, excluding 
safety-critical and essential-use information, and to the type of digital means that may 
be  used.  It  is  of  particular  importance  that  the  Commission  carry  out  appropriate 
consultations  during  its  preparatory  work,  including  at  expert  level,  and  that  those 
consultations  be  conducted  in  accordance  with  the  principles  laid  down  in  the 
Interinstitutional Agreement of 13 April 2016 on Better Law-Making65. In particular, 
to  ensure  equal  participation  in  the  preparation  of  delegated  acts,  the  European 
Parliament and the Council receive all documents at the same time as Member States’ 
experts,  and  their  experts  systematically  have  access  to  meetings  of  Commission 
expert groups dealing with the preparation of delegated acts. Article 21a of Regulation 
(EC) No 1831/2003 should therefore be amended accordingly. 

(50)  Regulation  (EC)  No  852/200466  sets  the  hygiene  requirements  for  foodstuffs  while 
Regulation  (EC) No 853/200467  lays down specific hygiene rules for food of animal 
origin. Regulations (EC) No 852/2004 and Regulation (EC) No 853/2004 provide for a 
specific  notification  procedure  to  be  followed  by  Member  States  wishing  to  adopt 
national measures adapting the requirements laid down in Annexes II and III to those 
regulations respectively. This procedure, aiming at informing the Commission and the 
Member States of the draft measures, is to be used where the Member States wish to 
adapt certain requirements related to traditional production, regions with geographical 
constraints  or  only  structure,  layout  and  equipment.  In  addition,  Member  States 
wishing  to  adapt  other  requirements  of  the  Annexes  are  to  notify  such  measures  in 
accordance  with  Directive  (EU)  No  2015/153568.  The  existence  of  two  notifications 
procedures has proved to be cumbersome and confusing. It would be more efficient to 
simplify the notification requirements for national measures and to bring them in line 
with the more general provisions of that Directive. Regulations (EC) No 852/2004 and 
Regulation (EC) No 853/2004 should be amended accordingly. 

(51)  Regulation  (EC)  No  1099/200969  establishes  minimum  rules  for  the  protection  of 
animals at the time of slaughter or killing. Under Article 18(4) of Regulation (EC) No 
, the competent authorities of Member States  are currently required to 
1099/2009 
submit specific annual reports to the Commission on depopulation operations carried 
out  the  previous  year  in  addition  to  the  annual  reports  submitted  in  accordance  with 
Regulation  (EU)  2017/625  on  official  controls  and  other  official  activities￼70  The 

for 

rules 

food  of  animal  origin 

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying 
(OJ  L  139,  30.4.2004,  p.  55,  ELI: 

OJ L 123, 12.5.2016. 
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the 

65 
66 
hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/852/oj ) 
67 
down  specific  hygiene 
http://data.europa.eu/eli/reg/2004/853/oj ) 
68 
Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 maying 
down  a  procedure  for  the  provision  of  information  in  the  fields  of  technical  regulations  and  of  rules  on 
Information Society services (OJ L 214, 17.9.2015, p.1, ELI: http://data.europa.eu/eli/dir/2015/1535/oj ) 
69 
of killing (OJ L 303, 18.11.2009, pp. 1–30, ELI: http://data.europa.eu/eli/reg/2009/1099/oj ) 
70 
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) 

Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time 

EN 

40 

  EN 

 
 
objective of Regulation (EC) No 1099/2009 is, however, to protect animals at the time 
of  killing.  The  annual  compliance  reports  under  Regulation  (EU)  2017/625  cover 
animal  welfare  during  killing,  including  during  depopulation  activities,  and  are 
sufficient to ensure that the objective of Regulation (EC) No 1099/2009 is met. This 
overlap of two separate reports provides limited added value and inefficiently diverts 
the  resources  of  competent  authorities  from  risk  management.  In  addition,  the 
information  provided  under  Regulation  (EC)  No  1099/2009  has  proven  to  be  of 
limited value since that Regulation lacks provisions ensuring a thorough analysis and 
comparability  of  the  reported  information,  when  compared  to  the  administrative 
burden of preparing the report. This additional reporting obligation should therefore be 
removed with a view to simplifying the requirements and reducing the administrative 
burden on Member State competent authorities. 

(52)  Regulation  (EC)  No  999/200171  lays  down  rules  for  the  prevention,  control  and 
eradication of certain transmissible spongiform encephalopathies in the Union. Article 
6 of Regulation (EC) No 999/2001 requires each Member State to carry out an annual 
monitoring programme for transmissible spongiform encephalopathies based on active 
and  passive  surveillance  in  accordance  with  Annex  III  and  it  also  specifies  the 
minimum  animal  subpopulations  to  be  covered  by  such  monitoring  programme  in 
respect  of  bovine  spongiform  encephalopathy  (BSE).  During  its  General  Session  in 
May 2023, the World Organisation for Animal Health (WOAH) revised Chapter 11.4 
“Bovine  Spongiform  Encephalopathy”  of  the  Terrestrial  Animal  Health  Code72  and 
updated  the  international  standards  as  regards  the  bovine  populations  and  the  age  of 
such  populations  to  be  covered  by  BSE  surveillance.  While  Article  6  of  Regulation 
(EC) No 999/2001 already provides that, after consultation of the appropriate scientific 
committee, the age laid down for certain bovine categories may be adapted according 
to  scientific  progress  under  the  procedure  referred  to  in  Article  24(3),  the  updated 
international standards also require adaptation of the minimum bovine subpopulations 
covered  by  the  monitoring  programme.  In  order  to  ensure  alignment  with  evolving 
scientific  knowledge  and  international  standards,  Article  6  should  therefore  be 
amended so that both the age thresholds and the bovine subpopulations covered by the 
monitoring  programme  may  be  adapted  under  the  procedure  referred  to  in  Article 
24(3). 

(53)  As  part  of  the  measures  aiming  to  prevent  BSE,  Article  8  of  Regulation  (EC)  No 
999/2001  requires  that  tissues  with  the  greatest  BSE  infectivity,  defined  as  specified 
risk material, be removed and disposed of in accordance with Annex V. This Article 
also  specify the minimum  list of tissues to be removed from  bovine animals  and the 
age limit of the animals affected by such removal. During its General Session in May 
2023,  the  World  Organisation  for  Animal  Health  revised  Chapter  11.4  “Bovine 
Spongiform Encephalopathy” of the Terrestrial Animal Health Code and updated the 

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 (Official Controls Regulation) (OJ L 95, 7.4.2017, 
pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj) 
71 
Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying 
down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, OJ 
L 147, 31.5.2001, http://data.europa.eu/eli/reg/2001/999/oj 
72 
and Manuals - WOAH - World Organisation for Animal Health 

World Organisation for Animal Health (WOAH), Terrestrial Animal Health Code, Chapter 11.4 Codes 

EN 

41 

  EN 

 
 
international  standards  as  regards  the  commodities  harbouring  the  greatest  BSE 
infectivity based on the BSE risk category of the country where such commodities are 
originating. 

(54)  Article  8  of  Regulation  (EC)  No  999/2001  provides  that,  after  consultation  of  the 
appropriate scientific committee, the data relating to the age of bovine animals to be 
taken into account for determining the list of specified risk material set out in Annex V 
to  that  Regulation.  In  order  to  ensure  timely  alignment  with  evolving  international 
standards and scientific knowledge, the list of specified risk material set out in Annex 
V  to  that  Regulation  should  also  be  adapted  taking  into  account  at  least  the  bovine 
spongiform encephalopathy risk categories of the country where it originates. 

(55)  Article  16  of  Regulation  (EC)  No  999/2001  lays  down  the  rules  on  placing  certain 
products  of  animal  origin  on  the  market,  including  restrictions  on  gelatine  and 
collagen derived from ruminant bones. The revised Chapter 11.4 “Bovine Spongiform 
Encephalopathy”  of  the  Terrestrial  Animal  Health  Code  adopted  in  2023  confirms, 
however,  that  gelatine  and  collagen  derived  from  ruminant  bones  are  safe 
commodities. This conclusion was further supported by the 2024 scientific opinion of 
the Authority on the BSE risk posed by ruminant collagen and gelatine derived from 
bones73.  To  reflect  both  the  international  standards  mentioned  as  well  as  the  latest 
scientific  evidence  in  this  regard,  the  provisions  of  Article  16  should  therefore  be 
amended to include these products, i.e. collagen and gelatine, in the scope of products 
not subject to restrictions for the placing on the market.  

(56) 

In  order  to  ensure  the  timely  alignment  with  evolving  international  standards  and 
scientific  knowledge,  the  list  of  products  of  animal  origin  derived  from  healthy 
ruminants that are not subject to restrictions on placing on the market or, if need be, 
export  pursuant  to  Article  16  of  Regulation  (EC)  No  999/2001  and  Annex  VIII, 
Chapters  C  and  D,  and  to  Annex  IX,  Chapters  A,  C,  F  and  G  should  also  be  made 
subject  to  adaptation  under  the  procedure  referred  to  in  Article  24(3)  of  that 
Regulation. 

(57)  Article  23  and  23a  of  Regulation  (EC)  No  999/2001  currently  empower  the 
Commission  to  amend  non-essential  elements  of  this  Regulation,  including  by 
supplementing it, through the regulatory procedure with scrutiny referred to in Article 
24(3). In order to achieve the objectives of Regulation (EC) No 999/2001 and ensure 
the timely adaptation to evolving epidemiological situations, scientific knowledge and 
international standards, it is appropriate to replace these empowerments with delegated 
acts  in  accordance with  Article 290 of the Treaty. The Commission should  therefore 
be empowered to amend the annexes and to supplement that Regulation. In particular, 
regarding the approval of rapid and alternative tests, the adaptation of requirements for 
bovine  spongiform  encephalopathy  monitoring  and  surveillance,  the  list  of  specified 
risk  materials,  and  the  conditions  for  placing  on  the  market  or,  where  appropriate, 
export of products of animal origin derived from healthy ruminants. Regulation (EU) 
2017/62574 establishes rules on the performance of official controls by the competent 

73 
the Authority BIOHAZ Panel, Scientiﬁc Opinion on the potential BSE risk posed bythe use of ruminant 
collagen and gelatine in feed for non-ruminant farmed animals.  the Authority Journal2020;18(10):6267, 68 pp. 
https://doi.org/10.2903/j.efsa.2020.6267ISSN: 1831-4732© 2020 European Food Safety Authority 
74 
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 

EN 

42 

  EN 

 
 
authorities  of  the  Member  States,  among  others,  on  animals  and  goods  entering  the 
Union  in  order  to  verify  compliance  with  Union  agri-food  chain  legislation.  Article 
50(3) of Regulation (EU) 2017/625 allows the splitting of consignments only after the 
completion  of  official  controls  and  the  finalisation  of  the  Common  Health  Entry 
Document (CHED), which implies that a consignment cannot be released until all the 
necessary checks for that consignment have been completed. 

(58)  Regulation (EU) 2017/625 establishes rules on the performance of official controls by 
the competent authorities of the Member States, among others, on animals and goods 
entering  the  Union  in  order  to  verify  compliance  with  Union  agri-food  chain 
legislation.  Article  50(3)  of  Regulation  (EU)  2017/625  allows  the  splitting  of 
consignments only after the completion of official controls and the finalisation of the 
Common Health Entry Document (CHED), which implies that a consignment cannot 
be released until all the necessary checks for that consignment have been completed. 

(59)  Consignments  of  goods  falling  under  the  rules  referred  to  in  Article  1(2)(g)  of 
Regulation (EU) 2017/625 may consist of plants and plant products of different types, 
classes or descriptions, covered by the same official phytosanitary certificate. Due to 
the diversity of plants and plant products in the same consignment, each item covered 
by the same phytosanitary certificate may be subjected to physical checks of various 
types and durations. In some cases, certain items could be released immediately while 
others  need  to  be  detained  pending  the  results  of  laboratory  analysis.  In  the  case  of 
perishable  products  with  a  limited  shelf  life,  this  situation  can  sometimes  lead  to 
spoilage  or  even  complete  loss  of  products  that  are  not  subjected  to  any  laboratory 
analysis. 

(60)  To ensure that official controls are carried out at border control posts without causing 
unnecessary  delay  or  financial  loss  for  the  operators,  and  without  compromising  the 
level  of  phytosanitary  protection  of  the  Union  territory,  Article  50(3)  of  Regulation 
(EU)  2017/625  should  be  amended  to  allow  the  competent  authorities  of  the  border 
control posts to split consignments of plant and plant products before completing the 
official  controls on the  entirety  of the consignment,  in  order to  enable the release of 
the parts for which official controls have been finalised.  

(61)  Regulation  (EU)  2017/625  provides  that  laboratory  analyses,  tests  and  diagnoses  on 
samples taken during official controls and other official activities are to be performed 
by  official  laboratories  which  have  been  designated  as  such  by  the  competent 
authorities  of  the  Member  States.    Official  laboratories  are  assisted  by  national 
reference  laboratories  designated  by  the  Member  States,  and  by  European  Union 
reference laboratories designated by the Commission. 

(62) 

In  accordance  with  point  (e)  of  Article  37(4),  point  (a)  of  Article  93(3),  and  Article 
100(2) of Regulation (EU) 2017/625, official laboratories, European Union reference 
laboratories and national reference laboratories are to operate and to be accredited in 
accordance with standard EN ISO/IEC 17025.  However, in certain cases, such as for 
example  the  analysis  for  certain  biological  food  safety  hazards,  sound  and  reliable 
results  can be ensured by accreditation in  accordance  with  other standards.  It  should 

(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 (Official Controls Regulation) (OJ L 95, 7.4.2017, 
pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj) 

EN 

43 

  EN 

 
 
 
(63) 

therefore  be  allowed  to  designate  as  official  laboratories,  European  Union  reference 
laboratories  and  national  reference  laboratories,  laboratories  which  operate  and  are 
accredited in accordance with another standard than EN ISO/IEC 17025, provided that 
those  laboratories  comply  with  the  conditions  established  by  the  Commission  by 
delegated  acts.  Articles  41,  93  and  100  of  Regulation  (EU)  2017/625  should  be 
amended accordingly. 

In  accordance  with  Article  93(3),  point  (a)  and  Article  100(2)  of  Regulation  (EU) 
2017/625, the scope of the accreditation of European Union reference laboratories and 
national  reference  laboratories  should  include  all  the  methods  of laboratory  analysis, 
test  or  diagnosis  they  use  when  operating  as  reference  laboratories.  However, 
accreditation  is  a  complex  and  costly  process,  which  results  in  a  heavy  burden 
especially where the numerous pests, contaminants and matrices imply a high number 
of  testing  methods.  Accrediting  all  the  potential  combinations  in  areas  such  as  plant 
health,  food  contact  materials,  feed  additives  and  food  additives,  food  enzymes  and 
flavourings  poses  a  burden  in  terms  of  time  and  resources  on  European  Union 
reference  laboratories  and  national  reference  laboratories.  In  order  to  ensure  the 
flexibility  and  proportionality  of  the  approach  without  affecting  the  soundness  and 
reliability of the results it should be allowed to designate as European Union reference 
laboratories and national reference laboratories, laboratories which are not accredited 
for all the methods they use for official controls and other official activities, provided 
that those laboratories comply with the conditions established by the Commission by 
delegated acts. Articles 93 and 100 of Regulation (EU) 2017/625 should be amended 
accordingly.  

HAVE ADOPTED THIS REGULATION: 

Article 1 
Amendments to Regulation (EC) No 1107/2009  

Regulation (EC) No 1107/2009 is amended as follows:  

(1) 

Article 2 is amended as follows: 

(a) 

paragraph 1, point (b) is replaced by the following: 

‘ (b) ‘disrupting life processes of plants, such as substances regulating  their 
growth, other than as a nutrient or a plant biostimulant’ 

(b)  paragraph 2 is replaced by the following: 

‘2.  This  Regulation  shall  apply  to  substances,  including  biocontrol 
substances  having  general  or  specific  action  against  harmful  organisms  or 
on  plants,  parts  of  plants  or  plant  products,  referred  to  as  ‘active 
substances.’; 

(2) 

Article 3 is amended as follows: 

(a) 

point 17 is replaced by the following: 

‘17. ´zone´ means a group of Member States as defined in Annex I.   

For  the  purpose  of  use  in  greenhouses,  as  post-harvest  treatment,  for 
treatment  of empty storage rooms and for seed treatment,  for uses  that  are 
solely  and  explicitly  needed  in  order  to  prevent  the  entry  into,  and  spread 
within,  the  Union,  of  pests  listed  in  accordance  with  Articles  5(2),  30(1), 
32(3), 37(2) of Regulation (EU) 2016/2031 and for plant protection products 

EN 

44 

  EN 

 
containing  as  active  substances  only  biocontrol  or 
substances, the zone means all zones defined in Annex I.’; 

low-risk  active 

(b)  point 34 is replaced by the following: 

‘34.  ‘plant  biostimulant’  means  a  product  having  at  least  one  of  the 
following actions: 

(1)  stimulating  plant  nutrition  processes  independently  of  the  product’s 
nutrient content with the sole aim of improving one or more of the following 
characteristics of the plant or the plant rhizosphere: 

(a) 

nutrient use efficiency; 

(b)  quality traits; 

(c) 

availability of confined nutrients in soil or rhizosphere; 

(2) stimulating life processes of crops to improve their tolerance to  abiotic 
stress.  

Substances  disrupting  life  processes  of  crops  which  are  not  fulfilling  the 
definition  of  plant  biostimulants  are  active  substances  covered  by  this 
Regulation.’; 

(c) 

the following point 35 is added: 

‘35. ‘biocontrol substance’ means: 

(a)  micro-organisms,  

(b) 

(c) 

inorganic  substances  as  occurring  in  nature,  with  the  exception  of 
heavy metals and their salts or  

substances  of  biological  origin  or  produced  synthetically  that  are 
functionally identical and structurally similar to them.’;  

(d) 

the following point 36 is added: 

‘36. ´basic substances´ means active substances that are not predominantly 
used  for  plant  protection  purposes,  including  foodstuffs  and  substances 
evaluated  in  accordance  with  other  Union  legislation,  but  are  nevertheless 
useful in plant protection.’; 

(3) 

in Article 4, paragraph 7 is replaced by the following: 

‘7.  By  way  of  derogation  from  paragraph  1,  where  on  the  basis  of 
documented evidence included in the application or information provided in 
the  course  of  the  approval  procedure  an  active  substance  is  necessary  to 
control a serious danger to plant health or plant production which cannot be 
contained by other reasonable means including non-chemical methods, such 
active substance may be approved for a limited period necessary to control 
that serious danger but not exceeding five years, provided that the use of the 
active  substance  is  subject  to  risk  mitigation  measures  to  ensure  that 
exposure of humans and the environment is minimised. For such substances 
maximum residue levels shall be set in accordance with Regulation (EC) No 
396/2005. 

The  derogation  provided  for  in  the  first  subparagraph  shall  not  apply  to 
active  substances  which  are  or  have  to  be  classified  in  accordance  with 
Regulation  (EC)  No  1272/2008,  as  mutagenic  category  1A  or  1B, 

EN 

45 

  EN 

 
carcinogenic category 1A, carcinogenic category 1B without a threshold, or 
toxic for reproduction category 1A, or persistent, bioaccumulative and toxic 
(PBT),  very  persistent  and  very  bioaccumulative    (vPvB),  or  that  are  a 
persistent  organic pollutant (POP) according to  the criteria set  out  in  point 
3.7.1 of Annex II. 

Member  States  may  authorise  plant  protection  products  containing  active 
substances  approved  in  accordance  with  this  paragraph  only  when  it  is 
necessary to control the serious danger to plant health or plant production in 
their territory identified pursuant to the first subparagraph.’; 

(4) 

Article 5 is replaced by the following: 

‘Article 5 

First approval 

The first approval shall be for an unlimited period except for: 

(a) 

active substances that are identified as candidates for substitution in 
accordance with Article 24; 

(b) 

active substances that are approved under Article 4(7); or 

(c) 

active  substances  for  which  a  limited  period  of  approval  is  set  in 
accordance  with  Article  6  (j)  in  particular  in  the  light  of  relevant 
uncertainties  emerging  from  the  risk  assessment,  including  as  a 
result of data gaps.’; 

(5) 

in Article 7, paragraph 1 is replaced by the following: 

‘(1)  An  application  for  the  approval  of  an  active  substance,  for  an 
amendment  of  the  conditions  of  approval,  or  for  a  change  of  status  for  an 
active substance as  identified in  the regulation  referred to  in  Article 13(4), 
shall  be  submitted  by  the  producer  of  the  active  substance  to  a  Member 
State  (the  “rapporteur  Member  State”)  together  with  a  summary  and  a 
complete dossier as provided for in Articles 8(1) and (2) this Regulation or a 
scientifically  reasoned  justification  for  not  providing  certain  parts  of  those 
dossiers. The application shall demonstrate that the active substance fulfils 
the approval  criteria provided for in  Article 4 of this Regulation  or, where 
applicable, that the change of status of the active substance is justified. The 
application  shall  be  submitted  in  accordance  with  standard  data  formats, 
where they exist pursuant to Article 39f of Regulation (EC) No 178/2002 of 
the  European  Parliament  and  of  the  Council,  which  shall  apply  mutatis 
mutandis.  

A  joint  application  may  be  submitted  by  an  association  of  producers 
designated  by  the  producers  for  the  purpose  of  compliance  with  this 
Regulation. 

The  application  shall  be  examined  by  the  Member  State  proposed  by  the 
applicant, unless another Member State agrees to examine it. 

By  way  of  derogation  from  the  first  subparagraph,  applications  for  the 
approval of biocontrol substances may be submitted to the Authority which 
shall assume the duties of the rapporteur Member State.’; 

(6) 

Article 11 is amended as follows: 

EN 

46 

  EN 

 
(a) 

the following paragraph 1a is added: 

‘1a.  The  rapporteur  Member  State  shall  give  priority  to  the  assessment  of 
applications for approval of biocontrol substances.’; 

(b) 

the following subparagraph is added at the end of paragraph 2:  

‘The  rapporteur  Member  State  may  ask  the  Authority  to  provide  technical 
and scientific support during the assessment required for the preparation and 
delivery  of  the  draft  assessment  report,  during  the  assessment  of  the 
additional information referred to in Article 12(3), and for the preparation of 
necessary updates of the draft assessment report after its initial submission.’; 

(7) 

in Article 13, paragraph 4 is replaced by the following: 

‘4.  Approved active substances shall be included in the Regulation referred 
to in Article 78(3) containing the list of active substances already approved. 
The  Commission  shall  maintain  a  list  of  approved  active  substances 
electronically  available  to  the  public.  This  list  shall  indicate  whether  an 
active substance is a biocontrol substance.’; 

(8) 

the heading of Subsection 3 is replaced by the following: 

‘Subsection 3 

Renewal, reassessment and review’; 

(9) 

Article 14 is replaced by the following:  

‘Article 14 

Renewal of approval 

 Upon  application,  the  approval  of  an  active  substance  with  a  limited 
1. 
approval  period  shall  be  renewed  where  it  is  established  that  the  approval 
criteria provided for in Article 4 are satisfied.  

Article  4  shall  be  deemed  to  be  satisfied  where  this  has  been  established 
with  respect  to  one  or  more  representative  uses  of  at  least  one  plant 
protection product containing that active substance.  

Such  renewal  of  the  approval  may  include  conditions  and  restrictions,  as 
referred to in Article 6.  

2.  The renewal of approval of active substances shall be for an unlimited 
period, except for: 

(a) 

(b) 

(c) 

active substances that are approved as candidates for substitution in 
accordance with Article 24, 

active substances whose approvals are renewed under Article 4(7); 
or 

active  substances  for  which  a  limited  period  of  renewal  is  set  in 
accordance  with  Article  6  (j)  in  particular  in  the  light  of  relevant 
uncertainties  emerging  from  the  risk  assessment  including  as  a 
result of data gaps.’; 

(10) 

Article 18 is replaced by the following:  

EN 

‘Article 18 

47 

  EN 

 
Work programme for renewal of approval of active substances with 

unlimited approval periods 

1.  The Commission  shall  periodically after consulting  the Authority, adopt 
implementing  acts  in  accordance  with  the  procedure  referred  to  in  Article 
79(3),  identifying  active  substances  or  groups  of  active  substances  with 
unlimited  approval  periods  for  which  a  renewal  procedure  shall  be 
conducted.  

The identification of the active substances concerned shall take into account, 
among others, indications of safety concerns for human or animal health or 
the  environment,  new  scientific  or  technical  knowledge  and  available 
monitoring data and may take into account requests from Member States.  

The  Commission  shall  adopt  an  implementing  act  identifying  all  relevant 
active  substances,  as  referred  to  in  the  first  subparagraph,  at  the  latest  3 
years after amendments to the approval criteria set out in Annex II relevant 
for these active substances, or when updated data requirements or guidance 
documents relevant for these active substances become applicable.  

2. The implementing acts referred to in paragraph 1 shall:   

(a) 

list the active substances concerned;   

(b) 

list the rapporteur and co-rapporteur Member States;    

(c) 

(d) 

set deadlines for the submission of applications for renewal of the 
approval  of  the  active  substances  concerned  that  allow  sufficient 
time for the generation of the necessary data and the submission of 
the said applications; and   

set  expiry  dates  for  the  approvals  of  the  active  substances 
concerned  that  allow  sufficient  time  for  the  submission  and 
evaluation of the applications and for the adoption of decisions on 
the renewal of the approval of the active substances concerned.   

3. Articles 14, 15(2), 16, 17 and 20 shall apply.’; 

(11) 

A new Article 18a is inserted: 

‘Article 18a 

Work programme for targeted reassessment of active substances 

1. The Commission may initiate a targeted reassessment of the approval of 
active substances at any time, to verify whether certain approval criteria or 
specific  aspects  thereof  are,  in  light  of  current  scientific  and  technical 
knowledge, still met.  

It may, after consulting the Authority, and in accordance with the procedure 
referred  to  in  Article  79(3),  adopt  implementing  acts  identifying  active 
substances or groups of active substances with limited or unlimited approval 
periods for targeted reassessment.  

The identification of the active substances concerned shall be based on the 
same criteria as laid down in Article 18(1).  

2. The implementing acts referred to in paragraph 1 shall:   

(a) 

list the active substances concerned;   

EN 

48 

  EN 

 
(b) 

list the rapporteur and co-rapporteur Member States;    

(c) 

(d) 

set  out  the  scope  of  the  targeted  reassessment  for  the  active 
substances  concerned,  and  indicate  the  specific  data  requirements 
that  apply  and,  where  relevant,  the  guidance  documents  and/or 
scientific opinions that shall be used; and 

set deadlines for the submission of the required information for the 
active  substances  concerned  that  allow  sufficient  time  for  the 
generation  of  the  necessary  data  and  the  submission  of  the 
information. 

3.  Where  the  Commission  concludes  that  compliance  with  the  relevant 
approval  criteria  covered  by  the  targeted  reassessment  is  demonstrated,  it 
shall adopt an implementing act, confirming the approval, where applicable 
with conditions and restrictions in accordance with Article 6, in accordance 
with the procedure referred to in Article 79(3).   

4. Where the information referred to in paragraph 2 point (d) has not been 
provided within the time period established, the Commission shall adopt an 
implementing  act  withdrawing  the  approval  in  accordance  with  the 
procedure referred to in Article 79(3). 

Where the Commission concludes that the approval criteria covered by the 
targeted reassessment are no longer satisfied, it shall adopt an implementing 
act withdrawing the approval in accordance with the procedure referred to in 
Article  79(3).  In  case  the  derogation  set  out  in  Article  4(7)  applies,  that 
implementing act may amend the approval. 

5. Articles 13(4), 17 and 20(2) shall apply.’; 

(12) 

Article 19 is replaced by the following: 

‘Article 19 

Implementing measures 

An implementing act, adopted in accordance with the procedure referred to in 
Article 79(3), shall set out the provisions necessary for the implementation of 
the  renewal  procedure  and  of  the  targeted  reassessment  procedure,  as 
provided for in this Subsection 3.’; 

(13) 

in Article 20, paragraph 2 is replaced by the following: 

‘2.  The  Regulation  referred  to  in  paragraph  1  shall  provide  for  a  maximum 
grace period that the Member States may set when withdrawing or amending 
authorisations for plant protection products as a result of that Regulation. That 
maximum  grace  period  shall  normally  not  exceed  6  months  for  the  sale  and 
distribution, and in addition a maximum of one year for the disposal, storage, 
and use of existing stocks of the plant protection products concerned.  

In  case  there  are  no  other  available  reasonable  means  to  plant  protection 
products  containing  the  active  substance  concerned,  the  maximum  grace 
period shall not exceed one year for the sale and distribution, and in addition a 
maximum of two years for the disposal, storage, and use of existing stocks of 
the  plant  protection  products  concerned.  In  case  of  immediate  and  serious 
concerns for human health  or animal  health or the environment  that led to a 

EN 

49 

  EN 

 
withdrawal  or  non  -renewal  of  the  approval,  the  Regulation  referred  to  in 
paragraph 1 shall provide that the Member States may not set a grace period.’; 

(14) 

Article 22, paragraphs 1 and 2 are replaced by the following: 

‘1. An active substance complying with the criteria provided for in Article 4 
and in point 5 of Annex II shall be approved as a low-risk active substance. 

2.  Articles  4  to  21  shall  apply.  Low-risk  active  substances  shall  be  listed 
separately in the Regulation referred to in Article 13(4).’; 

(15) 

Article 23 is replaced by the following: 

‘Article 23 

Approval criteria for basic substances 

1. An approval granted pursuant to this Article and Article 23a shall cover: 

(a) 

(b) 

the  direct  use  of  the  basic  substance  for  plant  protection  purposes 
as such or when produced by the user directly from plants or parts 
of plants after simple preparation; 

the use of the basic substance in  a  product  consisting of the basic 
substance  and  of,  as  applicable,  a  simple  diluent,  other  basic 
substances or substances necessary to stabilise the product. 

(c)  Any  product  containing  a  basic  substance  with  a  composition  not 
complying  with  point  (b)  of  the  first  subparagraph  shall  be 
considered  as  a  plant  protection  product  and  shall  require  an 
authorisation in accordance with Chapter III.  

2.  By  way  of  derogation  from  Article  4,  the  basic  substance  shall  be 
approved where all the following criteria are fulfilled: 

(a) 

(b) 

(c) 

(d) 

the  basic  substance  is  not  a  substance  of  concern  or  the  hazard 
classification of the substance in accordance with Regulation (EC) 
No 1272/2008 does not apply to the product in which it is approved 
for use; 

the basic substance or the product in which it is used does not have 
an  inherent  capacity  to  cause  endocrine  disrupting,  neurotoxic  or 
immunotoxic effects; 

is  not  an  approved  active  substance  for  use  in  plant  protection 
products  at  the  time  of  the  submission  of  the  application  for 
approval  as  basic  substance  and  no  application  for  an  approval  as 
an active substance is under assessment at that moment; 

the  basic  substance  or  the  product  in  which  it  is  used  has  neither 
immediate  or  delayed  harmful  effects  in  human  health,  including 
that  of  vulnerable  groups,  or  animal  health,  nor  unacceptable 
effects  on  the  environment,  arising  from  its  use(s)  for  plant 
protection purposes.’; 

(16) 

a new Article 23a is inserted: 

‘Article 23a 

Approval procedure and labelling of basic substances 

EN 

50 

  EN 

 
1.  By way of derogation from Article 7, an application for the approval of 
a basic substance shall be submitted by a Member State or by any interested 
party to the Commission. 

The application shall be accompanied by the following information: 

(a) 

(b) 

intended  uses  and  proposed  conditions  of  use  of  the  basic 
substance; 

any evaluations of its possible effects on human or animal health or 
the  environment  carried  out  in  accordance  with  other  Union 
legislation regulating the use(s) of the substance; and 

(c) 

other  relevant  information  on  its  possible  effects  on  human  or 
animal health or the environment. 

2.  The Commission shall ask the Authority for an opinion or for scientific 
or technical assistance. The Authority shall provide its opinion or the results 
of its work to the Commission within 3 months of the date of the request. 

3.  Articles 6 and 13 shall apply. Basic substances shall be listed separately 
in the Regulation referred to in Article 13(4). 

4.  The  approval  shall  cover  all  approved  uses  of  the  basic  substances  and 
any  product  containing  it  as  specified  under  Article  23a  without  being 
limited  by  the  uses  applied  for.  The  approval  shall  be  for  an  unlimited 
period and Articles 59 to 62 shall not apply.  

5.    Where  a  substance  approved  as  a  basic  substance  is  subsequently  also 
approved as an active substance that is not a basic substance, that approval 
shall  not  affect  the  existing  approval  as  a  basic  substance,  as  well  as  the 
placing  on  the  market  and  use  as  basic  substance  or  product  as  refer  to  in 
Article 23(1). 

6.  Any applicant may request an extension of the approved uses of a basic 
substance.  Paragraphs  1  to  4  apply.  Where  justified  in  the  light  of  the 
outcome  of  the  evaluation,  the  Commission  shall  update  the  review  report 
for the basic substance, including a reference to the applicable review report 
in the approval regulation. 

7.  The Commission may review the approval of a basic substance at any 
time. It may take into account the request of a Member State to review the 
approval. 

Where  the  Commission  considers  that  there  are  indications  that  the 
substance  no  longer  satisfies  the  criteria  provided  for  in  paragraph  2  of 
Article  23  it  shall  inform  the  Member  States,  the  Authority  and  the 
interested party, setting a period for their comments to be submitted. 

The Commission shall ask the Authority for an opinion, or for scientific or 
technical assistance. The Authority shall provide its opinion or the results of 
its work to the Commission within three months of the date of the request. 

Where the Commission concludes that the criteria referred to in paragraph 1 
are  no  longer  satisfied,  a  Regulation  to  withdraw  or  amend  the  approval 
shall be adopted in accordance with the regulatory procedure referred to in 
Article 79(3). 

EN 

51 

  EN 

 
8.  Basic  substances  and  products  referred  to  in  Article  23(1)  may  be 
labelled as “Products containing (a) basic substance(s) for plant protection”. 
In such case the label shall contain clear indications about their allowed use 
for plant protection. 

9.   Detailed rules for the implementation of this Article may be established 
in accordance with the procedure referred to in Article 79(3).’; 

(17) 

a new Article 27a is inserted: 

‘Article 27a 

Approval periods of already granted approvals 

1. For all active substances approved at the latest on (…) [OP please insert 
the  date of  entry into force of this  Regulation], approvals  shall be deemed 
unlimited in time, except for: 

(a) 

active  substances  identified  as  candidates  for  substitution  in 
accordance with Article 24; 

(b) 

active substances approved under Article 4(7);  

(c) 

(d) 

active  substances  for  which  the  submission  of  an  application  for 
renewal under Article 15(1) was required before [OP: please insert 
the  date  of  entry  into  force  of  this  Regulation]  but  was  not 
submitted before the deadline referred to in Article 15(1);  

active substances for which a procedure for the renewal of approval 
is ongoing on [OP: please insert the date of entry into force of this 
Regulation]. 

2. The Commission shall amend the Regulation referred to in Article 78(3) 
in accordance with the first paragraph.’; 

(18) 

in Article 28, paragraph 2 is amended as follows: 

(a) 

point (a) is replaced by the following: 

‘(a)  placing  on  the  market  and  use  of  basic  substances  or  products 

referred to in Article 23(1).’; 

(b) 

the following point (f) is added: 

‘(f) placing on the market and use of seeds and other plant reproductive 
material treated with plant protection products authorised for that use in  at 
least one Member State.’; 

(19) 

Article 30 is replaced by the following: 

‘Article 30 

Provisional authorisations for plant protection products containing 
biocontrol active substances 

1.   By  way  of  derogation  from  Article  29(1)(a),  Member  States  may 
authorise  for  a  provisional  period  not  exceeding  five  years,  the  placing  on 
the  market  of  plant  protection  products  containing  one  or  more  biocontrol 
active substances not yet approved, provided that 

(a) 

the  dossier  is  admissible  in  accordance  with  Article  9  and  the 
Rapporteur Member State has finalised the draft assessment report 

EN 

52 

  EN 

 
in accordance with Article 11 concluding that the not yet approved 
biocontrol  active  substances  in  the  plant  protection  product  are 
expected  to  satisfy  the  requirements  of  Article  4(2)  and  Article 
4(3); 

(b) 

the Member State concludes that all active substances in the plant 
protection product comply with the criteria of point 5 of Annex II 
or  qualify  as  biocontrol  active  substance  and  that  the  uses  of  the 
plant  protection  product  for  which  provisional  authorisations  are 
granted satisfy the requirements of Article 29(1)(b) to (h); 

(c)  where  relevant,  maximum  residue  levels  have  been  established  in 

accordance with Regulation (EC) No 396/2005. 

2.   When a Member State grants a provisional authorisation in accordance 
with  paragraph  1,  that  Member  State  shall  immediately  inform  the  other 
Member States and the Commission of its assessment of the dossier and of 
the  terms  of  the  authorisation,  providing  at  least  the  information  listed  in 
Article 57(1). 

3.   Article  44  applies  to  provisional  authorisations  granted  in  accordance 
with paragraph 1. 

4.   Following  the  approval  of  an  active  substance  contained  in  a  plant 
protection  product  for  which  a  Member  State  has  granted  a  provisional 
authorisation  in  accordance  with  this  Article,  the  Member  States  may 
transform  the  provisional  authorisation  into  an  authorisation  granted  in 
accordance with Article 36, unless the conditions set in the approval require 
amendment of the provisional authorisation.’; 

(20) 

Article 32 is replaced by the following: 

‘Article 32 

Duration 

1.   The period of authorisation shall be laid down in the authorisation. 

Without prejudice to Article 44, the duration of an authorisation shall be set 
for a period: 

(a) 

(b) 

not  exceeding  15  years  if  the  plant  protection  product  concerned 
contains  only  active  substances,  safeners,  and  synergists  with 
unlimited approval periods, or, 

 not  exceeding  1  year  from  the  earliest  date  of  expiry  of  the 
approval of the active substances, safeners and synergists contained 
in the plant protection product concerned. 

This period shall allow the examination as provided for in Article 43 to be 
carried out. 

2. Authorisations may be granted for shorter periods to synchronise the re-
evaluation of similar products for the purposes of a comparative assessment 
of products containing candidates for substitution as provided for in Article 
50.’; 

(21) 

in Article 33, paragraph 2, point (b) is replaced by the following: 

EN 

53 

  EN 

 
‘(b) a proposal as to which Member State the applicant expects to evaluate 
the application in the zone concerned. In the case of an application for use in 
greenhouses,  as  post-harvest  treatment,  for  treatment  of  empty  storage 
rooms and for seed treatment, for uses that are solely and explicitly needed 
in  order  to  prevent  the  entry  into,  and  spread  within,  the  Union,  of  pests 
listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation 
(EU)  2016/2031  and  for  a  plant  protection  product  containing  as  active 
substances only biocontrol or low-risk active substances, only one Member 
State  shall  be  proposed,  which  evaluates  the  application  taking  account  of 
all  zones.  In  this  case  the  applicant  shall  send  the  summary  or  complete 
dossier as referred to in Article 8 to other Member States on request.’; 

(22) 

in Article 36, paragraph 1, first subparagraph is replaced by the following: 

‘1. The Member State examining the application shall make an independent, 
objective  and  transparent  assessment  in  the  light  of  current  scientific  and 
technical knowledge using guidance documents available at the time of the 
application. It shall give all Member States in the same zone the opportunity 
to submit comments to be considered in the assessment. 

For  the  active  substances,  safeners  and  synergists  contained  in  the  plant 
protection  product,  Member  States  shall  rely  on  the  last  assessment 
conducted at EU level unless it considers that an update is necessary in the 
light  of  the  current  scientific  and  technical  knowledge.  In  this  case  the 
Member State shall request the Commission to act under Articles 18, 18a or 
21.’; 

(23) 

new paragraphs 5, 6 and 7 are added to Article 37: 

‘5. Where the application concerns a plant protection product containing as 
active  substances  only  biocontrol  or  low-risk  active  substances  and  the 
Member  States  concerned  have  not  adopted  a  decision  after  120  days,  the 
authorisation shall be deemed as having been granted by the Member States. 

6.  The  Member  State  examining  the  application  shall  give  priority  to  the 
processing of applications for plant protection products containing as active 
substances only biocontrol substances. 

7. The Member State examining an application for plant protection product 
uses that are solely and explicitly needed in order to prevent the entry into, 
and  spread  within,  the  Union,  of  pests  listed  in  accordance  with  Articles 
5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 shall endeavour 
to decide as early as possible and in any case within 6 months.’; 

(24) 

Article 40 is replaced by the following: 

‘Article 40 

Mutual recognition 

1. The holder of an authorisation granted in accordance with Article 29 may 
apply  for  an  authorisation  for  the  same  plant  protection  product,  the  same 
use  and  under  comparable  agricultural  practices  in  another  Member  State 
under the mutual recognition procedure, provided for in this subsection, in 
the following cases:  

EN 

54 

  EN 

 
(a) 

(b) 

(c) 

the  authorisation  was  granted  by  a  Member  State  (reference 
Member State) which belongs to the same zone and the authorised 
plant  protection  product  is  placed  on  the  market  in  the  reference 
Member State; 

the  authorisation  was  granted  by  a  Member  State  (reference 
Member State) which belongs to a different zone provided that the 
authorisation for which the application was made is not used for the 
purpose of mutual recognition in another Member State within the 
same zone and the authorised plant protection product is placed on 
the market in the reference Member State; 

the  authorisation  was  granted  by  a  Member  State  for  use  in 
greenhouses,  as  post-harvest  treatment,  for  treatment  of  empty 
rooms  or  containers  used  for  storing  plant  or  plant  products,  for 
seed  treatment,  for  uses  that  are  solely  and  explicitly  needed  in 
order to apply the provisions of Regulation (EU) 2016/2031 or for 
plant  protection  products  containing  as  active  substances  only 
biocontrol  active  substances  regardless  of  the  zone  to  which  the 
reference Member State belongs and the authorised plant protection 
product is placed on the market in the reference Member State. 

2.  Where  a  plant  protection  product  is  not  authorised  in  a  Member  State 
because  no  application  for  an  authorisation  has  been  submitted  in  that 
Member State, official or scientific bodies involved in agricultural activities 
or professional agricultural organisations may apply for an authorisation for 
the  same  plant  protection  product,  the  same  use  and  under  the  same 
agricultural  practices  in  that  Member  State  under  the  mutual  recognition 
procedure referred to in paragraph 1.’; 

(25) 

Article 42 is replaced by the following: 

‘Article 42 

Procedure 

1. The application shall be accompanied by the following: 

(a) 

(b) 

(c) 

(d) 

a copy of the authorisation granted by the reference Member State 
as well as a translation of the authorisation into an official language 
of the Member State receiving the application; 

a formal statement that the plant protection product  is  identical  to 
that authorised by the reference Member State; 

a  complete  or  summary  dossier  as  required  in  Article  33(3)  when 
requested by the Member State; 

an  assessment  report  of  the  reference  Member  State  containing 
information on the evaluation and decision on the plant protection 
product. 

Points  (c)  and  (d)  shall  not  apply  to  applications  submitted  under  Article 
40(2) and Article 51(7). 

2. The Member State to which an application under Article 40 is submitted 
shall decide on the application within 120 days.  

EN 

55 

  EN 

 
3. Where the application concerns a plant protection  product  containing  as 
active  substance  only  biocontrol  or  low-risk  active  substances  and  the 
Member  State  has  not  adopted  a  decision  after  120  days,  the  authorisation 
shall be deemed as having been granted by the Member State. 

4.  Where  requested  by  the  Member  State,  the  applicant  shall  submit  the 
application in the national or official languages of that Member State or one 
of those languages. 

5. Detailed rules for the implementation of this Article may be established in 
accordance with the procedure referred to in Article 79(3).’; 

(26) 

Article 43 is amended as follows: 

(a) 

paragraph 2 is replaced by the following: 

‘2. That application for renewal shall be submitted: 

(a)  No later than nine months before the expiry of an authorisation, if 
the  plant  protection  product  concerned  contains  only  active 
substances,  safeners,  and  synergists  with  unlimited  approval 
periods, or 

(b)  Within  3  months  from  the  renewal  of  the  approval  of  an  active 
substance,  safener  or  synergist  contained  in  the  plant  protection 
product. 

(27) 

The applicant shall provide the following information:   

(a) 

(b) 

(c) 

(d) 

a copy of the authorisation of the plant protection product; 

any  new  information  required  as  a  result  of  amendments  in  data 
requirements or criteria; 

evidence  that  the  new  data  submitted  are  the  result  of  data 
requirements  or  criteria  which  were  not  in  force  when  the 
authorisation  of  the  plant  protection  product  was  granted  or 
necessary to amend the conditions of approval; 

any  information  required  to  demonstrate  that  the  plant  protection 
product  meets  the  requirements  set  out  in  the  Regulation  on  the 
renewal of the approval of the active substance, safener or synergist 
contained therein; 

(e) 

a report on the monitoring information, where the authorisation was 
subject to monitoring.’; 

(28) 

(29) 

(30) 

(b) 

in Article 43, paragraph 5 is replaced by the following: 

‘Member States shall decide on the renewal of the authorisation of a plant protection 
product at the latest 12 months after the submission of the application;’; 

in Article 44, a new paragraph 1a is inserted: 

‘1a.  Member  States  shall  check  compliance  of  all  plant  protection  products 
containing  the active substance, safener or synergist concerned with  any conditions 
and restrictions provided for in the Regulation confirming the approval under Article 
18a.’; 

(31) 

Article 46 is replaced by the following: 

EN 

56 

  EN 

 
‘Article 46 
Grace period 

1. Where a Member State withdraws or amends an authorisation or does not 
renew it, as a result of a Regulation adopted pursuant to Article 20(1) or as a 
result  of  a  Regulation  adopted  pursuant  to  Article  21(3),  Member  States 
shall set a grace period within the limits of the maximum grace period set by 
the  Commission  on  the  basis  of  Article  20(2),  unless  the  Commission  has 
prohibited the setting of such a grace period on the basis of Article 20(2) . 

2. Where a Member State withdraws or amends an authorisation or does not 
renew it for other reasons than those referred to in paragraph 1, it may set a 
grace period that shall not exceed 6 months for the sale and the distribution 
and an additional  maximum  of 1 year  for the disposal,  storage, and use of 
existing stocks of the plant protection products concerned ).’; 

(32) 

Article 49 is replaced by the following: 

‘Article 49 
Placing on the market of treated seeds and plant reproductive material 

1.  The  treatment  of  seeds  and  plant  reproductive  material  with  plant 
protection  products  as  well  as  the  sowing  of  the  treated  seeds  and  plant 
reproductive material constitutes a use of a plant protection product.  

2.  Placing  on  the  market  and  use  of  seeds  and  plant  reproductive  material 
treated  with  a  plant  protection  product  which  is  not  authorised  in  any 
Member State is prohibited. 

3. Member States can only prohibit the placing on the market or the use of 
seeds  and plant reproductive material  treated  with  plant protection product 
authorised for that use in at least one Member State if there are substantial 
concerns that treated seeds are likely to constitute a serious risk to human or 
animal health or to the environment and that such risk cannot be contained 
satisfactorily  by  means  of  measures  taken  by  the  Member  State(s) 
concerned.  

4. In the cases referred under paragraph 3 above, the Commission may take 
measures to restrict or prohibit the use and/or sale of such treated seeds and 
plant reproductive material in accordance with the procedure referred to in 
Article 79(3). Before taking such measures, the Commission shall examine 
the  evidence  and  may  request  an  opinion  from  the  Authority.  The 
Commission  may  set  a  time  limit  within  which  such  an  opinion  shall  be 
provided. 

5. Articles 70 and 71 shall apply. 

the 

reproductive  material, 

6. Without  prejudice to  other Union legislation concerning the labelling  of 
seeds  and  plant 
label  and  documents 
accompanying  the  treated  seeds  and  plant  reproductive  material  shall 
include  the    name  of  the  plant  protection  product  with  which  they  were 
treated, its authorisation number and the Member State which authorised it, 
the name(s) of the active substance(s) in that product, standard phrases for 
safety  precautions  as  provided  for  in  Regulation  (EC)  No  1272/2008  and, 
where  applicable,  risk  mitigation  measures  set  out  in  the  authorisation  for 
that product.  

EN 

57 

  EN 

 
7.  Machinery  used  to  sow  treated  seeds  shall  not  be  considered  pesticide 
the  context  of  Article  8  of  Directive 
application  equipment 
2009/128/EC.’; 

in 

(33) 

Article 51 is amended as follows: 

(a) 

paragraph 2 is replaced by the following: 

‘2.  Member  States  shall  extend  the  authorisation  provided  that  all  the 
following conditions are met: 

(a) 

(b) 

(c) 

the intended use is minor in nature;  

the  conditions  provided  for  in  Article  4(3)(b),  (d)  and  (e)  and  Article 
29(1)(i) are fulfilled;  

the  documentation  and  information  to  support  the  extension  of  use  has 
been submitted by the persons or bodies referred to in paragraph 1 or is 
available  otherwise,  in  particular  data  on  the  of  residues  and  where 
necessary  on  the  risk  assessment  as  regards  the  operators,  workers  and 
bystanders.’ 

(b)  paragraph 3 is replaced by the following: 

‘3.  Member  States  shall  take  measures  to  facilitate  or  encourage  the 
submission of applications to extend the authorisation of already authorised 
plant protection products to minor uses.’; 

(c) 

paragraph 7 is replaced by the following: 

‘7.  The  applicants  referred  to  in  paragraph  1  may  also  apply  for 
authorisation of a plant protection product for minor uses in accordance with 
Article 40(1) even if the uses in the reference Member State are not minor 
uses.  Member  States  shall  authorise  such  uses  in  accordance  with  Article 
41.’; 

(d)  paragraph 9 is replaced by the following: 

‘9.  Detailed  rules  for  the  implementation  of  this  Article  51  may  be 
established in accordance with the procedure referred to in Article 79(3).’;. 

(34) 

Article 59 is replaced by the following: 

‘Article 59 

Data protection 

1.  Test  and  study  reports  shall  benefit  from  Union-wide  data  protection 
under the conditions laid down in this Article. 

2.  Data protection may be granted to test and study reports concerning the 
active  substance,  safener  or  synergist,  adjuvants  and  the  plant  protection 
product as referred to in Article 8(2) when they are submitted to a Member 
State  by  an  applicant  for  authorisation  under  this  Regulation,  (‘the  first 
applicant’), provided that those test and study reports were: 

(a) 

(b) 

necessary  for  the  authorisation  or  for  an  amendment  of  the 
authorisation in order to allow the use on another crop; and 

certified  as  compliant  with  the  principles  of  good  laboratory 
practice or of good experimental practice. 

EN 

58 

  EN 

 
3.   Data protection shall be granted to the test and study reports referred to 
in  paragraph  2  where  the  first  applicant  has  requested  it  at  the  time  of 
submitting the dossier and has provided to the Member State concerned, for 
each  test or study report, the information  referred to  in  point (f) of Article 
8(1) and in point (d) of Article 33(3) as well as confirmation that a period of 
data  protection  under  this  Regulation  has  never  been  granted  anywhere  in 
the Union.  

4. If the first applicant does not request data protection to be granted for a 
test  or  study  report  submitted  for  the  first  time  in  a  dossier  under  this 
Regulation, it shall not be data protected and it could be used for the benefit 
of any subsequent applicants. 

5.  Where  a  test  or  study  report  is  protected,  it  may  not  be  used  by  any 
Member  State  for  the  benefit  of  other  applicants  for  authorisation  of  plant 
protection products, safeners or synergists and adjuvants, except as provided 
in Article 62 or in Article 80, or where: 

(a) 

(b) 

the applicant has submitted a letter of access; or 

any period of data protection granted for the test and study reports 
under this Regulation has expired. 

6. The period of data protection shall be 10 years starting from the date of 
the authorisation  in  the first  Member State granting an authorisation  based 
on a dossier including the test or study report. That period is extended to 13 
years for plant protection products covered by Article 47. 

7. The period of data protection shall be extended by three months for each 
extension  of  authorisation  for  minor  uses  on  a  different  crop/pest 
combination  as  defined  in  Article  51(1),  except  where  the  extension  of 
authorisation  is  based  on  extrapolation,  if  the  applications  for  such 
extensions are made by the authorisation holder at the latest five years after 
the date referred to in paragraph 5.  

8. The same data protection rules as for the first authorisation shall also be 
granted to test and study reports submitted by third parties for the purpose of 
extension of authorisation for minor uses as referred to in Article 51(1). 

9. Data protection shall be granted to test and study reports necessary for the 
renewal  or review of an authorisation.  The period for data protection shall 
be  30  months  from  the  first  renewal  of  the  authorisation  granted  in 
accordance with Article 43 in any Member State or from the first conclusion 
of a review conducted in accordance with Article 44 in any Member State. 
The first to fifth paragraphs shall apply mutatis mutandis.  

10. The total  period of data protection may not  exceed 13 years. For plant 
protection products covered by Article 47 the total period of data protection 
may not exceed 15 years. 

11. Detailed rules for the implementation of this Article may be established 
in accordance with the procedure referred to in Article 79(3).’; 

(35) 

in Article 67, paragraph 1 is replaced by the following: 

‘1.  Producers,  suppliers,  distributors,  importers,  and  exporters  of  plant 
protection products shall keep records of the plant protection products they 

EN 

59 

  EN 

 
produce,  import,  export,  store  or  place  on  the  market  for  at  least  5  years. 
Professional  users  of  plant  protection  products  shall,  except  for  plant 
protection  products  containing  as  active  substances  only  biocontrol 
substances, for at least 3 years, keep records of the plant protection products 
they use, containing the name of the plant protection product, the time and 
the  dose  of  application,  the  area  and  the  crop  where  the  plant  protection 
product was used. 

They  shall  make  the  relevant  information  contained  in  these  records 
available  to  the  competent  authority  on  request.  Third  parties  such  as  the 
drinking  water  industry,  retailers  or  residents,  may  request  access  to  this 
information by addressing the competent authority 

Third parties such as the drinking water industry, retailers or residents may 
request access to this information by addressing the competent authority. 

The  competent  authorities  shall  provide  access  to  such  information  in 
accordance with applicable national or Union law’. 

(36) 

Article 68 is deleted. 

Article 2  

(1) 

(2) 

Transitional provisions concerning Regulation (EC) No 1107/2009 

Article  14(2)  of  Regulation  (EC)  No  1107/2009  as  amended  by  [OP:  please  insert 
the  reference  of  this  Regulation]  shall,  following  completion  of  the  renewal 
procedure,  also  apply  to  active  substances  for  which  an  application  for  renewal  of 
approval has been submitted before [date of entry force of this Regulation]. 

Article  59  of  Regulation  (EC)  No  1107/2009  as  it  stood  before  being  amended  by 
this Regulation shall continue to apply to test and study reports whose data protection 
period in a Member State started before (…) [OP please specify the entry into force 
of this Regulation]. Article 59 of Regulation (EC) No 1107/2009 as amended by this 
Regulation  shall  apply,  with  the  exception  of  Article  59(3),  last  sentence,  to  those 
test or study reports as of the date of their first submission for the authorisation in a 
plant protection product in any other Member State after (…) [OP please specify the 
entry into force of this Regulation] but shall not cover the Member States referred to 
in the previous sentence. 

(3) 

Article 23a (6) of Regulation (EC) No 1107/2009 as amended by [OP: please insert 
the  reference  of  this  Regulation]  shall  also  apply  to  all  basic  substances  approved 
before the entry into force of this Regulation.  

Article 3 

Amendments to Regulation (EC) No 396/2005 

Regulation (EC) No 396/2005 is amended as follows: 

(1) 

Article 3(2) is amended as follows: 

(a) 

point (a) is replaced by the following: 

‘(a) good agricultural practice’ (GAP) means the recommended, authorised 
or  registered  safe  use,  either  in  the  Union  or  a  third  country,  of  plant 
protection  products  under  actual  conditions  at  any  stage  of  production, 

EN 

60 

  EN 

 
storage,  transport,  distribution  and  processing  of  food  and  feed.  It  also 
implies the application, in conformity with Regulation (EC) 1107/2009 and 
Directive  2009/128/EC,  of  the  principles  of  integrated  pest  control  in  a 
given climate zone, as well as using the minimum quantity of pesticides and 
setting MRLs/temporary MRLs at the lowest level which allows the desired 
effect to be obtained. ; 

(b)  point (f) is replaced by the following: 

‘(f)  ‘limit  of  quantification’  (LOQ)  means  the  validated  lowest  residue 
concentration  which  can  be  quantified  and  reported  by  routine  monitoring 
with validated control methods;’; 

(c) 

point (g) is deleted; 

(2) 

In Article 6, paragraph (4) is replaced by the following: 

‘4. Applications for setting an MRL based on a GAP implemented in a third 
country shall be submitted to rapporteur Member States designated pursuant 
to  Regulation  (EC)  No  1107/2009.  If  no  such  rapporteur  has  been 
designated, applications shall be made to Member States designated by the 
Commission in accordance with the procedure referred to in Article 45(2) of 
this  Regulation  at  the  request  of  the  applicant.  Such  applications  shall  be 
made in accordance with Article 7 of this Regulation.’; 

(3) 

In Article 10, paragraph (1), point (b) is replaced by the following: 

‘(b) the anticipated LOQ for the pesticide/product combination;’; 

(4) 

Article 14 is amended as follows: 

(a) 

In paragraph (2), a new subparagraph is added: 

– 

‘By  way  of  derogation  from  point  (e),  where  the  active  substance 
has  one  or  more  of  the  properties  set  out  in  points  3.6.2  to  3.6.5, 
3.7.1  to  3.7.3,  and  3.8.2  of  Annex  II  to  Regulation  (EC)  No 
1107/2009  according  to  the  latest  available  evaluation  under 
Regulation  (EC)  No  1107/2009  or  to  a  specific  evaluation  in 
accordance  with  Article  43  of  Regulation  (EC)  No  396/2005,  a 
MRL that has been set based on a CXL or a GAP implemented in a 
third  country  can  be  revoked  and  set  in  accordance  with  Article 
18(1)(b) or Article 16 if considered  appropriate in  the light  of the 
outcome of an impact assessment.  ; 

(b)  A new paragraph 2a is inserted: 

‘2a.  Where  it  is  necessary  in  order  to  allow  for  the  normal  marketing, 
processing  and  consumption  of  products,  the  regulations  setting  or 
modifying  MRLs  provided  for  in  Article  14  may  establish  transitional 
measures allowing for the placing or remaining on the market in the Union 
of products that, at the time of their placing on the market or at the time of 
their  placing  into  storage  after  production,  were  compliant  with  the  MRLs 
applicable or to which no MRL was applicable. 

The  burden  of  proving  when  the  products  were  placed  on  the  market  or 
placed  into  storage  after  production  shall  be  borne  by  the  food  business 
operator.’ 

EN 

61 

  EN 

 
(5) 

(6) 

In Article 15, paragraph (1), point (c) is deleted. 

Article 16 is replaced by the following: 

‘Article 16 

Procedure for setting MRLs in certain circumstances 

1.  The  Commission  may  adopt  a  Regulation  under  Article  14(1)  setting  a 
MRL to be included in Annex III in the following circumstances: 

(a) 

in  exceptional  cases,  in  particular  where  pesticide  residues  may 
arise  as  a  result  of  environmental  or  other  contamination  or  from 
uses  of  plant  protection  products  pursuant  to  Regulation  (EC)  No 
1107/2009; or 

(b)  where the products concerned constitute a minor component of the 
diet of consumers, and do not constitute a major part of the diet of 
relevant subgroups, and, where relevant, of animals; or 

(c) 

for honey; or 

(d) 

for herbal infusions; or 

(e)  where  essential  uses  of  plant  protection  products  have  been 
identified by a Decision to delete an active substance from, or not 
to 
to  Directive 
91/414/EEC; or 

include  an  active  substance 

in,  Annex  I 

(f)  where new products, product groups and/or parts of products have 
been  included  in  Annex  I,  and  one  or  more  Member  States  so 
request,  in  order  to  allow  any  scientific  studies  necessary  for 
supporting an MRL to be undertaken and evaluated, provided that 
no  unacceptable  safety  concerns  for  the  consumer  have  been 
identified. 

2. The inclusion of MRLs as referred to in paragraph 1 shall be based on the 
opinion of the Authority, monitoring data and an assessment demonstrating 
that there are no unacceptable risks to consumers or animals.’; 

(7) 

In article 18, a new paragraph (1a) is inserted: 

‘1a.  Where  it  is  necessary  in  order  to  allow  for  the  normal  marketing, 
processing  and  consumption  of  products,  the  regulations  setting  or 
modifying  MRLs  provided  for  in  Article  18  may  establish  appropriate 
transitional measures allowing for the placing or remaining on the market in 
the Union of products that, at the time of their placing on the market or at 
the time of their placing into storage after production, were compliant with 
the MRLs applicable or to which no MRLs was applicable. 

The  burden  of  proving  when  the  products  were  placed  on  the  market  or 
placed  into  storage  after  production  shall  be  borne  by  the  food  business 
operator.; 

(8) 

in Article 31, paragraph (1), point(b) is replaced by the following: 

‘(b)  the  LOQs  applied  in  the  national  control  programmes  referred  to  in 
Article  30  and  under  the  Community  control  programme  referred  to  in 
Article 29;’; 

EN 

62 

  EN 

 
(9) 

Article 43 is replaced by the following: 

‘Article 43 

Scientific opinion of the Authority and review of MRLs 

1. The Commission or the Member States may request from the Authority a 
scientific  opinion  on  any  measure  related  to  the  assessment  of  risks  under 
this Regulation.  The Commission  may specify the time limit  within which 
such an opinion shall be provided. 

2. The Commission may review maximum residue levels established under 
this  Regulation  at  any  time  in  the  light  of  new  scientific  and  technical 
knowledge,  taking  into  account  the  scientific  opinion  referred  to  in 
paragraph 1 where appropriate.  ’. 

Article 4 
Amendments to Regulation (EU) No 528/2012 

Regulation (EU) No 528/2012 is amended as follows: 

(1) 

in Article 4, paragraph 1 is replaced by the following: 

‘1.  An  active  substance  shall  be  approved  if  at  least  one  biocidal  product 
containing  that  active  substance  may  be  expected  to  meet  the  criteria  laid 
down  in  Article  19(1),  point  (b),  taking  into  account  the  factors  set  out  in 
Article 19(2) and (5).   

Approvals  shall  be  for  an  unlimited  time  except  for  active  substances  that 
are identified as candidates for substitution in accordance with Article 10 or 
where  the  conditions  of  approval,  for  duly  justified  reasons,  specify  the 
expiry date of the approval in accordance with paragraph 3 of this Article. 
An active substance that falls under Article 5 may only be approved for an 
initial period not exceeding five years.’; 

(2) 

in Article 4, paragraph 3, point (h) is replaced by the following: 

‘(h)  the  date  of  approval  and,  when  appropriate,  the  expiry  date  of  the 
approval of the active substance.’ ; 

(3) 

in Article 9, paragraph (1), point (a) is replaced by the following: 

‘(a) adopt an implementing Regulation providing that an active substance is 
approved, and under which conditions,  including the date of approval  and, 
when appropriate, date of expiry of the approval; or’; 

(4) 

In Article 10, paragraph (4) is replaced by the following: 

‘The  approval  of  an  active  substance  that  is  considered  as  a  candidate  for 
substitution  and  each  renewal  shall  be  for  a  period  not  exceeding  seven 
years.’; 

(5) 

In Article 12, paragraph (3) is replaced by the following: 

‘3.  The  renewal  of  an  approval  of  an  active  substance  shall  be  for  an 
unlimited  time  for  all  product-types  to  which  the  approval  applies,  unless 
the  active  substance  is  identified  as  a  candidate  for  substitution  in 
accordance  with  Article  10  or  a  shorter  period  is  specified  in  the 

EN 

63 

  EN 

 
implementing  act  adopted  in  accordance  with    Article  14(4),  point  (a), 
renewing such an approval.’; 

(6) 

in Article 13, paragraph 1 is replaced by the following: 

‘1.  Applicants  wishing  to  seek  renewal  of  the  approval  of  an  active 
substance,  which  is  subject  to  a  specified  expiry  date  for  one  or  more 
product-types,  shall  submit  an  application  to  the  Agency  at  least  550  days 
before the expiry of the approval. Where there are different expiry dates for 
different product-types, the application shall be submitted at least 550 days 
before the earliest expiry date.’; 

(7) 

a new Article 14a is inserted: 

‘Article 14a 

Renewal of an active substance with unlimited approval 

1.  The  Commission  may  adopt  implementing  acts  in  accordance  with  the 
examination  procedure  referred  to  in  Article  82(3)  identifying  active 
substances with unlimited approval for which a renewal procedure shall be 
conducted.  The  implementing  acts  shall  list  the  active  substances  and 
product-types concerned, and set  the expiry date of their current  approvals 
that  allows  for  an  evaluation  of  the  applications  and  the  adoption  of  a 
decision on the renewal of approval. 

Article  13  and  Article  14  apply  mutatis  mutandis  for  the  submission, 
acceptance and evaluation of the applications. 

2.  The  identification  of  the  active  substances  concerned  shall  take  into 
account,  among  others,  relevant  new  or  updated  data  requirements  or 
guidance  documents,  indications  of  safety  concerns  for  human  or  animal 
health  or  the  environment,  new  scientific  or  technical  knowledge  and 
available monitoring data, and may take into account requests from Member 
States.’; 

(8) 

a new Article 15a is inserted: 

‘Article 15a 

Approval periods of active substances approved by [OP, please insert 
the date: date of the entry into force of this Regulation] 

For  all  active  substances  approved  under  Regulation  (EU)  No  528/2012  at 
the latest on [OP, please insert the date: date of the entry into force of this 
Regulation]  for  one  or  more  product-types,  approvals  shall  be  deemed 
unlimited in time for the concerned product-types, except for: 

(a) 

(b) 

(c) 

active substances identified as meeting the criteria set out in Article 
5(1) or Article 10; 

active  substances  for  which  an  application  for  renewal  was 
submitted  by  the  deadline  set  out  in  Article  13(1)  by  [OP,  please 
insert the date: date of the entry into force of this Regulation]; 

active  substances  for  which  no  application  for  renewal  was 
submitted  by  the  deadline  set  out  in  Article  13(1)  by  [OP,  please 
insert the date: date of the entry into force of this Regulation].’; 

(9) 

In Article 44, paragraph (5) is replaced by the following: 

EN 

64 

  EN 

 
 
 
 
‘5. Upon receipt of the opinion of the Agency, the Commission shall adopt 
either an implementing act granting the Union authorisation of the biocidal 
product  or  an  implementing  act  stating  that  the  Union  authorisation  of  the 
biocidal  product  has  not  been  granted.  Those  implementing  acts  shall  be 
adopted in accordance with the examination procedure referred to in Article 
82(3). 

Summaries  of  Commission  decisions  shall  be  published  in  the  Official 
Journal  of  the  European  Union,  indicating  the  decision  number,  the  nature 
of  the  decision,  the  name  of  the  biocidal  product,  the  active  substances 
contained  in  the  biocidal  product,  the  product-types,  the  authorisation 
number, the authorisation holder, and the expiry date of the authorisation. 

The  Commission  shall,  at  the  request  of  a  Member  State,  decide  to  adjust 
certain  conditions  of  a  Union  authorisation  specifically  for  the  territory  of 
that Member State or decide that a Union authorisation shall not apply in the 
territory of that Member State, provided that such a request can be justified 
on one or more of the grounds referred to in Article 37(1).’; 

(10) 

In Article 46, paragraph (4), the first subparagraph is replaced by the following: 

‘Upon receipt of the opinion of the Agency, the Commission shall adopt an 
implementing act renewing the Union authorisation or refusing to renew the 
Union  authorisation.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 82(3).’. 

Article 5 
Amendment to Regulation (EC) No 1829/2003 

Regulation (EC) No 1829/2003 is amended as follows: 

in Article 2, point (10), the following is added:  

‘Food  and  feed  which  are  obtained  using  as  production  strains  genetically 
modified  micro-organisms  within  the  meaning  of  Art  2(b)  of  Directive 
2009/41/EC, with the exception of animal and plant cells in culture,  are not 
food  and  feed  ‘produced  from  GMOs’  where  they  do  not  contain  those 
micro-organisms  and,  if  they  contain  residues  thereof,  such  residues  are 
limited to non-viable cells, their presence is minimized through reasonable 
attempts  to  remove  them  in  accordance  with  good  manufacturing  practice 
and they have no technological effect on the food or the feed.’. 

Article 6 
Amendments to Regulation (EC) No 1831/2003 

Regulation (EC) No 1831/2003 is amended as follows: 

(1) 

in Article 2, paragraph 2, the following points are added: 

‘(o) ‘label’ means any tag, brand, mark, pictorial or other descriptive matter, 
written, printed, stencilled, marked, embossed, impressed on, or attached to 
the packaging or the container of the feed additive or premixture; 

(p) ‘labelling’ means the attribution of any words, particulars, trade marks, 
brand name, pictorial matter or symbol to a feed additive or a premixture by 
placing this information on any medium referring to or accompanying such 

EN 

65 

  EN 

 
feed  additive  or  premixture,  such  as  packaging,  container,  notice,  label, 
document, ring, collar or digital means, including for advertising purposes.’; 

(q) ‘holder of the authorisation’ means the natural or legal person mentioned 
as  such  in  the  Community  Register  of  Feed  Additives  in  relation  to  the 
authorisation concerned.’; 

(2) 

(3) 

Article 3, paragraph 3, is replaced by the following: 

‘3. In the case of additives belonging to categories provided for under points (d) and 
(e) of Article 6(1) and of those additives falling within the scope of Union legislation 
relating  to  the  marketing  of  products  consisting  of,  containing  or  produced  from 
genetically  modified  organisms  (GMOs),  no  person  other  than  the  holder  of  the 
authorisation  referred  to  in  Article  9,  his  legal  successor  or  successor  in  title,  or  a 
person acting under his written authority, shall first place the product on the market.’; 

(4) 

Article 9 is amended as follows: 

(a) 

paragraph 6 is replaced by the following: 

‘6.  A  Regulation  granting  authorisation  for  additives  consisting  of, 
containing  or  produced  from  GMOs  shall  include,  where  appropriate,  the 
unique identifier attributed to the GMO as referred to in Regulation (EC) No 
1830/2003 of the European Parliament and of the Council*’; 

_________ 

*  Regulation  (EC)  No  1830/2003  of  the  European  Parliament  and  of  the  Council  of  22 
September 2003 concerning the traceability and labelling of genetically modified organisms 
and  the  traceability  of  food  and  feed  products  produced  from  genetically  modified 
organisms  and  amending  Directive  2001/18/EC  (OJ  L  268,  18.10.2003,  p.  24,  ELI: 
http://data.europa.eu/eli/reg/2003/1830/oj). 

(b)  paragraph 8 is replaced by the following: 

‘8. Without prejudice to Article 13, the authorisation granted in accordance 
with  the  procedure  laid  down  in  this  Regulation  shall  be  valid  for  an 
unlimited period of time throughout the Union. The authorised feed additive 
shall be entered in the Community Register of Feed Additives referred to in 
Article  17  (‘the  Register’)  )  upon  the  entry  into  force  of  the  Regulation 
granting the authorisation. Each entry in the Register shall state the date of 
authorisation and shall include the particulars referred to in paragraphs 5, 6 
and  7  of  this  Article.  In  addition,  each  entry  in  the  Register  concerning 
additives  belonging  to  categories  provided  for  under  points  (d)  and  (e)  of 
Article  6(1),  and  additives  consisting  of,  containing  or  produced  from 
GMOs, shall include the name of the holder of the authorisation.’; 

(c) 

the following paragraphs 8a and 8b are inserted: 

''8a.  The  Commission  may,  by  means  of  implementing  acts,  amend  the 
Regulations  granting  authorisations  adopted  before  [OP:  please  insert  the 
date = date of entry into force of this Regulation] which include the name of 
the respective holder of the authorisation, in order to remove such name and 
include  it  in  the  Register.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 22(2). 

8b.  By  way  of  derogation  from  paragraph  8,  the  authorisation  granted  to 
additives belonging to  the  category  provided  for  under point  (e) of Article 

EN 

66 

  EN 

 
6(1) in accordance with the procedure laid down in this Regulation shall be 
valid  throughout  the  Union  for  10  years  and  shall  be  renewable  in 
accordance with Article 14.’.; 

(5) 

the following new Article 9a is inserted: 

‘Article 9a 
 Authorisation periods of certain authorisations granted before  [OP: 
please insert the date = date of entry into force of this Regulation] 

Authorisations of feed additives granted before [OP: please insert the date 
=  date  of  entry  into  force  of  this  Regulation],  shall  be  deemed  to  be 
unlimited in time, except for: 

(a) 

feed additives belonging to the category provided for in point (e) of 
Article 6(1); 

(b)  urgent authorisations granted under Article 15; 

(c) 

(d) 

authorisations  for  which  no  application  for  renewal  has  been 
submitted  by  the  deadline  set  out  in  Article  14(1)  before  [OP: 
please insert the date = date of entry into force of this Regulation] 
or for which such application has been submitted but subsequently 
withdrawn; 

authorisations  for  which  an  application  for  renewalhas  been 
submitted in accordance with Article 14 before [OP: please insert 
the date = date of entry into force of this Regulation] and for which 
no decision has been taken by that date.’; 

(6) 

Article 13 is replaced by the following: 

'Article 13 

Modification, suspension and revocation of authorisations 

1. On its own initiative or following a request from a Member State or from 
the  Commission,  the  Authority  shall  issue  an  opinion  on  whether  an 
authorisation still meets the conditions set out in this Regulation, taking into 
account  scientific  and  technological  developments.  In  order  to  prepare  its 
opinion, the Authority may, where appropriate, request the person who was 
the  applicant  for  the  authorisation  concerned,  or,  where  applicable,  the 
holder  of  the  authorisation,  to  submit  within  a  specified  time  information 
and data relevant to the assessment. It shall forthwith transmit its opinion to 
the Commission, to the Member States and, where applicable, to the holder 
of the authorisation. The opinion shall be made public. 

2.  The  Commission  shall  examine  the  opinion  of  the  Authority  without 
delay.  It  shall,  by  means  of  implementing  acts,  take  a  decision  on  the 
modification,  suspension  or  revocation  of  the  authorisation  concerned. 
Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 22(2).  

3.  If  the  holder  of  the  authorisation  proposes  changing  the  terms  of  the 
authorisation by submitting an application to the Commission, accompanied 
by  the  relevant  data  supporting  the  request  for  the  change,  the  Authority 
shall  transmit  its  opinion  on  the  proposal  to  the  Commission  and  the 
Member States. The Commission shall examine the opinion of the Authority 

EN 

67 

  EN 

 
without delay and shall, by means of implementing acts, take a decision on 
the  change  concerned.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 22(2). 

3a. Where a change concerning the holder of an existing authorisation needs 
to be made, the holder of that authorisation shall submit to the Commission 
any request for modification of the name of the holder of the authorisation, 
accompanied  by  the  relevant  data  justifying  the  request.  The  Commission 
shall decide on the request for modification and shall notify the holder of the 
authorisation of its decision. Where the request is granted, the Commission 
shall adapt the relevant entry in the Register accordingly within 20 days. 4. 
In the  case of authorisations  not  issued to  a specific holder, any interested 
party may submit to the Commission an application for the modification of 
the terms of the authorisation, accompanied by the relevant data supporting 
the  request  for  the  change.  Such  modification  shall  aim  to  extend  the 
specifications  or  conditions  of  the  relevant  authorisation.  The  Authority 
shall transmit its opinion on the request to the Commission and the Member 
States. The Commission shall examine the opinion of the Authority without 
delay  and  shall,  by  means  of  implementing  acts,  take  a  decision  on  the 
modification of the authorisation concerned. Those implementing acts shall 
be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 22(2).  

laboratory  or 

the  Community  reference 

5. Where, taking account of scientific and technological developments, the 
the  Authority 
Commission, 
considers that the method of analysis included in the Regulation granting an 
authorisation  needs  to  be  modified,  a  new  evaluation  report  shall  be 
submitted  by  the  Community  reference  laboratory  to  the  Commission,  the 
Authority and, in the case of additives belonging to the categories provided 
for  in  points  (d)  and  (e)  of  Article  6(1),  and  additives  consisting  of, 
containing  or  produced  from  GMOs,  to  the  holder  of  the  authorisation 
concerned.  The  Authority  shall  issue  an  opinion  and  transmit  it  to  the 
Commission, to the Member States and, where applicable, to the holder of 
the  authorisation.  The  Commission  shall  examine  the  opinion  of  the 
Authority  without  delay  and  shall,  by  means  of  implementing  acts,  take  a 
decision  on  the  modification  of  the  authorisation  concerned.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 22(2). 

6. The Commission shall without delay inform the applicant of the decision 
taken in accordance with paragraphs 3, 4 and 5 as applicable. The Register 
shall be amended where appropriate. 

7. Articles 7, 8 and 9 shall apply accordingly.’; 

(7) 

Article 14 is replaced by the following: 

'Article 14 

Renewal of authorisations 

1. Authorisations granted under this Regulation to additives belonging to the 
category  provided  for  in  point  (e)  of  Article  6(1)  may  be  renewed  for  10-
year periods. An application for renewal shall be sent to the Commission by 
the  holder  of  the  authorisation  or  his  legal  successor  or  successors,  who 

EN 

68 

  EN 

 
shall be deemed to be the applicant, at the latest one year before the expiry 
date of the authorisation. 

2. At the same time as it sends the application, the applicant shall send the 
following to the Authority: 

(a) 

(b) 

(c) 

a reference to the current authorisation for placing the feed additive 
on the market; 

a  report  on  the  results  of  the  post-market  monitoring,  if  such 
monitoring requirements are included in the authorisation; 

any  other  new  information  which  has  become  available  since  the 
adoption of the current authorisation, with regard to the evaluation 
of  the  safety  in  use  of  the  feed  additive  and  the  risks  of  the  feed 
additive to animals, humans or the environment; 

(d)  where  appropriate,  a  proposal  for  amending  or  supplementing  the 

conditions of the current authorisation. 

3. Articles 7, 8 and 9 shall apply accordingly. 

4.  Where,  for  reasons  beyond  the  control  of  the  applicant,  no  decision  is 
taken on the renewal of an authorisation before its expiry date, the period of 
authorisation  of  the  product  shall  be  automatically  extended  until  the 
Commission takes a decision. Information on such extension shall be made 
available to the public in the Register.’; 

(8) 

the following new Article 14a is inserted: 

‘Article 14a 
 Rules for certain applications for renewal of authorisations submitted 
before [OP: please insert the date = date of entry into force of this 
Regulation] 

The  procedures  concerning  the  applications  for  renewal  of  authorisations 
submitted in accordance with Article 14 before [OP: please insert the date 
= date of entry into force of this Regulation] and for which no decision has 
been taken by that date, shall be completed in accordance with Article 14 as 
it stood  before that date. However, renewed authorisations concerned shall 
be valid for an unlimited period of time in accordance with Article 9(8).’; 

(9) 

Article 16 is replaced by the following: 

Labelling and packaging of feed additives and premixtures 

'Article 16 

The person responsible for the labelling shall be the feed business operator established within 
the Union who first places the feed additive or the premixture of additives on the market  or, 
where  applicable,  the  feed  business  operator  under  whose  name  or  business  name  the  feed 
additive or the premixture of additives is placed on the market.  

A feed additive or premixture of additives shall not be placed on the market unless a label is 
attached to its packaging or container and bears the following information, in a conspicuous, 
clearly  legible  and  indelible  manner,  in  at  least  the  national  language  or  languages  of  the 
Member State in which it is marketed, in relation to each additive contained in the material: 

EN 

69 

  EN 

 
(a) 

(b) 

the  specific  name  given  to  the  additives  upon  authorisation, 
preceded  by  the  name  of  the  functional  group  referred  to  in  the 
authorisation; 

the  name  or  business  name  and  the  address  or  registered  place  of 
business  of  the  person  responsible  for  the  labelling  referred  to  in 
this Article, and, where the producer is not the person responsible 
for  the  labelling,  the  name  or  business  name  and  address  of  the 
producer;  

(c) 

the  net  weight  or,  in  the  case  of  liquid  additives  and  premixtures, 
either the net volume or the net weight; 

(d)  where  appropriate,  the  approval  number  of  the  establishment  
placing  on  the  market,  and  where  applicable,  that  of  the 
establishment producing the additive or the premixture, pursuant to 
Article  10  of  Regulation  (EC)  No  183/2005  of  the  European 
Parliament and of the Council75.  

(e) 

directions  for  use,  any  safety  provisions  or  recommendations 
regarding  the  use  and  handling  of  the  additive  or  premixtures 
mentioned  in  the  authorisation,  including  animal  species  and 
categories  for  which  the  additive  or  premixture  of  additives  is 
intended, and other specific labelling requirements laid down in the 
authorisation; 

(f) 

the identification number;  

(g) 

the batch reference number and date of manufacture.  

In the case of premixtures, points (b), (d), (e) and (g) shall not apply to the 
incorporated feed additives. 

By way of derogation from the first subparagraph, the information referred 
to in points (b), (d) and (g) may be provided by digital means 

3.  For  flavouring  compounds,  the  list  of  additives  may  be  replaced  by  the 
words ‘mixture of flavouring compounds’. This shall not apply to flavouring 
compounds subject to a quantitative limitation when used in feed. 

4. In addition to the information specified in paragraph 2, the label attached 
to the packaging or container of an additive belonging to a functional group 
specified in Annex III or of a premixture containing an additive belonging to 
a  functional  group  specified  in  Annex  III  shall  bear  the  information 
provided for in point 1, point 2(a)(i) and 2(b)(i) of that Annex, presented in 
a conspicuous, clearly legible and indelible manner. 

5.  In  the  case  of  premixtures,  the  word  ‘premixture’  shall  appear  on  the 
label. Carriers shall be declared, in the case of feed materials, in compliance 
with Article 17(1)(e) of Regulation (EC) No 767/2009 , and, where water is 
used as  a carrier, the moisture content of the premixture shall be declared. 
Only  one  minimum  storage  life  may  be  indicated  in  respect  of  each 

75 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down 

requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1, ELI:  http://data.europa.eu/eli/reg/2005/183/oj). 

EN 

70 

  EN 

 
 
 
premixture  as  a  whole.  Such  minimum  storage  life  shall  be  determined  on 
the basis of the minimum storage life of each of its components. 

6. Additives and premixtures shall be marketed only in closed packages or 
closed  containers  which  shall  be  closed  in  such  a  way  that  the  fastener  is 
damaged upon opening and cannot be re-used. 

7. The information provided by digital means shall be: 

(a)  made available on a physical label to the competent authority upon 

request; 

(b) 

easily  and  directly  accessible,  free  of  charge,  through  all  major 
operating  systems  and  browsers,  without  a  need  to  register  in 
advance,  to  download  or  install  applications  or  to  provide  a 
password,  and  accessible  to  all  potential  users  in  the  Union  and 
competent authorities for control; 

(c)  made  available  for  a  period  of  two  years  from  the  date  that  the 
additive or premixture was placed on the market, including  in  the 
event  of  the  insolvency,  liquidation  or  cessation  of  activity  in  the 
Union of the economic operator that created it. 

8.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance 
with  Article  21a  amending  Annex  III  to  take  technological  progress  and 
scientific development into account. 

9.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance 
with Article 21a in order to supplement this Regulation by establishing rules 
to enhance and facilitate labelling by the use of digital means.  Those rules 
may  relate  in  particular  to  the  nature  of  the  information  concerned,  which 
may include information referred to in paragraphs 2, 4 and 5, or the type of 
digital  means 
that  may  be  used.  Safety-critical  and  essential-use 
information, such as that included in the authorisation, shall remain on the 
label attached to the packaging or container referred to in paragraph 2.’; 

(10) 

Article 21a is amended as follows: 

(a) 

paragraphs 2 and 3 are replaced by the following: 

‘2.    The  power  to  adopt  delegated  acts  referred  to  in  Article  3(5),  Article 
6(3),  Article  7(5),  Article  16(8)  and  Article  21  shall  be  conferred  on  the 
Commission  for  a  period  of  five  years  from  26  July  2019.  The  power  to 
adopt  delegated  acts  referred  to  in  Article  16(9)  shall  be  conferred  on  the 
Commission  for a period of five years from  [OP: please insert  the date = 
date of entry into force of this Regulation]. The Commission shall draw up a 
report  in  respect  of  the  delegation  of  power  not  later  than  nine  months 
before  the  end  of  the  five-year  period.  The  delegation  of  power  shall  be 
tacitly  extended  for  periods  of  an  identical  duration,  unless  the  European 
Parliament  or  the  Council  opposes  such  extension  not  later  than  three 
months before the end of each period.  

3. The delegation of power referred to in Article 3(5), Article 6(3), Article 
7(5), Article 16(8) and (9) and Article 21 may be revoked at any time by the 
European  Parliament  or  by  the  Council.  A  decision  to  revoke  shall  put  an 
end  to  the  delegation  of  the  power  specified  in  that  decision.  It  shall  take 
effect  the  day  following  the  publication  of  the  decision  in  the  Official 

EN 

71 

  EN 

 
Journal of the European Union or at a later date specified therein. It shall not 
affect the validity of any delegated acts already in force.’; 

(b)  paragraph 6 is replaced by the following: 

‘6.  A  delegated  act  adopted  pursuant  to  Article  3(5),  Article  6(3),  Article 
7(5),  Article  16(8)  and  (9)  and  Article  21  shall  enter  into  force  only  if  no 
objection  has  been  expressed  either  by  the  European  Parliament  or  by  the 
Council  within  a  period  of  two  months  of  notification  of  that  act  to  the 
European Parliament and the Council or if, before the expiry of that period, 
the  European  Parliament  and  the  Council  have  both  informed  the 
Commission that they will not object. That period shall be extended by two 
months at the initiative of the European Parliament or of the Council.’. 

Article 7 
Amendment to Regulation (EC) No 852/2004 

Regulation (EC) No 852/2004 is amended as follows: 

Article 13 is amended as follows: 

(a) 

paragraph 3 is replaced by the following: 

'3.  Member  States  may,  without  compromising  the  achievement  of  the 
objectives of this Regulation, adopt, in accordance with paragraphs 4 and 5 
of  this  Article,  national  measures  adapting  the  requirements  laid  down  in 
Annex II.’; 

(b)  paragraph 5 is replaced by the following: 

'5.  Any  Member  States  wishing  to  adopt  national  measures  referred  to  in 
paragraph 3 shall notify the Commission in accordance with the procedure 
laid down in Articles 5 and 6 of Directive (EU) 2015/1535. The notification 
shall:  

(a) 

provide a detailed description of the requirements that that Member 
State considers need to be adapted and the nature of the adaptation 
sought; 

(b)  describe the foodstuffs and establishments concerned;  

(c) 

explain the reasons for the adaptation, including, where relevant, by 
providing  a  summary  of  the  hazard  analysis  carried  out  and  any 
measures  to  be  taken  to  ensure  that  the  adaptation  will  not 
compromise the objectives of this Regulation;  

and 

(d)  provide any other relevant information.’; 

(c) 

paragraphs 6 and 7 are deleted. 

Article 8 
Amendment to Regulation (EC) No 853/2004 

Regulation (EC) No 853/2004 is amended as follows: 

Article 10 is amended as follows: 

(a) 

paragraph 3 is replaced by the following: 

EN 

72 

  EN 

 
'3.  Member  States  may,  without  compromising  the  achievement  of  the 
objectives of this Regulation, adopt, in accordance with paragraphs 4, 5 and 
8 of this Article, national measures adapting the requirements laid down in 
Annex III.’; 

(b)  paragraph 5 is replaced by the following:  

'5.  Any  Member  States  wishing  to  adopt  national  measures  referred  to  in 
paragraph 3 shall  notify the Commission in accordance with the procedure 
laid down in Articles 5 and 6 of Directive (EU) 2015/1535. The notification 
shall: 

(a) 

provide a detailed description of the requirements that that Member 
State considers need to be adapted and the nature of the adaptation 
sought;  

(b)  describe the foodstuffs and establishments concerned; 

(c) 

explain the reasons for the adaptation, including, where relevant, by 
providing  a  summary  of  the  hazard  analysis  carried  out  and  any 
measures  to  be  taken  to  ensure  that  the  adaptation  will  not 
compromise the objectives of this Regulation;  

and  

(d)  provide any other relevant information.’; 

(c) 

paragraphs 6 and 7 are deleted. 

Article 9 
Amendment of Regulation (EC) No 1099/2009 

In Regulation (EC) No 1099/2009 Article 18, paragraphs 4 and 6 are deleted.  

Article 10 
Amendment to Regulation (EC) No 999/2001 

Regulation (EC) 999/2009 is amended as follows: 

(1) 

in Article 5, paragraph 3, the third subparagraph is replaced by the following: 

‘The Commission is empowered to adopt delegated acts in accordance with 
Article 23b for the purpose of approval of the rapid tests and to amend the 
list set out in Annex X, Chapter C, point 4’; 

(2) 

Article 6 is amended as follows: 

(a)  Paragraph 1 is replaced by the following: 

‘1.  Each  Member  State  shall  carry  out  an  annual  monitoring  programme 
for TSEs based on surveillance in accordance with Annex III.  

The Commission is empowered to adopt delegated acts in accordance with 
Article 23b for the purpose of approval of the rapid tests . The Commission 
is  empowered  to  adopt  delegated  acts  in  accordance  with  Article  23b 
amending Annex X to list those tests.’; 

(b)  Paragraph 1a is replaced by the following: 

EN 

73 

  EN 

 
‘1a.  The  annual  monitoring  programme  referred  to  in  paragraph  1  shall 
cover  the  animal  subpopulations  listed  in  Annex  III.  The  Commission  is 
empowered to adopt delegated acts in accordance with Article 23b to amend 
the  provisions  of  that  paragraph  according  to  scientific  progress  and  after 
consultation of the European Food Safety Authority.’; 

(c) 

 In paragraph (1)b, the first sentence is deleted.; 

(3) 

Article 8 is amended as follows: 

(a)  Paragraph 1 is amended as follows: 

‘1.  The specified risk material shall be removed in accordance with Annex 
V to this Regulation and disposed of in accordance with Regulation (EC) No 
1069/2009.  

The Commission is empowered to adopt delegated acts in accordance with 
Article 23b to amend the list of specified risk material referred to in Annex 
V  .  Taking  into  account  the  different  risk  categories  laid  down  in  the  first 
subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) 
(b)  the  list  of  specified  risk  material  in  Annex  V  shall  be  amended 
accordingly. 

The  specified  risk  material,  referred  to  in  first  sub-paragraph,  shall  not  be 
imported into the Union.’; 

(b) 

in paragraph 2, the first subparagraph is replaced by the following: 

‘The Commission is empowered to adopt delegated acts in accordance with 
Article  23b  to  amend  the  list  of  the  approved  alternative  tests  allowing  to 
detect BSE prior to slaughter in Annex X. Paragraph 1 of this Article shall 
not apply to tissues from animals which have undergone the alternative test, 
provided that this test is applied under the conditions provided for in Annex 
V and the test results are negative.’; 

(c) 

paragraph 5 is replaced by the following: 

‘5.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance 
with Article 23b to amend the rules providing exemptions from paragraphs 
1 to 4 of this Article, with regard to the date of the effective enforcement of 
the  feeding  prohibition  provided  for  in  Article  7(1)  or,  as  appropriate  for 
third countries or regions thereof with a controlled BSE risk, with regard to 
the date of the effective enforcement of the ban of ruminant protein in feed 
for  ruminants  with  a  view  to  limiting  the  requirements  to  remove  and 
destroy  specified  risk  material  to  animals  born  before  that  date  in  the 
countries or regions concerned.’; 

(4) 

Article 16 is amended as follows: 

(a) 

point 1(b) is replaced by the following: 

‘(b) milk and dairy products, hides and skins, and gelatine and collagen’; 

(b) 

in paragraph (7) the first sentence is replaced by the following: 

‘7.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance 
with  Article  23b  supplementing  this  Regulation  to  adapt  the  provisions  of 
paragraphs 1 to 6’; 

(5) 

in Article 23, a new paragraph 3 is inserted: 

EN 

74 

  EN 

 
‘3. Without prejudice to paragraphs 1 and 2, the Commission is empowered 
to  adopt  delegated  acts  in  accordance  with  Article  23b  amending  the 
Annexes.  The  amendments  shall  have  the  aim  of  adapting  the  provisions 
contained in those annexes to the evolution of the epidemiological situation, 
of the available scientific knowledge, of the relevant international standards, 
of the available analytical  methods  for official  controls  or of the results of 
controls or studies on the implementation of those provisions and shall take 
into account the following criteria: 

i.  where relevant, the conclusions of the available the Authority opinion; 

the  need  to  maintain  a  high  level  of  protection  of  human  and  animal 

ii. 
health in the Union.’; 

(6) 

(7) 

Article 23a, points (a), (b), (g), (h) and (k) and (m) are deleted. 

a new Article 23b is inserted: 

'Article 23b 

Exercise of the delegation 

1.  The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission 
subject to the conditions laid down in this Article. 

2.  The  power  to  adopt  delegated  acts  referred  to  in  Article  5(3),  Article 
6(1) and (1a), Article 8(1), (2), and (5), and Article 16(7) and Article 23 (3)  
shall be conferred for an indeterminate period of time from the date of the 
entry into force of this Regulation. 

3.  The  delegation  of  powers  referred  to  in  Article  5(3),  Article  6(1)  and 
(1a), Article 8(1), (2), and (5), and Article 16(7) and Article 23 (3)  may be 
revoked  at  any  time  by  the  European  Parliament  or  by  the  Council.  A 
decision to revoke shall put an end to the delegation of the power specified 
in that decision. It shall take effect the day following the publication of the 
decision  in  the  Official  Journal  of  the  European  Union  or  at  a  later  date 
specified therein. It shall not affect the validity of any delegated acts already 
in force. 

4.  Before adopting a delegated act, the Commission shall consult experts 
designated  by  each  Member  State  in  accordance  with  the  principles  laid 
down in the Interinstitutional Agreement on Better-Law-making of 13 April 
2016. 

5.  As  soon  as  it  adopts  a  delegated  act,  the  Commission  shall  notify  it 
simultaneously to the European Parliament and to the Council. 

6.  A delegated act adopted pursuant to Article 5(3), Article 6(1) and (1a), 
Article 8(1), (2), and (5), and Article 16(7) and Article 23 (3) shall enter into 
force  only  if  no  objection  has  been  expressed  either  by  the  European 
Parliament or the Council within a period of two months of notification of 
that act to the European Parliament and the Council or if, before the expiry 
of that period, the European Parliament and the Council have both informed 
the Commission that they will not object. That period shall be extended by 
two months at the initiative of the European Parliament or the Council.’. 

EN 

75 

  EN 

 
Article 11 
Amendment to Regulation (EU) 2017/625 

Regulation (EU) 2017/625 is amended as follows: 

(1) 

Article 41 is replaced by the following: 

‘Article 41 

Powers to adopt derogations from the condition for the standard 
applied by the official laboratories and for the mandatory accreditation 
of all the methods of laboratory analysis, test and diagnosis used by 
official laboratories 

The Commission shall adopt delegated acts in accordance with Article 144 
to  supplement  this  Regulation  concerning  the  cases  where,  and  the 
conditions  under  which,  competent  authorities  may  designate  as  official 
laboratories,  in  accordance  with  Article  37(1),  laboratories  which  do  not 
fulfil: 

(a) 

(b) 

the condition referred to in point (e) of Article 37(4) in relation to 
the standards in accordance with which the laboratories operate and 
are accredited; and 

the condition referred to in point (a) of Article 37(5) in relation to 
the accreditation for all the methods they use for official controls or 
other  official  activities,  provided  that  such  laboratories  comply 
with the following conditions: 

i. 
they  operate  and  are  accredited  in  accordance  with  the  standard  EN 
ISO/IEC 17025 or with the standard defined in accordance with point (a) for 
the use of one or more methods  which are similar to  and representative of 
the other methods they use; and 

ii. 
they  make  regular  and  significant  use  of  the  methods  for  which  they 
have  obtained  the  accreditation  referred  to  in  point  (i)  ;  except,  as  regards 
the area governed by the rules referred to in point (g) of Article 1(2), where 
a validated method for the detection of the particular pests of plants referred 
to in Article 34(1) and (2) does not exist.’; 

(2) 

in Article 50, paragraph 3 is replaced by the following: 

‘3.  Consignments  shall  not  be  split  until  official  controls  have  been 
performed and the Common Health Entry Document (CHED) referred to in 
Article  56  has  been  finalised  in  accordance  with  Article  56(5)  and  Article 
57,  unless  requested  by  the  competent  authorities  in  the  case  of 
consignments  of  goods  referred  to  in  Article  47(1)(c)  for  the  purposes  of 
performing    physical  checks  on  only  part  of  a  consignment  presented  at  a 
border control post.’; 

(3) 

in Article 93, paragraph 4 is replaced by the following: 

‘4.  By  way  of  derogation  from  point  (a)  of  paragraph  3,  the  Commission 
may designate European Union reference laboratories whether or not those 
laboratories fulfil the conditions provided for in that point in relation to: 

(a) 

the standards in accordance with which the laboratories operate and 
are accredited; and  

EN 

76 

  EN 

 
(b) 

the accreditation for all the methods of laboratory analysis, test and 
diagnosis that the laboratories use.  

The  Commission  may  designate  such  laboratories  provided  that  they  fulfil 
the  conditions  set  out  in  the  delegated  acts  adopted  in  accordance  with 
paragraph 4a. 

4a.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance 
with Article 144 to supplement this Regulation concerning the establishment 
of  the  conditions  to  be  fulfilled  by  laboratories  to  be  designated  European 
Union reference laboratories in accordance with paragraph 4.’; 

(4) 

Article 100 is amended as follows: 

(a) 

paragraph 2 is amended as follows: 

(i) the first subparagraph is replaced by the following: 

‘2. The requirements provided for in Article 37(4), point (e), Article 37(5), 
Article 39 and Article 42, paragraph 1, paragraph 2, points (a) and (b), and 
paragraph 3, shall apply to national reference laboratories.’; 

(ii) the second subparagraph is deleted; 

(b)  paragraph 6 is replaced by the following: 

‘6.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance 
with Article 144 to supplement this Regulation concerning the cases where, 
and  the  conditions  under  which  competent  authorities  may  designate 
national  reference  laboratories  whether  or  not  the  laboratories  fulfil  the 
condition  provided  for  in  point  (e)  of  Article  37(4)  in  relation  to  the 
standards  in  accordance  with  which  the  laboratories  operate  and  are 
accredited  and  the  condition  provided  for  in  point  (a)  of  Article  37(5)  in 
relation  to  the  accreditation  for  all  the  methods of  laboratory  analysis,  test 
and diagnosis that the laboratories use.’; 

(5) 

Article 144 is amended as follows: 

(a) 

paragraph (2) is replaced by the following: 

‘2. The power to adopt delegated acts referred to in Articles 18(7) and 21(8), 
Article  41,  Articles  45(4)  and  47(3),  Article  48,  Article  50(4),  Article  51, 
and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 93(4a), 99(2), 
100(6),  101(2),  126(1),  142(1)  and  (2),  149(2),  150(3),  154(3),  155(3)  and 
165(3) shall be conferred on the Commission for a period of five years from 
28  April  2017.  The  Commission  shall  draw  up  a  report  in  respect  of  the 
delegation  of  power  not  later  than  nine  months  before  the  end  of  the  five-
year period. The delegation of power shall be tacitly extended for periods of 
an  identical  duration,  unless  the  European  Parliament  or  the  Council 
opposes such extension not  later than three months  before the end of each 
period.’; 

(b)  paragraph 3 is replaced by the following: 

‘3. The delegation of power referred to in Articles 18(7) and 21(8), Article 
41,  Articles  45(4)  and  47(3),  Article  48,  Article  50(4),  Article  51,  and 
Articles  53(1),  62(3),  64(2)  and  (5),  77(1)  and  (2),  92(4),  93(4a),  99(2), 
100(6),  101(2),  126(1),  142(1)  and  (2),  149(2),  150(3),  154(3),  155(3)  and 

EN 

77 

  EN 

 
165(3)  may  be  revoked  at  any  time  by  the  European  Parliament  or  by  the 
Council.  A  decision  to  revoke  shall  put  an  end  to  the  delegation  of  the 
power  specified  in  that  decision.  It  shall  take  effect  the  day  following  the 
publication of the decision in the Official Journal of the European Union or 
at  a  later  date  specified  therein.  It  shall  not  affect  the  validity  of  any 
delegated acts already in force.’; 

(c) 

paragraph 6 is replaced by the following: 

‘6. A delegated act adopted pursuant to Articles 18(7) and 21(8), Article 41, 
Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 
53(1),  62(3),  64(2)  and  (5),  77(1)  and  (2),  92(4),  99(2),  93(4a),  100(6), 
101(2),  126(1),  142(1)  and  (2),  149(2),  150(3),  154(3),  155(3)  and  165(3) 
shall enter into force only if no objection has been expressed either by the 
European  Parliament  or  the  Council  within  a  period  of  two  months  of 
notification of that act to the European Parliament and to the Council or if, 
before  the  expiry  of  that  period,  the  European  Parliament  and  the  Council 
have  both  informed  the  Commission  that  they  will  not  object.  That  period 
shall be extended by two months at the initiative of the European Parliament 
or of the Council.’. 

Article 12 
Entry into force and application 

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

Article 13(4)(a)(ii) shall apply from [date of entry into force of this Regulation plus 2 years] 
or from the date of the entry into force of the delegated act adopted in accordance with Article 
100(6) of Regulation (EU) 2017/625 in the area of protective measures against pests of plants, 
whichever is the earliest. 

This Regulation shall be binding in its entirety and directly applicable in all Member States  

Done at Strasbourg, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

78 

  EN 

 
LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT 

1. 

1.1. 

1.2. 

1.3. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 3 

Title of the proposal/initiative ...................................................................................... 3 

Policy area(s) concerned .............................................................................................. 3 

Objective(s) .................................................................................................................. 3 

1.3.1.  General objective(s) ..................................................................................................... 3 

1.3.2.  Specific objective(s) ..................................................................................................... 3 

1.3.3.  Expected result(s) and impact ...................................................................................... 3 

1.3.4. 

Indicators of performance ............................................................................................ 3 

1.4. 

1.5. 

The proposal/initiative relates to: ................................................................................. 4 

Grounds for the proposal/initiative .............................................................................. 4 

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative ............................................................ 4 

1.5.2.  Added value of EU involvement (it may result from different factors, e.g. 

coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this section 'added value of EU involvement' is the value resulting 
from EU action, that is additional to the value that would have been otherwise 
created by Member States alone. ................................................................................. 4 

1.5.3.  Lessons learned from similar experiences in the past .................................................. 4 

1.5.4.  Compatibility with the multiannual financial framework and possible synergies with 
other appropriate instruments ....................................................................................... 5 

1.5.5.  Assessment of the different available financing options, including scope for 

redeployment ................................................................................................................ 5 

1.6. 

1.7. 

2. 

2.1. 

2.2. 

2.2.1. 

2.2.2. 

Duration of the proposal/initiative and of its financial impact .................................... 6 

Method(s) of budget implementation planned ............................................................. 6 

MANAGEMENT MEASURES................................................................................... 8 

Monitoring and reporting rules .................................................................................... 8 

Management and control system(s) ............................................................................. 8 

Justification of the budget implementation method(s), the funding implementation 
mechanism(s), the payment modalities and the control strategy proposed .................. 8 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them............................................................................................................ 8 

2.2.3.  Estimation and justification of the cost-effectiveness of the controls (ratio between 

the control costs  and the value of the related funds managed), and assessment of the 
expected levels of risk of error (at payment & at closure) ........................................... 8 

2.3. 

3. 

3.1. 

Measures to prevent fraud and irregularities ................................................................ 9 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 10 

Heading(s) of the multiannual financial framework and expenditure budget line(s) 
affected ....................................................................................................................... 10 

EN 

1 

  EN 

 
3.2. 

Estimated financial impact of the proposal on appropriations ................................... 12 

3.2.1.  Summary of estimated impact on operational appropriations.................................... 12 

3.2.1.1.  Appropriations from voted budget ............................................................................. 12 

3.2.1.2.  Appropriations from external assigned revenues ....................................................... 17 

3.2.2.  Estimated output funded from operational appropriations......................................... 22 

3.2.3.  Summary of estimated impact on administrative appropriations ............................... 24 

3.2.3.1. Appropriations from voted budget .............................................................................. 24 

3.2.3.2.  Appropriations from external assigned revenues ....................................................... 24 

3.2.3.3.  Total appropriations ................................................................................................... 24 

3.2.4.  Estimated requirements of human resources.............................................................. 25 

3.2.4.1.  Financed from voted budget....................................................................................... 25 

3.2.4.2.  Financed from external assigned revenues ................................................................ 26 

3.2.4.3.  Total requirements of human resources ..................................................................... 26 

3.2.5.  Overview of estimated impact on digital technology-related investments ................ 28 

3.2.6.  Compatibility with the current multiannual financial framework.............................. 28 

3.2.7.  Third-party contributions ........................................................................................... 28 

3.3. 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

4.5. 

Estimated impact on revenue ..................................................................................... 29 

DIGITAL DIMENSIONS .......................................................................................... 29 

Requirements of digital relevance .............................................................................. 30 

Data ............................................................................................................................ 30 

Digital solutions ......................................................................................................... 31 

Interoperability assessment ........................................................................................ 31 

Measures to support digital implementation .............................................................. 32 

EN 

2 

  EN 

 
1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

Proposal  for  a  REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF 
THE  COUNCIL  amending  Regulation  (EC)  No  1107/2009,  Regulation  (EC)  No 
396/2005,  Regulation  (EU)  No  528/2012,  Regulation  (EC)  1829/2003,  Regulation 
(EC) No 1831/2003, Regulation (EC) No 852/2004, Regulation (EC) No 853/2004, 
Regulation  1099/2009,  Regulation  (EC)  No  999/2001,  Regulation  (EC)  No 
1069/2009, Regulation (EU) 2017/625 as regards simplifying and strengthening food 
and feed safety requirements 

1.2. 

Policy area(s) concerned  

Competitiveness, prosperity and Security 

1.3. 

Objective(s) 

1.3.1.  General objective(s) 

The  initiative  aims  to  simplify,  clarify  and  modernise  selected  provisions  across 
several  pieces  of  EU  food  and  feed  safety  legislation.  It  responds  to  long-standing 
calls from stakeholders and Member States to reduce administrative burden, improve 
legal clarity and increase the efficiency of regulatory procedures. More specifically, 
this  initiative  aims  to  remove  unnecessary  complexity,  enable  innovation  and 
strengthen  the  functioning  of  the  internal  market.  These  measures  aim  to  reduce 
administrative  burden  for  economic  operators  and  national  competent  authorities, 
while  maintaining  a  high  level  of  protection  for  human,  animal  and  environmental 
health. 

1.3.2. 

Specific objective(s) 

Specific objective No 

 By reducing administrative burdens for both industry and Member State competent 
authorities,  the  proposal  aims  to  help  EU  farmers  and  the  broader  food  and  feed 
sector become more competitive and to prevent unacceptable impacts on agricultural 
production.  The  proposal  aims  to  accelerate  access  to  innovative  biocontrol 
solutions. This will be achieved by tackling procedural inefficiencies and reallocating 
or  increasing  resources  in  Member  State  authorities  and  the  European  Food  Safety 
Authority (the Authority).  

1.3.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The  proposal  is  expected  to  reduce  administrative  burdens  for  economic  operators 
and  Member  State  authorities.  Compliance  costs  are  expected  to  fall,  while  a  high 
level of safety for human health, animal health and the environment will continue to 
be  maintained.  The  proposal  is  also  expected  to  help  EU  farmers  become  more 
competitive.  

By  making  the  approval  system  for  active  substances  more  efficient  for  plant 
protection products and biocidal products, and in particular speeding up approval for 
biocontrol active substances by pproviding the possibility for the Authority to act as 
rapporteur  Member  State,reduced  costs  and  faster  return  on  investment  for 
companies  placing  such  substances  (  i.e.  products  containing  them)  on  the  market. 

EN 

3 

  EN 

 
Combined with measures to strengthen mutual recognition of product authorisations, 
farmers are expected to benefit from access to more crop protection tools. 

1.3.4. 

Indicators of performance 

Specify the indicators for monitoring progress and achievements. 

-  faster  processing  of  approval  applications  for  biocontrol  active  substances  due  to 
the possibility for the Authority to act as rapporteur Member State  

-  increased  number  of  authorisations  of  biocontrol  plant  protection  products  in 
Member  States  (pending  on  the  willingness  of  applicants  to  market  in  a  certain 
Member State) 

1.4. 

The proposal/initiative relates to:  

 a new action  
 a new action following a pilot project / preparatory action76  

 the extension of an existing action  

 a merger or redirection of one or more actions towards another/a new action 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative 

Farmers  face  a  shrinking  toolbox  as  older  products  lose  authorisation  and  new 
alternatives  –  in  particular  biopesticides  –  are  slow  to  reach  the  market.  Slow 
approval of biopesticides makes it difficult to reap the competitive benefits of these 
substances,  including  on  international  markets.  There  are  systematic  delays  in  the 
procedures  for  approvals  and  renewals  of  approvals  of  active  substances,  while 
deadlines  laid  down  in  Regulation  (EC)  No  1107/2009  concerning  the  placing  of 
plant  protection  products  on  the  market  are  not  met  as  Member  States  lack  the 
capacity to process applications on time.   

1.5.2.  Added  value  of  EU  involvement  (it  may  result  from  different  factors,  e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the  purposes  of  this  section  'added  value  of  EU  involvement'  is  the  value  resulting 
from  EU  action,  that  is  additional  to  the  value  that  would  have  been  otherwise 
created by Member States alone. 

Reasons  for  action  at  EU  level  (ex-ante):  The  Member  States  are  overloaded  both 
with  active  substance  dossiers  as  well  as  with  plant  protection  products  dossiers. 
Some  Member  States  lack  sufficient  resources  and/or  expertise  to  process 
applications  for  biocontrol  active  substances  thus  it’s  difficult  for  the  applicants  to 
find  a  Member  State  willing  to  take  their  application  which  delays  the  approval 
procedure and the entry on the market of innovative biocontrol products.  

Expected  generated  EU  added  value  (ex-post)  The  involvement  of  the  Authority  is 
expected  to  speed  up  the  approval  of  biopesticides  and  consequently,  to  speed  up 
their entry on the market and increase the available tools for the farmers. 

76 

As referred to in Article 58(2), point (a) or (b) of the Financial Regulation. 

EN 

4 

  EN 

 
 
 
 
1.5.3.  Lessons learned from similar experiences in the past 

The  proposal  is  based  on  complaints  both  from  Member  States  and  stakeholders 
(applicants  and  farmers)  from  the  delays  in  the  approval/authorisation  procedures 
and  on  calls  for  faster  and  clearer  procedures,  especially  for  biocontrol  plant 
protection active substances and products. 

1.5.4.  Compatibility with the multiannual financial framework and possible synergies with 

other appropriate instruments 

The  Food  and  Feed  Safety  Simplification  Omnibus  is  part  of  the  cross-cutting 
legislative simplification package announced in the European Commission’s Vision 
for  Agriculture  and  Food.  The  aim  of  the  package  is  to  reduce  unnecessary 
regulatory  burdens  while  maintaining  high  standards  for  food  and  feed  safety,  for 
human and animal health, and for environmental protection. 

1.5.5.  Assessment  of  the  different  available  financing  options,  including  scope  for 

redeployment 

The amount required for the Authority to conduct the new tasks will be covered by 
an increase in the  Authority annual subsidy.  

EN 

5 

  EN 

 
 
 
1.6. 

Duration of the proposal/initiative and of its financial impact 

 limited duration  

–    in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–    financial  impact  from  YYYY  to  YYYY  for  commitment  appropriations  and 

from YYYY to YYYY for payment appropriations.  

 unlimited duration 

–  Implementation with a start-up period from YYYY to YYYY, 

–  followed by full-scale operation. 

1.7.  Method(s) of budget implementation planned77  

 Direct management by the Commission 

–   by its departments, including by its staff in the Union delegations;  

–   by the executive agencies  

 Shared management with the Member States  

 Indirect management by entrusting budget implementation tasks to: 

–   third countries or the bodies they have designated 

–   international organisations and their agencies (to be specified) 

–   the European Investment Bank and the European Investment Fund 

–   bodies referred to in Articles 70 and 71 of the Financial Regulation 

–   public law bodies 

–   bodies governed by private law with a public service mission to the extent that 

they are provided with adequate financial guarantees 

–   bodies governed by the private law of a Member State that are entrusted with 
the  implementation  of  a  public-private  partnership  and  that  are  provided  with 
adequate financial guarantees 

–   bodies or persons entrusted with the implementation of specific actions in the 
common  foreign  and  security  policy  pursuant  to  Title  V  of  the  Treaty  on 
European Union, and identified in the relevant basic act 

–  bodies  established  in  a  Member  State,  governed  by  the  private  law  of  a 
Member  State  or  Union  law  and  eligible  to  be  entrusted,  in  accordance  with 
sector-specific  rules,  with  the  implementation  of  Union  funds  or  budgetary 
guarantees,  to  the extent that such bodies are controlled by public law bodies or 
by bodies governed by private law with a public service mission, and are provided 
with adequate financial guarantees in the form of joint and several liability by the 
controlling bodies or equivalent financial guarantees and which may be, for each 
action, limited to the maximum amount of the Union support. 

If  more  than  one  budget  implementation  method  is  indicated,  please  provide  details  in  the 
‘Comments’ section. 

77 

Details of budget implementation methods and references to the Financial Regulation may be found on 
the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-
implementation/Pages/implementation-methods.aspx. 

EN 

6 

  EN 

 
 
Comments  

[…] 

[…] 

EN 

7 

  EN 

 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

All  Union  Agencies  work  under  a  strict  monitoring  system  involving  an  internal 
control coordinator, the Internal Audit Service of the Commission, the Management 
Board,  the  Commission,  the  Court  of  Auditors  and  the  Budgetary  Authority.  This 
system  is  reflected  and  laid  down  in  the  European  Food  Safety  Authority’s  (the 
Authority)  founding  regulation.  In  accordance  with  the  Joint  Statement  on  the  EU 
decentralised  agencies  (the  ‘Common  Approach’), 
the  framework  financial 
regulation  (2019/715)  and  related  Commission  Communication  C(2020)2297,  the 
annual  work  programme  and  Single  Programming  Document  of  the  Authority 
comprise  detailed  objectives  and  expected  results,  including  a  set  of  performance 
indicators.  

The Single Programming Document combines multiannual and annual programming 
as  well  as  “strategy  documents”,  e.g.  on  independence.  DG  SANTE  comments 
through  the  Authority’s  Management  Board  and  prepares  a  formal  Commission 
Opinion on the Single Programming Document. The activities of the Authority will 
be measured against these indicators in the Consolidated Annual Activity Report.   

The European Food Safety Authority will monitor periodically the performance of its 
internal  control  system  to  ensure  that  data  is  collected  efficiently,  effectively  and 
timely and to identify internal control deficiencies, register and assess the results of 
controls,  control  deviations  and  exceptions.  The  results  of  the  internal  control 
assessments,  including  significant  weaknesses  identified  and  any  differences  as 
compared to internal and external audit findings will be disclosed in the Consolidated 
Annual Activity Report. 

2.2.  Management and control system(s)  

2.2.1. 

Justification  of  the  budget  implementation  method(s),  the  funding  implementation 
mechanism(s), the payment modalities and the control strategy proposed 

The  annual  EU  subsidy  will  be  transferred  to  the  Authority  in  accordance  with  its 
payment needs and upon its request. The Authority will be subject to administrative 
controls including budgetary control, internal audit, annual reports by the European 
Court  of  Auditors,  the  annual  discharge  for  the  execution  of  the  EU  budget  and 
possible  investigations  conducted  by  OLAF  to  ensure,  in  particular,  that  the 
resources allocated to the Authority are put to proper use. Through its representation 
in  the  Authority's  Management  Board  and  Audit  Committee,  the  Commission  will 
receive  audit  reports  and  ensures  that  adequate  actions  are  defined  and  timely 
implemented  by  the  Authority  to  address  the  issues  identified.  All  payments  will 
remain pre-financing payments until the Authority’s accounts have been audited by 
the European Court of Auditors and the Authority has submitted its final accounts. If 
necessary, the Commission will recover unspent amounts of the instalments paid to 
the Authority.  

EN 

8 

  EN 

 
 
 
 
The  activities  of  the  Agency  will  also  be  subject  to  the  supervision  of  the 
Ombudsman  in  accordance  with  Article  228  of  the  Treaty.  These  administrative 
controls provide a number of procedural safeguards to ensure that account is taken of 
the  interests  of  the  stakeholders.  The  Authority’s  Internal  Control  Framework  is 
designed  to  provide  reasonable  assurance  regarding  the  achievement  of  five 
objectives set out in Article 303 of the  Authority Financial Regulation. 

2.2.2. 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them 

The  main  risks  relate  to  the  Authority’s  performance  and  independence  in 
implementing the tasks entrusted to it. Underperformance or impaired independence 
could  hamper  the  achievement  of  the  objectives  of  this  initiative  and  also  reflect 
negatively on the Commission’s reputation.  

The  Commission  and  the  Agency  have  put  in  place  internal  procedures  that  aim  at 
covering  the  risks  identified  above.  The  internal  procedures  are  in  full  compliance 
with  the  Financial  Regulation  and  include  anti-fraud  measures  and  cost-benefit 
considerations. First and foremost, sufficient resources should be made available to 
the  Authority  in  both  financial  and  staffing  terms  to  achieve  the  objectives  of  this 
initiative.  

include  both 

integrated  quality-
Furthermore,  quality  management  will 
management  activities  and  risk-management  activities  within  the  Authority.  A  risk 
review  is  a  continuous,  proactive  and  systematic  process,  conducted  annually,  with 
risks  being  assessed  at  a  residual  level,  i.e.  taking  into  account  controls  and 
mitigations  already  in  place.  Conducting  self-assessments  (as  part  of  the  EU 
Agencies benchmarking  programme), annual reviews of sensitive functions and ex-
post controls also fall within this area, as does maintain a register of exceptions.  

the 

To  preserve  impartiality  and  objectivity  in  every  aspect  of  the  Authority’s  work,  a 
number of policies and rules on management of competing interests have been put in 
place and will be regularly updated, describing specific arrangements, requirements 
and processes applying to the Authority’s Management Board, scientific committee 
members and experts, the Authority’s staff and candidates, as well as consultants and 
contractors.  

The  Authority’s  risk-based  internal  control  and  auditing  scheme  under  the  new 
integrated  management  system  framework,  and  with  the  cohesive  planning  and 
reporting  of  respective  Assurance  Management  activities  in  the  Authority.  The 
Commission  will  be  informed  timely  of  relevant  management  and  independence 
issues  encountered  by  the  Authority  and  will  react  upon  notified  issues  timely  and 
adequately. 

EN 

9 

  EN 

 
 
 
 
 
2.2.3.  Estimation  and  justification  of  the  cost-effectiveness  of  the  controls  (ratio  between 
the control costs  and the value of the related funds managed), and assessment of the 
expected levels of risk of error (at payment & at closure)  

the  Agency’s 

The  Commission’s  and 
into 
consideration the main cost drivers, and the efforts already taken over several years 
to  reduce  the  cost  of  controls,  without  compromising  the  effectiveness  of  controls. 
The  existing  control  systems  proved  to  be  able  to  prevent  and/or  to  detect  errors 
and/or irregularities, and in case of errors or irregularities, to correct them.  

internal  control  strategies 

take 

In  the  past  five  years,  the  Commission’s  yearly  costs  of  controls  under  indirect 
management represented less than 1% of the annual budget spent on subsidies paid to 
the  Authority.  The  Authority  allocated  5%  of  its  total  annual  budget  on  control 
activities  centering  around 
integrated  quality  management,  audit,  anti-fraud 
measures,  finance  and  verification  processes,  corporate  risk  management,  risk 
assessment and self-assessment activities. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures, e.g. from the anti-
fraud strategy. 

As for its activities in  indirect  management, the  Commission  shall take appropriate 
measures ensuring that the financial interests of the European Union are protected by 
the application of preventive measures against fraud, corruption and any other illegal 
activities,  by  effective  checks  and,  if  irregularities  are  detected,  by  the  recovery  of 
the  amounts  wrongly  paid  and,  where  appropriate,  by  effective,  proportional  and 
deterrent penalties.  

To this effect, the Commission adopted an anti-fraud strategy, latest update of April 
2019 (COM(2019)176), covering preventive, detective and corrective measures.  

The  Commission  or  its  representatives  and  the  European  Court  of  Auditors  shall 
have  the  power  of  audit,  on  the  basis  of  documents  and  on-the-spot,  over  all  grant 
beneficiaries, contractors and subcontractors who have received Union funds. OLAF 
shall  be  authorised  to  carry  out  on-the-spot  checks  and  inspections  on  economic 
operators concerned indirectly by such funding.  

As  regards  the  European  Food  Safety  Authority,  the  anti-fraud  measures  are 
provided  for  in  Article  25,  point  9,  of  Regulation  (EC)  No  178/2002  and  the 
framework financial Regulation (2019/715). The Management Board shall adopt the 
Authority's  financial  regulation  which  specifies  in  particular  the  procedure  for 
drawing up and implementing the Authority's budget, in accordance with Article 142 
of the Financial Regulation of 21 December 1977 applicable to the general budget of 
the  European  Communities  (26)  and  with  the  legislative  requirements  concerning 
investigations  conducted  by  the  European  Anti-Fraud  Office.  In  line  with  the 
Common  Approach  and  Article  42  of  the  framework  financial  Regulation,  an  anti-
fraud  strategy  has  been  developed,  in  accordance  with  the  European  Anti-Fraud 
Office methodology and guidance, and is followed by the Authority.  

EN 

10 

  EN 

 
 
 
 
 
the  Authority  set  up  and  implemented  measures  to  counter  fraud  and  any  illegal 
activities  affecting  the  interests  of  the    Authority  by  putting  in  place  a  sound  anti-
fraud  strategy  and  implementing  rules  to  improve  the  prevention,  detection  and 
conditions  for  investigating  fraud,  and  to  set  out  reparation  and  deterrence  actions, 
with  proportionate  and  dissuasive  measures  the  Authority’s  Anti-Fraud  Strategy  is 
aligned  with  the  Authority  Strategy.  The  Authority’s  Anti-fraud  strategy  is 
accompanied by a corresponding action plan, outlining both specific focus areas and 
actions for the next years, and several  continuous actions that are carried out every 
year,  such  as  a  specific  standalone  fraud  risk  assessment,  with  the  identified  fraud 
risks included in the overall Agency risk register. Mandatory anti-fraud trainings are 
organised as part of the awareness  anti-fraud sessions. Tailored training sessions to 
selected  Process  Owners  /Managers  are  developed  in  order  to  address  the  risks 
associated to the areas that resulted potentially more exposed to fraud. Staff are made 
aware of how to report any suspects of wrongdoings and disciplinary procedures are 
in place as per the rules of the Staff Regulations. 

EN 

11 

  EN 

 
 
3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

•  Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure 

Contribution  

Heading of 
multiannual 
financial 
framework 

Number  

Diff./Non-
diff.78 

from 
EFTA 
countries
79 

from 
candidate 
countries 
and 
potential 
candidates
80 

From 
other 
third 
countries 

other assigned 
revenue 

2.   

E.061002  European  Food  Safety 
Authority  

Diff  

YES  

NO  

NO  

NO  

78 
79 
80 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidates from the Western Balkans. 

EN 

12 

  EN 

 
 
 
3.2. 

Estimated financial impact of the proposal on appropriations  

3.2.1. 

Summary of estimated impact on operational appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–   The proposal/initiative requires the use of operational appropriations, as explained below 

3.2.1.1.  Appropriations from voted budget 

HEADING  2. Competitiveness, prosperity and Security 

Year 

2028 

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
MFF 
2028-2034 

EUR million (to three decimal places) 

DG: SANTE 

Operational appropriations  

06 10 02 European Food Safety Authority 

Commitments 

Payments 

(1a) 

(2a) 

1,087 

1,087 

2,217 

2,217 

2,261 

2,261 

2,307 

2,307 

2,353 

2,353 

2,400 

2,400 

2,448 

2,448 

Appropriations of an administrative nature financed from the envelope of specific programmes 
Budget line 

(3) 

TOTAL appropriations 

for DG SANTE 

Commitments 

=1a+1b+3 

Payments 

=2a+2b+3 

1,087 

1,087 

2,217 

2,217 

2,261 

2,261 

2,307 

2,307 

2,353 

2,353 

2,400 

2,400 

2,448 

2,448 

Figures in the tables above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged. 

EN 

13 

15,073 

15,073 

0,000 

15,073 

15,073 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
TOTAL 

• 
appropriations 
headings) 

(all 

operational 
operational 

Commitments 

Payments 

•  TOTAL  appropriations  of  an  administrative 
nature  financed  from  the  envelope  for  specific 
programmes (all operational headings) 

(4) 

(5) 

(6) 

EUR million (to three decimal places) 

Year 

2028 

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
MFF 
2028-2034 

1,087 

2,217 

1,087 

2,217 

2,261 

2,261 

2,307 

2,307 

2,353 

2,353 

2,400 

2,400 

2,448 

2,448 

15,073 

15,073 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

TOTAL appropriations 
Under Heading 1 to3 
of the multiannual financial 
framework 
(Reference amount) 

Commitments 

=4+6 

1,087 

2,217 

2,261 

2,307 

2,353 

2,400 

2,448 

15,073 

Payments 

=5+6 

1,087 

2,217 

2,261 

2,307 

2,353 

2,400 

2,448 

15,073 

Figures in the tables above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged. 

EUR million (to three decimal places) 

. 

[Agency]: EFSA 

Budget line: EFSA/ EU Budget 
contribution to the agency 

Year 

2028 

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
2028 - 2034 

POST 

2034 (Annual 
expenditure) 

GRAND 
TOTAL 

1,087 

2,217 

2,261 

2,307 

2,353 

2,400 

2,448 

15,073 

2,448 

17,521 

Figures in the tables above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged. 

EN 

14 

EN 

 
 
 
 
 
  
  
  
  
  
  
  
  
====================================================================================================  

Heading of multiannual 
financial 
framework 

4 

‘Administrative expenditure’[1] 

DG:SANTE 

Ÿ Human resources  

Ÿ Other administrative expenditure  

TOTAL DG SANTE 

Appropriations  

Year 

2028 

0,000 

0,000 

0,000 

Year 

2029 

0,000 

0,000 

0,000 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL MFF 
2028-2034 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

EUR million (to three decimal places) 

TOTAL appropriations under 
HEADING 4 of the multiannual 
financial framework  

(Total 
commitments 
= Total 
payments) 

0 

0 

0 

0 

0 

0 

0 

0 

                                                                                                                                                    EUR million (to three decimal places) 

TOTAL HEADING 1 to 4 C1 

Year 

2028 

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
MFF 
2028-2034 

TOTAL appropriations 
under HEADINGS 1 to 4 

Commitments 

1,087 

2,217 

2,261 

2,307 

2,353 

2,400 

2,448 

15,073 

EN 

15 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                                                                       
 
 
  
of the multiannual financial framework  

Payments 

1,087 

2,217 

2,261 

2,307 

2,353 

2,400 

2,448 

15,073 

Figures in the tables above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged. 

=================================================================================================  

3.2.2. 

Estimated output funded from operational appropriations (not to be completed for decentralised agencies)  

Commitment appropriations in EUR million (to three decimal places)  

Indicate objectives and 
outputs 

 

Year 

2028-2034 

TOTAL 
2028-2034 

POST 

2034 

GRAND 

TOTAL 

OUTPUTS 

Type 

Average 
cost 

No 

Cost 

No 

Cost 

No 

Cost 

No 

Cost 

SPECIFIC OBJECTIVE No 1… 

- Output 

- Output 

- Output 

Subtotal for specific objective No 1 

SPECIFIC OBJECTIVE No 2 ... 

- Output 

- Output 

- Output 

Subtotal for specific objective No 2 

TOTALS 

EN 

16 

EN 

 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
3.2.3. 

Summary of estimated impact on administrative appropriations  

–   The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature  

–    The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below 

3.2.3.1. Appropriations from voted budget 

VOTED APPROPRIATIONS  

HEADING 4  

Year   Year   Year   Year   Year   Year   Year   TOTAL 2028 - 
2028   2029   2030   2031   2032   2033   2034  

2034  

Human resources   

0.000   0.000   0.000   0.000   0.000   0.000   0.000  

Other administrative expenditure   

0.000   0.000   0.000   0.000   0.000   0.000   0.000  

Subtotal HEADING 4  

0.000   0.000   0.000   0.000   0.000   0.000   0.000  

Outside HEADING 4  

Human resources   

0.000   0.000   0.000   0.000   0.000   0.000   0.000  

Other expenditure of an administrative nature   0.000   0.000   0.000   0.000   0.000   0.000   0.000  

Subtotal outside HEADING 4  

0.000   0.000   0.000   0.000   0.000   0.000   0.000  

0.000  

0.000  

0.000  

0.000  

0.000  

0.000  

TOTAL  

0.000   0.000   0.000   0.000   0.000   0.000   0.000  

0.000  

3.2.4.  Estimated requirements of human resources  

–    The proposal/initiative does not require the use of human resources  

–  The proposal/initiative requires the use of human resources, as explained below 

–   

3.2.4.1.  Financed from voted budget 

Estimate to be expressed in full-time equivalent units (FTEs)81 

VOTED APPROPRIATIONS 

Year 

2024 

Year 

2025 

Year 

2026 

Year 

2027 

 Establishment plan posts (officials and temporary staff) 

20 01 02 01 (Headquarters and Commission’s Representation Offices) 

20 01 02 03 (EU Delegations) 

01 01 01 01 (Indirect research) 

01 01 01 11 (Direct research) 

Other budget lines (specify) 

• External staff (inFTEs) 

20 02 01 (AC, END from the ‘global envelope’) 

20 02 03 (AC, AL, END and JPD in the EU Delegations) 

Admin. Support 
line 
[XX.01.YY.YY] 

- at Headquarters 

- in EU Delegations  

01 01 01 02 (AC, END - Indirect research) 

 01 01 01 12 (AC, END - Direct research) 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

81 

Please specify below the table how many FTEs within the number indicated are already assigned to the 
management of the action and/or can be redeployed within your DG and what are your net needs. 

EN 

17 

  EN 

 
  
 
 
Other budget lines (specify) - Heading 7 

Other budget lines (specify) - Outside Heading 7 

TOTAL 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

3.2.5.  Overview of estimated impact on digital technology-related investments 

Compulsory: the best estimate of the digital technology-related investments entailed 
by the proposal/initiative should be included in the table below.  

Exceptionally,  when  required  for  the  implementation  of  the  proposal/initiative,  the 
appropriations under Heading 7 should be presented in the designated line.  

The appropriations under Headings 1-6 should be reflected as “Policy IT expenditure 
on operational programmes”. This expenditure refers to the operational budget to be 
used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation 
of the initiative and their associated investments (e.g. licences, studies, data storage 
etc).  The  information  provided  in  this  table  should  be  consistent  with  details 
presented under Section 4 “Digital dimensions”. 

TOTAL Digital and IT appropriations 

Year 

Year 

Year 

Year 

2024 

2025 

2026 

2027 

TOTAL 
MFF 2021 - 
2027 

HEADING 7 

IT expenditure (corporate)  

Subtotal HEADING 7 

Outside HEADING 7 

Policy IT expenditure on operational 
programmes 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

Subtotal outside HEADING 7 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

TOTAL 

0.000 

0.000 

0.000 

0.000 

0.000 

3.2.6.  Compatibility with the current multiannual financial framework  

The proposal/initiative: 

–   can be fully financed through redeployment within the relevant heading of the 

multiannual financial framework (MFF) 

–    requires use of the unallocated margin under the relevant heading of the MFF 

and/or use of the special instruments as defined in the MFF Regulation. 

3.2.7.  Third-party contributions  

The proposal/initiative: 

–   does not provide for co-financing by third parties 

–    provides for the co-financing by third parties estimated below: 

Appropriations in EUR million (to three decimal places) 

Year  
2024 

Year  
2025 

Year  
2026 

Year  
2027 

Total 

EN 

18 

  EN 

 
  
 
Specify the co-financing body  

TOTAL appropriations co-
financed  

3.2.8.  Estimated human resources and the use of appropriations required in a decentralised 

agency   

Staff requirements (full-time equivalent units)  

2028  

2029  

2030   2031   2032   2033   2034  

2034  

Temporary agents (AD Grades)  

Temporary agents (AST grades)  

Temporary agents (AD+AST) subtotal  

Contract staff  

Seconded National Experts  

Contract agents and SNE subtotal  

TOTAL staff  

9  

1  

10  

5 

5 

15  

9  

1  

10 

5  

5  

15  

9 

1  

10  

5  

5  

15  

9  

1  

10  

5  

5  

15  

9  

1  

10  

5  

5  

15  

9  

1  

10  

5  

5 

15  

9 

1  

10 

5  

5  

15  

9  

1  

10  

3  

5 

15  

Appropriations covered by the EU budget contribution in EUR million (to three decimal places)  

[Agency]: EFSA  Year 

Year 

Year 

Year 

Year 

Year 

Year 

2028 

2029 

2030 

2031 

2032 

2033 

2034 

TOTAL 
2028 - 
2034 

POST 

2034(annual 
expenditure) 

GRAND 
TOTAL 

1,087 

2,217 

2,261 

2,307 

2,353 

2,400 

2,448 

15,073  2,448 

17,521 

0,000 

0,000 

0,000 

0,000 

1,087  2,217  2,261  2,307  2,353  2,400  2,448  15,073  2,448 

17,521 

Title 1: Staff 
expenditure 

Title 2: 
Infrastructure 
and operating 
expenditure 
Title 3: 
Operational 
expenditure 
TOTAL of 
appropriations 
covered by the 
EU Budget  

 Figures  in  the  tables  above  are  all  strictly  indicative  pending  the  outcome  of  the  2028-2034  MFF  negotiations  which  cannot  be 
prejudged. 

Overview/summary  of  human  resources  and  appropriations  (in  EUR  million)  required  by  the 
proposal/initiative in a decentralised agency   

EN 

19 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
   
   
   
   
   
   
   
   
   
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
 
 
 
 
[Agency]: 
EFSA 

Year  Year  Year  Year  Year  Year  Year  TOTAL 
- 
2028  2029  2030  2031  2032  2033  2034 

2028 
2034 
10 

POST 
2034(annual 
expenditure) 
10 

GRAND 
TOTAL 

10,000 

10 

10 

10 

10 

10 

10 

5 

0 

5 

0 

5 

0 

5 

0 

5 

0 

5 

0 

5 

0 

5 

5,000 

0,000 

0 

10 

Temporary 
agents 
(AD+AST) 
Contract agents  5 

Seconded 
National 
Experts 
Total staff 

15 

15 

15 

15 

15 

15 

15 

15 

15 

15,000 

2,448 

0,000  0,000  0,000  0,000  0,000  0,000  0,000  0,000 

1,087  2,217  2,261  2,307  2,353  2,400  2,448  15,073 

Appropriations 
covered  by  the 
EU Budget 
Appropriations 
covered by fees 
Appropriations 
co-financed  (if 
applicable) 
TOTAL 
appropriations 
For the year 2028, staff expenditure has been estimated at 50% of the projected amount, as it 
is anticipated that not all  positions will be filled from the beginning of the year. 

1,087  2,217  2,261  2,307  2,353  2,400  2,448  15,073 

0,000  0,000  0,000  0,000  0,000  0,000  0,000  0,000 

2,448 

0,000 

0,000 

17,521 

0,000 

0,000 

17,521 

 Figures  in  the  tables  above  are  all  strictly  indicative  pending  the  outcome  of  the  2028-2034  MFF  negotiations  which  cannot  be 
prejudged. 

Description of tasks to be carried out by:  
Temporary staff  

1 AD5  

•  General coordination of the risk assessment process  
•  Organisation of authors meeting  
•  Organisation of meetings with applicants  
•  Organisation 
and 
experts/dedicated working group  
•  Proof reading and harmonisation of outcomes  

of  mtg  with 

chairing 

For the 8 AD6  

• 

final  risk  assessment  with  the  integration  of  the 

different lines of evidence;  

specific  activities  to  assess  horizontally  specific 

• 
species,  

•  drafting GD;  
• 

interface  with  competent  authorities  (mostly  senior 

civil servants) and stakeholders in general. 

•  Presubmission advice  
•  Experts’ consultation  

External staff  

1 ASTII  

5 FGIV:  

•  Administrative support to the operations  

• 

risk assessment in all areas ( lower complexity tasks) 

EN 

20 

  EN 

 
 
 
  
  
  
 
•  collect all lines of evidence, ie collect and report in a 
systematic  manner  all  the  info  in  dossiers,  as  well  as  from 
literature,  to  allow  TA  quick  extraction  and  Weight  of 
Evidence assessment;  

•  helpdesk  for  IUCLID  issues  for  biocontrol  active 

substances 

3.3. 

Estimated impact on revenue  

–   The proposal/initiative has no financial impact on revenue. 

–    The proposal/initiative has the following financial impact: 

 

 

on own resources  

on other revenue 

  please indicate, if the revenue is assigned to expenditure lines 

Appropriations 
available for the 
current financial 
year 

     EUR million (to three decimal places) 

Impact of the proposal/initiative82 

Year 2024 

Year 2025  Year 2026 

Year 2027 

Budget revenue line: 

Article …………. 

For assigned revenue, specify the budget expenditure line(s) affected. 

N/A 

Other  remarks  (e.g.  method/formula  used  for  calculating  the  impact  on  revenue  or 
any other information). 

N/A 

4. 

DIGITAL DIMENSIONS 

4.1. 

Requirements of digital relevance 

The  proposal  does  not  require  any  additional  digital  tools  besides  the  already 
existing ones. the Authority will use the UCLID platform when acting as rapporteur 
Member  State.  There  is  no  specific  form  prescribed  for  the  provision  of  technical 
advice  to  Member  States-  this  could  be  subject  to  specific  agreement  between  the 
Member States and the Authority 

4.2. 

Data 

N/A 

82 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 20% for collection costs. 

EN 

21 

  EN 

 
  
 
 
 
 
 
 
 
 
 
4.3. 

Digital solutions 

N/A 

4.4. 

Interoperability assessment 

N/A 

4.5.  Measures to support digital implementation 

N/A 

EN 

22 

  EN