Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 98/58/EC and Directive 2009/128/EC of the European Parliament and of the Council as regards the simplification and strengthening of food and feed safety requirements, and repealing Council Directives 82/711/EEC and 85/572/EEC
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: administrative formalities, animal feedingstuffs, drone, food safety, livestock farming, pesticide, plant health treatment, protection of animals, veterinary inspection

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   EUROPEAN COMMISSION  Strasbourg, 16.12.2025  COM(2025) 1021 final 2025/0409 (COD)  Simplification Omnibus Package Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 98/58/EC and Directive 2009/128/EC of the European Parliament and of the Council as regards the simplification and strengthening of food and feed safety requirements, and repealing Council Directives 82/711/EEC and 85/572/EEC  
 
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, which aims 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. More specifically, this initiative 
is aiming at simplification of certain provisions and procedures of the following acts: 

Directive 2009/128/EC2: Drones3 have the potential to be used for more targeted application 
of  pesticides  and,  in  certain  situations  may  present  a  lower  risk  to  the  operator  and 
environment  than  land-based  application  technologies.  However,  currently  they  are  covered 
by the general prohibition of aerial spraying under Directive 2009/128/EC, and granting and 
obtaining  individual  derogations  for  their  use  gives  rise  to  a  considerable  administrative 
burden  on  professional  users  and  competent  authorities  of  the  Member  States.  This  was 
identified as the most significant burden in the evaluation of the Directive conducted in 2022.4 
The  impact  of  this  burden  is  growing  as  opportunities  increase  to  apply  pesticides  using 
drones, hampering the development and uptake of this innovative technology in the EU. In the 
meeting  of  the  AGRIFISH  Council  in  December  2024,  several  Member  States  supported  a 
paper5  requesting  the  inclusion  in  the  Directive  of  certain  criteria  to  facilitate  use  of  drones 
such  as  those  that  had  already  been  identified  in  a  previous  Commission  proposal6  (since 
withdrawn7). A possibility for Member States to grant a general derogation from the ban on 
aerial  spraying  for  certain  types  of  drones  identified  by  the  Commission  in  delegated  act  is 
therefore proposed to be introduced in the Directive. The application of pesticides by drones 
would  be  subject  to  the  condition  that  the  respective  plant  protection  products  have  to  be 
explicitly  authorised  under  Regulation  (EC)  No  1107/2009  for  application  by  drones. 
Therefore,  the  Commission  will  mandate  the  European  Food  Safety  Authority  (EFSA)  to 
develop a guidance document on the risk assessment for authorising plant protection products 
for  aerial  application  under  Regulation  (EC)  No  1107/2009  and  will  consult  EFSA  and  the 
Member States in the preparation of the delegated act listing the types of drones that could be 
used  for  aerial  spraying.  The  application  of  pesticides  by  drones  would  also  continue  to  be 
subject  to  other  requirements  of  the  Directive,  including  those  regulating  training  and 
equipment inspection. In addition, they would continue be subject to detailed requirements in 

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4 

5 

6 

7 

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. 
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). 
Drones are referred to an ‘unmanned aircraft systems’ in this proposal. 
Study  Supporting  the  Evaluation  of  Directive  2009/128/EC  on  the  Sustainable  Use  of  Pesticides  and 
Impact Assessment of its possible revision: Final Report of the Evaluation, pp. 78-79. 
AOB item for the meeting of the "Agriculture and Fisheries" Council on 9 and 10 December 2024: The 
need  to  establish  appropriate  legislation  for  the  use  of  drones  to  contribute  to  the  resilience  of 
agricultural systems, https://data.consilium.europa.eu/doc/document/ST-16521-2024-INIT/en/pdf 
Proposal for a regulation of the European Parliament and of the Council on the sustainable use of plant 
protection products and amending Regulation (EU) 2021/2115 (2022/0196 (COD)). 
Withdrawal 
http://data.europa.eu/eli/C/2024/3117/oj. 

C/2024/3117, 

Commission 

Proposals, 

6.5.2024, 

OJ 

C, 

of 

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other EU legislation8, including on the competence of remote pilots, the operational limitations 
to  reduce  the  risk  posed  to  people  and  to  other  aircraft  and  the  technical  parameters 
applicable to the types of drone used. 

Directive 98/58/EC9: Owners or keepers of animals kept for farming purposes are currently 
required  to  keep  records  of  medicinal  treatments  given  to  animals  and  of  the  number  of 
mortalities as part of the horizontal directive for the welfare of animals kept in farms. Similar 
record  keeping  is  required  by  Regulation  on  the  veterinary  medicinal  products  and  by  the 
animal  health  Regulation  respectively.  While  the  potential  for  further  simplification  for 
farmers  in  general  will  be  considered  in  the  process  of  modernising  EU  animal  welfare 
legislation under the Vision for Agriculture and Food.10, this omnibus will already avoid the 
duplication  of  record  keeping  requirements  for  farmers  by  amending  Directive  98/58/EC  in 
this respect.  

Directive  82/711/EEC11  and  Directive  85/572/EEC12:  Regulation  (EC)  No  1935/200413 
provides  the  legal  framework  applicable  to  materials  and  articles  intended  to  come  into 
contact with food. It replaced and repealed Council Directive 89/109/EEC.  

Article 5(1) of Regulation  (EC) No 1935/2004  empowers the Commission  to  adopt  specific 
measures  for  the  materials  and  articles  listed  in  Annex  I  of  that  Regulation.  Pending  the 
adoption  by  the  Commission  of  a  specific  measure  on  plastic  food  contact  materials, 
Regulation  No  1935/2004  did  not  repeal  Council  Directives  82/711/EEC  and  85/572/EEC, 
which  laid  down  the  rules  necessary  for  testing  the  migration  of  the  constituents  of  plastic 
materials  and  articles  intended  to  come  into  contact  with  foodstuffs,  including  the  list  of 
simulants, to be used to that end for specific food categories. 

 Commission  Regulation  (EU)  No  10/201114  of  14  January  2011  was  adopted  as  a  specific 
measure for plastic materials and articles intended to come into contact with food. Regulation 
No  10/2011  covers  the  matters  regulated  by  Directives  82/711/EEC  and  85/572/EEC. 
Therefore, it is  appropriate to  repeal  Directives  82/711/EEC  and 85/572/EEC for reasons  of 
legal certainty. 

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14 

See  for example  Commission Implementing Regulation (EU)  2019/947 of 24 May 2019  on  the rules 
and  procedures  for  the  operation  of  unmanned  aircraft  (OJ  L  152,  11.6.2019,  p.  45);  Commission 
Delegated  Regulation  (EU)  2019/945  of  12  March  2019  on  unmanned  aircraft  systems  and  on  third-
country operators of unmanned aircraft systems (OJ L 152, 11.6.2019, p. 1). 
Council  Directive  98/58/EC  of  20  July  1998  concerning  the  protection  of  animals  kept  for  farming 
purposes, (OJ L 221, 8.8.1998, pp. 23–27, ELI: http://data.europa.eu/eli/dir/1998/58/oj). 
https://agriculture.ec.europa.eu/overview-vision-agriculture-food/vision-agriculture-and-food_en 
Council  Directive  82/711/EEC  of  18  October  1982  laying  down  the  basic  rules  necessary  for  testing 
migration  of  the  constituents  of  plastic  materials  and  articles  intended  to  come  into  contact  with 
foodstuffs, (OJ L 297, 23.10.1982, pp. 26–30, ELI: http://data.europa.eu/eli/dir/1982/711/oj). 
Council Directive 85/572/EEC of 19 December 1985 laying down the list of simulants to be used for 
testing  migration  of  constituents  of  plastic  materials  and  articles  intended  to  come  into  contact  with 
foodstuffs, (OJ L 372, 31.12.1985, pp. 14–21, ELI: http://data.europa.eu/eli/dir/1985/572/oj). 
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC, (OJ L 338, 13.11.2004, pp. 4–17, ELI: http://data.europa.eu/eli/reg/2004/1935/oj). 
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to  come  into  contact  with  food  Text  with  EEA  relevance,  (OJ  L  12,  15.1.2011,  pp.  1–89, 
ELI: http://data.europa.eu/eli/reg/2011/10/oj). 

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• 

Consistency with existing policy provisions in the policy area 

The amendments to Directive 2009/128/EC are in line with the overall aims of that Directive, 
which  is  to  reduce  the  risks  and  impacts  of  pesticide  use  on  human  health  and  the 
environment. Facilitating greater use of drones with the necessary safeguards would allow for 
the  targeted  aerial  application  of  plant  protection  products,  improve  operator  safety  and 
reduce the overall use and risk of pesticides.  

Since safeguards for animal health and welfare remain in place, the amendment to Directive 
98/58/EC is in line with the overall objective of that Directive, i.e. to protect animal welfare at 
farms. 

Since  Regulation  (EU)  No  10/2011  covers  the  matters  regulated  by  Directives  82/711/EEC 
and 85/572/EEC, those Directives are repealed for reasons of legal certainty.  

• 

Consistency with other Union policies 

The contribution of drones to pesticide reduction through more targeted application as part of 
precision  agriculture  is  consistent  with  the  European  Green  Deal’s  objective  that  all  EU 
policies should contribute to preserving and restoring Europe’s natural capital.15  

The  Commission  adopted  a  Drone  Strategy  2.0  in  November  2022.  It  notes  that  the 
digitalisation  of  the  economy  should  strengthen  the  Union's  competitiveness  and  empower 
people  with  a  new  generation  of  technologies,  leaving  no  one  behind,  in  line  with  the 
European  Pillar  of  Social  Rights.  A  viable  drone  eco-system  will  contribute  to  leverage 
European  research,  innovation,  and  entrepreneurship  to  achieve  the  objectives  of  the 
European  Green  Deal  and  Digital  Europe,  fully  in  line  with  the  new  growth  strategy  for 
Europe. 16  

The Drone Strategy 2.0 sets out a clear vision for 2030 of large scale highly automated and 
digitally connected affordable, safe, secure, and environmentally friendly drone operations in 
several  Member  States.  The  vision  aims  for  the  EU  drone  industry  to  become  viable  and 
accessible to EU citizens and businesses with an active participation of actors of all sizes. The 
drone eco-system  will provide jobs,  promote and protect  European technological  know-how 
and allow for growth opportunities for the EU economy as a whole. 17 Targeted amendments 
to  Directive  2009/128/EC  to  allow  drones  to  be  used  without  the  need  to  apply  for  an 
individual derogation would serve these wider aims of economic growth. 

The  proposed  amendment  to  Directive  2009/128/EC  is  also  in  line  with  the  Commission's 
ambition in its Communication on implementation and simplification to radically lighten the 
regulatory load for people, businesses and administrations, boost prosperity and resilience and 
unleash opportunities, innovation and growth.18 

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16 

17 
18 

Communication from the Commission to the European Parliament, the European Council, the Council, 
the  European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions,  ‘The  European 
Green Deal’ COM/2019/640 final, EUR-Lex - 52019DC0640 - EN - EUR-Lex (europa.eu). 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, A Drone Strategy 2.0 for a Smart 
and Sustainable Unmanned Aircraft Eco-System in Europe, COM(2022) 652 final.  
Ibid.  
European  Commission  2024-2029,  A  simpler  and  faster  Europe:  Communication  on  implementation 
and simplification. 

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By  eliminating  parallel  record  keeping  requirements,  the  amendment  to  Directive  98/58 
provides  for  a  more  streamlined  and  coherent  framework  which  simplifies  compliance  for 
farmers and ensures a clearer legal basis for enforcement by the competent authorities. This is 
in  line  with  the  Commission’s  overall  approach  to  reduce  administrative  burden  as  well  as 
with its ambition to ensure a better compliance and effective enforcement of the EU animal 
welfare rules. 

By  repealing  Directives  82/711/EEC  and  85/572/EEC,  whose  subject-matters  are  presently 
regulated  by  Regulation  (EU)  No  10/2011,  the  Commission  takes  into  account  better 
regulation  principles  and  guarantees  legal  certainty  for  the  operators  in  the  field  of  plastic 
food contact materials.  

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

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

• 

Subsidiarity (for non-exclusive competence)  

In accordance with the principle of subsidiarity, in areas which do not fall within its exclusive 
competence, the Union shall act only if and in so far as the objectives of the proposed action 
cannot be sufficiently achieved by the Member States. To address the difficulties arising from 
administrative burdens related to an individual application procedure for aerial application of 
pesticides, Directive 2009/128/EC needs to be amended, which can only be done at EU level. 
Similarly, to eliminate the duplication of record keeping requirements on mortalities and the 
use  of  veterinary  medicines,  Directive  98/58/EC  must  be  amended,  which  also  can  only  be 
done at EU level. Finally, the repeal of Directives 82/711/EEC and 85/572/EEC to guarantee 
legal  certainty  can  only  be  achieved  at  EU  level.  The  principle  of  subsidiarity  is  therefore 
respected. 

• 

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. 

The proposal amends Directive 2009/128/EC, Directive 98/58/EC only to the extent necessary 
to achieve the objectives outlined above.  

Directives  82/711/EEC  and  85/572/EEC  are  repealed  but  their  subject-matters  are  currently 
regulated by Regulation (EU) No 10/2011.  

• 

Choice of the instrument 

The  proposal  for  revision  is  a  legislative  proposal,  as  the  relevant  Directives  to  be 
amended/repealed  were  adopted  by  co-decision/  ordinary  legislative  procedure.  As  this 
omnibus  legislative  proposal  amends  two  directives  and  repeals  another  two  directives,  a 
Directive is the most appropriate legal instrument. 

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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  Directives 
2009/128/EC and 98/58/EC, based on existing data and information gathered during the call 
for  evidence  and  previous  analyses.  This  includes  drawing  on  an  ex-post  evaluation  of 
Directive 2009/128/EC that was conducted between May 2020 and June 202219 as part of a 
combined evaluation and impact assessment for its possible revision. 

The  repeal  of  Directives  82/711/EEC  and  85/572/EEC  does  not  require  either  an  impact 
assessment, or stakeholder consultation as the provisions of the directives are superseded by 
more recent legal acts. 

• 

Stakeholder consultations 

Following  the  Commission’s  fitness  check,  concluded  in  2022,  stakeholders  have  raised 
concerns  regarding  the  administrative  burden  caused  by  the  current  EU  animal  welfare 
legislation. For instance, in  the public consultation  that supported the fitness  check, 75% of 
companies  and  business  organisations  (495  of  660)  considered  the  current  rules  on  animal 
welfare to be too burdensome and/or costly for farmers. In the stakeholder interviews that also 
were performed in support of the fitness check, one business organisation specifically referred 
to  problems  related  to  record  keeping  at  farm  level  in  this  respect.20  As  noted  above,  the 
administrative burden of individual derogations was identified as the most significant burden 
in the evaluation Directive 2009/128/EC conducted in 2022.21 

This  is  not  applicable  for  the  repeal  of  Directives  82/711/EEC  and  85/572/EEC  for  the 
reasons explained above. 

• 

Collection and use of expertise 

Different stakeholder suggestions for simplification have been made concerning the removal 
of  excessive  administrative  burden  stemming  from  the  prohibition  of  aerial  spraying  under 
Directive 2009/128/EC, and parallel requirements for keeping records of medicinal treatments 
and animal mortalities under Directive 98/58/EC. In addition, the experience of implementing 
Directive 2009/128/EC and the findings of Commission audits in Member States and drawing 
on  an  ex-post  evaluation  of  Directive  2009/128/EC  conducted  between  May  2020  and  June 
202222 have informed the Commission’s understanding of this topic. 

This is not applicable to the repeal of Directives 82/711/EEC and 85/572/EEC for the reasons 
explained above. 

19 

20 

21 

22 

See  Study  Supporting  the  Evaluation  of  Directive  2009/128/EC  on  the  Sustainable  Use  of  Pesticides 
and Impact Assessment of its possible revision: Final Report of the Evaluation. 
Commission  Staff  Working  Document,  Fitness  Check  of  the  EU  Animal  Welfare  Legislation 
(SWD(2022) 329 final), p 119. 
Study  Supporting  the  Evaluation  of  Directive  2009/128/EC  on  the  Sustainable  Use  of  Pesticides  and 
Impact Assessment of its possible revision: Final Report of the Evaluation, pp. 78-79. 
Study  Supporting  the  Evaluation  of  Directive  2009/128/EC  on  the  Sustainable  Use  of  Pesticides  and 
Impact Assessment of its possible revision: Final Report of the Evaluation. 

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• 

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. 

In  addition,  the  proposed  amendment  to  Directive  2009/128/EC  is  informed  by  a  recent 
impact  assessment23  carried  out  between  May  2020  and  June  2022  by  the  Commission  in 
relation  to  the  now  withdrawn  proposal  for  a  regulation  on  the  sustainable  use  of  plant 
protection products.24  

This is not applicable to the repeal of Directives 82/711/EEC and 85/572/EEC for the reasons 
explained above. 

• 

Regulatory fitness and simplification 

This  proposal  is  part  of  the  commitment  of  the  European  Commission  to  lighten  the 
regulatory  burden  for  people,  businesses  and  administrations  in  the  EU  to  boost  prosperity 
and resilience of the EU. 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  and  observes  the  principles  enshrined  in  the 
Charter of Fundamental Rights of the European Union and adheres to the values 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 

This initiative will not imply any additional costs for the Commission.  

5. 

• 

OTHER ELEMENTS 

Explanatory documents (for directives) 

The  amendments  to  Directive  98/58/EC  do  not  require  Explanatory  Documents  on  the 
transposition  as  they  constitute  waiving  of  obligations  for  the  Member  States  and  do  not 
create new provisions to be transposed in national laws.   

23 

24 

Study  Supporting  the  Evaluation  of  Directive  2009/128/EC  on  the  Sustainable  Use  of  Pesticides  and 
Impact Assessment of its possible revision: Final Impact Assessment Report. 
Proposal for a regulation of the European Parliament and of the Council on the sustainable use of plant 
protection products and amending Regulation (EU) 2021/2115 (2022/0196 (COD)). 

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The  amendments  to  Directive  2009/128/EC  do  not  require  explanatory  documents  on  the 
transposition  either  as  the  proposal  empowers  the  Commission  to  adopt  delegated  act  in 
future.  

The  repeal  of  Directives  82/711/EEC  and  85/572/EEC  does  not  require  any  explanatory 
documents  on  the  transposition  as  their  provisions  were  replaced  by  Regulation  (EU)  No 
10/2011, which is directly applicable since its date of application. 

• 

• 

Detailed explanation of the specific provisions of the proposal 

Directive 98/58/EC 

Owners  or  keepers  of  animals  kept  for  farming  purposes  are  currently  required  to  keep 
records  of  medicinal  treatments  given  to  animals  and  of  the  number  of  mortalities  in 
accordance with points 5 and 6 of the Annex to Directive 98/58/EC. Article 108 of Regulation 
(EU) No 2019/6 contains more detailed record keeping requirements on the use of medicinal 
products for owners or keepers of food producing animals. Articles 102(1)(d) and 186(1)(d) 
of Regulation  (EU) No  2016/429  require operators to  keep  and maintain records  containing 
information  on  the  mortality  of  animals  in  their  establishments.  The  obligations  imposed 
should  be  simplified  to  avoid  duplication  of  record  keeping  requirements  for  farmers. 
Therefore, points 5 and 6 of the Annex to Directive 98/58/EC should be deleted  

• 

Directive 2009/128/EC 

The definition of "aerial spraying" in Article 3, point 5 of Directive 2009/128/EC is updated 
to  include  a  specific  reference  to  unmanned  aircraft  systems  (drones),  and  a  definition  of 
unmanned aircraft systems is provided for in the new point 5a of Article 3.  

A new Article 9a gives the possibility to Member States to exempt certain types of unmanned 
aircraft systems (drones) from the prohibition of aerial spraying provided for in Article 9(1) of 
Directive  2009/128/EC  where  an  assessment  has  shown  that  the  risks  are  equal  or  lower 
compared to the risks arising from the use of land-based application equipment for the same 
use. This exemption will become possible, once the Commission has adopted delegated acts 
identifying  the  types  of  drones  fulfilling  this  requirement.  The  Commission  will  be 
empowered to adopt the delegated acts. 

• 

Directives 82/711/EEC and 85/572/EEC  

Directives  82/711/EEC  and  85/572/EEC  are  repealed  since  Regulation  (EU)  No  10/2011 
regulates their subject-matters since its date of application.  

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2025/0409 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directive 98/58/EC and Directive 2009/128/EC of the European 
Parliament and of the Council as regards the simplification and strengthening of food 
and feed safety requirements, and repealing Council Directives 82/711/EEC and 
85/572/EEC 

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 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) 

1 

Directive 2009/128/EC of the European Parliament and of the Council1 lays down the 
legal  framework  for  the  sustainable  use  of  pesticides  (plant  protection  products). 
Article 9(1) of Directive 2009/128/EC provides for a prohibition of aerial spraying of 
pesticides by an aircraft. Article 9(2) to (6) thereof allows individual derogations from 
that prohibition, under certain conditions. 

Since  the  entry  into  force  of  Directive  2009/128/EC,  experience  has  shown  that  the 
procedure  for  individual  derogations  from  the  prohibition  of  aerial  spraying  of 
pesticides  entails  considerable  administrative  burden  for  professional  users  and  it 
slows  down  and  restricts  the  development  of  technologies  that  could  allow  for  safer 
choices  for  human  health  and  the  environment.  Certain  types  of  unmanned  aircraft 
systems  (commonly  referred  to  as  drones)  under  particular  conditions  are  capable  of 
minimising the exposure of the operator to the use of pesticides in the field and could 
allow  professional  users  to  apply  pesticides  in  more  targeted  ways.  Such  unmanned 
aircraft systems are likely to help reduce the use of pesticides and consequently help 
reduce  the  risks  to  human  health  and  the  environment  compared  to  the  use  of  land-
based  application  equipment.  It  is  therefore  appropriate  to  enable  Member  States  to 
exempt  such  types  of  unmanned  aircraft  systems  from  the  prohibition  of  aerial 
spraying provided for in Directive 2009/128/EC under certain conditions.  

In order to ensure protection of human health and the environment, it is appropriate to 
require that such exemption can only apply if the pesticides are explicitly authorised 
for aerial use by unmanned aircraft systems. Such explicit authorisation of pesticides 

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). 

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(4) 

(5) 

for  aerial  use  by  unmanned  aircraft  systems  would  ensure  that  any  potential  risks  to 
human  health  and  the  environment  from  exposure  to  such  pesticides  are  thoroughly 
assessed  as  part  of  the  authorisation  process.  As  the  authorisations  of  pesticides  are 
regulated under Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council2,  the  Commission  should  mandate  the  European  Food  Safety  Authority 
(EFSA)  to  develop  a  guidance  document  on  risk  assessment  of  pesticides  for 
application  by  unmanned  aircraft  systems  under  Regulation  (EC)  No  1107/2009  in 
order to ensure that a robust framework of safeguards is in place. 

The legislative  framework  governing the  operation  of unmanned  aircraft  systems 
includes  such  acts  as  Regulation  (EU)  2018/1139  of  the  European  Parliament  of  the 
Council3 and Commission Implementing Regulation (EU) 2019/9474. This legislative 
framework  does  not  identify  the  types  of  unmanned  aircraft  systems  that  could  be 
appropriate for use for aerial application of pesticides by professional users. Therefore, 
complementary  to  the  development  of  specific  guidance  on  the  risk  assessment  of 
pesticides  that  could  be  used  for  application  by  unmanned  aircraft  systems,  it  is 
necessary to identify the types of unmanned aircraft systems that have lower or equal 
risks as regards human health and the environment compared to the risks arising from 
land-based application equipment for the same use. 

In  order  to  identify  the  types  of  unmanned  aircraft  systems  that  may  be  used  for 
application of pesticides, 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 Directive 2009/128/EC to identify the types 
of  unmanned  aircraft  systems  that  have  lower  or  equal  risks  compared  to  the  risks 
arising  from  land-based  application  equipment  for  the  same  use.  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-Making.  In  particular,  to  ensure  equal  participation  in  the 
preparation of delegated acts, the European Parliament and the Council should receive 
all  documents  at  the  same  time  as  Member  States'  experts,  and  those  experts  should 
systematically have access to meetings of Commission expert groups dealing with the 
preparation of such delegated acts. 

(6) 

Given  the  need  to  address  perceived  remaining  knowledge  and  data  gaps  before  the 
types  of  unmanned  aircraft  systems  that  have  lower  or  equal  risks  compared  to  the 
risks arising from land-based application equipment for the same use can be identified, 
it is appropriate to allow time for the Commission to consult EFSA and the Member 
States  in preparation of a delegated act identifying those types of unmanned aircraft 

2 

3 

4 

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, 
ELI: http://data.europa.eu/eli/reg/2009/1107/oj). 
Regulation (EU) 2018/1139 of the European Parliament of the Council on common rules in the field of 
civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations 
(EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 
2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations 
(EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council 
Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, pp. 1, 
ELI: http://data.europa.eu/eli/reg/2018/1139/oj). 
Commission Implementing Regulation (EU) 2019/947 of 24 May 2019 on the rules and procedures for 
the operation of unmanned aircraft (OJ L 152, 11.6.2019, 
ELI: http://data.europa.eu/eli/reg_impl/2019/947/oj). 

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systems  that  may  be  exempted  from  the  prohibition  of  aerial  spraying.  The 
Commission should be empowered to adopt a delegated act in accordance with Article 
20a to identify types of unmanned aircraft systems for which it can be established that 
the risks from exposure to pesticides to human health and the environment is equal to 
or  lower  than  from  the  use  of  land-based  application  equipment  for  the  same  use. 
Adoption of this delegated act should be a precondition for the possibility for Member 
States  to  exempt  such  types  of  unmanned  aircraft  systems  from  the  prohibition  of 
aerial spraying.  Pending the identification of the types of unmanned aircraft systems 
that may be exempted and the decision by a Member State to exempt those identified 
unmanned aircraft systems from the prohibition on aerial spraying, it is appropriate to 
continue  to  require  a  professional  user  to  submit  requests  for  approval  of  aerial 
spraying by all unmanned aircraft systems. 

Directive No 98/58/EC sets minimum requirements for the protection of animals kept 
for  farming  purposes.  Owners  or  keepers  of  animals  kept  for  farming  purposes  are 
currently required to keep records of medicinal treatments given to animals and of the 
number  of  mortalities  in  accordance  with  points  5  and  6  of  the  Annex  to  Directive 
98/58/EC. Article 108 of Regulation (EU) 2019/6 of the European Parliament and of 
the  Council5  contains  more  detailed  record  keeping  requirements  on  the  use  of 
medicinal products for owners or keepers of food producing animals. At the same time 
Article  102(1)(d)  and  Article  186(1)(d)  of  Regulation  No  2016/429  of  the  European 
Parliament  and  of  the  Council6  require  operators  to  keep  and  maintain  records 
containing  information  on  the  mortality  of  animals  in  their  establishments.  Thus, 
parallel reporting obligations exist for both points 5 and 6 of the Annex to Directive 
98/58/EC. The obligations imposed should be simplified to avoid duplication of record 
keeping requirements for farmers. Therefore, points 5 and 6 of the Annex to Directive 
98/58/EC should be deleted. 

Regulation  (EC) No 1935/2004  provides the legal  framework applicable to  materials 
and articles intended to come into contact with food. Article 5(1) of Regulation (EC) 
No 1935/2004 empowers the Commission to adopt specific measures for the materials 
and  articles  listed  in  Annex  I  of  that  Regulation.  Pending  the  adoption  by  the 
Commission  of  a  specific  measure  on  plastic  food  contact  materials,  Regulation  No 
1935/2004  did  not  repeal  Council  Directives  82/711/EEC7  and  85/572/EEC8,  which 
laid  down  the  rules  necessary  for  testing  the  migration  of  the  constituents  of  plastic 
materials and articles intended to come into contact with foodstuffs, including the list 
of  simulants  to  be  used  to  that  end  for  specific  food  categories.  Commission 
Regulation (EU) No 10/20119  was adopted as a specific measure for plastic materials 

Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  of  11  December  2018  on 
veterinary  medicinal  products  and  repealing  Directive  2001/82/EC  (OJ  L  4,  7.1.2019,  p.  43, 
ELI: http://data.europa.eu/eli/reg/2019/6/oj). 
Regulation  (EU)  2016/429  of  the  European  Parliament  and  of  the  Council  of  9  March  2016  on 
transmissible  animal  diseases  and  amending  and  repealing  certain  acts  in  the  area  of  animal  health 
(‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1, ELI: : http://data.europa.eu/eli/reg/2016/429/oj). 
Council  Directive  82/711/EEC  of  18  October  1982  laying  down  the  basic  rules  necessary  for  testing 
migration  of  the  constituents  of  plastic  materials  and  articles  intended  to  come  into  contact  with 
foodstuffs, (OJ L 297, 23.10.1982, pp. 26–30, ELI: http://data.europa.eu/eli/dir/1982/711/oj).  
Council Directive 85/572/EEC of 19 December 1985 laying down the list of simulants to be used for 
testing  migration  of  constituents  of  plastic  materials  and  articles  intended  to  come  into  contact  with 
foodstuffs, (OJ L 372, 31.12.1985, pp. 14–21, ELI: http://data.europa.eu/eli/dir/1985/572/oj).  
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to  come  into  contact  with  food  Text  with  EEA  relevance,  (OJ  L  12,  15.1.2011,  pp.  1–89,  ELI: 
http://data.europa.eu/eli/reg/2011/10/oj). 

(7) 

(8) 

5 

6 

7 

8 

9 

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and  articles  intended  to  come  into  contact  with  food.  Since  Commission  Regulation 
covers the matters regulated by Directives 82/711/EEC and 85/572/EEC, it is therefore 
appropriate  to  repeal  Directives  82/711/EEC  and  85/572/EEC  for  reasons  of  legal 
certainty.  

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Amendments to Directive 2009/128/EC 

Directive 2009/128/EC is amended as follows: 

(1) 

Article 3 is amended as follows:  

(a) 

point 5 is replaced by the following: 

‘5. 

‘aerial spraying’ means application of pesticides from a manned aircraft 
or an unmanned aircraft system;’; 

(b) 

the following point 5a is inserted: 

‘5a.  ‘unmanned aircraft system’ means any aircraft with equipment for aerial 
application  of  pesticides,  operating  autonomously  or  piloted  remotely 
without a pilot on board;’; 

(2) 

Article 9 is amended as follows: 

(a) 

in paragraph 1, the following new subparagraph is added: 

‘The prohibition provided for in the first subparagraph may only be derogated 
from in accordance with paragraphs 2 to 6 of this Article or with Article 9a.’ 

(b) 

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

‘2.  By way of derogation from paragraph 1, aerial spraying may be allowed 

in special cases provided the following conditions are met:’; 

(3) 

the following new Article 9a is inserted: 

‘Article 9a 

Aerial spraying of pesticides by unmanned aircraft systems 

1. 

2. 

By  way  of  further  derogation  from  Article  9(1),  Member  States  may,  in  the 
case  of  professional  users,  exempt  from  the  prohibition  laid  down  in  that 
Article,  the  aerial  spraying  of  pesticides  by  unmanned  aircraft  systems 
identified pursuant to paragraph 2.  

Pesticides  to  be  used  for  aerial  spraying  by  such  unmanned  aircraft  systems 
shall  be  explicitly  authorised  for  that  use  by  the  Member  State  under 
Regulation  (EC)  No  1107/2009  following  a  specific  assessment  addressing 
risks from aerial spraying. 

The Commission shall adopt a delegated act by [OP: please insert the date = 4 
years after the entry into force of this Directive] in accordance with Article 20a 
supplementing this Directive to identify the types of unmanned aircraft systems 
that  have  lower  or  equal  risks  compared  to  the  risks  arising  from  land-based 
application equipment for the same use.’;  

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(4) 

Article 20a is replaced by the following:  

‘Article 20a 

Exercise of the delegation 

1. 

2. 

3. 

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

The  power  to  adopt  delegated  acts  referred  to  in  Article  5(3),  Article  8(7), 
Article  9a(2),  Article  14(4)  and  Article  15(1)  shall  be  conferred  on  the 
Commission for a period of [OP: please insert the date = five years after the 
date  of  entry  into  force  of  this  Directive].  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. 

The delegation of power referred to in Article 5(3), Article 8(7), Article 9a(2), 
Article  14(4)  and  Article  15(1)  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 of 13 April 2016 on Better Law-Making (6). 

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  8(7),  Article  9a(2), 
Article  14(4)  and  Article  15(1)  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 of the Council.’. 

Article 2 

Amendment to Directive 98/58/EC 

Points 5 and 6 of Annex I to Directive 98/58/EC are deleted. 

Article 3 

Repeal of Directives 82/711/EEC and 85/572/EEC 

1. 

Directive 82/711/EEC and Directive 85/572/EEC are repealed with effect from [OP: 
please insert the date = date of entry into force of this Directive].  

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2. 

1. 

2. 

References to the repealed Directives shall be construed as references to Commission 
Regulation (EU) No 10/2011. 

Article 4 

Transposition 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions necessary to comply with Article 1 of this Directive by [OP: please insert 
the date = 5 years after the entry into force of this Directive.] at the latest. They shall 
forthwith communicate to the Commission the text of those provisions. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  Articles  2  and  3  of  this  Directive  by  [OP: 
please insert the date = two years after the entry into force of this Directive.] at the 
latest. When Member States adopt the provisions referred to in paragraphs 1 and 2, 
they shall contain a reference to this Directive or be accompanied by such a reference 
on the occasion of their official publication. Member States shall determine how such 
reference is to be made. 

3. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

Article 5 

Entry into force 

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

Article 6 

Addressees 

This Directive is addressed to the Member States. 

Done at Strasbourg, 

For the European Parliament 
The President 

For the Council 
The President 

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