Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market {SEC(2006) 930} {SEC(2006) 931}
Date: 2006-07-12
Institutions: European Commission
Subjects: exchange of information, marketing, marketing standard, pharmaceutical product, plant health product

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 12.7.2006 
COM(2006) 388 final 

2006/0136 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

concerning the placing of plant protection products on the market 

(presented by the Commission) 

{SEC(2006) 930} 
{SEC(2006) 931} 

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EXPLANATORY MEMORANDUM 

1)  CONTEXT OF THE PROPOSAL 

110 

(a) 

Grounds for and objectives of the proposal 

On 26 July 2001, the Commission submitted a progress report to Council and 
Parliament  on  the  functioning  of  Directive  91/414/EEC  [COM(2001)  444]. 
The  report  highlighted  a  number  of  areas  where  the  Directive  could  be 
improved.  

The Commission concluded in its report that reform of the current legislation 
was necessary in order to achieve the following: 

– 

– 

– 

– 

– 

– 

– 

reinforce  the  high  level  of  protection  of  human  health  and  the 
environment, 

improve functioning of the internal market, 

maintain and enhance the competitiveness of the EU chemical industry, 

harmonise availability of plant protection products between farmers in 
different Member States, 

increase transparency, 

avoid repetition of animal testing, 

update the procedures in particular to take account of the creation of the 
European Food Safety Authority, 

– 

define the role of the European Food Safety Authority. 

120 

(b) 

General context 

Both Council and the European Parliament, in reacting to the progress report, 
called on the Commission to bring forward proposals to amend the Directive. 

The  Council  moreover  called  the  Commission inter  alia  to  consider  rules  in 
order to: 

– 

– 

– 

– 

– 

avoid repetition of testing on vertebrates 

protect non-professional users 

present criteria for approval of active substances 

further strengthen the rules for substances with a very hazardous profile 

introduce a simplified procedure for low risk substances and products. 

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The European Parliament stressed also aspects such as: 

– 

– 

– 

– 

the principle of comparative assessment and substitution 

exclusion of substances with a very hazardous profile 

increased transparency 

improvement  of  mutual 
authorisation zones. 

recognition  by 

introducing  product 

Both  the  European  Parliament  and  the  Council  called  the  Commission  to 
propose a thematic strategy for the sustainable use of pesticides and to make 
further progress on establishing maximum residue levels. 

130 

(c) 

Existing provisions in the area of the proposal 

The  Community  regulatory  framework  concerning  plant  protection  products 
includes: 

(1)  Directive  91/414/EEC  of  15  July  1991  concerning  the  placing  on  the 
market  of  plant  protection  products  which  intends  to  prevent  risks  at 
source through a very comprehensive risk assessment procedure of each 
active substance and the products containing the substance, before they 
can be authorised for marketing and use. 

(2)  Council  Directive  79/117/EEC  of  21  December  1978  prohibiting  the 
placing  on  the  market  and  use  of  plant  protection  products  containing 
certain active substances, which provides for a list of substances which 
have  been  banned  in  the  EU  and  which  may  not  be  included  in  plant 
protection products. 

(3)  Regulation  (EC)  No  396/2005  of  the  European  Parliament  and  of  the 
Council on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC 
which  sets  maximum  residue  levels  (MRLs)  of  active  substances  in 
agricultural produce, thus intending to limit the risks to consumers. In 
addition, monitoring the respect of MRLs is an important tool to assess 
whether farmers have correctly applied the instructions and restrictions 
outlined in the authorisations of plant protection products. 

(4)  Together  with  this  proposed  Regulation,  a  proposal  is  presented  for  a 
Directive of the European Parliament and of the Council establishing a 
framework  for  Community  action  to  achieve  a  sustainable  use  of 
pesticides. It intends to cover the use and distribution phase in so far as 
they are not addressed in the current proposal. 

140 

(d) 

Consistency with other policies 

– 

In  preparing  its  proposal  the  Commission  has  taken  into  account  key 
elements of the Lisbon strategy in order to extend and deepen the single 
market,  to  ensure  open  and  competitive  markets  inside  and  outside 

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to  encourage  and  stimulate 

Europe, 
research, 
development  and  innovation  within  the  EU  and  to  improve  regulation 
and cut red-tape. 

investment 

in 

– 

– 

– 

– 

– 

The Commission has been careful to avoid duplication of the provisions 
of  other  legislation,  while  avoiding  loopholes  and  ensuring  that 
necessary information is made available to other sectors. 

Certain  aspects  concerning  use  and  distribution  of  plant  protection 
products  are  covered  by  the  proposal  for  a  Directive  of  the  European 
Parliament and of the Council establishing a framework for Community 
action to achieve a sustainable use of pesticides.  

Coherence  with  the  legislation  on  setting  maximum  residue  limits  has 
been ensured.  

The  proposal  will  also  ensure  coherence  with  two  recently  adopted 
Regulations:  

• 

• 

Regulation (EC) No 882/2004 of the European Parliament and of 
the Council of 29 April 2004 on official controls.  

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. 

The  proposed  provisions  are  in  line  with  the  principles  of  Regulation 
(EC)  No  1049/2001  of  the  European  Parliament  and  of  the  Council 
regarding  public  access 
to  European  Parliament,  Council  and 
Commission documents.  

2)  CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

(a) 

Consultation of interested parties 

211 

Consultation  methods,  main  sectors  targeted  and  general  profile  of 
respondents 

Following the presentation of the Commission's progress report, there was a 
wide consensus on the need for  reform.  Both  the  Council  and  the  European 
Parliament clearly favoured development of more effective mechanisms and 
procedures,  to  strengthen  the  criteria  for  acceptance  of  substances  and 
products  and  to  ensure  that  they  would  be  used  more  safely.  Industry 
welcomed  the  reflection  on  more  effective  evaluation  and  authorisation 
procedures.  Industry  also  expressed  interest  that  any  new  rules  on  data 
protection  should  keep  a  fair  balance  between  the  interests  of  research  and 
generic  companies.  Environmental  non-governmental  organisations  (NGOs) 
and consumer organisations were strongly supportive of the need for change, 
in  particular  to  increase  transparency  and  to  strengthen  the  criteria  for 

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acceptance of active substances. 

The Commission organised a brainstorming meeting with Member States on 
27  February  2002  in  which  a  number  of  areas  were  identified  as  requiring 
discussion and possible amendment.  

The Commission subsequently organised a workshop with the Presidency in 
Corfu  in  July  2002.  Member  States,  Accession  countries,  the  European 
Parliament  and  NGOs  were  invited  to  participate,  to  prepare  background 
papers on each of the topics identified and to suggest other topics important 
to them.  

The report of the workshop formed the basis for further discussions.  

The  Commission  organised  a  further  meeting  with  stakeholders  in  Brussels 
on 30 January 2004. 

The objectives of this meeting were (i) to report back to stakeholders on the 
orientations  of  the  Commission  in  handling  all  of  the  topics  discussed  at 
Corfu,  (ii)  to  exchange  views  on  a  possible  compromise  approach  to  data 
protection  and  on  centralisation  of  the  system  for  authorisation  of  plant 
protection products and (iii) inform stakeholders on planned next steps in the 
process.  Also  the  status  and  plans  for  the  Thematic  Strategy  on  the 
Sustainable Use of Pesticides were discussed.  

The Commission consulted stakeholders again by mail on 18 April 2005 on a 
first  draft  proposal  and  a  draft  impact  assessment  on  which  written 
contributions were made.  

From  10  March  to  10  May  2005  the  Commission  carried  out  an  Interactive 
Policy Making consultation with the general public. 

A further consultation on the impact assessment was organised at a meeting 
with stakeholders on 25 January 2006. 

Among the stakeholders consulted were: 

AUDACE  (Association  of  Users  and  Distributors  of  AgroChemicals  in 
Europe) 

BEUC (Bureau Européen des Unions des Consommateurs) 

BUAV (British Union Against Vivisection) 

CEFIC (European Chemical Industry Council) 

CELCAA (Comité Européen de Liaison des Commerces Agricoles et Agro-
Alimentaires) 

COCERAL  (Comité  du  Commerce  des  céréales,  aliments  du  bétail, 
oléagineux, huile d'olive, huiles et graisses et agrofournitures) 

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COLEACP (Europe-Africa-Caribbean-Pacific Liaison Committee) 

COPA/COGECA  (Committee  of  Professional  Agricultural  Organisations  in 
the European Union/General  Confederation of Agricultural Co-operatives in 
the European Union) 

ECCA (The European Crop Care Association) 

ECPA (The European Crop Protection Association) 

EEB (European Environmental Bureau) 

EFTA (European Free Trade Association) 

ESA (European Seed Association) 

EPPO (European and Mediterranean Plant Protection Organisation) 

EUREAU (European Union of National Associations of Water Suppliers and 
Waste Water Services) 

EUREPGAP  (Euro-Retailer  Produce  working  Group  –  Good  Agricultural 
Practice) 

Eurogroup for Animal Welfare 

FEFAC (Fédération européenne des Fabricants d’Aliments Composés) 

Freshfel Europe (Forum for the European fresh fruits and vegetables chain) 

Friends of the Earth 

IBMA (International Biocontrol Manufacturers Association) 

Member States of E.U. + Bulgaria, Romania  

OECD (Organisation for Economic Co-operation and Development) 

PAN (Pesticides Action Network Europe) 

UEAPME  (Union  Européenne  de  l'Artisanat  et  des  Petites  et  Moyennes 
Entreprises) 

WWF (World Wildlife Fund) 

212 

Summary of responses and how they have been taken into account. 

A large number of comments were received. The input from stakeholders was 
considered when preparing the final proposal.  

The following are the main points that were raised and comments considered 
as follows: 

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Mutual  recognition  of  authorisations:  there  was  no  consensus  on  the  best 
approach  for  further  harmonization  of  authorisation  of  plant  protection 
products.  Some  stakeholders  are  opposed  because  they  fear  that  local 
conditions  can  not  be 
into  account  sufficiently,  whilst  other 
stakeholders  would  be  in  favour  of  a  fully  centralized  authorisation  system. 
The  proposed  system  is  a  compromise  between  the  current  situation  and  a 
fully  centralised  authorisation.  It  should  avoid  unnecessary  duplication  of 
work, speed up decision making and ensure a more harmonized availability of 
plant protection products in the different Member States. 

taken 

Data  protection  and  data  sharing:  Member  States  complain  that  the  current 
system  is  too  complicated  and  a  major  administrative  burden.  The  research 
industry  complains  that  the  data  protection  period  is  too  short  and  that  it 
should  be  extended  to  all  data;  data  sharing  is  accepted  but  only  for  data 
involving  vertebrate  animals.  The  generic  industry  complains  that  no  fair 
competition is possible because of data protection, in particular at the 10 year 
review  of  an  active  substance.  It  is  proposed  to  simplify  the  system.  Data 
protection for 10 years after the first  authorisation is maintained. Provisions 
on data protection at review of an active substance are removed. 

Comparative assessment: The European Parliament, some Member States and 
Environmental  and  Consumer  organisations  are  very  much  in  favour.  Other 
Member  States,  industry  and  farmer  organisations  are  against  because  they 
fear  that  the  availability  of  products  will  be  reduced  with  subsequent 
problems to deal with pest resistance; they prefer the principle to be applied 
at farmer level. The proposed system provides that certain active substances 
are  identified  as  candidates  for  substitution  and  that  Member  States  have  to 
apply  comparative  assessment  and  substitution  when  authorizing  plant 
protection  products.  The  problem  of  development  of  resistance  will  have  to 
be considered before substituting a product.  

Criteria  for  approval  of  active  substances:  most  stakeholders  agree  that 
criteria  have  to  be  established  but  do  not  necessarily  agree  on  the  criteria 
themselves. Such criteria are established in an annex of the proposal, taking 
into account the high level of protection of human and animal health and of 
the environment requested by the European Parliament and the Council. The 
establishment  of  criteria  will  also  enable  industry  to  take  an  informed 
decision before investing in the development of new active substances or to 
support the renewal of approval of existing active substances.  

Provisional  authorisations:  industry  and  some  Member  States  do  not  agree 
with  the  abolishment  of  provisional  authorisations.  The  principle  of 
provisional  authorisation  is  however  incompatible  with  Regulation  (EC)  No 
396/2005 which establishes a harmonised Community system for establishing 
MRLs.  Moreover  the  strict  deadlines  introduced  for  assessing  an  active 
substance will substantially reduce the period for decision making, which will 
compensate  for  the  abolishment  of  provisional  authorisations.  In  addition 
Member States must already start to evaluate applications for authorisation of 
plant protection products during the EU evaluation of the active substance. 

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Comments  were  also  raised  on  several  aspects  of  the  proposed  Regulation; 
these  comments  have  been  considered  and  taken  into  account  as  far  as 
possible.  It  should  however  be  noted  that  views  were  sometimes  totally 
opposed between stakeholders. 

(b) 

Collection and use of expertise 

229 

Internal  and  external  expertise  was  used  to  contribute  to  the  impact 
assessment. 

230 

(c) 

Impact assessment 

The  Commission  carried  out  an  impact  assessment  listed  in  the  Work 
Programme, whose report is accessible on   
http://europa.eu.int/comm/dgs/health_consumer/index_en.htm. 

For  each  of  the  main  measures  proposed,  three  to  five  options  have  been 
examined with regard to their economic and social impacts and their impacts 
on health and the environment. 

I. 

Provisional authorisations 

II.  Mutual recognition 

III.  Comparative assessment 

IV.  Data protection 

V. 

Informing neighbours of the use of plant protection products. 

3)  LEGAL ELEMENTS OF THE PROPOSAL 

305 

(a) 

Summary of the proposed action 

The  proposed  Regulation  replaces  Directive  91/414/EEC  concerning  the 
placing  of  plant  protection  products  on  the  market  and  repeals  Council 
Directive 79/117/EEC prohibiting the placing on the market and use of plant 
protection  products  containing  certain  active  substances.  In  a  nutshell,  it 
consists of the following elements: 

– 

– 

– 

– 

Establishment  at  EU  level  of  a  positive  list  of  active  substances, 
safeners, synergists and a negative list of co-formulants 

Authorisation of plant protection products at Member State level 

Compulsory  mutual  recognition  of  authorisations  in  Member  States 
belonging to the same authorisation zone 

Comparative  assessment  and  substitution  of  products  containing 
substances identified as candidates for substitution 

– 

Specific  provisions  for  basic  substances  or  products  containing 

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substances of low concern 

Detailed rules on data protection and transparency 

Provisions on packaging, labelling and advertising  

Obligation to keep records and to carry out controls 

Establishment of criteria for approval of active substances, safeners or 
synergists 

– 

– 

– 

– 

310 

(b) 

Legal basis 

Article 37(2) and Article 152(4)(b) 

320 

(c) 

Subsidiarity principle 

321 

324 

325 

327 

The subsidiarity principle applies insofar as the proposal does not fall under 
the exclusive competence of the Community. 

The objectives of the proposal cannot be sufficiently achieved by the Member 
States for the following reason(s). 

Action by Member States only could lead to different levels of protection for 
human and animal health and for the environment. Recommendations or self-
regulations  would  not  guarantee  a  sufficient  level  of  protection  of  human 
health or the environment. 

It  could  also  risk  creating  additional  burden  to  industry  when  different 
requirements would apply. Competition conditions between farmers would be 
unequal if availability of plant protection products is very diverse. 

Community  action  will  better  achieve  the  objectives  of  the  proposal  for  the 
following reason(s): 

Only  Community  action  can  lead  to  improvement  of  the  completion  of  the 
internal market for plant protection products. 

The large difference in authorisation of existing active substances shows that 
without  further  harmonisation  the  protection  levels  in  Member  States  may 
vary a lot. 

A  positive  list  of  about  500  active  substances  needs  to  be  managed.  This 
requires a harmonised and centralised approach. 

The proposal therefore complies with the subsidiary principle. 

(d) 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the  following 
reason: 

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331 

The proposal fully harmonizes the approval of active substances but leaves it 
to  Member  States  to  authorise  plant  protection  products  taking  into  account 
harmonised criteria and national conditions.  

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332 

The administrative and financial burden is reduced because of: 

– 

– 

the  provision  of  strict  deadlines  for  decisions  at  all  levels,  thus 
increasing predictability and improving access to the market 

increased worksharing at Member State level for assessing applications 
for authorisation. 

341 

342 

(e) 

Choice of instruments 

Proposed instruments: Regulation. 

Other means would not be adequate for the following reason: 

The  instrument  of  a  Regulation  is  justified  because  it  ensures  that  the 
provisions  are  implemented  at  the  same  time  and  in  the  same  way  in  all  25 
Member  States,  reducing  as  well  administrative  burden  and  ensuring  clarity 
for the economic actors. 

4)  BUDGETARY IMPLICATION 

401 

The Community may make a financial contribution up to 100% to the establishment of 
a harmonised policy and system. 

The appropriations required for the above measures shall be authorised each financial 
year as part of the budgetary procedure. 

DG SANCO shall recruit 2 staff for the implementation of the control measures. 

5)  ADDITIONAL INFORMATION 

520 

(a) 

Simplification 

The  recast  and  replacement  of  Directive  91/414/EEC  by  a  Regulation  was 
foreseen  in  the  Simplification  Rolling  Programme  of  the  Communication  of 
the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  - 
Implementing  the  Community  Lisbon  programme  -  A  strategy  for  the 
simplification of the regulatory environment [COM(2005) 535]. 

The  proposal  fully  implements  the  objectives  of  clarifying  and  improving 
legibility of legislation and reducing administrative costs.  

Replacing Directive 91/414/EEC by a Regulation brings clear benefits for the 
Member  States,  which  will  no  longer  have  to  transpose  approval  of 
substances  into  national  legislation.  Stakeholders  will  also  benefit  from 
clearer  criteria  in  the  legislation  and  the  fact  that  the  Regulation  will 
significantly  shorten  the  approval  time  for  active  substances  by  providing 
strict deadlines within which the process must be completed. 

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Administrative  procedures  for  authorisation  of  plant  protection  products  are 
simplified. The impact of the new mutual recognition rules applicable to the 
three  zones  is  positive  for  public  authorities  leading  to  better  streamlining, 
increased  efficiency  and  faster  administrative  procedures.  The  new  rules  on 
data  protection  are  clear  and  reduce  the  administrative  burden  for  industry 
and public authorities.  

For  industry,  obligatory  zonal  mutual  recognition  will  bring  benefits  of 
to  grant 
administative  and  procedural  simplification.  The  deadlines 
authorisations are much shorter. 

Farmers  will  obtain  a  quicker  and  more  harmonised  availability  of  plant 
protection products. 

The  proposal  is  included  in  the  Commission's  Work  and  Legislative 
Programme under the reference 2003/SANCO/61. 

520 

(b) 

Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of existing legislation. 

560 

(c) 

European Economic Area 

The proposed act concerns an EEA matter and should therefore extend to the 
European Economic Area. 

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2006/0136 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

concerning the placing of plant protection products on the market 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Articles 37(2) and 152(4)(b) thereof, 

Having regard to the proposal from the Commission, 

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 procedure laid down in Article 251 of the Treaty, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

1 
2 
3 

Council  Directive  91/414/EEC  of  15  July  1991  concerning  the  placing  of  plant 
protection  products  on  the  market1  provides  for  rules  governing  plant  protection 
products and the active substances contained in those products. 

In  their  conclusions  on  the  progress  report2  presented  by  the  Commission  under 
Directive  91/414/EEC,  the  European  Parliament  and  the  Council  asked  the 
Commission  to  review  the  Directive  and  identified  a  number  of  issues  for  the 
Commission to address. 

In the light of the experience gained from the application of Directive 91/414/EEC and 
of  recent  scientific  and  technical  developments,  Directive  91/414/EEC  should  be 
replaced. 

By  way  of  simplification,  the  new  act  should  also  repeal  Council  Directive 
79/117/EEC  of  21  December  1978  prohibiting  the  placing  on  the  market  and  use  of 
plant protection products containing certain active substances3. 

To  simplify  application  of  the  new  act  and  to  ensure  consistency  throughout  the 
Member States, it should take the form of a Regulation. 

OJ L 230, 19.8.19991, p. 1. Directive as last amended by … 
COM(2001) 444. 
OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (EC) No 850/2004 of the European 
Parliament and the Council (OJ L 158, 30.4.2005, p. 7, corrected version in OJ L 229, 29.6.2004, p. 5). 

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(6) 

(7) 

(8) 

(9) 

(10) 

Plant  production  has  a  very  important  place  in  the  Community.  One  of  the  most 
important  ways  of  protecting  plants  and  plant  products  against  harmful  organisms, 
including  weeds,  and  of  improving  agricultural  production  is  the  use  of  plant 
protection products. 

Plant  protection  products  can  also  have  non-beneficial  effects  on  plant  production. 
Their  use  may  involve  risks  and  hazards  for  humans,  animals  and  the  environment, 
especially if placed on the market without having been officially tested and authorised 
and if incorrectly used. Therefore, harmonised rules should be adopted on the placing 
on the market of plant protection products. 

The purpose of this Regulation is to ensure a high level of protection of both human 
and  animal  health  and  the  environment.  Particular  attention  should  be  paid  to  the 
protection of vulnerable groups of the population, including pregnant women, infants 
and  children.  The  precautionary  principle  should  be  applied  and  ensure that  industry 
demonstrates  that  substances  or  products  produced  or  placed  on  the  market  do  not 
adversely affect human health or the environment. 

Substances  should  only  be  included  in  plant  protection  products  where  it  has  been 
demonstrated  that  they  present  a  clear  benefit  for  plant  production  and  they  are  not 
expected to have any harmful effect on human or animal health or any unacceptable 
influence  on  the  environment.  In  order  to  achieve  the  same  level  of  protection  in  all 
Member States, the decision on acceptability or non-acceptability of such substances 
should be taken at Community level. 

In the interest of predictability, efficiency and consistency, a detailed procedure should 
be  laid  down  for  assessing  whether  an  active  substance  can  be  approved.  The 
information  to  be  submitted  by  interested  parties  for  the  purposes  of  approval  of  a 
substance  should  be  specified.  In  view  of  the  amount  of  work  connected  with  the 
approval  procedure,  it  is  appropriate  that  the  evaluation  of  such  information  be 
performed  by  a  Member  State  acting  as  a  rapporteur  for  the  Community.  To  ensure 
consistency in evaluation, an independent scientific review should be performed by the 
European  Food  Safety  Authority  established  by  Article  22  of  Regulation  (EC)  No 
178/2002 of the European Parliament and 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  safety4  (hereinafter 
referred to as ‘the Authority’). It should be clarified that the Authority performs a risk 
assessment whilst the Commission should perform the risk management and take the 
ultimate  decision  on  an  active  substance.  Provisions  should  be  included  to  ensure 
transparency of the evaluation process.  

(11)  For ethical reasons, the assessment of an active substance or a plant protection product 
should not be based on tests or studies involving the deliberate administration of the 
active  substance  or  plant  protection  product  to  humans  with  the  purpose  of 
determining  a  human  No  Observed  Effect  Level  of  an  active  substance.  Similarly, 
toxicological  studies  carried  out  on  humans  should  not  be  used  to  lower  the  safety 
margins for active substances or plant protection products.  

4 

OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  amended  by  Regulation  (EC)  No  1642/2003  (OJ  L  245, 
29.9.2003, p. 4). 

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(12)  To speed up the approval of active substances, strict deadlines should be established 

for the different procedural steps. 

(13) 

In the interest of safety, the approval period for active substances should be limited in 
time. The approval period should be proportional to the possible risks inherent in the 
use  of  such  substances.  Experience  gained  from  the  actual  use  of  plant  protection 
products  containing  the  substances  concerned  and  any  developments  in  science  and 
technology should be taken into account when any decision regarding the renewal of 
an approval is taken. After the first renewal, such substances should only be reviewed 
further  where  there  are  indications  that  they  no  longer  meet  the  requirements  of  this 
Regulation. 

(14)  The  possibility  of  amending  or  withdrawing  the  approval  of  an  active  substance  in 

cases where the criteria for approval are no longer satisfied should be provided for. 

(15)  The evaluation of an active substance may reveal that it presents considerably less of a 
risk than other substances. In order to favour the inclusion of such a substance in plant 
protection  products,  it  is  appropriate  to  identify  such  substances  and  to  facilitate  the 
placing on the market of plant protection products containing them. 

(16)  Certain  substances  which  are  not  predominantly  used  as  a  plant  protection  product 
may  be  of  value  for  plant  protection,  but  the  economic  interest  of  applying  for 
approval  may  be  limited.  Therefore,  specific  provisions  should  ensure  that  such 
substances,  as  far  as  their  risks  are  acceptable,  may  also  be  approved  for  plant 
protection use. 

(17)  Some  active  substances  may  only  be  acceptable  when  extensive  risk  mitigation 
measures  are  taken.  Such  substances  should  be  identified  at  Community  level. 
Member  States  should  regularly  re-examine  whether  plant  protection  products 
containing  such  active  substances  can  be  replaced  by  plant  protection  products 
containing active substances which require less risk mitigation. 

(18) 

In  addition  to  active  substances,  plant  protection  products  may  contain  safeners  or 
synergists  for  which  similar  rules  should  be  provided.  The  technical  rules  necessary 
for the  review of  such  substances  should be established. Substances currently on  the 
market should only be reviewed after those provisions have been established. 

(19)  Plant protection products may also contain co-formulants. It is appropriate to provide a 
list of co-formulants which should not be included in plant protection products. 

(20)  Plant  protection  products  containing  active  substances  can  be  formulated  in  many 
ways  and  used  on  a  variety  of  crops,  under  different  agricultural,  ecological  and 
climatic  conditions.  Authorisations  for  plant  protection  products  should  therefore  be 
granted by Member States. 

(21)  The provisions governing authorisation must ensure a high standard of protection. In 
particular, when granting authorisations of plant protection products, the objective of 
protecting human or animal health and the environment should take priority over the 
objective of improving plant production. Therefore, it should be demonstrated, before 
plant protection products are placed on the market, that they present a clear benefit for 

EN 

15 

   EN 

 
plant production and do not have any harmful effect on human or animal health or any 
unacceptable influence on the environment. 

(22) 

In  the  interest  of  predictability,  efficiency  and  consistency,  criteria,  procedures  and 
conditions  for  the  authorisation  of  plant  protection  products  should  be  harmonised, 
account being taken of the general principles of protection of human and animal health 
and the environment. 

(23)  The  active  substances  contained  in  a  plant  protection  product  can  be  produced  by 
different  manufacturing  processes,  leading  to  differences  in  specifications.  Such 
differences  may  have  safety  implications.  For  efficiency  reasons,  a  harmonised 
procedure  at  Community  level  should  be  provided  for  the  assessment  of  those 
differences. 

(24)  To avoid any duplication of work, to reduce the administrative burden for industry and 
for  Member  States  and  to  ensure  more  harmonised  availability  of  plant  protection 
products,  authorisations  granted  by  one  Member  State  should  be  accepted  by  other 
Member  States  where  ecological  and  climatic  conditions  are  comparable.  Therefore, 
the  European  Union  should  be  divided  in  authorisation  zones  with  comparable 
conditions in order to facilitate such mutual recognition. 

(25)  The  economic  interest  for  industry  to  apply  for  an  authorisation  is  limited  in  certain 
uses.  In  order  to  ensure  that  diversification  of  agriculture  and  horticulture  is  not 
jeopardised  by  the  lack  of  availability  of  plant  protection  products,  specific  rules 
should be established for minor uses. 

(26) 

In exceptional cases, Member States should be permitted to authorise plant protection 
products not complying with the conditions provided for in this Regulation, where it is 
necessary to do so because of a danger or threat to plant production which cannot be 
contained by any other means. Such authorisations should be reviewed at Community 
level. 

(27)  To promote innovation, special rules should be established permitting the use of plant 
protection products in experiments even where they have not yet been authorised. 

(28) 

In  order  to  ensure  a  high  level  of  protection  of  human  health  and  the  environment, 
plant  protection  products  should  be  used  properly  having  regard  to  the  principles  of 
integrated  pest  management.  The  Council  shall  include  in  the  statutory  management 
requirement referred to in Annex III of Regulation (EC) No 1782/2003 the principles 
of  integrated  pest  management,  including  good  plant  protection  practice  and  good 
environmental  practice.  A  transitional  period  should  therefore  be  foreseen  to  allow 
Member  States  to  put  in  place  the  necessary  structures  to  enable  users  of  plant 
protection products to apply the principles of integrated pest management. 

(29)  A  system  of  exchange  of  information  should  be  established.  Member  States  should 
make  available  to  each  other,  the  Authority  and  the  Commission  the  particulars  and 
scientific documentation submitted in connection with applications for authorisation of 
plant protection products. 

EN 

16 

   EN 

 
(30)  Adjuvants  may  be  used  to  increase  the  efficacy  of  a  plant  protection  product.  Their 
placing on the market or use should be forbidden where they contain a co-formulant 
which has been prohibited.  

(31)  Studies represent a major investment. This investment should be protected in order to 
stimulate  research.  For  this  reason,  studies  lodged  by  one  applicant  with  a  Member 
State  should  be  protected  against  use  by  another  applicant.  This  protection  should, 
however, be limited in time in order to allow competition. It should also be limited to 
studies  which  are  genuinely  necessary  for  regulatory  purposes,  to  avoid  applicants 
artificially extending the period of protection by submitting new studies which are not 
necessary.  

(32)  Rules  should  be  laid  down  to  avoid  duplication  of  tests  and  studies.  In  particular, 
repetition of studies involving vertebrates should be prohibited. In this context, there 
should be an obligation to allow access to studies on vertebrates on reasonable terms. 
In  order  to  allow  operators  to  know  what  studies  have  been  carried  out  by  others, 
Member States should keep a list of such studies even where they are not covered by 
the above system of compulsory access.  

(33)  As different rules are applied by Member States, the Authority or the Commission in 
relation  to  access  to  and  confidentiality  of  documents,  it  is  appropriate  to  clarify  the 
provisions  concerning  access  to  information  contained  in  the  documents  in  the 
possession of these authorities and the confidentiality of these documents.  

(34)  Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 
concerning the approximation of the laws, regulations and administrative provisions of 
the Member States relating to the classification, packaging and labelling of dangerous 
preparations5  applies  to  the  classification,  packaging  and  labelling  of  pesticides. 
However,  to  further  improve  the  protection  of  users  of  plant  protection  products,  of 
consumers of plants and plant products and of the environment, further specific rules 
are appropriate which take account of the specific conditions of use of plant protection 
products. 

(35)  To ensure that advertisements do not mislead users of plant protection products, it is 

appropriate to provide rules on the advertising of those products. 

(36)  Provisions  on  record  keeping  and  information  about  the  use  of  plant  protection 
products should be established in order to raise the level of protection of human and 
animal health and the environment by ensuring the traceability of potential exposure, 
to  increase  the  efficiency  of  monitoring  and  control  and  to  reduce  the  costs  of 
monitoring water quality. 

(37)  Provisions  on  control  and  inspection  arrangements  with  regard  to  the  marketing  and 
use  of  plant  protection  products  should  ensure  correct,  safe  and  harmonised 
implementation of the requirements laid down in this Regulation in order to achieve a 
high level of protection of both human and animal health and the environment. 

5 

OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission Directive 2006/8/EC (OJ L 19, 
24.1.2006, p. 12). 

EN 

17 

   EN 

 
                                                 
(38)  Regulation  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council  of  29 
April 2004 on official controls performed to ensure the verification of compliance with 
feed  and  food  law,  animal  health  and  animal  welfare  rules6  provides  for  control 
measures  for  the  use  of  plant  protection  products  at  all  stages  of  the  production  of 
food,  including  record  keeping  on  the  use  of  plant  protection  products.  Similar  rules 
should  apply  to  the  storage  and  use  of  plant  protection  products  not  covered  by 
Regulation (EC) No 882/2004. 

(39)  Close coordination should be ensured with other Community legislation, in particular 
Regulation  (EC)  No  396/2005  of  the  European  Parliament  and  of  the  Council  of  23 
February  2005  on  maximum  residues  levels  of  pesticides  in  or  on  food  and  feed  of 
plant  and  animal  origin  and  amending  Council  Directive  91/414/EEC7,  and 
Community  legislation  on  the  protection  of  workers  and  anyone  concerned  with  the 
contained use and deliberate release of genetically modified organisms. 

(40) 

It  is  necessary  to  establish  procedures  for  the  adoption  of  emergency  measures  in 
situations  where  an  approved  active  substance,  a  safener,  a  synergist  or  a  plant 
protection product is likely to constitute a serious risk to human or animal health or the 
environment. 

(41)  Member States should lay down rules on penalties applicable to infringements of this 
Regulation  and  should  take  the  measures  necessary  to  ensure  that  they  are 
implemented.  

(42)  General  civil  and  criminal  liability  in  the  Member  States  of  the  manufacturer  and, 
where applicable, of the person responsible for placing the plant protection product on 
the market or using it should remain applicable. 

(43)  Member  States  should  have  the  possibility  of  recovering  the  costs  of  the  procedures 
associated  with  the  application  of  the  Regulation  from  those  seeking  to  place,  or 
placing,  plant  protection  products  on  the  market  and  from  those  applying  for  the 
approval of active substances, safeners or synergists. 

(44)  Member States should designate the necessary national authorities. 

(45)  The  Commission  should  facilitate  the  application  of  this  Regulation.  Therefore,  it  is 
appropriate  to  provide  for  the  necessary  financial  resources  and  the  possibility  of 
amending  certain  provisions  of  the  Regulation  in  the  light  of  experience  or  of 
developing technical notes for guidance. 

(46)  The measures necessary for the implementation of this Regulation should be adopted 
in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the 
procedures for the exercise of implementing powers conferred on the Commission8. It 
is  appropriate  to  adopt  purely  technical,  administrative  or  urgent  measures  using  the 
advisory committee procedure. 

6 
7 
8 

OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004, p. 1. 
OJ L 70, 16.3.2005, p. 1. 
OJ L 184, 17.7.1999, p. 23. 

EN 

18 

   EN 

 
                                                 
(47)  Certain  provisions  of  Directive  91/414/EEC  should  remain  applicable  during  the 

transitional period,  

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
GENERAL PROVISIONS 

Article 1 
Subject matter 

This  Regulation  lays  down  rules  for  the  authorisation  of  plant  protection  products  in 
commercial form and for their placing on the market, use and control within the Community. 

This  Regulation  lays  down  both  rules  for  the  approval  of  active  substances,  safeners  and 
synergists, which plant protection products contain or consist of, and rules for adjuvants and 
co-formulants. 

Article 2 
Scope 

1. 

This Regulation shall apply to products, in the form in which they are supplied to the 
user,  consisting  of  or  containing  active  substances,  safeners  or  synergists,  and 
intended for one of the following uses: 

(a) 

(b) 

(c) 

protecting plants or plant products against all harmful organisms or preventing 
the  action  of  such  organisms,  unless  the  main  purpose  of  these  products  is 
considered to be for hygiene reasons rather than for the protection of plants or 
plant products; 

influencing  the  life  processes  of  plants,  such  as  substances  influencing  their 
growth, other than as a nutrient; 

preserving  plant  products,  insofar  as  such  substances  or  products  are  not 
subject to special Community provisions on preservatives; 

(d)  destroying undesired plants or parts of plants, except algae; 

(e) 

checking or preventing undesired growth of plants, except algae. 

These products are referred to hereinafter as ‘plant protection products’. 

2. 

This  Regulation  shall  apply  to  substances,  including  micro-organisms  and  viruses, 
having  general  or  specific  action  against  harmful  organisms  or  on  plants,  parts  of 
plants or plant products, hereinafter ’active substances’. 

3. 

This Regulation shall apply to the following: 

EN 

19 

   EN 

 
(a) 

(b) 

(c) 

(d) 

substances  or  preparations  which  are  added  to  a  plant  protection  product  to 
eliminate  or  reduce  phytotoxic  effects  of  the  preparation  on  certain  plants, 
hereinafter ‘safeners’; 

substances  or  preparations  which,  while  showing  no  or  only  weak  activity  in 
the sense of paragraph 1, can give enhanced activity to the active substance(s) 
in a plant protection product, hereinafter ‘synergists’;  

substances  or  preparations  which  are  used  or  intended  to  be  used  in  a  plant 
protection product or adjuvant, but are neither active substances nor safeners or 
synergists, hereinafter ‘co-formulants’; 

substances  or  preparations  which  consist  of  co-formulants  or  preparations 
containing one or more co-formulants, in the form in which they are supplied 
to  the  user  and  placed  on  the  market  to  be  mixed  by  the  user  with  a  plant 
protection  product  for  the  purpose  of  changing  its  properties  or  effects, 
hereinafter ‘adjuvants’. 

Article 3 
Definitions 

For the purposes of this Regulation, the following definitions shall apply: 

(1) 

'residues' 

One  or  more  substances  present  in  or  on  plants  or  products  of  plant  origin,  edible 
animal  products  or  elsewhere  in  the  environment  and  resulting  from  the  use  of  a 
plant  protection  product,  including  their  metabolites,  breakdown  or  reaction 
products; 

(2) 

'substances' 

Chemical elements and their compounds, as they occur naturally or by manufacture, 
including any impurity inevitably resulting from the manufacturing process; 

(3) 

'preparations' 

Mixtures composed of two or more substances intended for use as a plant protection 
product or as an adjuvant; 

(4) 

'substance of concern' 

Any substance which has an inherent capacity to cause an adverse effect on humans, 
animals  or  the  environment  and  is  present  or  is  produced  in  a  plant  protection 
product in sufficient concentration to present risks of such an effect. 

Such substances include, but are not limited to, substances classified as dangerous in 
accordance with Directive 67/548/EEC9, and present in the plant protection product 

9 

OJ 196, 16.8.1967, p. 1. 

EN 

20 

   EN 

 
                                                 
at  a  concentration  leading  the  product  to  be  regarded  as  dangerous  within  the 
meaning of Article 3 of Directive 1999/45/EC; 

EN 

21 

   EN 

 
(5) 

'plants' 

Live plants and live parts of plants, including fresh fruit, vegetables and seeds; 

(6) 

'plant products' 

Products in unprocessed state or having undergone only simple preparation, such as 
milling,  drying  or  pressing,  derived  from  plants,  but  excluding  plants  as  defined  in 
point (5);  

(7) 

'harmful organisms' 

Any  species,  strain  or  biotype  belonging  to  the  animal  or  plant  kingdom  or 
pathogenic agent injurious to plants or plant products; 

(8) 

'animals' 

Animals  belonging  to  species  normally  domesticated,  fed,  kept  or  consumed  by 
humans; 

(9) 

'placing on the market' 

The  holding  of  a  plant  protection  product  for  the  purpose  of  sale  within  the 
Community, including offering for sale or any other form of transfer, whether free of 
charge  or  not,  and  the  sale,  distribution,  and  other  forms  of  transfer  themselves. 
Release  for  free  circulation  of  a  plant  protection  product  into  the  territory  of  the 
Community shall be deemed to constitute placing on the market for the purposes of 
this Regulation; 

(10) 

'authorisation of a plant protection product' 

Administrative  act  by  which  the  competent  authority  of  a  Member  State  authorises 
the placing on the market of a plant protection product in its territory; 

(11) 

'producer' 

A  person  who  manufactures  active  substances,  safeners,  synergists,  co-formulants, 
plant  protection  products  or  adjuvants  on  his  own,  or  who  contracts  this 
manufacturing  to  another  party,  or  a  person  designated  by  the  manufacturer  as  his 
sole representative for the purpose of compliance with this Regulation; 

(12) 

'letter of access' 

A document by which the owner of data protected under this Regulation agrees to the 
use  of  such  data  by  the  competent  authority  for  the  purpose  of  granting  an 
authorisation  of  a  plant  protection  product  or  an  approval  of  an  active  substance, 
synergist or safener for the benefit of another person; 

EN 

22 

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(13) 

'environment' 

Waters  (including  ground,  surface,  transitional  and  coastal),  soil,  air,  land,  wild 
species  of  fauna  and  flora,  and  any  interrelationship  between  them,  and  any 
relationship with other living organisms; 

(14) 

'integrated pest management' 

Careful  consideration  of  all  available  pest  control  techniques  and  subsequent 
integration  of  appropriate  measures  that  discourage  the  development  of  pest 
populations  and  keep  plant  protection  products  and  other  forms  of  intervention  to 
levels that are economically justified and reduce or minimise risks to human health 
and  the  environment.  Integrated  pest  management  emphasises  the  growth  of  a 
healthy  crop  with  the  least  possible  disruption  to  agro-ecosystems  and  encourages 
natural pest control mechanisms; 

(15) 

'micro-organisms' 

Any  microbiological  entity,  including  lower  fungi  and  viruses,  cellular  or  non-
cellular, capable of replication or of transferring genetic material; 

(16) 

'genetically modified micro-organisms' 

Micro-organisms in which the genetic material has been altered within the meaning 
of  Article  2(2)  of  Directive  2001/18/EC  of  the  European  Parliament  and  of  the 
Council10; 

(17) 

'zone' 

Group  of  Member  States,  as  defined  in  Annex  I,  for  which  it  is  assumed  that  the 
agricultural,  plant  health  and  environmental  (including  climatic)  conditions  are 
relatively similar; 

(18) 

'Good Plant Protection Practice' 

Practice  whereby  the  treatments  with  plant  protection  products  applied  to  a  given 
crop, in conformity with the conditions of their authorised uses, are selected, dosed 
and timed to ensure optimum efficacy with the minimum quantity necessary, taking 
due  account  of  local  conditions  and  of  the  possibilities  for  cultural  and  biological 
control; 

(19) 

'Good Environmental Practice' 

Practice  in  plant  protection  which  includes  the  handling  and  application  of  plant 
protection  products  in  a  way  which  only  contaminates  the  environment  with  the 
smallest amount practicable; 

10 

OJ L 106, 17.4.2001, p. 1. 

EN 

23 

   EN 

 
                                                 
(20) 

'Good Laboratory Practice' 

Practice as defined by Directive 2004/10/EC11; 

(21) 

'Data protection' 

A test or study report is covered by data protection where its owner has the right to 
prevent it being used for the benefit of another person.  

CHAPTER II 
Active substances, safeners, synergists and co-formulants 

SECTION 1 
ACTIVE SUBSTANCES  

SUBSECTION 1 
REQUIREMENTS AND CONDITIONS FOR APPROVAL 

Article 4 
Approval criteria for active substances 

1. 

2. 

An  active  substance  shall  be  approved  in  accordance  with  Annex  II,  if  it  may  be 
expected, in the light of current scientific and technical knowledge, that, taking into 
account the approval criteria set out in points 2 and 3 of that Annex, plant protection 
products  containing  that  active  substance  will  fulfil  the  conditions  provided  for  in 
paragraphs 2 and 3. 

The  residues  of  the  plant  protection  products,  consequent  on  application  consistent 
with good plant protection practice, shall meet the following requirements:  

(a) 

they shall not have any harmful effects on human health, including vulnerable 
groups, or animal health, taking into account known cumulative and synergistic 
effects  when  the  methods  to  assess  such  effects  are  available,  or  on  ground 
water;  

(b) 

they shall not have any unacceptable effect on the environment; 

(c) 

for  residues  which  are  of  toxicological  or  environmental  significance,  there 
shall be methods in general use for measuring them. 

3. 

The use of the plant protection products, consequent on  application consistent with 
good  plant  protection  practice  and  having  regard  to  normal  conditions  of  use,  shall 
meet the following requirements: 

11 

OJ L 50, 20.2.2004, p. 44. 

EN 

24 

   EN 

 
                                                 
(a) 

it shall be sufficiently effective; 

(b) 

it  shall  have  no  immediate  or  delayed  harmful  effect  on  human  or  animal 
health, directly or through drinking water, food, feed or air, or consequences in 
the  workplace  or  through  other  indirect  effects,  taking  into  account  known 
cumulative and synergistic effects where the methods to assess such effects are 
available; or on groundwater;  

(c) 

it shall not have any unacceptable effects on plants or plant products; 

(d) 

it shall not cause unnecessary suffering and pain to vertebrates to be controlled;  

(e) 

it  shall  have  no  unacceptable  effects  on  the  environment,  having  particular 
regard to the following considerations: 

(i) 

its fate and distribution in the environment, particularly contamination of 
surface  waters,  including  estuarine  and  coastal  waters,  drinking  water, 
groundwater, air and soil; 

(ii) 

its impact on non-target species; 

(iii) 

its impact on biodiversity. 

4. 

5. 

For  approval  of  an  active  substance,  paragraphs  1,  2  and  3  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.  

In relation to human health, no data collected on humans shall be used to lower the 
safety margins resulting from tests or studies on animals. 

Article 5 
First approval 

First approval shall be for a period not exceeding ten years. 

Article 6  
Conditions and restrictions 

Approval may be subject to conditions and restrictions including:  

(a) 

(b) 

(c) 

(d) 

(e) 

the minimum degree of purity of the active substance; 

the nature and maximum content of certain impurities; 

restrictions  arising  from  the  evaluation  of  the  information  referred  to  in  Article  8 
taking account of the agricultural, plant health and environmental, including climatic, 
conditions in question; 

type of preparation; 

manner of application; 

EN 

25 

   EN 

 
(f) 

(g) 

(h) 

(i) 

(j) 

1. 

2. 

3. 

submission  of  further  confirmatory  information  to  Member  States  and  to  the 
European  Food  Safety  Authority,  hereinafter  ‘the  Authority’,  where  new 
requirements  are  established  during  the  evaluation  process  as  a  result  of  new 
scientific and technical knowledge; 

designation of categories of users, such as professional and non-professional; 

designation of places where plant protection products containing the active substance 
may be authorised according to specific conditions; 

the need to impose risk mitigation measures and monitoring after use;  

any  other  particular  conditions  that  result  from  the  evaluation  of  information  made 
available in the context of this Regulation. 

SUBSECTION 2 
APPROVAL PROCEDURE 

Article 7 
Application  

An  application  for  the  approval  of  an  active  substance  or  for  an  amendment  to  the 
conditions of an approval shall be submitted by the producer of the active substance 
to  a  Member  State  (hereinafter  referred  to  as  ‘rapporteur  Member  State’)  together 
with a complete and a summary dossier, as provided for in Article 8(1) and (2), or a 
letter  of  access  to  such  dossiers  or  a  scientifically  reasoned  justification  for  not 
providing  certain  parts  of  those  dossiers,  demonstrating  that  the  active  substance 
fulfils the approval criteria provided for in Article 4. 

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

Within 14 days of receiving the application, the rapporteur Member State shall send 
the applicant a written acknowledgement, stating the date of receipt. 

When submitting his application, the applicant may, pursuant to Article 60, request 
certain  parts  of  the  dossiers  referred  to  in  paragraph  1  to  be  kept  confidential.  He 
shall explain for each document or each part of a document why it is to be considered 
as confidential. 

He  shall  at  the  same  time  submit  any  claims  for  data  protection  pursuant  to 
Article 56. 

After giving the applicant the possibility to submit comments on the decision it plans 
to  adopt,  the  rapporteur  Member  State  shall  decide  what  information  is  to  be  kept 
confidential. It shall inform the applicant and the Authority of its decision. 

EN 

26 

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1. 

The summary dossier shall include the following:  

Article 8 
Dossiers 

(a)  Data with respect to one or more representative uses on a widely grown crop in 
each  zone  of  at  least  one  plant  protection  product  containing  the  active 
substance, demonstrating that the requirements of Article 4 are met; where the 
data  submitted  do  not  cover  all  zones  or  concern  a  crop  which  is  not  widely 
grown, justification for this approach;  

(b) 

(c) 

(d) 

(e) 

for each point of the data  requirements for the active substance referred to in 
Article  75(1)(b),  the  summaries  and  results  of  tests  and  studies,  the  name  of 
their  owner  and  of  the  person  or  institute  that  has  carried  out  the  tests  and 
studies;  

for each point of the data requirements for the plant protection product referred 
to in Article 75(1)(b), the summaries and results of tests and studies, the name 
of  their  owner  and  of  the  person  or  institute  that  carried  out  the  tests  and 
studies, relevant to the assessment of the criteria referred to in Article 4 for one 
or more plant protection products which are representative of the uses referred 
to  in  point  (a),  taking  into  account  the  fact  that  data  gaps  in  the  dossier,  as 
provided  for  in  paragraph  2,  resulting  from  the  proposed  limited  range  of 
representative  uses  of  the  active  substance,  may  lead  to  restrictions  in  the 
approval; 

a  checklist  demonstrating  that  the  dossier  provided  for  in  paragraph  2  is 
complete; 

the  reasons  why  the  test  and  study  reports  submitted  are  necessary  for  first 
approval  of  the  active  substance  or  for  amendments  to  the  conditions  of  the 
approval; 

(f) 

an assessment of all information submitted. 

2. 

3. 

The  complete  dossier  shall  contain  the  full  text  of  the  individual  test  and  study 
reports concerning all the information referred to in points (b) and (c) of paragraph 1. 
It  shall  not  contain  any  reports  of  tests  or  studies  involving  the  deliberate 
administration of the active substance or the plant protection product to humans.  

The format of the summary dossier and the complete dossier shall be established in 
accordance with the procedure referred to in Article 76(2).  

The  data  requirements  referred  to  in  Article  8(1)  shall  be  defined  in  Regulations 
adopted in accordance with the procedure referred to in Article 76(2), incorporating 
the  requirements  for  active  substances  and  plant  protection  products  in  Annexes  II 
and  III  to  Directive  91/414/EEC  with  any  necessary  modifications.  Similar  data 
requirements  shall  be  defined  for  safeners  and  synergists  in  accordance  with  the 
procedure referred to in Article 76(3). 

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Article 9 
Admissibility of the application  

1. 

2. 

3. 

Within 30 days of receiving the application, the rapporteur Member State shall check 
whether the dossiers submitted with the application contain all the elements provided 
for in Article 8, using the checklist referred to in Article 8(1)(d).  

Where  one  or  more  of  the  elements  provided  for  in  Article  8  are  missing,  the 
Member State shall inform the applicant, setting a time period for their submission.  

Where  at  the  end  of  that  period,  the  applicant  has  not  submitted  the  missing 
elements, the rapporteur Member State shall inform the applicant that the application 
is inadmissible. 

A new application for the same substance may be submitted at any time. 

Where the dossiers submitted with the application contain all the elements provided 
for  in  Article  8,  the  rapporteur  Member  State  shall  notify  the  applicant,  the 
Commission, the other Member States and the Authority of the admissibility of the 
application and start assessing the active substance.  

After  receiving  that  notification,  the  applicant  shall  immediately  forward  the 
summary dossier and the complete dossier to the other Member States, the Authority 
and the Commission. 

Article 10 
Access to the summary dossier  

The  Authority  shall  without  delay  make  the  summary  dossier  referred  to  in  Article  8(1) 
available to the public, excluding any information which is confidential under Article 60.  

Article 11 
Draft assessment report 

1. 

Within  twelve  months  of  the  date  of  the  notification  provided  for  in  the  first 
subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit 
to  the  Authority  a  report  (hereafter  called  “draft  assessment  report”)  assessing 
whether the active substance can be expected to meet the requirements of Article 4. 

Where the Member State needs additional information, it shall set a time period for 
the applicant to supply it. In that case, the twelve-months period shall be extended by 
the  additional  time  period  granted  by  the  Member  State.  It  shall  inform  the 
Commission and the Authority.  

The Member State may consult the Authority. 

2. 

The format of the draft assessment report shall be established in accordance with the 
procedure referred to in Article 76(2). 

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Article 12 
Conclusion by the Authority 

1. 

The Authority shall circulate the draft assessment report received from the rapporteur 
Member State to the applicant, the other Member States and the Commission.  

It  shall  make  it  available  to  the  public,  after  giving  the  applicant  two  weeks  to 
request,  pursuant  to  Article  60,  that  certain  parts  of  the  draft  assessment  report  be 
kept confidential.  

The  Authority  shall  allow  a  period  of  ninety  days  for  the  submission  of  written 
comments.  

Where appropriate, the Authority shall organise a consultation of experts, including 
experts from the rapporteur Member State. 

The  Authority  shall  adopt  a  conclusion  on  whether  the  active  substance  can  be 
expected to meet the requirements of Article 4 within ninety days of the end of the 
period  provided  for  in  paragraph  1  of  this  Article  and  communicate  it  to  the 
applicant, the Member States and the Commission.  

Where  appropriate,  the  Authority  shall  address  in  its  conclusion  the  risk  mitigation 
options identified in the draft assessment report.  

Where the Authority needs additional information, it shall set a time period for the 
applicant to supply it. In that case, the ninety-day period provided for in paragraph 2 
shall be extended by the additional period granted by the Authority. It shall inform 
the Commission and the Member States. 

The  Authority  may  ask  the  Commission  to  consult  a  Community  reference 
laboratory, designated pursuant to Regulation (EC) No 882/2004 for the purposes of 
verifying  whether  the  analytical  method  for  the  determination  of  the  residues 
proposed  by  the  applicant  is  satisfactory  and  meets  the  requirements  of  Article 
29(1)(f)  of  this  Regulation.  The  applicant  shall,  if  requested  by  the  Community 
reference laboratory, provide samples and analytical standards. 

The Authority shall establish the format for its conclusion which shall include details 
on  the  procedure  of  the  evaluation  and  the  properties  of  the  active  substance 
concerned. 

Article 13 
Approval Regulation  

Within six months of receiving the conclusion provided for in Article 12(2) from the 
Authority,  the  Commission  shall  present  a  report,  (herinafter  referred  to  as  “the 
review report”, to the Committee referred to in Article 76(1), taking into account the 
draft  assessment  report  by  the  Rapporteur  Member  State  under  Article  11  and  the 
conclusion of the Authority under Article 12.  

The applicant shall be given the possibility to submit comments on the review report.  

2. 

3. 

4. 

1. 

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2. 

On the basis of the review report provided for in paragraph 1, other factors legitimate 
to  the  matter  under  consideration  and  the  precautionary  principle  where  the 
conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a 
Regulation shall be adopted in accordance with the procedure referred to in Article 
76(3), providing that: 

(a) 

an  active  substance  is  approved,  subject  to  conditions  and  restrictions,  as 
referred to in Article 6, where appropriate; 

(b) 

an active substance is not approved; or 

(c) 

the conditions of the approval are amended. 

3. 

The Commission shall maintain a list of approved active substances. 

SUBSECTION 3 
RENEWAL AND REVIEW 

Article 14 
Renewal of approval 

1. 

On  application  the  approval  of  an  active  substance  shall  be  renewed  where  it  is 
established that the criteria referred to 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 shall be for an unlimited period of time.  

Article 15 
Application for renewal 

1. 

2. 

The  application  provided  for  in  Article  14  shall  be  submitted  by  a  producer  of  the 
active  substance  to  a  Member  State,  with  a  copy  to  the  other  Member  States,  the 
Commission and the Authority, no later than three years before the expiry of the first 
approval. 

When  applying  for  renewal,  the  applicant  shall  identify  new  data  he  intends  to 
submit  and  demonstrate  that  they  are  necessary,  because  of  data  requirements  or 
criteria  which  were  not  applicable  on  first  approval  of  the  active  substance  or 
because his request is for an amended approval. He shall at the same time submit a 
timetable of any new and ongoing studies. 

The  applicant  shall  identify,  giving  reasons,  the  parts  of  the  information  submitted 
that are to be kept confidential in accordance with Article 60.  

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Article 16 
Access to the application for renewal  

The Authority shall, without delay, make available to the public the information provided by 
the  applicant  under  Article  15,  excluding  any  information  declared  confidential  under 
Article 60.  

Article17 
Extension of approval period for the duration of the procedure 

Where for reasons beyond the control of the applicant it appears that the approval is likely to 
expire  before  a  decision  has  been  taken  on  renewal,  a  Regulation  shall  be  adopted  in 
accordance with the procedure referred to in Article 76(3), postponing the expiry for a period 
sufficient to examine the application. In particular, such a Regulation shall be adopted where 
applicants  could  not  give  the  three  years’  notice  required  under  Article  15(1)  because  the 
active  substance  was  included  in  Annex  I  to  Directive  91/414/EEC  for  a  duration  which 
expired less than three years after the date of application of this Regulation. 

The length of that period shall be established on the basis of the following: 

(a) 

(b) 

(c) 

the time needed to provide the information requested;  

the time needed to complete the procedure; 

the need to ensure the establishment of a coherent programme of work, as provided 
for in Article 18. 

Article 18  
Programme of work 

The  Commission  may  establish  a  programme  of  work  grouping  together  similar  active 
substances. This programme may require interested parties to submit all the necessary data to 
the  Commission,  the  Authority  and  the  Member  States  within  a  period  provided  for  in  the 
programme.  

The programme shall include the following: 

(a) 

(b) 

(c) 

(d) 

(e) 

the procedures concerning the submission and assessment of applications for renewal 
of approvals; 

the necessary data to be submitted; 

the time periods for submission of such data; 

rules on the submission of new information; 

rules on requests for confidentiality in accordance with Article 60.  

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Article 19  
Implementing measures 

A Regulation, adopted in accordance with the procedure referred to in Article 76(3), shall set 
out  the  provisions  necessary  for  the  implementation  of  the  renewal  and  review  procedure, 
including,  where  relevant,  the  implementation  of  a  programme  of  work,  as  provided  for  in 
Article 18. 

Article 20 
Renewal Regulation  

1. 

A  Regulation  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 76(3), providing that: 

(a) 

the  approval  of  an  active  substance  is  renewed,  where  appropriate,  subject  to 
conditions and restrictions; or 

(b) 

the approval of an active substance is not renewed. 

2. 

Where the reasons for not renewing the approval permit it, the Regulation referred to 
in  paragraph  1  shall  provide  for  a  grace  period  for  using  up  stocks  of  the  plant 
protection products concerned, which will be such that it does not interfere with the 
normal period of use of the plant protection product. 

Article 21  
Review of approval 

1. 

The Commission may review the approval of an active substance at any time.  

Where it considers that there are indications that the substance no longer satisfies the 
criteria provided for in Article 4, or further information required in accordance with 
point (f) of Article 6 has not been provided, it shall inform  the Member States, the 
Authority  and  the  producer  of  the  active  substance,  setting  a  time  period  for  the 
producer to submit its comments. 

The Commission may 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 request. 

Where  the  Commission  concludes  that  the  criteria  referred  to  in  Article  4  are  no 
longer  satisfied,  or  the  further  information  required  in  accordance  with  point  (f)  of 
Article  6  has  not  been  provided,  a  Regulation  to  withdraw  or  amend  the  approval 
shall be adopted in accordance with the procedure referred to in Article 76(3).  

2. 

3. 

Article 20(2) shall apply. 

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SUBSECTION 4 
DEROGATIONS 

Article 22  
Low risk active substances 

1. 

By way of derogation from Article 5, an active substance complying with the criteria 
provided  for  in  Article  4  shall  be  approved  for  a  period  not  exceeding  15 years, 
where  it  may  be  expected  that  plant  protection  products  containing  that  substance 
will  pose  only  a  low  risk  to  human  and  animal  health  and  the  environment,  as 
provided for in Article 46(1).  

2. 

Article 4(4) and Articles 6 to 21 shall apply. 

Article 23  
Approval criteria for basic substances 

1. 

Basic substances shall be approved in accordance with paragraphs 2 to 6. By way of 
derogation from Article 5, the approval shall be for an unlimited period of time. For 
the purpose of those paragraphs, a basic substance is an active substance which 

(a) 

is not predominantly used as a plant protection product but  

(b)  nevertheless has some use as a plant protection product, either directly or in a 

product consisting of the substance and a simple diluent, 

(c) 

is not a substance of concern, and 

(d) 

is not directly marketed for use as a plant protection product. 

2. 

3. 

By way of derogation from Article 5, a basic substance shall be approved where any 
relevant  evaluations  carried  out  in  accordance  with  other  Community  legislation, 
regulating  the  use  of  that  substance  for  purposes  other  than  as  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. 

An  application  for  the  approval  of  a  basic  substance  shall  be  submitted  by  any 
interested party or by a Member State to the Commission.  

The application shall be accompanied by the following information: 

(a) 

(b) 

any  evaluations  carried  out  in  accordance  with  other  Community  legislation 
regulating the use of the substance; or  

information indicating that the substance has neither an immediate or delayed 
harmful  effect  on  human  or  animal  health  nor  an  unacceptable  effect  on  the 
environment. 

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4. 

5. 

6. 

1. 

The Commission may 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 request. 

Articles 6 and 13 shall apply.  

The Commission may review the approval of a basic substance at any time.  

Where it considers that there are indications that the substance no longer satisfies the 
criteria  provided  for  in  paragraphs  1  and  2  it  shall  inform  the  Member  States,  the 
Authority  and  the  interested  party,  setting  a  time  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 3 months 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 procedure referred to in Article 76(3). Article 20(2) shall apply. 

Article 24 
Approval criteria for candidates for substitution 

By  way  of  derogation  from  Article  5  and  Article  14(2),  an  active  substance 
complying with the criteria provided for in Article 4 shall be approved for a period 
not  exceeding  seven  years,  where  other  already  approved  active  substances  are 
significantly less toxic for consumers or operators or present significantly fewer risks 
for the environment. The assessment shall  take account of the criteria laid down in 
point 4 of Annex II. 

Such a substance is referred to hereinafter as a ‘candidate for substitution’. 

2. 

Article 4(4) and Articles 6 to 21 shall apply.  

SECTION 2 
SAFENERS AND SYNERGISTS 

Article 25 
Approval of safeners and synergists 

1. 

2. 

A safener or synergist shall be approved, where it complies with Article 4.  

Articles 5 to 21 shall apply. 

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Article 26  
Safeners and synergists already on the market 

Within  5  years  of  the  entry  into  force  of  this  Regulation,  a  Regulation  shall  be  adopted  in 
accordance with the procedure referred to in Article 76(3) establishing a programme of work 
for the gradual review of synergists and safeners on the market when that Regulation enters 
into  force.  The  regulation  shall  include  the  establishment  of  data  requirements,  notification, 
evaluation,  assessment  and  decision-making  procedures  It  shall  require  interested  parties  to 
submit all the necessary data to the Commission, the Authority and the Member States within 
a specified time period. 

SECTION 3 
UNACCEPTABLE CO-FORMULANTS 

Article 27 
Prohibition 

1. 

A co-formulant shall be prohibited where it has been established that: 

(a) 

(b) 

its  residues,  consequent  on  application  consistent  with  good  plant  protection 
practice, have a harmful effect on human or animal health or on groundwater or 
an unacceptable effect on the environment; or 

its  use,  consequent  on  application  consistent  with  good  plant  protection 
practice and having regard to realistic normal conditions of use, has a harmful 
effect  on  human  or  animal  health  or  an  unacceptable  effect  on  plants,  plant 
products or the environment. 

2. 

Co-formulants prohibited pursuant to paragraph 1 shall be included in Annex III in 
accordance with the procedure referred to in Article 76(3). 

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CHAPTER III 
Plant protection products 

SECTION 1 
AUTHORISATION 

SUBSECTION 1 
REQUIREMENTS AND CONTENTS 

Article 28 
Authorisation for placing on the market and use 

1. 

2. 

A  plant  protection  product  shall  not  be  placed  on  the  market  or  used  unless  it  has 
been authorised in the Member State concerned in accordance with this Regulation. 

By  way  of  derogation  from  paragraph  1,  no  authorisation  shall  be  required  in  the 
following cases: 

(a) 

use  of  plant  protection  products  containing  exclusively  one  or  more  basic 
substances; 

(b)  placing  on  the  market  and  use  of  plant  protection  products  for  research  or 

development purposes in accordance with Article 51; 

(c) 

production, storage or movement of a plant protection product intended for use 
in  another  Member  State,  provided  that  the  product  is  authorised  in  that 
Member State and that the Member State of production, storage or movement 
has  put  in  place  inspection  requirements  to  ensure  that  the  plant  protection 
product is not used in its territory.  

Article 29 
Requirements 

1. 

A  plant  protection  product  shall  only  be  authorised  where  it  complies  with  the 
following requirements:  

(a) 

its active substances, safeners and synergists have been approved;  

(b)  where its active substance, safener or synergist is produced by a person  or in 
accordance  with  a  manufacturing  process  other  than  that  specified  in  the 
dossier on the basis of which that substance, safener or synergist was approved, 
the  active  substance,  safener  or  synergist  contained  in  the  plant  protection 
product  does  not  deviate  significantly  from  the  specification  included  in  the 
Regulation  approving  that  substance,  safener  or  synergist  and  has  no  more 
harmful  effects  within  the  meaning  of  Article  4(2)  and  (3),  due  to  its 

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impurities, than if it had been produced in accordance with the manufacturing 
process specified in that dossier; 

(c) 

its co-formulants have not been prohibited under Article 27; 

(d) 

(e) 

(f) 

(g) 

(h) 

in the light of current scientific and technical knowledge, it complies with the 
requirements provided for in Article 4(3); 

the  nature  and  quantity  of  its  active  substances,  safeners  and  synergists  and, 
where  appropriate,  any  toxicologically,  ecotoxicologically  or  environmentally 
significant  impurities  and  co-formulants  can  be  determined  by  appropriate 
methods; 

its  residues,  resulting  from  authorised  uses,  and  which  are  of  toxicological, 
ecotoxicological  or  environmental  significance,  can  be  determined  by 
appropriate methods in general use; 

its  physical  and  chemical  properties  have  been  determined  and  deemed 
acceptable for the purposes of the appropriate use and storage of the product; 

for feed and food crops, where appropriate, the maximum residue levels for the 
agricultural  products  affected  by  the  use  referred  to  in  the  authorisation  have 
been set or modified in accordance with Regulation (EC) No 396/2005. 

By way of derogation from point (a) of paragraph 1, a Member State may, during a 
period  of  5  years  following  the  adoption  of  the  programme  of  work  referred  to  in 
Article  26  authorise  the  placing  on  the  market  in  its  territory  of  plant  protection 
products  containing  synergists  and  safeners  which  are  not  approved,  but  which  are 
included in that programme. 

The applicant shall demonstrate that the requirements provided for in paragraph 1 are 
met. 

Compliance  with  the  requirements  set  out  in  point  (b)  and  points  (d)  to  (g)  of 
paragraph 1 shall be established by official or officially recognised tests and analyses 
carried out under agricultural, plant health and environmental conditions relevant to 
the  use  of  the  plant  protection  product  in  question  and  representative  of  the 
conditions prevailing in the zone where the product is intended to be used. 

With  respect  to  point  (e)  of  paragraph  1,  harmonised  methods  may  be  adopted  in 
accordance with the procedure referred to in Article 76(3). 

Uniform principles for evaluation and authorisation of plant protection products shall 
be  defined  in  Regulations  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 76(2), incorporating the requirements in Annex VI to Directive 91/414/EEC 
with any necessary modifications. 

2. 

3. 

4. 

5. 

6. 

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Article 30 
Contents 

1. 

2. 

The  authorisation  shall  define  the  crops  on  which  and  the  purposes  for  which  the 
plant protection product may be used.  

The authorisation shall set out the requirements relating to the placing on the market 
and  use  of  the  plant  protection  product.  Those  requirements  shall  include  the 
conditions of use necessary to comply with the conditions and requirements provided 
for  in  the  Regulation  approving  the  active  substances,  safeners  and  synergists.  The 
authorisation  shall  include  a  classification  of  the  plant  protection  product  for  the 
purpose of Directive 1999/45/EC. 

3. 

The requirements referred to in paragraph 2 may include: 

(a) 

a restriction of the product with respect to the distribution and use of the plant 
protection  product  to  protect  the  health  of  the  distributors,  users  and  workers 
concerned; 

(b) 

the  obligation  to  inform  any  neighbours  who  could  be  exposed  to  the  spray 
drift before the product is used and who have requested to be informed.  

Article 31 
Duration 

1. 

2. 

3. 

The period of authorisation shall be laid down in the authorisation. The duration of 
an  authorisation  shall  be  set  for  as  long  as  all  active  substances,  safeners  and 
synergists contained in the plant protection product are approved. 

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 48. 

After renewal of the approval of an active substance, safener or synergist contained 
in  the  plant  protection  product,  an  additional  authorisation  period  of  nine  months 
shall be granted to allow the examination as provided for in Article 42 to be carried 
out. 

SUBSECTION 2 
PROCEDURE 

Article 32 
Application for authorisation  

1. 

A person who wishes to place a plant protection product on the  market shall apply 
for an authorisation, in person or via a representative, to each Member State where 
the plant protection product is intended to be placed on the market.  

2. 

The application shall include the following: 

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(a) 

(b) 

(c) 

a  list  of  the  zones  and  the  Member  States  where  the  applicant  has  made  an 
application;  

a  proposal  as  to  which  Member  State  the  applicant  expects  to  evaluate  the 
application in the zone concerned; 

a certified copy of any authorisations already granted for that plant protection 
product in a Member State. 

3. 

The application shall be accompanied by the following:  

(a) 

(b) 

(c) 

(d) 

for the plant protection product concerned, a complete and a summary dossier 
for each point of the data requirements of the plant protection product; 

for  each  active  substance,  safener  and  synergist  contained  in  the  plant 
protection  product,  a  complete  and  a  summary  dossier  for  each  point  of  the 
data requirements of the active substance, safener and synergist; and 

for each test or study involving vertebrate animals, a justification of the steps 
taken to avoid duplicative testing; 

the  reasons  why  the  test  and  study  reports  submitted  are  necessary  for  first 
authorisation or for amendments to the conditions of the authorisation. 

4. 

When submitting his application, the applicant may, pursuant to Article 60, request 
that certain parts of the dossiers referred to in paragraph 3 are to be kept confidential. 
He  shall  explain  for  each  document  or  each  part  of  a  document  why  it  is  to  be 
considered as confidential. 

He  shall  at  the  same  time  submit  any  claims  for  data  protection  pursuant  to 
Article 56(3). 

After giving the applicant the possibility to submit comments on the decision it plans 
to  adopt,  the  rapporteur  Member  State  shall  decide  what  information  is  to  be  kept 
confidential. It shall inform the applicant and the Authority of its decision 

5. 

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

On request, the applicant shall provide the Member State with samples of the plant 
protection product and analytical standards of its ingredients.  

Article 33 
Exemption 

1. 

2. 

Applicants shall be exempted from supplying the test and study reports referred to in 
Article  32(3)  where  they  demonstrate  that  they  have  been  granted  access  in 
accordance with Article 56, 58 or 59 or that any data protection period has expired. 

However,  applicants  to  whom  paragraph  1  applies  shall  provide  the  following 
information: 

EN 

39 

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(a) 

(b) 

the  information  needed  to  identify  the  active  substance,  safener  or  synergist, 
where  they  have  been  approved,  and  to  establish  whether  the  conditions  for 
approval are met and comply with Article 29(1)(b), where appropriate; 

the  data  needed  to  demonstrate  that  the  plant  protection  product  has 
comparable effects to the plant protection product for which they show access 
to the protected data. 

Article 34 
Member State examining the application 

The  application  shall  be  examined  by  the  Member  State  proposed  by  the  applicant,  unless 
another Member State in the same zone agrees to examine it. The Member State which will 
examine the application shall inform the applicant. 

At the request of the Member State examining the application, the other Member States in the 
same zone to which an application has been submitted shall cooperate to ensure a fair division 
of the workload. 

The  other  Member  States  within  the  zone  to  which  an  application  has  been  submitted  shall 
refrain from proceeding with the file pending assessment by the Member State examining the 
application. 

Article 35 
Examination 

1. 

The  Member  State  examining  the  application  shall  make  an  independent,  objective 
and transparent assessment in the light of current scientific and technical knowledge.  

It  shall  apply  the  uniform  principles  for  evaluation  and  authorisation  of  plant 
protection  products,  referred  to  in  Article  29(6),  to  establish  whether  the  plant 
protection product meets the requirements provided for in Article 29, where used in 
accordance with Article 52, and under all realistic normal conditions of use, and the 
consequences of its use under the authorised conditions. 

The Member State examining the application shall make available its assessment to 
the  other  Member  States  within  the  same  zone  to  which  an  application  has  been 
made. 

The Member States concerned shall grant or refuse authorisations accordingly on the 
basis  of  the  conclusions  of  the  assessment  of  the  Member  State  examining  the 
application as provided for in Articles 30 and 31. The Member States shall authorise 
the  plant  protection  product  concerned  under  the  same  conditions,  including 
classification  for  the  purpose  of  Directive  1999/45/EC,  as  the  Member  State 
examining the application.  

By  way  of  derogation  from  paragraph  2  and  subject  to  Community  law,  additional 
conditions  may  be  imposed  with  respect  to  the  requirements  referred  to  in  Article 
30(3). 

2. 

3. 

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Article 36 
Time period for examination  

1. 

The  Member  State  examining  the  application  shall  decide  within  twelve  months  of 
receiving it whether the requirements for authorisation are met. 

2. 

3. 

1. 

2. 

3. 

4. 

Where the Member State needs additional information, it shall set a time period for 
the applicant to supply it. In that case, the twelve-month period shall be extended by 
the additional time period granted by the Member State. 

The  time-limits  provided  for  in  paragraph  1  shall  be  suspended  while  applying  the 
procedure set out in Article 37. 

For an application for authorisation of a plant protection product containing an active 
substance not yet approved, Member States shall start the evaluation as soon as it has 
received  the  draft  assessment  report  referred  to  in  Article  12(1).  In  such  case  the 
Member  State  shall  decide  on  the  application  at  the  latest  within  six  months  of  the 
active substance being approved. 

Article 37 
Assessment of equivalence under Article 29(1)(b) 

Where it is necessary to establish whether a plant protection product complies with 
Article  29(1)(b),  this  shall  be  assessed  by  the  Member  State  which  acted  as 
rapporteur for the active substance, safener or synergist as referred to in Article 7(1), 
hereafter  called  the  rapporteur  Member  State.  The  applicant  shall  submit  all 
necessary data to that Member State. 

After  giving  the  applicant  the  opportunity  to  submit  his  comments,  which  the 
applicant shall also communicate to the Member State examining the application, the 
rapporteur Member State shall adopt a conclusion which it shall communicate to the 
Commission, the other Member States and the applicant.  

Where the Member State examining the application for authorisation does not agree 
with the conclusion of the rapporteur Member State, it shall inform the applicant, the 
other Member States and the Commission stating its reasons. 

The  Member  State  examining  the  application  for  authorisation  and  the  rapporteur 
Member State shall try to reach agreement on whether Article 29(1)(b) is complied 
with. They shall provide the applicant with an opportunity to submit his comments.  

Where  the  Member  States  concerned  do  not  reach  agreement  within  90  days  the 
Member State examining the application for authorisation shall submit the matter to 
the Commission. A decision on whether the conditions referred to in Article 29(1)(b) 
are  complied with shall be  adopted  in accordance with the procedure referred to in 
Article  76(2).  The  90-day  period  begins  on  the  date  on  which  the  Member  State 
examining  the  application  for  authorisation  informed  the  rapporteur  Member  State 
that  it  does  not  agree  with  the  conclusion  of  the  latter,  in  accordance  with 
paragraph 3. 

EN 

41 

   EN 

 
Before  such  a  decision  is  adopted,  the  Commission  may  ask  the  Authority  for  an 
opinion, or for scientific or technical assistance which shall be provided within three 
months of the request.  

5. 

Detailed  rules  for  the  implementation  of  paragraphs  1  to  4  may  be  established  in 
accordance with the procedure referred to in Article 76(3), after consultation of the 
Authority. 

Article 38 
Reporting and exchange of information on applications for authorisation 

1. 

Member  States  shall  compile  a  file  on  each  application.  Each  file  shall  contain  the 
following: 

(a) 

a copy of the application;  

(b) 

(c) 

a report containing information on the evaluation of and decision on the plant 
protection product; 

a record of the administrative decisions taken by the Member State concerning 
the  application  and  the  documentation  provided  for  in  Article 32(3)  together 
with a summary of the latter.  

On request, Member States shall, without delay, make available to the other Member 
States,  the  Authority  and  the  Commission  a  file  containing  the  documentation 
provided for in points (a), (b) and (c) of paragraph 1. 

On  request,  applicants  shall  provide  a  copy  of  the  documentation  to  be  submitted 
with  an  application  pursuant  to  Article  32(2)  and  Article  33  to  Member  States,  the 
Authority and the Commission. 

2. 

3. 

SUBSECTION 3 
MUTUAL RECOGNITION OF AUTHORISATIONS 

Article 39 
Mutual recognition 

1. 

The  holder  of  an  authorisation  may  apply  for  an  authorisation  for  the  same  plant 
protection product and for the same use in another Member State under the mutual 
recognition procedure, provided for in this subsection, in the following cases:  

(a) 

(b) 

the  authorisation  was  granted  by  a  Member  State  (reference  Member  State) 
which belongs to the same zone; or 

the authorisation was granted by a Member State for use in greenhouses or as 
post-harvest treatment, regardless of the zone to which the reference Member 
State belongs. 

EN 

42 

   EN 

 
2. 

Mutual  recognition  shall  not  apply  to  plant  protection  products  containing  a 
candidate for substitution. 

Article 40 
Authorisation 

1. 

2. 

The  Member  State  to  which  an  application  under  Article  39  is  submitted  shall 
authorise  the  plant  protection  product  concerned  under  the  same  conditions, 
including  classification  for  the  purpose  of  Directive  1999/45/EC,  as  the  reference 
Member State. 

By  way  of  derogation  from  paragraph  1  and  subject  to  Community  law,  additional 
conditions  may  be  imposed  with  respect  to  the  requirements  referred  to  in 
Article 30(3). 

1. 

The application shall be accompanied by: 

Article 41 
Procedure 

(a) 

a certified copy of the authorisation granted by the reference Member State; 

(b) 

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

(c) 

a summary of the dossier as required in Article 32(3). 

2. 

The Member State to which an application under Article 39 is submitted shall decide 
on the application within 90 days.  

SUBSECTION 4 
RENEWAL AND WITHDRAWAL 

Article 42 
Renewal of authorisation  

1. 

An  authorisation  shall  be  renewed  upon  application  by  the  authorisation  holder, 
provided that the conditions provided for in Article 29 are still satisfied. 

The  application  shall  be  submitted  at  the  latest  one  year  before  the  expiry  of  the 
authorisation except where applicants cannot comply with this deadline because the 
active substance in question was included in Annex I to Directive 91/414/EEC for a 
duration  which  expired  less  than  a  year  after  the  date  of  application  of  this 
Regulation. 

2. 

The application shall be accompanied by the following information: 

(a) 

a copy of the authorisation of the plant protection product, 

EN 

43 

   EN 

 
(b) 

a  report  on  the  results  of  monitoring,  where  the  authorisation  was  subject  to 
monitoring. 

3. 

Within  three  months  of  renewal  of  the  approval  of  an  active  substance,  safener  or 
synergist  contained  in  the  plant  protection  product,  the  applicant  shall  submit  the 
following information: 

(a) 

(b) 

(c) 

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

justification 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;  

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 in it. 

Member  States  shall  check  that  all  plant  protection  products  containing  the  active 
substance,  safener  or  synergist  concerned  comply  with  any  conditions  and 
restrictions provided for in the Regulation renewing the approval under Article 20. 

The  Member  State  which  acted  as  rapporteur  for  the  active  substance,  safener  or 
synergist  shall  coordinate  performance  of  the  compliance  check  and  assessment  of 
the  results.  The  compliance  check  shall  be  performed  within  the  time  period  set  in 
the Regulation on the renewal of the approval. 

Guidelines  on  the  organisation  of  compliance  checks  may  be  established  in 
accordance with the procedure referred to in Article 76(2).  

Member  States  shall  decide  on  the  renewal  of  the  authorisation  at  the  latest  nine 
months after the renewal of the approval of the active substance, safener or synergist 
contained in it. 

Where, for reasons beyond the control of the holder of the authorisation, no decision 
is  taken  on  the  renewal  of  the  authorisation  before  its  expiry,  the  Member  State  in 
question  shall  extend  the  authorisation  for  the  period  necessary  to  complete  the 
examination and adopt a decision on the renewal. 

Article 43 
Withdrawal or amendment of an authorisation 

Member States may review an authorisation at any time where there are indications 
that a requirement referred to in Article 29 is no longer satisfied.  

Where  a  Member  State  intends  to  withdraw  or  amend  an  authorisation,  it  shall 
inform the authorisation holder and give him the possibility to submit comments.  

The Member State may ask the authorisation holder to submit further information. 

4. 

5. 

6. 

7. 

1. 

2. 

EN 

44 

   EN 

 
3. 

The Member State shall withdraw or amend the authorisation, as appropriate, where: 

(a) 

the requirements referred to in Article 29 are not or are no longer satisfied;  

(b) 

false or misleading information was supplied concerning the facts on the basis 
of which the authorisation was granted; 

(c) 

a condition included in the authorisation has not been met.  

Where  a  Member  State  withdraws  or  amends  an  authorisation  in  accordance  with 
paragraph  3,  it  shall  immediately  inform  the  holder  of  the  authorisation,  the  other 
Member  States,  the  Authority  and  the  Commission.  The  other  Member  States 
belonging to the same zone shall withdraw or amend the authorisation accordingly. 
Article 45 shall apply where appropriate. 

Article 44 
Withdrawal or amendment of an authorisation at the request of the authorisation holder 

An  authorisation  may  be  withdrawn  or  amended  at  the  request  of  the  holder  of  the 
authorisation, who shall state the reasons for his request. 

Amendments  may  only  be  granted  where  it  is  established  that  the  requirements  of 
Article 29 continue to be satisfied. 

4. 

1. 

2. 

Article 45 
Grace period 

Where  a  Member  State  withdraws  or  amends  an  authorisation  or  does  not  renew  it,  it  may 
grant a grace period for the disposal, storage, placing on the market and use of existing stocks.  

Where the reasons for withdrawal, amendment or not renewing the authorisation permit, grace 
periods for using up stocks of the plant protection products concerned shall be such that they 
do not interfere with the normal period of use of the plant protection product. 

SUBSECTION 5 
SPECIAL CASES 

Article 46 
Placing on the market and use of low-risk plant protection products  

1. 

Where  all  the  active  substances  contained  in  a  plant  protection  product  are 
substances  as  referred  to  in  Article  22  (‘low-risk  active  substances’),  that  product 
shall,  by  way  of  derogation  from  Article  29,  be  authorised  as  a  low-risk  plant 
protection product provided it meets the following requirements: 

(a) 

the  low-risk  active  substances,  safeners  and  synergists  contained  in  it  have 
been approved under Chapter II; 

EN 

45 

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(b) 

it does not contain a substance of concern; 

(c) 

it is sufficiently effective; 

2. 

3. 

(d) 

it does not cause unnecessary pain and suffering to vertebrates to be controlled; 

(e) 

it complies with Article 29(1)(b), (c) and (e) to (h). 

These products are referred to hereinafter as ‘low-risk plant protection products’. 

An  applicant  for  authorisation  of  a  low-risk  plant  protection  product  shall 
demonstrate  that  the  requirements  set  out  in  paragraph  1  are  met  and  shall 
accompany  the  application  with  a  complete  and  summary  dossier  for  each  point  of 
the data requirements of the active substance and the plant protection product. 

The Member State shall decide within 90 days on whether to approve an application 
for authorisation of a low-risk plant protection product.  

The period shall be 60 days where an authorisation has already been granted for the 
same low-risk plant protection product by another Member State located in the same 
zone.  

Where the Member State needs additional information, it shall set a time limit for the 
applicant  to  supply  it.  In  that  case,  the  90-day  period  shall  be  extended  by  the 
additional time limit granted by the Member State. 

4. 

Unless  otherwise  specified,  all  provisions  relating  to  authorisations  under  this 
Regulation shall apply.  

Article 47 
Placing on the market and use of plant protection products containing 
 a genetically modified micro-organism 

1. 

A plant protection product which contains a micro-organism falling within the scope 
of Directive 2001/18/EC shall be examined in respect of the genetic modification in 
accordance with that Directive, in addition to the assessment under this Chapter.  

An  authorisation  under  this  Regulation  shall  not  be  granted  for  such  a  plant 
protection  product  unless  written  consent,  as  referred  to  in  Article  19  of 
Directive 2001/18/EC, has been granted for it. 

2. 

Unless  otherwise  specified,  all  provisions  relating  to  authorisations  under  this 
Regulation shall apply. 

Article 48 
Comparative assessment of plant protection products containing candidates for substitution 

1. 

Member States shall not authorise a plant protection product containing a candidate 
for substitution where a comparative assessment weighing up the risks and benefits, 
as set out in Annex IV, shows that: 

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46 

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(a) 

(b) 

for the uses specified in the application an authorised plant protection product, 
or  a  non-chemical  control  or  prevention  method,  already  exists  which  is 
significantly safer for human or animal health or the environment; 

the  plant  protection  product  or  non-chemical  control  or  prevention  method 
referred  to  in  point  (a)  does  not  present  significant  economic  or  practical 
disadvantages;  

(c) 

the  chemical  diversity  of  the  active  substances  is  adequate  to  minimise  the 
occurrence of resistance in the target organism. 

By  way  of  derogation  from  paragraph  1,  a  plant  protection  product  containing  a 
candidate  for  substitution  shall  be  authorised  without  comparative  assessment  in 
cases where it is necessary to acquire experience first through using that product in 
practice. 

Such authorisations shall be granted for a period not exceeding three years. 

Member States shall repeat the comparative assessment provided for in paragraph 1 
regularly  and  at  the  latest  four  years  after  authorisation  or  renewal  of  the 
authorisation was granted. 

Based on the results of that comparative assessment, Member States shall maintain, 
withdraw or amend the authorisation. 

Where  a  Member  State  decides  to  withdraw  or  amend  an  authorisation  pursuant  to 
paragraph  3,  that  withdrawal  or  amendment  shall  take  effect  four  years  after  the 
decision of the Member State or at the end of the approval period of the candidate for 
substitution where that period ends earlier.  

Unless  otherwise  specified,  all  provisions  relating  to  authorisations  under  this 
Regulation shall apply. 

Article 49 
Extension of authorisations for minor uses  

For the purpose of this Article, minor use of a plant protection product in a particular 
Member State means the use of that product on a crop which is not widely grown in 
that Member State or on a widely grown crop to meet an exceptional need.  

The  authorisation  holder,  official  or  scientific  bodies  involved  in  agricultural 
activities  or  professional  agricultural  organisations  and  professional  users  may  ask 
for the authorisation of a plant protection product already authorised in the Member 
State concerned to be extended to minor uses not yet covered by that authorisation. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

Member States shall extend the authorisation provided that: 

(a) 

the intended use is minor in nature; 

(b) 

the conditions referred to in Article 4(3)(b), (d) and (e) and Article 29(1)(h) are 
satisfied; 

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47 

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4. 

5. 

6. 

7. 

1. 

2. 

3. 

(c) 

the extension is in the public interest; 

(d) 

the  documentation  and  information  to  support  an  extension  of  use  has  been 
submitted by the persons or bodies referred to in paragraph 2. 

The  extension  may  take  the  form  of  an  amendment  to  the  existing  authorisation  or 
may  be  a  separate  authorisation,  according  to  the  administrative  procedures  of  the 
Member State concerned. 

When Member States grant an extension of authorisation for a minor use, they shall 
inform the authorisation holder and request him to change the labelling accordingly. 

Where  the  authorisation  holder  declines,  the  Member  States  shall  ensure  that  users 
are fully and specifically informed as to instructions for use, by means of an official 
publication or an official website. 

Member States shall establish and regularly update a list of minor uses. 

Unless  otherwise  specified,  all  provisions  relating  to  authorisations  under  this 
Regulation shall apply. 

SUBSECTION 6 
DEROGATIONS 

Article 50 
Agricultural emergency situations 

By way of derogation from Article 28, in special circumstances a Member State may 
authorise,  for  a  period  not  exceeding  120  days,  the  placing  on  the  market  of  plant 
protection  products,  for  limited  and  controlled  use,  where  such  a  measure  appears 
necessary because of a danger to plant health which cannot be contained by any other 
reasonable means. 

The Member State concerned shall immediately inform the other Member States and 
the  Commission  of  the  measure  taken,  providing  detailed  information  about  the 
situation and any measures taken to ensure consumer safety. 

The Commission may 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 one month of the request. 

If necessary, a decision shall be taken, in accordance with the procedure referred to 
in Article 76(3), as to  

(a)  whether the treated crop may be safely marketed, and 

(b)  whether and under what conditions the Member State 

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4. 

1. 

2. 

3. 

4. 

(i)  may extend the duration of the measure or repeat it; or 

(ii) 

shall withdraw or amend its measure. 

Paragraphs 1 to 3 shall not apply to plant protection products containing or composed 
of genetically modified micro-organisms. 

Article 51 
Research and development 

By  way  of  derogation  from  Article  28,  experiments  or  tests  for  research  or 
development purposes involving the release into the environment of an unauthorised 
plant  protection  product  may  be  carried  out if  the  Member  State in  whose  territory 
the experiment or test is to be carried out has assessed the available data and granted 
an  authorisation  for  trial  purposes.  The  authorisation  may  limit  the  quantities  to  be 
used  and  the  areas  to  be  treated  and  may  impose  further  conditions  to  prevent  any 
harmful effects on human or animal health or any unacceptable adverse effect on the 
environment, such as the need to prevent entry into the food chain of feed and food 
containing  residues  unless  a  relevant  provision  has  already  been  established  under 
Regulation (EC) No 396/2005. 

The Member State may authorise a programme of experiments or tests in advance or 
require an authorisation for each experiment or test. 

An  application  shall  be  submitted  to  the  Member  State  in  whose  territory  the 
experiment  or  test  is  to  be  conducted,  together  with  a  dossier  containing  all  the 
available data to permit an assessment of possible effects on human or animal health 
or the possible impact on the environment. 

An  authorisation  for  trial  purposes  shall  not  be  granted  for  experiments  or  tests 
involving  the  release  into  environment  of  a  genetically  modified  micro-organism 
unless such release has been accepted under Directive 2001/18/EC.  

Detailed rules for the application of this Article, in particular the maximum quantities 
of plant protection products that may be released during experiments or tests and the 
minimum  data  to  be  submitted  in  accordance  with  paragraph 2,  may  be  adopted  in 
accordance with the procedure referred to in Article 76(3). 

SECTION 2 
USE AND INFORMATION 

Article 52 
Use of plant protection products 

Plant protection products shall be used properly. 

Proper  use  shall  include  compliance  with  the  conditions  established  in  accordance  with 
Article  30  and  specified  on  the  labelling,  and  application  of  the  principles  of  good  plant 

EN 

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   EN 

 
protection  practice  as  well  as,  whenever  possible,  the  principles  of  integrated  pest 
management and good environmental practice.  

At the latest by 1 January 2014 proper use of plant protection products shall comply with the 
principles of integrated pest management, including good plant protection practice and good 
environmental practise. 

Detailed  rules  for  the  application  of  this  Article  including  minimum  requirements  for  these 
principles may be adopted in accordance with the procedure referred to in Article 76(2). 

1. 

2. 

3. 

4. 

Article 53 
Information on potentially harmful effects 

The holder of an authorisation for a plant protection product shall immediately notify 
the Member States that granted an authorisation of any new information concerning 
that plant protection product, or an active substance, safener or synergist contained in 
the  plant  protection  product,  which  suggests  that  the  plant  protection  product  has 
harmful  effects  which  might  mean  that  the  plant  protection  product  or  the  active 
substance, safener or synergist no longer complies with the criteria set out in Articles 
29 and 4 respectively.  

In  particular,  potentially  harmful  effects  of  that  plant  protection  product,  or  of 
residues  of  an  active  substance,  safener  or  synergist  contained  in  it,  on  human  or 
animal health or on groundwater, or their potentially unacceptable effects on plants 
or plant products or the environment shall be notified.  

To  this  end  the  authorisation  holder  shall  record  and  report  all  suspected  adverse 
reactions in humans related to the use of the plant protection product. 

The  obligation  to  notify  shall  include  relevant  information  on  decisions  or 
assessments  by  public  bodies  which  authorise  plant  protection  products  or  active 
substances in third countries.  

The notification shall include an assessment of whether and how the new information 
means that the plant protection product or the active substance, safener or synergist 
no  longer  comply  with  the  requirements  set  out  in  Article  29  and  Article  4 
respectively.  

The  first  Member  State  which  granted  an  authorisation  within  each  zone  shall 
evaluate the information received and inform the other Member States, belonging to 
the  same  zone,  where  it  decides  to  withdraw  or  amend  the  authorisation  under 
Article 43. 

It shall inform the other Member States, the Authority and the Commission where it 
considers  that  the  conditions  of  the  approval  of  the  active  substance,  safener  or 
synergist contained in the plant protection product are no longer fulfilled and propose 
that the approval be withdrawn or the conditions amended. 

The holder of an authorisation for a plant protection product shall report annually to 
the  competent  authority  of  the  Member  State  which  authorised  his  plant  protection 
product  any  available  information  relating  to  the  lack  of  expected  efficacy,  the 

EN 

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development of resistance and to any unexpected effect on plants, plant products or 
the environment. 

Article 54 
Obligation to keep information available 

1. 

Member States shall keep information electronically available to the public on plant 
protection  products  authorised  or  withdrawn  in  accordance  with  this  Regulation, 
containing at least: 

(a) 

the name or business name of the holder of the authorisation, 

(b) 

the trade name of the product, 

(c) 

the type of preparation, 

(d) 

the  name  and  amount  of  each  active  substance,  safener  or  synergist  which  it 
contains, 

(e) 

the use or uses for which it is intended, 

(f)  where relevant, the reasons for withdrawal of an authorisation. 

2. 

3. 

The information referred to in paragraph 1 shall be readily accessible and updated at 
least once every three months. 

In  accordance  with  the  procedure  referred  to  in  Article  76(2),  a  standardised 
information system may be set up to facilitate the application of paragraphs 1 and 2. 

CHAPTER IV 
ADJUVANTS 

Article 55 
Placing on the market and use of adjuvants 

An adjuvant shall not be placed on the market or used if it contains a co-formulant which has 
been prohibited in accordance with Article 27. 

CHAPTER V 
DATA PROTECTION AND DATA SHARING 

Article 56 
Data protection  

1. 

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

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The protection applies to test and study reports submitted to a Member State by an 
applicant  for  authorisation  under  this  Regulation  (hereinafter  called  ‘the  first 
applicant’), provided that those test and study reports were  

(a) 

(b) 

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

certified as compliant with the principles of Good Laboratory Practice or Good 
Experimental  Practice  in  accordance  with  the  data  requirements  for  plant 
protection products referred to in Article 8(1)(c). 

Where a report is protected, it may not be used, by the Member State which received 
it, for the benefit of other applicants for plant protection products, except as provided 
in paragraph 2, in Article 59 or in Article 77.  

The period of data protection is ten years starting at the date of the first authorisation 
in  that  Member  State,  except  as  provided  in  paragraph  2,  in  Article  59  or  in 
Article 77. That period is extended to 12 years for plant protection products covered 
by Article 46. 

A study shall not be protected if it was only necessary for the renewal or review of an 
authorisation. 

2. 

Paragraph 1 shall not apply: 

(a) 

to  test  and  study  reports  for  which  the  applicant  has  submitted  a  letter  of 
access; or  

(b)  where  any  period  of  data  protection  granted  for  the  test  and  study  reports 

concerned in relation to another plant protection product has expired.  

3. 

Data protection under paragraph 1 shall only be granted where the first applicant has 
claimed data protection at the time of submitting the dossier and has provided to the 
Member State concerned for each test or study report the following information: 

(a) 

justification that the test and study reports submitted are necessary for the first 
authorisation,  or  for  the  amendment  of  the  authorisation  of  a  plant  protection 
product;  

(b) 

confirmation  that  any  period  of  data  protection  granted  for  the  test  or  study 
report has not expired. 

Article 57 
List of test and study reports 

1. 

For  each  active  substance,  safener  and  synergist,  rapporteur  Member  States  shall 
keep, and make available to any interested party upon request, a list of the test and 
study  reports  necessary  for  first  approval,  amendment  of  approval  conditions  or 
renewal of the approval. 

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52 

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2. 

For  each  plant  protection  product  which  they  authorise,  Member  States  shall  keep 
and make available to any interested party upon request: 

(a) 

(b) 

a list of the test and study reports necessary for first authorisation, amendment 
of the authorisation conditions or renewal of the authorisation; and 

a list of test and study reports for which protection is claimed under Article 56 
and any justifications submitted in accordance with that Article. 

The  lists  provided  for  in  paragraphs  1  and  2  shall  include  information  on  whether 
those test and study reports were certified as compliant with the principles of Good 
Laboratory Practice or with the principles of Good Experimental Practice.  

Article 58 
General rules on avoidance of duplicative testing 

Any persons intending to seek an authorisation for a plant protection product shall, 
before  carrying  out  tests  or  studies,  enquire  of  the  competent  authority  of  the 
Member State to which they intend to make an application whether an authorisation 
has  already  been  granted  in  that  Member  State  for  a  plant  protection  product 
containing the same active substance, safener or synergist. Such enquiry shall include 
consultation of the information available pursuant to Article 54. 

The prospective applicant shall submit all data regarding the identity and impurities 
of  the  active  substance  he  proposes  to  use.  The  enquiry  shall  be  supported  by 
evidence that the prospective applicant intends to apply for an authorisation. 

The  competent  authority  of  the  Member  State,  where  satisfied  that  the  prospective 
applicant intends to apply for an authorisation, shall provide him with the name and 
address of the holder or holders of previous relevant authorisations and shall at the 
same  time  inform  the  holders  of  the  authorisations  of  the  name  and  address  of  the 
applicant. 

The prospective applicant for the authorisation and the holder or holders of relevant 
authorisations shall take all reasonable steps to reach agreement on the sharing of any 
test and study reports protected under Article 56 that are required by the applicant for 
authorisation of a plant protection product. 

Article 59 
Sharing of tests and studies involving vertebrate animals 

Tests and studies involving vertebrate animals shall not be repeated for the purposes 
of  this  Regulation.  Any  person  intending  to  perform  tests  and  studies  involving 
vertebrate  animals  shall  take  the  necessary  measures  to  verify  that  those  tests  and 
studies have not already been performed or initiated. 

The  prospective  applicant  and  the  holder  or  holders  of  the  relevant  authorisations 
shall  make  every  effort  to  ensure  that  they  share  tests  and  studies  involving 
vertebrate  animals.  The  costs  of  sharing  the  test  and  study  reports  shall  be 
determined  in  a  fair,  transparent  and  non-discriminatory  way.  The  prospective 

3. 

1. 

2. 

3. 

1. 

2. 

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53 

   EN 

 
applicant is only required to share in the costs of information he is required to submit 
to meet the authorisation requirements. 

3. 

Where  the  prospective  applicant  and  the  holder  or  holders  of  the  relevant 
authorisations  of  plant  protection  products  containing  the  same  active  substance, 
safener or synergist cannot reach agreement on the sharing of test and study reports 
involving  vertebrate  animals,  the  prospective  applicant  shall  inform  the  competent 
authority of the Member State. The two parties shall nevertheless agree which courts 
have jurisdiction for the purpose of the second subparagraph. 

The  failure  to  reach  agreement,  as  provided  in  paragraph  2,  shall  not  prevent  the 
competent  authority  of  the  Member  State  from  using  the  test  and  study  reports 
involving  vertebrate  animals  for  the  purpose  of  the  application  of  the  prospective 
applicant. The holder or holders of the  relevant authorisation shall have a  claim on 
the prospective applicant for an equal share of the costs incurred by him, which shall 
be  enforceable  before  the  courts  of  a  Member  State,  as  designated  by  the  parties 
under  the  first  subparagraph.  Those  courts  shall  have  regard  to  the  principles  in 
paragraph 2. 

CHAPTER VI 
PUBLIC ACCESS TO INFORMATION  

Article 60 
Confidentiality 

1. 

A  person  claiming  under  Articles  7(3),  12(1),  15(2),  16  or  32(4)  that  information 
submitted by that person under this Regulation is to be treated as confidential shall 
provide a verifiable justification to show that the disclosure of the information might 
undermine his commercial interests, as referred to in the first indent of Article 4(2) of 
Regulation (EC) No 1049/2001 of the European Parliament and of the Council12, or 
any interest protected by Article 4(1) of that Regulation.  

2. 

As  regards  the  commercial  interests  referred  to  in  paragraph  1,  only  the  following 
elements shall be considered confidential: 

(a) 

the method of manufacture; 

(b) 

the specification of purity of the active substance except for the impurities that 
are  considered  to  be  toxicologically,  ecotoxicologically  or  environmentally 
relevant; 

(c) 

information on the complete composition of a plant protection product. 

This Article is without prejudice to Directive 2003/4/EC of the European Parliament 
and of the Council13. 

OJ L 145, 31.5.2001, p. 43. 
OJ L 41, 14.2.2003, p. 26. 

54 

   EN 

3. 

12 
13 

EN 

 
                                                 
CHAPTER VII 
PACKAGING, LABELLING AND ADVERTISING OF PLANT 
PROTECTION PRODUCTS AND ADJUVANTS 

1. 

2. 

3. 

1. 

2. 

3. 

Article 61 
Packaging and presentation  

Plant protection products and adjuvants that may be mistaken for food, drink or feed 
shall  be  packaged  in  such  a  way  as  to  minimise  the  likelihood  of  such  a  mistake 
being made. 

Plant protection  products and adjuvants available  to the general public that may be 
mistaken for food, drink or feed shall contain components to discourage or prevent 
their consumption. 

Article 9 of Directive 1999/45/EC shall also apply to plant protection products and 
adjuvants not covered by that Directive. 

Article 62 
Labelling 

The labelling of plant protection products shall comply with the requirements set out 
in a Regulation adopted in accordance with the procedure referred to in Article 76(2). 

That  Regulation  shall  also  contain  standard  phrases  for  special  risks  and  safety 
precautions which supplement the phrases provided for by Directive 1999/45/EC. It 
shall incorporate the text of the Annexes IV and V to Directive 91/414/EEC with any 
necessary modifications. 

Member  States  may  require  samples  or  mock-ups  of  the  packaging  and  drafts  of 
labels and leaflets to be submitted. 

Where  a  Member  State  considers  that  additional  phrases  are  necessary  to  protect 
human or animal health or the environment, it shall notify the other Member States 
and the Commission forthwith and shall forward the additional phrase or phrases and 
the reasons for these requirements. 

Such phrases shall be included in the Regulation referred to in paragraph 1. 

Pending  that  inclusion,  the  Member  State  may  require  the  use  of  the  additional 
phrase or phrases. 

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55 

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Article 63 
Advertising 

1. 

2. 

Every  advertisement  for  a  plant  protection  product  shall  be  accompanied  by  the 
sentences  ‘Use  plant  protection  products  safely.  Always  read  the  label  and  product 
information before use’. These sentences shall be clearly distinguishable in relation 
to the whole advertisement. The words ‘plant protection products’ may be replaced 
by  a  more  precise  description  of  the  product-type,  such  as  fungicide,  insecticide  or 
herbicide. 

The  advertisement  shall  not  include  information  which  could  be  misleading  as 
regards possible risks to human or animal health or to the environment, such as the 
terms ‘low risk’, ‘non-toxic’ or ‘harmless’. 

CHAPTER VIII 
CONTROLS  

Article 64 
Record keeping 

1. 

Producers, suppliers, distributors and professional users of plant protection products 
shall keep records of the plant protection products they produce, store or use.  

They shall make the relevant information contained in these records available to the 
competent  authority  on  request.  They  shall  also  keep  this  information  available  for 
neighbours or the drinking water industry who request access to it. 

Authorisation holders shall provide the competent authorities of the Member States 
with all data relating to the volume of sales of plant protection products. 

Implementing measures to ensure the uniform application of paragraphs 1 and 2 may 
be adopted in accordance with the procedure referred to in Article 76(3). 

2. 

3. 

Article 65 
Monitoring and controls 

Member  States  shall  carry  out  official  controls  in  order  to  enforce  compliance  with  this 
Regulation. They shall finalise and transmit to the Commission, a report on the scope and the 
results of these controls within six months of the end of the year to which the reports relate.  

Commission  experts  shall  carry  out  general  and  specific  audits  in  the  Member  States  for 
purposes of verifying the official controls carried out by the Member States.  

A Regulation, adopted in accordance with the procedure referred to in Article 76(3), shall set 
out  provisions  for  the  controls  on  the  production,  packaging,  labelling,  storage,  transport, 
marketing,  formulation  and  use  of  plant  protection  products.  That  Regulation  shall  contain 
provisions equivalent to Articles 1 to 13, 26, 27(1), 27(4)(a) and (b) and 27(5) to (12), 28, 29, 
32 to 45, 51, 53, 54, 66 and to Annexes I, II, III, VI, and VII to Regulation (EC) No 882/2004. 

EN 

56 

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It  shall  also  contain  provisions  concerning  the  collection  of  information  and  reporting  on 
suspected  poisonings  and  shall  detail  the  information  to  be  made  available  in  response  to 
medical demand. 

CHAPTER IX 
EMERGENCIES 

Article 66  
Emergency measures  

Where  it  is  clear  that  an  approved  substance,  safener,  synergist  or  co-formulant  or  a  plant 
protection product which has been authorised in accordance with this Regulation is likely to 
constitute  a  serious  risk  to  human  or  animal  health  or  the  environment,  and  that  such  risk 
cannot  be  contained  satisfactorily  by  means  of  measures  taken  by  the  Member  State(s) 
concerned,  measures  to  restrict  or  prohibit  the  use  and/or  sale  of  that  substance  or  product 
shall  be  taken  immediately  in  accordance  with  the  procedure  referred  to  in  Article  76(3), 
either  at  the  own  initiative  of  the  Commission  or  at  the  request  of  a  Member  State.  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. 

Article 67 
Emergency measures in cases of extreme urgency 

By way of derogation from Article 66, the Commission may provisionally adopt the measures 
referred to in Article 66 after consulting the Member State or Member States concerned and 
informing the other Member States. 

As  soon  as  possible,  and  at  the  latest  after  10  working  days,  those  measures  shall  be 
confirmed,  amended,  revoked  or  extended  in  accordance  with  the  procedure  referred  to  in 
Article 76(3). 

Article 68 
Other emergency measures  

1. 

2. 

3. 

Where  a  Member  State  officially  informs  the  Commission  of  the  need  to  take 
emergency measures, and no action has been taken in accordance with Articles 66 or 
67, the Member State may adopt interim protective measures. In this event, it shall 
immediately inform the other Member States and the Commission. 

Within 30 working days, the Commission shall put the matter before the Committee 
referred  to  in  Article  76(1)  in  accordance  with  the  procedure  provided  for  in 
Article 76(3) with a view to the extension, amendment or abrogation of the national 
interim protective measure. 

The  Member  State  may  maintain  its  national  interim  protective  measures  until 
Community measures have been adopted. 

EN 

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CHAPTER X 
ADMINISTRATIVE AND FINANCIAL PROVISIONS 

Article 69 
Penalties 

The Member States shall lay down the rules on penalties applicable to infringements of this 
Regulation  and  shall  take  the  measures  necessary  to  ensure  that  they  are  implemented.  The 
penalties provided for must be effective, proportionate and dissuasive. 

The  Member  States  shall  notify  those  rules  and  any  subsequent  amendment  to  the 
Commission without delay. 

Article 70 
Civil and criminal liability 

The granting of authorisation and any other measures in conformity with this Regulation shall 
be  without  prejudice  to  general  civil  and  criminal  liability  in  the  Member  States  of  the 
producer  and,  where  applicable,  of  the  person  responsible  for  placing  the  plant  protection 
product on the market or using it. 

Article 71 
Fees and charges 

1. 

2. 

1. 

2. 

Member States may recover the costs associated with any work they carry out arising 
from obligations under this Regulation, by means of fees or charges. 

Member States shall ensure that the fee or charge referred to in paragraph 1: 

(a) 

is established in a transparent manner; and 

(b) 

corresponds to the actual cost of the work involved. 

The fee or charge may include a scale of fixed charges based on average costs for the 
work referred to in paragraph 1. 

Article 72 
Member State authority 

Each Member State shall designate a competent authority or authorities to carry out 
the obligations of the Member States as defined in this Regulation. 

Each  Member  State  shall  designate  a  coordinating  national  authority  to  coordinate 
and  ensure  all  the  necessary  contacts  with  applicants,  other  Member  States,  the 
Commission and the Authority. 

EN 

58 

   EN 

 
3. 

4. 

Each Member State shall give the details concerning its national competent authority 
or  authorities  to  the  Commission,  the  Authority  and  the  coordinating  national 
authorities of the other Member States and inform them of any modifications thereof. 

The  Commission  shall  publish  and  keep  updated  on  its  website  a  list  of  the 
authorities referred to in paragraphs 1 and 2. 

Article 73 
Expenditure by the Commission  

1. 

The Commission may incur expenditure for activities contributing to the aims of this 
Regulation including the organisation of the following: 

(a) 

development  of  a  harmonised  system,  including  an  appropriate  database,  for 
gathering  and  storing  all  information  concerning  active  substances,  safeners, 
synergists,  co-formulants,  plant  protection  products  and  adjuvants  and  for 
making such information available to the Member States, producers and other 
interested parties;  

(b)  performance of studies needed to prepare and develop further legislation on the 
placing on the market and use of plant protection products and adjuvants; 

(c) 

(d) 

(e) 

(f) 

(g) 

performance  of  studies  needed  to  harmonise  procedures,  decision-making 
criteria and data requirements;  

coordination,  if  necessary  by  electronic  means,  of  cooperation  between 
Member  States,  the  Authority  and  the  Commission  and  measures  to  facilitate 
work sharing; 

development  and  maintenance  of  a  coordinated  electronic  submission  and 
evaluation system aimed at promoting electronic document exchange and work 
sharing  between  the  applicants,  the  Member  States,  the  Authority  and  the 
Commission; 

development  of  guidance  to  facilitate  the  day-to-day  implementation  of  this 
Regulation; 

travel and subsistence expenses that Member States’ experts incur as a result of 
the  Commission  appointing  them  to  assist  its  experts  in  the  framework  of 
control activities laid down under Article 65; 

(h) 

training of control staff; 

(i) 

financing  of  other  measures  needed  to  ensure  application  of  the  Regulation 
adopted under Article 65. 

2. 

The  appropriations  required  under  paragraph  1  shall  be  subject  to  authorisation  by 
the budgetary authority each financial year. 

EN 

59 

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Article 74  
Guidance documents 

The Commission may, in accordance with the procedure referred to in Article 76(2), adopt or 
amend  technical  and  other  guidance  documents  for  the  implementation  of  this  Regulation. 
The  Commission  may  ask  the  Authority  to  prepare  or  to  contribute  to  such  guidance 
documents.  

Article 75 
Amendments and implementing measures 

1. 

The  following  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 76(3): 

(a) 

(b) 

(c) 

amendments  to  the  Annexes,  taking  into  account  current  scientific  and 
technical knowledge; 

the  Regulations  on  data  requirements  for  active  substances  and  for  plant 
protection products, as referred to in Article 8(1)(b) and (c), taking into account 
scientific and technical knowledge; 

amendments  to  the  Regulation  on  uniform  principles  for  evaluation  and 
authorisation of plant protection products, as referred to in Article 29(6), taking 
into account scientific and technical knowledge; 

(d) 

amendments to the Regulation containing the requirements of the labelling of 
plant protection products as referred to in Article 62(1); 

(e) 

the measures needed to implement this Regulation. 

In accordance with the procedure referred to in Article 76(2), a Regulation shall be 
adopted  containing  the  list  of  active  substances  included  in  Annex  I  to  Directive 
91/414/EEC.  Those  substances  shall  be  deemed  to  have  been  approved  under  this 
Regulation. 

Article 76 
Committee 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal  Health,  as  established  by  Article  58  of  Regulation  (EC)  No  178/2002, 
hereinafter referred to as “the Committee”. 

reference 

Where 
this  paragraph,  Articles  3  and  7  of 
Decision 1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

is  made 

to 

reference 

Where 
this  paragraph,  Articles  5  and  7  of 
Decision 1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

is  made 

to 

2. 

1. 

2. 

3. 

EN 

60 

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The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 

4. 

The Committee shall adopt its Rules of Procedure. 

Chapter XI 
Transitional and final provisions 

Article 77 
Transitional measures  

1. 

2. 

3. 

4. 

Directive  91/414/EEC  (“the  Directive”)  shall  continue  to  apply,  with  respect  to  the 
procedure and the conditions for approval, to active substances for which a decision 
has been adopted in accordance with Article 6(3) of that Directive before the date of 
application of this Regulation. 

On the basis of the examination carried out under the Directive, a Regulation on the 
approval  of  such  a  substance  shall  be  adopted  in  accordance  with  Article  13(2)  of 
this Regulation. 

Article  13(1)  to  (4)  of  the  Directive  and  Annexes  II  and  III  to  the  Directive  shall 
continue  to  apply  with  respect  to  active  substances  included  in  Annex  I  to  the 
Directive and to active substances approved in accordance with paragraph 1: 

– 

– 

– 

For  a  period  of  five  years  from  the  date  of  their  inclusion  or  approval,  for 
active substances covered by Article 8(2) of the Directive. 

For a period of ten years from the date of their inclusion or approval, for active 
substances  which  were  not  on  the  market  two  years  after  the  date  of 
notification of the Directive. 

For  a  period  of  five  years  from  the  date  of  the  renewal  of  the  inclusion  or 
renewal  of  the  approval,  for  active  substances  whose  inclusion  in  Annex  I  to 
the Directive expires at the latest two years after the date of publication of this 
Regulation. This provision shall only apply to data necessary for the renewal of 
the approval and which were certified as compliant with the principles of Good 
Laboratory practice at the latest two years after the publication of Regulation. 

Where Article 13 of the Directive applies by virtue of paragraph 1 or paragraph 2, it 
shall be subject to any special rules concerning the Directive laid down in the Act of 
Accession by which a Member State joined the Community. 

For  active  substances  for  which  the  first  approval  expires  at  the  latest  three  years 
after the entry into force of this Regulation, the application provided for in Article 14 
shall be submitted by a producer of the active substance to a Member State, with a 
copy  to  the  other  Member  States,  the  Commission  and  the  Authority,  no  later  than 
two years before the expiry of the first approval. 

EN 

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5. 

6. 

Applications  for  authorisations  of  plant  protection  products  under  Article  4  of  the 
Directive which are pending in the Member States on the date of application of this 
Regulation shall be decided on the basis of national law in force on that date. 

After that decision, this Regulation shall apply. 

Products labelled in accordance with Article 16 of the Directive may continue to be 
placed on the market for four years from the date of application of this Regulation. 

Article 78 
Derogation for safeners and synergists 

By  way  of  derogation  from  Article  28(1),  a  Member  State  may,  for  a  period  of  five  years 
following the adoption of the programme referred to in Article 26 authorise the placing on the 
market  in  its  territory  of  plant  protection  products  containing  safeners  and  synergists  which 
have not been approved, where they are included in that programme. 

Article 79 
Repeal 

Directives  79/117/EEC  and  91/414/EEC,  as  amended  by  the  acts  listed  in  Annex V,  are 
repealed with effect from the date of application of this Regulation, without prejudice to the 
obligations of the Member States relating to the time-limits for transposition into national law 
and application of the Directives set out in that Annex. 

References to the repealed Directives shall be construed as references to this Regulation. 

Article 80 
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. 

The  Commission  shall  within  18  months  after  its  entry  into  force  adopt  the  following 
Regulations: 

– 

– 

– 

– 

– 

A  Regulation  containing  the  list  of  the  active  substances  already  approved  at  the 
moment of publication of that Regulation  

A  Regulation  on  data  requirements  for  active  substances,  as  referred  to  in  Article 
8(1)(b)  

A  Regulation  on  data  requirements  for  plant  protection  products,  as  referred  to  in 
Article 8(1)(c) 

A Regulation on uniform principles for risk assessment for plant protection products, 
as referred to in Article 35 

A  Regulation  containing  the  requirements  of  the  labelling  of  plant  protection 
products as referred to in Article 62(1). 

EN 

62 

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It  shall  apply  from  18  months  from  that  date  on  which  it  enters  into  force.  [OFFICE  OF 
PUBLICATIONS: INSERT DATE … AFTER PUBLICATION] 

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

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX I 

Definition of zones for the authorisation of plant protection products 

Zone A – North 

The following Member States belong to this zone: 

Denmark, Estonia, Latvia, Lithuania, Finland, Sweden 

The following Member States belong to this zone: 

Zone B – Centre 

Belgium,  Czech  Republic,  Germany,  Ireland,  Luxemburg,  Hungary,  Netherlands,  Austria, 
Poland, Slovenia, Slovakia, United Kingdom 

Zone C – South 

The following Member States belong to this zone: 

Greece, Spain, France, Italy, Cyprus, Malta, Portugal 

EN 

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ANNEX II 

Procedure  and  criteria  for  the  approval  of  active  substances,  safeners  and  synergists 
pursuant to Chapter II 

1. 

Evaluation 

1.1.  During  the  process  of  evaluation  and  decision-making  provided  for  in 
Articles 4 to 21, the rapporteur Member State and the Authority shall cooperate 
with applicants to resolve any questions on the dossier quickly or to identify at 
an early stage any additional studies necessary for the evaluation of the dossier, 
including information to eliminate the need for a restriction of the approval, or 
to amend any proposed conditions for the use of the plant protection product or 
to modify its nature or its composition in order to ensure full satisfaction of the 
requirements of this Regulation.  

1.2.  The  evaluation  by  the  Authority  and  the  rapporteur  Member  State  must  be 
based on scientific principles and be made with the benefit of expert advice. 

1.3.  During the process of evaluation and decision-making provided for in Articles 
4  to  21,  Member  States  and  the  Authority  shall  take  into  consideration  any 
further guidance developed in the framework of the Standing Committee on the 
Food Chain and Animal Health for the purposes of refining, where relevant, the 
risk assessments. 

2. 

General decision-making criteria 

2.1.  Article 7(1) shall only be considered as complied with, where, on the basis of 
the dossier submitted, authorisation in at least one Member State is expected to 
be  possible  for  at  least  one  plant  protection  product  containing  that  active 
substance for at least one of the representative uses. 

2.2.  Submission of further information 

In  principle  an  active  substance  shall  only  be  approved  where  a  complete 
dossier is submitted.  

In exceptional cases an active substance may be approved even though certain 
information is still to be submitted where: 

(a) 

(b) 

the data requirements have been amended or refined after the submission 
of the dossier or; 

the information is considered to be confirmatory in nature, as required to 
increase the confidence in the decision. 

In  such  cases  the  additional  information  shall  be  submitted  to  the  rapporteur 
Member  State  for  evaluation  within  a  deadline  set  by  the  Commission.  The 
Member State shall report to the Commission on the results of the assessment. 

EN 

65 

   EN 

 
 
 
 
2.3.  Restrictions on approval 

Restrictions on approval, where necessary, may be linked to: 

– 

– 

identification of unacceptable risks under particular conditions 

gaps  in  the  risk  assessment  resulting  from  the  limited  range  of 
representative uses and preparations notified by the applicant.  

Where  the  rapporteur  Member State considers  that the dossier provided lacks 
certain  information,  to  the  effect  that  the  active  substance  could  only  be 
approved subject to restrictions, it shall contact the applicant at an early stage 
to obtain more information which may possibly enable these restrictions to be 
removed. 

3. 

Criteria for the approval of an active substance 

3.1.  Dossier  

The  dossiers  submitted  pursuant  to  Article  7(1)  shall  contain  the  information 
needed 
to  establish,  where  relevant,  Acceptable  Daily  Intake  (ADI), 
Acceptable  Operator  Exposure  Level  (AOEL)  and  Acute  Reference  Dose 
(ARfD). 

In the case of an active substance for which the limited range of representative 
uses includes use on feed or food crops or leads indirectly to residues in food 
or  feed,  the  dossier  submitted  pursuant  to  Article  7(1)  shall  contain  the 
information  necessary  to  carry  out  a  risk  assessment  and  for  enforcement 
purposes. 

The dossier shall in particular: 

(a) 

permit any residue of concern to be defined; 

(b) 

reliably predict the residues in food and feed, including succeeding crops; 

(c) 

reliably  predict,  where  relevant, 
reflecting the effects of processing and/or mixing; 

the  corresponding  residue 

level 

(d)  permit  a  Maximum  Residue  Level  (MRL)  to  be  defined  for  the 
commodity and, where appropriate, for products of animal origin where 
the commodity or parts of it is fed to animals; 

(e) 

permit,  where  relevant,  concentration  or  dilution  factors  due  to 
processing and/or mixing to be defined;  

The  dossier  submitted  pursuant  to  Article  7(1)  shall  be  sufficient  to  permit, 
where relevant, an estimate of the fate and distribution of the active substance 
in the environment, and its impact on non-target species. 

EN 

66 

   EN 

 
 
 
 
 
 
 
3.2.  Efficacy 

An active substance shall only be approved where it has been established for a 
limited  range  of  representative  uses  that  the  plant  protection  product, 
consequent  on  application  consistent  with  good  plant  protection  practice  and 
having regard to realistic normal conditions of use is sufficiently effective. This 
requirement  shall  be  evaluated  in  the  light  of  the  uniform  principles  for 
evaluation  and  authorisation  of  plant  protection  products  referred  to  in  the 
second paragraph of Article 35.  

3.3.  Toxic relevance of breakdown products  

Where  the  limited  range  of  representative  uses  includes  use  on  food  or  feed 
crops,  the  documentation  submitted  shall  be  sufficient  to  permit  the 
establishment of  the toxicological relevance of breakdown products that were 
not  present  in  the  animals  used  in  the  test  or  studies  performed  on  the  active 
substance but which are formed in or on treated plants, as a result of processing 
or are found in studies performed on livestock animals. 

3.4.  Composition of the active substance 

3.4.1. The specification shall define the minimum degree of purity, the identity 
and  maximum  content  of  impurities,  and  where  relevant  of  isomers  / 
diastereo-isomers  and  additives,  and  the  content  of  impurities  of 
toxicological,  ecotoxicological  or  environmental  concern  within 
acceptable limits. 

3.4.2. The  specification  shall  be  in  compliance  with  the  relevant  FAO 
specification  where  such  specification  exists.  However  where  necessary 
for reasons of protection of human or animal health or the environment, 
stricter specifications may be adopted.  

3.5.  Methods of analysis  

3.5.1. The methods of analysis of the active substance as manufactured and of 
determination  of 
toxicological,  ecotoxicological  or 
environmental  concern  or  which  are  present  in  quantities  greater  than  1 
g/kg  in  the  active  substance  as  manufactured,  shall  have  been  validated 
and shown to be sufficiently specific, linear, accurate and precise. 

impurities  of 

3.5.2. The  method  of  analysis  in  environmental  matrices,  as  appropriate,  shall 
have been validated and shown to be sufficiently sensitive with respect to 
the levels of concern.  

3.5.3. The  evaluation  has  been  carried  out  in  accordance  with  the  uniform 
principles  for  evaluation  and  authorisation  of  plant  protection  products 
referred to in Article 35.  

EN 

67 

   EN 

 
 
 
3.6.  Impact on human health  

3.6.1. Where  relevant,  an  ADI,  AOEL  and  ARfD  shall  be  established.  When 
establishing  such  values  a  sufficient  safety  margin  shall  be  ensured 
taking into account the type and severity of effects and the vulnerability 
of specific groups of the population.  

3.6.2. An active substance shall only be approved, if, on the basis of assessment 
of higher tier genotoxicity testing carried out in accordance with the data 
requirements for the active substances and the plant protection products 
and  other  available  data  and  information,  it  is  not  classified,  in 
accordance  with  the  provisions  of  Directive  67/548/EEC,  as  mutagen 
category 1 or 2 unless the exposure of humans to that active substance in 
a  plant  protection  product,  under  realistic  proposed  conditions  of  use  is 
negligible. 

3.6.3. An active substance shall only be approved, if, on the basis of assessment 
of  carcinogenicity  testing  carried  out  in  accordance  with  the  data 
requirements for the active substances and the plant protection products 
and  other  available  data  and  information,  it  is  not  or  has  not  to  be 
classified, in accordance with the provisions of Directive 67/548/EEC, as 
carcinogen category 1 or 2 unless the exposure of humans to that active 
substance  in  a  plant  protection  product,  under  realistic  proposed 
conditions of use is negligible.  

3.6.4. An active substance shall only be approved, if, on the basis of assessment 
of  reproductive  toxicity  testing  carried  out  in  accordance  with  the  data 
requirements for the active substances and the plant protection products 
and  other  available  data  and  information,  it  is  not  or  has  not  to  be 
classified, in accordance with the provisions of Directive 67/548/EEC, as 
toxic for reproduction category 1 or 2 unless the exposure of humans to 
that  active  substance  in  a  plant  protection  product,  under  realistic 
proposed conditions of use is negligible.  

3.6.5. An  active  substance  shall  only  be  approved,  if,  on  the  basis  of  the 
assessment  of  Community  or  internationally  agreed  test  guidelines  it  is 
not  considered  to  have  endocrine  disrupting  properties  that  may  be  of 
toxicological  significance  in  humans  unless  the  exposure  of  humans  to 
that  active  substance  in  a  plant  protection  product,  under  realistic 
proposed conditions of use, is negligible. 

3.7.  Fate and behaviour in the environment 

3.7.1. An active substance shall only be approved where it is not considered to 

be a persistent organic pollutant. 

EN 

68 

   EN 

 
A persistent organic pollutant is defined as follows: 

(a)  Persistence: 

(i)  Evidence that its DT50 in water is greater than two months, 
or that its DT50 in soil is greater than six months, or that its 
DT50 in sediment is greater than six months; and 

(b)  Bio-accumulation: 

(i)  Evidence that its bio-concentration factor or bio accumulation 
factor  in  aquatic  species  is  greater  than  5,000  or,  in  the 
absence of such data, that the log Ko/w is greater than 5;  

(ii)  Evidence that a chemical presents other reasons for concern, 
such  as  high  bio-accumulation  in  other  non-target  species, 
high toxicity or ecotoxicity; and 

(c)  Potential for long-range environmental transport: 

(i)  Measured  levels  of  the  active  substance  in  locations  distant 

from the sources of its release that are of potential concern;  

(ii)  Monitoring  data  showing  that  long-range  environmental 
transport  of  the  active  substance,  with  the  potential  for 
transfer  to  a  receiving  environment,  may  have  occurred  via 
air, water or migratory species; or 

(iii)  Environmental  fate  properties  and/or  model  results  that 
demonstrate that the active substance has a potential for long-
range environmental transport through air, water or migratory 
species,  with  the  potential  for  transfer  to  a  receiving 
environment  in  locations  distant  from  the  sources  of  its 
release.  For  an  active  substance  that  migrates  significantly 
through  the  air,  its  DT50  in  air  should  be  greater  than  two 
days. 

3.7.2. An active substance shall only be approved if it is not considered to be a 

persistent, bioaccumulating and toxic (PBT) substance. 

A substance that fulfils all three of the criteria of the sections below is a 
PBT substance. 

3.7.2.1.  Persistence 

An active substance fulfils the persistence criterion where: 

– 

the half-life in marine water is higher than 60 days, or 

EN 

69 

   EN 

 
 
 
 
– 

– 

– 

the half-life in fresh or estuarine water is higher than 40 days, 
or 

the half-life in marine sediment is higher than 180 days, or 

the  half-life  in  fresh  or  estuarine  water  sediment  is  higher 
than 120 days, or 

– 

the half-life in soil is higher than 120 days. 

Assessment  of  persistency  in  the  environment  shall  be  based  on 
available  half-life  data  collected  under  appropriate  conditions, 
which shall be described by the applicant. 

3.7.2.2.  Bioaccumulation 

An active substance fulfils the bioaccumulation criterion where the 
bioconcentration factor (BCF) is higher than 2000.  

Assessment of bioaccumulation shall be based on measured data on 
bioconcentration in aquatic species. Data from both freshwater and 
marine water species can be used.  

3.7.2.3.  Toxicity 

An active substance fulfils the toxicity criterion where:  

– 

– 

– 

the  long-term  no-observed  effect  concentration  (NOEC)  for 
marine or freshwater organisms is less than 0.01 mg/l, or 

the substance is classified as carcinogenic (category 1 or 2), 
mutagenic  (category  1  or  2),  or  toxic  for  reproduction 
(category 1, 2, or 3), or 

there is other evidence of chronic toxicity, as identified by the 
classifications:  T,  R48  or  Xn,  R48  pursuant  to  Directive 
67/548/EEC.  

3.7.3. An active substance shall not be considered as complying with Article 4 

where it is very persistent, very bioaccumulating (vPvB). 

A  substance  that  fulfils  both  of  the  criteria  of  the  sections  below  is  a 
vPvB substance. 

EN 

70 

   EN 

 
 
 
 
 
 
3.7.3.1.  Persistence 

An active substance fulfils the very persistence criterion where: 

– 

– 

the half-life in marine, fresh- or estuarine water is higher than 
60 days, or 

the  half-life  in  marine,  fresh-  or  estuarine  water  sediment  is 
higher than 180 days, or 

– 

the half-life in soil is higher than 180 days. 

3.7.3.2.  Bioaccumulation 

An  active  substance  fulfils  the  very  bioaccumulative  criterion 
where the bioconcentration factor is greater than 5000. 

3.8.  Ecotoxicology 

3.8.1. An active substance shall only be considered as complying with Article 4 
if the risk assessment demonstrates risks to be acceptable in accordance 
with  the  criteria  laid  down  in  the  uniform  principles  for  evaluation  and 
authorisation of plant protection products referred to in Article 35 under 
realistic  proposed  conditions  of  use  of  a  plant  protection  product 
containing  the  active  substance.  The  assessment  must  take  into  account 
the  severity  of  effects,  the  uncertainty  of  the  data,  and  the  number  of 
organism  groups  which  the  active  substance  is  expected  to  affect 
adversely by the intended use. 

3.8.2. An active substance shall only be considered as complying with Article 4 
if, on the basis of the assessment of Community or internationally agreed 
test  guidelines,  it  is  not  considered  to  have  endocrine  disrupting 
properties  that  may  be  of  toxicological  significance  on  non-target 
organisms  unless  the  exposure  of  non-target  organisms  to  that  active 
substance  in  a  plant  protection  product,  under  realistic  proposed 
conditions of use is negligible. 

3.9.  Residue definition 

An  active  substance  shall  only  be  approved  if,  where  relevant,  a  residue 
definition  can  be  established  for  the  purposes  of  risk  assessment  and  for 
enforcement purposes.  

4. 

Criteria for approval as a candidate for substitution 

An  active  substance  shall  be  approved  as  a  candidate  for  substitution  pursuant  to 
Article 24 where: 

– 

its ADI, ARfD or AOEL is significantly lower than those of the majority of the 
approved active substances; 

EN 

71 

   EN 

 
 
 
 
– 

– 

it meets two of the criteria to be considered as a PBT substance; 

there are reasons for concern linked to the nature of the critical effects which, 
in combination with the use/exposure patterns, amount to situations of use that 
could  still  cause  concern,  even  with  very  restrictive  risk  management 
measures(such as extensive personal protective equipment or very large buffer 
zones); 

– 

it contains a significant proportion of non-active isomers. 

EN 

72 

   EN 

 
List of co-formulants which are not accepted for inclusion in plant protection products

ANNEX III 

EN 

73 

   EN 

 
ANNEX IV 

Comparative assessment pursuant to Article 48 

1. 

Conditions for comparative assessment 

A comparative assessment shall be performed by Member States when evaluating an 
application  for  authorisation  for  a  plant  protection  product  containing  an  active 
substance approved as a candidate for substitution. 

Where  refusal  or  withdrawal  of  an  authorisation  of  a  plant  protection  product  in 
favour  of  an  alternative  plant  protection  product  is  considered  (hereinafter 
‘substitution’),  the  alternative  must,  in  the  light  of  scientific  and  technical 
knowledge,  show  significantly  lower  risk  to  health  or  the  environment.  An 
assessment  of  the  alternative  plant  protection  product  shall  be  performed  to 
demonstrate  whether  it  can  be  used  with  similar  effect  on  the  target  organism  and 
without significant economic and practical disadvantages to the user or not. 

Further conditions for refusal or withdrawal of an authorisation are: 

(a) 

(b) 

(c) 

substitution  shall  be  applied  only  where  the  chemical  diversity  of  the  active 
substances  is  sufficient  to  minimise  the  occurrence  of  resistance  in  the  target 
organism; 

substitution  shall  be  applied  only  to  active  substances  which,  where  used  in 
authorised plant protection products, present a significantly higher level of risk 
to human health or the environment; 

substitution  shall  be  applied  only  after  allowing  for  the  possibility,  where 
necessary,  of  acquiring  experience  from  use  in  practice,  where  not  already 
available. 

2. 

Significant difference in risk 

A  significant  difference  in  risk  shall  be  identified  on  a  case-by-case  basis  by  the 
competent authorities.  The  properties of the active substance, and the possibility of 
exposure  of  different  population  subgroups  (professional  or  non-professional  users, 
bystanders, workers, residents, specific vulnerable groups or consumers) directly or 
indirectly through food, feed, water or the environment shall be taken into account. 
Other  factors  such  as  the  stringency  of  imposed  restrictions  on  use  and  prescribed 
personal protective equipment must also be considered. 

For  the  environment,  a  factor  of  at  least  10  between  the  Predicted  Environmental 
Concentration  (PEC)  and  the  Predicted  No  Effect  Concentration  (PNEC)  ratios  of 
different active substances is considered a significant difference in risk. 

EN 

74 

   EN 

 
3. 

Significant practical or economic disadvantages 

Significant  practical  or  economic  disadvantage  to  the  user  is  defined  as  a  major 
quantifiable impairment of working practices or business activity leading to inability 
to maintain sufficient control of the target organism. Such a major impairment might 
be,  for  example,  where  no  technical  facilities  for  the  use  of  the  alternative 
substance(s) are available or economically feasible. 

Where  a  comparative  assessment  indicates  that  restrictions/prohibitions  of  use  of  a 
plant protection product could cause such disadvantage, then this will be taken into 
account in the decision-making process. This situation must be substantiated. 

EN 

75 

   EN 

 
ANNEX V 

Repealed Directives and their successive amendments 

A. Directive 91/414/EEC 

Acts amending Directive 91/414/EEC 

Deadline for transposition 

Directive 93/71/EEC 

Directive 94/37/EC 

Directive 94/79/EC 

Directive 95/35/EC 

Directive 95/36/EC 

Directive 96/12/EC 

Directive 96/46/EC 

Directive 96/68/EC 

Directive 97/57/EC 

Directive 2000/80/EC 

Directive 2001/21/EC 

Directive 2001/28/EC 

Directive 2001/36/EC 

Directive 2001/47/EC 

Directive 2001/49/EC 

Directive 2001/87/EC 

Directive 2001/99/EC 

Directive 2001/103/EC 

Directive 2002/18/EC 

Directive 2002/37/EC 

3 August 1994 

31 July 1995 

31 January 1996 

30 June 1996 

30 April 1996 

31 March 1997 

30 April 1997 

30 November 1997 

1 October 1997 

1 July 2002 

1 July 2002 

1 August 2001 

1 May 2002 

31 December 2001 

31 December 2001 

31 March 2002 

1 January 2003 

1 April 2003 

30 June 2003 

31 August 2003 

EN 

76 

   EN 

 
Directive 2002/48/EC 

31 December 2002 

Directive 2002/64/EC 

Directive 2002/81/EC 

Directive 2003/5/EC 

31 March 2003 

30 June 2003 

30 April 2004 

Directive 2003/23/EC 

31 December 2003 

Directive 2003/31/EC 

30 June 2004 

Directive 2003/39/EC 

30 September 2004 

Directive 2003/68/EC 

31 March 2004 

Directive 2003/70/EC 

30 November 2004 

Directive 2003/79/EC 

Directive 2003/81/EC 

Directive 2003/82/EC 

Directive 2003/84/EC 

Directive 2003/112/EC 

30 June 2004 

31 January 2005 

30 July 2004 

30 June 2004 

30 April 2005 

Directive 2003/119/EC 

30 September 2004 

Regulation (EC) No 806/2003 

Directive 2004/20/EC 

- 

31 July 2005 

Directive 2004/30/EC 

30 November 2004 

Directive 2004/58/EC 

Directive 2004/60/EC 

Directive 2004/62/EC 

Directive 2004/66/EC 

Directive 2004/71/EC 

Directive 2004/99/EC 

31 August 2005 

28 February 2005 

31 March 2005 

1 May 2004 

31 March 2005 

30 June 2005 

Directive 2005/2/EC 

30 September 2005 

EN 

77 

   EN 

 
Directive 2005/3/EC 

30 September 2005 

Directive 2005/25/EC 

28 May 2006 

Directive 2005/34/EC 

30 November 2005 

Directive 2005/53/EC 

Directive 2005/54/EC 

Directive 2005/57/EC 

Directive 2005/58/EC 

31 August 2006 

31 August 2006 

31 October 2006 

31 May 2006 

Directive 2005/72/EC 

31 December 2006 

Directive 2006/5/EC 

Directive 2006/6/EC 

31 March 2007 

31 March 2007 

Directive 2006/10/EC 

30 September 2006 

Directive 2006/16/EC 

31 January 2007 

Directive 2006/19/EC 

30 September 2006 

Directive 2006/39/EC 

31 July 2007 

EN 

78 

   EN 

 
 
B. Directive 79/117/EEC 

Acts amending Directive 79/117/EEC 

Deadline for transposition 

Directive 83/131/EEC 

Directive 85/298/EEC 

Directive 86/214/EEC 

Directive 86/355/EEC 

1 October 1984 

1 January 1986 

- 

1 July 1987 

Directive 87/181/EEC 

1 January 1988 and 1 January 1989 

Directive 87/477/EEC 

1 January 1988 

Directive 89/365/EEC 

31 December 1989 

Directive 90/335/EEC 

1 January 1991 

Directive 90/533/EEC 

31 December 1990 and 30 September 1990 

Directive 91/118/EEC 

31 March 1992 

Regulation (EC) No 807/2003 

Regulation (EC) No 850/2004 

- 

- 

EN 

79 

   EN 

 
 
FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL : 

Proposal for a Regulation of the European Parliament and of the Council concerning 
the placing of plant protection products on the market. 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned: Health and Consumer Protection 

Activity/Activities:  Plant  health,  Food  Safety,  Animal  Health,  Animal  Welfare  and 
Protection of the Environment 

3. 

BUDGET LINES 

3.1.  Budget  lines  (operational  lines  and  related  technical  and  administrative 

assistance lines (ex- B..A lines)) including headings :  

17.01.04.01Plant health measures expenditure on administrative management. 

3.2.  Duration of the action and of the financial impact: 

Open ended 

3.3.  Budgetary characteristics (add rows if necessary) : 

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

17.01.04.01  Comp/ 

D 

NO 

NO 

NO 

NO [2] 

EN 

80 

   EN 

 
 
 
4. 

SUMMARY OF RESOURCES 

4.1.  Financial Resources 

4.1.1. Summary  of 

commitment 

appropriations 

(CA) 

and  payment 

appropriations (PA) 

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

Operational expenditure14 

Commitment 
Appropriations (CA) 

8.1 

Payment Appropriations 
(PA) 

a 

b 

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 

Administrative expenditure within reference amount15 

Technical & 
administrative assistance 
(NDA) 

8.2.4 

c 

1.0 

1.0 

1.0 

1.0 

1.0 

1.0 

6.0 

TTOOTTAALL  RREEFFEERREENNCCEE  AAMMOOUUNNTT  

Commitment 
Appropriations 

Payment 
Appropriations 

a+c 

1.0 

1.0 

1.0 

1.0 

1.0 

1.0 

6.0 

b+c 

1.0 

1.0 

1.0 

1.0 

1.0 

1.0 

6.0 

Administrative expenditure not included in reference amount16 

Human resources and 
associated expenditure 
(NDA) 

Administrative costs, other 
than human resources and 
associated costs, not 
included in reference amount 
(NDA) 

8.2.5 

d 

1.348  1.348 

1.348 

1.348 

1.348 

1.348 

8.088 

8.2.6 

e 

0.85 

0.85 

0.85 

0.85 

0.85 

0.85 

5.10 

Total indicative financial cost of intervention 

TOTAL CA including 
cost of Human 
Resources 

TOTAL PA including 
cost of Human 
Resources 

14 
15 
16 

No expenditure foreseen. 
Expenditure within article 17 01 04 01. 
Expenditure within chapter 17 01 01. 

EN 

a+c
+d+
e 

b+c
+d+
e 

81 

3.198  3.198 

3.198 

3.198 

3.198 

3.198 

19.188 

3.198  3.198 

3.198 

3.198 

3.198 

3.198 

19.188 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
                                                 
Co-financing details 

If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please 
specify  which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in 
the table below (additional lines may be added if different bodies are foreseen for the 
provision of the co-financing): 

Co-financing body 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

EUR million (to 3 decimal places) 

…………………… 

TOTAL CA including co-
financing 

f 

a+c
+d+
e+f 

4.1.2. Compatibility with Financial Programming 

(cid:50) 

(cid:133) 

(cid:133) 

Proposal is compatible with existing financial programming. 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the 
financial perspective. 

Proposal  may  require  application  of  the  provisions  of  the 
Interinstitutional Agreement17 (i.e. flexibility instrument or revision 
of the financial perspective). 

4.1.3. Financial impact on Revenue 

(cid:50) 

Proposal has no financial implications on revenue 

(cid:133) 

Proposal has financial impact – the effect on revenue is as follows: 

NB:  All details and observations relating to the method of calculating 
the effect on revenue should be shown in a separate annex. 

17 

See points 19 and 24 of the Interinstitutional agreement. 

EN 

82 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Budget line 

Revenue 

EUR million (to one decimal place) 

Situation following action 

[Yea
r n] 

[n+1] [n+2]

[n+3
] 

[n+4] 

[n+5]
18 

Prior to
action 
[Year 
n-1] 

a) Revenue in absolute terms 

b) Change in revenue 

 Δ 

(Please specify each revenue budget line involved, adding the appropriate number 
of rows to the table if there is an effect on more than one budget line.) 

4.2.  Human Resources FTE (including officials, temporary and external staff) – see 

detail under point 8.2.1. 

Annual requirements  Year n  n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 
number 
human resources 

of 

13 

13 

13 

13 

13 

13 

5. 

CHARACTERISTICS AND OBJECTIVES 

Details  of  the  context  of  the  proposal  are  required  in  the  Explanatory 
Memorandum.  This  section  of  the  Legislative  Financial  Statement  should 
include the following specific complementary information: 

5.1.  Need to be met in the short or long term 

In  order  to  assure  proportionality  of  the  implementing  measures  that  will  be 
taken  in  the  framework  of  the  proposed  regulation,  the  following  instruments 
are therefore needed:  

The  Legislation  on  placing  plant  protection  products  on  the  market  is 
harmonised  within  the  EU.  Decisions  on  active  substances  are  taken  at  EU 
level; decisions on plant protection products (products used by the farmers) are 
taken by Member States, based on uniform criteria and data requirements. 

Presently there are about 500 active substances under examination for approval 
at  EU  level  (inclusion  in  a  positive  list).  Such  a  list  has  to  be  managed 
continuously.  The  proposal  provides  for  obligatory  zonal  mutual  recognition 
which  has  to  be  coordinated.  Reinforced  control  measures  require  continuous 
follow-up. 

18 

Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years. 

EN 

83 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
The  following  instruments  are  foreseen  in  the  framework  of  the  proposed 
Regulation: 

(a) 

(b) 

(c) 

(d) 

(e) 

the  development  of  a  harmonised  system,  including  an  appropriate 
database,  for  gathering  and  storing  all  information  concerning  active 
substances, safeners, synergists, co-formulants, plant protection products 
and  adjuvants  and  for  making  such  information  available  to  the 
competent authorities, producers and other interested parties;  

the  performance  of  studies  necessary 
the  preparation  and 
development of further legislation on the placing on the market and use 
of plant protection products and adjuvants; 

for 

the performance of studies necessary to harmonise procedures, decision-
making criteria and data requirements;  

coordination,  if  necessary  by  electronic  means,  of  the  cooperation 
between  Member  States,  the  Authority  and  the  Commission  and 
measures to facilitate work sharing; 

the development and maintenance of a coordinated electronic submission 
and evaluation system aimed at promoting electronic document exchange 
and  work  sharing  between  the  applicants,  the  Member  States,  the 
Authority and the Commission; 

(f) 

development  of  guidance  to  facilitate  the  day-to-day  implementation  of 
this Regulation; 

(g)  measures  to  ensure  the  application  of  the  control  measures  such  as 
training  of  control  staff,  travel  and  subsistence  expenses  that  Member 
States’  experts  incur  as  a  result  of  the  Commission  appointing  them  to 
assist its experts in the framework of control activities 

5.2.  Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 

other financial instruments and possible synergy 

The data and information obtained will help in assuring: 

– 

– 

effective protection of plants 

protection  of  human  health  (consumers,  users  of  plant  protection 
products) and the environment 

– 

a harmonised and predictable legal environment for industry 

5.3.  Objectives,  expected  results  and  related  indicators  of  the  proposal  in  the 

context of the ABM framework 

Assure that the use of plant protection products does not lead to unacceptable 
risks for the user, the consumer or the environment and at the same time does 
not  impose  unnecessary  burden  to  the  industry  by  ensuring  an  appropriate 
functioning of the internal market for plant protection products. 

EN 

84 

   EN 

 
 
 
 
5.4.  Method of Implementation (indicative) 

Show below the method(s)19 chosen for the implementation of the action. 

X 

Centralised Management 

X 

ٱ 

Directly by the Commission 

Indirectly by delegation to: 

ٱ 

ٱ 

ٱ 

Executive Agencies 

Bodies set up by the Communities as referred to in art. 185 of 
the Financial Regulation 

National  public-sector  bodies/bodies  with  public-service 
mission 

ٱ 

Shared or decentralised management 

ٱ 

ٱ 

With Member states 

With Third countries 

ٱ 

Joint management with international organisations (please specify) 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The  number  of  active  substances  approved,  of  plant  protection  products 
authorised in Member States of the same  zone and  the implementation  of  the 
legislation by Member States.  

Evaluation 

6.1.1. Ex-ante evaluation 

The  proposed  measure  is  an  amendment  of  an  existing  Directive.  An 
intensive  stakeholder  consultation  has  taken  place.  Main  points  which 
during  the  consultation  were  identified  as  deserving  an  in-depth 
discussion  are  covered  by  the  impact  assessment.  Other  points  which 
bring consistency with other EU policies or optimise existing policies are 
included to improve the current system. 

19 

If  more  than  one  method  is  indicated  please  provide  additional  details  in  the  "Relevant  comments" 
section of this point. 

EN 

85 

   EN 

 
 
 
 
 
                                                 
6.1.2. Measures  taken  following  an  intermediate/ex-post  evaluation  (lessons 

learned from similar experiences in the past) 

6.1.3. Terms and frequency of future evaluation 

The Commission will perform an ongoing evaluation to monitor the need 
to propose implementing measures.  

Indicators  include  the  duration  of  the  evaluation  procedure,  the 
availability  of  plant  protection  products  in  different  zones  and  the 
availability  of  low  risk  plant  protection  products.  A  procedure  allowing 
to adopt implementing measures is foreseen in the Regulation. 

In  addition,  the  effectiveness,  efficiency  and  relevance  of  the  measure 
will be evaluated in accordance with a timetable, which allows the results 
of the evaluation to be used for the decision-making on the modification 
or renewal of the Regulation. 

7. 

ANTI-FRAUD MEASURES  

Full application of internal control standards No 14, 15, 16, 18, 19, 20, 21. 

The  Commission  shall  ensure  that,  when  actions  financed  under  the  present 
programme are implemented, the financial interests of the Community are protected 
by  the  application  of  preventive  measures  against  fraud,  corruption  and  any  other 
illegal activities, by effective checks and by the recovery of the amounts unduly paid 
and, if irregularities are detected, by effective, proportional and dissuasive penalties, 
in  accordance  with  Council  Regulations  (EC  Euratom)  No  2988/95  and  (Euratom, 
EC)  No  2185/96,  and  with  Regulation  (EC)  No  1073/1999  of  the  European 
Parliament and of the Council. 

EN 

86 

   EN 

 
 
 
 
8. 

DETAILS OF RESOURCES 

8.1.  Objectives of the proposal in terms of their financial cost 

Type of 
output 

Av. 
cost 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

Commitment appropriations in EUR million (to 3 decimal places) 

(Headings of Objectives, 
actions and outputs should 
be provided) 

OPERATIONAL 
OBJECTIVE No.1 ……… 

TOTAL COST 

EN 

87 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2  Administrative Expenditure 

8.2.1. Number and type of human resources 

Types of 
post 

Staff to be assigned to management of the action using existing and/or additional 
resources (number of posts/FTEs) 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 

Officials 
or 
temporary 
staff20 (17 
01 01) 

A*/AD 

7 existing 

7 existing 

7 existing 

7 existing 

7 existing 

7 existing 

2 new 

2 new 

2 new 

2 new 

2 new 

2 new 

B*, 
C*/AST 

4 

4 

4 

4 

4 

4 

Staff  financed21  by 
art. XX 01 02 

staff22 
Other 
financed  by  art.  XX 
01 04/05 

TOTAL 

13 

13 

13 

13 

13 

13 

8.2.2. Description of tasks deriving from the action 

Examination  of  technical  reports  from  Industry,  Member  States,  the 
European  Food  Safety  Authority  and  preparation  of  decisions  on 
substances 

Control  of  the  implementation  by  Member  States  of  the  measures 
foreseen in the Regulation 

Preparation  of  legislation  to  harmonise  data  requirements,  criteria, 
control measures 

Examination  of 
commitments and pass to payment 

technical  and  financial  reports,  preparations  of 

20 
21 
22 

Cost of which is NOT covered by the reference amount. 
Cost of which is NOT covered by the reference amount. 
Cost of which is included within the reference amount. 

EN 

88 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.3. Sources of human resources (statutory) 

(When  more  than  one  source  is  stated,  please  indicate  the  number  of 
posts originating from each of the sources) 

(cid:133) 

Posts  currently  allocated  to  the  management  of  the  programme  to 
be replaced or extended 

(cid:133) 

Posts pre-allocated within the APS/PDB exercise for year n 

X 

Posts to be requested in the next APS/PDB procedure 

(cid:133) 

(cid:133) 

Posts  to  be  redeployed  using  existing  resources  within  the 
managing service (internal redeployment) 

Posts  required  for  year  n  although  not  foreseen  in  the  APS/PDB 
exercise of the year in question 

8.2.4. Other  Administrative  expenditure  included  in  reference  amount  (XX  01 

04/05 – Expenditure on administrative management) 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and 
later 

TOTAL 

1.0 

1.0 

1.0 

1.0 

1.0 

1.0 

6.0 

Budget line 

(number and heading) 

1. 

Technical and administrative 
assistance  (including  related 
staff costs) 

Executive agencies23 

Other technical and 
administrative assistance 

– 

– 

intra muros  

extra muros. 
As mentioned in point 
5.01 this will involve the 
development of a 
harmonised system, the 
performance of studies, 
coordination, control 
measures etc. 

Total Technical and administrative 
assistance 

1.0 

1.0 

1.0 

1.0 

1.0 

1.0 

6.0 

23 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

89 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.5. Financial  cost  of  human  resources  and  associated  costs  not  included  in 

the reference amount 

EUR million (to 3 decimal places) 

Type of human resources 

Year n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and later 

Officials and temporary staff 
(XX 01 01) 

Staff financed by Art XX 01 02 
(auxiliary, END, contract staff, etc.) 

(specify budget line) 

Total cost of Human Resources 
and associated costs (NOT in 
reference amount) 

1.188 

1.188 

1.188 

1.188 

1.188 

1.188 

0.160 

0.160 

0.160 

0.160 

0.160 

0.160 

1.348 

1.348 

1.348 

1.348 

1.348 

1.348 

Calculation– Officials and Temporary agents 

Reference should be made to Point 8.2.1, if applicable 

11 officials x 0.108 

Calculation– Staff financed under art. XX 01 02 

Reference should be made to Point 8.2.1, if applicable 

2 END x 0.08 

EN 

90 

   EN 

 
 
 
8.2.6  Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

0.20 

0.20 

0.20 

0.20 

0.20 

0.20 

1.2 

XX  01  02  11  02  –  Meetings  & 
Conferences 

XX 01 02 11 03 – Committees24 
Standing Committee on the Food 
Chain and Animal Health 

XX  01  02  11  04  –  Studies  & 
consultations 

XX  01  02  11  05  -  Information 
systems 

Total  Other  Management 
Expenditure (XX 01 02 11) 

Other  expenditure  of  an 
administrative 
nature 
(specify  including  reference  to 
budget line) 

2. 

3. 

Total Administrative expenditure, 
other than human resources and 
associated costs (NOT included in 
reference amount) 

0.50 

0.50 

0.50 

0.50 

0.50 

0.50 

3.0 

0.15 

0.15 

0.15 

0.15 

0.15 

0.15 

0.90 

0.85 

0.85 

0.85 

0.85 

0.85 

0.85 

5.10 

Calculation - Other administrative expenditure not included in reference amount 

100 missions with a unit cost of 2000 € are foreseen, including in particular to follow the 
evaluations  performed  by  the  European  Food  Safety  Authority  and  to  assist  in  the 
coordination of Member State activities. 

The  organisation  of  meetings  to  prepare  the  necessary  implementing  measures  and  1 
conference to discuss major problems of principle. 

6 Meetings of the Standing Committee (unit cost 25.000 €) are foreseen every year. 

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the  allocation 
granted to the managing DG in the framework of the annual allocation procedure. 

24 

Specify the type of committee and the group to which it belongs. 

EN 

91 

   EN