Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market
Date: 2008-09-22
Institutions: European Commission
Subjects: exchange of information, marketing, marketing standard, pharmaceutical product, plant health product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.9.2008 
COM(2008) 578 final 

 2006/0136 (COD) 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning the 

common position of the Council on the adoption of a Regulation of the European 
Parliament and of the Council concerning the placing of plant protection products on 
the market 

(presented by the Commission) 

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COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning the 

common position of the Council on the adoption of a Regulation of the European 
Parliament and of the Council concerning the placing of plant protection products on 
the market 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM((2006)0388 final – 2006/0136(COD): 

19 July 2006 

Date of the opinion of the European Economic and Social 
Committee: 

31 May 2007 

Date of the opinion of the Committee of the Regions 

13 February 2007 

Date of the opinion of the European Parliament, first reading: 

23 October 2007 

Date of transmission of the amended proposal: 

11 March 2008 

Date of political agreement 

Date of adoption of the common position: 

23 June 2008 

15 September 
2008 

2. 

PURPOSE OF THE COMMISSION PROPOSAL 

The proposed Regulation would replace the existing legislation on the placing on the 
market  of  plant  protection  products  (Council  Directive  91/414/EEC),  thoroughly 
revising  the  procedures  for  the  safety  evaluation  of  active  substances  and  plant 
protection products. However, it keeps the two steps procedure of the Directive:  

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– 

Approval of active substances at EU level 

Authorisation of plant protection products, containing approved substances, by 
Member States. 

For  simplification,  it  would  also  repeal  Council  Directive  79/117/EEC  prohibiting 
the  placing  on  the  market  and  use  of  plant  protection  products  containing  certain 
active  substances.  The  main  aim  of  the  proposal  is  to  maintain  a  high  level  of 
protection  for  humans,  animals  and  the  environment;  to  reduce  the  administrative 
burdens of the present approval and authorisation procedures and to achieve a higher 
level of harmonization. 

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This  proposal  should  be  seen  as  part  of  a  package  together  with  the  Thematic 
Strategy  on  the  Sustainable  Use  of  Pesticides  and  the  proposal  for  a  Framework 
Directive, which fills a legal gap in the use phase of pesticides, as well as a proposal 
for  a  Regulation  on  the  collection  of  statistics  regarding  the  placing  on  the  market 
and the use of plant protection products.  

3. 

COMMENTS ON THE COMMON POSITION 

3.1. 

General comment 

The  Commission  supports  the  common  position  as  adopted  by  the  Council  on 
15 September  2008.  It  is  in  line  with  the  aims  and  the  approach  taken  in  the 
Commission's  original  proposal  and  reflects  the  principles  of  many  amendments 
proposed by the European Parliament.  

3.2. 

Amendments made by the European Parliament at first reading  

Amendments accepted by the Commission and which are in line with the common 
position:  

Amendments 5, 14 and 18 of the European Parliament strengthen the statements of 
recitals  8,  17  and  21  and  have  been  partially  incorporated.  Recital  8  introduces  the 
safeguard of the competitiveness of European agriculture. In recital 17 a reference to 
candidates  for  substitution  has  been  included.  Recital  21  introduces  a  reference  to 
vulnerable groups in the evaluation of any harmful effect on human or animal health.  

Amendment 96 on Article 20 on immediate disposal of a plant protection product in 
case of immediate concerns has been completely incorporated.  

Amendment  159  has  been  incorporated  as  such  in  the  common  position  and  in  the 
Commission  amended  proposal.  It  introduces  in  Article  43  on  the  withdrawal  or 
amendment  of  an  authorisation  of  a  plant  protection  product,  the  possibility  for 
Member  States  to  review  an  authorisation  when  it  concludes  that  the  objectives  of 
Directive 2000/60/EC (Water Framework Directive) may not be achieved.  

Most  elements  of  the  amendments  175  to  180  and  196  on  minor  uses,  aiming  to 
facilitate the authorisations for minor uses, have been accepted by the Commission. 
The  common  position  incorporated  the  ones  concerning  liability  and  extension  of 
data protection for minor uses. In addition, a definition of minor uses as proposed by 
amendment 59 has been included in the common position, while in the Commission 
modified proposal the same is laid down under Article 49 on minor uses.  

The  introduction  of  a  new  Article  49  (a)  on  parallel  trade,  as  proposed  by  the 
European Parliament in amendment 45 and 286, was accepted by the Council and the 
Commission. However the text of the common position reflects the judgment of the 
Court of Justice in more recent Cases. Furthermore, the need for controls on parallel 
trade has been added in Article 65.  

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Also  Amendment  189  has  been  included  as  such  in  the  common  position  and  the 
Commission  amended  proposal.  It  introduces  in  Article  53  the  possibility  for 
Member States to adopt interim protective measures when information on potentially 
harmful effects becomes available.  

The Commission accepted to include a definition of "advertisements" in Article 63. 
This is included in the common position in Article 3.  

The  common  position,  in  line  with  the  Commission  amended  proposal,  includes  in 
Annex II points 3.6.3 to 3.6.5. a detailed definition of "negligible exposure". This is 
in  line  with  amendment  300.  However  the  common  position  excludes  completely 
mutagenic substances, independently from exposure. 

Moreover,  developmental  neurotoxicity  and  immunotoxic  effects,  which  were 
proposed by the European Parliament as exclusion criteria, have been included by the 
common position in the criteria for definition of candidates for substitution, as in the 
Commission amended proposal. The clarification in amendment 248 that a substance 
is  a  candidate  for  substitution  if  one  of  the  relevant  criteria  is  fulfilled  was  also 
included.  

In relation to low risk substances, the common position has incorporated the criteria 
for exclusion of substances from the definition of "low risk" in line with amendment 
301. Such provision has been added in Part 5 of Annex II. One substantial difference 
concerns  "sensitising"  substances,  as  the  amendment  refers  only  to  "sensitising 
chemicals", while the Commission in its amended proposal and the common position 
refer  to  sensitising  in  general,  covering  in  this  way  also  micro–organisms  .  The 
provision  that  the  Commission  shall  review  and  if  necessary  specify  the  low  risk 
criteria has been included in Article 22, but without setting the deadline of one year 
proposed by the European Parliament. 

Other  amendments  which  clarify  the  text  or  better  define  procedures  have  been 
incorporated. They are included in Article 11 on the preparation of a draft assessment 
report  setting  a  maximum  period  of  6  months  for  submission  of  additional 
information,  Article  12  on  the  availability  to  the  public  of  the  conclusions  of  the 
Authority, Article 13 on a provision for a public list of approved substances which 
should  be  electronically  available,  Article  27  adding  a  reference  to  realistic 
conditions of use for co-formulants, Article 30 on adding some specific contents of 
the  authorisations  concerning  application  data  and  Article  36  on  the  procedure  for 
authorisations of plant protection products setting a maximum period of 6 months for 
submission of additional information. The provision for Member States to receive a 
complete dossier on request has been included in Article 41. In Article 62 the need to 
incorporate  the  existing  labelling  requirements  of  Directive  91/414/EEC  into  the 
implementing Commission Regulation on labelling has been introduced.  

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Amendments  not  incorporated  in  the  common  position,  which  are  nevertheless 
accepted  by  the  Commission  in  the  amended  proposal  as  such  or  subject  to 
rewording:  

The  Parliament  proposed  to  introduce  a  reference  to  compliance  with  Directive 
2000/60/EC (Water Framework Directive) in various amendments. The Commission 
amended proposal endorsed them in recital 14, Article 21 (review of approval), and 
Article  43  (withdrawal  or  amendment  of  an  authorisation).  Only  this  latter 
amendment has been incorporated also in the common position.  

The  proposed  amendments  for  recitals  34  and  35  have  been  included  or  partially 
included  in  the  amended  proposal.  They  concern  protection  of  residents  and 
bystanders and the need to ensure that advertisements do not mislead the public.  

Several  amendments  strengthen  the  objective  to  minimize  animal  testing.  The 
Commission incorporated most of these amendments (24, 75, 92, 108, 225) in recital 
32 and in Articles 8, 18, 26, 59 and 75. 

Amendment  34  proposes  to  clarify  in  Article  1  the  purpose  of  the  Regulation.  The 
Commission  accepted  to  include  a  reference  to  the  high  level  of  protection,  to  the 
precautionary  principle  and  to  the  harmonisation  of  availability  of  plant  protection 
products among European farmers.  

Several  new  definitions,  proposed  by  the  European  Parliament,  have  been 
incorporated in Article  3  such as  parallel trade, low risk, rapporteur Member State, 
test  and  studies  and  the  definition  concerning  non  chemicals  methods  of  plant 
protection.  This  last  concept  has  also  been  incorporated  in  the  definition  of  good 
plant protection practice.  

The  European  Parliament  emphasised  in  various  parts  of  the  act  the  reference  to 
vulnerable  groups  and  amendment  49  introduces  a  definition  of  such  groups.  The 
Commission  has  incorporated  most  of  them,  as  well  as  the  definition  of  vulnerable 
groups in Article 3.  

In the definition of integrated pest management, a reference to the encouragement of 
natural pest control mechanisms has been introduced.  

Moreover,  in  the  definition  of  a  substance  of  concern,  the  Commission  included 
endocrine  disrupting  properties,  neurotoxicity  or  immunotoxicity,  in  line  with 
amendment 39 of the European Parliament.  

As  proposed  by  the  European  Parliament,  a  reference  to  vulnerable  groups,  to 
locations  distant  from  use  of  a  substance  following  long  range  environmental 
transport,  its  impact  on  behaviour  of  non  target  species  and  its  impact  on  the 
ecosystem have been incorporated in the approval criteria in Article 4. In addition it 
has  been  clarified  that  analytical  methods  shall  be  standardised  and  sufficiently 
sensitive; this has been partially accepted in the common position.  

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The Commission accepted to include in Article 20 amendment 95 with respect to the 
period of grace for using up stocks of not approved plant protection products within a 
maximum period of one year. 

Amendment  274  establishes  that  foodstuffs  as  defined  by  Regulation  EC  No 
178/2002  have  to  be  considered  as  basic  substance  and  such  amendment  has  been 
directly incorporated in the amended Commission proposal in Article 23.  

The European Parliament introduced in Article 64 (Amendment 217) the obligation 
for  producers  to  undertake  post-registration  monitoring  and  the  Commission  has 
completely incorporated such provision.  

Moreover,  Parliament  proposed  amendment  220  to  include  in  Article  65  on 
monitoring and controls the need to verify compliance with use restrictions at farm 
level.  Such  clarification  has  been  directly  included  in  the  amended  Commission 
proposal. 

The  Commission  incorporated  partly  amendment  248  concerning  the  criteria  for 
approval  as  a  candidate  for  substitution  (Annex  II  point  4).  A  reference  to  a  high 
potential risk for groundwater and to neurotoxic or immunotoxic properties has been 
introduced. 

Furthermore,  in  Annex  IV  part  2  concerning  comparative  assessment,  amendment 
252  has  been  partially  incorporated  with  respect  to  the  consideration  of  cumulative 
and synergistic effects for health risk.  

Other  amendments,  which  were  introduced  by  the  Commission  in  its  amended 
proposal,  concern  the  requirement  in  Article  29  that  the  formulation  of  a  plant 
protection product should be such that it limits user exposure and other risks without 
compromising  efficacy  and  the  obligation  for  Member  States  in  Article  49  to  keep 
available  on  their  official  website  a  list  of  minor  uses.  In  Article  9(2),  the 
Commission proposed 6 months for completion of the dossier if elements are found 
to be missing, while the common position foresees 3 months.  

Comitology 

The alignment with Decision 2006/512/EC (on Comitology) was generally endorsed 
by the Commission amended proposal and by the common position as introduced by 
Parliament amendments.  

Amendments 88, 94, 99, 100, 142, 143, 158, 185, 219, 224, 226, 227 introduce the 
regulatory procedure with scrutiny in cases where the Commission sees the need for 
curtailment  of  time  (e.g.  efficiency  to  respect  time  limits  of  renewal  of  approvals, 
urgency  to  be  applied  in  case  of  threat  to  human  or  animal  health).  Moreover,  the 
approval of an active substance  is  considered  by  both  the  common  position  and  the 
amended proposal as an implementing measure to be adopted in accordance with the 
normal regulatory procedure. 

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In some cases, the co-decision procedure is proposed by the Parliament; however the 
Commission  and  Council  consider  the  concerned  measures  (data  requirements  for 
safeners  and  synergists,  regulation  establishing  a  program  of  work,  control 
regulation) of general scope and amending non essential elements of the Regulation. 
In  addition,  the  Commission  considers  that  the  co-decision  procedure  would  not  be 
appropriate for technical provisions which need to be continuously updated. Therefore, 
they should be adopted in accordance with the regulatory procedure with scrutiny.  

Amendment  120  would  require  the  co-decision  procedure  for  the  adoption  of  a 
Regulation concerning uniform principles incorporating requirements of Annex VI of 
Directive  91/414/EEC.  The  Commission  and  Council  consider  this  as  a  technical 
supplement (simple transfer of already existing requirements) to the basic text by the 
addition of non essential elements and consequently propose the advisory committee. 

In  a  few  cases,  the  Commission  included  the  need  for  urgency  and  efficiency 
provisions.  These  few  cases  refer  to  efficiency  to  respect  time  limits  of  renewal  of 
approvals and urgency to be applied in case of threat to human or animal health.  

3.3. 

New provisions introduced by the Council 

The Council added some technical definitions in Article 3, such as professional user, 
relevant metabolite, impurity etc... 

Some  additional  requirements  in  relation  to  the  use  of  plant  protection  products 
regarding in particular drinking water have been added in Article 4, which are in line 
with some of the amendments proposed by the European Parliament in amendment 
255. 

A  derogation  to  the  approval  criteria  of  Annex  II  has  been  inserted  by  the  Council 
under Article 4 (7). It would allow to approve substances which fail to meet specific 
approval  criteria  (substances  which  are  not  carcinogenic  or  toxic  to  reproduction 
category 2 or endocrine disruptors, as set out in paragraph 3.6.3, 3.6.4, 3.6.5 of 3.8.2 
of Annex II). 

In  Article  14,  a  time  schedule  for  the  renewal  of  approvals  of  active  substances  is 
introduced  (maximum  of  15  years  or  exceptionally,  in  case  of  derogations  under 
Article 4(7), a maximum of 5 years). 

The Council added for safeners and synergists the obligation for the Commission to 
define  data  requirements  (Article  25).  It  provided  also  that  the  assessment  of 
equivalence  (Article  37)  and  the  approval  criteria  (Annex  II,  paragraph  3.6  –  3.9) 
apply to safeners and synergists and not only to active substances. 

The  new  Article  29a  gives  Member  States  the  right  to  grant  provisional 
authorisations  under  certain  conditions  (complete  dossier,  delayed  assessment 
procedure, maximum residue level established). This provision is largely in line with 
amendment 281 of the European Parliament. 

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Article 35 clarifies that for the assessment of dossiers in the light of current scientific 
and technical knowledge, guidance documents as available at the time of application 
should be used. This is in line with amendment 136 of the European Parliament.  

The provisions on mutual recognition and the zonal system (recital 24, articles 35, 39 
and 78a and Annex I) have been re-grouped within the text and partly amended. In 
addition  to  the  Commission  proposal,  voluntary  mutual  recognition  would  be 
allowed for plant protection products authorised in another zone, for plant protection 
products  containing  candidates  for  substitution  (Article  39),  for  provisional 
authorisations  or  for  plant  protection  products  containing  an  active  substance 
approved under the derogation of Article 4(7). For use in seed treatment or in empty 
rooms/containers,  there  is  obligatory  mutual  recognition  at  EU  level.  Provisions  on 
placing on the market of treated seeds have been introduced in a specific Article. 

The  Council  also  added  a  procedure  which  allows  official  or  scientific  bodies 
in  agricultural  activities,  professional  agricultural  organisations  or 
involved 
professional users to apply for mutual recognition in a Member State, even if no such 
application is made or supported by the authorisation holder. 

The  common  position  maintains  compulsory  mutual  recognition,  but  a  derogation 
(Article  35(3))  allows  adaptation  to  local  conditions  and,  exceptionally,  for  the 
Member States to refuse authorisations due to specific and justified risks to health or 
the environment which could not be controlled otherwise. 

The Council added a provision on seed treatments (new recital 26a and Article 47a), 
which  lays  down  additional  labelling  requirements  for  treated  seeds  and  would 
empower  Member  States  to  restrict  the  use  of  treated  seeds  if  they  constitute  a 
serious danger because of the plant protection product used to treat the seed.  

An  additional  period  of  data  protection  of  two  years  and  6  months  is  foreseen  for 
studies necessary for the renewal or review of an authorisation (Article 56). 

Some changes have been done in Article 60, setting out the rules on confidentiality. 
These  amendments  are  mostly  technical  and  clarify  the  difference  between  the 
protection  of  commercial  rights  of  companies  and  the  protection  of  privacy  and 
integrity of individuals. 

The Council has deleted all explicit references of the initial Commission proposal to 
Regulation  (EC)  No  882/2004  on  monitoring  and  controls  for  food  and  feed  in 
Article  65,  to  which  these  controls  should  be  similar,  but  kept  the  reference  to  this 
Regulation in recital 38. 

In  Article  78,  the  Council  added  provisions  setting  out  derogations  for  using  co-
formulants  in  plant  protection  products  as  well  as  a  programme  of  work  for 
adjuvants. 

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Article 78a provides a review clause on the functioning of the mutual recognition of 
authorisation, the zonal system and the criteria for approval, with a report from the 
Commission within five years. 

The Council amended the text in paragraphs 3.6.2 to 3.6.5 and 3.8 of Annex II on the 
approval criteria. Mutagenic substances  of category 1 or 2 can not be approved for 
the  use  in  plant  protection  products.  Substances  which  are  carcinogenic  or  toxic  to 
reproduction as well as endocrine disruptors can only be approved if their use only 
leads  to  negligible  exposure  of  humans  or  the  environment  (the  latter  only  for 
endocrine  disruptors).  The  concept  of  negligible  exposure  for  consumers  is  further 
defined  by  a  reference  to  Regulation  (EC)  No  396/2005  on  setting  of  maximum 
residue levels. 

3.4.  Major problems when adopting the common position 

Legal base  

The  Commission  proposal  is  based  on  Articles  37  and  152  (4)  (b),  which  are  both 
agricultural bases. For the Commission the proposal is agricultural, because without 
plant protection products, agricultural yields would be affected (recital 6). Art. 37 is 
the appropriate basis for all rules on the "production and marketing" of agricultural 
products  which  contribute  to  the  attainment  of  one  or  more  objectives  of  the  CAP. 
The proposal defines what products can be used in the field, so it is clearly linked to 
agricultural  production.  Promoting  more  environmentally  friendly  forms  of 
agricultural production is also one of the aims of the CAP. 

Art. 152 (4) (b) establishes measures in the phytosanitary field which have as direct 
objective the protection of human health.  

The common position adds Article 95 (common market) but deletes Art. 152 (4) (b). 
The Commission has accepted this compromise but made a written statement. 

Data protection Article 56 

The  Commission  proposal  provides  for  data  protection  period  of  10  years.  The 
common position provides that the period can be extended up to 13 years in special 
cases  (e.g.  extensions  to  minor  crops).  It  also  provides  for  2.5  years  of  data 
protection after each renewal of the approval of the active substance. 

The additional data protection  for extensions of use for minor  crops,  also  proposed 
by  the  European  Parliament  (amendment  196),  is  not  controversial.  However, 
additional  data  protection  at  renewal  might  hamper  the  market  access  of  generic 
producers.  The  Commission  did  not  accept  the  proposal  of  the  Presidency  to  give 
5 years  data  protection  at  renewal  but  accepted  the  compromise  of  2.5  years.  The 
European Parliament referred in its amendment 194 to protection of additional data 
required for the purposes of amending the legislation. 

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Monitoring and Controls Article 65 

The Commission has accepted the deletion in Article 65 of the detailed references to 
Regulation  (EC)  No  882/2004  on  monitoring  controls  for  food  and  feed.  This  will 
give  less  certainty  on  the  scope  for  the  implementing  measures  on  control  and 
monitoring.  However,  the  common  position  still  refers  to  Regulation  (EC)  No 
882/2004  in  recital  38.  Therefore  the  same  objectives  are  maintained  for  the 
implementing measure. 

Criteria for approval  

The  Commission  proposal  sets  criteria  for  the  approval  of  active  substances.  The 
Commission proposed that substances which are carcinogenic, mutagenic or toxic for 
reproduction category 1 and 2 (classified or to be classified) (category 1: sufficient 
evidence  for  concerns  in  humans;  category  2:  strong  presumption  of  relevance  to 
humans)  or  which  are  endocrine  disruptors  cannot  be  approved  unless  exposure  is 
negligible. 

The common position maintains the Commission approach and reinforces the criteria 
for mutagens, which are completely excluded. Furthermore, carcinogens, substances 
toxic  for  reproduction  and  endocrine  disruptors,  which  could  be  approved  because 
there is negligible exposure, become candidates for substitution when it comes to the 
authorisation of plant protection products at Member State level (point 4 of Annex II, 
indents 5 and 6). 

A  derogation  (Article  4.7)  provides  that,  if  there  are  no  other  available  means  to 
control a serious danger to plant health, it would be possible to approve a substance 
for  a  maximum  of  5  years  even  if  it  does  not  satisfy  the  listed  criteria.  Their  use 
should  however  be  subject  to  risk  mitigation  measures  to  minimise  exposure  to 
humans and maximum residue levels in food and feed would be set according to the 
normal procedures. These substances would also be excluded from obligatory mutual 
recognition  (Article  40  (2)  (d)).  Substances  which  are  carcinogenic  or  toxic  for 
reproduction category 1 are excluded from the derogation.  

In  addition  in  Article  14  (renewal  of  approval  of  substances)  it  is  clarified  that 
renewal  of  approval  of  such  substances  will  not  be  for  15  years  (as  is  the  case  for 
other substances) but maximum for 5 years. 

The  Commission  has  made  a  written  statement  which  clarifies  how  it  would  apply 
the derogation. 

4. 

CONCLUSION 

The  Commission  takes  the  view  that  the  common  position  fully  reflects  the  key 
elements  of  its  initial  proposal  and  the  spirit  of  many  of  the  amendments  of  the 
European Parliament made in the first reading. 

The  Commission  therefore  agrees  with  the  common  position  as  adopted  by  the 
Council by qualified majority. 

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5. 

STATEMENTS BY THE COMMISSION 

The Commission made two written statements which are attached. 

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STATEMENTS BY THE COMMISSION 

ANNEX 

(1) 

"The  Commission  recognises  that  the  procedure  which  allows  possible  approval  of 
an active substance for a maximum period of 5 years, even if it does not satisfy the 
listed  criteria,  is  a  derogation  from  the  standard  procedure  to  approve  active 
substances. The Commission stresses that the derogation would only apply in cases 
where  documented  evidence  is  submitted  showing  that  there  are  no  other  available 
means  to  control  a  serious  danger  to  plant health.  The  approval  will  be  decided  by 
comitology,  thus  involving  all  Member  States  in  the  evaluation  not  only  of  the 
dossier on the active substance, but equally on the documentation showing that there 
are  no  alternatives.  Approval  which  may  be  proposed  will  be  subject  to  strict 
conditions, including risk mitigation measures, which would be part of the approval 
decision and aim at minimising exposure to humans and the environment." 

(2) 

"The  Commission  regrets  the  removal  of  Article  152.4(b)  of  the  Treaty  from  the 
legal basis of the proposal. One of the main aims of the proposal is to achieve a high 
level of human and animal health and to protect the environment. 

In order to allow the legislative process to move forward with a view to the timely 
adoption of the proposed Regulation, the Commission accepts the common position 
of the Council given that the substance of the compromise reached, taken as a whole, 
meets the objectives of the proposal. 

Should the European Parliament re-introduce during the second reading Article 152 
as one of the legal bases of the proposal, the Commission reserves the right to accept 
the relevant amendment." 

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