Proposal for a directive of the European Parliament and of the Council on machinery for pesticide application, amending Directive 2006/42/EC of 17 May 2006 on machinery
Date: 2008-09-05
Institutions: European Commission
Subjects: EC conformity marking, European standard, agricultural machinery, consumer protection, environmental protection, pesticide, product safety, protection of animals, safety standard

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.9.2008 
COM(2008) 535 final 

2008/0172 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on machinery for pesticide application, amending Directive 2006/42/EC of 17 May 2006 
on machinery 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

110 

CONTEXT OF THE PROPOSAL 

Grounds for and objectives of the proposal 

The  European  Parliament  and  the  Council  have  recognised,  in  the  Decision  adopting 
the 6th Community Environment Action Programme1, that the impact of pesticides on 
human  health  and  the  environment  must  be  further  reduced.  As  a  first  stage,  this 
objective  concerns  plant  protection  products.  The  purpose  is  to  achieve  a  more 
sustainable use of pesticides along with a reduction of the risks to human health and the 
environment  resulting  from  their  use,  consistent  with  the  necessary  crop  protection. 
The  approach  outlined  for  this  purpose  included  full  implementation  and  appropriate 
revision of the relevant legal framework and the development of a Thematic Strategy 
on  the  Sustainable  Use  of  Pesticides.  Since  then,  the  European  Commission  has 
adopted  the  strategy  (hereafter,  the  Thematic  Strategy)2,  and  proposed  a  Directive  of 
the European Parliament and of the Council establishing a framework for Community 
action  to  deal  with  the  main  legislative  aspects  of  its  implementation  (hereafter,  the 
Framework Directive)3. 

The Thematic Strategy sets out five main objectives: 

–  to minimise risks to health and the environment from the use of pesticides; 

–  to improve controls on the use and distribution of pesticides; 

–  to substitute the most dangerous pesticides with safer alternatives; 

–  to encourage low-input or pesticide-free cultivation; 

–  to establish a transparent system for reporting and monitoring progress. 

Regarding  the  objective  mentioned  first  in  the  list,  and  in  particular  pesticide 
application equipment, the proposed Framework Directive introduces requirements for 
Member  States  to  set  up  a  system  for  the  regular  maintenance  and  inspection  of 
equipment  in  use.  However,  in  order  to  complete  the  legislative  measures  relating  to 
the  equipment,  complementary  measures  are  needed  to  establish  the  environmental 
protection requirements to be fulfilled by new pesticide application equipment before it 
is placed on the market and put into service. 

In  its  Thematic  Strategy,  and  in  the  preamble  as  well  as  in  the  explanatory 
memorandum  to  the  proposed  Framework  Directive,  the  Commission  has  made  a 
commitment to introduce the necessary environmental protection requirements for new 
pesticide  application  equipment  into  a  separate  proposal.  For  this  purpose,  the 

Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community 
Environment Action Programme (OJ L 242, 10.9.2002, p. 1–15). 

COM(2006) 372 final – Communication from the Commission to the Council, the European Parliament, the European Economic 
and Social Committee and the Committee of Regions – A Thematic Strategy on the Sustainable Use of Pesticides, available at: 
http://ec.europa.eu/environment/ppps/pdf/com_2006_0372.pdf 

COM(2006)  373  final  –  Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  establishing  a  framework  for 
Community 
at: 
sustainable 
to 
http://ec.europa.eu/environment/ppps/pdf/com_2006_0373.pdf 

pesticides, 

available 

achieve 

action 

use 

of 

a 

Directive  2006/42/EC  of  the  European  Parliament  and  of  the  Council  of  17  May  2006  on  machinery,  and  amending  Directive 
95/16/EC (recast) (OJ L 157, 9.6.2006, p. 24-86). 

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Commission  is  now  proposing  a  Directive  amending  Directive  2006/42/EC  of  the 
European Parliament and of the Council of 17 May 2006 on machinery (hereafter, the 
Machinery Directive)4. 

120 

General context 

Well designed, constructed and maintained machinery for pesticide application plays a 
significant  role  in  reducing  the  adverse  impacts  of  pesticides  on  human  health,  in 
particular on the operators of the machinery, and on the environment. The objective of 
the  proposal  is  to  ensure  that  new  machinery  for  pesticide  application  does  not 
endanger  the  environment  unnecessarily.  To  this  end,  the  proposal  introduces 
supplementary  essential  environmental  protection  requirements  that  must  be  fulfilled 
by new machinery for pesticide application before it is placed on the market and/or put 
into service in the Community. Harmonisation of requirements for such machinery is a 
prerequisite  for  ensuring  a  high  standard  of  protection  while  ensuring  the  free 
movement of such products in the Community. 

130 

Existing provisions in the area of the proposal 

The  Machinery  Directive  98/37/EC  sets  out  the  essential  health  and  safety 
requirements that machinery placed on the Community market must meet if they are to 
benefit  from  free  movement  within  the  Community  and  the  procedures  required  to 
assess  conformity  with  these  requirements.  Directive  98/37/EC  will  be  repealed  by 
Directive  2006/42/EC  that  will  be  applicable  as  from  29  December  2009.  The 
Machinery Directive applies to machinery for pesticide application with respect to the 
protection  of  the  health  and  safety  of  users  of  such  machinery  and  other  persons 
exposed  to  risks  due  to  its  operation.  Environmental  protection  requirements  are  not 
currently covered by the Machinery Directive. However, several Member States have 
introduced  national  provisions  setting  out  environmental  protection  requirements  for 
pesticide  application  equipment.  Furthermore,  three  European  standards  have  been 
adopted in this area. 

140 

Consistency with the other policies and objectives of the Union 

The proposal is fully consistent with the objectives and aims of the Sixth Community 
Environment  Action  Programme,  the  European  Union  Sustainable  Development 
Strategy,  the  Lisbon  Strategy,  and  the  Thematic  Strategy  on  the  Sustainable  Use  of 
Pesticides.  The  proposal  also  contributes  to  other  policies  such  as,  in  particular,  the 
improvement of the protection of the health and safety of workers and of consumers. 
The  proposal  is  also  in  line  with  the  Inter-institutional  Agreement  on  Better  Law-
Making. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

211 

Consultation methods, main sectors targeted and general profile of respondents 

In  order  to  give  all  stakeholders  concerned  the  possibility  to  contribute  to  the 
development  of  the  Thematic  Strategy,  the  Commission  organised  an  extensive 
consultation  process  involving  the  European  institutions,  Member  States  and  other 
interested parties. It included four rounds of consultation, and the minimum standards 

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for consultation were fully respected. 

to  achieve 

the  specific  objectives  of 

In  July  2002,  the  Commission  adopted  the  Communication  ‘Towards  a  Thematic 
Strategy  on  the  Sustainable  Use  of  Pesticides’5,  which  presented  a  list  of  possible 
measures 
the  Thematic  Strategy.  The 
Communication  was  submitted  to  the  European  Parliament,  the  Council,  and  the 
Economic and Social Committee, and published on the internet for consultation of the 
general public. More than 150 contributions were received during this consultation. In 
addition,  in  November  2002,  the  Commission  organised  a  Stakeholders  Conference 
with  more  than  200  participants  from  all  relevant  stakeholder  groups  such  as  the 
pesticide  industry,  farmer  organisations,  authorities,  consumer  and  environmental 
organisations. 

In 2004, the Commission contracted a study to an external consultant (BiPRO) on the 
impacts of the legislative aspects of the Thematic Strategy. This study was elaborated 
on  the  basis  of  surveys  and  interviews  among  the  Member  States  (22  answered)  and 
key stakeholders. It was accompanied by an inter-services group involving all relevant 
Directorates-General  and  its  final  report  was  published  on  the  Commission’s  website 
(hereafter BiPRO Report)6. 28 organisations submitted comments on the conclusions of 
the study7. 

A final Interactive Policy Making consultation was conducted from 17 March until 12 
May 2005. It built on the results of the previous stakeholder consultations and outlined 
the main measures to be included in the Thematic Strategy. The Commission received 
1767 responses from the public and stakeholders. 

212 

Summary of responses and how they have been taken into account 

A  detailed  summary  of  the  consultation  process  and  its  outcome  can  be  found  in  the 
Commission staff working paper on the Impact Assessment of the Thematic Strategy 
on  the  Sustainable  Use  of  Pesticides  (hereafter,  the  Impact  Assessment)8.  The 
conclusions  of  the  Council,  the  Resolution  of  the  Parliament,  the  opinion  of  the 
Economic  and  Social  Committee  as  well  as  public  contributions  are  summarised  in 
Annex 1 to the Impact Assessment. All comments are also available on the internet9. 
The  responses  received  in  the  final  Interactive  Policy  Making  consultation  are 
summarised in Annex 2 to the Impact Assessment10.  

Collection and use of expertise 

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Scientific/expertise domains concerned 

Agriculture,  plant  protection,  machinery  and  engineering  (pesticide  application 

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COM(2002) 349, available at: http://europa.eu.int/comm/environment/ppps/1st_step_com.htm 

“Assessing economic impacts of the specific measures to be part of the Thematic Strategy on the Sustainable Use of Pesticides”, 
Final 
at: 
für 
http://ec.europa.eu/environment/ppps/pdf/bipro_ppp_final_report.pdf 

integrierte  Problemlösungen 

2004,  Beratungsgesellschaft 

report,  October 

(BiPRO), 

available 

These are available at: http://ec.europa.eu/environment/ppps/2nd_step_react.htm 

SEC(2006) 894 – Commission staff working paper on the Impact Assessment of the Thematic Strategy on the Sustainable Use of 
Pesticides, available at: http://ec.europa.eu/environment/ppps/pdf/sec_2006_0894.pdf 

For  all  comments,  see  http://ec.europa.eu/environment/ppps/1st_step_consul.htm.  The  documents  and  reports  from  the 
Stakeholder consultation are available at: http://ec.europa.eu/environment/ppps/1st_step_conf.htm 

The results are also available on the internet at http://ec.europa.eu/environment/ppps/pdf/stats_consult.pdf 

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equipment,  in  particular  sprayers  and  related  equipment),  aerial  spraying,  analysis  of 
economic, social and environmental impacts. 

Methodology used 

The methods used for collecting and using of expertise included bilateral consultations 
with stakeholders, organising meetings, participating in conferences, and contracting a 
study to an external consultant. 

Main organisations/experts consulted 

The  main  organisations  consulted  include  Member  State  authorities,  the  pesticide 
industry,  the  pesticide  application  equipment  industry,  farmers’  organisations, 
academia,  the  European  Committee  for  Standardization  (CEN),  and  environmental 
organisations. 

Summary of advice received and used 

With respect to new machinery for pesticide application, the advice confirmed that it is 
necessary  to  establish  environmental  protection  requirements  for  new  machinery  for 
pesticide  application  with  which  it  must  comply  before  being  placed  on  the  market 
and/or put into service. 

Means used to make the expert advice publicly available 
The expert advice has been made available on the internet11.  

230 

Impact assessment 

–  The  proposal  for  an  amendment  to  the  Machinery  Directive  (2006/42/EC)  on 
machinery  for  pesticide  application  is  based  on  the  BiPRO  Report  and  the  Impact 
Assessment of the legislative proposals based on the Thematic Strategy. 

Policy options considered 

The Impact Assessment deals with the policy options relating to pesticide application 
equipment  in  section  4.1.2  entitled  “Standards  for  control  and  certification  of 
application  equipment”.  In  the  Impact  Assessment,  the  term  ‘control’  refers  to  the 
maintenance  and  periodic  inspection  of  pesticide  application  equipment  that  is  the 
subject  of  measures  proposed  in  the  Framework  Directive.  The  term  ‘certification’ 
refers  to  the  design,  construction  and  conformity  assessment  of  new  pesticide 
application  equipment  that  are  the  subject  of  this  proposal.  With  respect  to  the 
certification  of  new  pesticide  application  equipment, 
the  Impact  Assessment 
considered the following policy options: 
–  No action at Community level (identified in the Impact Assessment as option 5)12; 

–  Introduction of a voluntary certification system (identified in the Impact Assessment 

as option 6)13; 

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See http://europa.eu.int/comm/environment/ppps/2nd_step_tech.htm 

See note 8 above, p. 38. 

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–  Obliging the Member States to set up a mandatory certification system at national 

level (identified in the Impact Assessment as option 1)14; 

–  Introduction  of  a  mandatory  certification  system  for  new  application  equipment  at 
Community  level  (identified  in  the  Impact  Assessment  as  option  2,  first 
paragraph)15. 

The conclusion of the Impact Assessment, set out in section 6.2.2 and tables 6-45 and 
6-46  of  the  document16,  is  that  introducing  a  mandatory  certification  system  for  new 
pesticide  application  equipment  at  Community level  is  the  only  option  that  is  able  to 
attain  the  desired  objectives  of  the  Thematic  Strategy  in  terms  of  protection  of  the 
environment and human health. Furthermore, the other policy options would perpetuate 
divergent  national  provisions  that  constitute  obstacles  to  the  free  movement  of  goods 
within the Community (see below, section 3 - subsidiarity principle). 

Potential impacts 

In the BiPRO Report, the possible impacts of introducing requirements for the placing 
on  the  market  of  new  pesticide  application  equipment  are  discussed17.  It  is  expected 
that  EU-wide  harmonisation  of  such  requirements  will  generally  raise  standards  for 
new  machinery  with  respect  to  environmental  protection.  As  a  consequence,  average 
production  costs  for  manufacturers  of  machinery  for  pesticide  application  equipment 
could  rise.  The  possible  cost  increase  would  be  unevenly  distributed,  since  many 
manufacturers  already  provide  machinery  that  is  at  a  satisfactory  level  in  order  to 
comply  with  regulations  or  certification  schemes  in  force  in  some  Member  States, 
while others would have to raise their product standards significantly. For the former, 
harmonisation of the environmental protection requirements at Community level would 
have the advantage of ensuring of fair competition in the internal market. 

The  possible  increase  in  compliance  costs  for  manufacturers  who  would  have  to 
upgrade  their  machines  can  be  separated  into  two  elements:  a  one-off  cost  due  to 
adaptation  of  designs  and  tooling  and  a  production  cost  due,  for  example,  to  the 
incorporation  into  the  machinery  of  additional  or  more  complex  control  devices  and 
systems. Neither of these costs can be estimated with precision, since manufacturers do 
not  generally  distinguish  between  cost  factors  linked  to  compliance  with  legal 
requirements  and  cost  factors  linked  to  the  regular  updating  of  their  designs  to  meet 
market demand for improved performance and other customer requirements. However, 
the costs that  may be  incurred  by those manufacturers  who would have to raise  their 
product  standards  significantly  will  probably  be  transferred  to  users,  in  so  far  as  the 
market conditions allow, via increased prices. 

The  Impact  Assessment,  assuming  an  average  lifetime  of  12–15  years  per  sprayer, 
estimates that approximately 125,000-250,000 new sprayers per year are purchased in 
the  Community.  Due  to  greater  efficiency,  sprayers  that  comply  with  the  new 

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See note 8 above, p. 38.. 

See note 8 above, p. 37. 

See note 8 above, p. 37. 

See note 8 above, p. 143 to 146.  

See note 6 above, in particular, Section 4.5 – p. 72 to 74, Impacts: Section 10 – p. 218 to 258. 

See  note  8  above,  in  particular,  Policy  opinions:  Section  4.1.2  –  p.  37,  Impacts:  Section  6.1.2  –  p.  90  to  98,  Comparing  the 
options: Section 6.2.2 – p. 143 to 146, and Comments received: Section 9.10 – p. 197 to 198. 

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environmental protection requirements are likely to consume less pesticide and reduce 
losses  of  pesticide  during  mixing,  loading,  spraying  and  cleaning  operations.  The 
resulting average annual reduction of pesticide use is difficult to estimate, however, it 
will  certainly  lead  to  savings  for  users  which  are  likely  to  compensate  the  possible 
increase in prices for some spraying equipment. On the other hand, the reduced use of 
pesticides can lead to losses in turnover for the pesticide industry which could lead to 
job losses. 

In the long run, it is expected that introducing environmental protection requirements 
for  new  machinery  for  pesticide  application  will  have  positive  impacts  on  human 
health and the environment via the expected decrease in exposure to pesticides and the 
reduction  of  adverse  effects  on  human  health  and  the  environment  due  to  such 
exposure.18 

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LEGAL ELEMENTS OF THE PROPOSAL 

Summary of the proposed action 

This proposal introduces new environmental protection requirements for the placing on 
the market and/or putting into service of new machinery for pesticide application in the 
EEA.  These  supplementary  essential  requirements  are  mandatory  provisions  intended 
to ensure that the products do not endanger the environment unnecessarily. 

310 

Legal basis 

The  legal  basis  of  the  proposal  for  an  amendment  to  the  Machinery  Directive  is 
provided  by  Article  95  of  the  EC  Treaty,  which  sets  out  the  principles  for  the 
establishment  of  the  internal  market.  The  Machinery  Directive  ensures  the  free 
movement of machinery falling within its scope that satisfies the essential health and 
safety requirements and conformity assessment procedures laid down by the Directive. 

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Subsidiarity principle 

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 reasons: 

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Certain  Member  States  have  already  introduced  mandatory  environmental  protection 
requirements  and  conformity  assessment  procedures  for  pesticide  application 
equipment.  Other  Member  States  have  announced  draft  regulations  in  this  field.  To 
leave the setting of environmental requirements for machinery for pesticide application 
to  a  voluntary  certification  scheme  or  to  certification  schemes  established  by  the 
Member  States  at  national  level  would  have  the  effect  of  perpetuating,  or  indeed 
multiplying  divergent  national  provisions  and  procedures  having  similar  objectives. 
This generates undue costs for industry and constitutes obstacles to the free movement 
of goods within the Community. 

Community action will better achieve the objectives of the proposal for the following 
reasons: 

Harmonisation  of 

the  environmental  protection  requirements  and  conformity 

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324 

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assessment  procedures  at  Community  level  is  the  only  way  to  achieve  the  desired 
environmental  protection  objective  while  ensuring  an  equivalent  level  of  protection 
throughout  the  Community,  fair  competition  between  manufacturers  and  the  free 
movement of goods in the internal market. 

The proposal therefore complies with the subsidiarity principle. 

Proportionality principle 

This proposal does not go beyond what is necessary in order to achieve its objective, 
and is therefore in accordance with the principle of proportionality, as set out in Article 
5 of the Treaty. 

The  proposal  is  limited  to  the  essential  requirements  with  which  machinery  for 
pesticide  application  must  comply  before  being  placed  on  the  market  and/or  put  into 
service, while the European standardisation organisations are responsible for drawing 
up  technical  standards  providing  detailed  specifications  enabling  manufacturers  to 
comply  with  these  requirements.  Application  of  these  harmonised  standards  remains 
voluntary,  but  confers  a  presumption  of  conformity  with  the  essential  requirements 
they cover. 

The administrative burden falling upon the Community and upon national authorities is 
minimised  by  including  the  environmental  protection  requirements  for  machinery  for 
pesticide  application  in  the  Machinery  Directive  as  proposed.  The  Member  States 
would have a one-off administrative burden linked to implementation of the amending 
Directive  into  national  law.  However,  once  the  amendment  is  implemented,  the 
administrative burdens for Member States and the Community entailed by management 
and  enforcement  of  the  new  environmental  requirements  (market  surveillance, 
administrative  cooperation,  organisation  of  and  participation  in  the  Machinery 
Committee  and  Working  Group,  management  of  standards  etc.)  would  be  essentially 
unchanged  compared  with  those  linked  to  the  management  and  enforcement  of  the 
existing Machinery Directive as a whole.  

Compliance with the new requirements set out in the Machinery Directive as proposed 
would  also  have  the  advantage  of  minimising  the  administrative  burden  for 
manufacturers of machinery for pesticide application. The manufacturer’s technical file 
would have to be updated, but the EC Declaration of conformity that must accompany 
each machine  would also cover the  new  environmental  protection requirements  –  the 
only  modification  needed  would  be  to  add  a  reference  to  the  relevant  harmonised 
standards  applied.  The  possible  increase  in  costs  linked  to  application  of  new 
harmonised  requirements  is  largely  outweighed  by  the  reduction  of  the  existing  and 
foreseeable  future  costs  resulting  from  non-harmonisation,  in  other  words  the  design 
and  production  costs  and  the  administrative  burden  for  manufacturers  incurred  when 
applying  divergent  national  regulations  and  procedures  in  an  increasing  number  of 
Member States. 

Choice of instruments 

341 

Proposed instrument: directive. 

New machinery for pesticide application is already subject to the Machinery Directive 
with respect to the protection of the health and safety of operators and other exposed 
persons. From the perspective of better regulation, it is considered preferable to set out 

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all  the  requirements  applicable  to  a  given  category  of  products  in  a  single  piece  of 
legislation, thereby avoiding overlapping or contradictory requirements and providing 
for  a  unique  conformity  assessment  procedure.  For  this  reason  it  is  proposed  to 
incorporate  the  environmental  protection  requirements  for  machinery  for  pesticide 
application into the Machinery Directive by means of an amending Directive. 

The  proposal  is  thus  in  line  with  the  Inter-institutional  Agreement  on  Better  Law-
Making. 

BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget. 

ADDITIONAL INFORMATION 

Correlation table 

342 

4. 

409 

5. 

550 

The  Member  States  are  required  to  communicate  to  the  Commission  the  text  of 
national  provisions  transposing  the  Directive  as  well  as  a  correlation  table  between 
those provisions and this Directive. 

560 

European Economic Area 

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

570 

Detailed explanation of the proposal 

The  preamble  to  the  proposal  includes  three  Recitals.  The  first  two  recitals  give  the 
background and state the objective of the proposal. The third recital explains why it is 
proposed to introduce environmental protection among the objectives of the Machinery 
Directive.  This  Recital  also  indicates  that,  in  this  proposal,  the  environmental 
protection  requirements  are  limited  to  machinery  for  pesticide  application  and  to  the 
risks  for  the  environment  covered  by  the  proposed  new  essential  requirements  to 
Annex I of the Directive. 

Appropriate amendments are proposed to certain Articles of the Directive in order to 
introduce environmental protection among its objectives.  

Article 2 gives definitions of certain key concepts used in the Directive. It is proposed 
to  add  a  new  definition  of  ‘essential  safety  and  health  requirements’  to  this  Article. 
Including  the  protection  of  the  environment,  where  appropriate,  in  the  definition  of 
‘essential  health  and  safety  requirements’  avoids  the  need  to  amend  the  numerous 
references to essential health and safety requirements in the Directive.  

The  objective  of  protection  of  the  environment  is  also  mentioned  in  appropriate 
amendments to Articles 4 (1), 9 (3) and 11 (1). 

Annex I sets out the essential health and safety requirements applicable to machinery. 
The first General Principle set out in introduction to the Annex is amended to include 
the  obligation  for  manufacturers  of  machinery  for  pesticide  application,  where 
appropriate, to estimate the risks of damage to the environment. 

It is proposed to include the environmental protection requirements for machinery for 

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pesticide  application  in  Part  2  of  Annex  I.  Part  2  sets  out  supplementary  essential 
health  and  safety  requirements  for  several  categories  of  machinery.  It  is  proposed  to 
add  a  reference  to  machinery  for  pesticide  application  to  the  first  paragraph  defining 
the scope of Part 2. The new supplementary environmental protection requirements are 
introduced in a new Section 2.4. 

The  requirements  set  out  in  the  proposed  new  Section  2.4  of  Annex  I  apply  to 
machinery  for  pesticide  application.  A  definition  of  ‘machinery  for  pesticide 
application’ in given in a first subsection 2.4.1. The definition makes it clear that the 
requirements apply to machinery intended for applying plant protection products19 and 
biocidal products for pest control20, in line with the scope of the Thematic Strategy and 
the Framework Directive. 

Machinery for pesticide application includes self-propelled machinery, towed, vehicle-
mounted  and  semi-mounted  machinery,  airborne  machinery  as  well  as  stationary 
machinery intended for pesticide application, both for professional and consumer use. 
It  also  includes  powered  portable  and  handheld  machinery  and  manually-operated 
portable  and  handheld  machinery  for  pesticide  application  with  a  pressure  chamber. 
However,  the  requirements  set  out  in  section  2.4  do  not  apply  to  manually-operated 
portable or handheld pesticide application equipment without a pressure chamber or to 
simple pesticide application equipment without moving parts, since such equipment is 
not in the scope of the Machinery Directive. 

Subsections  2.4.2  to  2.4.8  set  out  essential  requirements  that  aim  to  ensure  that 
machinery  for  pesticide  application  is  designed  and  constructed  in  order  to  minimise 
damage to the environment and is accompanied by the necessary instructions relating 
to its correct use, maintenance and inspection. 

It should be noted that the proposed new essential requirements apply to machinery for 
pesticide  application  equipment  in  addition  to  all  the  other  relevant  requirements  of 
Annex I, including the requirement set out in section 3.5.3 relating to the protection of 
the  operator  of  machinery  against  the  risk  of  exposure  to  hazardous  emissions,  in 
accordance with General Principle 4 set out in introduction to Annex I. 

The  proposed  new  essential  requirements  are  intended  to  be  supported  by  technical 
specifications  of  harmonised  standards  for  the  various  categories  of  machinery  for 
pesticide application. To that end, the Commission will give an appropriate mandate to 
the European Standardisation Organisations. 

19

20

See amended proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection 
products on the market, 11 March 2008, COM(2008) 93 final. 

See  product-types  14  to  19  as  set  out  in  Annex  V  to  Directive  98/8/EC  of  the  European  Parliament  and  of  the  Council  of  16 
February 1998 concerning the placing of biocidal products on the market - OJ L 123, 24.4.1998 p.1 (as last amended by Directive 
2007/47/EC (OJ L 247, 21.9.2007, p. 21). 

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2008/0172 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on machinery for pesticide application, amending Directive 2006/42/EC of 17 May 2006 
on machinery 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 

95 thereof 

Having regard to the proposal from the Commission21, 

Having regard to the opinion of the European Economic and Social Committee22, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty23, 

Whereas: 

(1) 

(2) 

(3) 

21

22

23

24

25

The  use  of  pesticides  is  recognised  as  posing  threats  both  to  human  health  and  the 
environment.  In  its  Communication  'A  Thematic  Strategy  on  the  Sustainable  Use  of 
Pesticides'24, the Commission has adopted a strategy which aims at reducing the risks 
to  human  health  and  the  environment  from  pesticides  use.  Furthermore,  the 
Commission has proposed a Directive of the European Parliament and of the Council 
establishing  a  framework  for  Community  action  to  achieve  a  sustainable  use  of 
pesticides25 (hereinafter the "Framework Directive"). 

The design, construction and maintenance of machinery for pesticide application play 
a  significant  role  when  aiming  at  reducing  adverse  impacts  of  pesticides  on  human 
health and on the environment. Regarding pesticide application equipment already in 
professional use, the Framework Directive introduces requirements for the inspection 
and maintenance to be carried out on such equipment.  

The  requirements  for  the  protection  of  the  health  and  safety  of  persons  and,  where 
appropriate,  domestic  animals  and  property  are  already  covered  by  Directive 
2006/42/EC  of  the  European  Parliament  and  the  Council  of  17  May  2006  on 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
COM(2006) 372 final 
COM(2006) 373 final 

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11 

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machinery26. In order to ensure the consistency of that Directive with the Framework 
Directive, it is appropriate that essential environmental protection requirements for the 
design and construction of new machinery for pesticide application are included in the 
Directive 2006/42/EC. 

(4) 

For  this  purpose,  it  is  also  necessary  to  include  a  reference  to  the  protection  of  the 
environment in the provisions of Directive 2006/42/EC while limiting this objective to 
the category of machinery and to the risks subject to specific environmental protection 
requirements. 

(5) 

Directive 2006/42/EC should be therefore amended accordingly,   

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Amendment of Directive 2006/42/EC 

Directive 2006/42/EC is amended as follows: 

1. 

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

“(m) ‘essential health and safety requirements’ means mandatory provisions to 
ensure that products do not endanger the health or safety of persons and, where 
appropriate, domestic animals, property or the environment.” 

2. 

Article 4 (1) is replaced by the following: 

“1. Member States shall take all appropriate measures to ensure that machinery may 
be  placed  on  the  market  and/or  put  into  service  only  if  it  satisfies  the  relevant 
provisions of this Directive and does not endanger the health and safety of persons 
or,  where  appropriate,  domestic  animals,  property  or  the  environment,  when 
properly  installed  and  maintained  and  used  for  its  intended  purpose  or  under 
conditions which can reasonably be foreseen.” 

3. 

In Article 9 (3), the first subparagraph is replaced by the following: 

“In  the  cases  referred  to  in  paragraph 1,  the  Commission  shall  consult  the  Member 
States and other interested parties indicating the measures it intends to take, in order 
to ensure, at Community level, a high level of protection of the health and safety of 
persons  and,  where  appropriate,  of  domestic  animals,  property  or  the 
environment.” 

4. 

Article 11 (1) is replaced by the following: 

“1.  Where  a  Member  State  ascertains  that  machinery  covered  by  this  Directive, 
bearing the CE marking, accompanied by the EC declaration of conformity and used 
in accordance with its intended purpose or under conditions which can reasonably be 
foreseen,  is  liable  to  endanger  the  health  and  safety  of  persons  or,  where 
appropriate,  domestic  animals,  property  or  the  environment,  it  shall  take  all 
appropriate  measures  to  withdraw  such  machinery  from  the  market,  to  prohibit  the 

26

OJ L 157, 9.6.2006, p. 24. 

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placing on the market and/or putting into service of such machinery or to restrict free 
movement thereof.”  

5. 

Annex I is amended as follows: 

(a) 

in the General Principles, point 1 is replaced by the following: 

“1.  The  manufacturer  of  machinery  or  his  authorised  representative  must  ensure 
that  a  risk  assessment  is  carried  out  in  order  to  determine  the  health  and  safety 
requirements  which  apply  to  the  machinery;  the  machinery  must  then  be  designed 
and constructed taking into account the results of the risk assessment. 

By the iterative process of risk assessment and risk reduction referred to above, the 
manufacturer or his authorised representative shall: 

–  determine  the  limits  of  the  machinery,  which  include  the  intended  use  and  any 

reasonably foreseeable misuse thereof, 

–  identify  the  hazards  that  can  be  generated  by  the  machinery  and  the  associated 

hazardous situations, 

–  estimate  the  risks,  taking  into  account  the  severity  of  the  possible  injury  or 
damage  to  health  and,  where  appropriate,  to  the  environment  and  the 
probability of its occurrence,  

–  evaluate the risks, with a view to determining whether risk reduction is required, 

in accordance with the objective of this Directive, 

–  eliminate  the  hazards  or  reduce  the  risks  associated  with  these  hazards  by 
application of protective measures, in the order of priority established in section 
1.1.2(b).” 

(b)  Part 2 is amended as follows: 

(i) 

the first paragraph is replaced by the following: 

“Foodstuffs  machinery,  machinery  for  cosmetics  or  pharmaceutical  products,  hand-
held  and/or  hand-guided  machinery,  portable  fixing  and  other  impact  machinery, 
machinery for working wood and material with similar physical characteristics, and 
machinery  for  pesticide  application  must  meet  all  the  essential  health  and  safety 
requirements described in this chapter (see General Principles, point 4).” 

(ii) 

the following Section 2.4. is added:   

“2.4.  MACHINERY FOR PESTICIDE APPLICATION 

2.4.1. Definition 

'Machinery for pesticide application' means machinery specifically intended for 
the  application  of  plant  protection  products  as  defined  in  Regulation  (EC)  N° 
[…]27 or of biocidal products for pest control belonging to product types 14 to 
19 as defined in Annex V to Directive 98/8/EC28. 

27

28

Regulation (EC) No [...] on plant protection products – OJ L [...], [...], p. [...]. 
Directive  98/8/EC  of  the  European  Parliament  and  of  the  Council  of  16  February  1998  concerning  the  placing  of  biocidal 
products on the market – OJ L 123, 24.4.1998 p.1 (as last amended by Directive 2007/47/EC) - OJ L 247, 21.9.2007, p. 21. 

EN 

13 

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2.4.2. General 

Machinery for pesticide application must be designed and constructed so that it 
can  be  operated,  adjusted  and  maintained  without  damaging  the  environment 
unnecessarily. 

2.4.3. Controls and monitoring 

It must be possible to control and monitor the operation of the machinery from 
the operating positions. 

2.4.4. Filling and emptying 

Machinery  must  be  designed  and  constructed  to  facilitate  precise  filling  and 
complete  emptying  and  to  prevent  any  unintentional  dispersal  of  pesticide 
during these operations. 

2.4.5. Application 

2.4.5.1. Application rate 

The  machinery  must  be  fitted  with  means  of  adjusting  the  application  rate 
easily, accurately, and reliably. 

2.4.5.2. Distribution and deposition 

The machinery must be designed and constructed to ensure an even distribution 
and homogeneous deposition of pesticide on target areas and to minimise losses 
to non-target areas. 

Losses must be prevented while the pesticide application function is stopped. 

2.4.6. Maintenance 

2.4.6.1. Cleaning 

The  machinery  must  be  designed  and  constructed  to  facilitate  cleaning,  in 
particular of the tank. 

2.4.6.2. Servicing 

The  machinery  must  be  designed  and  constructed  to  facilitate  the  changing  of 
worn parts. It must be possible to connect the necessary measuring instruments 
to the machinery to check its correct functioning. 

2.4.7. Marking 

2.4.7.1. Nozzles 

Nozzles must be marked so that their type and size can be identified directly or 
from information given in the instructions. 

2.4.7.2. Filters 

Filters  and  strainers  must  be  marked  so  that  their  type  and  mesh  size  can  be 
identified directly or from information given in the instructions. 

2.4.8. Instructions 

The instructions must provide the following information: 

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14 

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(a)  precautions  to  be  taken  during  filling,  emptying  and  cleaning  to  avoid 
contamination of the environment; 

(b) the conditions of use and the corresponding preparation and adjustments to 
ensure  even  distribution  and  homogeneous  deposition  of  pesticide,  avoiding 
losses; 

(c) the type and size of nozzles; 

(d) the type and mesh size of strainers and filters; 

(e)  the  frequency  of  verification  and  criteria  for  the  replacement  of  nozzles, 
strainers and filters; 

(f) restrictions on the use of particular pesticides; 

(g) the connexion and use of any special equipment or accessories; 

(h)  the  checks  to  be  carried  out  on  the  machinery,  in  accordance  with  the 
relevant provisions of Directive […]29.”   

Article 2 

Transposition 

1. 

2 

Member States shall adopt and publish the provisions necessary to comply with this 
Directive  by  [DATE…]  at  the  latest.  They  shall  forthwith  inform  the  Commission 
thereof. 

They shall apply those provisions with effect from [DATE…]. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  shall  be  accompanied  by  such  a  reference  on  the  occasion  of  their 
official  publication.  Member  States  shall  determine  how  such  reference  is  to  be 
made. 

Member  States  shall  communicate  to  the  Commission  the  text  of  the  provisions  of 
national law which they adopt in the field covered by this Directive, together with a 
table  showing  how  the  provisions  of  this  Directive  correspond  to  the  national 
provisions adopted.   

Article 3  

Entry into force 

This Directive shall enter into force on the 20th day following its publication in the Official 
Journal of the European Union. 

29

Directive […] of the European Parliament and of the Council of […] establishing a framework for Community action to achieve a 
sustainable use of pesticides - OJ L […] […], p.[…]. 

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15 

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Article 4  

Addressees 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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