EN    EN EN EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 5.9.2008 
COM(2008) 535 final 
2008/0172 (COD)   
Proposal for a 
DIRECTIVE OF THE EUROPEAN PA RLIAMENT AND OF THE COUNCIL  
on machinery for pesticide application, amending Directive 2006/42/EC of 17 May 2006 
on machinery 
(presented by the Commission) EN 2   EN EXPLANATORY MEMORANDUM  
1. C ONTEXT OF THE PROPOSAL  
110 Grounds for and objectives of the proposal  
The European Parliament and the Council ha ve 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 produc ts. The purpose is to achieve a more 
sustainable use of pesticides along with a re duction of the risks to human health and the 
environment resulting from their use, consis tent with the necessary crop protection. 
The approach outlined for this purpose included full implementation and appropriate revision of the relevant legal framework a nd the development of a Thematic Strategy 
on the Sustainable Use of Pesticides. Since then, the Eur opean Commission has 
adopted the strategy (hereafter, the Thematic Strategy)
2, and proposed a Directive of 
the European Parliament and of the Counc il establishing a fram ework for Community 
action to deal with the main legislative as pects of its implemen tation (hereafter, the 
Framework Directive)3. 
The Thematic Strategy sets out five main objectives: – to minimise risks to health and the en vironment from the use of pesticides; 
– to improve controls on the use and distribution of pesticides; 
– to substitute the most dangerous pe sticides with safer alternatives; 
– to encourage low-input or pesticide-free cultivation; 
– to establish a transparent system fo r reporting and monitoring progress. 
Regarding the objective mentioned first in the list, and in particular pesticide 
application equipment, the proposed Framew ork Directive introduces  requirements for 
Member States to set up a system for th e regular maintenance and inspection of 
equipment in use. However, in order to co mplete the legislative measures relating to 
the equipment, complementary measures ar e 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 Di rective, 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 
                                                 
1 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).  
2 COM(2006) 372 final – Communication from the Commission to th e 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  
3 COM(2006) 373 final – 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, available at: 
http://ec.europa.eu/environment/ppps/pdf/com_2006_0373.pdf  
4 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).  EN 3   EN 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 m achinery for pesticide application plays a 
significant role in reducing the adverse impacts of pes ticides on human health, in 
particular on the operators of the machin ery, 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 prot ection requirements that must be fulfilled 
by new machinery for pesticide application be fore 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 Comm unity market must meet if they are to 
benefit from free movement within the Co mmunity 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 a pplicable 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 prot ection 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. Furthermor e, 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 Eur opean Union Sustainable Development 
Strategy, the Lisbon Strategy, and the Thema tic 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. C ONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT  
 Consultation of interested parties 
211 Consultation methods, main sectors targ eted and general pr ofile of respondents 
In order to give all stakeholders concer ned the possibility to contribute to the 
development of the Thematic Strategy, the Commission organi sed an extensive 
consultation process involving the European institutions, Member States and other interested parties. It included four rounds  of consultation, and the minimum standards EN 4   EN for consultation were fully respected. 
In July 2002, the Commission adopted th e Communication ‘Towards a Thematic 
Strategy on the Sustaina ble Use of Pesticides’5, which presented a list of possible 
measures to achieve the specific objec tives of the Thematic Strategy. The 
Communication was submitted to the Europe an Parliament, the Council, and the 
Economic and Social Committee, and published on the internet for consultation of the general public. More than 150 contributions we re 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, au thorities, consumer and environmental 
organisations. 
In 2004, the Commission contracted a study to  an external consultant (BiPRO) on the 
impacts of the legislative as pects of the Thematic Strate gy. This study was elaborated 
on the basis of surveys and interviews am ong 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 consu ltation was conducted fr om 17 March until 12 
May 2005. It built on the results of the previous stakehol der 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 th ey have been taken into account 
A detailed summary of the consultation pr ocess 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 Resoluti on 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 comm ents are also available on the internet9. 
The responses received in the final Interactive Policy Making consultation are summarised in Annex 2 to the Impact Assessment
10.  
 Collection and use of expertise  
229 Scientific/expertise domains concerned 
Agriculture, plant protection, machiner y and engineering (p esticide application 
                                                 
5 COM(2002) 349, available at: http://europa.eu.int/comm/envi ronment/ppps/1st_step_com.htm  
6 “Assessing economic impacts of the specific measures to be part of the Thematic Strategy on the Sustainable Use of Pesticides” , 
Final report, October 2004, Beratungs gesellschaft für integrierte Probl emlösungen (BiPRO), available at: 
http://ec.europa.eu/environment/ppps/pdf/bipro_ppp_final_report.pdf  
7 These are available at: http://ec.europa.eu/environment/ppps/2nd_step_react.htm 
8 SEC(2006) 894 – Commission staff working paper on the Impact A ssessment of the Thematic Strategy on the Sustainable Use of 
Pesticides, available at: http://ec.europa.eu/environment/ppps/pdf/sec_2006_0894.pdf  
9 For all comments, see http://ec.europa.eu/environment/ppps/1 st_step_consul.htm. The documents and reports from the 
Stakeholder consultation are available at: http ://ec.europa.eu/environment/ppps/1st_step_conf.htm 
10 The results are also available on the internet at http://ec.europa.eu/environment/ppps/pdf/stats_consult.pdf  EN 5   EN equipment, in particular sprayers and relate d equipment), aerial sp raying, 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, par ticipating in conferences, and contracting a 
study to an external consultant.  
Main organisations/experts consulted 
The main organisations consulted include Member State author ities, the pesticide 
industry, the pesticide application equipm ent 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 prot ection 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 exper t advice publicly available 
The expert advice has been made available on the internet
11.  
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 proposal s 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 “Standa rds for control and certification of 
application equipment”. In the Impact Asse ssment, the term ‘control’ refers to the 
maintenance and periodic inspection of pe sticide application equipment that is the 
subject of measures proposed in the Framew ork 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 applica tion 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 cert ification system (identifie d in the Impact Assessment 
as option 6)13; 
                                                                                                                                                         
11 See http://europa.eu.int/comm/envi ronment/ppps/2nd_step_tech.htm  
12 See note 8 above, p. 38. EN 6   EN – Obliging the Member States to set up a ma ndatory certification system at national 
level (identified in the Imp act Assessment as option 1)14; 
– Introduction of a mandatory cer tification 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 opti ons 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 requireme nts for the placing 
on the market of new pesticide application equipment are discussed
17. It is expected 
that EU-wide harmonisation of such requirements will generally raise standards for new machinery with respect to environmen tal protection. As a consequence, average 
production costs for manufacturers of machin ery for pesticide application equipment 
could rise. The possible cost increase w ould be unevenly dist ributed, 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 pr oduct standards significantly. For the former, 
harmonisation of the environmental protecti on 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 in to two elements: a one-off cost due to 
adaptation of designs and t ooling and a production cost due, for example, to the 
incorporation into the machinery of additi onal or more complex control devices and 
systems. Neither of these costs can be es timated 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 thei r designs to meet 
market demand for improved performance and other customer requirements. However, 
the costs that may be incurred by those manu facturers 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 av erage 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 efficienc y, sprayers that comply with the new 
                                                                                                                                                         
13 See note 8 above, p. 38..  
14 See note 8 above, p. 37. 
15 See note 8 above, p. 37. 
16 See note 8 above, p. 143 to 146.  
17 See note 6 above, in particular, Section 4.5 – p.  72 to 74, Impacts: Section 10 – p. 218 to 258. 
18 See note 8 above, in particular, Policy opi nions: Section 4.1.2 – p. 37, Impacts: S ection 6.1.2 – p. 90 to 98, Comparing the 
options: Section 6.2.2 – p. 143 to 146, and Co mments received: Section 9.10 – p. 197 to 198.  EN 7   EN environmental protection requirements are li kely to consume less pesticide and reduce 
losses of pesticide during mixing, loadi ng, spraying and cleaning operations. The 
resulting average annual reducti on of pesticide use is diffi cult to estimate, however, it 
will certainly lead to savings for users which are likely to compensate the possible increase in prices for some spraying equipm ent. 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 expect ed that introducing environm ental protection requirements 
for new machinery for pesticide applica tion 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 heal th and the environment due to such 
exposure.
18 
3. L EGAL ELEMENTS OF THE PROPOSAL  
305 Summary of the proposed action  
This proposal introduces new environmental pr otection requirements for the placing on 
the market and/or putting into service of new machinery for pesticide application in the EEA. These supplementary essential require ments 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 satisf ies the essential health and 
safety requirements and conformity assessm ent procedures laid down by the Directive. 
320 Subsidiarity principle  
The subsidiarity principle applies, insofar as the pr oposal 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: 
321 Certain Member States have already intr oduced mandatory environmental protection 
requirements and conformity assessment procedures for pesticide application 
equipment. Other Member States have announ ced draft regulations in this field. To 
leave the setting of environm ental requirements for machinery for pesticide application 
to a voluntary certif ication 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 obj ectives of the proposal for the following 
reasons: 
Harmonisation of the environmental prot ection requirements and conformity EN 8   EN assessment procedures at Community level is the only way to achieve the desired 
environmental protection objective while ensu ring an equivalent level of protection 
throughout the Community, fair competiti on between manufacturers and the free 
movement of goods in the internal market. 
324 The proposal therefore complies with  the subsidiarity principle. 
 Proportionality principle  
331 This proposal does not go beyond wh at 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 be ing placed on the market and/or put into 
service, while the European standardisati on organisations are responsible for drawing 
up technical standards providing detailed specifications enabling manufacturers to 
comply with these requirements. Applicat ion of these harmonised standards remains 
voluntary, but confers a presumption of conf ormity with the essential requirements 
they cover. 
332 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, ma nagement 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 ou t in the Machinery Directive as proposed 
would also have the advantage of mi nimising the admini strative burden for 
manufacturers of machinery for pesticide a pplication. The manufacturer’s technical file 
would have to be updated, but the EC Declar ation 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 outwei ghed 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 EN 9   EN all the requirements applicable to a give n category of products in a single piece of 
legislation, thereby avoiding overlapping or contradictory require ments and providing 
for a unique conformity assessment proce dure. For this reason it is proposed to 
incorporate the environmental protection re quirements for machinery for pesticide 
application into the Machinery Directiv e by means of an amending Directive. 
342 The proposal is thus in line with the Inter-institutional Agreement on Better Law-
Making. 
4. B UDGETARY IMPLICATION  
409 The proposal has no implication for the Community budget. 
5. A DDITIONAL INFORMATION  
550 Correlation table  
The Member States are required to comm unicate to the Commi ssion the text of 
national provisions transposing the Direc tive as well as a correlation table between 
those provisions a nd this Directive. 
560 European Economic Area  
The proposed act concerns an EEA matter a nd should therefore exte nd 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 propos al. The third recital explains why it is 
proposed to introduce environmental protec tion among the objectives  of the Machinery 
Directive. This Recital also  indicates that, in this proposal, the environmental 
protection requirements are limited to machin ery for pesticide application and to the 
risks for the environment covered by the proposed new essent ial requirements to 
Annex I of the Directive. 
Appropriate amendments are proposed to certa in Articles of the Directive in order to 
introduce environmental prot ection among its objectives.  
Article 2 gives definitions of certain key concepts used in the Directiv e. 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 sa fety requirements applicable to machinery. 
The first General Principle set out in intr oduction to the Annex is amended to include 
the obligation for manufacturers of machin ery for pesticide a pplication, where 
appropriate, to estimate the risks of damage to the environment. 
It is proposed to include the environmenta l protection requirements for machinery for EN 10   EN pesticide application in Part  2 of Annex I. Part 2 sets  out supplementary essential 
health and safety requirements for several categories of machiner y. It is proposed to 
add a reference to machinery for pesticide ap plication to the firs t 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 subsecti on 2.4.1. The definition makes it clear that the 
requirements apply to machinery intende d for applying plant protection products
19 and 
biocidal products for pest control20, in line with the scope of the Thematic Strategy and 
the Framework Directive. 
Machinery for pesticide application include s self-propelled machinery, towed, vehicle-
mounted and semi-mounted machinery, airb orne 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 pesticid e application with a pressure chamber. 
However, the requirements set out in sec tion 2.4 do not apply to manually-operated 
portable or handheld pesticide application eq uipment without a pressure chamber or to 
simple pesticide application equipment wit hout moving parts, since such equipment is 
not in the scope of th e Machinery Directive. 
Subsections 2.4.2 to 2.4.8 set ou t essential requirements th at aim to ensure that 
machinery for pesticide application is desi gned and constructed in order to minimise 
damage to the environment and is accompan ied by the necessary instructions relating 
to its correct use, maintenance and inspection. 
It should be noted that the proposed new e ssential requirements apply to machinery for 
pesticide application equipmen t 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 ag ainst the risk of exposure to hazardous emissions, in 
accordance with General Principle 4 se t out in introduction to Annex I. 
The proposed new essential requirements are intended to be supported by technical 
specifications of harmonised standards fo r the various categories of machinery for 
pesticide application. To that end, the Commission will give an appropriate mandate to the European Standardisation Organisations. 
 
                                                 
19 See amended proposal for a Regulation of the European Parliame nt and of the Council concerning the placing of plant protection  
products on the market, 11 March 2008, COM(2008) 93 final. 
20 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 ma rket - 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 11   EN 2008/0172 (COD) 
Proposal for a 
DIRECTIVE OF THE EUROPEAN PA RLIAMENT 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 CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing the European Communit y, and in particular Article 
95 thereof 
Having regard to the proposal from the Commission
21, 
Having regard to the opinion of the Eu ropean Economic and Social Committee22, 
Acting in accordance with the procedure laid down in Article 251 of the Treaty23, 
Whereas: (1) The use of pesticides is recognised as posing threats both to human health and the 
environment. In its Communication 'A Them atic 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 
pesticides
25 (hereinafter the "Framework Directive"). 
(2) The design, construction and maintenance of  machinery for pesticide application play 
a significant role when aiming at reduci ng 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.  
(3) The requirements for the pr otection of the health and safety of persons and, where 
appropriate, domestic animals and prope rty are already covered by Directive 
2006/42/EC of the European Parliame nt and the Council of 17 May 2006 on 
                                                 
21 OJ C , , p. . 
22 OJ C , , p. . 
23 OJ C , , p. . 
24 COM(2006) 372 final 
25 COM(2006) 373 final EN 12   EN 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 Directiv e 2006/42/EC while limiting this objective to 
the category of machinery and to the risks su bject 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 re quirements’ means mandatory provisions to 
ensure that products do not endanger the he alth 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 e ndanger the health and safety of persons 
or
, where appropriate, domestic animals, property or the environment , when 
properly installed and maintained and used for its intende d purpose or under 
conditions which can reas onably be foreseen.”  
 
3. In Article 9 (3), the first subpa ragraph is replaced by the following: 
“In the cases referred to in  paragraph 1, the Commission shall consult the Member 
States and other interested parties indicati ng the measures it intends to take, in order 
to ensure, at Community level, a high level of protection of the h ealth and safety of 
persons and, where appropriate, of dome stic animals, property or the 
environment.”  
 
4. Article 11 (1) is repl aced 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 in tended purpose or under conditi ons 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 m achinery from the market, to prohibit the 
                                                 
26 OJ L 157, 9.6.2006, p. 24.  EN 13   EN placing on the market and/or puttin g into service of such mach inery 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 hi s 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 author ised 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 in to 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 risk s 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 cosme tics or pharmaceutica l products, hand-
held and/or hand-guided machinery, portabl e 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 PEST ICIDE APPLICATION  
2.4.1. Definition  
'Machinery for pesticide application' me ans machinery specifically intended for 
the application of plant protection produc ts 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 Regulation (EC) No [...] on plant protection products – OJ L [...], [ ...], p. [...].  
28 Directive 98/8/EC of the European Par liament 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 am ended by Directive 2007/47/EC) - OJ L 247, 21.9.2007, p. 21.  EN 14   EN  
  
2.4.2. General
 
Machinery for pesticide application must be  designed and constructed so that it 
can be operated, adjusted and maintain ed without damaging the environment 
unnecessarily.  
2.4.3. Controls and monitoring  
It must be possible to control and moni tor the operation of the machinery from 
the operating positions.  
2.4.4. Filling and emptying  
Machinery must be designed and constr ucted 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 mean s of adjusting the application rate 
easily, accurately, and reliably.  
2.4.5.2. Distribution and deposition  
The machinery must be designed and cons tructed 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 pest icide application f unction is stopped.  
2.4.6. Maintenance  
2.4.6.1. Cleaning  
The machinery must be designed and co nstructed to facilitate cleaning, in 
particular of the tank.  
2.4.6.2. Servicing  
The machinery must be designed and cons tructed to facilitate the changing of 
worn parts. It must be possible to co nnect 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 inform ation given in the instructions.  
2.4.8. Instructions  
The instructions must provide the following information:  EN 15   EN (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 a nd 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 cri teria 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. Member States shall adopt and publish the provisions necessary to comply with this 
Directive by [DATE…] at the latest. Th ey shall forthwith inform the Commission 
thereof. 
They shall apply those provision s with effect from [DATE…]. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or shall be accompanied by su ch a reference on th e occasion of their 
official publication. Member States shall determine how such reference is to be 
made. 
2 Member States shall communicate to the Commission the text of the provisions of 
national law which they adopt in the field c overed by this Directive, together with a 
table showing how the provisions of th is 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 fr amework for Community action to achieve a 
sustainable use of pesticides - OJ L […] […], p.[…].  EN 16   EN  
Article 4  
Addressees 
 
This Directive is addressed to the Member States. 
Done at Brussels,  
For the European Parliament For the Council 
The President The President