I 
(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)  
REGULATIONS  
REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
of 21 October 2009  
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE 
EUROPEAN UNION,  
Having regard to the Treaty establishing the European 
Community, and in particular Article 37(2), Article 95 and 
Article 152(4)(b) thereof,  
Having regard to the proposal from the Commission,  
Having regard to the opinion of the European Economic and 
Social Committee (  1 ), 
Having regard to the opinion of the Committee of the 
Regions (  2 ), 
Acting in accordance with the procedure laid down in 
Article 251 of the Treaty (  3 ), 
Whereas:  
(1) Council Directive 91/414/EEC of 15 July 1991 
concerning the placing of plant protection products on 
the market (  4 ) provides for rules governing plant 
protection products and the active substances contained 
in those products.  
(2) Following the progress report presented by the 
Commission under Directive 91/414/EEC, the European Parliament by its Resolution of 30 May 2002 (  5 ) and the 
Council in its Conclusions of 12 December 2001 asked 
the Commission to review Directive 91/414/EEC and 
identified a number of issues for the Commission to 
address.  
(3) In the light of the experience gained from the application 
of Directive 91/414/EEC and of recent scientific and 
technical developments, that Directive should be 
replaced.  
(4) By way of simplification, the new act should also repeal 
Council Directive 79/117/EEC of 21 December 1978 
prohibiting the placing on the market and use of plant 
protection products containing certain active 
substances (  6 ). 
(5) To simplify application of the new act and to ensure 
consistency throughout the Member States, it should 
take the form of a Regulation.  
(6) Plant production has a very important place in the 
Community. One of the most important ways of 
protecting plants and plant products against harmful 
organisms, including weeds, and of improving agri ­
cultural production is the use of plant protection 
products.  
(7) Plant protection products can however also have non- 
beneficial effects on plant production. Their use may 
involve risks and hazards for humans, animals and the 
environment, especially if placed on the market without 
having been officially tested and authorised and if 
incorrectly used.EN 24.11.2009 Official Journal of the European Union L 309/1  
( 1 ) OJ C 175, 27.7.2007, p. 44.  
( 2 ) OJ C 146, 30.6.2007, p. 48.  
( 3 ) Opinion of the European Parliament of 23 October 2007 (OJ C 263 
E, 16.10.2008, p. 181), Council Common Position of 15 September 
2008 (OJ C 266 E, 21.10.2008, p. 1) and European Parliament 
Position of 13 January 2009 (not yet published in the Official 
Journal). Council Decision of 24 September 2009.  
( 4 ) OJ L 230, 19.8.1991, p. 1.  ( 5 ) OJ C 187 E, 7.8.2003, p. 173.  
( 6 ) OJ L 33, 8.2.1979, p. 36.(8) The purpose of this Regulation is to ensure a high level 
of protection of both human and animal health and the 
environment and at the same time to safeguard the 
competitiveness of Community agriculture. Particular 
attention should be paid to the protection of vulnerable 
groups of the population, including pregnant women, 
infants and children. The precautionary principle should 
be applied and this Regulation should ensure that 
industry demonstrates that substances or products 
produced or placed on the market do not have any 
harmful effect on human or animal health or any unac ­
ceptable effects on the environment.  
(9) In order to remove as far as possible obstacles to trade in 
plant protection products existing due to the different 
levels of protection in the Member States, this Regulation 
should also lay down harmonised rules for the approval 
of active substances and the placing on the market of 
plant protection products, including the rules on the 
mutual recognition of authorisations and on parallel 
trade. The purpose of this Regulation is thus to 
increase the free movement of such products and avail ­
ability of these products in the Member States.  
(10) Substances should only be included in plant protection 
products where it has been demonstrated that they 
present a clear benefit for plant production and they 
are not expected to have any harmful effect on human 
or animal health or any unacceptable effects on the 
environment. In order to achieve the same level of 
protection in all Member States, the decision on accepta ­
bility or non-acceptability of such substances should be 
taken at Community level on the basis of harmonised 
criteria. These criteria should be applied for the first 
approval of an active substance under this Regulation. 
For active substances already approved, the criteria 
should be applied at the time of renewal or review of 
their approval.  
(11) The development of non-animal test methods should be 
promoted in order to produce safety data relevant to 
humans and to replace animal studies currently in use.  
(12) In the interest of predictability, efficiency and 
consistency, a detailed procedure should be laid down 
for assessing whether an active substance can be 
approved. The information to be submitted by interested 
parties for the purposes of approval of a substance 
should be specified. In view of the amount of work 
connected with the approval procedure, it is appropriate 
that the evaluation of such information be performed by 
a Member State acting as a rapporteur for the 
Community. To ensure consistency in evaluation, an 
independent scientific review should be performed by 
the European Food Safety Authority established by Regu ­
lation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the 
general principles and requirements of food law, estab ­
lishing the European Food Safety Authority and laying 
down procedures in matters of food safety (  1 ) (the 
Authority). It should be clarified that the Authority 
performs a risk assessment whilst the Commission 
should perform the risk management role and take the 
final decision on an active substance. Provisions should 
be included to ensure the transparency of the evaluation 
process.  
(13) For ethical reasons, the assessment of an active substance 
or a plant protection product should not be based on 
tests or studies involving the deliberate administration of 
the active substance or plant protection product to 
humans with the purpose of determining a human ‘no 
observed effect level’ of an active substance. Similarly, 
toxicological studies carried out on humans should not 
be used to lower the safety margins for active substances 
or plant protection products.  
(14) To speed up the approval of active substances, strict 
deadlines should be established for the different 
procedural steps.  
(15) In the interest of safety, the approval period for active 
substances should be limited in time. The approval 
period should be proportionate to the possible risks 
inherent in the use of such substances. Experience 
gained from the actual use of plant protection products 
containing the substances concerned and any devel ­
opments in science and technology should be taken 
into account when any decision regarding the renewal 
of an approval is taken. The renewal of the approval 
should be for a period not exceeding 15 years.  
(16) The possibility of amending or withdrawing the approval 
of an active substance in cases where the criteria for 
approval are no longer satisfied, or where compliance 
with Directive 2000/60/EC of the European Parliament 
and of the Council of 23 October 2000 establishing a 
framework for Community action in the field of water 
policy (  2 ) is compromised, should be provided for under 
certain conditions.  
(17) The evaluation of an active substance may reveal that it 
presents considerably less of a risk than other substances. 
In order to favour the inclusion of such a substance in 
plant protection products, it is appropriate to identify 
such substances and to facilitate the placing on the 
market of plant protection products containing them. 
Incentives should be given for the placing on the 
market of low-risk plant protection products.EN L 309/2 Official Journal of the European Union 24.11.2009  
( 1 ) OJ L 31, 1.2.2002, p. 1.  
( 2 ) OJ L 327, 22.12.2000, p. 1.(18) Certain substances which are not predominantly used as 
plant protection products may be of value for plant 
protection, but the economic interest of applying for 
approval may be limited. Therefore, specific provisions 
should ensure that such substances, as far as their risks 
are acceptable, may also be approved for plant protection 
use.  
(19) Some active substances with certain properties should be 
identified at Community level as candidates for substi ­
tution. Member States should regularly examine plant 
protection products containing such active substances 
with the aim of replacing them by plant protection 
products containing active substances which require less 
risk mitigation or by non-chemical control or prevention 
methods.  
(20) In certain Member States non-chemical control or 
prevention methods, which are significantly safer for 
human and animal health and for the environment, 
have been established and generally applied for certain 
uses. In exceptional cases Member States should also be 
able to apply the comparative assessment when granting 
authorisation for plant protection products.  
(21) In addition to active substances, plant protection 
products may contain safeners or synergists for which 
similar rules should be provided. The technical rules 
necessary for the evaluation of such substances should 
be established. Substances currently on the market 
should only be evaluated after those rules have been 
established.  
(22) Plant protection products may also contain co- 
formulants. It is appropriate to provide a list of co- 
formulants which should not be included in plant 
protection products.  
(23) Plant protection products containing active substances 
can be formulated in many ways and used on a variety 
of plants and plant products, under different agricultural, 
plant health and environmental (including climatic) 
conditions. Authorisations for plant protection products 
should therefore be granted by Member States.  
(24) The provisions governing authorisation must ensure a 
high standard of protection. In particular, when 
granting authorisations of plant protection products, 
the objective of protecting human and animal health 
and the environment should take priority over the 
objective of improving plant production. Therefore, it 
should be demonstrated, before plant protection 
products are placed on the market, that they present a 
clear benefit for plant production and do not have any 
harmful effect on human or animal health, including that 
of vulnerable groups, or any unacceptable effects on the 
environment.  
(25) In the interest of predictability, efficiency and 
consistency, criteria, procedures and conditions for the authorisation of plant protection products should be 
harmonised, account being taken of the general prin ­
ciples of protection of human and animal health and 
the environment.  
(26) Where the decision on approval cannot be finalised 
within the period provided for due to reasons not 
falling under the responsibility of the applicant, 
Member States should be able to grant the provisional 
authorisations for a limited period in order to facilitate 
the transition to the approval procedure provided for 
under this Regulation. In the light of the experience 
gained from the approval of the active substances 
under this Regulation, the provisions on provisional 
authorisations should cease to apply or be extended 
after the period of five years, if necessary.  
(27) The active substances contained in a plant protection 
product can be produced by different manufacturing 
processes, leading to differences in specifications. Such 
differences may have safety implications. For efficiency 
reasons, a harmonised procedure at Community level 
should be provided for the assessment of those 
differences.  
(28) Good administrative cooperation between Member States 
should be increased during all steps of the authorisation 
procedure.  
(29) The principle of mutual recognition is one of the means 
of ensuring the free movement of goods within the 
Community. To avoid any duplication of work, to 
reduce the administrative burden for industry and for 
Member States and to provide for more harmonised 
availability of plant protection products, authorisations 
granted by one Member State should be accepted by 
other Member States where agricultural, plant health 
and environmental (including climatic) conditions are 
comparable. Therefore, the Community should be 
divided into zones with such comparable conditions in 
order to facilitate such mutual recognition. However, 
environmental or agricultural circumstances specific to 
the territory of one or more Member States might 
require that, on application, Member States recognise 
or amend an authorisation issued by another Member 
State, or refuse to authorise the plant protection 
product in their territory, where justified as a result of 
specific environmental or agricultural circumstances or 
where the high level of protection of both human and 
animal health and the environment required by this 
Regulation cannot be achieved. It should also be 
possible to impose appropriate conditions having 
regard to the objectives laid down in the National 
Action Plan adopted in accordance with Directive 
2009/128/EC of the European Parliament and of the 
Council of 21 October 2009 establishing a framework 
for Community action to achieve a sustainable use of 
pesticides (  1 ).EN 24.11.2009 Official Journal of the European Union L 309/3  
( 1 ) See page 71 of this Official Journal.(30) The economic incentive for industry to apply for an 
authorisation is limited for certain uses. In order to 
ensure that diversification of agriculture and horticulture 
is not jeopardised by the lack of availability of plant 
protection products, specific rules should be established 
for minor uses.  
(31) Where identical plant protection products are authorised 
in different Member States, a simplified procedure for 
granting a parallel trade permit should be provided for 
in this Regulation, in order to facilitate the trade between 
Member States of such products.  
(32) In exceptional cases, Member States should be permitted 
to authorise plant protection products not complying 
with the conditions provided for in this Regulation, 
where it is necessary to do so because of a danger or 
threat to plant production or ecosystems which cannot 
be contained by any other reasonable means. Such 
temporary authorisations should be reviewed at 
Community level.  
(33) Community seeds legislation provides for free movement 
of seeds within the Community but does not contain a 
specific provision concerning seeds treated with plant 
protection products. Such a provision should therefore 
be included in this Regulation. If treated seeds constitute 
a serious risk to human or animal health or to the 
environment, Member States should have the possibility 
of taking protective measures.  
(34) To promote innovation, special rules should be estab ­
lished permitting the use of plant protection products 
in experiments even where they have not yet been auth ­
orised.  
(35) To ensure a high level of protection of human and 
animal health and the environment, plant protection 
products should be used properly, in accordance with 
their authorisation, having regard to the principles of 
integrated pest management and giving priority to non- 
chemical and natural alternatives wherever possible. The 
Council should include in the statutory management 
requirement referred to in Annex III to Council Regu ­
lation (EC) No 1782/2003 of 29 September 2003 estab ­
lishing common rules for direct support schemes under 
the common agricultural policy and establishing certain 
support schemes for farmers (  1 ), the principles of inte ­
grated pest management, including good plant protection 
practice and non-chemical methods of plant protection 
and pest and crop management.  
(36) In addition to this Regulation and Directive 
2009/128/EC, a thematic strategy on the sustainable 
use of pesticides was adopted. In order to achieve coherence between these instruments, the user should 
know from the product label where, when and under 
what circumstances a plant protection product may be 
used.  
(37) A system of exchange of information should be estab ­
lished. Member States should make available to each 
other, the Commission and the Authority the particulars 
and scientific documentation submitted in connection 
with applications for authorisation of plant protection 
products.  
(38) Adjuvants may be used to increase the efficacy of a plant 
protection product. Their placing on the market or use 
should be forbidden where they contain a co-formulant 
which has been prohibited. The technical rules necessary 
for the authorisation should be established.  
(39) Studies represent a major investment. This investment 
should be protected in order to stimulate research. For 
this reason, tests and studies, other than those involving 
vertebrate animals, which will be subject to obligatory 
data sharing, lodged by one applicant with a Member 
State should be protected against use by another 
applicant. This protection should, however, be limited 
in time in order to allow competition. It should also 
be limited to studies which are genuinely necessary for 
regulatory purposes, to avoid applicants artificially 
extending the period of protection by submitting new 
studies which are not necessary. Business operators, in 
particular small and medium sized enterprises, should 
have the same opportunities in respect of market access.  
(40) The use of non-animal test methods and other risk 
assessment strategies should be promoted. Animal 
testing for the purposes of this Regulation should be 
minimised and tests on vertebrates should be undertaken 
as a last resort. In accordance with Council Directive 
86/609/EEC of 24 November 1986 on the approxi ­
mation of laws, regulations and administrative provisions 
of the Member States regarding the protection of animals 
used for experimental and other scientific purposes (  2 ), 
tests on vertebrate animals must be replaced, restricted 
or refined. Therefore, rules should be laid down to avoid 
duplicative testing and duplication of tests and studies on 
vertebrates should be prohibited. For the purpose of 
developing new plant protection products, there should 
be an obligation to allow access to studies on vertebrates 
on reasonable terms and the results and the costs of tests 
and studies on animals should be shared. In order to 
allow operators to know what studies have been 
carried out by others, Member States should keep a list 
of such studies even where they are not covered by the 
above system of compulsory access.EN L 309/4 Official Journal of the European Union 24.11.2009  
( 1 ) OJ L 270, 21.10.2003, p. 1.  (  2 ) OJ L 358, 18.12.1986, p. 1.(41) As different rules are applied by Member States, the 
Commission and the Authority in relation to access to 
and confidentiality of documents, it is appropriate to 
clarify the provisions concerning access to information 
contained in the documents in the possession of these 
authorities and the confidentiality of these documents.  
(42) Directive 1999/45/EC of the European Parliament and of 
the Council of 31 May 1999 concerning the approxi ­
mation of the laws, regulations and administrative 
provisions of the Member States relating to the classifi ­
cation, packaging and labelling of dangerous prep ­
arations (  1 ) applies to the classification, packaging and 
labelling of plant protection products. However, to 
improve further the protection of users of plant 
protection products, of consumers of plants and plant 
products and of the environment, further specific rules 
are appropriate which take account of the specific 
conditions of use of plant protection products.  
(43) To ensure that advertisements do not mislead users of 
plant protection products or the public, it is appropriate 
to lay down rules on the advertising of those products.  
(44) Provisions on record-keeping and information about the 
use of plant protection products should be established in 
order to raise the level of protection of human and 
animal health and the environment by ensuring the 
traceability of potential exposure, to increase the effi ­
ciency of monitoring and control and to reduce the 
costs of monitoring water quality.  
(45) Provisions on control and inspection arrangements with 
regard to the marketing and use of plant protection 
products should ensure correct, safe and harmonised 
implementation of the requirements laid down in this 
Regulation in order to achieve a high level of protection 
of both human and animal health and the environment.  
(46) Regulation (EC) No 882/2004 of the European 
Parliament and of the Council of 29 April 2004 on 
official controls performed to ensure the verification of 
compliance with feed and food law, animal health and 
animal welfare rules (  2 ) provides for control measures for 
the use of plant protection products at all stages of the 
production of food, including record-keeping on the use 
of plant protection products. Similar rules on monitoring 
and controls relating to the storage and use of plant 
protection products not covered by Regulation (EC) No 
882/2004 should be adopted by the Commission. The 
bureaucratic burden on farmers should be as limited as 
possible.  (47) The measures provided for in this Regulation should 
apply without prejudice to other Community legislation, 
in particular Directive 2009/128/EC, Directive 
2000/60/EC, Regulation (EC) No 396/2005 of the 
European Parliament and of the Council of 23 February 
2005 on maximum residue levels of pesticides in or on 
food and feed of plant and animal origin (  3 ) and 
Community legislation on the protection of workers 
and anyone concerned with the contained use and 
deliberate release of genetically modified organisms.  
(48) It is necessary to establish procedures for the adoption of 
emergency measures in situations where an approved 
active substance, a safener, a synergist or a plant 
protection product is likely to constitute a serious risk 
to human or animal health or the environment.  
(49) Member States should lay down rules on penalties 
applicable to infringements of this Regulation and 
should take the measures necessary to ensure that they 
are implemented.  
(50) General civil and criminal liability in the Member States 
of the manufacturer and, where applicable, of the person 
responsible for placing the plant protection product on 
the market or using it should remain applicable.  
(51) Member States should have the possibility of recovering 
the costs of the procedures associated with the appli ­
cation of this Regulation from those seeking to place, 
or placing, plant protection products or adjuvants on 
the market and from those applying for the approval 
of active substances, safeners or synergists.  
(52) Member States should designate the necessary national 
competent authorities.  
(53) The Commission should facilitate the application of this 
Regulation. Therefore, it is appropriate to provide for the 
necessary financial resources and the possibility of 
amending certain provisions of this Regulation in the 
light of experience or of developing technical notes for 
guidance.  
(54) The measures necessary for the implementation of this 
Regulation should be adopted in accordance with 
Council Decision 1999/468/EC of 28 June 1999 laying 
down the procedures for the exercise of implementing 
powers conferred on the Commission (  4 ).EN 24.11.2009 Official Journal of the European Union L 309/5  
( 1 ) OJ L 200, 30.7.1999, p. 1.  
( 2 ) OJ L 165, 30.4.2004, p. 1.  ( 3 ) OJ L 70, 16.3.2005, p. 1.  
( 4 ) OJ L 184, 17.7.1999, p. 23.(55) In particular, the Commission should be empowered to 
adopt harmonised methods to determine the nature and 
quantity of active substances, safeners and synergists, and 
where appropriate of relevant impurities and co- 
formulants, and maximum quantities of plant protection 
products to be released, and to adopt Regulations 
concerning labelling requirements, controls and rules 
for adjuvants, establishing a work programme for 
safeners and synergists, including their data requirements, 
postponing the expiry of the approval period, extending 
the date for provisional authorisations, setting the 
information requirements for parallel trade and on 
inclusion of co-formulants, as well as amendments to 
the Regulations on data requirements and on uniform 
principles for evaluation and authorisation and to the 
Annexes. Since those measures are of general scope 
and are designed to amend non-essential elements of 
this Regulation,  inter alia , by supplementing it with new 
non-essential elements, they must be adopted in 
accordance with the regulatory procedure with scrutiny 
provided for in Article 5a of Decision 1999/468/EC.  
(56) On grounds of efficiency, the normal time limits for the 
regulatory procedure with scrutiny should be curtailed 
for the adoption of a Regulation postponing the expiry 
of the approval period for a period sufficient to examine 
the application.  
(57) Furthermore, it is appropriate to transfer certain current 
provisions set out in the Annexes to Directive 
91/414/EEC into separate legal instruments to be 
adopted by the Commission within 18 months after 
the entry into force of this Regulation. Since these 
current provisions should be, as a first step, transferred 
into new legal instruments and thus be adopted without 
any substantial modification, the advisory procedure is 
the most appropriate.  
(58) It is also appropriate to use the advisory procedure to 
adopt some purely technical measures, in particular 
technical guidelines in view of their non-binding 
character.  
(59) Certain provisions of Directive 91/414/EEC should 
remain applicable during the transitional period,  
HAVE ADOPTED THIS REGULATION:  
CHAPTER I  
GENERAL PROVISIONS  
Article 1  
Subject matter and purpose  
1. This Regulation lays down rules for the authorisation of 
plant protection products in commercial form and for their 
placing on the market, use and control within the Community.  2. This Regulation lays down both rules for the approval of 
active substances, safeners and synergists, which plant 
protection products contain or consist of, and rules for 
adjuvants and co-formulants.  
3. The purpose of this Regulation is to ensure a high level of 
protection of both human and animal health and the 
environment and to improve the functioning of the internal 
market through the harmonisation of the rules on the placing 
on the market of plant protection products, while improving 
agricultural production.  
4. The provisions of this Regulation are underpinned by the 
precautionary principle in order to ensure that active substances 
or products placed on the market do not adversely affect 
human or animal health or the environment. In particular, 
Member States shall not be prevented from applying the 
precautionary principle where there is scientific uncertainty as 
to the risks with regard to human or animal health or the 
environment posed by the plant protection products to be auth ­
orised in their territory.  
Article 2  
Scope  
1. This Regulation shall apply to products, in the form in 
which they are supplied to the user, consisting of or containing 
active substances, safeners or synergists, and intended for one of 
the following uses:  
(a) protecting plants or plant products against all harmful 
organisms or preventing the action of such organisms, 
unless the main purpose of these products is considered 
to be for reasons of hygiene rather than for the protection 
of plants or plant products;  
(b) influencing the life processes of plants, such as substances 
influencing their growth, other than as a nutrient;  
(c) preserving plant products, in so far as such substances or 
products are not subject to special Community provisions 
on preservatives;  
(d) destroying undesired plants or parts of plants, except algae 
unless the products are applied on soil or water to protect 
plants;  
(e) checking or preventing undesired growth of plants, except 
algae unless the products are applied on soil or water to 
protect plants.EN L 309/6 Official Journal of the European Union 24.11.2009These products are referred to as ‘plant protection products’.  
2. This Regulation shall apply to substances, including 
micro-organisms having general or specific action against 
harmful organisms or on plants, parts of plants or plant 
products, referred to as ‘active substances’.  
3. This Regulation shall apply to the following:  
(a) substances or preparations which are added to a plant 
protection product to eliminate or reduce phytotoxic 
effects of the plant protection product on certain plants, 
referred to as ‘safeners’;  
(b) substances or preparations which, while showing no or only 
weak activity as referred to in paragraph 1, can give 
enhanced activity to the active substance(s) in a plant 
protection product, referred to as ‘synergists’;  
(c) substances or preparations which are used or intended to be 
used in a plant protection product or adjuvant, but are 
neither active substances nor safeners or synergists, 
referred to as ‘co-formulants’;  
(d) substances or preparations which consist of co-formulants 
or preparations containing one or more co-formulants, in 
the form in which they are supplied to the user and placed 
on the market to be mixed by the user with a plant 
protection product and which enhance its effectiveness or 
other pesticidal properties, referred to as ‘adjuvants’.  
Article 3  
Definitions  
For the purposes of this Regulation, the following definitions 
shall apply:  
1. ‘residues’ means one or more substances present in or on 
plants or plant products, edible animal products, drinking 
water or elsewhere in the environment and resulting from 
the use of a plant protection product, including their meta ­
bolites, breakdown or reaction products;  
2. ‘substances’ means chemical elements and their 
compounds, as they occur naturally or by manufacture, 
including any impurity inevitably resulting from the manu ­
facturing process;  
3. ‘preparations’ means mixtures or solutions composed of 
two or more substances intended for use as a plant 
protection product or as an adjuvant;  
4. ‘substance of concern’ means any substance which has an 
inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced 
in a plant protection product in sufficient concentration to 
present risks of such an effect.  
Such substances include, but are not limited to, substances 
meeting the criteria to be classified as hazardous in 
accordance with Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council of 16 December 
2008 on classification, labelling and packaging of 
substances and mixtures (  1 ), and present in the plant 
protection product at a concentration leading the product 
to be regarded as dangerous within the meaning of 
Article 3 of Directive 1999/45/EC;  
5. ‘plants’ means live plants and live parts of plants, including 
fresh fruit, vegetables and seeds;  
6. ‘plant products’ means products of plant origin in an 
unprocessed state or having undergone only simple prep ­
aration, such as milling, drying or pressing, but excluding 
plants;  
7. ‘harmful organisms’ means any species, strain or biotype 
belonging to the animal kingdom or plant kingdom or 
pathogenic agent injurious to plants or plant products;  
8. ‘non-chemical methods’ means alternative methods to 
chemical pesticides for plant protection and pest 
management, based on agronomic techniques such as 
those referred to in point 1 of Annex III to Directive 
2009/128/EC, or physical, mechanical or biological pest 
control methods;  
9. ‘placing on the market’ means the holding for the purpose 
of sale within the Community, including offering for sale or 
any other form of transfer, whether free of charge or not, 
and the sale, distribution, and other forms of transfer them ­
selves, but not the return to the previous seller. Release for 
free circulation into the territory of the Community shall 
constitute placing on the market for the purposes of this 
Regulation;  
10. ‘authorisation of a plant protection product’ means an 
administrative act by which the competent authority of a 
Member State authorises the placing on the market of a 
plant protection product in its territory;  
11. ‘producer’ means a person who manufactures plant 
protection products, active substances, safeners, synergists, 
co-formulants or adjuvants on his own, or who contracts 
this manufacturing to another party, or a person designated 
by the manufacturer as his sole representative for the 
purpose of compliance with this Regulation;EN 24.11.2009 Official Journal of the European Union L 309/7  
( 1 ) OJ L 353, 31.12.2008, p. 1.12. ‘letter of access’ means an original document by which the 
owner of data protected under this Regulation agrees to the 
use of such data under the specific terms and conditions by 
the competent authority for the purpose of granting an 
authorisation of a plant protection product or an 
approval of an active substance, synergist or safener for 
the benefit of another applicant;  
13. ‘environment’ means waters (including ground, surface, 
transitional, coastal and marine), sediment, soil, air, land, 
wild species of fauna and flora, and any interrelationship 
between them, and any relationship with other living 
organisms;  
14. ‘vulnerable groups’ means persons needing specific 
consideration when assessing the acute and chronic 
health effects of plant protection products. These include 
pregnant and nursing women, the unborn, infants and 
children, the elderly and workers and residents subject to 
high pesticide exposure over the long term;  
15. ‘micro-organisms’ means any microbiological entity, 
including lower fungi and viruses, cellular or non-cellular, 
capable of replication or of transferring genetic material;  
16. ‘genetically modified organisms’ means organisms in which 
the genetic material has been altered within the meaning of 
Article 2(2) of Directive 2001/18/EC of the European 
Parliament and of the Council of 12 March 2001 on the 
deliberate release into the environment of genetically 
modified organisms (  1 ); 
17. ‘zone’ means a group of Member States as defined in 
Annex I.  
For the purpose of use in greenhouses, as post-harvest 
treatment, for treatment of empty storage rooms and 
for seed treatment the zone means all zones defined in 
Annex I;  
18. ‘good plant protection practice’ means a practice whereby 
the treatments with plant protection products applied to 
given plants or plant products, in conformity with the 
conditions of their authorised uses, are selected, dosed 
and timed to ensure acceptable efficacy with the 
minimum quantity necessary, taking due account of local 
conditions and of the possibilities for cultural and 
biological control;  
19. ‘good laboratory practice’ means a practice as defined in 
point 2.1 of Annex I to Directive 2004/10/EC of the 
European Parliament and of the Council of 11 February 
2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the 
principles of good laboratory practice and the verification 
of their applications for tests on chemical substances (  2 ); 
20. ‘good experimental practice’ means a practice in accordance 
with the provisions of European and Mediterranean Plant 
Protection Organisation (EPPO) Guidelines 181 and 152;  
21. ‘data protection’ means the temporary right of the owner of 
a test or study report to prevent it being used for the 
benefit of another applicant;  
22. ‘rapporteur Member State’ means the Member State which 
undertakes the task of evaluating an active substance, 
safener or synergist;  
23. ‘tests and studies’ means investigations or experiments 
whose purpose is to determine the properties and 
behaviour of an active substance or of plant protection 
products, predict exposure to active substances and/or 
their relevant metabolites, determine safe levels of 
exposure and establish conditions for the safe use of 
plant protection products;  
24. ‘authorisation holder’ means any natural or legal person 
holding an authorisation of a plant protection product;  
25. ‘professional user’ means a professional user as defined in 
Article 3(1) of Directive 2009/128/EC;  
26. ‘minor use’ means use of a plant protection product in a 
particular Member State on plants or plant products which 
are: 
(a) not widely grown in that Member State; or  
(b) widely grown, to meet an exceptional plant protection 
need;  
27. ‘greenhouse’ means a walk-in, static, closed place of crop 
production with a usually translucent outer shell, which 
allows controlled exchange of material and energy with 
the surroundings and prevents release of plant protection 
products into the environment.  
For the purpose of this Regulation, closed places of plant 
production where the outer shell is not translucent (for 
example, for production of mushrooms or witloof) are 
also considered as greenhouses;EN L 309/8 Official Journal of the European Union 24.11.2009  
( 1 ) OJ L 106, 17.4.2001, p. 1.  (  2 ) OJ L 50, 20.2.2004, p. 44.28. ‘post-harvest treatment’ means treatment of plants or plant 
products after harvest in an isolated space where no run-off 
is possible, for example in a warehouse;  
29. ‘biodiversity’ means variability among living organisms 
from all sources, including terrestrial, marine and other 
aquatic ecosystems and the ecological complexes of 
which they are part; this variability may include diversity 
within species, between species and of ecosystems;  
30. ‘competent authority’ means any authority or authorities of 
a Member State responsible for carrying out the tasks estab ­
lished under this Regulation;  
31. ‘advertisement’ means a means of promoting the sale or use 
of plant protection products (to anyone other than the 
authorisation holder, the person placing the plant 
protection product on the market and their agents) by 
printed or electronic media;  
32. ‘metabolite’ means any metabolite or a degradation product 
of an active substance, safener or synergist, formed either in 
organisms or in the environment.  
A metabolite is deemed relevant if there is a reason to 
assume that it has intrinsic properties comparable to the 
parent substance in terms of its biological target activity, or 
that it poses a higher or comparable risk to organisms than 
the parent substance or that it has certain toxicological 
properties that are considered unacceptable. Such a meta ­
bolite is relevant for the overall approval decision or for the 
definition of risk mitigation measures;  
33. ‘impurity’ means any component other than the pure active 
substance and/or variant which is present in the technical 
material (including components originating from the manu ­
facturing process or from degradation during storage).  
CHAPTER II  
ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND 
CO-FORMULANTS  
SECTION 1  
Active substances  
S u b s e c t i o n 1  
R e q u i r e m e n t s a n d c o n d i t i o n s f o r a p p r o v a l  
Article 4  
Approval criteria for active substances  
1. An active substance shall be approved in accordance with 
Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval 
criteria set out in points 2 and 3 of that Annex, plant 
protection products containing that active substance meet the 
requirements provided for in paragraphs 2 and 3.  
The assessment of the active substance shall first establish 
whether the approval criteria set out in points 3.6.2 to 3.6.4 
and 3.7 of Annex II are satisfied. If these criteria are satisfied the 
assessment shall continue to establish whether the other 
approval criteria set out in points 2 and 3 of Annex II are 
satisfied.  
2. The residues of the plant protection products, consequent 
on application consistent with good plant protection practice 
and having regard to realistic conditions of use, shall meet the 
following requirements:  
(a) they shall not have any harmful effects on human health, 
including that of vulnerable groups, or animal health, taking 
into account known cumulative and synergistic effects 
where the scientific methods accepted by the Authority to 
assess such effects are available, or on groundwater;  
(b) they shall not have any unacceptable effect on the 
environment.  
For residues which are of toxicological, ecotoxicological, envi ­
ronmental or drinking water relevance, there shall be methods 
in general use for measuring them. Analytical standards shall be 
commonly available.  
3. A plant protection product, consequent on application 
consistent with good plant protection practice and having 
regard to realistic conditions of use, shall meet the following 
requirements:  
(a) it shall be sufficiently effective;  
(b) it shall have no immediate or delayed harmful effect on 
human health, including that of vulnerable groups, or 
animal health, directly or through drinking water (taking 
into account substances resulting from water treatment), 
food, feed or air, or consequences in the workplace or 
through other indirect effects, taking into account known 
cumulative and synergistic effects where the scientific 
methods accepted by the Authority to assess such effects 
are available; or on groundwater;  
(c) it shall not have any unacceptable effects on plants or plant 
products;  
(d) it shall not cause unnecessary suffering and pain to verte ­
brates to be controlled;EN 24.11.2009 Official Journal of the European Union L 309/9(e) it shall have no unacceptable effects on the environment, 
having particular regard to the following considerations 
where the scientific methods accepted by the Authority to 
assess such effects are available:  
(i) its fate and distribution in the environment, particularly 
contamination of surface waters, including estuarine 
and coastal waters, groundwater, air and soil taking 
into account locations distant from its use following 
long-range environmental transportation;  
(ii) its impact on non-target species, including on the 
ongoing behaviour of those species;  
(iii) its impact on biodiversity and the ecosystem.  
4. The requirements of paragraphs 2 and 3 shall be evaluated 
in the light of uniform principles as referred to in Article 29(6).  
5. For approval of an active substance, paragraphs 1, 2 and 3 
shall be deemed to be satisfied where this has been established 
with respect to one or more representative uses of at least one 
plant protection product containing that active substance.  
6. In relation to human health, no data collected on humans 
shall be used to lower the safety margins resulting from tests or 
studies on animals.  
7. By way of derogation from paragraph 1, where on the 
basis of documented evidence included in the application an 
active substance is necessary to control a serious danger to 
plant health which cannot be contained by other available 
means including non-chemical methods, such active substance 
may be approved for a limited period necessary to control that 
serious danger but not exceeding five years even if it does not 
satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 
of Annex II, provided that the use of the active substance is 
subject to risk mitigation measures to ensure that exposure of 
humans and the environment is minimised. For such substances 
maximum residue levels shall be set in accordance with Regu ­
lation (EC) No 396/2005.  
This derogation shall not apply to active substances which are 
or have to be classified in accordance with Regulation (EC) No 
1272/2008, as carcinogenic category 1A, carcinogenic category 
1B without a threshold, or toxic for reproduction category 1A.  
Member States may authorise plant protection products 
containing active substances approved in accordance with this 
paragraph only when it is necessary to control that serious 
danger to plant health in their territory.  At the same time, they shall draw up a phasing out plan 
concerning the control of the serious danger by other means, 
including non-chemical methods, and shall without delay 
transmit that plan to the Commission.  
Article 5  
First approval  
First approval shall be for a period not exceeding 10 years.  
Article 6  
Conditions and restrictions  
Approval may be subject to conditions and restrictions 
including:  
(a) the minimum degree of purity of the active substance;  
(b) the nature and maximum content of certain impurities;  
(c) restrictions arising from the evaluation of the information 
referred to in Article 8 taking account of the agricultural, 
plant health and environmental, including climatic, 
conditions in question;  
(d) type of preparation;  
(e) manner and conditions of application;  
(f) submission of further confirmatory information to Member 
States, the Commission and the European Food Safety 
Authority, (the Authority), where new requirements are 
established during the evaluation process or as a result of 
new scientific and technical knowledge;  
(g) designation of categories of users, such as professional and 
non-professional;  
(h) designation of areas where the use of plant protection 
products, including soil treatment products, containing the 
active substance may not be authorised or where the use 
may be authorised under specific conditions;  
(i) the need to impose risk mitigation measures and moni ­
toring after use;  
(j) any other particular conditions that result from the 
evaluation of information made available in the context of 
this Regulation.EN L 309/10 Official Journal of the European Union 24.11.2009S u b s e c t i o n 2  
A p p r o v a l p r o c e d u r e  
Article 7  
Application  
1. An application for the approval of an active substance or 
for an amendment to the conditions of an approval shall be 
submitted by the producer of the active substance to a Member 
State, (the rapporteur Member State), together with a summary 
and a complete dossier as provided for in Article 8(1) and (2) or 
a scientifically reasoned justification for not providing certain 
parts of those dossiers, demonstrating that the active substance 
fulfils the approval criteria provided for in Article 4.  
A joint application may be submitted by an association of 
producers designated by the producers for the purpose of 
compliance with this Regulation.  
The application shall be examined by the Member State 
proposed by the applicant, unless another Member State 
agrees to examine it.  
2. Assessment of an application may be performed by a 
number of Member States together under a co-rapporteur 
system.  
3. When submitting the application, the applicant may 
pursuant to Article 63 request certain information, including 
certain parts of the dossier, to be kept confidential and shall 
physically separate that information.  
Member States shall assess the confidentiality requests. Upon a 
request for access to information, the rapporteur Member State 
shall decide what information is to be kept confidential.  
4. When submitting the application the applicant shall at the 
same time join a complete list of tests and studies submitted 
pursuant to Article 8(2) and a list of any claims for data 
protection pursuant to Article 59.  
5. When assessing the application the rapporteur Member 
State may at any time consult the Authority.  
Article 8  
Dossiers  
1. The summary dossier shall include the following:  
(a) information with respect to one or more representative uses 
on a widely grown crop in each zone of at least one plant 
protection product containing the active substance, demon ­
strating that the approval criteria provided for in Article 4 
are met; where the information submitted does not cover all 
zones or concern a crop which is not widely grown, justifi ­
cation for this approach;  (b) for each point of the data requirements for the active 
substance, the summaries and results of tests and studies, 
the name of their owner and of the person or institute that 
has carried out the tests and studies;  
(c) for each point of the data requirements for the plant 
protection product, the summaries and results of tests and 
studies, the name of their owner and of the person or 
institute that carried out the tests and studies, relevant to 
the assessment of the criteria provided for in Article 4(2) 
and (3) for one or more plant protection products which 
are representative of the uses referred to in point (a), taking 
into account the fact that data gaps in the dossier, as 
provided for in paragraph 2 of this Article, resulting from 
the proposed limited range of representative uses of the 
active substance, may lead to restrictions in the approval;  
(d) for each test or study involving vertebrate animals, a justifi ­
cation of the steps taken to avoid animal testing and dupli ­
cation of tests and studies on vertebrate animals;  
(e) a checklist demonstrating that the dossier provided for in 
paragraph 2 of this Article is complete in view of the uses 
applied for;  
(f) the reasons why the test and study reports submitted are 
necessary for first approval of the active substance or for 
amendments to the conditions of the approval;  
(g) where relevant, a copy of an application for a maximum 
residue level as referred to in Article 7 of Regulation (EC) 
No 396/2005 or a justification for not supplying such 
information;  
(h) an assessment of all information submitted.  
2. The complete dossier shall contain the full text of the 
individual test and study reports concerning all the information 
referred to in points (b) and (c) of paragraph 1. It shall not 
contain any reports of tests or studies involving the deliberate 
administration of the active substance or the plant protection 
product to humans.  
3. The format of the summary dossier and the complete 
dossier shall be established in accordance with the advisory 
procedure referred to in Article 79(2).  
4. The data requirements referred to in paragraphs 1 and 2 
shall contain the requirements for active substances and plant 
protection products as set out in Annexes II and III to Directive 
91/414/EEC and laid down in Regulations adopted in 
accordance with the advisory procedure referred to in 
Article 79(2) without any substantial modifications. Subsequent 
amendments to these Regulations shall be adopted in 
accordance with Article 78(1)(b).EN 24.11.2009 Official Journal of the European Union L 309/115. Scientific peer-reviewed open literature, as determined by 
the Authority, on the active substance and its relevant meta ­
bolites dealing with side-effects on health, the environment and 
non-target species and published within the last 10 years before 
the date of submission of the dossier shall be added by the 
applicant to the dossier.  
Article 9  
Admissibility of the application  
1. Within 45 days of receiving the application, the 
rapporteur Member State shall send the applicant a written 
acknowledgement, stating the date of receipt, and check 
whether the dossiers submitted with the application contain 
all the elements provided for in Article 8, using the checklist 
referred to in point (e) of Article 8(1). It shall also check the 
requests for confidentiality referred to in Article 7(3) and the 
complete lists of tests and studies submitted pursuant to 
Article 8(2).  
2. Where one or more of the elements provided for in 
Article 8 are missing, the rapporteur Member State shall 
inform the applicant, setting a period for their submission. 
Such period shall be a maximum of 3 months.  
Where at the end of that period, the applicant has not 
submitted the missing elements, the rapporteur Member State 
shall inform the applicant, the other Member States and the 
Commission that the application is inadmissible.  
A new application for the same substance may be submitted at 
any time.  
3. Where the dossiers submitted with the application contain 
all the elements provided for in Article 8, the rapporteur 
Member State shall notify the applicant, the other Member 
States, the Commission and the Authority of the admissibility 
of the application and start assessing the active substance.  
After receiving that notification, the applicant shall immediately 
forward the dossiers as provided for in Article 8 to the other 
Member States, the Commission and the Authority, including 
the information about those parts of the dossiers in respect of 
which confidentiality has been requested as referred to in 
Article 7(3).  
Article 10  
Access to the summary dossier  
The Authority shall without delay make the summary dossier 
referred to in Article 8(1) available to the public, excluding any 
information in respect of which confidential treatment has been 
requested and justified pursuant to Article 63, unless there is an 
overriding public interest in its disclosure.  Article 11  
Draft assessment report  
1. Within 12 months of the date of the notification provided 
for in the first subparagraph of Article 9(3), the rapporteur 
Member State shall prepare and submit to the Commission, 
with a copy to the Authority, a report, referred to as the 
‘draft assessment report’, assessing whether the active 
substance can be expected to meet the approval criteria 
provided for in Article 4.  
2. The draft assessment report shall also include where 
relevant, a proposal to set maximum residue levels.  
The rapporteur Member State shall make an independent, 
objective and transparent assessment in the light of current 
scientific and technical knowledge.  
Where, pursuant to Article 4(1), the assessment establishes that 
the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of 
Annex II are not satisfied, the draft assessment report shall be 
limited to those parts of the assessment.  
3. Where the rapporteur Member State needs additional 
studies or information, it shall set a period in which the 
applicant must supply those studies or that information. In 
that case, the 12-month period shall be extended by the addi ­
tional period granted by the rapporteur Member State. The 
additional period shall be of a maximum of 6 months and 
shall cease at the moment when the additional information is 
received by the rapporteur Member State. It shall inform the 
Commission and the Authority accordingly.  
Where at the end of the additional period, the applicant has not 
submitted the additional studies or information, the rapporteur 
Member State shall inform the applicant, the Commission and 
the Authority and shall state the missing elements in the 
assessment included in the draft assessment report.  
4. The format of the draft assessment report shall be estab ­
lished in accordance with the advisory procedure referred to in 
Article 79(2).  
Article 12  
Conclusion by the Authority  
1. The Authority shall circulate the draft assessment report 
received from the rapporteur Member State to the applicant and 
the other Member States at the latest 30 days after its receipt. It 
shall ask the applicant to circulate an update of the dossier 
where applicable to the Member States, the Commission and 
the Authority.EN L 309/12 Official Journal of the European Union 24.11.2009The Authority shall make the draft assessment report available 
to the public, after giving the applicant two weeks to request, 
pursuant to Article 63, that certain parts of the draft assessment 
report be kept confidential.  
The Authority shall allow a period of 60 days for the 
submission of written comments.  
2. The Authority, where appropriate shall organise a consul ­
tation of experts, including experts from the rapporteur Member 
State.  
Within 120 days of the end of the period provided for the 
submission of written comments, the Authority shall adopt a 
conclusion in the light of current scientific and technical 
knowledge using guidance documents available at the time of 
application on whether the active substance can be expected to 
meet the approval criteria provided for in Article 4 and shall 
communicate it to the applicant, the Member States and the 
Commission and shall make it available to the public. In the 
event of a consultation as provided for in this paragraph, the 
120-day period shall be extended by 30 days.  
Where appropriate, the Authority shall address in its conclusion 
the risk mitigation options identified in the draft assessment 
report.  
3. Where the Authority needs additional information, it shall 
set a period of a maximum of 90 days for the applicant to 
supply it to the Member States, the Commission and the 
Authority.  
The rapporteur Member State shall assess the additional 
information and submit it to the Authority without delay and 
at the latest within 60 days after receipt of the additional 
information. In that case the 120-day period provided for in 
paragraph 2 shall be extended by a period which shall cease at 
the moment when the additional assessment is received by the 
Authority.  
The Authority may ask the Commission to consult a 
Community reference laboratory, designated pursuant to Regu ­
lation (EC) No 882/2004 for the purposes of verifying whether 
the analytical method for the determination of the residues 
proposed by the applicant is satisfactory and meets the 
requirements in Article 29(1)(g) of this Regulation. The 
applicant shall, if requested by the Community reference 
laboratory, provide samples and analytical standards.  
4. The conclusion of the Authority shall include details 
concerning the evaluation procedure and the properties of the 
active substance concerned.  
5. The Authority shall establish the format for its conclusion 
which shall include details concerning the evaluation procedure 
and the properties of the active substance concerned.  6. The time limits for the Authority’s opinion on appli ­
cations concerning maximum residue levels set out in 
Article 11 and for decisions on applications concerning 
maximum residue levels set out in Article 14 of Regulation 
(EC) No 396/2005 shall be without prejudice to the time 
limits laid down in this Regulation.  
7. Where the conclusion of the Authority is adopted within 
the time limit set out in paragraph 2 of this Article, extended by 
any additional period set in accordance with paragraph 3, the 
provisions of Article 11 of Regulation (EC) No 396/2005 shall 
not apply and the provisions of Article 14 of that Regulation 
shall apply without delay.  
8. Where the conclusion of the Authority is not adopted 
within the time limit set out in paragraph 2 of this Article, 
extended by any additional period set in accordance with 
paragraph 3, the provisions of Articles 11 and 14 of Regulation 
(EC) No 396/2005 shall apply without delay.  
Article 13  
Approval Regulation  
1. Within six months of receiving the conclusion from the 
Authority, the Commission shall present a report, referred to as 
‘the review report’, and a draft Regulation to the Committee 
referred to in Article 79(1), taking into account the draft 
assessment report by the rapporteur Member State and the 
conclusion of the Authority.  
The applicant shall be given the possibility to submit comments 
on the review report.  
2. On the basis of the review report, other factors legitimate 
to the matter under consideration and the precautionary 
principle where the conditions laid down in Article 7(1) of 
Regulation (EC) No 178/2002 are relevant, a Regulation shall 
be adopted in accordance with the regulatory procedure referred 
to in Article 79(3), providing that:  
(a) an active substance is approved, subject to conditions and 
restrictions, as referred to in Article 6, where appropriate;  
(b) an active substance is not approved; or  
(c) the conditions of the approval are amended.  
3. Where the approval provides for the submission of further 
confirmatory information as referred to in Article 6(f), the 
Regulation shall provide the time limit to submit the 
information to the Member States, the Commission and the 
Authority.EN 24.11.2009 Official Journal of the European Union L 309/13The rapporteur Member State shall assess the additional 
information and submit its assessment to the other Member 
States, the Commission and the Authority without delay and 
at the latest six months after the receipt of the additional 
information.  
4. Approved active substances shall be included in the Regu ­
lation referred to in Article 78(3) containing the list of active 
substances already approved. The Commission shall maintain a 
list of approved active substances electronically available to the 
public.  
S u b s e c t i o n 3  
R e n e w a l a n d r e v i e w  
Article 14  
Renewal of approval  
1. On application the approval of an active substance shall 
be renewed where it is established that the approval criteria 
provided for in Article 4 are satisfied.  
Article 4 shall be deemed to be satisfied where this has been 
established with respect to one or more representative uses of at 
least one plant protection product containing that active 
substance.  
Such renewal of the approval may include conditions and 
restrictions, as referred to in Article 6.  
2. The renewal of the approval shall be for a period not 
exceeding 15 years. The renewal of approval of active 
substances covered by Article 4(7) shall be for a period not 
exceeding five years.  
Article 15  
Application for renewal  
1. The application provided for in Article 14 shall be 
submitted by a producer of the active substance to a Member 
State, with a copy to the other Member States, the Commission 
and the Authority, no later than three years before the expiry of 
the approval.  
2. When applying for renewal, the applicant shall identify 
new data he intends to submit and demonstrate that they are 
necessary, because of data requirements or criteria which were 
not applicable at the time of the last approval of the active 
substance or because his request is for an amended approval. 
The applicant shall at the same time submit a timetable of any 
new and ongoing studies.  
The applicant shall identify, giving reasons, the parts of the 
information submitted that he requests to be kept confidential in accordance with Article 63 and at the same time any data 
protection claims pursuant to Article 59.  
Article 16  
Access to the information for renewal  
The Authority shall, without delay, make available to the public 
the information provided by the applicant under Article 15, 
excluding any information in respect of which confidential 
treatment has been requested and justified pursuant to 
Article 63, unless there is an overriding public interest in its 
disclosure.  
Article 17  
Extension of approval period for the duration of the 
procedure  
Where for reasons beyond the control of the applicant it 
appears that the approval is likely to expire before a decision 
has been taken on renewal, a decision shall be adopted in 
accordance with the regulatory procedure referred to in 
Article 79(3), postponing the expiry of the approval period 
for that applicant for a period sufficient to examine the appli ­
cation.  
A Regulation postponing the expiry for a period sufficient to 
examine the application shall be adopted in accordance with the 
regulatory procedure with scrutiny referred to in Article 79(5) 
where an applicant could not give the three years’ notice 
required under Article 15(1) because the active substance was 
included in Annex I to Directive 91/414/EEC for a duration 
which expired before 14 June 2014.  
The length of that period shall be established on the basis of the 
following:  
(a) the time needed to provide the information requested;  
(b) the time needed to complete the procedure;  
(c) where appropriate, the need to ensure the establishment of 
a coherent work programme, as provided for in Article 18.  
Article 18  
Work programme  
The Commission may establish a work programme grouping 
together similar active substances setting priorities on the 
basis of safety concerns for human and animal health or the 
environment and taking into account, as far as possible, the 
need for an effective control and resistance management of 
target pest. The programme may require interested parties to 
submit all the necessary data to the Member States, the 
Commission and the Authority within a period provided for 
in the programme.EN L 309/14 Official Journal of the European Union 24.11.2009The programme shall include the following:  
(a) the procedures concerning the submission and assessment 
of applications for renewal of approvals;  
(b) the necessary data to be submitted, including measures to 
minimise animal testing, in particular the use of non-animal 
test methods and intelligent testing strategies;  
(c) the periods for submission of such data;  
(d) rules on the submission of new information;  
(e) period for assessment and decision making;  
(f) the allocation of evaluation of active substances to Member 
States, taking into account a balance in the responsibilities 
and work to be done among Member States acting as 
rapporteurs.  
Article 19  
Implementing measures  
A Regulation, adopted in accordance with the regulatory 
procedure referred to in Article 79(3), shall set out the 
provisions necessary for the implementation of the renewal 
procedure, including, where relevant, the implementation of a 
work programme, as provided for in Article 18.  
Article 20  
Renewal Regulation  
1. A Regulation shall be adopted in accordance with the 
regulatory procedure referred to in Article 79(3), providing that:  
(a) the approval of an active substance is renewed, subject to 
conditions and restrictions where appropriate; or  
(b) the approval of an active substance is not renewed.  
2. Where the reasons for not renewing the approval do not 
concern the protection of health or the environment, the Regu ­
lation referred to in paragraph 1 shall provide for a grace period 
not exceeding six months for the sale and distribution, and in 
addition a maximum of one year for the disposal, storage, and 
use of existing stocks of the plant protection products 
concerned. The grace period for the sale and distribution shall 
take into account the normal period of use of the plant 
protection product but the total grace period shall not exceed 
18 months.  
In the case of a withdrawal of the approval or if the approval is 
not renewed because of the immediate concerns for human 
health or animal health or the environment, the plant protection products concerned shall be withdrawn from the 
market immediately.  
3. Article 13(4) shall apply.  
Article 21  
Review of approval  
1. The Commission may review the approval of an active 
substance at any time. It shall take into account the request 
of a Member State to review, in the light of new scientific 
and technical knowledge and monitoring data, the approval of 
an active substance, including where, after the review of the 
authorisations pursuant to Article 44(1), there are indications 
that the achievement of the objectives established in accordance 
with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of 
Directive 2000/60/EC is compromised.  
Where, in the light of new scientific and technical knowledge it 
considers that there are indications that the substance no longer 
satisfies the approval criteria provided for in Article 4, or further 
information required in accordance with Article 6(f) has not 
been provided, it shall inform the Member States, the 
Authority and the producer of the active substance, setting a 
period for the producer to submit its comments.  
2. The Commission may ask the Member States and the 
Authority for an opinion, or for scientific or technical 
assistance. The Member States may provide their comments to 
the Commission within three months from the date of the 
request. The Authority shall provide its opinion or the results 
of its work to the Commission within three months of the date 
of the request.  
3. Where the Commission concludes that the approval 
criteria provided for in Article 4 are no longer satisfied, or 
the further information required in accordance with 
Article 6(f) has not been provided, a Regulation to withdraw 
or amend the approval shall be adopted in accordance with the 
regulatory procedure referred to in Article 79(3).  
Article 13(4) and Article 20(2) shall apply.  
S u b s e c t i o n 4  
D e r o g a t i o n s  
Article 22  
Low-risk active substances  
1. An active substance complying with the criteria provided 
for in Article 4 shall be approved for a period not exceeding 15 
years by way of derogation from Article 5, where it is 
considered a low-risk active substance and where it may be 
expected that plant protection products containing that 
substance will pose only a low risk to human and animal 
health and the environment as provided for in Article 47(1).EN 24.11.2009 Official Journal of the European Union L 309/152. Articles 4 and 6 to 21 and point 5 of Annex II shall 
apply. Low-risk active substances shall be listed separately in 
the Regulation referred to in Article 13(4).  
3. The Commission may review and if necessary specify new 
criteria for approving an active substance as low-risk active 
substance in accordance with Article 78(1)(a).  
Article 23  
Approval criteria for basic substances  
1. Basic substances shall be approved in accordance with 
paragraphs 2 to 6. By way of derogation from Article 5, the 
approval shall be for an unlimited period.  
For the purpose of paragraphs 2 to 6, a basic substance is an 
active substance which:  
(a) is not a substance of concern; and  
(b) does not have an inherent capacity to cause endocrine 
disrupting, neurotoxic or immunotoxic effects; and  
(c) is not predominantly used for plant protection purposes but 
nevertheless is useful in plant protection either directly or in 
a product consisting of the substance and a simple diluent; 
and 
(d) is not placed on the market as a plant protection product.  
For the purpose of this Regulation, an active substance which 
fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of 
Regulation (EC) No 178/2002 shall be considered as a basic 
substance.  
2. By way of derogation from Article 4, a basic substance 
shall be approved where any relevant evaluations, carried out in 
accordance with other Community legislation regulating the use 
of that substance for purposes other than for a plant protection 
product, show that the substance has neither an immediate or 
delayed harmful effect on human or animal health nor an unac ­
ceptable effect on the environment.  
3. By way of derogation from Article 7 an application for 
the approval of a basic substance shall be submitted by a 
Member State or by any interested party to the Commission.  
The application shall be accompanied by the following 
information:  
(a) any evaluations of its possible effects on human or animal 
health or the environment carried out in accordance with 
other Community legislation regulating the use of the 
substance; and  (b) other relevant information on its possible effects on human 
or animal health or the environment.  
4. The Commission shall ask the Authority for an opinion, 
or for scientific or technical assistance. The Authority shall 
provide its opinion or the results of its work to the Commission 
within 3 months of the date of the request.  
5. Articles 6 and 13 shall apply. Basic substances shall be 
listed separately in the Regulation referred to in Article 13(4).  
6. The Commission may review the approval of a basic 
substance at any time. It may take into account the request 
of a Member State to review the approval.  
Where the Commission considers that there are indications that 
the substance no longer satisfies the criteria provided for in 
paragraphs 1 to 3 it shall inform the Member States, the 
Authority and the interested party, setting a period for their 
comments to be submitted.  
The Commission shall ask the Authority for an opinion, or for 
scientific or technical assistance. The Authority shall provide its 
opinion or the results of its work to the Commission within 
three months of the date of the request.  
Where the Commission concludes that the criteria referred to in 
paragraph 1 are no longer satisfied, a Regulation to withdraw or 
amend the approval shall be adopted in accordance with the 
regulatory procedure referred to in Article 79(3).  
Article 24  
Candidates for substitution  
1. An active substance complying with the criteria provided 
for in Article 4 shall be approved, for a period not exceeding 
seven years, as a candidate for substitution if it meets one or 
more of the additional criteria laid down in point 4 of Annex II. 
By way of derogation from Article 14(2), the approval may be 
renewed once or more for periods not exceeding seven years.  
2. Without prejudice to paragraph 1, Articles 4 to 21 shall 
apply. Candidates for substitution shall be listed separately in 
the Regulation referred to in Article 13(4).  
SECTION 2  
Safeners and synergists  
Article 25  
Approval of safeners and synergists  
1. A safener or synergist shall be approved, where it 
complies with Article 4.EN L 309/16 Official Journal of the European Union 24.11.20092. Articles 5 to 21 shall apply.  
3. Similar data requirements to those referred to in 
Article 8(4) shall be defined for safeners and synergists in 
accordance with the regulatory procedure with scrutiny 
referred to in Article 79(4).  
Article 26  
Safeners and synergists already on the market  
By 14 December 2014, a Regulation shall be adopted in 
accordance with the regulatory procedure with scrutiny 
referred to in Article 79(4) establishing a work programme 
for the gradual review of synergists and safeners on the 
market when that Regulation enters into force. The Regulation 
shall include the establishment of data requirements, including 
measures to minimise animal testing, notification, evaluation, 
assessment and decision-making procedures. It shall require 
interested parties to submit all the necessary data to the 
Member States, the Commission and the Authority within a 
specified period.  
SECTION 3  
Unacceptable co-formulants  
Article 27  
Co-formulants  
1. A co-formulant shall not be accepted for inclusion in a 
plant protection product where it has been established that:  
(a) its residues, consequent on application consistent with good 
plant protection practice, and having regard to realistic 
conditions of use, have a harmful effect on human or 
animal health or on groundwater or an unacceptable 
effect on the environment; or  
(b) its use, consequent on application consistent with good 
plant protection practice and having regard to realistic 
conditions of use, has a harmful effect on human or 
animal health or an unacceptable effect on plants, plant 
products or the environment.  
2. Co-formulants which are not accepted for inclusion in a 
plant protection product pursuant to paragraph 1 shall be 
included in Annex III in accordance with the regulatory 
procedure with scrutiny referred to in Article 79(4).  
3. The Commission may review co-formulants at any time. It 
may take into account relevant information provided by 
Member States.  
4. Article 81(2) shall apply.  
5. Detailed rules for the implementation of this Article may 
be established in accordance with the regulatory procedure 
referred to in Article 79(3).  CHAPTER III  
PLANT PROTECTION PRODUCTS  
SECTION 1  
Authorisation  
S u b s e c t i o n 1  
R e q u i r e m e n t s a n d c o n t e n t s  
Article 28  
Authorisation for placing on the market and use  
1. A plant protection product shall not be placed on the 
market or used unless it has been authorised in the Member 
State concerned in accordance with this Regulation.  
2. By way of derogation from paragraph 1, no authorisation 
shall be required in the following cases:  
(a) use of products containing exclusively one or more basic 
substances;  
(b) placing on the market and use of plant protection products 
for research or development purposes in accordance with 
Article 54;  
(c) production, storage or movement of a plant protection 
product intended for use in another Member State, 
provided that the product is authorised in that Member 
State and that the Member State of production, storage or 
movement has put in place inspection requirements to 
ensure that the plant protection product is not used in its 
territory;  
(d) production, storage or movement of a plant protection 
product intended for use in a third country provided that 
the Member State of production, storage or movement has 
put in place inspection requirements to ensure that the 
plant protection product is exported from its territory;  
(e) placing on the market and use of plant protection products 
for which a parallel trade permit has been granted in 
accordance with Article 52.  
Article 29  
Requirements for the authorisation for placing on the 
market  
1. Without prejudice to Article 50 a plant protection product 
shall only be authorised where following the uniform principles 
referred to in paragraph 6 it complies with the following 
requirements:EN 24.11.2009 Official Journal of the European Union L 309/17(a) its active substances, safeners and synergists have been 
approved;  
(b) where its active substance, safener or synergist is produced 
by a different source, or by the same source with a change 
in the manufacturing process and/or manufacturing 
location:  
(i) the specification, pursuant to Article 38, does not 
deviate significantly from the specification included in 
the Regulation approving that substance, safener or 
synergist; and  
(ii) the active substance, safener or synergist has no more 
harmful effects within the meaning of Article 4(2) and 
(3) due to its impurities than if it had been produced in 
accordance with the manufacturing process specified in 
the dossier that supported the approval;  
(c) its co-formulants are not included in Annex III;  
(d) its technical formulation is such that user exposure or other 
risks are limited as much as possible without compromising 
the functioning of the product;  
(e) in the light of current scientific and technical knowledge, it 
complies with the requirements provided for in Article 4(3);  
(f) the nature and quantity of its active substances, safeners and 
synergists and, where appropriate, any toxicologically, ecot ­
oxicologically or environmentally relevant impurities and 
co-formulants can be determined by appropriate methods;  
(g) its residues, resulting from authorised uses, and which are of 
toxicological, ecotoxicological or environmental relevance, 
can be determined by appropriate methods in general use 
in all Member States, with appropriate limits of deter ­
mination on relevant samples;  
(h) its physical and chemical properties have been determined 
and deemed acceptable for the purposes of the appropriate 
use and storage of the product;  
(i) for plants or plant products to be used as feed or food, 
where appropriate, the maximum residue levels for the agri ­
cultural products affected by the use referred to in the auth ­
orisation have been set or modified in accordance with 
Regulation (EC) No 396/2005.  
2. The applicant shall demonstrate that the requirements 
provided for in points (a) to (h) of paragraph 1 are met.  
3. Compliance with the requirements set out in point (b) and 
points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agri ­
cultural, plant health and environmental conditions relevant to 
the use of the plant protection product in question and repre ­
sentative of the conditions prevailing in the zone where the 
product is intended to be used.  
4. With respect to point (f) of paragraph 1, harmonised 
methods may be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 79(4).  
5. Article 81 shall apply.  
6. Uniform principles for evaluation and authorisation of 
plant protection products shall contain the requirements set 
out in Annex VI to Directive 91/414/EEC and shall be laid 
down in Regulations adopted in accordance with the advisory 
procedure referred to in Article 79(2) without any substantial 
modifications. Subsequent amendments to these Regulations 
shall be adopted in accordance with Article 78(1)(c).  
Following these principles, interaction between the active 
substance, safeners, synergists and co-formulants shall be 
taken into account in the evaluation of plant protection 
products.  
Article 30  
Provisional authorisations  
1. By way of derogation from Article 29(1)(a), Member 
States may authorise for a provisional period not exceeding 3 
years, the placing on the market of plant protection products 
containing an active substance not yet approved, provided that:  
(a) the decision on approval could not be finalised within a 
period of 30 months from the date of admissibility of the 
application, extended by any additional period set in 
accordance with Article 9(2), Article 11(3) or 
Article 12(2) or (3); and  
(b) pursuant to Article 9 the dossier on the active substance is 
admissible in relation to the proposed uses; and  
(c) the Member State concludes that the active substance can 
satisfy the requirements of Article 4(2) and (3) and that the 
plant protection product may be expected to satisfy the 
requirements of Article 29(1)(b) to (h); and  
(d) maximum residue levels have been established in accordance 
with Regulation (EC) No 396/2005.  
2. In such cases the Member State shall immediately inform 
the other Member States and the Commission of its assessment 
of the dossier and of the terms of the authorisation, giving at 
least the information provided for in Article 57(1).EN L 309/18 Official Journal of the European Union 24.11.20093. The provisions laid down in paragraphs 1 and 2 shall 
apply until 14 June 2016. If necessary, that time limit may 
be extended in accordance with the regulatory procedure with 
scrutiny referred to in Article 79(4).  
Article 31  
Contents of authorisations  
1. The authorisation shall define plants or plant products and 
non-agricultural areas (for example railways, public areas, 
storage rooms) on which and the purposes for which the 
plant protection product may be used.  
2. The authorisation shall set out the requirements relating to 
the placing on the market and use of the plant protection 
product. Those requirements shall as a minimum include the 
conditions of use necessary to comply with the conditions and 
requirements provided for in the Regulation approving the 
active substances, safeners and synergists.  
The authorisation shall include a classification of the plant 
protection product for the purpose of Directive 1999/45/EC. 
Member States may provide that authorisation holders shall 
classify or update the label without undue delay following any 
change to the classification and labelling of the plant protection 
product in accordance with Directive 1999/45/EC. In such 
cases, they shall immediately inform the competent authority 
thereof.  
3. The requirements referred to in paragraph 2 shall also 
include where applicable:  
(a) the maximum dose per hectare in each application;  
(b) the period between the last application and harvest;  
(c) the maximum number of applications per year.  
4. The requirements referred to in paragraph 2 may include 
the following:  
(a) a restriction with respect to the distribution and use of the 
plant protection product in order to protect the health of 
the distributors, users, bystanders, residents, consumers or 
workers concerned or the environment, taking into 
consideration requirements imposed by other Community 
provisions; such restriction shall be indicated on the label;  
(b) the obligation before the product is used to inform any 
neighbours who could be exposed to the spray drift and 
who have requested to be informed;  
(c) indications for proper use according to the principles of 
Integrated Pest Management referred to in Article 14 of 
and Annex III to Directive 2009/128/EC;  (d) designation of categories of users, such as professional and 
non-professional;  
(e) the approved label;  
(f) the interval between applications;  
(g) the period between the last application and consumption of 
the plant product where applicable;  
(h) the re-entry interval;  
(i) the packaging size and material.  
Article 32  
Duration  
1. The period of authorisation shall be laid down in the 
authorisation.  
Without prejudice to Article 44, the duration of an authori ­
sation shall be set for a period not exceeding 1 year from the 
date of expiry of the approval of the active substances, safeners 
and synergists contained in the plant protection product and 
thereafter for as long as the active substances, safeners and 
synergists contained in the plant protection product are 
approved.  
This period shall allow the examination as provided for in 
Article 43 to be carried out.  
2. Authorisations may be granted for shorter periods to 
synchronise the re-evaluation of similar products for the 
purposes of a comparative assessment of products containing 
candidates for substitution as provided for in Article 50.  
S u b s e c t i o n 2  
P r o c e d u r e  
Article 33  
Application for authorisation or amendment of an 
authorisation  
1. An applicant who wishes to place a plant protection 
product on the market shall apply for an authorisation or 
amendment of an authorisation himself, or through a represen ­
tative, to each Member State where the plant protection product 
is intended to be placed on the market.  
2. The application shall include the following:EN 24.11.2009 Official Journal of the European Union L 309/19(a) a list of intended uses in each zone as indicated in Annex I 
and the Member States where the applicant has made or 
intends to make an application;  
(b) a proposal as to which Member State the applicant expects 
to evaluate the application in the zone concerned. In the 
case of an application for use in greenhouses, as post- 
harvest treatment, for treatment of empty storage rooms 
and for seed treatment, only one Member State shall be 
proposed, which evaluates the application taking account 
of all zones. In this case the applicant shall send the 
summary or complete dossier as referred to in Article 8 
to other Member States on request;  
(c) where relevant, a copy of any authorisations already granted 
for that plant protection product in a Member State;  
(d) where relevant, a copy of any conclusion of the Member 
State assessing equivalence as referred to in Article 38(2).  
3. The application shall be accompanied by the following:  
(a) for the plant protection product concerned, a complete and 
a summary dossier for each point of the data requirements 
of the plant protection product;  
(b) for each active substance, safener and synergist contained in 
the plant protection product, a complete and a summary 
dossier for each point of the data requirements of the active 
substance, safener and synergist;  
(c) for each test or study involving vertebrate animals, a justifi ­
cation of the steps taken to avoid animal testing and dupli ­
cation of tests and studies on vertebrate animals;  
(d) the reasons why the test and study reports submitted are 
necessary for first authorisation or for amendments to the 
conditions of the authorisation;  
(e) where relevant a copy of the application for a maximum 
residue level as referred to in Article 7 of Regulation (EC) 
No 396/2005 or a justification for not supplying such 
information;  
(f) where relevant for an amendment of an authorisation an 
assessment of all information submitted in accordance with 
point (h) of Article 8(1);  
(g) a draft label.  
4. When submitting the application, the applicant may 
pursuant to Article 63, request certain information, including 
certain parts of the dossier, to be kept confidential and shall 
physically separate that information.  The applicant shall at the same time submit the complete list of 
studies submitted pursuant to Article 8(2) and a list of test and 
study reports for which any claims for data protection pursuant 
to Article 59 are requested.  
Upon a request for access to information the Member State 
examining the application shall decide what information is to 
be kept confidential.  
5. Where requested by the Member State the applicant shall 
submit his application in the national or official languages of 
that Member State or one of those languages.  
6. On request, the applicant shall provide the Member State 
with samples of the plant protection product and analytical 
standards of its ingredients.  
Article 34  
Exemption from the submission of studies  
1. Applicants shall be exempted from supplying the test and 
study reports referred to in Article 33(3) where the Member 
State to which an application is made has the test and study 
reports concerned and the applicants demonstrate that they 
have been granted access in accordance with Article 59, 61 
or 62 or that any data protection period has expired.  
2. However, applicants to whom paragraph 1 applies shall 
provide the following information:  
(a) all necessary data for the identification of the plant 
protection product including its complete composition as 
well as a declaration that no unacceptable co-formulants 
are used;  
(b) the information needed to identify the active substance, 
safener or synergist, where they have been approved, and 
to establish whether the conditions for approval are met 
and comply with point (b) of Article 29(1), where appro ­
priate;  
(c) on the request of the concerned Member State, the data 
needed to demonstrate that the plant protection product 
has comparable effects to the plant protection product for 
which they show access to the protected data.  
Article 35  
Member State examining the application  
The application shall be examined by the Member State 
proposed by the applicant, unless another Member State in 
the same zone agrees to examine it. The Member State which 
will examine the application shall inform the applicant.EN L 309/20 Official Journal of the European Union 24.11.2009At the request of the Member State examining the application, 
the other Member States in the same zone to which an appli ­
cation has been submitted shall cooperate to ensure a fair 
division of the workload.  
The other Member States within the zone to which an appli ­
cation has been submitted shall refrain from proceeding with 
the file pending assessment by the Member State examining the 
application.  
Where an application has been made in more than one zone, 
Member States evaluating the application shall agree on the 
evaluation of data which are not related to the environmental 
and agricultural conditions.  
Article 36  
Examination for authorisation  
1. The Member State examining the application shall make 
an independent, objective and transparent assessment in the 
light of current scientific and technical knowledge using 
guidance documents available at the time of application. It 
shall give all Member States in the same zone the opportunity 
to submit comments to be considered in the assessment.  
It shall apply the uniform principles for evaluation and auth ­
orisation of plant protection products, referred to in 
Article 29(6), to establish, as far as possible, whether the 
plant protection product meets the requirements provided for 
in Article 29 in the same zone, where used in accordance with 
Article 55, and under realistic conditions of use.  
The Member State examining the application shall make 
available its assessment to the other Member States within the 
same zone. The format of the assessment report shall be estab ­
lished in accordance with the advisory procedure referred to in 
Article 79(2).  
2. The Member States concerned shall grant or refuse auth ­
orisations accordingly on the basis of the conclusions of the 
assessment of the Member State examining the application as 
provided for in Articles 31 and 32.  
3. By way of derogation from paragraph 2 and subject to 
Community law, appropriate conditions may be imposed with 
respect to the requirements referred to in Article 31(3) and (4) 
and other risk mitigation measures deriving from specific 
conditions of use.  
Where the concerns of a Member State relating to human or 
animal health or the environment cannot be controlled by the 
establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse auth ­
orisation of the plant protection product in its territory if, due 
to its specific environmental or agricultural circumstances, it has 
substantiated reasons to consider that the product in question 
still poses an unacceptable risk to human or animal health or 
the environment.  
That Member State shall immediately inform the applicant and 
the Commission of its decision and provide a technical or 
scientific justification therefor.  
Member States shall provide for the possibility of challenging a 
decision refusing the authorisation of such products before 
national courts or other instances of appeal.  
Article 37  
Period for examination  
1. The Member State examining the application shall decide 
within 12 months of receiving it whether the requirements for 
authorisation are met.  
Where the Member State needs additional information, it shall 
set a period for the applicant to supply it. In that case, the 12- 
month period shall be extended by the additional period 
granted by the Member State. That additional period shall be 
a maximum of 6 months and shall cease at the moment when 
the additional information is received by the Member State. 
Where at the end of that period the applicant has not 
submitted the missing elements, the Member State shall 
inform the applicant that the application is inadmissible.  
2. The time limits provided for in paragraph 1 shall be 
suspended during the application of the procedure set out in 
Article 38.  
3. For an application for authorisation of a plant protection 
product containing an active substance not yet approved, the 
Member State examining the application shall start the 
evaluation as soon as it has received the draft assessment 
report referred to in Article 12(1). In case the application 
concerns the same plant protection product and the same 
uses as contained in the dossier referred to in Article 8, the 
Member State shall decide on the application at the latest within 
six months of the active substance being approved.  
4. The other Member States concerned shall at the latest 
within 120 days of the receipt of the assessment report and 
the copy of the authorisation of the Member State examining 
the application decide on the application as referred to in 
Article 36(2) and (3).EN 24.11.2009 Official Journal of the European Union L 309/21Article 38  
Assessment of equivalence under point (b) of Article 29(1)  
1. Where it is necessary to establish for an active substance, 
safener or synergist whether a different source or, for the same 
source a change of the manufacturing process and/or manufac ­
turing location complies with point (b) of Article 29(1), this 
shall be assessed by the Member State which acted as rapporteur 
for the active substance, safener or synergist as referred to in 
Article 7(1) unless the Member State examining the application 
as referred to in Article 35 agrees to assess the equivalence. The 
applicant shall submit all necessary data to the Member State 
assessing equivalence.  
2. After giving the applicant the opportunity to submit 
comments, which the applicant shall also communicate to the 
rapporteur Member State or the Member State examining the 
application as the case may be, the Member State assessing 
equivalence shall prepare a report on equivalence within 60 
days from receiving the application and shall communicate 
the report to the Commission, the other Member States and 
the applicant.  
3. In the case of a positive conclusion on equivalence and 
where no objection to this conclusion has been raised, point (b) 
of Article 29(1) shall be considered to be complied with. 
However, where a Member State examining the application 
does not agree with the conclusion of the rapporteur Member 
State or vice versa, it shall inform the applicant, the other 
Member States and the Commission stating its reasons.  
The Member States concerned shall try to reach agreement on 
whether point (b) of Article 29(1) is complied with. They shall 
provide the applicant with an opportunity to submit comments.  
4. Where the Member States concerned do not reach 
agreement within 45 days, the Member State assessing equiv ­
alence shall submit the matter to the Commission. A decision 
on whether the conditions referred to in point (b) of 
Article 29(1) are complied with shall be adopted in accordance 
with the regulatory procedure referred to in Article 79(3). The 
45-day period begins on the date on which the Member State 
examining the application for authorisation informed the 
rapporteur Member State or vice versa that it does not 
agree with the conclusion of the latter, in accordance with 
paragraph 3.  
Before such a decision is adopted, the Commission may ask the 
Authority for an opinion, or for scientific or technical assistance 
which shall be provided within 3 months of the request.  
5. Detailed rules and procedures for the implementation of 
paragraphs 1 to 4 may be established in accordance with the 
regulatory procedure referred to in Article 79(3), after consul ­
tation of the Authority.  Article 39  
Reporting and exchange of information on applications for 
authorisation  
1. Member States shall compile a file on each application. 
Each file shall contain the following:  
(a) a copy of the application;  
(b) a report containing information on the evaluation of and 
decision on the plant protection product; the format of the 
report shall be established in accordance with the advisory 
procedure referred to in Article 79(2);  
(c) a record of the administrative decisions taken by the 
Member State concerning the application and of the docu ­
mentation provided for in Article 33(3) and Article 34 
together with a summary of the latter;  
(d) the approved label, where applicable.  
2. On request, Member States shall, without delay, make 
available to the other Member States, the Commission and 
the Authority a file containing the documentation provided 
for in points (a) to (d) of paragraph 1.  
3. On request, applicants shall provide a copy of the docu ­
mentation to be submitted with an application pursuant to 
Article 33(3) and Article 34 to Member States, the Commission 
and the Authority.  
4. Detailed rules for the implementation of paragraphs 2 and 
3 may be established in accordance with the regulatory 
procedure referred to in Article 79(3).  
S u b s e c t i o n 3  
M u t u a l r e c o g n i t i o n o f a u t h o r i s a t i o n s  
Article 40  
Mutual recognition  
1. The holder of an authorisation granted in accordance with 
Article 29 may apply for an authorisation for the same plant 
protection product, the same use and under the comparable 
agricultural practices in another Member State under the 
mutual recognition procedure, provided for in this subsection, 
in the following cases:  
(a) the authorisation was granted by a Member State (reference 
Member State) which belongs to the same zone;EN L 309/22 Official Journal of the European Union 24.11.2009(b) the authorisation was granted by a Member State (reference 
Member State) which belongs to a different zone provided 
that the authorisation for which the application was made is 
not used for the purpose of mutual recognition in another 
Member State within the same zone;  
(c) the authorisation was granted by a Member State for use in 
greenhouses, or as post-harvest treatment, or for treatment 
of empty rooms or containers used for storing plant or 
plant products, or for seed treatment, regardless of the 
zone to which the reference Member State belongs.  
2. Where a plant protection product is not authorised in a 
Member State because no application for an authorisation has 
been submitted in that Member State, official or scientific bodies 
involved in agricultural activities or professional agricultural 
organisations may apply, with the consent of the authorisation 
holder, for an authorisation for the same plant protection 
product, the same use and under the same agricultural 
practices in that Member State under the mutual recognition 
procedure referred to in paragraph 1. In that case the applicant 
must demonstrate that the use of such a plant protection 
product is of general interest for the Member State of intro ­
duction.  
Where the authorisation holder refuses its consent, the 
competent authority of the Member State concerned may 
accept the application, on grounds of public interest.  
Article 41  
Authorisation  
1. The Member State to which an application under 
Article 40 is submitted shall, having examined the application 
and the accompanying documents referred to in Article 42(1), 
as appropriate with regard to the circumstances in its territory, 
authorise the plant protection product concerned under the 
same conditions as the Member State examining the application, 
except where Article 36(3) applies.  
2. By way of derogation from paragraph 1, the Member State 
may authorise the plant protection product where:  
(a) an authorisation under point (b) of Article 40(1) was 
applied for;  
(b) it contains a candidate of substitution;  
(c) Article 30 has been applied; or  
(d) it contains a substance approved in accordance with 
Article 4(7).  Article 42  
Procedure  
1. The application shall be accompanied by the following:  
(a) a copy of the authorisation granted by the reference 
Member State as well as a translation of the authorisation 
into an official language of the Member State receiving the 
application;  
(b) a formal statement that the plant protection product is 
identical to that authorised by the reference Member State;  
(c) a complete or summary dossier as required in Article 33(3) 
when requested by the Member State;  
(d) an assessment report of the reference Member State 
containing information on the evaluation and decision on 
the plant protection product.  
2. The Member State to which an application under 
Article 40 is submitted shall decide on the application within 
120 days.  
3. Where requested by the Member State, the applicant shall 
submit the application in the national or official languages of 
that Member State or one of those languages.  
S u b s e c t i o n 4  
R e n e w a l , w i t h d r a w a l a n d a m e n d m e n t  
Article 43  
Renewal of authorisation  
1. An authorisation shall be renewed upon application by 
the authorisation holder, provided that the requirements 
referred to in Article 29 are still met.  
2. Within 3 months from the renewal of the approval of an 
active substance, safener or synergist contained in the plant 
protection product, the applicant shall submit the following 
information:  
(a) a copy of the authorisation of the plant protection product;  
(b) any new information required as a result of amendments in 
data requirements or criteria;  
(c) evidence that the new data submitted are the result of data 
requirements or criteria which were not in force when the 
authorisation of the plant protection product was granted or 
necessary to amend the conditions of approval;EN 24.11.2009 Official Journal of the European Union L 309/23(d) any information required to demonstrate that the plant 
protection product meets the requirements set out in the 
Regulation on the renewal of the approval of the active 
substance, safener or synergist contained therein;  
(e) a report on the monitoring information, where the auth ­
orisation was subject to monitoring.  
3. Member States shall check compliance of all plant 
protection products containing the active substance, safener or 
synergist concerned with any conditions and restrictions 
provided for in the Regulation renewing the approval under 
Article 20.  
The Member State referred to in Article 35 within each zone 
shall coordinate the compliance check and assessment of the 
information submitted for all Member States within that zone.  
4. Guidelines on the organisation of compliance checks may 
be established in accordance with the advisory procedure 
referred to in Article 79(2).  
5. Member States shall decide on the renewal of the auth ­
orisation of a plant protection product at the latest 12 months 
after the renewal of the approval of the active substance, safener 
or synergist contained therein.  
6. Where, for reasons beyond the control of the holder of 
the authorisation, no decision is taken on the renewal of the 
authorisation before its expiry, the Member State in question 
shall extend the authorisation for the period necessary to 
complete the examination and adopt a decision on the renewal.  
Article 44  
Withdrawal or amendment of an authorisation  
1. Member States may review an authorisation at any time 
where there are indications that a requirement referred to in 
Article 29 is no longer satisfied.  
A Member State shall review an authorisation where it 
concludes that the objectives of Article 4(1)(a)(iv) and (b)(i) 
and Article 7(2) and (3) of Directive 2000/60/EC may not be 
achieved.  
2. Where a Member State intends to withdraw or amend an 
authorisation, it shall inform the authorisation holder and give 
him the possibility to submit comments or further information.  
3. The Member State shall withdraw or amend the authori ­
sation, as appropriate, where:  
(a) the requirements referred to in Article 29 are not or are no 
longer satisfied;  (b) false or misleading information was supplied concerning the 
facts on the basis of which the authorisation was granted;  
(c) a condition included in the authorisation has not been met;  
(d) on the basis of developments in scientific and technical 
knowledge, the manner of use and amounts used can be 
modified; or  
(e) the authorisation holder fails to comply with the obligations 
resulting from this Regulation.  
4. Where a Member State withdraws or amends an authori ­
sation in accordance with paragraph 3, it shall immediately 
inform the holder of the authorisation, the other Member 
States, the Commission and the Authority. The other Member 
States belonging to the same zone shall withdraw or amend the 
authorisation accordingly taking into account national 
conditions and risk mitigation measures except for cases 
where the second, third or fourth subparagraphs of 
Article 36(3) have been applied. Article 46 shall apply where 
appropriate.  
Article 45  
Withdrawal or amendment of an authorisation at the 
request of the authorisation holder  
1. An authorisation may be withdrawn or amended at the 
request of the holder of the authorisation, who shall state the 
reasons for his request.  
2. Amendments may only be granted where it is established 
that the requirements referred to in Article 29 continue to be 
met.  
3. Article 46 shall apply where appropriate.  
Article 46  
Grace period  
Where a Member State withdraws or amends an authorisation 
or does not renew it, it may grant a grace period for the 
disposal, storage, placing on the market and use of existing 
stocks.  
Where the reasons for withdrawal, amendment or non-renewal 
of the authorisation are not related to the protection of human 
and animal health or the environment, the grace period shall be 
limited and shall not exceed 6 months for the sale and the 
distribution and an additional maximum of 1 year for the 
disposal, storage, and use of existing stocks of the plant 
protection products concerned.EN L 309/24 Official Journal of the European Union 24.11.2009S u b s e c t i o n 5  
S p e c i a l c a s e s  
Article 47  
Placing on the market of low-risk plant protection 
products  
1. Where all the active substances contained in a plant 
protection product are low-risk active substances as referred 
to in Article 22, that product shall be authorised as a low- 
risk plant protection product provided no specific risk miti ­
gation measures are needed following a risk assessment. This 
plant protection product shall also meet the following 
requirements:  
(a) the low-risk active substances, safeners and synergists 
contained in it have been approved under Chapter II;  
(b) it does not contain a substance of concern;  
(c) it is sufficiently effective;  
(d) it does not cause unnecessary pain and suffering to verte ­
brates to be controlled;  
(e) it complies with points (b), (c) and (f) to (i) of Article 29(1).  
These products are referred to as ‘low-risk plant protection 
products’.  
2. An applicant for authorisation of a low-risk plant 
protection product shall demonstrate that the requirements set 
out in paragraph 1 are met and shall submit with the appli ­
cation a complete and a summary dossier for each point of the 
data requirements of the active substance and the plant 
protection product.  
3. The Member State shall decide within 120 days whether 
to approve an application for authorisation of a low-risk plant 
protection product.  
Where the Member State needs additional information, it shall 
set a time limit for the applicant to supply it. In that case, the 
period specified shall be extended by the additional time limit 
granted by the Member State.  
The additional period shall be of a maximum of 6 months and 
shall cease at the moment when the additional information is 
received by the Member State. Where at the end of that period 
the applicant has not submitted the missing elements, the 
Member State shall inform the applicant that the application 
is inadmissible.  4. Unless otherwise specified, all provisions relating to auth ­
orisations under this Regulation shall apply.  
Article 48  
Placing on the market and use of plant protection products 
containing a genetically modified organism  
1. A plant protection product which contains an organism 
falling within the scope of Directive 2001/18/EC shall be 
examined in respect of the genetic modification in accordance 
with that Directive, in addition to the assessment under this 
Chapter.  
An authorisation under this Regulation shall not be granted for 
such a plant protection product unless written consent, as 
referred to in Article 19 of Directive 2001/18/EC, has been 
granted for it.  
2. Unless otherwise specified, all provisions relating to auth ­
orisations under this Regulation shall apply.  
Article 49  
Placing on the market of treated seeds  
1. Member States shall not prohibit placing on the market 
and use of seeds treated with plant protection products auth ­
orised for that use in at least one Member State.  
2. Where there are substantial concerns that treated seeds as 
referred to in paragraph 1 are likely to constitute a serious risk 
to human or animal health or to the environment and that such 
risk cannot be contained satisfactorily by means of measures 
taken by the Member State(s) concerned, measures to restrict or 
prohibit the use and/or sale of such treated seeds shall be taken 
immediately in accordance with the regulatory procedure 
referred to in Article 79(3). Before taking such measures the 
Commission shall examine the evidence and may request an 
opinion from the Authority. The Commission may set a time 
limit within which such an opinion shall be provided.  
3. Articles 70 and 71 shall apply.  
4. Without prejudice to other Community legislation 
concerning the labelling of seeds, the label and documents 
accompanying the treated seeds shall include the name of the 
plant protection product with which the seeds were treated, the 
name(s) of the active substance(s) in that product, standard 
phrases for safety precautions as provided for in Directive 
1999/45/EC and risk mitigation measures set out in the auth ­
orisation for that product where appropriate.EN 24.11.2009 Official Journal of the European Union L 309/25Article 50  
Comparative assessment of plant protection products 
containing candidates for substitution  
1. A comparative assessment shall be performed by Member 
States when evaluating an application for authorisation for a 
plant protection product containing an active substance 
approved as a candidate for substitution. Member States shall 
not authorise or shall restrict the use of a plant protection 
product containing a candidate for substitution for use on a 
particular crop where the comparative assessment weighing 
up the risks and benefits, as set out in Annex IV, demonstrates 
that:  
(a) for the uses specified in the application an authorised plant 
protection product, or a non-chemical control or prevention 
method, already exists which is significantly safer for human 
or animal health or the environment;  
(b) the substitution by plant protection products or non- 
chemical control or prevention methods referred to in 
point (a) does not present significant economic or 
practical disadvantages;  
(c) the chemical diversity of the active substances, where 
relevant, or methods and practices of crop management 
and pest prevention are adequate to minimise the 
occurrence of resistance in the target organism; and  
(d) the consequences on minor use authorisations are taken 
into account.  
2. By way of derogation from Article 36(2) Member States 
may in exceptional cases also apply the provisions of paragraph 
1 of this Article when evaluating an application for authori ­
sation of a plant protection product not containing a 
candidate for substitution or a low-risk active substance, if a 
non-chemical control or prevention method exists for the same 
use and it is in general use in that Member State.  
3. By way of derogation from paragraph 1, a plant 
protection product containing a candidate for substitution 
shall be authorised without comparative assessment in cases 
where it is necessary to acquire experience first through using 
that product in practice.  
Such authorisations shall be granted once for a period not 
exceeding five years.  
4. For plant protection products containing a candidate for 
substitution Member States shall perform the comparative 
assessment provided for in paragraph 1 regularly and at the 
latest at renewal or amendment of the authorisation.  
Based on the results of that comparative assessment, Member 
States shall maintain, withdraw or amend the authorisation.  5. Where a Member State decides to withdraw or amend an 
authorisation pursuant to paragraph 4, that withdrawal or 
amendment shall take effect 3 years after the decision of the 
Member State or at the end of the approval period of the 
candidate for substitution where that period ends earlier.  
6. Unless otherwise specified, all provisions relating to auth ­
orisations under this Regulation shall apply.  
Article 51  
Extension of authorisations for minor uses  
1. The authorisation holder, official or scientific bodies 
involved in agricultural activities, professional agricultural 
organisations or professional users may ask for the authori ­
sation of a plant protection product already authorised in the 
Member State concerned to be extended to minor uses not yet 
covered by that authorisation.  
2. Member States shall extend the authorisation provided 
that:  
(a) the intended use is minor in nature;  
(b) the conditions referred to in points (b), (d) and (e) of 
Article 4(3) and Article 29(1)(i) are satisfied;  
(c) the extension is in the public interest; and  
(d) the documentation and information to support the 
extension of use has been submitted by the persons or 
bodies referred to in paragraph 1, especially data on the 
magnitude of residues and where necessary on the risk 
assessment to the operator, worker and bystander.  
3. Member States may take measures to facilitate or 
encourage the submission of applications to extend the auth ­
orisation of already authorised plant protection products to 
minor uses.  
4. The extension may take the form of an amendment to the 
existing authorisation or may be a separate authorisation, in 
accordance with the administrative procedures of the Member 
State concerned.  
5. When Member States grant an extension of authorisation 
for a minor use, they shall inform if necessary the authorisation 
holder and request him to change the labelling accordingly.  
Where the authorisation holder declines, the Member States 
shall ensure that users are fully and specifically informed as 
to instructions for use, by means of an official publication or 
an official website.EN L 309/26 Official Journal of the European Union 24.11.2009The official publication or where applicable the label shall 
include a reference to the liability of the person using the 
plant protection product with respect to failures concerning 
the efficacy or to phytotoxicity of the product for which the 
minor use was granted. The minor use extension shall be 
separately identified in the label.  
6. Extensions on the basis of this Article shall be separately 
identified and separate reference shall be made to liability 
restrictions.  
7. The applicants referred to in paragraph 1 may also apply 
for authorisation of a plant protection product for minor uses 
in accordance with Article 40(1) provided that a plant 
protection product concerned is authorised in that Member 
State. Member States shall authorise such uses in accordance 
with the provisions of Article 41 provided that those uses are 
also considered minor in the Member States of application.  
8. Member States shall establish and regularly update a list of 
minor uses.  
9. By 14 December 2011, the Commission shall present a 
report to the European Parliament and the Council on the 
establishment of a European fund for minor uses, accompanied, 
if appropriate, by a legislative proposal.  
10. Unless otherwise specified, all provisions relating to 
authorisations under this Regulation shall apply.  
Article 52  
Parallel trade  
1. A plant protection product that is authorised in one 
Member State (Member State of origin) may, subject to 
granting a parallel trade permit, be introduced, placed on the 
market or used in another Member State (Member State of 
introduction), if this Member State determines that the plant 
protection product is identical in composition to a plant 
protection product already authorised in its territory (reference 
product). The application shall be submitted to the competent 
authority of the Member State of introduction.  
2. From receiving a complete application, a parallel trade 
permit shall be granted in a simplified procedure within 45 
working days if the plant protection product to be introduced 
is identical in terms of paragraph 3. Member States shall on 
request provide each other with the information necessary to 
assess whether the products are identical within 10 working 
days of receiving the request. The procedure for granting a 
parallel trade permit is interrupted from the day the request 
for information is sent to the competent authority of the 
Member State of origin until the complete information 
required is delivered to the competent authority of the 
Member State of introduction.  
3. Plant protection products shall be considered as identical 
to the reference products if:  (a) they have been manufactured by the same company or by 
an associated undertaking or under licence in accordance 
with the same manufacturing process;  
(b) they are identical in specification and content to the active 
substances, safeners and synergists, and in the type of 
formulation; and  
(c) they are either the same or equivalent in the co-formulants 
present and the packaging size, material or form, in terms 
of the potential adverse impact on the safety of the product 
with regard to human or animal health or the environment.  
4. The application for a parallel trade permit shall include the 
following information:  
(a) the name and registration number of the plant protection 
product in the Member State of origin;  
(b) the Member State of origin;  
(c) the name and address of the authorisation holder in the 
Member State of origin;  
(d) the original label and instructions for use with which the 
plant protection product to be introduced is distributed in 
the Member State of origin if it is considered as necessary 
for the examination by the competent authority of the 
Member State of introduction. This competent authority 
may require a translation of the relevant parts of the 
original instructions for use;  
(e) the name and address of the applicant;  
(f) the name to be given to the plant protection product to be 
distributed in the Member State of introduction;  
(g) a draft label for the product intended to be placed on the 
market;  
(h) a sample of the product which is intended to be introduced 
if it is considered as necessary by the competent authority 
of the Member State of introduction;  
(i) the name and registration number of the reference product.  
The information requirements may be amended or completed 
and further details and specific requirements shall be established 
in cases of application for a plant protection product for which 
a parallel trade permit has already been granted and in cases of 
an application for a plant protection product for a personal use 
in accordance with the regulatory procedure with scrutiny 
referred to in Article 79(4).EN 24.11.2009 Official Journal of the European Union L 309/275. A plant protection product for which a parallel trade 
permit has been issued shall be placed on the market and 
used only in accordance with the provisions of the authori ­
sation of the reference product. To facilitate monitoring and 
controls the Commission shall set out specific control 
requirements for the product to be introduced in a Regulation 
referred to in Article 68.  
6. The parallel trade permit shall be valid for the duration of 
authorisation of the reference product. If the authorisation 
holder of the reference product applies for a withdrawal of 
authorisation in accordance with Article 45(1) and the 
requirements of Article 29 are still fulfilled, the validity of the 
parallel trade permit shall expire by the date on which the 
authorisation of the reference product would normally have 
expired.  
7. Without prejudice to specific provisions of this Article, 
Articles 44, 45, 46, and 55 and Article 56(4) and Chapters 
VI to X shall apply to parallel traded plant protection 
products correspondingly.  
8. Without prejudice to Article 44, a parallel trade permit 
may be withdrawn if the authorisation of the introduced plant 
protection product is withdrawn in the Member State of origin 
because of safety or efficacy reasons.  
9. Where the product is not identical, in terms of paragraph 
3, to the reference product, the Member State of introduction 
may only grant the authorisation required for placing on the 
market and use in accordance with Article 29.  
10. The provisions of this Article shall not apply to plant 
protection products which are authorised in the Member State 
of origin in accordance with Article 53 or 54.  
11. Without prejudice to Article 63, Member State 
authorities shall make publicly available information about 
parallel trade permits.  
S u b s e c t i o n 6  
D e r o g a t i o n s  
Article 53  
Emergency situations in plant protection  
1. By way of derogation from Article 28, in special circum ­
stances a Member State may authorise, for a period not 
exceeding 120 days, the placing on the market of plant 
protection products, for limited and controlled use, where 
such a measure appears necessary because of a danger which 
cannot be contained by any other reasonable means.  
The Member State concerned shall immediately inform the 
other Member States and the Commission of the measure 
taken, providing detailed information about the situation and 
any measures taken to ensure consumer safety.  2. The Commission may ask the Authority for an opinion, 
or for scientific or technical assistance.  
The Authority shall provide its opinion or the results of its 
work to the Commission within 1 month of the date of the 
request.  
3. If necessary, a decision shall be taken, in accordance with 
the regulatory procedure referred to in Article 79(3), as to when 
and under what conditions the Member State:  
(a) may or may not extend the duration of the measure or 
repeat it; or  
(b) shall withdraw or amend its measure.  
4. Paragraphs 1 to 3 shall not apply to plant protection 
products containing or composed of genetically modified 
organisms unless such release has been accepted in accordance 
with Directive 2001/18/EC.  
Article 54  
Research and development  
1. By way of derogation from Article 28, experiments or 
tests for research or development purposes involving the 
release into the environment of an unauthorised plant 
protection product or involving unauthorised use of a plant 
protection product may be carried out if the Member State in 
whose territory the experiment or test is to be carried out has 
assessed the available data and granted a permit for trial 
purposes. The permit may limit the quantities to be used and 
the areas to be treated and may impose further conditions to 
prevent any harmful effects on human or animal health or any 
unacceptable adverse effect on the environment, such as the 
need to prevent entry into the food chain of feed and food 
containing residues unless a relevant provision has already 
been established under Regulation (EC) No 396/2005.  
The Member State may authorise a programme of experiments 
or tests in advance or require a permit for each experiment or 
test.  
2. An application shall be submitted to the Member State in 
whose territory the experiment or test is to be conducted, 
together with a dossier containing all the available data to 
permit an assessment of possible effects on human or animal 
health or the possible impact on the environment.  
3. A permit for trial purposes shall not be granted for 
experiments or tests involving the release into the environment 
of a genetically modified organism unless such release has been 
accepted under Directive 2001/18/EC.EN L 309/28 Official Journal of the European Union 24.11.20094. Paragraph 2 shall not apply if the Member State has 
granted the person concerned the right to undertake certain 
experiments and tests and has determined the conditions 
under which the experiments and tests have to be undertaken.  
5. Detailed rules for the implementation of this Article, in 
particular the maximum quantities of plant protection products 
that may be released during experiments or tests and the 
minimum data to be submitted in accordance with paragraph 
2, may be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 79(4).  
SECTION 2  
Use and information  
Article 55  
Use of plant protection products  
Plant protection products shall be used properly.  
Proper use shall include the application of the principles of 
good plant protection practice and compliance with the 
conditions established in accordance with Article 31 and 
specified on the labelling. It shall also comply with the 
provisions of Directive 2009/128/EC and, in particular, with 
general principles of integrated pest management, as referred 
to in Article 14 of and Annex III to that Directive, which 
shall apply at the latest by 1 January 2014.  
Article 56  
Information on potentially harmful or unacceptable effects  
1. The holder of an authorisation for a plant protection 
product shall immediately notify the Member States that 
granted an authorisation of any new information concerning 
that plant protection product, the active substance, its meta ­
bolites, a safener, synergist or co-formulant contained in the 
plant protection product, which suggests that the plant 
protection product no longer complies with the criteria set 
out in Articles 29 and 4 respectively.  
In particular, potentially harmful effects of that plant protection 
product, or of residues of an active substance, its metabolites, a 
safener, synergist or co-formulant contained in it, on human or 
animal health or on groundwater, or their potentially unac ­
ceptable effects on plants or plant products or the environment 
shall be notified.  
To this end the authorisation holder shall record and report all 
suspected adverse reactions in humans, in animals and the 
environment related to the use of the plant protection product.  
The obligation to notify shall include relevant information on 
decisions or assessments by international organisations or by public bodies which authorise plant protection products or 
active substances in third countries.  
2. The notification shall include an assessment of whether 
and how the new information would result in the plant 
protection product or the active substance, its metabolites, a 
safener, or synergist or co-formulant no longer complying 
with the requirements set out in Article 29 and Article 4 or 
Article 27, respectively.  
3. Without prejudice to the right of Member States to adopt 
interim protective measures, the Member State which first 
granted an authorisation within each zone shall evaluate the 
information received and inform the other Member States, 
belonging to the same zone, where it decides to withdraw or 
amend the authorisation under Article 44.  
That Member State shall inform the other Member States and 
the Commission where it considers that the conditions of the 
approval of the active substance, safener or synergist contained 
in the plant protection product are no longer fulfilled or 
whether in the case of a co-formulant it has been considered 
unacceptable and propose that the approval be withdrawn or 
the conditions amended.  
4. The holder of an authorisation for a plant protection 
product shall report annually to the competent authorities of 
the Member States which authorised his plant protection 
product if he has any information available relating to the 
lack of expected efficacy, the development of resistance and 
to any unexpected effect on plants, plant products or the 
environment.  
Article 57  
Obligation to keep information available  
1. Member States shall keep information electronically 
available to the public on plant protection products authorised 
or withdrawn in accordance with this Regulation, containing at 
least:  
(a) the name or business name of the holder of the authori ­
sation and the authorisation number;  
(b) the trade name of the product;  
(c) the type of preparation;  
(d) the name and amount of each active substance, safener or 
synergist which it contains;  
(e) the classification, risk and safety phrases in accordance to 
Directive 1999/45/EC and to the Regulation referred to in 
Article 65;EN 24.11.2009 Official Journal of the European Union L 309/29(f) the use or uses for which it is authorised;  
(g) the reasons for withdrawal of an authorisation if they are 
related to safety concerns;  
(h) the list of minor uses referred to in Article 51(8).  
2. The information referred to in paragraph 1 shall be readily 
accessible and updated at least once every 3 months.  
3. In accordance with the regulatory procedure referred to in 
Article 79(3), an authorisation information system may be set 
up to facilitate the application of paragraphs 1 and 2 of this 
Article.  
CHAPTER IV  
ADJUVANTS  
Article 58  
Placing on the market and use of adjuvants  
1. An adjuvant shall not be placed on the market or used 
unless it has been authorised in the Member State concerned in 
accordance with the conditions established in the Regulation 
referred to in paragraph 2.  
2. Detailed rules for the authorisation of adjuvants, including 
data requirements, notification, evaluation, assessment and 
decision making procedures shall be set out in a Regulation 
to be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 79(4).  
3. Article 81(3) shall apply.  
CHAPTER V  
DATA PROTECTION AND DATA SHARING  
Article 59  
Data protection  
1. Test and study reports shall benefit from data protection 
under the conditions laid down in this Article.  
The protection shall apply to test and study reports concerning 
the active substance, safener or synergist, adjuvants and the 
plant protection product as referred to in Article 8(2) when 
they are submitted to a Member State by an applicant for auth ­
orisation under this Regulation, (the first applicant), provided 
that those test and study reports were:  
(a) necessary for the authorisation or an amendment of an 
authorisation in order to allow the use on another crop; and  (b) certified as compliant with the principles of good laboratory 
practice or of good experimental practice.  
Where a report is protected, it may not be used by the Member 
State which received it for the benefit of other applicants for 
authorisation of plant protection products, safeners or synergists 
and adjuvants, except as provided in paragraph 2 of this Article, 
in Article 62 or in Article 80.  
The period of data protection is 10 years starting at the date of 
first authorisation in that Member State, except as provided in 
paragraph 2 of this Article or in Article 62. That period is 
extended to 13 years for plant protection products covered 
by Article 47.  
Those periods shall be extended by 3 months for each extension 
of authorisation for minor uses as defined in Article 51(1), 
except where the extension of authorisation is based on extra ­
polation, if the applications for such authorisations are made by 
the authorisation holder at the latest 5 years after the date of 
the first authorisation in that Member State. The total period of 
data protection may in no case exceed 13 years. For plant 
protection products covered by Article 47 the total period of 
data protection may in no case exceed 15 years.  
The same data protection rules as for the first authorisation 
shall also apply to test and study reports submitted by third 
parties for the purpose of extension of authorisation for minor 
uses as referred to in Article 51(1).  
A study shall also be protected if it was necessary for the 
renewal or review of an authorisation. The period for data 
protection shall be 30 months. The first to fourth 
subparagraphs shall apply  mutatis mutandis . 
2. Paragraph 1 shall not apply:  
(a) to test and study reports for which the applicant has 
submitted a letter of access; or  
(b) where any period of data protection granted for the test and 
study reports concerned in relation to another plant 
protection product has expired.  
3. Data protection under paragraph 1 shall only be granted 
where the first applicant has claimed data protection for test 
and study reports concerning the active substance, safener or 
synergist, adjuvant and the plant protection product at the time 
of submitting the dossier and has provided to the Member State 
concerned for each test or study report the information referred 
to in point (f) of Article 8(1) and in point (d) of Article 33(3) as 
well as confirmation that a period of data protection has never 
been granted for the test or study report or that any period 
granted has not expired.EN L 309/30 Official Journal of the European Union 24.11.2009Article 60  
List of test and study reports  
1. For each active substance, safener and synergist and 
adjuvant, rapporteur Member States shall prepare a list of the 
test and study reports necessary for first approval, amendment 
of approval conditions or renewal of the approval and make it 
available to the Member States and the Commission.  
2. For each plant protection product which they authorise, 
Member States shall keep and make available to any interested 
party upon request:  
(a) a list of the test and study reports concerning the active 
substance, safener or synergist, adjuvant and the plant 
protection product necessary for first authorisation, 
amendment of the authorisation conditions or renewal of 
the authorisation; and  
(b) a list of test and study reports for which the applicant 
claimed data protection under Article 59 and any reasons 
submitted in accordance with that Article.  
3. The lists provided for in paragraphs 1 and 2 shall include 
information on whether those test and study reports were 
certified as compliant with the principles of good laboratory 
practice or of good experimental practice.  
Article 61  
General rules on avoidance of duplicative testing  
1. In order to avoid duplicative testing, any persons 
intending to seek an authorisation for a plant protection 
product shall, before carrying out tests or studies, consult the 
information referred to in Article 57 to ascertain if and to 
whom an authorisation has already been granted for a plant 
protection product containing the same active substance, 
safener or synergist or for an adjuvant. The competent 
authority shall on request from the prospective applicant 
provide him with the list of test and study reports prepared 
in accordance with Article 60 for that product.  
The prospective applicant shall submit all data regarding the 
identity and impurities of the active substance he proposes to 
use. The enquiry shall be supported by evidence that the pros ­
pective applicant intends to apply for an authorisation.  
2. The competent authority of the Member State, where 
satisfied that the prospective applicant intends to apply for an 
authorisation, or the renewal or review thereof, shall provide 
him with the name and address of the holder or holders of 
previous relevant authorisations and shall at the same time 
inform the holders of the authorisations of the name and 
address of the applicant.  3. The prospective applicant for the authorisation, or the 
renewal or review thereof, and the holder or holders of 
relevant authorisations shall take all reasonable steps to reach 
agreement on the sharing of any test and study reports 
protected under Article 59, in a fair, transparent and non- 
discriminatory way.  
Article 62  
Sharing of tests and studies involving vertebrate animals  
1. Testing on vertebrate animals for the purposes of this 
Regulation shall be undertaken only where no other methods 
are available. Duplication of tests and studies on vertebrates 
undertaken for the purposes of this Regulation shall be 
avoided in accordance with paragraphs 2 to 6.  
2. Member States shall not accept duplication of tests and 
studies on vertebrate animals or those initiated where conven ­
tional methods described in Annex II to Directive 1999/45/EC 
could reasonably have been used, in support of applications for 
authorisations. Any person intending to perform tests and 
studies involving vertebrate animals shall take the necessary 
measures to verify that those tests and studies have not 
already been performed or initiated.  
3. The prospective applicant and the holder or holders of the 
relevant authorisations shall make every effort to ensure that 
they share tests and studies involving vertebrate animals. The 
costs of sharing the test and study reports shall be determined 
in a fair, transparent and non-discriminatory way. The pros ­
pective applicant is only required to share in the costs of 
information he is required to submit to meet the authorisation 
requirements.  
4. Where the prospective applicant and the holder or holders 
of the relevant authorisations of plant protection products 
containing the same active substance, safener or synergist, or 
of adjuvants cannot reach agreement on the sharing of test and 
study reports involving vertebrate animals, the prospective 
applicant shall inform the competent authority of the Member 
State referred to in Article 61(1).  
The failure to reach agreement, as provided in paragraph 3, 
shall not prevent the competent authority of that Member 
State from using the test and study reports involving vertebrate 
animals for the purpose of the application of the prospective 
applicant.  
5. By 14 December 2016, the Commission shall report on 
the effects of the provisions in this Regulation concerning data 
protection of tests and studies involving vertebrate animals. The 
Commission shall submit this report to the European Parliament 
and the Council accompanied, if necessary, by an appropriate 
legislative proposal.EN 24.11.2009 Official Journal of the European Union L 309/316. The holder or holders of the relevant authorisation shall 
have a claim on the prospective applicant for a fair share of the 
costs incurred by him. The competent authority of the Member 
State may direct the parties involved to resolve the matter by 
formal and binding arbitration administered under national law. 
Otherwise the parties may resolve the matter through litigation 
in the courts of the Member States. Awards from arbitration or 
litigation shall have regard to the principles determined in 
paragraph 3 and shall be enforceable in the courts of the 
Member States.  
CHAPTER VI  
PUBLIC ACCESS TO INFORMATION  
Article 63  
Confidentiality  
1. A person requesting that information submitted under this 
Regulation is to be treated as confidential shall provide 
verifiable evidence to show that the disclosure of the 
information might undermine his commercial interests, or the 
protection of privacy and the integrity of the individual.  
2. Disclosure of the following information shall normally be 
deemed to undermine the protection of the commercial 
interests or of privacy and the integrity of the individuals 
concerned:  
(a) the method of manufacture;  
(b) the specification of impurity of the active substance except 
for the impurities that are considered to be toxicologically, 
ecotoxicologically or environmentally relevant;  
(c) results of production batches of the active substance 
including impurities;  
(d) methods of analysis for impurities in the active substance as 
manufactured except for methods for impurities that are 
considered to be toxicologically, ecotoxicologically or envi ­
ronmentally relevant;  
(e) links between a producer or importer and the applicant or 
the authorisation holder;  
(f) information on the complete composition of a plant 
protection product;  
(g) names and addresses of persons involved in testing on 
vertebrate animals.  
3. This Article is without prejudice to Directive 2003/4/EC of 
the European Parliament and of the Council of 28 January 2003 
on public access to environmental information (  1 ). CHAPTER VII  
PACKAGING, LABELLING AND ADVERTISING OF PLANT 
PROTECTION PRODUCTS AND ADJUVANTS  
Article 64  
Packaging and presentation  
1. Plant protection products and adjuvants that may be 
mistaken for food, drink or feed shall be packaged in such a 
way as to minimise the likelihood of such a mistake being 
made.  
2. Plant protection products and adjuvants available to the 
general public that may be mistaken for food, drink or feed 
shall contain components to discourage or prevent their 
consumption.  
3. Article 9 of Directive 1999/45/EC shall also apply to plant 
protection products and adjuvants not covered by that 
Directive.  
Article 65  
Labelling  
1. The labelling of plant protection products shall include the 
classification, labelling and packaging requirements of Directive 
1999/45/EC and shall comply with the requirements set out in 
a Regulation adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 79(4).  
That Regulation shall also contain standard phrases for special 
risks and safety precautions which supplement the phrases 
provided for by Directive 1999/45/EC. It shall incorporate the 
text of Article 16 of and the text of the Annexes IV and V to 
Directive 91/414/EEC with any necessary modifications.  
2. Member States may require samples or mock-ups of the 
packaging and drafts of labels and leaflets to be submitted 
before the authorisation is granted.  
3. Where a Member State considers that additional phrases 
are necessary to protect human or animal health or the 
environment, it shall notify the other Member States and the 
Commission forthwith and shall forward the additional phrase 
or phrases and the reasons for these requirements.  
Such phrases shall be considered for inclusion in the Regulation 
referred to in paragraph 1.  
Pending that inclusion, the Member State may require the use of 
the additional phrase or phrases.EN L 309/32 Official Journal of the European Union 24.11.2009  
( 1 ) OJ L 41, 14.2.2003, p. 26.Article 66  
Advertising  
1. Plant protection products which are not authorised shall 
not be advertised. Every advertisement for a plant protection 
product shall be accompanied by the sentences ‘Use plant 
protection products safely. Always read the label and product 
information before use’. These sentences shall be easily legible 
and clearly distinguishable in relation to the whole adver ­
tisement. The words ‘plant protection products’ may be 
replaced by a more precise description of the product-type, 
such as fungicide, insecticide or herbicide.  
2. The advertisement shall not include information in text or 
graphic form which could be misleading as regards possible 
risks to human or animal health or to the environment, such 
as the terms ‘low risk’, ‘non-toxic’ or ‘harmless’.  
Only in the case of low-risk plant protection products shall the 
term ‘authorised as low-risk plant protection product in 
accordance with Regulation (EC) No 1107/2009’ be allowed 
in the advertisement. It cannot be used as a claim on the 
label of the plant protection product.  
3. Member States may prohibit or restrict the advertising of 
plant protection products in certain media, subject to 
Community law.  
4. All statements used in advertising shall be technically 
justifiable.  
5. Advertisements shall not contain any visual representation 
of potentially dangerous practices, such as mixing or application 
without sufficient protective clothing, nor any use near food or 
use by or in the vicinity of children.  
6. Advertising or promotional material shall draw attention 
to the appropriate warning phrases and symbols as laid down in 
the labelling.  
CHAPTER VIII  
CONTROLS  
Article 67  
Record-keeping  
1. Producers, suppliers, distributors, importers, and exporters 
of plant protection products shall keep records of the plant 
protection products they produce, import, export, store or 
place on the market for at least 5 years. Professional users of 
plant protection products shall, for at least 3 years, keep records 
of the plant protection products they use, containing the name 
of the plant protection product, the time and the dose of 
application, the area and the crop where the plant protection 
product was used.  They shall make the relevant information contained in these 
records available to the competent authority on request. Third 
parties such as the drinking water industry, retailers or residents, 
may request access to this information by addressing the 
competent authority.  
The competent authorities shall provide access to such 
information in accordance with applicable national or 
Community law.  
By 14 December 2012, the Commission shall present a report 
to the European Parliament and the Council on the costs and 
benefits of the traceability of information from users to retailers 
concerning the applications of plant protection products on 
agricultural products, accompanied, if necessary, by appropriate 
legislative proposals.  
2. Producers of plant protection products shall undertake 
post-authorisation monitoring on the request of the 
competent authorities. They shall notify the competent 
authorities of the relevant results.  
3. Authorisation holders shall provide the competent 
authorities of the Member States with all data relating to the 
volume of sales of plant protection products in accordance with 
Community legislation concerning statistics on plant protection 
products.  
4. Implementing measures to ensure the uniform application 
of paragraphs 1, 2 and 3 may be adopted in accordance with 
the regulatory procedure referred to in Article 79(3).  
Article 68  
Monitoring and controls  
Member States shall carry out official controls in order to 
enforce compliance with this Regulation. They shall finalise 
and transmit to the Commission a report on the scope and 
the results of these controls within six months of the end of 
the year to which the reports relate.  
Commission experts shall carry out general and specific audits 
in the Member States for purposes of verifying the official 
controls carried out by the Member States.  
A Regulation, adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 79(4), shall set 
out provisions for the controls, in particular on the production, 
packaging, labelling, storage, transport, marketing, formulation, 
parallel trade and use of plant protection products. It shall also 
contain provisions concerning the collection of information and 
reporting on suspected poisonings.EN 24.11.2009 Official Journal of the European Union L 309/33CHAPTER IX  
EMERGENCIES  
Article 69  
Emergency measures  
Where it is clear that an approved active substance, safener, 
synergist or co-formulant or a plant protection product which 
has been authorised in accordance with this Regulation is likely 
to constitute a serious risk to human or animal health or the 
environment, and that such risk cannot be contained satis ­
factorily by means of measures taken by the Member State(s) 
concerned, measures to restrict or prohibit the use and/or sale 
of that substance or product shall be taken immediately in 
accordance with the regulatory procedure referred to in 
Article 79(3), either at the own initiative of the Commission 
or at the request of a Member State. Before taking such 
measures the Commission shall examine the evidence and 
may request an opinion from the Authority. The Commission 
may set a time limit within which such an opinion shall be 
provided.  
Article 70  
Emergency measures in cases of extreme urgency  
By way of derogation from Article 69, the Commission may in 
cases of extreme urgency provisionally adopt emergency 
measures after consulting the Member State or Member States 
concerned and informing the other Member States.  
As soon as possible, and at the latest after 10 working days, 
those measures shall be confirmed, amended, revoked or 
extended in accordance with the regulatory procedure referred 
to in Article 79(3).  
Article 71  
Other emergency measures  
1. Where a Member State officially informs the Commission 
of the need to take emergency measures, and no action has 
been taken in accordance with Article 69 or 70, the Member 
State may adopt interim protective measures. In this event, it 
shall immediately inform the other Member States and the 
Commission.  
2. Within 30 working days, the Commission shall put the 
matter before the Committee referred to in Article 79(1) in 
accordance with the regulatory procedure referred to in 
Article 79(3) with a view to the extension, amendment or 
repeal of the national interim protective measure.  
3. The Member State may maintain its national interim 
protective measures until Community measures have been 
adopted.  CHAPTER X  
ADMINISTRATIVE AND FINANCIAL PROVISIONS  
Article 72  
Penalties  
The Member States shall lay down the rules on penalties 
applicable to infringements of this Regulation and shall take 
the measures necessary to ensure that they are implemented. 
The penalties provided for shall be effective, proportionate and 
dissuasive.  
The Member States shall notify those rules and any subsequent 
amendment to the Commission without delay.  
Article 73  
Civil and criminal liability  
The granting of authorisation and any other measures in 
conformity with this Regulation shall be without prejudice to 
general civil and criminal liability in the Member States of the 
producer and, where applicable, of the person responsible for 
placing the plant protection product on the market or using it.  
Article 74  
Fees and charges  
1. Member States may recover the costs associated with any 
work they carry out within the scope of this Regulation, by 
means of fees or charges.  
2. Member States shall ensure that the fees or charges 
referred to in paragraph 1:  
(a) are established in a transparent manner; and  
(b) correspond to the actual total cost of the work involved 
except if it is in public interest to lower the fees or charges.  
The fees or charges may include a scale of fixed charges based 
on average costs for the work referred to in paragraph 1.  
Article 75  
Competent authority  
1. Each Member State shall designate a competent authority 
or authorities to carry out the obligations of the Member States 
laid down in this Regulation.  
2. Each Member State shall designate a coordinating national 
authority to coordinate and ensure all the necessary contacts 
with applicants, other Member States, the Commission and the 
Authority.EN L 309/34 Official Journal of the European Union 24.11.20093. Member States shall ensure that competent authorities 
have a sufficient number of suitably qualified and experienced 
staff so that the obligations laid down in this Regulation shall 
be carried out efficiently and effectively.  
4. Each Member State shall give the details concerning its 
national competent authority or authorities to the Commission, 
the Authority and the coordinating national authorities of the 
other Member States and inform them of any modifications 
thereof.  
5. The Commission shall publish and keep updated on 
its website a list of the authorities referred to in paragraphs 1 
and 2.  
Article 76  
Expenditure by the Commission  
1. The Commission may incur expenditure for activities 
contributing to the aims of this Regulation including the organi ­
sation of the following:  
(a) development of a harmonised system, including an appro ­
priate database, for gathering and storing all information 
concerning active substances, safeners, synergists, co- 
formulants, plant protection products and adjuvants and 
for making such information available to the Member 
States, producers and other interested parties;  
(b) performance of studies needed to prepare and develop 
further legislation on the placing on the market and use 
of plant protection products and adjuvants;  
(c) performance of studies needed to harmonise procedures, 
decision-making criteria and data requirements;  
(d) coordination, if necessary by electronic means, of coop ­
eration between Member States, the Commission and the 
Authority and measures to facilitate work sharing;  
(e) development and maintenance of a coordinated electronic 
submission and evaluation system aimed at promoting elec ­
tronic document exchange and work sharing between the 
applicants, the Member States, the Commission and the 
Authority;  
(f) development of guidance to facilitate the day-to-day appli ­
cation of this Regulation;  
(g) travel and subsistence expenses that Member States’ experts 
incur as a result of the Commission appointing them to 
assist its experts in the framework of control activities laid 
down under Article 68;  
(h) training of control staff;  (i) financing of other measures needed to ensure application of 
the Regulation adopted under Article 68.  
2. The appropriations required under paragraph 1 shall be 
subject to authorisation by the budgetary authority each 
financial year.  
Article 77  
Guidance documents  
The Commission may, in accordance with the advisory 
procedure referred to in Article 79(2), adopt or amend 
technical and other guidance documents such as explanatory 
notes or guidance documents on the content of the application 
concerning micro-organisms, pheromones and biological 
products, for the implementation of this Regulation. The 
Commission may ask the Authority to prepare or to contribute 
to such guidance documents.  
Article 78  
Amendments and implementing measures  
1. The following measures designed to amend non-essential 
elements of this Regulation,  inter alia , by supplementing it shall 
be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 79(4):  
(a) amendments to the Annexes, taking into account current 
scientific and technical knowledge;  
(b) amendments to the Regulations on data requirements for 
active substances and for plant protection products, as 
referred to in points (b) and (c) of Article 8(1), taking 
into account current scientific and technical knowledge;  
(c) amendments to the Regulation on uniform principles for 
evaluation and authorisation of plant protection products, 
as referred to in Article 29(6), taking into account current 
scientific and technical knowledge;  
(d) a Regulation postponing the expiry of the approval period 
referred to in the second subparagraph of Article 17;  
(e) a Regulation on data requirements for safeners and 
synergists referred to in Article 25(3);  
(f) a Regulation establishing a work programme for safeners 
and synergists referred to in Article 26;  
(g) adoption of the harmonised methods referred to in 
Article 29(4);  
(h) inclusion of co-formulants in Annex III, as referred to in 
Article 27(2);EN 24.11.2009 Official Journal of the European Union L 309/35(i) extension of the date of application of this Regulation to 
provisional authorisations, as referred to in Article 30(3);  
(j) information requirements for parallel trade, as referred to in 
Article 52(4);  
(k) rules for the application of Article 54, in particular the 
maximum quantities of plant protection products to be 
released;  
(l) detailed rules for adjuvants, as referred to in Article 58(2);  
(m) a Regulation containing the requirements of the labelling of 
plant protection products, as referred to in Article 65(1);  
(n) a Regulation on controls, as referred to in the third 
subparagraph of Article 68.  
2. Any further measures necessary for the implementation of 
this Regulation may be adopted in accordance with the regu ­
latory procedure referred to in Article 79(3).  
3. In accordance with the advisory procedure referred to in 
Article 79(2), a Regulation shall be adopted containing the list 
of active substances included in Annex I to Directive 
91/414/EEC. Those substances shall be deemed to have been 
approved under this Regulation.  
Article 79  
Committee procedure  
1. The Commission shall be assisted by the Standing 
Committee on the Food Chain and Animal Health, as estab ­
lished by Article 58 of Regulation (EC) No 178/2002.  
2. Where reference is made to this paragraph, Articles 3 and 
7 of Decision 1999/468/EC shall apply, having regard to the 
provisions of Article 8 thereof.  
3. Where reference is made to this paragraph, Articles 5 and 
7 of Decision 1999/468/EC shall apply, having regard to the 
provisions of Article 8 thereof.  
The period laid down in Article 5(6) of Decision 1999/468/EC 
shall be set at 3 months.  
4. Where reference is made to this paragraph, Article 5a(1) 
to (4) and Article 7 of Decision 1999/468/EC shall apply, 
having regard to the provisions of Article 8 thereof.  
5. Where reference is made to this paragraph, Article 5a(1) 
to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall 
apply, having regard to the provisions of Article 8 thereof.  The time limits laid down in Article 5a(3)(c) and (4)(b) and (e) 
of Decision 1999/468/EC shall be set at two months, one 
month and two months respectively.  
CHAPTER XI  
TRANSITIONAL AND FINAL PROVISIONS  
Article 80  
Transitional measures  
1. Directive 91/414/EEC shall continue to apply, with respect 
to the procedure and the conditions for approval:  
(a) to active substances for which a decision has been adopted 
in accordance with Article 6(3) of Directive 91/414/EEC 
before 14 June 2011;  
(b) to active substances listed in Annex I to Regulation (EC) No 
737/2007 (  1 ); 
(c) to active substances for which completeness has been estab ­
lished in accordance with Article 16 of Regulation (EC) No 
33/2008 (  2 ); 
(d) to active substances for which completeness has been estab ­
lished in accordance with Article 6 of Regulation (EC) No 
33/2008 before 14 June 2011.  
On the basis of the examination carried out under Directive 
91/414/EEC, a Regulation on the approval of such a 
substance shall be adopted in accordance with Article 13(2) 
of this Regulation. For active substances referred to in point 
(b) of this paragraph that approval shall not be considered as 
the renewal of approval referred to in Article 14 of this Regu ­
lation.  
2. Article 13(1) to (4) and Annexes II and III to Directive 
91/414/EEC shall continue to apply with respect to active 
substances included in Annex I to that Directive and to active 
substances approved in accordance with paragraph 1 of this 
Article:  
(a) for a period of five years from the date of their inclusion or 
approval, for active substances covered by Article 8(2) of 
Directive 91/414/EEC;  
(b) for a period of 10 years from the date of their inclusion or 
approval, for active substances which were not on the 
market on 26 July 1993;EN L 309/36 Official Journal of the European Union 24.11.2009  
( 1 ) OJ L 169, 29.6.2007, p. 10.  
( 2 ) OJ L 15, 18.1.2008, p. 5.(c) for a period of five years from the date of the renewal of the 
inclusion or renewal of the approval, for active substances 
whose inclusion in Annex I to Directive 91/414/EEC expires 
by 24 November 2011. This provision shall only apply to 
data necessary for the renewal of the approval and which 
were certified as compliant with the principles of good 
laboratory practice by that date.  
3. Where Article 13 of Directive 91/414/EEC applies by 
virtue of paragraph 1 or paragraph 2 of this Article, it shall 
be subject to any special rules concerning Directive 91/414/EEC 
laid down in the Act of Accession by which a Member State 
joined the Community.  
4. For active substances for which the first approval expires 
by 14 December 2012, the application provided for in 
Article 14 shall be submitted by a producer of the active 
substance to a Member State, with a copy to the other 
Member States, the Commission and the Authority, no later 
than two years before the expiry of the first approval.  
5. Applications for authorisations of plant protection 
products:  
(a) under Article 4 of Directive 91/414/EEC which are pending 
in the Member States; or  
(b) which are due to be amended or withdrawn following an 
inclusion in Annex I to Directive 91/414/EEC or following 
an approval in accordance with paragraph 1 of this Article;  
on 14 June 2011 shall be decided on the basis of national law 
in force before that date.  
After that decision, this Regulation shall apply.  
6. Products labelled in accordance with Article 16 of 
Directive 91/414/EEC may continue to be placed on the 
market until 14 June 2015.  
7. By 14 December 2013, the Commission shall establish a 
list of substances included in Annex I to Directive 91/414/EEC 
which satisfy the criteria set out in point 4 of Annex II to this 
Regulation and to which the provisions of Article 50 of this 
Regulation shall apply.  
Article 81  
Derogation for safeners and synergists, co-formulants and 
adjuvants  
1. By way of derogation from Article 28(1), a Member State 
may, for a period of 5 years following the adoption of the 
programme referred to in Article 26, authorise the placing on the market in its territory of plant protection products 
containing safeners and synergists, which have not been 
approved, where they are included in that programme.  
2. By way of derogation from Article 27 and without 
prejudice to Community law, Member States may apply 
national provisions for co-formulants not included in Annex 
III until 14 June 2016.  
Where, after 14 June 2016, a Member State has serious grounds 
for considering that a co-formulant not included in Annex III is 
likely to constitute a serious risk to human or animal health or 
the environment, it may temporarily prohibit or restrict the 
application of a co-formulant in question within its territory. 
It shall immediately inform the other Member States and the 
Commission thereof and give reasons for its decision. Article 71 
shall apply.  
3. By way of derogation from Article 58(1) Member States 
may apply national provisions for authorisation of adjuvants 
until the adoption of detailed rules referred to in Article 58(2).  
Article 82  
Review clause  
By 14 December 2014, the Commission shall present a report 
to the European Parliament and the Council on the functioning 
of mutual recognition of authorisations and in particular on the 
application by the Member States of the provisions referred to 
in Article 36(3) and Article 50(2), the division of the 
Community into three zones and on the application of the 
criteria for the approval of active substances, safeners and 
synergists as set out in Annex II and the impact thereof on 
the diversification and competitiveness of agriculture as well 
as on human health and on the environment. The report may 
be accompanied, if necessary, by the appropriate legislative 
proposals to amend those provisions.  
Article 83  
Repeal  
Without prejudice to Article 80, Directives 79/117/EEC and 
91/414/EEC, as amended by the acts listed in Annex V, are 
repealed with effect from 14 June 2011, without prejudice to 
the obligations of the Member States relating to the time limits 
for transposition into national law and application of the 
Directives set out in that Annex.  
References to the repealed Directives shall be construed as 
references to this Regulation. In particular, references in other 
Community legislation, such as Regulation (EC) No 1782/2003, 
to Article 3 of Directive 91/414/EEC shall be construed as 
references to Article 55 of this Regulation.EN 24.11.2009 Official Journal of the European Union L 309/37Article 84  
Entry into force and application  
This Regulation shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
By 14 June 2011, the Commission shall adopt the following:  
(a) a Regulation containing the list of the active substances 
already approved at the moment of adoption of that Regu ­
lation;  
(b) a Regulation on data requirements for active substances, as 
referred to in Article 8(1)(b);  (c) a Regulation on data requirements for plant protection 
products, as referred to in Article 8(1)(c);  
(d) a Regulation on uniform principles for risk assessment for 
plant protection products, as referred to in Article 36;  
(e) a Regulation containing the requirements of the labelling of 
plant protection products, as referred to in Article 65(1).  
This Regulation shall apply from 14 June 2011.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Strasbourg, 21 October 2009.  
For the European Parliament 
The President  
J. BUZEK  For the Council 
The President  
C. MALMSTRÖMEN L 309/38 Official Journal of the European Union 24.11.2009ANNEX I  
Definition of zones for the authorisation of plant protection products as referred to in Article 3(17)  
Zone A — North  
The following Member States belong to this zone:  
Denmark, Estonia, Latvia, Lithuania, Finland, Sweden  
Zone B — Centre  
The following Member States belong to this zone:  
Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, 
Slovakia, United Kingdom  
Zone C — South  
The following Member States belong to this zone:  
Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, PortugalEN 24.11.2009 Official Journal of the European Union L 309/39ANNEX II  
Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II  
1. Evaluation  
1.1. During the process of evaluation and decision-making provided for in Articles 4 to 21, the rapporteur Member 
State and the Authority shall cooperate with applicants to resolve any questions on the dossier quickly or to 
identify at an early stage any further explanations or additional studies necessary for the evaluation of the dossier, 
including information to eliminate the need for a restriction of the approval, or to amend any proposed 
conditions for the use of the plant protection product or to modify its nature or its composition in order to 
ensure full satisfaction of the requirements of this Regulation.  
1.2. The evaluation by the Authority and the rapporteur Member State must be based on scientific principles and be 
made with the benefit of expert advice.  
1.3. During the process of evaluation and decision-making provided for in Articles 4 to 21, Member States and the 
Authority shall take into consideration any further guidance developed in the framework of the Standing 
Committee on the Food Chain and Animal Health for the purposes of refining, where relevant, the risk 
assessments.  
2. General decision-making criteria  
2.1. Article 4 shall only be considered as complied with, where, on the basis of the dossier submitted, authorisation 
in at least one Member State is expected to be possible for at least one plant protection product containing that 
active substance for at least one of the representative uses.  
2.2. Submission of further information  
In principle an active substance, safener or synergist shall only be approved where a complete dossier is 
submitted.  
In exceptional cases an active substance, safener or synergist may be approved even though certain information 
is still to be submitted where:  
(a) the data requirements have been amended or refined after the submission of the dossier; or  
(b) the information is considered to be confirmatory in nature, as required to increase confidence in the decision.  
2.3. Restrictions on approval  
Where necessary, the approval may be subject to conditions and restrictions as referred to in Article 6.  
Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect 
that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early 
stage to obtain more information which may possibly enable these restrictions to be removed.  
3. Criteria for the approval of an active substance  
3.1. Dossier  
The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, 
Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD).  
In the case of an active substance, safener or synergist for which one or more representative uses includes use on 
feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 7(1) 
shall contain the information necessary to carry out a risk assessment and for enforcement purposes.  
The dossier shall in particular:  
(a) permit any residue of concern to be defined;  
(b) reliably predict the residues in food and feed, including succeeding crops;EN L 309/40 Official Journal of the European Union 24.11.2009(c) reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or 
mixing;  
(d) permit a maximum residue level to be defined and to be determined by appropriate methods in general use 
for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it 
is fed to animals;  
(e) permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined.  
The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the 
fate and distribution of the active substance in the environment, and its impact on non-target species.  
3.2. Efficacy  
An active substance alone or associated with a safener or synergist shall only be approved where it has been 
established for one or more representative uses that the plant protection product, consequent on application 
consistent with good plant protection practice and having regard to realistic conditions of use is sufficiently 
effective. This requirement shall be evaluated in accordance with the uniform principles for evaluation and 
authorisation of plant protection products referred to in Article 29(6).  
3.3. Relevance of metabolites  
Where applicable the documentation submitted shall be sufficient to permit the establishment of the toxico ­
logical, ecotoxicological or environmental relevance of metabolites.  
3.4. Composition of the active substance, safener or synergist  
3.4.1. The specification shall define the minimum degree of purity, the identity and maximum content of impurities 
and, where relevant, of isomers/diastereo-isomers and additives, and the content of impurities of toxicological, 
ecotoxicological or environmental concern within acceptable limits.  
3.4.2. The specification shall be in compliance with the relevant Food and Agriculture Organisation specification as 
appropriate, where such specification exists. However, where necessary for reasons of protection of human or 
animal health or the environment, stricter specifications may be adopted.  
3.5. Methods of analysis  
3.5.1. The methods of analysis of the active substance, safener or synergist as manufactured and of determination of 
impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater 
than 1 g/kg in the active substance, safener or synergist as manufactured, shall have been validated and shown to 
be sufficiently specific, correctly calibrated, accurate and precise.  
3.5.2. The methods of residue analysis for the active substance and relevant metabolites in plant, animal and environ ­
mental matrices and drinking water, as appropriate, shall have been validated and shown to be sufficiently 
sensitive with respect to the levels of concern.  
3.5.3. The evaluation has been carried out in accordance with the uniform principles for evaluation and authorisation 
of plant protection products referred to in Article 29(6).  
3.6. Impact on human health  
3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate 
safety margin of at least 100 shall be ensured taking into account the type and severity of effects and the 
vulnerability of specific groups of the population. When the critical effect is judged of particular significance, 
such as developmental neurotoxic or immunotoxic effects, an increased margin of safety shall be considered, and 
applied if necessary.  
3.6.2. An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher tier 
genotoxicity testing carried out in accordance with the data requirements for the active substances, safeners or 
synergists and other available data and information, including a review of the scientific literature, reviewed by the 
Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 
1272/2008, as mutagen category 1A or 1B.EN 24.11.2009 Official Journal of the European Union L 309/413.6.3. An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity 
testing carried out in accordance with the data requirements for the active substances, safener or synergist and 
other available data and information, including a review of the scientific literature, reviewed by the Authority, it 
is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as 
carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a 
plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in 
closed systems or in other conditions excluding contact with humans and where residues of the active substance, 
safener or synergist concerned on food and feed do not exceed the default value set in accordance with 
Article 18(1)(b) of Regulation (EC) No 396/2005.  
3.6.4. An active substance, safener or synergist shall only be approved if, on the basis of assessment of reproductive 
toxicity testing carried out in accordance with the data requirements for the active substances, safeners or 
synergists and other available data and information, including a review of the scientific literature, reviewed by 
the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 
1272/2008, as toxic for reproduction category 1A or 1B, unless the exposure of humans to that active 
substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is 
negligible, that is, the product is used in closed systems or in other conditions excluding contact with 
humans and where residues of the active substance, safener or synergist concerned on food and feed do not 
exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.  
3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community 
or internationally agreed test guidelines or other available data and information, including a review of the 
scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties 
that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or 
synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the 
product is used in closed systems or in other conditions excluding contact with humans and where residues of 
the active substance, safener or synergist concerned on food and feed do not exceed the default value set in 
accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.  
By 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal 
Health a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting 
properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).  
Pending the adoption of these criteria, substances that are or have to be classified, in accordance with the 
provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, 
shall be considered to have endocrine disrupting properties.  
In addition, substances such as those that are or have to be classified, in accordance with the provisions of 
Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the 
endocrine organs, may be considered to have such endocrine disrupting properties.  
3.7. Fate and behaviour in the environment  
3.7.1. An active substance, safener or synergist shall only be approved where it is not considered to be a persistent 
organic pollutant (POP).  
A substance that fulfils all three of the criteria of the points below is a POP.  
3.7.1.1. Persistence  
An active substance, safener or synergist fulfils the persistence criterion where there is evidence that the time it 
takes for a degradation of 50 % (DT50) in water is greater than 2 months, or that its DT50 in soil is greater than 
6 months, or that its DT50 in sediment is greater than 6 months.  
3.7.1.2. Bioaccumulation  
An active substance, safener or synergist fulfils the bioaccumulation criterion where there is:  
— evidence that its bio-concentration factor or bioaccumulation factor in aquatic species is greater than 5 000 
or, in the absence of such data, that the partition coefficient n-octanol/water (log Ko/w) is greater than 5, or  
— evidence that the active substance, safener or synergist present other reasons for concern, such as high 
bioaccumulation in other non-target species, high toxicity or ecotoxicity.EN L 309/42 Official Journal of the European Union 24.11.20093.7.1.3. Potential for long-range environmental transport:  
An active substance, safener or synergist fulfils the potential for long-range environmental transport criterion 
where:  
— measured levels of the active substance, safener or synergist in locations distant from the sources of its release 
are of potential concern,  
— monitoring data show that long-range environmental transport of the active substance, safener or synergist, 
with the potential for transfer to a receiving environment, may have occurred via air, water or migratory 
species, or  
— environmental fate properties and/or model results demonstrate that the active substance, safener or synergist 
has a potential for long-range environmental transport through air, water or migratory species, with the 
potential for transfer to a receiving environment in locations distant from the sources of its release. For an 
active substance safener or synergist that migrates significantly through the air, its DT50 in air is to be 
greater than 2 days.  
3.7.2. An active substance, safener or synergist shall only be approved if it is not considered to be a persistent, 
bioaccumulative and toxic (PBT) substance.  
A substance that fulfils all three of the criteria of the points below is a PBT substance.  
3.7.2.1. Persistence  
An active substance, safener or synergist fulfils the persistence criterion where:  
— the half-life in marine water is higher than 60 days,  
— the half-life in fresh or estuarine water is higher than 40 days,  
— the half-life in marine sediment is higher than 180 days,  
— the half-life in fresh or estuarine water sediment is higher than 120 days, or  
— the half-life in soil is higher than 120 days.  
Assessment of persistency in the environment shall be based on available half-life data collected under appro ­
priate conditions, which shall be described by the applicant.  
3.7.2.2. Bioaccumulation  
An active substance, safener or synergist fulfils the bioaccumulation criterion where the bioconcentration factor 
is higher than 2 000.  
Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data 
from both freshwater and marine water species can be used.  
3.7.2.3. Toxicity  
An active substance, safener or synergist fulfils the toxicity criterion where:  
— the long-term no-observed effect concentration for marine or freshwater organisms is less than 0,01 mg/l,  
— the substance is classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for 
reproduction (category 1A, 1B or 2) pursuant to Regulation (EC) No 1272/2008, or  
— there is other evidence of chronic toxicity, as identified by the classifications STOT RE 1 or STOT RE 2 
pursuant to Regulation (EC) No 1272/2008.  
3.7.3. An active substance, safener or synergist shall only be approved if it is not considered to be a very persistent and 
very bioaccumulative substance (vPvB).  
A substance that fulfils both of the criteria of the points below is a vPvB substance.EN 24.11.2009 Official Journal of the European Union L 309/433.7.3.1. Persistence  
An active substance, safener or synergist fulfils the ‘very persistent’ criterion where:  
— the half-life in marine, fresh- or estuarine water is higher than 60 days,  
— the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or  
— the half-life in soil is higher than 180 days.  
3.7.3.2. Bioaccumulation  
An active substance, safener or synergist fulfils the ‘very bioaccumulative’ criterion where the bioconcentration 
factor is greater than 5 000.  
3.8. Ecotoxicology  
3.8.1. An active substance, safener or synergist shall only be approved if the risk assessment demonstrates risks to be 
acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of 
plant protection products referred to in Article 29(6) under realistic proposed conditions of use of a plant 
protection product containing the active substance, safener or synergist. The assessment must take into account 
the severity of effects, the uncertainty of the data, and the number of organism groups which the active 
substance, safener or synergist is expected to affect adversely by the intended use.  
3.8.2. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community 
or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may 
cause adverse effects on non-target organisms unless the exposure of non-target organisms to that active 
substance in a plant protection product under realistic proposed conditions of use is negligible.  
3.8.3. An active substance, safener or synergist shall be approved only if it is established following an appropriate risk 
assessment on the basis of Community or internationally agreed test guidelines, that the use under the proposed 
conditions of use of plant protection products containing this active substance, safener or synergist:  
— will result in a negligible exposure of honeybees, or  
— has no unacceptable acute or chronic effects on colony survival and development, taking into account effects 
on honeybee larvae and honeybee behaviour.  
3.9. Residue definition  
An active substance, safener or synergist shall only be approved if, where relevant, a residue definition can be 
established for the purposes of risk assessment and for enforcement purposes.  
3.10. Fate and behaviour concerning groundwater  
An active substance shall only be approved where it has been established for one or more representative uses, 
that consequently after application of the plant protection product consistent with realistic conditions on use, the 
predicted concentration of the active substance or of metabolites, degradation or reaction products in 
groundwater complies with the respective criteria of the uniform principles for evaluation and authorisation 
of plant protection products referred to in Article 29(6).  
4. Candidate for substitution  
An active substance shall be approved as a candidate for substitution pursuant to Article 24 where any of the 
following conditions are met:  
— its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances 
within groups of substances/use categories,  
— it meets two of the criteria to be considered as a PBT substance,EN L 309/44 Official Journal of the European Union 24.11.2009— there are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or 
immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that 
could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk 
management measures (such as extensive personal protective equipment or very large buffer zones),  
— it contains a significant proportion of non-active isomers,  
— it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen 
category 1A or 1B, if the substance has not been excluded in accordance with the criteria laid down in point 
3.6.3,  
— it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for 
reproduction category 1A or 1B if the substance has not been excluded in accordance with the criteria laid 
down in point 3.6.4,  
— if, on the basis of the assessment of Community or internationally agreed test guidelines or other available 
data and information, reviewed by the Authority, it is considered to have endocrine disrupting properties that 
may cause adverse effects in humans if the substance has not been excluded in accordance with the criteria 
laid down in point 3.6.5.  
5. Low-risk active substances  
An active substance shall not be considered of low risk where it is or has to be classified in accordance with 
Regulation (EC) No 1272/2008 as at least one of the following:  
— carcinogenic,  
— mutagenic,  
— toxic to reproduction,  
— sensitising chemicals,  
— very toxic or toxic,  
— explosive,  
— corrosive.  
It shall also not be considered as of low risk if:  
— persistent (half-life in soil is more than 60 days),  
— bioconcentration factor is higher than 100,  
— it is deemed to be an endocrine disrupter, or  
— it has neurotoxic or immunotoxic effects.EN 24.11.2009 Official Journal of the European Union L 309/45ANNEX III  
List of co-formulants which are not accepted for inclusion in plant protection products as referred to in 
Article 27EN L 309/46 Official Journal of the European Union 24.11.2009ANNEX IV  
Comparative assessment pursuant to Article 50  
1. Conditions for comparative assessment  
Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant 
protection product or a non-chemical control or prevention method is considered, referred to as ‘substitution’, the 
alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the 
environment. An assessment of the alternative shall be performed to demonstrate whether it can be used with similar 
effect on the target organism and without significant economic and practical disadvantages to the user or not.  
Further conditions for refusal or withdrawal of an authorisation are as follows:  
(a) substitution shall be applied only where other methods or the chemical diversity of the active substances is 
sufficient to minimise the occurrence of resistance in the target organism;  
(b) substitution shall be applied only to plant protection products where their use presents a significantly higher level 
of risk to human health or the environment; and  
(c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from 
use in practice, where not already available.  
2. Significant difference in risk  
A significant difference in risk shall be identified on a case-by-case basis by the competent authorities. The properties 
of the active substance and plant protection product, and the possibility of exposure of different population 
subgroups (professional or non-professional users, bystanders, workers, residents, specific vulnerable groups or 
consumers) directly or indirectly through food, feed, drinking water or the environment shall be taken into 
account. Other factors such as the stringency of imposed restrictions on use and prescribed personal protective 
equipment shall also be considered.  
For the environment, if relevant, a factor of at least 10 for the toxicity/exposure ratio (TER) of different plant 
protection products is considered a significant difference in risk.  
3. Significant practical or economic disadvantages  
Significant practical or economic disadvantage to the user is defined as a major quantifiable impairment of working 
practices or business activity leading to inability to maintain sufficient control of the target organism. Such a major 
impairment might be, for example, where no technical facilities for the use of the alternative are available or 
economically feasible.  
Where a comparative assessment indicates that restrictions on and/or prohibitions of use of a plant protection 
product could cause such disadvantage, then this shall be taken into account in the decision-making process. This 
situation shall be substantiated.  
The comparative assessment shall take authorised minor uses into account.EN 24.11.2009 Official Journal of the European Union L 309/47ANNEX V  
Repealed Directives and their successive amendments as referred to in Article 83  
A. Directive 91/414/EEC  
Acts amending Directive 91/414/EEC  Deadline for transposition  
Directive 93/71/EEC  3 August 1994  
Directive 94/37/EC  31 July 1995  
Directive 94/79/EC  31 January 1996  
Directive 95/35/EC  30 June 1996  
Directive 95/36/EC  30 April 1996  
Directive 96/12/EC  31 March 1997  
Directive 96/46/EC  30 April 1997  
Directive 96/68/EC  30 November 1997  
Directive 97/57/EC  1 October 1997  
Directive 2000/80/EC  1 July 2002  
Directive 2001/21/EC  1 July 2002  
Directive 2001/28/EC  1 August 2001  
Directive 2001/36/EC  1 May 2002  
Directive 2001/47/EC  31 December 2001  
Directive 2001/49/EC  31 December 2001  
Directive 2001/87/EC  31 March 2002  
Directive 2001/99/EC  1 January 2003  
Directive 2001/103/EC  1 April 2003  
Directive 2002/18/EC  30 June 2003  
Directive 2002/37/EC  31 August 2003  
Directive 2002/48/EC  31 December 2002  
Directive 2002/64/EC  31 March 2003  
Directive 2002/81/EC  30 June 2003  
Directive 2003/5/EC  30 April 2004  
Directive 2003/23/EC  31 December 2003  
Directive 2003/31/EC  30 June 2004  
Directive 2003/39/EC  30 September 2004  
Directive 2003/68/EC  31 March 2004  
Directive 2003/70/EC  30 November 2004  
Directive 2003/79/EC  30 June 2004  
Directive 2003/81/EC  31 January 2005  
Directive 2003/82/EC  30 July 2004  
Directive 2003/84/EC  30 June 2004  
Directive 2003/112/EC  30 April 2005  
Directive 2003/119/EC  30 September 2004  
Regulation (EC) No 806/2003  —EN L 309/48 Official Journal of the European Union 24.11.2009Acts amending Directive 91/414/EEC  Deadline for transposition  
Directive 2004/20/EC  31 July 2005  
Directive 2004/30/EC  30 November 2004  
Directive 2004/58/EC  31 August 2005  
Directive 2004/60/EC  28 February 2005  
Directive 2004/62/EC  31 March 2005  
Directive 2004/66/EC  1 May 2004  
Directive 2004/71/EC  31 March 2005  
Directive 2004/99/EC  30 June 2005  
Directive 2005/2/EC  30 September 2005  
Directive 2005/3/EC  30 September 2005  
Directive 2005/25/EC  28 May 2006  
Directive 2005/34/EC  30 November 2005  
Directive 2005/53/EC  31 August 2006  
Directive 2005/54/EC  31 August 2006  
Directive 2005/57/EC  31 October 2006  
Directive 2005/58/EC  31 May 2006  
Directive 2005/72/EC  31 December 2006  
Directive 2006/5/EC  31 March 2007  
Directive 2006/6/EC  31 March 2007  
Directive 2006/10/EC  30 September 2006  
Directive 2006/16/EC  31 January 2007  
Directive 2006/19/EC  30 September 2006  
Directive 2006/39/EC  31 July 2007  
Directive 2006/41/EC  31 January 2007  
Directive 2006/45/EC  18 September 2006  
Directive 2006/64/EC  31 October 2007  
Directive 2006/74/EC  30 November 2007  
Directive 2006/75/EC  31 March 2007  
Directive 2006/85/EC  31 January 2008  
Directive 2006/104/EC  1 January 2007  
Directive 2006/131/EC  30 June 2007  
Directive 2006/132/EC  30 June 2007  
Directive 2006/133/EC  30 June 2007  
Directive 2006/134/EC  30 June 2007  
Directive 2006/135/EC  30 June 2007  
Directive 2006/136/EC  30 June 2007  
Directive 2007/5/EC  31 March 2008  
Directive 2007/6/EC  31 July 2007  
Directive 2007/21/EC  12 December 2007  
Directive 2007/25/EC  31 March 2008  
Directive 2007/31/EC  1 September 2007EN 24.11.2009 Official Journal of the European Union L 309/49Acts amending Directive 91/414/EEC  Deadline for transposition  
Directive 2007/50/EC  31 May 2008  
Directive 2007/52/EC  31 March 2008  
Directive 2007/76/EC  30 April 2009  
Directive 2008/40/EC  30 April 2009  
Directive 2008/41/EC  30 June 2009  
Directive 2008/45/EC  8 August 2008  
Directive 2008/66/EC  30 June 2009  
B. Directive 79/117/EEC  
Acts amending Directive 79/117/EEC  Deadline for transposition  
Directive 83/131/EEC  1 October 1984  
Directive 85/298/EEC  1 January 1986  
Directive 86/214/EEC  —  
Directive 86/355/EEC  1 July 1987  
Directive 87/181/EEC  1 January 1988 and 1 January 1989  
Directive 87/477/EEC  1 January 1988  
Directive 89/365/EEC  31 December 1989  
Directive 90/335/EEC  1 January 1991  
Directive 90/533/EEC  31 December 1990 and 30 September 1990  
Directive 91/188/EEC  31 March 1992  
Regulation (EC) No 807/2003  —  
Regulation (EC) No 850/2004  —EN L 309/50 Official Journal of the European Union 24.11.2009