2009R1107 — EN — 01.07.2013 — 001.001 — 1This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents►B

REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCILof 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives
79/117/EEC and 91/414/EEC(OJ L 309, 24.11.2009, p. 1)

Amended by:
Official Journal►M1

Council Regulation (EU) No 518/2013 of 13 May 2013

167

No

page

date

L 158

72

10.6.2013

2009R1107 — EN — 01.07.2013 — 001.001 — 2▼B
REGULATION (EC) No 1107/2009 OF THE EUROPEANPARLIAMENT 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 PARLIAMENTEUROPEAN UNION,

AND

THE

COUNCILOF

THE

Having regard to the Treaty establishing the European Community, andin 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 theTreaty (3),Whereas:(1)

Council Directive 91/414/EEC of 15 July 1991 concerning theplacing of plant protection products on the market (4) provides forrules 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 Conclusionsof 12 December 2001 asked the Commission to review Directive
91/414/EEC and identified a number of issues for theCommission to address.

(3)

In the light of the experience gained from the application of
Directive 91/414/EEC and of recent scientific and technicaldevelopments, 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 theplacing on the market and use of plant protection products
containing certain active substances (6).

(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 (OJC 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.

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2009R1107 — EN — 01.07.2013 — 001.001 — 3▼B(5)

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

(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 agricultural 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 andhazards for humans, animals and the environment, especially ifplaced on the market without having been officially tested andauthorised and if incorrectly used.

(8)

The purpose of this Regulation is to ensure a high level ofprotection of both human and animal health and the environment
and at the same time to safeguard the competitiveness ofCommunity agriculture. Particular attention should be paid tothe protection of vulnerable groups of the population, including
pregnant women, infants and children. The precautionary
principle should be applied and this Regulation should ensurethat industry demonstrates that substances or products producedor placed on the market do not have any harmful effect on humanor animal health or any unacceptable 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 ofprotection 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 toincrease the free movement of such products and availability ofthese 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 unacceptableeffects on the environment. In order to achieve the same level ofprotection in all Member States, the decision on acceptability or
non-acceptability of such substances should be taken atCommunity 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 alreadyapproved, 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.

169

2009R1107 — EN — 01.07.2013 — 001.001 — 4▼B(12)In the interest of predictability, efficiency and consistency, adetailed procedure should be laid down for assessing whether
an active substance can be approved. The information to besubmitted by interested parties for the purposes of approval ofa substance should be specified. In view of the amount of work
connected with the approval procedure, it is appropriate that theevaluation 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 establishedby Regulation (EC) No 178/2002 of the European Parliamentand of the Council of 28 January 2002 laying down thegeneral principles and requirements of food law, establishing
the European Food Safety Authority and laying down proceduresin matters of food safety (1) (the Authority). It should be clarified
that the Authority performs a risk assessment whilst theCommission should perform the risk management role and takethe 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 aplant protection product should not be based on tests or studies
involving the deliberate administration of the active substance orplant 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 propor­
tionate 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 andany developments 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 aperiod not exceeding 15 years.

(16)

The possibility of amending or withdrawing the approval of anactive substance in cases where the criteria for approval are nolonger satisfied, or where compliance with Directive 2000/60/EC
of the European Parliament and of the Council of 23 October2000 establishing a framework for Community action in the fieldof water policy (2) is compromised, should be provided for undercertain conditions.

(17)

The evaluation of an active substance may reveal that it presents
considerably less of a risk than other substances. In order tofavour 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.

(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 327, 22.12.2000, p. 1.

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2009R1107 — EN — 01.07.2013 — 001.001 — 5▼B(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 forplant protection use.

(19)

Some active substances with certain properties should be
identified at Community level as candidates for substitution.
Member States should regularly examine plant protection
products containing such active substances with the aim ofreplacing 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 andgenerally 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 themarket should only be evaluated after those rules have been
established.

(22)

Plant protection products may also contain co-formulants. It isappropriate to provide a list of co-formulants which should not be
included in plant protection products.

(23)

Plant protection products containing active substances can beformulated in many ways and used on a variety of plants andplant products, under different agricultural, plant health and envi­
ronmental (including climatic) conditions. Authorisations forplant protection products should therefore be granted by
Member States.

(24)

The provisions governing authorisation must ensure a highstandard of protection. In particular, when granting authorisationsof plant protection products, the objective of protecting humanand 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 principles of protection of human and animal healthand the environment.

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2009R1107 — EN — 01.07.2013 — 001.001 — 6▼B(26)

Where the decision on approval cannot be finalised within the
period provided for due to reasons not falling under the respon­
sibility of the applicant, Member States should be able to grant
the provisional authorisations for a limited period in order tofacilitate the transition to the approval procedure provided forunder 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 canbe produced by different manufacturing processes, leading todifferences in specifications. Such differences may have safety
implications. For efficiency reasons, a harmonised procedure atCommunity level should be provided for the assessment of thosedifferences.

(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 formore harmonised availability of plant protection products, auth­orisations granted by one Member State should be accepted byother Member States where agricultural, plant health and envi­
ronmental (including climatic) conditions are comparable.
Therefore, the Community should be divided into zones withsuch comparable conditions in order to facilitate such mutual
recognition. However, environmental or agricultural circum­
stances specific to the territory of one or more Member Statesmight require that, on application, Member States recognise oramend an authorisation issued by another Member State, orrefuse to authorise the plant protection product in their territory,
where justified as a result of specific environmental or agri­
cultural circumstances or where the high level of protection ofboth human and animal health and the environment required bythis Regulation cannot be achieved. It should also be possible toimpose 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 theCouncil of 21 October 2009 establishing a framework forCommunity action to achieve a sustainable use of pesticides (1).

(30)

The economic incentive for industry to apply for an authorisation
is limited for certain uses. In order to ensure that diversificationof agriculture and horticulture is not jeopardised by the lack ofavailability of plant protection products, specific rules should beestablished for minor uses.

(31)

Where identical plant protection products are authorised indifferent Member States, a simplified procedure for granting aparallel trade permit should be provided for in this Regulation,in order to facilitate the trade between Member States of suchproducts.

(1) See page 71 of this Official Journal.

172

2009R1107 — EN — 01.07.2013 — 001.001 — 7▼B(32)In exceptional cases, Member States should be permitted toauthorise plant protection products not complying with theconditions provided for in this Regulation, where it isnecessary to do so because of a danger or threat to plant
production or ecosystems which cannot be contained by anyother 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 aprovision 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 thepossibility of taking protective measures.

(34)

To promote innovation, special rules should be establishedpermitting the use of plant protection products in experimentseven where they have not yet been authorised.

(35)

To ensure a high level of protection of human and animal healthand the environment, plant protection products should be usedproperly, 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 Regulation (EC)No 1782/2003 of 29 September 2003 establishing common
rules for direct support schemes under the common agricultural
policy and establishing certain support schemes for farmers (1),the principles of integrated 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, athematic 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 established.
Member States should make available to each other, theCommission and the Authority the particulars and scientific docu­
mentation 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 beenprohibited. The technical rules necessary for the authorisation
should be established.

(1) OJ L 270, 21.10.2003, p. 1.

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2009R1107 — EN — 01.07.2013 — 001.001 — 8▼B(39)

Studies represent a major investment. This investment should beprotected in order to stimulate research. For this reason, tests andstudies, 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 byanother 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 ofthis 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 theapproximation of laws, regulations and administrative provisionsof the Member States regarding the protection of animals used forexperimental and other scientific purposes (1), tests on vertebrate
animals must be replaced, restricted or refined. Therefore, rules
should be laid down to avoid duplicative testing and duplicationof 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 andstudies 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 notcovered by the above system of compulsory access.

(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 thepossession of these authorities and the confidentiality of these
documents.

(42)

Directive 1999/45/EC of the European Parliament and of theCouncil of 31 May 1999 concerning the approximation of thelaws, regulations and administrative provisions of the Member
States relating to the classification, packaging and labelling of
dangerous preparations (2) 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 theenvironment, further specific rules are appropriate which takeaccount of the specific conditions of use of plant protection
products.

(1) OJ L 358, 18.12.1986, p. 1.
(2) OJ L 200, 30.7.1999, p. 1.

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2009R1107 — EN — 01.07.2013 — 001.001 — 9▼B(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 ofplant protection products should be established in order to raise
the level of protection of human and animal health and theenvironment by ensuring the traceability of potential exposure,
to increase the efficiency of monitoring and control and to reducethe 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 ofprotection 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 toensure the verification of compliance with feed and food law,animal health and animal welfare rules (1) provides for control
measures for the use of plant protection products at all stages ofthe production of food, including record-keeping on the use ofplant protection products. Similar rules on monitoring andcontrols 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 (2) and Community
legislation on the protection of workers and anyone concernedwith the contained use and deliberate release of geneticallymodified 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 islikely to constitute a serious risk to human or animal health or theenvironment.

(49)

Member States should lay down rules on penalties applicable toinfringements of this Regulation and should take the measuresnecessary to ensure that they are implemented.

(1) OJ L 165, 30.4.2004, p. 1.
(2) OJ L 70, 16.3.2005, p. 1.

1752009R1107 — EN — 01.07.2013 — 001.001 — 10
▼B
(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 costsof the procedures associated with the application of this Regu­
lation from those seeking to place, or placing, plant protection
products or adjuvants on the market and from those applying forthe approval of active substances, safeners or synergists.

(52)

Member States should designate the necessary national competentauthorities.

(53)

The Commission should facilitate the application of this Regu­
lation. Therefore, it is appropriate to provide for the necessaryfinancial resources and the possibility of amending certain
provisions of this Regulation in the light of experience or ofdeveloping 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 forthe exercise of implementing powers conferred on theCommission (1).

(55)

In particular, the Commission should be empowered to adopt
harmonised methods to determine the nature and quantity ofactive substances, safeners and synergists, and where appropriate
of relevant impurities and co-formulants, and maximum quantitiesof plant protection products to be released, and to adopt Regu­
lations concerning labelling requirements, controls and rules for
adjuvants, establishing a work programme for safeners andsynergists, 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 toamend 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 withscrutiny provided for in Article 5a of Decision 1999/468/EC.

(56)

On grounds of efficiency, the normal time limits for the regu­
latory 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 thesecurrent provisions should be, as a first step, transferred into newlegal instruments and thus be adopted without any substantial
modification, the advisory procedure is the most appropriate.

(1) OJ L 184, 17.7.1999, p. 23.

176

2009R1107 — EN — 01.07.2013 — 001.001 — 11
▼B
(58)

It is also appropriate to use the advisory procedure to adopt some
purely technical measures, in particular technical guidelines inview 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 themarket, 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 ofprotection of both human and animal health and the environment andto improve the functioning of the internal market through the harmon­
isation 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 shallnot 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 authorised 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 thanfor 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;177

2009R1107 — EN — 01.07.2013 — 001.001 — 12▼B(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 unlessthe 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.
These products are referred to as ‘plant protection products’.
2.
This Regulation shall apply to substances, including
micro-organisms having general or specific action against harmfulorganisms or on plants, parts of plants or plant products, referred toas ‘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 ina 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 prep­
arations 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 shallapply:
1. ‘residues’ means one or more substances present in or on plants orplant products, edible animal products, drinking water or elsewherein the environment and resulting from the use of a plant protection
product, including their metabolites, breakdown or reaction
products;
2. ‘substances’ means chemical elements and their compounds, as theyoccur naturally or by manufacture, including any impurity
inevitably resulting from the manufacturing process;3. ‘preparations’ means mixtures or solutions composed of two or
more substances intended for use as a plant protection product oras an adjuvant;178

2009R1107 — EN — 01.07.2013 — 001.001 — 13▼B
4. ‘substance of concern’ means any substance which has an inherent
capacity to cause an adverse effect on humans, animals or theenvironment 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 meetingthe criteria to be classified as hazardous in accordance with
Regulation (EC) No 1272/2008 of the European Parliament andof the Council of 16 December 2008 on classification, labellingand packaging of substances and mixtures (1), and present in theplant 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 unprocessedstate or having undergone only simple preparation, 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 onagronomic techniques such as those referred to in point 1 ofAnnex 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 salewithin the Community, including offering for sale or any other formof transfer, whether free of charge or not, and the sale, distribution,and other forms of transfer themselves, but not the return to theprevious seller. Release for free circulation into the territory of theCommunity shall constitute placing on the market for the purposesof this Regulation;
10. ‘authorisation of a plant protection product’ means an adminis­
trative act by which the competent authority of a Member Stateauthorises the placing on the market of a plant protection productin 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 toanother party, or a person designated by the manufacturer as hissole representative for the purpose of compliance with this Regu­
lation;12. ‘letter of access’ means an original document by which the ownerof data protected under this Regulation agrees to the use of suchdata under the specific terms and conditions by the competentauthority 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;(1) OJ L 353, 31.12.2008, p. 1.

179

2009R1107 — EN — 01.07.2013 — 001.001 — 14▼B
13. ‘environment’ means waters (including ground, surface, transitional,
coastal and marine), sediment, soil, air, land, wild species of faunaand 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 andresidents 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 repli­
cation or of transferring genetic material;
16. ‘genetically modified organisms’ means organisms in which thegenetic material has been altered within the meaning of Article 2(2)of Directive 2001/18/EC of the European Parliament and of theCouncil of 12 March 2001 on the deliberate release into theenvironment 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 thezone means all zones defined in Annex I;
18. ‘good plant protection practice’ means a practice whereby thetreatments 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 acceptableefficacy with the minimum quantity necessary, taking due accountof local conditions and of the possibilities for cultural andbiological 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 Parliamentand of the Council of 11 February 2004 on the harmonisation oflaws, regulations and administrative provisions relating to the appli­
cation of the principles of good laboratory practice and the verifi­
cation of their applications for tests on chemical substances (2);20. ‘good experimental practice’ means a practice in accordance withthe 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 anotherapplicant;22. ‘rapporteur Member State’ means the Member State which
undertakes the task of evaluating an active substance, safener orsynergist;(1) OJ L 106, 17.4.2001, p. 1.
(2) OJ L 50, 20.2.2004, p. 44.

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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 levelsof 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 theenvironment.
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;
28. ‘post-harvest treatment’ means treatment of plants or plant products
after harvest in an isolated space where no run-off is possible, forexample 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 establishedunder this Regulation;
31. ‘advertisement’ means a means of promoting the sale or use ofplant protection products (to anyone other than the authorisation
holder, the person placing the plant protection product on themarket and their agents) by printed or electronic media;
32. ‘metabolite’ means any metabolite or a degradation product of anactive substance, safener or synergist, formed either in organisms orin the environment.
A metabolite is deemed relevant if there is a reason to assume thatit has intrinsic properties comparable to the parent substance interms of its biological target activity, or that it poses a higher orcomparable risk to organisms than the parent substance or that it
has certain toxicological properties that are considered unac­
ceptable. Such a metabolite is relevant for the overall approval
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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 manufacturing process
or from degradation during storage).
CHAPTER IIACTIVESUBSTANCES,
SAFENERS,
CO-FORMULANTSSYNERGISTSANDSECTION 1

Active substances
Subsection 1
Requirements and conditions for approval
Article 4
Approval criteria for active substances1.
An active substance shall be approved in accordance with
Annex II if it may be expected, in the light of current scientific andtechnical knowledge, that, taking into account the approval criteria set
out in points 2 and 3 of that Annex, plant protection products containingthat active substance meet the requirements provided for in paragraphs 2
and 3.
The assessment of the active substance shall first establish whether theapproval 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 toestablish whether the other approval criteria set out in points 2 and 3 ofAnnex II are satisfied.
2.
The residues of the plant protection products, consequent on appli­
cation 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, includingthat of vulnerable groups, or animal health, taking into accountknown cumulative and synergistic effects where the scientificmethods accepted by the Authority to assess such effects areavailable, or on groundwater;(b) they shall not have any unacceptable effect on the environment.
For residues which are of toxicological, ecotoxicological, environmental
or drinking water relevance, there shall be methods in general use formeasuring 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 humanhealth, 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 consequencesin the workplace or through other indirect effects, taking into
account known cumulative and synergistic effects where thescientific methods accepted by the Authority to assess such
effects are available; or on groundwater;

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2009R1107 — EN — 01.07.2013 — 001.001 — 17▼B(c) it shall not have any unacceptable effects on plants or plant
products;(d) it shall not cause unnecessary suffering and pain to vertebrates to becontrolled;(e) it shall have no unacceptable effects on the environment, having
particular regard to the following considerations where the scientificmethods accepted by the Authority to assess such effects areavailable:(i) its fate and distribution in the environment, particularly
contamination of surface waters, including estuarine andcoastal waters, groundwater, air and soil taking into accountlocations 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 thelight of uniform principles as referred to in Article 29(6).
5.
For approval of an active substance, paragraphs 1, 2 and 3 shall bedeemed to be satisfied where this has been established with respect toone or more representative uses of at least one plant protection productcontaining 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 isnecessary 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 torisk mitigation measures to ensure that exposure of humans and theenvironment is minimised. For such substances maximum residue
levels shall be set in accordance with Regulation (EC) No 396/2005.
This derogation shall not apply to active substances which are or haveto be classified in accordance with Regulation (EC) No 1272/2008, as
carcinogenic category 1A, carcinogenic category 1B without athreshold, 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 intheir territory.
At the same time, they shall draw up a phasing out plan concerning thecontrol of the serious danger by other means, including non-chemical
methods, and shall without delay transmit that plan to the Commission.

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Article 5First approvalFirst 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 toin Article 8 taking account of the agricultural, plant health andenvironmental, 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, (theAuthority), where new requirements are established during theevaluation process or as a result of new scientific and technicalknowledge;(g) designation of categories of users, such as professional andnon-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 monitoring afteruse;(j) any other particular conditions that result from the evaluation of
information made available in the context of this Regulation.

Subsection 2
Approval procedure
Article 7
Application
1.
An application for the approval of an active substance or for anamendment 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 justifi­
cation for not providing certain parts of those dossiers, demonstratingthat 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 thisRegulation.

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The application shall be examined by the Member State proposed by theapplicant, unless another Member State agrees to examine it.
2.
Assessment of an application may be performed by a number ofMember 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 thedossier, 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 sametime 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 awidely grown crop in each zone of at least one plant protection
product containing the active substance, demonstrating that theapproval criteria provided for in Article 4 are met; where theinformation submitted does not cover all zones or concern a cropwhich is not widely grown, justification for this approach;(b) for each point of the data requirements for the active substance, thesummaries and results of tests and studies, the name of their ownerand of the person or institute that has carried out the tests andstudies;(c) for each point of the data requirements for the plant protection
product, the summaries and results of tests and studies, the nameof 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 inparagraph 2 of this Article, resulting from the proposed limited
range of representative uses of the active substance, may lead torestrictions in the approval;(d) for each test or study involving vertebrate animals, a justification of
the steps taken to avoid animal testing and duplication of tests andstudies 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 theconditions of the approval;

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▼B(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 ora 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 inpoints (b) and (c) of paragraph 1. It shall not contain any reports oftests 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 shallbe established in accordance with the advisory procedure referred to in
Article 79(2).
4.
The data requirements referred to in paragraphs 1 and 2 shallcontain 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 theadvisory 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).
5.
Scientific peer-reviewed open literature, as determined by the
Authority, on the active substance and its relevant metabolites dealing
with side-effects on health, the environment and non-target species andpublished within the last 10 years before the date of submission of thedossier 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 submittedwith 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 thecomplete 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 themissing elements, the rapporteur Member State shall inform theapplicant, the other Member States and the Commission that the appli­
cation 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 theelements provided for in Article 8, the rapporteur Member State shallnotify the applicant, the other Member States, the Commission and the
Authority of the admissibility of the application and start assessing theactive substance.

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After receiving that notification, the applicant shall immediately forward
the dossiers as provided for in Article 8 to the other Member States, theCommission and the Authority, including the information about thoseparts of the dossiers in respect of which confidentiality has beenrequested as referred to in Article 7(3).
Article 10
Access to the summary dossier
The Authority shall without delay make the summary dossier referred toin Article 8(1) available to the public, excluding any information in
respect of which confidential treatment has been requested andjustified pursuant to Article 63, unless there is an overriding public
interest in its disclosure.
Article 11
Draft assessment report1.
Within 12 months of the date of the notification provided for in
the first subparagraph of Article 9(3), the rapporteur Member State shallprepare and submit to the Commission, with a copy to the Authority, areport, referred to as the ‘draft assessment report’, assessing whether theactive 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 andtransparent assessment in the light of current scientific and technicalknowledge.
Where, pursuant to Article 4(1), the assessment establishes that theapproval 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 thoseparts of the assessment.
3.
Where the rapporteur Member State needs additional studies orinformation, it shall set a period in which the applicant must supply
those studies or that information. In that case, the 12-month period shallbe extended by the additional period granted by the rapporteur Member
State. The additional period shall be of a maximum of 6 months andshall 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 established inaccordance 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 otherMember States at the latest 30 days after its receipt. It shall ask theapplicant to circulate an update of the dossier where applicable to theMember States, the Commission and the Authority.

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The 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 consultation ofexperts, 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 ofcurrent scientific and technical knowledge using guidance documents
available at the time of application on whether the active substancecan 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 120day 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 theMember States, the Commission and the Authority.
The rapporteur Member State shall assess the additional information andsubmit 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 isreceived by the Authority.
The Authority may ask the Commission to consult a Community
reference laboratory, designated pursuant to Regulation (EC)No 882/2004 for the purposes of verifying whether the analyticalmethod for the determination of the residues proposed by theapplicant 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 substanceconcerned.
5.
The Authority shall establish the format for its conclusion whichshall include details concerning the evaluation procedure and theproperties of the active substance concerned.
6.
The time limits for the Authority’s opinion on applications
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 ofArticle 14 of that Regulation shall apply without delay.

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8.
Where the conclusion of the Authority is not adopted within thetime limit set out in paragraph 2 of this Article, extended by any
additional period set in accordance with paragraph 3, the provisionsof 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 thereview report.
2.
On the basis of the review report, other factors legitimate to thematter under consideration and the precautionary principle where theconditions laid down in Article 7(1) of Regulation (EC) No 178/2002
are relevant, a Regulation shall be adopted in accordance with theregulatory procedure referred to in Article 79(3), providing that:(a) an active substance is approved, subject to conditions andrestrictions, 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.
The rapporteur Member State shall assess the additional information andsubmit its assessment to the other Member States, the Commission and
the Authority without delay and at the latest six months after the receiptof the additional information.
4.
Approved active substances shall be included in the Regulationreferred 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.
Subsection 3
Renewal and review
Article 14
Renewal of approval
1.
On application the approval of an active substance shall berenewed where it is established that the approval criteria provided forin Article 4 are satisfied.
Article 4 shall be deemed to be satisfied where this has been establishedwith 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.

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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 theother 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 ofdata requirements or criteria which were not applicable at the time of
the last approval of the active substance or because his request is for anamended approval. The applicant shall at the same time submit atimetable 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 theinformation provided by the applicant under Article 15, excluding any
information in respect of which confidential treatment has beenrequested 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 theapproval is likely to expire before a decision has been taken on renewal,
a decision shall be adopted in accordance with the regulatory procedurereferred to in Article 79(3), postponing the expiry of the approval period
for that applicant for a period sufficient to examine the application.
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 anapplicant 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 thefollowing:(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 acoherent work programme, as provided for in Article 18.

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Article 18
Work programme
The Commission may establish a work programme grouping together
similar active substances setting priorities on the basis of safetyconcerns for human and animal health or the environment and taking
into account, as far as possible, the need for an effective control andresistance management of target pest. The programme may requireinterested parties to submit all the necessary data to the Member
States, the Commission and the Authority within a period provided
for in the programme.
The programme shall include the following:(a) the procedures concerning the submission and assessment of appli­
cations 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 andintelligent 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 bedone among Member States acting as rapporteurs.

Article 19
Implementing measures
A Regulation, adopted in accordance with the regulatory procedurereferred to in Article 79(3), shall set out the provisions necessary forthe 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 Regulation referred to inparagraph 1 shall provide for a grace period not exceeding six months
for the sale and distribution, and in addition a maximum of one year forthe disposal, storage, and use of existing stocks of the plant protection
products concerned. The grace period for the sale and distribution shalltake into account the normal period of use of the plant protection
product but the total grace period shall not exceed 18 months.

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In the case of a withdrawal of the approval or if the approval is notrenewed because of the immediate concerns for human health or animal
health or the environment, the plant protection products concerned shallbe 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 substanceat any time. It shall take into account the request of a Member State toreview, in the light of new scientific and technical knowledge andmonitoring data, the approval of an active substance, including where,
after the review of the authorisations pursuant to Article 44(1), there areindications that the achievement of the objectives established inaccordance 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 tosubmit 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 threemonths from the date of the request. The Authority shall provide its
opinion or the results of its work to the Commission within threemonths 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.

Subsection 4
Derogations
Article 22
Low-risk active substances1.
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).
2.
Articles 4 and 6 to 21 and point 5 of Annex II shall apply.
Low-risk active substances shall be listed separately in the Regulationreferred to in Article 13(4).

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3.
The Commission may review and if necessary specify new criteria
for approving an active substance as low-risk active substance inaccordance with Article 78(1)(a).
Article 23
Approval criteria for basic substances1.
Basic substances shall be approved in accordance with paragraphs
2 to 6. By way of derogation from Article 5, the approval shall be foran 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 productconsisting 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 thecriteria 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 beapproved where any relevant evaluations, carried out in accordance withother Community legislation regulating the use of that substance forpurposes other than for a plant protection product, show that thesubstance has neither an immediate or delayed harmful effect onhuman or animal health nor an unacceptable effect on the environment.
3.
By way of derogation from Article 7 an application for theapproval of a basic substance shall be submitted by a Member Stateor 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 dateof 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 toreview the approval.
Where the Commission considers that there are indications that thesubstance 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.

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The Commission shall ask the Authority for an opinion, or for scientificor 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 inparagraph 1 are no longer satisfied, a Regulation to withdraw oramend 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 Regulationreferred 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.
2.

Articles 5 to 21 shall apply.

3.
Similar data requirements to those referred to in Article 8(4) shallbe 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 accordancewith the regulatory procedure with scrutiny referred to in Article 79(4)establishing a work programme for the gradual review of synergists andsafeners 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, theCommission and the Authority within a specified period.

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SECTION 3

Unacceptable co-formulants
Article 27
Co-formulants1.
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 groundwateror 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 ofuse, has a harmful effect on human or animal health or an unac­
ceptable 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 PRODUCTSSECTION 1

Authorisation
Subsection 1
Requirements and contents
Article 28
Authorisation for placing on the market and use
1.
A plant protection product shall not be placed on the market orused unless it has been authorised in the Member State concerned inaccordance 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 forresearch or development purposes in accordance with Article 54;

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▼B(c) production, storage or movement of a plant protection productintended 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 placeinspection requirements to ensure that the plant protection productis not used in its territory;(d) production, storage or movement of a plant protection productintended for use in a third country provided that the Member
State of production, storage or movement has put in placeinspection requirements to ensure that the plant protection productis exported from its territory;(e) placing on the market and use of plant protection products forwhich 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 inparagraph 6 it complies with the following requirements:(a) its active substances, safeners and synergists have been approved;(b) where its active substance, safener or synergist is produced by adifferent source, or by the same source with a change in the manu­
facturing process and/or manufacturing location:(i) the specification, pursuant to Article 38, does not deviatesignificantly 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 arelimited as much as possible without compromising the functioningof 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 andsynergists and, where appropriate, any toxicologically, ecotoxico­
logically or environmentally relevant impurities and co-formulants
can be determined by appropriate methods;(g) its residues, resulting from authorised uses, and which are of toxi­
cological, ecotoxicological or environmental relevance, can be
determined by appropriate methods in general use in all Member
States, with appropriate limits of determination on relevant samples;(h) its physical and chemical properties have been determined anddeemed acceptable for the purposes of the appropriate use andstorage of the product;196

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▼B(i) for plants or plant products to be used as feed or food, whereappropriate, the maximum residue levels for the agricultural
products affected by the use referred to in the authorisation havebeen set or modified in accordance with Regulation (EC)No 396/2005.
2.
The applicant shall demonstrate that the requirements provided forin 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 officiallyrecognised tests and analyses carried out under agricultural, plant healthand environmental conditions relevant to the use of the plant protection
product in question and representative of the conditions prevailing in thezone 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 inAnnex VI to Directive 91/414/EEC and shall be laid down in Regu­
lations 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 isadmissible in relation to the proposed uses; and(c) the Member State concludes that the active substance can satisfy therequirements of Article 4(2) and (3) and that the plant protection
product may be expected to satisfy the requirements ofArticle 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 otherMember States and the Commission of its assessment of the dossier andof the terms of the authorisation, giving at least the information
provided for in Article 57(1).

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3.
The provisions laid down in paragraphs 1 and 2 shall apply until
14 June 2016. If necessary, that time limit may be extended inaccordance 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 andnon-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 theplacing on the market and use of the plant protection product. Thoserequirements 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 andsynergists.
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 andlabelling of the plant protection product in accordance with Directive
1999/45/EC. In such cases, they shall immediately inform the competentauthority 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 thefollowing:(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 theenvironment, taking into consideration requirements imposed byother 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 andnon-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.

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Article 32
Duration
1.

The period of authorisation shall be laid down in the authorisation.

Without prejudice to Article 44, the duration of an authorisation shall be
set for a period not exceeding 1 year from the date of expiry of theapproval 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 tobe 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 asprovided for in Article 50.
Subsection 2
Procedure
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 representative, to each Member State
where the plant protection product is intended to be placed on themarket.
2.

The application shall include the following:(a) a list of intended uses in each zone as indicated in Annex I and theMember States where the applicant has made or intends to make anapplication;(b) a proposal as to which Member State the applicant expects toevaluate the application in the zone concerned. In the case of an
application for use in greenhouses, as post-harvest treatment, fortreatment of empty storage rooms and for seed treatment, only
one Member State shall be proposed, which evaluates the appli­
cation taking account of all zones. In this case the applicant shallsend the summary or complete dossier as referred to in Article 8 toother Member States on request;(c) where relevant, a copy of any authorisations already granted for thatplant protection product in a Member State;(d) where relevant, a copy of any conclusion of the Member Stateassessing 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 asummary dossier for each point of the data requirements of theplant protection product;(b) for each active substance, safener and synergist contained in theplant protection product, a complete and a summary dossier foreach point of the data requirements of the active substance,
safener and synergist;199

2009R1107 — EN — 01.07.2013 — 001.001 — 34▼B(c) for each test or study involving vertebrate animals, a justification of
the steps taken to avoid animal testing and duplication of tests andstudies 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 theauthorisation;(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 ora justification for not supplying such information;(f) where relevant for an amendment of an authorisation an assessmentof 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 thedossier, 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 forwhich any claims for data protection pursuant to Article 59 arerequested.
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 Stateor one of those languages.
6.
On request, the applicant shall provide the Member State withsamples 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 theapplicants demonstrate that they have been granted access in accordancewith 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 declarationthat no unacceptable co-formulants are used;(b) the information needed to identify the active substance, safener orsynergist, 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 appropriate;(c) on the request of the concerned Member State, the data needed todemonstrate that the plant protection product has comparable effects
to the plant protection product for which they show access to theprotected data.

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Article 35
Member State examining the application
The application shall be examined by the Member State proposed by theapplicant, unless another Member State in the same zone agrees to
examine it. The Member State which will examine the application
shall inform the applicant.
At the request of the Member State examining the application, the otherMember States in the same zone to which an application has been
submitted shall cooperate to ensure a fair division of the workload.
The other Member States within the zone to which an application has
been submitted shall refrain from proceeding with the file pending
assessment by the Member State examining the application.
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 inde­
pendent, 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 inthe same zone the opportunity to submit comments to be considered in
the assessment.
It shall apply the uniform principles for evaluation and authorisation ofplant 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 accordancewith 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 established in accordancewith the advisory procedure referred to in Article 79(2).
2.
The Member States concerned shall grant or refuse authorisations
accordingly on the basis of the conclusions of the assessment of theMember 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 therequirements referred to in Article 31(3) and (4) and other risk miti­
gation 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 firstsubparagraph, a Member State may refuse authorisation 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.

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That Member State shall immediately inform the applicant and theCommission of its decision and provide a technical or scientific justifi­
cation therefor.
Member States shall provide for the possibility of challenging a decisionrefusing the authorisation of such products before national courts orother 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 theMember State. That additional period shall be a maximum of 6months and shall cease at the moment when the additional informationis received by the Member State. Where at the end of that period theapplicant 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 productcontaining an active substance not yet approved, the Member State
examining the application shall start the evaluation as soon as it hasreceived the draft assessment report referred to in Article 12(1). In casethe application concerns the same plant protection product and the sameuses 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 theapplication as referred to in Article 36(2) and (3).

Article 38
Assessment of equivalence under point (b) of Article 29(1)1.
Where it is necessary to establish for an active substance, safeneror synergist whether a different source or, for the same source a changeof the manufacturing process and/or manufacturing 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 orsynergist 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 theMember 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 onequivalence within 60 days from receiving the application and shallcommunicate the report to the Commission, the other Member States
and the applicant.

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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 theapplicant with an opportunity to submit comments.
4.
Where the Member States concerned do not reach agreement
within 45 days, the Member State assessing equivalence 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 theMember State examining the application for authorisation informed
the rapporteur Member State or vice versa that it does not agree withthe 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 assistancewhich shall be provided within 3 months of the request.
5.
Detailed rules and procedures for the implementation ofparagraphs 1 to 4 may be established in accordance with the regulatory
procedure referred to in Article 79(3), after consultation 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 fileshall 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 documentation 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 tothe other Member States, the Commission and the Authority a filecontaining the documentation provided for in points (a) to (d) ofparagraph 1.
3.
On request, applicants shall provide a copy of the documentation
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).

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Subsection 3
Mutual recognition of authorisations
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 inanother 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;(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 thesame 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, orfor 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 inthat Member State, official or scientific bodies involved in agriculturalactivities or professional agricultural organisations may apply, with theconsent of the authorisation holder, for an authorisation for the sameplant protection product, the same use and under the same agricultural
practices in that Member State under the mutual recognition procedurereferred to in paragraph 1. In that case the applicant must demonstratethat the use of such a plant protection product is of general interest for
the Member State of introduction.
Where the authorisation holder refuses its consent, the competentauthority 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 thecircumstances in its territory, authorise the plant protection productconcerned 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).

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Article 42
Procedure
1.

The application shall be accompanied by the following:(a) a copy of the authorisation granted by the reference Member Stateas well as a translation of the authorisation into an official languageof the Member State receiving the application;(b) a formal statement that the plant protection product is identical tothat authorised by the reference Member State;(c) a complete or summary dossier as required in Article 33(3) whenrequested 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 Stateor one of those languages.

Subsection 4
Renewal, withdrawal and amendment
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 datarequirements or criteria;(c) evidence that the new data submitted are the result of datarequirements 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;(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 orsynergist contained therein;(e) a report on the monitoring information, where the authorisation 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 Regu­
lation renewing the approval under Article 20.

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The Member State referred to in Article 35 within each zone shallcoordinate 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 beestablished in accordance with the advisory procedure referred to in
Article 79(2).
5.
Member States shall decide on the renewal of the authorisation ofa 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 nolonger satisfied.
A Member State shall review an authorisation where it concludes thatthe 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 thepossibility to submit comments or further information.
3.
The Member State shall withdraw or amend the authorisation, as
appropriate, where:(a) the requirements referred to in Article 29 are not or are no longer
satisfied;(b) false or misleading information was supplied concerning the facts
on the basis of which the authorisation was granted;(c) a condition included in the authorisation has not been met;(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 authorisation inaccordance 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 shallwithdraw or amend the authorisation accordingly taking into accountnational 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.

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Article 45
Withdrawal or amendment of an authorisation at the request of theauthorisation 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 therequirements 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 theauthorisation are not related to the protection of human and animal
health or the environment, the grace period shall be limited and shallnot exceed 6 months for the sale and the distribution and an additional
maximum of 1 year for the disposal, storage, and use of existing stocksof the plant protection products concerned.

Subsection 5
Special cases
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 productprovided no specific risk mitigation measures are needed following arisk assessment. This plant protection product shall also meet thefollowing 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 vertebrates to becontrolled;(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’.

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▼B2.
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 application a complete and a summary
dossier for each point of the data requirements of the active substanceand the plant protection product.
3.
The Member State shall decide within 120 days whether toapprove 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 shallcease at the moment when the additional information is received by theMember State. Where at the end of that period the applicant has not
submitted the missing elements, the Member State shall inform theapplicant that the application is inadmissible.
4.
Unless otherwise specified, all provisions relating to authorisations
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 fallingwithin 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 aplant protection product unless written consent, as referred to in
Article 19 of Directive 2001/18/EC, has been granted for it.
2.
Unless otherwise specified, all provisions relating to authorisations
under this Regulation shall apply.

Article 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 authorised for that use in atleast 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 saleof such treated seeds shall be taken immediately in accordance with theregulatory procedure referred to in Article 79(3). Before taking suchmeasures the Commission shall examine the evidence and may
request an opinion from the Authority. The Commission may set atime limit within which such an opinion shall be provided.
3.

Articles 70 and 71 shall apply.

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4.
Without prejudice to other Community legislation concerning thelabelling of seeds, the label and documents accompanying the treatedseeds 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 auth­orisation for that product where appropriate.

Article 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 useof a plant protection product containing a candidate for substitution foruse 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 authorisation of a plant
protection product not containing a candidate for substitution ora 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 productcontaining 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 substi­
tution Member States shall perform the comparative assessment
provided for in paragraph 1 regularly and at the latest at renewal oramendment of the authorisation.
Based on the results of that comparative assessment, Member Statesshall maintain, withdraw or amend the authorisation.

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5.
Where a Member State decides to withdraw or amend an auth­orisation pursuant to paragraph 4, that withdrawal or amendment shalltake effect 3 years after the decision of the Member State or at the endof the approval period of the candidate for substitution where that
period ends earlier.
6.
Unless otherwise specified, all provisions relating to authorisations
under this Regulation shall apply.

Article 51
Extension of authorisations for minor uses
1.
The authorisation holder, official or scientific bodies involved inagricultural activities, professional agricultural organisations or profes­
sional users may ask for the authorisation of a plant protection productalready authorised in the Member State concerned to be extended tominor 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 paragraph1, especially data on the magnitude of residues and where necessaryon the risk assessment to the operator, worker and bystander.
3.
Member States may take measures to facilitate or encourage thesubmission of applications to extend the authorisation 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 theadministrative procedures of the Member State concerned.
5.
When Member States grant an extension of authorisation for aminor use, they shall inform if necessary the authorisation holder andrequest him to change the labelling accordingly.
Where the authorisation holder declines, the Member States shall ensurethat users are fully and specifically informed as to instructions for use,by means of an official publication or an official website.
The official publication or where applicable the label shall include areference to the liability of the person using the plant protection productwith 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 inaccordance with the provisions of Article 41 provided that those uses
are also considered minor in the Member States of application.

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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 aEuropean fund for minor uses, accompanied, if appropriate, by a legis­
lative proposal.
10.
Unless otherwise specified, all provisions relating to authori­sations under this Regulation shall apply.
Article 52
Parallel trade1.
A plant protection product that is authorised in one Member State(Member State of origin) may, subject to granting a parallel tradepermit, be introduced, placed on the market or used in anotherMember 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 authorityof the Member State of introduction.
2.
From receiving a complete application, a parallel trade permit shallbe 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 informationnecessary to assess whether the products are identical within 10 working
days of receiving the request. The procedure for granting a parallel tradepermit is interrupted from the day the request for information is sent tothe competent authority of the Member State of origin until thecomplete information required is delivered to the competent authorityof the Member State of introduction.
3.
Plant protection products shall be considered as identical to thereference products if:(a) they have been manufactured by the same company or by anassociated undertaking or under licence in accordance with thesame 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 thefollowing 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 examinationby the competent authority of the Member State of introduction.
This competent authority may require a translation of the relevant
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▼B(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 isconsidered 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 andfurther details and specific requirements shall be established in casesof application for a plant protection product for which a parallel tradepermit has already been granted and in cases of an application for aplant protection product for a personal use in accordance with theregulatory procedure with scrutiny referred to in Article 79(4).
5.
A plant protection product for which a parallel trade permit has
been issued shall be placed on the market and used only in accordancewith the provisions of the authorisation of the reference product. To
facilitate monitoring and controls the Commission shall set out specificcontrol requirements for the product to be introduced in a Regulationreferred 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 thereference product applies for a withdrawal of authorisation inaccordance with Article 45(1) and the requirements of Article 29 arestill fulfilled, the validity of the parallel trade permit shall expire by thedate 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 productis 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 thereference product, the Member State of introduction may only grant theauthorisation required for placing on the market and use in accordancewith 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 shallmake publicly available information about parallel trade permits.
Subsection 6
Derogations
Article 53
Emergency situations in plant protection
1.
By way of derogation from Article 28, in special circumstances a
Member State may authorise, for a period not exceeding 120 days, theplacing on the market of plant protection products, for limited andcontrolled use, where such a measure appears necessary because of adanger which cannot be contained by any other reasonable means.

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The Member State concerned shall immediately inform the otherMember 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 theCommission within 1 month of the date of the request.
3.
If necessary, a decision shall be taken, in accordance with theregulatory procedure referred to in Article 79(3), as to when andunder 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 unlesssuch 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 forresearch or development purposes involving the release into theenvironment of an unauthorised plant protection product or involving
unauthorised use of a plant protection product may be carried out if theMember State in whose territory the experiment or test is to be carriedout has assessed the available data and granted a permit for trial
purposes. The permit may limit the quantities to be used and theareas 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 thefood 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 adossier containing all the available data to permit an assessment ofpossible 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 geneticallymodified organism unless such release has been accepted underDirective 2001/18/EC.
4.
Paragraph 2 shall not apply if the Member State has granted theperson concerned the right to undertake certain experiments and tests
and has determined the conditions under which the experiments andtests have to be undertaken.

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5.
Detailed rules for the implementation of this Article, in particular
the maximum quantities of plant protection products that may bereleased during experiments or tests and the minimum data to besubmitted in accordance with paragraph 2, may be adopted inaccordance with the regulatory procedure with scrutiny referred to in
Article 79(4).

SECTION 2

Use and information
Article 55
Use of plant protection productsPlant 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 inaccordance 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 thelatest by 1 January 2014.

Article 56
Information on potentially harmful or unacceptable effects
1.
The holder of an authorisation for a plant protection product shallimmediately notify the Member States that granted an authorisation of
any new information concerning that plant protection product, the active
substance, its metabolites, a safener, synergist or co-formulant containedin 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 unacceptable effects on plants orplant 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 tothe 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 whichauthorise 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 theactive substance, its metabolites, a safener, or synergist or co-formulant
no longer complying with the requirements set out in Article 29 andArticle 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 andinform the other Member States, belonging to the same zone, where
it decides to withdraw or amend the authorisation under Article 44.

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That Member State shall inform the other Member States and theCommission 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 ofa co-formulant it has been considered unacceptable and propose thatthe approval be withdrawn or the conditions amended.
4.
The holder of an authorisation for a plant protection product shallreport annually to the competent authorities of the Member States whichauthorised his plant protection product if he has any information
available relating to the lack of expected efficacy, the development ofresistance and to any unexpected effect on plants, plant products or theenvironment.

Article 57
Obligation to keep information available
1.
Member States shall keep information electronically available tothe public on plant protection products authorised or withdrawn inaccordance with this Regulation, containing at least:(a) the name or business name of the holder of the authorisation andthe 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;(f) the use or uses for which it is authorised;(g) the reasons for withdrawal of an authorisation if they are related tosafety 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 IVADJUVANTS

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 withthe conditions established in the Regulation referred to in paragraph 2.

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2.
Detailed rules for the authorisation of adjuvants, including datarequirements, notification, evaluation, assessment and decision making
procedures shall be set out in a Regulation to be adopted in accordancewith the regulatory procedure with scrutiny referred to in Article 79(4).
3.

Article 81(3) shall apply.

CHAPTER VDATA PROTECTION AND DATA SHARING

Article 59
Data protection
1.
Test and study reports shall benefit from data protection under theconditions laid down in this Article.
The protection shall apply to test and study reports concerning theactive 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 authorisation under this Regulation,(the first applicant), provided that those test and study reports were:(a) necessary for the authorisation or an amendment of an authorisationin order to allow the use on another crop; and(b) certified as compliant with the principles of good laboratory practiceor 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 ofplant protection products, safeners or synergists and adjuvants, except asprovided 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 firstauthorisation in that Member State, except as provided in paragraph 2 ofthis Article or in Article 62. That period is extended to 13 years forplant 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 extrapolation, if the appli­
cations 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 purposeof 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 orreview of an authorisation. The period for data protection shall be 30
months. The first to fourth subparagraphs shall apply mutatis mutandis.

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2.

Paragraph 1 shall not apply:(a) to test and study reports for which the applicant has submitted aletter 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 thefirst applicant has claimed data protection for test and study reports
concerning the active substance, safener or synergist, adjuvant and theplant 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.

Article 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 uponrequest:(a) a list of the test and study reports concerning the active substance,
safener or synergist, adjuvant and the plant protection productnecessary 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 dataprotection under Article 59 and any reasons submitted in accordancewith that Article.
3.
The lists provided for in paragraphs 1 and 2 shall include
information on whether those test and study reports were certified ascompliant with the principles of good laboratory practice or of goodexperimental practice.

Article 61
General rules on avoidance of duplicative testing1.
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 toascertain 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 shallon request from the prospective applicant provide him with the list of
test and study reports prepared in accordance with Article 60 for that
product.

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The prospective applicant shall submit all data regarding the identity
and impurities of the active substance he proposes to use. The enquiry
shall be supported by evidence that the prospective applicant intends toapply for an authorisation.
2.
The competent authority of the Member State, where satisfied thatthe prospective applicant intends to apply for an authorisation, or the
renewal or review thereof, shall provide him with the name and addressof the holder or holders of previous relevant authorisations and shall at
the same time inform the holders of the authorisations of the name andaddress of the applicant.
3.
The prospective applicant for the authorisation, or the renewal orreview thereof, and the holder or holders of relevant authorisations shalltake all reasonable steps to reach agreement on the sharing of any test
and study reports protected under Article 59, in a fair, transparent andnon-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. Dupli­
cation of tests and studies on vertebrates undertaken for the purposes ofthis Regulation shall be avoided in accordance with paragraphs 2 to 6.
2.
Member States shall not accept duplication of tests and studies onvertebrate animals or those initiated where conventional methods
described in Annex II to Directive 1999/45/EC could reasonably havebeen 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 andstudies involving vertebrate animals. The costs of sharing the test andstudy reports shall be determined in a fair, transparent andnon-discriminatory way. The prospective applicant is only required toshare in the costs of information he is required to submit to meet theauthorisation requirements.
4.
Where the prospective applicant and the holder or holders of therelevant authorisations of plant protection products containing the sameactive substance, safener or synergist, or of adjuvants cannot reachagreement on the sharing of test and study reports involving vertebrate
animals, the prospective applicant shall inform the competent authorityof the Member State referred to in Article 61(1).
The failure to reach agreement, as provided in paragraph 3, shall notprevent the competent authority of that Member State from using thetest 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 effectsof 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.

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6.
The holder or holders of the relevant authorisation shall have a claimon 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 admin­
istered under national law. Otherwise the parties may resolve the matter
through litigation in the courts of the Member States. Awards from arbi­
tration or litigation shall have regard to the principles determined inparagraph 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 Regu­
lation is to be treated as confidential shall provide verifiable evidence toshow that the disclosure of the information might undermine hiscommercial 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, ecotoxico­
logically 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 manu­
factured except for methods for impurities that are considered to be
toxicologically, ecotoxicologically or environmentally 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 theEuropean Parliament and of the Council of 28 January 2003 on publicaccess to environmental information (1).
CHAPTER VII
PACKAGING, LABELLING AND ADVERTISING OF
PROTECTION PRODUCTS AND ADJUVANTS

PLANT

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 thelikelihood of such a mistake being made.
(1) OJ L 41, 14.2.2003, p. 26.

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2.
Plant protection products and adjuvants available to the generalpublic that may be mistaken for food, drink or feed shall containcomponents 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 clas­
sification, labelling and packaging requirements of Directive
1999/45/EC and shall comply with the requirements set out in a Regu­
lation 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 andsafety 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 withany 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 arenecessary 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 forthese 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 theadditional phrase or phrases.

Article 66
Advertising
1.
Plant protection products which are not authorised shall not be
advertised. Every advertisement for a plant protection product shall beaccompanied 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 advertisement. 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’, ‘nontoxic’ 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.

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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 ofpotentially dangerous practices, such as mixing or application without
sufficient protective clothing, nor any use near food or use by or in thevicinity of children.
6.
Advertising or promotional material shall draw attention to theappropriate warning phrases and symbols as laid down in the labelling.

CHAPTER VIIICONTROLS

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 productwas 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 tothis information by addressing the competent authority.
The competent authorities shall provide access to such information inaccordance with applicable national or Community law.
By 14 December 2012, the Commission shall present a report to theEuropean Parliament and the Council on the costs and benefits of the
traceability of information from users to retailers concerning the appli­
cations of plant protection products on agricultural products, accom­
panied, if necessary, by appropriate legislative proposals.
2.
Producers of plant protection products shall undertake
post-authorisation monitoring on the request of the competentauthorities. They shall notify the competent authorities of the relevant
results.
3.
Authorisation holders shall provide the competent authorities ofthe 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 ofparagraphs 1, 2 and 3 may be adopted in accordance with the regulatory
procedure referred to in Article 79(3).

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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 thesecontrols within six months of the end of the year to which thereports relate.
Commission experts shall carry out general and specific audits in theMember States for purposes of verifying the official controls carried out
by the Member States.
A Regulation, adopted in accordance with the regulatory procedure withscrutiny referred to in Article 79(4), shall set out provisions for thecontrols, 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 thecollection of information and reporting on suspected poisonings.
CHAPTER IXEMERGENCIES

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 inaccordance with this Regulation is likely to constitute a serious risk tohuman or animal health or the environment, and that such risk cannot be
contained satisfactorily by means of measures taken by the Member
State(s) concerned, measures to restrict or prohibit the use and/or saleof that substance or product shall be taken immediately in accordancewith the regulatory procedure referred to in Article 79(3), either at theown initiative of the Commission or at the request of a Member State.
Before taking such measures the Commission shall examine theevidence and may request an opinion from the Authority. The
Commission may set a time limit within which such an opinion shallbe provided.
Article 70
Emergency measures in cases of extreme urgency
By way of derogation from Article 69, the Commission may in cases ofextreme urgency provisionally adopt emergency measures after
consulting the Member State or Member States concerned andinforming the other Member States.
As soon as possible, and at the latest after 10 working days, thosemeasures shall be confirmed, amended, revoked or extended inaccordance 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 theneed to take emergency measures, and no action has been taken inaccordance with Article 69 or 70, the Member State may adopt
interim protective measures. In this event, it shall immediately informthe other Member States and the Commission.

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2.
Within 30 working days, the Commission shall put the matter
before the Committee referred to in Article 79(1) in accordance withthe regulatory procedure referred to in Article 79(3) with a view to theextension, 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 toinfringements of this Regulation and shall take the measures necessary
to ensure that they are implemented. The penalties provided for shall beeffective, 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 andcriminal liability in the Member States of the producer and, whereapplicable, 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 inparagraph 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.

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2.
Each Member State shall designate a coordinating national
authority to coordinate and ensure all the necessary contacts withapplicants, other Member States, the Commission and the Authority.
3.
Member States shall ensure that competent authorities have asufficient number of suitably qualified and experienced staff so thatthe 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 andthe coordinating national authorities of the other Member States andinform them of any modifications thereof.
5.
The Commission shall publish and keep updated on its website alist 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 organisation of thefollowing:(a) development of a harmonised system, including an appropriate
database, for gathering and storing all information concerning
active substances, safeners, synergists, co-formulants, plant
protection products and adjuvants and for making such information
available to the Member States, producers and other interested
parties;(b) performance of studies needed to prepare and develop further legis­
lation on the placing on the market and use of plant protection
products and adjuvants;(c) performance of studies needed to harmonise
decision-making criteria and data requirements;

procedures,(d) coordination, if necessary by electronic means, of cooperation
between Member States, the Commission and the Authority andmeasures to facilitate work sharing;(e) development and maintenance of a coordinated electronic
submission and evaluation system aimed at promoting electronic
document exchange and work sharing between the applicants, theMember States, the Commission and the Authority;(f) development of guidance to facilitate the day-to-day application ofthis 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 theRegulation adopted under Article 68.
2.
The appropriations required under paragraph 1 shall be subject toauthorisation by the budgetary authority each financial year.

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Article 77
Guidance documents
The Commission may, in accordance with the advisory procedurereferred to in Article 79(2), adopt or amend technical and otherguidance documents such as explanatory notes or guidance documentson the content of the application concerning micro-organisms,
pheromones and biological products, for the implementation of thisRegulation. The Commission may ask the Authority to prepare or tocontribute to such guidance documents.

Article 78
Amendments and implementing measures
1.
The following measures designed to amend non-essential elementsof this Regulation, inter alia, by supplementing it shall be adopted inaccordance with the regulatory procedure with scrutiny referred to in
Article 79(4):(a) amendments to the Annexes, taking into account current scientificand technical knowledge;(b) amendments to the Regulations on data requirements for active
substances and for plant protection products, as referred to inpoints (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 technicalknowledge;(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 andsynergists 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);(i) extension of the date of application of this Regulation to provi­
sional 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.

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2.
Any further measures necessary for the implementation of thisRegulation may be adopted in accordance with the regulatory
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 ofactive substances included in Annex I to Directive 91/414/EEC.
Those substances shall be deemed to have been approved under thisRegulation.

Article 79
Committee procedure
1.
The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health, as established by Article 58 ofRegulation (EC) No 178/2002.
2.
Where reference is made to this paragraph, Articles 3 and 7 ofDecision 1999/468/EC shall apply, having regard to the provisions ofArticle 8 thereof.
3.
Where reference is made to this paragraph, Articles 5 and 7 ofDecision 1999/468/EC shall apply, having regard to the provisions ofArticle 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 theprovisions 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) ofDecision 1999/468/EC shall be set at two months, one month andtwo months respectively.

CHAPTER XI
TRANSITIONAL AND FINAL PROVISIONS

Article 80
Transitional measures1.
Directive 91/414/EEC shall continue to apply, with respect to theprocedure and the conditions for approval:(a) to active substances for which a decision has been adopted inaccordance 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);(1) OJ L 169, 29.6.2007, p. 10.

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2009R1107 — EN — 01.07.2013 — 001.001 — 61▼B(c) to active substances for which completeness has been established inaccordance with Article 16 of Regulation (EC) No 33/2008 (1);(d) to active substances for which completeness has been established inaccordance 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 shallbe adopted in accordance with Article 13(2) of this Regulation. For
active substances referred to in point (b) of this paragraph thatapproval shall not be considered as the renewal of approval referred
to in Article 14 of this Regulation.
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 approvedin accordance with paragraph 1 of this Article:(a) for a period of five years from the date of their inclusion orapproval, for active substances covered by Article 8(2) ofDirective 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;(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 datanecessary for the renewal of the approval and which werecertified as compliant with the principles of good laboratory
practice by that date.
3.
Where Article 13 of Directive 91/414/EEC applies by virtue ofparagraph 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 ofAccession 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, witha 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 theMember 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 inaccordance 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.
(1) OJ L 15, 18.1.2008, p. 5.

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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 towhich 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 toCommunity 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 forconsidering that a co-formulant not included in Annex III is likely toconstitute 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 otherMember 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 clauseBy 14 December 2014, the Commission shall present a report to theEuropean 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 thereofon 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
RepealWithout prejudice to Article 80, Directives 79/117/EEC and91/414/EEC, as amended by the acts listed in Annex V, are repealedwith 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.

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References to the repealed Directives shall be construed as references tothis 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 Regu­
lation.
Article 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 alreadyapproved at the moment of adoption of that Regulation;(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 inall Member States.

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ANNEX 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 — SouthThe following Member States belong to this zone:
Bulgaria, Greece, Spain, France, Croatia, Italy, Cyprus, Malta, Portugal

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ANNEX II
Procedure and criteria for the approval of active substances, safeners andsynergists 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 shallcooperate 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 tomodify 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 theStanding 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 basisof the dossier submitted, authorisation in at least one Member State is
expected to be possible for at least one plant protection productcontaining 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 beapproved where a complete dossier is submitted.
In exceptional cases an active substance, safener or synergist may beapproved even though certain information is still to be submitted where:(a) the data requirements have been amended or refined after thesubmission 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 andrestrictions 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 theinformation needed to establish, where relevant, Acceptable Daily
Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute
Reference Dose (ARfD).

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In the case of an active substance, safener or synergist for which one ormore representative uses includes use on feed or food crops or leads
indirectly to residues in food or feed, the dossier submitted pursuant to
Article 7(1) shall contain the information necessary to carry out a risk
assessment and for enforcement purposes.
The dossier shall in particular:(a) permit any residue of concern to be defined;(b) reliably predict the residues in food and feed, including succeeding
crops;(c) reliably predict, where relevant, the corresponding residue levelreflecting the effects of processing and/or mixing;(d) permit a maximum residue level to be defined and to be determinedby appropriate methods in general use for the commodity and, whereappropriate, for products of animal origin where the commodity orparts of it is fed to animals;(e) permit, where relevant, concentration or dilution factors due toprocessing and/or mixing to be defined.
The dossier submitted pursuant to Article 7(1) shall be sufficient topermit, where relevant, an estimate of the fate and distribution of theactive 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 repre­
sentative uses that the plant protection product, consequent on appli­
cation 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 forevaluation 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 topermit the establishment of the toxicological, ecotoxicological or envi­
ronmental 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 toxico­
logical, ecotoxicological or environmental concern within acceptable
limits.

3.4.2.

The specification shall be in compliance with the relevant Food andAgriculture Organisation specification as appropriate, where such spec­
ification exists. However, where necessary for reasons of protection ofhuman 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, ecot­
oxicological 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.

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3.5.2.

The methods of residue analysis for the active substance and relevant
metabolites in plant, animal and environmental 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 health3.6.1.

Where relevant, an ADI, AOEL and ARfD shall be established. Whenestablishing 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 thecritical effect is judged of particular significance, such as developmental
neurotoxic or immunotoxic effects, an increased margin of safety shallbe 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 inaccordance with the data requirements for the active substances, safeners
or synergists and other available data and information, including areview of the scientific literature, reviewed by the Authority, it is notor has not to be classified, in accordance with the provisions ofRegulation (EC) No 1272/2008, as mutagen category 1A or 1B.

3.6.3.

An active substance, safener or synergist shall only be approved, if, on
the basis of assessment of carcinogenicity testing carried out inaccordance 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 ofRegulation (EC) No 1272/2008, as carcinogen category 1A or 1B,
unless the exposure of humans to that active substance, safener orsynergist 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 whereresidues of the active substance, safener or synergist concerned on foodand 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 inaccordance with the data requirements for the active substances, safeners
or synergists and other available data and information, including areview of the scientific literature, reviewed by the Authority, it is notor has not to be classified, in accordance with the provisions ofRegulation (EC) No 1272/2008, as toxic for reproduction category 1A
or 1B, unless the exposure of humans to that active substance, safener orsynergist 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 whereresidues of the active substance, safener or synergist concerned on foodand feed do not exceed the default value set in accordance with point (b)of Article 18(1) of Regulation (EC) No 396/2005.

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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 ofthe scientific literature, reviewed by the Authority, it is not considered tohave endocrine disrupting properties that may cause adverse effect inhumans, unless the exposure of humans to that active substance, safeneror 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 whereresidues of the active substance, safener or synergist concerned on foodand 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 themeasures concerning specific scientific criteria for the determination of
endocrine disrupting properties to be adopted in accordance with theregulatory procedure with scrutiny referred to in Article 79(4).
Pending the adoption of these criteria, substances that are or have to beclassified, 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 theendocrine 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 aPOP.

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 isgreater than 6 months, or that its DT50 in sediment is greater than 6months.
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 suchdata, that the partition coefficient n-octanol/water (log Ko/w) is
greater than 5, or— evidence that the active substance, safener or synergist present otherreasons for concern, such as high bioaccumulation in other
non-target species, high toxicity or ecotoxicity.
3.7.1.3. 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
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— monitoring data show that long-range environmental transport of theactive 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 thatthe 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 inlocations distant from the sources of its release. For an active
substance safener or synergist that migrates significantly throughthe 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 appropriate conditions, whichshall 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 andmarine 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 clas­
sifications 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.

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3.7.3.1. 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 60days,— 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 bioaccumu­
lative’ 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 therisk assessment demonstrates risks to be acceptable in accordance withthe criteria laid down in the uniform principles for evaluation and auth­orisation of plant protection products referred to in Article 29(6) underrealistic proposed conditions of use of a plant protection productcontaining the active substance, safener or synergist. The assessment
must take into account the severity of effects, the uncertainty of thedata, 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 isnegligible.

3.8.3.

An active substance, safener or synergist shall be approved only if it isestablished following an appropriate risk assessment on the basis ofCommunity 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 anddevelopment, taking into account effects on honeybee larvae andhoneybee 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 appli­
cation of the plant protection product consistent with realistic conditions
on use, the predicted concentration of the active substance or of meta­
bolites, degradation or reaction products in groundwater complies withthe respective criteria of the uniform principles for evaluation and auth­orisation of plant protection products referred to in Article 29(6).

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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 ofsubstances/use categories,— it meets two of the criteria to be considered as a PBT substance,— there are reasons for concern linked to the nature of the criticaleffects (such as developmental neurotoxic or immunotoxic effects)
which, in combination with the use/exposure patterns, amount tosituations of use that could still cause concern, for example, highpotential 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 ofRegulation (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 ofRegulation (EC) No 1272/2008, as toxic for reproduction category
1A or 1B if the substance has not been excluded in accordance withthe criteria laid down in point 3.6.4,— if, on the basis of the assessment of Community or internationallyagreed 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 thecriteria 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.

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ANNEX III
List of co-formulants which are not accepted for inclusion in plant
protection products as referred to in Article 27

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ANNEX IV
Comparative assessment pursuant to Article 50
1. Conditions for comparative assessment
Where refusal or withdrawal of an authorisation of a plant protection productin favour of an alternative plant protection product or a non-chemical control
or prevention method is considered, referred to as ‘substitution’, the alter­
native must, in the light of scientific and technical knowledge, show
significantly lower risk to health or the environment. An assessment of thealternative shall be performed to demonstrate whether it can be used withsimilar effect on the target organism and without significant economic andpractical 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 occurrenceof resistance in the target organism;(b) substitution shall be applied only to plant protection products where theiruse presents a significantly higher level of risk to human health or theenvironment; and(c) substitution shall be applied only after allowing for the possibility, where
necessary, of acquiring experience from use in practice, where notalready 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 asignificant difference in risk.
3. Significant practical or economic disadvantages
Significant practical or economic disadvantage to the user is defined as amajor 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.

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ANNEX 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 2004240

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Acts amending Directive 91/414/EEC

Deadline for transposition

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—

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

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Acts amending Directive 91/414/EEC

Deadline for transposition

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 2007

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

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Acts amending Directive 79/117/EEC

Deadline for transposition

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—

243