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Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilDangos y teitl llawn

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

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F1F2SECTION 1U.K.Authorisation

Subsection 1U.K.Requirements and contents

Article 28U.K.Authorisation for placing on the market and use

1.A plant protection product shall not be placed on the market or used [F3in a constituent territory] unless it has been authorised [F4by the relevant competent authority] in accordance with this Regulation.

2.By way of derogation from paragraph 1, no authorisation shall be required in the following cases:

(a)use of products containing exclusively one or more basic substances;

(b)placing on the market and use of plant protection products for research or development purposes in accordance with Article 54;

(c)production, storage or movement of a plant protection product intended for use in [F5the constituent territory of another competent authority], provided that the product is authorised [F6by that other competent authority for that constituent territory];

(d)production, storage or movement of a plant protection product intended for use [F7outside Great Britain] provided that [F8there are inspection requirements in place] to ensure that the plant protection product is exported from [F9the United Kingdom or, where the product is intended for use in Northern Ireland, is transported to Northern Ireland];

(e)placing on the market and use of plant protection products for which a parallel trade permit [F10is in force] in accordance with [F11Article 52A and, for these purposes, a plant protection product subject to a grace period granted in accordance with Article 46 (as applied by Article 52A) is to be treated as though it were a product for which a parallel trade permit is in force].

Textual Amendments

Article 29U.K.Requirements for the authorisation for placing on the market

1.Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 [F12for the constituent territory of authorisation] it complies with the following requirements:

(a)its active substances, safeners and synergists [F13are approved in the constituent territory of authorisation, and approval is not suspended in accordance with Article 69];

(b)where its active substance, safener or synergist is produced by a different source, or by the same source with a change in the manufacturing process and/or manufacturing location:

(i)

the specification, pursuant to Article 38, does not deviate significantly from the specification [F14of that substance, safener or synergist as approved in the constituent territory of authorisation]; 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 [F15on the unacceptable co-formulants register in relation to the constituent territory of authorisation];

(d)its technical formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product;

(e)in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3);

(f)the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally relevant impurities and co-formulants can be determined by appropriate methods;

(g)its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use in [F16Great Britain], with appropriate limits of determination on relevant samples;

(h)its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;

(i)for plants or plant products to be used as feed or food, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified [F17in relation to the constituent territory of authorisation] in accordance with Regulation (EC) No 396/2005.

2.The applicant shall demonstrate that the requirements provided for in points (a) to (h) of paragraph 1 are met.

3.Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the [F18areas of Great Britain] where the product is intended to be used.

F194.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F195.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.[F20(a)The appropriate authority may, by regulations, prescribe uniform principles for the evaluation and authorisation of plant protection products.]

[F21(b)]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.

Textual Amendments

Article 30U.K.Provisional authorisations

1.By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding 3 years, the placing on the market of plant protection products containing an active substance not yet approved, provided that:

(a)the decision on approval could not be finalised within a period of 30 months from the date of admissibility of the application, extended by any additional period set in accordance with Article 9(2), Article 11(3) or Article 12(2) or (3); and

(b)pursuant to Article 9 the dossier on the active substance is admissible in relation to the proposed uses; and

(c)the Member State concludes that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product may be expected to satisfy the requirements of Article 29(1)(b) to (h); and

(d)maximum residue levels have been established in accordance with Regulation (EC) No 396/2005.

2.In such cases the Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57(1).

3.The provisions laid down in paragraphs 1 and 2 shall apply until 14 June 2016. If necessary, that time limit may be extended in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

Article 31U.K.Contents of authorisations

1.The authorisation shall define plants or plant products and non-agricultural areas (for example railways, public areas, storage rooms) on which and the purposes for which the plant protection product may be used.

2.The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product. Those requirements shall as a minimum include the conditions of use necessary to comply with the conditions and requirements provided for in the [F22approval of] the active substances, safeners and synergists [F23in the constituent territory of authorisation].

The authorisation shall include a classification of the plant protection product for the purpose of [F24Regulation (EC) No 1272/2008 of the European Parliament and of the Council]. [F25A competent authority] may provide that authorisation holders shall classify or update the label without undue delay following any change to the classification and labelling of the plant protection product in accordance with [F26Regulation (EC) No 1272/2008 of the European Parliament and of the Council]. In such cases, they shall immediately inform the competent authority thereof.

3.The requirements referred to in paragraph 2 shall also include where applicable:

(a)the maximum dose per hectare in each application;

(b)the period between the last application and harvest;

(c)the maximum number of applications per year.

4.The requirements referred to in paragraph 2 may include the following:

(a)a restriction with respect to the distribution and use of the plant protection product in order to protect the health of the distributors, users, bystanders, residents, consumers or workers concerned or the environment, taking into consideration requirements imposed by other [F27retained EU law]; such restriction shall be indicated on the label;

(b)the obligation before the product is used to inform any neighbours who could be exposed to the spray drift and who have requested to be informed;

(c)indications for proper use according to the principles of Integrated Pest Management referred to in Article 14 of and Annex III to Directive 2009/128/EC;

(d)designation of categories of users, such as professional and non-professional;

(e)the approved label;

(f)the interval between applications;

(g)the period between the last application and consumption of the plant product where applicable;

(h)the re-entry interval;

(i)the packaging size and material.

[F285.For the purposes of paragraph 4(c), Directive 2009/128/EC is to be read as if—

(a)Article 3(10)(b) were omitted;

(b)in Article 14—

(i)obligations on Member States were obligations on the competent authorities;

(ii)paragraph 3 were omitted.]

Textual Amendments

Article 32U.K.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 the approval [F29in the constituent territory of authorisation] 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 [F30in the constituent territory of authorisation].

This period shall allow the examination as provided for in Article 43 to be carried out.

2.Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 50.

Textual Amendments

Subsection 2U.K.Procedure

Article 33U.K.Application for authorisation or amendment of an authorisation

[F311.An applicant or a representative of the applicant may apply to the competent authority for authorisation to place a plant protection product on the market in a constituent territory.

1A.An applicant or a representative of the applicant may apply to the competent authority which granted an authorisation to amend that authorisation.]

2.The application shall include the following:

(a)a list of intended uses [F32and the competent authorities to whom] the applicant has made or intends to make an application;

F33(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)where relevant, a copy of any authorisations already granted for that plant protection product [F34by a competent authority];

(d)where relevant, a copy of any conclusion of the [F35competent authority] assessing equivalence as referred to in Article 38(2).

3.The application shall be accompanied by the following:

(a)for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product;

(b)for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist;

(c)for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals;

(d)the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation;

(e)where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information;

(f)where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1);

(g)a draft label.

4.When submitting the application, the applicant may pursuant to Article 63, request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.

The applicant shall at the same time submit the complete list of studies submitted pursuant to Article 8(2) and a list of test and study reports for which any claims for data protection pursuant to Article 59 are requested.

Upon a request for access to information the [F36competent authority] examining the application [F37(see Article 35)] shall decide what information is to be kept confidential.

[F385.Where permitted by the competent authority, the applicant may submit an application in a language other than English.]

6.On request, the applicant shall provide the [F39competent authority] with samples of the plant protection product and analytical standards of its ingredients.

Textual Amendments

Article 34U.K.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 [F40competent authority examining the application] has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article 59, 61 or 62 or that any data protection period has expired [F41, or where paragraph 3 applies].

2.However, applicants to whom paragraph 1 applies shall provide the following information:

(a)all necessary data for the identification of the plant protection product including its complete composition as well as a declaration that [F42, in respect of each constituent territory to which the application relates,] no unacceptable co-formulants are used;

(b)the information needed to identify the active substance, safener or synergist, where they have been approved [F43in respect of each constituent territory to which the application relates], 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 [F44competent authority examining the application], the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data.

[F453.This paragraph applies where another competent authority has the test and study reports concerned.

4.Where paragraph 3 applies—

(a)the competent authority examining the application must request those reports from the competent authority which has those reports, and

(b)the competent authority which has those reports must send them to the competent authority examining the application as soon as reasonably practicable.]

Textual Amendments

[F46Article 35U.K.Competent authority examining the application

1.For the purposes of this Subsection “the competent authority examining the application” is the competent authority which receives the application under Article 33.

2.But a competent authority may examine an application on behalf of one or more of the other competent authorities (and consequently for the purposes of this Subsection is “the competent authority examining the application”) where—

(a)each competent authority receives the same application;

(b)each competent authority agrees which competent authority is to examine the application;

(c)each active substance, safener or synergist in the plant protection product to which the application relates—

(i)is approved in relation to the constituent territory of each competent authority, and the conditions of each approval are compatible with the proposed authorisation, and

(ii)has an equivalent technical specification in relation to each constituent territory, where necessary as determined in accordance with Article 38;

(d)any co-formulant in the plant protection product to which the application relates is not included on the unacceptable co-formulants register in relation to the constituent territory of each competent authority; and

(e)any data requirements specified in regulations made under Article 8(4)(a) and (b), any uniform principles for evaluation and authorisation of plant protection products prescribed in regulations made under Article 29(6)(a) and any guidance relating to those requirements or principles are the same in relation to the constituent territory of each competent authority.

3.Where paragraph 2 applies in relation to an application—

(a)the competent authority examining the application must inform the applicant that it is to examine the application;

(b)the other competent authorities must —

(i)not proceed to determine the application pending assessment by the competent authority examining the application;

(ii)at the request of the competent authority examining the application, cooperate to ensure a fair division of the workload.]

Textual Amendments

Article 36U.K.Examination for authorisation

1.The [F47competent authority] examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of application. [F48Where Article 35(2) applies in relation to an application, the competent authority examining the application must give the other competent authorities] the opportunity to submit comments to be considered in the assessment.

It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in [F49Article 29(6)(a)], to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 F50... , where used in accordance with Article 55, and under realistic conditions of use.

[F51Where Article 35(2) applies in relation to an application, the competent authority examining the application must make available its assessment to the other competent authorities.]

2.[F52Where Article 35(2) applies in relation to an application, the competent authorities which received that application] shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the [F53competent authority] examining the application as provided for in Articles 31 and 32.

3.By way of derogation from paragraph 2 and subject to [F54retained EU] law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use.

Where the concerns of a [F55competent authority] relating to human or animal health or the environment cannot be controlled by the establishment of the F56... risk mitigation measures referred to in the first subparagraph, [F57that competent authority] may refuse authorisation of the plant protection product in its [F58constituent] territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment.

That [F59competent authority] shall immediately inform the applicant and the [F60other competent authorities] of its decision and provide a technical or scientific justification therefor.

F61...

Textual Amendments

Article 37U.K.Period for examination

1.The [F62competent authority] examining the application shall decide within 12 months of receiving it whether the requirements for authorisation are met.

Where the [F62competent authority] needs additional information, it shall set a period for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the [F62competent authority]. That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the [F62competent authority]. Where at the end of that period the applicant has not submitted the missing elements, the [F62competent authority] shall inform the applicant that the application is inadmissible.

2.The time limits provided for in paragraph 1 shall be suspended during the application of the procedure set out in Article 38.

3.For an application for authorisation of a plant protection product containing an active substance not yet approved, the [F63competent authority] examining the application shall start the evaluation as soon as [F64the draft assessment report for that active substance is circulated in accordance with Article 12(1)(a)]. In case the application concerns the same plant protection product and the same uses as contained in the dossier referred to in Article 8, the [F63competent authority] shall decide on the application at the latest within six months of the active substance being approved.

[F653A.Where Article 35(2) applies in relation to an application, the requirement in paragraph 3 to decide on the application within 6 months of the active substance being approved is to be read as a requirement to decide on the application within 6 months of the earliest date on which the active substance is approved by one of the competent authorities which received the application for authorisation.]

4.[F66Where Article 35(2) applies in relation to an application, the competent authorities which received the application for authorisation] shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the [F67competent authority] examining the application decide on the application as referred to in Article 36(2) and (3).

Textual Amendments

[F68Article 38U.K.Assessment of equivalence under Article 29(1)(b)

1.This Article applies where it is necessary in relation to an application to establish for an active substance, safener or synergist whether a different source or, for the same source a change of the manufacturing process or location complies with Article 29(1)(b).

1A.Where this Article applies, equivalence—

(a)may be assessed by a competent authority examining the application, where—

(i)each of the other competent authorities examining the application consents to that competent authority assessing equivalence, and

(ii)in relation to the active substance, safener or synergist for which equivalence is to be assessed, any data requirements specified in regulations made under Article 8(4)(a) and (b), any uniform principles for evaluation and authorisation of plant protection products prescribed in regulations made under Article 29(6)(a) and any guidance issued under Article 77 relating to those requirements or principles are the same in relation to the constituent territory of each competent authority examining the application;

(b)otherwise, must be assessed by each competent authority examining the application.

1B.The applicant must submit all necessary data to each competent authority assessing equivalence.

2.A competent authority assessing equivalence must—

(a)give the applicant the opportunity to submit comments,

(b)prepare a report on the competent authority's conclusion on equivalence within 60 days from receiving the application, and

(c)provide a copy of that report to—

(i)the applicant, and

(ii)where the assessment is undertaken in accordance with paragraph 1A(a), the other competent authorities examining the application.

3.Where an assessment is undertaken in accordance with paragraph 1A(a), a competent authority examining the application which does not agree with the conclusion in the report provided in accordance with paragraph 2(c)(ii) must notify the competent authority which assessed equivalence, the other competent authorities examining the application and the applicant, stating its reasons for not agreeing.

3A.Following a notification under paragraph 3, the competent authorities concerned must—

(a)give the applicant the opportunity to submit comments, and

(b)try to reach agreement on whether Article 29(1)(b) is complied with.

4.Article 29(1)(b) is deemed not to be complied with where the competent authorities concerned under paragraph 3A do not reach agreement within 45 days of the latest date on which a notification from a competent authority is communicated in accordance with paragraph 3.]

Textual Amendments

Article 39U.K.Reporting and exchange of information on applications for authorisation

1.[F69A competent authority] shall compile a file on each application [F70it receives]. Each file shall contain the following:

(a)a copy of the application;

(b)a report containing information on the evaluation of and decision on the plant protection product; F71...

(c)a record of the administrative decisions taken by the [F72competent authority] 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, [F73a competent authority] shall, without delay, make available to the other [F74competent authorities] a file containing the documentation provided for in points (a) to (d) of paragraph 1.

3.On request, applicants shall provide a copy of the documentation to be submitted with an application pursuant to Article 33(3) and Article 34 to [F75the competent authorities].

F764.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Subsection 3U.K. [F1Ongoing applications for] mutual recognition of authorisations

F77Article 40U.K.Mutual recognition

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F78Article 40AU.K. Application and interpretation

1.This Subsection applies where—

(a)before IP completion day the holder of an authorisation of a plant protection product granted by a member State or EEA state in accordance with Article 29 as it had effect immediately before IP completion day had applied for—

(i)authorisation of the same product in the United Kingdom in accordance with Article 40 as it had effect immediately before IP completion day, or

(ii)authorisation of the same product for minor uses in accordance with Articles 40 and 51(7) as those Articles had effect immediately before IP completion day, and

(b)immediately before IP completion day that application had not been determined.

2.In this Subsection—

(a)a reference to an Article as it had effect immediately before IP completion day in relation to an EEA state is a reference to that Article as adapted by the EEA Agreement as it had effect immediately before IP completion day;

(b)“reference state” means the member State or EEA state referred to in paragraph 1(a).]

Textual Amendments

Article 41U.K.Authorisation

1.The [F79competent authority] to which an application under Article 40 [F80as it had effect immediately before IP completion day] is submitted shall, having examined the application and the accompanying documents referred to in Article 42(1), as appropriate with regard to the circumstances in its territory, authorise the plant protection product concerned under the same conditions as the [F81reference state], except where Article 36(3) applies.

[F821A.But where the application was for authorisation of minor uses in accordance with Article 51(7) as it had effect immediately before IP completion day, the competent authority must authorise such uses, except where—

(a)Article 36(3) applies, or

(b)the competent authority considers that those uses are not minor.]

2.By way of derogation from [F83paragraphs 1 and 1A, the competent authority] may authorise the plant protection product where:

(a)an authorisation under point (b) of Article 40(1) [F84as it had effect immediately before IP completion day] was applied for;

(b)it contains a candidate of substitution; [F85or]

(c)Article 30 has been applied; or

F86(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 42U.K.Procedure

1.The application shall be accompanied by the following:

(a)a copy of the authorisation granted by the reference [F87state] as well as a translation of the authorisation into [F88English or another language permitted by the competent authority];

(b)a formal statement that the plant protection product is identical to that authorised by the reference [F89state];

(c)a complete or summary dossier as required in Article 33(3) [F90as it had effect immediately before IP completion day, when requested by the competent authority];

(d)an assessment report of the reference [F91state] containing information on the evaluation and decision on the plant protection product.

2.The [F92competent authority] to which [F93the application] is submitted shall decide on the application within 120 days.

[F943.Where permitted by the competent authority, the applicant may submit an application in a language other than English.]

Textual Amendments

[F2Subsection 3AU.K.Mutual recognition of authorisations within Great Britain

Article 42AU.K. Mutual recognition

1.This Subsection applies where a plant protection product has been authorised by a competent authority in accordance with Article 29 (the “reference competent authority”).

2.The following persons may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices within the constituent territory of another competent authority—

(a)the holder of the authorisation granted by the reference competent authority;

(b)an official or scientific body involved in agricultural activities or a professional agricultural organisation—

(i)with the consent of the authorisation holder, or

(ii)where consent is refused, with the consent of the competent authority to which the application is made on the grounds of public interest.

3.An applicant under paragraph 2(b) must demonstrate that the use of such a plant protection product is of general interest within the constituent territory of the competent authority.

4.An application may not be made under paragraph 2 where—

(a)the plant protection product contains an active substance, safener, synergist, low-risk active substance, basic substance or candidate for substitution which is not approved in relation to the constituent territory of the other competent authority;

(b)the plant protection product contains an active substance, safener, synergist, low-risk active substance, basic substance or candidate for substitution which is approved in relation to the constituent territory of the other competent authority, but—

(i)the conditions of that approval are incompatible with the product to which the application relates, or

(ii)the technical specification relating to that approval is not equivalent to the technical specification of the approval of the same substance, safener, synergist or candidate in relation to the constituent territory of the reference competent authority, where necessary as determined in accordance with Article 38;

(b)the plant protection product contains a co-formulant which is entered on the unacceptable co-formulants register in relation to the constituent territory of the other competent authority; or

(c)the relevant data requirements specified in regulations made under Article 8(4)(a) and (b), the relevant uniform principles for evaluation and authorisation of plant protection products prescribed in regulations made under Article 29(6)(a) or any guidance issued under Article 77 relating to those requirements or principles are not the same in relation to the constituent territory of each competent authority.

Article 42BU.K. Authorisation

1.The competent authority to which an application under Article 42A(2) is submitted, having examined the application and the accompanying documents referred to in Article 42C(1), and as appropriate with regards to the circumstances in its constituent territory, must authorise the plant protection product concerned under the same conditions as the reference competent authority, except in accordance with paragraph 2 or 3.

2.The competent authority may authorise the plant protection product where it contains a candidate for substitution or a substance approved in accordance with Article 4(7).

3.Paragraphs 1 and 2 do not apply where Article 36(3) applies.

Article 42CU.K. Procedure

1.An application under Article 42A must be accompanied by the following—

(a)a copy of the authorisation granted by the reference competent authority;

(b)a formal statement that the plant protection product is identical to that authorised by the reference competent authority;

(c)a complete or summary dossier as required in Article 33(3) when requested by the competent authority;

(d)an assessment report of the reference competent authority containing information on the evaluation and decision on the plant protection product.

2.The competent authority to which an application under Article 42A is submitted must decide on the application within 120 days.]

Subsection 4U.K.Renewal, withdrawal and amendment

Article 43U.K.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 [F95in relation to a constituent territory] of an active substance, safener or synergist contained in the plant protection product [F96authorised in that constituent territory], the applicant shall submit the following information [F97to the competent authority for that constituent territory]:

(a)a copy of the authorisation of the plant protection product;

(b)any new information required as a result of amendments in data requirements or criteria;

(c)evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval;

(d)any information required to demonstrate that the plant protection product meets the requirements set [F98by the competent authority] on the renewal of the approval of the active substance, safener or synergist contained therein;

(e)a report on the monitoring information, where the authorisation was subject to monitoring.

3.[F99(a)][F100The competent authority examining the application] shall check compliance of all plant protection products containing the active substance, safener or synergist concerned with any conditions and restrictions provided for [F101on renewal of the approval of the active substance, safener or synergist].

[F102(b) The competent authority which examined the plant protection product application in accordance with Article 35(2) may coordinate the compliance check and assessment of the information submitted for all competent authorities which receive an application for renewal of authorisation for the same product, provided that the conditions in Article 35(2) apply in relation to the renewal application.]

F1034.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.[F104The competent authority examining the application] shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein.

6.Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the [F105competent authority examining the application] shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.

Textual Amendments

Article 44U.K.Withdrawal or amendment of an authorisation

1.[F106A competent authority] may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.

A [F107competent authority] shall review an authorisation where it concludes that the [F108environmental objectives of a river basin district] may not be achieved.

2.Where a [F109competent authority] intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information.

3.The [F110competent authority] 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 [F111competent authority] withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation [F112and the other competent authorities]. The other [F113competent authorities may] withdraw or amend the authorisation accordingly taking into account [F114conditions in its constituent territory] and risk mitigation measures except for cases where the second [F115or third] subparagraphs of Article 36(3) have been applied. Article 46 shall apply where appropriate.

[F1165.In paragraph 1, “environmental objectives”—

(a)in relation to the Northumbria River Basin District, means the objectives referred to in the WFD Regulations as applied by regulation 5 of the Water Environment (Water Framework Directive) (Northumbria River Basin District) Regulations 2003;

(b)in relation to the Solway Tweed River Basin District, means the objectives as defined in regulation 2 of the Water Environment (Water Framework Directive) (Solway Tweed River Basin District) Regulations 2004;

(c)in relation to any other river basin district, within the meaning of the WFD Regulations, has the same meaning as in those regulations;

(d)in relation to a river basin district in Scotland, means the objectives set under section 9(1)(a)(i) of the Water Environment and Water Services (Scotland) Act 2003.

6.In paragraph 4, the “conditions” in the constituent territory of a competent authority include—

(a)any data requirements specified in regulations made under Article 8(4)(a) or (b) in relation to that constituent territory;

(b)any uniform principles prescribed by regulations made under Article 29(6)(a) in relation to that constituent territory;

(c)any guidance issued under Article 77 in relation to that constituent territory.

7.In this Article—

(a)“river basin district” means any of the following—

(i)the Northumbria River Basin District;

(ii)the Solway Tweed River Basin District;

(iii)a river basin district within the meaning of the WFD Regulations;

(iv)in relation to Scotland, an area designated as a river basin district by order under section 4(1) of the Water Environment and Water Services (Scotland) Act 2003;

(b)“the WFD Regulations” means the Water Environment (Water Framework Directive) (England and Wales) Regulations 2017.]

Textual Amendments

Article 45U.K.Withdrawal or amendment of an authorisation at the request of the authorisation holder

1.An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request.

2.Amendments may only be granted where it is established that the requirements referred to in Article 29 continue to be met.

3.Article 46 shall apply where appropriate.

Article 46U.K.Grace period

Where a [F117competent authority] withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.

Where the reasons for withdrawal, amendment or non-renewal of the authorisation are not related to the protection of human and animal health or the environment, the grace period shall be limited and shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned.

Textual Amendments

Subsection 5U.K.Special cases

Article 47U.K.Placing on the market of low-risk plant protection products

1.Where all the active substances contained in a plant protection product are low-risk active substances as referred to in Article 22, that product shall be authorised as a low-risk plant protection product provided no specific risk mitigation measures are needed following a risk assessment. This plant protection product shall also meet the following requirements:

(a)the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II [F118in relation to the constituent territory of application];

(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 be controlled;

(e)it complies with points (b), (c) and (f) to (i) of Article 29(1).

These products are referred to as ‘low-risk plant protection products’.

2.An applicant for authorisation of a low-risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall submit with the application a complete and a summary dossier for each point of the data requirements of the active substance and the plant protection product.

3.[F119A competent authority] shall decide within 120 days whether to approve an application for authorisation of a low-risk plant protection product.

Where the [F120competent authority] 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 [F120competent authority].

The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the [F120competent authority]. Where at the end of that period the applicant has not submitted the missing elements, the [F120competent authority] shall inform the applicant that the application is inadmissible.

4.Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

Textual Amendments

Article 48U.K.Placing on the market and use of plant protection products containing a genetically modified organism

1.A plant protection product which contains [F121a genetically modified organism] shall be examined in respect of the genetic modification in accordance with [F122the examination legislation], in addition to the assessment under this Chapter.

An authorisation under this Regulation shall not be granted for such a plant protection product unless written consent [F123to market the genetically modified organism under section 111(1) of the Environmental Protection Act 1990] has been granted for it.

2.Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

[F1243.In paragraph 1, “the examination legislation” means—

(a)in relation to England, regulation 23(1)(c) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002;

(b)in relation to Wales, regulation 24(1)(c) of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

(c)in relation to Scotland, regulation 23(1)(c) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002.]

Textual Amendments

Article 49U.K.Placing on the market of treated seeds

1.[F125A competent authority] shall not prohibit placing on the market and use of seeds treated with plant protection products authorised for that use [F126by at least one competent authority].

[F1272.The appropriate authority may, by regulations, implement measures to restrict or prohibit the use or sale of treated seeds as referred to in paragraph 1 where the appropriate authority has substantial concerns that—

(a)the treated seeds are likely to constitute a serious risk to human or animal health or to the environment, and

(b)such risk cannot be contained satisfactorily by measures taken by the competent authorities concerned.

2A.Before making regulations in accordance with paragraph 2, the appropriate authority may obtain independent scientific advice where the appropriate authority considers it appropriate to do so.]

F1283.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.Without prejudice to other [F129retained EU law] concerning the labelling of seeds, the label and documents accompanying the treated seeds shall include the name of the plant protection product with which the seeds were treated, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in [F130Regulation (EC) No 1272/2008 of the European Parliament and of the Council] and risk mitigation measures set out in the authorisation for that product where appropriate.

Textual Amendments

Article 50U.K.Comparative assessment of plant protection products containing candidates for substitution

1.A comparative assessment shall be performed by [F131a competent authority] when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution [F132in relation to its constituent territory]. [F133A competent authority] shall not authorise or shall restrict the use of a plant protection product containing a candidate for substitution for use on a particular crop where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that:

(a)for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment;

(b)the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages;

(c)the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism; and

(d)the consequences on minor use authorisations are taken into account.

2.By way of derogation from Article 36(2) [F134a competent authority] 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 or a low-risk active substance, if a non-chemical control or prevention method exists for the same use and it is in general use in [F135Great Britain].

3.By way of derogation from paragraph 1, a plant protection product containing a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using that product in practice.

Such authorisations shall be granted once for a period not exceeding five years.

4.For plant protection products containing a candidate for substitution [F136a competent authority] shall perform the comparative assessment provided for in paragraph 1 regularly and at the latest at renewal or amendment of the authorisation.

Based on the results of that comparative assessment, [F137the competent authority] shall maintain, withdraw or amend the authorisation.

5.Where a [F138competent authority] decides to withdraw or amend an authorisation pursuant to paragraph 4, that withdrawal or amendment shall take effect 3 years after the decision of the [F138competent authority] or at the end of the approval period of the candidate for substitution [F139in relation to its constituent territory] where that period ends earlier.

6.Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

Textual Amendments

Article 51U.K.Extension of authorisations for minor uses

1.The authorisation holder, official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users may ask for the authorisation of a plant protection product already authorised [F140by a competent authority] to be extended to minor uses not yet covered by that authorisation.

2.[F141The competent authority] shall extend the authorisation provided that:

(a)the intended use is minor in nature;

(b)the conditions referred to in points (b), (d) and (e) of Article 4(3) and Article 29(1)(i) are satisfied;

(c)the extension is in the public interest; and

(d)the documentation and information to support the extension of use has been submitted by the persons or bodies referred to in paragraph 1, especially data on the magnitude of residues and where necessary on the risk assessment to the operator, worker and bystander.

3.[F142A competent authority] may take measures to facilitate or encourage the submission 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 F143...

5.When [F144the competent authority grants] an extension of authorisation for a minor use, [F145the competent authority] shall inform if necessary the authorisation holder and request him to change the labelling accordingly.

Where the authorisation holder declines, the [F146competent authority] shall ensure that 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 a reference to the liability of the person using the plant protection product with respect to failures concerning the efficacy or to phytotoxicity of the product for which the minor use was granted. The minor use extension shall be separately identified in the label.

6.Extensions on the basis of this Article shall be separately identified and separate reference shall be made to liability restrictions.

7.The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with [F147Article 42A, except where one or more of the conditions in Article 42A(4) are met]. [F148The competent authority which receives such an application] shall authorise such uses in accordance with the provisions of [F149Article 42B] provided that those uses are also considered minor [F150by that competent authority].

8.[F151Each competent authority] shall establish and regularly update a list of minor uses.

9.By 14 December 2011, the Commission shall present a report to the European Parliament and the Council on the establishment of a European fund for minor uses, accompanied, if appropriate, by a legislative proposal.

10.Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

Textual Amendments

F152Article 52U.K.Parallel trade

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F153Article 52AU.K.Parallel trade

1.This Article applies in respect of a parallel trade permit which—

(a)immediately before IP completion day was a permit of a description referred to in Article 52(4A), and

(b)by virtue of Article 52(6)(b), ceased to be valid on 1st January 2023 (an “original parallel trade permit”).

2.The person to which an original parallel trade permit was issued may submit an application to the competent authority for the reinstatement of that permit as it had effect in relation to a constituent territory immediately before it ceased to be valid.

3.An application for the reinstatement of the original parallel trade permit must be made no later than 1st April 2024.

4.The application must be accompanied by—

(a)a duplicate of the information that was submitted in connection with—

(i)the initial application for the original parallel trade permit, and

(ii)any subsequent application to amend that permit before it ceased to be valid;

(b)where applicable, notification of any changes to the contact details supplied in connection with applications concerning the original parallel trade permit;

(c)as regards the plant protection product authorised in the Member State of origin at the time of application for the original parallel trade permit—

(i)confirmation that the product remains authorised and available for sale in the Member State of origin at the time of application for the reinstatement of the permit,

(ii)confirmation that the label for the product as submitted with the application for the original parallel trade product remains unchanged as regards the identification of the product in the Member State of origin at the time of application for the reinstatement of the permit, and

(iii)photographs of the plant protection product container (including all sides of the container) with visible and readable label, showing the product as it is being marketed in the Member State of origin at the time of application for the reinstatement of the permit;

(d)as regards the label for the plant protection product as it is to be marketed in the constituent territory concerned—

(i)confirmation that the label for the product as submitted with the initial application for the original parallel trade product remains unchanged, or

(ii)notification of any change to the label for the plant protection product, together with the draft label which is to be attached to the product as it is to be marketed in the constituent territory concerned;

(e)a declaration by the applicant that, to the best of that person’s knowledge—

(i)all information supplied in accordance with this paragraph is accurate, as it applies to the manufacture and placing on the market of the plant protection product in respect of which the application for reinstatement of the original parallel trade permit is made, and

(ii)for the purposes of paragraph (i), that the duplicate information supplied in accordance with subparagraph (a) continues to apply in respect of that product, subject to any changes required to be notified in accordance with this paragraph.

5.At any time after receiving an application and before determining it the competent authority may require the applicant to provide it with such further information as it reasonably considers necessary to determine the application.

6.The competent authority must grant the application for the reinstatement of the original parallel trade permit where—

(a)at the time of application for that permit, the authorisation of the reference product granted prior to the application for the original parallel trade permit has not been withdrawn by that authority in relation to the constituent territory concerned;

(b)the authority is satisfied that—

(i)the application complies with the requirements of paragraphs 2 and 3;

(ii)all information and documentation required to accompany the application in accordance with paragraphs 4 and 5 is complete;

(iii)where the applicant has notified a change to the label for the plant protection product in accordance with paragraph 4(d), that change—

(aa)is consistent with the proposition that the product must be placed on the market and used only in accordance with the provisions of the authorisation of the reference product, or

(bb)is a minor change (such as a change of address) that is not material to the identicality of that label with the label for the reference product;

(iv)the declaration made by the applicant in accordance with paragraph 4(e) is valid on the basis of all relevant information available to the authority concerning the plant protection product.

7.Where the reinstatement of a parallel trade permit is granted in accordance with this Article—

(a)the competent authority must issue the parallel trade permit and must specify the date on which the permit has effect, and

(b)the parallel trade permit is valid in relation to a constituent territory until the earlier of—

(i)the date on which the authorisation of the reference product expires in relation to that constituent territory;

(ii)the date two years after the day on which the permit was specified to have effect under this Article.

8.A plant protection product for which a parallel trade permit has been issued in accordance with this Article must be placed on the market and used only in accordance with the provisions of the authorisation of the reference product.

9.The plant protection product for which the parallel trade permit has been issued may be the subject of a grace period granted in accordance with Article 46 as though the permit for the product concerned were an authorisation and, for these purposes, Article 46 applies—

(a)where a parallel trade permit ceases to be valid in accordance with paragraph 7(b), or

(b)where a parallel trade permit is withdrawn under paragraph 10(a).

10.A parallel trade permit that has been issued in accordance with this Article is to be treated as an authorisation for the purposes of Articles 44 and 45 and—

(a)may be withdrawn—

(i)in accordance with either Article, or

(ii)without prejudice to Article 44, where the authorisation of the plant protection product in respect of which the original parallel trade permit was issued is withdrawn in the Member State of origin for safety or efficacy reasons;

(b)may be amended in accordance with either Article, but only to the extent necessary to enable the product to be placed on the market and used in accordance with the provisions of the authorisation of the reference product.

11.The holder of a parallel trade permit must report any available information to the competent authority in accordance with Article 56(4) as though the authority had authorised the plant protection product concerned.

12.Chapters 6 to 10 apply in respect of any plant protection product for which a parallel trade permit has been granted in accordance with this Article, as if references in those Chapters to an authorisation were references to the parallel trade permit.

13.Subject to Chapter 6, each competent authority must take steps to make publicly available information which it holds about parallel trade permits.

14.In this Article—

  • “Member State of origin” means the Member State or EEA state which was the Member State of origin in accordance with paragraph 1 of Article 52 as it had effect immediately before IP completion day, as adapted by the EEA agreement as it had effect immediately before IP completion day;

  • “reference product” means the plant protection product which was already authorised in the United Kingdom prior to the application for the original parallel trade permit, and to which the product to which that permit relates (including that permit in its reinstated form), is identical in composition.]

Textual Amendments

Subsection 6U.K.Derogations

Article 53U.K.Emergency situations in plant protection

1.By way of derogation from Article 28, in special circumstances a [F154competent authority] may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use [F155in its constituent territory], where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means.

The [F156competent authority] concerned shall immediately inform the other [F157competent authorities] of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety.

F1582.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1583.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.[F159Paragraph 1] shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with [F160section 111(1) of the Environmental Protection Act 1990].

Textual Amendments

Article 54U.K.Research and development

1.By way of derogation from Article 28, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product or involving unauthorised use of a plant protection product may be carried out if the [F161competent authority] in whose [F162constituent] territory the experiment or test is to be carried out has assessed the available data and granted a permit for trial purposes. The permit may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005 [F163in relation to that constituent territory].

The [F161competent authority] 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 [F164competent authority] in whose [F165constituent] territory the experiment or test is to be conducted, together with a dossier containing all the available data to permit an assessment of possible effects on human or animal health or the possible impact on the environment.

3.A permit for trial purposes shall not be granted for experiments or tests involving the release into the environment of a genetically modified organism unless such release has been accepted under [F166section 111(1) of the Environmental Protection Act 1990].

4.Paragraph 2 shall not apply if the [F167competent authority] has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken.

F1685.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Textual Amendments

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