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Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilShow full title

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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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 [F1in 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.[F2A competent authority] shall decide within 120 days whether to approve an application for authorisation of a low-risk plant protection product.

Where the [F3competent 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 [F3competent 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 [F3competent authority]. Where at the end of that period the applicant has not submitted the missing elements, the [F3competent 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 [F4a genetically modified organism] shall be examined in respect of the genetic modification in accordance with [F5the 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 [F6to 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.

[F73.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.[F8A competent authority] shall not prohibit placing on the market and use of seeds treated with plant protection products authorised for that use [F9by at least one competent authority].

[F102.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.]

F113.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.Without prejudice to other [F12retained 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 [F13Regulation (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 [F14a competent authority] when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution [F15in relation to its constituent territory]. [F16A 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) [F17a 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 [F18Great 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 [F19a 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, [F20the competent authority] shall maintain, withdraw or amend the authorisation.

5.Where a [F21competent 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 [F21competent authority] or at the end of the approval period of the candidate for substitution [F22in 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 [F23by a competent authority] to be extended to minor uses not yet covered by that authorisation.

2.[F24The 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.[F25A 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 F26...

5.When [F27the competent authority grants] an extension of authorisation for a minor use, [F28the competent authority] shall inform if necessary the authorisation holder and request him to change the labelling accordingly.

Where the authorisation holder declines, the [F29competent 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 [F30Article 42A, except where one or more of the conditions in Article 42A(4) are met]. [F31The competent authority which receives such an application] shall authorise such uses in accordance with the provisions of [F32Article 42B] provided that those uses are also considered minor [F33by that competent authority].

8.[F34Each 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

F35Article 52U.K.Parallel trade

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Textual Amendments

[F36Article 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

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