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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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Changes over time for: Subsection 5

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Version Superseded: 31/12/2023

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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.]

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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

Article 52U.K.Parallel trade

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[F364A.This Article applies to a parallel trade permit issued before IP completion day by the United Kingdom as the Member State of introduction in accordance with this Article as it had effect immediately before IP completion day, where immediately before IP completion day the validity of that permit had not expired.]

5.A plant protection product for which a parallel trade permit has been issued shall be placed on the market and used only in accordance with the provisions of the authorisation of the reference product. To facilitate monitoring and controls [F37the appropriate authority may] set out specific control requirements for the product to be introduced in [F38regulations] referred to in [F39Article 68(3)].

[F406.The parallel trade permit is valid in relation to a constituent territory until the earlier of—

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

(b) the date two years after the day after the day on which IP completion day falls.

6A.Paragraph 6B applies to a parallel trade permit where—

(a)the authorisation holder of the reference product for that permit applies for a withdrawal of authorisation in accordance with Article 45(1), and

(b)the requirements of Article 29 are still fulfilled in respect of the product to which that permit relates.

6B.Where this paragraph applies, the date of expiry of the reference product for the purposes of paragraph 6(a) is deemed to be the date on which the authorisation of the reference product would have expired if the application under Article 45(1) had not been made.

6C.In paragraphs 4 to 6B, “reference product” means the plant protection product which was already authorised in the United Kingdom prior to the application for the parallel trade permit under paragraph 1 of this Article as it had effect immediately before IP completion day, and to which the product to which that permit relates is identical in composition.]

7.Without prejudice to specific provisions of this Article, Articles 44, 45, 46, and 55 and Article 56(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly.

8.Without prejudice to Article 44, a parallel trade permit may be withdrawn if the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy reasons.

[F418A.In paragraph 8, “Member State of origin” means the member State or EEA state which was the Member State of origin in accordance with paragraph 1 of this Article as it had effect immediately before IP completion day, as adapted by the EEA agreement as it had effect immediately before IP completion day.]

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11.Without prejudice to Article 63, [F43competent] authorities shall make publicly available information about parallel trade permits.

Textual Amendments

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