CHAPTER IIPROCEDURE FOR APPLICATIONS FOR MRLS

SECTION 1Submission of applications for MRLs

Article 6Applications

F11.

Where a competent authority envisages granting an authorisation for the use of a plant protection product in accordance with Regulation (EC) No 1107/2009, the competent authority must consider whether, in relation to its constituent territory—

(a)

as a result of such use an MRL listed in Part 2 or 3 of the MRLs register needs to be modified;

(b)

as a result of such use it is necessary to set a new MRL;

(c)

the active substance contained in the plant protection product does not require the setting of an MRL and therefore should be listed in Part 4 of the MRLs register.

(1A.

The competent authority referred to in paragraph 1 may require the person requesting the grant of that authorisation for the plant protection product to submit an application in accordance with Article 7.

2.

All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers, importers and producers of products F2listed in Part 1 of the MRLs register in relation to a constituent territory may also submit an application to F3the competent authority for that constituent territory in accordance with Article 7.

3.

Where a F4competent authority considers that the setting, modification or deletion of an MRL is necessary, that F4competent authority may also compile and evaluate an application F5... in accordance with Article 7.

4.

Applications for import tolerances shall be submitted to F6any competent authority. Such applications shall be made in accordance with Article 7 of this Regulation.

Article 7Requirements relating to applications for MRLs

1.

The applicant shall include in an application for an MRL the following particulars and documents:

(a)

the name and address of the applicant;

(b)

a presentation of the application dossier including:

  1. (i)

    a summary of the application;

  2. (ii)

    the main substantive arguments;

  3. (iii)

    an index of the documentation;

  4. (iv)

    a copy of the relevant GAP applying to the specific use of that active substance;

(c)

a comprehensive overview of relevant concerns raised in the available scientific literature about the plant protection product and/or its residue;

(d)

the data F7required under Article 8(4) of Regulation (EC) No 1107/2009 relating to data requirements for the setting of MRLs for pesticides F8in relation to the constituent territory to which the application relates including, where appropriate, toxicological data and data on routine analytical methods for use in control laboratories, as well as plant and animal metabolism data.

However, where relevant data are already publicly available, in particular when an active substance has already been evaluated under F9Regulation (EC) No 1107/2009 in relation to that constituent territory or when a CXL exists and such data are submitted by the applicant, a F10competent authority may also use such information in evaluating an application. In such cases, the evaluation report shall include a justification for using or not using such data.

2.

The evaluating F11competent authority may, where appropriate, request the applicant to provide supplementary information in addition to information required under paragraph 1 within a time limit specified by the F11competent authority. In no event may this period exceed two years.

Article 8Evaluation of applications

1.

A F12competent authority to which an application complying with Article 7 is submitted pursuant to Article 6 shall immediately F13notify the other competent authorities and draw up an evaluation report without undue delay.

F14(1A.

A competent authority notified in accordance with paragraph 1 may request from the notifying competent authority a copy of the application received, and where such a request is received the notifying competent authority must provide a copy as soon as reasonably practicable.

F152.

Applications must be evaluated in accordance with—

(a)

principles set by regulations made under paragraph 2A in relation to the constituent territory, or

(b)

where there are no such regulations, the uniform principles for the evaluation and authorisation of plant protection products prescribed in accordance with Article 29(6) of Regulation (EC) No 1107/2009 in relation to the constituent territory.

(2A.

The appropriate authority may, by regulations, set evaluation principles for applications for MRLs.

(2B.

In paragraph 2A, “the appropriate authority” means—

(a)

for regulations applying in relation to England, the Secretary of State;

(b)

for regulations applying in relation to Wales, the Welsh Ministers;

(c)

for regulations applying in relation to Scotland, the Scottish Ministers.

(2C.

But the appropriate authority is the Secretary of State if consent is given by—

(a)

for regulations applying in relation to Wales, the Welsh Ministers;

(b)

for regulations applying in relation to Scotland, the Scottish Ministers.

3.

A competent authority may, by agreement, transfer the evaluation of an application to another competent authority, provided the relevant principles referred to in paragraph 2 are the same in relation to the constituent territory of each of those competent authorities.

(3A.

A transfer in accordance with paragraph 3 does not affect anything done by a competent authority prior to transfer.

F164.

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F17Article 8AThe competent authority's opinion on applications concerning MRLs

1.

An evaluation report under Article 8 must include the competent authority's reasoned opinion on, in particular, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL.

2.

The reasoned opinion must include—

(a)

an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes;

(b)

the anticipated LOD for the pesticide/product combination;

(c)

an assessment of the risks of the acceptable daily intake or acute reference dose being exceeded as a result of the modification of the MRL;

(d)

the contribution to the acceptable daily intake due to the residues in the product for which the MRL was requested;

(e)

any other element relevant to the risk assessment.

3.

The reasoned opinion must clearly define the basis for each conclusion reached.

4.

The competent authority may request supplementary information from the applicant where necessary for the giving of a reasoned opinion.

F18Article 9Notification of evaluated applications

1.

After completion of the evaluation report under Article 8 the competent authority must without delay—

(a)

forward the application, evaluation report and supporting dossier to the other competent authorities;

(b)

forward a copy of its reasoned opinion to the applicant;

(c)

make a copy of the reasoned opinion public, subject to paragraphs 2 and 3.

2.

The duty in paragraph 1(c) does not apply to third party confidential information received by the competent authority for which confidential treatment has been requested and justified.

3.

Paragraph 2 does not apply to—

(a)

information which must be made public in order to protect public health;

(b)

the conclusions of the reasoned opinion relating to foreseeable health effects.