Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances Text with EEA relevance

Article 1

Scope

This Regulation lays down the procedure for the renewal of the inclusion in Annex I to Directive 91/414/EEC of the active substances listed in Annex I to this Regulation.

Article 2

Definitions

For the purposes of this Regulation the following definitions shall apply:

(a) ‘producer’ means the person who manufactures the active substance on his own or who contracts out the manufacturing to another party or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation;

(b) ‘applicant’ means a producer who applies for the renewal of the inclusion of an active substance referred to in column A of Annex I;

(c) ‘rapporteur Member State’ means the Member State which evaluates an active substance, as listed in column B of Annex I for the respective active substance;

(d) ‘co-rapporteur Member State’ means a Member State which cooperates in the evaluation carried out by the rapporteur Member State, as listed in column C of Annex I for the respective active substance;

(e) ‘inclusion’ means inclusion of an active substance in Annex I to Directive 91/414/EEC;

(f) ‘renewal’ means renewal of the inclusion of an active substance in Annex I to Directive 91/414/EEC.

Article 3

Coordinating authority of the Member State

Each Member State shall appoint an authority, hereinafter ‘the coordinating authority’, which coordinates and ensures contacts with applicants, other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, in accordance with this Regulation. Each Member State shall communicate the name and the contact details of its coordinating authority and any modifications to the Commission.

The Commission shall publish a list including the names and the contact details of the coordinating authorities of the Member States. It shall keep that list updated according to the modifications communicated to it.

Article 4

Submission of application

At the same time, the applicant shall submit any data protection claims pursuant to Article 13 of Directive 91/414/EEC.

Article 5

Format and content of application

Hereinafter, that part of the application is referred to as ‘the updating statement’.

The updating statement shall separately list new studies the applicant intends to submit on vertebrate animals.

Article 6

Checking of application

Where, at the end of the period set for rendering the application compliant, the rapporteur Member States considers that the application still does not fulfil the requirements of Articles 4 and 5, it shall, stating its reasons, immediately so inform the applicant, the Commission and the Authority.

Upon receiving the communication from the rapporteur Member State, the Commission shall, taking into account the view of the rapporteur Member State, decide whether the application fulfils the requirements of Articles 4 and 5 and inform the rapporteur Member State, the other Member States and the Authority of its decision. The rapporteur Member State shall immediately inform the applicant of that decision.

Article 7

Pre-submission contacts

Where an application fulfils the requirements of Articles 4 and 5, the applicant may request a meeting with the rapporteur Member State and the co-rapporteur Member State to discuss the updating statement. If requested, such pre-submission contacts shall take place prior to the submission of supplementary dossiers, as provided for in Article 9.

Article 8

Access to the application

Upon request from any interested party, the rapporteur Member State shall make available the application, excluding any information for which confidential treatment has been requested and is justified pursuant to Article 14 of Directive 91/414/EEC.

Article 9

Submission of supplementary dossiers

Article 10

Contents of supplementary dossiers

The supplementary summary dossier shall include the following:

(a) a copy of the application, where the applicant is joined by another applicant the name and address of that applicant and of the joint representative, provided for in Article 4(4), where the applicant is replaced by another applicant the name and address of that applicant;

(b) information with respect to one or more representative uses on a widely grown crop of at least one plant protection product containing the active substance, demonstrating that the inclusion requirements provided for in Article 5(1) and (2) of Directive 91/414/EEC are fulfilled; where the information submitted does not concern a widely grown crop, a justification shall be submitted;

(c) data and risk assessments which were not part of the original dossiers and which are necessary to reflect changes: (i) in requirements under Annexes II and III to Directive 91/414/EEC; (ii) in scientific and technical knowledge since the first inclusion of the active substance concerned; or (iii) to representative uses;

(d) for each point of the requirements for the active substance, as set out in Annex II to Directive 91/414/EEC, for which new data are necessary within the meaning of point (c), the summaries and results of tests and studies, the name of their owner and of the person or institute having carried these out and the reason why each test or study is necessary either in the light of current scientific and technical knowledge or with a view to an amended renewal;

(e) for each point of the requirements for the plant protection product, as set out in Annex III to Directive 91/414/EEC, for which new data are necessary within the meaning of point (c), the summaries and results of tests and studies, the name of their owner and of the person or institute having carried out the tests and studies, for one or more plant protection products which are representative of the supported uses, and the reason why each test or study is necessary either in the light of current scientific and technical knowledge or with a view to an amended renewal of the active substance;

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

(g) where relevant, a copy of an application for maximum residue levels as referred to in Article 7 of Regulation (EC) No 396/2005 of the European Parliament and of the Council (³);

(h) an assessment of all information submitted;

(i) a checklist demonstrating that the supplementary dossiers referred to in paragraph 3 are complete, indicating which data are new.

Article 11

Checking of supplementary dossiers

The rapporteur Member State shall then start assessing the active substance.

Where, at the end of the period set for rendering the supplementary dossiers compliant, the dossiers contain all the elements provided for in Article 10(1) and 10(3), paragraph 2 shall apply.

Where, at the end of the period set for rendering the supplementary dossiers compliant, the dossiers still do not contain all the elements provided for in Article 10(1) and 10(3), the rapporteur Member State shall immediately inform the applicant, the Commission and the Authority that the application is rejected, explaining the reasons for its decision.

Article 12

Withdrawal and replacement of the applicant

Article 13

Submission of information by third parties

Any person or Member State wishing to submit information which might contribute to the assessment, in particular with regard to the potentially dangerous effects of the active substance or its residues on human and animal health and on the environment, shall do so to the rapporteur Member State by the date set out for the respective active substance in column D of Annex I.

The rapporteur Member State shall, without delay, communicate any information received to the co-rapporteur Member State, the Authority, and the applicant. The applicant may send its comments on the submitted information to the rapporteur Member State and the other parties concerned at the latest by 2 months after receipt.

Article 14

Assessment by the rapporteur Member State and the co-rapporteur Member State

The renewal assessment report shall also include the following:

(a) a recommendation with regard to the renewal of the inclusion;

(b) where relevant, a suggestion for maximum residue levels to be set;

(c) a conclusion on which of the new studies included in the supplementary dossiers are relevant for the assessment;

(d) a recommendation as to the parts of the report on which a consultation of experts is to be organised in accordance with Article 16(2);

(e) the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State, where relevant.

In addition, the rapporteur Member State shall request the applicant to submit the supplementary complete dossier to the Authority, to the other Member States and, on request, to the Commission.

Article 15

Comments upon the renewal assessment report and access to that report and to the supplementary summary dossiers

Article 16

Evaluation of the renewal assessment report

The Authority shall deliver its conclusion at the latest 6 months after receipt of the request.

Where paragraph 3 applies, that period shall be extended by the periods referred to in the first and the second subparagraph of that paragraph.

The rapporteur Member State shall, within 2 months of receipt, evaluate the information received and send its evaluation to the Authority.

Article 17

Review report and presentation of draft acts

The applicant shall be given the possibility to submit comments on the draft review report within a period set by the Commission.

The Commission shall present to the Committee referred to in Article 19(1) of Directive 91/414/EEC the draft review report within 6 months of receipt of the comments referred to in Article 15(1) or, where the Commission has consulted it in accordance with Article 16(2), of receipt of the conclusion of the Authority.

On the basis of the review report and taking into account any comments submitted by the applicant within the period set by the Commission pursuant to the second subparagraph of paragraph 1, the Commission shall submit to the Committee:

(a) a draft act renewing the inclusion of the active substance concerned in Annex I to Directive 91/414/EEC, setting out, where appropriate, the conditions and restrictions, including the period for such inclusion; or

(b) a draft act removing the active substance from Annex I to Directive 91/414/EEC and providing for its non-inclusion and the withdrawal of the authorisations of plant-protection products containing that active substance.

Article 18

Access to review report

The Commission shall make the review report available to the public, with the exception of parts of it for which confidential treatment has been requested and is justified pursuant to Article 14 of Directive 91/414/EEC.

Article 19

Fees and charges

Member States shall ensure that the fees or charges referred to in paragraph 1:

(a) are established in a transparent manner; and

(b) correspond to the actual total cost of the work involved except if it is in public interest to lower the fees or charges.

The fees or charges may include a scale of fixed charges based on average costs for the work referred to in paragraph 1.

Article 20

Other charges, levies or fees

Article 19 is without prejudice to Member States’ rights to maintain or introduce, in accordance with the Treaty, charges, levies or fees with regard to the authorisation, placing on the market, use and control of active substances and plant protection products other than the fee provided for in Article 19.

Article 21

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Column A		Column B	Column C	Column D
Substance	New RMS	Co-RMS	Deadline for submission of dossier
2,4-D	2012	EL	PL	29 February 2012
Amitrole	2011	FR	HU	29 February 2012
Esfenvalerate	2011	UK	PT	29 February 2012
Flumioxazine	2012	CZ	FR	29 February 2012
Lambda-Cyhalothrin	2011	SE	ES	29 February 2012
Acibenzolar-s-methyl	2011	FR	ES	29 February 2012
Bentazone	2011	NL	DE	29 February 2012
Cyclanilide	2011	AT	EL	29 February 2012
Fenhexamid	2011	UK	IT	29 February 2012
Ferric phosphate	2011	DE	PL	29 February 2012
Pymetrozine	2011	DE	BE	29 February 2012
Flupyrsulfuron-methyl	2011	FR	DK	31 May 2012
Diquat	2011	UK	SE	31 May 2012
Glyphosate	2012	DE	SK	31 May 2012
Iprovalicarb	2012	IE	IT	31 May 2012
Paecylomyces fumosoroseus	2011	BE	NL	31 May 2012
Thiabendazole	2011	ES	NL	31 May 2012
Pyridate	2011	AT	LV	31 May 2012
Sulfosulfuron	2012	SE	IE	31 May 2012
Pyraflufen-ethyl	2011	NL	LT	31 May 2012
Prosulfuron	2012	FR	SK	31 May 2012
Thifensulfuron-methyl	2012	UK	AT	31 August 2012
Cinidon-ethyl	2012	HU	UK	31 August 2012
Cyhalofop butyl	2012	IT	AT	31 August 2012
Florasulam	2012	PL	BE	31 August 2012
Metalaxyl-M	2012	BE	EL	31 August 2012
Picolinafen	2012	DE	LV	31 August 2012
Isoproturon	2012	DE	CZ	31 August 2012
Metsulfuron methyl	2011	SI	SE	31 August 2012
Triasulfuron	2011	FR	DK	31 August 2012
Famoxadone	2012	UK	FI	31 August 2012

ANNEX II

Format for application, as provided for in Article 5(1)

The application shall be in writing, signed by the applicant, and sent by registered mail to the rapporteur Member State listed in column B of Annex I and to the co-rapporteur Member State listed in column C of Annex I.

A copy of the application without the updating statement shall be sent to the European Commission, DG Health and Consumers, unit E3, 1049 Brussels, Belgium and to the Authority, European Food Safety Authority, Largo N. Palli 5/A, 43121 Parma, Italy.

The application shall be submitted in accordance with the following model.

MODEL

1.1.Name and address of the applicant including the name of the natural person responsible for the application and further engagements resulting from this Regulation:

1.2.1. (a) Telephone No: (b) Fax No: (c) E-mail address:

1.2.2. (a) Contact: (b) Alternative:

2.1.Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters or amines produced by the manufacturer.

2.2.Chemical name (IUPAC and CAS nomenclature).

2.3.CAS, CIPAC and EEC numbers (if available).

2.4.Empirical and structural formula, molecular mass.

2.5.Specification of purity of the active substance in g/kg which should be whenever possible identical or already accepted as equivalent to the one included in Annex I to Directive 91/414/EEC.

2.6.Classification and labelling of the active substance in accordance with the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (⁴) (health and environment effects).

An updating statement, as provided for in Article 5(2), shall be attached as an Annex to the application.

The applicant confirms that the above information submitted on … (date) is correct.

Signature (of the person competent to act for the applicant referred to under 1.1)