Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (Text with EEA relevance)

CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Scope

This Regulation lays down detailed rules for the submission and evaluation of applications for inclusion in Annex I to Directive 91/414/EEC of active substances which have been evaluated by the Commission within the framework of the review programme provided for in Article 8(2) of that Directive but which, by the dates set out in points (a), (b) and (c), had not been included into Annex I to that Directive:

(a) for first stage substances, by 31 December 2006, or in the case of metalaxyl, by 30 June 2010;

(b) for second stage substances, by 30 September 2007;

(c) for third and fourth stage substances, by 31 December 2009.

Article 2

Definitions

For the purpose of this Regulation, the following definitions shall apply:

(a) ‘applicant’ means the person who manufactures the active substance on his own or who contracts 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) ‘committee’ means the Standing Committee on the Food Chain and Animal Health, referred to in Article 19 of Directive 91/414/EEC;

(c) ‘first stage substances’ means active substances listed in Annex I to Regulation (EEC) No 3600/92;

(d) ‘second stage substances’ means active substances listed in Annex I to Regulation (EC) No 451/2000;

(e) ‘third stage substances’ means active substances listed in Annex I to Regulation (EC) No 1490/2002;

(f) ‘fourth stage substances’ means active substances listed in Annex I to Regulation (EC) No 2229/2004.

CHAPTER II

REGULAR PROCEDURE

Article 3

Application

The applicant shall at the same time submit any claims for data protection pursant to Article 13 of Directive 91/414/EEC.

The applicant shall submit separately the information to be kept confidential.

Article 4

Dossiers

The summary dossier shall include the following:

(a) data with respect to a limited range of representative uses of at least one plant protection product containing the active substance, demonstrating that the requirements of Article 5 of Directive 91/414/EEC are met;

(b) for each point of the data requirements for the active substance referred to in Annex II to Directive 91/414/EEC, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies;

(c) for each point of the data requirements for the plant protection product referred to in Annex III to Directive 91/414/EEC, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies relevant to the assessment of the requirements referred to in Article 5 of that Directive taking into account that data gaps in the Annex II or Annex III dossier, resulting from the proposed limited range of representative uses, may lead to restrictions in the Annex I inclusion;

(d) a checklist demonstrating that the dossier provided for in paragraph 2 is complete;

(e) the reasons why the test and study reports submitted are necessary for first inclusion of the active substance;

(f) an assessment of all information submitted.

Article 5

Completeness check of the dossier

Article 6

Publication of information

For applications for which completeness has been established the Commission shall make public the following information:

(a) the name of the active substance;

(b) the date of application;

(c) the name and address of applicants;

(d) the rapporteur Member State.

Article 7

Submission of information by third parties

Article 8

Assessment by the rapporteur Member State

Article 9

Receipt of and access to the draft assessment report

The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant, the other Member States and the Commission after receiving the dossier provided for in Article 8(1).

It shall make it available to the public, after giving the applicant two weeks to request that certain parts of the draft assessment report be kept confidential.

The Authority shall allow a period of 90 days for the submission of written comments from Member States and the applicant.

Where appropriate, the Authority shall organise a peer review, including experts from the Member States.

Article 10

Conclusion by the Authority

Where appropriate, the Authority shall address in its conclusion the risk mitigation options in relation to the intended uses identified in the draft assessment report.

The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within sixty days after the receipt of the additional information.

In that case, the six months period for the adoption of the conclusion by the Authority, as provided for in paragraph 1, shall be extended by a period which shall cease at the moment when the assessment of the additional information is received by the Authority.

Article 11

Presentation of a draft directive or draft decision

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

On the basis of the review report provided for in paragraph 1, and taking into account any comments submitted by the applicant within the deadline set by the Commission under paragraph 1, a Directive or a Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of the Directive 91/414/EEC, providing that:

(a) an active substance is included in Annex I to Directive 91/414/EEC subject to conditions and restrictions, where appropriate;

(b) an active substance is not included in Annex I to that Directive.

Article 12

Access to the review report

The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of the Directive 91/414/EEC, shall be made available for public consultation.

CHAPTER III

ACCELERATED PROCEDURE

Article 13

Conditions for the application of accelerated procedure

Where a second, third or fourth stage substance has been the subject of a non-inclusion Decision in accordance with Article 6(1) of Directive 91/414/EEC, and a draft assessment report has been prepared, any person who had participated as notifier in the procedure leading up to that decision or any person who in agreement with the original notifier replaced him for the purposes of this Regulation, may submit an application in accordance with the accelerated procedure provided for in Articles 14 to 19 of this Regulation. Such an application must be submitted within six months from the date of publication of the non-inclusion decision as regards third and fourth stage substances, or, within six months from the date of entry into force of this Regulation as regards second stage substances.

Article 14

Application

The applicant shall submit separately the information to be kept confidential.

He shall at the same time submit any claims for data protection pursuant to Article 13 of Directive 91/414/EEC.

Article 15

Substantive and procedural requirements

The following substantive requirements shall apply:

(a) the specification of the active substance is the same as was the subject of the non-inclusion Decision. It may only be changed insofar as this is necessary, in the light of the reasons which gave rise to the non-inclusion Decision, to permit inclusion of that substance in Annex I to Directive 91/414/EEC;

(b) the supported uses are the same as those that were the subject of the non-inclusion Decision. They may only be changed insofar as this is necessary, in the light of the reasons which gave rise to the non-inclusion Decision, to permit inclusion of that substance in Annex I to Directive 91/414/EEC;

(c) it shall be for the applicant to demonstrate that the requirements in Article 5 of Directive 91/414/EEC are fulfilled.

With the application the applicant shall submit the following:

(a) the additional data necessary to address the specific issues that led to the adoption of the non-inclusion Decision concerned;

(b) any additional data reflecting the current scientific and technical knowledge and in particular changes to scientific and technical knowledge since the submission of the data which led to the non-inclusion decision;

(c) a supplement to the original dossier, where appropriate;

(d) a checklist demonstrating that the dossier is complete and indicating which data are new.

Article 16

Publication of information

For applications for which completeness has been established the Commission shall make public the following information:

(a) the name of the active substance;

(b) the date of application;

(c) the name and address of applicants;

(d) the Rapporteur Member State.

Article 17

Submission of information by third parties

Article 18

Assessment by the rapporteur Member State

The rapporteur Member State may consult the Authority.

Article 19

Access to the additional report

Article 20

Evaluation

The Commission may consult the Authority. Such consultation may, if appropriate, include a request to arrange a peer review, including experts from the Member States.

For third and fourth stage substances, where the Authority needs additional information, which shall not concern the submission of new studies, it shall set a time period of maximum 90 days for the applicant to supply it to the Authority and to the rapporteur Member State. In that case, the sixth months period referred to in the previous subparagraph shall be extended by the additional period granted by the Authority.

The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within 60 days after the receipt of the additional information.

Article 21

Presentation of a draft directive or draft decision

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

On the basis of the review report provided for in paragraph 1, and taking into account of any comments submitted by the applicant within the deadline set by the Commission under paragraph 1, a Directive or a Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC, providing that:

(a) an active substance is included in Annex I to Directive 91/414/EEC subject to conditions and restrictions, where appropriate;

(b) an active substance is not included in Annex I to that Directive.

Article 22

Access to the review report

The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of Directive 91/414/EEC, shall be made available for public consultation.

CHAPTER IV

GENERAL PROVISIONS

Article 23

Fees

For this purpose, the Member States shall:

(a) require the payment of a fee or charge corresponding as far as possible to their costs in carrying out all the different procedures associated with the evaluation for each submission of additional data or dossiers;

(b) ensure that the amount of the fee or charge is established in a transparent manner with a view to corresponding to the real cost of the examination and administrative handling of additional data or dossiers; however, Member States may provide for a scale of fixed charges based on average costs for the calculation of the total fee;

(c) ensure that the fee or charge is received in accordance with the instructions given by the authority in each Member State and that the income from the fee is used to finance exclusively the costs actually incurred by the rapporteur Member State for the evaluation and administrative handling of additional data or dossiers for which that Member State is rapporteur or to finance general actions for the implementation of its obligations as a Member State resulting from this regulation.

Article 24

Other charges, levies or fees

Article 23 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 that Article.

Article 25

Entry into force

This Regulation shall enter into force on the seventh 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.