COMMISSION IMPLEMENTING REGULATION (EU) No 844/2012
of 18 September 2012
setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 (1), and in particular Article 19 thereof,
Whereas:
(1)
Regulation (EC) No 1107/2009 provides that the approval of an active substance may be renewed upon expiry.
(2)
It is appropriate to set out the provisions necessary for the implementation of the renewal procedure.
(3)
In particular, periods should be set for the different steps of the renewal procedure to ensure that it functions properly.
(4)
Rules should be set out as regards confidentiality and the publication of the application for renewal, the supplementary dossiers and their updates.
(5)
Rules should also be set out as regards the submission of the application for renewal and its contents and format. The applicant should be obliged to justify the submission of new information and to list separately studies concerning vertebrate animals that they intend to submit.
(6)
Rules should be set out as regards the checking of the application by the rapporteur Member State.
(7)
In order to ensure the proper functioning of the renewal procedure, the rapporteur Member State should, at the applicant’s request, organise prior to the submission of the supplementary dossier, a meeting to discuss the application.
(8)
The supplementary dossiers submitted for renewal should, in particular, include necessary new data and new risk assessments and demonstrate why such data and risk assessments are necessary.
(9)
Rules should be set out as regards the establishment of the admissibility of the application by the rapporteur Member State.
(10)
Where all applications submitted are inadmissible, the Commission should adopt a Regulation on the non-renewal of the active substance concerned.
(11)
Rules should be set out to ensure an independent, objective and transparent assessment of the active substance.
(12)
The applicant, the Member States, with the exception of the rapporteur Member State, and the public should be given the opportunity to submit comments on the draft renewal assessment report.
(13)
The European Food Safety Authority should provide conclusions and organise consultations of experts, except where the Commission informs it that a conclusion is not necessary.
(14)
Rules should be set out as regards the renewal report and the adoption of a regulation on the renewal of the approval of the active substance.
(15)
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 (2) should continue to apply with respect to the renewal of the approval of the active substances listed in Annex I thereto.
(16)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
CHAPTER 1
ADMISSIBILITY
SECTION 1
Application for renewal
Article 1
Submission of the application
1. An application for the renewal of an approval of an active substance shall be submitted by a producer of the active substance to the rapporteur Member State, as set out in the second column of the Annex to Commission Implementing Regulation (EU) No 686/2012 (3) and to the co-rapporteur Member State, as set out in the third column of that Annex, no later than three years before the expiry of the approval.
When submitting an application, the applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request certain information to be kept confidential. In that event, the applicant shall present such parts of the application physically separated, setting out the reasons for requesting confidentiality.
At the same time, the applicant shall submit any data protection claims pursuant to Article 59 of Regulation (EC) No 1107/2009.
2. The applicant shall send a copy of the application to the Commission, the other Member States and to the European Food Safety Authority (‘the Authority’), including the information on those parts of the application in respect of which confidentiality has been requested as referred to in paragraph 1.
3. A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.
Article 2
Format and contents of the application
1. The application shall be submitted in the format set out in the Annex.
2. The application shall list the new information the applicant intends to submit. It shall demonstrate that such information is necessary in accordance with the first subparagraph of Article 15(2) of Regulation (EC) No 1107/2009.
The application shall list separately any new studies involving vertebrate animals that the applicant intends to submit.
Article 3
Checking of the application
1. Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2, the rapporteur Member State shall, within one month of the date of receipt of the application, inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the application and the fact that it has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2.
The rapporteur Member State shall assess any request for confidentiality. Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
2. Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) but one or more elements provided for in Article 2 are missing, the rapporteur Member State shall, within one month of the date of receipt of the application, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the Rapporteur Member State and to the co-rapporteur Member State.
Where the application contains all the elements provided for in Article 2 at the expiry of that period, the rapporteur Member State shall, without delay, proceed in accordance with paragraph 1.
3. Where the application has not been submitted by the date provided for in the first subparagraph of Article 1(1), or where the application still does not contain all the elements provided for in Article 2 at the expiry of the period set for the submission of the missing elements in accordance with paragraph 2, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application is inadmissible and of the reasons why it is inadmissible.
4. Within 14 days from the date of receipt of the information that the application has been submitted by the date provided for in the first subparagraph of Article 1(1) and that it contains all the elements provided for in Article 2, the applicant shall submit to the Authority a copy of the application, including the information about those parts of the application in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
At the same time, the applicant shall forward a copy of the application to the Authority, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
5. Where, by the date provided for in the first subparagraph of Article 1(1), two or more applications for the same active substance have been submitted separately and each of them contains all the elements provided for in Article 2, the rapporteur Member State shall communicate the contact details of each applicant to the other applicant(s).
6. The Commission shall publish, for each active substance, the names and the addresses of the applicants whose applications have been submitted by the date provided for in the first subparagraph of Article 1(1) and contain all the elements provided for in Article 2.
Article 4
Contacts prior to submission of supplementary dossiers
The applicant may request a meeting with the rapporteur Member State and the co-rapporteur Member State to discuss the application.
If requested, such pre-submission contacts shall take place prior to the submission of supplementary dossiers, as provided for in Article 6.
Article 5
Access to the application
Upon receipt of the application, as provided for in Article 3(4), the Authority shall make it available to the public without delay, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
SECTION 2
Supplementary dossiers
Article 6
Submission of supplementary dossiers
1. Where the rapporteur Member State has informed the applicant in accordance with Article 3(1) that its application has been submitted by the date provided for in the first subparagraph of Article 1(1) and that it contains all the elements provided for in Article 2, the applicant shall submit the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the Authority.
2. The contents of the supplementary summary dossier and the supplementary complete dossier shall comply with Article 7.
3. The supplementary dossiers shall be submitted no later than 30 months before the expiry of the approval.
4. Where there is more than one applicant requesting renewal of the approval of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly.
Where such dossiers are not submitted jointly by all the applicants concerned, the reasons shall be set out in the dossiers.
5. When submitting the supplementary dossiers, the applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
Article 7
Contents of supplementary dossiers
1. The supplementary summary dossier shall include the following:
(a)
a copy of the application;
(b)
where the applicant is joined or replaced by one or more other applicants, the name and address of that applicant or those other applicants and, if applicable, the name of the association of producers provided for in Article 1(3);
(c)
information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are fulfilled; where the information submitted does not cover all zones or does not concern a widely grown crop, a justification shall be submitted;
(d)
data and risk assessments which were not part of the approval dossier or subsequent renewal dossiers and which are necessary:
(i)
to reflect changes in legal requirements which have occurred since the approval or last renewal of the approval of the active substance concerned;
(ii)
to reflect changes in scientific and technical knowledge since the approval or last renewal of the approval of the active substance concerned;
(iii)
to reflect changes to representative uses; or
(iv)
because the application is for an amended renewal;
(e)
for each point of the data requirements for the active substance, as set out in a Regulation setting out data requirements for active substances under Regulation (EC) No 1107/2009, for which new data are necessary in accordance with point (d), the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried them out and the reason why each test or study is necessary;
(f)
for each point of the data requirements for the plant protection product, as set out in a Regulation setting out data requirements for plant protection products under Regulation (EC) No 1107/2009, for which new data are necessary in accordance with point (d), 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, for one or more plant protection products which are representative of the supported uses, and the reason why each test or study is necessary;
(g)
where relevant, documented evidence as referred to in Article 4(7) of Regulation (EC) No 1107/2009;
(h)
for each test or study involving vertebrate animals, a description of the steps taken to avoid animal testing on vertebrate animals;
(i)
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 (4);
(j)
where relevant, a copy of the proposal for classification where it is considered that the substance has to be classified or reclassified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5);
(k)
an assessment of all information submitted;
(l)
a checklist demonstrating that the supplementary dossier provided for in paragraph 3 is complete in view of the uses applied for and indicating which data are new;
(m)
the summaries and results of scientific peer-reviewed open literature, as referred in Article 8(5) of Regulation (EC) No 1107/2009.
2. The uses referred to in paragraph 1(c) shall, where appropriate, include the uses evaluated for the approval or subsequent renewals. At least one plant protection product referred to in paragraph 1(c) shall contain no other active substance, where such a product exists for a representative use.
3. The supplementary complete dossier shall contain the full text of each test and study report referred to in paragraph 1(e), (f) and (m).
It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product containing it to humans.
Article 8
Admissibility of the application
1. Where the supplementary dossiers have been submitted by the date provided for in Article 6(3) and contain all the elements provided for in Article 7, the rapporteur Member State shall, within a period of one month, inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the supplementary dossiers and of the admissibility of the application.
The rapporteur Member State shall assess any requests for confidentiality. In the event of a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
2. Where the supplementary dossiers have been submitted by the date provided for in Article 6(3), but one or more elements provided for in Article 7 are missing, the rapporteur Member State shall, within a period of one month from the date of receipt of the supplementary dossiers, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the rapporteur Member State and co-rapporteur Member State.
Where at the expiry of that period the supplementary dossiers contain all the elements provided for in Article 7, the rapporteur Member State shall, without delay, proceed in accordance with paragraph 1.
3. After receiving the information that the application is admissible, the applicant shall immediately forward the supplementary dossiers to the other Member States, the Commission and the Authority, including the information about those parts of the dossier in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
At the same time, the applicant shall forward the supplementary summary dossiers to the Authority, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
4. The Authority shall make the supplementary summary dossier available to the public, without delay, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
5. At the request of the Authority or a Member State, the applicant shall make available the dossiers submitted for the approval and subsequent renewals of the approval, where it has access to them.
6. Where the supplementary dossiers have not been submitted by the date referred to in Article 6(3), or where at the end of the period set for the submission of the missing elements in accordance with paragraph 2 of this Article the supplementary dossiers still do not contain all the elements provided for in Article 7, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application is inadmissible and of the reasons why it is inadmissible.
Article 9
Replacement of the applicant
An applicant may be replaced by another producer in respect of all of its rights and obligations under this Regulation by informing the rapporteur Member State, through a joint declaration by the applicant and the other producer. In that case, the applicant and the other producer shall, at the same time, inform the co-rapporteur Member State, the Commission, the other Member States, the Authority and any other applicants that have submitted an application for the same active substance of the replacement.
Article 10
Adoption of non-renewal Regulation
The Commission shall adopt a Regulation on the non-renewal of the approval of an active substance in accordance with Article 20(1)(b) of Regulation (EC) No 1107/2009 where all of the applications submitted for that active substance are inadmissible in accordance with Article 3(3) of this Regulation or Article 8(6) thereof.
CHAPTER 2
ASSESSMENT
Article 11
Assessment by the rapporteur Member State and the co-rapporteur Member State
1. Where the application is admissible in accordance with Article 8(1), the rapporteur Member State shall, after consulting the co-rapporteur Member State, at the latest 12 months after the date referred to in Article 6(3), prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to meet the approval criteria, as provided for in Article 4 of Regulation (EC) No 1107/2009 (‘the draft renewal assessment report’).
2. The draft renewal assessment report shall also include the following:
(a)
a recommendation with regard to the renewal of the approval;
(b)
a recommendation on whether the substance should be considered a ‘low-risk’ substance;
(c)
a recommendation on whether the substance should be considered a candidate for substitution;
(d)
where relevant, a proposal to set maximum residue levels;
(e)
where relevant, a suggestion for the classification or reclassification of the active substance in accordance with Regulation (EC) No 1272/2008;
(f)
a conclusion on which of the new studies included in the supplementary dossiers are relevant for the assessment;
(g)
a recommendation as to the parts of the report on which a consultation of experts is to be organised in accordance with Article 13(1);
(h)
the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State, where relevant.
3. The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. It shall take into account the supplementary dossiers, and, where appropriate, the dossiers submitted for the approval and subsequent renewals of approval.
4. The rapporteur Member State shall first establish whether the approval criteria set out in points 3.6.2, 3.6.3, 3.6.4 and 3.7 of Annex II to Regulation (EC) No 1107/2009 are satisfied.
Where those criteria are not satisfied, the draft renewal assessment report shall be limited to those parts of the assessment, unless Article 4(7) of Regulation (EC) No 1107/2009 applies.
5. Where the rapporteur Member State requires additional information, it shall set a period for the applicant to supply that information. That period shall not lead to an extension of the period of 12 months provided for in paragraph 1. The applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request such information to be kept confidential.
6. The rapporteur Member State may consult the Authority and request additional technical or scientific information from other Member States. Such consultations and requests shall not lead to an extension of the period of 12 months provided for in paragraph 1.
7. Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first sentence of paragraph 5, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
8. When submitting the draft renewal assessment report to the Commission, the rapporteur Member State shall request the applicant to submit the supplementary summary dossiers, updated to include the additional information requested by the rapporteur Member State in accordance with paragraph 5 or submitted in accordance with Article 56 of Regulation (EC) No 1107/2009, to the co-rapporteur Member State, the Commission, the other Member States and to the Authority.
The applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request such information to be kept confidential. Any such requests shall be addressed to the Authority.
Article 12
Comments on the draft renewal assessment report
1. The Authority shall circulate the draft renewal assessment report received from the rapporteur Member State to the applicant and to the other Member States at the latest 30 days after its receipt.
2. The Authority shall make the draft renewal assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63 of Regulation (EC) No 1107/2009, that certain parts of the draft renewal assessment report are kept confidential.
3. The Authority shall allow a period of 60 days from the date the report is made available to the public for the submission of written comments. Such comments shall be communicated to the Authority, which shall collate and forward those comments, including its own comments, to the Commission.
4. The Authority shall make the updated supplementary summary dossiers available to the public, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
Article 13
Conclusion by the Authority
1. Within five months from the expiry of the period referred to in Article 12(3), the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the supplementary dossiers on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority shall, where appropriate, organise a consultation of experts, including experts from the rapporteur Member State and co-rapporteur Member State. The Authority shall communicate its conclusion to the applicant, the Member States and the Commission.
By way of derogation from the first subparagraph, the Commission may inform the Authority without delay after the period referred to in Article 12(3) has expired that a conclusion is not necessary.
2. After giving the applicant two weeks to request, pursuant to Article 63 of Regulation (EC) No 1107/2009, that certain parts of the conclusion be kept confidential, the Authority shall make its conclusion available to the public, excluding any information in respect of which confidentiality has been granted by the Authority, unless there is an overriding public interest in its disclosure.
3. Where the Authority considers that additional information from the applicant is necessary, it shall, in consultation with the rapporteur Member State, set a period not exceeding one month for the applicant to supply such information to the Member States, the Commission and the Authority. The rapporteur Member State shall, within 60 days from the date of receipt of the additional information evaluate the information received and send its evaluation to the Authority.
Where the first subparagraph applies, the period referred to in paragraph 1 shall be extended by the periods referred to in the first subparagraph of this paragraph.
4. The Authority may ask the Commission to consult a European Union reference laboratory designated, pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council (6), for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and complies with the requirements in Article 29(1)(g) of Regulation (EC) No 1107/2009. The applicant shall, if requested by the European Union reference laboratory, provide samples and analytical standards.
5. Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first subparagraph of paragraph 3, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
Article 14
Renewal report and renewal Regulation
1. The Commission shall present to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 a renewal report and a draft Regulation within six months from the date of receipt of the conclusion of the Authority or in cases where there is no such conclusion of the Authority, the expiry of the period referred to in Article 12(3) of this Regulation.
The renewal report and the draft Regulation shall take into account the draft renewal assessment report of the rapporteur Member State, the comments referred to in Article 12(3) of this Regulation and the conclusion of the Authority, where such a conclusion has been submitted.
The applicant shall be given the possibility to submit comments on the renewal report within a period of 14 days.
2. On the basis of the renewal report and taking into account comments submitted by the applicant within the period referred to in the third subparagraph of paragraph 1, the Commission shall adopt a Regulation in accordance with Article 20(1) of Regulation (EC) No 1107/2009.
CHAPTER 3
TRANSITIONAL AND FINAL PROVISIONS
Article 15
Transitional provisions
Regulation (EU) No 1141/2010 shall continue to apply with respect to the renewal of the approval of active substances listed in Annex I thereto.
Article 16
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 September 2012.