CHAPTER 3SUBMISSION AND ADMISSIBILITY OF THE APPLICATION FOR RENEWAL

Article 6Content of the application for renewal

1.

An application for renewal shall consist of a renewal dossier in the format as set out in Article 7.

2.

The renewal dossier shall include the following:

(a)

the name and address of the applicant responsible for the application for renewal and for the obligations under this Regulation;

(b)

where the applicant is joined by one or more other applicants, the name and address of that or those other applicants and, if applicable, the name of the association of producers mentioned in Article 5(2);

(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;

(d)

data and risk assessments which are necessary:

  1. (i)

    to reflect changes in legal requirements since the approval or last renewal of the approval of the active substance concerned;

  2. (ii)

    to reflect changes in scientific and technical knowledge since the approval or last renewal of the approval of the active substance concerned;

  3. (iii)

    to reflect changes to representative uses; or

  4. (iv)

    because the application is for an amended renewal;

(e)

for each of the data requirements for the active substance, as set out in Commission Regulation (EU) No 283/20138, the full text of each test or study report and summaries thereof, including those that were part of the approval dossier or subsequent renewal dossiers;

(f)

for each of the data requirements for the plant protection product, as set out in Commission Regulation (EU) No 284/20139, the full text of each test or study report and summaries thereof, including where relevant, those that were part of the approval dossier or subsequent renewal dossiers;

(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 Council10;

(j)

a proposal for classification where it is considered that the substance has to be classified or reclassified in accordance with Regulation (EC) No 1272/2008;

(k)

a checklist demonstrating that the renewal dossier is complete in view of the uses applied for and indicating which data are new;

(l)

the summaries and results of scientific peer-reviewed open literature, as referred in Article 8(5) of Regulation (EC) No 1107/2009;

(m)

an assessment according to the current scientific and technical knowledge of all information submitted, including, where relevant, a reassessment of studies and information that were part of the approval dossier or subsequent renewal dossiers;

(n)

a consideration and proposal for any necessary and appropriate risk mitigation measures;

(o)

all relevant information related to the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002.

The information referred to in point (o) of the first subparagraph shall be clearly identifiable.

The renewal dossier 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.

3.

Applicants shall make their best efforts to obtain access to and provide the studies which were part of the approval dossier or subsequent renewal dossiers as required under points (e) and (f) of paragraph 2.

The Member State that acted as rapporteur for the previous approval and/or subsequent renewal dossiers or the Authority shall endeavour to make available such studies where the applicant provides evidence that its attempts to obtain access from the study owner have failed.

4.

If the information submitted in accordance with point (c) of paragraph 2 does not cover all zones or does not concern a widely grown crop, a justification shall be submitted.

5.

The uses referred to in point (c) of paragraph 2 shall, where appropriate, include the uses evaluated for the approval or subsequent renewals. At least one plant protection product referred to in point (c) of paragraph 2 shall contain no other active substance, where such a product exists for a representative use.

6.

The applicant shall identify and list the new data it submits, including any new studies involving vertebrate animals in a separate list. It shall demonstrate that the new data is necessary in accordance with the first subparagraph of Article 15(2) of Regulation (EC) No 1107/2009 and, where applicable, refer to advice received during the pre-submission phase in accordance with Articles 32a and 32c of Regulation (EC) No 178/2002.

7.

When requesting certain information to be kept confidential in accordance with Article 63(1), (2) and (2a) of Regulation (EC) No 1107/2009, the applicant shall identify the confidential and a non-confidential versions of the information submitted.

8.

The applicant may submit any data protection claims pursuant to Article 59 of Regulation (EC) No 1107/2009.