Commission Implementing Regulation (EU) No 844/2012Show full title

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(1);

(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(2);

(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.

(1)

OJ L 70, 16.3.2005, p. 1.

(2)

OJ L 353, 31.12.2008, p. 1.