The documents which must be submitted for the application for authorising a plant protection product shall also include the so-called draft Registration Report (dRR). A new template has been made available for this purpose since 1 January 2016. The new quantity of documents/studies to be referenced makes it necessary to present the procedure in Germany clearly and understandably in order to avoid misunderstandings and resulting extra work for authorities.

Separation of the active substance approval and the plant protection product authorisation

The procedure for authorising plant protection products will be preceded by the procedure for approving active substances. Only active substances which have been approved at the EU level can be authorised for incorporation in plant protection products (exception: Article 30 of Regulation (EC) No 1107/2009). All documents which have been submitted during the active substance approval procedure will be distributed to the member states and will already be assessed in this context. Therefore, it is not necessary to resubmit these documents during the authorisation procedure for plant protection products.

Access to a complete active substance dossier

The proof that access to the results of the active substance approval is permitted, forms the prerequisite for the authorisation of a plant protection product. For this purpose, access to a complete active substance dossier must be demonstrated, i.e. the studies that have been the subject of the active substance approval. This can be accomplished by

• proving property rights
• submitting a letter of access of the right holder
• proving that the studies relevant for the evaluation of an active substance ("studies relied upon")
  - are no longer protected because time has elapsed, or
  - are not required for the present application, or
  - can be replaced by its own equivalent studies. In this case, the replacement studies have to be submitted with the application for authorisation.
  This proof shall take the form of a compliance check for all studies indicated in the "studies relied upon”, which shall be submitted with the application (described in Annex 1 of the Guidance Document Sanco/10796/2003 - rev. 12, Guidance document on the procedures relating to the authorisation of Plant Protection Products following inclusion of an existing active substance in Annex I of Council Directive 91/414/EEC).

Reference lists

In the dRR, the following studies are to be referenced in parts B or C:

• all studies on the plant protection product, irrespective of whether they had already been assessed elsewhere (for example EU active substance approval)
• all additional active substance studies which were not included in the approval of the active substance and which are required for the evaluation of the present application. This includes, inter alia, the above mentioned studies which shall replace protected studies of the active substance approval

Irrespective of whether they had already been assessed elsewhere (EU active substance approval, procedure for setting / reviewing maximum residue levels) the studies to be referenced must also include

• all studies on residue behaviour and residue analysis
• documents necessary to prove the toxicological relevance of groundwater metabolites
• documents on the identity of the technical active substance, in particular its specification

Furthermore, an overall reference list containing the studies listed above must be submitted, it represents the total of the B parts. Additional studies which do not appear in the B parts should not be listed here. All other active substance studies which have already been assessed within the framework of the active substance approval and which are quoted, inter alia, in Vol. 2 of the DAR and in the corresponding addenda, will not be referenced in the dRR.

It is not permitted to submit reference lists from former authorisation procedures which have been made available by the BVL upon request. It is also expected from secondary applicants to list the references in the manner described above and to distinguish between studies on the active substance and studies on the plant protection product, as well as between studies which were already considered in the active substance approval and those which were not.

There is no need to re-evaluate the studies if they have already been evaluated at EU level (DAR; EFSA Conclusion) and if the evaluation carried out there is still valid in the context of the current guidance documents.

Submission of studies

The submission of authorisation dossiers takes the form of CADDY dossiers in CADDY XML format. The studies on active substance(s) and the studies on the plant protection product must be submitted as individual CADDY dossiers (one dossier for the plant protection product and one each for the active substance). Information on compiling and submitting CADDY dossiers can be found below. All information on residue behaviour is submitted for active substance annex points (KCA, Guidance document for applicants on preparing dossiers, SANCO/10181/2013– rev. 2.1, 13 May 2013). According to Article 34 of Regulation (EC) No 1107/2009, studies which have already been submitted to the BVL do not need to be resubmitted.

Year of issue 2016
Date 22.03.2016