What is a check of completeness?

During the check of completeness, the BVL-staff examines the submitted dossier closely. It is checked if all necessary studies and documents (GLP-certificates, reference lists, etc…) are submitted according to the respective data requirements.

Are publications accepted?

It is possible to submit publications instead of studies. A decision on whether they are accepted will be made on a case-by-case basis during the evaluation. The completeness check will only cover formal criteria ("whether a document or statement has been submitted for each data requirement").

Are applicants obliged to co-operate with each other?

As laid down in the respective Commission Regulations, applicants should make the effort to submit collective dossiers in order to avoid duplication of work, and in particular studies involving vertebrate animals.

Where can the format for the submission of dossiers be found?

Dossiers have to be submitted in the content and format as defined in the following Guidance Documents, which can be accessed via the website of the European Commission:

• For chemical active substances:
  SANCO/10181/2013– latest version - on preparing dossiers for the approval of a chemical new active substance and for the renewal of approval of a chemical active substance according to Regulation (EU) No 283/2013 (Annex Part A) and Regulation (EU) No 284/2013
• For microorganisms:
  SANCO/12545/2014– latest version - on preparing dossiers for the approval or renewal of approval of a micro-organism including viruses according to Regulation (EU) No 283/2013 (Annex Part B) and Regulation (EU) No 284/2013
• For semiochemicals:
  SANTE/12815/2014-latest version - Guidance Document on “Semiochemical active substances and plant protection products”
• For plant extracts:
  SANCO/11470/2012- latest version, Guidance Document on "Botanical active substances used in plant protection products"

• Administrative guidance:

  Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances
  SANCO/12580/2012- latest version – Guidance document on preparing list of test and study reports according to article 60 of Regulation (EC) No 1107/2009

What is the relevance of the approval of active substances for the national authorisation of plant protection products?

The approval of an active substance is a prerequisite for a national authorisation of a plant protection product in any Member State of the European Union, i.e. if an active substance is not approved an authorisation is not possible. However, the approval does not mean that national authorisation of a plant protection product is automatically granted. An application for the national authorisation of a plant protection product must be submitted to the respective zonal Rapporteur Member State (zRMS) and the concerned Member States (cMS). In this context the Member State must verify the requirements of the approval regulation of the active substance and the access to the active substance dossier. Furthermore, each approval of an active substance must be reviewed within a specified time frame and, following renewal of approval of the active substance, national authorisations must be renewed, too.

Which requirements must be fulfilled for micro-organisms?

The requirements are given in Part B of Regulations (EU) No 283/2013 and Regulation (EU) No 284/2013.

The document SANCO/12545/2014 – latest version - is the guidance for applicants on preparing dossiers for the approval or renewal for microorganisms including viruses.

How is the evaluation as active substance for plant protection products linked to the classification and labelling of chemicals (CLH)?

According to article 36 ff. of Regulation (EC) No. 1272/2008 a Europe-wide harmonised classification and labelling of hazardous properties of active substances in plant protection products is envisaged.
In parallel to the peer review on the active substance the procedure for classification and labelling harmonisation (CLH) will be initiated with ECHA being the responsible authority. Therefore, Vol. 1 of the assessment report contains the proposal for classification and labelling. In Germany, the BAuA (Federal Institute for Occupational Safety and Health) coordinates the process and is responsible for submitting a CLH proposal at ECHA.