Procedure for the assessment of an active substance
In the first stage of the European assessment process, an EU Member State, referred to as the Rapporteur Member State or abbreviated to RMS, will assess the dossier submitted by one or more applicants (industry). The RMS will draw up a provisional conclusion regarding the active substance. This provisional opinion, which is often referred to by the term DAR (Draft Assessment Report), is then transferred to the EFSA (European Food Safety Authority), which coordinates the risk assessment of active substances. DARs which were drawn up after July 2005 are available on the website of the EFSA. DARs drawn up before July 2005 can be obtained by requesting the RMS who drew up the DAR in question. DARs drawn up in Belgium (before July 2005) can be requested from us. Following a peer review - in which the RMS, the other EU Member States, the applicant and the EFSA are all involved - the EFSA will draw up a conclusion based on the risk assessment of the active substance.
Based on this conclusion, the European Commission will formulate a proposal on whether or not to approve the active substance and the associated conditions. This proposal is explained in an additional report, referred to as the Review Report. These documents are subject to an internal consultation by various directorates of the European Commission and are then discussed in the Working Group WG Legislation, in which all EU Member States are represented. The EU Member States finally vote on these proposals in the 'Standing Committee on Plants, Animals, Food and Feed' (SCoPAFF). If a proposal is approved with a qualified majority, it is then published in the Official Journal of the EU.
If Belgium acts as RMS or co-RMS
Applicants who wish to submit a dossier in Belgium, whereby Belgium acts as RMS (or co-RMS), can find instructions and detailed information regarding the various stages in the assessment process here.
If Belgium does not act as RMS or co-RMS
Even for active substances for which Belgium does not act as RMS, the applicant must submit the complete EU dossier (and any possible updates) in Belgium. This must enable Belgium's participation in the EU peer review.
Regulation (EC) 1107/2009 specifies that this will take place at the following moments:
- following reception of the declaration of the RMS regarding the admissibility of the application (cfr. art. 9, 3, 2nd paragraph);
- at the start of the comments stage of the DAR (cfr. art. 12, 1, 1st paragraph): if applicable, an update of the dossier (e.g. with additional data submitted with the RMS during the assessment of the dossier and the drawing up of the DAR);
- during the submission of additional information requested by the EFSA (cfr. art. 12, 3, 1st paragraph).
Our service would like to receive this information in the following form:
- 1 electronic copy of the complete dossier in Caddy XML (if available), or individual documents on CD (summaries doc. A, B, C, D, E, F, G, H, I, J, L, M, N, O in Word format; doc. K in pdf or Word format)