Which Birds and Mammals Guidance should I use?

UK registrations
The UK regulatory authority have recently issued advice on which Bird and Mammal guidance should be used for risk assessments for each type of submission to CRD after 1 July 2010 following the implementation of the new EFSA Guidance Document (EFSA GD) on Risk Assessment for Birds and Mammals as follows:

• new active substances and Annex I renewals submitted after 1 July 2010 which are to be reviewed by EFSA - EFSA Guidance Document will apply
• product dossiers CRD will accept evaluations based on, either the existing Guidance Document or the new EFSA Guidance Document for submissions after 1 July 2010.

Whilst CRD will still accept evaluations based on the existing Guidance Document after 1 July 2010, applicants may determine that the new EFSA Guidance Document may be more appropriate. The use of either guidance document needs to be scientifically justified and appropriate to the use.  These guidance documents can be found in the Knowledge Library under Agrochemical Documentation.

Other MS registrations
It is unclear whether or not all Member States (MS) will apply the new EFSA Guidance Document for national product authorisations, or whether they will be assessed against the existing Bird and Mammal Guidance Document - SANCO/4145/2000 - final.  Again, this guidance can be found in the Knowledge Library under Agrochemical Documentation.

Where necessary JSC can obtain information of how individual EU member states will apply the latest Birds and Mammals Guidance Document.  Please contact us for further details.