Regulatory Update: 32/2012
Issued: 27 September 2012
Green route active substances that were included on Annex I of Directive 91/414/EEC (deemed approved under Regulation (EC) No 1107/2009) as fulfilling the 'not harmful' criteria were subject to peer review by the European Food Safety Authority (EFSA ) post-inclusion (see Regulatory Update 34/2007). In the interim period between inclusion and noting of the EFSA conclusions at the Standing Committee on the Food Chain and Animal Health (SCoFCAH) the endpoints and risk assessment in the draft assessment report (DAR ) are used for all product evaluations including re-registration applications.
This Regulatory Update sets out how CRD will deal with any changes in the endpoints and risk assessments as a result of the EFSA peer review.
Green route active substances
- CRD have authorised new products or re-registered products based on the endpoints/risk assessment in the DAR. Will these be revisited following noting of the EFSA peer review?
Yes – but only where the changes are to critical endpoints (ADI , AOEL , ARfD) or there are new or amended Specific Provisions (Part A) which result in an amended Commission Implementing Regulation with new re-registration deadlines. In this case CRD will notify authorisation holders of the changes and action required. Where a revised risk assessment is necessary the authorisation holder may need to submit an updated draft registration report (dRR).
No – if neither of the above scenarios apply. Any other changes to end points/risk assessments as a consequence of the EFSA peer review process will be taken into account at renewal of authorisation.
Confirmatory data/ information specified in Part B of the Commission Implementing Regulation following peer review must be addressed by the notifier by the dates specified in the Commission Implementing Regulation.
If an application is submitted before noting of the EFSA peer review and the evaluation starts afterwards which endpoint/risk assessment will be used?
The endpoints in place at the time of application (those in the DAR) will be used unless there are changes to the critical endpoints (ADI , AOEL , ARfD) or there are new or amended Specific Provisions (Part A) which result in an amended Commission Implementing Regulation with new re-registration deadlines. Where the dossier requires updating to reflect such changes, this will be requested in line with CRD’s procedure for requesting further information during the course of an evaluation (further details can be found in the Applicant Guide).
If an application is submitted after noting of the EFSA peer review can reference be made to a ‘risk envelope’ established for products authorised prior to this?
If there are no changes to the critical endpoints (ADI , AOEL , ARfD) or there are no new or amended Specific Provisions (Part A) which result in an amended Commission Implementing Regulation with new re-registration deadlines, then the risk envelope approach as set out in the Guidance document on the preparation and submission of dossiers for plant protection products according to the “risk envelope approach” (SANCO/11244/2011) may be used. As detailed in 1 above any other changes to the end points or risk assessments as a consequence of the EFSA peer review process will be taken into account at renewal.
This only applies to uses that fall within a risk envelope established in accordance with Uniform Principles. In some instances it may be necessary to check that older assessments will be likely to meet modern risk assessment standards such as that used for the ecotoxicological risk assessments. This will be considered on a case by case basis and further details can be found in Regulatory Update 43/2011. Any new uses that do not fall within the established risk envelope will require an assessment using the new endpoints and risk assessment resulting from the EFSA peer review.
If you have any questions relating to this Regulatory Update, please contact CRD Applicant Enquiries and your enquiry will be sent to the appropriate person to respond:
Postal address: Pesticides Branch, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK.