Filter by Subject
Tags
MRL setting in the EU – Guidance Document SANTE/2015/10595 Rev. 4

The procedures for MRL setting in the EU are included in Regulations (EU) 396/2005 and 1107/2009.  A guidance document is available from the EU Commission that is intended to provide clarity on the various steps involved in the procedure, on the timelines and on specific circumstances related to the MRL setting process.  The document does not provide new information on the MRL setting process, rather it acts as a useful condensed source of all relevant information relevant to the process and as such is a helpful resource.

The document includes an overview of the following issues:

  • Current procedures for MRL setting under Reg (EU) 396/2005 – this includes an overview of the current Annexes to Reg (EU) 396/2005, who is involved in the different steps of the process, and the procedural steps for setting, modifying or deleting an MRL. The various responsibilities of the applicant, the evaluating Member State (EMS), the EU Commission, the European Food Safety Authority (EFSA) are also clarified.
  • Clarification of specific cases – this includes requests for Import Tolerances, implementation of Codex Maximum Residue Limits (CXLs), and the setting of Temporary MRLs
  • A number of useful resources are also listed, including links to relevant Data Requirement documents, EU contact points, IT tools, a glossary of commonly used abbreviations, and a flow diagram that indicates the timescale of the various activities involved in the MRL setting procedure.

The document is available on the EU Commission website at https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_mrl-setting-proc.pdf

For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, enquiries@jsci.co.uk.

Published 1st November 2016
Categories Agrochemicals, Links, News
Related Articles
CRD announces new arrangements where authorisation is dependent on the establishment of a Maximum Residue Level (MRL)
Applicants to submit a new ‘administrative’ application to HSE
Read More >
Prioritisation of Maximum Residue Level (MRL) assessments in applications for the authorisation of Plant Protection Products
The aim is to reduce the overall processing time for such applications.
Read More >
Get In Touch
Drop us a line using the form below.
Or if you want to speak to us urgently call +44 (0)1423 520245
Name
Company
Email
Phone
Message

Please leave this field empty.

 
* Required

JSC International Limited
The Exchange, Station Parade
Harrogate, North Yorkshire
HG1 1TS

The Exchange is a ten storey building next to Harrogate train station (we are on the 5th floor).

Parking is available at Station Parade car park (HG1 1TT) or the Victoria Multi Storey (HG1 5LQ) car park on East Parade. 

 

JSC International Limited is an ERM Group company   www.erm.com

 

Tel
+44 (0)1423 520245

Email
Map
© 2014 JSC International Limited. Registered in England No. 10054379. The Exchange, Station Parade, Harrogate HG1 1TS.