Regulatory status of glyphosate:
1. Glyphosate was first registered in Europe in 1974 and has since undergone major regulatory reviews confirming its safety.
2. While glyphosate has a long history of safe use, some regulators overlook the substantial data when re-evaluating it.
3. Current regulatory challenges include addressing surface water monitoring results, claims from non-standard studies, and ensuring weed resistance management plans.
2. Some history
Q: When was the first European registration of a glyphosate product?
A: 1974. The first sales of Roundup were in the UK for perennial weed
control in autumn stubbles
Three consequences of that long history which affect regulatory status:
1. Over 2-3 generations of users, the major impact of the ability to control perennial
weeds has been forgotten. Glyphosate is now a “tool” - benefits are underestimated
2. The considerable data generated on efficacy & benefits, and the years of successful
use, are sometimes forgotten by regulators when they need to “tick boxes”
3. Glyphosate is one of the most researched pesticides or chemicals – efficacy, crop
safety, fate, toxicity, environmental impact. It is targetted by “campaigning scientists”
3. Major regulatory reviews
• EU review completed 2001
– All uses reviewed and considered “acceptable” for all exposures
– Including on glyphosate tolerant crops (beet, maize, cotton)
• FAO/WHO JMPR (Joint Meeting on Pesticide Residues)
– 2004 toxicology, 2005 residues
– Short & long term dietary intake unlikely to present a public health
concern
• WHO Environmental Health Criteria 159
– and WHO water criteria (5000 µg/L)
• Other major OECD countries including Japan, USA, Canada, Brazil,
Australia
– Many countries will review in the near future
4. Some broad challenges
• Addressing monitoring & findings in surface water
– Below threshold of ecotoxicological risk (Environmental Quality Standard)
– Removed by chlorination and ozonation for drinking water
– Demonstrate reduced levels (Water Framework Directive)
• Address allegations of findings in ground water
– Typically direct link to surface water or not a real finding
• Demonstration of practical weed resistance risk mitigation plans,
effective monitoring and resistance management plans
• Questions not covered by standard regulatory requirements
– Allegations derived from in vitro studies e.g. Seralini, Belle, Walsh
– Claims from epidemiology studies e.g. US AgHealth study
– Alleged impact on micro nutrient uptake e.g. Roemheld, Huber
• Studies are being undertaken to address these
5. Regulatory status in the EU
• Inclusion in Annex I of Directive 91/414/EC in November 2001
– Thorough evaluation by Germany as rapporteur Member State
– Peer reviewed by all Member States (MS)
– Stakeholder inputs
– No significant restrictions
• maximum annual dose 4.32 kg a.s./ha
• Re-registration of all products by Member States (MS) by July 2006
– Thorough evaluation now completed in most MS
– Maintained broad range of uses
6. Registration of Roundup Ready herbicide
• Evaluated in Annex I inclusion process
• Roundup Ready herbicide is approved in RR crops:
– Germany (beet 2003, maize 2006)
– Czech Republic (beet 2003, maize 2007)
– Slovakia (maize 2009)
– Romania (soyabean)
– Spain (maize: evaluation completed awaiting maize approval)
• Dossiers submitted in other major maize growing countries
• Covers events containing CP4
– Alone and in stacks
7. Renewal of Annex I inclusion
• Under current legislation, inclusion expires June 2012
• Draft AIR2 Regulation (Annex I Renewal, 2nd list of active
substances)
– Includes glyphosate (and its salts)
– Extension to end 2013?
• Glyphosate Task Force set up to submit a single notification
– Interested companies are working together
– New studies and risk assessments to meet latest requirements
– Output = joint dossier
8. Regulatory timelines and process
Schedule under draft AIR2 regulation
Current expiry
June 2012
Nov 2010 March 2012 Dec 2013
Formal notification? Submit dossier? Extension?
9. Looking ahead
• Active stewardship
– Promotion of Risk mitigation
– Demonstrate Risk management
• New legislation
– Sustainable Use Directive
– Water Framework Directive
– New Pesticide Authorisation Regulation
• Common Agriculture Policy
