The European Food Safety Authority (EFSA) is today publishing the conclusions of its assessment as part of the procedure to renew the ten-year approval granted to the active substance glyphosate at European level. On the basis of a thorough study by the German risk assessment agency (BfR) in its capacity as rapporteur Member State, to which ANSES contributed in the framework of the European procedures, the conclusions will lead to a tightening of the assessment criteria and consider that the substance is unlikely to pose a carcinogenic hazard to humans.
These conclusions also call for further work on two complementary points, on which ANSES has undertaken specific studies: one aims to explore the possibilities of changing the classification of glyphosate in the framework of the REACh-CLP Regulations, on the basis of the data collected by the BfR and EFSA at European level, and by the International Agency for Research on Cancer (IARC) during its recent expert appraisal; the other is intended to assess the need for additional studies on the human health effects of co-formulants found in commercial preparations in association with glyphosate. The findings of this work will be published in early 2016.
Glyphosate is an active substance authorised in Europe and used very widely as a herbicide, both by professionals (8660 tonnes marketed in France in 2013) and amateur gardeners (2055 tonnes marketed in France in 2013).
It is currently the subject of a European-level procedure to renew its ten-year approval as an active plant protection substance under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. In this framework, the European Food Safety Authority (EFSA) is coordinating the assessment of the substance, with Germany (BfR) as the rapporteur Member State.
Last September, the International Agency for Research on Cancer (IARC), part of the World Health Organization, published a report concluding that glyphosate should now be classified in Group 2A, as "probably carcinogenic to humans".
In this framework, the European Commission asked EFSA to take the IARC's conclusions into account in its final assessment, in particular the potentially carcinogenic nature of glyphosate or plant protection products containing glyphosate.
The conclusions from this work are today being published by the European authority. On the basis of a thorough study by the German risk assessment agency (BfR) in its capacity as rapporteur Member State, to which ANSES contributed in the framework of the European procedures, the conclusions will lead to a tightening of the assessment criteria for glyphosate and commercial preparations containing glyphosate, by establishing an Acute Reference Dose (ARfD) that must be complied with, in addition to the toxicity reference values ADI and AOEL. They also consider that the substance is unlikely to pose a carcinogenic hazard to humans.
These conclusions also call for further work on two complementary points, on which ANSES has already undertaken specific work in the context of a formal request received from the Ministries:
- The first aims to assess whether the information presented in the IARC and EFSA assessments would be likely to support a proposal for a change to the classification of glyphosate according to the rules defined in the European regulation on the classification of chemical substances (Regulation (EC) 1272/2008 known as the CLP Regulation). Depending on the results of this work, the substance's classification by the European Chemicals Agency (ECHA) could lead to restrictions on the use of glyphosate products.
- The second aims to further examine the results of genotoxicity studies on a commercial preparation combining glyphosate with co-formulants (studies provided as part of the glyphosate re-assessment dossier), in order to assess the need for additional studies on the effects of combinations of co-formulants found in commercial preparations in association with glyphosate.
The expert group must publish its conclusions on the first point in January 2016, and on the second point by the end of the first quarter of 2016. This information will supplement the results of the analyses carried out by the BfR, EFSA and ECHA, with a view to informing the decisions on re-approval of the active substance that are due to be taken at European level by the European Commission and the Member States by the summer of 2016.