ECHA's role in assessing glyphosate

ECHA/NI/16/35

ECHA is responsible for managing the harmonised classification and labelling (CLH) process for hazardous chemical substances. Active substances in plant protection products normally have harmonised classification and labelling throughout the European Union.

A Member State competent authority can begin the process to have a harmonised classification for an active substance by submitting a proposal to ECHA. The proposal needs to describe the scientific reasoning behind the request to harmonise the classification.

As a pesticide, glyphosate is subject to the Plant Protection Products Regulation (PPP) and its use has to be authorised by the Member State where the plant protection product is used. A harmonised classification and labelling proposal was submitted at the end of May 2016 by the German Member State competent authority (BAuA).

The German proposal to harmonise the classification for glyphosate is subject to a 45-day public consultation. It was launched on 2 June and will end on 18 July 2016.

ECHA welcomes comments on the classification proposed by Germany, as well as on other potential hazards like carcinogenicity, germ cell mutagenicity and reproductive toxicity, which have been addressed in the dossier. Non-confidential comments that are received will be made available for all to read on ECHA's website.

After the public consultation is over, the dossier submitter (BAuA) will respond to the comments submitted. Then ECHA's Committee for Risk Assessment (RAC) will draft an opinion on the classification of the substance. RAC's independent scientific opinion will take into account the scientific data on glyphosate that is available, including any scientifically relevant data and comments received during the public consultation.

When assessing a substance for proposed harmonised classification, ECHA performs an assessment of whether the intrinsic properties of the active substance meet the hazard criteria set out in the Classification, Labelling and Packaging (CLP) Regulation. Classification is based solely on the hazardous properties of the substance. It does not take into account exposure and, hence, does not address the associated risks. The risks of using the products containing glyphosate are considered under the Plant Protection Products Regulation.

The European Commission then considers ECHA's opinion on the harmonised classification before deciding on the approval of the active substances under the Plant Protection Products (PPP) Regulation.

The legal deadline for the adoption of RAC's opinion is 18 months after the launch of the public consultation – by the end of November 2017.

ECHA will publish the committee's scientific opinion and forward it to the Commission for decision making. Any agreed classification will then be included in the list of harmonised classifications in Annex VI to the CLP Regulation.