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Food, Farming, Fisheries
Food Safety

First renewal of approval process: 2012-2017

Approval

Glyphosate was initially approved for use in PPPs in the EU for a 10-year period, beginning on 1 July 2002. Glyphosate’s initial approval had to be extended several times after 2012, to allow sufficient time for the first renewal evaluation to be completed.

Renewal of Approval

The approval of glyphosate was first renewed in 2017 (see Commission Implementing Regulation (EU) 2017/2324 renewing glyphosate's approval). The approval process ran from 2012 to 2017, after which glyphosate was approved for another 5 years, until 15 December 2022.

Timeline of events

  1. 2012

    Following the submission of an application for renewal of approval by the Glyphosate Task Force (GTF), Member States and EFSA carry out a comprehensive scientific assessment according to the rules for renewal of active substance approvals.

    This renewal review was the first time glyphosate was assessed according to the approval critiera laid down in Regulation (EC) No 1107/2009 (the EU pesticides legislation in place from 2009).

  2. 2015
    November

    EFSA publishes its Conclusion following the renewal assessment and deems that “glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008."

    Glyphosate risk assessment - conclusion on the peer review

  3. 2016
    29 June

    The Commission calls for a vote on the renewal proposal. No majority of Member States can be found in favour of or against renewal.

    The International Agency for Research on Cancer and EFSA disagree on the potential carcinogenicity of glyphosate. Therefore, the Commission adopts an extension of the approval of glyphosate for a limited period to allow the European Chemicals Agency (ECHA) to assess glyphosate’s carcinogenicity.

  4. 2016
    11-12 July

    Member States vote to amend the conditions of the existing approval of glyphosate, adding further restrictions to ensure the highest safety standards for humans and the environment.

  5. 2017
    16 May

    The Commission agreed that the discussions with the Member States about the possible renewal of the approval of glyphosate could restart. The Commission proposed a renewal of the approval of glyphosate for 10 years.

  6. 2017
    22 May

    ECHA's Committee for Risk Assessment (RAC) concludes there is no justification for classifying glyphosate as a carcinogen, confirming the current classification. RAC also concludes that glyphosate does not meet the criteria to be classified as mutagenic or toxic for reproduction.

  7. 2017
    15 June

    ECHA communicates to the Commission its opinion that the available scientific evidence does not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction.

    The earlier approval of glyphosate will now expire on 15 December 2017.

  8. 2017
    20 July

    The Commission restarted the discussions with Member States. The proposal put forward by the Commission included:

    • Specific provisions that Member States have to take into account when considering applications for glyphosate-based products, namely:
      • protection of groundwater
      • protection of terrestrial animals and non-target plants
    • Certain elements that Member States must ensure during assessment and decision making for authorisation (for example the use in public areas should be minimised)
    • The ban of POE-tallowamine (a 'co-formulant' that was previously used in glyphosate-based products) that was put in place in 2016
  9. 2017
    17 September

    In an assessment, EFSA concludes that glyphosate does not have endocrine-disrupting properties.

  10. 2017
    5-6 October

    A further round of discussions with the Member States took place. The Commission made available to the Member States an updated version of the proposal that took into account the EFSA Conclusion on the potential endocrine disrupting properties of glyphosate that was published on 7 September 2017.

  11. 2017
    25 October

    The Commission held another round of discussions with the Member States on the proposal for the renewal of approval of glyphosate for 10 years at the Standing Committee on Plants, Animals, Food and Feed. All Member States took the floor and expressed their views on which the Commission took note.

  12. 2017
    9 November

    At the Standing Committee on Plants, Animals, Food and Feed, Member States voted on the Commission's proposal (revision 3) for the renewal of approval of glyphosate for 5 years. The Committee delivered a no opinion on this proposal (see minutes of the meeting below for further details).

  13. 2017
    27 November

    A qualified majority in favour of the proposal by the European Commission to renew the approval of glyphosate for a period of 5 years was reached by the Appeal Committee. Some modifications were made to the draft Implementing Regulation during the meeting (see revision 4 below for the text voted in the Appeal Committee).

  15. 2017
    12 December

    Is published in the Official Journal.

    It is the Member States that decide whether to authorise plant protection products containing approved substances, such as glyphosate, for use on their territory. However, the regulation establishes conditions for further use of glyphosate, including:

    • products containing glyphosate may not contain the co-formulant POE-tallowamine
    • Member States must ensure that the use of PPS containing glyphosate is minimised in public spaces such as parks, public playgrounds and gardens
    • Member States must pay particular attention to the compliance of pre-harvest uses with good agricultural practices

Drafts of the implementing regulation

Standing Committee on Plants, Animals, Food and Feed – extracts from summary reports 2017

European Chemicals Agency's conclusions

On 15 March 2017, the Risk Assessment Committee (RAC) of the European Chemicals Agency concluded by consensus that:

  • There is no evidence to link glyphosate to cancer in humans, based on the available information
  • Glyphosate should not be classified as a substance that causes genetic damage (mutagen) or disrupts reproduction.

The same conclusion was also reached by the following organisations:

The International Agency for Research on Cancer remains, therefore, the only agency with a divergent view.