12 Jan 2018
European Commission Renews Approval of Herbicide Glyphosate for Five Years After In-depth Re-evaluation
On 15 December 2017, the European Commission’s implementing Regulation 2017/2324, which renews the approval for glyphosate for five years following a favourable vote of Member States on 27 November 2017, was published in the EU’s Official Journal.
Glyphosate is a non-selective herbicide (weed killer) which is applied directly to plant foliage. Effective in controlling most weed species in many environments, glyphosate is mostly used in agriculture. Its agricultural use has considerably increased since the development of crops that have been genetically modified to make them resistant to glyphosate.
Hong Kong traders may be familiar with glyphosate as it has the highest global product volume of all herbicides and is sold as an everyday consumer good. In the EU, glyphosate is widely used by farmers, gardeners and public authorities for weed control, in particular in public spaces such as playgrounds and on train tracks.
Glyphosate has been detected in the air, in water and in food. The general population is exposed primarily when residing near sprayed areas (if used in the streets and parks of towns and cities), as well as through home use and in the diet.
The EU-wide use of glyphosate was approved back in 2002. As the approval period was going to expire in December 2017, glyphosate underwent a comprehensive re-evaluation process. The re-evaluation serves to consider new findings in research and development and to take into account new risk assessment aspects to decide on whether a substance may continue to be used in plant protection products in the future.
In 2015, the European Food Safety Authority (EFSA) conducted a comprehensive scientific assessment according to the rules for renewal of active substance approvals. This was done so as to confirm that glyphosate complies with the approval criteria laid down in the EU pesticides legislation, taking into account the latest scientific and technical knowledge. EFSA concluded that glyphosate is unlikely to pose a carcinogenic hazard to humans.
However, controversy was generated due to conflicting reports on the risks posed by glyphosate. In 2015, the International Agency for Research on Cancer (IARC), a WHO research agency whose mission is to identify causes of cancer, declared glyphosate a probable carcinogen (i.e. a substance which is directly involved with causing cancer). The IARC has published a report which linked glyphosate to tumours in mice and rats and identified DNA damage to human cells from exposure to glyphosate. Although the IARC does not have regulatory powers and cannot therefore implement a ban or restriction directly, as an agency of the WHO, its research is authoritative and widely influential.
Therefore, the renewal process of the approval for the use of glyphosate generated a great deal of interest and a broader debate on the authorisation and use of pesticides in the EU. Given the diverging opinions of the IARC and EFSA on the potential carcinogenicity of glyphosate, the European Chemicals Agency (ECHA) was asked to assess the hazard properties of the substance.
Already in 2016, the European Commission unsuccessfully proposed renewing the approval of glyphosate to the Member States. Then, a vote on the re-approval failed to reach a qualified majority in favour of extension. The European Commission then extended the approval of glyphosate for a limited period to allow ECHA sufficient time to conduct its assessment of the potential carcinogenicity of glyphosate.
The Risk Assessment Committee (RAC) of ECHA concluded that in the light of current scientific and technical knowledge there is no scientific evidence which links glyphosate to cancer in humans. Moreover, glyphosate should not be classified as a substance that causes genetic damage (mutagen) or disrupts reproduction.
With regard to this finding, the European Commission deemed it appropriate to renew the approval of glyphosate for a period of five years ensuring a priority re-assessment of glyphosate over other active substances. Usually, the European Commission proposes renewal of authorisations for a period of 15 years when all approval criteria are met. However, glyphosate is no standard case. For setting the appropriate period for renewal, factors such as the fact that additional information on the substance is being published at a high rate were taken into consideration.
In order to ensure a level of safety and protection consistent with the high standards for humans and the environment sought within the EU, the inclusion of certain conditions and restrictions was deemed necessary. The Regulation establishes conditions for the further use of glyphosate in the Member States:
- Member States shall ensure that plant protection products containing glyphosate do not contain the dangerous co-formulant called polyethoxylated tallow amine or polyoxyethyleneamine (POEA);
- When considering applications for glyphosate-based products, Member States have to take into account the protection of groundwater and of terrestrial animals and non-target plants;
- During the authorisation procedure, Member States must ensure minimising the use in public spaces, such as parks, public playgrounds and gardens and scrutinise the pre-harvest use of glyphosate.
Hong Kong traders should be aware that glyphosate-based products are not automatically re-authorised. Only the approval of active substances is decided at EU level. It is the individual Member States who are responsible for the authorisation and use on their territories of specific plant protection products containing active substances such as glyphosate.
Following an EU-wide renewal of the approval of glyphosate, Member States must now re-evaluate all existing authorised products containing this active substance. Should authorisation holders request national authorities to maintain the earlier authorisations, Member States might decide to introduce restrictions or bans for some or all of them, where this is warranted on the basis of the new conditions mentioned above.
The decision continues to incite controversy at European as well as Member State level. As recently as October 2017, the European Parliament had called for a full phase-out of glyphosate within five years.
While consumer associations feel that the European Commission has failed to adequately protect the health of its citizens and the environment, farmers and the pesticide industry expressed disappointment that the renewal was only pronounced for a period of five years.
A citizens’ initiative opposing the use of glyphosate in Europe was rejected, but was successful in its demand for increased transparency in the decision-making process and access to the scientific studies underlying the approval of active substances. Legislative proposals requiring EU agencies to make publicly available all the research material used in their product assessments, possibly including confidential studies conducted by industry, may be expected by spring 2018.