To be carcinogenic or not!
Brussels, 1 June 2016 – The EU’s authorisation procedure as regards pesticides is the strictest in the world. It takes years of scientific assessment before an active substance is authorised – or renewed at EU level. Our scientific process is very stringent and relies on pooling of expertise between the European Food Safety Authority and all 28 Member States. Our proposals and decisions on glyphosate were based on the guided assessment done by EFSA and before it – German Federal institute for Risk Assessment (Bundesinstitut für Risikobewertung). They both concluded that Glyphosate is unlikely to be carcinogenic.
Since last autumn, my services have been discussing with the Member States the best way forward on the renewal of glyphosate in the Expert Committee. We have been aiming at a solution that commands the widest possible support of the Member States. So far, even though a majority of Member States is in favour of the renewal, no qualified majority has been reached, in spite of the Commission’s efforts to accommodate requests and concerns from a number of national governments, as well as from the European Parliament (which expressed itself in favour of a 7-year renewal). Some Member States have been reluctant to take a position.
It is important to clarify that once an active substance is approved – or renewed at EU level – it is then up to Member States to authorise the final products (the herbicides and pesticides themselves) put on their respective markets.
The EU approval of an active substance only means that the Member States can authorise plant protection products on their territory, but they are not obliged to do that. The Member States who wish not to use glyphosate based products have the possibility to restrict their use. They do not need to hide behind the Commission’s decision.
However, if there is no EU approval, Member States have no choice anymore: the authorisation expires on the 1st of July. Should there be no extension, Member States would have to withdraw the authorisations for plant protection products containing glyphosate from their market.
We have now called for the Expert Committee to meet on the 6th of June to discuss the file once again and take the vote on the basis of a limited extension of the current approval, until ECHA opinion dispels the remaining doubts.
Indeed, under the EU law, the last word belongs to the ECHA (European Union’s Agency for Chemical Products), this is why the Commission proposes to ask ECHA for its scientific assessment on the carcinogenicity of the glyphosate and to extend the current approval of glyphosate until it receives ECHA’s opinion.
Next Monday, Member States will therefore be asked to vote on such a measure. Once again, this is a collective decision.
Going beyond these immediate measures, the Commission is preparing a second decision, reviewing the conditions of use of glyphosate. In this decision, I would like to make 3 clear recommendations to the Member States:
* Ban a co-formulant called POE-tallowamine from glyphosate based products;
* Minimise the use in public parks, public playgrounds and gardens;
* Minimise the pre-harvest use of glyphosate.
The responsibility to introduce such type of measures belongs to the Member State, but I believe this is important to promote sustainable use of pesticides and herbicides. The Commission has done its outmost to reach a suitable solution, based on sound scientific evidence. The high level of protection of human health and the environment, as provided for by the EU legislation, is paramount. At the same time, I remained deeply convinced that our decisions should remain based on science, not on political convenience.
Frequently Asked Questions: Glyphosate
What is glyphosate?
Glyphosate is an active substance used for the production of pesticides, which has been authorised in the EU since 2002. It is the most frequently used herbicide worldwide and in the EU, and one of several hundred active substances that have been assessed by Member States and the European Food Safety Authority (EFSA) in recent years Every year, around 40 such active substances are approved or renewed at European level. .
Glyphosate-based pesticides (i.e. formulations containing glyphosate and other chemicals) are used in agriculture and horticulture, primarily to combat weeds that compete with cultivated crops.
Does the EU authorise the placing on the market of pesticides?
No, that’s the role of the Member States, but active substances in the pesticides have to be approved at EU level.
Once an active substance has been approved or renewed at EU level, the safety evaluation of every pesticide (also referred to as Plant Protection Products PPPs) formulation is done at a later stage by individual Member States before they grant, refuse or restrict – the use of pesticides formulations at national level.
In their authorisation decision, Member States can therefore define the conditions for use of the product, for instance; restricted to certain crops; to professional use; for use in glass houses only.
An active substance undergoes an intensive evaluation and peer-review by Member States and the European Food Safety Authority, before a decision can be made on approval.
Before an active substance can be used within a product in the EU, it must be approved at EU level.
Pesticides and herbicides sold in the market also referred to as Plant Protection Products (PPPs) contain at least one approved active substance.
Before any pesticide can be placed on the market or used, it must be authorised in the Member State(s) concerned.
Member States could grant, refuse or restrict the use of a specific product.
Regulation (EC) No 1107/2009 lays down the rules and procedures for authorisation of Plant Protection Products.
What has been so far the procedure for a possible renewal of glyphosate?
The EU has one of the strictest systems in the world for the assessment of pesticides. Hundreds of other active substances, like glyphosate, have gone through or are going through a stringent scientific assessment process. The EU approval of an active substance is only granted for a limited period of time (up to 15 years) and must be renewed regularly.
As regards glyphosate, it had been under evaluation, since 2012, for a possible renewal of the approval, following the procedures laid down in EU legislation on plant protection products (PPPs).
The EU approval of an active substance means that the Member States can authorise plant protection products on their territory, but they are not obliged to do that. Nonetheless, if there is no EU approval, Member States have no choice.
1. May 2012: Assessment of the active substance by the Rapporteur Member State, in this case Germany. Germany’s national authority receives dossier for possible renewal of the approval of the active substance glyphosate.
2. December 2013: Germany sends report to the European Food Safety Authority (EFSA) so that the peer review by EFSA and all Member States can start (January 2014). It includes a public consultation (March 2014); Additional information requested from applicants (August 2014).
3. February – March 2015: Nationalexperts’ meetings including risk assessors from all 28 Member States’ organized by EFSA.
4. March 2015: Publication of a report by the International Agency for Research on Cancer (IARC) on glyphosate – Commission asks EFSA to include it in its peer review.
5. September 2015: A new experts’ consultation specifically dedicated to carcinogenicity organised by EFSA.
6. October 2015: Glyphosate approval provisionally extended until June 2016, pending finalization of the EU peer review.
7. November 2015: Publication of EFSA’s conclusion.
8. May 2015: The Joint UN Food and Agriculture Organisation/ World Health Organisation Meeting on Pesticide Residues (JMPR) publish their risk assessment on glyphosate.
9. June 2016: End of the provisional extension at EU level of the active substance glyphosate.
In all, the EU’s assessment of glyphosate has taken 3 years, involving public sector scientific experts from EU’s agencies (EFSA and ECHA) and national authorities in all 28 Member States.
27 Member States agree with EFSA’s conclusion on carcinogenicity (Sweden was in favour of another classification).
Will there be additional scientific work on glyphosate?
Yes. Primarily, EFSA continues its on-going review of the existing Maximum Residue Levels (MRLs) for glyphosate. A Maximum Residue Level is the highest level of pesticide residue that is legally tolerated in, or on food or feed, when pesticides are applied correctly.
Moreover, at EU level, an evaluation of glyphosatebythe European Chemicals Agency (ECHA), which is responsible for managing the harmonised classification process for chemical substances, was recently initiated.
Finally, the Commission can review the approval at any time – in case relevant scientific elements are published.
What will be the European Chemicals Agency work on glyphosate?
The European Chemicals Agency (ECHA) is responsible for managing the harmonised classification (CLH) process for hazardous chemical substances. Active substances in Plant Protection Products (PPPs) are normally subject to harmonised classification and labelling. The CLH process for an active substance is triggered when a proposal for harmonised classification of that chemical substance is submitted by a Member State competent authority to the Agency. Thereof, and as part of the procedure for a possible renewal of glyphosate approval under the PPP legislation, a harmonised classification and labelling proposal has been prepared by the German national competent authority (BAuA), since the country is the Rapporteur Member State for glyphosate. For details on the process please see here: ECHA Harmonised classification and labelling. Once the opinion of the Agency has been adopted by the ECHA’s Committee for Risk Assessment (RAC), it will be published and forwarded to the Commission.
Why is the ECHA opinion important?
ECHA is the competent EU agency for the assessment of dossiers for the classification of chemical substances. Moreover, the procedure for harmonised classification of glyphosate was already initiated. The discussions in the Standing Committee on Plants, Animals, Food and Feed on 18 and 19 May 2016 showed that in the specific situation of glyphosate a number of Member States, in their role as risk managers, considered that it was appropriate to have an opinion of the Committee for Risk Assessment of ECHA on the harmonised classification as regards carcinogenicity of glyphosate, before taking a decision. Such an opinion is relevant for the approval based on the criteria set out in EU Regulation (EC No 1107/2009).
What is the Commission proposing to Member States?
The Commission called for the Standing Committee to meet on June 6 to discuss with the Member States the extension of the current approval of glyphosate for a limited period until the European Chemical Agency ECHA has concluded its review.
The Commission is also preparing a second decision, reviewing the conditions of use of glyphosate that will contain three clear recommendations to Member States: 1) ban a co-formulant called PAO-tallowamine from glyphosate based products: 2) minimise the use of the substance in public parks, public playgrounds and gardens; 3) minimise the pre-harvest use of glyphosate.
The Commission will make these recommendations to promote a sustainable use of pesticides and herbicides, although the ultimate responsibility to introduce such type of measures, concerning the use of the final products, belongs to Member States.
What could be done in particular as regards the co-formulants?
Co-formulants are used to produce pesticides, but are neither active substances, safeners, nor synergists. They can already be banned or restricted for use at national level.
POE-tallowamine, one of the co-formulants used for glyphosate-based products, has raised concerns regarding its toxicity. The Commission is in favour of banning POE-tallowamine as a co-formulant in glyphosate-based products and will address this issue with Member States. It must also be noted that an EU experts’ group has already been put together by the Commission with a view to set up the criteria in order to identify an EU list of banned co-formulants.
Are additional measures envisaged by the Commission?
Yes. As mentioned above, the Commission will present to Member States a series of recommendations on the use of glyphosate in public parks and playgrounds, as well as the pre-harvesting use of this substance, as part of its overall policy on sustainable use of pesticides.
It must be noted that it is primarily the responsibility of Member States to decide upon and enforce such measures.
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