Glyphosate: Latest Situation on the EU Approval Renewal Procedure for the Active Substance

The scientists of the EU Chemicals Agency ECHA completed their assessment on a European-wide, harmonised hazard classification on 15th March, 2017: according to their findings, glyphosate is neither carcinogenic, nor toxic for reproduction nor mutagenic. Glyphosate causes eye damage and is toxic for water organisms with long-term effects.

GECHA Glyphosate Hazard Classification (2017)

Glyphosat: EFSA Risk Assessment (2015)

The ECHA’s Committee for Risk Assessment (RAC) sent the European Commission its independent scientific opinion on glyphosate on 15th June, 2017. The Commission will discuss this opinion together with the Member States as part of the decision as to whether the approval for using glyphosate as an active substance in plant protection products will be extended.

FAQ of ECHA: What happens next? 

EU Commission: Temporarily Extended Approval of Glyphosate

Now that all the scientific decision criteria – including the hazard classification by the ECHA and the risk assessment carried out by the EFSA – were sent to the EU Commission, the Commission can now consider the renewal the approval for glyphosate. No qualified majority (= 55 % of Member States, who represent at least 65 % of the EU population) has been reached during the meetings with experts from all 28 Member States up to now, as many Member States wanted clarification on suspicions of the substance’s potential carcinogenic properties; as a result, the College of Commissioners agreed unanimously on a temporary renewal of the existing approval of the substance in a written procedure in 2016 (see EU Comitology/Legislative).

This means that the existing approvals for pesticides containing glyphosate and authorised for the use in Austria remain unchanged in Austria. The extension will be valid up to six months after completing the hazard classification carried out by ECHA or 31st December, 2017 at the latest. By that time, the EU Commission and Member States will be required to reach an agreement on risk management measures, i.e. application regulations to protect users, consumers and the environment.

Austria Backing Limits for a Better Environment

The AGES risk assessors consider the active substance as safe for humans, thus, meeting the key standards for user and consumer protection. However, all possible effects on the environment should be reduced to a minimum. Austria has demanded repeatedly at expert levels to limit the use of glyphosate in agricultural and non-agricultural fields to protect biodiversity and the environment.

In view of integrated plant protection, Austria has already implemented “as few as possible and as many as really necessary” legal limitations at the Federal and licencing levels. As a result, the use of plant protection products directly on sealed areas is prohibited. Moreover, using glyphosate to kill off culture plants to speed up their ripening before harvest (siccation) has also been prohibited, as long as the harvested plants are intended to be served as food or feedstuffs. The authorisation agency BAES has been revoking existing approvals for glyphosate-containing plant protection products with the additive tallow amine since August 2016 (BAES), so that there is no license for glyphosate-containing plant protection products with tallow amine in Austria at present. However, the regulation and limitation of the use of plant protection products is subject to the individual plant protection laws of the nine Austrian provinces.

The European Agency for Food Safety EFSA and risk assessors from the European Member States have reassessed the active substance glyphosate. They conclude that it is unlikely that glyphosate is a carcinogenic substance or that it damages the genetic material of humans. No causal link (link between cause and effect) between glyphosate exposure and cancer in humans is shown in epidemiologic data regarding humans, nor in the results of studies conducted on animals. Glyphosate causes no harm to human reproduction and has no neurotoxic effects.
All available and published scientific studies were used in the reassessment of glyphosate. These studies include original studies, which must be provided by applicants as part of  licensing procedures, and studies conducted and published by research institutes on a worldwide basis. These studies also include the studies used by the International Agency for Research on Cancer (IARC) for its assessment. Furthermore, there are assessment reports by various non-European authorities, which consider glyphosate – in unison with the EFSA and ECHA -  as non-carcinogenic:

• the US Environmental Protection Agency EPA 
• the Canadian assessment body Pest Management Regulatory Agency (PMRA) 
• the Australian assessment body Australian Pesticides and Veterinary Medicines Authority (APVMA)
• the Japanese Food Safety Commission
• the New Zealand EPA 
• the Joint FAO/WHO Meeting on Pesticide Residues (JMPR)

Thus, the classification of glyphosate as “probably carcinogenic to humans” by the International Agency for Research on Cancer (IARC) is in clear contradiction to the assessments provided by other authorities and committees.

EFSA Risk Assessment: Glyphosate Safe to Use

The European Agency for Food Safety EFSA and risk assessors of the European Member States have reassessed the active substance glyphosate. They conclude that it is unlikely that glyphosate is carcinogenic or that it damages the genetic material of humans. No causal link between glyphosate exposure and cancer in humans has been shown in epidemiologic data regarding humans, nor in the results of studies conducted on animals. Glyphosate causes no harm to human reproduction and has no neurotoxic effects. This view is similar to that of the group of risk assessment experts for plant protection product residues at the World Health Organization WHO, the Joint FAO/WHO  Meeting on Pesticide Residues (JMPR). Whereas the International Agency for Research on Cancer (IARC) of the WHO classifies the substance as probably carcinogenic to humans. However, the IARC evaluates the body of evidence that glyphosate could cause cancer, and not the risk of actually developing cancer. On top of that, the IARC did not have access to all the data used by the EFSA and ECHA as a basis for their assessment. The classification by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans is unjustified, according to the EFSA and ECHA.

EFSA Conclusion

EFSA Explains Risk Assessment: Glyphosate

EFSA: Peer Review Background Documents 

Federal Institute for Risk Assessment (BfR) on Glyphosate 

New Health-Related Limit

A so-called acute reference dosage (ARfD) has been defined for glyphosate for the very first time: this is the quantity of a substance in a food product that can be ingested on a short-term basis – usually within a day or during a meal – without any risk to health.
This reference dose is 0.5 milligram per kilogram bodyweight per day for glyphosate. This means that a person weighing 70 kilos can ingest a one-time dose of 35 milligrams of glyphosate without any health risk. Additionally, the same dosage of 0.5 milligrams (at present: 0.3) per kilogram bodyweight per day was suggested as the acceptable daily intake – the amount of a substance that can be ingested on a daily basis over a person’s lifetime without suffering any adverse health effects.

A separate health-related limit (AOEL = acceptable operator exposure level) was defined for individuals working with glyphosate: this limit has been set to 0.1 milligrams (currently 0.2) per kilogram bodyweight per day. This means that a person weighing 70 kilos working with this active substance can ingest 7 milligrams of glyphosate per day without risking adverse health effects.

Why do the EFSA and national risk assessment agencies in Europe contradict the International Agency for Research on Cancer (IARC) and say that glyphosate is probably not carcinogenic to humans?

All the available and published scientific studies were used for the latest reassessment of glyphosate at the European level. These studies include original studies, which must be provided by applicants as part of licensing procedures, and studies conducted and published by research institutes on a worldwide basis. They also include the studies used by the International Agency for Research on Cancer (IARC) for its assessment. In other words, the European authorities have assessed more studies and data than the IARC.

The European scientists participating in this reassessment evaluated more studies on rats and mice than the IARC scientists: three out of five studies on mice and three out of nine long-term studies on rats were not assessed by the IARC. Additionally, the statistical evaluations that were carried out were interpreted differently. The EFSA and the European Member States also included biological plausibility and relevant historic control data providing information on the spontaneous cancer rate in their conclusions.

Such research uses specially bred laboratory mice and rats so that the results of different studies are comparable. These animals ingest the tested chemical substance in different dosages with their food over their entire lifespan. Cancer development at the end of their lives must be compared to the “natural” cancer rate in untreated animals. The IARC did not carry out this comparison.

EFSA and ECHA Answer IARC (Joint Statement English)

EFSA and ECHA Answer Christopher Portier (BfR in German)

IARC Monography Glyphosate

ECHA Hazard and Labelling Classification

The hazard and labelling classification of glyphosate is carried out by the European Chemicals Agency ECHA. The assessment by the Committee for Risk Assessment (RAC) of the ECHA is based solely on the dangerous properties of the substance and the question whether the substance may cause damaging effects. The risk or extent to which individuals and the environment are exposed to this substance is not taken into account. The German Federal Institute for Risk Assessment (BfR) sent the data of their tests on the active substance to ECHA in 2016.

The ECHA Risk Assessment Committee (RAC) confirmed the existing classification of glyphosate as eye-damaging and chronically toxic for bodies of water (Eye dam 1, H318; aquatic chronic 2, H411) in a press statement released on 15th March, 2016. The classification of the substance as having mutagenic, carcinogenic or reproduction-toxic properties or specific toxicity for organs is considered unjustified in line with Regulation (EU) 1272/2008.

Details on the ECHA Assessment 

Glyphosate Residues in Foodstuffs

AGES examined a total of 1,268 official food samples (oilseed, pulses, vegetables, cereals, fruit, other products) for glyphosate between 2012 and 2016.
463 samples (37 %) came from organic farming
433 samples (34 %) came from Austria

Results

• None of the samples exceeded the legal residue maximum in line with the “pesticide regulation“ (Regulation (EC) No 396/2005). 
• 95 % of the samples tested were free from glyphosate residues. 
• 5 % of the samples tested showed measurable glyphosate residue levels (58 samples). 
• Glyphosate residues were found especially in lentils (30 out of 110 samples; 27%) and linseeds (11 out of 62 samples; 18%)
• Samples from organic farms: 4 out of the 58 samples with measurable glyphosate residues came from organic farms (lentils and linseeds from third countries). Glyphosate is not allowed to be used as plant protection product in organic farming.
• Origin Austria: 9 out of 433 food products originating in Austria (2%) showed measurable glyphosate residue levels.

Drinking Water Survey: No Residues in Austrian Drinking Water Supply

The quality of drinking water is monitored as part of self-checks carried out by the operators of drinking water supply facilities. Austrian drinking water suppliers are legally obliged to have their water tested at accredited laboratories. AGES has been carrying out tests for glyphosate and AMPA for drinking water supply facilities since 2008 and has found no residues in any of the samples taken to date. For further information consult the Austrian Drinking Water Report 2011 – 2013.

Control of Feedstuffs: Limits not Exceeded in Feedstuffs

The Austrian Federal Office for Food Safety (BAES) examines feedstuffs for glyphosate. A total of 10 random samples per year – mainly soy products (including imports) – are tested specifically for glyphosate, in addition to the risk-based control plan, which does not include glyphosate analysis.

Analysis

Examinations on residues in plant protection products in food and feedstuffs are carried out at the AGES Institute for Food Safety, which is the National Reference Laboratory for plant protection product residues. A new study on a new analytical method to determine glyphosate presence was published together with the National Reference Laboratory of Belgium (ISP Brussels) Goscinny S.,  Unterluggauer H.,  Aldrian J.,  Hanot V. and Masselter S., 2012: Food Analytical Methods, October 2012, Volume 5, Issue 5, pp 1177-1185, Determination of Glyphosate and Its Metabolite AMPA (Aminomethylphosphonic Acid) in Cereals After Derivatization by Isotope Dilution and UPLC-MS/MS).

The use of plant protection products always has an indirect effect on the ecosystem and biological diversity. The use of highly-effective broad-spectrum herbicides, such as glyphosate, inevitably results in reduced plant diversity, which in turn will take away the source of nutrition for many birds, mammals and other animal species. The active protection of non-cultivated land and introduction of ecological compensation areas can counteract these indirect effects.

• Given its chemo-physical properties, glyphosate forms strong bonds with minerals in the soil (= adsorption). This feature prevents the substance from sinking into deeper soil-layers and, consequently, into groundwater. 
• The active substance glyphosate and its metabolite AMPA were classified as non-toxic to soil-dwelling organisms (earthworms, springtails and predatory mites) in laboratory tests.
• Effects on earthworms (behaviour, weight, reproduction) caused by the use of pesticides containing glyphosate cannot be fully excluded, given recent studies in the appropriate literature.
• Glyphosate is degraded by microorganisms in the soil. Additionally, some species and genii were very glyphosate sensitive, while others show no effects at all. This could result in a change of the combination of species present in the soil, which could affect both processes and life in the soil.
• Using laboratory and field data, it could be shown that glyphosate has no toxic effect on insects (useful insects such as predatory mites) and pollinating insects (bees). 
• Glyphosate has no acute toxic effects on birds and mammals, but has moderately, chronic toxic effects on birds and mammals. Especially birds and mammals feeding on plants could consume high residue levels via their food depending on the quantity of glyphosate used.

Glyphosate is used in many fields: in addition to its use in agriculture (incl. weed control in various cultures, preparing cultures for cultivating), it has also many applications in non-agricultural fields, such as urban areas (industrial sites, tracks, roads, pavements and squares) and also in homes and home gardens – see application guidelines in the Plant Protection Product Register of the Austrian Federal Office for Food Safety.

Every year, the Austrian Federal Office for Food Safety (BAES) surveys the quantity of the active substance “placed on the market” for the first time in Austria in the given calendar year: however, this marketed quantity does not give any indication how much of it has been actually used on local fields or gardens.

The BAES has no statistical data on the annual use of plant protection products in Austria. As part of the implementation of EU Regulation (EC) No. 1185/2009, the development of operator statistics were commissioned. The first data was expected for 2016. For private use, it must be said that survey data on the use of pesticides is subject to the Austrian provincial governments.