Glyphosate is unlikely to cause cancer in humans, according to the European Food Safety Authority (EFSA), which proposed higher limits on Thursday (12 November) on the amount of residue of the weedkiller deemed safe for humans to consume.
The EFSA advises EU policymakers and its conclusion could pave the way for the 28-member European Union to renew approval for glyphosate, which was brought into use by Monsanto in the 1970s and is used in its top selling product Roundup as well as in many other herbicides around the world.
Environmental groups have been calling for a ban after the International Agency for Research on Cancer (IARC), part of the World Health Organisation, said in March that glyphosate was “probably carcinogenic to humans”.
A campaign group said that 1.4 million people had signed a petition calling on the European Union to suspend glyphosate approval pending further assessment.
The EFSA said it had carried out a thorough analysis and taken account of the IARC’s findings.
“This has been an exhaustive process — a full assessment that has taken into account a wealth of new studies and data,” said Jose Tarazona, head of the pesticides unit at the EFSA, based in Parma, Italy.
“Regarding carcinogenicity, it is unlikely that this substance is carcinogenic.”
Higher safety limits
The EFSA is proposing a limit on the maximum safe daily dose over a period of time, of 0.5 milligrams per kilogram (kg) of body weight. It is also proposing a new acute limit, of the same level, for a single intake of glyphosate over a short period, for instance in one meal.
The previous EU evaluation had set an acceptable daily intake (ADI) of 0.3 milligrams per kg of body weight per day.
The scientists say an 80-kg (180-lb) person could eat food containing a residue of 40 milligrams of glyphosate per day for the rest of their life. Monsanto said that was the equivalent of eating 400 kg (900 lbs) of fruit or vegetables a day.
EFSA scientists, who worked with experts from EU member states, said their study differed from the IARC’s in that it considered only glyphosate, whereas the IARC had assessed groups of related chemicals. They said the toxic effects could be related to reactions with other constituents.
One of the 28 EU nations, Sweden, voiced reservations, saying it “considered that the classification criteria for limited evidence of cancer in humans were fulfilled,” the EFSA said.
The EU must decide over the coming months whether to renew existing approval for glyphosate use.
But Greenpeace called the EFSA’s report “a whitewash”.
“EFSA has defied the world’s most authoritative cancer agency,” Greenpeace EU food policy director Franziska Achterberg said in a statement.
Monsanto and other users of glyphosate, which is widely used by farmers, welcomed the report.
“It confirms the previous evaluations of glyphosate by regulatory authorities around the world, which have consistently concluded that the application of glyphosate poses no unacceptable risk to human health, animals or the environment,” Richard Garnett, chair of the Glyphosate Task Force, said in a statement.
The GTF brings together representatives of Monsanto and other companies.
Commission spokesman Enrico Brivio said the Commission took note of the report and that EU regulators now had until June next year to take a decision.
The Pesticide Action Network Europe, an environmental campaign group, said the EFSA opinion violated the precautionary principle. "EFSA only concludes to adverse effects in case of overwhelming evidence; in case of doubt they give the advantage of the doubt to industry instead of giving priority to the protection of human health and the environment,” said Hans Muilerman, Chemicals Officer at PAN Europe.
PAN Europe said EFSA’s work is "a copy of the German Government agency BfR’s assessment and the pesticide industry dossier compiled by the Glyphosate Task Force, hiding and misinterpreting the tumour incidences from experimental studies. This opens the road to the re-authorisation of this dangerous pesticide in the EU, which was recently classified as 'probable human carcinogen'".
In the European Parliament, the Greens were equally dissapointed. "There is a sad predictability about EFSA's decision to play down the risks associated with glyphosate," said Martin Häusling, the Green's agriculture and public health spokesperson. "The finding that glyphosate is probably carcinogenic to humans by the WHO should be leading to a global moratorium on its use. However, the industry lobby has been actively sowing seeds of doubt to maintain its products on the market, at the expense of human health. The ground for today's EFSA opinion had already been laid by the German risk assessment authority."
"This whole saga again raises serious questions about the flawed risk assessment procedure employed by EFSA, notably as regards its reliance on industry-supplied data, which necessarily skews its findings. There is a need to reform this to reduce the potential conflict of interest. Until this is done, the Commission [should] not continue to approve substances for which there is evidence of risks to human health."
Amid growing public concern over the impact of pesticides, the European Commission in 2006 presented a 'pesticides package' aimed at protecting human health and the environment from their dangerous or excessive use in agriculture.
Agreement on the package was reached in December 2008. The new regulations divide the EU into three zones (north, centre, south) inside of which mutual recognition of pesticides will become the rule.
However, member states will still be allowed to ban a product on the basis of specific environmental or agricultural circumstances:
- Certain highly toxic chemicals, namely those which are genotoxic, carcinogenic or toxic to reproduction (unless their effect would in practice be negligible) including neurotoxic, immunotoxic and certain endocrine-disrupting substances, if deemed to pose a significant risk.
- Asks member states to adopt national action plans on safer use of pesticides as well as overall usage reduction targets
- Bans aerial crop spraying, with exceptions subject to approval by member-state authorities.
- Asks member states to establish approporiate measures, such as buffer zones, to protect aquatic organisms.
- Bans the use of pesticides in public places, such as parks and school grounds, or at the very minimum asks for their use to be restricted.
The European Parliament voted to seal the agreement in January 2009.
European Food Safety Authority (EFSA)
- Glyphosate: EFSA updates toxicological profile (12 Nov. 2015)
Business & Industry
- Glyphosate Facts: EFSA confirms earlier regulatory assessments regarding glyphosate’s safety profile (12 Nov. 2015)
NGOs and think tanks
- Greenpeace: EU whitewash on cancer risk from world’s most used weedkiller (12 Nov. 2015)
- PAN Europe: EFSA’s (un-)scientific opinion: glyphosate not a carcinogen (12 Nov. 2015)