WASHINGTON, March 15, 2017 – Glyphosate is not a carcinogen, the European Chemicals Agency has concluded, setting the stage for the chemical – the active ingredient in Roundup – to receive long-term approval in Europe.

ECHA's Committee for Risk Assessment (RAC) found that “the available scientific evidence did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction,” ECHA said in a news release issued today. The RAC said, however, that the chemical causes “serious eye damage” and is “toxic to aquatic life with long-lasting effects.”

The committee emphasized that its conclusion “is based solely on the hazardous properties of the substance. It does not take into account the likelihood of exposure to the substance and therefore does not address the risks of exposure,” which would be considered “when deciding whether to renew the approval of glyphosate as a pesticide in accordance with the EU’s Plant Protection Product Regulation.”

European Crop Protection Association spokesman Graeme Taylor said that “science prevailed” in the decision, consistent with the existing 90,000 pages of evidence, 3,300 peer-reviewed studies, the opinions of the European Food Safety Authority (EFSA), the German Federal Institute for Risk Assessment (BfR) and regulatory agencies worldwide (that) glyphosate is not carcinogenic.

“We expect the European Commission to move swiftly with the registration process for the substance in the (European Union) and grant a 15-year approval – the same approval that was originally suggested by the EC before the substance became the subject of a political and emotional debate rather than a scientific one,” he said.

And Richard Garnett, chairman of the European Glyphosate Task Force, said, "The conclusion reached by the RAC reinforces the outcome of other evaluations of glyphosate which have been conducted by regulatory authorities around the world. The scientific evidence to support the renewal of glyphosate is overwhelming. On the basis of RAC’s robust assessment of scientific evidence, there is now no barrier to member states renewing the approval for glyphosate in the EU.”

An ECHA spokesman said it could be 10-15 weeks before the final RAC opinion is published and sent to the European Commission.

The announcement comes just a day before the expected release in the U.S. of a highly anticipated scientific review of the substance’s carcinogenicity. An Environmental Protection Agency Scientific Advisory Panel is due to issue a report tomorrow examining the evaluation by EPA’s Cancer Assessment Review Committee, which concluded glyphosate is “not likely to be carcinogenic to humans.” The SAP met for four days in December.

ECHA conducted its review in response to a submission from Germany’s BfR, which also has concluded glyphosate is not likely to be carcinogenic.

Developed by Monsanto and the active ingredient in the company’s Roundup herbicide products, glyphosate has been called the most widely used weed-killer in history. But its efficiency in the field has led some farmers to overuse it, which in turn has created glyphosate-resistant weeds.

The chemical’s toxicity also has been subjected to increasing scrutiny by scientific and regulatory bodies around the world. Virtually all, however, have said the chemical does not raise carcinogenicity concerns. “No regulatory agency in the world considers glyphosate to be a carcinogen,” Monsanto says.

A notable exception is the International Agency for Research on Cancer (IARC), which concluded in March 2015 that glyphosate probably causes cancer in humans, sparking a debate with long-lasting repercussions. The IARC report was partially behind EPA’s decision to have its Cancer Assessment Review Committee conduct a review.

Christopher Portier, who has become well known for defending the IARC review, criticized the ECHA evaluation.

“They got it wrong, it’s that simple,” he said today. ECHA’s guidelines for classifying evidence are “virtually identical” to IARC’s, sorting it into categories labeled “sufficient, limited or inadequate.” But in its draft document, on which Portier and many other interested parties submitted comments, ECHA classified the human evidence as “very limited.”

“They’ve made up a category,” he said. Portier is a former director of the U.S. National Center for Environmental Health at the Centers for Disease Control and Prevention. He was an “invited specialist” on the IARC glyphosate panel.

In its monograph, IARC said it came to its conclusion on carcinogenicity based on “limited evidence” from epidemiological studies that glyphosate causes non-Hodgkin lymphoma (NHL), and on “sufficient evidence” from mouse and rat studies.

Regarding the epidemiological studies, Portier said that “an association between glyphosate exposure and NHL exists that is probably not due to chance.” He also said there are “fairly consistent findings in mouse studies where you would have to conclude it causes cancer in mice.”

In a press briefing, RAC members said that IARC’s conclusion may have differed from theirs because IARC looked at studies of glyphosate formulations while RAC looked at studies using the “pure chemical.”

“We’re looking at different datasets,” said Ari Karjalainen, a scientific officer at ECHA.

Karjalainen said that in the animal studies RAC looked at, there was scant or inconsistent evidence of tumors.

The RAC members also said they looked at more studies than IARC did. The IARC committee relied on publicly available studies; ECHA also looked at studies provided by industry.

“Apart from the published studies on glyphosate, the committee also had full access to the original reports of studies conducted by industry,” the ECHA press release said.


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