A Brief History
Glyphosate, chemically known as N-phosphonomethyl-glycine, was discovered in the 1970s by American chemist John E. Franz. It was first commercialized by Monsanto under the brand name Roundup®. Due to its effectiveness in eliminating a wide range of weeds, glyphosate quickly gained popularity in the U.S. and soon became the best-selling herbicide globally.
Monsanto wasn’t the only company to formulate glyphosate; over time, many formulations containing glyphosate entered the market. Riding on its success, Monsanto also began marketing glyphosate-resistant crops, enhancing both the effectiveness and selectivity of the herbicide.
How Glyphosate Works
Glyphosate works by inhibiting the synthesis of specific aromatic amino acids—phenylalanine, tyrosine, and tryptophan—which are essential for plant survival. These amino acids are not produced by the human body and must be consumed through food, making glyphosate’s toxicity to humans appear negligible. As a result, its widespread use in both the U.S. and Europe was not initially considered health- threatening.
Rising Health and Environmental Concerns
Despite the theoretical scientific rationale supporting its safety, glyphosate has come under increasing scrutiny. Over time, it has become a symbol of concern for both public health and environmental risk. Some U.S. states have banned its use, and numerous consumer advocacy groups have opposed it, citing potential risks from residue in food.
There is growing concern over a potential link between glyphosate exposure—particularly among agricultural workers—and the development of cancer, including non-Hodgkin’s lymphoma. In 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans” (Group 2A), based on studies indicating genotoxic effects.
Regulatory Reviews and Renewals in the EU
In 2017, the European Union granted glyphosate a five-year renewal, set to expire on December 15th, 2022. This deadline was later extended by one year. Four EU Member States—France, the Netherlands, Sweden, and Hungary—launched a joint risk assessment and submitted their findings to both the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA).
Their report did not propose changes to glyphosate’s current classification. A public consultation followed, and other Member States also reviewed the dossier. EFSA’s peer-reviewed assessment was submitted to the European Commission in July 2023. A draft renewal regulation was then presented in September 2023. On October 13, 2023, the Commission finalized the renewal, supporting the adoption of Implementing Regulation (EU) 2023/2660, which renews glyphosate’s approval until December 15, 2023.
What’s Next?
According to the final report, current evidence does not justify classifying glyphosate as carcinogenic, mutagenic, or toxic for reproduction (CMR). However, some changes were made to toxicological reference values:
- Acceptable Daily Intake (ADI): Remains at 0.5 mg/kg body weight
- Acceptable Operator Exposure Level (AOEL): Remains at 0.1 mg/kg body weight
- Acute Reference Dose (ARfD): Increased from 0.5 to 1.5 mg/kg body weight
- Acute AOEL: Newly introduced at 0.3 mg/kg body weight
The introduction of the acute AOEL aims to better assess acure exposure risks for operators and workers handling glyphosate-based products.
New Usage Restrictions
The renewal regulation also introduced several use restrictions, particularly in terms of dosage:
- Agricultural use: Maximum of 1.44 kg of glyphosate per hectare per year
- Invasive species control (agricultural and non-agricultural areas): 1.8 kg/ha/year
- Non-agricultural use: 3.6 kg/ha/year
These new limits, along with other regulatory conditions, will take effect after the renewal process for formulated products is completed, likely in the coming years.
