05/11/2018 2 mins

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or the environment involving a plant protection product.

Metam-sodium is an active substance found in plant protection products used to control pests such as soil fungi or nematodes (soil-dwelling worms, some of which attack crops). These products are used to disinfect the soil before a crop is planted, mainly on market gardening crops such as lamb's lettuce and tomatoes, and in horticulture. 

Although these products are applied to small areas in open fields or greenhouses, they need to be used in large quantities to be effective. They are therefore applied at a rate of between 300 and 1200 litres per hectare, which represents nearly 700 tonnes used in France each year.

Following the active substance's approval at European level, ANSES reviewed all the marketing authorisations for products containing metam-sodium in France. It assessed the risks to human health and the environment associated with each use of the products, considering their conditions of use. After reassessment, ANSES concluded that all of these uses represented a risk to human health and the environment. The Agency has therefore notified the industrial companies concerned of its intention to withdraw the marketing authorisations for all metam-sodium products.

Moreover, recent poisoning events involving local residents and professionals have demonstrated the importance of reporting to ANSES any adverse events related to the use of plant protection products. ANSES reminds professionals that the reporting of adverse effects is a regulatory requirement, pursuant to Article L. 253-8-1 of the French Rural and Maritime Fishing Code. These phytopharmacovigilance reports enable the Agency to act promptly to prevent and control risks.

Phytopharmacovigilance: reporting health effects associated with plant protection products

The purpose of phytopharmacovigilance is to monitor all adverse effects associated with plant protection products available on the market. This vigilance scheme covers both the impact on human health and the environment, and phenomena of emerging resistance.

The reports received enable ANSES to intervene in real time to take all the measures needed to prevent or control risks associated with plant protection products.

Professional stakeholders, such as the marketing authorisation holders, manufacturers, importers, distributors or professional users of plant protection products, in addition to the advisers and trainers of these users, are required to report adverse effects. These reports are essential to the phytopharmacovigilance scheme, since these stakeholders are professionals on the ground, or are directly in contact with these professionals. It is therefore vital for ANSES to be notified of reports, whether by professionals or monitoring bodies belonging to the phytopharmacovigilance network, to enable the Agency to identify any products, substances or uses that pose a threat to public health or the environment.