Today, the General Court of the EU clarified in a judgement that EU Member States are required to demand toxicity data for co-formulants used in pesticides. The absence of such data in the pesticide industry applications must inevitably lead to a rejection of the request and a suspension of the national authorisation.
Martin Dermine, PAN Europe’s Executive Director, said: “Currently, the industry systematically fails to submit the needed toxicity information on co-formulants. This positive outcome of our legal action should lead to the rejection of all ongoing national pesticide authorisation requests from the pesticide industry. It will help give EU citizens better protection against exposure to these harmful chemicals.”
While the General Court rejected PAN Europe's request to force the European Commission to revise its 2023 regulation on co-formulants to make it more protective for citizens' health, the Court made important clarifications that reinforce Member States’ responsibilities:
- The industry must provide, in their initial application dossier, all necessary information to evaluate the toxicity of co-formulants.
- Member States have the obligation to ensure that the industry's pesticide application dossiers are complete and contain all needed information to allow for the evaluation of the toxicity of co-formulants.
- If a dossier lacks sufficient data to evaluate the toxicity of all co-formulants within the legal timeframe, the application must be rejected.
Pr. Antoine Bailleux, PAN Europe's Counsel said: “While the General Court failed to acknowledge that detailed data requirements for all co-formulants must be set out in an EU implementing regulation, it nonetheless made it clear that the lack of such requirements does not relieve the Member States from their obligation to carry out a systematic and explicit evaluation of each co-formulant present in pesticides. This is the major take-away of this ruling.'”
Salomé Roynel, Policy Officer at PAN Europe, concluded: “Co-formulants are currently a black box. For around half of them, we do not even know if they are carcinogens or mutagens, even though they are petroleum derivatives that are intentionally sprayed on the food we eat. This judgement will help put some rigour in the way Member States deal with pesticide evaluations.”
Background information
In December 2023, PAN Europe filed a legal action against the new EU regulation on pesticide co-formulants, which are additional ingredients used to increase the toxicity of the product. [1]
This regulation is a weak legislation without an obligation for pesticide companies to provide the toxicity data of these substances. For more than half of all co-formulants, the Commission holds no information at all about their potential toxic effects. [1] However, many of these substances are known to pose serious risks to human health and the environment, particularly to insects and aquatic life.
EU pesticide law (Article 27) clearly requires that co-formulants should not have any harmful effect on human health or the environment. However, the Commission's recent regulation on co-formulants shifts the burden of proof for the safety of these substances from the pesticide industry to Member States — without providing them with the necessary toxicity data. As a result, the Commission imposed that the 27 Member states carry out 27 times the same risk assessment for co-formulants, instead of centralising it at EU-level (EFSA). [3]
PAN Europe calls for co-formulants to be subjected to the same level of safety assessment as active substances under EU pesticide law. There is no scientific or legal reason to treat co-formulants in a different way. Many co-formulants are petrol-derived volatile solvents, exposing farmers and rural residents to untested mixtures of carcinogens or reprotoxins. PAN Europe maintains that the Commission’s approach undermines EU pesticide regulation and leaves citizens and ecosystems unprotected.
EU pesticide legislation is designed to ensure a high level of health and environmental protection. Whenever there is significant uncertainty about a product’s safety, the precautionary principle should apply. This principle was reaffirmed in a landmark court ruling in 2023 concerning derogations for banned pesticides. [4]
What are co-formulants?
A co-formulant is a chemical that is added to a pesticide active substance (such as glyphosate or imidacloprid) to increase its toxicity. For instance, glyphosate kills weeds while imidacloprid kills insects, but in order to be effective, they need co-formulants to be added to the product. Added co-formulants can make up to more than 50% of a product formulation.
Although the pesticide industry presents them as “inert” or harmless, many co-formulants are in fact carcinogenic or toxic to reproduction. Despite their widespread use — thousands of different co-formulant chemicals are sprayed on food and released into the environment — their risks remain largely unassessed and unregulated. [5]
The toxicity and effects of pesticide products vary significantly depending on the co-formulants used. These substances not only enhance the performance of the active ingredient but can also increase the overall toxicity of the formulation or exhibit their own harmful properties. However, only the active substance goes through a harmonised risk assessment and approval procedure at EU level.
The European Commission has overlooked its responsibility regarding co-formulants. For decades, they were simply assumed to be “safe”. In 2021, the Commission finally adopted the long-overdue list of “unacceptable co-formulants”, containing 144 substances to be banned due to their hazardous properties. [6] Despite acknowledging the harmful impacts of these substances through this list, the Commission has yet failed to adopt comprehensive and harmonised risk assessment procedures to review and screen the added substances used in pesticides.
Contact:
- Martin Dermine, Executive Director, +32 486 32 99 92, martin [at] pan-europe.info
- Tjerk Dalhuisen, Communications Officer, +31 6 146 99 126, tjerk [at] pan-europe.info
Read more:
See the court judgement HERE.
Notes:
[2] Data collection on co‐formulants (EFSA)
[4] Groundbreaking EU Court ruling should stop all highly toxic pesticide derogations – now
[5] Co-formulants in pesticides
[6] Regulation (EC) 2021/383 amending Annexe III to Regulation (EC) No 1107/2009
