The problems with the new European proposal on plant protection product risk assessment

Proposals currently being discussed by EU policymakers and Member States to simplify the approval and use of pesticides could weaken environmental risk assessment, with potentially harmful consequences for biodiversity and human health. This is the warning  issued in Science da un gruppo internazionale di studiose e studiosi nel campo dell’ecologia, delle scienze agrarie e del monitoraggio ambientale.

The proposal, known as the “Omnibus X” package, is part of the European Commission’s simplification agenda and has already received initial backing from the Council of the EU. It aims to streamline rules and procedures for the approval and oversight of pesticides and other chemicals, as well as controls on animal feed and animal welfare.

UniboMagazine discussed the proposal with Fabio Sgolastra, Professor at the University of Bologna’s Department of Agricultural and Food Sciences and one of the authors of the commentary published in Science.

Professor Sgolastra, what concerns do you have about the EU proposal?

The proposal has a reasonable objective: to speed up the process and reduce the administrative burden involved in approving new plant protection products for sale and use. However, the current EU regulatory framework already has a number of weaknesses, and this new simplification package risks making them even more significant.

How so?

One of our main concerns is the proposal to remove the requirement for authorisations to be renewed periodically. At present, many of these substances are authorised for ten years, after which they must undergo a new risk assessment. Under the new proposal, approvals would no longer be subject to a time limit and would remain valid unless evidence emerged of specific adverse effects. The problem is that without systematic monitoring once a substance is on the market, it is extremely difficult to detect any harmful effects that may emerge over time.

The current system has, however, led to long delays in renewing authorisations.

These delays are primarily due to staff shortages. EFSA, the European Food Safety Authority, has estimated that an investment of €15 million would be enough to clear the entire backlog of renewal applications. This is a relatively modest amount when you consider that the chemical industry can spend hundreds of millions of euros developing a single active substance and bringing it to market.

You also point out that companies can choose which country to apply to for the necessary authorisations. Why is this a problem?

The Omnibus package would introduce a single-zone authorisation system, replacing the current system based on three geographical zones. At present, companies can apply for authorisation in a country within a particular zone and, once granted, market the new substance in any EU country belonging to that zone. Each country has its own regulatory authority, and the decision taken by one Member State then applies throughout the zone. The problem is that some countries apply more stringent assessment standards than others, leading to clear disparities in risk assessment procedures.

 What other weaknesses do you see in the current risk assessment system?

There are several. One is the use of “model species” to assess the risks posed by new pesticides. For pollinators, for example, the honey bee is used as the model species, but it is not truly representative: there are thousands of other pollinating insects, and they differ greatly from one another. For risk assessment to be effective, we should instead identify and use the species that are potentially most vulnerable. If we can protect the most vulnerable organisms, we can be confident that the others will be protected too. We also need to take sublethal effects into account.

What does that mean?

Current assessments focus on mortality caused by these products, but do not take other effects into account, such as physiological or behavioural changes. To return to the example of the honey bee, some products may not kill bees but can impair their ability to navigate and find their way back to the hive. That is a very serious sublethal effect: a bee that cannot find its way back to the hive is unlikely to survive for long. More broadly, one of the most challenging issues is understanding the real-world effects of these substances under field conditions.

What do you mean?

For example, current risk assessments assess each pesticide separately, in isolation from other products. But we know that multiple substances are often present in the environment at the same time. That is why data on which products are being used, and in what quantities, need to be made available to the scientific community. This would allow researchers to assess and monitor the effects of the combinations of products most commonly found in the environment.

Data transparency is another issue you highlight in your commentary.

Farmers are already required to keep records of the products they use on their fields, but in practice these data are largely inaccessible. The same is true of the data companies submit when seeking approval to market new products: these are not publicly available. Giving the scientific community access to this information would make it possible to carry out independent checks and assessments.