Covance releases report on regulatory revolution in biopesticides

The growth of global biopesticide market is much higher than conventional (synthesized) pesticides nowadays. The slowdown in the conventional pesticide market may result from the tightening of regulation across the world. The growth in the biopesticide market is picking up as consumers and regulators want to find products that are less toxic than conventional chemicals, and that support a more sustainable approach to food production. 

Despite this, biopesticides are usually regulated in exactly the same way as conventional pesticides and this creates an unnecessarily high barrier to approval and a huge burden on the small- and medium-sized enterprises, which are the current main innovators in biopesticides.

Issues in biopesticide regulation

Europe and the U.S. differ in their regulatory approaches to biopesticides, with the U.S. system being recognized by many as faster, and with a more appropriate evaluation approach, than the one in the EU.

Although both the EPA and EU are committed to encouraging biopesticide development, the EU system is lagging behind. One study showed that by 2016 there were:

- In the U.S.: 400 registered biopesticide-active ingredients (the EPA has a searchable list of all biopesticide-active ingredients registered to date).

- In the EU: 68 registered biopesticide-active ingredients (the EU also has a searchable list of all plant protection products, but it does not flag up which are biopesticides).

There are a number of issues and uncertainties related to biopesticide regulation, specifically in the EU, which act as a barrier to biopesticide approval and have multiple consequences.

Issues and consequences of the EU regulatory framework for biopesticides

Towards an ideal biopesticide regulatory framework

In 2017, the UN Food and Agriculture Organization (FAO) and World Health Organization (WHO) produced guidelines for the registration of microbial, botanical and semiochemical pest-control agents for plant protection and public health uses.

The goal was to provide a framework of practical guidance to facilitate best practice in biopesticide registration with a focus on data requirements and evaluation approaches that still ensure appropriate protection of human and animal health and the environment.

For biopesticides, approval may be granted on the basis of scientific arguments constructed using literature data. Evidence of efficacy and safety in humans, animals and the environment is required, although higher-tier testing is not usually necessary. In the EU, this is achieved through the use of sound waivers for specific data requirements. For some situations, there are no recognized test guidances, in which case all relevant scientific, peer-reviewed, open literature should be provided in any application to support the scientific justifications.

An additional challenge with botanicals and some semiochemicals under chemical regulation frameworks is that there are no set standards for efficacy, so these are at the discretion of the registrant, in discussion with regulators.

Download full report to see the best-practice requirements proposed by FAO and WHO guidelines, and more details in the regulatory framework >>