3 Questions with BioTecnologie BT’s Piffanelli on EU Regulatory Environment

3 Questions with BioTecnologie BT's Piffanelli on EU Regulatory Environment


BioTecnologie BT, a Perugia, Italy-based contract research organization (CRO) specialized in the regulatory testing of biopesticides and biostimulants, develops innovative studies to enhance the understanding of the molecular mechanisms behind the beneficial effects of a diversified array of biologicals. These range from natural chemicals that are extracted from plants or microorganisms to bacteria and fungi that compete with pathogenic fungi and/or produce compounds that inhibit their attack on plants.


AgriBusiness Global had the chance to ask Pietro Piffanelli, General Director of BioTecnologie BT, a few questions about his thoughts on Europe’s challenging regulatory regarding biological products.

What is the current environment like surrounding regulation of biopesticides and biostimulants in Europe?

Presently in Europe, biopesticides need to undergo the same registration process of the conventional pesticides (Regulation (EC) N. 1107/2009). There is a strong push to change these guidelines to have a specific framework for biopesticides.

In Europe there is also an ongoing revision of the regulatory framework for the registration of biostimulants (2016/0084 – COD). In fact, presently, biostimulants are mainly registered as fertilizer. The objective is to create a specific new regulatory category (Product Function Category 05) for biostimulants, differentiating them with clarity from fertilizers.

Europe’s regulatory environment for conventional plant protection products does not look to be getting any easier – see the recent backing of ban on neonicotinoids. How might this impact the market for biologicals – including biopesticides and plant health products?

The recent restrictions on the use of a significant set of pesticides by the European Union or by specific Member States, indeed has paved the way to enhance the opportunities of developing innovative products with lower environmental impact. The European Commission want their farmers to use more environmentally-friendly biocontrol agents, but currently is not making that easy.

In fact, the current EU legislation does not envisage complexity of living organisms (biologicals) and focus on their biocontrol or plant protection properties.

There is a strong need of developing an integrated and harmonized approach involving all actors of the food production chain to overcome the current limitations on the adoption of biologicals at a larger scale in Europe.

Do you expect regulation of biological products become more difficult and costly in Europe, following the trend of conventional agrichemicals?

There is a clear-cut need of a dedicated regulatory framework for the registration of biologicals in Europe. The current European regulatory system for biologicals is highly precautionary and the registration process is lengthy and cumbersome when compared to that in U.S.

Although the food system as a whole is becoming increasingly globalized, the oversight systems under which these products are regulated has a limited degree of international harmonization. This undermines the features of reasonable costs and predictable timelines for regulatory approvals.