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.

Topics: ,

Leave a Reply


Pam Marrone

Marrone Enters Distribution Partnership in Vietnam, Cambodia

Key factors driving the rapid adoption of biologicals in Vietnam include pesticide residue problems in agro-products for local consumption, new requirements for Maximum Residue Levels on agro-products imported to the EU and U.S., and a growing number of banned pesticides.


STK REGEV Biofungicide Now Registered in Argentina

STK bio-ag technologies, the innovative Israeli-based leader in bio-ag technologies for sustainable crop protection and aquaculture, has announced its ‘hybrid’


BioConsortia Promotes Dr. Hong Zhu to Sr. VP of Research and Development

BioConsortia, Inc., innovator of microbial solutions for natural plant trait enhancement and yield improvement, has promoted Dr. Hong Zhu to


Marrone Bio Innovations Submits Novel Bioherbicide for EPA Approval

Marrone Bio Innovations, Inc. (MBI), a leading provider of bio-based pest management and plant health products for the agriculture, turf


PepsiCo in Deal with Arysta LifeScience Chile on Biological Products

Under the agreement, the select group of Chilean potato farmers that supplies PepsiCo on an exclusive basis will use the solutions from the Arysta LifeScience Pronutiva program, which combines traditional crop protection inputs with biological solutions.


Biorational Processes in Biopesticide Discovery and Development

Agchem companies are expanding their biopesticide R&D and portfolios, driven by stricter pesticide regulatory requirements, consumer awareness regarding hazards caused


Corbion CEO Tjerk de Ruiter Appointed as New EuropaBio Chairman

EuropaBio’s Executive Board and General Assembly of Members confirmed the appointment of Tjerk de Ruiter as Chairman of the association.


FaunaSmart, BioScience Solutions Form Innovative Collaboration in Crop Protection

FaunaSmart and BioScience Solutions have announced a cooperation within strategic business development and innovation strategies in crop protection. Harry Teicher,


FMC, Chr. Hansen Extend Collaboration on Natural Crop Protection

FMC Corp. and Chr. Hansen have announced a five-year extension of their collaboration to develop and commercialize natural solutions for the agricultural industry.


Tradecorp Acquires Spain’s Idai Nature

Idai Nature is currently present in 35 countries and has posted annual growth of more than 30% in recent years. The company’s consolidated revenues amount to 16 million euros.


A (Surprisingly Long) Biopesticide Timeline

The application of biopesticides in plant protection is certainly not a new innovation. A few examples are presented in the


Marrone Bio Innovations Names Hammill as Chief Commercial Officer

Most recently, Hammill was Chief Operating Officer at Pivot Bio, a startup company.


Biopesticides: Assessing the Opportunities and Challenges in R&D, Formulation

Editor’s note: Dr. Harry Teicher, an independent Strategic R&D consultant with over 20-plus years of AgChem and BioScience R&D Management


STK, BASF in Deal to Expand Distribution in Brazil

STK will grant BASF exclusive rights to maket and sell the biological fungicide bactericide in the country.

Africa/Middle East

Affinity in East Africa: Marrone Bio Innovations Finds Harmonious Partner in Kenya Biologics

Farmers in East Africa are set to benefit from a wide range of zero-residue biopesticides that will help to increase


Marrone Bio Innovations Enters Partnership with Israel’s Lidorr

Lidorr Chemicals Ltd., will develop and market three of MBI's products in Israel.


IPM and ICM: The Unique Opportunities and Challenges for Biopesticides

Integrated crop management (ICM) is a holistic approach to crop management, integrating agricultural and environmental management practices such as optimal


Monsanto, AgriMetis Enter Global Licensing Agreement

The agreement includes an exclusive global license from AgriMetis to Monsanto for agricultural research in row, vegetable, and other crops for a three-year period.


ADAMA’s Nimitz Gets Regulatory Approval in Brazil

Global crop protection company ADAMA announced that it has successfully obtained regulatory approval for its proprietary nematicide, NIMITZ®, in Brazil.

Latest News


Trump Trade War Divides Farming World as China Demand Shifts

Soybeans have become something of a poster child for the U.S.-China trade war, with everyone from Treasury Secretary Steven Mnuchin


India Could Fill Gap in Agricultural Imports Amid China-U.S. Trade War

The ongoing China-U.S. trade dispute will provide a chance for China and India to strengthen their agricultural trade, which will

Industry News

Escalating Trade War with China Will Increase Damage to American Soybean Farmers

The Administration’s decision to impose 10% tariffs on an additional $200 billion in Chinese imports — and China’s subsequent retaliation

Plant Health

Favorable Soil pH: Does it Really Increase Nutrient Use Efficiency?

More than ever agriculture needs to follow principles of sustainability that ensure build up and maintenance of long-term soil productivity,

Plant Health

Diagnosing and Mapping the Need for Soil Improvement in Brazil

Brazil has lacked the data for creating a soil fertility survey that could be used for assessing if any nutritional