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US still leads the way in biopesticides, as EU rules remain complex

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A plethora of different scientific, regulatory and commercial definitions of the term ‘biopesticide’ exists, so there is no single internationally-agreed designation. From a regulatory perspective, the precise terminology and scope can vary considerably between different countries.

The following article is an extract from the Informa Agribusiness Intelligence Global Biopesticide Regulations 2017 report, produced by IEG Policy's sister title Agrow. To download a sample copy of the report, follow this link

In its broadest sense, the sector covers a wide spectrum of biologically-based agents used for pest control.  Major product categories comprise microbials; biochemicals; semiochemicals, and macrobials. Some countries also include genetically modified plants that express introduced genes conferring protection against pest or diseases, such as ‘Plant Incorporated Protectants’ (PIPs).

There are a number of regulatory ‘grey’ areas.  Examples include biostimulants, biofertilizers and some bioinoculants that claim to deliver plant protection effects as well as nutritional and plant health benefits.

Others areas of uncertainty include new genetic technologies such as RNA interference, mutagenesis and Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), particularly in the European Union.

Market size

Estimates of market size vary but there is broad agreement that the biopesticide market has shown remarkable growth over the last 15 years.  Global biopesticide sales have increased from around US$0.6 billion in 2003 to around US$ 3 billion today and are projected to reach US$11 billion by 2025. With a Compound Annual Growth Rate (CAGR) of 16-17%, biopesticides are currently the fastest growing sector in the crop protection market sector. 

North America and Europe together account for two thirds of the total market but Latin America is the fastest growing region and seems set to overtake Asia Pacific as the third largest regional market by 2025. 

The value and growth rate of different product categories varies by region but overall, microbials constitute the largest and most rapidly growing segment and are expected to make up almost 60% of the market by 2025. 

Bioinsecticides and biofungicides currently dominate the market but bionematicides are growing rapidly with a spate of new products entering the market and others in development.  The bioherbicide sector remains very small with no significant or successful products to date.

Key drivers of growth include political and societal pressure for greener, safer and more sustainable crop protection technologies; food retailer and consumer demands for low or no residues on food crops; an increasingly tough regulatory climate for chemical products; resistance development to existing conventional chemical pesticides and a lack of novel chemistry.

Biologicals can offer effective solutions to many of these issues through multiple and novel modes of action to combat pest resistance; reduced residues on food crops; greater worker safety and flexibility, along with reduced regulatory costs and timelines. Additionally, technology advancements have improved product efficacy and reliability and increased confidence among growers and input suppliers.

The sector is characterised by a large and diverse membership with a high proportion of small and medium-sized enterprises (SMEs) and many start-up companies.  It has attracted considerable attention from the major multi-national agrochemical companies over recent years that recognise clear opportunities for using biologicals in portfolio management and business growth.

Recent years have witnessed multiple R&D and commercial agreements as well as a number of mergers and acquisitions.  These developments have significantly improved market access and expansion for biopesticide products through faster product commercialization, increased R&D investment and more effective technology transfer to growers.

US leads the way

Registration is widely perceived to be the single most important barrier to successful commercialisation of biopesticide products.  In many countries, the regulatory system has been designed for conventional chemical pesticides and has difficulty in responding to the different properties and characteristics of biological products.

The registration process is further complicated by different regulatory frameworks, most notably in the key markets of North America and the European Union. Additionally, there are significant inconsistencies between the rules for products destined for organic and conventional agricultural production.

At a global level, OECD’s Expert Group on BioPesticides (formerly known as the BioPesticides Steering Group) is leading efforts to promote a harmonized and proportionate approach to biopesticide regulation, develop guidance documents and facilitate communication and information exchange across a wide range of stakeholders.

Other key players include the United Nations Food and Agriculture Organisation (FAO) and World Health Organisation (WHO), the International Organization of Biological Control (IOBC), the European and Mediterranean Plant Protection Organisation (EPPO) as well as Global BioProtection, the worldwide federation of biocontrol and biopesticides industry associations.

At a regional level, the picture is mixed with some countries clearly leading the way while others are lagging behind.

In North America, the US Environmental Protection Agency (EPA) has established itself as the world leader in biopesticide regulation.  It has pioneered the simplification of the registration process for biopesticide products through the development of modified test methodologies with reduced data requirements that have significantly lowered registration costs and timescales.  The success of this approach is reflected in the fact that today there are over 430 biopesticide active ingredients and 1320 products available to US growers.

Canada’s biopesticide registration requirements are closely aligned with those used by the US and the two work closely together to promote biopesticide registration in both countries through joint review, work share and other regulatory processes.

EU complexity

In the EU, microbial, biochemical and semiochemical biopesticides are registered under the same regulatory framework as chemical pesticides although some special provisions have been developed.  The legislation provides for measures that favour the registration of products defined as ‘low risk’ (most of the biopesticides) but the process has not worked well in practice.

The EU regulatory process remains complex and cumbersome; registration timescales can be at least twice as long and double the cost of registration elsewhere. This situation is discouraging product developers from applying for registration in Europe.   Proposals to improve the situation were approved by the European Parliament earlier this year but there are real concerns that implementation could be delayed for several years because of the ongoing EU REFIT exercise, which aims to simplify existing regulation. 

Nevertheless, there are some clear examples of regulatory innovation at Member State level, most notably in the Netherlands, the UK, France and Hungary.  In addition, the EU is leading the way in clarifying the regulatory boundaries between biopesticides and plant biostimulants. It is widely anticipated that the revised Regulation (EC) on Fertilising Products could set the benchmark for a more appropriate and harmonised approach to biostimulant regulation elsewhere. 

Industrial standards

The main challenge facing regulators is to develop predictive and efficient regulatory processes that ensure product safety and consistency without inhibiting commercialisation.  This is especially vital for the many small and medium enterprises in this sector where lengthy registration delays and disproportionate data demands can have a major impact on their willingness and ability to submit products for regulatory review.  

However, an extensive body of regulatory and industry experience around biopesticides is already in place.  It identifies some clear examples of regulatory innovation as well as good regulatory practice.  

Examples include creation of a dedicated specialist regulatory team with expertise in different biopesticide categories; the development of biopesticide-specific guidance documents and training for regulators and applicants;  the use of pre-submission meetings between applicants and regulators to identify potential issues early in the process; reduced data requirements and a flexible approach to interpreting data needs; a predictable and transparent review process and timeline; priority review for low risk biopesticide products; and reduced or subsided fees and creation of fora for sharing experience and best practices. 

A common theme in the key North American and European markets is that data requirements continue to become ever more demanding. Regulators are requesting new ‘non-standard data’ requirements, often late in the registration process, making the timelines longer and unpredictable.  Additionally, increasing numbers of biopesticide registrations coupled with less staff and resources in the regulatory agencies are leading to slower review processes, a challenge also being seen for conventional agrochemical registrations.

As the biopesticides market matures, so these challenges will grow, leading to calls for greater coherence and harmonisation across the world.

This article is an extract from the Informa Agribusiness Intelligence Global Biopesticide Regulations 2017 report, produced by IEG Policy's sister title Agrow. To download a sample copy of the report, follow this link

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