The regulation that governs the marketing, sale and use of pesticides is just a fact of life for us in 2018 but the standards imposed are constantly evolving as our scientific insight and knowledge increases. Understand how global regulators define pesticides and their approval. Find out here.
Humans have been using chemicals to protect plants from pests and diseases since 2,500 BC, when, as records show, ancient Sumarians used sulphur to control mites/insects; however, it was really towards the end of the 19th century that the industrial usage of inorganic products and those derived naturally, such as pyrethrum, became common and widespread.
This is the first to come in a series of informational blogs designed to examine how existing active substances (ASs) are managed through the current regulatory renewal systems in the EU and USA.
With the rise in the use of such products came increasing concerns about their effect on health and the environment. In the USA, specific regulation of such chemicals first appeared in the early 1900s, but it was not until 1970 that the Environmental Protection Agency (EPA) was created, with the remit of protecting the environment, and the health of humans and other animals. In Europe, the European Council (EC) issued its first directive on pesticide residues in 1976, with extensive regulatory activity beginning in the early 1990s.
Today's regulation that governs the marketing, sale and use of plant protection products (PPPs) is just a fact of life and a standard part of international agrochemical business. To learn more about "Preserving lifecycles: renewing existing plant protection active substances" download this informative e-book.
However, the standards imposed by regulation are constantly evolving
1. Current agrochemicals market backdrop
The global market for PPPs is expected to register a compound annual growth rate of 5.79% between 2017 and 2022. The growth in the market will mainly be driven by increasing food demand from a growing global population and the need to increase crop yields.
On a broader political front, the EU is reviewing its current legislation through the REFIT program, while in the USA, President Trump’s reforms to the EPA may also impact the regulatory environment. Challenges and opportunities also exist in the plant protection market.
Important patent expires are expected in the coming year, and merger and acquisition activity among agrochemical companies is changing the competitive landscape; for example, the merger of Dow Chemical and DuPont has required divestment of certain parts of each company’s business, with the USA requiring DuPont to shed its herbicide/insecticide business (acquired by FMC), and Brazil’s CADE (Administrative Council for Economic Defense) requiring Dow to divest part of its corn hybrid seed business, which it has sold to China’s Citic Agri Fund.
Against this backdrop, the history, knowledge and insight about established active substances could get ‘lost’, and such changes may pose risks for reauthorization of PPPs.
AS review and re-approval regulation
In major global markets, regulatory approval usually constitutes two parts: first, approval of the so-called AS or technical-grade active ingredient (TGAI) and, second, approval of the actual end-use or formulated PPPs containing one or more approved ASs. Approvals are usually time-limited; therefore, both the ASs and the PPPs must be reapproved and reauthorized once approval lapses.
The most sophisticated and developed programs for review and re-approval of ASs and PPPs are in the major US and European markets. This series of blogs focuses on the review programs in use by those regions, while recognizing that other important markets, such those in Japan, Australia and New Zealand, Canada and Brazil, have well-developed crop protection legislation to ensure safety to humans and the environment when PPPs are authorized for use in their territories.
The next blog “Are you up to speed on US regulation of active substances and PPPs?” in the series will explore US regulation of ASs and PPPs.
Everywhere you go, crop protection businesses face an ever-changing commercial and regulatory landscape. But with a good CRO in place, you can supercharge your time-to-market.
To learn more about "Preserving lifecycles: renewing existing plant protection active substances" download this informative e-book.
About the author
Gary Dean started his career at Envigo in 1985 and is currently the Business Lead Consultant for Crop Protection. As business lead, Gary provides regulatory advice to Envigo’s customers to ensure their programs of work and applications for active substance approval or product registration meet the highest possible scientific and regulatory standards set by global authorities.
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- 3 steps to achieve successful active substance renewal