Important patent expiries are expected this year, and merger and acquisition activity among agrochemical companies is changing the competitive landscape. Against this backdrop, the history, knowledge and insight about established active substances could get ‘lost’, and such changes may pose risks for reauthorization of plant protection products (PPP). Find out here.Continue reading
The last REACH deadline was in May 2018 and brought to a close the period of active information gathering on the safety of chemical products marketed in the EU/EEA. It has resulted in a massive database of safety information on a wide range of substances and heralds an exciting new phase of evolution in scientific and regulatory thinking. So, with the data in, the decision letters start to roll out.Continue reading
Residues of plant protection products (PPPs) are inevitably present in or on food, even when they are applied in line with good agricultural practice. The upper limit of residue permitted on food or feed is the ‘maximum residue level’ (MRL), which, in Europe, is legislated by the European Commission based on scientific advice from the (EFSA).
MRLs are measured via crop residue field trials, which replicate the real-life agricultural conditions under which a PPP would be used. It sounds a simple enough procedure, but what studies are commonly used and what are the secrets to success?Continue reading
The New EU Nanotechnology Regulation
On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing , amending the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, to directly address nanoparticles. The nanotechnology regulation applies to any substance that might be, or might contain, a nanomaterial (e.g., powder), whether or not it has been manufactured as a nanotechnology. Crucially the revised nanoparticle regulation applies to both new and registered substances and all dossiers will need to be updated with the necessary data.Continue reading
The new EU requirements for endocrine disruptor identification will impact any active ingredient (AI) renewals with expected decisions from November 2018 onwards. Learn more about these requirements and key strategies to meet them, below[CS1] [CS2].
The European Commission has adopted new criteria for identifying endocrine disruptors (EDs) – these criteria apply to new active ingredients (AIs) and those going through renewal (). So, if the AIs in your plant protection products (PPPs) are due for renewal you need to understand the new requirements and how you can meet them.Continue reading
Neonicotinoids were developed to find safer, more effective alternatives to chlorinated hydrocarbons, organophosphates, carbamates, and pyrethroids, so, ironically, some neonicotinoids are now banned in the EU because of their toxicity to bees and other pollinators, as well as to a wider group of species.
The agricultural and environmental consequences of neonicotinoid use and the recent EU regulatory restriction have made neonicotinoids one of the most controversial areas of science and policy.Continue reading
Avoiding obstacles with REACH Annexes VII-X
Posted by Dr. David Howes, Expert Consultant in Chemical Legislation and Chemistry, Covance
In the EU, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations address the manufacturing and import of chemicals to ensure they are safe for human health and the environment. The registration dossier outlines the standard information requirements for a substance and minimum data required that describe the physicochemical, toxicological, environmental fate and ecotoxicological properties of the substance.
With this information, the European Chemicals Agency (ECHA) can make a decision regarding the safety of the substance. However, data requirements vary with the amount of substance used. Often, more complex information is required to manufacture or import a substance into the EU and the European Economic Area (EEA).Continue reading
The regulation that governs the marketing, sale, and use of pesticides is just a fact of life, but the standards imposed are constantly evolving as our scientific insight and knowledge increases. This series of informational blogs is designed to examine how existing active substances (ASs) are managed through the current regulatory renewal systems in the EU and USA.
We have been using chemicals to protect plants from pests and diseases since 2,500 BC, when, as records show, ancient Sumerians used sulfur 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.Continue reading
As the regulatory landscape across the globe is rapidly evolving, more sophisticated requirements must be met by registrants and scientists. In parallel, scientific advances have impacted previous methodologies that were once seen as cutting edge but now may fail to adequately address new regulatory challenges.
Clients should consider techniques to future-proof their studies to flexibly adapt to pre- and post-registration regulatory and scientific environments and keep up with trends in the crop protection market.Continue reading