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.
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.
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.
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).
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.
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