We have the expertise to help you navigate the biocontrol regulatory maze both locally and globally!
BIOCONTROL REGULATORY SERVICES
Politically and socially there has been a great deal of debate, activity and progress towards a more sustainable use of our environmental resources to grow the food we need to feed an ever-increasing global population as well as trying to reduce the impact on biodiversity. The area of crop protection (pesticides) has been one such area that has seen the creation of regulatory frameworks such as in the European Union, USA and Brazil designed to support the registration of active substances and products that do not fit into the designation of conventional crop protection. They are often generically called “biocontrols” and can cover a multitude of diverse active substances and products. Biocontrols are often considered to be one of the solutions for sustainable crop production. In the European Union for example the biocontrol products will be an important enabler in the Farm-to-Fork objectives of the Green Deal.
There is no global definition for biocontrol and sometimes other terminology is used such as biopesticides, biological pesticides, natural pesticides, or biochemical pesticides. Generally, biocontrols fall into the following categories:
- Microorganisms/Microbials -bacteria, fungi, viruses and viroids
- Macroorganisms/Macrobials – beneficial invertebrates e.g., insects, mites, and nematodes
- Natural substances – plant, animal or fungal extracts, minerals, peptides, enzymes, and nature identical synthesised chemicals
- Semiochemicals – pheromones and allelochemicals
How such substances and their subsequent products are registered will depend on the legislative framework of the country or region that you wish to market them in. Understanding whether your active substance or product would be considered as a biocontrol or conventional pesticide is particularly important as it will have an impact on the data generation requirements, the registration timelines, and overall costs.
Our experts are here to help you through the legislative maze and make sure you get to market.
our Biocontrol solutions for you
Knowing your regulatory environment is essential to stay in the market: with a global network of affiliates, knoell keeps track of the developments concerning global regulations. Read more about our strategic and regulatory consulting solutions.
Are you looking for a partner with whom you can master any current or future challenges related to sustainability in the industry?
Then take a glance at our portfolio to see how our knoell experts can help you.
- Task Force management
- Communication with authorities
- Support with data sharing and Letter of Access (LoA) negotiations
- In-country registration support by locally based knoell employees or our trusted partners
- Coordination of the entire authorisation process
- Portfolio management
- Dossier preparation and compilation (active substance and products, CODEX/JMPR, MRL, Import Tolerances), also in electronic format as required (e.g. CADDY, IUCLID for Crop Protection)
- Study summaries (OECD format)
- Post-submission commenting, expert statements
- Label amendments and notifications
- Application and submission forms
- Import tolerance petitions
- State registrations
Read more about our submission support services.
With a team of nearly 40 toxicologists, more than 70 environmental fate and modelling experts as well as approximately 45 ecotoxicologists your assessments for whatever challenge you have are in expert hands.
- Bee Services
- Endocrine Disruptor (ED) assessments
- Risk assessments using computer based (in silico) methods
- (Preliminary) environmental and ecotoxicological exposure and risk assessments. Standard and higher tier approaches
- Human health. Human exposure (e.g. operator and bystander), dietary safety, metabolism and residues
- Animal dietary burden assessment
- Data gap analysis
- Check of completeness (CoC)
- Technical equivalence, identity and physical-chemical parameter determination
- Evaluation of analytical methods
- (Preliminary) risk and exposure assessments
- GAP (Good Agricultural Practice) scoping
- Literature search and evaluation
- Environmental fate of active substances and their metabolites. Study management & monitoring, kinetic evaluations
- Efficacy evaluation for conventional agrochemicals and biocontrol agents. Study management & monitoring, comparative assessment (EPPO 1/271) for Plant Protection Products containing candidates for substitution active substances (CfS), resistance risk analysis and management strategies (EPPO 1/213), development of strategies for Integrated Pest Management (IPM), "agronomic equivalence" evaluation (evaluation of genetically-modified plants (GMOs) in comparison to conventional varieties)
- Import tolerance services
Study management and monitoring can be challenging tasks. Besides the various problems caused by complicated test substances, the right laboratory needs to be identified for the required study, and ideally you want a study to be performed in a way that it can be used for submissions in more than one country or region if your business is international. Find out why knoell might be the right choice for you when it comes to study management and monitoring.
Optimise the way you perform your day-to-day work. Automation can help.
Particularly for submissions in the EU with their extensive environmental risk assessments, a tool that combines all FOCUS standard models via one user interface helps to safe valuable time and to reduce the potential for man made mistakes when transferring data. At knoell, we developed exactly this! Read more about our efam (environmental fate automated modelling) here.
Benefit from our up-to-date expert training modules, seminars and workshops held on scheduled dates at our training premises, online or at a location of your choice and individually designed for you. Explore our knoell academy programme!