No matter if your business focusses on pesticides or biocontrol agents, registration of your active ingredient and product is a prerequisite for market access in most countries.
Pesticides have been used in agriculture for a long time and still play a vital role in feeding the world. However, continuous research and developing regulations keep changing the landscape of use and accessibility. In this changing environment staying compliant in order to maintain your portfolio is a challenge.
For the last decades, there has been a growing need for more sustainable use of our environmental resources. This, together with an ever-increasing global population, has prompted the development of environmentally friendly but yet efficient control agents to complement the use of large amounts of conventional plant protection products.
Biocontrol agents, also known as biopesticides, biologicals, biological pesticides, natural pesticides or biochemical pesticides, can be either based on ‘microbials’ such as bacteria, fungi, viruses and viroids or on macroorganisms ('macrobials'). Besides, biochemically active extracts from microorganisms and plants ('botanicals') and pheromones or other semiochemicals are included in the category of biocontrol agents. Other natural products such as hormones, minerals, enzymes, peptides and nucleic acids can also act as active substance in plant protection products. Depending on the national context of the legislative framework, these active substances can be directly marketed as biocontrol agents or conventional pesticides. However, they can also be used in biostimulants and biocides.
As diverse as their name, as diverse is their regulation: no globally harmonized data requirements and regulations exist for biocontrol agents used for plant protection. However, risk assessments for human health and environment have to be performed for the approval of biocontrol agents practically everywhere in the world.
Our biocontrol core team, consisting of microbialists, (bio)chemists, molecular biologists and horticultural scientists, has vast experience in supporting the registration and renewal of a large number of biocontrol active substances and products. Amongst others, they have been working on projects for products containing
Through our broad global scientific network, we facilitate the contact between you, the client, and leading contract research organisations to help you solve technical problems and we advise you on the most appropriate regulatory approaches for your products. Regardless of whether you are looking for support in Europe, Asia, the Americas or anywhere else.
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.
- 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 about 40 toxicologist, more than 70 environmental fate and modelling experts as well as approx. 45 ecotoxicologists your assessments are in competent hands.
- (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
- Risk assessments using computer based (in silico) methods
- Endocrine Disruptor (ED) assessments
- 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!