Europe, Asia or the Americas. Our experts with long standing expertise and local knowledge will support you to meet your regulatory obligations.
Disinfectants, insecticides, antimicrobials, preservatives, and other forms of pest control are widely used to protect humans, animals, materials, or articles against harmful organisms, pests or bacteria in many jurisdictions across the globe.
Regulations, such as the Biocidal Product Regulation (EU) No. 528/2012/EC (BPR), the MOA Order (2017) No. 3 Measures on the Management of Pesticide Registration in China, or the Korean Act on Safe Control of Household Chemical Products and Biocides (K-BPR) have placed some regulatory hurdles for manufacturers and formulators to place their products on the global market. Data requirements are not fully harmonised at a global level, and deadlines, which you need to be aware of, are fast approaching in parallel.
A well-planned authorisation strategy needs to be established to ensure the economic success of your active substances or products worldwide and knoell can help you achieve this.
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.
- Communication with authorities
- In-country registration support by locally based knoell employees or our trusted partners
- Coordination of the entire authorisation process
- Dossier preparation and compilation, also in electronic format as required (e.g. IUCLID 6)
- Study summaries (OECD format)
- Post-submission commenting, expert statements
- Application and submission forms
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.
- Environmental exposure and risk assessments (standard and higher tier modelling)
- Human health and dietary safety
- Animal safety and livestock exposure
- Risk assessments using computer based (in silico) methods
- Endocrine Disruptor (ED) assessments
- Data gap analysis
- Check of completeness (
- Technical equivalence, identity and physical-chemical parameter determination
- Preliminary risk assessments to develop testing and analysis strategies, to serve as basis for adjustments to the product’s use pattern, to identifying potential problem areas
- Risk assessments for all product types
- Literature search and evaluation
- Efficacy against relevant target organisms. The variety of indications and application methods for biocides means that the appropriate efficacy studies must be specifically selected. Study management & monitoring, data evaluation, test strategies.
- Environmental fate of active substances and their metabolites. Study management and monitoring, kinetic evaluations, data evaluation.
- Analysis and evaluation of available ecotoxicological data, study management & monitoring.
Read more how we can support you with technical and scientific solutions.
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.
Developing a product is one thing, but making sure that it is used and transported safely a completely other. It is essential that you know your obligations as manufacturer or importer. For example, classification of mixtures in accordance with the CLP Regulation (EU) No 1272/2008 is something you need to consider for your biocidal products. Additional information on transport, classification and labelling.
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!