Regulatory obligations for a wide range of products and uses. Staying up-to-date with the regulations is key to ensure compliance.
Crop Nutrition products cover a wide range of available products that help farmers to adapt their nutrition practices to their respective environmental and farming conditions: organic fertilisers, organo-mineral fertilisers, mineral fertilisers with or without control release techniques, inhibitors, liming materials, growing media, soil improvers and the continuously growing industry of plant biostimulants.
Rising innovation and product type segmentation is driving the growth of the market and these various types of products are subject to a large number of laws and provisions. Attuning registration activities to the quickly evolving conditions of the regulatory landscape requires constant attention and intelligent foresight. Our experts are not only exceptionally familiar with current rules in many jurisdictions across the globe, but also remain on top of new regulations and guidance documents that are under development.
From 16 July 2022, fertiliser producers and traders will need to comply with the Fertilising Products Regulation (EU) 1009/2019. This regulation will radically change the way fertilisers receive the CE marking, just as the labelling requirements for the products are being changed.
We offer a full service to support the transition from Regulation (EC) 2003/2003 to Regulation (EU) 1009/2019, ensuring the conformity and marketability of your products from day one.
On 24 November 2020, US EPA published the updated EPA guidance for Biostimulants and Plant Growth Regulators public comment with an expected completion date of January 2021. The update takes into account public comments and feedback from stakeholders on the original draft guidance published 25 March 2019 to clarify claims considered to be plant regulator claims subject to pesticide regulation. EPA removed the infamous “Table 4“ (Plant Regulator Active Ingredients contained in EPA-Registered Products Having Modes of Action that Trigger Regulation Under FIFRA as a Pesticide) and replaced the table with an in-depth discussion of “Substances that have no other use than as plant regulators or pesticides” and “Substances that may have plant regulator and non-plant regulator activity.” EPA acknowledged substances may have dual modes of action but indicated a review of “multiple use” products may be needed.
If your product needs review, we offer full support for submissions of PRIA Code M009 (Non-FIFRA Regulated Determination).
We have in-depth product knowledge and understand the complexity of the nature and specification of your products.
We work in different regions and can help you to navigate the regulatory landscape across a range of geographies and jurisdictions.
We provide all services to support businesses from product innovation to go-to-market and legally compliant marketability.
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. We also conduct product portfolio surveys for your biostimulants, fertilisers and related materials evaluating the possibilities for registration under national legal frameworks.
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.
- Portfolio management.
- Label review, preparation and amendments.
- Application and submission forms.
- Study summaries (OECD format).
- Dossier preparation and compilation.
- Post-submission commenting, expert statements.
Read more about our submission support services.
We provide a review, preparation and submission service in accordance with Regulation (EU) 2018/848 and Regulation (EC) No 889/2008, as well as support for the authorisation of products and substances for use in organic production.
We work with an extensive network of cooperation partners for in-country field studies and testing. Services range from trial design and protocols, product screening, rate studies or GEP study supervision to uniform field testing, evaluations and holistic production system trials. Early product evaluations begin in laboratory and greenhouse trials, then progress to small plot replicated trials, to field evaluations and then to large demonstration trials.
- Data gap analysis.
- Check of completeness (CoC).
- Environmental and ecotoxicological exposure and risk assessments.
- Literature search and evaluation.
Read more how our experts can support you.
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. Read more about classification, labelling, poison centre notifications, (extended) safety data sheets and dangerous goods.
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!