TOXLAB -Crop Care Products
Accelerate Your Crop Care Product to Market
As an agriculture industry player, bringing your product to market efficiently is crucial.
TOXLAB is your partner in achieving this goal.
From initial data gap analysis to final dossier submission, our team guides you through the complex regulatory landscape to ensure successful product registration.
How Crop Care Products Get Approved
Before a plant protection product can hit the market, it undergoes a rigorous approval process.
Step 1: Extensive Testing for Crop Care Products
Extensive testing is a cornerstone in ensuring the safety and efficacy of plant protection products. It involves a rigorous evaluation process to assess various aspects of the product, including:
Residue Analysis
- Monitoring chemical residues in food, feed, and the environment to determine safe exposure levels.
- Assessing the potential for residue accumulation in the food chain.
Toxicological Studies
- Evaluating the potential health risks to humans and animals through various exposure routes (oral, dermal, inhalation).
- Identifying and characterizing adverse effects.
Ecotoxicological Studies
- Assessing the impact of the product on aquatic and terrestrial organisms.
- Evaluating the potential for bioaccumulation and biomagnification.
Environmental Fate Studies
- Understanding the behavior of the product in the environment (soil, water, air).
- Determining degradation rates and potential for persistence.
Efficacy Studies
- Evaluating the product’s effectiveness in controlling pests and diseases.
- Optimizing application methods and rates for maximum benefit.
Other Studies
- Depending on the product and its intended use, additional studies may be required, such as those related to product stability, compatibility, and residue depletion.
By conducting a comprehensive suite of tests, regulatory authorities can make informed decisions about product approval and establish safe use guidelines. This rigorous process safeguards both human health and the environment.
Step 2: Dossier Preparation: The Foundation for Approval
A dossier is a comprehensive collection of data and information required for the registration of a plant protection product. It serves as a crucial document for regulatory authorities to evaluate the product’s safety and efficacy.
- Product information: Detailed description, composition, and intended use.
- Safety data: Toxicology, ecotoxicology, and residue studies.
- Efficacy data:Demonstrating the product’s ability to control pests.
- Environmental fate data:Understanding the product’s behavior in the environment.
- Analytical methods: Procedures for detecting and quantifying the product and its residues.
- Labeling and packaging information: Clear instructions for product use and storage.
- Risk assessment:Evaluating potential risks to humans, animals, and the environment.
Key components of a plant protection product dossier include:
Dossier preparation is a complex process requiring expertise in various scientific disciplines and a deep understanding of regulatory requirements. A well-structured and comprehensive dossier significantly increases the chances of successful product registration.
Step 3: Regulatory Review: The Gatekeeper for Product Approval
Key aspects of regulatory review include:
- Data Verification:Thorough scrutiny of the data presented in the dossier to ensure accuracy, completeness, and reliability.
- Risk Assessment Evaluation: Assessing the manufacturer’s evaluation of potential risks to humans, animals, and the environment.
- Label Review:Ensuring that product labels provide clear and accurate information for safe use.
- Compliance Check: Verifying adherence to all relevant laws, regulations, and guidelines.
- Peer Review:Involving experts in various fields to evaluate the dossier.
When and Why Conduct Studies?
Triggering Factors for Studies:
- Initial Registration:Obtaining approval for a new active substance or formulation.
- Renewal of Authorization:Extending the registration period for existing products, often due to expiring authorizations (e.g., 15-year limit in Europe).
- Regulatory Requirements:Complying with evolving regulations and scientific standards.
Global Harmonization:
While registration processes vary by country or region, the underlying scientific principles are aligned with international guidelines established by organizations like OECD, EPA, CODEX, EFSA, and others. To ensure data quality and reliability, studies are conducted in accordance with Good Laboratory Practice (GLP) standards.
By adhering to these rigorous standards, the industry can demonstrate the safety and efficacy of plant protection products, protecting both human health and the environment.
Agrochemicals – Active Substance Approval & Product Registration in EU (EUROPE and BEYOND)
At TOXLAB, we provide expert regulatory support for agrochemical products, including active substance approvals and national product registrations. We help you navigate the complex regulatory landscape of the EU and beyond, ensuring your products meet all safety, efficacy, and environmental standards required for market access.
Active Substance Approval (EU Regulation EC No. 1107/2009)
We offer comprehensive services for the approval of active substances under EU Regulation (EC) No 1107/2009, which governs the authorization of plant protection products in the European Union. Our expertise includes:
- Support for Existing Substances: We assist in the renewal process for existing active substances under the EU Renewal Programme (AIR), ensuring compliance with the latest regulatory updates.
- New Active Substance Support: We provide full support for the approval of new active substances, from initial application to final approval.
- Completeness Checks & Validation: We conduct thorough completeness checks and validate existing studies to ensure your dossiers meet the regulatory requirements.
- Literature Surveys: Our team performs extensive literature surveys to support risk assessments and ensure your dossiers are well-founded and scientifically robust.
- Full Dossier Preparation: We handle all aspects of dossier preparation, including risk assessments, literature search reports, and submission to the competent authorities. We also provide expert defence of dossiers during the review and evaluation process.
Product Registration for National Authorisations in EU Member States
In addition to active substance approval, we support the registration of plant protection products across EU member states, including the preparation of zonal dossiers for mutual recognition. Our services cover:
- Registration and Re-registration Dossiers (dRRs): We prepare all necessary documentation for the registration and re-registration of plant protection products, including label extensions, formulation changes, and mutual recognition.
- Comprehensive Document Compilation: Our team compiles all required documents, including exposure and risk assessments, biological dossiers, and other essential documentation for registration.
- Risk Assessments & Data Gap Analysis: We conduct exposure and risk assessments, as well as identify and close any data gaps to ensure regulatory compliance.
- Experimental Study Supervision: We provide oversight for experimental studies and data generation to meet the requirements of the regulatory authorities.
- Submission & Liaison with Competent Authorities: We manage the submission process to the relevant competent authorities, ensuring smooth communication and handling any issues that arise during the registration process.
Expertise in Agrochemical Categories
Our team has extensive experience in registering a wide range of agrochemical products, including but not limited to:
- Herbicides
- Fungicides
- Insecticides
- Rodenticides
- Nematicides
- Growth Regulators
With a deep understanding of the regulatory requirements for these product categories, we provide tailored solutions that ensure your products meet all necessary standards for market approval.
Why Choose TOXLAB for Agrochemical Registration?
- End-to-End Regulatory Support: From active substance approval to national product registrations, we offer comprehensive services that cover every stage of the regulatory process.
- Expert Knowledge: Our team has extensive experience in agrochemical regulations, ensuring that your products comply with the most current and stringent requirements.
- Efficient Project Management: We manage the entire registration process, from dossier preparation to submission and liaison with authorities, streamlining the process and ensuring timely approvals.
- Proven Track Record: Our experience spans multiple product categories, and we have successfully navigated the regulatory landscape for a wide variety of agrochemicals, including herbicides, fungicides, and more.
Our Services : Regulatory Affairs and Product Development Support
- Registration and Approval:
- Technical equivalence applications
- Active substance approvals/renewals
- Product authorizations
- Me-too registrations
- Product Evaluation:
- Comprehensive product compliance analysis
- data gap assessments
- Endocrine Disruption Risk assessments.
- Scientific Expertise:
- QSAR modeling
- GLP study supervision
- Technical Consulting
- Market Entry: Establishment of India and EU branches to support your global expansion.
Our Advantage - Why Choose Us?
Proven Expertise and Unmatched Success
- Pioneers in the Field: As the first Chinese consultancy to independently secure EU pesticide registration, we bring unparalleled experience to the table.
- Proven Track Record: Our successful completion of hundreds of TE applications for diverse products, coupled with a 100% approval rate, speaks for itself.
- Trusted Partner: Our services are sought after by over 80% of China’s top 100 pesticide enterprises.
Technical Excellence and Global Reach
- Strong Scientific Foundation: Our team of experts boasts a deep understanding of analytical chemistry, biology, pharmacology, and environmental science.
- International Network: Collaborations with world-class laboratories and fluency in multiple languages ensure seamless global operations.
- Regulatory Mastery: Our in-depth knowledge of EU pesticide regulations and strong relationships with key authorities enable efficient and successful registrations.
Customer-Centric Approach
- Problem-Solving Focus: We excel at overcoming complex challenges and delivering tailored solutions.
- Dedicated Support: Our commitment to exceptional service ensures your project’s success.
