Our Agrochemical team specialises in regulatory compliance and registration of plant protection products under Regulation (EC) 1107/2009 and the GB/NI equivalent. We have in-depth knowledge and experience of managing the complexities associated with the registration of active substances and formulations used in agriculture. We ensure that our clients successfully meet their regulatory obligations in the EU and UK – addressing the unique challenges posed by both chemical and bio-based pesticides.
Regulatory Expertise for Plant Protection Products
Comprehensive Regulatory Compliance
The registration and approval of plant protection products (PPPs) in the EU and UK require a thorough understanding of evolving regulatory frameworks, data requirements, and risk assessments. Blue Frog Scientific provides expert end-to-end support in overcoming the challenges associated with PPP registration, renewal, and post-approval management.
Specialised Services for Plant Protection Product Categories
Chemical Pesticides
We manage the entire registration process for traditional chemical pesticides, focusing on their efficacy and safety to ensure they meet stringent regulatory standards, whilst addressing sustainability concerns for their future market viability.
Biopesticides
Specialising in the registration of biopesticides, including biologicals, plant extracts, and semiochemicals, we offer bespoke services that cover the specific technical and scientific needs for these more sustainable alternatives.
Strategic Support for Registration Challenges
Regulatory Complexity and Dual Compliance
Where our clients have interests in both the EU and UK, we can support clients in identifying the similarities and differences in the separate regulatory pathways for EU and UK PPP registration, which has resulted in diverging interpretations of existing legislation, and evolving policies that separate compliance requirements between EFSA and HSE.
Active Substance versus Product Registration
The registration of active substances and plant protection products under Regulation (EC) No 1107/2009 and its GB/NI equivalent presents distinct challenges. Active substance approvals require extensive toxicological, ecotoxicological, and environmental fate assessments, including endocrine disruptor evaluation and candidate substitution analysis. Diverging regulatory frameworks between the EU and GB add complexity, particularly in data requirements, mutual recognition, and renewal processes.
Product registration, by contrast, focuses on formulation safety, efficacy, and risk mitigation, with differing approval pathways such as zonal authorisation in the EU versus a national system in GB. Variances in Maximum Residue Levels (MRLs) and risk assessment criteria further complicate market access.
Depending on your market strategy, Blue Frog Scientific can provide strategic regulatory planning is essential to efficiently address all jurisdictional requirements and identify where divergence will require additional resources.
Advocacy and Stakeholder Engagement
Engagement with regulatory authorities is integral to the registration process for active substances and plant protection products. In the EU, applicants interact with rapporteur member states, EFSA, and the European Commission throughout dossier submission, evaluation, and approval. In GB, the Health and Safety Executive (HSE) independently assesses applications, providing scientific opinions and risk management decisions. Pre-submission meetings, technical discussions, and ongoing dialogue help address data requirements, regulatory expectations, and potential concerns, ensuring a transparent and efficient approval process.
Blue Frog Scientific can support engagement with regulatory authorities through pre-submission meetings, dossier submission, and responses to data requests. During the evaluation phase, we can lead the provision of additional information, clarifying data, or submission of supplementary data in response to expert reviews from EFSA and rapporteur member states (RMS) in the EU, or HSE in GB.
We can also participate in public consultations or technical hearings, particularly if concerns arise regarding safety, efficacy, or environmental impact.
Information Requirements and Testing Strategies
Blue Frog Scientific provides expert support for data gap analysis and integrated testing strategies for active substances and plant protection products in both the EU and UK. Our team identifies critical data deficiencies, optimises study designs, and aligns testing strategies with regulatory requirements under Regulation (EC) No 1107/2009 and its GB equivalent. We ensure compliance with evolving EFSA and HSE guidance, streamlining dossier preparation while minimising costs and unnecessary testing.
Tailored Dossier Preparation & Regulatory Affairs
Blue Frog Scientific has extensive experience in preparing successful active substance dossiers (also in IUCLID format), draft registration reports (dRRs), and other regulatory documentation that may be required for active substances and plant protection products in both the EU and UK. We ensure compliance with Regulation (EC) No 1107/2009 and its GB equivalent, delivering high-quality dossiers aligned with EFSA and HSE requirements.
Ensuring Market Access & Sustainability
Lifecycle Management & Market Strategy
From initial concept through to market launch and beyond, we provide lifecycle management services that ensure your plant protection products remain compliant and competitive in the market.
With a proven track record of successful registrations and a deep understanding of both chemical and biological plant protection products, Blue Frog Scientific is the ideal partner overcoming complexities relating to regulations. Our tailored solutions are designed to meet the specific needs of your products and business, ensuring successful market entry and sustained compliance.
If you’re involved in the manufacture, distribution, or sale of plant protection products and face regulatory challenges, contact us today. Our plant protection product experts are ready to provide customised guidance and support – call and speak with one of us today.
