Registering an active substance and securing product authorisation under the EU and GB plant protection product (PPP) regulations is a complex, multi-stage process requiring detailed scientific evaluations, extensive data requirements, and strict regulatory objectives. At Blue Frog Scientific, we provide strategic regulatory solutions to help businesses overcome these challenges, ensuring seamless market access in both jurisdictions.
Regulatory Compliance for Active Substances and Plant Protection Products
Dual Regulatory Systems in the EU and GB
Since Brexit, the UK has established its own independent regulatory framework for plant protection products, meaning companies must now submit separate applications for approvals in the EU and GB. The European Food Safety Authority (EFSA) and Member State Competent Authorities (MSCAs) assess PPP approvals in the EU, whereas in GB, the Health and Safety Executive (HSE) oversees a separate evaluation process.
We develop tailored regulatory strategies that address both EU and GB requirements, ensuring dossier submissions meet the specific demands of each system. Our team manages communications with EFSA, MSCAs, and HSE, coordinating parallel submissions to streamline approvals and minimise time-to-market delays.
Managing Complex and Evolving Data Requirements
Both EU Regulation (EC) No 1107/2009 and the GB equivalent require extensive scientific data to assess the safety, efficacy, and environmental impact of active substances and formulated products. Recent regulatory changes—including requirements for endocrine disruption, environmental modelling, and New Approach Methodologies (NAMs)—have increased the complexity of data generation.
We conduct comprehensive data gap analyses, identifying missing studies required for compliance with standard or triggered information requirements. Our scientific and technical experts prepare robust dossiers covering:
- Human safety
- Environmental safety
- Residues and metabolism studies
- Efficacy
- Endocrine disruption
- Modelling for operator, bystander, and environmental exposure
Where possible, we apply read-across justifications, data waivers, and alternative testing strategies to reduce unnecessary studies and regulatory costs. While adoption of these methods by regulators has been slow, we actively engage with authorities to promote their use and reduce testing burdens for our clients.
Optimising Active Substance and Product Dossier Preparation
Active substance dossiers must be submitted in IUCLID format, while product authorisations require a draft registration report (dRR) submission, following strict OECD and EFSA guidelines. GB follows a similar approach but has distinct submission requirements for the HSE.
We prepare high-quality IUCLID and dRR dossiers, ensuring compliance with EFSA, MSCAs, and HSE. Our team’s extensive regulatory experience in agencies, industry, and testing enables us to anticipate potential challenges and proactively address regulatory expectations.
Managing Active Substance Renewal and Re-Approval Processes
Both EU and GB PPP regulations require active substances to undergo periodic renewal assessments to account for advances in scientific understanding and evolving regulatory requirements. The Active Substance Renewal (AIR) process in the EU and the UK renewal process both demand updated scientific data, which can be costly and time-consuming.
We guide clients through renewal and re-approval, offering strategic data gap assessments, advice on new study requirements, and dossier updates. Our experts ensure dossiers remain scientifically robust and fully compliant for successful re-approval.
Understanding MRL and Residue Compliance Challenges
Maximum Residue Levels (MRLs) for active substances in food and feed must comply with Regulation (EC) No 396/2005 in the EU and GB MRL legislation in the UK. Regulatory divergence between EU and GB MRL requirements adds complexity for companies seeking approval in both jurisdictions.
We provide residues and metabolism study support, ensuring MRL compliance across both EU and GB regulatory frameworks. Our specialists help clients navigate differing MRL requirements, ensuring harmonised strategies for dual market access.
Addressing Regulatory Changes and Sustainability Initiatives
We provide regulatory intelligence services, monitoring emerging EU and UK policy developments and their potential impact on active substances and products. Our team helps businesses anticipate regulatory shifts, develop long-term compliance strategies, and mitigate risks associated with regulatory tightening.
Minimising the Risk of Rejections and Delays
Failure to meet regulatory expectations for data quality, risk assessments, or efficacy studies can result in application rejections or prolonged delays. The scientific complexity of PPP approvals means regulatory authorities frequently request additional information, delaying market access.
We conduct pre-submission dossier audits, ensuring scientific and technical robustness before submission. If we have compiled your dossier, we proactively address potential concerns to minimise regulatory challenges.
Blue Frog Scientific brings together a team of expert consultants with first-class experience in regulatory agencies, industry, and regulatory testing, providing unmatched insight into EU and GB plant protection product registration. Our scientific expertise, regulatory knowledge, and strategic approach ensure smooth approvals for active substances and plant protection products.
Contact us today to discuss how we can support your EU and UK active substance registration and product authorisation.
