Labeling & Market Readiness

• Label Alignment: Rewrite and harmonize labels for clarity, regulatory compliance, and brand consistency.
• Safe Messaging: Translate R&D data into compliant, marketing‑ready claims and product narratives.
• Compliance Audits: Identify gaps and risks in labeling, technical documentation, and marketing claims.

 U.S. State Registration

• End‑to‑end support for first‑time registrations, renewals, and fee payments across all 50 U.S. states, the District of Columbia, and U.S. territories, where required for:
  • Fertilizers
  • Soil and plant amendments (including microbial inoculants)
  • Specialty fertilizers and crop nutrition products
• Preparation and submission of complete state submission packages, including:
  • Applications
  • Product labels
  • Safety Data Sheets (SDS)
  • Technical data and reports
  • Authorization letters and product summaries
• Ongoing annual renewal and tonnage management in accordance with state‑specific schedules and fee structures.

 Regulatory Strategy & Scientific Support

• Product Categorization & Strategy: Regulatory pathway development for non‑FIFRA regulated products.
• EPA Engagement: Assembly and submission of Non‑FIFRA Regulated Determination (M009) requests to the U.S. Environmental Protection Agency (EPA).
• APHIS Support: Preparation and submission of APHIS PPQ 526 permit applications for the importation and interstate movement of microbial organisms (bacteria, fungi, and viruses).
• Regulatory Intelligence: Ongoing advice on emerging regulatory and scientific developments that may affect current or future product registrations.
• Compliance Transitions: Tailored strategies to bring existing products into alignment with new or evolving regulations.

 Scientific & Technical Documentation

• Technical Dossiers: Development of regulatory dossiers, efficacy summaries, white papers, and supporting technical narratives.
• Data Review: Scientific review and interpretation of product performance and efficacy data.
• Risk & Eligibility Assessments: Determination of whether products or organisms are prohibited, restricted, or unrestricted for import or interstate movement.

 Literature & Assessments

• Literature Reviews: Evaluation of public‑domain scientific literature to support registrations and regulatory submissions.
• Microbial Assessments: Review of microbial products to identify potential regulatory hurdles, including:
  • Taxonomic or nomenclature changes
  • Emerging research findings
  • Safety and toxicity considerations

 Process Optimization & Operational Support

• Process Optimization: Design and implementation of SOPs, batch record templates, and regulatory workflows to streamline approvals and reduce time to market.

The approval of fertilisers and biostimulants is regulated by a combination of European and national legislation. Regulation (EC) No. 2003/2003 applies to the European Economic Area (EEA) – the 27 EU Member States, plus Iceland, Liechtenstein and Norway – and mainly covers mineral fertilisers, which can be marketed EU-wide as CE-marked products. From 16 July 2022, the new Fertilising Products Regulation (EU) 2019/1009 will apply allowing a broader range of fertilisers, liming materials, growing media, soil improvers and biostimulants to be marketed across the EEA as CE-marked. National legislation will still apply covering those products not included in the new regulation, and in the UK.

Compliance with the new EU Fertilising Products Regulation

• Advice regarding regulatory strategy, data gap analysis, data generation and dossier preparation to ensure compliance of fertilisers and related products including liming materials, growing media, soil improvers and biostimulants under Regulation (EU) 2019/1009.
• Liaison with European regulatory agencies as appropriate.

Compliance with National Legislation

• Study identification and monitoring, and dossier preparation, to meet national requirements in the European Economic Area (EEA) (EU27 plus Iceland, Liechtenstein and Norway), where necessary.
• Compliance with UK national legislation including the Fertiliser Regulation 1991 No. 2197 as amended and Regulation 2006 No. 2468.
• Liaison with European regulatory agencies, EEA Member State, and UK national regulatory authorities, as appropriate.

Classification & Labelling

• Support for clients manufacturing, importing, using or distributing crop nutrition products into the European Economic Area (EEA) (EU27 plus Iceland, Liechtenstein and Norway) including review to ensure compliance with the Classification, Labelling and Packaging (CLP) Regulation (EC 1272/2008) and REACH Regulation (2006/1907/EC).