EPA Regulatory Affairs

• Regulatory strategies for fertilizers and biostimulants including application for a Non-FIFRA Regulated Determiniation (M009).

State Registration Management

• First-time registration, renewals, and fee payment support in all 50 states, District of Columbia, and US territories where licensing and/or registration is required for fertilizers, soil/plant amendments, and other crop nutrition products.
• State submission package preparation (applications, labels, SDSs, technical data, reports, authorization letters, product summaries).
• Annual renewal of product licenses and tonnage reporting according to State schedules and fees.

Regulatory & Scientific Insights

• Advice on emerging regulatory and scientific developments that may impact current and future registrations.
• Tailored approaches to bring client products into compliance with new regulations.

Literature Review

• Evaluation of public domain scientific literature and data in support of registration.

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).