Registering a pesticide product in the US and EU: two approval systems, one evidence base
Treat supplier, site and formula changes as regulatory questions in both systems before the first commercial batch.
In Short
- US: no sale unless registered.
- EU: substance approval, then product.
- Source changes can matter.
Companies that sell crop protection products in the US and EU face two different approval systems. This guide compares FIFRA section 3 (7 U.S.C. 136a), read in the 2023 US Code edition for subsections (a) to (c), with Regulation (EC) No 1107/2009 as published in 2009 (Articles 4, 28 and 29). Not opened: 40 CFR Parts 152 and 158, EU data requirement regulations, amendments to 1107/2009, endocrine criteria and renewal procedures. For establishment and production records, see our FIFRA manufacturing guide. It is orientation, not legal advice. Sources checked 5 Oct 2026.
Different questions in each system
FIFRA section 3(a) says no person in any State may distribute or sell a pesticide that is not registered, with limited exceptions in section 3(b), such as transfers between establishments of the same producer for packaging or use in another pesticide. The EU works at two levels.
Two systems side by side
| Question | US (FIFRA s.3) | EU (Reg 1107/2009) |
|---|---|---|
| What is approved? | The pesticide product | Active substance (EU), then product (member state) |
| Where? | EPA | EU level, then each member state (Art 28(1)) |
| Basic rule | No sale unless registered (3(a)) | No placing on market or use unless authorised |
- What is approved?
- US (FIFRA s.3)
- The pesticide product
- EU (Reg 1107/2009)
- Active substance (EU), then product (member state)
- Where?
- US (FIFRA s.3)
- EPA
- EU (Reg 1107/2009)
- EU level, then each member state (Art 28(1))
- Basic rule
- US (FIFRA s.3)
- No sale unless registered (3(a))
- EU (Reg 1107/2009)
- No placing on market or use unless authorised
More on different questions in each system
Active substances are approved at EU level against the criteria in Article 4 and Annex II of Regulation 1107/2009. Products are then authorised by each member state: Article 28(1) says a product must not be placed on the market or used unless authorised in the member state concerned.
What a US application contains
Section 3(c)(1) requires a statement with the name and address of the applicant and anyone else named on the labelling; the name of the pesticide; a complete copy of the labelling, all claims and directions for use; the complete formula; a request for general or restricted use classification, or both; and, if EPA requests it, a description of tests and results supporting the claims, or a citation to data EPA may consider. Each item should map to a controlled document with an owner and a revision history.
US applicant statement (section 3(c)(1))
The US Approval Standard
Under section 3(c)(5), EPA registers a pesticide if its composition warrants the proposed claims, its labelling and other required material comply, it will perform its intended function without unreasonable adverse effects on the environment, and, when used in accordance with widespread and commonly recognised practice, it will not generally cause such effects. EPA may waive efficacy data requirements, and lack of essentiality is not a ground for refusal.
More on the US Approval Standard
Data requirements are set in regulations this guide did not open.
Keeping the dossier and the plant aligned
Both systems tie approval to what is actually made. The US statement includes the complete formula; the EU checks source and specification of the active substance.
Worked example: changes at formulator site F-12
- Compare specification and impurities.
- Regulatory review before first batch.
More on keeping the dossier and the plant aligned
A change of supplier, site or process can therefore become a regulatory question, not only a purchasing one. Route such changes through change control with regulatory review before the first commercial batch. Your regulatory team decides whether a change needs notification, amendment or a new application in each market.
Questions
Are EU pesticide products authorised centrally?
No. Active substances are approved at EU level, but under Article 28(1) a product needs authorisation in each member state where it is placed on the market or used.
Can changing the active substance supplier affect an EU authorisation?
It can. Article 29(1)(b) addresses active substances from a different source or changed process or location, comparing specification and impurities with the approved substance.
Does a US registration application include the full formula?
Yes. Section 3(c)(1)(D) of FIFRA requires the complete formula of the pesticide in the applicant's statement.
Does V5 prepare registration dossiers?
No. V5 keeps formulas, specifications, supplier records and change control linked. Your regulatory team prepares and submits every application.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Global Agrochemical Quality & Compliance Readiness Guide
Biopesticide & Microbial Registration Readiness Guide
Pesticide Residue Limits for Exporters: EU 396/2005 and US Tolerances
EPA Pesticide Establishment Readiness: Registration, Annual Reports and Records
EU REACH for Agrochemicals: 1907/2006 Meets 1107/2009
FAO/WHO Pesticide Specifications (JMPS) Readiness Guide