European and national (France) regulations for fertilising products are subject to major changes. On a European scale, the new Regulation (EU) No 2019/1009 or FPR (“Fertilising Product Regulation”) comes into force in July 2022 and repeals the Regulation (EC) No 2003/2003. The level of requirement is clearly increased. Safety, risk management for human, animal or plant health become essential in the process of development and marketing of fertilising products.
In addition to these obligations, there is the regulatory framework of Regulation (EC) No 1272/2008 (CLP) guaranteeing the safety of users, notably, through labelling.
Whether you are a manufacturer or distributor of fertilising products, Equitox supports you in your compliance with European and French regulations. From the diagnosis of your obligations, your product ranges and/or your claims, we define the best strategy for your products, their labelling and their compliance.
I wish to sell a fertilising product in the EU and/or in France
How to determine whether my product is a fertilising product?
- Determines the status of your product: fertilising product? Borderline cases fertilising product and plant protection product?
I would like to know if my project is viable
- Establishes a prior diagnosis and assesses this data with regard to the information requirements set out in the Fertilising Product Regulation and its annexes, and/or the French Rural and Maritime Fishing Code (CRPM) (e.g., marketing authorisation, NF U standards…), in REACh regulation, in CLP regulation.
I would like assistance in placing my product on the market
- Determines the best strategy: EU conformity assessment procedure, NF U standard, national marketing authorisation, mutual recognition, authorisation renewal? Costs? Timelines?
- Prepares the regulatory dossier and provides you with everything you need for the final submission of the dossier to the authorities,
- Monitors the entire assessment process.
I would like assistance from the R&D phase to anticipate all impacts as early as possible
Acceptability of the formulation and its raw materials
Equitox provides its expertise on:
- Hazard assessment,
- Harmonised classifications of substances,
- Substances subject to restriction or authorisation,
- SVHC substances, endocrine disruptors …
To identify hazards and/or blocking co-formulants.
Compliance of raw materials
- Identifies and implements your obligations with regards to REACh: regulatory status of substances, communication of uses, substance registration, notification to the C&L inventory, SDS audit.
What if I only need occasional support?
Compliance of commercial documents (SDS, labels, commercial documentation)
- Analyses the content of regulatory and commercial documents with regard to claims, authorisations granted and the regulatory requirements,
- Helps you comply with European and national requirements.
I would like to be informed of regulatory developments and anticipate future changes
- Anticipates legislative changes and their consequences, by monitoring the regulations in force (FPR amendments, review of NF U standards…), the new regulations (microplastic restriction), new objects (Polymers), emerging issues (Endocrine disruptors, PBT/vPvB/PMT),
- Monitors the classification, restriction or authorisation projects likely to have an impact on you,
- Monitors scientific developments (bibliographic analysis) on your ranges of strategic products or specific properties.
Equitox is an associate member of Afaïa, a professional association of manufacturers and marketers of fertilising products.