REACH Registration and the Fertilising Products Regulation (FPR): Obligations for Placing EU Fertilising Products on the Market

With the entry into application of the Fertilising Products Regulation (EU) 2019/1009 – FPR, many companies are realising that the uses declared in their REACH registrations are no longer sufficient. Why? Because the new regulation requires that EU fertilising products bearing the CE marking contain substances specifically registered for their use as EU fertilisers.

And this is where the questions begin.

What is an EU fertilising product?

According to the FPR, an EU fertilising product is one that:

Meets the composition, labelling and safety requirements set out in the FPR.
Is manufactured using substances or mixtures whose use as fertilisers is covered in their REACH registration.
Bears the CE marking, allowing free circulation throughout the European Economic Area.

Must all substances be registered under REACH?

The FPR requires that all substances contained in an EU fertilising product be registered under REACH with a dossier that includes at least:

The information requirements applicable to the >10 tonnes/year tonnage band under REACH, and
A Chemical Safety Report (CSR), prepared in accordance with REACH, covering the use of the substance as a fertiliser.

This means that even substances manufactured or imported in quantities below one tonne per year must be registered under REACH if they are to be incorporated into an EU fertilising product (meeting the minimum requirements above).

If I already have a registered substance, do I need to update my REACH registration?

Possibly yes. If your company has registered a substance and now intends to place it on the market as part of a CE-marked fertiliser, you must ensure that the REACH registration dossier meets the minimum requirements established by the FPR.

Updating your REACH registration to cover this use may involve:

Drafting new exposure scenarios.
Conducting new studies or risk assessments.
Updating the CSR (Chemical Safety Report).

I have a substance registered at >10 t/year with several assessed uses, but none as a fertiliser. What should I do?

This is a common situation. The answer depends on your role in the supply chain:

If you are the registrant of the substance:
- Extend the scope of your registration to include the use as a fertiliser, updating your dossier with new exposure scenarios. This includes:
  - Describing the use as an EU fertiliser.
  - Assessing the risks related to this use.
  - Adding the corresponding scenario to the CSR.

If you purchase the substance from an EU supplier:
- Ask your supplier to provide exposure scenarios including the use as an EU fertiliser.
- If they do not have these (and do not intend to generate them), you will need to find another supplier that does.
- Alternatively, you can prepare your own Chemical Safety Report as a downstream user, assessing the use of the substance as a fertiliser.

Are there exemptions?

Yes. The exemptions from REACH registration referred to in the FPR include:

Substances listed in Annex IV of REACH (substances with sufficient information and considered to present minimal risk).
Substances described in points 6, 7, 8 and 9 of Annex V of REACH (substances for which registration is considered inappropriate or unnecessary).

In addition, a company may choose to market the fertilising product without CE marking. In that case, the product would only need to comply with national rules in the countries where it is placed on the market.

How can ServiREACH help?

At ServiREACH, we support companies in meeting their obligations under both REACH and the FPR. We can help you to:

Verify whether your registration properly covers the use as an EU fertiliser.
Contact suppliers and assess their exposure scenarios.
Draft and submit REACH dossier updates.
Prepare downstream user reports if necessary.
Ensure full compliance with both REACH and the FPR.