Regulation 2019/1009: digestate as an EU fertilising product with the CE marking

Regulation (EU) 2019/1009 creates a uniform system of EU fertilising products in which digestate and compost may be sold freely throughout the Union with the CE marking, provided they meet the requirements of the product category and the components. It has applied since 16 July 2022 and replaced Regulation 2003/2003 (the "EC FERTILISER" system), but covers a much broader scope, including organic fertilisers, soil improvers and biostimulants. For biogas plants it is an alternative to national permits and to the national digestate product.

How the system is built

• PFC (product function categories) — define what the product is, e.g. an organic fertiliser, soil improver, growing medium, inhibitor, biostimulant or blend.
• CMC (component material categories) — define what the product may be made from; the input materials and processes for each component are described in the annexes. For biogas plants the key ones are: CMC 3 (compost), CMC 4 (digestate from fresh crop biomass) and CMC 5 (digestate other than from fresh crop biomass).
• Quality requirements — limits on contaminants (including heavy metals), pathogens and macroscopic impurities, and minimum nutrient contents.
• Conformity assessment — the producer carries out the procedure specified for the given category, and in many cases, especially for compost and digestate, involves a notified body; it ends with an EU declaration of conformity and the CE marking.
• Labelling — the label contains the declared content of components, information on use, the producer and the number of the body (if applicable).

Digestate and compost in the CMCs

For CMC 3 and 5, sewage sludge, industrial sludge and dredging sludge are not a permitted input material. An appropriate process and hygienisation are also required, and products containing material of animal origin must additionally meet the requirements of Regulation 1069/2009.

Relationship to waste law

The regulation provides that materials meeting the criteria cease to be waste once a conforming product is placed on the market, which facilitates their trade in the EU. For a biogas plant this means that a product with the CE marking can leave the waste regime and national permits, but only if the whole chain, the feedstock, the process and the tests, meets the requirements of the regulation.

Poland: four routes side by side

1. EU fertilising product (CE) — Regulation 2019/1009 directly, supervised under the act on conformity assessment systems and market surveillance and the act on fertilisers and fertilisation (supervised by the Plant Health and Seed Inspection Service).
2. The national digestate product from agricultural biogas plants (since 11 September 2023) — without a ministerial permit, after notifying the voivodeship inspector, with a declaration of content and contaminant limits for some substrates; a ban on packaging and an obligation of a written agreement when disposing of it for direct agricultural use.
3. An organic fertiliser with a ministerial permit — for digestate outside the agricultural route.
4. R10 recovery — where the digestate remains waste.

When it is worth choosing CE

• When the product is to be sold in bags or in large batches on the EU market, also outside Poland.
• When the feedstock and process are stable and the composition repeatable, so that the cost of conformity assessment is spread over a large production.
• When recipients expect labelling and declared parameters.

It is often less profitable when digestate goes only to a few nearby farms — then the national route is simpler.

What implementation looks like step by step

1. Choosing the product category — e.g. an organic fertiliser from digestate as a PFC for fertilisers, or a soil improver.
2. Verifying the input materials against the list in the annex for the chosen CMC.
3. Adapting the process — hygienisation, control of time and temperature, digestate quality.
4. Product testing — contaminants, pathogens, macroscopic impurities, declared components.
5. Conformity assessment — choosing the procedure and, if needed, a notified body.
6. Technical documentation and the EU declaration of conformity.
7. CE marking and label in line with the requirements.
8. Maintaining the system — repeatable composition, control samples, changes of recipe reported to the body.

Costs and risks

The CE system requires investment in documentation, testing and assessments, which makes sense at greater scale and repeatability. The risk is feedstock variability: every significant change of recipe may require new tests or an update of the documentation. The benefit, in turn, is free trade throughout the EU and a simplification of waste status. On the recipients' side, what matters is the predictability of parameters and not having to check whether a local permit covers the given product.

What the regulation does not cover

The CE system concerns products placed on the market, not all ways of managing digestate. Digestate spread on one's own fields or passed to neighbours can still use national solutions (R10 recovery, natural fertiliser, digestate product). The regulation also does not replace the UPPZ provisions, the nitrates programme or the bans on applying fertilisers to frozen or flooded soil — these apply in parallel.

What to do first

• Check whether the feedstock falls within the input materials of CMC 4 or CMC 5 (or CMC 3 for compost).
• Identify the PFC that fits the product (e.g. an organic fertiliser, a soil improver).
• Test the digestate for contaminant and pathogen limits.
• Ask a notified body about the scope of conformity assessment and the costs.
• Compare with the costs and limitations of the national route.

This text is for information purposes only and does not constitute legal advice; before an investment or formal decision, check the current wording of the provisions and consult a lawyer or the competent authority.