Biodegradability in CE fertilizers: what changes for manufacturers

Key data

Manufacturers of CE-marked fertilizers incorporating coatings or water-retaining polymers have a technical obligation in force since 28 October 2024: to apply the biodegradability criteria corrected by Commission Delegated Regulation (EU) 2024/2770. This corrigendum directly affects the conformity of their products with Regulation (EU) 2019/1009, the European regulatory framework for CE-marked fertilising products.

This is not a substantive change in fertilizer policy, but rather a technical correction of inaccuracies in the biodegradability criteria. However, its practical consequences are direct: products that do not comply with the corrected criteria cannot be placed on the European single market under the CE marking.

What does this regulation establish?

Commission Delegated Regulation (EU) 2024/2770, published on 28 October 2024, amended Regulation (EU) 2019/1009 to update the biodegradability criteria applicable to two types of components in CE-marked fertilizers:

• Coating agents: materials that encapsulate fertilizer granules to control nutrient release.
• Water-retaining polymers: compounds that improve the soil's capacity to retain moisture.

The corrigendum published under reference CELEX:32024R2770R(01) rectifies technical inaccuracies identified in those biodegradability criteria. Although the text does not specify which particular inaccuracies were corrected, the regulatory effect is clear: the corrected criteria are the ones with legal validity and must be applied to demonstrate conformity.

Economic and operational impact

The impact is not a direct regulatory cost (no fee or financial penalty is published in this corrigendum), but rather a market access risk. The specific operational effects are:

• Risk of commercial blockage: CE-marked fertilizers that do not comply with the corrected criteria cannot be placed on the European single market. For manufacturers distributing across several EU countries, this may result in product withdrawal or batch suspension.
• Cost of documentary review: updating technical data sheets and certification files entails an internal cost in technical hours and, where applicable, laboratory costs if new biodegradability tests are required.
• Recertification cost: if the corrected criteria differ materially from those previously applied, it may be necessary to repeat conformity tests before the relevant notified body.

The risk is greater for manufacturers who already have products on the market under the CE marking based on the criteria prior to the correction, as they must verify whether their documentation remains valid.

Who is affected?

• Manufacturers of controlled-release fertilizers using polymeric or other types of coatings in their CE-marked products.
• Manufacturers of fertilizers with water-retaining polymers (hydrogels and similar) marketed under the CE marking in the EU.
• Distributors of CE-marked fertilizers who must verify the conformity of the products they place on the market.
• Quality and certification managers in plant nutrition companies with a presence in the European market.
• Technical advisors and compliance consultants supporting manufacturers in certification processes under Regulation (EU) 2019/1009.

Practical example

A Spanish manufacturer of controlled-release fertilizers markets in Germany, France and Poland a CE-marked product incorporating a polymeric coating. Certification was obtained in 2023 under the biodegradability criteria of Regulation (EU) 2019/1009 as they were worded at that time.

Following the technical correction published on 28 October 2024, the quality manager must:

1. Compare the corrected biodegradability criteria with those applied in the original certification process.
2. Determine whether the corrected inaccuracies affect the parameters against which the coating was evaluated.
3. If there is a discrepancy, update the product's technical data sheet and, if necessary, initiate a recertification process before the relevant notified body.

If no action is taken and a market surveillance check in any of the three countries detects non-compliance with the current criteria, the product may be withdrawn from the market in that Member State.

What should companies do now?

1. Identify affected products: review the catalogue of CE-marked fertilizers and determine which ones incorporate coating agents or water-retaining polymers.
2. Consult the corrected text: access the full text of corrigendum CELEX:32024R2770R(01) in the Official Journal of the EU and compare the corrected biodegradability criteria with those applied in the current certification.
3. Update technical data sheets: incorporate the corrected criteria into the technical documentation of each affected product.
4. Review certification files: verify with the notified body whether the existing documentation remains valid or whether a formal update is required.
5. Assess the need for new tests: if the corrected criteria involve parameters different from those previously evaluated, plan the necessary biodegradability tests to maintain conformity.
6. Document the review: keep an internal record of the analysis carried out and the actions taken, as evidence of due diligence in the event of market surveillance checks.

Official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, please consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32024R2770R(01)