Preservatives E 200, E 202 and E 310: What Changes for Food Manufacturers

Key data

If your company manufactures, imports or labels food products containing sorbic acid (E 200), potassium sorbate (E 202) or propyl gallate (E 310), this regulatory correction directly affects you. The European Commission has published a corrigendum to Regulation (EU) 2024/2597, which modified the conditions of use of these three preservatives under the Regulation (EC) No 1333/2008 on food additives.

This is not a minor wording change: the corrections affect the annexes that regulate what is permitted and under what conditions, which directly impacts the legal validity of your current formulations.

What does this regulation establish?

The corrigendum acts on two key regulatory texts:

The Annex II to Regulation (EC) 1333/2008 is the master document that determines in which food categories each additive can be used and at what maximum doses. Any error in that annex—even if typographical or a cross-reference error—can invalidate the use of a preservative in a specific product category.

The Annex to Regulation (EU) 231/2012 sets the technical purity and quality specifications that each additive must meet to be considered compliant. If the corrected specifications differ from those your supplier certifies, there may be a conformity issue with the ingredient.

The corrigendum is published because the original text of Regulation (EU) 2024/2597—published on 7 October 2024—contained errors that needed to be corrected. The corrected text is the one with legal validity from the publication of this corrigendum.

Economic and operational impact

This corrigendum does not generate new fees or direct sanctions, but it can have real economic consequences if your company does not act:

• Commercialization problems: If your technical sheets or labels reference the original text with errors, you could face difficulties in market controls or when exporting to other EU countries.
• Health inspections: Competent authorities will apply the corrected text. A discrepancy between your documentation and the current regulation can trigger an inspection or require additional documentation.
• Internal review cost: Updating formulations, technical sheets and supplier documentation has a real operational cost, especially for companies with large catalogs.
• Supply chain risk: If you are a distributor or importer, you must ensure that the original manufacturers also work with the corrected text, not the original erroneous one.

Who does it affect?

• Food manufacturers using E 200, E 202 or E 310 in their formulations (preserves, dairy products, bakery, beverages, sauces, etc.).
• Food importers introducing into the EU products containing these preservatives.
• Distributors and labelers responsible for product compliance in the European market.
• Quality and regulatory managers (QA/RA) of food companies managing technical documentation and additive sheets.
• Food additive suppliers certifying the compliance of E 200, E 202 or E 310 against the specifications of Regulation (EU) 231/2012.

Practical example

Imagine a Spanish meat company using potassium sorbate (E 202) as a preservative in its packaged sausage line. Until now, its product technical sheet and declaration of conformity referenced Regulation (EU) 2024/2597 published on 7 October 2024.

With the publication of this corrigendum, the valid legal text is the corrected one. If the company exports to France or Germany and an inspector verifies the documentation, the valid reference text is the corrected one. If the technical sheet cites conditions of use that corresponded to the original text with errors, the company may face requests for additional documentation or, in the worst case, temporary withdrawal of the product from the distribution channel while the discrepancy is resolved.

The solution is simple but requires immediate action: review all references to Regulation (EU) 2024/2597 in internal documentation and update them to the corrected text.

What should companies do now?

1. Identify affected products: Review the catalog and identify all products containing E 200 (sorbic acid), E 202 (potassium sorbate) or E 310 (propyl gallate) in their formulation.
2. Consult the corrected text: Access the corrigendum published on 08/09/2026 in the EU Official Journal and compare it with the original text of Regulation (EU) 2024/2597.
3. Update technical documentation: Review technical sheets, declarations of conformity and product specifications to ensure they reflect the corrected text, not the original.
4. Verify with additive suppliers: Request that suppliers of E 200, E 202 and E 310 confirm that their analysis certificates and purity specifications comply with the corrected Annex to Regulation (EU) 231/2012.
5. Inform the quality and regulatory team: Ensure that QA/RA managers are aware of the corrigendum and take it into account in internal and external audits.
6. Document the review process: Keep evidence that the company has reviewed and updated its documentation following the publication of the corrigendum. This protects against potential health inspections.

Official source

Consult complete regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202690748