EFSA has issued a scientific opinion on a GMO-derived enzyme:
what food producers must know before using dextransucrase

Dextransucrase (EC 2.4.1.5) is an enzyme that catalyses the synthesis of dextran from sucrose – used, among other applications, in baking to improve crumb texture and moisture, and in syrup production. When produced by a genetically modified microorganism (GMO), it falls within the scope of at least two parallel EU legal regimes: the food enzymes regulation and GMO legislation. An EFSA scientific opinion initiates the procedure, but does not conclude it.

What EFSA actually assessed and what this opinion means in legal terms

The EFSA Panel on Food Additives and Flavourings (FAF Panel) assessed the safety of dextransucrase produced by a genetically modified strain of Bacillus subtilis. An EFSA scientific opinion is not a legal act – it does not confer the right to use the enzyme, does not amend the list of permitted enzymes, and does not relieve the producer of any obligation. It is an input document for the legislative procedure conducted by the European Commission.

The legal basis for a food enzyme is Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (OJ L 354, 31.12.2008). Article 17 of that Regulation provides that an enzyme may be used in food only after it has been entered in the EU list of permitted food enzymes. Until that list is published in the form of a Commission implementing regulation, transitional provisions based on national law apply – but this does not mean there is unlimited discretion.

Expert Tip: Producers should verify whether dextransucrase from the specific GMO strain in question appears on the list of enzymes covered by the transitional procedure under Article 17(3) of Regulation 1332/2008 and in notifications submitted by Member States. If it does not, using that enzyme prior to its inclusion in the EU list is impermissible, regardless of the EFSA scientific opinion.

The dual legal regime: food enzyme PLUS GMO – where producers fall into the trap

This is where a problem arises that is frequently overlooked by producers during GIS inspections: dextransucrase from GMO B. subtilis is subject not only to Regulation 1332/2008, but also in parallel to Regulation (EC) No 1829/2003 on genetically modified food and feed. The key question is: does an enzyme produced by a GMO, but not itself containing GMO DNA or protein (a so-called processing enzyme, or processing aid), require authorisation under Regulation 1829/2003?

The answer depends on whether the enzyme is used as a food additive (and is present in the final product) or solely as a processing aid removed from the product. Article 3(1) of Regulation 1829/2003 covers food containing or consisting of GMOs or produced from GMOs. The Court of Justice of the EU (CJEU) in its judgment in Case C-331/16 [TO BE VERIFIED as to its application in the context of enzymes] and the Commission's position indicate that enzymes used as processing aids that are not detectable in the final product do not in principle require a separate GMO authorisation – but the producer must be able to demonstrate this.

• Enzyme as a processing aid (removed, undetectable in the final product) → in principle outside the scope of Regulation 1829/2003, but documentation confirming absence from the product is required
• Enzyme as a food additive present in the final product → potentially requires authorisation under Regulation 1829/2003 AND inclusion in the list under Regulation 1332/2008
• GMO production strain → must hold authorisation as a GMO for industrial or feed applications, depending on the regulatory pathway
• Absence of documentation confirming processing aid status → risk of the enzyme being classified as a GMO food ingredient and a labelling obligation arising under Article 13 of Regulation 1829/2003

Expert Tip: A producer purchasing an enzyme from a supplier should require the technical specification to include an unambiguous statement on the enzyme's status (processing aid vs. additive), details of the GMO strain used in production, and documentation confirming that strain's authorisation in the EU. The absence of this documentation is a risk that materialises at the first inspection.

graph LR
    A[Dextransucrase\nfrom GMO B. subtilis] --> B{How is it used\nin production?}
    B -- Processing aid\nremoved from product --> C[Regulation 1332/2008\nfood enzyme]
    B -- Additive\npresent in product --> D[Regulation 1332/2008\n+ Regulation 1829/2003 GMO]
    C --> E{Detectable\nin final product?}
    E -- No + documentation --> F[No GMO labelling\nobligation]
    E -- Yes or no evidence --> G[Labelling obligation\nArt. 13 Regulation 1829/2003]
    D --> H[GMO authorisation required\n+ mandatory labelling]
    style H fill:#ff9999,stroke:#cc0000
    style F fill:#99ff99,stroke:#009900

From EFSA scientific opinion to legal use: what the procedure looks like and how long it takes

The authorisation procedure for a food enzyme following a positive EFSA scientific opinion proceeds as follows: the European Commission prepares a draft implementing regulation updating the EU list of food enzymes (which to date has not been finally published – work on it has been ongoing for more than a decade). The draft is submitted to the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) and then enters the committee procedure.

In practice, this means that from the publication of a positive EFSA scientific opinion to the actual inclusion of the enzyme in the list, several years may pass. The EU list of food enzymes, provided for by Regulation 1332/2008, has not yet been adopted as a separate legal act – meaning the entire sector operates on the basis of the transitional provisions of Article 17(2) and (3) of that Regulation, referring to national law in force before 20 January 2010.

For Polish producers, this means verifying whether the enzyme in question was permitted for use in Poland before that date and whether a notification to the Commission was submitted by Poland within the time limit required by Article 17(3) of Regulation 1332/2008. If not, use of the enzyme in Poland is formally impermissible until the EU list is adopted.

graph TD
    A[EFSA scientific opinion\nFAF Panel] --> B[European Commission\ndraft implementing regulation]
    B --> C[SCoPAFF\nstanding committee]
    C --> D{Positive\nvote?}
    D -- Yes --> E[Publication in the\nOfficial Journal of the EU]
    E --> F[Inclusion in the list\nof food enzymes\nRegulation 1332/2008]
    F --> G[Legal use\nin the EU]
    D -- No / No consensus --> H[Appeal procedure\nAppeal Committee]
    H --> B
    A -.-> I[Producer CANNOT\nuse the enzyme\nautomatically]
    style I fill:#ff9999,stroke:#cc0000
    style G fill:#99ff99,stroke:#009900

Labelling: when must GMO information appear on the label

Regulation (EC) No 1829/2003, Article 13, imposes a labelling obligation on food containing or produced from GMOs. The quantitative threshold is 0.9% for each ingredient (Article 12(2)), below which the presence of GMOs is exempt from the labelling obligation – provided it is technically unavoidable or adventitious. For an enzyme used as a processing aid that is not present in the final product at any detectable concentration, the labelling obligation does not in principle arise.

The problem arises when the producer cannot demonstrate the absence of the enzyme in the final product. The absence of validated analytical methods for a specific enzyme from a specific GMO strain is a situation in which the supervisory authority may apply the precautionary principle and challenge the product. In such cases, the Polish Chief Sanitary Inspectorate (GIS) refers the matter to reference laboratories, and proceedings may last for months.

Expert Tip: A producer using GMO-derived enzymes as processing aids should hold a validated analytical method confirming the absence of any detectable presence of the enzyme or GMO strain DNA in the finished product. This documentation should be available on request by the supervisory authority – its absence is not only an administrative risk, but potentially a breach of Article 18 of Regulation (EC) No 178/2002 (traceability obligation).

What penalties apply to a producer using an enzyme without a proper legal basis

Using a food enzyme not included in the list (or not meeting the transitional conditions of Article 17 of Regulation 1332/2008) constitutes a breach of food safety legislation. In Poland, administrative liability arises under the Act of 25 August 2006 on food and nutrition safety (consolidated text: Journal of Laws 2023, item 1448). Article 103 of that Act provides for a financial penalty of up to ten times the financial benefit obtained from the infringement, with a minimum of PLN 1,000.

Independently of the financial penalty, the Polish Chief Sanitary Inspectorate (GIS) may issue a decision ordering the withdrawal of the product from the market and – in the case of infringements of GMO regulations – refer the matter to RASFF (Rapid Alert System for Food and Feed). A RASFF notification means automatic notification to all Member States and may result in the withdrawal of the product from markets across the entire EU if the producer exports.

• Administrative penalty: up to ten times the financial benefit from the infringement (Article 103 of the Act on food and nutrition safety)
• GIS decision ordering withdrawal of the product from the market – immediately enforceable
• Entry in RASFF → automatic notification to all EU Member States → potential withdrawal from export markets
• Criminal liability for placing non-compliant food on the market – Article 100 of the Act on food and nutrition safety (fine)
• Infringement of GMO labelling provisions under Regulation 1829/2003 → additional proceedings for misleading consumers (Article 7 of Regulation (EU) No 1169/2011)

What producers should do now – a list of concrete steps

The positive EFSA scientific opinion on dextransucrase from GMO B. subtilis is a signal that the enzyme has passed a safety assessment – but not a signal for immediate implementation. Producers who plan to use this enzyme, or who are already using it on the basis of transitional provisions, should act according to the following sequence.

• Step 1: Verify whether the specific enzyme preparation (specific supplier, specific GMO strain) appears on the list notified to the Commission by Poland under Article 17(3) of Regulation 1332/2008 – notifications are available in the Commission register
• Step 2: Obtain from the supplier a full technical specification covering: the name of the GMO strain, the EU authorisation number for the strain (if applicable), confirmation of processing aid or additive status, and data on the absence of GMO biological activity in the final product
• Step 3: Commission a legal analysis: whether the use of the specific preparation in the intended food product falls within the scope of the transitional provisions or requires waiting for the EU list
• Step 4: Prepare documentation confirming the absence of any detectable presence of the enzyme or GMO DNA in the final product (validated analytical method or laboratory test results)
• Step 5: Monitor progress of SCoPAFF work on the food enzymes list – the Commission publishes agendas and minutes of committee meetings on the DG SANTE website
• Step 6: In case of doubt regarding labelling – submit an interpretative query to the Polish Chief Sanitary Inspectorate (GIS) or use the consultation mechanism with the Commission via BPKP [TO BE VERIFIED as to the national procedure]

Expert Tip: Producers who purchase ready-made enzyme blends from distributors often do not know that the composition may include a GMO-derived enzyme. The technical specification from the supplier should contain unambiguous information on the origin of each enzyme – including whether the production strain is a GMO. The absence of this information does not relieve the food producer of responsibility for the product's compliance with applicable regulations.