EFSA Scientific Opinion on a GMO-Derived Enzyme (Dextransucrase):
What It Means for EU Food Producers

What is dextransucrase and why EFSA examined it

Dextransucrase (EC 2.4.1.5) is an enzyme that catalyses the synthesis of dextran from sucrose. In the food industry, it may be used as a texturising agent, thickener, or processing aid. The enzyme manufacturer submitted an application for safety assessment to EFSA in accordance with Article 17 of Regulation (EC) No 1332/2008 on food enzymes.

The EFSA Panel on Food Enzymes (FEZ) issued a favourable scientific opinion, concluding that the enzyme does not give rise to safety concerns under the proposed conditions of use. The production organism is a genetically modified strain of Bacillus subtilis DP-Eyp97. EFSA confirmed that no viable production organism or its DNA was detected in the enzyme preparation.

Key point: A favourable EFSA opinion is a safety assessment, not an authorisation for use. The enzyme has not yet been entered in the Union list of permitted food enzymes (Article 4 of Regulation 1332/2008), because that list has still not been established.

Legal regime: Regulation 1332/2008 vs Regulation 1829/2003 (GMO)

A producer of a food enzyme manufactured with the aid of a GMO must determine which legal regime applies. Regulation (EC) No 1829/2003 concerns genetically modified food, i.e. food that contains a GMO, consists of a GMO, or is produced FROM a GMO. The critical distinction is between "produced FROM a GMO" and "produced WITH the aid of a GMO".

Recital 16 of Regulation 1829/2003 provides that products obtained not FROM but WITH the aid of a GMO (e.g. enzymes produced by genetically modified micro-organisms where the production organism is not detectable in the final product) do not fall within the scope of that Regulation. If the enzyme preparation contains no viable GMO cells or their DNA, the enzyme is subject solely to Regulation 1332/2008, with no requirement for GMO authorisation and no GMO labelling obligation.

graph TD
    A["Enzyme produced by a GMO<br/>e.g. dextransucrase from B. subtilis DP-Eyp97"] --> B{"Is GMO material present<br/>in the product?<br/>viable cells, DNA, protein"}
    B -- "No<br/>no DNA, no viable cells" --> C["Produced WITH the aid of a GMO<br/>outside scope of Reg. 1829/2003<br/>Recital 16"]
    B -- "Yes" --> D["Produced FROM a GMO<br/>scope of Reg. 1829/2003<br/>and Art. 8 of Reg. 1332/2008"]
    C --> E["Regime: Reg. 1332/2008<br/>no GMO authorisation or labelling"]
    D --> F["GMO authorisation required<br/>and mandatory labelling"]
    style E fill:#22c55e,color:#fff
    style F fill:#ef4444,color:#fff

From EFSA opinion to lawful use: a procedure that has not yet been completed

Regulation 1332/2008 provides that food enzymes may be lawfully used only after their inclusion in the Union list (Article 4). The inclusion procedure requires: (1) a favourable EFSA opinion, (2) a draft implementing regulation prepared by the European Commission, (3) a positive vote in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF), (4) publication in the Official Journal of the EU.

The problem is that the Union list of food enzymes has never been established. Article 24 of Regulation 1332/2008 introduced a transitional period: until the list is established, food enzymes remain subject to national provisions of the Member States. In practice, this means that a favourable EFSA opinion alone does not give a producer the right to use the enzyme, but equally the mere absence of an entry in the (non-existent) list does not automatically constitute an offence.

A food producer wishing to use dextransucrase from GMO B. subtilis must therefore determine: (1) whether the enzyme satisfies the safety requirements of Article 14 of Regulation 178/2002, (2) whether it meets the labelling requirements of Articles 10-13 of Regulation 1332/2008, (3) whether the Member State in question has additional national provisions restricting the use of food enzymes during the transitional period.

graph TD
    A["EFSA Scientific Opinion<br/>Panel on Food Enzymes FEZ"] --> B["European Commission<br/>draft implementing regulation"]
    B --> C["SCoPAFF<br/>Standing Committee"]
    C --> D{"Positive vote?"}
    D -- "Yes" --> E["Publication in the Official Journal of the EU"]
    E --> F["Entry in the Union list of enzymes<br/>Art. 4 of Reg. 1332/2008"]
    F --> G["Lawful use throughout the EU"]
    D -- "No consensus" --> H["Appeal Committee"]
    H --> B
    A -.-> I["The opinion alone does NOT<br/>authorise use of the enzyme"]
    style I fill:#ef4444,color:#fff
    style G fill:#22c55e,color:#fff

Labelling: when the enzyme must appear in the list of ingredients

Article 20(b) of Regulation (EU) No 1169/2011 on the provision of food information to consumers exempts from declaration in the list of ingredients substances that function as processing aids and have no technological function in the final product. If dextransucrase is used as a processing aid and is deactivated or removed during the production process, it need not be declared on the label.

However, if the enzyme performs a technological function in the finished product (e.g. as a texturising agent present in the food matrix), it is subject to the declaration obligation under Articles 18-19 of Regulation 1169/2011. The distinction between a processing aid and an ingredient is critical and must be documented by the food producer.

Irrespective of its function in the final product, Articles 10-13 of Regulation 1332/2008 impose additional labelling requirements on food enzymes sold as such (not in the final product). The enzyme manufacturer must indicate on the label, inter alia, the name of the enzyme, its activity, and storage conditions.

Situation in Poland: no national list

Article 10a of the Act of 25 August 2006 on Food and Nutrition Safety refers, in respect of food enzymes, directly to Regulation (EC) No 1332/2008. Poland has not established a separate national list of permitted food enzymes. During the transitional period (Article 24 of Regulation 1332/2008), the use of food enzymes is governed by the general national provisions in force before the Regulation took effect.

In practice, this means that a food producer in Poland using dextransucrase does not breach Article 4 of Regulation 1332/2008 (absence of an entry in the list), because the list does not exist. The producer must, however, satisfy: (1) the general safety requirement of Article 14 of Regulation (EC) No 178/2002, (2) the labelling requirements of Regulation 1332/2008, (3) the obligation to hold documentation confirming the safety of the enzyme (the EFSA opinion constitutes strong support here).

Expert Tip: A favourable EFSA opinion, although it does not automatically confer a right to use the enzyme, constitutes the strongest available evidence of safety in the event of a check by the competent authority. The producer should incorporate the EFSA opinion into its HACCP documentation as an element justifying the use of the enzyme.

Penalties: Article 103 of the Food Safety Act

Article 103 of the Act on Food and Nutrition Safety provides for monetary penalties for infringement of food law provisions. The penalty may amount to up to 30 times the average monthly national salary. During the transitional period (absence of the Union list of enzymes), the mere lack of an entry for the enzyme in the list does not constitute an administrative offence. The operative obligations whose infringement may give rise to a penalty are:

• Food safety (Article 14 of Regulation 178/2002): use of an enzyme that is not safe
• Labelling (Articles 10-13 of Regulation 1332/2008): absence of required information on the label of a food enzyme
• Traceability (Article 18 of Regulation 178/2002): inability to trace the enzyme in the supply chain

Criminal liability (Article 165(1)(2) of the Penal Code) arises only where the use of the enzyme creates an actual danger to the life or health of many persons, which in the case of an enzyme with a favourable EFSA opinion is a marginal scenario.

What a food producer should do now

If you are considering using dextransucrase from GMO Bacillus subtilis in food production, the essential steps are:

• STEP 1: Obtain the full enzyme specification from the supplier, including confirmation of the absence of viable production organism and DNA in the final preparation
• STEP 2: Verify whether the application of the enzyme qualifies as a processing aid (no function in the final product) or as an ingredient (presence of a technological function)
• STEP 3: Incorporate the EFSA opinion into HACCP documentation as evidence of enzyme safety
• STEP 4: Ensure labelling compliance with Articles 10-13 of Regulation 1332/2008 (if the enzyme is sold as such) or Articles 18-20 of Regulation 1169/2011 (if it is an ingredient of the final product)
• STEP 5: Monitor progress on the Union list of food enzymes — once established, the legal situation will change

The above text is of a general and informational nature. It does not constitute legal advice in any individual case; assessment of a specific product requires analysis of its full composition, supplier documentation, and quality management system.