EU Food Enzyme and Food Enzyme Preparation Application

What is a food enzyme and food enzyme preparation in the EU?

As defined in the Regulation (EC) No 1332/2008 on food enzymes,

• A “food enzyme” means a product obtained from plants, animals, or micro-organisms or products thereof, including a product obtained by a fermentation process using micro-organisms:
  • containing one or more enzymes capable of catalyzing a specific biochemical reaction; and
  • added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport, or storage of foods; and
• A “food enzyme preparation” means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardization, dilution, or dissolution.

Why apply for food enzyme (food enzyme preparation)?

According to the Regulation (EC) No 1332/2008, only food enzymes included in the Community list* may be placed on the market as such and used in foods, in accordance with the specifications and conditions of use.

* The Community list of authorized food enzymes is currently under development. Until the finalization of this list, national provisions in force concerning the placing on the market and use of food enzymes and food produced with food enzymes shall continue to apply in the EU Member States.

Who can apply for food enzyme (food enzyme preparation)?

As regulated in Regulation (EC) No 1331/2008 on common authorization procedure for food additives, food enzymes and food flavorings, applications may be made by a Member State or by an interested party, who may represent several interested parties, in accordance with the conditions provided for by the implementing measures.

Authorization procedure

Applications for authorization are submitted to the European Commission and evaluated by the European Food Safety Authority (EFSA). The procedures are as follows:

Pre-submission phase

• Potential applicant requests general pre-submission advice (optional); and
• Potential applicant notifies studies commissioned or carried out as of March 27, 2021.

Submission phase & completeness check

• Applicant submits application via the e-submission system to the EC;
• The EC tasks EFSA and makes the application available to EFSA;
• Receipt of the application by EFSA and suitability check (30 working days); and
• EFSA declares the application suitable.

Risk assessment phase (9 months + Request of additional information)

• EC validates the application;
• EFSA launches public consultation on the application dossier;
• EFSA performs a thorough risk assessment; and
• EFSA Panel adopts the scientific output.

Post-adoption phase

• EFSA publishes the scientific output;
• Based on EFSA’s opinion, the EC prepares a draft regulation.

Materials required for the application

As regulated in Regulation (EU) No 234/2011 on implementing Regulation (EC) No 1331/2008 (common authorization procedure for food additives, food enzymes and food flavorings), the information on the specific requirements for application dossiers is summarized below.

Administrative data

• Applicant’s contact details;
• Manufacturer(s)’s contact details, if different from the applicant’s;
• Contact details of the person responsible for the dossier;
• Basic information about the food enzymes.

Data required for risk assessment 

• Name(s), including synonyms, abbreviations and classification(s), and Enzyme Commission number;
• The proposed specifications, including the origin;
• The properties;
• The manufacturing process and source material;
• The stability, reaction, and fate in foods in which the food enzyme is used;
• The proposed uses in food and, where applicable, the proposed normal and maximum use levels;
• The dietary exposure assessment;
• The biological and toxicological data: subchronic toxicity and genotoxicity should be covered. The toxicological data can be exempted under defined conditions.

Data required for risk management

• The identity of the food enzyme;
• The function and technological need, including a description of the typical process(es) in which the food enzyme may be applied;
• The effect of the food enzyme on the final food;
• Why the use would not mislead the consumer;
• The proposed normal and maximum use levels where applicable; and
• The dietary exposure assessment.

Our services

• EU food enzyme (food enzyme preparation) application feasibility analysis;
• EU food enzyme (food enzyme preparation) application service; and
• Other customized compliance services

CIRS strength

The Food Business Division of CIRS Group, established in 2012, has successfully assisted over 1,000 domestic and international food and feed companies in achieving "one-stop" regulatory compliance. Leveraging our extensive expertise and resources across multiple jurisdictions, we provide comprehensive compliance solutions including:

• China - “Three New” Food Registration: new food material, new food additives, and new food contact materials (including synthetic biology-derived products)
• China - New Feed and New Feed Additive Application
• US - FDA GRAS Notice
• US - Animal Food GRAS Conclusions
• EU - Novel Food Application
• EU - Food Enzyme (Food Enzyme Preparation) Application
• EU - Feed Additive Application

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.