Food Enzyme Application in the EU

Over the past decade, the EU regulatory landscape with respect to food enzymes has constantly evolved and has included some major technical updates. As a result, navigating the guidance for preparation of compliant? food enzyme dossiers (applications) can be challenging. CEA is up to date with those changes and has gained significant experience in preparing and submitting food enzyme dossiers to EFSA (including the recent e-submission requirement). A brief summary of our insights is provided below.

 

What is a food enzyme?

As defined in the Regulation (EC) No 1332/2008 on food enzymes, a food enzyme is “a product obtained from plants, animals, or micro-organisms (bacteria or fungi) or products thereof, including a product obtained by a fermentation process using micro-organisms and:

  • Containing one or more enzymes capable of catalysing a specific biochemical reaction
  • Incorporated into food for a technological purpose during any phase of food production including manufacturing, processing, preparation, treatment, packaging, transportation or storage.”
  • Why apply for food enzyme?

Under Regulation (EC) No 1332/2008, food enzymes may only be marketed and utilised as such and used in food products in accordance with the specifications and conditions of use if they appear on the Community list. The Community list of authorised food enzymes is currently in development, with EU member state national regulations applying until its realisation.

Who can apply for food enzyme?

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

Authorisation procedure

Food enzyme applications for authorisation are submitted to the European Commission and evaluated by the European Food Safety Authority (EFSA). The procedure involves multiple communication steps between EFSA, the European Commission and the interested party, and consists of pre-submission and submission phases, authority completeness check, EFSA risk assessment (and possible additional data request), dossier adoption, and finally publication of EFSA opinion.

Materials required for the food enzyme dossier

Specific regulatory requirements for application of enzyme dossiers are summarised below.

Administrative data

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

Risk assessment data requirements

  • 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: sub-chronic toxicity and genotoxicity should be covered. The toxicological data can be exempted under defined conditions (e.g. enzyme production source has “Qualified Presumption of Safety” (QPS) status.

QPS, introduced in 2007, uses existing knowledge about the safety of specific microbes to differentiate those which are not of concern (and can therefore be given QPS status) from those which may represent a risk and should undergo a full safety assessment. The QPS list is established and major updates occurs every three years by EFSA’s Panel on Biological Hazards (BIOHAZ).

Risk management data requirement

  • 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.

 

EU regulations and EFSA statements (2020-2025)

The period 2020-2025 represents the most significant regulatory evolution for food enzymes since the original framework establishment in 2008, with major changes in:

  1. Transparency and Public Access (2021)
  2. Scientific Assessment Standards (2021, 2024)
  3. Molecular Characterisation Requirements (2021, 2024)
  4. Exposure Assessment Methodology (2023)
  5. Digital Tools and Data Management (2024-2025)

Why CEA?

As an interested party, CEA can prepare and submit enzyme dossiers in the EU on behalf of clients from both EU and non-EU countries. For the latter, our CEA(Ireland) affiliate office can operate as an EU-based interested party.

The multidisciplinary team at CEA has considerable experience in preparing and submitting EU food enzyme applications (dossiers) in line with current EU guidelines. Enzyme applications CEA has prepared so far include both QPS and non-QPS production sources. Some of our submitted dossiers have been approved while a couple of applications are still being assessed by EFSA. Leveraging our expertise and resources across multiple disciplines, CEA can provide support and comprehensive compliance solutions to EU Food Enzyme Applications by representing, advising and guiding clients through the entire authorisation process. Our expertise include

  1. Navigating the fast-evolving EU regulatory landscape for food enzymes.
  2. Advising the client on information requirements and he need for generating experimental data.
  3. Conducting a data-gap analysis and advising the client on new data requirements.
  4. Placing and monitoring studies on behalf of the client (e.g. whole genome sequence (WGS) analysis, anti-microbial resistance genes analysis, in vitro and in vivo toxicological studies) including peer-review and finalisation of study reports.
  5. Conducting literature searches for various sections of the dossier, online homology searches for allergenicity and dietary exposure assessment-led derivation of margin-of-safety specific to use cases.
  6. Redacting business-sensitive information ahead of E-submission.
  7. Addressing additional data requests from EFSA towards a successful outcome.

If you need any assistance or have any questions, please get in touch with us via enquiries@cea-res.co.uk .

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