Call for input data for the Exposure Assessment of Food Enzymes

10 January 2017
Document (255.83 KB)

Background and Objective

According to Regulation (EC) No 1332/2008[1], all food enzymes currently on the EU market as well as new food enzymes shall be subject to a safety evaluation by the European Food Safety Authority (EFSA). The outcome of this evaluation supports the European Commission in establishing a Community list for authorised substances.

In September 2016, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) adopted a Statement on the ‘Exposure assessment of food enzymes’[2]. A food process based methodology will be used to estimate dietary exposure to food enzymes, and the EFSA Comprehensive European Food Consumption Database (Comprehensive Database)[3] will be the source of consumption data.

Exposure assessment of food enzymes relies on two inputs: i) the enzyme use levels in foods and ii) the consumption data of the corresponding foods. In applications submitted according to Regulation (EC) No 1332/2008, applicants provide recommended use levels of food enzymes and a description of intended conditions of use. The enzyme use levels are expressed at the raw material level[4], and the intended uses are described by giving examples of commonly consumed foods and/or food processes. In almost all the applications received, the raw materials do not correspond directly to the foods that can be produced under the intended uses; the intended uses are often poorly described and varies from one application to another; and the example of foods does not reflect an exhaustive list of foods that can be produced.

To harmonise the description of food processes, the European Commission (EC) is currently finalising a ‘Working document describing the food processes in which food enzymes are intended to be used’[5]. EFSA has been making use of this document to assign a list of foods corresponding to each food process.

Foods are coded according to the FoodEx classification system[6] in the Comprehensive Database. The harmonisation between the raw material (to which food enzymes are added) and the consumption data (collected as foods as consumed) required technical conversion factors. Making use of publically available recipe information, food label information (such as Mintel’s Global New Products Database, as well as the FAO technical conversion factors[7], EFSA is in the process of deriving technical factors specific to the corresponding FoodEx categories, in order to convert between raw agriculture commodities, food ingredients and foods as consumed.

The technical factors and food categories can vary for different reasons, especially those related to recipes that might be influenced by industrial practices, country to country variability, etc. The choice of each specific factor is therefore subject to expert judgment, and consequently is associated with a certain level of uncertainty.

To ensure uniform application of FoodEx food categories and technical factors in all assessments, stakeholders are invited to submit feedback/information on the selected food categories and technical factors related to recipe and food manufacturing processes.

As each technical factor corresponds to a FoodEx category, and each FoodEx category is a descriptor for many similar foods (e.g. brand is not reflected in the category), a potential range of values can apply to a specific technical factor. Therefore, EFSA invites stakeholders to propose different values only in cases where the figures proposed by EFSA significantly differ from the information available for a certain factor.

EFSA will consider the feedback received from interested stakeholders, when estimating exposure to food enzymes.

Open calls

A series of calls will be published on the EFSA website.

Up to 18 calls can be expected, corresponding to the number of food processes defined by the European Commission.

EFSA may consult on ³ 1 food processes in each call.

MS Excel ® file

Each file can contain multiple separate sheets.

The first sheet is the legend; the last sheet is the FoodEx catalogue. In between a separate sheet contains input data of a food process.

Deadline of the call

The deadline will be specified in each call. A call will last about 8 weeks.

Within the deadline, interested parties and stakeholders should provide their input and send by email to: foodenzyme.datacall [at]

Disclosure of contact details

In order to facilitate the collaboration of all interested parties to provide the data needed, we are seeking your consent to disclose your personal data (name, e-mail address and telephone number) to the other parties that has expressed an interest to provide the requested information. If you do not wish to make your contact details available, clearly indicate it in your communication.

Confidentiality on submitted data

In accordance to Article 12 of the Regulation (EC) No 1331/2008[8], the interested parties should indicate which information wish to be treated as confidential and provide verifiable justification supporting this request.

1st Call : Input data for the Exposure Assessment of Food Enzymes

Food processes

  • Baking processes
  • Brewing processes

Instruction for completing the attached MS Excel ® file

Sheet 1 contains a legend for the information given in Sheets 2 and 3.

EFSA is seeking your feedback on the information listed in the Excel file concerning the FoodEx categories (column B), and the associated recipe/ingredient factors (column E) for Baking processes (Sheet 2) and Brewing processes (Sheet 3)

1.For FoodEx categories (column B), should any food group be excluded? Or are there any food groups missing from the list?

In column G, please indicate ‘Remove’ for foodgroups to be exluded, and list any additionally proposed food groups with the corresponding FoodEx category at the end of this column.

The FoodEx categories are available in the FoodEx list (Sheet 4).

2.In column E, the average standard recipe fractions (f2) derived from open information sources are listed.

If the derived factor for each FoodEx category differs significantly from the one applicable to the product of which you are aware (considering the variability between foods in the category), please propose an alternative average factor for the FoodEx category in column H.

3.For the baking process, EFSA has derived the factor f2 based on flour. However, in some food enzyme applications, the enzyme use level for baking processes refers to starch. In these cases, EFSA intends to derive the starch content from the compositional databases available on, unless alternative and more relevant information is provided.

If known, please indicate the starch content for a specific type of flour in column F.

For transparency purposes, please provide a short text using columns I, J and K to justify any feedback given in columns F, G and H, respectively. Any references should be provided in column L.

Submission of data

Data should be submitted directly to EFSA using the dedicated e-mail address for this service: foodenzyme.datacall [at] This mailbox is also the contact point for any technical support/advice you need for the reporting of this data.

10 November 2016