EFSA Takes a Closer Look at Food Enzyme Exposure Assessments

Deadline for Public Consultation is 31 March 2016

19 February 2016

Foods such as cheese, flour, fruit juice, and cider are processed using food enzymes, intended to catalyse specific biochemical reactions in the substrate (for example, breaking down starches to sugars). In 2008, regulations in the European Union (EU) established requirements that all food enzymes must be approved under Regulation (EC) 1332/2008. The deadline for submitting food enzyme applications was 11 March 2015, with over 300 applications submitted for scientific evaluation!

Recently, the European Food Safety Authority (EFSA) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) met with stakeholders, including members from Intertek, to discuss the approaches used for assessing exposure to these food enzymes.

In line with the original guidance, most applications submitted to EFSA included an estimate of exposure based on the “Budget Method”, a simple and conservative method of estimating exposure which was originally designed to estimate exposure to a food additive. EFSA have been cognisant of the differences between additives and enzymes and have therefore proposed that, going forward, the first tier of exposure estimates include an assessment using the principles of the “Budget Method” without the standard assumptions which assign a default proportion of food and beverages containing the substance (which was established for food additives). Rather, EFSA proposes that Tier 1 assumes that all foods and beverages consumed in the diet are assumed to be processed using the food enzyme at the maximum addition level. This is expected to result in an increase in the exposure estimates for most enzyme applications that were submitted.

In the case that exposure estimates do not meet an appropriate margin of exposure for the enzyme, EFSA further suggested two options for a second tier (or “refined”) assessment. Tier 2a utilises food consumption data from the “EFSA Comprehensive European Food Consumption Database” - the use of these statistics on food consumption for European populations would allow for a more realistic calculation of exposure using specific food categories. Tier 2b is a refinement of the Tier 1 “Budget Method” by applying specific factors applicable to the individual food enzyme - this would allow the proportion of foods and beverages processed with the enzyme and the presence of the food enzyme therein to be taken into account. However, factors applicable to each enzyme would need to be considered on a case-by-case basis, which creates difficulty for applicants to identify a suitable proportion to apply to these assessments.

Additional details and public consultation on the draft statement on the exposure assessment of food enzymes is now available at http://www.efsa.europa.eu/en/consultations/call/160216 . Written comments are welcome until 31 March 2016.

Confused? You are not alone! If you have a question regarding exposure assessments for food enzymes or other ingredients added to food (additives, flavours and so on), contact the experts at Intertek and/or sign up for our upcoming webinar on “Understanding Intakes - Focus on Enzymes” by registering here.

Today's expert blogger, Annette Lau, is a scientific and regulatory associate with broad experience in preparing safety evaluations for food ingredients/additives, dietary supplement ingredients, consumer products, cosmetic ingredients, and drug excipients. She has compiled application dossiers for submission to various departments of the United States Food and Drug Administration, Health Canada, the European Food Safety Authority, and authoritative bodies in Europe. Her familiarity with the regulatory requirements for substantiating safety in each product category makes her an asset to the Intertek Scientific & Regulatory Consultancy team.