Public health risks represented by certain composite products containing food of animal origin Pietro Stella - Unit on Biological Hazards SCoFCAH – 19 February 2013

EFSA Scientific Opinion Mandate from European Commission in March 2011 Scientific Opinion adopted by the BIOHAZ Panel in April 2012

Composite products “a foodstuff intended for human consumption that contains both processed products of animal origin and products of plant origin and includes those where the processing of primary product is an integral part of the production of the final product” (Decision 2007/275/EC)

Background of the mandate Currently imports of composite products into the EU are subject to rules relating to: Public health Animal health Regulation 853/2004: Processed products of animal origin used to prepare composite products must be produced in a EU approved plant and controlled at BIPs Regulation 1162/2009: Derogation until 31/12/2013 Decision 2007/275/EC: Veterinary checks at BIPs are foreseen for composite products when they contain: processed meat product ≥50% other processed animal product … Derogation for a specific list of products (see next slide) Commission needs to develop harmonised risk- based public health rules

Terms of reference (ToRs) 1.Recommend/identify physico-chemical parameters for composite products containing no meat and/or less than 50% of products of animal origin, that could be relevant for the growth/survival of pathogenic microorganisms of public health importance, taking into account the importance of other factors such as processing conditions, transport and/or storage conditions, and therefore assisting the risk manager on deciding to carry out risk based controls. All composite products covered by the mandate

Terms of reference (ToRs) 2.Identify and profile the microbiological hazards for public health related to import of certain composite products containing no meat and/or less than 50% of products of animal origin. In the first instance the following list of products should be assessed: Biscuits Bread Cakes Chocolate Confectionery including sweets) Unfilled gelatine capsules Food supplements Olives stuffed with fish Pasta and noodles Meat extracts and meat concentrates Soup stocks and flavorings Certain specific composite products

Composite products

Approach taken Identify physico-chemical parameters: Hazards in composite products Risk factors related to composite products Review of food predictive microbiology modelling tools Definition of parameters having impact on survival and growth of microorganisms in composite products Identify and profile microbiological hazards: Review information on hazards in certain composite products (list in the mandate) Development of a tool to rank/categorise risks from those hazards in those composite products

Biological hazards (in composite products) Hazards from animal, human and environmental reservoir: carried by the ingredients contaminating the food during its preparation In practice, all the microbial hazards commonly transmitted by foods Categorisation of hazards with respect to their need to growth in food to cause illness: categories of hazards with similar behaviour → useful to identify physico-chemical parameters → useful later to rank/categorise risks in composite products

Biological hazards (in composite products)

Factors impacting on risk (in composite products) Review of factors influencing survival and growth Intrinsic factors (a w, pH, Eh) Processing factors (heating, chemical decontamination, irradiation) Extrinsic or environmental factors (temperature, humidity of storage) Implicit factors (developing microflora) Examples provided in the Opinion

Factors impacting on risk (in composite products) Predictive microbiology: using mathematical equations to summarise information on microbial responses in foods under different conditions and provide estimations

General conclusions on ToR 1 (physico-chemical parameters) From conclusions of the Opinion:

General conclusions on ToR 1 (physico-chemical parameters) From conclusions of the Opinion:

Ranking hazard/composite product combinations Providing to the risk manager a tool to perform risk-based controls: Ranking risks from composite products through 2 approaches: 1.Based on characteristics of hazards/foods/processing 2.Based on past data Distribution storage Processing Raw material PreparationConsumption Foodborne illness Backward approach Forward approach RISK

“Forward approach”  Data needed: Hazard-related data: pathogenicity, spores, toxins, survival and growth… Food-related data: pH, a w … Processing-related data: pasteurisation, freezing, cooking…  Methods: EFSA WG developed decision trees for each of the 3 hazard categories

“Forward approach” 1.Illness may occur without growth of hazards in the food Low = inactivation or prevention hazardous level Moderate = hazard may be present, consider e.g. cross- contamination other foods, type of cooking Qualified Presumption of Risk = if present, pathogen has the potential to cause disease. Further information needed, including info from “backward approach”

“Forward approach” 2.Growth of hazards in the food is usually required to cause illness

“Forward approach” 3.Growth of hazards in the food is required for production of toxins or toxic metabolites that cause illness

“Forward approach” Ranking through a table

“Forward approach” Overall results

“Backward approach”  (Past) data needed: Prevalence data Outbreak data RASFF alerts Reports in scientific literature

“Backward approach” EU foodborne outbreak data ( )

“Backward approach” Prevalence ( ), RASFF ( ), scientific papers

“Backward approach”  (Past) data needed: Prevalence data Outbreak data RASFF alerts Reports in scientific literature  Methods: Listing and discussing evidence available Expert opinion: Experts provided criteria and scores to establish the relevance of each combination for each source of data Calculation of scores based on those criteria Calculation of average scores Establishment of thresholds to define level of importance of combinations

“Backward approach” Overall results

General conclusions on ToR 2 (ranking of composite products) From conclusions of the Opinion on “forward approach”:

General conclusions on ToR 2 (ranking of composite products) From conclusions of the Opinion on “backward approach”: In addition:

Integration of the two approaches The two approaches are complementary, to be applied in parallel Forward approach should prevail over the results of the backward approach, because it is based on the food characteristics and can take into account the diversity of the composite products and possible future changes Trees indicate a low risk  due to the intrinsic composition or processing of the food, independently of past information available Trees indicate a risk for a given hazard/product  this risk can then be further qualified with the past data available Main advantagesMain drawbacks “Forward” (based on hazard, food, processing) Takes into account diversity of composite products Needs good knowledge of products and conditions “Backward” (based on past data) Uses past occurrence/outbreak data Limitations in data available and representativeness Subjective criteria Specificity of composite products

Thank you for your attention!  Acknowledgments: EFSA BIOHAZ Panel EFSA WG on composite products: Christophe Nguyen-The (chair), Olivier Cerf, Kostas Koutsoumanis, John Sofos, Antonio Valero, Marcel Zwietering  Contacts in EFSA: