Aligning Safe Food Production to Risk - Based Food Safety Management

Transcription

1 ILSI SEA Region 6th Asian Conference on Food and Nutrition Safety (Nov 2012) Aligning Safe Food Production to Risk - Based Food Safety Management Leon Gorris Unilever, Shanghai, China

2 Outline Introduction to Unilever & safety assurance approach Relevance of Microbiological Risk Assessment (MRA) for Industry Using MRA techniques to support product innovation MRA for safe market access assessment MRA: microbiological risk assessment 2

3 Unilever Food products (50% of port-folio of consumer products) Home products (detergents, bleaches, etc.) Personal care products (deo s, cosmetics, shampoo s etc) ~ employees ~ 60 billion$ annual turnover ~ 100 countries with active operations

4 Unilever s food products h Spreads and cooking products h Ice cream, yoghurts h Tea-based beverages h Savoury products & dressings h Frozen foods h Food service products h Sandwiches, delicatessen products 4

5 Unilever s view on food safety Safe performance of foods on the market needs to be assured. We use standards / guidelines from competent authorities to benchmark product safety. Industries share knowledge & technologies regarding safety. For industry to be competitive, requires major innovations and ideas that attract customers, but product safety is not negotiable. Any innovation has to be safe by design and execution 5

6 Unilever & food safety assurance More than 6,000 R&D professionals Global centres for Discover (6); global (14) and regional (37) R&D centres for Design & Deploy Unilever and third party manufacturing operations for Safe execution / Deploy Breakthroughs From Discover Brilliance In Product Design Fast, Large Scale Deploy Independent safety assessment by Safety & Environmental Assurance Centre (SEAC) 6

7 Unilever & product innovation Port Sunlight UK Vlaardingen The Netherlands Colworth UK 7 Trumbull USA Shanghai China Bangalore India

8 Safety & Environmental Assurance Centre (SEAC) SEAC Ice Cream Beverages Discover Patents

9 SEAC s role in Unilever Independent safety assessments as part of assurance of human safety and environmental care Toxicology Microbiology Contaminants Chemistry Physical Hazards Occupational Hygiene Occupational & Process Safety Environmental lifecycle Environmental management systems Sustainability Risk assessment to inform Risk management Design safety Safe performance on the marketplace 9

10 Safe Process and product design Safety is designed in into innovations specifically understanding, e.g.: ingredients, final formulation, int./ext. factors processing, handling post-process contamination intended use(r) Considering the available safety benchmarks : Guidance/guidelines from gov./ind. bodies Regulations (e.g. limits, criteria) Internal guidance 10

11 Food safety assurance Chain of events: Establish Safe Product + Process design Validate design: from lab-scale to operational-scale Implement design in operational management systems Verify control during manufacture Run tracing & tracking system Monitor & Review as appropriate 11

12 Outline Introduction to Unilever & safety assurance approach Relevance of Microbiological Risk Assessment (MRA) for Industry Using MRA techniques to support product innovation MRA for safe market access assessment MRA: microbiological risk assessment 12

13 Food Safety Control & Foods Safety Management Country level Policy Standards Food Safety Control (Risk focused): high level, generic policy bases guidance specific standards, criteria Operation level Food Safety Management (Hazard focused): Specific Hazard Management Local, specific management at supply chain level INCLUDES ALL HAZARDS Generic Hazard Management 13

14 Risk Analysis = the common framework Risk Analysis: Risk Management Risk Assessment Risk Communication Triggered by World Trade Organisation (WTO) Advocated by many governments and intergovernmental organisations (FAO, WHO) RA FSO/PO HACCP GHPs/GMPs/GAPs 14

15 Risk Analysis = the common framework Risk Assessment Risk Management Consumer health protection Risk Communication The Risk Analysis paradigm Fair (global) trade 15

16 Codex Alimentarius RA Framework Risk Assessment Hazard Identification Hazard Characterisation Exposure Assessment Risk Characterisation Risk Management Risk Evaluation Option Assessment Option Implementation Monitoring & Review Risk Communication Interactive exchange of information and opinions concerning risks 16

17 Risk Management drives Risk Analysis Governmental Risk manager owns issue: Decides on need to deal with the issue Risk Assessment Risk Management Risk Assessment as appropriate Risk Management decision Risk Communication Iterative interaction with: Risk assessors Risk communicators Stakeholder / interested parties 17

18 Microbiological Risk Assessment: purpose for governments? To systematically assess the level of risk associated to pathogenic microorganisms in foods. To make an inventory of typical risk contributing factors. To elaborate possible risk mitigation strategies. To provide a basis for decision-making by risk manager 18

19 Microbiological Risk Assessment: process steps Hazard identification Identify food-borne pathogen of interest Hazard Characterization Determine the dose-response relationship (volunteers, animals) when possible, or investigate outbreaks Exposure Assessment Calculate the exposure to the hazard at consumption from hazard level and consumption volume/frequency Risk Characterization Combine exposure and dose-response to obtain an estimation of the prevailing risk level or rate of illness 19

20 Microbiological Risk Assessment: hazard & food Salmonella Escherichia coli O157 Vibrio parahaemolyticus Listeria monocytogenes Microbiological Risk Assessment is performed for pathogen/food combinations that are associated with food-borne illness 20 Campylobacter

21 The image cannot be displayed. Your computer may not have enough memory to open the image, or the image may have been corrupted. Restart your computer, and then open the file again. If the red x still appears, you may have to delete the image and then insert it again. Microbiological Risk Assessment: farm to fork chain Microbiological Risk Assessment evaluates the relevant steps of a (typical) food supply chain between primary production to consumption. 21

22 Microbiological Risk Assessment estimates Population level: - Estimated number of cases of illness per year per population (e.g persons) caused by a micro-organism present in a particular food or food group Consumer level - Chance of illness due to consumption of a specific foodproduct to which a particular hazard can be associated (per serving / event) 22

23 The image cannot be displayed. Your computer may not have enough memory to open the image, or the image may have been corrupted. Restart your computer, and then open the file again. If the red x still appears, you may have to delete the image and then insert it again. Governmental Risk Management decision-making Risk Level (RL) RISK ANALYSIS Decisions? Risk Assessment Risk Management RL < PL: e.g. no action needed RL = PL: e.g. no action needed Risk Communication RL > PL: e.g. risk reduction action needed Policy Level of risk (PL): ALOP 1 or public health goal FSO 1 : ALOP, Appropriate Level Of Protection

24 Examples of Risk Management Options n n n n n n prohibiting marketing of the foods mandating microbiological criteria defining process criteria for key food supply chain operations requiring import certificates carrying out educational programs setting an FSO 24

25 Country level Explicit, risk-based guidance of levels of a hazard not to be surpassed Exposure Performance Objective Performance Objective Food Safety Objective primary production manufacturing transport retail Preparation / cooking for consumption Micro criterion Performance standard Performance criterion Performance criterion Performance criterion SEAC Operational food chain level Operational actions, building onto HACCP and Good practices

26 Role of FSO-PO-PC hierarchy in designing safe foods Allows for a quantitative benchmark that integrates the performance of the whole food supply chain, disregarding its make-up.. The FSO gives the hazard level that should not be surpassed in the food at consumption for a safe product.. The various players in the food chain can then establish what the maximum hazard level can be at the output of the step that they control (PC/PO). 26

27 Making the connection Country level Policy Standards Food Safety Control/Risk Management high level, generic policy bases guidance specific standards, criteria Operation level ALOP - FSO - PO - PC HACCP Hazard Control/Food Chain Management: Local and specific management at supply chain level GHPs/GMPs/GAPs 27

28 Does industry need to conduct Risk Assessment? Industry does not need to conduct risk assessments as governments do, but need to ensure they have proper food safety management systems, incl. good practices and HACCP, in place However, MRA studies may contain valuable information that can help strengthen their food safety management systems 28

29 Is risk assessment relevant for food industry? Food industry can use the results of MRA to - learn about differences in levels of hazard control between (typical) operations - appreciate different intervention strategies or management options - insight in critical processes, handling, use - see examples of how to meet government requirements / performance standards 29

30 Designing safe foods new tool available Expertise, scientific and technical knowledge Historical evidence (products with history of safe performance) Product design performance simulation - Predictive mathematical modelling - MRA approaches & techniques Validation of design - Predictive mathematical modelling - Challenge and shelf-life tests Benchmarks - regulatory requirements (Micro-criteria, PC) - Industry standards (PC) - FSO/PO/PC 30

31 Outline Introduction to Unilever & safety assurance approach Relevance of Microbiological Risk Assessment (MRA) for Industry Using MRA techniques to support product innovation MRA for safe market access assessment MRA: microbiological risk assessment 31

32 Unilever & Exposure assessment Simulating consumer safety of complex or radical product innovations Simulating safe changes to heat-processing for quality improvements Determining performance standards that would meet particular PO / FSO Simulating safe shelf-life to enter new markets 32

33 Assessing safe shelf-life using a probabilistic MRA technique Key product characteristics - Heat treatment > 90ºC-10min, in-pack - ph= A w = Stored at chilled temperatures Relevant hazard? - Bacillus cereus - Benchmark: 10 5 cfu/g Design question? - The likely hazard level in different shelf-life scenario s 33

34 Input data? Raw material contamination (prevalence, number, spread) Heat Treatment model to calculate spore inactivation and possible survival Models for Lag time (incl. germination) of injured spores and for growth rate of recovered cells versus Temperature Supply-Chain information: temperature of fridges in the market (warehouse, Retail, Consumer s) Consumer behaviour information: time spent for shopping, time the product is left in the fridge 34

35 Exposure assessment: components Bacterial concentration in raw materials Heat treatment Bacterial heat resistance Prevalence and Bacterial concentration in processed food Time in pre-retail (transport + warehouse) Time in retail (local market, supermarket) Time in consumer fridge Lag time and growth rate of surviving spores, at chilled temperatures Temperature of pre- retail fridges Temperature of retail fridges Temperature of consumer fridges 35 Pr{logN>5) versus shelf-life

36 Heat Treatment B. cereus D-values at 90C Density of Probability D-values (log min) 36

37 Heat Treatment 0.3 Number of surviving spores in contaminated packs Density of Probability Number of Spores surviving the HT (cfu/g) J.-M. Membré, A. Amézquita, J. Bassett, P. Giavedoni, C. de W. Blackburn, L.G.M. Gorris A probabilistic modeling approach in thermal inactivation: estimation of postprocess Bacillus cereus spore prevalence and concentration. Journal of Food Protection, 69:

38 Supply-chain information 5.1% 0.7% Consumers fridges in Europe 4.9% 16.1% 13.0% 28.1% below 0C between 0.1 and 2.0C between 2.1 and 4.0C between 4.1 and 6.0C between 6.1 and 8.0C between 8.1 and 10.0C above 10C 32.1% 0.7% Domestic fridges: USA 8.3% 2.2% 10.0% 21.6% below 0C between 0.1 and 2.0C between 2.1 and 4.0C between 4.1 and 6.0C between 6.1 and 8.0C between 8.1 and 10.0C above 10C 23.2% % based on data analysis, 26/07/2005

39 Lag time: Literature Stress increases mean and variance of Lag time Individual cell response to the stress (V) Several factors impact on the lag time: - HT time - HT Temperature Distributions of true lag times of single cells of L. plantarum (n=160) as calculated from optical density (OD) measurements. Source: Smelt et al., C 10C - Chilled Storage Temperature - ph - Aw Lag time (d) 39

40 How many packs are contaminated after the heat treatment? heat treatment efficiency : thermal process bacterial thermal resistance Variations in log D values at 90 o C of mesophilic B. cereus strains bacterial thermal resistance variability between strains of the same species Cumula ative frequency thermal process Variability inside the packs 40 Temperature ( o C) log D Time (min)

41 MRA to understand safe performance in different markets Likelihood of not me eeting design criterion (1 1/X) 100,000 10,000 1, Retail 7C Consumer 7C Retail 7C Consumer 10C Retail 7C Consumer 9C Temperature scenarios Retail 8C Consumer 8C Market 2 Market 1 41

42 Learnings Model results very informative for internal decision making and external communication: - Learned about major risk factors - Learned where key data-gaps were - Defined window for testing / experimentation But, further progression requires validation of key aspects 42

43 Food safety assurance Chain of events: Establish Safe Product + Process design Validate design: from lab-scale to operational-scale Implement design in operational management systems Verify control during manufacture Run tracing & tracking system Monitor & Review as appropriate 43

44 谢谢 Thank you