Managing Allergens within a manufacturing context Helen Brown CampdenBRI Chipping Campden
Food Allergens An unusual food safety issue Harmless natural substances however In allergic individuals cause reactions, some that can be life threatening
Food allergens - the hazard
Food manufacturers Protect allergic customers Require systems to: Assess risks posed by food allergens Manage risks posed by food allergens
Allergen Risk Assessment Systems Identify risk, hazard and probability of occurrence Identify control measures, validate them & modify them where improvement is required Define communication requirements in line with risks
Clear Communication an objective of Allergen Management Clear accurate communication through product labelling allergens used as a deliberate ingredient allergens present unintentionally due to cross contact Free-from products
Clear Communication an objective of Allergen Management Product contains allergens as a deliberate ingredient - labelling
Clear Communication an objective of Allergen Management Free from foods What does society expect? 1. Food shall not be placed on the market if it is unsafe. 2. Food shall be deemed to be unsafe if it is considered to be: (a) injurious to health 3.......... 4. In determining whether any food is injurious to health, regard shall be had: (c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers Article 14: Reg. (EC) 178/2002
Free-from: Implications for Food Safety Management Systems Exemplary: Good Manufacturing Practice Supplier quality assurance (SQA) Crisis management (TACCP/ CARVER + SHOCK)
...Presence of allergens that are not part of the product formulation Total avoidance of cross-contact is not always practicable...
Clear Communication an objective of Allergen Management If unintentionally present allergens must ensure: Allergens only occur at levels judged to pose negligible risk to allergic individuals OR only when above not possible Use precautionary labelling ( may contain)
Objectives of Food Allergen Management Reduce the risk of cross-contamination to protect sensitive consumers from illness and potentially fatal reactions Not unnecessarily restrict food choices for allergic individuals and their family through the over use of may contain labelling.
Opportunity Consistent Communication of risk ALLERGEN RELATED LABELLING FREE FROM ON PACK INGREDIENT DECLARATION ONLY ADDITIONAL MAY CONTAIN PUBLIC HEALTH OUTCOME No mild reactions in the vast majority of highly sensitive allergic Individuals No reactions In the vast majority of allergic Individuals No severe reactions in the vast majority of allergic individuals Manufacturing facility IN CONTROL MANAGEMENT PARAMETER Lower limit of analytical detection Action Level Allergen analytically absent to a high degree of confidence, GMPs to ensure absence of specific allergen Residual allergen below action level as verified through periodic validation of process Residual allergen above action level despite application of appropriate GMPs etc Ward, R. 2014 lower AMOUNT OF ALLERGENIC PROTEIN higher
Allergen Management Fully integrated within overall Food Safety Management System (FSMS) GMP (Good Manufacturing Practice) HACCP (Hazard Analysis Critical Control Point) Considered at all stages in product life cycle (NPD to delivery to customer)
Allergen Management Allergen management policy Aims and objectives clearly described Include all levels of employees Define roles and responsibilities of all relevant personnel Guidelines & Guidance Documents Details and procedures to deliver the policy
Allergen management Employee Training & Awareness Include all staff, part-time & temporary & contractors/visitors Hazards posed by common allergens; site allergen policy; site procedures for allergen management Specific Training & Training Materials Differentiated according to roles & need Frequent, refresh & update awareness
Allergen management Ingredients/Raw materials suppliers Good communication between supplier & customer Questionnaire to assess supplier allergen management system, scope & quality of allergen controls, what ingredients the supplier has on site Accurate specifications, quantitative information on allergens Conduct supplier audits Supplier to notify & seek approval for changes System to approve and review new suppliers
Allergen management Ingredients/Raw materials Handling and storage Receipt of allergen containing materials Assess on intake issues during transport Clarity of labels Storage - designed to prevent or minimise crosscontamination of non-allergenic materials Dedicated areas in warehouse Bottom of shelving can not fall onto non-allergen containing ingredients Allergen clean-up procedure available in case of spill
Allergen management Ingredients/Raw materials Handling and storage Dedicated utensils, containers to separate handling of different allergens Containers returned from production Means of sealing opened containers Check still clearly labelled
Allergen management Rework Allergen-containing rework Clearly labelled Stored separately from non-allergen containing rework Rework only into products containing allergen Ideally exact-into exact rework Records of rework complete & current Rework a vulnerability in manufacturing systems
Allergen management Production Equipment & process design, the environment Understand site equipment and flow of materials through site particularly areas that present high risk for cross-contact Changes to equipment or processes review risk assessment, take opportunity to reduce risk.
Allergen management Production Separate production of products that contain specific allergens from products that do not contain the same allergen (segregation) Separation in space Dedicated production areas, lines, equipment, factory Separation in time Production scheduling, effective cleaning
Allergen management Systems to manage change Labels - approval and control Copy approval against recipe, verification of all on-pack allergen information, incoming labels checked...from one product to another Management of controls to prevent cross-contact at risk points Cleaning, Operator hand washing, apron change Management of controls to prevent cross-packing Check-lists for issue of correct packaging, lineclearance and line checks on correct labels.
(source FSA) Number of Allergen Incidents by Cause in UK 2009-2014* (FSA).
Numbers of Allergen Incidents Total No. of Allergen Alerts in UK (FSA)
Opportunities to improve Improve Industry Supply Chain Communication Allergen management only as good as the weakest link in the supply chain promote best practice in risk assessment & reduce inconsistencies in approaches to allergen risk management Improve consistency across industry of communication to consumers when to use advisory warnings
Opportunities to improve Risk based approach Risk assessment - are allergens in food and/or the food handling environment? Risk management - how to control and assure finished product status Risk communication - how to identify product status
Summary Effective allergen management... does the information on the wrapper reflect the reality?
Thank you for your attention Dr Helen Brown Campden BRI Chipping Campden, Glos. E-mail: helen.brown@campdenbri.co.uk