Code of Practice Version 2 Management of Food Allergens
Contents Page No. 1. Introduction & Objective 3 2. Risk Assessment 4 3. Allergen Management 8 Appendix 1 10 Appendix 2 11 Appendix 3 12 Appendix 4 13 Appendix 5 14 Page 2 of 16
1. INTRODUCTION & OBJECTIVE Customer awareness of Allergies and food intolerances is increasing and there are specific concerns in certain customer groups e.g. nut allergy sufferers and children for clearer labelling and the removal of potential allergens from the food chain. Woolworths will develop products where the use of allergenic ingredients is avoided wherever possible and in particular where they would not be expected e.g. milk powders in cooked meat. Where a product is reformulated and the new recipe results in the addition of an allergen this should be highlighted on the packaging through the addition of a new recipe flash for 3 months. Compliance to this COP will be determined during visits to the supplier by Woolworths Quality Specialist and through the Supplier Excellence Program. The use of risk assessment is paramount in developing policy and resource for each manufacturing site. Risk Assessment must be performed on an individual manufacturing site basis. In identifying any hazards that must be prevented, eliminated or reduced to acceptable levels the risk assessment needs to consider: The amount of allergenic protein required to provoke a reaction in a sensitive individual. How common adverse reactions are to that particular food in the population. Are there particular subgroups of the population that are likely to be at risk? The relative allergenicity of the allergenic ingredients being used (is it high or low in protein). The physical nature of the allergenic ingredient (e.g. liquid ingredients pose a lower cross contamination risk than powders). The nature of the product environment. When new products are introduced, it is important that they are assessed not only for their own allergen status but also for the impact on the allergen status of the existing products. This evaluation must take place during concept development. Woolworths suppliers must not rely on labelling as an alternative to implementing effective controls over allergen cross contamination. Page 3 of 16
To help identify how the requirements must be met for each clause of the Industry Standard - Supply Chain Service Providers a P, R, O has been indicated in the column between each clause number and the detailed description of the Standard Requirements. P = Procedure: A documented procedure that has been fully implemented. R = Record: Documented and accurately completed records have been maintained. O = Observation: Compliance will be checked through observation of practices or adherence to procedures. Clause Section No. 2 Risk Assessment 2.1 General Requirements P R O Requirement 2.1.1 R The Supplier shall carry out as a minimum a risk assessment using the 6 steps in the Woolworths mandatory Risk Assessment Methodoloy: STEP 1 List all allergens on site. List all allergens handled on site for each finished product and in what form the allergen is used. STEP 2 Detailed assessment of SKU. Determine the allergen cross contamination risk level at each step in the process for every finished product manufactured on the site (clearly identifying Woolworths product). STEP 3 Assessment of allergen of concern against process flow step. STEP 4 Allergen Management Plan, inclusive of an Allergen Improvement Plan where identified improvement in practice is identified. Prioritise the allergen action plan based on the results of Step 2 to reduce the identified cross contamination risks. Step 5 Use of Cross Contact Labelling Decision Tree. To make a decision on whether to apply cross contact labelling to Woolworths products. Step 6 Factory Grading To decide upon the overall grading of the site with regards to the allergen risk status based on the results of Appendix 3 - TABLE 3. 2.1.2 R The risk assessment must be conducted by a multi - disciplinary team, that will ensure the risk assessment has been formally reviewed and approved Compliance (Y/N add comments) Page 4 of 16
2.1.3 P R Ensure that the allergy status of all raw material supplying sites is known through formally signed off raw material specifications and where necessary supplier audits. 2.2 STEP 1 List All Allergens On Site (Raw Materials) 2.3 STEP 2 List All Allergens On Site By SKU (Finished Product) (Refer Section 4 Food Manufacturing Requirements - Approved Supplier / Raw Material Management ) 2.1.4 R Where the supplier does not handle any allergens or only a single allergen, (1), that is in every Woolworths product, then only Step 1 of the Risk Assessment needs to be completed. The supplier is however expected to have an Allergen Management Plan to prevent the risk of contamination of products. 2.1.5 R The risk assessment and allergen management plan must be reviewed: if new allergens, new products, new processes (or any other changes that may affect the allergen risk assessment) are introduced that could affect the sites allergen status as a minimum annually 2.2.1 R List all allergens on site (raw materials) The objective of this stage of risk assessment is to establish: Which allergenic materials are handled on site and in what form. Which products manufactured on site, contain these allergens as an intentional ingredient. To achieve this: All Raw Materials received to the site must be listed and assessed for the allergens contained (trace) and format of allergen. Checking every ingredient and sub-ingredient of components, a matrix of which products contain any allergens as an intentional ingredient, must be produced. Where the product intentionally contains the ingredient, a brief description of the form of the allergen takes should be included. Results to be recorded. (Appendix 1 - Table 1 or equivalent template may be used.) 2.3.1 R List all allergens on site (by finished product SKU) The objective of this stage of risk assessment is to establish: Which products manufactured on site, contain these allergens as an intentional ingredient. To achieve this: All products manufactured on site must be listed Checking every ingredient and sub-ingredient of components, a matrix of which products contain any allergens as an intentional ingredient, must be produced. Where the product intentionally contains the ingredient, a brief description of the form of Page 5 of 16
2.4 STEP 3 Allergen Assessment by Process Step Plan 2.5 Step 4 Allergen Improvement and Management Plans 2.6 Step 5 Use of Cross Contact Labelling Decision Tree the allergen takes should be included. Results to be recorded. (Appendix 2 - Table 2 or equivalent template may be used.) 2.4.1 R O Using the documented HACCP process flow steps; each finished product produced must be assessed against the identified allergens which are not present within the product but are handled on site. The objective of this stage of the risk assessment is to establish any risks of contamination from allergens present on site through every stage of production. From this assessment, a detailed map of where allergens have the greatest impact in the factory will be available to aid allergy management at the site. This will also aid in generating an accurate Allergen Improvement Plan for the site. 2.4.2 R The risk assessment must be carried out following HACCP principles, including; trained multi- disciplinary team documented hazard analysis for each stage all process steps incorporated desktop assessment, followed by factory verification. 2.4.3 R Identified hazards should be graded as Low, Medium and High. Where it is determined that the risk is not applicable, supporting evidence must be available to justify the decision. 2.4.4 R The results of the risk assessment must be recorded in Table 3, (see Appendix 3), or an equivalent template may be used. Ideally colour coding should be used to provide clear information on the table. 2.5.1 R Following completion of the Risk Assessment, any issues identified for improvement should be included within an Allergen Improvement Plan. 2.5.2 P R O Controls for any hazards identified through the risk assessment must be included in a documented Allergen Management Plan. The Allergen Management plan must be designed to control the cross contamination risks identified through the risk assessment. Any improvements required should be prioritised; with the risks rated as High given the highest priority. 2.6.1 R Following completion of the Risk Assessment and the implementation of appropriate control measures for any identified cross contamination hazards, the requirement for any cross contact labelling of Woolworths products must be determined using the decision tree (See Appendix 4). Note: The VITAL tool may be used as an alternative method for determining the cross contact labelling requirement. Page 6 of 16
2.7 Step 6 - Overall Factory Grading 2.6.2 R Each Woolworths finished product must be assessed against each allergen handled on site which is not an intentional ingredient. 2.6.3 R O It is recognized that in some circumstances even robust controls cannot reduce cross contamination risks. If the assessment indicates that allergen risks cannot be effectively controlled advisory labelling must be applied to products which are at risk of allergen contamination, for example; Substantial quantities of the allergen are used Most products manufactured contain the allergen as an intentional ingredient. The allergen is extensively handled and is not contained within packaging Cleaning to a level which will minimize allergen traces on equipment and in the environment is impractical 2.7.1 R Following the completion of the Risk Assessment an overall RED, AMBER or GREEN risk rating should established to reflect the current status of the site. Risk Rating Criteria defined as: RED Significant risks of allergen cross contamination. Cross contact labelling will need to be applied. AMBER Significant potential for allergen cross contamination, however suitable controls and standards are in place as required by the COP and Allergen Management Plan. GREEN Minimal risk of cross contamination. Suitable controls and standards in place as defined in an Allergen Management Plan. 2.7.2 R O The risk assessment and cross contact labelling assessment must be attached within PLMS and form part of product specification. Page 7 of 16
Section Clause No. P R O Requirement 3 Allergen Management 3.1 General Requirements 3.1.1 P R All sites must have a written allergen risk assessment and allergen management plan which includes details of all processes, products and allergens (including details of physical form e.g. particulate & dispersible) used on site. This must take into account compound raw materials and the potential for hidden allergens. (Refer Steps 1-5 Risk Assessment) 3.1.2 R Allergen Management & Control Plans must be included in the Supplier s Senior Management Review process. 3.2 Operational Controls (Refer Section 1.2 Supplier Excellence Food Manufacturing Requirements) 3.2.1 P R O The supplier must ensure methods are in place for prevention of contamination of finished product with undeclared allergens either directly or indirectly. This must include where identified through the risk assessment: Raw material assessment and selection, receival and monitoring Effective segregation while allergen-containing materials are being stored, processed or packed The use of separate or additional protective clothing when handling allergenic materials Staff movement and personal hygiene Use of dedicated equipment and utensils for processing Scheduling of production to reduce changes between products containing an allergen and products not containing the allergen Systems to restrict the movement of airborne dust containing allergenic material Waste and spillage controls Restrictions on food brought onto site by staff, visitors, and contractors and for catering purposes and through vending machines. Where rework is used, procedures implemented to ensure rework containing allergens is not used in products not containing the allergen 3.2.2 P R O Procedures must be developed, documented and implemented to ensure product is packed into the correct and current packaging, both retail pack and shipper There must only be one set of packaging and labels present on each production line at any one time and these must be stored in one clearly identifiable location near to its point of use.. (Refer COP Control & Verification of Packaging, Labelling & Coding) Compliance (Y/N add comments) Page 8 of 16
3.3 Allergen Training 3.2.3 R O Maintenance activities and staff shall not present a risk of allergen cross contamination. Maintenance staff and contractor s tools and tool boxes must be clean and controlled to prevent contamination of production environment and equipment. Tools for use in specific handling areas e.g. allergen specific areas. Machinery lubricants must be assessed for any allergenic components Maintenance staff and contractors must be aware of appropriate policy and procedures in regards Allergen Management Plan 3.2.4 P R O Procedures must be developed, documented and implemented for the cleaning and sanitation of the production facility, fixtures and equipment to eliminate potential for allergen cross contamination. The implementation of the procedures must result in clean equipment and a clean facility regardless if the cleaning is carried out by contract cleaners or employed staff. The objectives for cleaning must be: Removal of allergens and methods to avoid recontamination of clean equipment Clear instructions and direction for special cleaning ie allergen cleans. Post cleaning, a detailed independent visual and physical inspection of the finished cleaning standard must be carried out. The cleaning methods employed must be validated to ensure they are effective and the effectiveness of the cleaning procedures routinely verified. Allergen swabs must be used as part of the validation of cleaning methods and verification of effectiveness of cleaning. A swab schedule must be developed and defined by risk and historical data. Corrective action must be applied and documented for any out of specification result and followed up by a re-test. A nominated member of the Management Team must be responsible for managing the cleaning program 3.3.1 R All new staff, permanent, casual or agency; visitors and contractors must be trained in allergen controls and retrained at a frequency proportionate with risk and complexity of Allergen Management Plan. 3.3.2 R At least one staff representative must be formally trained in the use of the latest version of VITAL, where VITAL allergen labelling is used. Page 9 of 16
Appendix 1 - Table 1 Table 1 List of all Raw Materials and the Allergens contained on site Gluten Crustacea Egg Fish Milk Peanuts Soybeans Tree Nuts Sesame Seeds Sulphites Lupin Wheat Flour Wheat Flour (Particulate) Chocolate Particulate Trace Liquid Trace Walnuts Nibbed Glucose Rye Flour Wheat >10ppm Rye Particulate Soy Sauce Liquid Key Allergen not contained Allergen contained (include trace) Page 10 of 16
Appendix 2 - Table 2 Table 2 List of all allergens handled on site and in what products Woolworths Chicken with Noodles Gluten Crustacea Egg Fish Milk Peanuts Soybeans Tree Nuts Wheat Flour (Powder) Noodle (Solid) Noodle (Solid) Sesame Seeds Sulphites Lupin Woolworths Chicken & Prawn Curry Wheat Flour (Powder) Prawns (Solid) Fish Sauce (Liquid) Woolworths Chicken Curry Wheat Flour (Powder) Cream (Liquid) Woolworths Thai Curry Prawns (Solid) Fish Sauce (Liquid) Sesame Seeds (Solid) Own Brand Paella Barley Gluten In Malt Vinegar (Liquid) Prawns (Solid) Fish (Solid) Milk Protein in Chorizo Sausage (Solid) Other Thai Spicy Prawns Soya sauce (Liquid) Prawns (Solid) Fish Sauce (Liquid) Soya sauce (Liquid) KEY: Allergen not used on site Allergenic ingredient used in this product as an intentional ingredient. Allergen used on site but not used in this product as an intentional ingredient Page 11 of 16
Appendix 3 - Table 3 Table 3 Detailed assessment of products against process flow Allergen of concern Product at risk (i.e. Does not contain the allergen as an intentional ingredient) Intake Stores Sieve Weigh Up Mixing Area Rack Ovens Sauce Cooking Vessels Disinfectant Spray Tunnel WIP Blast Chill Assembly Lines Packing Despatch Crustacea Woolworths Chicken with Noodles Low Low Low Medium Medium Low High Low High Medium Low Low Fish Woolworths Chicken with Noodles Low Low Mediu m High High Low High Low High Medium Low Low Milk Woolworths Chicken with Noodles Low Low Mediu m High High Low High Low High Medium Low Low Sesame Seeds Woolworths Chicken with Noodles Low Low High High High Low Low High Low High Low Low Milk Other Chicken & Prawn Curry Low Low Mediu m High High Low High Low High Medium Low Low Soybeans Sesame Seeds Other Chicken & Prawn Curry Other Chicken & Prawn Curry Low Low Low Low Low Low Low Low Low Low Low Low Low Low High High High Low Low High Low High Low Low Page 12 of 16
APPENDIX 4 LEVEL 1 - Assess cross contamination risk from unintentional presence What is the likelihood under normal operating conditions of cross contamination of the food by the specified allergenic ingredient (refer to Risk Assessment step 2) HIGH (Go to LEVEL 2) MEDIUM (Go to LEVEL 2) LOW (No Alibi Cross Contact Labelling Required Go to LEVEL 4) LEVEL 2 Can the identified risk of cross contamination for this allergen be suitable controlled YES (No Alibi Cross Contact Labelling Required Go to LEVEL 4) NO (Go to LEVEL 3) LEVEL 3 Include Cross Contact Labelling for this allergen on finished product packaging LEVEL 4 Check other relevant allergens Have all relevant allergens been considered? YES (Repeat for all other Woolworths products) NO (Go back to LEVEL 1) Page 13 of 16
Appendix 5 8.3 Example - Rating Table Peanuts Sesame Fish - Molluscs Crustacea Cereals containing Gluten Tree Nuts Milk Soybeans Sulphites Lupin HIGH LOW MED HIGH MED LOW LOW LOW LOW LOW Date Page 14 of 16
Amendments 1. Introduction & Objective No change 2. Risk Assessment 2.1.1 Step 4 description expanded to incorporate definition of an Allergen Management Plan as well as Allergen Improvement Plan where needed. 2.1.1 Remove term Alibi and define as Cross Contact. 2.1.2 Remove requirement for QS sign off of Allergen Risk Assessment. 2.1.3 Include linkage to Approved Supplier / Raw Material Management. 2.1.4 Include requirement for sites with single allergen in all products to have Allergen Management Program. 2.5.2 Require controls to be documented in an Allergen Management Plan 2.7.2 Factory Rating and Risk Assessment no longer required to be signed off by the Quality Specialist. 3. Allergen Management Section 3 New Section incorporating exiting Allergen Management Requirements from Full Standards. Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 No change No change No change No change No change Page 15 of 16
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