Addressing the allergen challenge
EU food labelling legislation has recently been modified and now requires all ingredients that may induce food allergies and/or food intolerances (as defined by a specific list) must be declared on food product labels (Annex IIIa of Directive 2003/89/EC ). This includes cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk and dairy products including lactose, nuts, sesame seeds, celery, mustard, and sulphite at a concentration of 10 mg/kg and above. Be aware
There is, therefore, a requirement on every food producer to have a thorough understanding of how and where these allergens might come into contact with their own food products, to prevent contamination where necessary, and to label products accurately according to the presence or absence of allergens.
In some cases, this requirement is relatively easy to satisfy. In others, it is more difficult, not least because some sources of contamination are not at all obvious. For example, some packaging materials contain release agents that are wheat-based and can transfer to the product packaged inside. Hence, even where products that contain no known allergens are processed in facilities where no allergenic ingredients are handled, there is still the potential for allergens to contaminate the end product. HACCP and allergens
That is not to suggest that every food item has to be tested for the presence/absence of allergens, or that testing is the main means by which food manufacturers must address the issue. Testing has an important role to play in verifying the success of procedures designed to prevent contamination, and of course, in investigating customer complaints. Testing may also play a part in defining what procedures need to be put in place to prevent contamination problems, and this subject will form the basis of an article to appear in the next issue of FIAI.
The main focus for manufacturers should be to incorporate allergen control into their established HACCP system. HACCP Plan/Ingredient Review
Clearly, it is important for any manufacturer to identify all potential sources of allergens. Single ingredients known to be the sources of allergenic materials are readily identifiable from ingredient labelling or from the details contained in the ingredient specification. It is, however, more difficult for the manufacturer using a compound ingredient to be confident that the ingredient is free from allergenic materials. The formulation of the ingredient may be changed by the supplier to include allergenic materials. It is vital the supplier understands the implications that may arise from a simple formulation change or change of sub-ingredient or supplier of a sub-ingredient. Manufacturers should ensure that suppliers inform them of any intended changes to the compound ingredient, which will allow the manufacturer to carry out a formal review and ensure that the details and decisions made in relation to the use of the material are recorded.
In terms of managing an ingredient base that may include ingredients with allergenic components, some manufacturers use colour coding or prominent statements on specifications to ensure that there is no confusion between those ingredients that contain allergenic components from those that don't. This is particularly useful for those personnel working in new product development. Cross-Contamination and Cleaning
Within the manufacturing environment the key to managing allergens is to avoid cross-contamination, which means identifying the steps in the process flow where contamination of product with allergenic materials may occur. Clearly, if the same allergenic ingredient is used in all product formulations, then cross-contamination is not an issue. However, this is generally not the case.
Therefore, polices and procedures should be established to address the prevention and elimination of cross-contamination. These policies should include but are not limited to:
- allergen changeover inspections
- pre-operational inspections
- colour coding, or other designation, and segregation of containers
- coding of scoops and sampling devices; by dedication, segregation or other means
- providing plastic aprons, gloves or other clothing barriers to reduce the likelihood that allergens may be transferred by clinging to clothing
The factory should also consider the dedication of lines, the order in which products are processed and use of barriers to protect the product. Equipment used for grinding/handling of re-work material should also be evaluated as part of the cleaning verification program, as this is a commonly missed potential point for cross-contamination.
Whether wet cleaning or dry cleaning, an approved testing method must be used to verify that cleaning has been effective. Similarly, where Clean In Place (CIP) systems are used, equipment should be examined for evidence of pitting or rough welds that cannot be adequately cleaned or may trap allergenic residues.
Dedicated equipment should be used to process allergen-containing products or should be washed between uses. Non-dedicated equipment should be examined to ensure that effective cleaning has taken place and allergen-containing residues have been eliminated. Validation of cleaning procedures can be achieved periodically using verified test methods. The frequency of testing should be established as part of the allergen policy.
Physical barriers must be provided where lines cross over other lines, and when barriers are used, the barriers themselves must be cleaned and maintained in good condition to prevent allergen accumulations and/or overflow.
Allergen-containing materials should be segregated in raw material storage areas. Labelling of ingredients, dedicated rack storage areas, storage of like above like, storage of allergenic ingredients on the bottom rack, or other means of separation should be provided to protect ingredients in storage. Re-work
The only acceptable means of utilising allergen-containing re-work is like product into like product. Re-work, when added back into the process, should be recorded on the batch sheet for traceability. Colour coding or other viable means of separation of allergen-containing re-work must be provided to protect the product from potential cross-contamination. If single-colour containers are used for re-work, they must be properly labelled, cleaned, and swabbed between uses to verify adequate segregation and cleaning of the product contact surface. The swabbing frequency must meet the plant-defined protocol. Supplier Approval
Part of the supplier approval process for both ingredients and packaging material should include review of the supplier's allergen programme. A poor or non-existent programme at the supplier level could lead to inadvertent contamination of ingredients used. Protocols should also be provided for use of an emergency or temporary supplier.
The approved supplier list should indicate the supplier name, contact name, telephone number, and ingredients approved for receipt from that supplier. The policy for acceptance of an emergency or temporary supplier should include testing of the ingredient for allergenic proteins. Reformulation
If reformulation is a corporate programme, then a statement should be provided as part of the allergen policy. This policy should state how formulas are controlled and the protocol for changing of formulas.
The protocol for the finished product specification should also include any changes in the packaging material and ingredient labelling.
Reformulation of product may also affect the supplier ingredient specifications for the product being used.
Again, if this is a corporate programme and the new ingredient has been approved either as a temporary or emergency supply, then documentation of this should be provided. The new ingredients must be evaluated as part of the hazard analysis or a separate allergen ingredient review and would also need to be identified as being allergen-containing if that were the case. Ingredients used must match the ingredients specified in the formulation.
The ingredient legends on new packaging material should be verified for accuracy, by the plant or at the corporate level, and compliance with formulation changes that could affect the product label or ingredient statement determined. As packaging material becomes obsolete as a result of formula changes, then the obsolete packaging material should be segregated, controlled, and accounted for to prevent accidental use. Documentation of control or destruction of obsolete packaging material should provide evidence that all of the material has been identified and that it matches the inventory levels of the material. Allergen Awareness
It is essential that staff understand not only how to implement procedures to avoid cross-contamination, but also why they are important. Again, there are external organisations that can provide in-house training courses on allergens. Growing importance
The issue of allergenicity is likely to increase in importance, not least because more people seem to be developing allergic responses to different foods. For the food processing and ingredients businesses, the challenge is to keep abreast of the science, to gain a better understanding of our products and to identify, then label or remove the potential allergens within our products.
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