ISO 22000:2018 Allergen Management - II

The Practical Aspects of Implementation of Allergen Management Programs in Food Industry   

Allergen management is but one of the many efforts to prevent and minimize foodborne infections in humans, but the development of and adherence to an effective allergen management program will go far beyond protecting allergic consumers and reducing the food manufacturer’s risk to reputational and recall costs. Hence, a first step in developing an ISO 22000:2018 allergen management program is to assess the existing process allergens as part of the hazard analysis while developing an ancillary prerequisite program for the facility’s Hazard Analysis and Critical Control Points (HACCP) plan. 

 

An allergen within a food product is considered a chemical hazard, and allergens that come across the process steps are still considered as it was previously evaluated in ISO 22000:2005 version. Thus, the application of critical control points applied within the hazard analysis in due process and continue through the hazard control plan as usual chemical hazards. However, the difference is that there are many other concerns within the industry as non-process allergens and allergen cross-contact are not prevented without a robust allergen management program within the HACCP if there is a gap between the existing sanitation programs. Thus, specific allergen management practices are required for the compliance of such customer requirements. 

 

Once an allergen is identified within the operation as a raw ingredient or contained within a raw ingredient, control steps must be established if the product is not run on a separate line or a complete wet cleaning is performed between allergen and non-allergen containing products as well as verification of contact surfaces and environment. Furthermore, possible processing errors or oversights that result in allergen-containing product contamination can occur due to inadequate cleaning of shared equipment, where non-allergen containing products run after allergen-containing products resulting in cross-contamination; use of rework without using “like into like” practices; switching of ingredients without following up with an allergen assessment of the new ingredients; and labeling terms such as the use of uncommon or incorrect terminology for the food allergens; and frequency of HACCP plan review.

 

Hence, to comply with growing rigorous food allergen standards, current food manufacturers must ensure that their products are declared for the presence of any allergen if it is involved intentionally or unintentionally. As a matter of fact, the manufacturer must have a written allergen management program in place while ensuring to train staff on the importance of allergens within the production process and have strategies and systems in place to manage the unintentional presence of allergens. The practice of sharing lines for allergen-containing and allergen-free food products is now a commonplace practice due to more food and food varieties are produced by the same manufacturer. If a manufacturer shares production lines within its facility for multiple products, then strategies must be implemented to minimize the risk of cross-contact and the unintentional addition of allergens during food production.

 

The allergen risk assessment involves a hazard analysis by a multifunctional team that includes members from departments that include manufacturing, quality, food safety, sanitation, research and development, and regulatory compliance. The allergen risk assessment must identify potential sources of food allergens and maps their path through each step of the manufacturing process. Once the path is identified, controls can be put in place in target areas such as reception and storage, scheduling of production runs, variations in production, equipment design, and cleaning materials, where It is important to review and reassess risk assessment periodically as new products, formulation changes or vendor changes may change production conditions. 

 

Once the risk is identified, that needs to be managed through a standard prerequisite program as an ISO 22000:2018 and all other global food safety standards such as BRC, SQF, GFSI, etc. consider it as a major component of the good manufacturing practice. The key to successful allergen management is developing consistent rules and regulations including work instructions and standard operating procedures that control the possibility of unintentional allergen contamination. These procedures and instructions must include requirements of interested parties against quality and food safety requirements of vendor ingredients, segregation, production controls, manufacturing scheduling, equipment, and plant design, as well as cleaning and sanitation procedures. The allergen management procedure must be validated using a science-based approach before implementation to verify that the practices are effective, routinely reviewed, and evaluated for effectiveness. A successful allergen management program relies on continuous training, clear explanation of procedures, and documentation of the existence and effectiveness of the PRP. 

 

The communication of intentional or unintentional contamination of allergens throughout the product life cycle plays an important part in most of food allergies, which can be easily prevented through communication. If the manufacturer has an allergenic food in his facility that could be unintentionally found in the finished food product, which is essential information that must appear on the food label. Thus, the allergen risk assessment must be used to define the nature of the potential allergen and if it is the final product manufactured from ingredients that contain allergens, or is it manufactured on equipment that is in direct contact with allergenic ingredients? Such analysis can easily ensure proper labeling, either as a declared allergen or as a precautionary allergen label (PAL). Continual communication and training will increase the safety of manufactured products, where food allergen management programs require management commitment to succeed.

 

Thus, when developing ISO 22000:2018 documented information for the control and prevention of contamination must be in place and visible or readily available to all employees in the work area. The prerequisite program must contain information about the product development guidelines in terms of allergens. Good hygiene including, rules regarding clothing, hand-washing, and hand contact with foods. Cleaning of premises, equipment, and tools. Handling of rework materials, the conditions under which such products may be used. Waste management must explain how waste should be labeled and kept separate from rework in case of allergenic waste materials. Situations where potential cross-contamination can occur between raw materials, products, production lines, or equipment, and each employee’s responsibility for preventing such activities and all possible methods based on specific product or material must be documented. Production scheduling, labeling of raw materials, semi-finished goods, and finished products must be practiced visibly. 

 

Employees (and other interested parties as appropriate) must be provided with general allergen awareness including the nature and possible consequences of their unintended or undeclared presence in products and specifics from a consumer perspective. They must be further educated on awareness of allergen presence in raw materials and ingredients. 

 

Awareness must include the ISO 22000:2018 hazards and allergen risks identified at each stage of the food supply chain, including production, storage, transport, and/or distribution process and the corrective measures, the preventive measures, and documentation procedures applicable in the individual’s business. The practical approach for the hygienic design of facilities and equipment in relation to allergens will simplify the control process. The allergen management PRP must include standard sanitation operating procedures (SSOPs) for storage of raw materials and products, verified and validated cleaning regimes, re-work, label controls, and waste management. The PRP must further explain how to minimize cross-contact, including hand washing, use of protective clothing, including laundering and instructions for people traffic patterns around the site, for reasons such as people changing production line or site, the movement to the canteen and of visitors. Equipment movement around the site has to be advised considering maintenance tools, food trays, etc. Sources of allergen information must include supplier specifications, supplier audit reports, as well as human resources procedures to manage the risk of allergic employees who may come into contact with ingredients.

 

The risk arising from the likelihood of cross-contact happening with people being the vector of the contamination needs to be assessed. For instance, allergens present as dry products such as powders are much more likely transferred by people than non-volatile liquids containing allergens. Provision of dedicated workwear for use in areas handling specific allergens, or where a high risk of cross-contact through clothing exists, such workwear should be restricted to working areas. Employees must not be permitted to bring food or drink into areas where products, ingredients, or primary packaging is exposed.

 

Allergenic raw materials, semi-finished products, etc., have to be identified upon receipt and, if possible, kept in sealed packaging or store separately from each other, and from other foods. As a best practice strategy, use clear labeling of the presence of allergenic materials, or PCL reduces the risk of mix-ups and cross-contact. All deliveries need to be inspected before unloading commences. Implement a special “allergen spillage” procedure for all deliveries, including allergenic materials, where allergenic materials are sampled on delivery, measures must be in place to make sure that the sample and the sampling tools do not create a cross-contact risk, such as the use of color-coded and/or disposable sampling equipment. Bulk delivery points should be locked when not in use to prevent unauthorized off-loading prior to the completion of necessary inspections.

 

The inspection must assure that the allergenic materials are delivered clearly labeled, and securely packed to prevent accidental misuse, cross-contact or damage prior to receipt. As an implementation point, store allergenic raw materials in clearly identified areas, using color-coded boxes, as well as the demarcation of storage areas using painted lines on the floor, etc. All allergenic materials should be stored in clearly marked packaging until required. When allergenic raw materials are de-bagged or de-boxed, the products must be placed in dedicated closed and clearly labeled containers, which must only be used for storage of other raw materials after appropriate cleaning using validated procedures. Ingredients, in dry powder form, can present a particular danger of cross-contamination during handling. Special care should be taken with these types of ingredients. Establish methods for segregation and management of allergenic materials at all stages of the manufacturing process, including picking and transfer. In cases where allergenic materials or semi-finished products are stored in non-segregated areas, appropriate means of preventing cross-contact must be used, such as the utilization of bottom-level racking, while including information on the identity of raw materials. 

 

Methods of Cross-contact Prevention

Separation  

Use of dedicated facilities. 

Use of designated areas or zones for specific allergens. 

Use of physical barriers between the production lines. 

Minimization of unnecessary movement of materials and personnel. 

Implementation of Scheduled production runs (production planning), where possible, production runs must be scheduled in such a way that products without allergenic materials are produced first after the last full cleaning and then use for allergenic materials sequentially. 

Separation of air supply, where appropriate and practicable, or combinations of the above.

 

Successful implementation of new products into existing manufacturing facilities will be a challenging work, which requires the attention of the following principles prior to starting production or running trials: 

Ensure all documentation is updated accurately and completely. 

Inform relevant personnel in good time when new allergenic ingredients are to be used, so that they can perform an ingredient assessment and as required design a plan to manage them. 

Ensure conduct of factory trials of allergen-containing products includes measures to avoid allergen cross-contact with existing products. 

Ensure information on the presence, or potential presence, of allergens, is made available to those involved in factory trials, and in taste testing. 

Ensure information is clearly conveyed with products presented for wider test and marketing purposes. 

Key Cleaning Principles for Allergen Control 

Ensure that cleaning equipment itself is dedicated (if possible) and cleaned after use to minimize the risk that it may carry and transfer allergen traces. Then establish appropriate cleaning regimes and validate cleaning regimes. Once implemented, verify that cleaning is being done effectively and keep records of cleaning.

 

The first step of a good ‘cleaning validation’ is to define a ‘worst case’ scenario, considering which allergenic derivative is the most complicated/challenging to clean such as sticky materials, particulates, and which one is used in a higher quantity? And which one is used in the highest proportion in a recipe?

 

The typical applications of analytical testing are the provision of quantitative data for the purposes of risk assessment, including confirmation of raw materials composition, validation of allergen control measures such as cleaning practices, scheduling, and segregation barriers, monitoring suppliers’ control capability, and confirming the status of any allergen claims.

 

The choice of an appropriate method needs to be based on sensitivity, selectivity, specificity, and reproducibility. Confirmation that an analytical test has been validated for each of the food matrices to be tested, will be a valid point when a risk-based sampling program has been properly implemented relevant to the site, production equipment, and process and product.

References:

ISO 22000:2018

https://www.fooddrinkeurope.eu/uploads/press-releases_documents/temp_file_FINAL_Allergen_A4_web1.pdf

https://multimedia.3m.com/mws/media/1648172O/food-safety-anz-edm-allergen-control-plan.pdf

https://erudus.com/14-major-food-allergens-for-eu-food-information-for-consumers/

https://www.iso.org/obp/ui/#iso:std:iso:ts:22002:-2:ed-1:v1:en