Allergen Management

Developing, implementing and maintaining an allergen management plan may be perceived as a daunting and unattainable task. To assist you and your team on the allergen management journey, we have developed a holistic approach to allergen control. We can do this because our team understands the medical, legal, analytical, food safety and practical control aspects of allergens and allergen control. Our focus is to help you formulate rational, simple and effective allergen management plans. FACTS is your expert partner, and we offer multiple allergen management consultation services. We are passionate about working with you, our client, to help you meet your allergen management objectives.

Allergen Management Consulting

An allergen management plan is an organisation’s formal, documented plan that describes all the controls and processes in place to manage food allergens, from start to finish, as part of your food safety management system.

Typically, allergens must be controlled at many different stages of manufacturing, from ordering and receiving ingoing ingredients through to final product packing. The objective of allergen controls is to prevent and mitigate the risk of allergen cross-contact or contamination, and the risk of the presence of undeclared allergens in a final product.

Through practical, on-site or remote consultation and/or coaching, we can:

  • Help you to develop, implement or improve your allergen management plan and controls.
  • Develop and execute or support you to develop and execute allergen cleaning validation studies.
  • Support you in developing meaningful allergen cleaning verification plans and strategies.

Allergen risk review

To establish and implement effective allergen controls, it is essential to (1) identify all potential allergen sources and cross-contact points in the manufacturing process (where allergen contamination may occur), and (2) evaluate whether existing controls (which form part of the PRPs) reduce the likelihood of allergen cross-contact to an acceptable level, and whether additional allergen controls are required.

Every step in the manufacturing process should be considered; points where allergens are introduced must be identified, and allergen contamination controls must be established, implemented and monitored to ensure that cross-contact is avoided.

Through on-site or remote consultation and/or coaching, we can help you to:

  • Complete or facilitate raw material and supplier allergen risk assessments; we can also make recommendations as to whether allergen precautionary labelling is required.
  • Identify allergen cross-contact points and sources of cross-contact in your processing environment.
  • Review the strength and deficiencies of an existing allergen management plan.
  • Assist in completing allergen contamination root cause analyses.

Basic allergen quantitative risk assessment

If a product or its ingredients have the potential to be contaminated by common allergens, the South African Labelling Regulations (R.146/2010, as amended) require manufacturers to complete a risk assessment and determine whether precautionary allergen labelling (PAL) is required.

Quantitative Risk Assessment (QRA) is a formal and systematic risk analysis approach to quantify risks; an allergen QRA guides an organisation’s decision regarding whether or not PAL is necessary.

Basic allergen QRA, as used in the VITAL® programme, considers known allergen threshold values, the form the contamination takes, the extent of the cross-contamination, batch sizes, and how much protein from the cross-contact allergen the consumer is likely to consume in a worst-case serving size.

The objective is to determine, based on known threshold values, whether cross-contact may pose a significant risk to allergic consumers, and thus whether or not PAL is needed.

Food Allergen Testing

There are various reasons why it may be necessary to test samples for the presence of allergens. One of the reasons is to prove that a ‘free-from’ claim can be made – for example, ‘gluten-free’. Other reasons include checking for accidental allergen contamination, and as part of a due-diligence testing schedule. However, the most frequent reason for testing is the validation and verification of the efficacy of allergen cleaning.

The FACTS Laboratory is SANAS accredited and uses cutting-edge analytical approaches to accurately detect and quantify food allergens in a variety of sample types and products.

As part of our allergen management support services, we offer a comprehensive range of food allergen testing.

Food products are highly complex biological samples, due to the countless biomolecules that comprise them. The complexity of these samples demands careful consideration when selecting the methods used to process samples. The most suitable method ensures a high degree of confidence in detecting and confirming the absence or presence of trace amounts of allergens.

Rapid On-site Testing Kits

Rapid on-site testing kits are ideal for allergen cleaning verification and screening activities, and can be used to test rinse water, surface swabs, ingredients, and finished products (once a matrix check has been completed).

There is no ‘one-size-fits-all’ rapid on-site test kit; whether a kit is suitable for you or not will depend on an array of factors, such as the manufacturing environment, the product composition, cleaning methods, etc.

As part of our allergen management support services, we offer a range of curated rapid on-site testing kits, which have been selected for their technical performance and ease of use. We also provide matrix-checking services to confirm that a specific kit will provide reliable results for your specific circumstances and samples.

Allergen Training

We offer a range of general and customised allergen training programmes. Please visit our training calendar page to see which of our popular general programmes are coming up next.

Customised training, meaning a training programme can be designed for your organisation’s specific requirements, can be done virtually or on-site. FACTS will include practical examples directly related to the products and/or systems used by your facility, enabling your team to workshop innovative solutions to your particular challenges. 

If you’re interested in the training we offer and you know your teams need’s please provide us with more information about your company and team by completing our easy-to-use online form. If you would like to take the opportunity to explore your training needs with FACTS, please contact us.

VITAL® Training

The Australia/New Zealand Allergen Bureau’s VITAL® (Voluntary Incidental Trace Allergen Labelling) Programme is a science-based, internationally recognised and standardised allergen risk assessment process to assess the risk of food allergens.

Carrying out a VITAL® risk assessment using the VITAL® tools – including VITAL® Online – assists a food company in thoroughly reviewing the allergen status of all its ingredients and the processing conditions that contribute towards the allergen status of the finished product.

What to learn more about the VITAL® Programme? Contact us or visit the Allergen Bureau or VITAL® websites.


Allergen Training

Do we need to have a fully equipped training room?

No; FACTS can supply a data projector, screen and sound, and can also arrange a training room if necessary.

Do you supply training in other languages apart from English?

Yes; allergen awareness training can also be facilitated in Xhosa, Zulu and Afrikaans.

Allergen Management

Why is allergen management important?

Food allergens, when present in a food, can trigger potentially life-threatening reactions in highly sensitive individuals. There is also a growing body of scientific evidence that shows a marked increase in the number of individuals suffering from food allergies. The food industry’s responsibilities in terms of allergen control are well described in various South African regulations. Some of these responsibilities include the establishment of policies and procedures to facilitate food allergen declaration, control and risk assessment. In recent years, GFSI (Global Food Safety initiative) benchmarked food safety standards have increasingly emphasised the importance of allergen management, leading to a marked increase in the number of allergen-related findings and the need for tighter allergen controls.

I have to develop an allergen control plan for our facility. Where do I start?

It’s always a good idea to start at the beginning, with your raw-material suppliers and raw materials. You need to know which allergens you are working with, and in which raw materials they are found, before you can start to put control measures in place.

What are the legal limits for food allergens in South Africa?

There are no legal limits for food allergens other than for gluten, the limit for which is 20ppm before a claim to being gluten-free can be made on the label. VITAL® is a risk assessment tool that incorporates LOAELs (lowest observed adverse effect levels) into the process of determining whether a precautionary statement is necessary.

What is the difference between allergen cleaning validation and verification?

Allergen cleaning validation and verification are two very distinct and different processes. Allergen Control Validation entails proving that a control programme is effective – for example, allergen cleaning validation. It often involves submitting samples to a reputable and accredited laboratory. Allergen Control Verification shows that the validated control was performed correctly – for example, cleaning verification. Ideally, it should be done on site; due to the associated financial and time constraints, laboratory-based methods are not ideal for verification.

Do we need to control celery and mustard as allergens in our facility?

Celery and mustard are not regulated common allergens in South Africa. If you supply only to the SA market and do not export to regions such as the EU, where these foods are regulated allergens, you do not have to control celery and mustard.

Rapid On-site Testing Kits

I need a kit that I can use on site. Does FACTS sell rapid on-site testing kits?

Yes, we sell a range of allergen, total-protein and meat-species test kits that are ideal for on-site testing. View our catalogue for more information.

How long does it take to do an on-site rapid kit test?

Rapid kits generally generate results within 11 to 45 minutes, depending on the system you choose.

How do I go about ordering a rapid on-site testing kit?

You can request a quote from our website. If you are not sure which kit to select, you are welcome to contact one of our knowledgeable team members. On receiving your request we will send you a quote, together with any other relevant information.

When will kits be delivered?

Lead times can be as short as three working days, but range between three and 14 working days; the exact time depends on availability. Lead times exclude weekends and public holidays. Note that the day the order is received is not included in the lead time; for example, if we receive an order on Monday, Tuesday will be day one of the lead time.

If you are interested in our services, please contact us.

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