Manufacturing 'freefrom' – testing and risk assessment for small manufacturers
At the Food and Drink Innovation Network FreeFrom Seminar in September (2012) Sonia Miguel from RSSL (Reading Scientific Services) gave a brief run down on what you need to do to make sure you can manufacture successfully allergen free. The following is based on her presentation.
One of the major concerns of new freefom manufacturers is the cost of testing their products to ensure that they genuinely are 'freefrom' whatever allergen they are claiming to exclude.But as Sonia Miguel, one of the senior scientists working in the department of DNA and Protein at RSSL, explained, targeted testingforms a part of the overall strategy for allergen management but should never be used in isolation and therefore need not cost them that much.
What are the regulations?
As seasoned freefrom manufacturers know only too well, there are in fact, very few regulations governing freefrom as such; in fact, with the exception of gluten free – none at all! However, all manufacturers do have to comply with the law.
The Food Standards Agency has a very helpful page called Know the Law on its site which covers the legal implications of selling food which contains allergens. An edited and highlit version is reproduced below but it is worth reading the full advice and following the links to the FSA Guidance notes.
The problem is that, as far as other allergens apart from gluten (dairy, milk, eggs, nuts etc) are concerned, no 'thresholds' or 'levels' (ie. how much per 100grams etc) have yet been set at which it is deemed that allergen would cause an allergic reaction (known as a threshold level).
(There is currently a massive European initiative (EuroPrevall Action levels – brief report here) using the available clinical data in order to set some action levels for labelling for a cross contact may contain level. It is likely that the levels will be published in the next 2 years but how these will be applied throughout industry is unclear at this stage.)
However, those people wishing to make gluten-free products are in a somewhat better position. As of January this year (2012) the following apply to all foods sold either pre-packed or loose:
• 'very low gluten' can be used when there is less than 100ppm of gluten – eg foods that contain cereal ingredients which have been processed to remove gluten.
So, given that there are very few regulations to guide you, what do you need to do to make sure that your operationand consequently your product could be deemed illegal and prompt a possible recall?
Well, as you will see from the 'Know the law' extract below, the main thing that you have to do is to show 'due diligence' as far as allergen management is concerned. In other words, you have to do everything reasonably practical to ensure that your products are free of the allergens that they claim to be free of.
This means that, no matter what size your company is, you must have worked out, and operate, an effective allergen control system from the time that you order your ingredients until the moment that the finished products leave your premises to go to the wholesaler, shop or courier company. All of this will need to be documented. This will include the following all of which should fit together as in Sonia's diagram:
• applying full HACCP (Hazard Analysis and Critical Control Points) procedures to your manufacture – which you would need to do anyhow if you are manufacturing food for human consumption
• knowing exactly where your ingredients are coming from and that your suppliers have good allergen control measures in place – the Supply Assessment Chain
• having a good prerequisite programme for Good Manufacturing Practices (GMPs) – 'prerequisite programs are procedures that address operational conditions providing the foundation for HACCP'.
• having good staff training procedures
• having a targeted sampling and analysis programme set up for your products
• being able to produce accurate and informative labels for your products
• having a quality control system set up which will allow you to monitor all of the above
For much more detailed guidance on risk assessment and allergen management, see an excellent article by Simon Flanagan of RSSL on the IFST website.
Sampling and testing
It must be remembered that the 'results of testing (analysis) are only as representative as the samples submitted'.
You will also need to discuss with the laboratory which method of analysis will be most appropriate.The ELISA antibody test method is the most frequently used as it detects proteins (which are the molecules that will cause an allergic reaction in sensitised individuals) and also it is a quantitative method within a standard range. These tests need not be hugely expensive – usually running at from £30–£60 per sample tested (£50–£59 at RSSL). This price may not include sample validation, a vital part of the testing procedure.
There are a number of laboratories scattered round the country and you need to pick the most appropriate. Ideally they should be UKAS accredited and ensure that they do internal validation of the matrices tested. You should be able to find one here.
• Obviously, the last thing you want to happen, from every possible point of view, is for your allergen-free product to be contaminated with an allergen and cause a customer to have a reaction.
• However, the vast majority of problems and product recalls occur not because the product has been contaminated with an allergen but because it has been put into the wrong packaging or the packaging has the wrong information. So while following all the procedures above is extremely important, it is vital that your controls of your printing of your packaging, and then packaging your products are really stringent.
Know the law
These provide for the declaration of the specified allergenic foods when they are used as ingredients in pre-packed foods. The provisions in this legislation do not relate to foods sold loose or non-prepacked or those pre-packed for direct sale.
The Food Labelling (Declaration of Allergens) Regulations 2008 replaces the 1996 list of allergens with a revised list, which includes those ingredients that are permanently exempt from allergen labelling.
Article 14 of EC Regulation 178/2002 (General Food Law Regulation)
In the allergy context, this refers particularly to foods sold as free from certain allergens or suitable for people with particular health needs (for example, those people who have coeliac disease). (See section 3.3.2)
It should be noted that criminal legislation is enforced through local enforcement authorities.
It would be prudent for manufacturers to advise their local officers of the management measures they have adopted, to obtain advice on the adequacy of the measures, and to increase the likelihood of the acceptability of such measures as constituting a defence of due diligence, should the need arise. Ultimately, however, in the event of a prosecution the adequacy of a manufacturer's due diligence procedures would be a matter for the Courts.
Under the Consumer Protection Act 1987 (CPA), a manufacturer can be held liable to consumers for injury, loss or damage suffered as a result of them supplying a defective product2, whether or not they are negligent.
Sonia's full presentation can be found on the FDIN site here.
First Published in September 2012