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.)

Gluten regulations

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:

• 'gluten free' can be used on any product which has less than 20 parts per million (ppm) of gluten when it is sold (not when it is consumed as the manufacturer cannot be held liable for what may happen to it between sale and consumption).

• '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.


Due Diligence

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:

allergn 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'.
It is obviously impractical from every point of view to test everything that you make so any analysis you undertake must be as a result of a thorough risk assessment. It must also be planned to 'maximise the probability of detecting contamination (an allergen) if it exists'.
You will need to discuss this with the laboratory that you are using but the concentration of the allergen in the recipe and the level of processing that it has already undergone will all need to be taken into account.

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.


Nota bene.

• 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
There are both criminal and civil legal regimes that are relevant to the sale of foods containing allergens and the provision of 'allergen-free' lists. It is essential that these are given careful consideration.......

Criminal law

EU Directives on allergen labelling (Directive 2003/89/EC of the European Parliament and Commission Directive 2006/142/EC) are implemented into law in England, Scotland, Wales and Northern Ireland by amendments to the 1996 Food Labelling Regulations.

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.

The above Regulations do not cover accidental cross-contamination of a product with the listed allergenic foods or food ingredients. There is other law which may be applicable to the possible allergen cross-contamination of foods that do not deliberately contain one of the EC listed foods.

Article 14 of EC Regulation 178/2002 (General Food Law Regulation)
This provision applied from 1/1/2005. Paragraph (1) prohibits unsafe food from being placed on the market. ........ Food is deemed to be unsafe if it is injurious to health or unfit for human consumption, and Article 14 contains provisions for determining whether food falls within this prohibition.
Paragraphs (3) and (4) of this article are particularly relevant:
"(3). In determining whether any food is unsafe, regard shall be had:
a)to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and
b)to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods."
"(4) In determining whether any food is injurious to health, regard shall be had:
a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;
b) to the probable cumulative toxic effects;
c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers."

Various criteria, have to be considered, including information provided to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods (see Article 14(3)(b)); and also the particular health sensitivities of a specific category of consumers where the food is specifically intended for that category of persons (see Article 14(4)(c)).

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)

Article 16 of EC Regulation 178/2002 (General Food Law Regulation)This article requires that the labelling, advertising and presentation of food, including the information made available, should not mislead consumers.

Section 14 of the Food Safety Act 1990
This provision makes it an offence for anyone to sell to the purchasers prejudice, any food which is not of the nature, substance or quality demanded by the purchaser.
(Ed. e.g. an 'allergen-free' food which was not, in fact, allergen free)

Section 15 of the Food Safety Act 1990
This provision makes it an offence to falsely describe or present food. More particularly, it is an offence for food labelling to be false or likely to mislead as to the nature, substance or quality of the food. The section also applies in relation to the advertising and presentation of food.
It remains widely accepted that individuals who have allergic reactions to certain foods should take care to scrutinise food labels more closely than an average consumer does.

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.
(NB. Ed. To show 'due diligence' you need to show that you have done everything reasonably practical to manage allergens and that the systems you have adopted to do so, work.)

Civil law

In addition to the criminal regime, liability can also arise at civil law under the product liability provisions of the Consumer Protection Act 1987 or under the common law of negligence.

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.

In negligence, it is well established that manufacturers owe a duty of care to their consumers to supply safe products. In order to discharge their duty satisfactorily they are required to take all the steps a reasonable manufacturer in the same circumstances would have taken to ensure the safety of his products.

Labelling implications
A manufacturer's position under the Consumer Protection Act 1987 for supplying a defective product and under the rules of negligence will vary in different circumstances.

Unintentional presence
Allergens that are, or may be, unintentionally present in products will not, of course, be labelled as ingredients.

Under the Consumer Protection Act 1987, a product unintentionally cross-contaminated with an allergen may be defective especially when the presence is outside the specification.

The question then arises as to whether or not advice about the possible presence of the allergen
(eg a 'may contain flash') will effectively cure such a defect. The ability of such advice to cure such a defect may depend on a number of factors (for example the size and prominence of the advisory statement and consumer expectation as to the nature of the product) and would be decided on a case by case basis.

A manufacturer may be deemed to be negligent either in the manufacture of the product or in its presentation.
Where good manufacturing practices or other due diligence measures are in place, they will go a long way to rebutting negligence in manufacture.
Nonetheless, a manufacturer could be negligent in respect of their labelling if they fail to give advice in a situation where, despite the operation of good manufacturing practices (GMP), the manufacturer should have been aware of a significant likelihood of product contamination.

In practice, it will become more difficult for a manufacturer who does not provide the relevant advice to establish that their product is not defective under the Consumer Protection Act 1987, or that they are not negligent in the labelling of their product where a significant number of other suppliers are providing advice on the potential presence of allergens in their products.

Consumer redress

In civil law, individual consumers have the right to bring actions against manufacturers directly for compensation in respect of any loss, damage or injury they have suffered.

Manufacturers who employ good manufacturing practices reduce the risk of cross-contamination of their food products by any allergens, and should therefore minimise their legal liability in respect of on-pack claims or other indications of freedom from specified allergens.
However, the provision of an incorrect list could bring such manufacturers within the food safety and consumer protection controls detailed above, and it is thus a matter for individual companies' commercial judgement to decide whether or not such claims should be made or lists compiled. Such advice should not be provided unless supported by an appropriately documented quality system.


Sonia's full presentation can be found on the FDIN site here.

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First Published in September 2012