May contain ...

Would thresholds for adventitious presence of soy, nuts and sesame make allergen management any easier for manufacturers? Elaine Watson reports

Officially, say the experts, all allergens are equal and must be treated accordingly. Unofficially, some are more equal than others. In practice, says one industry source, manufacturers handling multiple allergens on one site will typically rank them from most to least risky when putting together their hazard analysis critical control point (HACCP) plans.

But this in itself is a risky strategy, he admits. "Some retailers rank allergens with peanuts, tree nuts, sesame and shellfish as most dangerous and things like soya and celery further down the pecking order. But it's not always clear whether these rankings are based on the potential risk to the allergy sufferer, the prevalence of the allergen in compositional percentage terms or the risk of cross- contamination in the supply chain."

Grading them is also risky because a small percentage of people can have severe reactions to all of the allergens on the EU list, which is why they are on it in the first place, he observes. Besides, if you have a recall because of undeclared celery, it will still cost you a fortune whether celery kills anyone or not, he adds.

Some firms think in terms of "nuts and everything else", says one technical manager. "But nuts aren't our biggest challenge because our legal department tells us we've got to put a variant of 'may contain nuts' on everything. But the other allergens are different."

Approaches to advisory labelling ('may contain') have definitely changed from when EU allergen labelling legislation first hit UK statute books in late 2005, says Peter Littleton, technical services manager at cleaning specialist Holchem. "Initially, may contains labelling was used as a blanket 'get out of jail free' card, but now there is much more pressure to justify its use, which is obviously good news for allergy sufferers."

While there are no legally defined 'safe' limits for the adventitious presence of allergens with the exception of gluten (gluten free claims can be made at less than 20ppm), some manufacturers still work to unofficial limits for example 20ppm on casein, he claims. "But this is also risky as companies are not always clear about the basis on which the thresholds are set, while the amount of protein that causes an allergic reaction varies enormously from person to person."

Allergen thresholds

Work is continuing to establish thresholds in Europe for several allergens, but this is unlikely to bear fruit for several years, which is frustrating for manufacturers, says Littleton. That said, a threshold-based system such as the voluntary incidental trace allergen labelling (VITAL) scheme in Australia does not come without risks of its own, he says.

"It's a brave manufacturer who decides not to use a 'may contain nuts' warning just because detectable levels are below a threshold." A lot also depends on the nature of the allergen in question when making such a decision, adds RSSL's allergens guru Simon Flanagan. "You could test 20 samples and find no peanuts, so decide not to use a warning label, but the 21st product could contain a peanut fragment that could kill someone."

VITAL covers peanuts, gluten, fish, milk, soybeans, tree nuts, sesame and crustacea and includes three action levels based on set thresholds: green (no advisory label required); yellow (advisory label required eg 'may be present: sesame'; and red (the allergen must be listed in the ingredients list).

A similar system would certainly help UK manufacturers, agrees British Retail Consortium (BRC) assistant director, food policy, Andrea Martinez-Inchausti, although more work needs to be done to establish how it might work here. "Thresholds would certainly make advisory labelling more consistent and would help manufacturers at a practical level."

Reformulate

Another strategy is to keep as many allergens out of your supply chain in the first place, or even add them where appropriate, says Littleton. Instead of busting a gut to keep milk out of the 5% of your products that don't contain it, he says, why not reformulate so that all of your products contain milk?

Likewise, if you can make life easier by eliminating allergens at source for example by switching from soy lecithin to sunflower lecithin or from wheat starch to corn starch without incurring huge costs, this is clearly sensible, says Gary Hoyle, technical director at sauces and dips manufacturer Panesar Foods.

"We've done a lot of work with suppliers to come up with blends that don't contain mustard seed, for example, but we still handle about six allergens on site. We have a colour coding system whereby everything connected to nuts is yellow and all the other allergens are purple, but it would be really helpful if there was a clear ranking system for all the allergens and set thresholds for testing purposes."

One of the big unknowns of course is how many more allergens will be added to the current EU list of 14, and whether things could become unmanageable if the list starts to get out of hand. "It's possible that the list could grow or shrink," says RSSL's Flanagan. "But there are markets such as Japan that have 60+ official allergens so anything is possible.

"However, when deciding what goes onto the official EU allergen list they will take into account prevalence across multiple EU markets plus things like how biochemically stable the allergen is as well as the severity of individual reactions."

In other words, just because a handful of people in Milton Keynes have a severe allergic reaction to something doesn't mean it will automatically make it on to the list. Which is just as well, notes Littleton. "The number of allergens already in the legislation means that complete physical or temporal segregation is becoming increasingly difficult or indeed impossible for many manufacturers."

Best practice guidance

When it comes to the practicalities of allergen controls, the FSA 2006 Guidance on allergen management and consumer information is a great starting point, says Flanagan. But manufacturers need more practical advice, he says. "The decision trees in the guide ask you to assess whether cross-contamination is 'probable' or 'remote'. But how do you actually interpret that?"

A lot of the things RSSL works on with manufacturers relate to protocols: what systems are in place so the right product is always put in the right box? How are changeovers handled? What are firms doing to make allergens easier to identify on packaging in ranges with multiple flavours or variants? How does allergen management fit into production scheduling and cleaning regimes?

One of the best guides out there at the moment is the Anaphylaxis Campaign allergen control standard, the first third-party accreditation standard specifically addressing allergen control, he says. "Even if the certification and logo route wasn't the right one [the standard is no longer being promoted as a formal standard with an associated certification scheme, training, audit and logo owing to lack of trade buy-in], it's still a useful document in itself. The costs of certification were always going to be a challenge and the logo was problematic, but the standard itself was useful."

At a practical level, good training is also vital if paper-based policies are to work in practice, adds Littleton. "Making staff aware of the potentially fatal consequences of the failure to control allergens often leads to increased diligence particularly where someone in the session suffers personally or knows someone that does." Training also works best with small groups, he argues: "It reduces the psychological reasoning you get with large groups that allergen control is 'someone else's problem'."

As for cleaning, all of the supermarkets' manufacturing guides/codes of practice and version five of the BRC Global Standard require manufacturers to provide evidence of validation of cleaning regimes for allergen management through combinations of ELISA enzyme immunoassay; RAPID-3D and ATP adenosine triphosphate tests. It is also important to understand what you are trying to achieve with your cleaning regime, notes Littleton. "The use of neutral detergents may lift food residue from surfaces through an emulsification process but will not materially affect the allergen. Likewise, cleaning at highly elevated temperatures may assist in breaking down the allergen however at this time research has not shown if this reduces the allergenicity."

The weakest link?

A large number of allergy alerts /recalls still arise from silly and avoidable errors such as salt and vinegar crisps ending up in cheese and onion flavour packets, the failure to highlight allergens in the allergy box when they are correctly listed in the ingredients declaration or a disparity between labelling on multipack wrappers and individual packs. Others are caused by simple communication breakdowns whereby the introduction of an allergen to a recipe following a reformulation is not communicated to the packaging supplier, or simply inadequate segregation or cleaning in the factory leading to cross-contamination.

However, the weakest links in the supply chain are often raw materials suppliers, says Stephen Whyte, business development manager at supply chain assurance expert Qadex. Manufacturers typically secure relevant information from suppliers via questionnaires, but they are not always rigorous enough when it comes to allergen management, he suggests.

"When we have started asking some raw materials suppliers based overseas more probing questions about HACCP plans on behalf of UK manufacturers, it sometimes becomes clear that just because they have ticked a box on a questionnaire, they don't necessarily have the controls in place."

Kevin Swoffer, formerly head of technical services at the BRC and now an independent consultant, says this remains a significant challenge: "Let's just say that for food manufacturers and ingredients suppliers in some of the countries I've visited recently, allergens are just not on the radar."