UK: FSA Consultation on Draft "May Contain" Guidance

The UK Foods Standards Agency (the "FSA") opened a consultation on the draft "Best Practice Guidance on Allergen Control and Consumer Information", the so-called "May Contain" Guidance, on 6 September 2005.

The aim of the consultation is to settle voluntary best practice guidelines for food producers and retailers on controlling food allergens, focusing on avoiding cross-contamination and using appropriate advisory labelling, and to seek comments on the impact of the Guidance on food businesses through a partial regulatory impact assessment.

The main factors behind developing the Guidance are:

Food allergies affect approximately 1.5 million people in the UK and, at their most severe, can be life-threatening. Food intolerances are not life-threatening, but can make people feel ill and affect their long-term health. As some people react to just a few milligrams of an allergenic food, crosscontamination needs to be reduced or eliminated if possible. If this cannot be achieved, the consumer needs to be fully informed about the nature and content of the foods that they buy. This includes clear labelling of both the deliberate use of allergenic ingredients and the identification of possible cross-contamination with allergenic ingredients during production of the food.

The variability of wording currently used by different food manufacturers and retailers has resulted in consumer confusion and mistrust of allergen labelling. The excessive use of allergen warning labels not only unnecessarily restricts consumer choice but also devalues the impact of the warnings.

A lack of legislation and authoritative advice has led to industry confusion and inconsistent labelling. Some sectors of the food industry, such as the Food and Drink Federation and the British Retail Consortium, have issued their own advice on handling certain allergens, but believe that overarching guidance on allergen labelling is needed. Although there is legislation¹ requiring the labelling of certain² deliberate allergenic ingredients, it does not cover the labelling of allergens unintentionally present in foods from cross-contamination during manufacture or distribution.

Therefore, there is a need for suitable guidance to create a common understanding by food producers and retailers, enforcement bodies and consumers of when it is appropriate to use advisory labelling, and what it means. The Guidance should reduce the unnecessary use of such warning labels, giving allergenic consumers greater choice when selecting pre-packed foods whilst ensuring that where such warnings are used, consumers understand the risk involved.

The Guidance aims to set out general principles that can be applied to the control of specific allergenic ingredients in different situations:

• Factors to consider as part of a risk-based approach to allergen assessment and labelling

• The amount of the allergenic food needed to provoke a reaction in a sensitive individual.
• How common are adverse reactions to that particular food.
• Whether there are population subgroups who are particularly at risk (for example, children).
• The relative allergenicity of the particular ingredient being used (for example, highly processed foods such as refined nut oils pose less risk than whole nuts).
• The physical nature of the particular ingredients being used and the geography of the manufacturing environment (for example, airborne particles of milk powder vs. liquid milk).

• Wherever possible, allergenic ingredients should be substituted by less allergenic equivalents.
• Extending a brand name into a different product sector, or deliberate product reformulations, which introduces allergens should result in clear on-pack labelling.
• Information on the presence, or potential presence, of allergens should be made available to those involved in factory trial, taste testing and sampling for marketing purposes.

• Wording used to communicate cross-contamination risk should be consistent between products and manufacturers.

• Hazard management techniques such as Hazard Analysis Critical Control Point (HACCP) systems should be used to identify cross-contamination risks.
• Good Manufacturing Practices (GMP) should be employed, including making staff aware of food allergens and establishing appropriate policies for assessing the allergen status of the raw materials.
• Where manufacturing facilities dedicated to products including allergenic ingredients are not available, other techniques for minimising cross-contamination should be used, such as physical barriers between production lines and cleaning equipment after production runs.

• Warning statements need to be easily visible and clearly legible.
• There must be a clear distinction in the labelling information between deliberate ingredients and possible allergen cross-contamination³. Recipe changes should be very clearly indicated, preferably on the front of the pack, using warnings such as "New recipe" or "Now contains", and manufacturers should consider providing information on changes to consumer support organisations.
• The preferred phrases to convey advisory information are "may contain (traces of) X" and "ingredient Y may contain (traces of) X".
• Detailed explanations of the mechanisms by which contamination occurs should be avoided.

The Guidance sets out general principles for controlling allergens and encourages the use and development of more detailed sector specific guidance and codes of practice that build on the approach set out.

PARTIAL REGULATORY IMPACT ASSESSMENT

Alongside the draft Guidance, the FSA is also seeking comments on the impact of the Guidance on food businesses in the form of a partial regulatory impact assessment (RIA).

The FSA believes that the increase in control and labelling burden resulting from the Guidance would be limited and offset by a reduction in business risk. Many larger food manufacturers, retailers and food service companies already have traceability arrangements in place, and the EU General Food Law Regulation⁴, which came into force on 1 January 2005, introduced a broad, non-prescriptive traceability requirement. These existing systems could be built on to control food allergen cross-contamination and label changes could be worked into existing label change cycles, thereby reducing costs to manufacturers. Following the Guidance would create a check on manufacturing operations that would provide evidence of due diligence in managing allergens and reduce the likelihood of a product recall due to inaccurate labelling.

The FSA is seeking views on the Guidance and partial RIA, including:

• Whether the Guidance should only apply to the allergens previously associated with this type of advisory labelling (peanuts, tree nuts and seeds, such as sesame) or should its application be extended?
• If the phrases suggested to convey possible allergen cross-contamination are appropriate?
• The development of a single ‘allergen symbol’ to help consumers locate allergen labelling information?
• If the Guidance should be voluntary, or whether some form of statutory control might be introduced, and if so, what form should this take?
• What would the impact be of this Guidance if it remains voluntary, and what would be the impact of any statutory form of control?
• Does the partial RIA accurately reflect the cost implications for food businesses and are there any other implications for consumers, enforcement officers and businesses which should be taken into account?

Responses to the consultation are requested by 6 December 2005, and the Guidance should be finalised in 2006.

The European Commission announced a proposed review of food labelling laws in 2004 and indicated that allergen advisory labelling could be considered within the review. Any such review will take a number of years and by developing voluntary guidance now, the UK should be in a position to influence EU discussions on allergen control and labelling in the future.

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