internationally in the Codex Alimentarius Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (C
AOAC Food Allergen Community
NEWSLETTER
Volume 3 | Issue 3
Summer 2012
Olympic Achievements
The reward to perseverance
This summer we have the opportunity to be witnesses of the efforts of many men and women who have prepared themselves very hard during four long years for the Olympic games. Only few of them will see their dreams come true. In our food allergen community we are also working around the clock in a life time effort to ensure the safety of allergy and celiac sufferers. However, we all can see our reward daily in all those customers who can enjoy something that sounds as simple as eating safe food. The Editorial Team of the AOAC Food Allergen Community Newsletter
IN THIS ISSUE
Editorial Comment
Editorial Comment Sit and wait - or take action?
1
Ask the Expert Dr. Susan Hattersley
2
News Health Canada’s position on the use of food allergen precautionary labelling
4
Health Canada’s Position on GlutenFree Claims
5
Manufacturers’ Corner
5
Sit and wait – or take action?
Allowing food allergic consumers to make an informed choice is manifested in many countries’ regulations. However, only some countries’ authorities are actively taken measures to not only help consumers to have reliable labeling, but also provide industry with guidance on how to handle inadvertent contaminations, which often is the greatest challenge. The problems faced by enforcement, consumers and industry alike are the lack of validated methods to provide reliable allergen detection and quantification as well as the proliferation of precautionary labeling. And here, governments and government working groups in three countries appear to be leading developments for all the others. Germany with its strong method development and validation group (§64LFGB - see previous issue). Canada with its very strong allergen program including industry consultation groups and labeling guidance activities. And last but not least Britain, which has been funding predominantly work in the clinical field thereby contributing to establishing thresholds as well as developing an essential guidance document, jointly with industry groups, does not only help the international businesses but also small and medium size businesses. But there is so much more to do when it comes to providing reliable methods for allergen analysis and guidance to industry. It is not time to sit and wait – neither for method developers nor for governmental working groups of any country with an allergen labeling regulation. Bert Popping | AOAC Food Allergen Community Newsletter Board Member
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Editor in Chief: Carmen Diaz-Amigo
Editorial Members: Terry Koerner Jupiter Yeung Michael Abbott James Roberts Bert Popping
Graphic Design: Carmen Diaz-Amigo
AOAC Food Allergen Community Newsletter:
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NEWSLETTER
Volume 3 | Issue 3 Summer 2012
Q&Ask the Expert Sue Hattersley, Ph.D.
Head of Food Allergy Branch Food Standards Agency London, UK FSA is very active protecting allergic consumers while still not putting a too heavy burden on the food industry. Could you briefly elaborate on the work FSA is undertaking for allergic consumer? One of the FSA’s main priorities is to ensure that consumers have the information they need to make informed choices about the food they eat – which of course is a key concern for people with food allergies. Working with our European Union partners, we develop and implement legislation that requires food businesses to provide detailed and clear allergen ingredient information. An example would be the recent EU Food Information for Consumers Regulation, agreed at the end of 2011. This introduces new mandatory requirements to highlight allergen information in the ingredients lists on pre-packed foods and the provision of allergy information for foods sold unpackaged, including in catering. However, it is important that the legal requirements are practical – for both consumers and food businesses alike. Occasionally there are errors with food allergen labelling. In cases like this, we work with the food business and enforcement officers to ensure that the error is corrected quickly. However, we think it is important to inform consumers who may have already bought the product. This is why we issue Food Allergy Alerts that give details about the brands and products affected. This information is available on our website and we also have a free service that consumers can subscribe to, so they can receive free e-mail or SMS messages whenever an Allergy Alert is issued. For more information, see: http://www.food.gov.uk/policy-advice/allergyintol/alerts/ Another very important area of the FSA’s work is the research that we fund. We are funding some ground-breaking studies that we hope will advance understanding of the mechanisms and factors involved in determining why some people develop food allergy and others do not. These studies are concentrating on factors such as the timing of introduction
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of the allergenic food into an infant’s diet and the role of the skin as a route of first exposure to a food allergen. We are also funding research and supporting a number of international initiatives to drive forward the development of allergen management thresholds. How do you support food industry to facilitate accurate and easy to understand labelling? The FSA supports food businesses by producing detailed guidance explaining their obligations, and what they have to do, in clear terms. In recent years we have also produced best practice guidance in two areas of allergen information that were outside the legislative requirements. The first concentrated on the management of allergen cross contamination and advisory labelling. The second focused on the provision of allergen information for unpackaged foods. These guidance documents were produced in collaboration with a range of industry stakeholders, including food businesses, enforcement bodies and the consumer support organizations for people with allergies. As mentioned above, we are also heavily involved in international efforts to develop workable allergen management thresholds. We think these will be beneficial to businesses as they will have a consistent basis for making allergen advisory labelling decisions. It will also be helpful to consumers, who can have more confidence in the labelling they see on food products. Would you say that precautionary labelling in the UK has been harmonized? We have had good feedback on the usefulness of the Agency’s best practice guidance on allergen management and advisory labelling. However, as with any voluntary guidance, it is perhaps being applied differently across the range of food businesses. This is probably inevitable as the guidance is qualitative in nature – but this just reinforces the need for the development and agreement of quantitative allergen management thresholds.
NEWSLETTER
Volume 3 | Issue 3
Over the many years that FSA has worked on Allergens and Intolerance, what were the most significant findings? I have been responsible for the food allergy and intolerance team in the FSA for the last 10 years and there have been a number of significant achievements in that time. Improvements in the labelling of allergenic ingredients used in pre-packed foods, and the new requirement to provide allergy information for foods sold unpackaged, have done much to make it easier for allergic consumers in the UK to make safe and informed food choices. Our research programme over the last 15 years has also contributed greatly to the understanding of factors that impact on the acquisition of sensitisation to food proteins and the development of food allergy, as well as providing a much clearer picture of the prevalence of food allergy in the UK. The programme is now concentrating on furthering understanding of how the early life environment influences the development of sensitisation to food. In future, this will help us to develop better preventative strategies to try and reduce the risk of developing food allergies. Would you say that through the work FSA has done or commissioned, the quality of life of the allergic consumer group in Britain has been improved? I very much hope so! The FSA’s objective of ensuring that the labelling of allergenic ingredients in food is clearer and more detailed allows consumers with allergies to make safe and informed food choices. Moreover, they can be confident and trust the labelling that they see. I am also optimistic that the
Summer 2012
work we are involved in to develop allergen management thresholds will make a significant improvement to the lives of allergic consumers by leading to less widespread use of precautionary labelling, increasing the range of products without such labelling and giving consumers greater confidence in the decisions that food businesses have made about the need for such warnings. Looking across Europe, the allergen work of FSA is certainly outstanding. Why do you think similar efforts are not seen in other European member states? What advice would you give to the equivalent agencies? The relatively high prevalence of food allergy in the UK compared to some other European countries may explain the greater emphasis and resource that the FSA has applied to food allergy issues. When working with stakeholders and industry, the key is to try to engage openly with all the parties affected by food allergy: food businesses, food allergy support groups and to work collaboratively with all of them. This gets everyone on board sooner; helps to iron out any issues earlier and develop effective solutions. One of the strengths of the FSA work on food allergy is that we have been able to help meet the needs of allergic consumers in ways that are practical for food businesses and not unduly burdensome. I hope other regulatory bodies around the world will consider the allergen management thresholds being developed. I also encourage businesses to adopt a consistent, sciencebased approach to allergen management and when making decisions about the use of precautionary labelling.
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NEWSLETTER Volume 3 | Issue 3
Summer 2012
News Health Canada’s position on the use of food allergen precautionary labelling A food allergen precautionary statement is a declaration on the label of a prepackaged food of the possible inadvertent presence of an allergen in the food. Precautionary statements are made by food manufacturers and importers on a voluntary basis above and beyond the basic ingredient and nutrition labelling requirements stipulated in the Food and Drug Regulations (FDR) and other related legislation. There is no regulatory requirement for, or prohibition of, precautionary labelling. However, like all labelling statements, precautionary statements are subject to section 5(1) of the Food and Drugs Act (FDA), which requires any labelling to be truthful and not misleading. The original policy on the use of food allergen precautionary statements was set in 1994 by Health Canada’s Food Directorate. When used, precautionary statements aim to: (1) alert the consumer to the possible presence of an allergen in a food, and (2) prevent the consumption of products labelled with a precautionary statement by persons having a food allergy. Health Canada’s policy has been non-prescriptive with respect to the wording of precautionary statements, requiring only that such statements be truthful, clear and non-ambiguous, and that they not be a substitute for Good Manufacturing Practices. Health Canada and the Canadian Food Inspection Agency (CFIA) have committed to reviewing the current policy, because: 1. The use of food allergen precautionary statements on prepackaged foods has substantially increased since the mid1990s.
y Sta ! ed n u T
2. A variety of statements are being employed, some of which are no longer providing food allergic consumers with meaningful information on the potential presence of allergens in pre-packaged foods hence misleading consumers on the possible occurrence, levels and risks associated with allergens in food. Health Canada still considers the use of allergen precautionary statements to be a useful tool in mitigating adverse reactions to priority food allergens if the statements are used appropriately. Precautionary labelling should only be used when, despite all reasonable measures, the inadvertent presence of allergens in food is unavoidable. It must not be used when an allergen or allergen-containing ingredient is deliberately added to a food. Furthermore, the use of a precautionary statement where there is no real risk of an allergen being present in the food is contrary to the Department’s goal of enabling a variety of safe and nutritious food choices for the allergic consumer. To address potential confusion surrounding different wording being used in precautionary statements Health Canada is recommending that food manufacturers and importers begin to use only one precautionary statement on food labels: “may contain [X]” where X is the name by which the allergen is commonly known. More information on food allergen precautionary labelling can be found on the Health Canada website at : http://www.hcsc.gc.ca/fn-an/label-etiquet/allergen/precaution_labeletiquette-eng.php Michael Abbott Health Canada
Can’t wait to hear from us? Do you want to share good news with the community? Find the AOAC Food Allergen Community in
AOAC Food Allergen Community Newsletter 99 Regulatory Updates You can contribute with articles, news items or suggestions Submission deadline for the Fall 2012 issue: September 28, 2012
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99 Food Industry Initiatives 99 Regional developments 99 Upcoming events 99 Questions for our Experts 99 Interested in a topic?
NEWSLETTER
Volume 3 | Issue 3
Summer 2012
News Health Canada’s Position on Gluten-Free Claims Division 24 of the Canadian Food and Drug Regulations is intended to protect the health and safety of individuals who require the use of foods for special dietary use that are covered by these regulations due to an existing physical or physiological condition. With respect to gluten-free foods, only those foods that have been specially processed or formulated to meet the needs of individuals, including individuals with Celiac disease, who need to follow a gluten-free diet in order to protect their health, are considered foods for special dietary purposes and are allowed to carry a gluten-free claim. For example, bread specially formulated with substitute flours from grains that are not identified as one of the gluten sources referred to in section B.24.018 of the Regulations, and specifically listed in subsection B.01.010.1(1) (i.e., wheat, rye, barley, oats, triticale), could be labelled gluten-free if it meets all other requirements of the Food and Drug Regulations. If a food is determined to be protective of the health of people with Celiac disease, and meets the other requirements of Division 24 (specially processed and formulated), it follows that such a food should be able to use the claim “Gluten-free”, as long as it is being done in a manner that is truthful and not misleading. While no specific threshold is mentioned in the Regulations themselves, the best currently available scientific evidence indicates that levels of gluten below 20 ppm in gluten-free foods would be protective of the health of the vast majority of people with Celiac disease. This level is recognized
internationally in the Codex Alimentarius Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (Codex Stan 118-1979) which states that the gluten content of foods labelled gluten free shall not exceed 20 ppm. Based on the available scientific evidence, Health Canada considers that gluten-free foods, prepared under good manufacturing practices, which contain levels of gluten not exceeding 20 ppm as a result of cross-contamination, meet the health and safety intent of B.24.018 when a gluten-free claim is made. Based on the enhanced labelling regulations for food allergens and gluten sources, any intentionally added gluten sources, even at low levels (e.g. wheat flour as a component in a seasoning mixture which makes up a small proportion of the final food), must be declared either in the list of ingredients or in a “Contains” statement. In these cases, a gluten-free claim would be considered false and misleading. If, however, a manufacturer using a cereal-derived ingredient includes additional processing steps which are demonstrated to be effective in removing gluten, then the food may be represented as gluten-free. More information on Health Canada’s position on gluten-free claims can be found on the Health Canada website at: http:// www.hc-sc.gc.ca/fn-an/securit/allerg/cel-coe/gluten-positioneng.php Michael Abbott Health Canada
Manufacturers’ Corner Romer Labs® launched the new AgraQuant® Milk Kit. The sandwich ELISA has three 20 minute incubations with standards ranging from 0.4 to 10 ppm milk protein. The antibodies detect beta-lactoglobulin and casein. It is designed for analysis of raw and processed foods, rinse water and swabs. More information on www.romerlabs.com/allergens
The AOAC Food Allergen Community is a forum serving the scientific community working on Food Allergens: The community is aimed to help AOAC INTERNATIONAL in its consensus-based scientific and advisory capacity on methods of analysis for allergens in foods and other commodities.It is also meant to serve the broader Stakeholder Community whose objectives it is to enhance the protection of food allergic consumers worldwide. Contact us at
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