Claims

Healthy & Wholesome — A regulatory perspective

Health claims were first introduced into legislation with the introduction of R146 in 2010. This legislation has a standard list of specific claims and also a list of words that indicate some form of health claim that may not be used.

The prohibited words are: health, healthy, wholesome, nutritious and any indication that a food can provide balanced or complete nutrition. In the course of consulting I have regularly encountered food marketers who insist that their food is healthy, wholesome or nutritious so why can they not say so?

The simple answer is no food is in itself healthy. Any given food can only be considered healthy if part of a balanced diet. Nobody can argue with the fact that water is necessary for daily life and therefore is healthy. But it is only healthy as part of a balanced diet that includes numerous other foods. Conversely sodium is considered unhealthy by many, but a diet that excludes sodium in its entirety would be harmful. These simple examples hopefully illustrate why no single food can be labelled using any of the above mentioned words.

Industry has attempted to get around this law with numerous methods, two commonly used (or attempted) are the use of endorsements and registering words as a brand.

The regulations published in 2010 closed the gap on endorsements. No product may be endorsed by a health practitioner or related organisation or even individuals that may insinuate a specific health aspect of food. There is exception made for organisations who are registered with the Department of Health for use of specific logos. This has not stopped companies still using this methodology of marketing whether it be by using a reference to a certain diet or having an Olympian training in the background of advertisements. Some of these products have been removed from the market, but walking through the supermarket many of these products are still on the shelf. This is indicative more of a lack of enforcement on the ground than a retraction of this part of the regulation.

The second avenue, registration of words as trademarks, is dealt with in the current draft regulation where this practice is outlawed. There is some indication that a grace period will be given for those brand names registered prior to 1995, although the dates given in the draft are now long come and gone. It will be interesting to see how far this regulation is taken. Will only specific use of words be targeted or any hint of the use? Words such ‘Pure’, ‘Fresh’ and ‘Natural’ appearing in brand names come to mind.

An issue with how nutrient content claims are currently dealt with is that generally only one requirement needs to be fulfilled e.g. for low fat a product simply has to have less than 3 g of fat per 100 g. This allowed manufacturers to push up for example sugar levels and use synthetic substitutes to make up for mouth feel and taste while still being low fat. Ultimately this does not make for a “healthier” product. A nutrient profile calculator has been introduced in the draft regulations requiring a food product to achieve a certain score before a claim can be applied to the product. The score takes into account total energy contribution, sugar, fats, sodium, protein, fibre, fruit and vegetable content. This can almost be seen as an attempt to create a scoring system for the term healthy, although this word may not be used.

A criticism of this system in previous drafts has been that some seemingly “healthy” foods would then not be allowed to carry a claim. This has been largely solved by having different categories of food products namely beverages, naturally high fat foods (e.g. oils and cheeses) and other food products.
Although no system is perfect this has gone some way to close the gaps in the regulation.

The use of any term on a label must be substantiated by sufficient scientific evidence, normally some form of laboratory study. Where no specific test can be associated with a claim e.g. there is no test that can prove “healthy”. So as a food marketer if you can’t substantiate a claim through legal reference the chances are that the specific word may not be used.

Article by: Norah Hayes

Microbiological limits

Just give me the limit already!

An International perspective:

When it comes to conducting a hazard analysis, microbiological risks and their associated limits are often difficult to define. Although everybody in industry recognises the need for microbial limits, newcomers often do not have the technical knowledge in the field to accurately write up specifications for their products. This inevitably results in a search for regulations, as one would for contaminants such as pesticides and heavy metals. However, consistent and specific micro limits are often hard to find. Unfortunately microbiological guidelines are predominantly set up for a limited list of products, in general for single agricultural products. Therefore it is difficult to find a specification for more complex foods such as baked pasta dishes or cooked stews.

One of the major reasons why microbiological specifications are generally conservative, is because microbiological testing is seen as a tool that contributes to food safety, but is fundamentally supported by other facets such as product and process design (European Commission, 2016). Microbiological testing needs to take into account various factors, one of which is the ability of the product to support the growth of the bacteria being tested for.

Internationally, Codex Alimentarius is advised by the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA). JEMRA uses a risk based model to advise Codex on new and emerging microbiological risks, which in turn advises signatories to Codex.

The European Union issued regulations on the microbiological criteria for foodstuffs in 2005. The regulations cover mainly pathogens and not indicator organisms and stipulate methodology for testing. The European regulation gives details regarding the number of samples to be tested and how many of these samples can exceed the limit, if any. For example, for sprouts, within 5 samples, no sample may contain Salmonella in 25 g when tested according to EN/ISO 6579 (Official Journal of the European Union, 2005).

The Food and Drug administration (FDA) of the United States of America has a variety of regulations and guidance documents published that cover aspects of microbiological testing, but not a single standard. These cover items such as seafood [1], fruit juice [2] and low acid canned foods [3]. It is therefore recommended that manufacturers exporting, or looking for reference documentation, do a product specific search on the FDA website. The FDA also publishes the “Bad Bug Book” that covers various pathogens and their growth conditions [4]. It is a useful guide for professionals in the food industry having to write specifications.

The Australia New Zealand food standards authority has a microbiological standard (1.6.1), published as part of their food standards. The document includes similar information as with the European regulation, but covers fewer products. It is also interesting to note that the standard not only covers pathogens, but also indicators of poor hygiene such as coliforms (FSANZ, 2000).

It is important that microbiological specifications be applied to the entire shelf life of the product and not just at the time of production. Product developers need to take into account the physical and chemical parameters of the product during storage that could support growth. In addition, abuse of the product by the consumer, such as incorrect storage temperature should also be considered when setting up micro limits. Thus, although the legal requirements must be consulted, the risk of the product and its storage must also be carefully considered. It always remains the responsibility of the producer to supply safe food even in the absence of legislation.

Article by: Norah Hayes

References:
1. FDA. 2010. Compliance Program Guidance Manual: Import Seafood Products Compliance Program – 7303.844. Available from: <http://www.fda.gov/downloads/Food/ ComplianceEnforcement/UCM219993.pdf>. [25 April 2016].
2. FDA. 2015. Compliance Program Guidance Manual: Juice HACCP Inspection Program – 7303.847. Available from: <http://www.fda.gov/Food/ComplianceEnforcement/ FoodCompliancePrograms/ucm236946.htm>. [25 April 2016].
3. FDA. 2010. Compliance Program Guidance Manual: Domestic Acidified and Low-Acid Canned Foods – 7303.803A. Available from: <http://www.fda.gov/ downloads/Food/ComplianceEnforcement/ UCM406274.pdf>. [25 April 2016].
4. FDA. 2012. Bad Bug Book, Foodborne Pathogenic Microorganisms and Natural Toxins. Second Edition. Available from: <http://www.fda.gov/downloads/Food/ FoodborneIllnessContaminants/UCM297627.pdf>. [25 April 2016].

Microbiological limits

Mycotoxic Foods

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Aflatoxin B1 chemical structure

Mycotoxins are potentially serious contaminant in foods. These toxins are produced by fungi when storage conditions favour fungal growth, such as in damp grain. Mycotoxins are not easily destroyed by thermal processes that would kill fungi, such as cooking or freezing. As such, prevention of fungal contamination of foods is critical as these toxins can cause illnesses or even death. The most significant mycotoxins include aflatoxins, citrinin, ergot alkaloids, fusarium, ochratoxin, and patin [1]. South African limits for mycotoxin levels in certain foods have been set for Ergot sclerotia, patulin and aflatoxin [2].

Ergot alkaloids are produced by Claviceps species and affect grass species, including cereals. The toxin causes Ergotism which affects the blood supply to the limbs and central nervous system. It is suspected that the Salem witchcraft allegations arose from rye infected with Claviceps resulting in convulsive ergotism. In South Africa grains must contain less than 0.05% Ergot sclerotia by mass.

Patulin is an antiobiotic produced by the soft rot blue mould, Penicillium expansum found on fruit infected. It is toxic to humans and the South African limit for patulin is 50 μg/l in apple juice and other beverages containing apple derivatives.

The risks of mycotoxin contamination are controllable if products are sampled and tested correctly, and health authorities and manufacturers respond appropriately.

Manufacturers must be aware of the legal limits for mycotoxins that must be abided by. As always, manufacturers have the responsibility to ensure their food products are safe.

As a manufacturer, it would be your responsibility to set up specifications covering potential contaminants not only for your finished product, but also raw materials. It is vital to cover all regulations when compiling your specifications, but also to look at, based on industry experience, the chemical, physical and microbial contaminants associated with your product.

Aflatoxin conundrum

Aflatoxins, of which aflatoxin B1 is the most toxic, are more strictly regulated than other mycotoxins. This is due to the risks of chronic, low-level exposure which may result in numerous conditions including immune suppression and even cancer. Studies suggest that increased exposure to aflatoxin increases risk of cancer, especially liver cancer [1]. No ready-to-eat food in South Africa may contain more than 10 μg/kg of aflatoxin (with aflatoxin B1 < 5 μg/kg).

Unfortunately, the fungi that produces aflatoxins grows on maize and peanuts, which are both staple foods. Peanuts are high in protein and due to its high nutritional value is frequently used in nutritional programmes in poorer communities. In 2001 greater than 30 times the legal limit of aflatoxin B1 was found in non-commercial peanut butter used in an Eastern Cape Primary School Nutrition Programme [3]. This potentially increasing cancer risk for millions of school children from 1994.

High levels of aflatoxin can be due to manufacturers’ ignorance, or in some cases the unethical practice of combining contaminated, with uncontaminated product to reduce the level of aflatoxin in the final
product.

Articles by: Gillian de Villiers, co-authored by Norah Hayes

References:
1. Clin. Microbiol. Rev. July 2003 vol. 16 no. 3 497-516 Mycotoxins, J.W. Bennett, and M. Klich
2. Regulations governing tolerance for fungus produced toxins in foodstuffs R.1145 of 2004, October 8.
3. MRC policy brief. August 2001 Aflatoxin in peanut butter (http://scienceinafrica.com/health/aflatoxin-peanut-butter-mrc-policy-brief)

Contaminants

A Weed is just a misplaced plant

bee-549221_1920The Foodstuffs, Cosmetics and disinfectants Act No. 54 of 1972 [1] requires that food marketed to humans is not injurious to health. This is a “catch all” statement – so where no specific regulation exists, in court the onus would be on the producer to ensure the food is safe for human consumption.

Codex defines a contaminant as “Any substance not intentionally added to food or feed for food producing animals, which is present in such food or feed as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or feed, or as a result of environmental contamination.” Interestingly they exclude physical contamination such as insect fragments and rodent hair. (CODEX STAN 193-1995)

Currently there are many South African regulations that deal with contaminants including: heavy metals (R500 of 2004), pesticides (R246 of 2005) colourants (R1008 of 1999), hydrocarbons (R230 of 1977) and toxins; even allergens in the labelling regulations (R146 of 2010) could be classed under contaminants.

Rather than expecting a complete absence of a contaminant, regulations often state a permissible level for a specific food group, or all foodstuffs. So it is vital to understand that if a limit exists in a certain product group, this does not mean that other groups are not regulated. Thus, other groups should not contain the contaminant. For example preservatives are permitted in certain food categories, but considered contaminants in similar categories.

This was certainly true for the Pimaricin in export wine case (2009). Pimaricin, commonly used to preserve fruit juices and fruit concentrate was found in some export wines; it was present due to the addition of grape concentrate, occasionally used in the winemaking process. Although allowed in South African wines it is prohibited in some countries.

In some cases regulations do not exist for contaminants, either as the need for regulation has not yet arisen, or because no amount of contamination should be allowed. Two examples that illustrate this point are Sudan red and melamine. When these scares hit in 2005 and 2008 respectively, industry started looking for regulations specifying limits for these compounds.

Sudan red is a colourant used in various industries mainly oil and gas, and should never be in contact with food. As such, there was, and still is, no need for it to be specifically legislated. No amount of Sudan red would be safe for consumption.

For melamine, no legislation existed at the time, but now R1054 of 2009 is in place. Apart from adulteration and food fraud, melamine may also come into contact with food through use of certain containers. Prior to this regulation the onus would have been on the producer to prove that a small amount is firstly safe in the product and secondly present purely due to unavoidable circumstances.

Whether added or unintentional, if it is harmful or not permitted, much like ‘a weed is just a misplaced plant’, these substances if present in foodstuffs are contaminants.

Article by: Norah Hayes

Footnote:
1. Regulations are listed under number and year of first print and should include all subsequent amendments.