Labeling

This information is has been researched from a variety of resources believed to be trustworthy and based on scientific research. It is provided only as a resource and is not intended as medical advice or endorsement. If you believe that you have a food allergy or intolerance, it is very important to discuss your concerns with a medical professional.



Food Allergen/Gluten Labeling

American Food Allergens and Gluten Labeling Law

As of January 1, 2006, food regulated by the Food and Drug Administration (FDA) is required to label sources of the top 8 food allergens plus sulfites on packaging.  The two acceptable ways to label these items are listed in the ingredients in common language and/or as a separate “Contains:” statement immediately below the ingredient statement.  Common language means that scientific names for ingredients such as lactoglobulin must use a word that all consumers can understand with the ingredient such as lactoglobulin (milk) or fish (salmon).  Or, at the bottom of the ingredient list, “Contains:  milk” or “Contains:  salmon”.

Food manufacturers providing Food and Drug Administration (FDA) regulated food in the USA must label the following 8 most common food allergens:

Wheat

Peanuts

Tree Nuts (specific nut must be declared)

Milk products

Eggs

Soy

Fish (finned – specific fish must be declared)

Crustacean shellfish (not molluscs – specific shellfish must be declared)

For specific fact sheets on each of these allergens, please see the Food Allergy Research and Education (FARE) website .

In addition, labels must declare the group of preservatives known as sulfites at 10 or more parts per million.

While the FDA had indicated that they would provide a definition of gluten free by 2010, there is still no definition of gluten free.  Most food manufacturers label according to the suggested recommendation of below 20 parts per million unless they are certified gluten free by a 3rd party who has lower parts per million as their certification criteria.

Symbols and words indicating that an item is free of a specific food allergen (i.e. peanut free, gluten free) or produced in a dedicated plant are voluntary but must be truthful and meet the FDA’s labeling regulations.

Please note that if you are traveling outside of the USA, the top food allergens and labeling laws may be different.  Products that are considered “safe” for your food allergen in America may be different outside of the country.  Read ingredient labels every time.

Labeling Law Exceptions

Refined Oil Labeling Exemption

In the United States, the FDA does not require the top 8 allergens to be labeled on refined oil.  This is due to research that shows that refined oils have been so heavily processed that only a minute amount of the food allergen protein remains. 

This does not apply to expeller pressed oil which is not refined enough to remove all proteins nor lecithin which may still contain enough of the protein to cause a reaction.

 

Foodservice and Produce Labeling Exemption

Food items pre-packaged and sold for foodservice such as vending, restaurants and cafes are required to provide ingredient labeling.  However, labeling is exempted for an item that you order and have made for you whether that is in a café, restaurant, or deli section of a grocery store.

Fresh produce is exempt from the labeling but is no longer allowed to be sprayed with sulfites due to documented asthma reactions in susceptible individuals.  However, sulfites are still allowed to be sprayed on fresh cut potatoes.  Fresh grapes, if sprayed with sulfites to inhibit mould growth, must have less than 10 ppm of sulfites.

 

Alcohol Labeling Exemption

Because alcohol and spirits are not regulated by the FDA, they are not required to follow the food allergen declaration regulations.  However, the TTB (Alcohol and Tobacco Tax and Trade Board) has suggested that producers voluntarily label for the top 8 allergens.

Sulfites are often added to wine and must be declared.  Additionally, fermentation during wine making creates naturally occurring sulfites so even organic wines without added sulfites will have sulfites naturally occurring in the wine.  If those naturally occurring sulfites reach levels of 10 ppm or more, they must be declared.

 

Agricultural Exemptions

The FDA does not regulate agricultural products such as meat, poultry and certain egg products.  These are covered by The United States Department of Agriculture and regulated by the Food Safety and Inspection Service.  Under their rules, any item that has 2 or more ingredients must have an ingredient statement on it which includes the declaration of major allergens.

This same exemption covers crops that require no ingredient label as they are a single ingredient (i.e. corn, wheat).  Due to North American farming practices, agricultural cross contamination is widespread and common although the risk to allergic consumers is considered to be low.

"May Contain" Labeling

Although many food manufacturers voluntarily list May Contain statements, they are not required or regulated and there is no standard by which they are applied.  This is left up to the food manufacturer.

Many consumers incorrectly believe that manufacturers place these statements on labels for legal purposes, not because the food contains the allergen.  Governments everywhere around the world are reviewing food allergy statements on ingredient labels after alarming studies showing that many of the food allergic ignore those warning statements. 

However, several studies worldwide have shown that many food products with “May contain” statements on them have demonstrated measurable levels of allergenic proteins.  Therefore, ignoring the warning may have dire consequences.

Is a Dedicated Facility Important?

A dedicated facility is where food is manufactured without a specific top allergen used in that facility.  A manufacturer may have a dedicated facility for only one specific food allergen while another may indicate that their facility is free of several different top food allergens.

Whether a dedicated facility is important to you is highly dependent on the level of severity of your reaction, the type of products that the business is making and the allergen and gluten controls that are in place for manufacturing the product you’re eating.  It is really up to the consumer’s comfort level.

For example, a bakery that is dedicated only to gluten free products is often recommended for those with Celiac Disease because testing has clearly documented that gluten containing flours are difficult to contain and remain airborne up to 24 hours past the time that they were used.  If you’ve ever had the opportunity to tour a bakery, you’ve seen that flour is everywhere, even with good cleaning.  However, if the only gluten containing ingredient in that bakery is malt flavouring (made from barley), the facility and equipment would be much easier to clean and a safe gluten free product would be easier to provide.  A dedicated facility is therefore reduced in importance.

If you’ve got gluten sensitivity, a non-dedicated bakery may be suitable as long as there are gluten and allergen controls in place that you trust.  This might include thorough washing of the equipment between gluten and non-gluten containing products and finished product testing to ensure no gluten is in the gluten free product

For someone with a walnut allergy, a bakery using walnuts may be able to provide you with some safe products.  For example, if the walnuts are only used in a separate section of the bakery with dedicated equipment for those pastry products, you may feel comfortable enough to eat the bread made in a different section that the manufacturer tests regularly for walnut cross contamination.

Even if you’re buying products that are from a dedicated facility, that does not guarantee their safety, it simply reduces the risk.  Ingredients coming into that facility may still be accidentally cross contaminated and humans do make mistakes, no matter how careful they are.  A dedicated facility, if provided, is only one part of a thorough food allergen and gluten food safety plan that a reputable manufacturer has in place.

Allergy Free, Allergy Friendly and Guarantees

Often people refer to “allergy free” food products as those that are completely free of the top food allergens for their country.  However, any food can be a life threatening food allergen to any individual whether it is on the top food allergen list or not.  Further, the term “allergy free” is not specifically regulated by food labeling laws or certified by any 3rd party organization. So “allergy free” labeling must be approached with caution and ingredient lists should be read every time regardless of an “allergy free” label.

If a product states a specific "free" statement on the front, such as peanut free, checking the ingredient list is still highly recommended.  There are companies that have free from statements on the front of the package with may contain statements for that same food allergen on the back.

The term “Allergy Friendly” on a label often indicates that the company is producing items suitable for various food allergies and the ingredients should be read every time.

A Note About Guarantees
At one point, it was common for food manufacturers to guarantee that a product was free of a particular allergen.  However, as discussed below under Allergen Thresholds, science can’t even test down to 0 parts per million so to guarantee 100% safety is scientifically impossible.  Instead, it has now become common practice for reputable manufacturers to provide consumers with the steps they take to determine that their product is free of a particular allergen.

The Bottom Line
As a food allergic consumer, you need to always read food labels and research what reasonable allergen safeguards a company has put in place and then determine your comfort level based on that information.

Food Allergy Certification and Allergen Thresholds

Beyond voluntary labeling by food manufacturers, we do not yet have widespread food allergen certifications or defined food allergen thresholds that are considered safe with the exception of gluten and sulfites.

To put it into perspective, the threshold for gluten is 20 ppm (parts per million). Anything under 20 ppm is considered safe by the leading scientists in gluten research, even when taking into account eating many products under 20 ppm during the day - the cumulative effect. Sulfites are given the threshold of 10 ppm.  Following these accepted levels, the government can then create labeling laws that specify the threshold and food producers follow this in the labeling/marketing of their own products. 

To date, no other food allergens have been given a definitive ppm below which they are considered safe for people with food allergies.  Therefore, the current level that they are considered safe at is at the lowest amount that an allergen can be tested at using scientifically valid methods.  At this time, there are no scientifically valid tests available down to 0 ppm of a specific allergen.

In November 2011, an Allergy Task Force was put together with researchers around the globe including the widely renowned Stephen Taylor from the University of Nebraska's Food Allergy Research and Resource Program (FARRP). The task force is currently working on determining threshold amounts for peanut, milk and egg.

So what does that mean for food allergens? The task force has already been reviewing and conducting scientific research to determine at what level food allergens must be present to create an allergic reaction. Just because we can test a food down to 2 ppm for an allergen doesn't mean that anyone would react to it at that level.  If, for example, it is determined that the threshold for peanut allergy reactions is 10 ppm, only food products consistently testing less than 10 ppm could be labelled as peanut free.

It could also help determine the "may contain" statements. Perhaps on occasion, a product tests at over 10 ppm. A food manufacturer could then put a "may contain peanut" on the label. If a product consistently tested above 10 ppm, the "may contain" may no longer be appropriate because peanut is consistently in the product so it must be labelled "contains peanut" or peanut must be placed on the ingredient list.

For governments, these definitive thresholds can be placed into labeling laws and governments would have the authority to recall products that are unsafe and/or conduct legal investigations and actions for producers disregarding the law.

For food producers, it means that they can also stop guessing and create specific sanitation and testing protocols for their products and food production lines.  They can also label very specifically and if indeed they are putting blanket "may contains" on all of their products, they can stop doing that and allow more of their products to become available to allergic consumers.

Unfortunately, we do not have a timeline for when this international committee will finish their research and present their findings.

Gluten Free Certification

Gluten Free Certifications are voluntary for food manufacturers and are not required by any labeling laws.  Therefore, a manufacturer may indicate that a product is gluten free on the label without any certifications as long as that statement is true according to the gluten free labeling regulation. The new US regulation defines gluten free as a food under 20 parts per million (ppm) of gluten containing grains. Gluten free certifications are often more stringent and require testing to 5-10 ppm.

For those with life threatening wheat allergies, gluten free regulations may not be sensitive enough to avoid wheat.  Contacting gluten free manufacturers for complete details on their methods is recommended.

There are now 2 recognized gluten free certifications on food and non-food products (i.e. cosmetics, drugs).

The first, from the Gluten Free Certification Organization (formed by the non-profit support group Gluten Intolerance Group out of the USA in 2005), is a simple GF symbol in a black circle with a white background.  According to GFCO’s website, they were certifying over 13 000 products as of February 2013.  Both individual products and facilities may be certified.  For GFCO, certification requires that all products must be testable using current accepted scientific procedures to below 10 parts per million (ppm).  GFCO does conduct audits and monitors more than just testing including the effectiveness of good manufacturing processes.  For more details, see their FAQ page at:  http://www.gluten.net/Programs/industry-programs/gluten-free-certification-organization/faq-gfco

The second program is quite new and from Quality Assurance International (QAI) that many might recognize as a leader in Organic Certification.  They also require that certified products test below 10 ppm.  http://www.qai-inc.com/media/docs/gluten_free_certification.pdf

The Celiac Sprue Association (USA) does have a logo on some products but it is not a certification process that includes facility inspections.  Instead, it is a recognition seal that declares those companies have agreed to follow the criteria set by the association.