Allergens
Attached Files
As allergens are a hot topic in the Food Industry at the moment (although not on Saferpak
) find attached an excellent AIB publication regarding allergens and auditing. It might be a usefull, but daunting, starting point for anyone thinking about controlling allergens.
Say you produce a product from an allergen, as part of the production process the bit that makes it an allergen is removed, so there is no trace of the allergen there, How do you label it?
We make vinegar out of Malted Barley, the vinegar when it is still in a raw state goes through a process that removes the proteins, to the point where, when we sent it away for analysis there was less than 10ppm (limit of detection) gluten in the product, what do we put on the label.
At the ,oment we are putting that is contains malted barley, but not making any allergen statement. According to the Coeliac society, if the product contains less than 200ppm of gluten it is considered safe, but speak to someone who suffers from an allergy to gluten and they say they would not touch it with a barge pole. Even though I do know people who suffer from this, and still use malt vinegar with no adverse effects.
My Head hurts!!
Nadine.x
At the moment we are putting that is contains malted barley, but not making any allergen statement. According to the Coeliac society, if the product contains less than 200ppm of gluten it is considered safe,
Trust the Coeliac society. Up to the best of my knowledge, gluten is the only allergen for which there is a threshold safe value
Remember this is true only for gluten. Other allergens should be either banned from food or labelled as such.
but speak to someone who suffers from an allergy to gluten and they say they would not touch it with a barge pole. Even though I do know people who suffer from this, and still use malt vinegar with no adverse effects.
Forget 'em
Thanks for the link, I will work my way (slowly) through all of the documents attached to this thread.
Why can't life be simple?
Nadine
Why can't life be simple?
Otherwise there would be no need of SDF
You just have to register, it's free.
Allergen Bureau
You're a star!!
Nadine
You're a star!!
Thanks Nadine
Would you like to be the MOTW on next week ?
Nadine
It's Friday afternoon and there are no takers.Maybe, if there are no other takers, I have a really boring life though!!
Nadine
http://www.saferpak....?showtopic=1236
No pressure or anything.
Regards,
Steve
Attached Files
Thanks Franco. Will read through the link.
BTW,
up to the best of my knowledge, a threshold value has been established for gluten only.
BTW,
up to the best of my knowledge, a threshold value has been established for gluten only.
Yep Franco, you're right its in the Codex Alimentarius Standard for gluten free products at 200ppm.
For peanuts, the Food Standards Agency agree reactions can be triggered by less than 1mg of peanut protein, equivalent to a few 1/1000ths of a peanut. Eeeeek.
Yep Franco, you're right its in the Codex Alimentarius Standard for gluten free products at 200ppm.
For peanuts, the Food Standards Agency agree reactions can be triggered by less than 1mg of peanut protein, equivalent to a few 1/1000ths of a peanut. Eeeeek.
Thanks for the info Jane. I knew there was a threshold, but missed it.
Below is the executive summary:
http://www.cfsan.fda...lrgn2.html#exec
Executive Summary
Background
The Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282) (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and requires that the label of a food product that is or contains an ingredient that bears or contains a "major food allergen" declare the presence of the allergen as specified by FALCPA. FALCPA defines a "major food allergen" as one of eight foods or a food ingredient that contains protein derived from one of those foods. A food ingredient may be exempt from FALCPA's labeling requirements if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein. FALCPA also requires FDA to promulgate a regulation defining the term "gluten-free."
This report summarizes the current state of scientific knowledge regarding food allergy and celiac disease, including information on dose-response relationships for major food allergens and for gluten, respectively. The report presents the biological concepts and data needed to evaluate various approaches to establish thresholds that would be scientifically sound and efficacious in relation to protection of public health. Each approach has strengths and weaknesses, and the application of each is limited by the availability of appropriate data. It is likely that there will be significant scientific advances in the near future that will address a number of the limitations identified in this report.
The Threshold Working Group expects that any decisions on approaches for establishing thresholds for food allergens or for gluten would require consideration of additional factors not covered in this report. Furthermore, one option that is implicit in the report's discussion of potential approaches is a decision not to establish thresholds at this time.
Approaches to Establish Thresholds
The report identifies four approaches that could be used to establish thresholds:Any approach used to establish a threshold to protect consumers with food allergies or those susceptible to celiac disease should be reexamined periodically to consider new knowledge, data, and approaches.
- Analytical methods-based-thresholds are determined by the sensitivity of the analytical method(s) used to verify compliance.
- Safety assessment-based-a "safe" level is calculated using the No Observed Adverse Effect Level (NOAEL) from human challenge studies and an appropriate Uncertainty Factor (UF) applied to account for knowledge gaps.
- Risk assessment-based-examines known or potential adverse heath effects resulting from human exposure to a hazard; quantifies the levels of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate.
- Statutorily-derived-uses an exemption articulated in an applicable law and extrapolates from that to other potentially similar situations.
Threshold Working Group Findings For Major Food AllergensThreshold Working Group Findings For Gluten
- Finding 1. The initial approach selected to establish thresholds for major food allergens, the threshold values, and any uncertainty factors used in establishing the threshold values should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings.
- Finding 2. The analytical methods-based approach can be used to establish thresholds for those major food allergens for which validated analytical methods are available. However, if this approach is used, the thresholds should be replaced by thresholds established using another approach as quickly as possible.
- Finding 3. The safety assessment-based approach, based on currently available clinical data, is a viable way to establish thresholds for the major food allergens. If this approach is employed, the Lowest Observed Adverse Effect Level (LOAEL) or No Observed Adverse Effect Level (NOAEL) determinations used should be based on evidence of the "initial objective sign." Individual thresholds should be established for each of the major food allergens. If it is not feasible to establish individual thresholds, a single threshold based on the most potent food allergens should be established. In those instances where a LOAEL is used rather than a NOAEL to establish a threshold, an appropriate uncertainty factor should be used. Thresholds established using this approach should be reevaluated periodically as new data and tools become available.
- Finding 4. Of the four approaches described, the quantitative risk assessment-based approach provides the strongest, most transparent scientific analyses to establish thresholds for the major food allergens. However, this approach has only recently been applied to food allergens, and the currently available data are not sufficient to meet the requirements of this approach. A research program should be initiated to develop applicable risk assessment tools and to acquire and evaluate the clinical and epidemiological data needed to support the quantitative risk assessment-based approach. Thresholds established using this approach should be reevaluated periodically as new data and tools become available.
- Finding 5. The statutorily-derived approach provides a mechanism for establishing thresholds for allergenic proteins in foods based on a statutory exemption. Potentially, this approach could be used to set a single threshold level for proteins derived from any of the major food allergens. This approach might yield thresholds that are unnecessarily protective of public health as compared with thresholds established using the safety assessment-based approach or the risk assessment-based approach. However, confirming this would require additional data. If this approach is employed to establish thresholds, it should be used only on an interim basis and should be reevaluated as new knowledge, data, and risk assessment tools become available.
- Finding 6. The initial approach selected to establish a threshold for gluten, the threshold value selected, and any uncertainty factors used to establish the threshold should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings.
- Finding 7. The analytical methods-based approach can be used to establish a threshold for gluten. However, if this approach is used, the threshold should be replaced by a threshold established using another approach as quickly as possible.
- Finding 8. The safety assessment-based approach is a viable approach to establish a threshold for gluten using currently available LOAEL data for celiac disease. An overall uncertainty factor should be estimated from the data and applied to the LOAEL to establish a threshold for gluten. Any threshold derived from this approach should be reevaluated as new research data become available. Available data are insufficient at the current time to use this approach to establish a threshold for oat gluten for those individuals with celiac disease who may also be sensitive to oats. However, it is likely that a threshold level based on wheat gluten would be protective for individuals susceptible to oat gluten.
- Finding 9. Use of the quantitative risk assessment-based approach to establish a threshold for gluten does not appear to be feasible at the present time. However, considering the benefits that could be gained from using the risk assessment-based approach, priority should be given to establishing a research program to acquire the knowledge and data needed.
- Finding 10. There appear to be no suitable legal requirements or exemptions that would serve as the rationale for using the statutorily-derived approach to establish a threshold for gluten. This approach is not viable.