Allergen Declarations on Labels
If we producing product with allergens and non-allergens which label for packaging work? May contain or Contains traces of? I think if we don't clean between the different products we should use contains traces of. What if we clean between the two products?
Nope nope and nope
You cannot use labeling as a cover for poor GMP's
What is cross-contact?
Cross-contact is the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may occur when multiple foods are produced in the same facility. It may occur due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.
SEC. 205. INSPECTIONS RELATING TO FOOD ALLERGENS. 21 USC 374a.The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) of facilities in which foods are manufactured, processed, packed, or held--
- (1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and
- (2) to ensure that major food allergens are properly labeled on foods.
https://www.fda.gov/...s/ucm106187.htm
You need to clean between product lines and validate that the allergen has been removed prior to running a allergen free product. I would still label your products "produced in a facility that has (nuts/peanuts what have you)
Nope nope and nope
You cannot use labeling as a cover for poor GMP's
What is cross-contact?
Cross-contact is the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may occur when multiple foods are produced in the same facility. It may occur due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.
SEC. 205. INSPECTIONS RELATING TO FOOD ALLERGENS. 21 USC 374a.The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) of facilities in which foods are manufactured, processed, packed, or held--
- (1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and
- (2) to ensure that major food allergens are properly labeled on foods.
https://www.fda.gov/...s/ucm106187.htm
You need to clean between product lines and validate that the allergen has been removed prior to running a allergen free product. I would still label your products "produced in a facility that has (nuts/peanuts what have you)
We will clean between the two allergens. Should our label state contain traces of or may contain? I searched online and got mixed answers. To my understanding may contain means the same thing as product is ran on same line but proper cleaning is performed. Contain traces of means allergen is present in product. Correct?
We will clean between the two allergens. Should our label state contain traces of or may contain? I searched online and got mixed answers. To my understanding may contain means the same thing as product is ran on same line but proper cleaning is performed. Contain traces of means allergen is present in product. Correct?
Probably Incorrect. You can also find "may contain traces ......"
Usually all the statements are intended to be purely semantically self-protective in case of trouble later on. Some are more poetic than others.
You typically need to Clean + Validate.
Whenever I see a label note indicating "Made in a facility that also has soy, tree nuts, etc. on it - that says to me that the company is diligent in being transparent with their valued customers, it doesn't mean they don't painstakenly clean between runs that have allergens present.
Standard is to clean and validate that cleaning was effective and then do the next different run.
Coverups don't work.
I think I worded the question wrong . I was asking about labeling if both products are ran on same line but washes in between non allergen and allergen product.We will clean and validate with ATP swabs. But labels should say may contain or contains traces which one?
Hi MsPloveyou,
It doesn't matter (in the USA/FDA anyway) unless it's "misleading"). See -
precautionary allergen labelling (current).pdf 384.45KB 60 downloads
Also (1) -
Examples of precautionary labels. The term in brackets [ ] may differ depending on the food concerned.
"May contain [fish]"
"Manufactured in a facility that uses [egg] ingredients"
"Manufactured in a facility which processes [egg]"
"Processed in a facility that uses [milk]"
"Manufactured on equipment that processes products containing [peanuts]"
"Manufactured on equipment that uses [milk]"
"Manufactured in a facility that processes [tree nuts], but not on the same equipment"
"Manufactured on shared equipment…may contain [peanuts, tree nuts, wheat, soy, milk…]"
Precautionary labelling
This is the type of labelling that uses terms such as 'may contain'. This type of labelling (also termed advisory labelling or defensive labelling) is strictly voluntary and not required by federal regulation. Consequently, situations when precautionary labelling may be used vary among food companies, as does the wording of the statements used (see Table for some examples but note this list is not exhaustive!!). FDA specifies that such labelling cannot be used as a substitute for good manufacturing practices such as allergen identification and control, cleaning of shared equipment, and segregation during processing. Some consumers believe manufacturers use precautionary labels as a way to protect themselves from legal action in case a food causes a reaction. This is not typically the case since this type of label should only be used by food manufacturers when there actually is a possibility (however small) that the food may contain an allergen which is not an ingredient but may be present as a result of the manufacturing process.
We know this type of labelling is not liked by consumers but currently it is the only way for food manufacturers to inform consumers if there is a possibility that an allergen which is not part of the final product may be present in the food. In the future, some restrictions may be placed on the use of precautionary labels but that is not yet the case.
From the above table detailing different examples of precautionary labels, it can be seen how manufacturers choose to word their precautionary statements can vary greatly. Consumers MUST NOT interpret this difference in wording as a difference in the likelihood that the stated allergen is present. All precautionary labels mean the same thing, regardless of the words they use. They all mean that there is a possibility that an allergen which is not part of the final product may be present. Consequently all precautionary labels must be treated with the same level of care, regardless of their wording.
https://farrp.unl.ed...lergic-consumer
Also (2) see -
https://link.springe...0603-017-9358-8
Also (3) -
allergen labelling, may contain traces of (X),2012.pdf 1.53MB 32 downloads
Undeclared allergens in Food,2016.pdf 1.95MB 36 downloads
Note that ATP (on its own) may not be acceptable for "allergen-free" validations/verifications, eg -
Validation
The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen of
concern. This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable
level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence.
The acceptable validation testing methods involve the use of a test specific to the allergen being removed. These
generally require the use of a test method which uses an antigen (the allergen) and an antibody specific to the
antigen. One example of the antigen and antibody test is the enzyme linked immuno-assay or ELISA method. The
ELISA method can be either quantitative or qualitative and can be conducted in a laboratory or with test kits
available for in plant use; either is acceptable. ELISA test kits are available from several manufacturers and are
commonly used in the food processing industry. Lateral flow test devices also use an ELISA-based method and are
also effective in detecting specific allergens. While lateral flow devices are qualitative only, most have sensitivities
around 10 parts per million (ppm) and are available for most of the common allergens and are designed for use in
a plant environment.
Both the ELISA tests and lateral flow test kits have been accepted by recognized allergen research scientists and
meet the requirements for sanitation validation of the SQF Code. It must be noted that there may be other
‘acceptable’ tests for validation methods that can be used but the test must meet the “allergen specific” criteria or
provide some other evidence that the validation is effective. The SQF Institute does not endorse any particular
technology or methodology and relies on the site to provide the evidence of a scientifically validated and effective
cleaning method. Like any validation of any food safety control, periodic re-validation is required to account for
any changes that may have occurred. Not all allergens have specific test kits available which includes some fin fish
and allergens that have been modified by fermentation, heating or hydrolysis.
Verification
Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must
verify that the validated procedures were used each time. This verification must be documented by a responsible
person from the site who has been trained in the validated cleaning method. The most common method used is
direct observation of the validated cleaning procedure during the sanitation process. Another acceptable
verification method is the use of highly sensitive swabs that test for proteins. These recently developed swabs will
detect total protein at approximately 20 ppm. Since these devices only test for total protein and not specific
allergens, they are not acceptable for validation but will serve to verify that equipment has been thoroughly
cleaned. There are also sensitive ATP test swabs available however the presence of ATP does not indicate the
presence of protein which is the allergenic material. The use of these total protein swabs or the ATP sensitive
swabs must be calibrated with the validated cleaning procedure by using them immediately after the validated
method is used and recording the results of both the allergen specific test and the protein or ATP swab test. It is
also to ensure surface swabbing is occurring at corners, joins, and crevices in the equipment as well as open
surfaces, to check for protein held up in equipment.
(SQF8)
I think I worded the question wrong . I was asking about labeling if both products are ran on same line but washes in between non allergen and allergen product.We will clean and validate with ATP swabs. But labels should say may contain or contains traces which one?
Just an FYI. You dont validate Allergen removal with ATP swab... That is not an indicator for allergen removal. Allergens are proteins NOT microbes.