19 replies to this topic

[The Food Scientist]

Sulfite is not really the major 8 according to FDA. If we are not sure if the product contains sulfites or not, can we say "may contain sulfites" ? At my company before I got hired they went through a recall because they did not declare sulfites in the label because it was above the threshold (supplier failed to state this) To save our selves if we are not sure, can we say may contain sulfites on our labels? I am trying to search for this on the guidance but found no luck, anyone help?

[Ryan M.]

FDA does not regulate "may contain statements".  They really do not favor these statements on packaging labels.  FDA has always stressed companies due their diligence to determine what allergens and sensitive agents are in their products and label as appropriate.

 

If you are unsure you need to test and determine.  If you have a supplier who provides inconsistent levels of sulfites in the raw material you purchase then you hold them to an allowable level.  If your process contributes to sulfites then you need to test it out in your finished products to determine actual sulfite levels.

 

A "may contain statement" does not protect you or absolve you from the necessary due diligence.  If, however, through your due diligence show that sometimes sulfites are present above the 10 PPM limit and sometimes not, then it is best to label sulfites on your label and protect yourself.

[Scampi]

FYI CFIA regulates the amount of sulphites that are allowed and declared.........so if you're exporting to Canada, double check that 

[The Food Scientist]

FYI CFIA regulates the amount of sulphites that are allowed and declared.........so if you're exporting to Canada, double check that 

 

Nope, all within the U.S. 

[Ryan M.]

US regulates it as well....10 PPM is the limit.  Refer to the link below for more specific information if you need it.

 

https://www.accessda....cfm?fr=101.100

[larissaj]

I was told that as long as that it is in the ingredient statement right next to the product then you wont have to have the may contains statement. For example: Diced Pineapple (sulfites), sugar, sunflower seeds. However a supplier puts it in a warning due to their standards. 

 

I called my suppliers and a few other people because I freaked out over it.

[The Food Scientist]

I was told that as long as that it is in the ingredient statement right next to the product then you wont have to have the may contains statement. For example: Diced Pineapple (sulfites), sugar, sunflower seeds. However a supplier puts it in a warning due to their standards. 

 

I called my suppliers and a few other people because I freaked out over it.

 

Now you include it in the ingredient statement like the example you made when it's added as an ingredient in your product. ofcourse you must make it visible. What I mean here is when you have a product that naturally contains sulfites. We are not really sure if it has some or not. 

[larissaj]

I was told that natural sulfites never really reach the ppm limit of 10.

[The Food Scientist]

Apparently they did a few years ago at the company I currently work at (I wasn't hired yet). They had more than 10ppm, and the product was naturally occurring (I believe it was ginger) and they didn't declare them on the label  :/

[larissaj]

And how did they find it out? I'm just learning about sulfites myself but for me its added in our dried fruit. 

[The Food Scientist]

Dept. of Agriculture randomly selected that product from the shelf and decided to test it, they found those levels in the ginger and how the label had no sign of sulfites :/ 

[kettlecorn]

Now you include it in the ingredient statement like the example you made when it's added as an ingredient in your product. ofcourse you must make it visible. What I mean here is when you have a product that naturally contains sulfites. We are not really sure if it has some or not. 

As Ryan says, the FDA does not favor "May contain" statements, and it does nothing to remove liability. Why do you suspect sulfites in your product, and (if you have good reason to suspect their presence) why don't you just test for sulphites? 

Edited by kettlecorn, 10 July 2019 - 08:19 PM.

[Hank Major]

Only added sulfites are required to be labeled:

 

"...any sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium metabisulfite) that has been added to any food or to any ingredient in any food and that has no technical effect in that food will be considered to be present in an insignificant amount only if no detectable amount of the agent is present in the finished food. A detectable amount of sulfiting agent is 10 parts per million or more of the sulfite in the finished food."

[Charles.C]

Hi Food Scientist,

 

Unfortunately I doubt that consumer allergenic reactions  differ depending on whether intrinsic or from added ingredients.

 

"May contain"  labelling is a (legal) global activity, whether FDA likes it or not. I suggest you search for "FARRP" on this forum to read up on it.

 

I also suggest you acquire some SO₂ data on the relevant product..

[Ryan M.]

Hi Food Scientist,

 

Unfortunately I doubt that consumer allergenic reactions  differ depending on whether intrinsic or from added ingredients.

 

"May contain"  labelling is a (legal) global activity, whether FDA likes it or not. I suggest you search for "FARRP" on this forum to read up on it.

 

I also suggest you acquire some SO₂ data on the relevant product..

 

While other countries may consider "may contains" statements as legally binding, they are NOT SO in the US.  I have discussed this with a number of FDA regulators and every one of them has stated it offers no protection for companies from a legal standpoint.  

 

If a company has a "may contains sulfites", and there is in fact sulfites in the product (above the 10 PPM limit), yet it is not labeled appropriately on the label the product can be recalled by the FDA.

 

Since the OP operates in the US it would behoove him/her to follow US regulations and requirements.

[Ryan M.]

Only added sulfites are required to be labeled:

 

"...any sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium metabisulfite) that has been added to any food or to any ingredient in any food and that has no technical effect in that food will be considered to be present in an insignificant amount only if no detectable amount of the agent is present in the finished food. A detectable amount of sulfiting agent is 10 parts per million or more of the sulfite in the finished food."

 

Not entirely true...see the interpretation and explanation from FARRP.  This is the most direct explanation I've seen.  

 

https://farrp.unl.edu/sulfites-usa

 

"The U.S. Food and Drug Administration (FDA) requires that the presence of sulfites be declared on food labels when used as an ingredient in the food and also when used as a processing aid or when present in an ingredient used in the food (e.g. dried fruit pieces). Sulfites must be declared in these cases when the concentration in the food is ≥10 ppm total SO2. "

[Charles.C]

JFI -

 

 

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

 

Out of curiosity, I wonder if there is any evidence to support the ^^^  belief ?

[FoodSafetyPlanet]

Hi Food Scientist: 

 

"At my company before I got hired they went through a recall because they did not declare sulfites in the label". 

 

Doesn't sound like FDA fits into the equation. 

 

Hopefully your company has documentation from the recall to help guide you. 

 

If not, I recommend checking online databases, customer agreements, information from foreign consignees etc. 

[kettlecorn]

Food Scientist:

 

Again, the simplest way to solve this is to test for sulfites. That way you know whether you have to label "Contains..." or not, which is what the FDA prefers. 

[The Food Scientist]

Thanks for everyone's insight! And to all that told me to test for sulfites: we do. well, not all the time. We count on COAs 99% of the time, or at least always "try" request that. But then again top management don't see any value in paying for every test :/ this question came up from one of the to managers and I wasn't sure about the answer, so I just came here to gain some insight. I am kind of new at the company so it's still challenging to want to make things right! Thanks again!