US and EU regulation regarding the labeling of bulk ingredients

Can some one point me to US and EU regulation regarding the labeling of bulk ingredients intended for industrial application/ further processing at customer plants. The only thing turning up in my search is a guidance doc open for public comment by the FDA

 

Thanks,

 

Pete

Hi Pete,

 

Interesting one!- I saw the consultation document

 

 

I guess until the new guidance is implemented-the previous allergen  labelling guidance ( updated 2006) still applies?

 

 

 

Single ingredient foods must comply with the allergen declaration requirements in section 403(w)(1). A single ingredient food that is, or contains protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, or soybeans, may identify the food source in the name of the food (e.g., "all-purpose wheat flour") or use the "Contains" statement format. FDA recommends that if a "Contains" statement format is used, the statement be placed immediately above the manufacturer, packer, or distributor statement. For single ingredient foods intended for further manufacturing where the "Contains" statement format is used, the statement should be placed on the principal display panel of the food.

 

Kind Regards

 

Mike

Hi Pete,

 

Interesting one!- I saw the consultation document

 

 

I guess until the new guidance is implemented-the previous allergen  labelling guidance ( updated 2006) still applies?

 

 

Kind Regards

 

Mike

 

Thanks, Mike. The consultation document you linked to was the one I was referencing in my OP. FALCPA and the guidance documents still leave me in a grey area.

 

FALCPA only applies to finished goods packaged for retail sales; leaving a loop holes for RTE restaurant and grocery packaged goods but in my case packaged ingredient sold to other food manufacturers.

 

 

What your opinion/ thought in this scenario.

Hi Pete,

 

I'm UK based so possibly not best placed to comment on the finer detail of FALCPA! 

 

 tbh I have never seen anything from FDA specifically referencing the  labelling allergens in bulk ingredients- apart from the quote from the 2006 guidance I posted earlier

 

(If it is any consolation-there is (as far as I can tell) even less available here)

 

 

I have asked a couple of questions of the'powers that be' here with regard to the EU situation-if anything interesting arises from this- I will let you know!

 

Regards

 

Mike

Addendum to previous post!

 

This from food safety magazine May 2014  examining food safety recalls (US)

 

 

 

The third most common cause of allergen recalls was failure to carry forward allergen information from an ingredient to the final product label. In some cases, the failure to carry forward allergen information resulted from changes in an ingredient formulation by a supplier; in others, it was caused by changing ingredient suppliers to one with a different formulation. In other cases, allergen information was difficult to find on the ingredient labels, because it was not declared in a standard format or location on containers for bulk ingredients. Frequently, the certificate of analysis or product specification sheet for a bulk ingredient was sent to a customer separately from the actual lot of the ingredient, and the allergen information in these documents was not reconciled with the expected allergen content for the ingredient. These situations show that it is important for an ingredient user to develop procedures to recognize and respond to changes in ingredient formulations (see “RFR Notable Outcomes,”).

 

It looks like standard labelling it is something that has not (yet) been satisfactorily addressed for bulk ingredients?

 

Regards

Mike

Mike,

 

Thanks for the link. The Uppers will have to come to a decision about this.

Sadly it will be years before this is addressed legally, if at all. I think we will see more incidents related to bulk ingredient labeling issues in the future.

If you check the Food information Consumer regulations (FIR) effective Dec 13 2014 it clearly describes what's required,
Product name, ingredients, allergens highlighted in the text, net weight, production or frozen on date, expirary date- either use by ( food safety) or best before ( quality).
But as its bulk this information can be added to the travel documentation accompanying and identified with the product.
Hope this helps.
Regards
Brendan.

Dear SPL,

 

Not sure whether the OP had a specific food category  in mind ?

 

Surely this general topic also overlaps traceability albeit in a lesser detail ? From memory, there are several threads here where specific food organisations have issued their own requirements for bulk products.

 

How about USDA etc, eg the grain trade ?

 

Rgds / Charles.C

 

PS - there are numerous references displayed if you google -

 

[us labelling law "bulk" food ingredients]

 

But i presume you have worked through these already. :smile:

Mike,

 

Thanks for the link. The Uppers will have to come to a decision about this.

Sadly it will be years before this is addressed legally, if at all. I think we will see more incidents related to bulk ingredient labeling issues in the future.

Hi Pete

 

The official answer for the EU/UK as per my previous post (straight from the horses mouth-so to speak! )

 

 

Food businesses supplying food to other food businesses, that is not intended for the final consumer and / or not intended for mass caterers, must ensure that business to business sales of food (pre-packed and non pre-packed) are accompanied with sufficient information to enable subsequent food businesses to meet their responsibilities. 

 

so again nothing too specific on where or how!

 

Kind Regards

 

Mike

Charles,

 

Working with  extracts and flavorings with allergen ingredients or derived from allergenic material both industrial and retail packaging.

 

This topic/discussion was a result of an internal review of HAACP, manufacturer control and traceability. The final control point is a verification of allergen labeling.  The problem is industrial/ bulk product have no label indicating allergen. Beside label with product name, company name date of manufacture and lot code.  

 

Our documentation provided to our customers states the product is contains allergic material. Labeling in regards to industrial products will need to be an organizational decision.

 

Under current CFR and regulations

 

Raw agricultural commodities are exempt from labeling and allergen labeling.

 

Bulk ingredients intended for further processing and manufacturing do not require nutritional labeling

 

FALCP only addresses retail packages.

 

In summary, there are EU and US regulations regarding allergen labeling, but they are weak and with numerous loops and grey areas.  I would like more global consensus and directive on the issue and not addressed by any GSFI schemes.

Dear SPL,

 

Yes, i noticed that  21CFR101.9 para (j) et seq addresses yr Para 6 in previous post.

 

Rgds / Charles.C