FDA Regulations for ESL Products
Good day all,
I was hoping to ask a couple questions about ESL products and the requirements they have when being transported from Canada to the United States. I work for a plant-based beverage manufacturing company with a UHT capable of making aseptic product (>139C) as well as, of course, ESL product, which is also a heat-treated product, but at lower temperatures. The packaging we utilize does not qualify as an FDA Low Acid Canned Food and thus has to be classified as ESL to be sold in retailer stores, which involves packaging, shipping and storing the product cold chain.
My question is, if we sell our product to a company that utilizes our products within their own products, making our product somewhat of an ingredient, do we still have to send our product as ESL cold-chain or are we able to send it down as an aseptic product and avoid cold chain?
I ask also in part because of the packaging my sales team would like to utilize. The packaging is 1L portions, but is capable of holding aseptic, or ESL products, but does not currently have NFTs or product labels other than what we can inkjet onto it. Picture it as a carton of milk that doesn't actually say milk and only has the brand name. Are we able to send these packages/products to this company, and simply provide them with a general NFT for all of the product on the pallet? Does it become their discretion?
I understand this may be somewhat of a confusing question, so I'd be happy to provide more detail, if needed. I am just trying to avoid us penning in a deal that can't happen until we get new packaging, and also to gauge what kind of freight my sales team can expect.
Thank-you and regards
A couple of things i noticed from your post
A) low acid or acidified foods are dependent on formulation and has NOTING to do with the packaging
B) you will need a FDA FSVA in all likely hood
C) you need to register to export
Specifically to your question:
HOW it's shipped (ambient or refrigerated) will be dependent on what your customer wants------maybe they don't want to pay extra for refrigeration and want it packaged after UHT
you CANNOT ship unlabeled product, even when it's going to be further processed in/out of Canada, so you will need to label the units in order to ship it REGARDLESS of HOW you ship it (unless it's a full liquid tank full)
https://inspection.c...6/1625073023844
For the purposes of this information, foods in shipping containers are considered to be prepackaged foods and include those that are packaged in any outer receptacle in which foods are sold or distributed at levels of trade other than to consumers at the retail level (that is to say, not consumer prepackaged). The foods inside shipping containers may be in bulk (meaning not further packaged inside the shipping container) or they may be further packaged into smaller units. Shipping containers may be destined for:
- further industrial processing
- catering use
- use by a commercial enterprise or an institution such as a restaurant, hospital, school, etc.
- repackaging from bulk into consumer prepackaged food
- resale directly from bulk container into consumer-sized portions, with the packaging done either by a clerk at the time of sale or by the consumer
- retailers who will remove units of consumer prepackaged foods from shipping containers to display them for sale
In the Safe Food for Canadians Regulations (SFCR), shipping containers must meet the requirements that apply to prepackaged foods, as well as those that apply to "prepackaged other than consumer prepackaged" foods. For more information on the terminology used in the SFCR, refer to definition of "prepackaged" and "consumer prepackaged".
The Weights and Measurements Act (WMA) and the Weights and Measures Regulations (WMR) also apply at all levels of trade, and include a requirement for a net quantity declaration on shipping containers. However, the WMA and WMR are not enforced by the CFIA. Refer to Measurement Canada for more information.
Thank-you for such a prompt response, Scampi!
This is what I was feeling as well. I am just facing pressure from the sales side of things, which is why I wanted the reassurance. So, the products will be in this blank slate portioned packages, say, 1000mL units, packed 12 per case @ say...50 cases per pallet. Do the SFCR regulations require that each 1L unit needs the general requirements (common name, ingredients, NFT etc.) or is it possible to label the case itself with said information as representation of the 12 individual units within?
I believe the product would be going into the food service industry, to be incorporated into other products, as stated already. They're viewing of it is that because it's the food service industry, as opposed to the retail industry, the restrictions are somewhat alleviated and is depending on the buyer's (within the US) discretion.
I am under the impression that appropriate labeling requirements will be needed for each portion unit, but we are exploring possible alternatives.
Thank-you again!!
Each case will have to have the required information as per the link i attached, but it's in your best interest to label the units as well, particularly since you're selling it as "for further processing" you may not get an export certificate if they are not marked
Tell your sales team that you have to follow CFIA for exports and FDA for imports, not just one or the other
https://www.fda.gov/...s-united-states
Imported food products are subject to FDA inspection when offered for import at U.S. ports of entry. FDA may detain shipments of products offered for import if the shipments are found not to be in compliance with U.S. requirements. Both imported and domestically-produced foods must meet the same legal requirements in the United States.