FDA registration of packaging material
Hello, I know that FDA Food Packaging Material Registration registration is a requirement by the FDA for any food-contact packaging if their chemical components are deemed to be indirect food additives or food contact substances, but does anyone have any more information about what is actually required to register a packaging material with the FDA. Do they need to provide migration studies etc...
I need to approve a new Chinese supplier and need to know what to tell them is required. I have requested a spec, cert of analysis and a letter of guarantee that they adhere to both Division 23 of the Food Packaging Materials of the Canadian Food & Drug Regulations and/or Section 303©(2) of the U.S.Food & Drug Administration’s certifying that a particular product is acceptable for the intended food-contact use.
This is new to me so i need to know exactly what is needed to be able to use them in the US market.
any help would be useful thanks
I am not sure of the answer to out of country suppliers, but if the lab is not a well know recognized lab you may want to retest to verify that the material is indeed safe for use. Based on some of the issues coming out of China, I would be inclined to test anyway to make sure that the material meets all of the food safety standards.
You don't register food contact packaging or their raw materials with the FDA like you used to do for Health Canada/CFIA or migration testing like Europe. Your raw material suppliers have to cite the appropriate 21 CFR code that applies to their product (parts 174 through 186: http://www.accessdat...R/CFRSearch.cfm) along with any restrictions on use.
For example, most printing inks for packaging are not regulated or approved by the FDA as an indirect food additive. Therefore you need to have a functional barrier between the ink and the food product so you don't get significant levels of harmful substances migrating from the ink into the food.
If you don't trust your Chinese supplier to have adequate understanding or transparency (honesty), you can ask them to provide 3rd party test data. You may also want to ask them for 3rd party certification of their plant.
You, as a supplier of food contact packaging, have to review the cited 21 CFR codes and any limitations as to food type and packing/storing conditions to state to your customers how your packaging can be used in compliance with FDA regulations. See Keller & Heckman website: http://www.packaging...com/2547_.shtml.
The user of the imported packaging must receive a “continuing letter of guarantee” from the packaging manufacturer that confirms that the raw materials used in the packaging have US FDA pre-market clearance (obtain from raw material suppliers) and that the packaging was manufactured using good manufacturing practices.
The US system relies on pre-market clearance declarations by the last level of the supply chain to actually cause chemical changes to packaging materials.
The user of the imported packaging must receive a “continuing letter of guarantee” from the packaging manufacturer that confirms that the raw materials used in the packaging have US FDA pre-market clearance (obtain from raw material suppliers) and that the packaging was manufactured using good manufacturing practices.
The US system relies on pre-market clearance declarations by the last level of the supply chain to actually cause chemical changes to packaging materials.
Hello, I have a letter of continuing guarantee from the packaging supplier saying that they adhere to Section 303©(2) of the U.S.Food & Drug Administration’s certifying that a particular product is acceptable for the intended food-contact use. I have also requested third party migration testing from a reputable lab but do i have to do anything else? They consider the packaging material proprietary information so i cannot review the cited 21 CFR codes and any limitations as to food type and packing/storing conditions to state to your customers how your packaging can be used in compliance with FDA regulations. I do not believe that this is a question of being dishonest or secretive about risk but a business decision. They have been quite open with our local representative who has seen the plant and read their audit reports. This is new to me and i want to make sure i have done my due diligence. By law are they required to register the material or not?
ANother question, If I use GRAS must i submit GRAS notification or is this for new things not already on Gras substances database?
In the US, packaging is not required to be registered. GRAS does not require notification.
In the US, packaging is not required to be registered. GRAS does not require notification.
Agree. Some--but not all--- materials are GRAS listed. "GRAS" may be a self determination, using criteria listed in the regulations. US FDA has a GRAS notice submission process, but is rarely used or anything but commercial purposes.
Dear katjad,
Interesting query. Regulatory questions invariably open up the nitty-gritty details. :smile:
I deduce from the previous threads that so far you have avoided putting any of your registration-related queries to any officially responsible bodies. I would have thought this was a logical (first) information source unless somehow contra-advised ? (Forewarned is ....?) I apologize for my ignorance but I noticed yr OP refers to both Canada / USA regulations. Are the requirements in fact mainly interchangeable ? (it seemed unlikely to an outside observer). For example, post 7 implies, I think, that the opening premise in the OP is incorrect for USA, but does Canada = USA ?.
TBH yr comment that the suppliers regard knowledge of their packaging material as proprietary information would IMEX substantially worry many importers from a basic safety POV. But perhaps this is a standard scenario for the specific case you mention and importers simply have to accept the (potentially) heightened ("business") risks involved while complying with the relevant regulatory requirements.
I was surprised that the document referred to in post 4 might represent an adequate "defence" in the event of any, for example, subsequent safety issues. It appeared not dis-similar to a COC, as against a COA.
Rgds / Charles.C