No Objection Letter for Recycled Plastics #61
February 3, 2000
M. Elizabeth Bierman
Morgan, Lewis & Bockius
1800 M. Street, N.W.
Washington, DC 20036-5869
Dear Ms. Bierman:
This responds to your letter of January 14, 2000, requesting on behalf of your client, Ivex Packaging Corporation, concurrence from FDA that an amendment of the food additive regulations is not required for certain uses of post-consumer recycled (PCR) polyethylene terephthalate (PET) in the manufacture of laminate material used to fabricate food packaging. You note that your request is a follow-up to a submission from Ultra-Pac (now a wholly owned subsidiary of Ivex), which we responded to in a letter dated August 25, 1992. In that letter, we concluded that the proposed use of PCR-PET would be acceptable providing that: 1) the recycled PET is separated from food by a layer of virgin PET that is at least one-mil thick, 2) the virgin PET used as the food-contact layer complies with 21 CFR 177.1630, and 3) use of the laminate is limited to short term storage (less than two weeks) at refrigerated and room temperatures. Our review only considered that the packaging material would be used in contact with prepared bakery and deli products. You are requesting elimination of the restrictions on food types and storage time, and state that all other aspects of the previously considered recycled PET will not change.
We have previously concluded that a one-mil thick virgin PET food-contact layer is a suitable functional barrier for a post-consumer PET core layer when used in food-contact applications at room temperature or below without restrictions on food types or storage times, if the post-consumer PET is from food containers and has undergone physical processing. Therefore, we concur that Ivex's intended use of recycled PET as the inner core of a laminate material for packaging all types of food with no restriction on storage time is acceptable providing that: 1) the PCR-PET is from food containers recycled by the same method referred to in our August 25, 1992, letter, 2) the recycled PET is separated from food by a layer of virgin PET that complies with 21 CFR 177.1630 and is at least 1.0 mil thick, and 3) use of the laminate is limited to contact with food at room temperature and below.
If you have any further questions concerning this matter, please do not hesitate to contact us.
Eugene C. Coleman