Description
The purpose of this document is to highlight the chemistry issues that FDA recommends that a manufacturer of recycled plastic consider during the manufacturer's evaluation of a recycling process for producing material suitable for food-contact applications. This document supersedes the December 1992 “Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations” (1992 “Points to Consider”). The possibility that chemical contaminants in plastic materials intended for recycling may remain in the recycled material and could migrate into the food the material contacts is one of the major considerations for the safe use of recycled plastics for food-contact applications. Other aspects of plastics recycling, such as microbial contamination and structural integrity of the recycled plastic, are also important, but are not discussed in this document.
Scope & Applicability
Product Classes
3Use of Recycled Plastics in Food Packaging
virgin PET has captured a dramatically larger share of the food-packaging market
Polyethylene terephthalate used for food and non-food containers
Stakeholders
3Entity responsible for submitting NDINs
Recyclers of plastics intended for food-contact articles
Entities performing the recycling process and surrogate testing
Regulatory Context
Attributes
8The amount of an NDI expected to be consumed based on labeling (EDI).; The highest possible total daily intake level of an NDI determined from proposed conditions of use.
FDA will assume a default CF of 0.05 for any recycled polymer
Finished polymer suitable for food-contact use
D value (cm²/s) of the surrogate in plastic
0.5 parts per billion (ppb) dietary concentration
Default consumption factor (CF) of 0.05; value of 0.05 assumed for recycled PET
Virgin polymer layer separating recycled plastic from food
Estimated Daily Intake limit of 1.5 µg/person/day
Identified Hazards
Hazards
3Potential chemical contaminants include pesticide and drug residues, heavy metals, and natural toxins.
Risk associated with tattoo inks that can lead to infection.; Risk associated with insanitary conditions in tattoo ink preparation
Result of consumer misuse or non-food container feedstock
Related CFR Sections (3)
- 21CFR176.260§ 176.260 Pulp from reclaimed fiber.
(a) Pulp from reclaimed fiber may be safely used as a component of articles used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of paragraph (b) of this section.Read full regulation →
- 21CFR174.5§ 174.5 General provisions applicable to indirect food additives.
(a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purpose of this part and parts 175 , 176 , and 177 of this chapter , good manufacturing practice shall be defined to include the folRead full regulation →
- 21CFR170.39§ 170.39 Threshold of regulation for substances used in food-contact articles.
(a) A substance used in a food-contact article (e.g., food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food will be exempted from regulation as a food additive because it becomes a component of food at levels that are below the threshold of regulatRead full regulation →
See Also (8)
- Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations) (Status: Final)
- Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry (Status: Final)
- Guidance for Industry: Preparation of Food Contact Substance Notifications (Toxicology Recommendations) (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Status: Draft)
- Guidance for Industry: Antimicrobial Food Additives (Status: Final)