U.S. and EU Requirements for Recycled Food Contact Materials
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PACKAGING By George G. Misko way of its food additive regulations (21 U.S. and EU Requirements C.F.R. Sections 170 et seq.) or through the Food Contact Notification program. FDA does not, however, mandate spe- for Recycled Food Contact cial regulatory review or preclearance of recycled food contact materials. This is because FDA regulates food contact Materials materials based on their composition, not on the specific process by which they are manufactured or the source of their raw materials. Accordingly, re- Food manufacturers are cycled food contact material must meet the same regulatory specifications that responsible for ensuring that food virgin material is required to meet (with the exception of paper, see below). Re- packages comply with applicable cycled food contact materials also must comply with the FDA Good Manufac- regulatory requirements turing Practices (GMP) requirements that apply to food contact materials (21 C.F.R. Section 174.5), which require, reen is in. And although one must be con- among other things, packaging materi- cerned with the types of environmental als to be of a purity suitable for their claims made for recycled materials that may intended use. be used in food packaging, one should be Since recycled food contact materi- just as concerned that such materials com- als don’t require preclearance from Gply with the legal requirements pertaining to their safe FDA, a company can establish to its use. own satisfaction—using scientifically In this regard, the use of recycled materials in food sound methods—that a recycled material packaging applications is governed by the same prin- complies with the existing regulations ciples that apply to all food packaging. Namely, in the and is suitably pure for its intended U.S., the packaging materials must comply with any use. Or a company can establish an ac- applicable regulations and must meet the suitable pu- ceptable regulatory status for a recycled rity requirements of the Food, Drug and Cosmetic Act food contact material by demonstrat- (FD&C Act). In the European Union (EU), the materials ing through appropriately conducted must comply with any applicable EU or Member State extraction studies or calculations that it legislation (depending on whether the recycled material is not reasonably expected to become is plastic or paper) and must meet the safety require- a component of food and therefore is ments outlined in the EU Framework Regulation. Safety not a food additive under the FD&C requirements in this context generally mean the product Act when used as intended (just as one is suitably pure so that it will not adulterate the food it may for a virgin material). Because FDA contains. can challenge a determination of this Below is a summary of the regulatory systems govern- sort postmarket (although that doesn’t ing recycled food contact materials in the U.S. and the happen very often), and because some EU. product end-users demand it, some companies that produce recycled food U.S. Regulation of Recycled Food Contact contact materials will also request FDA Materials to review their determinations and issue The U.S. Food and Drug Administration (FDA) gen- a letter of no objection if the agency erally regulates the use of materials in food packaging by agrees with the determination. R EP R INTED F R OM F OOD S AFETY M AGAZINE , O CTOBE R /N OVEMBE R 2013, WITH PE R MI ss ION OF THE PUBLI S HE rs . © 2013 by T h e T a r g eT g r o u p • w w w . f o o d s a f eT y m ag a z i n e . co m PACKAGING Recycled Plastic: FDA provided guid- contaminant level equivalent to an EDI been used to hold or ship poisonous or ance on the use of recycled plastics in of 1.5 µg/day would be 220 µg/kg. deleterious substances. This regulation its August 2006 document, “Guidance FDA’s guidance on surrogate con- does not, however, require that addi- for Industry: Use of Recycled Plastics in taminant testing recommends exposing tives found in the recycled pulp must Food Packaging: Chemistry Consider- virgin flake or bottles from feedstock comply with the regulations applicable ations.” In this guidance, FDA discusses that contain only food contact materials to paper (21 C.F.R. Sections 176.170 some specific issues manufacturers to surrogate cocktails of contaminants et seq.). Food contact pulp, including should address in establishing the safety for 2 weeks at 40 °C. If the feedstock recycled pulp, must be suitably pure and regulatory compliance of recycled may include non-food contact materi- for its intended use. There are currently polymers for food als, virgin flake, not three approaches used to establish the packaging, including bottles, should be suitable purity of recycled pulp, namely, the need for recyclers “…the use of recycled exposed to higher batch testing, surrogate testing or no- to ensure that possible concentrations of sur- discernible-difference testing. contaminants from materials in food rogates for 2 weeks Batch testing involves baseline sam- prior use are removed at 40 °C. Surrogate pling with an initial test to establish that sufficiently by the re- concentrations must a mill produces suitably pure recycled cycling process. packaging applications be equal to or greater paper. It focuses on a comprehensive There are three than the sorption val- list of unintentional chemical contami- types of plastics recy- is governed by the ues provided by FDA nants, including heavy metals, pesticides cling operations: 1) in the guidance. Once and polychlorinated biphenyls (PCBs), primary recycling (e.g., surrogate exposure is volatile and semivolatile organics and industrial scrap); 2) same principles that completed and the dioxins. Pass/fail criteria—based on secondary recycling flake or bottles are demonstrating potential exposure below (e.g., physical repro- apply to all food rinsed, the cleaning thresholds of concern for a specific cessing, such as grind- and recycling process chemical—are used. Periodic, focused ing, melting, reform- is followed and then sampling, or follow-up testing of com- ing); and 3) tertiary packaging.” residual contaminant mon and mill-specific contaminants, is recycling (or regenera- levels may be deter- also required to confirm that contami- tion of purified starting materials, such mined. nants of high concern remain within re- as by methanolysis or glycolysis). Re- Suitable purity of the resin is es- quired limits. The trick here, of course, cyclers can establish suitable purity for tablished if the data show that these is determining the list of substances that secondary and tertiary recycling opera- residual levels are below those noted in should be examined. tions by demonstrating the effectiveness the guidance. If the maximum residual With surrogate testing, selected of the cleanup and reprocessing steps levels are exceeded, several alternatives chemicals, which model classes of con- in removing contaminants through sur- are available, including conducting mi- taminants, are spiked into the source rogate contaminant testing and, if ap- gration studies that simulate actual use material. The surrogates are selected to propriate, additional migration testing. conditions for the recycled materials to address incidental contaminants and In the guidance, FDA states that esti- determine whether the surrogate con- intentional additives. The contaminated mated daily intakes (EDIs) of contami- taminants are likely to transfer to food; source material is then sent through nants from recycled food contact ar- blending the recycled material with the recycling process and the recycled ticles on the order of 1.5 µg/person/day virgin polymers to dilute out the level paper is analyzed to confirm that the (0.5 ppb dietary concentration) or less of the contaminants; limiting end-uses process removed the spiked surrogates. generally present no more than a neg- to those in which migration of the con- Functional-barrier testing also may be ligible risk. An example is provided of taminants to food is unlikely; and using necessary. FDA issued a draft guidance how to calculate the maximum accept- the recycled materials with a functional document several years ago that lends able contaminant level in polyethylene barrier that prevents migration of the credence to this determination method. terephthalate (PET) that would result in recycled material to the food. No-discernible-difference testing an EDI of no more than 1.5 µg/person/ Recycled Paper: FDA permits the use involves comparing paper samples day. Based on a consumption factor of of pulp from reclaimed (recycled) fiber produced from virgin fiber with ones 0.05, a food-type distribution factor of if certain conditions are met (see 21 produced from recycled fiber. The 1.0, consumption of 3 kg of food per C.F.R. Section 176.260). In particular, samples are analyzed for contaminants day, a surface-area-to-volume ratio of 10 the pulp may not contain “poisonous and substances of concern—such as g/in2 and a container wall thickness of 2 or deleterious substances” that migrate polyaromatic hydrocarbons, heavy met- mils (0.50 mm), the maximum residual to food, and the source may not have als, dioxins, PCBs—to demonstrate “no R EP R INTED F R OM F OOD S AFETY M AGAZINE , O CTOBE R /N OVEMBE R 2013, WITH PE R MI ss ION OF THE PUBLI S HE rs . © 2013 by T h e T a r g eT g r o u p • w w w . f o o d s a f eT y m ag a z i n e . co m PACKAGING discernible difference” in potential con- ropean Food Safety Authority (EFSA). and new processes for recycled plastics taminants between them. The analysis After EFSA issues an opinion, the EC for use in food contact materials.