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 e p r i n t e d f r o m F o o d S a f et y M ag a z i n e , O c to b e r /N ov e m b e r 2013, w i t h p e r m i ss i o n o f t h e p u b l i s h e 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 e p r i n t e d f r o m F o o d S a f et y M ag a z i n e , O c to b e r /N ov e m b e r 2013, w i t h p e r m i ss i o n o f t h e p u b l i s h e 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. New also can include comparison of total will adopt a decision either granting or recycling processes are those that began chloroform-soluble, nonvolatile (TNV) refusing authorization of the recycling operation after April 17, 2008 and for extractives between virgin and recycled process. which an application was submitted samples. This can be accomplished by EC 282/2008 requires that the plastic after December 31, 2009. exhaustively extracting the samples with input originates from plastic materials Recycled Paper: The EU does not have food simulants and measuring TNVs, and articles that have been manufac- harmonized legislation governing the then comparing the analytical “finger- tured in accordance with EU legislation use of food contact paper and board prints” with gas-liquid chromatography, on plastic food contact materials and materials. Therefore, in addition to be- high-pressure liquid chromatography, articles, and that the recycling process ing governed by the Framework Regu- ultraviolet-visible spectroscopy and/ eliminates contamination or reduces it lation, these materials must comply or infrared spectroscopy to identify to a concentration that does not pose a with the appropriate laws of each EU and quantify differences. The problem risk to human health. Member State, subject here, of course, is that the method as- Monomers and oligo- “Heightened interest to the principle of mu- sumes that the virgin paper used for the mers resulting from tual recognition, and baseline comparison is itself of suitable chemical depolymer- this includes recycled purity. ization are subject to in environmental paper as well. Some In addition to any of the above, mi- the same requirements Member States have crobiological loading analysis should be as monomers manu- issues is pressuring specific legislation or done using a swab or disintegration test. factured by chemical recommendations on And, of course, ongoing quality assur- synthesis and, there- food contact paper, ance testing should be conducted to fore, are not covered food manufacturers to which are described ensure that the recycling process contin- by this regulation. below. ues to produce suitably pure products. In addition, recycled consider using more The German material used behind Federal Institute for EU Regulation of Recycled Food a functional barrier is Risk Assessment or Contact Materials not covered by the au- recycled materials in Bundesinstitut für As mentioned above, in the EU, all thorization procedure Risikobewertung (BfR) food contact materials must comply in this regulation. food packaging.” Recommendation with the Framework Regulation (EC) The regulation of 36 covers the use of 1935/2004. It requires that food contact plastics used in food paper and board for materials and articles be manufactured contact materials is harmonized in the food contact applications. While the in accordance with GMPs, and that ma- EU under the Plastics Regulation, EU German BfR Recommendations are not terials and articles not transfer constitu- No. 10/2011. This regulation includes legally binding, they are respected by ents to food that would endanger public an overall migration limit and a list of industry throughout the EU. The annex health, bring about unacceptable change authorized substances for the manufac- to Recommendation 36 specifically ad- in composition of food or deteriorate its ture of plastic food contact materials dresses the use of recycled fibers as raw organoleptic characteristics. with corresponding specific migration materials for the production of paper. Recycled Plastic: The European Com- limits. Pointing out that care must be used in mission (EC) published a regulation EFSA issued its first opinion on the selecting fiber sources with respect to on recycled plastic materials and ar- safety of a process for manufacturing potential migration of substances into ticles intended to come into contact recycled plastics to be used as food food, the annex specifies migration with foods, EC 282/2008, on March contact materials on December 20, 2010 limits for: primary aromatic amines, 27, 2008. Under this regulation, only and adopted its first three scientific 4,4'-bis(dimethylamino)-benzophenone, food contact materials and articles that opinions on the safety of processes to phthalates (di-2-ethylhexyl phthalate, contain recycled plastic obtained from recycle PET for use in food contact ma- di-n-butyl phthalate, diisobutyl phthal- an authorized recycling process may terials on August 2, 2012. Once the ate), benzophenone, bisphenol A and be marketed in the EU after petitions EC adopts decisions on the authoriza- diisopropylnaphthalene. for recycling processes received by De- tion of the recycling processes for which In Italy, recycled paper is permit- cember 31, 2009 are evaluated. Applica- a valid application was submitted— ted for use only in contact with foods tions for recycling process must first be expected in 2014—the initial phase that are not subject to migration test- submitted to a Member State authority, will be completed. EFSA is currently ing (i.e., dry, nonfatty foods). In the which will then forward them to the Eu- reviewing applications for both existing Netherlands, recycled fibers are ex-

R e p r i n t e d f r o m F o o d S a f et y M ag a z i n e , O c to b e r /N ov e m b e r 2013, w i t h p e r m i ss i o n o f t h e p u b l i s h e 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 plicitly allowed; however, they are not are mineral oil saturated hydrocarbons a test method that BfR will make avail- permitted for use in paper for cooking (MOSHs) and mineral oil aromatic hy- able. An earlier version of the ordinance applications or filtering drinks above drocarbons (MOAHs). also addressed the transfer of MOSHs 80 °C. In the Czech Republic, reuse of EFSA published a scientific opinion to food, but since MOSHs and MO- paper packages in direct contact with on the potential presence of mineral AHs exist in recycled board at a fairly food is not allowed, whereas the use oil hydrocarbons (MOHs) in food in constant ratio, it is thought that control- of reclaimed fibers from specific paper June 2012. Although EFSA stressed that ling the MOAHs in the board will also classes is permitted in the production there are several uncertainties regard- control the MOSHs. of paper if there are no safety concerns. ing the chemical composition of MOH In Slovakia, recycled fibers are currently mixtures to which humans are exposed, Conclusion permitted, with some limitations, al- EFSA added, “on the basis of new infor- Heightened interest in environmen- though this legislation may be revised in mation on the lack of toxicological rel- tal issues is pressuring food manufac- the near future. evance for humans of previous animal turers to consider using more recycled studies, the temporary acceptable daily materials in food packaging. While Mineral Oil Migration from intakes of some ‘saturated’ MOH pres- regulations exist in some jurisdictions Recycled Packaging ent in specific food products warrant specifically addressing the safety of recy- The detection of “mineral oil” com- revision.” cling processes and materials, ultimately pounds in food packaged in recycled Currently, there are no migra- food and food packaging manufacturers cardboard by Swiss researchers and oth- tion limits for mineral oils to food are responsible for ensuring that food ers led to further investigations on the in the EU. However, the German packages comply with applicable regula- extent of these compounds in food and Federal Ministry of Food, Agriculture tory requirements and are of a suitable their safety. Sources of mineral oils in and Consumer Protection (BMELV) purity for their intended use. n food from food contact materials are is currently drafting an ordinance that thought to include recycled paper and would prohibit the transfer of MOAHs George G. Misko is a partner in the board (especially from the ink used on to food from recycled board. The draft Washington, DC, office of Keller and newspapers), printing inks applied to ordinance does not specify a level of Heckman LLP. His practice focuses paper and board and additives used in detection, but BMELV has indicated on food and drug matters and the manufacture of plastics. The main that the confirmation of “no” transfer of environmental concerns. He can be compounds of interest in recycled paper MOAHs to food will be determined by reached at [email protected].

R e p r i n t e d f r o m F o o d S a f et y M ag a z i n e , O c to b e r /N ov e m b e r 2013, w i t h p e r m i ss i o n o f t h e p u b l i s h e 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