Plastic And Polymeric Food Contact Materials - UL

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Plastic and polymericfood contact materialsTake advantages from your supply chain managementto navigate a complex global regulatory landscape

A complex regulatorylandscapeOverviewThis whitepaper discussesthe difficulties companiesmay face when placingplastic and polymeric foodcontact materials into a globalmarketplace, strategies whichcompanies can use to helpensure compliance and therole UL can play in applyingthese strategies for compliancepurposes. International and localregulations can change and eachcustomer’s situation is different.This information should beconsidered to be an overview andnot intended as specific advice.Understanding regulation in the destination market is not always easy.The European Union, for example, has a complex regulatory landscape withmany countries requiring different national standards. Commission Regulation(EC) No 1935/2004 provides a harmonized legal EU framework but sets out onlythe general principles for safety and inertness for all food contact materials.The U.S. Food and Drug Administration (FDA) regulates the U.S. market, butindividual states may have specific regulations as well.IntroductionThe articles we use to package, store, hold, prepare and cook our food are widelymanufactured with plastics or polymeric materials. These products includestorage containers, kitchenware and appliances. Because of the possibilitythat substances used to manufacture these products may migrate to the foodwe consume, governments have enforced strict health and safety regulationsthat cover food contact materials. These regulations are complex and notglobally harmonized. They are not offered a la carte; rather, they are crucial formanufacturers, retailers and brands to consider and comply with during theentire life of the product. Noncompliant products can result in recalls that canbe costly, not only monetarily, but also to brand reputation.How can companies make sure their products meet safety and qualityregulations across the global marketplace?One important step is for companies to look at compliance from a new perspective.Waiting until final product testing can be too late for most companies to changethe recipe. Focusing on compliance in the initial product concept phase can helpfood contact manufacturers avoid regulatory tangles before they arise.Often, noncompliance derives from issues within the supply chain. Supply chainscan be large and complex, made up of hundreds of suppliers across the world.Companies must maintain robust communication throughout the supply chainto make sure suppliers know about regulations in destination markets. If they failin requesting appropriate documentation through the supply chain, the productis likely to fail in the testing phase.2China’s National Food Safety Standards specify requirements on food contactmaterials and articles, but these are not the same as the European or U.S.regulations.The use of plastics, specifically, in food contact materials comes under increasedscrutiny and more complicated regulations across global markets. Plasticsand polymers are extremely important to modern life, but some have provento have adverse effects on human health, including endocrine-disruptingchemicals that disturb many different hormones. Regulation aims to set SpecificMigration Limits (SML), quantifying the maximum allowed quantity of a specificsubstance that can migrate from a food contact material into the food itself.Toxicological studies helped derive the safety limits.China’s National Food Safety Standards GB 4806.6-2016 and GB 4806.7-2016govern the use of plastics and polymers in food contact materials. In the EU,Regulation (EU) No 10/2011 guides Specific Migration Limit (SML), OverallMigration Limit (OML), migrated heavy metals and polyaromatic amines. In theU.S., regulatory status of plastic food contact materials is governed by the FDAunder the Food Drug and Cosmetic Act (FD&C Act) and Title 21 Code of FederalRegulations (21 CFR) 170-199 as well as prior sanctioned materials, Thresholdof Regulations (TOR), Generally Recognized as Safe (GRAS) and Food ContactNotifications.The lack of a unified standard makes it more challenging to deliver productsthat fit the bill in every scenario. It’s worth delving more deeply into the specificrequirements for three major world markets. Regulations are regularly amendedso the information presented here is accurate as of the publication date of thispaper but should not be considered an exhaustive list.3

United States In the U.S., the overall regulatory status of food contact materials is governed by the FDA1 under the FD&C Act and 21 CFR 170199. Each individual substance in the formulation of a food contact article must be evaluated for its regulatory compliance todetermine the regulatory status of the final item. A food contact material is regulatory compliant only if all substances in theformulation are approved for food contact use and required testing meets the regulations listed below. The FDA website defines a food contact substance as “a substance intended for use as a component of materials used in themanufacturing, packaging, transporting, cooking or holding food.” It classifies food contact substances that migrate into food asindirect food additives. If a functional barrier prevents a substance from migrating into the food, it is not considered an indirectfood additive and is not required to have FDA approval. The overall status of the each individual substance that is expected tomigrate to food because of its intended use is covered by one of the categories listed below, all listed on the FDA website. Thisoverview should be considered a tool. It is current as of the publication date of this paper but may not reflect all recent revisions: A regulation listed in 21 CFR 170-1992 The requirement for premarket approval in section 409of the FD&C Act in 1958 resulted in the developmentof a petition process by which a company could requestapproval of a food additive for an intended use. Theapproval resulted in a regulation listed in 21 CFR.Components of a food packaging material used incompliance with a regulation in 21 CFR 174-179 need nofurther FDA review. Most of the regulated indirect foodadditives can be found in Center for Food Safety andApplied Nutrition’s “Indirect Additive” Database. 4General Indirect Food Additives (21 CFR 1743)Adhesives and Components of Coatings (21 CFR 1754)Paper and Paperboard Components (21 CFR 1765)Polymers (21 CFR 1776) Substances GRAS in food (21 CFR 18210)Threshold of Regulation (TOR) exemption request14A substance used in a food contact article may beexempted by FDA from the need of a Food ContactNotification (FCN) or a petition (regulation) as a foodadditive if the use in question has been shown to resultin a very low concentration (0.5 ppb). For details see,“Submitting Requests Under 21 CFR 170.39 Thresholdof Regulation for Substances Used in Food ContactArticles.”Generally Recognized as Safe (GRAS), including but notlimited to GRAS regulations found in 21 CFR 182, 184and 186 or GRAS notice Prior Sanction letter13Prior Sanctioned substances are those substances whoseuse in contact with food is the subject of a letter issuedby FDA or USDA before 1958 offering no objection to aspecific use of a specific substance.Adjuvants, Production Aids, and Sanitizers (21 CFR1787)Irradiation in the Production, Processing andHandling of Food (21 CFR 1798)Not all substances which are GRAS are listed inFDA’s regulations. FDA has instituted a procedurewhereby someone may inform FDA of their own GRASdetermination. A list of these GRAS notices, with FDA’sresponse letter to the notifier, is also available on the FDAwebsite under “Summary of all GRAS Notices9.Substances affirmed as GRAS in food (21 CFR184111)Substances affirmed as GRAS for use in foodpackaging (21 CFR 18612) Effective Food Contact Substance Notification (FCN)15In 1997, the FDA amended the Food, Drug and CosmeticAct to streamline the way which the FDA conductedapprovals. The new procedures established a notificationprocess for food contact substances. This process isintended to replace the petition process as the primarymeans for authorizing new food contact substances.However, it is the FDA’s decision as to when the petitionprocess is more appropriate for evaluating data toprovide an adequate assurance of safety. The listingof effective food contact substance notifications,the regulation, guidance documents16 and additionalinformation regarding the notification program are listedon the Food Contact Substance web page. However, youshould be aware that FCNs are proprietary and usersmust be able to trace the substance they use back to themanufacturer for which the notification is effective.In accordance with Section 409(h)(2)(C) of the FederalFood, Drug and Cosmetic Act and FCN is specific tothe manufacturer that applies for the approval of thefood contact substance and the conditions of usedidentified in the notification. It is not an approval fora similar or identical substance produced or preparedby a manufacturer other than the manufactureridentified in the notification. FCNs are proprietary tothe manufacturer for which the notification has beenapproved, therefore, the food contact substance must beobtained from the manufacturer noted on the FCN.The FDA has stated, “It is the responsibility of themanufacturer of a Food Contact Substance (FCS) to ensurethat food contact materials comply with the specificationsand limitations in all applicable authorizations. Whenreviewing your composite formulations to determinecompliance, consider each authorization to be composedof three parts: the identity of the substance, specificationsincluding purity or physical properties and limitations on theconditions of use.”5

ChinaTest methodsIn China, food container and packaging materials are regulated under the Food SafetyLaw of the People’s Republic of China. This law prohibits the import, use or purchaseof food-related products, including food packaging materials, that do not comply withthe applicable Chinese Food Safety Standards promulgated by the National HealthCommission (NHC). In November 2016, the NHC published a list of 53 mandatorynational standards (FCM GB standards) for food contact materials and articles. With the release of these new standards, a new scheme of Chinese FCM GB standardswere established. This new scheme includes four major sections: General Standards,Product Standards, Test Methods and General Hygiene Requirement. These regulationsare current as of the publication of this paper. This overview may be considered a toolbut may not contain all recent revisions. General standards GB 4806.1-2016 National Food Safety Standard — General Safety Requirementsfor Food Contact Materials and Articles defined the definition of food contactmaterials in China. It specifies the basic requirements, restrictions, compliance,test methods, traceability, product information requirements, declarationof compliance and the Good Manufacturing Practice (GMP) on food contactmaterials and articles (FCMs). It sets out the framework which apply to all kinds offood contact materials and articles in China.GB 9685-2016 National Food Safety Standard — Standards for Uses of Additives inFood Containers and Packaging Material, sets out a positive list of additives thatcan be used to produce various food contact materials and articles including theiruse scope and restrictions. If the additives to be used in these kinds materials andarticles are not explicitly listed, it must be approved by the NHC first before theycan be used to produce certain types of food contact materials and articles inChina.Product standards GB 4806.3-2016: National Food Safety Standard - Enamel articlesGB 4806.4-2016: National Food Safety Standard - Ceramic articlesGB 4806.5-2016: National Food Safety Standard - Glass articlesGB 4806.6-2016: National Food Safety Standard - Food contact plastic resinsGB 4806.7-2016: National Food Safety Standard - Food contact plastic materialsand articlesGB 4806.8-2016: National Food Safety Standard - Food contact paper, paperboardand paper articlesGB 4806.9-2016: National Food Safety Standard - Food contact metal materialsand articlesGB 4806.10-2016: National Food Safety Standard - Food contact coatingsGB 4806.11-2016: National Food Safety Standard - Food contact rubber materialsand articlesGB 14934-2016: National Food Safety Standard - Disinfection tableware GB 31604.1-2016 and GB 5009.156-2016 are the basic standards on howtest conditions should be selected and how to conduct pre-treatment fortest specimen.GB 31604.2-2016 – GB 31604.9-2016 are detection methods for differenttest indicators required in product standards, such as the determinationof overall migration, potassium permanganate consumption, among otherthings.GB 31604.10-2016 – GB 31604.49-2016 are test methods for varioussubstances that may have SML or QM restrictions in GB 9685 or GB 4806standards.Food contact material compliance in China is now more comprehensiveand systematic after the implementation of new scheme. It is essential tounderstand all the requirements to ensure compliance with the new ChineseFCM regulation.General hygiene requirement for manufacturing GB 31603:2015 – National Food Safety Standard - General Health Codefor Production of Food-contacted Materials and Products, sets basicrequirements for the entire manufacturing process for various food contactmaterials and articles. Manufacturers should establish detailed workflowto ensure compliance. It can act as Good Manufacturing Practice (GMP) forfood contact materials.European UnionIn the European Union, all materials and articles intended to come in contactwith food have to respect the general criteria imposed by the FrameworkRegulation 1935/2004. The goal is to ensure that in every phase of contactbetween food contact materials (FMCs) and food, sufficient inertia is ensuredand any type of negative influence on the quality, nutritional and organolepticproperties of the food is avoided. In addition, all food contact materials shouldbe manufactured according to Good Manufacturing Practice as regulated byRegulation (EC) 2023/2006.Commission Regulation (EC) No 1935/200417 provides a harmonized legal EUframework. It sets out the general principles of safety and inertness for allFCMs.The principles set out in Regulation (EC) No 1935/2004 require that materials donot: Release their constituents into food at levels harmful to human healthChange food composition, taste and odor in an unacceptable wayThis series of new product standards combined and superseded many old hygienestandards for materials and articles. In those revised standards, there are requirementsfor composition, physical and chemical indicators, specific test conditions, and labeling.67

Moreover, the framework provides: Special rules on active and intelligent materials(they are by their design not inert)Powers to enact additional EU measures forspecific materials, e.g., for plasticsThe procedure to perform safety assessments ofsubstances used to manufacture FCMs involvingthe European Food Safety Authority18Rules on labeling including an indication for use,e.g., coffee maker, wine bottle, or a soup spoonor by reproducing the appropriate symbol. Formore information, please refer to the followingdocument on Symbols for labeling food contactmaterials.19Rules for compliance documentation andtraceabilityCommission Regulation (EC) No 2023/200620 ensuresthat the manufacturing process is well controlled sothat the specifications for FCMs remain in conformitywith the legislation: Premises fit for purpose and staff awareness ofcritical production stagesDocumented quality assurance and quality controlsystems maintained at the premises, andSelection of suitable starting materials for themanufacturing process with a view to the safetyand inertness of the final articlesGood manufacturing rules apply to all stages in themanufacturing chain of food contact materials,although the production of starting materials iscovered by other legislation.In the frame of the CAST Project21 (Food Contact Safetyand Technology) general and specific guidelines for theapplication of the Regulation No. 2023/2006/CE on GoodManufacturing Practice in the supply chain of materialsand articles intended to come into contact withfood were developed. The guidelines are structuredin a section for general application and in a sectionfor specific applications, in particular the chains ofaluminum, paper and boards, flexible packaging,plastics, coated and uncoated metals and alloys, wood,cork, glass.The most comprehensive specific EU measureis Commission Regulation (EU) No 10/201122 onplastic materials and articles. It sets out rules on thecomposition of plastic FCMs and establishes a UnionList of substances that are permitted for use in themanufacture of plastic FCMs. The Regulation alsospecifies restrictions on the use of these substancesand sets out rules to determine the compliance ofplastic materials and articles.8Regulations are regularly amended. The consolidated version should beconsidered as a tool for your convenience but may not contain all the mostrecent amendments:Consolidated version of Commission Regulation (EU) No 10/2011An important mechanism to ensure the safety of plastic materials is the useof migration limits. These limits specify the maximum amount of substancesallowed to migrate to food. For the substances on the Union List the Regulationsets out Specific Migration Limits (SML). These are established by EuropeanFood Safety Authority (EFSA) on the basis of toxicity data of each specificsubstance. To ensure the overall quality of the plastic, the overall migration toa food of all substances together may not exceed the Overall Migration Limit(OML) of 60 mg/kg food, or 10 mg/dm2 of the contact material.The regulation sets out detailed migration testing rules. Although migrationtesting in the food prevails, migration is usually tested using simulants. Thesesimulants are representative for a food category, e.g. Acetic acid 3 % (w/v) isassigned for acidic foods. The migration testing is done under specific time/temperature conditions, representative for a certain food use and considers theworst foreseeable real food contact conditions.To ensure the safety, quality and compliance of plastic materials, adequatedata on the composition of (intermediate) materials has to be communicatedvia the manufacturing chain, up to but not including the retail stage. For thispurpose, a Declaration of Compliance (DoC) needs to be provided. The DoC isbased on supporting documentation which records the reasoning on the safetyof a plastic food contact material, and which must be provided to enforcementAuthorities on their request. The supporting documentation also provides animportant link to the manufacturer’s responsibility under GMP (CommissionRegulation (EC) No 2023/2006).23In order to allow the exchange of relevant information, the information tobe included in the DoC is set out in a standard format in Annex IV of theRegulation (EU) No 10/2011. It is crucial to understand that plastic foodcontact material is compliant with the regulation only if all substances in theformulation are approved for the intended food contact use and all appropriateinformation is transmitted through the supply chain.Developing a successfulapproachWhen a particular food contact material is deemed unsafe, regulators reactquickly to recall items. In Europe, the information is disseminated throughthe Rapid Alert System for Food and Feed (RASFF), an urgent notificationsystem. In the United States, recalls are handled by the Consumer ProductSafety Commission (CPSC). Both the RASFF and CPSC work with haste to notifyconsumers and manufacturers in order to minimize potential harm.Strong management is crucial to create and nurture a trusted supply chainthat can deliver safe, compliant food contact products to your target market.This includes mechanisms to continually monitor product production. Further,food contact materials require extensive documentation because of thesensitive nature of their potential effect on human health and safety. Withoutappropriate technical files, bills of materials or chemical lists, product testingwill be incomplete. This may lengthen time to market or increase the possibilitythat an unsafe food contact product will reach consumers.9

For many companies, enlisting a competent and independent third-party like UL can help deliver a recipe for success. Safetyscience expertise, independent objectivity and a data-driven approach can help guide your decision-making process andassist you in navigating the necessary compliance regulations for exporting food contact materials to your target markets.The UL Global Regulatory Research team can help companies identify the different requirements for specific markets,guiding requests to suppliers for specific documentation. We support brands and retailers in creating customizedtesting, inspection, audit and training programs that address numerous needs during all stages of the supply chain, fromdeveloping a product to efficiently getting it onto shelves in target markets.Tips to successfully approach complianceIf you are a manufacturer of a food contact product or you will be responsible for making the productavailable on the market you should keep in mind the following key steps to successfully approach compliance:1Map your suppliers (Tier 1, Tier 2, Tier 3)3Identify a detailed testing program2Clearly identify the responsibilitiesof each tier of your supply chain.Typically, chemical substances andother raw materials produced and soldfor the production of FCM shall havedocumentation for compliance withthe requirements set in the applicableregulations. Producers of intermediates,e.g., formulations of printing inks, shoulduse chemicals for which a risk assessmentis available and produce products thatwill comply with the legislation whenused in accordance with guidance orinstructions of use given to the user.Producers of final FCM are producing theFCM from the chemical raw materialsand/or from intermediates. Materialscan be suitable for contact with a widevariety of food under many differentconditions of use, while others can have alimited area of use. The FCM shall complywith the legislation, e.g., it must notcause deterioration in the organolepticproperties of the food4Support your suppliers in theunderstanding of the regulations, provideguidance document(s), testing programsand propose training sessions with yourfood contact materials experts5Provide suppliers with clear instructionsrelated to the product you wish tomanufacture including the destinationmarket. Verify that suppliers understandyour expectations of the documents yourequire in support of compliance6Scrupulously commit to a competentreview of all the documents you receivefrom your suppliers7Organize audits and inspections atsuppliers’ facility to ensure not onlycompliance, but also safety and qualityobligations are being met (for example,GMP where expected, astatically correct,sharp points and edges)ConclusionThere are complex regulations and standards to help ensure the safety andquality of plastic and polymeric food contact materials worldwide. Theseregulations are not harmonized and continue to change. Products that are noncompliant can put a company and their brand reputation at risk for recalls.How can UL help you ensure your products are compliant to the destinationcountry regulations?UL can help identify requirements, guide in the request for documentation,review positive lists against the formulation, perform testing, audits andinspections. Through testing and training, UL supports manufacturers tocomply with rigorous regulations and standards to bring safe and high-qualityfood contact materials to market. We work with customers to establishcomprehensive written testing programs that provide the customer with ahigh degree of assurance that their products comply with the applicable foodcontact standards. The testing programs are designed based on relationshipswith suppliers, destination countries regulations, documentation reviewand the quantity, frequency and method of testing required. When scientificexpertise, objective authority and market access matters, working with ULexperts may help you navigate the road ahead.For more information aboutUL’s food contact materialsservices visit CRS.UL.com orcontact us at QAInfo@ul.com.1011

Endnotes1.“Determining the Regulatory Status of Components of a Food Contact Material.” U.S. Food andDrug Administration website. Accessed Sept. 22, 2020. ts-food-contact-material2.“CFR - Code of Federal Regulations Title 21.” U.S. Food and Drug Administration website.Accessed Sept. 22, 2020. /cfcfr/CFRSearch.cfm?CFRPart 1703.“Part 174—Indirect Food Additives: General.” Electronic Code of Federal Regulations. AccessedSept. 22, 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID e956d645a8b4e6b3e34e4e5d1b690209&mc true&node pt21.3.174&rgn div514. “Threshold of Regulation Exemptions for Substances Used in Food-contact Articles.” U.S.Food and Drug Administration website. Accessed Sept. 22, 2020. ances-usedfood-contact-articles15. “Inventory of Effective Food Contact Substance (FCS) Notifications.” U.S. Food and DrugAdministration website. Accessed Sept. 22, 2020. ance-fcs-notifications16. “Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information” U.S.Food and Drug Administration website. Accessed Sept. 22, 2020. uments-regulatory-information4.“Part 175—Indirect Food Additives: Adherives and Components of Coatings.” Electronic Code ofFederal Regulations. Accessed Sept. 22, 2020.5.“Part 176—Indirect Food Additives: Paper and Paperboard Components.” Electronic Code ofFederal Regulations. Accessed Sept. 22, 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID e956d645a8b4e6b3e34e4e5d1b690209&mc true&node pt21.3.176&rgn div517. “Consolidated text: Regulation (EC) No 1935/2004 of the European Parliament and of the Councilof 27 October 2004 on materials and articles intended to come into contact with food andrepealing Directives 80/590/EEC and 89/109/EEC.” EUR-Lex website. Accessed Sept. 22, T/?uri CELEX:02004R1935-200908076.“Part 177—Indirect Food Additives: Polymers.” Electronic Code of Federal Regulations. AccessedSept. 22, 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID e956d645a8b4e6b3e34e4e5d1b690209&mc true&node pt21.3.177&rgn div518. “Food contact materials.” European Food Safety Authority website. Accessed Sept. 22, d-contact-materials7.“Part 178—Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers. Electronic19. “Symbols for labelling food contact materials.” Document accessed Sept. 22, 2020. docs/cs fcm legis fcm-symbols.doc8.“Part 179—Irradiation in the Production, Processing and Handling of Food.” Electronic Code ofFederal Regulations. Accessed Sept. 22, 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID e956d645a8b4e6b3e34e4e5d1b690209&mc true&node pt21.3.179&rgn div59.“GRAS Notice Inventory.” U.S. Food and Drug Administration website. Accessed Sept. 22, -safe-gras/gras-notice-inventory10. “Part 182—Substances Generally Recognized as Safe.”Electronic Code of Federal Regulations.Accessed Sept. 22, 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID e956d645a8b4e6b3e34e4e5d1b690209&mc true&node pt21.3.182&rgn div511. “Part 184—Direct Food Substances Affirmed as Generally Recognized as Safe.” Electronic Code ofFederal Regulations. Accessed Sept. 22, 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID e956d645a8b4e6b3e34e4e5d1b690209&mc true&node pt21.3.184&rgn div512. “Part 186—Indirect Food Substances Affirmed as Generally Recognized as Safe.” Electronic Codeof Federal Regulations. Accessed Sept. 22, 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID e956d645a8b4e6b3e34e4e5d1b690209&mc true&node pt21.3.186&rgn div520. “Consolidated text: Commission Regulation (EC) No 2023/2006 of 22 December 2006 on goodmanufacturing practice for materials and articles intended to come into contact with food (Textwith EEA relevance).” EUR-Lex website. Accessed Sept. 22, 2020. https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri CELEX:02006R2023-2008041721. “Progetto CAST – Linee Guida per L’Applicazione del Reg 2023/2006/CE alla Filiera di Produzionedei Materiali e Oggetti a Contatto con Alimenti.” Istituto Superiore di Sanità website. AccessedSept. 22, 2020. http://old.iss.it/moca/index.php?lang 1&id 148&tipo 422. “Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articlesintended to come into contact with food Text with EEA relevance.” EUR-Lex website. AccessedSept. 22, 2020. i CELEX:32011R001023. “Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturingpractice for materials and articles intended to come into contact with food (Text with EEArelevance).” EUR-Lex website. Accessed Sept. 22, 2020. i CELEX:32006R202313. “Part 181—Prior-Sanctioned Food Ingredients.” Electronic Code of Federal Regulations. AccessedSept. 22, 2020. https://www.ecfr.gov/cgi-bin/text-idx?SID e956d645a8b4e6b3e34e4e5d1b690209

GB 4806.7-2016: National Food Safety Standard - Food contact plastic materials and articles GB 4806.8-2016: National Food Safety Standard - Food contact paper, paperboard and paper articles GB 4806.9-2016: National Food Safety Standard - Food contact metal materials and articles food contact materials. European Union 7

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