Global legislation for regenerated cellulose materials in contact with food

Global legislation for regenerated cellulose materials in contact with food

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A. Ariosti1,2 1 National Institute of Industrial Technology (INTI), Research and Technological Development Centre for the Plastics Industry, San Martı´n, Buenos Aires, Argentina; 2 University of Buenos Aires, Junı´n, Buenos Aires, Argentina

5.1 5.1.1

Introduction Definition of regenerated cellulose

Regenerated cellulose (RC) is a transparent material with optical properties very similar to thermoplastic materials (e.g., polyethylene terephthalate, PET; clarified or bioriented polypropylene, PP). RC is obtained by regenerating (coagulating) in an acid solution, a dissolution of a chemically modified form of cellulose (viscose), into either a continuous film of very thin gauge or a continuous seamless tube, such as that used for casings (Taylor, 1986; Petersen et al., 1999). The most known trademark of RC is Cellophane®, originally the property of E.L. du Pont de Nemours & Co., and at present owned by Innovia Films Group. This term derives from the first and final syllables of the French words cellulose and diaphane (meaning transparent), respectively. In some countries, this trademark is used as cellophane as a generic synonym of RC. If viscose is coagulated into continuous filaments for the manufacture of textile fibers, the material is known as Rayon®. This chapter deals with the sanitary and regulatory aspects of RC (i.e., cellophane films and casings) as a food contact material (FCM).

5.1.2

Manufacture of regenerated cellulose

The RC film manufacture method was developed originally by Swiss chemist J.E. Brandenberger in 1902. The modern industrial production of RC films comprises the following stages (Rebenfeld, 1986; Taylor, 1986; Petersen et al., 1999): (1) Steeping: The basic raw material is especial-grade sulfite pulp (a type of dissolving pulp), consisting mainly of cellulose (a natural polysaccharide), obtained from wood or cotton linters. The solid pulp sheets or rolls are dissolved in a solution of 14–20% (w/v) sodium hydroxide (NaOH, or caustic soda) in water. Alkali cellulose is formed as a consequence of oxidative aging during several hours in the presence of air, and, as a consequence, cellulose

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(2)

(3)

(4)

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is depolymerized. In this process, catalysts based on manganese (Mn2+), cobalt (Co2+), and iron (Fe2+) ions are used. Xanthation: The alkali cellulose reacts with carbon disulfide (CS2) to form sodium cellulose xanthate. Subproducts of the side reaction that takes place are thiocarbonate (Na2CS3) and sodium sulfide (Na2S). The cellulose xanthate is then dissolved in a dilute aqueous solution of caustic soda (approx. 8% [w/v]) to obtain viscose. Ripening: The viscose is filtered and is allowed to ripen for several days, during which further chemical reactions occur. The typical color of ripe viscose is light orange, due to the sulfur compounds. Extrusion and regeneration: The viscose is filtered once more, deaerated and extruded by a casting machine. In this process, the viscose is pumped through a horizontal die into a dilute sulfuric acid solution bath containing zinc sulfate (ZnSO4) and other additives. The caustic soda of the viscose is neutralized by the sulfuric acid, and the sodium cellulose xanthate reconverts into an insoluble cellulose gel. In the manufacture of RC films, the die exit is a horizontal slit. In the case of RC casings, the die exit is annular (e.g., in the Kalle process) (Wilfer and Beck, 2011). The die exits have adjustable lips, and these devices, along with regulation of film or tube take off speed, allow the final product effective thickness control. Conditioning: RC gel is passed through a series of several dip tanks containing solutions, in order to remove sulfur compound residues (thus eliminating the light orange color) and to add plasticizers, softeners, or mixtures. (e.g., monoethyleneglycol [EG], diethyleneglycol [DEG], polyethyleneglycol [PEG], 1,2-propyleneglycol [PG]). Drying: The RC gel is dried to obtain a solid material—up to the desired moisture level (generally 7–8% [w/w])—by a series of steam-heated rollers. Finishing: RC is finally slit and wound in reels. Coating: RC can be coated with nitrocellulose, poly(vinylidene chloride) (PVDC) or vinylidene chloride copolymers to add value to the basic material with specialized functionalities. RC passes through a dip tank with the coating formulation (polymers and additives in solution in organic solvents), and then through a drying vertical tower where solvents are evaporated and the basic material is rehumidified to the above-mentioned desired moisture content level.

RC is not a thermoplastic material, thus it is not heat sealable. Coating RC with nitrocellulose allows it to be heat sealable, thus becoming useful in a wide range of food packaging applications (Taylor, 1986; Petersen et al., 1999). The Chemical Abstract Service reference number (CASRN) of RC is 68442-85-3.

5.2

Interactions environment-regenerated cellulose foodstuffs

The external environment, the foodstuffs and their internal packaging atmosphere, and all types of FCMs have interactions between them. Of interest in the case of RC are mainly: (1) permeability of water vapor, gases (oxygen, carbon dioxide, and nitrogen), and aromas; (2) migration of RC components to the foodstuffs; and (3) sorption of foodstuff components by the RC. Permeability evaluation is important for the determination or prediction of the food shelf life and migration tests are necessary for the sanitary assessment of FCMs (Kopper and Ariosti, 2010).

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RC has poor barrier properties (high permeability) to water vapor. At low relative humidity (RH), RC is a good barrier to gases and aromas, but being a hydrophilic material, at medium and high RH, this barrier diminishes (Taylor, 1986; Guilbert et al., 1996; Petersen et al., 1999; Robertson, 2006). Surface coatings can be applied to RC to enhance its barrier to gases, aromas, and water vapor, as mentioned in Section 5.1.2. Traditional PVDC and vinylidene chloride copolymer coatings used to this end provide also good sealing-jaw release in high-speed packaging machines (Taylor, 1986; Jenkins, 1997; Petersen et al., 1999; Brandsch and Piringer, 2008). Debeaufort et al. (1995) measured RC permeability to and sorption of an aroma compound (1-octen-3-ol, with a flavor typical of mushrooms). Data on migration of traditional RC components (e.g., phthalates, EG, DEG, urea, glycerol) that can migrate to different foodstuffs can be found in Lancaster and Richards (1996). The authors also provide a discussion on changes in RC formulation with the use of alternative and new softeners and migration data into food. Balafas et al. (1999) have performed determinations of phthalates and adipate plasticizers content in packaging materials (including RC) used in the Australian market. Residual organic solvents used during the RC coating process can remain in the material, for example, by retention by the softener PG (Taylor, 1986). Subsequent migration of residual solvents may produce tainting in foods, with undesirable changes of their sensory characteristics (e.g., aroma, taste, flavor). (See Definition 3.5 on “taints” of BS ISO 13302:2003 [BS ISO, 2003].) This is one of the causes for the development of the BCL (British Cellophane Ltd.) aqueous-based PVDC coating process (Taylor, 1986). Another source of possible taints associated with RC packages may be the poor quality of inks or the printing process or both, or softeners migration (though these additives do not usually confer strong odors or tastes) (Lord, 2003). With respect to sorption of food components, RC is resistant to the penetration of fats and oils (Robertson, 2006; Brandsch and Piringer, 2008), thus it can be used in contact with fatty foodstuffs. On the other way, being a hydrophilic material, RC absorbs water and this complicates or hinders migration tests (Scha¨ffer, 2010).

5.3

Food and other sanitary applications

Since its invention up to the 1960s, RC films were widely used as transparent packaging material for all kinds of goods. With the massive introduction of thermoplastic films (e.g., bi-oriented polypropylene (BOPP), clarified PP, PET) with better properties and lower cost, RC lost its preeminence (Simon et al., 1998; Petersen et al., 1999; Brandsch and Piringer, 2008). RC casings were also replaced by fibrose, collagen, and plastics (e.g., polyamides [PA], PET) casings in the processed meats and sausages production. Taylor (1986) reported this descending trend: the RC annual capacity production was estimated at 680,000 metric tons in the early 1960s, and at 41,000 metric tons in 1986. Jenkins (1997) estimated a worldwide RC consumption for 1995 of 14,600 metric tons. Simon et al. (1998) also analyzed this market decline for RC films in the packaging sector. Typical reported uses of coated RC films—either transparent, metallized, or colored— for foods are snacks, sugar, candies, boiled sweets, cookies, cakes, biscuits, bread, baked

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fatty products, dried fruits, tree nuts, pralines, marzipan, chocolate, cheese, pasta, spices, condiments, chopped meat, meat pies, processed and cured meats, sandwiches, fresh produce, yeast, and gum packaging (Taylor, 1986; Lancaster and Richards, 1996; Poma, 1998; Petersen et al., 1999; Lord, 2003; Brandsch and Piringer, 2008). RC casings are used for sausages and other processed meat products. Multilayer laminates of RC films with plastic materials, paper, and aluminum foil are also used in food packaging (Taylor, 1986). Scha¨ffer (2011) and Broughton (2014) present very interesting descriptions of the regulatory status of multimaterial, multilayer structures for food contact in the European Union, and in the European Union and the United States, respectively. Some of these applications can be explained by certain RC properties (Jenkins, 1997), such as resistance to high temperature (in the case of hot filling), and dead-fold (in the case of twist-wrap for hard candies). During the 1980s, RC was used for retail packaging of small bolognas (an Italian-origin processed meat product, called mortadela in Spanish) in the Argentine market (Benticuaga et al., 1985; Tesone et al., 1986). In Argentina, RC films are still used for hard candy strip packaging, as layers separating hot-filled traditional jams (e.g., sweet potato, quince) from their molds until solidification, and for the temporary conditioning in bags (embossage in French; embuchado in Spanish) during the ripening process of certain types of cured meats (e.g., bondiola, another Italian-origin cured pork meat specialty). Other reported uses of RC are packaging of cough drops (Taylor, 1986), membranes for dialysis (David Halpern and Tong, 1987), ultrafiltration membranes (Klinkowski, 1989), and fibers for biomedical applications (Dhingra and Lauterbach, 1986).

5.4

Regulatory aspects of regenerated cellulose (RC) for food contact applications

5.4.1

European Union and other European countries

RC films are FCMs, which have been harmonized by the European Union. That means that all the member states (MS) must have national regulations in line with the harmonized EU legislation (i.e., EU legislation must be transposed into the national regulations). Besides, Germany has issued a specific recommendation on RC casings, which are FCMs not harmonized at present at the EU level. Also Italy has established a mandatory requisite on RC casings. Western Europe non-EU countries have also adopted EU legislation on RC films.

5.4.1.1

European Union

The essential features of the EU FCMs’ regulations and updates have been recently described by Scha¨ffer (2007, 2010, 2011), The Packaging Group at Keller and Heckman LLP (2008a), Hegarty (2009), Kopper and Ariosti (2010), Schupp (2012), Kernoghan (2013), Weel (2013), and Irvine (2014).

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The EU regulations, guidelines, and complementary information on FCMs can be found at the following websites: http://ec.europa.eu/food/food/chemicalsafety/foodcontact/index_en.htm http://ec.europa.eu/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm http://ec.europa.eu/food/food/chemicalsafety/foodcontact/legisl_list_en.htm http://ec.europa.eu/food/food/chemicalsafety/foodcontact/sci_advice_en.htm http://ec.europa.eu/food/food/chemicalsafety/foodcontact/emerging_en.htm http://ec.europa.eu/food/food/chemicalsafety/foodcontact/documents_en.htm https://webgate.ec.europa.eu/sanco_foods/main/?event¼display

For the status of transposition of EU FCMs’ legislation into national MS regulations and other information (including additional non-EU MS regulations), see “Working Document References of the European and National Legislations” (updated version September 29, 2014) (EU, 2014a). Part III—“Compendium of National Legislation on Food Contact Materials and Articles” does not claim to be a complete compilation, and is based on information provided by the MS to the EU Commission Services. Analytical methods to assess compliance of FCMs with regulations can be found at the Web site of the EU Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP), located in Ispra (Italy): http://crl-fcm.jrc.it/ At all FCMs, RC must comply with the Framework Regulation (EC) 1935/2004 (EU, 2004) and the GMP Regulation (EC) 2023/2006 (EU, 2006). RC films must comply also with the specific Directive 2007/42/EC (EU, 2007). The Framework Regulation (EC) 1935/2004 establishes in Article 3 that FCMs must be produced according to good manufacturing practices (GMPs) not to transfer their components to food in quantities which could endanger human health, or bring about unacceptable changes of food composition, or of food sensory properties owing to taints. Article 3 also establishes the principle that FCMs’ labeling, advertising, and presentation must not mislead the consumers. Article 4 sets special requirements for active and intelligent materials (AIMs) and articles. Article 5 deals with specific measures for groups of materials and articles, that is, different possible requirements according to the type of material (e.g., in the case of RC, its components must be included in positive lists, with possible restrictions on the conditions of use, or the quantity of the components used in the RC). Article 6 foresees the adoption of MS national specific measures in absence of harmonized community regulations. Other provisions of the Framework Regulation include the general requirements for the authorization of substances (Article 8); the role of the European Food Safety Authority (EFSA, located in Parma, Italy) in risk assessment (Articles 7, 9-12); role of the European Commission in the process of authorization of substances (risk management) (Articles 11-14); role of the MS competent authorities (Article 13); labeling, including the use of the symbol specified in Annex II (Article 15); declaration of compliance (DoC) of FCMs with regulation (Article 16); traceability (Article 17); safeguard measures (Article 18); public access to information (Article 19); confidentiality (Article 20); possibility of sharing existing data between applicants during the substances authorization process (Article 21); role of the Standing Committee on the Food Chain and Animal Health (instituted by Article 58(1) of Regulation (EC) 178/2002) in assisting the European

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Commission (Article 23); inspection and control measures (Article 24); and sanctions (Article 25). Annex I “List of groups of materials and articles which may be covered by specific measures,” covers 17 types of materials, RC among them. The GMP Regulation (EC) 2023/2006 establishes in Article 4 that the FCM manufacturer must ensure that general rules on GMP (set in Articles 5-7), and specific rules on GMP related to printed FCMs (set in the Annex), are applied. Article 5 establishes requirements on the quality assurance system; Article 6 deals with the quality control system; and Article 7 refers to documentation. Directive 2007/42/EC is a specific regulation on RC films (within the meaning of Article 5 of Regulation (EC) 1935/2004). According to Article 2, it applies to (a) uncoated RC films, (b) coated RC films with cellulose-based coatings, (c) coated RC films with plastics-based coatings.

Article 3 establishes that RC films corresponding to Article 2(a) and (b), must be manufactured only with substances listed in Annex II (positive list), subject to the restrictions established there, and with substances not listed in this Annex, if they are employed as coloring agents (dyes and pigments) or as adhesives, and, if there is no migration of these substances to foods, detectable by a validated method. Article 4 establishes that in the case of coated RC films corresponding to Article 2(c), RC films prior to coating must be manufactured only with substances listed in Annex II, subject to the restrictions established there; and that the plastics-based coatings to be applied, must be manufactured only with substances listed in Annexes II–VI to Directive 2002/72/EC (EU, 2002) on plastic materials, subject to the restrictions established there; besides, this type of plastic-coated RC films and articles must comply with Article 2 (overall migration limits, OMLs), Article 7 (expression of the specific migration tests results), and Article 8 (rules to be followed when performing overall and specific migration tests) of Directive 2002/72/EC. It must be taken into account that Directive 2002/72/EC was amended by Commission Directive 2004/1/EC, Commission Directive 2004/19/EC, Commission Directive 2005/79/EC, Commission Directive 2007/19/EC, Commission Directive 2008/39/EC, Commission Regulation (EC) 975/2009, and Commission Directive 2011/8/EU, and finally repealed by Commission Regulation (EU) 10/2011 (EU, 2011a), now in force. This last regulation has been amended by Commission Regulation (EU) 1282/2011 (EU, 2011b), Commission Regulation (EU) 1183/2012 (EU, 2012a), corrigendum to Commission Regulation (EU) 1183/2012 (EU, 2012b), and Commission Regulation (EU) 202/2014 (EU, 2014b). In summary, for plastics there are now a new positive list and new conditions and rules for the overall and specific migration tests to be taken into account (Scha¨ffer, 2011; Weel, 2013; Broughton, 2014). Article 5 of Directive 2007/42/EC establishes that printed surfaces of RC films should not come into contact with foods. Article 6 deals with DoC and labeling of RC films. Article 7 states that Commission Directive 93/10/EEC on RC films, and its amendments (Commission Directives 93/111/EC and 2004/14/EC), are repealed by Directive 2007/42/EC.

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The positive list (Annex II to Directive 2007/42/EC) has two parts: (a) First Part—Uncoated RC films: – RC as basic material (not less than 72% [w/w]); and – additives (e.g., softeners, anchoring agents), subject to restrictions (e.g., quantity in material [QM], specific migration limit [SML], average molecular weight). (b) Second Part—Coated RC films: – RC as basic material (not less than 72% [w/w]); – additives (see first part); and – coatings: polymers, resins, plasticizers, other additives and solvents; subject to restrictions, in general expressed as a maximum quantity of the substance per area of contact surface with food (i.e., in mg/dm2 of the coating on the side in contact with food).

5.4.1.2 Germany The main features of the FCMs’ regulatory status in Germany have been discussed in detail by Pump (2010). Section 31 “Transfer of substances onto food” of the German Food, Consumer Articles and Feed Code (Lebensmittel-, Bedarfsgegensta¨nde- und Futtermittelgesetzbuch, LFGB) is equivalent to Article 3 of the EU Framework Regulation (EC) 1935/2004, which sets the main requisites for FCMs’ interaction with foodstuffs (Pump, 2010; BfR, 2014a). Since 2002, the German Federal Institute for Risk Assessment (Bundesinstitut f€ur Risikobewertung, BfR) has been issuing recommendations on FCMs. Previously, this task had been the responsibility of the German Federal Health Office (Bundesgesundheitsamt, BGA) up to 1994, and afterward, of the German Federal Institute for Consumer’s Health Protection and Veterinary Medicine (Bundesinstitut f€ur gesundheitlichen Verbraucherschutz und Veterina¨rmedizin, BgVV) (Pump, 2010). The BfR recommendations on FCMs are not mandatory regulations but represent the best scientific and technical basis to ensure the fulfillment of the requisites of the LFGB section 31. These recommendations are based on the EU regulations and their transposition into the German legislation (BfR, 2014a). The BfR has issued “Recommendation XLIV. Artificial Sausage Casings,” last version October 1, 2014 (BfR, 2014b). The casings are not intended to be eaten and are suitable for their intended use if they comply with the requisites set in Recommendation XLIV positive lists for: I Artificial casings of cellulose hydrate (cellophane) A Base film. 1 Base substances. (a) RC. (b) RC strengthened with natural or synthetic fibers based on cellulose, or with wetstrengthened fibers based on cellulose, provided they comply with amended “Recommendation XXXVI/1. Cooking Papers, Hot Filter Papers and Filter Layers,” last version October 1, 2014. 2 Moisturizers. 3 Opacifiers and lubricants. 4 Residues of production aids: ashes value, copper content. 5 Surface refining agents. 6 Preservatives.

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B Coatings. 1 Plastics (provided they comply with the corresponding BfR recommendations). 2 Protein, hardened with glyoxal. 3 Dispersions of PVDC (provided it complies with BfR “Recommendation XIV. Polymer Dispersions,” last version October 1, 2014). Artificial casings made of real parchment. A. Base materials. 1 Fibers: bleached fibers of natural cellulose. 2 Fillers. 3 Inorganic production aids. B. Coatings: Plastics (provided they comply with the corresponding BfR recommendations). Artificial casings made of protein-coated woven fabric. A Base material. 1 Filaments of RC (e.g., Rayon©). 2 Filaments of PA (provided they comply with BfR recommendation X, “Polyamides,” last version June 1, 2013). 3 Silk filaments. 4 Cotton filaments. B Coating. 1 Protein (collagen). 2 Production aids and additives. Artificial casings made of hardened protein. A. Base film. 1 Base substances. (a) Hardened collagen. (b) Hardened collagen with cellulose fibers (provided they comply with BfR recommendation XXXVI/1). (c) Hardened collagen with PA fibers (provided they comply with BfR recommendation X). (d) Hardened collagen with fibers of poly(terephthalic acid diol esters) (provided they comply with BfR recommendation XVII, “Poly(terephthalic acid diol esters),” last version June 1, 2014). 2 Moisturizers. 3 Production aids. B. Coating: 1 Calcium alginate. 2 Polyvinyl pyrrolidone. 3 Carboxymethyl cellulose. Artificial casings made from plastic-coated woven fabric. A Base material. 1 Filaments of RC (e.g., Rayon©). 2 Opacifiers and lubricants. 3 Cotton fibers. B Coatings: Plastics (provided they comply with Commission Regulation [EU] of October 2011 and with the corresponding BfR recommendations). Artificial casings made from protein-coated woven fabric of PA or poly(terephthalic acid diol esters). A Base material: must comply with Commission Regulation (EU) of October 2011 and with BfR recommendations X and XVII.

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B Coating. 1 Protein (gelatin). 2 Production aids and additives.

A general requirement is that if colorants are used to color the artificial casings, they must comply with amended BfR recommendation IX, “Colorants for Plastics and Other Polymers Used in Commodities,” last version January 1, 2010. In summary, RC casings are not harmonized at the EU level, but the BfR recommendation XLIV establishes requirements for the use of RC in the manufacture of three types of casings (I, III, and V).

5.4.1.3 Italy The main features of the FCMs’ regulatory status in Italy have been discussed in detail by Milana (2010), Borrello and Milana (2011), Rossi (2011), and the MHIR (2014a). The main FCMs’ regulation is the Ministry of Health Decree of March 21, 1973 (in Italian: Decreto Ministeriale, DM 1973) (MHIR, 1973). From 1974 to 2013 (last amendment, November 11, 2013), it has been amended 45 times (Borrello and Milana, 2011; MHIR, 2014b [last update, November 12, 2014]). DM 1973 deals with RC in Title II—Chapter III—Articles 20–26. These articles comprise the requirements of EU Directive 2004/14/EC. EU Directive 2007/42/EC has not been transposed yet (EU, 2014a; MHIR, 2014b). Besides, Article 21 establishes that RC synthetic casings (in Italian: budelli sintetici) may be softened only using glycerol; prior to their use, RC casings must be cleaned, and after this process, the maximum content of glycerol in the casings must be 13% (w/w). Furthermore, DM 1973 comprises also technical Annex (in Italian: Allegato) IV—Section V, “Analytic Control of the RC Films Composition.”

5.4.1.4 Western Europe Non-EU countries Iceland, Liechtenstein, Norway, and Switzerland are not EU MS and have constituted the European Free Trade Association (EFTA) since 1960. In 2004, the EU MS and the EFTA MS, except Switzerland, created the European Economic Area (EEA), an internal market consolidated by the same basic rules. As EEA MS, Iceland, Liechtenstein, and Norway can participate in the preparation of EU regulations, the latter must be accepted by the EFTA MS before their implementation in these three countries. Switzerland sanctions its own regulations and can sign agreements with the EU. Iceland and Norway, along with Denmark, Finland, and Sweden (the three countries are EU MS), participate in the Nordic Council of Ministers (Rossi, 2007; Fabech et al., 2010). In general, there is a trend to align the four non-EU countries’ FCMs’ regulations with the EU legislation. In Iceland and Liechtenstein, EFTA or EU FCMs’ legislations apply in absence of national regulations. In Lichtenstein, Swiss regulations apply directly if there are no national, EFTA, or EU FCMs’ legislations. On the other hand, Norway and Switzerland apply national FCMs’ regulations when there is no harmonized EU legislation (Rossi, 2007; Fabech et al., 2010; Meuwly and Dudler, 2010; EU, 2014a).

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In Norway, almost all of the EU FCMs’ regulations have been implemented. In the case of RC films, EU Directive 2004/14/EC has been transposed into the national legislation (last update, December 21, 2011) (Rossi, 2007; Fabech et al., 2010; EU, 2014a). In Switzerland, the main FCMs’ regulations in force are the Federal Law on Food and Commodities (reference number SR 817.0); the Ordinance on Food and Commodities (SR 817.02); and the Ordinance on Materials and Articles (SR 817.023.21) (Rossi, 2007; Meuwly and Dudler, 2010). This last Ordinance adopted EU Directive 2007/42/EC on RC films (Swiss DFI, 2014). Requirements on RC films are established by Section 4: Cellulose film (cellophane) objects of Ordinance SR 817.023.21 (Articles 13–19), and by Annex 2 (positive list for uncoated RC films) and Annex 3 (positive list for coated RC films). In the case of using plastics-based coatings on the RC base film, Section 3: Plastic objects and materials (Articles 6–12) and Annex 1 (plastics positive list) are mandatory.

5.4.2 5.4.2.1

The Americas US Food and Drug Administration (FDA)

The essential features of the US FDA FCMs’ regulations and updates have been recently described by Twaroski et al. (2007), The Packaging Group at Keller and Heckman LLP (2008b), Misko (2009), Baughan and Attwood (2010), Kopper and Ariosti (2010), Greenberg (2011), Twaroski (2011), Bailey (2012), Irvine and Kernoghan (2013), Greenberg and Rost (2014), and Jacobs (2014). The regulations can be found at the following Web site: www.fda.gov. The US FDA regulates the use of RC in contact with foodstuffs mainly in the following sections of the Code of Federal Regulations (CFR), Title 21: 1 177.1200 Cellophane (US FDA, 2014a): Cellophane is defined as an RC base material to which the following optional substances can be added: (a) substances generally recognized as safe (GRAS); (b) substances for which prior approval or sanctions (i.e., those issued before 1958) exist that allow their use in cellophane; (c) substances that may be safely used in cellophane according to any regulation issued under section 409; and (d) substances included in the positive list at section 177.1200, subjected to residue limits and limits of addition. 2 179.45 Packaging materials for use during the irradiation of prepackaged foods (US FDA, 2014b): nitrocellulose or vinylidene chloride copolymer-coated cellophane complying with section 21 CFR 177.1200, may be subjected to a dose of radiation (gamma, electron beam, or X-radiation) not to exceed 10 kilograys, during the treatment of prepackaged foods.

Substances that can be used in the manufacture of RC are also mentioned in sections 21 CFR 178.2010, 178.3280, and 178.3870. Besides, Food Contact Notification (FCN) No. 45 (granted to Life Technologies, Inc., June 10, 2000) (US FDA, 2014c) allows the use of two quaternary amine cellulose ion exchange resins (based on a matrix of RC cross-linked and alkylated with epichlorhydrin and propylene oxide) for the treatment of water and foods passing through them at temperatures up to 50 °C, and in a pH range 2–10.

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5.4.2.2 Canada The essential features of the Canadian FCMs’ regulations and updates have been recently described by Vivas (2013), Mattu (2014), Health Canada/Sante´ Canada (HC/SC, 2014), and the Canadian Food Inspection Agency/Agence Canadienne d´ Inspection des Aliments (CFIA/ACIA, 2014). The last two are official agencies involved in FCMs’ regulation and control. More details can be found at the respective Web sites: www.hc-sc.gc.ca and www.inspection.gc.ca. All FCMs must comply with the basic requirement of Division 23 “Food Packaging Materials” of the Food and Drugs Act and Regulations (last update December 8, 2014), Section B.23.001 forbids the sale of foods in packages that may transfer to the product, substances that may be injurious to the consumers’ health. In Canada, this is the responsibility of the food seller (manufacturer, distributor, etc.) to ensure that food packaging will meet that requirement. Though the premarket approval of FCMs is voluntary rather than mandatory, even for certain FCMs previously cleared by the CFIA/ACIA, since July 2, 2014 (CFIA/ACIA, 2014), companies are expected to comply with that basic requirement. For the voluntary clearance of an FCM, the process consists of the submission of an application with the required information by the FCM manufacturer; its assessment by HC/CS; the emission of a Letter of No Objection (LONO) to the use of the FCM by HC/ CS; and its inclusion in the “Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products” available from the CFIA/ ACIA Web site (CFIA/ACIA, 2014). This list will not include new LONO (according to the above-mentioned changes of July 2, 2014), but will be kept as a reference only. The reference list is not a positive list, as the FCMs are included for each company on a case-by-case basis; and they are mentioned either by their trademark, or a special code, or a brief material description. For instance, in a search for Category: packaging materials, and Subcategory: casing unprinted (q4) from the database updated June 27, 2014, 605 items were retrieved, several of which specifically mentioned RC.

5.4.2.3 MERCOSUR (the Common Market of the South) The essential features of the MERCOSUR FCMs’ regulations and updates have been described by Padula and Ariosti (2002), Padula and Cuervo (2004), Padula (2010, 2013), Kopper and Ariosti (2010), Ariosti (2011, 2012, 2013a, 2013b, 2014), and Ariosti and Olivera Carrio´n (2014). The regulations can be found at the following Web sites: www.mercosur.int (in Portuguese and Spanish), www.puntofocal.gov.ar (in Spanish), and www.anvisa.gov.br (in Portuguese). In summary, the Common Market of the South (MERCOSUR, in Spanish; MERCOSUL, in Portuguese) was founded by the Treaty of Asuncio´n (Paraguay) in 1991. The original MS were Argentina, Brazil, Paraguay, and Uruguay. The MERCOSUR Technical Secretariat is located in Montevideo, the capital of Uruguay. Afterward, in 1994, the MERCOSUR present institutional structure was established by the Protocol of Ouro Preto (Brazil). Venezuela applied as candidate MS in July 2006, and joined the block on July 31, 2012. The MERCOSUR executive body is the Common

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Market Group (GMC) that sanctions the harmonized resolutions on different subjects, thus being responsible for risk management. In the case of FCMs, the MERCOSUR Food Commission (specifically through its Food Packaging Group), that depends on the MERCOSUR SGT 3 (Technical Subgroup 3 Technical Regulations and Conformity Evaluation), is responsible for risk assessment. The GMC Resolutions are referenced by the designation xx/yy, where xx is the consecutive Resolution number in a determined year, and yy are the two last digits of that year. For instance, the last regulation on FCMs sanctioned by the GMC was GMC Resolution 02/12 (the positive list of plastic polymers and monomers) in 2012. To be legally binding in each MS, the GMC Resolutions must be transposed into the national legislations (as the EU Directives). At present, no legal instruments similar to the EU Regulations (which do not need a formal transposition to be legally binding) are foreseen in MERCOSUR. The first regulation issued on FCMs was GMC Resolution 3/92, General criteria for packaging materials and articles for food contact (MERCOSUR, 1992a). This Framework Resolution establishes general requirements for FCMs as in the European Union, for example, manufacture according to GMPs, inclusion of components in positive lists, purity criteria, and restrictions of use for certain components (e.g., QM), controlled levels of components migration (OMLs and SMLs) that ensure nonsignificant risk for the consumers’ health, and no sensory changes in foods due to taints. The Framework Resolution establishes a premarket approval of food packaging and other final articles intended to come into contact with food, before introducing them into the market. According to this system, the food packaging or final article manufacturer must submit a petition (along with documentation demonstrating its compliance with the MERCOSUR regulations) to the safety authorities, which then issue the clearances (approvals or authorizations of use on a case-by-case basis). The system has been applied in Argentina since the late 1970s, even before the creation of the MERCOSUR. However, in Brazil, since 2000, only FCMs manufactured with new technologies (e.g., recycled materials) must be submitted to this system of premarket approval. Nevertheless, in Brazil all types of FCMs (with or without mandatory premarket approval) must comply with the MERCOSUR regulations. Besides, there are two specific regulations for RC in force: (1) GMC Resolution 55/97 RC films for food contact (MERCOSUR, 1997). This Resolution is based on the former EU Directive 93/10/EEC (EU, 1993) (which has been repealed by EU Directive 2007/42/EC [EU, 2007]). This GMC Resolution does not apply to: (a) RC casings (in Portuguese and Spanish: tripas sinte´ticas). (b) RC films coated with a layer of resins or polymers in a quantity greater than 50 mg/dm2 of the coating on the side in contact with food. In this last case, several GMC Resolutions on plastic FCMs apply. For a complete updated list of these GMC Resolutions in force, see Ariosti (2014), and Ariosti and Olivera Carrio´n (2014). The main requirements for plastic FCMs are (Ariosti, 2014) as follows: – Inclusion of components (monomers, polymers, and additives) in positive lists. – Compliance with the OMLs. – Compliance with the SMLs.

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Compliance with QMs. To avoid undesirable changes of food sensory properties due to taints. Specific requisites on pigments and colorants. General prohibition of plastics reuse (with exceptions, e.g., in the case of recycled postconsumer PET decontaminated by means of validated technologies). In Paragraph 3, “General dispositions,” GMC Resolution 55/97 establishes that:

(a) RC films must be manufactured according to GMPs. (b) Only substances included in the positive list (Paragraph 4) can be used in the manufacture of RC films for food contact. (c) The criteria for updating the positive list are those described in GMC Resolution 56/92, General criteria for plastic materials and articles for food contact (MERCOSUR, 1992b). These criteria have been updated by GMC Resolution 32/07, Positive list of additives for plastic materials and articles for food contact (MERCOSUR, 2007) and by GMC Resolution 02/12, Positive list of monomers, other starting substances and polymers for plastics for food contact (MERCOSUR, 2012). (d) Printed surfaces of RC films must not be in contact with foods. (e) Only colorants and pigments that comply with the requirements of GMC Resolution 56/92 and GMC Resolution 28/93, Pigments and colorants for plastics for food contact (MERCOSUR, 1993) must be used; these requirements have been updated by GMC Resolution 15/10, Pigments and colorants for plastics for food contact (MERCOSUR, 2010a), which repealed GMC Resolution 28/93. (f) RC films must be authorized/approved by the safety authorities before their manufacturers put them into the market; (g) Changes in the composition of RC films must be informed to the safety authorities. Paragraph 4 contains the positive list, which is divided into two parts: (a) Part 1: Uncoated RC films. This part mentions RC as basic material (no less than 72% [w/w]), and different kinds of additives (e.g., softeners, anchoring agents). (b) Part 2: Coated RC films. This part mentions RC as basic material (no less than 72% [w/w]), different kinds of additives for the RC film, and coating components (polymers, resins, additives [e.g., plasticizers, with restrictions], and solvents). Coatings in general must be present in a quantity not greater than 50 mg/dm2 of the coating on the side in contact with food; in particular, cellulose nitrate coatings must be present in a quantity not greater than 20 mg/dm2 of the coating on the side in contact with food; in the case of certain resins, they must be present in a quantity not greater than 12.5 mg/dm2 of the coating on the side in contact with food; solvents must be present in a quantity not greater than 0.6 mg/dm2 of the coating on the side in contact with food. (2) GMC Resolution 68/00, RC synthetic casings for food contact (MERCOSUR, 2000) This Resolution is based on the BfR recommendation XLIV, Artificial Sausage Casings, according to the version in force in 2000. This GMC Resolution does not apply to the following: (a) RC films. (b) RC casings coated with a layer of resins or polymers greater than 100 mg/dm2 of the coating on the side in contact with food. In paragraph 3, “General dispositions” of GMC Resolution 68/00 sets the same requirements as GMC Resolution 55/97. In addition, it establishes the following:

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(a) Overall migration tests must be performed according to the MERCOSUR regulation in force for plastics. At present, this is GMC Resolution 32/10, Migration of plastic materials intended to come into contact with foodstuffs (MERCOSUR, 2010b), that repeals GMC Resolutions 30/92, 36/92, 10/95, 11/95, 15/97, 32/97, and 33/97. The OMLs are 50 mg/kg or 8 mg/dm2, which are established in GMC Resolution 56/92 (MERCOSUR, 1992b). (b) RC casings must comply with microbiological specifications compatible with the foods in contact. (c) RC casings must not taint food. Paragraph 4 contains the positive list that covers the following: (a) Basic components (RC, RC reinforced with natural or synthetic cellulose-based fibers, RC reinforced with wet-strengthened RC fibers). (b) Additives (e.g., moisturizers, opacifiers, lubricants, surface refining agents, preservatives). (c) Coatings. (d) Requisites for maximum ashes value, and for maximum sulfur and copper contents.

Both GMC Resolutions have been transposed into the Argentine Food Code, Chapter IV—Article 186 tris (RC films) and Article 186 quarter (RC casings); and into the Brazilian Federal legislation by resolution of the Collegiate Directorate of the National Agency of Sanitary Surveillance (ANVISA RDC) No. 217/02 of August 1, 2002 (RC films) and ANVISA RDC No. 218/02 of August 1, 2002 (RC casings).

5.4.2.4

Colombia

The essential features of the Colombian FCMs’ regulations and updates have been recently described by Ariosti (2011, 2012, 2013a,b, 2014). In South America, Colombia belongs to the Andean Community of Nations (in Spanish: Comunidad Andina de Naciones, CAN) block, along with Bolivia, Ecuador, and Peru. The following national regulations sanctioned by the Colombian Ministry of Health and Social Protection are of interest in the case of RC: – – –

Resolution 683/2012 (March 28, 2012)—Framework Resolution on FCMs in contact with foodstuffs and beverages. Resolution 834/2013 (March 26, 2013)—General and specific dispositions on cellulosic materials in contact with foodstuffs and beverages (RC is defined as a cellulosic material). Resolution 2674/2013 (July 22, 2013)—Sanitary requirements for the manufacture, packaging, handling, storage, and retailing of foodstuffs.

The Colombian Ministry of Health and Social Protection has also sanctioned the following regulations: – – –

Resolution 4142/2012 (December 7, 2012)—General and specific dispositions on metallic materials in contact with foodstuffs and beverages. Resolution 4143/2012 (December 7, 2012)—General and specific dispositions on plastic and elastomeric materials in contact with foodstuffs and beverages. Resolution 835/2013 (March 26, 2013)—General and specific dispositions on glass and ceramic materials in contact with foodstuffs and beverages.

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FCMs must be manufactured according to GMPs, using substances included in the positive lists established by the regulations in force in the European Union, MERCOSUR, or the United States. FCMs shall be approved by the National Institute of Drug and Food Surveillance (in Spanish: Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA). The INVIMA shall also establish migration methods and other tests on FCMs. For instance, the INVIMA has recently sanctioned Resolution 22808/2014 (July 22, 2014), Migration tests and verification of the compliance of the global and specific migration limits established by Resolution 4142/2012 and Resolution 4143/2012.

5.4.3

Asia Pacific

5.4.3.1 Japan The essential features of the Japanese FCMs’ regulations and updates have been recently described by Mori (2010), Kopper and Ariosti (2010), Ota (2011), Ettinger and Clark (2012), Kawamura (2013), and Mutsuga (2014). In summary, the following regulations deal with FCMs (JETRO, 2011): (a) Two national laws on food safety. (1) The Food Sanitation Act (Act 233 of December 24, 1947; last reported revision Act 49 of June 5, 2009), which is under the jurisdiction of the Ministry of Health, Labour, and Welfare (MHLW, 2014); and (2) The Food Safety Basic Act (Act 48 of May 23, 2003) (Japan Food Safety Commission, 2014), which is under the jurisdiction of the Japan Cabinet Office. (b) Two ministerial regulations on food safety (JETRO, 2011). (1) Ministerial Ordinance on milk and milk products concerning compositional standards, etc. (Ministry of Health and Welfare Ordinance 52, 1951; last reported revision on October 30, 2007, MHLW Ministerial Ordinance 132); and (2) Specifications and standards for food and food additives, etc. (Ministry of Health and Welfare Notification 370, 1959; last reported revision on September 6, 2010, MHLW Notification 336).

There are two documents published in English by the Japan External Trade Organization (JETRO) of particular importance: –

–

Document 1: Specifications and standards for foods, food additives, etc., under the Food Sanitation Act (Abstract) 2010 (JETRO, 2011), is an outline of specifications and standards for foods; milk and milk products; food additives, apparatus and containers/packages (Chapter IV); toys; and cleaning agents (detergents); corresponding to (a)(1), (b)(1), and (b)(2). Document 2: Specifications, standards, and testing methods for foodstuffs, implements, containers, and packaging, toys, detergents 2008 (JETRO, 2009) contain the standards and testing methods for foods; implements, containers and packaging (Chapter II); toys; and detergents; corresponding to (a)(1) and (b)(2).

There is no specific regulation on RC, but in the case of colored RC, the material must comply with Section 3—Part A. Specifications for Apparatus or Containers/Packages, or their Materials in General—Item 6 Colors (Table AP01 of document 1), that establishes that for all types of colored materials, only the coloring agents listed in Table 1

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of the Enforcement Regulations must be used (excepting the cases where the coloring agents have no possibility of migrating into foods). In some practical cases, for instance, moisture-proof RC coated with PVC or PVDC, or RC combined by lamination with PE or PP, the plastic resins must comply with the requisites established in Section 3—Part D. Specifications for Apparatus and Containers/Packages, or their Materials by Material (Table AP02 of document 1). These requisites are, for instance, maximum content of cadmium (Cd) and lead (Pb) in plastics, evaporation residue and quantity of potassium permanganate (KMnO4) consumed in the elution (migration) test with different simulants, maximum content of certain specific components of plastics (e.g., vinyl chloride monomer [VCM] in PVC, etc.). RC is specifically mentioned in Table AP05, Specifications and Standards for Milk and Milk Products of document 1, for the manufacture of containers or packages of synthetic resins laminated with aluminum foil, cellophane or paper, for prepared milk powder. Table AP05 establishes several requisites according to the type of plastic (PE, LLDPE, or PET) that comes into contact with food; for instance, in the case of structures in which PET is the material in contact with food, Table AP05 establishes SMLs for germanium (Ge) and antimony (Sb) in the elution (migration) test. Finally, RC is also mentioned in document 2 (Section D-2 Powdered drink beverages—Item 2. Production standards for powdered drink beverages). General requisites related to GMPs for packaging and storage of this kind of products are established.

5.4.3.2

China

The essential features of the Chinese FCMs’ regulations and updates have been recently described by Eldred et al. (2010), Li and Bian (2010), Fan (2011), Zhu (2012, 2013), Baughan (2013), Bian (2013), Kenny (2013a), and Zhang (2014). FCMs in China are regulated pursuant to the Food Safety Law, which became effective on June 1, 2009. A draft revision to the Food Safety Law was recently proposed but has not yet been finalized (The People’s Republic of China, 2013). The draft revision was principally approved by the State Council on May 14, 2014 (The People’s Republic of China, 2014). The law requires that FCMs comply with an applicable Food Safety Standard. In addition, there are a wide variety of standards applicable to food-contact coatings, paper, and polymers. There are two main types of national standards in force in China: GB standards, which are mandatory, and GB/T standards, which are voluntary or recommended. GB is the acronym of Guobiao, in Chinese, meaning “national standard.” Besides, there are local or provincial standards (DB), and professional or industry standards (QB, BB, HG, etc.). When the standard nomenclature includes “/T,” it means that they are voluntary, independently of being national, local, or professional standards (Kenny, 2013a). China’s “Hygienic Standard for Uses of Additives in Food Containers and Packaging Materials” (GB 9685-2008) provides a list of additives permitted in FCMs and became effective on June 1, 2009. This is the most well-known Chinese FCMs standard.

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Although GB 9685-2008 does not include any listing that specifically references RC, there are a number of listings relevant to cellulose-based materials. For example, GB 9685 includes listings for cellulose, 2-hydroxypropyl methyl ether (CASRN 900465-3); cellulose, 2-hydroxyethyl ether (CASRN 9004-62-0); cellulose, carboxymethyl ether, sodium salt (CASRN 9004-32-4); cellulose, methyl ether (CASRN 9004-67-5); cellulose, ethyl 2-hydroxyethyl ether (CASRN 9004-58-4); and cellulose, ethyl ether (CASRN 9004-57-3). Regarding food-contact articles composed of RC, the most relevant Chinese standard is GB/T 24695-2009 “Standard for cellophane used for food packaging.” This standard primarily includes performance specifications for RC films. For example, the standard sets specifications on categorization, testing methods, labeling, packaging, transportation, and storage for RC used for food packaging. Further, GB/T 24695-2009 requires that hygienic specifications in GB 11680-1989 “Hygienic standard of paper used for food packaging” be met. The latter standard establishes sensory requirements, physicochemical specifications (e.g., lead [Pb], arsenic [As]; decoloring test), and limits on fluorescent substances and microbial specifications. Fluorescent substance is also one of the physicochemical specifications in GB 19305-2003, Hygienic standard for foodstuff vegetable fiber of container. In addition, GB 19305-2003 regulates food containers made from fiber plant pulp and starch as well as other manufacturing processes. Both GB/T 24695-2009 and GB 19305-2003 are finished article standards, which do not provide explicit clearances for RC. However, their existence presumes that RC may be used for certain food-contact applications. The Food Safety Law currently requires that individual substances be approved, in addition to the requirement that they comply with any specifications applicable to that food packaging material under Chinese standards. China has also published a number of other national standards that are relevant to cellulose-based materials. Though these standards are not directly applicable to foodcontact applications, they may be useful references in this regard. Specifically, China’s GB 29946-2013, Standard for food additive cellulose, will take effect on June 1, 2014. This standard applies to food additive cellulose derived from purified and ground a-cellulose pulp of fibrous plants. Finally, the Chinese authorities have published a number of testing methods relevant to RC and/or cellulose fibers used in FCMs (e.g., SN/T 3551-2013, “Food contact materials—Paper, regenerated fiber— Determination of benzophenone and 4-methylbenzophenone via GCMS”; SN/T 3550-2013 Food contact materials—Paper, regenerated fiber—Determination of 4,40 -bis(dimethylamino)-benzophenone and 4,40 -bis(diethylamino)-benzophenone via GCMS; SN/T 2205-2008 “Food contact materials—Paper and regenerated cellulose— Evaluation method for fiberboard box”).

5.4.3.3 South Korea The essential features of the South Korean FCMs’ regulations and updates have been recently described by Yoon and Lee (2010), Lee and Yoon (2011), Kenny (2013b), Keithline (2014), and MFDS (2014). The South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration (KFDA), Web site (in English) is www.mfds.go.kr/eng/

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The main FCMs’ regulation is the Food Code. Article 7, Standards and specifications for equipment, containers and packages (MFDS, 2014) establishes general requirements for FCMs in Part 1, General Standards, along with specific requirements for different types of materials in Part 2, Material Standards. For instance, Part 2—Section 2, Cellophane: RC film, establishes specific requisites for coated and uncoated RC films (heavy metals content, arsenic [As] content, and nonvolatile residue of the migration test under certain conditions). Part 2—Section 1 Synthetic polymers, may be applied for plastics-based coatings. This section sets requirements for 41 synthetic polymers (e.g., VCM maximum content in PVC, VDCM maximum content in PVDC).

5.4.3.4

Australia and New Zealand

The essential features of the Australia and New Zealand FCMs’ regulations and updates have been described by Nielsen (2002), Brent (2007), Steele (2010), and Magnuson et al. (2013). The regulations and summaries of standards related to FCMs can be found at the following Web sites: www.comlaw.gov.au, www.comlaw.gov.au/ Search/Australia New Zealand Food Standards, www.foodstandards.gov.au, and www.foodsafety.govt.nz. The Commonwealth of Australia and the Australian States and Territories signed an Inter-Governmental Food Regulation Agreement (FRA) on November 3, 2000, agreeing to have a new food regulatory system. The last update of the FRA was in 2008. The Governments of Australia and New Zealand signed an Agreement on December 5, 1995, establishing a System for the Development of Joint Food Standards (the Treaty), to create a joint Australia New Zealand Food Standards Code, and the first binational government agency (Australia New Zealand Food Authority or ANZFA) between both countries. New Zealand adopted the Code in 2001 and it took full effect in 2002. Besides, New Zealand sanctioned regulations to cover food safety requirements on issues that fall outside the scope of the joint system. On July 1, 2002 the Food Standards Australia New Zealand (FSANZ) was given the responsibility for developing, varying, and reviewing food standards for both countries. The treaty was last updated in 2010 (FSANZ, 2014; The Ministry for Primary Industries—New Zealand, 2014). The Australia New Zealand Food Standards Code does not set specific requirements for FCMs, but establishes general requisites for them in Standard 1.4.3 Articles and materials in contact with food (FSANZ, 2000), that is, articles and materials may be placed in contact with food, if they are not capable of being swallowed or of obstructing any alimentary or respiratory passage, or of causing bodily harm, distress, or discomfort. Besides, it is the responsibility of food manufacturers and retailers to ensure that their FCMs are safe and that they comply with all relevant legislation. Standard 1.4.3 indicates that Standards Australia has developed Australian Standard AS 2070-1999 for plastic materials for food contact use. AS 2070-1999 is a voluntary guide for the industry for the manufacture of plastic materials that can be used for food contact. This standard refers to the US and EU regulations in force for plastics intended to come into contact with foods. Besides, Standard 1.4.1, Contaminants and natural toxicants (FSANZ, 2013) regulates the maximum level of certain substances that can be present in food from different sources, including FCMs. For instance, of special interest for tinplate is tin

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(maximum quantity in canned foods: 250 mg/kg); and for plastic FCMs, the monomers, acrylonitrile (maximum quantity in all types of food: 0.02 mg/kg) and VCM (maximum quantity in all types of food (except packaged water): 0.01 mg/kg). AS 2070-1999 and Standard 1.4.1 are of interest in the case of coated RC intended to come into contact with foodstuffs. Magnuson et al. (2013) present a useful summary of the food regulatory framework in Australia and New Zealand (Table 2, item “Food contact substances”). In it, the authors report that for the approval process of new substances, submissions for food packaging applications are generally not necessary if there is a previous recognition/ approval in the United States or the European Union.

5.5

Perspectives and future trends

A new interest developed in the last decades regarding the use of abundant renewable resources-based FCMs, which can be biodegradable and compostable without leaving residues that can pose any ecotoxicological or other environmental risk (Paunonen, 2013). RC and coated RC biodegradability in landfills or soil has been reported by Taylor (1986), Zhang and Liu (1996), Simon et al. (1998), Zhang et al. (1999), Tharanathan (2003), Lu et al. (2004), and Yam and editorial staff (2009). The possible pollution issues of carbon disulfide, hydrogen sulfide (H2S), and other hazardous by-products produced during RC manufacture via the traditional viscose route must be considered (Yam and editorial staff, 2009; Paunonen, 2013). RC is a material that belongs to a wider family of modified natural polymers called cellulose derivatives. Several new approaches to the dissolution of cellulose and for its chemical modification in dissolved state are being studied or developed. The objectives of these developments are not only to improve the processability and the performance (mechanical and barrier properties) of cellulose derivatives but also to diminish possible environmental risks (Paunonen, 2013). In her review, Paunonen (2013) describes the following environmental friendly methods for dissolving cellulose that could be applied in the manufacture of RC: (1) NMMO method (Fink et al., 2001) uses an NMMO (N-methylmorpholine-N-oxide)/water mixture as a dissolving agent. NMMO can be recovered after the process of regeneration of cellulose in a precipitation bath. (2) AU method (Yang et al., 2011) uses an alkali/urea/water mixture as a dissolving agent, and regeneration with acetone. The RC films thus obtained had better oxygen barrier than conventional RC films. (3) Enzymatic method in which purified Trichoderma reesei endoglucanases are used to help dissolve hardwood dissolving pulps in alkali (Rahkamo et al., 1996). RC thereby obtained can be used for the manufacture of cellophane films, fibers, and cellulose or cellulosecontaining composite membranes.

Pang et al. (2013) also used ionic liquid 1-allyl-3-methylimidazolium chloride (AmimCl) as the solvent for dissolving pulp to manufacture RC films. To reduce costs, some methods to produce new types of cheaper dissolving pulps (different from the conventional sulfite pulps) have been explored (Higson, 2011). One of these

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technologies began its commercial application in Finland in 2011. Two other technologies have been developed: biomass fractionation (into lignin, cellulose and hemicelluloses) and production of cellulose by bacteria (e.g., Acetobacter xylinum) by a fermentative way. Recently, surface modification of RC membranes by esterification with two fatty acid derivatives (hexanoyl and dodecanoyl chlorides) has been performed (Tome´ et al., 2011; Paunonen, 2013). Modified RC membranes had lower thermal stability, but higher barrier to water vapor, and to gases in the wet state (however, not in the dry state), than the conventional untreated RC membranes. These property changes could open the way to new applications of food packaging. RC has been studied as a potential active FCM, by means of absorption of nisin—a bacteriocin (peptide of bacterial origin)—onto RC films. When nisin migrates to foodstuffs during storage, it can act as an antimicrobial active agent on certain types of microorganisms, and thus as a preservative that improves the shelf life of certain types of foods (Guerra et al., 2005; Ga´lvez et al., 2007; Paunonen, 2013). RC films with incorporated lactic acid or sodium lactate have also been studied as active FCMs (Hanusˇova´ et al., 2009). In their review, Kerry et al. (2006) report the studies of control of the pathogen Listeria monocytogenes in meat-derived foods with active RC casings containing pediocin (another bacteriocin) and nisin (Ming et al., 1997), and a heat-resistant Pediococcus-derived bacteriocin in combination with a chelating agent (Katz, 1999). For the commercial applications of these kinds of active RC, specific regulations in force in a determined jurisdiction must be taken into account. For instance, EU Commission Regulation (EC) 450/2009 (EU, 2009) establishes the requisites for AIMs. In the case of active FCMs, the requisites for the active agent established by the food regulations must also be accomplished (Rijk, 2007; Scha¨ffer, 2010; Kopper and Ariosti, 2010). A revival of RC (conventional and new types) in food applications, then, is an open issue of discussion, taking into account their biodegradable/compostable properties but also concerns about the environmental impact of some of their manufacture reactants and residues. The latter would be diminished if new developments based on scientific work could successfully be brought into industrial sustainable applications, to provide safe materials for consumers, with enhanced environmental friendly properties.

Acknowledgments I wish to thank Dr. Yoko Kawamura (senior advisor at the Japan National Institute of Health Sciences [NIHS]), for her useful comments on practical cases of RC assessment according to the Japanese regulations; Joan Baughan and the Keller & Heckman LLP team, for kindly providing information in English on the Chinese FMCs’ regulations and standards; and the management team and staff of DECERNIS, whose g-Comply system was used for the preliminary search of regulations on RC.

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References Ariosti, A., 2011. Recent general and country-specific developments in FCMs legislation in South America. In: Proceedings of the Global Food Contact Conference (Frankfurt am Main, Germany, 14-16 June). Pira International, Leatherhead, UK, pp. 1–49. Ariosti, A., 2012. General situation of FCMs regulations in Latin America and an update of the MERCOSUR advancement. In: Proceedings of the Plastics and Paper in Contact with Foodstuffs Conference (Vienna, Austria, 11-14 December). Smithers Pira, Leatherhead, UK, pp. 1–121. Ariosti, A., 2013a. Regulations on plastics in contact with foodstuffs—present situation in MERCOSUR and other Latin American countries. In: Proceedings of the 11th Biennial International Symposium on Worldwide Regulation of Food Packaging (Baltimore, Maryland, USA, 4-6 June). The Society of the Plastics Industry Inc., Washington DC, pp. 1–37. Ariosti, A., 2013b. Panorama of legislative advancements in the MERCOSUR region and other Latin American countries. In: Proceedings of the Global Food Contact Conference (Barcelona, Spain, 14-16 May). Smithers Pira, Leatherhead, UK, pp. 1–61. Ariosti, A., 2014. Food contact materials regulatory developments in MERCOSUR and other South American countries. In: Proceedings of the Global Food Contact Conference (Silver Spring, Maryland, USA, 12-14 May). Smithers Pira, Leatherhead, UK, pp. 1–35. Ariosti, A., Olivera Carrio´n, M., 2014. Argentina. In: Kirchsteiger-Meier, E., Baumgartner, T. (Eds.), Global Food Legislation: An Overview. Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, pp. 1–32. Bailey, A., 2012. An update of the US FDA´s Food Contact Notification (FCN) Program. In: Proceedings of the Global Food Contact Conference (Baltimore, Maryland, USA, 15-17 May). Smithers Pira, Leatherhead, UK, pp. 1–28. Balafas, D., Shaw, K.J., Whitfield, F.B., 1999. Phthalate and adipate esters in Australian packaging materials. Food Chem. 65, 279–287. Baughan, J.S., 2013. Food contact regulatory developments in China. In: Proceedings of the Plastics and Paper in Contact with Foodstuffs Conference (London, UK, 9-12 December). Smithers Pira, Leatherhead, UK, pp. 1–34. Baughan, J.S., Attwood, D., 2010. Food packaging in the United States. In: Rijk, R., Veraart, R. (Eds.), Global Legislation for Food Packaging Materials. Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, pp. 223–242. Benticuaga, I.V., Tesone, S., Quevedo, F., 1985. Microflora de mortadela envasada en celofa´n y almacenada en refrigeracio´n y a temperatura ambiente. Noticiteca 15 (88), 113–118. BfR, 2014a. Database BfR Recommendations on Food Contact Materials. Bundesinstitut f€ ur Risikobewertung, Berlin. Available from: www.bfr.bund.de/en/database_bfr_recommen dations_on_food_contact_materials__formerly__plastics_recommendations__-1711. html[Accessed 1 July 2014]. BfR, 2014b. Recommendation XLIV. Artificial Sausage Casings—As of 01.10.2014. Bundesinstitut f€ur Risikobewertung, Berlin. Available from: http://bfr.zadi.de/kse/faces/ resources/pdf/440-english.pdf [Accessed 19 December 2014]. Bian, S., 2013. Food contact compliance in China: the view from industry. In: Proceedings of the 11th. Biennial International Symposium on Worldwide Regulation of Food Packaging (Baltimore, Maryland, USA, 4-6 June). The Society of the Plastics Industry Inc., Washington DC, pp. 1–31. Borrello, S., Milana, M.R., 2011. Perspectives from the host regulator—current challenges in Italian food contact legislation. In: Proceedings of the Plastics and Paper in Contact with

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Appendix: list of acronyms AIM ANVISA RDC

ANZFA BfR BGA BgVV

BOPP BS CAN CASRN CFIA/ACIA CFR DEG DFI DM 1973 DoC EEA EFSA EFTA EG EU FCM FCN FCS FDA FRA FSANZ GCMS GMC GMP GRAS HC/SC IHCP INVIMA

active and intelligent material Resolution of the Collegiate Directorate of the National Agency of Sanitary Surveillance (in Portuguese: Resoluc¸a˜o da Diretoria Colegiada da Ageˆncia Nacional de Vigil^ancia Sanita´ria) (Brazil) Australia New Zealand Food Authority German Federal Institute for Risk Assessment (in German: Bundesinstitut f€ur Risikobewertung) German Federal Health Office (in German: Bundesgesundheitsamt) German Federal Institute for Consumer’s Health Protection and Veterinary Medicine (in German: Bundesinstitut f€ ur gesundheitlichen Verbraucherschutz und Veterina¨rmedizin) bi-oriented polypropylene British Standard Andean Community of Nations (in Spanish: Comunidad Andina de Naciones) Chemical Abstract Service reference number Canadian Food Inspection Agency/Agence Canadienne d´ Inspection des Aliments Code of Federal Regulations (US) diethyleneglycol Federal Department of Home Affairs (In French: De´partement Fe´de´ral de l’Inte´rieur) (Switzerland) Ministerial Decree 21 March 1973 (Italy, Ministry of Health) Declaration of Compliance European Economic Area European Food Safety Authority (Parma, Italy) European Free Trade Association monoethyleneglycol European Union food contact material Food Contact Notification food contact substance Food and Drug Administration (US) Food Regulation Agreement (Australia) Food Standards Australia New Zealand gas chromatography/mass spectrometry Common Market Group (in Spanish: Grupo Mercado Comu´n; in Portuguese: Grupo Mercado Comum) (MERCOSUR) good manufacturing practice generally recognized as safe Health Canada/Sante´ Canada Institute for Health and Consumer Protection (EU) National Institute of Drug and Food Surveillance (in Spanish: Instituto Nacional de Vigilancia de Medicamentos y Alimentos) (Colombia)

Global legislation for regenerated cellulose materials

ISO JRC LFGB LLDPE LONO MERCOSUR (Spanish)/MERCOSUL (Portuguese) MFDS MHLW MS OML PA PE PEG PET PG PP PVC PVDC QM RC RH SGT 3

SML VCM VDCM

139

International Organization for Standardization EU Joint Research Centre (Ispra, Italy) German Food, Consumer Articles and Feed Code (in German: Lebensmittel-, Bedarfsgegensta¨nde- und Futtermittelgesetzbuch) linear low density polyethylene Letter of No Objection (Canada) the Common Market of the South

Ministry of Food and Drug Safety (South Korea) (former KFDA, Korean Food and Drug Administration) Ministry of Health, Labour and Welfare (Japan) Member State (EU, MERCOSUR) overall migration limit polyamide polyethylene polyethylene glycol polyethylene terephthalate 1,2-propyleneglycol polypropylene poly(vinyl chloride) poly(vinylidene chloride) quantity in material regenerated cellulose relative humidity Technical Subgroup 3 “Technical Regulations and Conformity Evaluation” (in Spanish: Subgrupo Te´cnico 3 “Reglamentos Te´cnicos y Evaluacio´n de la Conformidad”) (MERCOSUR) specific migration limit vinyl chloride monomer vinylidene chloride monomer