HP Indigo for Food Flexible Packaging

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1 White paper HP Indigo for Food Flexible Packaging Regulatory Overview

Introduction HP Indigo customers who print food flexible packaging operate their businesses within a complex and strict set of regulations and guidelines set forth by both government bodies and

2 Introduction HP Indigo customers who print food flexible packaging operate their businesses within a complex and strict set of regulations and guidelines set forth by both government bodies and nongovernmental industry associations to help ensure that printed packaging does not negatively impact the products they contain. HP Indigo develops solutions and inks that enable Print Service Providers to produce flexible food packaging that can comply with regulations and industry standards. This document aims to give an overview of the status of HP Indigo ElectroInk in relation to food packaging regulations. HP Indigo ElectroInk is safe and suitable for printing flexible packaging, under set conditions of use and compliance with Good Manufacturing Practices (GMP), a framework of rules for all parties involved in the development of packaging and provides recommendations to maintain quality assurance and safety. packaging through the substrate to the packaged goods, is negligible, making HP Indigo ElectroInk compatible with regulations. Our testing has also shown that set-off, the transfer of ink or its components from the non-food contact side to the food contact side of the package, while in a stack or a roll, can be mitigated while printing on HP Indigo solutions by using drying systems and other methods. HP Indigo seeks to provide customers with the information they need about HP Indigo ElectroInk and the HP Indigo printing process, so that while maintaining the highest standards of safety, they can compete and differentiate within the ever-changing and highly regulated food packaging industry. HP Indigo has conducted tests to validate the use of our inks for printing on commonly used flexible packaging substrates, under frequently referenced conditions of use. These tests indicate that on these substrates, migration, or the transfer of substances from the 2

ElectroInk. HP Indigo ElectroInk is a liquid ink developed by HP Indigo and used exclusively by our presses, that contains electrically charged ink particles, dispersed in liquid.

3 HP Indigo ElectroInk HP Indigo sets the benchmark in the world of digital printing, with unique printing technology. In order to understand how these solutions can be used for the production of flexible food packaging, it is important to have a basic knowledge of the HP Indigo printing process and HP Indigo ElectroInk. HP Indigo ElectroInk is a liquid ink developed by HP Indigo and used exclusively by our presses, that contains electrically charged ink particles, dispersed in liquid. Strictly controlled electrical fields move charged colour particles, enabling accurate placement on the printing material. HP Indigo ElectroInk is supplied as a concentrated paste that is loaded into the press in tubular cartridges in a clean hands operation. Inside the press it is automatically fed into ink supply tanks and diluted with imaging oil, to form a fluid mixture of carrier liquid and colourant particles ready for printing. HP Indigo ElectroInk particles are very small, only 1-2 microns, allowing for higher resolution, uniform gloss, sharp image edges and very thin image layers. HP Indigo ElectroInk complies with: Article 3 of the EU Framework Regulation No. 1935/2004 when printing on the non-contact side of common polymeric food packaging materials, where the resulting packages may be used to hold all types of food at temperatures up to 100 C. Good Manufacturing Practices (GMP) of the European Union, The Swiss Ordinance on Materials and Articles in Contact with Food (RS ). The Federal Food Drug and Cosmetic Act 21 U.S.C 201 (FFDCA) requirements for printing on the non-contact side of common polymeric food packaging materials, where the resulting packages may be used to hold all types of food at temperatures up to 100 C. The EUPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles (November 2011 version). All pigments used in HP Indigo ElectroInk formulations are on either list1 or list 2 of Technical Document 1 of the Council of Europe Resolution AP (2005)2). Substrate Priming An additional important step is substrate priming. The function of the primer is to enhance adhesion of the ink to the substrate. The priming can be performed on the press itself, on the press floor, or at an offsite location. 3

4 Migration and Set-off Packaging components can be transferred to contained foods in a variety of ways. The two main types of transfer discussed here in regards to HP Indigo printed packaging are migration and set-off. Migration is defined as the transfer of a substance through the packaging material into the food. The concentration of migrants is expressed in mg/dm 2 packaging or mg/kg of foodstuff (package contents). Set-off can occur post-printing, when packaging is in stacks or rolls. At this phase of the printing process there is a risk of molecular substances transferring from the printed side of one substrate to the side of the substrate that will come into contact with food. Migration Set-off Ink Ink Ink Printed Substrate A Printed Substrate A Printed Substrate A Set Off Ink Food Printed Substrate B Parts per million (ppm) vs. parts per billion (ppb) Sugar cube (2.5 g) dissolved in: Migration Limits The volumes of migrant molecules that transfer from packaging to the packaged product depend on the starting concentration of migrants in the printed packaging, the migration speed, and the solubility of the migrant in the packaging or in the food product. To regulate within these variable factors, two major migration limit concepts have been established, measured by parts per billion (ppb). Overall Migration Limit (OML) is the maximum permitted amount of all non-volatile substances that transfer from the packaging to the contents. The maximum permitted amount of a given substance released into the food is called the Specific Migration Limit (SML). Water well 2500 L 1 milligram per kilogram (1 ppm) Reservoir 2.5 Million L 1 microgram per kilogram (1 ppb) Testing and Assessing Migration HP Indigo has conducted extensive evaluation according to recognised standards in well-known European and US laboratories and consultants, in order to evaluate HP Indigo ElectroInk compliance with food packaging regulations, shown on the tables that follow. These evaluations simulate the contact of packaging with food under defined conditions. The conditions are carefully chosen to reflect the likely conditions of use, and to simulate even more extreme conditions to assure compliance with applicable regulations. 4

5 Regulation Overview United States Food and Drug Administration (FDA) vs. European Union Systems The US (i.e. FDA) and EU systems, have very different approaches to the notion of regulatory compliance for food packaging. The EU system is based on a hazard assessment of the substance. The hazard assessment will generate a restriction on migration of the substance to food (expressed as a Specific Migration Limit or SML ). In contrast, the US conceptualisation of compliance is predicated on a safety evaluation of the intended uses of a substance in the food packaging construction, with a satisfactory evaluation resulting in a clearance that specifies the upper limit of severity of permitted uses. Compliance requires conformity to the permitted conditions of use. In both systems similar toxicology data must be evaluated, but the place that the evaluation of migration data takes in the US system differs from the EU system. For US FDA, the threshold question is What is the dietary exposure based on the migration data, for the specified conditions of use? The migration level then dictates the toxicology data needed to establish the safety of the intended use. For the EU, however, the threshold question is Are there migrating substances in the ink? The migration data comes into play after the toxological data is evaluated, in order to determine compliance once a clearance is officially adopted. USA Regulation and Food Legislation HP Indigo Compliance with US Regulations FFDCA of the FDA The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Among other functions, the FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety. The US legislation surrounding food regulation is rooted in the food additive concept. Thus, the Federal Food Drugs and Cosmetics Act defines a food additive as: any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in...packaging.). Substances are excluded from authorisation or affirmative exemption procedures if they are (1) not reasonably expected to become a component of food; (2) generally recognised as safe (GRAS) among experts qualified by scientific training and experience to evaluate their safety; or (3) prior sanctioned. With reference to (1) above, No-migration is a very significant clause. It is commonly relied upon to determine that a food packaging material need not be subjected to any of FDA s clearance or exemption processes. Based on this exclusion, manufacturers are free to market food packaging materials without prior FDA review when there is a sound basis for concluding that any food-contact substance not otherwise excluded or regulated is not a food additive because it is not reasonably expected to become a component of food under the conditions of its intended use. A sound basis for adopting a no migration no food additive position exists when diligently designed and performed extraction studies show no migration to food. This same conclusion can be derived in principle by modeling using recognised calculation methods. US Food and Drug Administration (FDA) Status of HP Indigo ElectroInk for Food Packaging HP Indigo ElectroInk, specifically, Indigo s Cyan, Magenta, Yellow, Black, White, Orange, Violet and Green, has been assessed in relation to the Federal Food, Drug,and Cosmetic Act (FFDCA) and all applicable food additive regulations, and may be used to print on the non-food contact side of the food-contact layer of polymeric multilayer food packaging. The food-contact layer may be comprised of one of the following materials: 1. Low-density polyethylene (LDPE) that is at least 40 microns thick 2. Polypropylene that is at least 20 microns thick 3. Polyester which is at least 12 microns thick 4. Polycarbonate (Lexan) that is at least 20 microns thick. The resulting packages may be used to hold all types of food at temperatures up to 100 C (also known as FDA s Condition of Use B, Boiling Water Sterilized, under 21 CFR ). These conclusions are based upon the formulation of the inks, the intended conditions of use, the results of evaluation conducted at an FDA-recognised laboratory, and the advice and opinion of independent consultants and advisors. Michelman Primers Michelman Digiprime 4431 Primer helps the adhesion of ink to the substrate, used for printing on substrates for flexible packaging. It may be used at levels up to 0.5 g/m 2, on a dry basis, and safely come into contact with all types of food without limitation on temperature, except for those consistent with good manufacturing practice. According to Michelman, Michelman Digiprime 4431, when used according to these practice guidelines fully complies with the FFDCA and all applicable food additive regulations. 5

6 EU Regulation and Food Legislation HP Indigo Status on EU Regulations Good Manufacturing Practices (GMP) Since 1 August 2008, the manufacture of materials intended to come into contact with food must comply with the regulations on good manufacturing practice harmonised for the whole of the European Union (EU), so that these materials do not represent a danger for the consumer, nor change the composition of food nor the organoleptic characteristics thereof. In particular manufacturers must comply with Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food, including packaging. This GMP Regulation details rules for all business operators, at all stages of the manufacturing and supply chains to ensure safety, quality, and process control. The rules that regulate manufacturing processes under the GMP requirements pertain, among other things, to the use of printing inks on the non-food contact side of the substrate under stipulated conditions that aim to prevent migration and set-off, as well as other safety measures. GMP specifies that detailed documentation must be kept of many aspects of the manufacturing process, including specifications, formulae, processing, performed manufacturing operations, as well as the results of testing and other quality assurance systems. Such a system is also intended to monitor and correct any failure to achieve GMP. European Union Framework Regulation Framework Regulation (EC) No 1935/2004, related to materials and articles intended to come into contact with foodstuffs provides the basis for the assurance of a high level of protection of human health and of consumers interests in relation to food packaging, whether printed or not. Plastics Implementation Measure Plastics used in food packaging are subject to Regulation 10/2011 of the EU, or Plastics Implementations Measure (PIM), a comprehensive set of requirements for categories of plastic materials used in the production of food packaging. This Regulation provides a list of monomers, additives (excluding colour additives), polymer production aids excluding solvents and macromolecules from microbial fermentation that may be used in the production of food flexible packaging. The categories of these materials are: a. Exclusively plastic materials, articles and parts b. Plastic multi-layer materials and articles held together by adhesives or other means c. Materials and articles mentioned in a) and b) that are printed or covered by a coating d. Plastic layers or plastic coatings forming gaskets that compose a set of two or more layers of different types of materials e. Plastic layers in multi-layer materials and articles Good Manufacturing Practices HP Indigo follows the GMP by producing and shipping uncontaminated inks of consistent composition and quality, and by following robust quality control systems, which continuously and carefully monitor the production process. European Framework Regulation HP Indigo ElectroInk printed on the non-food-contact side of polymeric multilayer food packaging may properly be described as complying fully with the applicable provisions of German and European food legislation. Specifically, Indigo s Cyan, Magenta, Yellow, Black, Orange, Violet FP, Green and White, is in compliance with Article 3 of the EU Framework Regulation Nr. 1935/2004 for food contact materials when the contact layer comprises one of the materials listed below. Plastics Implementation Measure The food-contact layer may be comprised of one of the following materials: 1. Low-density polyethylene (LDPE) that is at least 40 microns thick 2. Polypropylene that is at least 20 microns thick 3. Polyester which is at least 12 microns thick The resulting packages may be used to hold all types of food at temperatures up to 100 C. These conclusions are based upon the formulation of the inks, the intended conditions of use, the results of evaluation at an accredited European laboratory, and the advice and opinion of independent consultants and advisors. 6

EU Regulation and Food Legislation HP Indigo Status on EU Regulations Swiss Ordinance 816.023.

7 EU Regulation and Food Legislation HP Indigo Status on EU Regulations Swiss Ordinance The Swiss Ordinance of the Federal Department of Home Affairs (FDHA) on articles and materials was introduced on 7 March 2008 and came into force on 1 April 2010 detailing certain provisions relating to packaging inks. This amendment provides a positive list of substances to be used specifically in food packaging inks. Article 26g of this ordinance determines that Printing inks used on Food Contact Materials (FCM) only may be manufactured from the substances set out in annex 1 (lists I, II and III of plastics) and in annex 6 (lists I - V of packaging inks). The lists of permitted substances of annex 6 are: (I) binders (monomers), (II) dyes and pigments, (III) solvents, (IV) additives, and (V) photoinitiators. Each list is divided into two an A list for evaluated substances and a B list for unevaluated ones. Additionally, the migration limit(s) applicable to the substance(s) must not be exceeded and Good Manufacturing Practices (GMP) for printing ink manufacturing and printing must be used. Substances on a B list must comply with a migration limit of 0.01 milligrams per kilogram (mg/kg), or 10 parts per billion (ppb). This is in line with the EUPIA guidance (see below), which sets a 10 ppb limit for substances with insufficient toxicological data. For components with at least two negative mutagenicity tests, the limit is 50 ppb. Non-regulatory Industry Guidelines : The European Printing Ink Association EUPIA The European Printing Ink Association is a widely recognised industry association that works to give industry members guidance on safe manufacturing, use and handling of printing inks, related products, and their applications including food packaging production. EUPIA issues Guidelines on printing inks applied to the nonfood contact side of food packaging materials and articles. The Guideline also predicates adherence to Good Manufacturing Practices. Swiss Ordinance on Materials and Articles in Contact with Food HP Indigo ElectroInk colours Yellow, Magenta, Cyan, Black, Orange, Green, Violet FP and White comply with the Swiss Ordinance on Materials and Articles in Contact with Food (RS ) (Swiss Bedarfsgegenständeverordnung ) article 26g. The Ordinance provides: Packaging inks may only be manufactured from the substances set out in Annex 1 Lists I and II and in Annex 6, subject to the requirements set out therein. EUPIA Status of HP Indigo ElectroInk HP Indigo ElectroInk colours Yellow, Magenta, Cyan, Black, Orange, Green, Violet FP, and White comply with the European Printing Inks Association (EUPIA) Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles, November 2011 version. Furthermore, HP Indigo ElectroInk does not contain any chemical substances as described in the EuPIA Exclusion List for printing inks and related products. 7

8 North America Hewlett-Packard Company 5555 Windward Pkwy Alpharetta, GA USA Tel: Europe, Middle East, and Africa Hewlett-Packard Española S.L Cami de Can Graells, Sant Cugat del Valles Barcelona Spain Tel: Fax: Asia Pacific Hewlett-Packard Company 138 Depot Road Singapore Tel: Fax: Latin America Hewlett-Packard Company 5200 Blue Lagoon Drive Suite 950 Miami, FL USA Tel: Fax: informahpindigo@hp.com Israel Hewlett-Packard Company Kiryat Weizmann P.O. Box 150 Rehovot Israel Tel: Fax: To learn more, visit Copyright 2012 Hewlett-Packard Development Company, L.P. The information contained herein is subject to change without notice. The only warranties for HP products and services are set forth in the express warranty statements accompanying such products and services. Nothing herein should be construed as constituting an additional warranty. HP shall not be liable for technical or editorial errors or omissions contained herein. 4AA4-1406EEW, April This is an HP Indigo digital print.

SWISS ORDINANCE ON MATERIALS AND ARTICLES IN CONTACT WITH FOOD (SR ) Permitted Substances for Packaging Inks. Questions & Answers

SWISS ORDINANCE ON MATERIALS AND ARTICLES IN CONTACT WITH FOOD (SR 817.023.21) Permitted Substances for Packaging Inks Questions & Answers Page 1 of 5 The Swiss Federal Department of Home Affairs (FDHA)