We contribute To Safe Food Packaging - Realisation

Printing Inks for Food Packaging Legal provisions: ingredients, migration, GMP Specific requirements of certain brand owners Technical requirements Objective: Safe packaging compliant with Regulation (EC) No 1935/2004:  No transfer of substances to food in quantities which could a) endanger human health, or b) bring about an unacceptable change in the composition or c) a deterioration in the organoleptic characteristics of the food. Legal provisions for printing inks and varnishes: Swiss Ordinance on Materials and Articles (containing a positive list for ink ingredients with migration limits) EU: no specific legislative measure. The provisions of the framework regulation 1935/2004 and the GMP regulation 2023/2006 apply. In short: No migration of substances above legal limits from the finished packaging into the packed food. Manufacture of inks according to Good Manufacturing Practices (GMP). Brand owners: Many brand owners have created their own Guidances and Specifications, some with additional specific requirements and exclusion lists Technical requirements of packaging: for example fastness, rub resistance, adhesion, slip properties

Communication along the Supply Chain Details of Intended Application Substrate Adhesive Printing Ink Manufacturer Printer, Converter Packer Food Manufacturer Raw Materials Processing Instructions, Constituents, Restrictions Effective Communication along Food Packaging Chain Fundamental for safe food packaging and Recommendation of suitable printing inks Communication from converter / distributor to raw material supplier: Details about the intended application Communication from raw material supplier to converter / distributor: All information to enable the food packer to demonstrate conformity

Communication along the Supply Chain Details of Intended Application Printing Ink Manufacturer Printer, Converter Packer Food Manufacturer Raw Materials Application: Type of Food, Direct Contact y/n, Storage Conditions, Packaging Design, … Constituents : Listing in 10/2011, SR 817.023.21 or Toxicological Evaluation … Processing: Printing Process, Substrate, Further Processing Packing Process, … Supply chain: from right to left: Starting with Food Manufacturer Printing inks in direct food contact ? Type of food Packaging design (film, paper, laminate, barrier, ratio packed food to packaging surface, applied ink weight, ….) Storage conditions (shelf life, temperature) Packaging process (any temperature stress like hot filling, sterilization, … ) Preparation of the food (oven, microwave, water bath, …) Requirements concerning fastness of printing ink film (mechanical resistance, light fastness, resistance to filled goods) Restriction in uses of certain substances Printer / Converter Printing process (flexo, gravure, offset, digital printing,…) Ink system (water- or solvent based, UV) Printing process (printing speed, drying process, applied ink weight, … ) Substrate Ink Manufacturer Raw materials: all substances should be evaluated accordingly (listed in Regulation 10/2011, Swiss Ordinance, or with sufficient toxicological evaluation)

Communication along the Supply Chain TI, SDS, Statement of Composition with List of Potential Migrants TI, SDS, Regulatory Information Sheet Declaration of Conformity Evaluation of Potential Migration Printing Ink Manufacturer Printer, Converter Packer Food Manufacturer Raw Materials Processing Instructions, Constituents, Restrictions Supply chain: from left to right Raw Material Supplier The only legal obligation for raw material suppliers is to provide information regarding REACH and CLP regulation. This covers only details about substances classified as hazardous, which are present above 0,1%. For raw materials of food packaging inks, this is not sufficient. Regulatory Information Sheet, including information on listing in food contact regulations Ink Manufacturer: General information about processing (Technical Information Sheet) Safety data sheet Statement of Composition: potential migrants, WCC Formulations conform with Swiss Ordinance Formulations to enable producing of printed packaging materials conform with 1935/2004 Printer / Converter: Declaration of Conformity for printed packaging materials: All information provided by sub-suppliers is needed Evaluation of conformity: WCC and/or migration testing using simulants or migration testing with food

Formulation of Printing Inks Since 2005 EuPIA Guideline Upgrade by EuPIA GMP (2009) Since March 2016 new, very detailed EuPIA GMP Continuous development of self-proclaimed standard Printing ink manufacturers in EuPIA have committed to strict provisions for the formulation of printing inks. The road (History): - Since 2005 EuPIA Guideline (short explanation about objective and content) Increased requirements of customers, authorities and consumers - Upgrade by EuPIA GMP (Explanation: What is GMP, difference between GMP and Guideline, both supplement each other, Guideline defines principles and basics, GMP sets specific requirements of implementation and control) Since March 2016 new EuPIA GMP, amended and completely reworked, adapted to the state of the art

EuPIA GMP GMP Regulation (EC) No 2023/2006 requires: Processes must be defined Appropriate documentation EuPIA GMP: Internationally harmonised Good Manufacturing Practices Detailed guidance for manufacturers of printing inks for food packaging Enables manufacturing of legally compliant food contact materials This Good Manufacturing Practices (GMP) document has been prepared by the European Printing Ink Association (EuPIA), a sector of the European Council of Paint, Printing Ink and Artists' Colours Industry (CEPE). Products developed and manufactured in compliance with this GMP are supporting manufacturers of food contact materials in supplying products compliant to the applicable legislation in Europe for materials and articles intended to come into contact with food such as the Framework Regulation (EC) No 1935/2004, and GMP Regulation (EC) No 2023/2006. It describes requirements on product composition, quality and hygiene management

EuPIA GMP: DFC and non-DFC The new GMP applies to the manufacturing of printing inks for food contact materials for Direct Food Contact (DFC), and for non Direct Food Contact (non DFC) This Good Manufacturing Practice (GMP) aims to assist in controlling food safety hazards in the design and manufacture of inks, varnishes and coatings designed to be printed onto Food Contact Materials, and formulated for use on either the non-food contact or the food contact surfaces of food contact materials.

EuPIA GMP EuPIA GMP… … does not only contain requirements for the production but also for Customer requirements, Product recommendations Purchasing, Raw material specifications Production, Quality management, Hygiene management Traceability of batches ... ensures safe formulations, recommendations, production, quality and traceability

EuPIA GMP - Production Production   Production instructions Control of production formulations: only approved raw materials Avoiding contamination Hygiene rules For all process stages, risk assessment is required by using a specific FMEA method.

EuPIA GMP – Quality Control Raw material control In process controls Final quality control Retained samples

Raw Material Selection Knowledge: Categorization: C o m p o s i t i o n Potential to migrate Purity Migration behaviour Analysis methods SML (Specific Migration Limit) Criteria for the selection of raw materials: Knowledge of the composition and the purity of the raw materials. Knowledge of methods for analysis of the raw material itself as well as migration analysis Depending on the substrate to be printed, suitable simulants must be used With this information the raw material can be categorized  It can be assessed whether the raw material will exceed the SML What is associated with the term SML?  next slide

SML (Specific Migration Limit) Consideration of all substances in the raw material Evaluated Substances - SML [mg/kg foodstuff] listed in positive lists Not evaluated substances  Detection limit 0.01 mg/kg food Additional limits: Metals, primary aromatic Amines (paA)

Primary Aromatic Amines (paA) Pigment Production Many pigments contain traces of paA due to the production process. Purity requirements from AP(89)1: paA < 500 ppm Pigments which can decompose to paA* are not used. *see Annex 1, ETAD notice No.6, 2008 / Annex 10, REACH (1907/2006) Organic azo pigments are made from PAA. Therefore, the final pigment still contains small amounts as contamination. For many color shades there is no alternative to azo pigments due to technical, regulatory or commercial reasons. In this context there is a limit of 500 ppm for PAA in pigments in the Council of Europe Resolution AP(89)1. Pigments that are used for inks for FCM usually contain much lower amounts. Pigments that can decompose via reductive cleavage to yield PAA are not used for printing inks for FCM.

Primary Aromatic Amines (paA) Migration from the finished FCM: sum of paA: < 0.01 mg/kg Regulation (EU) No. 10/2011 carcinogenic paA: < 0.002 mg/kg BfR Recommendation IX , Draft German Ink Ordinance Migration depends on the structure of the packaging Substrate, weight, amount of ink, area coverage Critical for lightweight papers (bakery bags, napkins) Cold water extract EN 645 is currently under revision You have to consider that there are no PAA limits for printing inks but only for the final product, the packaging. The migration from a final product must be lower than 0.01 mg/kg (or 10 ppb) calculated as the sum of all PAA. Additionally there is a limit in Germany for listed, carcinogenic PAA of 0.002 mg/kg (or 2 ppb). Printing ink manufacturers carefully select the pigments so that the limits can be met. Whether there is migration of PAA from the final packaging, and to which extent, depends on several factors: The kind of substrate, for example film, foil, cardboard, paper; the weight of the substrate and the amount of printing ink and the area coverage. For most packaging there is no problem (the limits are met) but you have to be careful especially for lightweight papers with high area coverage. This is due to the current analysis method for paper (cold water extract DIN EN 645) which puts lightweight papers at a disadvantage. The German printing ink association is participating in a working group with the aim of revising the norm.

Nanoparticles Nanoparticles (NP): Diameter <100 nm Nanomaterial: >50% NP (number) Pigments and fillers in printing inks have a portion in the nano range. Image source: Article “Nanoskalige Pigmentpartikel”; written by Henker, Theisen, Becker, Schleß (Deutsche Lebensmittel-Rundschau, April 2013) What exactly are nanoparticles? There are several scientific and regulatory definitions. The European Commission has recommended the following definition (2011/696/EU) Nanoparticles: At least 1 dimension between 1-100 nm. In case of spherical particles this is the diameter. Nanomaterial: A material is defined as nanomaterial if more than 50% of the number of particles are in the nano range. As the impact on health is unknown for most nanomaterials, the legislator usually wants that nanomaterials are not used for FCM or that there is no migration. Printing inks have always containedfinely ground pigments and fillers. A fraction of those is in the size range of nanoparticles, this makes it impossible NOT to use nanoparticles. To examine possible migration the German printing ink association has done a study which was released 2013 in the „Deutsche Lebensmittelrundschau“. Picture 1: This picture is from this study, you can see the size distribution of a blue pigment in a standard printing ink. A significant fraction is smaller than 100 nm. As the number of small particles is much higher with the same volume, this is probably a nanomaterials according to the definition. Picture 2: Here you can see the size distribution of the white pigment titanium dioxide. The particles are much bigger but also here a small fraction is in the nano range.

Nanoparticles Results of the study NP are bound in the ink layer No migration through the packaging no transfer to the reverse side New ongoing study: Direct contact, abrasion Conclusion: Nanoparticles are contained in printing inks, but they do not pose any risk. Image source: Article “Nanoskalige Pigmentpartikel”; written by Henker, Theisen, Becker, Schleß (Deutsche Lebensmittel-Rundschau, April 2013) Results Picture 1: Blue Pigment. The pigment particles are firmly bound in the ink layer. There is no migration of particles in or through the substrate. Picture 2: Titanium Dioxide. Bigger particles. Here you can really see that there is no migration of particles into the substrate. The samples were each printed and stored in the roll or stack. This means that set-off is possible. The back of the substrate was also examined and no free nanoparticles were found, too. An ongoing new study also examines direct food contact and what happens under abrasive conditions. The conclusion is: Printing ink almost always contains nanoparticles, but according to current scientific knowledge this is no problem for food packaging.

Information Package for Customers Technical Information Sheets with explicit description of the scope of application Safety Data Sheet „Statement of Composition“ CAS No PM Ref No FCM No Name Restrictions and specific migration limits (SML)   Regulation (EC) 1333/2008 1334/2008 Maximum amount in dried ink film in [%] Comments   Regulation (EU) No 10/2011 Swiss Ordinance 817.023.021 (non-volatile / non-reactive substances) Xxx-xx-x XXXXX XXX Substance X SML = 12 mg/kg 9% Ink makers give information to their customers: Technical data sheets with detailed information Safety data sheet, if the ink is a classified a dangerous product „Statement of Composition“ containing information on migratable substances in the dried ink film

Risk Assessment Risk assessment of a packaging material using the information from the „Statement of Composition“ Example: Flexible plastic film, printed with 1 g dried ink/m² Calculate max. amount of Substance X present in 1 dm² Assumption: 1 kg of foodstuff packed in 6 dm² film Worst case calculation, assuming 100% transfer Case: SML cannot be exceeded: OK! Case: SML could be exceeded:  Migration testing! Migration testing: OK! Image source: hubergroup Deutschland GmbH The information in the “Statement of Composition” allows the calculation of the max. possible quantity of substance X which could be transferred to 1 kg of packed foodstuff. Risk assessment can be done for a packaging material, or for a specific packaging. For calculation, the ink coveraqe must be known. The worst case calculation assumes that the total amount of the potential migrant substance X present is transferred to the foodstuff (by migration or set-off). The calculated quantity is compared to the SML. If the calculation shows that the SML might be exceeded, the actual migration must be determined (by migration testing or modelling). If the SML is met: The packaging is conform. If the SML is exceeded, the packaging design must be modified: e.g. packaging surface per kg foodstuff, manufacturing process, substrate, addition of a barrier, less ink, different ink, etc.

Inks for Safe Food Packaging Conclusion: The manufacture of safe food packaging requires a lot of know-how. Important: Information exchange along the supply chain Printing ink manufacturers, members of VdL, are good partners They offer suitable inks and varnishes They support the packaging manufacturer