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1 Recent developments regarding Food Packaging Inks in Europe: Legal and activities update Dr. Jörg-Peter Langhammer 4th FCM Forum, Suzhou Friday, 2 December 2016

2 Agenda 1. Legal German Update: Ink Ordinance German Ink Ordinance, Swiss Ordinance 2. EuPIA GMP (Good Manufacturing Practice) 3. Siegwerk Risk Assessment Risk Assessment on NIAS from Strategy ink manufacturers on NIAS perspective (Siegwerk)

3 Agenda 1. Food Legal packaging Update: German safety Ink a must Ordinance have 2. Ensuring EuPIA GMP compliance (Good Manufacturing a complex challenge Practice) 3. Siegwerk Risk Assessment how we on support NIAS from our ink customers manufacturers perspective (Siegwerk)

4 4 Draft German Ink Ordinance Intention of regulation First introduction December 2010/Status as of July st Amendment to the German regulation on food contact materials (German Ink Ordinance) (Basis: EU Framework Regulation 1935/2004, Article 6 on National specific measures: In the absence of specific measures referred to in Article 5, this Regulation shall not prevent Member States from maintaining or adopting national provisions provided they comply with the rules of the Treaty.) Intention of regulation: Prevention of unauthorised substance transfer from printed layers on food contact materials

5 5 Draft German Ink Ordinance - Scope 2 Definitions, No. 7: Printing Inks: Printing Inks or varnishes, which are applied on food contact materials via a printing or varnishing process. to be specifically regulated: - printing inks for front and lamination print - printing inks for intentional direct Food Contact ( DFC ) - printing inks for foreseeable direct Food Contact (e.g. bread bags, napkins) Ink layers on absolute barriers are not regulated by the Ink Ordinance Decorating colours for food contact materials made from ceramics are not printing inks Preparations for mass colouring of food contact materials are excluded

6 6 Draft German Ink Ordinance Regulation contents positive list principle for direct food contact Authorised to use exclusively materials from Annex 14, Table 1 (includes Annex 1 of Regulation No. 10/2011) further materials authorised for indirect (foreseeable) food contact Annex 14, Table 1 and 2 (Table 2 will be applicable only for 4 years) Nanomaterials authorised, as long as no detectable migration (no limit!) Non listed materials as long as not CMR and < 10ppb Migration limits for metals (Ba, Fe, Co, Cu, Li, Mn, Zn) in analogy to Regulation EU No. 10/2011 Migration limits for primary aromatic amines 10 µg/kg as a sum 2 µg/kg for 22 specifically mentioned PAAs (CMR Category 1A and 1B)

7 7 Draft German Ink Ordinance Positive list Annex 14 Categories: Monomers, Colorants, Solvents, Additives, Photoinitiators SMGs (Spezifische Migrationsgrenzwerte) = SMLs Group limits Other specifications

8 8 Comparison positive list entries for ink raw materials in different legislation Legislation/Country Number of raw material entries GB /China Appendix A.4: 189 Swiss Ordinance Annex 6: A-1090/B-4005 Draft German Ink Ordinance Annex 14: (10/2011)

9 9 German ink ordinance: Stakeholder criticism and arguments Favour European harmonized Regulation on printing inks Oppose firmly any measure on a national level Risk of patchwork legislation in Europe German Ordinance could lead to disruption of internal EU market Where is the health concern? Positive list is incomplete Massive cost burden

10 10 Draft German Ink Ordinance: Timeline so far th draft 06/07/16 Notification Notification (TRIS) (WTO ) intra-ministry consultations 8 MS submitting detailed opinion! Breaking News - On European Commission officially anounced: - to have requested Germany to postpone their unilateral legal initiative - to be willing to launch EU legislation on printed FCM/printing inks by Currently it is unknown what Germany will do after July /07/17 end of official postponement End of impact assessment (compliance costs)

11 Agenda 1. Food Legal packaging Update: German safety Ink a Ordinance must have 2. Ensuring EuPIA GMP compliance (Good Manufacturing a complex challenge Practice) 3. Siegwerk Risk Assessment how we on support NIAS from our ink customers manufacturers perspective (Siegwerk)

12 A sector of CEPE aisbl EuPIA in a Nutshell European Printing Ink Association Founded in 2003 Operates under the umbrella of CEPE, the European Council of the Paint, Printing Ink and Artists Colours Industry Represents > 80 manufacturers of printing inks and varnishes in > 160 manufacturing sites Represents > 90% of ink sales in Europe Employs ~ 12,000 people Membership: Every member of a National Association representing the printing ink industry is automatically a member of EuPIA (dual membership principle) 12

13 13 GMP requirements globally In many parts of the world, we see legal requirements that companies producing food contact materials must comply with GMPs - In Europe this is regulated by the European regulation (EC) No 2023/ In the USA this is regulated by FDA regulation 21 CFR Part In China this is regulated by the National Standard of the People s Republic of China GB Many trade associations along the food packaging chain have created Good Manufacturing guides, so EuPIA as well - EuPIA has recently updated its GMP policy. It became public on 31 st March 2016 (new GMP comprises of 47 [13] pages) - This GMP policy 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

14 14 GMP on EuPIA s website EuPIA homepage: Published 31 st March 2016 The new GMP is publically available on the EuPIA website, currently in English & German.

15 15 EuPIA GMP: differences old/new version Scope Differences GMP March 2009 GMP March 2016 Non-DFC surfaces of food packaging only Both DFC and non-dfc surfaces of FCM s Level of detail Overview Greater level of detail, includes flow-charts & worked examples Risk Assessment Not explicitly mentioned FMEA process, including guidelines for scoring Demonstrating compliance Not explicitly mentioned Evidence based, example analytical result validating cleaning process Auditing Internal audit using checklist External audit by customers, in addition to internal audits Updating Last updated 2009 Will be regularly updated to reflect changes

16 16 EuPIA GMP adresses direct food contact scenario The EuPIA GMP recognises that there is a higher potential risk for contamination & hygiene issues associated with Direct Food Contact (DFC) inks & coatings, due to the much shorter diffusion path. To mitigate this risk the following controls are implemented: A more rigorous process of selection of raw materials, and formulation design, to minimise the presence of nonintentionally added substances (NIAS). This limits the number of raw materials that can be used A more controlled process for manufacture in which contamination control (from previous batches & cleaning materials), and hygiene control are implemented

17 17 EuPIA GMP in comparison The EuPIA GMP is a stand-alone GMP Standard and is specific to ink requirements. Members of EuPIA need to adopt this GMP (in Europe). Siegwerk is about to roll-out this EuPIA GMP globally. Being EuPIA GMP compliant automatically means being both EU GMP regulation 2023/2006 and Chinese GB compliant There is high similarity between EuPIA GMP and IFS 6 (Interna-tional Food Standard) accredited standards such as BRC IOP or ISO EuPIA GMP can be easily audited by converters and brand owners: ink manufacturers will be able to present continuous improvement by audits/corrective measures, FMEA (Failure Mode and Effects Analysis) based risk assessments

18 Agenda 1. Food Legal packaging Update: German safety Ink a Ordinance must have 2. Ensuring EuPIA GMP compliance (Good Manufacturing a complex challenge Practice) 3. Siegwerk Risk Assessment how we on support NIAS our from customers ink manufacturers perspective (Siegwerk)

19 19 Definition of NIAS dealing with NIAS NIAS are all chemical substances which are not IAS and do not have an intended and specific function within the ink formulation.

20 20 IAS/NIAS examples: different perspectives IAS in the ink raw material example: Styrene-acrylic dispersion Styrene Acrylic acid Emulsifier Initiator NIAS in the ink example: water-based ink Styrene Acrylic acid Emulsifier Initiator

21 21 Regulatory framework for risk assessment of NIAS Regulation (EU) No 10/2011: In principle, non-intentionally added substances will have to comply with the general safety requirements of Article 3 of the Framework Regulation and are subject to risk assessment in line with Article 19 of the Plastics Regulation. Status of NIAS Listed in positive lists with SML (evaluated) Not listed in positive lists (not evaluated) Evaluated as by-product in official toxicological dossier How to handle? Apply that SML Risk assessment Considered safe up to evaluated amount; for higher amounts perform risk assessment

22 22 Categories of NIAS Known NIAS (usually added by the raw material producer) known chemical structure - Starting monomers - Catalysts - Process aids Unpredicted NIAS (may result from side reactions, degradation reactions, former production steps, crosscontamination in the production) often unknown chemical structure At Siegwerk for consumer safety reasons all migratory species are subject to risk assessments. No differences are made whether talking about IAS or NIAS!

23 23 Risk Assessment process Risk = Hazard x Assessment Assessment Exposure Assessment

24 24 Hazard Assessment procedure in detail What is the safe tolerable daily dose of NIAS? Hazard Assessment Start: Definition of basic data requirements acc. to field of application (NP, H) Raw Material Introduction Process (RMIP) SMLs No SMLs - Published and recognised toxicological data - QSAR predictions - Read across - TTC concept (ToxTree) - (Bioassays for exclusion of genotoxicity and endocrine activity) Self-derived SML

25 25 Exposure Assessment procedure What is the estimated daily exposure to NIAS? Exposure Assessment Migration (tiered approach) Worst Case Calculation (100% migration) Migration Modelling (AKTS) Migration Testing Advanced approach* e.g. FACET analysis (European stakeholder software a.o. incorporating food consumption data) * taking into account real food consumption data and usage of packaging material Exposure concentration in food = food consumption (migration level) x x packaging material usage

26 26 Risk Management Measures RMM Risk Assessment Protection of consumer by reduction of exposure/hazard Substitution (change hazard) = Hazard x Assessment Exposure Assessment Barrier (change exposure)

27 27 NIAS - flow of information Supply chain Raw Material based from supplier Risk Assessment strategy Product based (SoC) internal to customer

28 28 Guidance documents on NIAS PlasticsEurope Risk Assessment of Non-Listed Sustances (NLS) and NIAS under Article 19 (EC/10/2011) (2014) ILSI Guidance on best practices on the Risk Assessment of NIAS in Food Contact Materials (FCM) and Articles (2015) CEFIC/FCA Guideline on Risk Assessment of Non-Listed Sustances (NLS) and NIAS under the requirements of Article 3 of the Framework Regulation (EC) 1935/2004 (2016) Draft EuPIA Guidance for Risk Assessment of Non Intentionally Added Substances (NIAS) and Non Listed Substances (NLS) in printing inks for food contact materials (to be published soon)

29 Thank you! Contact person: Dr. Jörg-Peter Langhammer Vice President Global HSE + Sustainability Joerg-peter.langhammer@siegwerk.com Phone: