How can the packaging chain work together for compliance with the GMP directive and other legislation in regard to printing inks?

Transcription

1 How can the packaging chain work together for compliance with the GMP directive and other legislation in regard to printing inks? October 1st, 2009 Dr. Jörg-Peter Langhammer

2 EuPIA (European Printing Ink Association) - Sector group of CEPE (= European Paints, Printing Inks and Artist Colours Industries) - Represents > 90% of ink sales in Europe - Focus of technical work in EuPIA on Food Packaging Inks Technical Committee PIFOOD - 18 ink + varnish manufacturers from all over Europe - issues Guidelines, Guidance Papers - contact partner to EU Commission, Packaging Chain, Converters and End User Associations 2

3 What will we be talking about? Packaging inks, mean any preparations (mixtures) manufactured from colorants (pigments, dyes), binders, plasticisers, solvents, driers and additives. They are solvent-based, water-borne, oleo-resinous or energy-curing (UV or electron beam) systems. They are applied to the non-food contact surface by a printing and/or coating process, such as flexography, gravure, letterpress, offset, screen, nonimpact printing or roller coating. 3

4 Migration Risk: Case study (1) 2005: ITX in liquid food set-off phenomenon 4

5 Migration Risk: Case study (2) 2009: Benzophenone/4-Methylbenzophenone in muesli Migration INK BOARD POUCH (PE or PAPER) INK BOARD POUCH (with ALU FOIL BARRIER) Inner pouch made from PE is no barrier aluminium required! 5

6 Migration Risk: Case study (3) 2009: Benzophenone in dairy products Migration from (labels) sleeves (wall thickness of bottle material as critical parameter) 6

7 Critical Migration Parameters Substance transfer from (printed) packaging into foodstuff depends on: suitability of ink / varnish formulations substrate selection design of the packaging: primary, secondary printing conditions (drying, curing, speed, storage, ) the final packaging use (type of food, pasteurisation, sterilisation, ) packaging size (surface-volume ratio) shelf life.. 7

8 Facts + Learnings from recent food safety alerts Lack of communication between packaging chain partners Interdependencies between converting steps not well understood Migration risks vs. packaging design not really known Concept of low migration inks not entirely accepted from market Cost considerations against low migration inks Lack of procedures for proper ink + coating selection Better differentiation of non-use/recommended use scenarios Lacking transparency on ink ingredients Need for high quality information on ink properties More Packaging Safety Expertise needed 8

9 The GMP Regulation (EC). 2023/ Annex Printing Processes Processes involving the application of printing inks to the non-food contact side of a material or article 1. Printing inks applied to the non food-contact side of materials and articles shall be formulated and/or applied in such a manner that substances from the printed surface are not transferred to the food-contact side: (a) through the substrate or; (b) by set-off in the stack or the reel, in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) 1935/ Printed materials and articles shall be handled and stored in their finished and semi-finished states in such a manner that substances from the printed surface are not transferred to the food-contact side: (a) through the substrate or; (b) by set-off in the stack or reel, in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) 1935/2004. Conclusion: The GMP Regulation applies to all stakeholders of the packaging chain The final confirmation of legal compliance cannot be delegated to the ink manufacturer 9

10 Communication within the packaging chain Concrete lists of substances to be toxicologically evaluated Concrete specs: which substances are ok & not ok, vs. specific printing process, design,... Concrete specs: which migration is ok & not ok, vs. specific food type & required print & packaging design Raw Mat suppliers Ink manufacturers Printers Food Packers Discuss safety aspect, deliver tox assessments Discussion on printer s own migration control, with lists of potential migratory substances Discussion on barrier properties & migration behaviour 10

11 EuPIA Guidance Documents: EuPIA Guideline (September 2009) (on Packaging Inks applied to the non-food contact surface of food packaging materials and articles) Key items: - Raw Material Selection - (Ink Manufacturers) Responsibility - Risk Assessment for non-evaluated substances - Test Methods..endorsed by legislators and market partners! 11

12 - listed in existing EU or national legislation on food contact materials - evaluated by EFSA/SCF or other bodies e.g. JECFA, WHO, FSANZ - National Recommendations (e.g. BfR) - Council of Europe Resolutions for direct food contact materials - FDA regulations - Food additives regulations Evaluation of Migration a) Experimental testing b) Alternative scientific tools Migration <10 ppb Migration <50 ppb Risk assessment Raw Materials Authorised for direct food contact use Compliance with Exclusion Criteria Raw Material is a Colourant Molecular Weight > 1000 Dalton Can be used meets 3 mutagenicity tests Adequate Tox data Can be used Rejection Compliance with Purity Requirements Can be used Substances with MW < 1000 Dt present in packaging inks which have insufficient toxicological data shall be subject to the following target migration limit deadlines: 50 ppb migration December ppp migration December 2015 Rejection EuPIA Guideline on Packaging Inks Details (1) The Selection Scheme of Raw Materials (1/2) Raw Materials - listed in existing EU or national legislation on food contact materials - evaluated by EFSA/SCF or other bodies e.g. JECFA, WHO, FSANZ - National Recommendations (e.g. BfR) - Council of Europe Resolutions for direct food contact materials - FDA regulations - Food additives regulations Authorised for direct food contact use Can be used Exclusion of Raw Materials - Classified and labelled as carcinogenic, mutagenic and toxic for reproduction - Classified and labelled as very toxic (T+) or toxic (T) - Pigment colorants based on and compounds of Antimony,Arsenic, Cadmium, Chromium (VI), Lead, Mercury and Selenium - Banned by the REACH Regulation 1907/2006/EC Compliance with Exclusion Criteria Raw Material is a Colourant Rejection Compliance with Purity Requirements Evaluation of Migration a) Experimental testing b) Alternative scientific tools Molecular Weight > 1000 Dalton Can be used 12

13 - listed in existing EU or national legislation on food contact materials - evaluated by EFSA/SCF or other bodies e.g. JECFA, WHO, FSANZ - National Recommendations (e.g. BfR) - Council of Europe Resolutions for direct food contact materials - FDA regulations - Food additives regulations Evaluation of Migration a) Experimental testing b) Alternative scientific tools Migration <10 ppb Migration <50 ppb Risk assessment Raw Materials Authorised for direct food contact use Compliance with Exclusion Criteria Raw Material is a Colourant Molecular Weight > 1000 Dalton Can be used meets 3 mutagenicity tests Adequate Tox data Can be used Rejection Compliance with Purity Requirements Can be used Substances with MW < 1000 Dt present in packaging inks which have insufficient toxicological data shall be subject to the following target migration limit deadlines: 50 ppb migration December ppp migration December 2015 Rejection EuPIA Guideline on Packaging Inks Details (2) The Selection Scheme of Raw Materials (2/2) Migration <10 ppb Can be used Migration <50 ppb meets 3 mutagenicity tests Substances with MW < 1000 Dt present in packaging inks which have insufficient toxicological data shall be subject to the following target migration limit deadlines: 50 ppb migration December ppp migration December 2015 Risk assessment Adequate Tox data Rejection 13

14 Overview on currently accepted migration thresholds they depend on documentation of toxicological data and on toxicological expertise by the European Food Safety Authority EFSA Threshold (ppb) Specific Migration Limit SML Evaluated substances n evaluated substances adequate tox data 3 favorable mutagenicity tests 90 days Feeding Study --> X ppb X = depends on tox expert judgement 14

15 EuPIA Guidance Documents: EuPIA GMP Contents 1. Scope and Objective 2. Quality Management System 2.1 Documentation Manuals Production Instruction Documents Product Test Specifications 2.2 Quality Review Procedures n conformity management GMP audit 2.3 Records 3. Personnel and Training 3.1 Commitment 3.2 Training 4. Formulation 5. Raw Material Controls 5.1 Objective 5.2 Identification 5.3 Specifications 5.4 Conformity 5.5 Usage 6. Production 6.1 Objective 6.2 Manufacturing Instruction Document 6.3 Manufacturing Formulation 6.4 Equipment 7. Quality Control 7.1 Objective 7.2 Production Quality Control 7.3 Final Inspection and Testing 7.4 Test Methods 7.5 Test Equipment 8. Product Information 8.1 Identification 8.2 Certification 8.3 Data Sheets 8.4 Statement of Composition 9. Packaging 9.1 Specification 9.2 Cleanliness 9.3 Accurate Filling 9.4 Labelling 10. Storage 11. Delivery 12. Traceability 13. Converter In-plant operations 15

16 EuPIA responsibilities: Tailor-made customer communication Guidance on pertinent and didactic Technical Data Sheets: Intended uses and applications Processing conditions Migration (testing data, worst-case calculation) Guidance on Statements of Composition : Information on evaluated substances and their SML s Enables the converter to issue his declaration of conformity for the printed packaging Recommendation on ingredient disclosure process to allow risk assessment for non-evaluated substances: To PS+R departments of converters, to migration testing labs, in specific cases to end-users Done on basis of previous confidentiality agreement Includes all ingredients with migration potential Statement of Composition 16

17 Transparency: EuPIA s Inventory List on " Contents: Additives (Chemical Groups) Photoinitiators Pigments Dyes Pigment Additives Polymeric Resins (Groups) Resin Monomers Solvents Energy curing monomers 17

18 Transparency: EuPIA s input into Swiss Packaging Ordinance Swiss Bedarfsgegenstände-Verordnung ( ) - Section on Packaging Inks: Will come into force includes a positive list for ink materials EuPIA has fully cooperated on this positive list List will impose migration thresholds for evaluated and nonevaluated substances (< 10 ppb) 18

19 EuPIA and the Packaging Chain: PIJITF (1) PIJITF The Packaging Ink Joint Industry Task Force Subgroup Flexibles/ Beverage Cartons Subgroup Metal Packaging Subgroup Paper and Board Subgroup Rigid Plastics 19

20 PIJITF discussion Draft: 7 cases to define migration risk (2) Packaging has either an inner wrap or an inner+outer wrap Migration risks characterised by barrier properties of inner/outer wrap and set-off and vapour phase transfer Low migration inks are key. 20

21 EuPIA s definition of Low migration ink A "low migration ink" designed for use on food packaging is formulated using selected components ensuring that migration from the resultant printing ink film is intrinsically within official migration limits in the intended application. This should be supported by relevant analytical testing and/or relevant worst case calculations. 21

22 Resumé: Key elements of the EuPIA concept for Packaging Safety Highest focus on consumer safety Strict ink raw material control toxic raw materials Control of substance transfer (migration, set-off) Strict differentiation between food and non-food inks Improved communication along the supply chain Working on agreed specifications in packaging chain Ultimate responsibility remains with the food packer Practicability in the packaging chain 22

23 23