Complying with the Legislation from the Food Contact Materials perspective

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Julius Dean
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Product Safety Manager Amcor Flexibles Europe &

1 Complying with the Legislation from the Food Contact Materials perspective Robert Broughton Product Safety Manager Amcor Flexibles Europe & Americas Location: Morrison Hotel, Dublin Date: 16 November 2010

2 Complying with the Legislation from the Food Contact Materials perspective Agenda 1. The New Amcor 2. My expertise what will be covered by this presentation (and what will not) 3. How Amcor manages compliance 4. Any questions 2

3 A New Visual Identity The new visual identity is a symbol of the creation of the New Amcor. It represents: the internal changes that have been underway to cement what our beliefs, values and operating model are across the company and celebrates the integration of two great packaging companies (Alcan and Amcor) 3

4 Amcor s Evolution Amcor has evolved from a paper and packaging company operating predominately in the Australian market into a truly international company focused on packaging Today our strategic focus is on our chosen markets covering a broad geographic spread Australian Paper & Packaging Paper Divestment Acquisitions Flexibles Pet Focused International Packaging Acquisitions Parts Of Alcan Packaging Sales $A 6.5B - 75% Australia & NZ - 25% Rest of World 20,000 co-workers 140 manufacturing sites 21 countries Sales $A 9.5B - 20% Australia & NZ - 80% Rest of World 21,000 co-workers 226 manufacturing sites 34 countries Sales $A14.0B - 15% Australia & NZ - 85% Rest of World 35,000 co-workers 300+ manufacturing sites 43 countries 4

5 The New Amcor In 2010, Amcor acquired parts of Alcan Packaging in a deal worth more than US $2 billion. The combined companies form the new Amcor. Amcor (Pre-closing total business) Alcan Packaging* (Acquired businesses only) The New Amcor (Estimates only) Sales A$9.5 billion A$4.8 billion* A$14 billion Employees 21,000 14,000* 35,000 Sites * > 300 Countries 34 28* 43 Current ownership Listed on Australian Stock Exchange & London Stock Exchange (Eurobonds) Subsidiaries of Rio Tinto, Rio Tinto Alcan, Alcan Packaging, Listed on Australian Stock Exchange & London Stock Exchange (Eurobonds) Previous acquisitions Rentsch, Danisco, Schmalbach-Lubeca, Rexam, Akerlund & Rausing, Tobepal Pechiney, VAW, Alusuisse 5

6 Amcor Today Sales 7.6 billion Co-workers Headquartered in Melbourne, Australia. Listed on the Australian Stock Exchange (ASX) and London Stock Exchange (Eurobonds). 35,000 Countries 43 Sites

7 JP1 Amcor Markets Served Amcor supplies a broad range of flexible, rigid plastic, fibre, metal and glass packaging and related services to enhance products used everyday. Primary Packaging Secondary & Tertiary Packaging Food and Beverages Home & Personal Care Medical & Hospitals Cartons Corrugated Packaging Pharmaceuticals Tobacco Industrial Applications Technical Specialties 7

8 Slide 7 JP1 Have included the TechSpech market offer in the mix. Jasmina Peri, 02/08/2010

9 JP2 Flexibles Europe & Americas 8

10 Slide 8 JP2 Amended AFEA map- July 14. Added 3 plants in US further to Medflex acquisition Jasmina Peri, 02/08/2010

11 JP3 AFEA Markets Served 9 Fresh, Dairy & Capsules Pharmaceutical & Medical Processed Foods Snacks & Confectionery Home & Personal Care Technical Specialties

12 Slide 9 JP3 Few pics added or changed as per latest requests in order to reflect full range. Jasmina Peri, 02/08/2010

13 Complying with the Legislation from the Food Contact Materials perspective My expertise years experience in the flexible packaging industry 2. Product Safety Manager for Amcor Flexibles Europe & America (AFEA) 3. Chairman of Packaging & Films Association (PAFA) technical committee and Flexible Packaging Europe (FPE) technical committee 4. Represent Amcor on Campden BRI Packaging Panel 5. Represent trade associations on various other committees and at meetings dealing with food contact issues e.g. Packaging Inks Joint Industries Task Force (PIJITF) 6. Main focus today on flexible packaging but most concepts apply to all food packaging 10

14 Complying with the Legislation from the Food Contact Materials perspective What is required? Business operations. Trained and knowledgeable person with responsibility for Food Contact issues Defined process for compliance integrated within the company business system e.g. ISO 9001 Assessment of risk associated with Food Contact issues included at the product and process development stage (design for compliance). Assessment of risk ongoing when modifications made to existing products (change management) Raw material suppliers understand their responsibilities Migration testing carried out as necessary Production/quality control understand the critical points affecting Food Contact Declarations of compliance issued as necessary 11

15 Complying with the Legislation from the Food Contact Materials perspective How to achieve the requirements - knowledge Training courses run by PIRA Contact/Regulatory-Compliance.aspx Web sites e.g. FSAI UK FSA Eur-Lex Europa EFSA CRL-FCM Networking with suppliers, trade associations, customers 12

16 Complying with the Legislation from the Food Contact Materials perspective National Associations Flexible Packaging Europe EU Committees e.g. PIJITF, PCG Publications, Seminars Customers & Suppliers Food Alerts e.g. from FSA Amcor Flexibles Group of Experts, monthly conference call, yearly meeting Amcor Flexibles Asia and Pacific Amcor Australasia Members of National Associations Members of EU Committees Amcor Product Safety Manager and Regulatory Affairs Specialist Material Experts Analytical & Chemical Experts Legal Opinion QuickPlace/In tranet Site Site Site Site Site 13

17 Complying with the Legislation from the Food Contact Materials perspective Working with suppliers Is there a clear expectation of the information expected from suppliers? Is the information received acceptable/comprehensive? Is the information assessed and approved? Is the information regularly updated? Is there sufficient information given to suppliers to ensure that final end user requirements are known by the supplier? Is Food Contact part of the supplier audit process? Material selection must take into account the Food Contact assessment as well as technical functionality e.g. sealing, barrier, machineability 14

18 Complying with the Legislation from the Food Contact Materials perspective What is required migration testing (OML and SML) Use a family approach no need to test everything Where possible, use the suppliers data to support your declaration of compliance Have a plan for testing new raw materials, repeats etc. Follow a sampling procedure to avoid cross contamination Use a competent laboratory e.g. PIRA, Campden BRI Assess the results Pro active monitoring 15

19 Complying with the Legislation from the Food Contact Materials perspective Means of demonstrating compliance for SML substances complies based on OML test results (***) i.e. OML result < SML cannot exceed the limit even if total quantity migrates compliance was verified by validated migration modelling compliance is confirmed by our supplier GC-MS / GC-FID screening shows substance is not detected/identified at 10 ppb (***) GC-MS / GC-FID screening shows substance migration is well below the limit (***) compliance was confirmed by specific test for this substance (***) (***) results obtained on sample(s) relevant for this specific restriction. 16

20 Complying with the Legislation from the Food Contact Materials perspective Critical points during production/quality control Control of application weights supplier statements may be based on nominal weight Control of mixing for multi component systems reactions may rely on correct mixing to give a satisfactory product Knowledge of reactive systems e.g. isocyanate based adhesives, UV curing inks and lacquers need to know consequence of not following procedures e.g. despatching material before cure time is complete, not following supplier recommendations. Have procedures that align with Good Manufacturing Practice (GMP). Flexible Packaging Europe have an excellent GMP document available on their web site. Carry out necessary quality control checks e.g. taint/odour, set off of printing inks, incoming solvents 17

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23 Complying with the Legislation from the Food Contact Materials perspective Declarations of compliance Worthy of a presentation in their own right! Legal obligation to supply a declaration of compliance for materials mentioned in the Framework Directive that are covered by specific directives e.g. plastics Directive gives guidance as to what is required. Annex VIA of 2002/72/EC. New legislation (PIM) intends to make things easier to follow but there will be transitional periods. (and probable confusion). Ensure that you know what your customer is doing with the material you supply so that the declaration covers known applications. (and all the testing carried out by you and your supplier is relevant). Have all of the supporting documentation available for inspection by the national competent authorities. 20

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25 DoC - Plastics Implementing Measure ANNEX IV Declaration of compliance The written declaration referred to in Article 15 shall contain the following information: (1) the identity and address of the business operator issuing the declaration of compliance; (2) the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles; (3) the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the manufacturing of those materials and articles; (4) the date of the declaration; (5) confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet relevant requirements laid down in this Regulation and Regulation (EC) No 1935/2004; (6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions; (7) adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food; (8) specifications on the use of the material or article, such as: (i) type or types of food with which it is intended to be put in contact; (ii) time and temperature of treatment and storage in contact with the food; (iii) ratio of food contact surface area to volume used to establish the compliance of the material or article; (9) when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation. 22

26 Complying with the Legislation from the Food Contact Materials perspective Thank-you for your attention Any questions 23

27 THANK YOU

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