Sicurezza Alimentare: Le Sfide per i Produttori di Adesivi
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1 Sicurezza Alimentare: Le Sfide per i Produttori di Adesivi Sonia Khandjian, Product Stewardship EMEA Dow.com
2 Dow s Commitment to Product Safety, Customers, Sustainability and Society 1897 Formation of The Dow Chemical Company 1934 The Dow Chemical Company s Toxicology Laboratory Established 1937 Dow stock listed on N.Y. stock exchange 1966 Dow scientists develop Biohazard symbol 1958 Dow publishes first Material Safety Data Sheet 1938 First long-term animal carcinogenicity studies completed 1970 OSHA adopted 1976 TSCA enacted 1970 Dow publicly commits to product stewardship role 1970 U.S. EPA established 1991 Dow established corporate environmental advisory council 2007 U.S. EPA launches ToxCast TM 2007 NAS Toxicity Testing in the 21 st Century published 2010 REACh is enacted 2010 Dow fulfills REACh registration mandates 2011 Dow establishes Predictive Toxicology
3 European Panorama European panorama on food contact matters is still diversified It is composed of European Legislations and Member States Legislations Not all materials are regulated in the same way in Europe 3
4 What Are Food Contact Materials? ALL materials and articles intended to come into contact with foodstuffs Also: materials and articles which are in contact with water intended for human consumption Does not cover fixed public or private water supply equipment 4
5 Hierarchy EU Food Contact Regulations EU Food Law Food safety: Regulation (EC) No 178/2002 Food hygiene: Regulation (EC) 852/2004 GMP food stuff EU Framework Regulations Food Contact Materials & Articles Safety: EU Framework Regulation (EC) No 1935/2004 GMP: Regulation (EC) No 2023/2006 EU Harmonised Regulations Specific FCM s or Substances e.g. Plastics: Regulation (EC) No 10/2011 (PIM: Plastics Implementation Measure) COE Resolutions & National Regulations (non-plastic FCM s) Council of Europe Resolutions: coatings, paper & board, IER s, rubbers National regulations: Dutch Warenwet, German BfR, Swiss BAG etc. Industry Code of Practice 5
6 Food Contact Legislation in the EU The Framework Regulation Regulation (EC) No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC 6
7 Food Contact Legislation in the EU The Framework Regulation Article 1: Purpose and subject matter The purpose of this Regulation is to ensure the effective functioning of the internal market in relation to the placing on the market in the Community of materials and articles intended to come into contact directly or indirectly with food, whilst providing the basis for securing a high level of protection of human health and the interests of consumers. 7
8 Regulatory Background on Adhesives and Coatings in EU No harmonized EU legislation specific to Adhesives & Coatings Regulation 1935/2004: Safety clause in Art. 3, including GMP Traceability Declaration of compliance Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with Good Manufacturing Practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: (a) endanger human health, or (b) bring about an unacceptable change in the composition of the food, or (c) bring about a deterioration in the organoleptic characteristics. 8
9 Regulatory Background on Adhesives and Coatings in the EU (cont.) Regulation 2023/2006 on GMP National legislations where available Plastic Regulation 10/2011 as amended despite adhesives not fully in scope o Monomers and Additives o Functional barrier concept, ie migration < DL, DL = 10ppb (no CMR, no nano) o Migration testing o Risk Assessment 9
10 Challenges for Adhesives Industry Adhesives are used with different packaging materials A global market with diversified regulatory requirements Increased public awareness on food safety matters Delisting or increased restrictions on substances from Regulatory Bodies Need to meet the needs of sustainability Need to consider intentional and non-intentionally added substances in the assessment process 10
11 Challenge for Adhesive Compliance According to Regulation (EU) No 10/2011 adhesive layer may contain other substances than those authorized at EU level for plastics For adhesives used in plastic materials or articles in the scope of Regulation 10/2011 adequate information should be provided to the manufacturer of the final plastic article to enable him to comply Requirements of Article 3 of the framework regulation should be assessed on the finished material or article at the real or best foreseeable conditions of use 11
12 FEICA Guidance Paper Highlights of the guidance New documentation issued on February 5 th 2013, available in 5 languages Includes comprehensive regulatory background Explains requirements for adhesives producers Explains how downstream user can evaluate the adhesive Request information from raw material suppliers Template for Food Contact Status Declaration Rejection List 12
13 FEICA Flow Chart Source: FEICA 13
14 FEICA Flow Chart Source: FEICA 14
15 FEICA Flow Chart Source: FEICA 15
16 Adhesives Evaluation Process Robust process to qualify raw materials and vendors Exact knowledge of product compositions Identify status of individual components/ ingredients versus positive lists Apply Risk Assessment reviews Define status and issue adequate documentation 16
17 Tiered Approach for Safety Assessment Exposure assessment Chemical identity and quantity of substances that enter food Global cross-functional team To ensure novel Dow products are compliant and safe for their intended end use Toxicological assessment Tiered assessment based on exposure and hazard potential Regulatory assessment Ensure compliance with global food contact regulations Research & Development Product Stewardship TERC Consulting Analytical Toxicology Testing/QSAR Product Regulatory Services
18 Steps in Safety Assessment of a Food Contact Material Food Contact Substance Exposure Assessment Toxicity & Risk Assessment Production of a food contact material Migration assessment with food simulants/modeling Qualitative and quantitative analysis for residuals/migrants Threshold concept (TOR/TTC) QSAR Regulatory Assessment Toxicity testing
19 Case Example for Adhesives Assessment of NIAS-Cyclic Polyester Oligomers (CPO) Example of cross-functional collaboration for product innovation/safety R&D and TS&D product fabrication, Analytical Characterization, R&D Data Analysis, TERC Assessment for Genotoxicity-QSAR, Migration Modeling, Regulatory Review/Validation Adhesive Product / Laminate Structure EFFICIENCY QUALITY Migration Modeling at Use Conditions and Laminate Structure COST SPEED 19
20 Shared Responsibility and Sharing of Information Composition Impurities Raw Material Supplier Adhesive Supplier Packaging Producer Food Industry Surface volume ratio Time & temperature conditions Structures Type of food... 20
21 Dow.com THANK YOU
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