Sicurezza Alimentare: Le Sfide per i Produttori di Adesivi

Size: px
Start display at page:

Download "Sicurezza Alimentare: Le Sfide per i Produttori di Adesivi"

Transcription

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

Information leaflet Printing Inks for Food Packaging

Information leaflet Printing Inks for Food Packaging Page 1 of 7 Information leaflet Printing Inks for Food Packaging 1. Introduction Food packaging is printed to provide information to the final consumer in accordance with Directive 2000/13/EC relating

More information

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles April 2008 (Replaces the May 2007 version) 1. Introduction EuPIA member companies have,

More information

Guidance for a food contact status declaration for adhesives

Guidance for a food contact status declaration for adhesives FEICA - GUIDANCE PAPER Brussels, 08 September 2014 Guidance for a food contact status declaration for adhesives FEICA, the Association of the European Adhesive & Sealant Industry is a multinational association

More information

Active Intelligent. Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent

Active Intelligent. Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent ก : Active intelligent ก ก 2552 Active intelligent (Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food) : ก Active Intelligent

More information

Coatings in NL. Regulation and risk assessment of Coating as FCM in The Netherlands. Bianca van de Ven RIVM

Coatings in NL. Regulation and risk assessment of Coating as FCM in The Netherlands. Bianca van de Ven RIVM Coatings in NL Regulation and risk assessment of Coating as FCM in The Netherlands Bianca van de Ven RIVM Content 1. Regulation of FCM in NL - General provisions - Coating specific provisions 2. Substance

More information

The Reform of Chinese FCM regulations and the legal compliance Part 2 National reference laboratory for Food contact material(nrl-fcm-iqtc)

The Reform of Chinese FCM regulations and the legal compliance Part 2 National reference laboratory for Food contact material(nrl-fcm-iqtc) The Reform of Chinese FCM regulations and the legal compliance Part 2 National reference laboratory for Food contact material(nrl-fcm-iqtc) 钟怀宁 Zhong Huai ning Marco_zhong@iqtc.cn,13924163757 General safety

More information

Establishing Fitness for Use in a Global Plastic Additives Business

Establishing Fitness for Use in a Global Plastic Additives Business Establishing Fitness for Use in a Global Plastic Additives Business David Horst, Product Stewardship, BASF Corporation Anne Christian, Quality Management, BASF Corporation Dr. Tobias Eltze, Product Stewardship,

More information

Joint safety evaluation of substances in printing inks by Germany (BfR) and Switzerland (FSVO)

Joint safety evaluation of substances in printing inks by Germany (BfR) and Switzerland (FSVO) Federal Department of Home Affairs FDHA Federal Food Safety and Veterinary Office FSVO Risk Assessment Division Joint safety evaluation of substances in printing inks by Germany (BfR) and Switzerland (FSVO)

More information

PoliPET ECO 84F RESIN GRADE Last review: APR 2017

PoliPET ECO 84F RESIN GRADE Last review: APR 2017 PoliPET ECO 84F RESIN GRADE Last review: APR 2017 1. COMPLIANCE WITH EU REGULATIONS FOR FOOD CONTACT PLASTICS FOOD CONTACT STATEMENT Polisan Hellas hereby declares that the mentioned product PoliPET ECO

More information

3 rd revised version. March Replaces the October 2005 version

3 rd revised version. March Replaces the October 2005 version Good Manufacturing Practices for the Production of Packaging Inks formulated for use on the non-food-contact surfaces of food packaging and articles intended to come into contact with food 3 rd revised

More information

Understanding the requirements of EU food contact legislation

Understanding the requirements of EU food contact legislation Understanding the requirements of EU food contact legislation Dr. Annette Schäfer Head of Sector Food Contact Materials DG SANCO The content of this lecture does not necessarily represent the position

More information

Workshop on Food Contact Material legislation in the EU

Workshop on Food Contact Material legislation in the EU Workshop on Food Contact Material legislation in the EU Bangkok, Thailand, 1 st November 2007 National legislations and Council of Europe s Resolutions on Food Contact Materials Luigi Rossi Summary General

More information

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

More information

EN SANCO/2006/ EN EN

EN SANCO/2006/ EN EN EN SANCO/2006/ EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 02.28.2006 SANCO/2006/ EMB/1110 THIS WORKING DOCUMENT DOES NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION SERVICES NON PAPER

More information

Legal requirements for contact materials Roberto Massini

Legal requirements for contact materials Roberto Massini Roberto Massini Contents European legislation Supplementary Italian legislation US Federal legislation Conclusions European legislation Communitary and National rules Reg. (EC) No 1935/2004 (Framework

More information

SWISS ORDINANCE ON MATERIALS AND ARTICLES IN CONTACT WITH FOOD (SR ) Permitted Substances for Packaging Inks. Questions & Answers

SWISS ORDINANCE ON MATERIALS AND ARTICLES IN CONTACT WITH FOOD (SR ) Permitted Substances for Packaging Inks. Questions & Answers SWISS ORDINANCE ON MATERIALS AND ARTICLES IN CONTACT WITH FOOD (SR 817.023.21) Permitted Substances for Packaging Inks Questions & Answers Page 1 of 5 The Swiss Federal Department of Home Affairs (FDHA)

More information

Food Contact Materials gaps to be addressed the roadmap excercise

Food Contact Materials gaps to be addressed the roadmap excercise Food Contact Materials gaps to be addressed the roadmap excercise The content of this lecture does not necessarily represent the position of the European Commission 1 ANEC, Brussels, 29.10.2013 Overview

More information

Adhesive Food Safety: Henkel Approach Nayan Bezbaruah Henkel Adhesives Technologies India Private Limited July 27 th, 2018 New Delhi

Adhesive Food Safety: Henkel Approach Nayan Bezbaruah Henkel Adhesives Technologies India Private Limited July 27 th, 2018 New Delhi Nayan Bezbaruah Henkel Adhesives Technologies India Private Limited July 27 th, 2018 New Delhi Agenda 1. 2. 3. 4. Why Has Food Safety Become Important? Legislations in Action Henkel s Food Safe Packaging

More information

EFSA Network of the Food Ingredients and Packaging (FIP) Unit on Food Contact Materials (FCM)

EFSA Network of the Food Ingredients and Packaging (FIP) Unit on Food Contact Materials (FCM) EFSA Network of the Food Ingredients and Packaging (FIP) Unit on Food Contact Materials (FCM) Eric Barthelemy Scientific Oficer, coordinator of the FIP FCM network EFSA Advisory Forum - 9 March 2016 -

More information

The Ink Industry's Contribution To Compliant Food Packaging. Dr Martin Kanert Leicester, 28 November 2013

The Ink Industry's Contribution To Compliant Food Packaging. Dr Martin Kanert Leicester, 28 November 2013 The Ink Industry's Contribution To Compliant Food Packaging Dr Martin Kanert Leicester, 28 November 2013 (Food contact) materials and articles, ( ), shall be manufactured in compliance with good manufacturing

More information

Intertek Compliance Program for Packaging to:

Intertek Compliance Program for Packaging to: Compliance Program for Packaging to: Framework Regulation 1935/2004 (EC) European Commission Regulation (EU) 10/2011 for plastics Resolution ResAP (2002)1 for paper and board and others 1 Table of contents

More information

Practical Challenges for Food Contact Materials (FCM) Stakeholders: A Regulatory View

Practical Challenges for Food Contact Materials (FCM) Stakeholders: A Regulatory View Practical Challenges for Food Contact Materials (FCM) Stakeholders: A Regulatory View Dr Bernard Hegarty Food Safety Authority of Ireland Abbey Court, Lower Abbey St, Dublin 1, Ireland bhegarty@fsai.ie

More information

Workshop on Food Contact Material legislation in the EU

Workshop on Food Contact Material legislation in the EU Workshop on Food Contact Material legislation in the EU Bangkok, Thailand, 1 st November 2007 Compliance with legislation Rinus Rijk 1 Scope Legal requirements: Framework Regulation Plastics Directive

More information

NORMPACK GUIDE. A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm.

NORMPACK GUIDE. A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm. NORMPACK GUIDE A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm Kristina Salmén Foreword The Normpack guide is a support for Normpack members

More information

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents 2006R2023 EN 17.04.2008 001.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COMMISSION REGULATION (EC) No 2023/2006 of 22

More information

RECYCLED PLASTICS IN FOOD CONTACT PACKAGING EVALUATION PROCEDURE, RISK ASSESSMENT, NOTIFICATION

RECYCLED PLASTICS IN FOOD CONTACT PACKAGING EVALUATION PROCEDURE, RISK ASSESSMENT, NOTIFICATION RECYCLED PLASTICS IN FOOD CONTACT PACKAGING EVALUATION PROCEDURE, RISK ASSESSMENT, NOTIFICATION Bernard Hegarty, 26 November 2012 Contents Why recycled plastics? EU legislation on the topic EFSA evaluation

More information

The role of the Council of Europe/EDQM in setting standards for FCM in Europe. Luxembourg, 30 September 2015 Dr. Francois-Xavier Lery EDQM

The role of the Council of Europe/EDQM in setting standards for FCM in Europe. Luxembourg, 30 September 2015 Dr. Francois-Xavier Lery EDQM The role of the Council of Europe/EDQM in setting standards for FCM in Europe Luxembourg, 30 September 2015 Dr. Francois-Xavier Lery EDQM The Council of Europe The Council of Europe is the continent's

More information

The Reform of Chinese FCM legislations and the challenges for compliance

The Reform of Chinese FCM legislations and the challenges for compliance The Reform of Chinese FCM legislations and the challenges for compliance National reference laboratory for Food contact material(nrl-fcm-iqtc) 钟怀宁 Zhong Huai ning Marco_zhong@iqtc.cn,13924163757 CONTENTS

More information

Migrations des emballages : un grand trou dans la sécurité alimentaire et comment on pourrait le remplir.

Migrations des emballages : un grand trou dans la sécurité alimentaire et comment on pourrait le remplir. Migrations des emballages : un grand trou dans la sécurité alimentaire et comment on pourrait le remplir. Koni Grob Kantonales Labor Zürich FCM: the largest gap in food safety? Migrates from FCM might

More information

Food Safe Packaging Hotmelt Adhesives Everything you need to know. Ralf Eberhardt & Philippe Cordier June 19, 2015

Food Safe Packaging Hotmelt Adhesives Everything you need to know. Ralf Eberhardt & Philippe Cordier June 19, 2015 Food Safe Packaging Hotmelt Adhesives Everything you need to know Ralf Eberhardt & Philippe Cordier Disclaimer The information provided herein, especially recommendations for the usage and the application

More information

DECLARATION OF COMPLIANCE

DECLARATION OF COMPLIANCE DECLARATION OF COMPLIANCE 1 The identity and address of the business operator issuing the declaration of compliance: Kreis Pack Spółka z o. o. ul. Leśna 22 64-320 Niepruszewo Poland 2 The identity and

More information

1- GENERAL INTRODUCTION

1- GENERAL INTRODUCTION Page 1/8 1- GENERAL INTRODUCTION Article 3 of Regulation (EC) No 1935/2004 of 27 October 2004 foresees that food contact materials and articles, including active and intelligent materials and articles,

More information

Printing inks for food packaging materials. D. MANTIS Druckfarben HELLAS

Printing inks for food packaging materials. D. MANTIS Druckfarben HELLAS Printing inks for food packaging materials D. MANTIS Druckfarben HELLAS Current EC regulations Regulation 2011/10 On plastic materials and articles intended to come into contact with food - Plastic materials

More information

REGULATORY ASSURANCE R&D SUPPORT

REGULATORY ASSURANCE R&D SUPPORT CHEMICALS & MATERIALS SCIENCES REGULATORY ASSURANCE R&D SUPPORT Helping you to achieve Total Quality Assurance INTERTEK REGULATORY ASSURANCE Chemicals and Materials Sciences Regulatory Assurance and R&D

More information

Migration Guidelines for nonplastic. Update for DGSante and Member State Experts 9 th September 2016

Migration Guidelines for nonplastic. Update for DGSante and Member State Experts 9 th September 2016 Migration Guidelines for nonplastic FCMs Update for DGSante and Member State Experts 9 th September 2016 1 Migration Guidelines for 10/2011 The professional associations involved in a task force to develop

More information

INDUSTRIAL GUIDELINES ON TRACEABILITY OF MATERIALS AND ARTICLES FOR FOOD CONTACT

INDUSTRIAL GUIDELINES ON TRACEABILITY OF MATERIALS AND ARTICLES FOR FOOD CONTACT INDUSTRIAL GUIDELINES ON TRACEABILITY OF MATERIALS AND ARTICLES FOR FOOD CONTACT 0 INDEX I. OBJECTIVE 1 II. SCOPE 2 Page II.1 Materials 3 II.2 Applications 3 III. STAKEHOLDERS WITHIN THE FOOD 4 CONTACT

More information

What you need to know about primary aromatic amines (PAA)

What you need to know about primary aromatic amines (PAA) Press release 31.03.2016 Food Safety in flexible packaging What you need to know about primary aromatic amines (PAA) Food safety has been very high on the agenda of the primary packaging material manufacturers

More information

Packaging and package materials

Packaging and package materials Packaging and package materials Modern trends in food industry Malatya AGR 41 896 Yves Opsomer 27 September 2010 Materials in contact food Regulation european 1935/2004 national Belgian organisation of

More information

PP Quality Assurance Procurement Clauses for Suppliers

PP Quality Assurance Procurement Clauses for Suppliers PP 360.3 Quality Assurance Procurement Clauses for Suppliers Version No: 7 Created By: Approved By: Erik Keim on 01/29/2019 at 10:44 PM Eric Deffarges on 02/05/2019 at 09:17 AM Valid From: 06/12/2017 Strictly

More information

Version: February 20, 2012

Version: February 20, 2012 Certificate Version: 2012.1 February 20, 2012 Declaration of Compliance Trade name Tambrite and Tambrite HS (hereafter referred to as folding boxboards) Product description Folding boxboard Tambrite grammage

More information

Food Contact Requirements in Asia and Latin America

Food Contact Requirements in Asia and Latin America Food Contact Requirements in Asia and Latin America Agenda Types of regulatory systems Overview of regulatory requirements and new developments Japan South Korea India China MERCOSUR A comparison: similarities

More information

DECLARATION OF COMPLIANCE

DECLARATION OF COMPLIANCE DECLARATION OF COMPLIANCE 1 The identity and address of the business operator issuing the declaration of compliance: Kreis Pack Spółka z o. o. ul. Leśna 22 64-320 Niepruszewo Poland 2 The identity and

More information

CONSTRUCTION SECTOR STANDARDIZATION GUIDANCE DOCUMENT

CONSTRUCTION SECTOR STANDARDIZATION GUIDANCE DOCUMENT TF N 548 Rev1 2012-03-29 CONSTRUCTION SECTOR STANDARDIZATION GUIDANCE DOCUMENT How to draft clauses on Assessment and Verification of the Constancy of Performance (AVCP) in harmonized standards for construction

More information

NIAS: The new challenges for safety assessment of Food Contact Materials. Dr. Thomas Gude

NIAS: The new challenges for safety assessment of Food Contact Materials. Dr. Thomas Gude NIAS: The new challenges for safety assessment of Food Contact Materials Dr. Thomas Gude Stating Compliance Stating compliance with the Framework Regulation (EU) No 1935/2004 does not only cover the safety

More information

Food Packaging: A Guide to Best Practice for Sheetfed Offset Print

Food Packaging: A Guide to Best Practice for Sheetfed Offset Print Food Packaging: A Guide to Best Practice for Sheetfed Offset Print Version: May 2017 CONTENT The aim of this guide 2 1 Interaction between food and printed packaging: the danger areas 3 2 Legislation and

More information

Technical Documentation Bill of Materials Enhanced Format Revised Toy Safety Directive 2009/48/EC

Technical Documentation Bill of Materials Enhanced Format Revised Toy Safety Directive 2009/48/EC Technical Documentation Bill of Materials Enhanced Format Revised Toy Safety Directive 2009/48/EC Contents 1. Obligations of Economic Operators 2. Introduction 3. Why have a standard BoM format? 4. BoM

More information

Graphic Arts REACH. Registration, Evaluation and Authorization of Chemicals.

Graphic Arts REACH. Registration, Evaluation and Authorization of Chemicals. Graphic Arts REACH Registration, Evaluation and Authorization of Chemicals. REACH background information, implications for the coating and plastics industries, and how ACTEGA Terra is getting ready for

More information

HEALTH AND CONSUMERS DIRECTORATE-GENERAL

HEALTH AND CONSUMERS DIRECTORATE-GENERAL EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL - Directorate E- Safety of the Food chain E6- Innovation and sustainability EU guidelines on conditions and procedures for the import of polyamide

More information

10/2011 EC - Statement of Compliance

10/2011 EC - Statement of Compliance 10/2011 EC - Statement of Compliance Manufacturer: Arjobex Limited 10 Stephenson Road. Clacton-on-Sea Essex CO15 4NS United Kingdom Date: 9 th March 2018 Product: Standard 2 Side Coated Polyart Product

More information

Review of the scope of REACH and other relevant EU legislation according to Article 138(6) REACH: description of gaps and overlaps

Review of the scope of REACH and other relevant EU legislation according to Article 138(6) REACH: description of gaps and overlaps 1 December 2010 DISCLAIMER: This document is a Cefic contribution to the present day to the REACH scope review consultation launched by the Commission and commissioned to the consultancy Milieu. It has

More information

End of the Plastics Directive (EU) 10/2011 transitional period with consequences for suppliers of plastic layer pads, container producers, and fillers

End of the Plastics Directive (EU) 10/2011 transitional period with consequences for suppliers of plastic layer pads, container producers, and fillers End of the Plastics Directive (EU) 10/2011 transitional period with consequences for suppliers of plastic layer pads, container producers, and fillers As a quality-conscious filler proceed without risk

More information

Possible risk assessment for Nano-particles in Food Contact Materials

Possible risk assessment for Nano-particles in Food Contact Materials Possible risk assessment for Nano-particles in Food Contact Materials 4 th Nanotechnology Dialogue FoodDrinkEurope Brussels 5 th October 2011 P.K.T. Oldring Valspar Corporation 1 Nanotechnology and FCM

More information

Regulatory Developments in India

Regulatory Developments in India Regulatory Developments in India Alistair Irvine, Smithers Pira May 2013 Smithers Pira the worldwide authority on the packaging, paper and print industry supply chains Introduction Background New Regulatory

More information

1. Scope of the decree of 8th July, 1992.

1. Scope of the decree of 8th July, 1992. Page 4 GENERAL SHEET RELATING TO THE REGULATION OF MATERIALS IN CONTACT WITH FOODSTUFFS The basic text regulating the suitability of materials and objects intended to be in contact with foodstuffs, food

More information

COMMISSION RECOMMENDATION. of XXX

COMMISSION RECOMMENDATION. of XXX EUROPEAN COMMISSION Brussels, XXX C(2014) 267 /3 COMMISSION RECOMMENDATION of XXX on minimum principles for the exploration and production of hydrocarbons (such as shale gas) using high volume hydraulic

More information

Explanations on the content of the INEOS O&P Europe PP or PE Regulatory Compliance Certificate (RCC)

Explanations on the content of the INEOS O&P Europe PP or PE Regulatory Compliance Certificate (RCC) Explanations on the content of the INEOS O&P Europe PP or PE Regulatory Compliance Certificate (RCC) Objectives of the RCC The RCC provides in a concise way with all regulatory information legally needed

More information

COMMISSION RECOMMENDATION

COMMISSION RECOMMENDATION L 39/72 Official Journal of the European Union 8.2.2014 RECOMMENDATIONS COMMISSION RECOMMENDATION of 22 January 2014 on minimum principles for the exploration and production of hydrocarbons (such as shale

More information

REACH and RoHS updates for EU and Asia Pacific countries Mike McNally Antea Group

REACH and RoHS updates for EU and Asia Pacific countries Mike McNally Antea Group REACH and RoHS updates for EU and Asia Pacific countries Mike McNally Antea Group Agenda Overview REACH RoHS Related regulations Discussion: Key Risks Key Considerations Overview We have witnessed an unprecedented

More information

Guidance for the use of printing inks for paper and board packaging used for contact with food

Guidance for the use of printing inks for paper and board packaging used for contact with food Annex 1 to JIG/002/10E- PIJITF 1 Guidance for the use of printing inks for paper and board packaging used for contact with food 1-Regulations The Framework Regulation (EC) No 1935/2004 states that materials

More information

Guidance on. Good Manufacturing Practices for food contact plastic materials and articles

Guidance on. Good Manufacturing Practices for food contact plastic materials and articles Guidance on Good Manufacturing Practices for food contact plastic materials and articles Edited by AVEP (Valencian Plastic Industries Association) Evaluation group: Mar Canós Cerdá, Claudia McAllister

More information

Context. Food safety: release of chemicals from FCM into foods. Framework regulation establishes principles of safety assessment and management

Context. Food safety: release of chemicals from FCM into foods. Framework regulation establishes principles of safety assessment and management Context Food safety: release of chemicals from FCM into foods Framework regulation establishes principles of safety assessment and management Not all harmonised Some materials have EU wide approach Others

More information

Hygienic evaluation of materials for the production of elastomers in contact with drinking water

Hygienic evaluation of materials for the production of elastomers in contact with drinking water Gummi Fasern Kunststoffe, 67, No. 11, 2014, pp. 697 701 Hygienic evaluation of materials for the production of elastomers in contact with drinking water R. Schuster Federal Environment Agency, Section

More information

Version: July 24, 2014

Version: July 24, 2014 Certificate Version: 2014.4 July 24, 2014 Declaration of Compliance Trade name Tambrite and Tambrite HS (hereafter referred to as folding boxboards) Product description Folding boxboard Tambrite grammage

More information

bluesign system Version 1.0 April 01, 2014

bluesign system Version 1.0 April 01, 2014 bluesign system Version 1.0 April 01, 201 Content 1 Introduction 2 Scope Definitions.1.2...5.6.7.8.9.10.11 BAT bluesign system bluesign system partner bluesign applications bluesign system substances list

More information

NORMPACK GUIDE. A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm.

NORMPACK GUIDE. A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm. NORMPACK GUIDE A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm Kristina Salmén Foreword The Normpack guide is a support for Normpack members

More information

HP Indigo for Food Flexible Packaging

HP Indigo for Food Flexible Packaging White paper HP Indigo for Food Flexible Packaging Regulatory Overview Introduction HP Indigo customers who print food flexible packaging operate their businesses within a complex and strict set of regulations

More information

TSC34 MIGRATION TESTING GUIDELINES FOR RIGID METAL PACKAGING COATED WITH ORGANIC

TSC34 MIGRATION TESTING GUIDELINES FOR RIGID METAL PACKAGING COATED WITH ORGANIC TSC34 MIGRATION TESTING GUIDELINES FOR RIGID METAL PACKAGING COATED WITH ORGANIC COATINGS INTENDED FOR DIRECT FOOD CONTACT VERSION 6.3 10 TH OCTOBER, 2017 Page 1 of 12 CONTENTS 1. SUMMARY... 3 Migration

More information

PLANNING FOR REACH 2018 AS A NON-EU COMPANY

PLANNING FOR REACH 2018 AS A NON-EU COMPANY PLANNING FOR REACH 2018 AS A NON-EU COMPANY Joyce Borkhoff Vice President, Chemicals Group Intertek Scientific & Regulatory Consultancy AGENDA 01 02 Overview of REACH Requirements Specific to Non-EU Companies

More information

INKS & COATINGS. for Food Packaging Applications

INKS & COATINGS. for Food Packaging Applications INKS & COATINGS for Food Packaging Applications 2 MIGRATION IN PACKAGING GLOBAL VISION, GLOBAL CAPABILITIES, LOCAL SOLUTIONS Migration is the transfer of various components from the finished packaging

More information

Materials and Articles in Contact with Food

Materials and Articles in Contact with Food Materials and Articles in Contact with Food Emma Bradley Fera Science Ltd Date: July 2017, Version 1 Overview What is migration? Factors affecting migration Legislation How it all started EU legislation

More information

REGULATION (EU) NO 1169/ ORIGIN OF MEAT USED AS AN DEFINITION OF 'ENGINEERED ON THE PROVISION OF FOOD INFORMATION TO CONSUMERS

REGULATION (EU) NO 1169/ ORIGIN OF MEAT USED AS AN DEFINITION OF 'ENGINEERED ON THE PROVISION OF FOOD INFORMATION TO CONSUMERS REGULATION (EU) NO 1169/2011 ON THE PROVISION OF FOOD INFORMATION TO CONSUMERS 1. 1. ORIGIN OF MEAT USED AS AN INGREDIENT 2. 2. DEFINITION OF 'ENGINEERED NANOMATERIALS' 1 1. 1. ORIGIN OF MEAT USED AS AN

More information

Werknorm BN e Material Compliance Blatt 1 von 7

Werknorm BN e Material Compliance Blatt 1 von 7 Material Compliance Blatt 1 von 7 Dokument-Version: BN 905-003e - 1 Purpose This company standard bundles all material- and substance-related requirements from national and international laws, directives,

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Medicinal Product quality, safety and efficacy Brussels, 16 August 2013 EudraLex The Rules Governing Medicinal

More information

DRAFT UGANDA STANDARD

DRAFT UGANDA STANDARD DRAFT UGANDA STANDARD DUS 1659 First Edition 2016-11-09 Materials in Contact with Food Requirements for Packaging materials Reference number DUS 1659: 2016 UNBS 2016 DUS 1659: 2016 Compliance with this

More information

Titelformat bearbeiten

Titelformat bearbeiten Austrian Research Institute for Chemistry and Technology - ofi Codex-UK Gebrauchsgegenstände Titelformat bearbeiten 3. Juni 2008 / BMGFJ Mumbai, 2014-02-11 Global Approach for Food Safety in Packaging

More information

4 Material specific regulations and demands

4 Material specific regulations and demands 4 Material specific regulations and demands This chapter contains information about material specific legislations/regulations/recommendations. In the following sub-chapters, you will find for each material:

More information

General Approach for Prioritisation of Substances of Very High Concern (SVHCs) for Inclusion in the List of Substances Subject to Authorisation

General Approach for Prioritisation of Substances of Very High Concern (SVHCs) for Inclusion in the List of Substances Subject to Authorisation 28 May 2010 General Approach for Prioritisation of Substances of Very High Concern (SVHCs) for Inclusion in the List of Substances Subject to Authorisation Document developed in the context of ECHA s second

More information

POSITION PAPER Moving from the MDD to the MDR

POSITION PAPER Moving from the MDD to the MDR A summary of Key Changes regarding Sterile Packaging and considerations on recommended changes to standards Introduction EN ISO 11607 specifies the requirements and test methods for materials, preformed

More information

EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Single Market Policy, Regulation and Implementation Standards for Growth Ref. Ares(2016)6548298-22/11/2016

More information

Printed paper and board: Priority setting strategy for toxicological assessment

Printed paper and board: Priority setting strategy for toxicological assessment Printed paper and board: Priority setting strategy for toxicological assessment M. Van Bossuyt 1,2, E. Van Hoeck 1, T. Vanhaecke 2, V. Rogiers 2* and B. Mertens 1* 1 Food, Medicines and Consumer Safety,

More information

Assessment of IAS and NIAS in Packaging A global brand owner approach

Assessment of IAS and NIAS in Packaging A global brand owner approach Assessment of IAS and NIAS in Packaging A global brand owner approach The 5 th Food Contact Material Symposium November 2-3 Xi an Dr Lionel Spack Nestlé Quality Assurance Center Zone EMENA AGENDA 1 2 3

More information

Dr. Annelie Struessmann Technical Director, CONUSBAT Johannesburg, 16. October 2012

Dr. Annelie Struessmann Technical Director, CONUSBAT Johannesburg, 16. October 2012 Dr. Annelie Struessmann Technical Director, CONUSBAT Johannesburg, 16. October 2012 1 REACH & THE EU COSMETICS REGULATION - RESULTS AND GAINS IN A WORLD WIDE PERSPECTIVE 2 Gains from Regulatory Affairs

More information

REACH REGULATION: the new management of chemicals in Europe and operational tools. R egistration. E valuation. A Ch. uthorisation.

REACH REGULATION: the new management of chemicals in Europe and operational tools. R egistration. E valuation. A Ch. uthorisation. REACH REGULATION: the new management of chemicals in Europe and operational tools R egistration E valuation A Ch uthorisation emicals Index of topics Set of rules before REACH Regulation REACH REGULATION

More information

GRIP 212 SPRAY AND WIPE

GRIP 212 SPRAY AND WIPE SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product name Product No. 143575 GRIP 212 SPRAY AND WIPE 1.2. Relevant identified uses of the substance

More information

Valmet guidance on restricted materials in products 1/8

Valmet guidance on restricted materials in products 1/8 Valmet guidance on restricted materials in products 1/8 1 Introduction Legislation in various countries is limiting the use of potentially dangerous substances. Potentially dangerous substances are chemicals

More information

The JRC baseline study. The European Commission s science and knowledge service Joint Research Centre

The JRC baseline study. The European Commission s science and knowledge service Joint Research Centre The JRC baseline study The European Commission s science and knowledge service Joint Research Centre Context Food safety: release of chemicals from FCM into foods Framework regulation establishes principles

More information

A European Strategy for Plastics in the circular economy Hugo-Maria Schally DG ENVIRONMENT

A European Strategy for Plastics in the circular economy Hugo-Maria Schally DG ENVIRONMENT A European Strategy for Plastics in the circular economy Hugo-Maria Schally DG ENVIRONMENT Maintaining value Reducing waste Bringing economic, social and environmental gains TRANSITION TOWARDS A CIRCULAR

More information

GUIDANCE DOCUMENT ON APPLICATIONS FOR TECHNICAL EQUIVALENCE

GUIDANCE DOCUMENT ON APPLICATIONS FOR TECHNICAL EQUIVALENCE G U I D A N C E GUIDANCE DOCUMENT ON APPLICATIONS FOR TECHNICAL EQUIVALENCE 1 1 2 3 4 5 6 7 8 9 10 LEGAL NOTICE This document contains guidance on Regulation (EU) No 528/2012 of the European Parliament

More information

HBCD Factsheet. Brominated Flame retardant October Hexabromocyclododecane

HBCD Factsheet. Brominated Flame retardant October Hexabromocyclododecane HBCD Factsheet Brominated Flame retardant October 2012 Hexabromocyclododecane HBCD Factsheet Hexabromocyclododecane > Introduction Hexabromocyclododecane (HBCD) 1 is a brominated flame retardant used for

More information

PCR PET for food packaging. Facts and challenges. Lisa Straub Feb 22, 2012

PCR PET for food packaging. Facts and challenges. Lisa Straub Feb 22, 2012 PCR PET for food packaging. Facts and challenges. Lisa Straub Feb 22, 2012 viscotec - SSP division of Starlinger decon Solid state polycondensation plants for the iv increase and decontamination of PET

More information

Guidance on applications for technical equivalence

Guidance on applications for technical equivalence 1 guidance Guidance on applications for technical equivalence Guidance on Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Version 1.0 August 2013

More information

AmCham EU s position on the proposed Directive on lightweight plastic carrier bags

AmCham EU s position on the proposed Directive on lightweight plastic carrier bags AmCham EU s position on the proposed Directive on lightweight plastic carrier bags Emphasising the importance of achieving a reduction in plastic bag littering through consistent and coherent legislation

More information

European Packaging Legislation and Packaging Waste Recovery

European Packaging Legislation and Packaging Waste Recovery 22 European Packaging Legislation and Packaging Waste Recovery P Fielding Packaging Consultant, DuPont Nonwovens, Luxembourg The primary objective of the European Commission s new approach to environmental

More information

European Code of Practice For Feed Additive and Premixture Operators

European Code of Practice For Feed Additive and Premixture Operators European Code of Practice For Feed Additive and Premixture Operators INTRODUCTION This European Code of Practice for Animal Feed Additive and Premixture Operators ( Code ) responds to the Regulation of

More information

Impact of the REACH Regulation (EC) n 1907/2006

Impact of the REACH Regulation (EC) n 1907/2006 Impact of the REACH Regulation (EC) n 1907/2006 Analysis of the consequences of REACH on the supply chain from the exporter s point of view. www.tuv.com/reach Introduction The REACH regulation came into

More information

DRAFT UGANDA STANDARD

DRAFT UGANDA STANDARD DRAFT UGANDA STANDARD DUS 1666 First Edition 2017-01-02 Polystyrene for its safe use in contact with foodstuffs, pharmaceuticals and drinking water Specification Reference number DUS 1666: 2017 UNBS 2017

More information

Combination Products Part 4 Compliance and Implementation at multi-site Network

Combination Products Part 4 Compliance and Implementation at multi-site Network Combination Products Part 4 Compliance and Implementation at multi-site Network Vijay Damodaran Eli Lilly & Company September 27, 2017 Contents Key cgmp requirements for combination products How to perform

More information

The content of this document is not legally binding, since only the Court of Justice can give an authoritative interpretation of Community law.

The content of this document is not legally binding, since only the Court of Justice can give an authoritative interpretation of Community law. Composition and undesirable effects of cosmetic products to be made easily accessible to the public - practical implementation of article 7a(1)(h) 2nd paragraph of Council directive 76/768/EEC Under article

More information

COMMISSION IMPLEMENTING DECISION. of

COMMISSION IMPLEMENTING DECISION. of EUROPEAN COMMISSION Brussels, 8.2.2017 C(2017) 661 final COMMISSION IMPLEMENTING DECISION of 8.2.2017 granting an authorisation for a use of sodium dichromate under Regulation (EC) No 1907/2006 of the

More information

Primary Aromatic Amines

Primary Aromatic Amines Dr. Dennis Bankmann and Dr. Roberto Pela July 2017 Primary Aromatic Amines Globally relevant content 02/11 Primary Aromatic Amines Relevant Legislation (EC) No. 1935/2004, recital 3: [ ] any material or

More information