Presentazione Eugenio Cavallini Milano 10 May 2017

State of the art of harmonisation for P&B for food contact applications: the proposal from the P&B supply chain and the situation in Europe

Eugenio Cavallini CEPI Technical Manager May 2017

About CEPI The Confederation of European Paper Industries (CEPI) is a Brussels-based non-profit making organisation representing the European pulp and paper industry www.cepi.org

Summary • • • • • •

On harmonisation The three documents approach Document 2: the P&B Guidance Document 3: the collections of GMPs A few words on Mineral Oils Conclusions 3

On Harmonisation • Many initiatives asking for harmonization of non-harmonized materials and articles • NGOs have joined asking for harmonization

• EP report on the implementation of the food contact materials regulation 1935/04  calls for «adoption of specific measures for … materials not yet regulated at EU level» (C. Schaldemose - October 2016)

On Harmonisation • Nine Member States joint letter to EC «on the need for European specific measures for food contact materials» (October 2016)  Austria, Belgium, Denmark, Finland, France, Germany, Luxembourg, the Netherlands and Sweden • «propose to start the work on developing European specific measures for non-harmonized groups of food contact materials as soon as possible»

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On Harmonisation • Nine Member States joint letter to EC «on the need for European specific measures for food contact materials» (October 2016)  Austria, Belgium, Denmark, Finland, France, Germany, Luxembourg, the Netherlands and Sweden • «propose to start the work on developing European specific measures for non-harmonized groups of food contact materials as soon as possible»

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On Harmonisation • Nine Member States joint letter to EC «on the need for European specific measures for food contact materials» (October 2016)  Austria, Belgium, Denmark, Finland, France, Germany, Luxembourg, the Netherlands and Sweden • «propose to start the work on developing European specific measures for non-harmonized groups of food contact materials as soon as possible»

Recent announcements DGSante + JRC baseline study

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30 January: DGSante Food Contact Materials Technical meeting > Evaluation of the 40 years old existing legislation on FCM scopes and activities; likely in the view of its updating. > Launch of the activity on harmonisation of printed Food Contact Materials (p-FCM) with a deadline mid 2018. > “p-FCM” not fully clear yet: ink layer only? substrate included? > Many options, including industry doing risk assessment by its own  a more self-regulating approach? > High importance on flow of information along the supply chain, Declarations of Compliance and backing documentation. > P&B: very likely, the first harmonised p-FCM 8

Preamble to the presentation of our proposal for a H.M. 1. Clear need for non-harmonised materials to be harmonised 2. Harmonisation cannot work with the existing approach 3. An innovative, new approach is needed ‌ 4. ‌ as the one we propose as a MODEL

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The existing approach • Reg. 1935/2004

Reg. 10/2011

• What and How • • • •

Reg. 2023/2006 GMP

All mandatory In fine detail Need for guidance docs No or limited room • for interpretation • for changes

• Principles/guidance, not rules • Adoption: mandatory • Implementation: customised, based on RA • Self regulation

A number of very thick guidance documents, given the high level of detail in the mandatory rules of the Regulation + amendments 10

The three documents approach under assessment in the light of the recent announcements 1. The ÂŤRealÂť Regulation WHAT

1.

2.

2. The P&B Guidance

3.

HOW

This document will provide guidance on how the requirements in the Specific Measure can be met.

A CEN standard?

3. The GMP Guidelines HOW

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Risk Assessment is at the centre Reg. 1935/2004 Paper and Board Guidance

Reg. GMP N° Guidelines XX/yyyy Based on on P&B • Guidance/soft law/CEN RA for Standards food contact • Adoption: mandatory applications • Implementation: customised, based on RA What

How

How

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Contents of our proposal CONTENTS DICTATED BY: LEARNING FROM:

Regulations 1935/2004 and 2023/2006 Regulation 10/2011 on Plastics Existing Industry Guideline, GMPs

Same contents, different split

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What is not new in document 2: the P&B guidance • • • • •

GMP: is mandatory (art. 3 Reg. 1935/2004) Composition (art. 5) Rules on Labelling (art.15) Rules on DoC/Documentation (art.16) Rules on Traceability (art.17)

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What is new in document 2: the P&B guidance • Risk Assessment approach  IAS and NIAS • Soft law/Self-Regulation, using guidelines • A Measure Covering the Whole P&B Sector  Materials (paper making),  Articles (paper converting)  Tissue products 15

Table of Contents of the Paper and Board Guidance INTRODUCTION

Purpose Scope MANUFACTURING PROCESS COMPLIANCE REQUIREMENTS Before placing on the market Risk Management GMP Composition Traceability Labelling DoC CHECKLISTS/SUPPLY CHAIN COMMS DoC Documents Supply Chain Documents REFERENCES ANNEXES Cross Reference Table Manufacturing process details Definitions DoC Contents DoC supporting docs checklist Supply Chain Checklists Testing Traceability Labelling 16

Table of Contents of the Paper and Board Guidance INTRODUCTION

Purpose Scope MANUFACTURING PROCESS COMPLIANCE REQUIREMENTS Before placing on the market Risk Management GMP

Composition Traceability Labelling DoC CHECKLISTS/SUPPLY CHAIN COMMS DoC Documents Supply Chain Documents REFERENCES ANNEXES Cross Reference Table Manufacturing process details Definitions DoC Contents DoC supporting docs checklist Supply Chain Checklists

Testing Traceability Labelling 17

Compositional requirements IAS

• Adopt the approach laid down in Reg. 1935/2004 art. 5: only substances that are in a “list of substances authorised for use in the manufacturing of materials and articles“ can be used > Already in the existing Industry Guideline

• New substances: according to the rules laid down in Reg. 1935/2004 art. 8 – 13 • Starting point: existing positive lists from member states (e.g. German BfR, Dutch Warenwet, Italian decree 21.3.73 and so on) and American FDA > Positive lists widely used and followed by our industry

• Use of Paper for Recycling is allowed under specified conditions 18

Compositional requirements NIAS • Pending the results of the project on NIAS that is going to investigate a possible approach based on Risk Assessment (see next slides) • Meanwhile: the same approach as in the existing Industry Guideline, i.e.: • Purity Requirements for certain potential contaminants • Differentiation between virgin and recycled papers and uses • Ad hoc testing methods

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Compositional requirements NIAS • An ongoing CEPI Food Contact Group / UK FERA / Italian Chemstamp R&D project: • First part: collecting/assessing already existing information on the presence of NIAS in P&B materials, and laying the foundations for next steps • Second part: definition of a methodical guide for dealing with the NIAS on a daily business basis.

… the present stage 20

Compositional requirements NIAS • A highly innovative approach • Moving from existing knowledge on NIAS in P&B (analytical findings, quantities, migration, …)

• Filling the gaps (additional analytical work)

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Compositional requirements NIAS • Processing of the data • Testing/assessing: including the use of Bioassays • Definition of a methodical guideline to deal with the NIAS on a daily business basis  a real TOOL for companies

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The document N.3: the GMPs Regulation 2023/06 on GMP

Document 3 provides guidance

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Implementing GMP REGULATION 1935/2004 REGULATION 2023/2006 General Guidelines Industry guidelines Paper, Converting,Tissue

Corporate GMP

RISK ASSESSMENT

Quality Assurance System (art. 5) Quality Control System (art. 6)

“CUSTOMIZATION ” at corporate level (department) Documentation (art. 7)

Implementing GMP REGULATION 1935/2004 REGULATION 2023/2006 General Guidelines

Industry guidelines Papermaking, Converting, Tissue

Already existing: just make them homogeneous

RISK ASSESSMENT

Quality Assurance System (art. 5) Quality Control System (art. 6)

“CUSTOMIZATION ” at corporate level (department) Documentation (art. 7)

On Mineral Oils: the communication In 2016 and in 2017: another dose of “post-truth” *

* an expression describing situations … …. in which objective facts are less influential than appeals to emotion’

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On Mineral Oils  a Recommendation has been adopted «on the

monitoring of mineral oil hydrocarbons in food and materials and articles intended to come into contact with food»  EC Recommendation 2017/84  This is the only rational starting point to shed some light on MO issue  EC recent announcements are once more in the direction of not specifically regulating MO.

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On Mineral Oils  The sense of having a Member State dealing with the MO issue at this point sounds a bit unclear.  Need to collect solid information: an official EC/JRC protocol is needed (sampling, analytical method, evaluation of the results).  All potential sources of contamination, and not just recycled paper and board, should be taken in consideration.

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Conclusions • On harmonization: it takes to explore advanced and innovative approaches to get out of the quicksand of the existing regulatory concept.

• On NIAS (as well as on IAS): it takes to explore advanced and innovative approaches • On Mineral oils: it takes to work on a science-based approach

• Focusing on a substance at a time is of little benefit

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Conclusions • On harmonization: it takes to explore advanced and innovative approaches to get out of the quicksand of the existing regulatory concept.

• On NIAS (as well as on IAS): it takes to explore advanced and innovative approaches • On Mineral oils: it takes to work on a science-based approach

• Focusing on a substance at a time is of little benefit

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