CODE FOR GMP FOR

FLEXIBLE AND FIBRE-BASED

PACKAGING FOR FOOD

John Dixon

28th November 2013

FPE Portrait

• 72 member companies

• About 75% of European flexible packaging turnover

• 6 national associations are FPE members

• 6 companies of World’s top 10 are FPE members

• Extract of FPE membership:

… and many more in Western, Central and Eastern Europe (see more at www.flexpack-europe.org)

FPE Membership

• AB TEFCO

• Alfa Beta

• AL INVEST Bridlicna

• Aluberg

• Aluflexpack

• Aluminium Féron

• Alu-Vertriebsstelle

• Amcor Flexibles

• Ampac Flexibles

• Aliberico Packaging

• Ariflex

• ASAS

• BAK Ambalaj

• Ballerstaedt

• Beucke & Söhne

• Carcano Antonio

• Cellografica Gerosa

• Cellpack Packaging

• Clondalkin

• Constantia Flexibles

• Danapak

• Di Mauro

• Emsur

• Enteco Pharma

• Exopack

• Felix Schoeller Packaging

• Formica

• Frith’s Flexible Packaging

• Gascogne Laminates

• Goglio

• Hatzopoulos

• Huhtamaki

• Hydro Aluminium

• ISPAK

• Leeb Flexibles

• Leipa

• Maria Soell

• Mondi Packaging

• Multifoil

• Novelis

• O Kleiner

• online laminating

• PAVAG Folien

• PAWAG Verpackungen

• Perlen Converting

• Pilenpak

• ppg pre pac group

• Printpack

• Sacchital

• SAFTA

• Schmid Folien

• Schur Flexibles

• SEDA

• SELIG

• SIT

• Südpack Verpackungen

• Symetal

• TEKO

• Tsimis

• UC Rusal

• Uniprint Knaur

• Vedreine

• Wipak

• Wipf

Associated Members:

Companies:

• Elopak

• Greatview

• SIG Combibloc

• Tetra Pak

National Flexible Packaging Associations:

• EFE (Spain)

• ELIPSO (France)

• FASD Turkish Flexible Packaging

• FPE German Group

• GIFLEX (Italy)

• PAFA (United Kingdom)

FPE Objectives and

Key Activities

Compliance

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Goals of the Guidance

• To provide certainty of certifiable compliance with Art. 3

of the EU Framework Regulation 1935/2004/EC,

– That excessive migration of components from the

packaging into the food is prevented

– That the packaging will neither endanger human

health nor bring about unacceptable changes in the

composition of food or cause organoleptic changes

thereof,

• To ensure that the packaging will be in compliance with

the essential requirements of the Packaging and

Packaging Waste Directive 94/62/EC (as amended).

Approach

• Developed by FPE and CITPA

• The code is a management tool providing the methods by which these goals can be attained

• It is not a stand alone document

– The methods must be embedded in a good, independently audited quality assurance system, e.g. ISO 9001

– It demands the implementation of a complete system for hygiene control

• It focuses on “design for compliance”

– Selection of suppliers with appropriate audited systems for traceability and compliance with legislation

– Selection of those raw materials and conversion processes which will almost inevitably result in a finished product which meets the goals

• Method

• Migration

• Organoleptic

Changes

• Contamination

• Essential

Requirements

• Raw Materials

• Production

• Quality Assurance

• Change Control

• Personnel and

Training

Contents

• Method

• Migration

• Organoleptic

Changes

• Contamination

• Essential

Requirements

• Raw Materials

• Production

• Quality Assurance

• Change Control

• Personnel and

Training

Contents

Design for Compliance

• A material should be “Fit-For-Use” in accordance with its

foreseeable applications. It should meet:

– The required performance

– The requirements for migration

– The requirements on organoleptic properties

– The essential requirements regarding the Packaging

and Packaging Waste Directive 94/62/EC and related

standards

• Contamination must be avoided

Performance

Maximum

Shelf Life

Food

Type

Surface/

Volume

Ratio

Filling,

Sealing and

Storage

Methods

In Pack

Processing

Methods

Performance

Technical

Specifications

Communication

• Information flow along the supply chain must be two way

• Necessary both to create the initial design and to adapt it

to changing customer needs

Coatin

g o

r Inks

Manufa

ctu

rer

Coatings/ Inks

Potential Migrants

Finished Print

Migration Info.

Info on Use incl.

Food Type

Co

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Inks a

nd/ o

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Info on Use incl.

Food Type

Packer/ F

iller

Finished Goods

Info on Use

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Development Considerations

• The need to listen to the recommendations of your raw material suppliers:

– For the choice of substrates and “wets”

– For the correct production processes and conditions

– For the compatibility of different materials and the avoidance of unintended chemical reactions

• The need to specify production conditions so that:

– Intended chemical reactions do not give rise to potentially hazardous by-products

– Intended chemical reactions are completed so as to prevent unacceptable amounts of residual reactants

– Residual solvents do not result in unacceptable organoleptic changes, set-off or migration

– Extrusion of plastic does not produce unintended changes in the plastic

Migration

• The objective is to minimize the risk of health hazards by:

– Full compliance of all components with relevant Food Contact legislation – or with best available guidelines if legislation is not available

• Obtaining and verifying supplier information about such compliance

• Controlling or verifying the composition of raw materials

– Full compliance of the finished materials with Overall Migration Limits, Specific Migration Limits and other limitations as applicable

• Understanding the migration features of the raw materials

• Using functional barriers

• Tests on the finished product

Migration Testing

• A converter may produce many hundreds, if not

thousands, of different products each year. Testing each

of them would be impractical so a rational testing plan

must be developed

• Two approaches can help:

– Family Approach: define a product family and test an

appropriate selection to demonstrate compliance by a

sufficiently wide margin

– Building Blocks concept: use the compliance of a

number of products or components to infer the

compliance of other products made with different

combinations of similar components

Family Approach

• There is not always a “worst case” in multi layer structures, e.g.:

– A thick food contact layer is the worst case for migration from the food contact layer

– A thin food contact layer is the worst case for migration from the outer layers

• One must therefore concentrate on relevant samples. The Guidelines set out some principles to follow, e.g. for overall migration:

– The direct food contact layer is the main driver and must be considered in detail

– Outer layers can be considered at a more generic level, e.g. PET, PE, PP etc

– The margin between a test result and the OML will determine whether a structure with a thicker direct food contact layer can be considered to belong in the same family

Legislation

• The Guidance gives guidance on the legislation to be considered – in order of preference:

– EU legislation (or national legislation resulting from its transposition)

– National legislation

• The issue of which national legislation is discussed

– Recommendations of states within the EU (e.g. BfR)

– Non EU national legislations (e.g. FDA or Swiss Ink Ordinance)

– Council of Europe Resolutions

– Policies and standards established by European trade associations (e.g. the EuPIA Guideline on Printing Inks Applied to the Non-Food Contact Surface of Food Packaging Materials and Articles)

Non Regulated Substances

• In cases where a converter cannot rely on his supplier’s

declarations of safety assessment of non regulated

substances, the Guidelines give a number of tools to

use, e.g.:

– Evaluation of the substance by a competent authority

in another relevant field, e.g. as a direct food additive

– Use of the functional barrier concept

– Use of the Threshold of Toxicological Concern (TTC)

in combination with a conservative estimation of

consumer intake of packaged food with the migrant

under consideration

Organoleptic Changes

• The Guidelines gives some basic principles for avoiding unacceptable changes:

– The use of raw materials that are certified or known by the converter from previous experience to be organoleptically inert for the specified food under defined conditions of use

– Testing the finished or intermediate products appropriately for the specified food under the defined conditions of use

• It notes that this objective can only be achieved jointly with the customer who must also contribute by preventing the use of the packaging material in circumstances other than those specified.

Summary

• The guidelines are intended to be used in combination with quality and hygiene management systems

• They concentrate on “Design for Compliance”

• They are regularly revised – currently we are on the 6th Edition – and a further revision will be needed when the Commission’s Guidelines on the Plastics Regulation are finalised

• We welcome suggestions for their improvement, whether such suggestions come from our members, our customers, our suppliers or the regulatory authorities

• The Guidelines can be seen by all and are available at:

http://www.flexpack-europe.org

For more information visit:

www.flexpack-europe.org