CODE FOR GMP FOR FLEXIBLE AND FIBRE-BASED PACKAGING FOR FOOD Packaging Summit 2013... · FLEXIBLE...
Transcript of CODE FOR GMP FOR FLEXIBLE AND FIBRE-BASED PACKAGING FOR FOOD Packaging Summit 2013... · FLEXIBLE...
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CODE FOR GMP FOR
FLEXIBLE AND FIBRE-BASED
PACKAGING FOR FOOD
John Dixon
28th November 2013
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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)
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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)
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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).
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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
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• Method
• Migration
• Organoleptic
Changes
• Contamination
• Essential
Requirements
• Raw Materials
• Production
• Quality Assurance
• Change Control
• Personnel and
Training
Contents
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• Method
• Migration
• Organoleptic
Changes
• Contamination
• Essential
Requirements
• Raw Materials
• Production
• Quality Assurance
• Change Control
• Personnel and
Training
Contents
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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
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Performance
Maximum
Shelf Life
Food
Type
Surface/
Volume
Ratio
Filling,
Sealing and
Storage
Methods
In Pack
Processing
Methods
Performance
Technical
Specifications
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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
nverte
r/ User o
f
Inks a
nd/ o
r Co
atin
g
Info on Use incl.
Food Type
Packer/ F
iller
Finished Goods
Info on Use
Bra
nd
Ow
ne
r
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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
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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
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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
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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
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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)
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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
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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.
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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
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For more information visit:
www.flexpack-europe.org