Global Guidance On Migration From Packaging Materials Into Food

GLOBAL GUIDANCE
ON MIGRATION
FROM PACKAGING
MATERIALS
INTO FOOD
LIABILITY
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CONTENTS
PART 1
INTRODUCTION
1.1 Disclaimer 3
1.2 Document scope 3
1.3 About the three organisations 4
PART 2
LEGISLATION AND CODES OF PRACTICE
2.1 EU food-contact materials legislation 6
2.2 US Food and Drug Administration 12
2.3 Keeping up to date with industry technical and scientific information 14
PART 3
ABOUT MIGRATION
3.1 Types of migration 17
3.2 Factors affecting migration 19
3.3 Migration modelling and testing 21
3.4 What the BRC Global Standards say 24
PART 4
PRODUCT DEVELOPMENT PROCESSES
4.1 New product development and change control 29
4.2 Selection of materials and design of low-migration inks and adhesives 29
4.3 Other factors complicating packaging material selection 30
APPENDICES
1 Other sources of information 32
2 Glossary 33
3 Acknowledgements 40
4 Migration testing process flow 40
GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD 1

PART 1
INTRODUCTION
1.1 Disclaimer 3
1.2 Document scope 3
1.3 About the three organisations 4
2 GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD

Welcome to the first edition of Guidance on Migration from Packaging Materials into Food.
This guideline has been developed to provide those who have an active interest in the food supply
chain with a common understanding, terminology and point of reference for good practice with
regard to migration.
This guideline is comprehensive in its approach, outlining what migration is, how it occurs and
how it can be minimised through new product or existing product development. It proffers a
best-practice approach to reducing the risk of migration of harmful substances into food products
of all types. The guideline also gives an outline of the legislative requirements relating to migration.
While the legislation primarily relates to European Union (EU) and US Food and Drug
Administration (USFDA) requirements, its application can be used as a guide in other regions.
This guideline should be used by any and all organisations interested in the delivery of safe food
to consumers, including retailers, brand owners, agents or brokers, food processors, packaging
manufacturers and companies providing storage and distribution services.
1.1 DISCLAIMER
This document is for guidance purposes only and in no way replaces any regulatory legislation
or other legal guidance documentation. The authors and publishers accept no liability for the
contents of this document, nor for how an individual chooses to apply it.
The information contained herein was correct at the time of publication. Users should ensure
relevance to their material sector and applicable legislation before proceeding.
1.2 DOCUMENT SCOPE

The objective of this document is to reduce the risk of migration of packaging material components
into food. Therefore, the scope focuses on packaged food in the supply chain, the regulatory
obligations along the chain and best practice to mitigate risk of migration. However, the concepts
discussed in the document can equally be applied to food raw materials in the supply chain.
The supply chain can only mitigate the risk of chemical migration, not eliminate it altogether, as there
are so many factors within a largely uncontrollable supply chain and retail environment that can also
engender migration. For example, appropriate packaging materials may have been selected for a
food product as it moves from the food packer through to the retail store, but in the interim it may be
stored in a warehouse adjacent to products containing potential migrating substances.
This document is intended to apply to activities carried out by the food supply chain (which
includes food processors, manufacturers and packers), the packaging supply chain (which
includes manufacturers, converters and component manufacturers), packaging specifiers
(such as brand owners and retailers) and intermediary services such as storage and distribution.
The intended audience includes users of any of the Global Food Safety Initiative (GFSI) standards
and this document makes specific reference to the BRC Global Standards.

For the purposes of providing an overview of broadly applicable requirements, the guideline
focuses on EU legislation and does not explore legislation specific to member states. Companies
that operate in or export to member states should check for specific legislation. A summary is given
in Appendix 1 of known member state legislation or conventions.
The following are excluded from the scope of this document:
○○ processing, packaging and other handling equipment (e.g. conveyor belts and equipment)
○○ non-food-chain activities, although the principles are applicable (e.g. packaging of non-food
products, consumer products)
○○ transient food-contact ‘packaging’ materials (e.g. plastic cutlery, paper plates)
○○ edible and non-edible decorations in contact with food
○○ changes in food products caused by degradation of packaging materials
○○ the release of substances from a material (usually metals) as a result of corrosion
○○ shelf life and compatibility testing of new product development.
1.3 ABOUT THE THREE ORGANISATIONS

BRC Global Standards is the world’s largest product safety and quality management systems
scheme, with more than 24,000 certificated sites in 134 countries. BRC Global Standards produces
industry-leading standards and guidelines for the food, packaging, storage and distribution,
consumer products, agents and brokers, and retail industries.
The Food and Drink Federation (FDF) is the voice of the UK food and drink industry, the largest
manufacturing sector in the country. It accounts for 19% of the total manufacturing sector by
turnover and employs around 400,000 people in the UK across 6,815 businesses. It is an incredibly
diverse sector, made up of global brands and thriving small businesses.
The FDF helps its members to operate in an appropriately regulated marketplace and maximise
their competitiveness. It communicates the industry’s values and concerns to government,
regulators, consumers and the media. It also works in partnership with key players in the food
chain to ensure that food and drink products are safe and that consumers can have trust in them.
Campden BRI provides scientific, technical and regulatory support to the food, drink and allied
industries. Working closely with industry and membership-based, Campden BRI offers a wide range
of analysis and testing services and operational support underpinned by a vigorous programme of
research and innovation, all promoted through extensive knowledge management activities.
For more information about the Food and Drink Federation please see: http://www.fdf.org.uk.

PART 2
LEGISLATION
AND CODES
OF PRACTICE
2.1 EU food-contact materials legislation 6

2.2 US Food and Drug Administration 12
2.3 Keeping up to date with industry technical
and scientific information 14

2.1 EU FOOD-CONTACT MATERIALS LEGISLATION
There are several pieces of legislation applicable to food-contact materials in the EU. At the time of writing, not all materials have
specific migration requirements; however, other materials may require migration testing to comply with the Framework Regulation
(EU 1935/2004). Technical documents from specific industries contain material-specific testing protocols and it is recommended
that companies remain aware of this type of guidance within their industry.
FIGURE 1 OVERVIEW OF EU LEGISLATION
(EC) NO 1935/2004
FRAMEWORK
REGULATION
2023/2006/EC
GOOD MANUFACTURING
PRACTICE
(applicable to all food
contact materials)
2007/42/EC 84/500/EEC PLASTIC ELASTOMERS (EC) NO

REGENERATED CERAMICS MATERIALS AND RUBBERS 450/2009
CELLULOSE ACTIVE AND
FILM INTELLIGENT
MATERIALS
+ COATINGS
2005/31/EC
1ST AMENDMENT
93/8/EEC (EC) NO 1895/2005/ 93/11EEC

(EU) NO 10/2011 NITROSAMINES
1ST AMENDMENT 282/2008 EC BADGE/BF/N
PLASTICS
RECYCLED OGE
REGULATION ON
PLASTICS
PLASTIC
MATERIALS AND
ARTICLES
INTENDED TO 97/48/EC
COME INTO 2ND AMENDMENT
CONTACT WITH
FOOD (AS
AMENDED)
PAPER AND GLASS WOOD CORK METALS TEXTILES ADHESIVES ION- PRINTING SILICONES VARNISHES WAXES
BOARD AND EXCHANGE INKS AND
ALLOYS RESINS COATINGS

Article 3 of Regulation (EC) 1935/2004 on materials and articles intended to come into contact with food requires that:
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:
○○ endanger human health;

○○ bring about an unacceptable change in the composition of the food; or
○○ bring about a deterioration in the organoleptic characteristics thereof.
This is a key piece of legislation, as where substances migrate from packaging into foods, they may contravene at least one of the
provisions in the bulleted list above.
Regulation 2023/2006 on good manufacturing practice (GMP) for materials and articles intended to come into contact with food
provides further clarification on good manufacturing practice applicable to all sectors and stages of the packaging supply chain,
up to but excluding the production of starting substances. The regulation requires all the above parties to establish and implement
quality assurance and quality control systems and to maintain related records and documentation to demonstrate compliance with
good manufacturing practice (and hence with Article 3 of Regulation 1935/2004).
The annex of EU Regulation 2023/2006 provides specific rules for processes involving the application of printing inks to the
non‑food-contact side of materials and articles (to prevent transfer to the food-contact side). These rules state that:
Printing inks applied to the non food-contact side of materials and articles shall be formulated and/or applied in such a manner
that substances from the printed surface are not transferred to the food-contact side:
○○ through the substrate or

○○ by set-off in the stack or the reel
in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation
(EC) No 1935/2004.
Article 5 of Regulation 1935/2004 enabled the future adoption of specific measures for the groups of materials and articles listed
in Annex 1. To date, specific measures have been adopted only for the following:
○○ Ceramics Directive 84/500/EEC (as amended by Directive 2005/31/EC) lays down limits for the migration of lead and cadmium
from ceramic articles. Note that this legislation is currently under review.
○○ Regenerated cellulose film (e.g. materials such as Cellophane™) Directive 2007/42/EC lays down a list of approved
substances which can be used in regenerated cellulose film and sets maximum limits for migration into food for certain substances
(mono and di-ethylene glycol).
○○ Recycled plastics Regulation 282/2008.
○○ Active and intelligent materials Regulation 450/2009.
○○ Plastics Regulation 10/2011 (as amended) – see detail later in this section.
There is also EU legislation relating to specific substances:
○○ N-nitrosamines/N-nitrosatables from elastomer or rubber teats and soothers Directive 93/11 sets limits for
the release of N-nitrosamines/N-nitrosatables under defined test methods.
○○ Epoxy derivatives These include BADGE, BFDGE and NOGE (see Appendix 2). Regulation 1895/2005 prohibits BFDGE
and NOGE and sets specific migration limits for BADGE and derivatives.
○○ Bisphenol A in polycarbonate baby bottles Regulation 321/2011 prohibits the use of bisphenol A (BPA) in the
manufacture of polycarbonate infant feeding bottles.

Although some of the above legislation sets limits on migration, by far the most relevant part of current EU legislation for migration is
the Plastics Regulation 10/2011, which replaced Directive 2002/72/EC. The regulation establishes specific requirements for plastic
materials which will come into contact with food. The scope of the regulation covers:
○○ food-contact materials consisting exclusively of plastics

○○ plastic multi-layer materials held together by adhesives
○○ both of the above that are printed and/or covered by a coating
○○ plastic layers and/or coatings, forming gaskets in caps and closures
○○ plastic layers in multi-material multi-layer materials.
Article 5 establishes a Union list of authorised substances consisting of:
○○ monomers or other starting substances

○○ additives excluding colorants
○○ polymer production aids excluding solvents
○○ macromolecules obtained from microbial fermentation.
Article 11 and Annex I of the Plastics Regulation establishes specific migration limits (SMLs) for a range of substances, while Article 12
specifies overall migration limits (OMLs) for plastic materials and articles. The limits in Article 12 are as follows:
1. Plastic materials and articles shall not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total
constituents released per dm2 of food contact surface (mg/dm2).
2. By derogation from paragraph 1, plastic materials and articles intended to be brought into contact with food intended for infants
and young children, as defined by Commission Directives 2006/141/EC and 2006/125/EC, shall not transfer their constituents to
food simulants in quantities exceeding 60 milligrams of total of constituents released per kg of food simulant.
For multi-layer plastics and multi-material multi-layer materials, any plastic layers that are not in direct contact with food and separated
by a functional barrier do not have to comply with compositional requirements. They may be manufactured from substances not on
the Union list, provided that these are not carcinogenic, mutagenic or toxic to reproduction, or substances ‘in nanoform’ (see Articles
13 and 14).
A ‘functional barrier’ is defined by Article 3 (15) as:
a barrier consisting of one or more layers of any type of material which ensures that the final material or article complies with Article 3
of Regulation (EC) No 1935/2004 and with the provisions of this Regulation.
Article 15 requires the business operator putting the product onto the market to issue a written declaration of compliance (DoC)
at all marketing stages other than the retail stage. This applies to products from intermediate stages of manufacturing as well as
the substances intended for the manufacturing of materials and articles.
Coatings, printing inks and adhesives are not covered by specific legislation and are therefore not subject to DoC requirements,
except where they are in scope of substance measures such as 1895/2005 etc. Suppliers of printing inks and adhesives used
in plastic articles are required to provide ‘adequate information’ to enable the manufacturer of the final plastic article to ensure
compliance with migration limits.
The Plastics Regulation 10/2011 assigns food simulants (Annex III) and migration testing conditions (Annex V) to be used for
compliance testing. Note that the exclusive use of the new migration test methods laid down by the Plastics Regulation came
into effect on 1 January 2016.

Article 3 defines a ‘non-intentionally added substance’ (NIAS) as ‘an impurity in the substances used or a reaction
intermediate formed during the production process or a decomposition or reaction product’.
Recital 20 requires that potential health risks arising from NIASs be assessed by the manufacturer ‘in accordance with
internationally recognised scientific principles on risk assessment’.
The Plastics Regulation is by far the most well developed EU-specific measure for food-contact materials. The Union list
of substances and migration limits took many years to develop. Where substances on the list occur in other categories
of food-contact materials, and where no harmonised legislation exists (e.g. printing inks or adhesives), both regulators
and business operators use the SMLs laid down in the Plastics Regulation as a guide to compliance. Some member states
also apply the migration testing conditions laid down for plastics to other categories of food-contact materials. However,
it is not always technically feasible to use all plastics testing methods for all non-plastic materials such as can coatings,
paper or board.
The European Commission has published Union Guidelines on the Plastics Regulation for those plastic materials and
articles intended to come into contact with food, and these are available at:
http://ec.europa.eu/food/safety/docs/cs_fcm_plastic-guidance_201110_en.pdf
The following materials are not yet covered by specific harmonised EU legislation:
○○ paper and board

○○ printing inks
○○ varnishes and coatings
○○ adhesives
○○ metals and alloys
○○ glass
○○ wood
○○ cork
○○ ion exchange resins
○○ waxes
○○ silicones
○○ textiles
○○ rubber.
All of the above materials are covered by national legislation or standards in at least one member state. The German
Bundesinstitut für Risikobewertung (BfR) recommendations are an example of standards in the form of guidance that
do not have full legal status, but provide useful guidance on compliance in the absence of harmonised EU legislation.
The European Commission maintains a summary of national legislation. Further details are available from the various
member state authorities such as Germany (BfR recommendations) and The Netherlands (updated Warenwet).
The Council of Europe (CoE) also provided a set of standards for food-contact materials in the form of resolutions and
guidance. The CoE was active in developing standards for food-contact materials until 2008. Development of the CoE
resolutions has since been taken over by the European Directorate for the Quality of Medicines (EDQM) and there has been
renewed interest recently from some member states and trade organisations. With the exception of the Resolution and
Technical Guide on Metals and Alloys published in 2013 (which lays down specific release limits (SRLs) for metals such as
iron and aluminium), most of the CoE resolutions are somewhat out of date. They can, however, be used as a technical
reference for compliance in areas where harmonised EU legislation is not in place.

2.1.1 DUAL-USE ADDITIVES
Certain additives used in food-contact plastics are, at the same time, food additives or flavourings authorised respectively by
Regulation (EC) No 1333/2008 or Regulation (EC) No 1334/2008 or their implementing measures. These substances are called
‘dual-use additives’.
To avoid the unauthorised presence of food additives or flavourings in food, specific requirements are set out for the migration of
these substances from food-contact materials. The substances shall not be released into foods in quantities that have a technological
function in the food.
If substances are added to the plastics to be released into food to have a technological function in the food, they are covered by the
EU Regulation 450/2009 on active and intelligent materials and articles intended to come into contact with food and should comply
with the relevant EU and national provisions applicable to food.
If the substances are added to the plastics with no intention of being released into food to have a technological function in the food,
but they are authorised as a food additive or flavouring, the additional unintentional migration from food-contact materials shall not
lead to an exceedance of the authorised limit set out by the specific legislation on food additives or flavourings, even if this limit is
lower than the SML set out in the Plastics Regulation.
If the substance is not authorised as a food additive or flavouring in a certain food, then the migration from food-contact materials into
this food should not achieve a technological function in the food, and should impart neither odour nor taste (flavouring); nor should
the SML be exceeded. In cases where the substance does not exhibit a technological function in food, migration up to the SML
should be allowed, even if the substance is not authorised as food additive or flavouring in that type of food.
To decide whether a substance can be considered as a dual-use additive, it is sufficient that the chemical identity of the plastic
additive matches that of an authorised food additive or flavouring, regardless of its purity or whether or not the substance is subject
to a restriction in food and/or in the plastic.
Tables 1 and 2 of the Union Guidelines on the Plastics Regulation (see above) include a non‑exhaustive list of dual-use additives.

2.1.2 DECLARATION OF COMPLIANCE
The regulatory context in Europe allows the user of the packaging to receive more information from the supplier. The EU Framework
Directive 1935/2004 includes a requirement for a declaration of compliance (DoC) in Article 16:
1. The specific measures referred to in Article 5 shall require that materials and articles covered by those measures be accompanied
by a written declaration stating that they comply with the rules applicable to them.
Appropriate documentation shall be available to demonstrate such compliance and that documentation shall be made available
to the competent authorities on demand.
2. In the absence of specific measures, this Regulation shall not prevent member states from retaining or adopting national provisions
for declarations of compliance for materials and articles.
Role of the declaration of compliance for food-contact materials and articles

The DoC is a document delivered by the supplier to its customer with the purpose of confirming that the supplier’s product complies
with the Framework Regulation (EC) 1935/2004 and any material-specific legislation (e.g. EU Plastics Regulation 10/2011, Article 15
and Annex IV). It is designed to provide the customer with adequate information to allow it, in turn, to establish or check the
compliance of its own product.
A DoC might not necessarily be a single document, but it should contain sufficient documentation or evidence to ensure that starting
materials, including chemicals, intermediates and the final food-contact materials are in line with existing EU regulation and the
minimum requirements in it.
The DoC is mandatory within the EU for plastics (including recycled plastics), ceramics, regenerated cellulose, and active and
intelligent packaging.
There is a level of understanding of the use and role of a DoC. Some organisations may want the actual results or certificate with
migration data, rather than a declaration stating legal compliance and conditions of use. This is beyond the legal requirement,
however, and represents ‘supporting documentation’ which should be shared with the competent authorities.
A DoC is not necessarily reliable if the supplier has combined data from the accumulated raw materials suppliers. Such combinations
may exacerbate the potential for migrants, so materials or articles should be tested in their final state, as the supplier sells them on to
its customer. Only the beginning and end of the supply chain are exempt; for example, the user of a paper cup to vend hot drinks.
It’s important that the ownership of the declaration is retained by the relevant company. It can be tempting to provide data according to a
pre-described or standardised template, but this can lead to loss or omission of data that is vital for users further down the supply chain.
For guidance on information to be generated and exchanged in the supply chain, refer to the Union Guidelines on the Plastics
Regulation (see above).

2.2 US FOOD AND DRUG ADMINISTRATION
The overall regulatory status of a food-contact material is dictated by the regulatory status of each individual substance that
comprises the article. The individual substance that is reasonably expected to migrate to the food (because of its intended use
in a food-contact material) shall be covered by one of the following:
○○ a regulation listing in Title 211 of the Code of Federal Regulations (CFR)

○○ meeting the criteria for generally recognized as safe (GRAS) status (including, but not limited to, a GRAS regulation or GRAS notice)
○○ a prior sanction letter
○○ a threshold of regulation (TOR) exemption request
○○ an effective food-contact substance notification (FCN).
The Federal Food and Drug Cosmetic Act (FDCA) prohibits the adulteration of food. Food packaging may adulterate the food if:
○○ the packaging material makes the food unsafe

○○ the packaging material makes the food unfit for consumption
○○ the packaging material qualifies as a food additive and is not the subject of an FDA
pre-market clearance.
To establish the regulatory status of an individual substance, it is necessary to establish whether the substance is a food additive,
a food-contact substance (FCS) or both. It is the responsibility of the manufacturer of an FCS to ensure that food-contact materials
comply with the specifications and limitations in all applicable authorisations. The FDA regulations refer only to intentional
direct food-contact materials, and do not cover coatings applied to the non-food-contact side of the packaging.
2.2.1 CODE OF FEDERAL REGULATIONS TITLE 21

Section 170.3: Definitions
Food additives are defined by section 201(s) of the FDCA as ‘any substance the intended use of which results, or may reasonably
be expected to result … in its becoming a component or otherwise affecting the characteristics of any food’ unless the substance
is GRAS. Food additives require FDA premarket clearance and any uncleared food additives are automatically considered to be
adulterants.
Food-contact substances are defined in section 409(h) (6) as ‘any substance intended for use as a component of materials used in
manufacturing, packaging, transporting, or holding food if such use is not intended to have a technical effect in food’. Food-contact
substances will only require premarket clearance if they are also food additives.
There are three types of food additive:
○○ direct – food ingredients

○○ secondary direct – added to food during processing but removed
○○ indirect – food packaging and other food-contact materials.
There are two types of indirect additive:
○○ d irect contact with food

○○ indirect contact – separated from food by another material.

1
Title 21 refers to the Code of Federal Regulations that governs food and drugs within the US for the Food and Drug Administration (FDA). Title 21 is divided into three chapters,
and most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act of 1958.

A material used in the production of containers and packages is subject to the definition if it may reasonably be expected to become
a component, or to affect the characteristics, directly or indirectly, of food packed in the container.
‘Affecting the characteristics of food’ does not include such physical effects as protecting contents of packages, preserving shape,
and preventing moisture loss.
If there is no migration of a packaging component from the package to the food, it does not become a component of the food and
thus is not a food additive.
Section 174: Indirect food additives: general

This regulation prescribes the conditions under which food additive substances may be safely used. It also defines good
manufacturing practice (GMP) for parts 174, 175, 176 and 177.
GMP includes the following restrictions:
1. The quantity of any food additive substance that may be added to food as a result of use in articles that contact food shall not
exceed, where no limits are specified, that which results from use of the substance in an amount not more than reasonably required
to accomplish the intended physical or technical effect in the food-contact article.
2. Any substance used as a component of articles that contact food shall be of a purity suitable for its intended use.
The regulation also refers to materials generally regarded as safe (GRAS) with regard to food as well as packaging. It also allows
for ‘prior-sanctioned’ or approved materials.
For more detailed requirements for specific materials, refer to the main parts of CFR Title 21 relating to food-contact materials
(listed in Table 1).
TABLE 1 PARTS OF CFR TITLE 21 RELATING TO FOOD-CONTACT MATERIALS

Part Food-contact material covered
170 Food additives
171 Food additive petitions
172 Food additives permitted for direct addition to food for human consumption
173 Secondary direct food additives permitted in food for human consumption
174 Indirect food additives: general
175 Indirect food additives: adhesives and components of coatings
176 Indirect food additives: paper and paperboard components
177 Indirect food additives: polymers
178 Indirect food additives: adjuvants, production aids, and sanitizers
179 Irradiation in the production, processing and handling of food
180 Food additives permitted in food or in contact with food on an interim basis pending additional study
181 Prior-sanctioned food ingredients

Section 171.8: Threshold of regulation for substances used in food-contact articles
Substances used in food-contact articles (e.g. food packaging or food-processing equipment) that migrate or that may be expected
to migrate into food at negligible levels may be reviewed
under 170.39 of this chapter. The Food and Drug Administration will exempt substances whose
uses it determines meet the criteria in 170.39 of this chapter from regulation as food additives and, therefore, a food additive petition
will not be required for the exempted use.
A substance used in a food-contact article (e.g. food-packaging or food-processing equipment) that migrates, or that may be
expected to migrate, into food will be exempted from regulation as a food additive because it becomes a component of food at levels
that are below the threshold of regulation if:
○○ it has not been shown to be a carcinogen

○○ it presents no other health or safety concerns
○○ it has no technical effect in or on the food to which it migrates
○○ there is no significant adverse impact on the environment.
Table 2 provides an overview of the US requirements regarding food-contact materials.
TABLE 2 GENERAL US REGULATIONS ON FOOD-CONTACT MATERIALS

Food, Drug and Cosmetic Act (1958)
Code of Federal
Regulations, Title 21
Authorisation/notification Exempted from authorisation
required*
Direct additive (CFR 21, Threshold of regulation rule
Part 170.3)
Indirect additive (CFR 21, GRAS
Parts 174–179)
○○ Common food ingredient before 1958
○○ Manufacturer self-determined GRAS
○○ FDA listed GRAS
○○ FDA approved GRAS
○○ FDA GRAS notification
*Food-contact notification Sanctioned before 1958
(FCN) program (only
notification required)
2.3 KEEPING UP TO DATE WITH INDUSTRY TECHNICAL

AND SCIENTIFIC INFORMATION
Membership of a recognised industry trade association will enable companies to track updates in legislation. Industry bodies are
more likely to be involved at the draft or consultation stages of new legislation and as a member the company may be kept informed
of planned changes before they occur. Another way of keeping up to date would be to refer to websites and the alert systems of the
government bodies responsible for regulations, obtaining updates when they become available.

PART 3
ABOUT
MIGRATION
3.1 Types of migration 17

3.2 Factors affecting migration 19
3.3 Migration modelling and testing 21
3.4 What the BRC Global Standards say 24

In the context of food-contact materials legislation, migration means the transfer of substances from packaging materials into food.
Note that migrating substances can potentially come from packaging substrates, such as paper, board or plastics, as well as from
packaging components such as adhesives, printing inks or coatings used to make up the complete package. It is therefore important
to consider the overall packaging material or article. The migration of substances into food will potentially result in non-compliance
with food-contact materials legislation.
Note that because of the safety margins built in during the establishment of SMLs, a marginal exceedance of an SML, while a
regulatory breach, would typically be unlikely to give rise to an immediate health concern. However, should an SML exceedance
be identified in relation to a food product which has already been placed on the market, this should be reported to the competent
authority (e.g. Food Standards Agency in the UK), which would carry out an appropriate risk assessment.

3.1 TYPES OF MIGRATION
Migration can occur in a number of different ways: contact, gas-phase, penetration, set-off and condensation or distillation.
The following sections explain these in more detail.
3.1.1 CONTACT MIGRATION

Contact migration involves the direct transfer of substances from the food-contact surface of the packaging into the food; for
example, from a cardboard pizza box to the underside of a pizza, or from a plastic tub, tray, pouch or wrapping into food (see Figure 2).
FIGURE 2 CONTACT MIGRATION
PACKAGING SUBSTRATE
FOOD
3.1.2 GAS-PHASE MIGRATION

Gas-phase migration involves the transfer of volatile substances through the airspace between food and packaging and into the food
by the process of diffusion. A good example might be the diffusion of mineral oil from recycled paper-board into solid, dry foodstuffs.
Note that in this case, mineral oil can potentially migrate from the cartons, through an airspace, through a plastic inner pouch
(subject to its barrier properties) and through a second airspace into the food (see Figure 3).
FIGURE 3 GAS-PHASE MIGRATION
PACKAGING SUBSTRATE
AIR GAP
PLASTIC POUCH
AIR GAP
FOOD
3.1.3 PENETRATION (THROUGH) MIGRATION

Penetration migration (Figure 4) involves the transfer of substances from the non-food-contact (often printed or coated) surface of
the product’s packaging, through the substrate and onto the food-contact side of the packaging. Once on the food-contact surface,
the migrating substances can be transferred to the food by either contact or gas-phase migration.
FIGURE 4 PENETRATION MIGRATION
INK OR COATING
PACKAGING SUBSTRATE
FOOD (OR AIR GAP)

3.1.4 SET-OFF MIGRATION
Set-off migration (Figure 5) involves the transfer of substances from the non-food-contact side of the packaging to the food-contact
side, as a result of the stacking of items (e.g. carton flats, or when winding a film into a reel). This may include, but is not limited to,
printing inks, coatings or varnishes. Note that set-off migration may be either visible or invisible. Once on the food-contact surface,
substances arising through set-off can be transferred to the food by either contact or gas-phase migration.
A potential cause of set-off is poor control procedures, allowing incompletely cured print and varnish to come into contact with the
food-contact side of printed material.
FIGURE 5 SET-OFF MIGRATION
STACK OR REEL
INK OR COATING
PACKAGING SUBSTRATE
FOOD CONTACT SIDE
NON FOOD CONTACT SIDE
INK OR COATING
PACKAGING SUBSTRATE
3.1.5 CONDENSATION OR DISTILLATION MIGRATION

Condensation or distillation migration involves the transfer of substances into food during heating processes such as sterilisation or
boiling (e.g. pouched food, or oven/microwave cooking of food in cartons or trays). It involves the evaporation of volatile components
from the packaging and by steam distillation in the case of moist or aqueous foods (see Figure 6).
FIGURE 6 CONDENSATION OR DISTILLATION MIGRATION
HEAT (OR STEAM)
INK OR COATING
PACKAGING SUBSTRATE
FOOD
(OR AIR GAP)

3.2 FACTORS AFFECTING MIGRATION
The rate of migration is affected by a large number of factors, including the molecular size of the migrant, temperature and time,
as explained in the following sections.
3.2.1 MOLECULAR SIZE OF THE MIGRANT

Generally speaking, small molecules migrate faster than larger ones. As a rule of thumb, substances with a molecular weight of
greater than 1,000 Da are deemed too large to migrate to any significant degree. If they do migrate, they are usually too large to be
absorbed into the body; see Recital 8 of the EU Plastics Regulation 10/2011.
For example, the substance benzophenone has been used as a photoinitiator in printing inks. Benzophenone has a molecular weight
of 182.2 Da and has been found to migrate into foods under certain conditions.
3.2.2 TEMPERATURE
Migration occurs through physico-chemical processes and it significantly increases with rising temperature. Typically, little
appreciable migration occurs under frozen conditions; however, other factors, such as humidity, may still apply and may affect
migration activity. Note that storage, processing and cooking temperatures need to be considered.
Special consideration should be given to potential migration from ovenable or microwaveable packaging (see section 4.1 on new
product development and section 4.3.1 on non-intentionally added substances. For plastics, Annex V, section 2.1 of the EU Plastics
Regulation 10/2011 states that ‘verification of compliance of migration into foods with the migration limits shall be carried out under
the most extreme conditions of time and temperature foreseeable in actual use’.
3.2.3 TIME
Migration is time-dependent. A food package that is compliant at the beginning of its shelf life could become non-compliant by the
end of its life (e.g. a long-life ambient product).
3.2.4 NATURE AND/OR COMPOSITION OF THE FOOD

Migration is affected by the nature of the food and its composition. For example, is it liquid or solid? Is it aqueous or fatty? What is
its moisture and fat content? Is it granular or particulate? What is its surface area? Polar materials (e.g. polyaromatic amines, metals,
nitrosamines and salts) tend to be hydrophilic, and non-polar materials (e.g. phthalates and hydrocarbons) tend to be lipophilic.
3.2.5 NATURE AND/OR STRUCTURE OF THE PACKAGING

Different substrates vary in their permeability to potential migrants. Metal and glass packaging materials are considered to form
absolute barriers to gas migration. However, release of substances from metal containers and their coatings into the food should
be considered. The rate of migration through plastic films and aluminium foils will depend on thickness, density and chemical
composition. Typically speaking, aluminium foils above 6 microns are considered to be a functional barrier, but still carry a risk
of pinholing unless they are part of a laminated film. The risk of pinholing is much reduced at thicknesses of 9–10 microns.
In technical terms the rate of migration will be determined by diffusion coefficients. Note that a given film may form a reasonable
barrier to one potential migrant while presenting virtually no barrier to a chemically different migrant. Whether a given barrier can be
considered functional should be determined on a case-by-case basis by testing. The presence of a plastic film (e.g. in a ‘bag in box’
format) will not necessarily provide an effective barrier to migration.
3.2.6 AMOUNT OF MIGRATABLE SUBSTANCE IN THE PACKAGING

In the case of substances migrating from printing inks, coatings, varnishes or adhesives, migration will relate to both the amount of
migrant present in the ink, coating or adhesive and the weight of the ink, coating, varnish or adhesive applied. It is possible that the
same potential migrant could be present in several of the components of the package; for example, in a printing ink applied to a
carton, in a plastic inner pouch and in an adhesive used to seal the carton (e.g. bag in box). Therefore, all components of a particular
package need to be considered.

3.2.7 RATIO BETWEEN PACKAGING SURFACE AREA AND VOLUME (WEIGHT) OF PACKAGED FOOD
Foods with a high ratio of surface area to volume are typically more susceptible to migration. The larger the packaging surface area
in relation to the weight of food, the greater will be the impact of any potential migration. For example, the impact of migration into
an individual portion of butter would be proportionately greater than into a catering pack packaged in the same materials. This is
because of the higher ratio of packaging per gram of product.
Specific migration and limits are always expressed as mg/kg food. Overall migration and limits are expressed as mg/dm2 of
food‑contact surface, except for baby foods where they are expressed as mg/kg food. Other than baby foods, containers of <500 ml
(or <500 g) should have the measured specific migration corrected to assume a surface area to volume ratio of 6 dm2/kg (litre)
(see Article 17 of the EU Plastics Regulation 10/2011).
For plastics, the OML should not exceed 10 mg of total constituents released per dm2 of food-contact surface (with the exception
of materials intended to be brought into contact with infant foods, for which the OML should not exceed 60 mg of total constituents
released per kg of food simulant – see Article 12 of the EU Plastics Regulation 10/2011). Regulation 2023/2006 on good
manufacturing practice (GMP) for materials and articles intended to come into contact with food provides further clarification on
GMP. This is applicable to all sectors and stages of the packaging supply chain, up to but excluding the production of starting
substances. The regulation requires all the above parties to establish and implement quality assurance and quality control systems
and to maintain related records and documentation to demonstrate compliance with GMP (and hence with Article 3 of Regulation
1935/2004).
Annex 1 of Regulation 2023/2006 provides specific rules for ‘processes involving the application of printing inks to the non-food
contact side of a material or article’:
Printing inks applied to the non food-contact side of materials and articles shall be formulated and/or applied in such a manner
that substances from the printed surface are not transferred to the food-contact side:
○○ through the substrate or

○○ by set-off in the stack or the reel
in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation
(EC) No 1935/2004.
In addition there is EU legislation relating to specific substances. The EU Plastics Regulation 10/2011 assigns food simulants
(Annex III) and describes migration testing conditions (Annex V) to be used for compliance testing.
3.2.8 IMPLICATIONS FOR DIRECT AND NON-DIRECT CONTACT MATERIALS

Since migration can occur by penetration through a substrate, through set-off from the non-contact side and by gas-phase transfer
through air gaps, it is not just an issue for surfaces in direct contact with food. Any or all components of the primary packaging could
potentially be involved; for example, both a carton and an inner pouch or liner. Indeed, in the case of mineral oils, it has been shown
that gas-phase migration from secondary recycled-board transit cases can occur through virgin-board cartons and inner plastic
liners into packaged dry foods.

3.3 MIGRATION MODELLING AND TESTING
3.3.1 WHAT IS MIGRATION TESTING?
Migration testing is undertaken to ensure that the ingredients or materials in the packaging material do not transfer their constituents
into the foodstuff at limits defined in the regulations or at levels that could be harmful.
Migration testing undertaken using defined simulants as food products can be complex and may require storage at a different
temperature from that required for migration testing because of microbiological concerns.
The main advantage of testing with simulants is that they provide a consistent test material. The same test undertaken using the
same simulant should produce a similar result. By contrast, the same test undertaken with milk produced at different times of the year,
for example, will give a different result because of seasonal variations in the product. The milk will also spoil microbiologically while
on test.
3.3.2 WHAT IS MIGRATION TESTING LOOKING FOR?

Migration testing may be undertaken to confirm compliance with legislative requirements. The limits for migrating substances from
food-contact materials into foodstuffs are covered by regulations. Two types of migration testing are undertaken:
○○ OML The test results indicate the total of all potential migrating substances coming from the packaging material into the food or
food stimulant. This is a test for inertness of the material, and takes place in conventional test conditions not necessarily closely
matching the actual conditions of use.
○○ SML This relates to specific chemicals as defined within the regulations.
3.3.3 TYPES OF CERTIFICATES

Migration data can be reported in a range of formats. The most common is by certificate.
The EU regulations require a declaration of compliance (DoC). This is required for materials covered by specific measures in Article 5
of EU Regulation 1935/2004, with enhanced details specified for plastic materials in the Plastics Regulation 10/2011. There is no
requirement to list migration data in this declaration; however, packaging manufacturers can choose to include it if they wish.
Other formats include a certificate of analysis. These tend to be fairly basic in that they cover the OMLs. They generally include the
actual migration data from the analysis and any information relating to specific or overall migration, depending on what the lab has
been asked to do. They should also include the material type and the test simulants.
3.3.4 ROLE OF CONFIDENTIALITY WITH CERTIFICATES AND TESTING

At times, it may be necessary to test material with regard to specific migration. In order to test for the substance, it is necessary to have
a full disclosure of all ingredients and additives present in the formulation. When reporting the results, these substances may be listed
under a generic name such as ‘monomer A’ because of the need to maintain product confidentiality.
Because the manufacturer requires the formulation to be confidential, disclosure under a confidentiality agreement is possible,
either to the customer or to a third party.
The confidentiality agreements are such that the test laboratory cannot legally disclose any test data and/or formulations or other
information to unauthorised organisations. The only exception would be if so instructed by a court of law.
This practice is common and acceptable where the output is a certificate (such as a DoC) that declares compliance with any legal
requirements.

3.3.5 MIGRATION MODELLING (WHEN/HOW)
Migration modelling is usually used for risk assessment and DoC statements. There are a number of specialist programs suitable for
migration modelling, based on the laws of diffusion, molecular weight and partition coefficients. Note that the techniques generally
overestimate migration.
Migration modelling is permitted under the EU Plastics Regulation 10/2011 (Recital 32), which states:
At each stage of [packaging] manufacture, supporting documentation, substantiating the declaration of compliance, should be kept
available for the enforcement authorities. Such demonstration of compliance may be based on migration testing. As migration testing
is complex, costly and time consuming it should be admissible that compliance can be demonstrated also by calculations, including
modelling, other analysis, and scientific evidence or reasoning if these render results which are at least as severe as the migration
testing. Test results should be regarded as valid as long as formulations and processing conditions remain constant as part of a
quality assurance system.
Further details can be found in Article 16 (supporting documents) of the EU Plastics Regulation 10/2011:
1. Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their
manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the
requirements of this Regulation shall be made available by the business operator to the national competent authorities on request.
2. That documentation shall contain the conditions and results of testing, calculations, including modelling, other analysis, and
evidence on the safety or reasoning demonstrating compliance. Rules for experimental demonstration of compliance are set out
in Chapter V.
3.3.6 OTHER TOOLS FOR TESTING

Chapter 2 of Annex V of the EU Plastics Regulation 10/2011 gives the following details on testing:
Testing for specific migration of materials and articles not yet in contact with food
2.2 Screening approaches

To screen if a material or article complies with the migration limits any of the following approaches can be applied which are
considered more severe than the verification method described.
2.2.1 Replacing specific migration by overall migration

To screen for specific migration of non-volatile substances, determination of overall migration under test conditions at least
as severe as for specific migration can be applied.
2.2.2 Residual content

To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the
material or article assuming complete migration.
2.2.3 Migration modelling

To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the
material or article applying generally recognised diffusion models based on scientific evidence that are constructed such as to
overestimate real migration.
2.2.4 Food simulant substitutes

To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence
that the substitute food simulants overestimate migration compared to the regulated food simulants.
Note that the results of specific migration testing obtained in food shall prevail over the results obtained in food simulants.
The results of specific migration testing obtained in food simulants shall prevail over the results obtained by screening approaches.

3.3.7 RISK ASSESSMENT APPROACH
A risk assessment approach can in some instances determine that migration testing is not required. For example, knowing the
amount of a potential migrating substance in a printing ink and the weight of ink applied it is possible to calculate a worst-case
migration scenario and compare this with the permitted SML. This type of modelling is acceptable where evidence is robust and
consistent, taking into consideration any factors of variability over the course of a print run.
3.3.8 WHEN AND HOW TO USE MIGRATION TESTING

The use of the migration process flow can help users to understand when migration testing or modelling should be applied to food
packaging materials.
This process flow, shown in Table 3, represents the typical steps in a product development or redevelopment process, and the
best-practice activities and responsibilities at each step. It is designed to guide both the food packer/filler and packaging
manufacturer to establish the specific activities they will need to complete in order to bring a product to market.
TABLE 3 PRODUCT DEVELOPMENT PROCESS FLOW

STEP ACTIVITIES RESPONSIBILITIES
Initiation of idea/change of Hold a collaborative meeting of product development and Food manufacturer
product (e.g. new breakfast packaging suppliers, e.g. cartonboard (including consideration
Packaging manufacturer
cereal) of inks), flexible plastic and corrugated. Discuss:
○○ product formulation
○○ known potential chemical migrants for the product
○○ known interactions between packaging and product
Consider packaging materials other than that used (e.g. reel

cores) and their impact in terms of chemical migrants
Development of packaging Use DoC information to determine appropriate material types: Food manufacturer
concepts for approval
○○ establish laboratory’s requirements for test samples Packaging manufacturer
○○ simulate supply chain
○○ carry out migration modelling or testing/screening techniques
Approval of packaging Food manufacturer
concepts
Packaging material Carry out quality assurance procedures such as validating the Packaging manufacturer
production correct curing of inks
Retain important documents (reference record keeping in 3.3)
Existing product Validate existing migration data Food manufacturer
development/change
Renew migration testing
Ongoing: monitoring Packaging manufacturer
of legislation

3.4 WHAT THE BRC GLOBAL STANDARDS SAY
While the most obvious Standards relating to migration are the Global Standards for Food Safety and Packaging Materials, other BRC
Global Standards will also have a direct impact on the potential for migration throughout the supply chain. Other GFSI-benchmarked
standards are available. Within the scope of this document, direct reference is made to the activities of agents, brokers, warehousing
and distribution, and their operations must also be considered in order to mitigate the risk of migration of harmful substances into
food. Definitions of each clause can be found in the relevant BRC Global Standard.
The following sections summarise how migration is referenced within each Standard, and provide specific references as well as
points where the potential for migration should be considered.
3.4.1 GLOBAL STANDARD FOR FOOD SAFETY

Main requirements
Technically, there is only one clause that specifically refers to aspects including migration.
When purchasing or specifying food contact packaging the supplier of packaging materials shall be made aware of any particular
characteristics of the food (e.g. high fat content, pH or usage conditions such as microwaving) which may affect packaging suitability.
Certificates of conformity or other evidence shall be available for product packaging to confirm it complies with relevant food safety
legislation and is suitable for its intended use (Issue 7, clause 5.5.1).
A valid declaration of compliance (DoC) meets this requirement. See more on types of certification in section 2.1.2 above.
However, the Standard also refers to the potential for migration from contact with manufacturing equipment. This is out of scope
of this document, but is mentioned here for completeness.
Suitability of food-contact equipment

Equipment which is in direct contact with food shall be suitable for food contact and meet legal requirements where applicable
(Issue 7, clause 4.6.2).
Additional requirements
There are a number of additional requirements throughout the Standard where it is expected that a company will have thought about
packaging and migration and therefore should either include the requirements or know why it has excluded them (e.g. because the
risk assessment shows no issue). These are:
○○ the food safety plan, based on HACCP principles

○○ risk assessment of raw materials, including packaging
○○ goods receipt (specifying, for example, certificates and other checks for the acceptance of raw materials and packaging)
○○ specifications for raw materials and packaging
○○ product testing (packaging is not specifically mentioned but all relevant safety, quality and legal parameters are).

3.4.2 GLOBAL STANDARD FOR PACKAGING AND PACKAGING MATERIALS
Main requirements
The Packaging Standard specifically refers to migration. The clauses quoted below apply equally to both hygiene categories
(high hygiene for direct food-contact materials, and basic hygiene for all other materials).
Migration is regarded as a type of chemical contamination with regard to packaging materials; therefore the most pertinent clauses
will be those to do with identifying and managing those hazards.
Identification of all potential hazards in the hazard and risk analysis

The hazard and risk analysis team shall identify and record all potential hazards that are reasonably expected to occur at each step
in relation to the product and process (Issue 5, clause 2.2.5).
Packaging suppliers are required to take note of customer requirements, which will be likely to include any barrier properties required
for the food. Such barrier properties would be critical-use parameters.
Identification of critical-use parameters or testing as part of customer requirements

Customer requirements relating to the design, development, specification, manufacture and distribution of the product shall be
documented and agreed with the customer.
This shall take into consideration process requirements and end use, where possible.
Any critical-use parameters shall be identified and defined; for example, barrier requirements, max/min use temperature, machine
running, use of recycled materials, and testing requirements (including migration, where relevant).
Special attention shall be paid to any materials that are required or requested to be manufactured from recycled materials, to ensure
that they are both appropriate and legal (Issue 5, clause 5.1.1)
The Standard mandates the use of DoCs for all packaging producers that are certificated to it. The minimum level of information,
such as any recycled material content, is stated within the clause, but additional information, such as any completed testing results,
can and should be included where possible.
Declaration of compliance requirements, including the nature of the material and any post-consumer
recycled materials
A declaration of compliance shall be maintained which enables users of the packaging materials to ensure compatibility between
those materials and the product with which they may be in contact (Issue 5, clause 3.4.3).
Other requirements to consider

Other requirements that the company should consider when assessing the potential for migration are as follows:
○○ review of the hazard and risk analysis (where product composition has changed and may include materials containing potentially
harmful migrating substances)
○○ compliance of specifications with minimum safety and legal requirements
○○ assessment of materials not drawn from approved suppliers
○○ evaluation of any risks from subcontracting of manufacturing processes
○○ traceability of all materials
○○ appropriate protection of all materials (work in progress and product)
○○ control of storage to prevent contamination of the product
○○ appropriate handling of hazardous chemicals.

3.4.3 GLOBAL STANDARD FOR STORAGE AND DISTRIBUTION
There is no specific mention of migration as with the other Standards. The risk of migration is reduced because all products need
to be pre-packaged. Requirements to consider include:
○○ hazard and risk analysis

○○ effective quarantine of non-conforming products pending further investigation
○○ provision of adequate segregated storage facilities for incompatible products
○○ ventilation and segregation of areas where fumes may build up (e.g. battery-charging areas)
○○ provision and siting of appropriate facilities for the control and storage of cleaning and maintenance chemicals
○○ incorporation of exhaust filter systems in all diesel-powered handling equipment where a contamination risk to product exists
○○ assessment of cross-contamination risk where allergenic materials are stored or transported
○○ conduct of factory trials and product conformity checks to verify the production of safe and legal product
○○ notification by suppliers (to wholesalers) of changes in product formulation or process and the assessment of these changes
for safety and legality
○○ provision of adequate and accurate specifications that comply with relevant safety and legislative requirements
○○ monitoring of incoming products for compliance to specification
○○ storage conditions for product and packaging materials used in contract packing (repacking, assembly packing)
○○ segregation of the cleaning area from the product storage and handling areas
○○ handling of materials received for waste/recycling to prevent the risk of contamination.
3.4.4 GLOBAL STANDARD FOR AGENTS AND BROKERS

Migration is not specifically mentioned in the Global Standard for Agents and Brokers but it will still be a factor in some instances.
If a company is a trader of food products and the food is already packaged, appropriate testing and legality checks may be
applicable. However, where the company is a trader of packaging, then a number of clauses might imply a need to consider migration
and companies should either specifically include or exclude the following:
○○ hazard and risk assessment

○○ product inspection and laboratory testing: appropriate tests should be completed and the potential for specific migration may
be one of those tests
○○ legality: the requirement includes reference to compositional requirements
○○ product design/development (relevant where the trader is responsible for developing new products or amending formulation).
3.4.5 LEGAL AND CUSTOMER-SPECIFIC REQUIREMENTS

Each of the Standards also requires that the manufacturing company maintains compliance with legal requirements, not only in the
country of manufacture but also in the country of use, where known. Additionally, each Standard requires the certificated company
to have a mechanism in place to ensure that it stays informed of legislation, codes of practice and scientific or industry developments.
Although the legal requirements in various regions are set and continually evolve, individual customers may have their own policies
or requirements with regard to the levels of migration permitted that exceed the legal requirement. Where this is the case, suppliers
should take care to ensure they understand and remain up to date with those requirements in order to ensure continual compliance.
Similarly, it is essential that the user of the packaging informs the packaging manufacturer of their requirements so the packaging
manufacturer can assist in ensuring compliance.

PART 4
PRODUCT
DEVELOPMENT
PROCESSES
4.1 New product development and change control 29

4.2 Selection of materials and design of low-migration
inks and adhesives 29
4.3 Other factors complicating packaging
material selection 30

Ultimate responsibility for the compliance of packaged food placed on the market rests with the food manufacturer or packer; this is
the organisation responsible for putting the product on the market. However, it is unlikely that the manufacturer or packer can achieve
this in isolation. The food manufacturer or packer needs to ensure that all necessary specification/design information relating to the
potential for migration has been communicated to its packaging supplier and further up the supply chain, as required. Essentially,
therefore, the compliance of packaging and the prevention or minimisation of migration is a shared responsibility, with the necessary
information flowing in both directions along the supply chain. Table 3 (product development process flow) in section 3.3.8 is an
example of best practice in the supply chain.
Suppliers of food packaging are responsible for ensuring that the materials supplied are fit for purpose and compliant. For example,
with the Plastics Regulation, suppliers of plastic materials and articles to the EU are required to provide a DoC. In the case of suppliers
of materials covered by other harmonised EU-specific measures (e.g. ceramics), a DoC is also required under Article 16 of Regulation
1935/2004. The Plastics Regulation requires suppliers of printing inks and adhesives to supply ‘adequate information’ to enable the
supplier of the plastic item to carry out the necessary compliance work. Adequate information could take the form of a statement of
composition detailing potential migrating substances in the ink or adhesive.
The potential for and rate of migration is, however, highly dependent on the nature of the food being packed, the design of the overall
package (taking all components into account), filling and storage temperatures, shelf life and usage instructions (such as temperature
and time conditions); for example, if the food is intended to be heated in the pack. The packaging supplier needs this information in
order to select appropriate materials and processes and hence to ensure compliance of the packaging material supplied.
Therefore, it is essential that any packaging material samples for migration testing are discussed with the laboratory that will be
conducting the testing to ensure the right materials are sent, as well as ensuring they are received at the laboratory in a condition
that enables effective testing.
It is good practice for compliance work to be completed as early as possible in the chain to avoid duplication of effort. However, there
are circumstances in which migration testing or modelling may have to be conducted further down the supply chain. For example,
a supplier of ink for a carton may not be aware of the weight of ink applied to the carton or the drying conditions. Similarly, an ink
supplier may not be aware of the nature of the plastic forming the inner bag of the overall pack, yet this may contain the same potential
migrant as is present in the ink.

4.1 NEW PRODUCT DEVELOPMENT AND CHANGE CONTROL
It follows that compliance (and prevention or minimisation of migration) needs to be ‘designed in’ to the overall packaged product
and that this should be completed at the product development stage. Where a range of products is being developed, it may be
possible and cost-effective to carry out compliance work (including possible migration testing or modelling) on the ‘worst case’
of a family of products (i.e. the product in the range most susceptible to migration). However, where any raw material (ink, substrate)
changes, new testing will probably be required.
Once compliance has been designed into the packaged food, it is important that change control procedures are put in place along
the supply chain. Packaging (and component) suppliers should inform the food manufacture or packer of any proposed changes in
specification, raw materials or manufacturing processes, which might invalidate the completed compliance work. Migration testing
or modelling may need to be repeated to validate the change in the packaging material.
Similarly, food manufacturers or packers should not use existing packaging for a food product with different migration potential,
or use packaging designed for one purpose for a different purpose. For example, a printed carton designed for ambient storage is
unlikely to be suitable for an ovenable or microwaveable pack. A lid that is compliant for a jar filled with an aqueous food may not be
suitable for an oil-based food.
When sending packaging material samples for migration testing, it is important to record technical details at an appropriate level that
will be transferred to the migration certificate. Such details could include the product code, product description (such as size, weight,
thickness) and raw material (including technical codes, such as masterbatch reference and supplier) to allow traceability.
4.2 SELECTION OF MATERIALS AND DESIGN OF LOW-MIGRATION

INKS AND ADHESIVES
In the light of knowledge of the intended use of the pack, packaging suppliers and converters can specify appropriate materials and
components to ensure compliance. For plastic packaging, an example would be the selection of an appropriate polymer to act as a
barrier to potential migrating substances under the correct storage conditions. Polymers with low residual monomer content should
be selected.
Where a risk assessment identifies the potential for migration from recycled board into a given food product under given storage
conditions, the options are to use a different grade of recycled board, to use virgin board, or to employ a suitable ‘functional barrier’
to prevent migration.
A functional barrier might be functional only against specific substances. Careful design of a polymer may be required to create
an appropriate barrier. Ink and adhesive manufacturers also have the ability to design and select appropriate low-migration inks or
adhesives for specific applications. One possible option is the use of polyolefin-based hot-melt adhesives, which have a narrower
molecular weight distribution (a lower proportion of molecules less than 1,000 Da) and hence a reduced migration risk compared
to ethylene-vinyl acetate-based hot melts. However, note that this may affect some of the desired characteristics of the material,
such as tack.
Another option is to select plasticiser-free dispersion adhesives. Copolymer dispersions can be used instead of homopolymers with
plasticisers. Plasticisers are typically substances of low molecular weight, so eliminating them from the formulation reduces the risk
of migration. Similarly, migratable substances can be minimised by limiting additives, preservatives and stabilisers, etc. to the smallest
amount necessary. In some cases, polymeric or polymer-bound additives can be used instead of low-molecular-weight substances.
These principles can be applied to inks, coatings and adhesives.
In the case of ultraviolet (UV) curing inks, some of the photoinitiators used are potentially small, readily migratable molecules.
High-molecular-weight polymeric photoinitiators can, however, be selected, alongside increased acrylate functionality or cross-
linking density, to design a low-migration UV ink. It is also important to ensure that UV inks are appropriately cured to minimise
the potential migration of unreacted monomers. UV lamps should therefore be correctly specified and in good working order.
Ink manufacturers have also developed low-migration versions of other types of ink; for example, water-based inks or coatings
and conventional offset inks. However, there do not appear to be standardised definitions of the terms ‘low migration’ or ‘reduced
migration’, so it is important for all parties in the supply chain to clarify the exact meaning of any terminology used.
Ink and adhesive manufacturers have a great deal of knowledge in formulating components to prevent or minimise migration.
Food manufacturers or packers and their packaging suppliers are encouraged to take advantage of this supply-chain expertise
to determine the right solution for the specific packaging/product combination and its use.

4.3 OTHER FACTORS COMPLICATING PACKAGING MATERIAL SELECTION
Where printed inserts are included within a pack, their potential contribution to migration should be considered. Similarly, the
possibility of migration from printed adhesive labels should be taken into account, especially when these are applied either directly to
food such as fruit, or to plastic films covering microwaveable products (ready meals etc.) which are not removed before microwaving.
Potential migration from inks used for inkjet coding of packaged foods should be borne in mind. The possibility of migration from
point-of-sale displays should also be assessed. In both cases a risk assessment should be carried out and suppliers’ advice should
be sought as to whether appropriate materials have been used for the application concerned.
The Biocidal Products Regulation (BPR) (EU Regulation 582/2012) requires all biocidal products to be authorised for use in specific
‘product types’. A programme for the submission and review or evaluation of biocidal product applications is under way. Biocides are
used in the paper-making process and in water-based inks, coatings, adhesives, sealants, etc. Biocides are therefore potentially
present in a wide range of food-contact materials. Biocides are typically relatively small molecules and so are also potential migrants.
Anecdotal evidence suggests that some suppliers in the supply chain of food-contact packaging may be changing the biocides they
use in order to ensure that the biocides are authorised under the BPR, or will be in the future. The effect on migration of any such
changes should be considered at all stages of the supply chain.
The European Commission is now understood to be taking a more pragmatic approach to what constitutes a ‘treated article’ in terms
of the BPR. Under this revised approach, the addition of process biocides (e.g. in the paper-making process) would not confer
treated-article status, unless there is biocidal activity in the finished material. The Commission has indicated that it also intends to set
limits for residual process biocides in food-contact materials; however, the process and timescale for this is unknown.
Queries have been received with regard to the potential transfer of allergens and/or genetically modified material into food from
packaging materials (especially from bioplastics). Initial investigations have suggested that this is fairly unlikely, given the range
of bioplastics currently used in food packaging. However, this is a rapidly developing field and an appropriate risk assessment
is important.
4.3.1 NON-INTENTIONALLY ADDED SUBSTANCES

Non-intentionally added substances (NIASs) are defined in Article 3 of the Plastics Regulation, which lays down the responsibilities
of the manufacturer in assessing any health risks (see section 2.1). NIASs are not new; they have always been present. However,
there has been much recent discussion of NIASs in other, non-plastic, food-contact materials and there is an expectation that the
packaging supply chain should also consider potential health risks from NIASs in non-plastic packaging. This is not straightforward
in cases where the chemistry is either unknown or very complex. Nevertheless, it would be good practice to consider potential
migration from NIASs. Further information can be found in the ILSI Europe ‘Guidance on Best Practices on the Risk Assessment
of Non Intentionally Added Substances (NIAS) in Food Contact Materials and Articles’.
This is particularly important in ovenable and microwaveable packs, where the temperatures achieved during cooking can cause
some chemical breakdown; for example, of the inks, adhesives and even potentially of substances in the substrates used. It is
recommended that this possibility be discussed with packaging suppliers, taking into account views and information from the
extended supply chain.

APPENDICES
1 Other sources of information 32

2 Glossary 33
3 Acknowledgements 40
4 Migration testing process flow 40

APPENDIX 1:
OTHER SOURCES OF INFORMATION
Technical guidelines for compliance testing are currently being prepared by the Joint Research Centre. The joint guidelines should
complement the technical guidelines and not exist in isolation.
Confederation of European Paper Industries (CEPI): Industry http://www.cepi.org/system/files/public/documents/

Guideline for the Compliance of Paper & Board Materials publications/foodcontact/2012/Industry%20guideline-
and Articles for Food Contact updated2012final.pdf
International Confederation of Paper and Board Converters http://www.citpa-europe.org/library/industry-guidelines

in Europe (CITPA): Industry Guideline for the Compliance of
Paper & Board Materials and Articles for Food Contact
European Carton Makers Association (ECMA): Good http://www.ecma.org/uploads/Bestanden/Publications/GMP/

Manufacturing Practice Guide UK%20GMP%20%20Version%201.1%20%2016%2012%20
2013%20%20-%20FINAL.pdf
European Printing Ink Association (EuPIA): Good http://www.eupia.org/uploads/tx_edm/2016-03-31-EuPIA_

Manufacturing Practice (GMP) Printing Inks for Food GMP_4th_version_final.pdf
Contact Materials
European Corrugated Packaging Association (FEFCO): http://www.fefco.org/sites/default/files/documents/

GMP International Good Manufacturing Practice Standard International%20GMP%20Standard%20for%20
for Corrugated & Solid Board Corrugated%20%26%20Solid%20Board%20%202nd%20
Editon_0.pdf
Association of the European Adhesive and Sealant Industry http://www.feica.eu/cust/documentview.aspx?DocID=1775

(FEICA): Migration Testing of Adhesives Intended for Food
Contact Materials
FoodDrinkEurope: Guidelines on the Safe Use of Paper and http://www.fooddrinkeurope.eu/publication/guidelines-on-

Board made from Recycled Fibres for Food Contact Use the-safe-use-of-paper-and-board-made-from-recycled-
fibres-for/
FoodDrinkEurope: Guidance on Printed Cartons http://www.fooddrinkeurope.eu/publication/guidance-on-

printed-cartons/
Flexible Packaging Europe (FPE): Code for Good http://www.flexpack-europe.org/tl_files/FPE/downloads/

Manufacturing Practices for Flexible and Fibre-based FPE_GMP_Code_6.0.pdf
Packaging for Food

APPENDIX 2
GLOSSARY
Agent/non-manufacturing A company that facilitates trade between a manufacturer or broker and their customer through
service provider the provision of services, but does not at any point own or take title to the goods.
Allergen A known component of food which causes physiological reactions due to an immunological
response (e.g. nuts and others identified in legislation relevant to the country of production or sale).
AQL Acceptable quality limit as defined in ISO 2859 part 1.
Assembly packer A business that assembles a collection of two or more market-ready finished consumer products
into outer packaging for sale as a single product. These companies do not manufacture any
of the component products, which are supplied to them for the assembly into the final pack.
Assembly packing A process that assembles a collection of two or more market-ready finished products into outer
packaging for sale as single product. Companies undertaking this process do not manufacture
any of the component products, but are supplied with them for assembly into the final pack.
Audit A systematic examination to measure compliance of practices with a predetermined system,
whether the system is implemented effectively and is suitable to achieve objectives, carried
out by certified bodies.
Auditor A person possessing the appropriate competence and skills to carry out an audit.
Back-haul To collect a load following delivery of products for return to the distribution depot or warehouse.
BADGE Bisphenol A diglycidyl ether, an organic colourless compound used in epoxy resins that melts
at low temperatures.
Batch A discrete quantity of products made using the same operation and raw materials (alternative
term is ‘lot’).
BFDGE Bisphenol F diglycidyl ether, a clear colourless oil.
Bill of materials List of the materials used, including component parts in the make-up of a product.
Brand owner The owner of a brand logo or name who places the said logo or name on to retail products.
Branded product Products bearing the logo, copyright or address of a company that is not a retailer.
Broker A company which purchases or ‘takes title to’ products for resale to businesses, e.g.
manufacturers, retailers or food service companies, but not to the ultimate consumer.
Business continuity A framework that enables an organisation to plan and respond to incidents of business
interruption in order to continue business operations at an acceptable predetermined level.
Calibration A set of operations that establish, under specified conditions, the relationship between values
of quantities indicated by a measuring instrument or measuring system, or values represented
by a material measure or reference material, and the corresponding values realised by standards.
Certification The procedure by which an accredited certification body, based on an audit and assessment
of a company’s competence, provides written assurance that a company conforms to a
standard’s requirements.
Certification body Provider of certification services, accredited to do so by an authoritative body and registered
with the BRC.
Cleaning in place (CIP) The process of cleaning and sanitising food-processing equipment in its assembled position
without the need for dismantling and cleaning the individual parts.
Client Company or person to whom a product or service has been supplied, either as a finished product
or as a component of a finished product.
Codex Alimentarius A body responsible for establishing internationally recognised standards, codes of practice and
Commission guidelines, of which HACCP (hazard analysis and critical control points) is one standard.
Company The entity with legal ownership of a site.
Competence Demonstrable ability to apply skill, knowledge and understanding of a task or subject to achieve
intended results.

Compliance Meeting the regulatory or customer requirements concerning product safety, legality and quality.
Consumer The end-user of the finished product, commodity or service.
Consumer product All systems related to product hazard and risk processes, which determine and control product
management system safety, legality and quality.
Consumer products Non-food products normally bought by or supplied to private consumers for personal or
household use and included within the scope of the BRC Consumer Products Standard.
Contamination Introduction or occurrence of an unwanted organism, taint or substance to packaging,
food or the food environment. Contamination includes physical, chemical, biological
and allergen contamination.
Contract packer A company that packages the final product into consumer packaging.
Contractor or supplier A person or organisation providing services or materials.
Control To manage the conditions of an operation so that compliance with established criteria is
maintained, and/or the state wherein correct procedures are being followed and criteria
are being met.
Control measure Any action or activity that can be used to prevent or eliminate a product safety hazard or reduce
it to an acceptable level.
Controlled document A document which is identifiable and for which revisions and removal from use can be tracked.
The document is issued to identified individuals and their receipt of the document is recorded.
Corrective action Action to eliminate the cause of a detected non-conformity.
Critical control point (CCP) A step at which control can be applied which is essential to prevent or eliminate a food or product
safety hazard or reduce it to an acceptable level.
Cross-docking Material is unloaded at distribution premises and handled, but not formally put away into storage.
This may be a staging area where inbound materials are sorted, consolidated and temporarily
stored until the outbound shipment is complete and ready to dispatch.
Customer A business or person to whom a service or product has been provided, either as a finished product
or as a component part of the finished product.
Customer focus A structured approach to determining and addressing the needs of an organisation to which the
company supplies products and which may be measured by the use of performance indicators.
Dalton The dalton (Da) is a unit used for indicating mass on an atomic or molecular scale and is an
alternative name for the unified atomic mass unit (i.e. one-twelfth of the mass of a carbon-12 atom).
Dispatch The point at which the product leaves the factory site or is no longer the responsibility
of the company.
Distribution The transportation of goods within any container (goods on the move) by road, rail, air or ship.
Environmental aspect Element of an organisation’s activities or products that can interact with the environment.
Environmental impact Any change to the environment, whether adverse or beneficial, wholly or partially resulting
from an organisation’s activities, goods or services.
Exporter A company facilitating the movement of products out of a country, across an international border.
Factored goods Goods not manufactured or part-processed on site but bought in and sold on.
Final manufacturer The site where the last processing act is undertaken on a product before supply to the agent
or broker.
Flow diagram A systematic representation of the sequence of steps or operations used in the production or
manufacture of a particular food item.
Food Products as defined by the EU Food Safety Regulations 178/2002.
Food handler Anyone who handles or prepares food, whether open (unwrapped) or packaged.

Food safety Assurance that food will not cause harm to the consumer when it is prepared and/or eaten
according to its intended use.
Genetically modified An organism whose genetic material has been altered by the techniques of genetic modification
organism (GMO) so that its DNA contains genes not normally found there.
Global Food Safety Initiative Managed by the Consumer Goods Forum, a project to harmonise and benchmark international
(GFSI) food safety standards. See www.mygfsi.com
Good hygiene practice The combination of process, personnel and/or service control procedures intended to ensure
that product and/or services consistently achieve appropriate levels of hygiene.
Good manufacturing Implemented procedures and practices undertaken using best practice principles.
practice (GMP)
Harmonised standard A standard listed by the European Commission or member state as suitable for determining
compliance with essential safety requirements. The list can be found at: https://ec.europa.eu/
growth/single-market/european-standards/harmonised-standards_en
Hazard An agent of any type with the potential to cause harm (usually biological, chemical, physical
or radiological).
Hazard analysis and critical A system that identifies, evaluates and controls hazards which are significant for food safety.
control points (HACCP)
Hazard and risk A system that identifies, evaluates and controls hazards which are significant for product safety
management (HARM) and integrity.
High-care area An area designed to a high standard where practices relating to personnel, ingredients,
equipment, packaging and environment aim to minimise product contamination by
pathogenic micro-organisms.
Hub depot A storage and distribution site receiving products from external companies and supplying
products to other depots within the company’s own distribution network (see satellite depot).
Hygiene All measures necessary to ensure the wholesomeness, quality and safety of an entity that might
otherwise be hazardous.
Identity-preserved A product which has a defined origin or purity characteristic which needs to be retained
throughout the food chain (e.g. through traceability and protection from contamination).
Importer A company facilitating the movement of products across an international border. Usually the first
recipient of the products in that country.
Incident An event that has occurred that may result in the production or supply of unsafe, illegal or non-
conforming products.
Infant A child under 36 months.
Inspection A systematic examination involving professional judgement to determine acceptability against
a specified standard.
Internal audit General process of audit, for all the activity of the company. Conducted by or on behalf of the
company for internal purposes.
Invasive A device which, in whole or in part, penetrates inside the body, either through a body orifice or
through the surface of the body. ‘Invasive’ does not include products entering the mouth or outer
ear for periods of less than 30 minutes of continuous use. A surgically invasive device is a device
which penetrates inside the body through the surface of the body, with the aid or in the context
of a surgical operation.
Job description A list of the responsibilities for a given position at a company.
Key staff Those staff whose activities affect the safety, legality and quality of the finished product.
Legality In compliance with the law in the place of production and in the countries where the product(s)
is intended to be sold.

Location The geographical area within which individual premises reside in order to be classed as a single site
for auditing purposes (i.e. a radius of 50 km from the usual place of work of the management team).
Loose/open food Food ingredients or finished products that are unwrapped or not stored in packaging that is
designed to protect the product when it is sold to the consumer (e.g. trays of fresh produce,
meat carcasses).
Lot See batch.
Mandatory standard Standard which must be met to demonstrate legal compliance with the law in a country or region.
Manufacturer A company that produces product from raw materials and/or components and packs the product
into retail units or supplies product in bulk to a packing company that packs the product into retail
units. A packer that packs product into retail units from bulk-supplied material can also be classed
as a ‘manufacturer’.
Nanomaterials Materials that have structured components with at least one dimension which is less than 100 nm.
Nanotechnology Technology using nanomaterials in order to impart specific properties.
NOGE Novolac glycidyl ether and epoxy derivative.
Non-conformity The non-fulfilment of a specified product safety, legal or quality requirement or a specified
system requirement.
Office An office is a dedicated workplace where two or more people work, that has accessibility
to company files, and is a registered postal address for the company.
OML Overall migration limit, the sum of all substances that can migrate from the food-contact material
to the food (or food simulant).
Original copy A document, whether in electronic or printed form, that has been legally obtained and does not
infringe any copyright.
Performance indicators Summaries of quantified data that provide information on the level of compliance against agreed
targets (e.g. customer complaints, product incidents, laboratory data).
Photoinitiator A compound that undergoes a photoreaction on absorption of light, producing a reactive species
(free radicals, cations or anions). These are capable of initiating or catalysing chemical reactions
that result in significant changes in the solubility and physical properties of suitable formulations.
Positive release Ensuring a product or material is of an acceptable standard prior to release for use.
Post-consumer recyclate Material generated by households or by commercial, industrial and institutional facilities in their
(PCR) role as end-users of the goods or services which can no longer be used for their intended purpose.
This includes returns of material from the distribution chain.
Post-consumer waste Waste collected after the consumer has used and disposed of the product.
(PCW)
Post-industrial waste (PIW) Waste collected after processing but before the product has reached the supply chain.
Potable water Water that is safe to drink, free from pollutants and harmful organisms and conforming to local
legal requirements.
Pre-packaged products Products in their final packaging that is designed for sale to the consumer.
Premises A physical building or place owned by the company and audited as part of a site.
Prepared primary product A food product which has undergone a washing, trimming, size-grading or quality-grading
process and is pre-packed.
Prerequisite conditions The basic environmental and operational conditions in a food business that are necessary for the
production of safe food. These control generic hazards covering good manufacturing practice and
good hygienic practice and shall be considered within the HACCP study.
Primary customer The first customer who receives the goods on dispatch from the factory.
Primary packaging That packaging which constitutes the unit of sale, used and disposed of by the consumer
(e.g. bottle, closure and label).

Procedure Agreed method of carrying out an activity or process which is implemented and documented
in the form of detailed instructions or a process description (e.g. a flowchart).
Processed food A food product which has undergone any of the following processes: aseptic filling, baking,
battering, blending, bottling, breading, brewing, canning, coating, cooking, curing, cutting,
dicing, distillation, drying, extrusion, fermentation, freeze-drying, freezing, frying, hot-filling,
irradiation, microfiltration, microwaving, milling, mixing, being packed in modified atmosphere,
being packed in vacuum packing, packing, pasteurisation, pickling, roasting, slicing, smoking,
steaming or sterilisation.
Processing aid Any substance not consumed as a food by itself, intentionally used in the processing of raw
materials, foods or their ingredients to fulfil a certain technological purpose during treatment or
processing, and which may result in the unintentional but technically unavoidable presence of the
residues of the substance or its derivatives in the final product – provided that these residues do
not present any health risk and do not have any technological effect on the finished product.
Product integrity The ability of the packaging material to provide an effective protective barrier for the product it is
designed to contain.
Product recall Any measures aimed at achieving the return of an unfit product from customers and final
consumers.
Product withdrawal Any measures aimed at achieving the return of out-of-specification or unfit products from customers,
but not from final consumers.
Protective clothing Clothing designed to protect the product from potential contamination by the wearer.
Provenance The origin or the source of food or raw materials.
Quality The standard required when meeting the customer’s specification and expectation.
Quantity check/mass A reconciliation of the amount of incoming raw material against the amount used in the resulting
balance finished products, taking into account process waste and rework.
Quantity control A check on amount of product in the consumer pack. May be related to weight, volume, number
of pieces, size etc.
Quarantine The status given to any material or product set aside while awaiting confirmation of its suitability
for intended use or sale.
Raw material Any base or semi-finished material used by the organisation for the manufacture of a product.
Ready-to-cook food Food designed by the manufacturer as requiring cooking or other processing effective to eliminate
or reduce to an acceptable level micro-organisms of concern.
Ready-to-eat food Food intended by the manufacturer for direct human consumption without the need for cooking
or other processing, effective to eliminate or reduce to an acceptable level
micro-organisms of concern.
Ready-to-reheat food Food designed by the manufacturer as suitable for direct human consumption without the need for
cooking, but which may benefit in organoleptic quality from some warming prior to consumption.
Recognised laboratory Laboratory accreditation schemes that have gained national and international acceptance,
accreditation awarded by a competent body and recognised by government bodies or users of the Standard
(e.g. ISO 17025 or equivalents).
Recycled material Material that has been reprocessed from recovered (reclaimed) material by means of a
manufacturing process and made into a final product or into a component for incorporation
into goods or services.
Reference sample Agreed product or components for referral by the manufacturer for production.
Requirement Those statements comprising a clause with which compliance will allow sites to be certificated.
Retail brand A trademark, logo, copyright or address of a retailer.

Retailer-branded products Products bearing a retailer’s logo, copyright, address or ingredients used to manufacture within
retailer’s premises are products that are legally regarded as the responsibility of the retailer.
Retailer A business selling products to the public by retail.
Retained production Representative product or components taken from a production run and securely held for
sample future reference.
Reuse Cleaning and/or refurbishing an old product to be used again.
Risk The likelihood of occurrence of harm from a hazard.
Risk analysis A process consisting of three components: risk assessment, risk management and risk
communication.
Risk assessment The identification, evaluation and estimation of the levels of risk involved in a process to determine
an appropriate control process.
Root cause The underlying cause of a problem, which, if adequately addressed, will prevent a recurrence of that
problem.
Safety Freedom from unacceptable risk or harm.
Sampling plan A documented plan defining the number of samples to be selected, the acceptance or rejection
criteria, and the statistical confidence of the result.
Satellite depot A warehouse/distribution site receiving products only from another site within the same company.
Schedule A tabulated statement giving details of actions and/or timings.
Seasonal or intermittent A product produced on a site that is opened specifically for the duration of the short-term
production production (typically 6 months or less) during a 12-month cycle.
Seasonal production site A product harvested and processed on a site that is opened specifically for the duration
of the short term of that harvest (typically 12 weeks or less) during a 12-month cycle.
Secondary packaging Packaging that is used to collate and transport sales units to the retail environment
(e.g. corrugated case).
Senior management Those with strategic/high-level operational responsibility for the company and the capability to
authorise the financial or human resources necessary for the implementation of a BRC Global
Standard and the maintenance of legal compliance.
Site A unit of a company; the entity which is audited and which is the subject of the audit report and
certificate. A site may be made up of more than one premises within a location. For distribution
this will be the address from which vehicles operate.
Skin contact Product in intimate contact with the skin for more than 30 minutes at one use. Examples include face
paints and lingerie. Products handled during use such as books, keyboards etc. are not included
in this description.
SML Specific migration limit: this applies to an individual substance and toxicological studies determine
the presence and level of that substance.
Specification An explicit or detailed description of a material, product or service.
Specifier Company or person requesting the product or service.
Stakeholders Brand owners, certification bodies, enforcement agencies, consumers, suppliers, manufacturers
or others.
Stock reconciliation The process by which the location and quantities of raw material and intermediate and finished
product are identified and matched to product schedules and quantities.
Subcontractor A firm, company or individual carrying out a process on products on behalf of the site being
certificated to a BRC Global Standard.
Supplier The person, firm, company or other entity to which a site’s purchase order to supply is addressed.

Technical dossier A collection of technical documents which together form the technical specification and product
conformity information on a specific product.
Tertiary packaging Also known as transport packaging, used to facilitate the handling and transport of products
(e.g. pallets and stretchwrap).
Testing A technical operation that consists of the determination of one or more characteristics of a given
product, process or service following a specific procedure and against an agreed requirement.
Traceability Ability to trace and follow raw materials, components and products through all stages of receipt,
production, processing and distribution, both forwards and backwards.
Trans-shipment A direct transfer of goods from one vehicle or container to another.
Trend An identified pattern of results.
Unannounced audit An audit undertaken on a date unknown to the company in advance.
Utilities Commodities or services (e.g. electricity, water) that are provided by a public body.
Validation Confirmation through the provision of objective evidence that the requirements for the specific
intended use or application have been fulfilled.
Vehicle Any device used for the conveyance of product that is capable of being moved upon highways,
waterways or airways. Vehicles can be motorised (e.g. a lorry) or non-motorised (e.g. container
or rail truck).
Verification Confirmation through the provision of objective evidence that specified requirements have been
fulfilled.
Waste recovery Where any type of waste is recovered, typically to be processed to provide energy.
Wholesaler A distributor or middleman who purchases products to sell mainly to retailers, institutions or other
companies rather than to consumers.
Wholesaler exclusive Products not bearing the wholesaler’s logo but produced with a brand exclusively for sale and
products distribution by the wholesaler.
Wholesaler own brand Products bearing a wholesaler’s logo, copyright and address that are legally regarded as the
responsibility of the wholesaler.
Work-wear Company-issued or authorised clothing worn in the work place, usually to provide protection
to the wearer or the wearer’s own clothing.

APPENDIX 3
ACKNOWLEDGEMENTS
This document was developed by the following:
Elizabeth Andoh-Kesson British Retail Consortium

Alan Campbell Campden BRI
John Figgins BRC Global Standards
Joanna Griffiths BRC Global Standards
John Lepley Food and Drink Federation (FDF)
Contributions were also made by members of the following organisations: British Coatings Federation (BCF), British Plastics
Federation (BPF), British Retail Consortium (BRC), Campden BRI, Confederation of Paper Industries (CPI), Food and Drink
Federation (FDF), Metal Packaging Manufacturers Association (MPMA) and Smithers Pira.
APPENDIX 4:
MIGRATION TESTING PROCESS FLOW
Migration can occur from one product on a shelf to another nearby whilst in storage and in the retail environment. This could be
a consideration in developing outer packaging or, indeed, in determining the barrier properties of the primary packaging, and
merchandising. Figure 7 illustrates the process for migration testing.
FIGURE 7 MIGRATION TESTING PROCESS FLOW
DEFINE MATERIAL
RISK ASSESSMENT
ARTICLE IN FINISHED STATE?

GLOSSARY
CONTINUE TO FINISHED
NO YES
STATE
METAL PAPER AND

GLASS
PLASTIC 1935/2004 BOARD
(10/ 2011)
CONSULT NATIONAL LEGISLATION
MIGRATION
MODELLING
(OTHER TOOLS)
SML OML
COMPLIANCE
VALID DOC
10/ 2011

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GLOBAL GUIDANCE

For more information about BRC, contact:

BRC Global Standards

Tel: +44 (0)20 3931 8150

GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD 1

2 GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD

1.2 DOCUMENT SCOPE

GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD 3

The following are excluded from the scope of this document:

1.3 ABOUT THE THREE ORGANISATIONS

4 GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD

2.1 EU food-contact materials legislation 6

GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD 5

FIGURE 1 OVERVIEW OF EU LEGISLATION

2007/42/EC 84/500/EEC PLASTIC ELASTOMERS (EC) NO

93/8/EEC (EC) NO 1895/2005/ 93/11EEC

6 GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD

○○ endanger human health;

○○ through the substrate or

There is also EU legislation relating to specific substances:

GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD 7

○○ food-contact materials consisting exclusively of plastics

Article 5 establishes a Union list of authorised substances consisting of:

○○ monomers or other starting substances

A ‘functional barrier’ is defined by Article 3 (15) as:

8 GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD

○○ paper and board

GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD 9

10 GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD

Role of the declaration of compliance for food-contact materials and articles

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○○ a regulation listing in Title 211 of the Code of Federal Regulations (CFR)

○○ the packaging material makes the food unsafe

2.2.1 CODE OF FEDERAL REGULATIONS TITLE 21

There are three types of food additive:

○○ direct – food ingredients

There are two types of indirect additive:

○○ d irect contact with food

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Section 174: Indirect food additives: general

GMP includes the following restrictions:

TABLE 1 PARTS OF CFR TITLE 21 RELATING TO FOOD-CONTACT MATERIALS

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○○ it has not been shown to be a carcinogen

Table 2 provides an overview of the US requirements regarding food-contact materials.

TABLE 2 GENERAL US REGULATIONS ON FOOD-CONTACT MATERIALS

2.3 KEEPING UP TO DATE WITH INDUSTRY TECHNICAL

14 GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD

3.1 Types of migration 17

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16 GUIDANCE ON MIGRATION FROM PACKAGING MATERIALS INTO FOOD

3.1.1 CONTACT MIGRATION

FIGURE 2 CONTACT MIGRATION

3.1.2 GAS-PHASE MIGRATION

FIGURE 3 GAS-PHASE MIGRATION

3.1.3 PENETRATION (THROUGH) MIGRATION

FIGURE 4 PENETRATION MIGRATION

FOOD (OR AIR GAP)

2.1 EU food-contact materials legislation 6

3.1 Types of migration 17

4.1 New product development and change control 29

1 Other sources of information 32