Food Control 20 (2009) 476482

Contents lists available at ScienceDirect

Food Control
journal homepage: www.elsevier.com/locate/foodcont

Assurance of compliance within the production chain of food contact materials

by good manufacturing practice and documentation Part 1: Legal background
in Europe and compliance challenges
Koni Grob a,*, Julian Stocker b, Ron Colwell b
a
b

Ofcial Food Control Authority of the Canton of Zurich, P.O. Box, CH-8032 Zurich, Switzerland
H.J. Heinz Co. Ltd. Wigan, Lancashire WN5 0JL, England, United Kingdom

a r t i c l e

i n f o

Article history:
Received 12 February 2008
Received in revised form 23 June 2008
Accepted 27 July 2008

Keywords:
Food contact materials
European legislation
Good manufacturing practice
Supporting documentation
Condentiality
Delegation of compliance work

a b s t r a c t
EU legislation requires that compliance of food contact materials with the legal requirements must be
assured at each stage of the supply chain. The process has to respect good manufacturing practice
(GMP), and for this purpose GMP is dened as the tool to ensure compliance. Communication through
the production chain is an essential part, clarifying which work has been done and what is delegated
to subsequent business stages.
At early production stages it is often not possible to conclude on compliance of the nal material or
article. For instance, migration can only be measured from the nal material and compliance of a nonregulated substance may be uncertain at an early stage. In fact, assuming responsibility either means concluding compliance with justication in the supporting documentation or specifying the work to be done
at later stages in the documentation accompanying the product.
This paper interprets existing legislation and indicates difculties regarding the needs of food business
operators and the role of the enforcement authorities.
2008 Elsevier Ltd. All rights reserved.

1. Introduction
Many consumers are concerned about chemicals entering food
during farming, processing and packaging. They rely on the producers and the control authorities to guarantee that the product
is safe. If, for instance, a new substance enables the pack designer
to achieve a more striking and eye-catching pack decoration and a
food packer wants to use it to promote the product, the consumer
accepts this because of trust in adequate control.
The manufacturers are responsible for providing the evidence
for the compliance of food contact materials (FCMs; including
packaging materials as well as materials in contact with food during production, storage and in households). In the past, many thousands of FCMs were created, most at a time when the requirements
regarding demonstration of safety were no serious obstacle against
Abbreviations: CD, compliance declaration; CMR, carcinogenic, mutagenic or
reprotoxic; EFSA, European Food Safety Authority; FCM, food contact material;
GMP, good manufacturing practice; HCl, hydrogen chloride; ITX, isopropylthioxanthone; NIAS, not intentionally added substances; OML, overall migration limit;
PVC, polyvinyl chloride; QM, maximum concentration in the FCM; QMA, maximum
content in 6 dm2 of the FCM; SD, supporting documentation; SML, specic
migration limit; TDI, tolerable daily intake.
* Corresponding author. Tel.: +41 43 244 71 31; fax: +41 43 244 71 01.
E-mail address: koni@grob.org (K. Grob).
0956-7135/$ - see front matter 2008 Elsevier Ltd. All rights reserved.
doi:10.1016/j.foodcont.2008.07.021

such diversication. Currently in the order of 10,000 substances

are used in the manufacture of FCMs. Because also impurities
and reaction products migrate into food, the number of compounds
of concern is even signicantly greater and it is a demanding task
to demonstrate compliance of all of these.
1.1. Control by starting substances
Present European control focuses on the starting substances to
manufacture FCMs, assuming that the migrates essentially consist
of these and derivatives (e.g. oligomers) having the same toxicological characteristics. This approach has advantages, such as that
control can largely be achieved on paper, avoiding expensive
chemical analysis, and that the substances required for toxicological testing are available in sufcient quantity.
The control of the starting substances is a rst and important
step, but awed by serious shortcomings. For instance, oligomers
of authorized monomers are not investigated. They are considered
covered by the monomers, but although they are assumed to have
the same toxicological properties, they are not included in the specic migration limit (SML) for the monomer. Furthermore, it is not
always safe to assume that oligomers have the same toxicological
prole as the monomer as, e.g., illustrated by the oligomers of
styrene (Date et al., 2002; Ohyama, Nagai, & Tsuchiya, 2001).

K. Grob et al. / Food Control 20 (2009) 476482

Impurities of starting substances and other unintentionally

added substances are also considered covered by the listed compounds. For complex mixtures, such as the resins used for producing coatings, inks or adhesives, usually only the starting substances
are controlled, though they are primarily composed of reaction
products, and the migrate from the nal product almost exclusively consists of substances other than these starting substances
(Grob, Spinner, Brunner, & Etter, 1999; Grob, Biedermann, Scherbaum, Roth, & Rieger, 2006).
1.2. Comprehensive migrate analysis
An alternative concept focuses on the migrate, not distinguishing between intentionally and unintentionally added substances or
between categories like starting materials, resins and reaction
products. Only the presence and the concentration of a substance
in the migrate is relevant. Those starting substances which are
fully reacted or do not migrate for other reasons are not taken into
account, but migrating reaction products and impurities are
considered.
Migrate-oriented control is based on comprehensive compositional analysis of the migrate. It leaves open the question of
whether toxicological investigation occurs individually for each
compound or for the whole mixture, but even in the latter case,
comprehensive compositional analysis is required to dene the
mixture for which the evaluation was performed (Grob, 2002). So
far, this most direct approach focusing on the relevant substances
has been avoided for the practical reasons of difculty and cost.
1.3. Control at each step of production
The concept more explicitly introduced by recent EU legislation
(Directive 2007/19 and Regulation 2023/2006) and discussed below less focuses on the control of the nal FCM, but divides compliance work into portions to be carried out by the most
competent, i.e. the producers at each stage in the manufacturing
chain. Aspects relevant for compliance are investigated and documented at each stage, both on the basis of the suitability of the
starting materials and the safety of the migration to be expected.
Whenever compliance cannot be stated, the subsequent stages
are informed to ensure that the open compliance tasks will be considered at later stages. Recently the producer association Flexible
Packaging Europe published a code for good manufacturing practices based on this approach (FPE, 2007).
Production of a FCM typically passes through numerous stages
and the manufacturer of the nal FCM may have no overview of
the chemical composition and the processes involved. This is
why the process should be broken into subunits, using the knowledge at each stage and engaging each manufacturer in the process.
An additional benet of engaging all contributors is likely to be
that substances potentially causing difculties are eliminated or
minimized to begin with.
This paper is the rst in a series that investigates the potential
of this approach by outlining how it should work. Part 1 focuses on
the legal background and requirements for compliance; Part 2 proposes the compliance box as a system for structuring documentation; Part 3 investigates an example: the metal closures for glass
jars.

nants. Article 14 species that food shall not be placed on the

market if it is unsafe. Food shall be deemed to be unsafe if it is considered to be (a) injurious to health or (b) unt for human consumption. Article 14(5) adds that regard should be had to. . .
contamination. . .. Migration from FCM is one of several sources
of contamination to be kept under control, in a similar way to pesticides, mycotoxins or contaminants from processing.
The nal responsibility is with the food producer. Article 17 even
states that the food and feed business operators at all stages of production, processing and distribution within the businesses under
their control shall ensure that foods satisfy the requirements of
food law. . .. The manufacturer of food packaging materials is, however, usually an independent company and outside of their control.
As discussed below, legislation does not support the food business
operator in verifying compliance at stages outside the businesses
under their control. In practice the food producer may audit the
producer of the packaging material, but this is the subject of trade
agreement and not requested by law although it is part of GMP.
The food producers were reminded of their responsibility
during the issue concerning 2-isopropylthioxanthone (ITX, a
photoinitiator contaminating baby milk in plastic-foil-laminated
paperboard cartons by set-off from the outside print; RASSF,
2005), when they were informed by the Commission that it is their
primary responsibility to guarantee that the food they place on the
market is safe.
2.2. Framework Regulation on FCM
The EU Framework Regulation 1935/2004 covers in general
terms all requirements for all FCMs (Fig. 1). It governs specic legislation, but so far only a minority of the FCMs is specically regulated: materials and articles exclusively consisting of plastic
(Directive 2002/72 and its ve amendments), ceramics (Directives
84/500 and 2005/31) and regenerated cellulose (Directive 2004/
14). Specic legislation on all other FCMs only exists as non-harmonized national regulation or is absent. The Council of Europe
passed resolutions on numerous types of FCMs, but most of these
have not been transposed into national legislation.
Article 3 of the Framework Regulation 1935/2004 addresses the
three key requirements on FCMs. The migrates must not:
 endanger human health,
 bring about an unacceptable change in the composition of the
food (unacceptably contaminate), and
 bring about a deterioration in the organoleptic characteristics
thereof.
This refers to all migrate components, i.e. not only to the substances used, and to all FCMs, regardless whether these are specifically regulated or not.

2. Legal requirements
2.1. Food law
Article 2 of the European General Food Law, Regulation 178/
2002, states that food shall not include residues and contami-

477

Fig. 1. Main legal network regulating FCMs in the EU.

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K. Grob et al. / Food Control 20 (2009) 476482

It provides that compliance with these requirements is achieved

by GMP: Materials and articles. . . shall be manufactured in compliance with good manufacturing practice so that. . .. This denes
GMP: it must be designed to achieve compliance with the key
points of Article 3 (Gergely, 2006).
Article 5 provides limits for specic migrants (specic migration
limits, SMLs) and overall migration (overall migration limit, OML)
for FCMs with specic regulation. Since migration limits apply to
food rather than simulants (Grob, 2008), specic migration may
need to be determined in the packaged food and the overall migration checked by adding up the main migrate components.
Article 16 states: The specic 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. This compliance declaration
(CD) is required for materials and articles for which specic regulation exists, such as those exclusively consisting of plastic, but not,
e.g., for multimaterials, paper and board, silicones and elastomers.
Article 16 also requires appropriate documentation. . . to demonstrate such compliance (supporting documentation, SD). It shall
be made available to the competent authorities on demand, which
implies that legislation does not require supporting documentation
to be disclosed to other business operators in the chain. So,
although the food producer is responsible for the safety and wholesomeness of the food, he may not see the information that supports
his position. Article 17 requires traceability by the principle that
each business operator documents his direct suppliers and
customers.
2.3. GMP Regulation
The Regulation 2023/2006 (GMP regulation) species GMP as
the process to ensure compliance with Article 3 of the Framework
Regulation. It has a general section and an Annex specically referring to printing inks and set-off from the non-food contact to the
food contact side. The key points relevant to this paper are:
1. The regulation applies to all FCMs.
2. It applies to all sectors and to all stages of manufacture, processing and distribution of materials and articles, up to but
excluding the production of starting substances.
3. Specically it requires that the business operator engages personnel with the knowledge and skills required to perform
compliance work (Article 5.1a).
4. The starting materials shall be selected and comply with preestablished specications that shall ensure compliance of the
material or article with the rules applicable to it (Article 5.2).
This means that the substances must comply with lists, or
safety must be demonstrated otherwise. The specications
include the control of the impurities.
5. The quality control system shall include monitoring of the
implementation and. . . identify measures to correct any failure. . ., i.e. the control of compliance, such as the quality of
the substances used, is a continuous process (Article 6).
6. Article 7 calls for documentation with respect to specications,
manufacturing formulae and processing which are relevant to
compliance and safety of the nished material or article.
7. The documentation shall be made available. . . to the competent authorities at their request.
Article 7 does not deal with documentation accompanying
products, but if GMP has to ensure compliance with the rules over
the whole of the manufacturing process, it follows that communication is required to support the compliance work of the nal
material or article. Formally the documentation for GMP is not
linked with the CD and SD required by the Framework Regulation,

but since the purpose of GMP is to ensure compliance, they pursue

the same goal.
2.4. Plastic Directive
The Plastic Directive 2002/72 covers plastics as dened by
polymerization, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by
chemical alteration of natural macromolecules, but excludes
regenerated cellulose, elastomers, paper and board, coatings
including parafn waxes, ion exchangers and silicones from the
scope (Article 1). Also FCM with layers not consisting of plastics
are excluded. When applied to plastics, surface coatings, adhesives
and printing inks are included, even though they are excluded from
the positive lists of substances, which means that CDs and SDs are
required, the OML must be respected, but substances other than
those listed can be used.
The 4th amendment, Directive 2007/19, expands on the concept
of the compliance documentation. It species that at the marketing stages other than the retail stage, materials and articles as well
as the substances intended for the manufacturing of these materials and articles, shall be accompanied by a written declaration, i.e.
that the whole manufacturing process carries responsibility for
compliance. This is analogous to the GMP Regulation, but with
the difference that the starting substances are included. The SD
contains proprietary information to be made available to the competent authorities on request.
Annex VII species the content of the CD. In point (4), the conrmation is required that the materials or articles meet the relevant requirements laid down in this Directive, such as
compliance with the substance lists and restrictions, and the general requirements of the Framework Regulation 1935/2004, which
includes compliance of not specically regulated substances with
Article 3. Point (5) refers to stages not yet issuing the nal compliance declaration: the downstream business operators must be informed about substances for which compliance with restrictions
must be ensured (delegated compliance work). Point (6) requires
migration data and possibly other information being disclosed
about substances which are also subject to a restriction in food,
e.g. those which may also be used as food additives (dual use substances). This is primarily to rule out failing compliance owing to
accumulated presence from more than one source. Point (7) calls
for specications on the intended use of the product, such as the
materials or articles for which a substance or intermediate product
is adequate, type(s) of food the material or article may be suitable
for, restrictions on time and temperature of treatment and storage
in contact with the food, or packaging size (like ratio of food contact surface area to volume) and thus specications and restrictions within which compliance can be assured. Finally, point (8),
when a functional barrier is applied in order to use non-regulated
substances, the functional barrier must be declared. It must be conrmed that these substances do not belong to those classied as
carcinogenic, mutagenic or toxic to reproduction (CMR) by
Council Directive 67/548/EEC or under the self-responsibility criteria according to the rules of Directive 67/548/EEC (they must not
be known to be CMR and they must be tested if there is some suspect). Migration must be below the detection limit of 0.01 mg/kg.
The Directive is less clear on what needs to be done on points for
which compliance cannot (yet) be declared, as they often occur at
early production stages. Point (3), the conrmation that the plastic
materials or articles meet relevant requirements laid down in this
Directive and Regulation (EC) No. 1935/2004 cannot always fullled. It should be interpreted as referring to the nal product for
which a concluding compliance declaration is required. At earlier
stages there must be a way to avoid assuming responsibility, which
is by delegation, as mentioned for migration in point (5).

K. Grob et al. / Food Control 20 (2009) 476482

3. Compliance work through the manufacturing chain

With the tools of CDs and GMP, legislation engages each manufacturer in the chain in contributing his part to the nal compliance (Fig. 2). Each manufacturer must see his product as a
component in the context of the nal FCM and be aware of the aspects relevant for compliance at his as well as the subsequent
steps.
Either a producer can state compliance in a given aspect or he
must delegate this to the following stages, specifying the work to
be done, such as the substances for which migration must be controlled, possibly with an indication of the content to enable calculation/modeling of the migration from the nal material. His
considerations must be documented, rendering the process transparent for enforcement authorities.
3.1. Compliance of the substances used
For each substance introduced into the production process,
including, e.g., solvents, catalysts, chain stoppers for polymerization and production aids, the manufacturer must show compliance.
If there is an EU positive list for the given category (monomers,
soon also additives for plastics), the substance must be from this
list. In the absence of a positive list, the manufacturer is freer to select substances, but it is his responsibility to show their compliance. The simplest case is a fully evaluated substance in a list of
FCM legislation or a substance with an opinion from the European
Food Safety Authority (EFSA). Authorization by national authorities
has the same level of unambiguousness in the given country, but
the recognition in other countries depends on the quality of the
evaluation behind it. Presence in an inventory list is of no signicance, if this listing is not based on an appropriate safety
evaluation.
For substances applied behind a functional barrier, no authorization is required if they are not CMR and migration is below the
European detection limit of 0.01 mg/kg (Directive 2007/19).
CMR components cannot be used without petitioning, even if
migration is very low. There is no such threshold for negligible
migration of substances used in the food contact layer, but there
might be little resistance if the same rule is applied.
Compliance with Article 3 of a substance which is not authorized in Europe and which does not belong to a category covered
by a positive list presupposes a safety evaluation satisfying at the
likely level of exposure of the consumer. Within the present system of calculating SMLs, migration of a substance is considered

Substance

Substance

+ impurities

+ impurities

Polymer

Substance

Substance

+ impurities
+ reaction products

+ impurities

+ impurities

Polymer

Coated metal

+ impurities
+ reaction products

+ impurities
+ reaction products

Final
Final FCM
FCM
Packed
Packedfood
food
Fig. 2. Substances (and their precursors) as well as prefabricates merging to the
nal FCM, each box being a manufacturer.

479

safe when a limit of safety is not exceeded for a consumption of

1 kg/d food containing the given substance or the food in contact
with 6 dm2/d of the FCM. Worst case conditions and consumption
in a single day are assumed. In the absence of a tolerable daily intake (TDI), the migration must remain below the concentration up
to which the toxicity evaluation has shown safety. The Note for
Guidance of the EFSA (2006) provides the core sets of toxicological
data requirements for ranges of migration up to 0.05 mg/kg to
ranges up to 5 and above 5 mg/kg (again with the option of recalculation into mg/dm2 contact surface area, dividing by 6 dm2/kg).
For instance, for a substance migrating into food at concentrations
up to 0.05 mg/kg, three in vitro mutagenicity tests must be
negative.
Although not being legal text, it is widely assumed that for compliance of not specically regulated substances with Article 3 of the
Framework Regulation less stringent assumptions are accepted,
such as a more tightly calculated exposure (lower consumption
per day). Then migration may drop into a class requiring a smaller
core set of toxicity data. Still all uses of a substance must be considered for exposure assessment, but some basic rules await being
established, such as whether all other producers of the given type
of FCM should be assumed to also use the substance. The detection
limit of 0.01 mg/kg remains dened for a particular food, i.e. cannot be increased by an exposure scenario.
3.2. Compliance with restrictions
The manufacturer introducing a substance with an SML or another specic restriction carries part of the responsibility in making sure that this restriction will be respected in the nal FCM.
Sometimes the amount added is so small that even total transfer
into food would not exceed the SML, i.e. compliance can be stated.
More commonly, however, migration must be determined analytically or calculated by modeling for the nal FCM. Then the manufacturer introducing the substance must delegate this work,
possibly across several stages.
Commonly FCMs are tested by simulation, using simulants AD
and conditions established by legislation. However, the Framework
Regulation 1935/2004 refers SMLs and the OML to food, and since
simulation sometimes seriously underestimates migration into
food (e.g. for gaskets in lids, Biedermann, Fiselier, & Grob, 2008),
limits respected in simulation do not always guarantee compliance. For this reason it may be important to inform the food producer about the way compliance was established.
Compliance work must be delegated if compliance is not declared and if there is a possibility of accumulating migration from
various sources. A substance must also be mentioned if it is a food
additive with a restriction in food (and the amount migrating may
cause the limit for the food additive to be exceeded) and to enable
the food producer to make sure that it has no technical effect in
the food at its level of migration (even if migration respects the
SML).
3.3. Impurities
The manufacturer introducing an impurity (an unintentionally
added substance, e.g. accompanying a substance used) has to verify
compliance or delegate this to a later stage. As the intentionally
used substances, impurities must be controlled to a concentration
low enough to ensure safety. This presupposes a threshold of analysis, but there is no such value specied by law. It may be plausible
that the migration into food should remain below the detection
limit (0.01 mg/kg, provided they are not CMR) or below the threshold of toxicological concern.
At stages other than the nal product, a producer has at least
three possibilities to meet the demands. He can identify all impu-

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K. Grob et al. / Food Control 20 (2009) 476482

rities and verify their compliance in his supporting documentation.

As he probably does not know migration into food, this must be
based on some estimates or modeling. To rule out being involved
in an issue in case migration is higher than he assumed, he may
state in his CD up to which detection limit he analyzed the
impurities.
The producer applying the second option does not want to conclude on the safety of at least some substances (perhaps since there
are no unambiguous criteria) and lists these in the documentation
accompanying his product, possibly with arguments as to why he
believes that they do comply. Information about the approximate
concentration in the substance or intermediate product may help
the evaluation.
A producer may even decide not to care about the impurities at
all (e.g. because he is not really interested in selling to this business
sector) and to completely delegate control by stating that he did
not determine the impurities. It is up to the customer whether
he wants to buy the product under such conditions and do the
compliance work by himself or delegate it even further.
It is often argued that the impurities were toxicologically tested
together with the substance they accompany. This presupposes,
rstly, that the impurities and their concentrations really correspond to those in the substance tested, i.e. that they are known
down to the critical level for the substance toxicologically tested
as well as that which is now used. It may be acceptable to demonstrate that the substances were produced from the same starting
substances containing the same impurities at the same level and
by the same procedure/purication. Secondly, the impurities of
concern must migrate into the food at no more than the same proportion as the substance they accompany. This is, for instance, seldom the case for impurities accompanying a reactive substance,
such as a monomer, since the substance will largely be removed
whereas the impurities tend to be enriched. Hence the argument
that impurities are covered by the toxicological evaluation can
only be used when suitably substantiated.
Since most impurities are not listed as authorized substances, in
most cases toxicological facts are needed for the maximum exposure the migration might cause.
3.4. Reaction products
As with the impurities, the reaction products are usually not
specically regulated, but must comply with Article 3. The simplest
reaction products are the oligomers and cyclic compounds of low
molecular weight migrating from a polymer. The EU-Practical
Guide (SANCO, 2003) instructs that oligomers often have the
same structural elements and functional groups as the toxicologically investigated monomers and, therefore, the toxicological prole is assumed to be the same. It seems to be a logical
consequence that oligomers with a molecular mass sufciently
low to be resorbed (below 1000 Da) should then be included in
the SML or a QM/QMA of the monomer. On the one hand, there
are less of the alert functions per molecular mass as this mass increases and resorption tends to decrease. On the other hand,
migration may be far higher than that of the monomer. This requires clarication, since presently it is common practice to consider oligomers as covered by the authorization of the
monomer and the SML of the latter. Furthermore, as mentioned
in the introduction, there are also oligomers having toxicological
proles fundamentally different from those of the monomers.
A second category consists of products formed by reaction between different types of components. Such reaction may be intended, such as the curing of thermosetting polymers, the
conversion of antioxidants or the reaction of an HCl scavenger in
PVC with HCl formed during curing. Other reactions are unintended, but predictable when the composition of a material is

known, such as the thermal degradation during a curing process.

Again other transformations can only be detected by migrate analysis. The EU Commission asked for the toxicological evaluation of
the reaction products of bisphenol A diglycidyl ether (BADGE)
and epoxidized soy bean oil (ESBO) with HCl (Directive 1895/
2005; EFSA, 2004), but most reaction products have not been ofcially investigated.
A third and most difcult case concerns the migrates from FCM
manufactured from resins, such as coatings, adhesives and inks. Already the resins are complex mixtures, and curing of resins by
reaction with other resins adds to the complexity. The Practical
Guide considers the substances used to prepare the resins as starting substances, but this is of little help to show compliance of the
migrates, as they typically consist almost exclusively of reaction
products. Point 3.4 of the Framework Resolution ResAP(2004)1
for coatings of the Council of Europe requires the safety of the migrate components be assured (by a wording essentially reecting
Article 3 of the Framework Regulation). In their Code of Practice
for Coated Articles (CEPE, 2007), industry would like to return to
the former position, focusing on the starting substances; compliance of reaction products with Article 3 is just shortly mentioned
in an annex.
It is basic chemistry knowledge that reaction products may not
have the properties of the starting substances. As the conventions
reected by the Practical Guide cannot be relied on, manufacturers
introducing reactive substances have to take into consideration
possibilities that these substances form potentially toxic compounds at later stages of production. Unless compliance can be stated for the reaction products under all circumstances,
corresponding compliance work must be delegated to the subsequent production stages, often also because the supplier does not
know with which substances his reactive compound will contact.
3.5. Set-off and other technological effects
The GMP Regulation was drafted because of ITX from printing
inks being transferred from the outer to the inner surface by stacking or rolling the printed FCM before the lling process (set-off).
The Annex requires the processes to be performed such that the
transfer is in line with Article 3 and a permanent control be established and documented. The ink or coating manufacturer carries
his share of the responsibility to prevent such problems by providing instructions and a method of control. There are other technological effects causing substances to enter food or new
substances being formed (e.g. irradiation, light pulses). GMP must
be designed in such a way that it ensures compliance with Article 3
of the Framework Regulation in all situations.

4. Documentation
4.1. Delegation of compliance work
Documentation plays a key role in two respects. Firstly, there is
the in-house documentation (SD or GMP documentation) with data
and reasoning to support compliance statements and render compliance work traceable. It is condential, but must be made available to competent authorities on demand. Secondly, to get GMP
working over several manufacturing stages, documentation
accompanying the product is required to inform the next manufacturing stages about compliance work they need to do resulting
from the use of the supplied product or which aspects to be aware
of in processing this material (e.g. reaction products). What is not
delegated in the documentation accompanying the product is considered concluded by the supplier and no longer needs to be
investigated.

K. Grob et al. / Food Control 20 (2009) 476482

The customer buys not only the product, but also the documentation accompanying it with the delegated compliance work. Contrary to common practice, it is not the customer who has to nd
out what compliance work remains to be done related to the product he buys; the supplier has to inform the customer. If no compliance work is delegated, the customer should be condent that the
supplier assumed his responsibility and cleared the compliance
work.
For FCMs for which CDs are required, GMP documentation is
complementary in that it discloses in the form of specied delegated work the points for which compliance is not declared. The
CD covers all aspects except those delegated. The backgrounds of
GMP and CD are somewhat different, but since they serve the same
task, the documentations can be combined.
4.2. Clarication of responsibility
Documentation claries responsibilities. For specically regulated FCMs accompanied by a CD, the producer must explicitly
state compliance in all except those points for which compliance
work is delegated. Coverage of FCMs by CDs is limited, but GMP
is also required for all other FCMs and largely works in the same
way: being responsible, the producer can either conclude compliance or delegate it. He is not asked to spell out compliance, but
an aspect not mentioned in the documentation accompanying
the product automatically falls under his responsibility.
Clarication of responsibility is important in cases of liability.
Documentation must make it clear for which aspects compliance
is declared. Documents declaring compliance, but ending with a
sentence like ultimate responsibility is with the user or the producer of the nal product, are unacceptable: either compliance
is declared and ultimate responsibility taken or the compliance
work remaining to be done is specied.
4.3. Condentiality
The main obstacle against open information passing to the next
stage of manufacture is the risk that valuable trade secrets will be
leaked, which may have a severe economic impact on the supplier.
The problem tends to be worse the closer the product gets to the
nal FCM. Condentiality should be respected as far as possible,
but consumer safety and the need to assure compliance with legal
requirements prevail over condentiality.
The above interpretation of the legislation regarding disclosure
is restrictive, since the applied principal of responsibility enables
condentiality practically impedes double checks. For instance, if
producers at early stages declare compliance and do not provide
compositional information, it is virtually impossible to conrm nal compliance work by comprehensive migrate analysis, as it is
unreasonable to have to identify all the components and control
their compliance just to check if one of them escaped investigation.
The same applies to food producers and brand owners: they do not
normally have a realistic option to check completeness of the compliance work performed on the FCM they buy.

481

5.1. Procedure of the enforcement

Enforcement authorities act locally, normally addressing the food
producer if national, otherwise the importer or the distributor(s),
mostly starting out from products collected at the retail level. To access the documentation, they have to proceed stepwise backwards
through the manufacturing chain. The label of the packaged food reveals the responsible food business operator, who in turn knows his
source(s) one stage back (concept of traceability). Since the suppliers
do not have to disclose their documentation to the business chain,
they will probably prefer to send it directly to the authority.
Enforcement authorities control foods and FCMs marketed in
the area for which they are responsible, but have no power over
business operators situated outside. At this point, the Food Law
assigning the food business operator responsible for the nal product is of key importance: it renders the local food business operator
responsible for the documentation to be presented to the given
authority, no matter where the FCM is produced.
In practice, the local food business operator must start a cascade
process (Fig. 3): on request from the enforcement authority, he
asks his suppliers to send their documentation to the authority
and to ask their suppliers to do the same. The process ends at a
stage predetermined by the authority or at the individual substances used for the FCM. This may easily turn out to be a long
exercise through numerous steps and branching into the various
intermediate products. For instance, to check the documentation
of a plasticizer producer and bring it into the context of the compliance work performed by the partners in the production chain,
enforcement easily needs to pass through many stages.
5.2. Means for the enforcement authorities to leverage response
Enforcement authorities need tools to exert pressure on producers not responding within a reasonable time period or delivering
unsatisfactory compliance documentation. Article 3 of the Framework Regulation denes GMP as the tool for achieving compliance
with the basic requirements. If GMP regarding the safety aspects is
not properly performed, foods packaged in corresponding FCMs
must be deemed unsafe and their sale stopped until the complete
documentation is available.
This is a tough procedure, as it leaves trade and distributors in a
difcult situation: they depend on the prompt delivery of adequate
documentation by the supply chain, but have no control over it.
However, it was the packaging manufacturers associations who insisted on condentiality and wanted the SDs to be solely controlled
by the authorities and these have no other means to accomplish
the job they were given.
5.3. Demanding task for authorities
The GMP and CD/SD system for the production of FCMs confronts enforcement authorities with a demanding task. These

5. Verication of GMP: role of enforcement authorities

Enforcement authorities play an important role in this compliance process: since legislation allows access to the formulations
and the safety evaluation behind the compliance statements only
to authorities, control within the business chain is ineffective.
The business chain has to rely on enforcement. Even worse: as
the work of the enforcement authorities is mostly condential,
food business operators are left in the dark about the results and
may not be informed about non-compliant suppliers.

Fig. 3. Cascade process for the control of documentation by enforcement

authorities.

482

K. Grob et al. / Food Control 20 (2009) 476482

should build up competence in the chemistry and technology of

the broad range of FCMs, the man-power to collect and study documentation from tens of thousands of products, develop methods
for analyzing thousands of substances and evaluate the arguments
used to verify compliance of migrate components. Furthermore, resources will be needed to take measures if results are not
satisfactory.
In many parts of Europe, enforcement in the sector of FCM is
weak or almost non-existent; in other countries the capacity of
the enforcement authorities is in a process of being strongly reduced. The few selective campaigns that can be performed with
the present resources are far from what is needed to build up condence in the system. International cooperation and sharing the
work may liberate some additional capacity, but it is obvious that
present enforcement authorities are not ready to fulll the role required by legislation.
6. Conclusion
GMP is a promising tool to control compliance of FCMs. It engages all manufacturers in the process and compels them to take
a clear position, either stating compliance or delegating issues for
which they are unable to take responsibility. This by itself might
result in improvements of FCMs, since producers are likely to
avoid substances and materials which necessitate the delegation
of difcult compliance work. It might also promote regulation,
as specic regulation of substances and clear rules facilitate compliance work.
GMP is exible as to who in the chain of manufacturers performs what compliance work, but transparency is required. It
leaves the market to nd the best procedures. A producer within
the FCM manufacturing chain may do little, provided he declares
this and hands over to his customers the information required
for having this work performed at a later stage. It might, in fact,
be efcient to do most of the compliance work in one step (e.g.
by a specialist institute). It depends on the customer whether he
wants to accept such a heavy burden of compliance work. It may
also be a market opportunity to supply a substance or material
with largely completed compliance work.
The above description also reveals weaknesses and gaps. The
main problem probably concerns verication of the compliance
work: the present rules are shaped by a maximum of condentiality conceded to the producers of the FCMs. It places the burden of
control largely onto enforcement authorities, but these would have
to massively increase their capacities to create condence in the
system. Such expansion of authorities is difcult, especially at a
time when self-control by industry and a reduction of the role of
authorities is en vogue.
For the same reason, the brand owners are left in an unsatisfactory position. Ethical food business operators have earned the trust
of their consumers and need to maintain this trust by guaranteeing
the safety of their products. This is severely hindered if there is not
openness in the food safety history of the packaging materials
available for use.
It is entirely reasonable for a consumer to expect that the food
producer underwrites the safety of the entire food package, and the
regulations should be written entitling the latter to have all information necessary. The food business operators get into media
headlines if a problem is detected, even if the source is a FCM over

which they do not have direct control. Enforcement authorities

also act on the food business operators in the rst instance.
Provided the manufacturing of the FCM is by an independent
producer, the law does not require more than that the food business operator asks for a CD if this is requested or the identication
of the material or article as a FCM, which automatically means that
it has to respect GMP. The food manufacturer does not have the
statutory power to interrogate the CD, but satisfying food law does
require due diligence on behalf of the food producer. There is a
serious conict between what is required of the food producer
and what he is legally entitled to see.
The packaging producer cannot effectively take over nancial
responsibility. In the case of a serious crisis, the damage will be
large and a supplier of a raw material making a small contribution
to the FCM will be incapable of underwriting the loss. For an owner
of a valuable brand, the guarantee of a small producer of a raw
material will be worthless. This situation may well apply to large
suppliers as well.
Acknowledgement
We thank Anna Gergely, Mayer Brown International LLP, Brussels for helpful comments.
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