COSMETICS EUROPE

ADVISORY DOCUMENT

INFORMATION EXCHANGE ON
COSMETIC PACKAGING MATERIALS
ALONG THE VALUE CHAIN IN THE
CONTEXT OF THE EU COSMETICS
REGULATION EC 1223/2009

13 June 2019
Aim and Scope of this document:

This document identifies a set of useful information from packaging/material suppliers that
supports the assessment of the impact of the packaging on the safety of the cosmetic product
contained therein.

There is no legal obligation that this information has to be collected by a cosmetic manufacturer
by using this document. It is possible to apply other approaches, provided that they result in
necessary, relevant information being available to the cosmetic product safety assessor.

The document concerns the exchange of information. It does not provide safety assessment
methodologies for integrating such information into the cosmetic product safety assessment. This
remains fully in the role of the cosmetic product safety assessor.

At the time of publication (June 2019), the principles described in this document have been
thoroughly tested in a number of pilot studies, involving actors from all steps in the packaging /
material supply chain. However, given the complexity and diversity of the supply chain, the
approach cannot (yet) be considered as widespread industry practice. Implementation
throughout the supply chain will take place over time and the document itself will evolve with the
practical experience gained.

1
Table of contents

Introduction 3
Regulatory context
Background and challenges regarding
cosmetic packaging
General approach
Methodology

Chapter A – Stating compliance with food contact legislation/ standards 9

Assessing Migration

Chapter B - If food contact compliance cannot be stated 11

Chapter C - Addressing substances of concern to cosmetic safety assessors 12

ANNEX 1 : Methodology : Decision Tree 15

ANNEX 2 : Useful EU and non-EU reference documents 16
ANNEX 3 : TTC concept and Cramer Classification 19
ANNEX 4 : Glossary / Definitions 21
ANNEX 5 : Template of Packaging Supplier Statement 23
ANNEX 6 : Application of food contact material compliance information 27
to cosmetics packaging
APPENDIX 1 Guidance List of Disclosable Substances 30

2
Introduction

Regulatory context

In accordance with the EU Cosmetics Regulation (EC) No. 1223/2009, a cosmetic product made
available on the market must be safe for human health when used under normal or reasonably
foreseeable conditions of use. In order to meet this requirement, the person responsible for
placing the product on the market must carry out a safety assessment, based on the intended
use of the cosmetic product and the anticipated exposure to the individual ingredients:
Article 10 : In order to demonstrate that a cosmetic product complies with Article 3 (safety
requirement), the responsible person shall, prior to placing a cosmetic product on the market,
ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant
information and that a cosmetic product safety report is set up in accordance with Annex I. …

Annex I of the Cosmetics Regulation describes the information that needs to be considered FOR
the Cosmetic Product Safety Report. Section 4 provides details with regard to impurities, traces,
and information about the packaging material :
• The purity of the substances and mixtures
• In the case of traces of prohibited substances, evidence for their technical unavoidability.
• The relevant characteristics of packaging material, in particular purity and stability.

Commission Implementing Decision 2013/674/EU establishes guidelines on the practical

application of the above requirements and, in its Annex provides further guidance with regard to
the information about the packaging material and the potential release of substances from the
packaging:
Section 3.4 Packaging material means the container (or primary packaging) that is in direct
contact with the formulation. The relevant characteristics of packaging materials in direct contact
with the final product are important for the safety of the cosmetic product. Reference to
Regulation (EC) No 1935/2004 of the European Parliament and of the Council could be useful.
Experience with similar formulation/packaging combinations already on the market provides
useful indications. Materials that have been developed for food packaging have often already been
tested, so relevant information on stability and migration may be available. Additional testing may
not be required. However, more evaluation may be needed for new or novel packaging.
The combination of packaging material, formulation of the cosmetic product and contact with the
external environment may have an impact on the safety of the finished product, due to the
following factors:
(a) interaction between the product and the packaging material;
(b) barrier properties of the packaging material;
(c) substance migration from/to the packaging material.
The information on relevant characteristics of the packaging materials in direct contact with the
product should allow an estimation of potential risks. Relevant characteristics could include, for
example, the following:
(a) composition of the packaging material, including technical substances such as
additives;
(b) technically unavoidable impurities;
(c) possible migration from the packaging.

3
 This information only indicates the hazard. It is up to the safety assessor to evaluate the risk.
Studies on interactions/suitability between formulation and packaging allow testing of the
potential migration of small amounts of substances from the primary packaging material to the
product. These tests are performed under specific and relevant test conditions. There are, however,
no standard procedures for cosmetic products. An appropriate assessment may be made based on
knowledge of the formulation and primary packaging materials and experienced expert judgment.
If migration is dependent on storage conditions, the correct conditions should be indicated on the
product labelling. If the formulation is sensitive to light or air, and would degrade in a way that
impacts product safety or product efficacy, appropriate packaging should be used.

Consequently, documentation provided by the packaging supplier is an important building block

for the legally required safety assessment of the final cosmetic product by the responsible
person’s safety assessor. In the absence of detailed regulatory requirements on the information
exchange along the value chain, a number of industry associations, representing the value chain
of cosmetic packaging 1, worked out a common understanding of the relevant and appropriate
information on packaging materials to be provided to the cosmetic product safety assessor.

The scope of the resulting document extends to the following types of materials used in the
manufacturing of cosmetic packaging: plastics, adhesives, metals, alloys, paper, board, printing
inks, varnishes, rubber, silicones, glass and ceramics.

The document aims at identifying which information regarding the packaging is relevant for
conducting the safety assessment of the cosmetic product, where the main concern is the
possible migration of substances from the packaging into the cosmetics formulation. It presents
a common sense, harmonised approach for the exchange of information within the value chain.
This information supports a safety assessor deliberation and conclusion if a packaging material /
item has an impact on the safety of the cosmetic formulation. However, the document does not
provide detailed methodology on how to integrate this information into the cosmetic product
safety assessment.

The document does also not deal with technical performance, quality / stability issues arising
from the use of a specific packaging for a specific cosmetic formulation. It is obviously vital in
the product development process to assess compatibility between the formulation and the
packaging, but this is not primarily a consumer safety issue and hence not dealt with in this
paper.

1
FLEXIBLE PACKAGING EUROPE, FEBEA, COSMETICSEUROPE, ELIPSO, IKW, EUROPEAN TUBE
MANUFACTURERS ASSOCIATION, EUROPEAN METAL PACKAGING, EUROPEAN COUNCIL OF PAINT
PRINTING INK AND ARTIST COLOURS INDUSTRY, INDUSTRIEVEREINIGUNG
KUNSTSTOFFVERPACKUNGEN, UNIONPLAST – FEDERAZIONE GOMMA PLASTICA, COSMETICA
ITALIA, EUROPEAN PLASTICS CONVERTERS, PLASTICS EUROPE, CEFIC FCA

4
Background and challenges regarding cosmetic products packaging

The development of a packaging for a cosmetics product needs to take account of a number of
factors. It should meet:

a) The required technical performance of the pack, e.g. product protection, compatibility
with product, filling line performance.
b) The requirements of the Cosmetics Regulation for safety assessment (i.e. the packaging
must not negatively impact the safety of the cosmetic formulation)
c) Requirements regarding REACH, the Packaging and Packaging Waste Directive 94/62/EC
and other legislation

Regarding a potential impact of the packaging on the safety of the cosmetic product, the main
concern lies with the potential migration of substances from the packaging into the cosmetic
formulation. Depending on the material combination used, such migration may be unavoidable
– and indeed, the Cosmetics Regulation acknowledges in Article 17 that: “The non-intended
presence of a small quantity of a prohibited substance, stemming from … migration from
packaging, which is technically unavoidable in good manufacturing practice, shall be permitted
provided that such presence is in conformity with Article 3” (i.e. the requirement for products to
be safe). It is therefore important that the cosmetic product safety assessor receives relevant
information on the composition and migration behavior of the packaging material in order to be
aware if any significant migration occurs and assess whether it would impact the cosmetic
formulation safety.

Packaging materials are not simple chemical substances or mixtures. The packaging of a
cosmetics product may consist of a number of different components, some in direct contact with
the cosmetic formulation, others not (or only for a brief time during use). Each component in
itself may be made from a number of different raw materials. These raw materials may
themselves have multi stage supply chains.

While the broad chemical nature of these components may be known, the details of the
individual chemical substances and additives that are used to make them are often trade secrets.
Hence an apparently straightforward enquiry of “what chemical substances does your packaging
contain?” is often difficult to answer, both due to the complexity of the supply chain and due to
justified concerns of suppliers over sharing business-sensitive information. A full breakdown of
compositional detail would create a disproportionate administrative burden along the supply
chain without being necessary for an adequate safety assessment by the cosmetic product safety
assessor. There is therefore a need for a pragmatic approach that meets the need of the cosmetic
responsible person and his safety assessor for accurate relevant information, while avoiding a
flood of unnecessary detail on the composition of every packaging component.

The following approach was developed, which aims to provide the necessary level of information,
while preserving the know-how of every supply chain member. It builds on the fact that a well-
established process exists for providing information along the supply chain of food packaging
materials.

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General approach for the information exchange

The EU Framework Regulation for food contact materials (Regulation (EC) No 1935/2004) sets
out the general principles of safety and inertness for all Food Contact Materials. It requires in
particular that materials are manufactured according to Good Manufacturing Practices and do
not release their constituents into food at levels harmful to human health and provides rules for
compliance documentation and traceability. Moreover, additional EU as well as national
measures exist for specific types of materials (e.g. plastics, ceramics, metals/alloys, etc.). Note
that other regions in the world have similar requirements/approaches to food packaging safety
(see Annex 2).

For the following reasons, the information generated under food packaging legislation can in
principle also be used for the safety assessment of packaging used for cosmetic products (see
Chapter A and Annex 6 for more details) :
• Physico-chemical similarities between many cosmetic formulations and typical food
materials
• Manufacturing standards based on Good Manufacturing Practices
• Safety assessment of the food packaging based on its composition and potential
migration of substances into the food
• Similar worst-case ratio of packaging surface to packaging content between food and
cosmetics

Thus, it is possible in many instances that documented compliance with food packaging
legislation becomes the main information to the cosmetics product safety assessor. Additionally,
some limited information on the presence of specific substances of concern under the Cosmetics
Regulation remains necessary. However, a complete composition breakdown of all packaging
constituents would not be required,

In the case where a packaging material complies with food packaging legislation of a non-EU
country, it is still possible to apply a similar approach to the one developed here. It may be
necessary, however, that the supplier provides the cosmetics product safety assessor with
information on the specific requirements and standards that these third country food regulations
prescribe.

The present approach can also be applied in case of partial non-compliance with the food
packaging legislation or incomplete information on the compliance of the packaging with food
packaging legislation. In this case, the guidance can be applied as such for those materials of the
packaging that are compliant, and additional information would be required on those
materials/substances that create the non-compliance or uncertainty (see Chapter B).

It has to be emphasised that this document does not aim to set a requirement or
recommendation that cosmetics packaging must be compliant with EU food contact legislation.
Obviously, any packaging material / item that does not impact the safety of the cosmetics
formulation is acceptable. However, the logic of the present approach may be difficult to
apply/not applicable and the supplier needs to discuss on a case-by-case basis with the cosmetic
company to identify the necessary information that the latter needs for their safety assessment.

6
Methodology

The following methodology for information exchange can be applied throughout the supply
chain, regardless of whether it concerns supply of a packaging raw material, bulk material, or a
packaging component 2 or packaging item.

Firstly, all specific items or materials (depending on what is supplied) should be described with
their general chemical composition.

Note that the safety assessment of a cosmetic product must ultimately consider the potential
impact arising from the transfer of substances from the packaging into the cosmetic formulation.
Therefore it is usually only necessary to provide information to the cosmetic safety assessor on
those components / materials used for the primary packaging (since the secondary packaging is
typically not in contact with the cosmetic formulation). However, if the primary packaging does
not provide a functional barrier, one should also consider the potential for transfer of substances
from the secondary packaging into the cosmetic formulation, whether by migration or by vapour
phase transfer.

Compliance with the requirements of the EU Chemicals Legislation and packaging/packaging

waste legislation is mandatory, including certain information that the suppliers need to provide
to downstream users. It is useful to include also the following relevant regulatory information for
each material or component 3:

REACH : It is mandatory to declare the presence of Candidate list Substances of Very High
Concern (http://echa.europa.eu/web/guest/candidate-list-table ) when present in a
component at a quantity at or above 0.1% w/w (i.e. ≥ 1000 mg/kg) and to provide the
identity of such substances. (It is also useful to declare if such substances are not present).
Heavy Metals : It is often required to confirm that the product is in compliance with the
limit of 100 ppm laid down in Packaging Waste Directive 94/62/EC for the sum of
concentration levels of lead, cadmium, mercury and hexavalent chromium.

Secondly, all those components / materials which are potentially capable of transferring
chemical substances to the cosmetics formulation should be identified.

Thirdly, having thus identified those packaging components / materials which can have a
potential impact on the safety of the cosmetics product, adequate information needs to be
communicated about them to allow the cosmetic product safety assessor to evaluate their
impact (if any) on the safety of the cosmetic formulation. The following chapters describe the
actions recommended in this approach (see also the flowchart in Annex 1):

2Component: A part of the packaging system which can exist as a separate entity, either being assembled by the
packaging supplier or being incorporated into the final pack by the packer

3
Different component parts of the packaging are considered separately, in line with the CJEU position (Case C-
106/14).

7
 Chapter A. If possible, the supplier declares and documents compliance with food
contact legislation/ standards.

Chapter B. Where food contact compliance cannot be claimed, the supplier provides
relevant information for the safety evaluation of the packaging by other
means.

In either case :

Chapter C. The supplier addresses substances that are of specific concern under to the
cosmetic product safety assessor (i.e. banned or restricted under the
Cosmetic Regulation Annex II, Annex III and CMR substances as well as
substances classified as skin sensitisers).

Annex 5 provides an example for reporting of the relevant information by the final packaging
supplier to the cosmetic responsible person.

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Chapter A – Stating compliance with food contact legislation/
standards
The Food Contact supply chain has developed a practical approach based on existing legislation
which can be adapted for Cosmetics. The principle has been adopted that, in the majority of
cases, if the packaging is safe for a specific type of food, it should also be suitable for cosmetics
that have similar physical chemical properties as this food (see Annex 6 for more details).

For each component where this is possible, the supplier should therefore state and document
• compliance with the general requirements of EU Framework Regulation (EC) No
1935/2004 on food contact materials
• compliance with the Good Manufacturing Practices (GMP Regulation (EC) N°2023/2006)
• compliance with requirements of EU or national legislation that are applicable for the
specific type of food material (see below)
• the types of food (food simulants) for which this statement of compliance is valid. This
allows the cosmetic product safety assessor to determine whether the information on
food packaging safety is relevant for his specific cosmetic formulation.

Compliance with the requirements of Regulation 1935/2004 Article 3 for a specific material type
is usually documented by demonstration of compliance with specific European legislation, with
appropriate National legislation, with Council of Europe Resolutions, European standards or with
codes of practice, e.g. developed by Trade Associations. Such rules often feature:

• A general requirement that substances used in the manufacture of materials and articles
“shall be of a technical quality and purity suitable for the intended and foreseeable use of
the materials or articles”,
• Positive lists of substances that may be used to make the material,
• Limits for the use levels of a substance in a material or, more often, specific migration
limits with regard to the transfer into the food which are based on a risk assessment of
the substance carried out by EFSA or other official body,
• A risk assessment of unlisted or non-intentionally added substances (worst case risk
assessment).

A list of the main relevant legislative and other references can be found in Annex 2.

Assessing Migration

An important mechanism to ensure the safety of food contact materials is the use of migration
limits. These limits specify the maximum amount of a substance allowed to migrate to food.
An Overall Migration Limit (OML) is a limit for the migration into food of all substances together.
It is a measure for the inertness of the material.
'Specific Migration Limits' (SML) can be set in EU or national regulation on the basis of toxicity
data for specific substances

9
For plastic food contact materials the rules for migration testing are clearly stipulated in the
Commission Regulation EU 10/2011. (e.g. the OML is set at 60mg/kg food, or 10 mg/dm2 of the
contact material). For many other materials like paper & board, metals, rubbers or migration of
printing inks through substrates, the rules for migration testing have been established in national
regulations or in industry guidelines.
Migration results to demonstrate compliance with these limits can be obtained in food itself, or
in food simulants, or can originate from migration modelling or worst case assumptions (i.e.
assuming that 100% of the substance would migrate into the food).
Migration can also be estimated based on worst-case assumptions or conservative modelling.
More detailed assessments and/or tests are only necessary when these assumptions proof to be
overly conservative. If compliance has been based on modelling or worst case calculation, there
is no need to further evaluate migration through testing.
If compliance has been based on migration into food / food simulants, the cosmetics assessor
needs to decide whether the food/simulants and test conditions / assumptions are applicable to
the cosmetics formulation. Regulation (EU) No 10/2011 on plastic materials and articles defines
5 food simulants representing the main food characteristics that are influencing migration (see
Annex 6 for more information). Regarding food groups not specifically assigned to a food
simulant, the Regulation encourages that expert judgement be used based on the similarities
with other food groups to assign an appropriate simulant. For most cosmetic formulations, the
physical/chemical properties relevant for migration from the packaging correspond to the
properties of typical food stuff. Therefore, a similar expert judgement approach can be taken to
decide whether information based on a particular food/simulant is applicable to the cosmetic
formulation.
Note that some formulations, e.g. alkali preparations such as some hair care products, cannot be
represented by existing recognised food simulants. If suitable simulants do not exist or if
migration assessment using appropriate simulants mimicking the cosmetic product exceed OML
and/or SML values, the “safe for food, safe for cosmetics” argument cannot be used. The
packaging material must then be assessed as if it were a non-food contact compliant structure.
Information on migration that was established upstream in the supply chain can be transmitted
and does not need re-established at all steps in the supply chain of the packaging item/material.

10
Chapter B - If food contact compliance cannot be stated
A Cosmetic packaging material might not be food contact compliant because of the presence of
a substance that is not authorised for food contact materials or used outside of restrictions set
for such use. Non-compliance could also be linked to the material not having been manufactured
according to GMP Regulation (EC) N°2023/2006. Such packaging may still be perfectly safe for
use in a cosmetic application after the performance of the safety assessment. References to other
standards like e.g. pharmaceutical standards or food and feed additives might be helpful in
generating useful support information.
Firstly it is important to demonstrate that the cosmetic packaging is produced in a consistent
way. ISO 9001 or any other equivalent quality system are appropriate.
Secondly attention has to be paid to the non-authorised substance(s). It should be noted that the
presence of such substance(s) render the packaging non-compliant for food, but it does not
necessarily indicate that the packaging is less safe for cosmetics use than food law compliant
packaging. The approach under Chapter A can still be followed for all those components and
materials that are food contact compliant. However, for those materials or components that are
not compliant, the supplier should inform the cosmetics product safety assessor on the reason(s)
for non compliance :
• Presence of non-approved substance(s)
• Presence of approved substance(s) that do not respect the purity criteria of food contact
legislation
• No evaluation of migration (by testing or other means of assessment)
• Presence of substance(s) above the SML / OML
• Material/item not manufactured according to EU Good Manufacturing Practice (EC) No
2023/2006 (or an equivalent GMP)
Additional information would need to be given only on the specific substances or circumstances
that lead to the non-compliance with food contact legislation. If the non-compliance is related to
a specific substance, its identity (chemical name, CAS Number) and concentration in the
packaging material / component should be communicated. If the substance is present at in the
material/component a very low level at which it can be considered as posing no appreciable risk
to the safety, it may not be necessary to provide such information. Please see Annex 3
(“Threshold for Toxicological Concern, TTC) for guidance on relevant cut-off levels. If a TTC
approach cannot be taken, substances should be communicated if they are present above 1 ppm.

The following additional information can give further guidance to the cosmetic product safety
assessor to decide whether or not the non-compliance has an impact on the safety of the
cosmetic formulation contained in the packaging. :
 Has the substance been evaluated by official bodies in relevant regulations (cosmetic,
food additives…) and are there recognised safe levels to be considered?
 In absence of the above, what is the toxicity profile of the substance?
 If full toxicity profiles are not available, can other approaches based on read across,
QSAR (Quantitative Structural-Activity Relationship) 4 be taken into account ?

4
http://www.oecd.org/chemicalsafety/testing/oecdquantitativestructure-activityrelationshipsprojectqsars.htm

11
Chapter C - Addressing substances of concern to cosmetic safety
assessors
The information exchange approach described above addresses most of the needs of the
cosmetic product safety assessor. However, there are additional regulatory considerations
arising from the Cosmetics Regulation 1223/2009/EC with regard to the presence/ limits of
specific substances in the cosmetic formulation.

Article 14 prohibits or restricts the presence of certain substances in the cosmetic formulation.
These substances are listed in Annex II and III. Similarly, article 15 prohibits the use of substances
classified as CMR substances under Regulation 1272/2008/EC, unless they receive a specific
exemption. CMR substances are systematically listed in the corresponding Annexes of the
Cosmetics Regulation within 15 months after the entry into force of the chemical classification.
If any of these substances were present in the packaging and migrated into the formulation,
although usually at trace level, they could potentially impact compliance with the above
restrictions.

It should be noted that it is neither useful nor possible under today’s analytical technology to
certify the absolute absence of any substance. This issue is addressed in Article 17 of the
cosmetic regulation which stipulates:
The non-intended presence of a small quantity of a prohibited substance, stemming from
impurities of natural or synthetic ingredients, the manufacturing process, storage,
migration from packaging, which is technically unavoidable in good manufacturing
practice, shall be permitted provided that such presence is in conformity with Article 3. (i.e.
safety of the product)

Thus, in order to allow the responsible person of cosmetic products to cope with the
requirements of articles 14, 15 and 17, the supplier should provide information on the identity
(chemical name, CAS Number) and concentration of Annex II and III, including CMR-classified,
substances present in his packaging material / component.

Furthermore, the information generated under the approach described under Chapter A and B
is addressing systemic toxicity concerns and does not allow evaluation of local effects (skin
irritation, skin sensitisation) of substances migrating into the cosmetic formulation. Whilst skin
irritation can generally be addressed through skin compatibility evaluation of the final cosmetic
product, migration of skin sensitisers in to the formulation needs to be known to the cosmetic
product safety assessor to carry out a predictive safety assessment.

It should be noted that there are currently about 4,000 substances which may fall into the above
categories of Annex II and III (including CMR substances) or skin sensitisers (based on the publicly
available lists under Regulation 1223/2009 and Regulation 1272/2008). However, many of those
substances, such as for instance specific oil refinery streams, medicinal / toxic plants, prescription
drugs, …) have no relevance for the manufacturing of packaging materials, be it as raw materials
or as by products. Based on expert judgement and experience, such substances can be excluded
to allow suppliers of food contact grade and non-food contact grade materials to work with a
smaller list of substances to be considered.

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For food contact grade materials, it is possible to reduce further the number of substances by
cross referencing the remaining substances with inventory lists of substances that can potentially
be used in food packaging materials or are known breakdown or reaction by products.

An expert group from Cosmetics Europe and Packaging Supplier Associations has been set up to
combine its expert judgement to identify from the lists of Cosmetics Regulation Annex II, Annex
III (including CMR substances) and/or skin sensitisers those substances that would never be
expected to be present in packaging. This allowed to create a shorter list of substances of concern
that can be used as a reference for providing information to the cosmetic product safety assessor.
„Guidance List of Disclosable Substances Used in FCM”

This list is based on information which is publicly available and the opinions of experts in the
packaging and cosmetics industries. It is only a guide and it remains under the responsibility of
a supplier to disclose the presence of any substance present in food contact material which
would be of interest for the evaluation of the packaging to its clients. Anyone discovering such
a substance is invited to inform Cosmetics Europe so that it can be added to the list.

Note : The original database Excel spreadsheet on which the „Guidance List of Disclosable
Substances Used in FCM” is based can be made available to members of the supply chain,
together with a detailed explanation of how they are compiled, to allow individual refinement
of the filtering settings to their company ingredient portfolio.

Several scenarios are possible for reporting of information on specific substances along the
supply chain to allow the Cosmetics Safety Assessor to evaluate the possible impact of the
packaging on the safety of the formulation. In all cases, the basis for considering/excluding
substance from the scope of information exchange should be indicated, for instance by
reference to the „Guidance List of Disclosable Substances Used in FCM

No presence of reportable substances:

Substances specifically banned or restricted in Annex II or III of the Cosmetics Regulation

1223/2009 (including CMR substances):
The packaging supplier states that the packaging component or material does not
contain, such substances, intentionally added or known to be present at levels
above 10 ppm. Alternatively, the packaging supplier can state that the packaging
component or material does not contain, such substances, intentionally added or
known to be present, migrating in levels above 100 ppb in a relevant simulant 5.

Substances classified as Skin Sensitisers category 1, 1A or B according CLP Annex VI table

3.1:
The packaging supplier states that the packaging component or material does not
contain, intentionally added or known to be present, skin sensitisers Cat.1 or 1B
5
Compliance with migration limits can be verified either by real migration tests with food simulants, either by
extraction test with an adequate solvent, either by migration modelling experiments.
Reference: Annex I of the Plastic Regulation (EU) No 10/2011: If …the specific migration limit is non-detectable
(ND) a detection limit of 0,01 mg substance per kg food is applicable unless specified differently for an individual
substance.

13
 at levels above 0.1 %, nor does it contain skin sensitisers Cat. 1A at levels above
0.01 %.

Alternatively, the packaging supplier can state that the packaging component or
material does not contain skin sensitisers, intentionally added or known to be
present, migrating in levels above 100 ppb or 1000 ppb for sensitisers categorised
as Cat 1A or 1/1B respectively in a relevant simulant5.

Presence of reportable substances:

The packaging supplier declares the identity and concentration in the relevant component
of the packaging or packaging material of :

o Substances specifically banned or restricted in Annex II or III of the Cosmetics

Regulation 1223/2009, including CMR substances, when present at above 10 ppm
or , alternatively, when migrating in levels above 100 ppb in a relevant simulant5.

o Substances listed in classified as skin sensitisers according to CLP Regulation,

Annex VI table 3.1 Annex VI table 3.1 when present at above 0.1 % (for skin
sensitisers Cat 1B or 1) or 0.01 % (for skin sensitisers Cat 1A) or, alternatively,
when migrating in levels above 100 ppb or 1000 ppb for sensitisers categorised
as Cat 1A or 1/1B respectively in a relevant simulant5. If such substance has
already been declared because of its listing in Annex II or III of the Cosmetics
Regulation, it is not necessary to declare it again.

Note: the 10 ppm cut-off level for reporting of Annex II and III materials is chosen based on
the safety related considerations presented in chapter A, B and Annex 3 as well as a
reasonable traceability of such materials in the raw material supply chain for packaging
materials. The 0.1 % and 0.01 % cut-off levels for skin sensitisers are based on Classification
and Labelling thresholds under the CLP Regulation for sensitisers classified as category “1B or
1” and category “1A”, respectively.

For specific substances a different threshold may be determined due to specific requirements
under the Cosmetics Regulation. For example, the presence of Nitrosamines in cosmetic
products is strictly limited to 50 ppb. In a worst case, migration from packaging
materials/components containing 10 ppm of nitrosamines could lead to levels above this limit
in the cosmetic formulation. Similarly, the Cosmetics Regulation sets a limit for acrylamide
monomer in a cosmetic formulation of 100 ppb (leave-on products) and 500 ppb (rinse-off
products). Consequently, nitrosamines and acrylamide monomer should be reported to the
cosmetic company if they are known to be present in the packaging above 1 ppm.

14
ANNEX 1 - Methodology Flow-Chart

15
 ANNEX 2
Useful EU and non-EU reference documents

1. EU Food Contact References

1.1 General EU Legislation
Regulation (EC) No. 1935/2004 on materials and articles intended to come into
contact with food (Framework Regulation)
Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles
intended to come into contact with food

1.2 Plastics
1.2.1 EU Legislation
Regulation (EU) No. 10/2011 on plastic materials and articles intended to come
into contact with food (includes specific requirements for inks, adhesives,
coatings) as amended by
Regulation (EU) No. 321/2011
Regulation (EU) No. 1282/2011
Regulation (EU) No 1183/2012
.
4th Amendment, Regulation (EU) No 202/2014
5th Amendment, Regulation (EU) No 2015/174
6th Amendment, Regulation No 2016/1416
7th Amendment, Regulation (EU) No 2017/752
These seven amendments are included in a Consolidated Version of the
Regulation

When relevant: Regulation EC 282/2008 on recycled plastic materials and articles

intended to come into contact with foods
1.2.2 Guidance
Union Guidelines on Regulation (EU) No 10/2011 on plastic materials and
articles intended to come into contact with food.
EU Guidance on information in the plastics supply chain. This gives
information on the contents of the declaration of compliance.
Technical guidelines for compliance testing (not yet finalised)

1.3 EU Legislation on Other Materials

Regulation 1895/2005/EC on the restriction of use of certain epoxy derivatives in
materials and articles intended to come into contact with food
Directive 2007/42/EC on regenerated cellulose film
Directive 93/11/EEC on release of N-nitrosamines and N-nitrosatable
substances from rubber teats and soothers

1.4 National legislations (where existing and when relevant ) for materials with no
European legislation. The EU Commission publishes two overviews
EU and national laws
Summary of national legislation additional to EU legislation

16
 1.5 Council of Europe Resolutions. Note that CoE resolutions are
recommendations and are not legally binding. They either have to be adopted
into EU law or into national legislations to become legally binding.
Resolution AP (89) 1 on the use of colourants in plastic materials coming
into contact with food
Resolution AP (92) 2 on control of aids to polymerisation for plastic
materials and articles
Resolution ResAP (2004)5 on silicones used for food contact applications
Resolution AP(2002) 1 on paper and board materials and articles
intended to come into contact with foodstuffs
Framework Resolution AP(2004)1 on coatings intended to come into
contact with food (replacing Resolution AP (96) 5)
Resolution AP(2005)2 on packaging inks applied to the non-food contact
surface of food packaging materials and articles intended to come into
contact with food
Resolution CM/Res(2013)9 on metals and alloys used in food contact
materials. This is accompanied by a Technical Guide. This is not available
for free. It can be bought from https://store.edqm.eu/index.html for
€30.00.

1.6 Codes of practice issued by European Trade Associations. These can be found on
their web sites, e.g.:
CEPE, the Conseil Européen del’Industrie des Peintures, des Encres d’Imprimerie
et des Couleurs d’Art
CEPI, the Confederation of European Paper Industries
EAA, the European Aluminium Association
EuPIA, the European Printing Ink Association
FEICA, the Association of European Adhesive and Sealant Industry
FPE, Flexible Packaging Europe
PlasticsEurope, the association of plastics manufacturers

2. Other EU References

Scientific Committee on Consumer Safety (SCCS), Scientific Committee on Health and

Environmental Risks, (SCHER) Scientific Committee on Emerging and Newly Identified
Health Risks (SCENIHR) : OPINION ON Use of the Threshold of Toxicological Concern (TTC)
Approach for Human Safety Assessment of Chemical Substances with focus on Cosmetics
and Consumer Products
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_092.p
df

REACH (EU Chemicals Legislation)

European Parliament and Council Regulation (EC) No 1907/2006
Unofficial consolidation of the REACH legal text

17
 CLP Regulation: the consolidated version of the Regulation (EC) No 1272/2008 on the
classification, labelling and packaging of substances and mixtures (CLP Regulation) can be
downloaded from: http://echa.europa.eu/regulations/clp/legislation
Note that the consolidated version may not always contain the latest amendments and
technical adaptations which can also be found on this page.

Packaging Waste: Directive 94/62/EC on Packaging and Packaging Waste, as amended by

Directive 2004/12/EC

3. Non EU References

Swiss Ink Ordinance: A revised Swiss Ordinance 817.023.21 on materials and articles
intended to come into contact with foodstuffs came into force on 1st May 2017. At the
time of writing, there was no official English translation. The following languages are
available:
• French
• German
• Italian
Section 12 deals with packaging inks and there is a revised Annex 10 listing substances
that may be used in their manufacture. So far, it is only available as a .pdf file

United States Federal Food Drug and Cosmetic Act § 402(a), 409(c)

Japanese Food Sanitation Law; Ministry of Health and Welfare Notice Vol. 20 and 85

Code of practice issued by Japanese Trade Association : Voluntary Standards PL (Positive

Lists) for Food Contact Substances and Polymers, issued by Japan Hygienic Olefin and
Styrene Plastics Association (JHOSPA)

Chinese Food Contact Legislation : Introduction and overview can be found here :
http://www.cirs-
reach.com/China_Chemical_Regulation/Food_Contact_Regulations_Food_Conta
ct_Materials_in_China.html

18
 ANNEX 3
TTC concept and Cramer Classification

The “TTC” (Threshold of Toxicological Concern) is a risk assessment tool that establishes human
exposure levels for certain types of chemicals below which there is no appreciable risk to human
health. It is a useful tool for assessing trace substances of unknown toxicity, where the structure
of the compound is known, but no substance specific toxicity data or data on a similar substance
exist. The TTC approach is used by EFSA for the safety assessment of flavouring substances and
metabolites, degradation and reaction products of pesticides. Further applications are risk
assessments for cosmetic ingredients, household products and impurities in therapeutic drugs.
See SCCS opinion on TTC for application of the approach regarding cosmetics (SCCS Notes of
Guidance, 10th Revision, SCCS/1602/18).

The TTC approach is valuable if a packaging material/component is not food contact compliant
due to the presence of a specific substance, present at relatively low level.

As a first step, it should be determined if the TTC approach can be used to assess the substance
of interest (see SCCS, 2018). If TTC is not suitable to assess the safety of this trace level
substance, substance specific data should be provided.

If the TTC approach is applicable, it needs to be checked in which “Cramer Class” the substance
falls; i.e. which default TTC value applies, depending on the chemical structure of the
substance. ToxTree is a predictive software program which is freely available to download and
is required to perform the Cramer classification(ToxTree, 2009,
http://ihcp.jrc.ec.europa.eu/our_labs/eurl-ecvam/laboratories-
research/predictive_toxicology/qsar_tools/toxtree). The Cramer decision tree is used to classify
substances on the basis of their expected level of oral toxicity based on the answer to 33
questions. The trace substance is classified as either Cramer Class I, II or III. This classification is
explained on the following internet site: http://ihcp.jrc.ec.europa.eu/our_labs/eurl-
ecvam/laboratories-research/predictive_toxicology/background/TTC .

Note that the EU Scientific Advisory Bodies, including SCCS 2018 recommend that Cramer Class II
is not used in the context of substances used in cosmetics. Cramer Class II substances should be
treated like Cramer Class III.

Based on the worst-case assumption that the substance completely migrates into formulation,
the appropriate reporting threshold can be determined from the table below.

19
 Exposure Acceptable safe level (ppm) in 1kg cosmetics
µg/person/day by packaging, taking the assumption that 17,4 g
ingestion of cosmetics are packed in 10 g of packaging*
Cramer Class I 1800 180
Cramer Class II or
III 90 10

*Final judgement should always be made based on the actual ratio of cosmetic weight to
packaging weight

If present below the threshold, the packaging suppliers may still inform the cosmetic company
that a substance of “Cramer Class … “ is present in the material/component, without necessarily
disclosing its identity. Given that the application of the TTC concept requires experience and
expert judgement, further information may be required from the supplier in the course of the
safety assessment, e.g. regarding the chemical family of the substance.

The reasoning is based on the following data for a substance belonging to Cramer Class III (the
reasoning is the same for class I or II, with the appropriate figures in the table):
a) 17.4 g of cosmetics are used per person per day
b) These 17.4 g are packed in 10 g of packaging per person per day (can be adapted to
other ratio when more appropriate)
c) Cramer class III allows an exposure of 90 µg/person/day by ingestion
d) Worst case: all is migrating out of the packaging
e) 10g of packaging are containing 90 µg of substance belonging to Cramer Class III
f) 1kg of packaging contains 9000 µg of substance = 9 ppm (~10ppm)

If the ratio of packaging material to product is significantly greater than in the example (line b)
above, a separate calculation should be made.

Note that TTC is developed for certain classes of organic molecules and is not a validated
methodology for inorganic chemicals such as heavy metals. Furthermore, whilst scientific work
is ongoing on a TTC approach for skin sensitisation, this is not yet validated.

20
 ANNEX 4
Glossary / Definitions

Absolute Barrier: A materials at given thickness which excludes any permeation of potential
migrants from outside into the packed product at any foreseeable contact condition. Examples
include:
• Glass of any thickness (not: SiOx layers)
• Metal cans and lids
• Aluminium foils at thickness when pinholes or other damages can be excluded

CMR Substance: A substance listed as Carcinogenic, Mutagenic or toxic to Reproduction

Category 1A, 1B or 2 in CLP Regulation 1272/2008 Annex VI table 3.1

Container : see primary packaging

EFSA: European Food Safety Authority

Consumer Exposure: the quantity of a substance that a consumer is exposed to, by ingestion,
skin absorption, inhalation or other means. It can be further refined to refer to specific consumer
groups, e.g. children or infants, or to a statistical fraction of the consumer population, e.g. those
consumers exposed at the P95 level.

Functional Barrier: One or more layers of any material type which limits the transfer of relevant
substances into the packed product to either a) less than 10 ppb or b) below another level of
regulatory or safety concern. For example, in the context of the Plastics Regulation 10/2011,
Functional Barrier means a barrier consisting of one or more layers of any type of material which
ensures that he final material or article complies with Article 3 of Regulation(EC)No 1935/2004
and with the provisions of the regulation.

Migratable Substance: A chemical substance that is capable of transfer in detectable amounts

from the packaging to the packed product. It is generally accepted that substances with a
molecular weight greater than 1,000 Daltons are not migratable. Inert, insoluble inorganic
substances embedded in a polymeric matrix are not migratable.

Packaging component: A part of the packaging system which can exist as a separate entity, either
being assembled by the packaging supplier or being incorporated into the final pack by the packer

Packaging Material: Chemical substance or mixture of substances that is used for the
manufacturing of packaging components

Primary Packaging: Packaging that is in direct contact with the product

Safety Assessor: The qualified person who is designated by the cosmetic product’s “Responsible
Person” to carry out a safety assessment

21
Secondary Packaging: Packaging that is used to collate, protect or display the primary pack. It
does not come into direct contact with the product and may or may not be capable of transferring
substances to the product

Sensitiser: A substance classified as a skin sensitiser in CLP Regulation 1272/2008 Annex VI table
3.1 (Hazard statement code H317). See section 3.4 of Annex I for definitions, classification criteria
etc.

Simulant: A test medium used to represent a type of packed product when measuring the
migration of substances from the packaging. Food simulants are specified in Annex III of the
Plastics Regulation 10/2011.

Specific Migration Limit (SML): the maximum concentration of a substance that may transfer
from packaging into food, as defined in the Union List (Annex I) in the Plastics Regulation
10/2011.

Tertiary Packaging: Packaging that is used to collate and protect primarily for transport and
storage purposes

Worst Case Calculation: This assumes that all the migrant will transfer from the packaging
material into the packed product. To do it you need:
• Maximum concentration (MC) of substance in the material layer (in ppm)
• Maximum grammage per square metre (G) of material layer (or thickness and density) (in
g/m² )
• Maximum surface area of packaging to weight of cosmetics packed (SV) (in dm²/ kg)

The formula to calculate maximum amount of substance that could migrate into the
cosmetics is
MC x G x SV ÷ 100000 mg/kg (ppm)

22
 ANNEX 5
Example of Packaging Supplier Statement

Statements according to this example can be generated with the Excel Macro distributed together with this Guidance Document.

REGULATORY INFORMATION FILE FOR PACKAGING SUPPLIERS

TO FACILITATE COMPLIANCE WITH THE REGULATORY REQUIREMENTS
APPLICABLE TO THE EU COSMETIC PRODUCTS REGULATION
REGULATION 1223/2009 Art. 10 and Annex I)

SECTION I) DOCUMENT SCOPE

SUPPLIER NAME
PACKAGING ITEM/MATERIAL
SUPPLIER REFERENCE NUMBER
CLIENT REFERENCE NUMBER
CONFIDENTIALITY AGREEMENT
REFERENCE

23
 SECTION II) OVERVIEW OF COMPONENTS IN THE PACKAGING MATERIAL / ITEM

Heavy metals
sum of Pb, Cd, SVHC
General Hg, Cr(VI) < 100 substances Contact with
Component Chemical Material ppm (Directive (Regulation cosmetic
Nr. Name Type of material Description Reference Weight 94/62/EC) 1907/2006) formulation
identify substance
e.g. LDPE with internal
e.g. plastic, and level OR state
1 colorant and refernce yes/no yes/no
silicone, steel, ... 'No SVHC > 1000
additives number
ppm'

SECTION III) SPECIFIC INFORMATION ON COMPONENTS THAT ARE IN MIGRATEABLE CONTACT WITH THE FORMULATION

Component Name; Material Type; Company Reference

Packaging item/material compliant with the requirements of EU Food Contact Framework Regulation 1935/2004 EC, and in particular
Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food yes
Compliance is valid for the following conditions: describe conditions

24
Type of information available on migration (e.g. test
with food, test with simulant, modeling, worst case describe in general terms by which approach migration potential was assessed
asumptions, supplier information, ...)

Substances restricted under Food Contact Legislation

(Regulation 10/2011 EC )by a specific migration limit
(SML), a maximum concentration (QM) in the plastic
identify substances and their level
or a “no detectable migration” requirement at a
certain detection limit (DL) - with a residual quantity
greater or equal to 1/10 of the SML / QM

The component is / is not manufactured according to EU Good Manufacturing Practice (EC) No 2023/2006. (if not, indicate if another
GMP standard has been followed)
This component contains the
Refernce list used to identify
following substances of concern Substance name Type of concern
substances of concern
(see Note below)

Refernce list used to identify

Substance name Type of concern
substances of concern

Component Name; Material Type; Company Reference

Packaging item/material compliant with the requirements of EU Food Contact Framework Regulation 1935/2004 EC no

Reason for non compliance describe reasons for non-compliance

The component is / is not manufactured according to EU Good Manufacturing Practice (EC) No 2023/2006. (if not, indicate if another
GMP standard has been followed)
This component does not contain substances of concern (see Note below)
Component Name; Material Type; Company Reference
… etc

25
Note : Substances of concern:
(a) = classified skin sensitiser Cat1A in Regulation 1272/2008 at/above 1000 ppm, or alternatively, migrating at levels above 100 ppb in a relevant simulant
(b) = classified skin sensitiser Cat1 or 1B in Regulation 1272/2008 at/above 100 ppm, or alternatively, migrating at levels above 1000 ppb in a relevant simulant(c) = banned/restricted in
Cosmetics Regulation 1223/2009 Annex II/III at/above 10 ppm, or alternatively, migrating at levels above 1O0 ppb in a relevant simulant

SECTION IV) ADDITIONAL INFORMATION

e.g. reference to DoC

SECTION V) DATE AND SIGNATURE

DATE:
CONTACT & FUNCTION:
SIGNATURE:

26
 ANNEX 6

Application of food contact material compliance information to cosmetics

packaging
The Food Contact supply chain has developed a practical approach based on existing
legislation which can be adapted for Cosmetics. The principle has been adopted that, in the
majority of cases, if the packaging is safe for a specific type of food, it should also be suitable
for cosmetics that have similar physical chemical properties as this food. However, this
principle requires some justification and considerations.

Note that, whilst this present guidance document was developed around the EU Food Contact
Legislation, a similar approach can be taken for packaging that is compliant with equivalent,
non-EU food packaging legislation. It may be necessary, however, that the supplier provides
the cosmetics product safety assessor with information on the specific requirements and
standards that these regulations prescribe.

A short description of the approach for Food Contact Materials is given by the European
Commission
(https://ec.europa.eu/food/safety/chemical_safety/food_contact_materials/legislation_en)

The Food Contact Material Framework Regulation

Regulation (EC) No 1935/2004 provides a harmonised legal EU framework. It sets out the
general principles of safety and inertness for all Food Contact Materials (FCMs).
The principles set out in Regulation (EC) No 1935/2004 require that materials do not:

• Release their constituents into food at levels harmful to human health

• Change food composition, taste and odour in an unacceptable way

Moreover, the framework provides:

• for special rules on active and intelligent materials (they are by their design not inert)
• powers to enact additional EU measures for specific materials (e.g. for plastics)
• the procedure to perform safety assessments of substances used to manufacture FCMs
involving the European Food Safety Authority
• rules on labelling including an indication for use (e.g. as a coffee machine, a wine bottle,
or a soup spoon) or by reproducing the appropriate symbol. For more information,
please refer to the following document on Symbols for labelling food contact materials.
• for compliance documentation and traceability

27
Regulation on Good Manufacturing Practices
Regulation (EC) No 2023/2006 ensures that the manufacturing process is well controlled so
that the specifications for FCMs remain in conformity with the legislation:

• premises fit for purpose and staff awareness of critical production stages
• documented quality assurance and quality control systems maintained at the premises,
and
• selection of suitable starting materials for the manufacturing process with a view to
the safety and inertness of the final articles

Good manufacturing rules apply to all stages in the manufacturing chain of food contact
materials, although the production of starting materials is covered by other legislation.

Physical chemical characteristics of cosmetics vs food

Regulation (EU) No 10/2011 on plastic materials and articles assigns 6 different food simulants
representing the main food characteristics that are influencing migration.

A Ethanol 10 % (v/v)
B Acetic acid 3 % (w/v)
C Ethanol 20 % (v/v)
D1 Ethanol 50 % (v/v)
D2 Any vegetable oil containing less than 1 % unsaponifiable matter
E Poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm

Food simulants A, B and C are assigned for foods that have a hydrophilic character and are
able to extract hydrophilic substances. Food simulant B is used for those foods which have a
pH below 4.5. Food simulant C is used for alcoholic foods with an alcohol content of up to 20
% and those foods which contain a relevant amount of organic ingredients that render the
food more lipophilic. Food simulants D1 and D2 are assigned for foods that have a lipophilic
character and are able to extract lipophilic substances. Food simulant D1 is also used for
alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions. Food
simulant D2 is used for foods which contain free fats at the surface. Food simulant E is assigned
for testing specific migration into dry foods.

Regarding food groups not specifically assigned to a food simulant, the Regulation ecourages
that expert judgement be used based on the similarities with other food groups to assign the
appropriate simulant.

Cosmetics are usually chemically inert, water based / oil based mixtures with a pH that is
neutral or slightly acidic. For most cosmetic formulations, the physical/chemical properties
relevant for migration correspond to the properties of typical food stuff described above.
Therefore, a similar expert judgement approach can be taken to . (However, some
formulations, e.g. alkali preparations such as some hair care products, cannot be represented
by existing recognised food simulants.)

28
Comparison of consumer exposure scenario’s between food packaging and cosmetic
packaging

It is reasonable to assume that consumer exposure to the same substance from a cosmetic,
typically by absorption through the skin, is not intrinsically more hazardous than exposure
from food, typically by ingestion (except potentially for skin sensitisation, see below).

Thus, any difference in risk from food packaging vs. cosmetic packaging will arise from
differences in exposure between these uses. The calculation of exposure to substances in food
contact materials is based on the assumption of a consumer eating each day 1 kg of a food
packed in 6 dm2 of a particular material. Cosmetics packs tend to be much smaller than food
packs and hence may have a higher surface area to weight ratio than 6 dm²/kg. However, the
usage of cosmetics is much lower, the generally accepted figure being 17,4 g of cosmetics
rather than 1 kg of food per consumer per day (SCCS Notes of Guidance for testing of cosmetic
substances and their safety evaluation, 8th Revision 2012, SCCS/1501/12).

As a common worst case of a high surface area to weight ratio, a 40 mm x 70 mm sachet could
contain 2 g of product, giving a surface to volume ratio of 280 dm2/kg. The consumer using
17.4 g of this product would, in theory, be exposed to migration from 280 x 0.0174 = 4,9 dm2
of packaging. This is still less than their exposure from 6 dm2 of food packaging.

On this basis, it is reasonable and conservative to consider that the surface area’s to be used
in consumer exposure scenarios are comparable for food packaging and for cosmetics.
Furthermore, systemic availability of substances in food via the oral route is typically higher
than availability of dermally applied substances.

29
 APPENDIX 1

Guidance List of Disclosable Substances

Version December 14, 2015
The Information Exchange Guidelines require the packaging supplier to disclose the identity and
concentration of certain substances if they exceed defined limits so that the cosmetics packer can
conduct a safety assessment:
• Substances that are listed in Annex II and III (including CMR substances), and/or classified as
skin sensitiser according to CLP Annex VI table 3.1 at levels above 10 ppm, or migrating in
levels above 100 ppb in a relevant simulant

There are over 3,000 such substances and there is a practical difficulty for the packaging supply chain
to ascertain which of them may be present in their materials. The Working Group therefore decided
to:
a) Create a single Excel format listing of these substances
b) Create shorter list of those substances which are known to be used as substances in food
contact materials (FCM) and articles. Note that this also includes those substances which are
not used in layers that are in direct contact with the food but which are used in the outer layers

Figure 1 illustrates the process of how the Excel files were built up. In summary:

1. A list of Disclosable Substances was built from

a. ECHA’s C&L Inventory for
i. CMR substances
ii. Skin sensitisers
b. Annex II and Annex III of 1223/2009

2. Substances used in FCM were identified from

a. Annex I of 10/2011
b. Annex 6 of the Swiss Ink Ordinance
c. The FACET Inventory List which was built up from:
i. EU and European National positive lists
ii. Submissions by the plastics, coatings, adhesives, ink and paper industries

3. These lists were combined into a tool that enables the identification of substances that appear
in both lists

4. This tool has been used to make a shorter list that can be used by the entire supply chain –
i.e. Appendix I – “The Guidance List of Disclosable Substances Used in FCM”.

Note that this list is based on information which is publically available and the opinions of experts in
the packaging and cosmetics industries. It can only act as a guide; the possibility will always exist
that it does not include a substance which should be disclosed and which may be found in FCM.
Anyone discovering such a substance should inform Cosmetics Europe so that it can be added to the
list.

GUIDANCE LIST OF DISCLOSABLE SUBSTANCES USED IN

Appendix I v4
221215.xlsx
FOOD CONTACT MATERIALS (click on icon to open Excel File) :

30
 C&L C&L 1223/2009 Plastics Swiss Ink EU Lists, National Industry
CMR Skin Annex II & Regulation Ordinance e.g. Lists, e.g.
Substances Sensitisers III 10/2011 Annex 6 10/2011 BfR
Annex I XXXVI

FACET Inventory List for

Plastics, Coatings, Adhesives,
Inks and Paper
Disclosable
Substances List

Disclosable Food Contact

Substances Tool

Appendix I
“The Guidance List of
Disclosable Substances
Used in FCM”

Figure 1 Process for building the Guidance List (Excel file)

31