1. Cosmetic Regulations
Cosmetic Science Technology 2015
1
Abstract
There is currently no European legislation that specifically
regulates colourants for use in cosmetic packaging. The
provisions for packaging set forth in the European regulation
on cosmetic products give no guidance either. It is, however,
commonly accepted that colourants complying with the
legislation for food contact materials are safe for use in cosmetic
packaging. Therefore the requirements for colourants intended
for food contact are used as reference to ensure the safety of
colourants for cosmetic packaging. This document presents the
key elements to consider in the selection of colourants which
respect the safety requirements of the European Cosmetics
Regulation. It is intended as guidance for manufacturers of
colourants and packaging as well as the cosmetics industry as a
whole in order to clarify understanding of the current regulatory
framework. The approach developed in this review is the result
of consultations and agreement with key suppliers of colourants
operating in the European market.
Introduction
The use of colour is a key element in attracting the attention of
the consumer. This is particularly true for cosmetic packaging.
Not only is it used for aesthetic reasons but also as a means
of protecting the product. There is currently no European
legislation that specifically regulates colourants used in
cosmetic packaging. From a legal perspective, as the colourant
is part of the finished packaging material, it is covered by the
requirements for cosmetic packaging.
The European cosmetics regulation(1)
is very imprecise
concerning the requirements for cosmetic packaging and has
no requirement specifically addressing the colourants of the
packaging. Based on the assumption that packaging safe for
food is also safe for cosmetic products, it is commonly accepted
that colourants complying with food contact legislation should
be safe for use in cosmetic packaging. Therefore the legislative
requirements of colourants intended for food contact materials
Colourants for Cosmetic Packaging: How to EnsureTheir Safety inAccordance
with the European Regulation on Cosmetics?
Authors: Martin Foe, Patrick Prevost, Aptar Beauty+Home, Le Neubourg France
Key-words: colourants, cosmetic, packaging, legislation, Europe
are viewed as a useful reference to ensure the safety of
colourants used in cosmetic packaging.
This document is divided into three sections. The first section
summarises the regulatory situation in Europe regarding
colourants used in cosmetic packaging. The second section
reviews the legislative framework for colourants used in food
packaging. In the third section, we share our experience and
practical knowledge in the assessment of the safety of colourants.
Requirements for Colourants Under the European
Regulation on Cosmetic Products
The European regulation on cosmetic products contains no
specific provision for colourants. However since colourants
are part of the cosmetic packaging, they are covered by the
requirements of the cosmetics regulation.
The European Regulation on cosmetic products is very
imprecise concerning the requirements for packaging. Article
3 of the regulation states that: any cosmetic product that is
placed on the market shall be safe for human health, when
used under normal or reasonably foreseeable conditions of use.
This general rule also applies to the packaging, including any
colourant it may contain.
Annex I of the regulation specifies that the cosmetic product
safety report shall contain, as a minimum, information
regarding impurities, traces and information about the
packaging material. The regulation also requires that the
packaging must not release into the cosmetic product traces
of prohibited substances in such amounts that bring about a
toxicological risk. A list of prohibited substances is given in
Annex II. The regulation also prohibits substances classified
as Carcinogenic, Mutagenic and toxic to Reproduction by CLP
(Classification, Labelling and Packaging) Regulation(2)
.
The cosmetic regulation makes clear that the safety and
the regulatory compliance of the finished cosmetic product,

2. Cosmetic Regulations
Cosmetic Science Technology 2015
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including the packaging, is the responsibility of the entity that
places the product on the market. Therefore the obligation
of the other operators in the supply chain is to provide
information that allows the safety assessment of the finished
cosmetic product. However the General Product Safety
Directive(3)
requires each operator to ensure the safety of the
material it supplies.
Due to the lack of clarity of the cosmetics regulation with regards
to packaging, it is suggested by the European Commission(4)
that the regulatory requirements for food contact materials
may be a useful reference. Since colourants for food packaging
are not different from those used for cosmetic packaging, the
requirements established by food legislation are valid.
Overview of the Regulatory Requirements
on Colourants for Food Packaging in the
European Union
The European Commission has not yet harmonised the
legislation of colourants used in food packaging in the
European Union. Therefore, there is currently no community-
wide legislation specifically dealing with these types of
materials. However different pieces of legislation both at Union
and national level may be relevant to colourants.
Legislation Applicable to Colourants at European
Union level
The Framework Regulation(5)
, which is the cornerstone of
European legislation on food contact materials, establishes
the general safety requirements that apply to all food contact
materials. The key requirement is that the packaging should
not transfer its constituents to food in quantities that could
endanger human health, result in an unacceptable change in
the composition of the food, or deterioration of its organoleptic
characteristics. Colourants, as part of the packaging material,
are therefore covered by this requirement.
Although the European Regulation on plastics for food contact(6)
does not apply to colourants, per se, it governs the use of
colourants. Indeed, Annex I of the plastic regulation provides
a list of substances authorised in the manufacture of plastic for
food contact. This positive list otherwise known as the ‘Union
List’ also includes certain colouring agents such as carbon black
(CAS N° 1333-86-4), titanium dioxide (CAS N° 13463-67-7),
talc (CAS N° 14807-96-6), iron oxide (CAS N° 1345-25-1) and
mica (CAS N° 12001-26-2). Article 6 of the same regulation
makes clear that colourants are additives that are subject to
national laws. This is clearly a validation of the different
legislation existing in the European Member States on the topic.
The specifications set forth in Council of Europe Resolution(7)
,
although not legally binding, are recognised as representing the
current state of scientific and technical knowledge with regard
to the safety of colourants. The Resolution recommends that
colourants should be sufficiently integrated within the plastic
materials and articles in order to preclude any visible migration
into foodstuffs. Furthermore, it requires that colouring agents
meet purity criteria concerning given amounts of soluble
or extractable residues of substances such as metals and
metalloids, aromatic amines and polychlorinated biphenyls
(see Table 1). It also introduces the requirement that the
colourant should be toxicologically safe. Reference is made to
the Scientific Committee on Food guidelines(8)
as a useful tool
for the safety assessment of colourants.
Legislation on Colourants in the European
Member States
The different member states within the EU have a wide range
of approaches to the regulation of colourants. The Member
States can be divided into three groups: those Members
States with a specific legislation on colourants, those with no
legislation and France, which is a special case.
The particularity of France is that it is the only State in the
European Union with a positive list of permitted colourants.
The French ‘positive list’ of colourants is found in Circulaire No.
176(9)
and its different amendments. However this list is only
to be considered as a draft law, since it has not been officially
notified to the European Commission. Therefore it should be
treated as a recommendation. The complete list of pigments
with their use limitations (e.g. concentration, type of polymers,
etc.) is provided in the document No. 1227(10)
. French
legislation on colourants has two additional requirements with
respect to purity specifications (see Table 1) and non-visible
migration. Switzerland is another European country with a
positive list of colourants for food contact application. Part
of the Swiss positive list(11)
has its origin in the French list
of colourants. However, as Switzerland is not a Member of
the European Union, its positive list of colourants should be
considered only as a recommendation.

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In those States with specific legislation (e.g. Belgium(12)
, Italy(13)
and The Netherlands(14)
), a colourant can be used if it meets the
purity requirements and, of course, provided that it does not raise
any safety concern or bring about unacceptable compositional
change. The requirement on the purity on colourants is related
to the presence of metals and metalloids, aromatic amines and
some other specific organic compounds of concern. The limits
vary slightly from country to country, as illustrated in Table 1.
Additionally, the legislation in these countries requires that no
coloured substances be released into the food.
In those States with no specific legislation, it is only necessary
that the colourant be safe for its intended use and not adversely
affect the organoleptic properties of the food, in accordance with
the general safety rule of the European Framework Regulation.
The Key Elements to Consider in the Choice of
Colourants for Cosmetic Packaging for the
European Market
The selection of colourants for use in cosmetic packaging can
be very challenging for companies operating in the European
market, since there is no legislation specifically addressing
the topic. Therefore it is important to have an appropriate
approach and a good understanding of the different legislations
and recommendations existing in Europe.
The review of the legislation on colourants for food contact
materials has highlighted the following three factors to be
used in the determination of the safety of colourants: purity
requirement, non-visible migration and toxicological safety.
These three elements are the basis of the approach presented
below for assessing the colourants.
Belgium France Italy The Netherlands Resolution AP(89)1
Metals and Metalloids
Lead (Pb) 100 ppm 100 ppm 100ppm 100 ppm 100 ppm
Arsenic (As) 100 ppm 50 ppm 50 ppm 100 ppm 100 ppm
Mercury (Hg) 50 ppm 50 ppm 50 ppm 50 ppm 50 ppm
Cadmium (Cd) 100 ppm 1000 ppm 100 ppm 1000 ppm 100 ppm
Zinc (Zn) 2000 ppm
Selenium (Se) 100 ppm 100 ppm 100 ppm 100 ppm 100 ppm
Barium (Ba) 100 ppm 100 ppm 100 ppm 100 ppm 100 ppm
Antimony (Sb) 500 ppm 500 ppm 2000 ppm 500 ppm
Chromium (Cr III) 1000 ppm 1000 ppm 1000 ppm 1000 ppm
Amines Compounds
Primary aromatic
amines
500 ppm 500 ppm 500 ppm 500 ppm
Unsulphonated primary
aromatic amines
500 ppm 500 ppm
Content of benzidine
+β-naphthalene and
4-aminobiphenyl
individually or together
< 10 mmg/kg
Content of benzidine
+β-naphthalene and
4-aminobiphenyl
individually or
together < 10 mg/kg
Others
Polychlorinated
bisphenyls (PCBs)
< 25 mg/kg
Carbon black Toluene extractable
fraction < 0.15%
Extractible benzene
< 1000 ppm
Free of Benzo 3-4
pyrene
Extractable toluene
<0.1%
Benzo[a]
pyrene<0.25 mg/kg
Toluene extractible
fraction < 0,15%
Table 1. Comparison of Purity Requirements in Different European Member States

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The Purity Requirement
The purity requirement is a key factor in the European
legislation for the demonstration of colourant safety. It is
related to maximum limits on heavy metals and metalloids
(e.g. antimony, arsenic, barium, cadmium and chromium),
aromatic amines and some other specific organic compounds
of concern in colouring agents. As the maximum limits defined
in the various national laws differ slightly, those set forth in the
Council of Europe Resolution should be viewed as reference.
Details on the purity requirement established by the European
Resolution are given in Table 1.
Non Visible Migration
The suitability of colourants for the packaging material is a
key factor for product safety and non-visible migration is
the main criteria for checking suitability. As prescribed by
the cosmetic regulation, it is the entity placing the cosmetic
product on the market that has to ensure by suitable practical
trials that no colourants, not even in traces, migrate. However,
the suitability of colourants should also be checked up the supply
chain. It is a common practice that colourant manufacturers test
their products for visible migration and provide their customers
with corresponding recommendations. It is also usual that the
packaging manufacturer performs such tests.
Toxicological Safety
The safety of packaging materials is, according to the European
legislation, generally based on the principle of positive or
exclusion lists. This is considered as the best way to protect the
consumer ensuring that none of the materials used contain any
substance likely to endanger human health. Indeed, the listing of
a substance in the legislation comes as result of risk-assessment
including toxicological evaluation. Assessment of a packaging
material therefore requires knowledge of its composition. The
basic composition of colourants is well-known. Typically they
contain one or more colouring agents, one or more additives and
a carrier (solid or liquid).
Concerning the colouring agents, France is the only European
Member State which has a positive list. However it is not
legally binding but rather a recommendation. Compliance with
this list is therefore preferable but should not be considered
mandatory. The European regulation on plastics also lists some
Legislation or Soft-law Key Requirements for Compliance
Colouringagents
French Circulaire N°176 • Listed in the French positive list on colouring agents, with conditions of use
Swiss Ordonnance • Listed in the Swiss positive list of colourants
Regulation 1223/2009 • Listed in Annex II and III of Cosmetics Regulation
CLP Regulation (EC) No 1272/2008 • Classified as CMRs 1A, 1B and 2,
Regulation (EU) 10/2011 • Listed in the EU Regulation on plastic material for food contact
• Self-assessed by suppliers, in accordance with internationally recognised scientific
principles for risk assessment
Resolution AP(89) • Fulfil purity requirement on metals, metalloids and other substances
Regulation (EC) No 1907/2006 • Fulfil conditions in Annex XIV, Annex XVII
Additives
Regulation (EU) 10/2011 • Listed in the EU Regulation on plastic material for food contact
Carrier
Regulation (EU) 10/2011 • Substances are listed in the Regulation on plastic materials for food contact
• Substances self-assessed by suppliers, in accordance with internationally recognised
scientific principles on risk assessment
Directive 94/62/EC • Level of heavy metals (lead, cadmium, mercury and chromium VI) below 100 ppm
0
Disqualifying criteria,
0
Non mandatory but preferable
Table 2. Inventory of Legislation and Soft-laws that are Relevant to Ensure the Safety of Colourants

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colouring agents. The evaluation of these substances, prior to
their inclusion in the Union List, was based on their toxicity,
irrespective of the application. Therefore these colouring agents
should be regarded as safe for use in cosmetic packaging. Self-
assessment is another option offered by the European Regulation
for substances used in packaging materials. Therefore colouring
agents that have been self-assessed by operators, respecting
the requirement of the framework regulation, should also be
considered as safe for use in cosmetic packaging.
Carriers and additives are the other key elements of the
composition of colourants. A carrier is either a polymer resin
(polypropylene, polyethylene, acrylonitrile butadiene styrene) for
solid colourants, or usually oil or hydrocarbon-based carriers for
liquid colourants. The European Regulation N°10/2011 provides
a list of substances that are safe for use in the manufacture of
plastic materials for food contact. This list includes monomers,
additives other constituent elements of carriers for both solid
and liquid colourants.
Other texts should also be considered in the assessment
of the toxicological safety of colourants. They include
REACH regulation(15)
with its authorization (Annex XIV) and
restriction (Annex XVII) lists and the Cosmetics regulation
with its prohibition list (Annex II). A comprehensive list of
texts that are relevant for the safety of colourants is given
in Table 2.
Conclusion
The selection of safe and compliant colourants for use
in cosmetic packaging is a difficult exercise that requires
navigation through different European legislation and soft-laws.
Therefore it is important to have a good understanding of the
legislation before finalising colourant selection. This document
presents the key elements to consider in the choice of safe
colourants for the European market. It also lists legislation
and other guidance documents that can be referenced when
conducting the assessment of colourants. It is intended to be a
practical guidance aimed at all players in the supply chain of the
cosmetics industry.
References
1. Regulation (EC) No 1223/2009 on cosmetic products
2. Regulation (EC) No 1272/2008 on classification, labelling and
packaging of substances and mixtures
3. Directive 2001/95/EC on General Product Safety
4. Commission implementing Decision on Guidelines on Annex I to
Regulation (EC) No 1223/2009 of the European Parliament and
of the Council on cosmetic products.
5. Regulation (EC) No 1935/2004 on materials and articles
intended to come into contact with food
6. Regulation (EU) No 10/2011 on plastic materials and articles
intended to come into contact with food
7. Resolution AP (89)1 on the use of colourants in plastic materials
coming into contact with food
8. Guidelines of the Scientific Committee on Food for the presentation
of an application for safety assessment of a substance to be used
in food contact materials prior to its authorisation. SCF/CS/PLEN/
GEN/100 Final 19 December 2001
9. Circulaire No 176 of 2 December 1959 relating to pigments and
colourants in plastic materials and packaging
10. Matériaux au contact des denrées alimentaires, produits de nettoyage
de ces matériaux – Edition (July 2002) No. 1227. (France)
11. “Ordonnance du FDI sur les objets et matériaux” of 23 November
2005, Annexe 1.III.9 Pigments et matière colourantes (Pigments
and Colourants) (Switzerland)
12. Koninklijk besluit/Arrêté royal (Royal Decree) of 11 May 1992, Annex
1, Chapter VII, point 1/ purity of colourants for plastics (Belgium)
13. Decreto Ministeriale del 21/03/1973 Disciplina igienica degli
imballaggi, recipienti, utensili, destinati a venire in contatto con le
sostanze alimentari o con sostanze d’uso personale – Last update
February 4, 2013, No. 23 (Italy)
14. “VGB (Warenwet)” (Packaging and Utensils Decree) of 1 October
1979, Aa, I, 4 / purity of colourants for plastics and Aa, II,1.2.2.g /
purity of colourants for paper and board. (The Netherlands)
15. Regulation (EC) No 1907/2006 concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals
Authors’ Biographies
Martin Foe obtained his Master’s Degree in 1997 from the University
of Clermont-Ferrand in France, where he studied Human Nutrition
and Food Science. After graduation, Martin set up Nutralis, his own
consultancy business where he spent 10 years advising multinational
companies and OSEO, France’s National Innovation Agency.
Martin ceased his consultancy activity in 2009 to work as a regulatory
expert for Puratos group in Belgium, followed by Danone Baby Division
in The Netherlands. He returned to France in 2013 to join Aptar
Beauty+
Home, where he currently focuses on the legal framework of
packaging materials that are not harmonised by European legislation,
such as colourants, aluminium and stainless steel, for food and cosmetic
applications. Martin has over 15 years experience as an international
scientist and regulatory expert.
In addition Martin Foe has been lecturing on European food legislation
at a French University (Polytechnic Institute Lasalle-Beauvais), since
2008. He has actively participated in high level debates and discussions
with the European commission, EFSA and European federations such as
FoodDrinkEurope and CAOBISCO. His is also an author of publications
and textbooks, on human nutrition and food legislation.
Patrick Prevost graduated as an engineer from ESPCI Paris in 1979
(Engineering School of Industrial Physics and Chemistry) and in 1980
he obtained his Master’s Degree in organic chemistry. Patrick started
his working career by joining Pechiney Aluminium, where he spent the
first 7 years as Research Engineer at the company’s Voreppe Research
Centre and then went on to hold the position of Quality/Production
Manager at their Ussel Aluminium Foundry until 1992.
He then joined Framatome Group, where the following 6 years were
spent as Quality Assurance and Logistics Manager. In 1998 Patrick
entered the Cosmetic Packaging industry as Quality Director at Valois
SAS, where he served for 12 years. Patrick Prevost joined Aptar Beauty
+ Home Europe in 2010 as Quality and Regulatory Affairs Director,
where he remains to the present day.
Patrick regularly gives presentations at conferences and, most recently,
has been actively involved in the European Task Force on Cosmetic
Packaging and Materials to establish Regulatory Guidelines facilitating
the collection of material data for Safety Assessment of these Packaging
Materials.