If it is the intention of cosmetic manufacturers to export to Europe, they have to make sure that their products are inline with the European Directives for cosmetics. A summary description of these directives along with their interpretation is available all through this section of the guideline.
·
To
provide harmonised regulations for the cosmetic, toiletry & perfumery
industry in the European Union
·
To
assure the safety of cosmetic products for human use
·
To
set requirements to be met by the manufacturer, distributor or importer
responsible for putting cosmetic products on the market
·
Consumer
safety related to
-
Product
composition
-
Packaging
-
Information
·
Free
market access lies at the heart of the EU Cosmetics Directive.
·
All
products meeting the requirements of the Directive should have equal and
immediate access to the market
·
Facilitation
of free circulation of cosmetic products throughout the EU
·
European
consumers to benefit rapidly from scientific developments achieved by the
Cosmetic, Toiletry And Perfumery Industry (CTP).
·
For
25 years, the model provided by the Cosmetics Directive is effective, safe, and
meets the needs of consumers, industry and regulators.
·
In
today’s 15 EU Member States, the model works successfully to ensure safety to
European consumers and to encourage lively trade.
·
The
European Cosmetics, Toiletry and Perfumery (CTP) industry continues to flourish
and maintain its position as a world leader.
·
The
consumer’s safety is carefully guarded and scientifically supported by
statistics pointing to a ratio of just 1 to 3-million for any adverse reaction.
·
Includes
specific procedures to ensure that its requirements can be adapted readily in
light of new developments or scientific knowledge.
·
First
adopted in 1976
·
6
amendments by the Council
·
Its
annexes have undergone 24 adaptations to technical progress
·
The
6th Amendment, introduced major modifications and improvement to the regulatory
system then in place.
·
The
6th Amendment was adopted in June 1993 and became effective in January 1997.
·
18
articles and 8 annexes.
·
Annexes
II to VII list the chemical ingredients the use of which in cosmetic products
is either prohibited or specifically regulated.
·
These
ingredients represent a small portion of the total number of substances that
are employed by the cosmetic industry.
Indeed, most cosmetic ingredients
are not subject to restrictions and can be freely used by manufacturers, provided
the finished products meet the general safety requirements of the Directive. In
close collaboration with Colipa, the European Commission has compiled an
indicative inventory of ingredients used in the cosmetic sector. This inventory
provides useful information on the identity (including International Nomenclature of Cosmetic Ingredients (INCI) names) and function of approximately 8000
substances.
The Cosmetics Directive applies to a clearly delineated product sector.
Products for both consumer and professional use are treated equally under the
Directive.
A cosmetic product is defined as:
" …Any substance or preparation intended to be placed
in contact with the various external parts of the human body (epidermis, hair
system, nails, lips and external genital organs) or with the teeth and the
mucous membranes of the oral cavity with a view exclusively or mainly to
cleaning them, perfuming them, changing their appearance and/or correcting body
odours and/or protecting them or keeping them in good condition". Annex I
of the directive provides an illustrative list by category of products within
the meaning of this definition.
There are three preliminary questions, which should be addressed when
deciding whether a product could legally be classified as a cosmetic:
1.
Is
the purpose of the product wholly or mainly cosmetic i.e. is it intended to:
-
Clean
-
Perfume
-
Change
appearance
-
Correct
body odour
-
Protect
-
Keep
in good condition
If
the main purpose of the product is not to perform one of these functions it is
unlikely to be a cosmetic: a product intended to be applied to a spot in order
to treat that spot is not a cosmetic; however, a product intended to be applied
to a spot in order to conceal it, even if it has a secondary purpose of
preventing the formation of further spots, is a cosmetic is a cosmetic
2.
Is
the product intended to be applied to one of the following body organs?
-
Epidermis
-
Hair
system
-
Nails
-
Lips
-
External
genital organs
-
Teeth
-
Mucous
membrane of the oral cavity
If
it is not, the product is unlikely to be a cosmetic. Accordingly, eye drops,
vaginal douches, nose drops and orally ingested tablets intended to improve
appearance, are not cosmetics. The Fifth Recital to Directive 76/768, the
Cosmetic Directive, foresees cosmetic products having a secondary preventative
(but not curative) purpose.
3. What is the main purpose of the product?
In deciding whether a product is a cosmetic with a secondary
preventative purpose or medical product (subject to licensing), account will be
taken of the main purpose of the product, the claims made for it, the
composition of the product and the purpose for which it is likely to be used by
the consumer. The Medicines Control Agency produces a guideline on borderline
products. In the first instance a copy of this document should be obtained.
The
Fifth Recital to Directive 76/768/EEC excludes from the scope of the Directive
products "which fall under the definition of cosmetic product but are
exclusively intended to protect from disease". Accordingly the primary
purpose of the product is critical in establishing its legal status. Directive
65/65/EEC defines a medicinal product as:
"Any substance or combination of substances presented for treating
or preventing disease in human beings or animals."
or
"Any substance or combination of substances which may be
administered to human beings or animals with a view to making a medical
diagnosis or to restoring, correcting or modifying physiological functions in
human beings or animals is likewise considered a medicinal product."
While aiming at guaranteeing safety, the philosophy of the Directive is equally to ensure a competitive and innovative environment for the industry. The key principles of such a balanced regulatory approach is: Manufacturers and importers hold responsibility for product safety;
·
Manufacturers
and importers are liable to meet all requirements and ensure that the products
they market are safe.
·
Whilst
manufacturers are generally in the best position to assess the safety of the
products; the Product information requirement of Article 7a provides guidance
on how product safety should be assessed.
Provided the safety requirements of the Directive are met, manufacturers are free to choose ingredients and formulae for their products.
·
No
pre-market approval is required for cosmetic products in the EU.
·
Products
are assumed to meet the requirements of the Directive and controls take place
on the market.
·
Cosmetic
products, when put on the market of one Member State, may freely circulate on
the whole territory of the European Union.
·
Article
7.1: "Member States may not, for reasons related to the requirements laid
down in this Directive and the Annexes thereto, refuse, prohibit, or restrict
the marketing of any cosmetic products which comply with the requirements of
this Directive and the Annexes thereto".
However
importers will ask for further documentation, approvals, in order to check the
compliance with the Directives.
Implementation
and enforcement of the Directive’s requirements fall under the responsibility
of the competent authorities of the Member States.
·
There
exist cosmetics directives in the EU member states (e.g. Germany, UK etc.)
·
Other
national laws regulate the cosmetics business
·
National
inspectors may visit department stores, supermarkets, small shops and market
stalls to check products being sold.
·
Such
inspectors may take any product from the market to be tested for compliance
with EU regulations.
·
They
may also have access to product information in consultation with the
distributor and/or manufacturer.
·
In case
of non-compliance with the Directive, penalties are those provided under the
national laws of the Member States.
The Amendment’s provisions have applied to manufacturers and
importers into the EU of the marketed cosmetic products since January 1997
·
To
remove legal ambiguities from previous text
·
To improve
information to customer
·
To
increase safety and transparency requirements for cosmetic products
·
To
contribute to European trade efficiency by harmonising rules in cosmetic
marketplace
Potential
ban on animal testing (Article 4)
·
Labelling
of cosmetic products (Article 6)
·
Product
Information to be kept in a single place within EU (Article 7a)
Clarification
of the definition of a cosmetic product (Article 1)
·
Extension
of the general safety clause (Article 2)
·
Information
in case of emergency (Article 7.3)
·
Faster
procedure for technical adaptation of the different Annexes (Article 8)
·
Modification
and clarification in the definition of a cosmetic product.
·
Modification
to the general requirement for industry to market only safe cosmetic products.
·
Introduction
of a ban on marketing cosmetic products that have been tested on animals or
containing ingredients tested on animals as of January 1998.
·
The ban
has been postponed until June 2002 as no scientifically validated alternative
methods offering an equivalent degree of consumer protection exist at present.
·
An
obligation for the European Commission to prepare an annual report on the
progress in the development of alternative methods.
·
The
compilation of an indicative inventory of cosmetic ingredients based on
information supplied by the cosmetic industry.
·
Affixing
the International Nomenclature of Cosmetic Ingredients (INCI) to define the
ingredients of a cosmetic product in the EU
·
A
change to the labelling provisions, where required labelling covering
conditions of use and warnings may, in certain cases, be provided on a leaflet,
tag, tape or card provided with the packaging.
·
In such
cases, reference must be made on both the container and the packaging, using
suitable wording or a newly introduced symbol defined in a new Annex VIII to
the Cosmetics Directive.
·
A new
labelling requirement on the container and the packaging indicating the
function of the marketed cosmetic, unless this is clear from the name of the
product or the way in which the product is presented to the consumer.
·
The
introduction of full ingredient labelling on the outer packaging of cosmetic
products, using a common nomenclature AND OFF-PACK LABELLING
·
A new
provision specifying that any claims made concerning animal testing must state
clearly whether such tests involve the finished product and/ or its
ingredients.
·
An
adaptation to the requirement for industry to provide information on product
composition in the event of difficulties.
·
A new
requirement whereby EU manufacturers, or their agent, or the person to whose
order a product is manufactured, and importers into the EU shall hold certain
information on each marketed product which is readily accessible, via the
address on the label, to the competent authorities of the EU Member State
concerned.
·
Manufacturers
within the EU and importers into the EU of cosmetics shall have to notify the
competent authorities of the EU Member State concerned of the place of
manufacture or of the first importation.
·
Changes
are made to the legal procedures to modify the Annexes to the Cosmetics
Directive.
·
There
is a new Annex VIII that is a graphic illustration of a hand inside an open
book. This illustration may be used on the packaging to indicate that certain
information can be found in a leaflet, label, tape or card provided with the
product.
Ensuring consumer safety and protection has been the number one
principle of the European Union Cosmetics Directive. The Directive’s fundamental requirement is the
responsibility of individual companies operating in the EU to ensure that all
cosmetics products marketed to consumers are safe. In the Directive’s 6th Amendment, Article 2, this
fundamental requirement is spelled out: “A cosmetic product put on the market within the
Community must not cause damage to human health when applied under normal or
reasonably foreseeable conditions of use”.
This must take into account the product’s presentation, labelling, and
instructions for its use and disposal.
Additionally,
any other indication or information provided by the manufacturer, authorised
agent or by any other person responsible for placing the product on the Community
market, is also covered by the requirement. At the same time, providing
warnings does not exempt any person from compliance with the other requirements
laid down in the Directive. To help guarantee safety, the Directive requires
that comprehensive Product Information on all products marketed in the EU is
readily available to the competent authorities.
For the consumer, complete ingredient listings as well as other pertinent information about the product must be clearly labelled on the products.
·
To
increase transparency of cosmetics in the market, the 6th Amendment introduced
a Product Information Requirement for manufacturers and importers of cosmetics
in the EU.
·
Keeping
Product Information on the safety of cosmetics available gives additional
assurance to consumers and public health authorities.
·
From
Article 7a:
·
"The
manufacturer or his agent or the person to whose order a cosmetic product is
manufactured or the person responsible for placing an imported cosmetic product
on the Community market shall for control purposes keep the following
information readily accessible to the competent authorities of the Member State
concerned at the address specified on the label in accordance with Article 6
(1) (a)."
·
Form of
Information Required
Any convenient form, from paper to the most up-to-date
information technology, may be used.
·
Location of Product Information
The
information should be available at a single place within the EU, with the
address listed on the product. The address may appear in complete or
abbreviated form (See Art.6.1.a)
·
Language of the Information
Product
Information must be available in the national language or languages of the
State concerned, or in a language readily understood by the competent authorities
·
Address of Manufacturing or Initial Importation
Premises:
Manufacturers,
agents, and marketers must notify competent authorities of the Member States of
place of manufacture of cosmetics products on the European market
·
Product Information to be made Available:
For
checks by national authorities, each manufacturer, importer or marketer of a
cosmetic product must keep certain elements of Product Information accessible,
including:
-
Product
Composition
-
Physico-Chemical
and Microbiological Specifications of Raw Materials and Finished Product
-
Method
of Manufacture
-
Safety
Assessment
-
Information
on the Safety Assessor
-
Undesirable
Effects on Human Health
-
Proof
of Effect
·
To
ensure greater transparency for the consumer, Article 6.1 of the Cosmetics
Directive stipulates mandatory labelling of the information detailed below.
·
This
information should appear on the container and packaging of each product
(except for the ingredient list, which should appear only on the packaging), in
indelible, easily legible and visible lettering.
-
Name
and address of manufacturer or importer or distributor of product within EU
-
Nominal
content at time of packaging (by weight or volume)
-
Date
of minimum durability (only when shelf life is < 30 months)
-
Particular
precautions to be observed in use (if regulated in Annexes of Cosmetic
Directive)
-
Reference
for identifying the goods (e.g. batch number)
-
Product’s
function (unless clear from presentation)
-
Ingredient
list (on packaging) in descending order of weight at time added, using INCI
nomenclature
·
The 6th
Amendment of the Cosmetics Directive introduced new mandatory requirements for
labelling of cosmetic products marketed in the EU.
·
Ingredient
labelling ensures transparency to consumers by providing product ingredient
information.
·
The
requirement applies to the outer packaging of all cosmetic products and should
be indelible, easily legible and visible.
·
Benefits
of ingredient labelling include:
-
Transparency
to the consumer
-
Information
to enable purchase decision
-
Facilitation
of post-market surveillance
-
Consistent
application to all cosmetic products
1) Identify
all raw materials added at the time of manufacturing.
2) Ignore
any processing aids that do not remain in the product.
3) Identify
all the components of raw materials that are mixtures.
4) Identify
the INCI name of each component
5) Add
together the quantities of all components with the same INCI name, so that each
INCI name appears on the ingredient list only once.
6) Sort
list into descending order of quantity, down to 1
7) Colorants
are listed in any order after all other ingredients.
8) Place
resulting list on the pack label
·
WHEN:
all products on the market as of January 1, 1997
·
WHAT:
all types of products marketed in whatever way
·
WHERE:
on outer packaging only
·
WHICH
INGREDIENTS: All ingredients to be listed except:
- Impurities
- Subsidiary technical preparation
materials
-
Solvents
or carriers for perfumes or aromas
·
HOW:
-
In
decreasing order of ingredient concentration
-
Ingredients with a concentration below 1%
at random after other ingredients
-
Colorants
in any order after all other ingredients
·
NOMENCLATURE:
INCI names (formerly known as CTFA names)
·
EU SPECIAL
NOMENCLATURE FOR:
-
Cosmetic
colorants: CI number (not for hair dyes)
-
Perfume
ingredients: all as "PARFUM"
-
Flavouring
ingredients: all as "AROMA"
-
Plant
Materials: Latin name under "LINNE" System (genus and species)
-
Trivial
names: based on the EUROPEAN PHARMACOPOEIA (Latin name)
-
Denatured
ethanol: as "ALCOHOL DENAT"
-
The
term "ingredients": as "INGREDIENTS"
-
The
term "may contain": as [+ / -]