1)
Before
launching a cosmetic product on the market, what steps must be fulfilled?
Any cosmetic product complying
with the Cosmetics Directive can be directly launched on the market. Therefore,
the manufacturer/ importer must refer to the Cosmetics Directive to make sure
that the products meets the requirements of the latest version of the Directive
and is in compliance with other relevant legislation, before putting it on the
market.
2)
Are any
requirements for cosmetics imported into the EU different from those for
products manufactured within the EU?
There is no difference in legal
requirements between products exported to the EU and products manufactured in
the EU: they both must comply with the requirements of the Cosmetics Directive.
3)
How are
cosmetic products separated from pharmaceuticals or foods?
"A cosmetic product shall
mean 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 Cosmetics
Directive provides an illustrative list of the products to be considered as
cosmetic products within this definition. In the EU there are no intermediate
product categories between cosmetics and pharmaceuticals or foods.
4)
Does
the Cosmetics Directive distinguish between what is safe for adults and what is
safe for children?
There are no additional
requirements for children, as the Directive’s rigorous requirements ensure that
products are safe for use by all consumers under normal or reasonably
foreseeable conditions of use. If special care has to be taken with particular
ingredients where children are concerned, this is regulated in the annexes.
1)
How
many units of cosmetics are sold in the EU each year? How many cases of adverse
reactions or injury from cosmetics are being reported?
While precise statistics are not kept, Colipa estimates that around five billion
units are sold in the EU each year. Experience suggests that there is roughly
one adverse reaction in three million units sold.
2)
Who is
responsible for the safety of cosmetics?
The person or company who puts
the product on the market is responsible for the safety of the product. That
person or company (which may be the manufacturer or the importer) must ensure
that all the requirements of the Cosmetics Directive are met). Once the product
has been put on the market, if any question about the safety of the product
arises, the person or company responsible for placing the product on the market
will be held liable.
3)
In the
event that emergency treatment is necessary as the result of use or misuse of a
cosmetic product, what procedure is available?
To deal with unforeseeable emergencies,
a channel of information exists between a Competent Authority in each Member
State (normally the Poison Information Centre) and the person responsible for
the market placement. According to Article 7.3, appropriate and adequate
information on substances used in cosmetic products are made available to the
Competent Authority, which shall ensure that this information is used only for
the purpose of prompt and appropriate medical treatment.
4)
If a
consumer complains that a cosmetic product has caused a health problem, what
steps are taken?
The company concerned will
investigate the complaint and may arrange for the consumer to see a medical
specialist or dermatologist. The doctor or dermatologist will help the consumer
to identify the cause of the problem so that it could be avoided in the future.
5)
Who
guarantees the quality of cosmetic products? Is quality certification
necessary?
Quality certification is not
necessary. The responsible national authorities, the trade and distribution
channels, and competitors closely monitor compliance with the Cosmetics
Directive. Competent Authority investigations of potentially non-complying
products can be triggered by input from the consumer, the trade, the
competition or from its own regular market surveys. This process works
effectively in keeping non-compliant products off the market in the EU. The
clearest proof is that non-compliant products are completely absent from the
marketplace in the EU. Although no certifications are legally required, the
availability of ISO 9000 certificate, Ministry of Health Approval, and any
other certification body that guarantees your products composition or safety is
highly favourable by importers and reduces the potentiality of future penalties
or lawsuits.
1)
Is pre-market
registration with the Health Authorities required?
No, there is no pre-market
registration for products at Member State or EU level.
2)
How is
conformity with the Cosmetics Directive ensured?
It is up to the Member States to
ensure that only cosmetic products that conform to the provisions of the
Cosmetics Directive and its Annexes are on the market. This can be achieved
through effective in-market control.
3)
Which
methods are used for in-market survey?
Control of cosmetic products
within the EU is assured through an in-market surveillance system. Inspectors
appointed at national level visit department stores, supermarkets, small shops
and market stalls to check the products being sold. Inspectors may take any
product to official laboratories to be tested for compliance with EU
regulations. If needed, they may also check the product information with the
manufacturer. If there is any irregularity, the person or company responsible
will be penalised.
4)
Do the
Authorities perform cosmetics controls on a regular basis?
Yes, controls are carried out
regularly on a random basis.
5)
How
does the system enforcing the Cosmetic Directive deal with unscrupulous
manufacturers?
The Authorities may have the
right to seize products or to order their withdrawal from the market.
Manufacturers may also be prosecuted and imprisoned and/ or fined. However, the
Authorities are also empowered to work to resolve the issue directly with the
manufacturer through notification, discussion and product changes. This freedom
allows the Authorities to have appropriate response based on the seriousness of
a violation and the commitment of industry to resolve it.
6)
How is
the in-market survey system financed?
This varies from Member State to
Member State. Each Government decides how to manage the system within its own
budget limitations.
7)
What
about notification of production site or place of first importation into the
EU?
Manufacturers in the EU must
notify their manufacturing sites to the Authorities of each relevant EU Member
State, prior to placing cosmetic products on the EU market. The same
requirement applies to all importers into the EU, referring only to the first
site of importation.
1)
What
are the labelling requirements for cosmetics?
-
To
ensure greater transparency for the consumer, Article 6.1 of the Cosmetics
Directive stipulates mandatory labelling of the information below. It should
appear on the container and packaging of each product, in indelible, easily
legible and visible lettering
-
Name
and address of the manufacturer or the importer or distributor of the cosmetic
product within the EU- Nominal content at time of packaging (by weight or by
volume).
-
The
date of minimum durability (only when the shelf life is less than 30 months).
-
Particular
precautions to be observed in use (if regulated in the Annexes).
-
Reference
for identifying the goods (e.g. batch numbers).
-
The
function of the product (unless clear from the presentation).
-
A
list of ingredients in descending order of weight at the time they were added,
according to the INCI nomenclature. This list must be indicated on the
packaging.
2)
Why is
ingredient labelling required?
Ingredient labelling is required by the Cosmetics Directive to help dermatologists to advise consumers in case of allergy. It also helps to ensure greater transparency regarding ingredients used in cosmetics.
3)
Is
ingredient labelling required in the national languages or alphabet?
No, ingredient labelling should
be given in INCI, the International Nomenclature for Cosmetic Ingredients.
4)
Which
nomenclature is used for ingredient labelling?
INCI,
the International Nomenclature for Cosmetic Ingredients, is a common
nomenclature to identify each ingredient used in a cosmetic product and has
been developed by the European and American cosmetic industries. Used by
pharmacists and scientists world-wide, it has already been officially adopted
by the 15 Member States of the EU and by a growing number of other countries in
Europe and beyond, for example, the USA, Australia, Singapore and South Africa.
5)
Isn’t this
ingredient labelling system difficult for the average consumer to understand?
It
is not always easy for the layman to understand technical information.
Chemists, physicians and other health care professionals will understand INCI
names. This is important for dealing with potential adverse reactions and in
identifying individual cases of possible allergy.