Survey and health assessment of cosmetic products ... - Miljøstyrelsen

4 Legislation
In the following the Cosmetics Statutory Order (In Danish:
Kosmetikbekendtgørelsen) is described. This legislation is the legislation relevant
for cosmetic products in Denmark.
In 2009, the EU adopted a new regulation on cosmetic products (Regulation
No 1223, 2009). However, this regulation does not apply before 11 July 2013,
with the exception of a few articles that apply on 1 December 2010 and 11
January 2013. All the cosmetic products investigated in this project were on
the market in the fall of 2009 and therefore they are not regulated under the
new regulation No 1223/2009. Therefore, only the existing legislation relevant
for the investigated products – The Danish Cosmetics Statutory Order, which
implements the EU Cosmetic Directive No. 768 (1976), is described in
details.
The Cosmetics Statutory Order is not described in details here. Instead, focus
is on aspects relevant for non-preserved cosmetics like rules about the content
declaration, shelf life and safety of the cosmetic products.
4.1 The Cosmetics Statutory Order
Cosmetic products are regulated in the Danish “Cosmetics Statutory Order”
– Statutory Order no. 422 dated 4 May 2006 (Stat. Ord. 422, 2006) – with
several later amendments (primarily to appendixes). The statutory order
implements the European provisions in the cosmetics area and includes a
number of provisions about the content of chemical substances in cosmetics
as well as labelling of the products.
According to § 10 of the Cosmetics Statutory Order, cosmetic products that
are marketed in the EU must not be harmful to human health when they are
used under normal conditions or under conditions which reasonably can be
foreseen. A number of restrictions for different chemicals substances as
ingredients in cosmetic products are listed, i.e. only certain preservatives are
allowed (positive list).
4.1.1 Labelling of cosmetic products
Cosmetic products have to be labelled with the following information on the
actual product (Stat. Ord. 422, 2006):
� Company name and address of the manufacturer who within the EU is
responsible for the marketing (§ 19).
� Content in weight or volume (if more than 5 g or more than 5 ml (§ 20)).
� Durability date (if the shelf life is below 30 months (§ 21)).
� Safety regulations for application (§ 22).
� The number of the production batch or the reference specification so
that date and place of production can be identified (§ 23).
� The function of the agent (unless it appears from its presentation (§ 24).
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