Introductory provisions
section 1 of this regulation are notified
1. pursuant to chapter 14. 19 § 1 the Environment Act in respect of 4 and
6 §§,
2. by virtue of section 20 of the personal data Act (1998:204)
section 5,
3. under Chapter 8. section 7 of the Constitution Act in terms of section 8,
4. with the support of 26 kap. section 6 of the environmental code in question on 13 and
15 sections,
5. in General, with the support of Chapter 14. section 8 of the environmental code.
for the purposes Of paragraph 2 of the cosmetic products in accordance with
European Parliament and Council Regulation (EC) no 1223/2009 of the
30 november 2009 on cosmetic products, chemical substances
or mixtures of chemical substances which are intended to
is applied on the external parts of the human body (epidermis, hair and
scalp, nails, lips and external genital organs) or on
the teeth and the mucous membranes of the oral cavity in the exclusion or
main purpose of cleaning or perfuming them, changing
their appearance, protect them, maintain them in good condition or
correcting body odours.
Referred to in article 2(2) of Regulation (EC) no 1223/2009
substances or mixtures which are intended to be swallowed,
inhaled, injected or used as implants in humans
not be considered as cosmetic products.
For the purposes of making available on the market in accordance with
Regulation (EC) no 1223/2009 delivery of a cosmetic
product for distribution, consumption or use on the
the Community market in the course of a commercial activity, to
payment or free of charge.
With end users referred to in accordance with Regulation (EC) no
1223/2009 either consumer or professional use
a cosmetic product.
Other terms and expressions in this regulation has the same
meaning as in chapter 14. the environmental code. Regulation (2014:241).
section 3 of the Regulation (2008:245) on chemical products and
biotechnical organisms there are additional provisions
applies to cosmetic products.
Labeling with information on Swedish
section 4 of the Information referred to in article 19 (1) (b), (c), (d) and (f) of the
Regulation (EC) no 1223/2009 is set at Swedish when a
cosmetic product is provided to the end user on the market
in Sweden.
Even information as referred to in article 19(2) — article 19(4) thereof,
with the exception of the information in the list of
elements referred to in article 19 (1) (g) of the same regulation,
stated on Swedish as a cosmetic product provided
the end user on the market in Sweden. Regulation (2014:241).
Exemptions from the Privacy Act
section 5 of the medical products agency, despite section 13, second subparagraph
personal data Act (1998:204) perform the treatments of
personal data relating to health and which are necessary in order to
comply with the obligations laid down in Regulation (EC) no
1223/2009 and otherwise perform the treatments of
personal data concerning health within the scope of the treatment
covered by the Swedish medical products Agency's regulatory activities.
The MPA is personal responsible for the treatment of
personal data that the FDA in order to fulfil
data referred to in the first subparagraph.
Appropriations
section 6 of the MPA may provide for how
information according to article 19(1) of Regulation (EC) no
1223/2009 shall be provided in the case of cosmetic products which do not
are pre-packaged, are packaged at the point of sale at the buyer's
request or are pre-packaged for direct sales.
section 7 of the MPA may notify such provisions as
referred to in chapter 14. paragraph 2 and 3 of the environmental code in
goods intended for cosmetic and hygiene
purposes and which, because of their content of a cosmetic
product, or because they have been treated with a
cosmetic product likely to cause harm in humans.
section 8 of the FDA may announce further provisions concerning
enforcement of Regulation (EC) no 1223/2009 and this
Regulation.
Competent authority, etc.
section 9 of the medical products agency is the competent authority referred to in
Article 34 of Regulation (EC) no 1223/2009.
section 10 of the MPA is by poison control center the
bodies referred to in article 13(6) of Regulation (EC) no
1223/2009.
Annual report on animal testing
section 11 of the FDA is to report information about animal testing
to the European Commission in accordance with article 35 of the
Regulation (EC) no 1223/2009.
Supervision and fees
section 12 of the Regulations on supervision, see chapter 26. the environmental code and
in the environmental protection Decree (2011:13). Provisions on the
operational supervisory responsibilities associated with this regulation
see Chapter 2. 4, 23, 31, 34 and 35 of the
environmental protection regulation.
Provisions on fees can be found in Chapter 27. the environmental code and the
Ordinance (1998:940) if the fees for the examination and supervision
According to the environmental code.
Notification of decisions
13 § When a municipal board or general physician has announced
an injunction or prohibition under Chapter 26. the environmental code that
related to a cosmetic product, the municipal board and
General doctor also send the decision on the injunction or
prohibition to the MPA.
Review of supervisory activities
section 14 of the food and Drug Administration is responsible for reviewing
supervisory activities, assess how the work and report
the results of the review in accordance with article 22 of the
Regulation (EC) no 1223/2009.
section 15 of the Municipal Board that has responsibility for the supervision of
cosmetic products as well as general doctor should annually to
The medical products agency send a report on the monitoring and
evaluation of supervision that the municipal board and
General physician performed in accordance with Chapter 1. section 12
environmental protection Regulation (2011:13) in the case of supervision of
cosmetic products.
Penalties and forfeiture
section 16 of the 29 Cape. Environment Act lays down rules on the penalties and
confiscation.
