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Regulation (2013:413) On Cosmetic Products

Original Language Title: Förordning (2013:413) om kosmetiska produkter

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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.


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


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


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