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Regulation (2014:1039) On Market Surveillance Of Products And Other Related Supervision

Original Language Title: Förordning (2014:1039) om marknadskontroll av varor och annan närliggande tillsyn

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Introductory provisions

section 1 of this regulation complements the following EU regulations:

1. European Parliament and Council Regulation (EC) no 765/2008

of 9 July 2008 setting out the requirements for accreditation and

market surveillance relating to the marketing of products and

repeal of Regulation (EEC) No 339/93, as regards the

market surveillance of products,

2. European Parliament and Council Regulation (EC) no 764/2008

of 9 July 2008 laying down procedures relating to the application of certain

national technical rules to products lawfully

marketed in another Member State and repealing decision

No 3052/95/EC, and

3. Council Regulation (EC) No 2679/98 of 7 december 1998

about the functioning of the internal market in the context of the

free movement of goods between Member States.

The regulation also contains other provisions regarding

market surveillance and of the intelligence and

Advisory duty in some cases.

Expression of the regulation

paragraph 2 of this regulation means

market surveillance: the activities of a public body

or a municipality carries on and the actions that it is taking

to ensure that a product available on the market

complies with the applicable requirements,

market surveillance authority "shall mean a State authority or a

municipality responsible for carrying out market surveillance, and

coordinating authority: a government market surveillance authority

which, according to the regulations has central responsibility for

guidance or coordination within a certain area.

Market surveillance programmes and information to

the public

paragraph 3 of the State market surveillance authorities shall annually draw up

and carry out market surveillance programmes and follow up

previous years ' programs. Authorities should submit these to the

The Swedish Board for accreditation and technical control.

Municipal market surveillance authorities shall assist the coordinating

authorities with a basis for applications referred to in the first subparagraph.

section 4 of the Government market surveillance authorities shall inform the

the public about their activities and leave the corresponding

information to the Board for accreditation and conformity


Market surveillance Council

§ 5 In the Swedish Board for accreditation and technical control

There is a market surveillance Council.

The Director-General of the Swedish Board for accreditation and conformity

control is market surveillance Council President.

Market surveillance Council shall decide on the rules of procedure.

6 § market surveillance Council is made up of State

market surveillance authorities, the Board of trade and the Customs and Excise Department.

The market surveillance authorities that are part of the Council set out in the

the annex to this regulation.

Even bodies other than those referred to in the first paragraph, on

invitation of market surveillance Council Chair participate in meetings

in market surveillance Council.

Market surveillance the President nominates the representatives of the

market surveillance authorities which form part of the Council, acting on a proposal

from these authorities.

section 7 market surveillance Council

1. serve as a national coordinating body in matters of

market surveillance,

2. promote collaboration and efficiency in the control,

3. organise the continuous exchange of experiences,

4. be responsible for the dissemination of General information on

market surveillance,

5. facilitate public and business contacts with

the market surveillance authorities,

6. promotion of cooperation with the market surveillance authorities of other

Member States, and

7. annually prepare and implement a national action plan

for market surveillance.

section 8 market surveillance Council shall consult with and obtain

comments relevant to market control from

authorities, representatives of the business community, consumers and

other stakeholders.

§ 9 the Swedish Board for accreditation and technical control is responsible

the Secretariat in market surveillance Council and shall

1. establish and make available to the public a

list of the national market surveillance authorities,

their responsibilities and contact persons, as well as provide this

information to the European Commission, pursuant to article 17(1)

of Regulation (EC) no 765/2008,

2. make available to the public, the program and

plans for surveillance as specified in section 3 and section 7 of the

7 and shall inform the European Commission thereof.

The documents referred to in the first subparagraph shall be submitted to

the Government.

Exchange of information between authorities and the European

the Commission

section 10 of the Consumer Agency should be responsible for providing information

to the European Commission in the system for fast

Exchange of information (RAPEX) pursuant to article 20 (1) and 22 of the

Regulation (EC) no 765/2008.

The market surveillance authorities shall provide the consumer the

information that really need to be able to fulfil their

obligations under the first subparagraph.

Swedish Board for accreditation and verification,

administer the General information support system (ICSMS)

According to article 23 of Regulation (EC) no 765/2008 as

market surveillance authorities should use.

section 11 of the Government, but provincial governments,

inform the Board of trade about the decisions they have made

to economic operators pursuant to article 6(2) of Regulation (EC)

No 764/2008.

Municipalities and county councils will leave decision pursuant to the first

paragraph to the coordinating authorities. The coordinating

authorities shall inform the Board of trade.

National Board shall notify the European Commission of


section 12 of the State authorities or municipalities that decide if

temporary injunction in accordance with article 7 of Regulation (EC) no

764/2008 shall fulfil its obligation vis-à-vis

The European Commission, in conjunction with the

authority to notify the economic operator concerned, submit

decision to the Board of trade, which immediately

forward it to the European Commission.

County Councils or municipalities that informs a decision under

the first subparagraph shall also inform the coordinating


paragraph 13 of the Information referred to in paragraphs 10 and 12 shall be supplied without delay.

Responsibility of the Board of trade as contact point

section 14 of the Board of trade, as contact point in accordance with article 9 of

Regulation (EC) no 764/2008

1. fulfill the obligation which the contact point under the

Article 10 of the regulation, and

2. provide the Government with statistics and data for the annual

reporting to the European Commission, pursuant to article

12 of the regulation.

15 § public authorities and municipalities shall, without delay,

provide the information needed to Trade in

as a point of contact to provide information

According to article 10 of Regulation (EC) no 764/2008.

Procedures in response to the actual obstacles to

the free movement of goods

section 16 of the National Board, on behalf of Sweden

1. fulfill the obligation for Member States

referred to in articles 3 to 5 of Regulation (EC) No 2679/98,


2. receive the information referred to in article 4(2)

and 5(1) of that regulation.

section 17 of the Police, the customs service and the coast guard should

without delay inform the National Board of

1. the obstacles referred to in article 1 of Regulation (EC) No 2679/98

and of which they become aware in the course of their activities, and

2. the measures taken or envisaged to

remove the obstacles.

The authorities referred to in the first subparagraph shall, on request,

submit such information to the Board of trade who is

necessary to enable the authority to discharge its

information under section 16. Regulation (2014:1304).

Intelligence and advisory obligation

Notice to Government and other agencies

section 18 of the National Board, the Swedish Board for accreditation and

technical control and consumer protection agency should keep the Government and

the relevant authorities informed on the details of particular

importance for the application of this regulation.

Notification of the formal objection to standards

section 19 of the State market Inspectorate shall inform the

National Board if there is reason to object to a

harmonised standard referred to in article 11 of the European Parliament

and Council Regulation (EC) no 1025/2012 of 25 October

2012 on European standardisation and amending Council

Directive 89/686/EEC and 93/15/EEC and decision of the European Parliament

and Council Directive 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,

98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC

and repealing Council decision 87/95/EEC and

European Parliament and Council decision 1673/2006/EC, or

the proposal for such a standard on the basis that the standard

does not meet the requirements that it aims to fulfill.

Advisory obligation

section 20 of the National Board, the Swedish Board for accreditation and

technical control and consumer protection agency should, within the framework of their

respective areas of responsibility, provide advice to other agencies on

the application of this regulation.


paragraph 21 of the Board of trade may provide for

enforcement of 11 – 12, 15 sections and section 17, second subparagraph.

Annex/expires U: 2016-01-01-list of market surveillance authorities in accordance with paragraph 6 of

included in market surveillance Council

The Swedish work environment authority

Building and planning

The Swedish National Electrical Safety Board

The Swedish Energy Agency

Inspectorate for health and social care

The Swedish Chemicals Agency

The Swedish consumer Agency

The medical products agency

Authority for radio and television

The Swedish civil contingencies Agency

The Swedish environmental protection agency

The Swedish post and Telecom Agency

The National Board of health and welfare

The Swedish radiation safety authority

The Swedish Board for accreditation and technical control

Transport Agency

Entry into force annex/in: 2016-01-01-list of market surveillance authorities in accordance with paragraph 6 of part of market surveillance Council

The work environment authority Swedish National Electrical Safety Board Energy Authority Inspectorate for health and social care

The Swedish Chemicals Agency Consumer Agency FDA Authority for press, radio and television, the Swedish civil contingencies agency environmental protection agency Swedish National Post and Telecom Agency National Board of the Swedish radiation protection authority Swedish Board for accreditation and control Transport Agency Regulation (2015:625).