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
control.
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
decisions.
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
authority.
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,
and
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.
Authorization
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).