Scope of application and definitions
section 1 of this Act is complementary to the European Parliament and of the 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 repealing Regulation (EEC) No 339/93, when
terms of accreditation and CE marking.
This law shall also apply in respect of
1. bodies which are notified to the European Commission and the other
Member States for information in connection with the assessment of the
conformity according to harmonised EU legislation,
2. bodies which are notified to the European Commission for information
in relation to conformity assessment according to agreement
The European Union concluded with third countries,
3. national standards laboratories and laboratories for the measurement, and
4. additional accreditation by the Swedish Board for accreditation and
technical control.
section 2 for the purposes of this Act applies to the definitions
see Regulation (EC) no 765/2008.
paragraph 3 of the assessment of conformity and other technical control
performed under this Act by or with the involvement of
accredited agencies or bodies referred to in paragraph 1, second subparagraph
1 and 2 If the control
1. is prescribed in law or regulation,
2. have been imposed on anyone by decision of a public authority, or
3. after completion, specific legal effect under the law
or other statutes.
Accreditation
Accreditation bodies, etc.
section 4 of the Swedish Board for accreditation and verification
designated to be national accreditation body, is responsible for
accreditation in accordance with Regulation (EC) no 765/2008.
The Board is also responsible for accreditation in other organs
for conformity assessment.
When such accreditation referred to in the second paragraph, article
5.1 and 5.3 – (4) of Regulation (EC) no 765/2008 shall apply.
Decision on accreditation
5 § the Swedish Board for accreditation and technical control decides
in the case of accreditation in accordance with article 5(1) of Regulation (EC)
No 765/2008. Accreditation is granted by the issue of
accreditation certificate.
Accreditation certificate is valid for a fixed period or until further notice and
shall contain the conditions that apply for accreditation.
When the accreditation certificate may be limited or withdrawn
section 6 of the Swedish Board for accreditation and conformity control decides
If the limitation or revocation of a certificate of accreditation
According to article 5(4) of Regulation (EC) no 765/2008.
The Board of Directors may determine that a decision on the limitation or
withdrawal of accreditation certificate will apply with immediate
effect.
Bodies to be notified to the European Commission and the
other Member States
How conformity assessment body shall be appointed and notified
section 7 If a conformity assessment body requests
be appointed and notified for information in connection with the assessment
of conformity, the Swedish Board for accreditation and
technical control in consultation with the relevant authorities to determine whether
body meets the requirements for the indication in question
According to
1. harmonised EU legislation, or
2. agreements which the European Union concluded with third countries.
In such cases covered by the first subparagraph of paragraph 1, the Board of Directors
assessment done by accreditation, unless otherwise
before written.
Such bodies referred to in the first subparagraph of paragraph 2 shall be deemed to meet the
the requirements correspondingly for the task in question if the
they appear meet the requirements of the applicable standards by
accreditation or equivalent procedure.
8 § the Swedish Board for accreditation and technical control makes
decision to designate bodies for registration that meets the
the prerequisites under section 7.
§ 9 When a body has been designated under section 8 for information under the
7 paragraph 1, should the Swedish Board for accreditation and
technical monitoring report the body to the European Commission
and the other Member States, and shall inform the European
the Commission and the other Member States of any changes in
notification.
When a body has been designated under section 8 for information under section 7
item 2 of the first paragraph, the Board of Directors shall notify the body to the European
the Commission and inform it of any changes to the notification.
When the notification of conformity assessment bodies,
be limited or withdrawn
section 10 of the Swedish Board for accreditation and technical control,
decide to restrict or withdraw, temporarily or completely
a notification under section 9 If the notified body no longer
meets the requirements for carrying out the tasks
been notified, or has seriously failed to meet their
obligations.
The Board of Directors may determine that a decision on the limitation or
withdrawal of notification of a body shall apply with
immediate effect.
National standards laboratories and laboratories for the measurement
section 11 with the national laboratory referred to a body which has been designated to
a certain greatness officially responding for such measurement as in
relation to national measurement standards or scientific
defined units of measurement to ensure accuracy of measurements
carried out within the country and ensure that these measurement standards and
units of measure are affiliated with internationally accepted units.
section 12 of A national laboratory appointed by the Government for one or more
greats.
section 13 Laboratories that carry out metrological activities,
accredited to perform metering that should not occur in a
National Laboratory.
CE marking
The conditions for the CE marking
section 14 of the provisions concerning the CE marking provided for in article 30(1) to in
Regulation (EC) no 765/2008 and acts that have been designed
for some products, in accordance with the Council resolution of 7
May 1985 on a new approach to technical harmonisation and
standards.
section 15 CE marking of a product may only be made
1. If the labelling is in compliance with the specified in paragraph 14 of the
acts, and
2. If, when the Act consists of directives, regulations on
identification is in the law that implements the
the directive.
Obligation to take corrective action
section 16 If a product is CE-labelled, although it does not
in conformity with the requirements of the CE marking, the
responsible for CE-marking immediately take corrective action so
the infringement ceases.
Responsibility
section 17 of The who wilfully or negligently contravenes section 15
shall be liable to a fine if the Act is not subject to punishment according to the
other statutes.
The person who has infringed a imposition of fines handed down with
support of other statutes, shall not be liable under the
the first paragraph of an offence covered by the injunction.
Supervision
section 18 of the Swedish Board for accreditation and control exercise
overseeing the bodies referred to in this Act or in the
regulations issued under the law.
section 19 of the Swedish Board for accreditation and technical control has the right
that of bodies covered by the supervision on request
access to premises, as well as access to information and
documents to the extent necessary for the purposes of supervision.
Fees
section 20 of the national standards laboratories may levy a fee to cover the costs
for measurements according to what the Government or the
authority the Government closer.
paragraph 21 of the Accredited body or bodies that are assessed under section 7 shall
pay the fee to the Board for accreditation and conformity
check to cover the costs of accreditation, supervision
and assessment.
Privacy
section 22 of The dealing with a matter under this Act,
not improperly disclose or make use of what he or she thereby
been told if anyone's business or operating conditions.
In the public activities apply instead the provisions
in publicity and secrecy (2009:400).
Penalty
Conditions for the decision on penalty
section 23 of the Swedish Board for accreditation and technical control,
decide to charge a penalty of the unduly has
stated to be accredited or registered by the Board of
information in relation to conformity assessment.
The fine may be imposed even if the violation is not
committed with intent, recklessly or negligently.
section 24 of the Swedish Board for accreditation and technical control,
decide to take out the penalty by someone only if he has
been served a notice that the Board is considering taking
such a decision within five years of the infringement
occurred.
section 25 of the penalty may not be imposed for an infringement
subject to a penalty payment mechanism or a sanction under
other statutes.
Penalty may not be imposed for a violation of
the penalty has been imposed under other statutes.
Amount
section 26 of the penalty may be imposed in an amount determined by
account of the nature and scope of what is known
If the offender's economic conditions and fees
the facts are otherwise.
The Government may provide for how the fine
to be determined.
Exemption from penalty
section 27 If a violation is excusable or that of someone else
reason would be unfair to charge a fee,
It referred to in section 23 is wholly or partly released from
penalty.
The first paragraph also applies if it hasn't produced anything
claim for exemption from penalty.
Decision on the penalty
section 28 of the Swedish Board for accreditation and verification,
immediately inform regulators about the decision taken to
take out the penalty.
The Board shall also inform others that also have the opportunity to
take sanctions against infringement.
section 29 decision to fine to be levied from a physical
person shall be made to the County Administrative Board in the county where this has
their place of residence.
Decision to fine to be levied from a legal person
should be sent to the County Board in the county where this has its
seat.
section 30 of the penalty to be paid to the County Board where the
charging the culprit has his habitual residence, domicile or registered office. Payment must
be made within two months of the decision on the penalty
became final. An indication of this should be mentioned in the decision.
If the fine is not paid within the time specified in the
first subparagraph, shall also include a late-payment fee under
Act (1997:484) If late payment fee.
If the fine is not paid within the time specified in the
the first subparagraph, the County Administrative Board to which payment would
have occurred to request recovery of the fine and the
late payment fee to be charged in accordance with the second subparagraph.
Provisions of the Recovery Act (1993:891) if
recovery of State assets, etc. and in
enforcement regulation (1993:1229). During recovery,
enforcement under the enforcement code occur.
section 31 of the fine to the State.
32 § penalty falls away to the extent
enforcement has not been made within five years from the
the decision became final.
Appropriations
33 § Government or authority the Government determines
may provide for accreditation.
The Government or the authority that the Government may
provide, in the case of bodies to be notified under
§ 9.
Appeal
34 § decision under 5, 6 and 8 of the first paragraph, section 10, 19, 21
and 23 sections may be appealed to the administrative court.
Leave to appeal is required for an appeal to the administrative court.
Transitional provisions
2011:791
1. this law shall enter into force on 1 August 2011. By the law
repeals the Act (1992:1119) if technical control and the law
(1992:1534) about CE marking
2. A body notified under the Act (1992:1119) if
technical control of data in the context of the assessment of
conformity shall continue to be authorized to
carry out the tasks which it has been notified, provided
to meet the demands made at the time of notification.
This applies until 31 december 2014,
or the time before that when the Board for accreditation
and technical control makes a reassessment of the body.
3. for the purposes of section 6 of the equivalent accreditation certificate
decision on accreditation granted under the Act (1992:1119)
If technical control.
4. the provisions on sanctioning fee shall apply only to
violations that have taken place after this Act came into
force.
5. In other respects, shall apply the provisions of this law concerning
national standards laboratories, as well as accredited and notified bodies, even on
bodies at the time of entry into force is the national standards laboratories, or
accredited and notified, in accordance with the Act (1992:1119) if
technical control.
