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NLF-adapted EU regulations and Notified Bodies

1/25/2016

FINAS and TEM will remind the various bodies of the schedules associated with the evaluations of the NLF compliant directives and EU regulations:


1) National legislation

The legislative work regarding the national implementation of the new directives in the package of directives has been completed only in part. The Ministry of Employment and the Economy (TEM) will provide information on the schedule and progress of the legislative work. For more information on the package of directives, visit TEM’s website.


2) Schedule
The directives included in the package, and still in effect, will be revoked in full (or in part) on 20 April 2016, also leading to an automatic revoking of notifications issued in accordance with the above-mentioned directives. The new directives will be applied as of 20 April 2016. For this reason, all bodies must report their readiness regarding the new directives before the above mentioned date. As the notification procedure is associated with a period during which other member states are allowed to provide comments, and as the extent of the reform can be expected to lead to a backlog, Finland has set as its target that all bodies must have been found to be ready to submit their notifications by 20 February 2016 at the latest.
 
FINAS will carry out evaluations in accordance with the new directives, beginning in part during the summer of 2015 and completing them mainly during the autumn of 2015.


3) Evaluations by FINAS
Whenever possible, FINAS will carry out evaluations related to the new directives as part of evaluations associated with regular accreditation. The various bodies are obligated to apply for assessment in accordance with the regular procedure for submitting applications for change. Applications are asked to be submitted to FINAS in sufficient time in order to take into account the wishes of the applicants regarding the schedule.
 
In accordance with the accreditation requirements, the operation of each Notified Body is accredited according to the requirements of a single standard. Accreditation is defined based on modules covered by the Body's operations. In addition, assessment covers other possibly applied accreditation standards that may be applicable based on the Notified Body's operations and module division. These standards are mentioned in the scope of accreditation.
 
After national legislation has been completed, it will be taken into consideration in evaluations.


4) Application to the Ministry of Employment and the Economy
With regard to regulations falling within the competence of the Ministry of Employment and the Economy (TEM), a body that wishes to become a Notified Body must submit its application to TEM. The application must include complete information on the assessment of conformity, on the module(s) for assessing conformity, on the product(s) in question, and an appropriate certificate on competence.
 
The Ministry of Employment and the Economy will take a decision on the Notified Body, ensuring that the information will be stored in the NANDO database of the Commission.

The body in question may perform the functions of a Notified Body only if the Commission or other member states do not object:
 

  • within two weeks of the submittal of the notification if the body holds accreditation, and
  • within two months of the submittal of the notification if no accreditation is held.


 
NB: The European co-operation body for Accreditation (EA) and the European Commission (EC) are working on a project aimed at specifying an accreditation requirement standard to be used in the first instance for each directive and module. With regard to assessments, FINAS will comply with the results of this project, taking account the schedule specified by EA/EC. 

 

List of the EU regulations applied

Commencement date of application:

  • DIRECTIVE 2009/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 on the safety of toys
  • DIRECTIVE 2010/35/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC
  • REGULATION (EU) No 305/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC

 

Application will commence on 1 July 2015; the administrative branch of the Ministry of Employment and the Economy:

  • DIRECTIVE 2013/29/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (recast)

 

Application will commence on 18 January 2016; the administrative branch of the Ministry of Transport and Communications:

  • DIRECTIVE 2013/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC

 

Application of the directives included in the package of directives will begin on 20 April; the administrative branch of the Ministry of Employment and the Economy:

  • DIRECTIVE 2014/28/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (recast)
  • DIRECTIVE 2014/29/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (recast)
  • DIRECTIVE 2014/30/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast)
  • DIRECTIVE 2014/31/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (recast)
  • DIRECTIVE 2014/32/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast)
  • DIRECTIVE 2014/33/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (recast)
  • DIRECTIVE 2014/34/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)
  • DIRECTIVE 2014/35/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits


Application will commence on 13 June 2016; the administrative branch of the Ministry of Transport and Communications:

 

  • DIRECTIVE 2014/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC

 

Application will commence on 19 July 2016; the administrative branch of the Ministry of Employment and the Economy:

  • DIRECTIVE 2014/68/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast)

 

Application will commence on 18 September 2016; the administrative branch of the Ministry of Transport and Communications:

  • DIRECTIVE 2014/90/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC

 

Further information:

Varpu Rantanen, Lead Assessor, firstname.lastname@finas.fi, tel. +358 29 5052 224

legislation; NLF