Import af færdigt elektronisk udstyr

For finished electric and electronic equipment to be placed on the market in EU the following is required by the producer outside the EU and compliance should be documented to the EU importer:

  • The equipment must comply with the RoHS-directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast), i.e. the equipment must not contain the following hazardous substances; Lead, Mercury, Cadmium, Hexavalent chromium, Polybrominated biphenyls (PBB), Polybrominated diphenyl ethers (PBDE), Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP)

    The restriction on the use of DEHP, BBP, DBP og DIBP will apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, only from 22 July 2021.

  • The Manufacturers should follow an internal production control procedure in line with module A Annex II to Decision No 768/2008/EC and have the relevant technical documentation drawn up. With respect to the RoHS directive the technical documentations should prove that the hazardous substances listed above are below their respective limit values either by test result or producer declarations.
  • The equipment must not contain substances restricted in Annex XVII of the REACH Regulation (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)).

For finished electric and electronic equipment to be placed on the market in EU the following is required and should follow the equipment and be provided to the EU-importer:

  • An EU declaration of conformity and CE-marking of the product
  • Information on any substances in the product, which is on the Candidate List of substances of very high concern (SVHC ) for Authorization published on the ECHA homepage (http://echa.europa.eu/candidate-list-table) in accordance with Article 59 (10) of the REACH regulation.

For electric and electronic equipment containing batteries the following is required and should be confirmed to the EU-importer:

  • The equipment must comply with the Battery Directive (Directive 2006/66/EC of the European Parliament and the Council of 6. September 2006 on batteries and accumulators).

For electric and electronic equipment being classified as toys according to the definition of toys in the EU toy directive (Toy Safety Directive 2009/48/EC) the following is required and should be confirmed to the EU-importer:

  • The products must comply with the requirements described in Annex II part III point 1 to 13. 
  • The Manufacturers should follow an internal production control procedure in line with module A Annex II to Decision No 768/2008/EC and have the relevant technical documentation drawn up. With respect to chemical substances restricted in the Toys directive the technical documentations should relate to the demands described in Annex II part III point 1 to 13.

Further, for electric and electronic equipment being classified as toys according to the definition of toys in the EU toy directive (Toy Safety Directive 2009/48/EC) the following is required and should follow the equipment and be provided to the EU-importer:

  • The EU declaration of conformity should refer to the both the RoHS directive and the Toys directive.

Siden er opdateret 20. december 2020