Det kan være svært at forklare på engelsk, hvilke krav man som importør ønsker, at produkterne skal leve op til. For at hjælpe danske importører af komponenter og færdige produkter har Miljøstyrelsen udformet en huskeliste på engelsk, som du kan benytte dig af, når du udformer dine ordrer.
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.
For components to be used by European producers of electric and electronic equipment the following is required:
- The component 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) in homogeneous materials above 0,1 % and Cadmium in homogeneous materials above 0,01%.
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 e.g. by following the harmonized standard EN 50581:2012. 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)).
- 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 in accordance with Article 59 (10) of the REACH regulation.
For components applied in electric and electronic equipment being defined as toys according to 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. The technical documentations of the chemical substances restricted in the Toys directive should relate to the demands described in Annex II part III point 1 to 13.
The European producer should be provided with documentation on these requirements from their suppliers of components.