RoHS Harmonized Standard EN 63000 Update

*This blog was updated in May 2020. Further regulatory developments may have occurred after publication.
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On 18 May 2020, the EU published in the Official Journal that standard EN 63000:2018 will become a RoHS Directive harmonized standard which has a presumption of conformity from the date of publication (18 May 2020). By fully complying with a harmonized standard, the EU assumes that the product complies with the application legislation, which simplifies the conformity assessment procedure. The standard EN 63000 outlines the “technical documentation required for assessing materials, components and electrical and electronic equipment drafted in support of Directive 2011/65/EU” [the RoHS Directive]. The Official Journal also announced that the very similar RoHS harmonized standard EN 50581:2012 published in 2012, will cease to provide a presumption of conformity from 18 November 2021.

When a manufacturer fully follows a harmonized standard, there is a presumption that the equipment complies and so the use of harmonized standards can simplify the documentation required to be included in the technical file. Manufacturers list the standards that they use to demonstrate compliance in EU Declarations of Conformity (DoC) and many have included EN 50581 in their products’ DoC to demonstrate compliance with the RoHS Directive. Manufacturers who currently include EN 50581 in their DoCs should note that this standard will continue to give a presumption of conformity until 18 November 2021.

The contents of EN63000 and EN 50581 are very similar and so where a manufacturer has used EN 50581, they would also be very likely to comply with EN 63000. Manufacturers have two options before 18 November 2021:

• Do not change DoCs and continue to include EN 50581 in DoCs, but compare the two standards to determine whether the differences between EN 50581 and EN 63000 have any effect on conformity. If not, then include in the technical file an explanation that the two standards have been compared and as a result, the manufacturer has determined that the differences between the standards make no difference to the product’s compliance with the RoHS Directive, or alternatively
• Before 18 November 2021, check that compliance is not affected by use of EN 63000 and then amend DoCs to include EN 63000