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The International Electrotechnical Commission (IEC) has published the standard EN IEC 63000 to guide technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances

Technical Documentation for RoHS

IEC 63000 Technical File RoHS

Directive 2011/65/EU, commonly known as RoHS, requires manufacturers to supply technical documentation and to do a production control procedure within their company. Additionally, Module A of Annex II of Decision 768/2008/EC details the marking of products, including the CE marking covering RoHS.

With this in mind, the EU Commission has developed a harmonized standard that guides producers in providing proper RoHS documentation.

These standards aim at ensuring that manufacturers properly assess electrical and electronic equipment regarding RoHS. Consequently, they increase trust in producers.

EN 50581:2012


The first standard created by the EU Commission was 50581:2012 EN. This standard was available as of September 21, 2012, with the help of the European Committee for Electrotechnical Standardization (CENELEC).

EN IEC 63000:2016

IEC 63000 and RoHS assessment

Then in 2016, IEC published the first edition of this standard based on the foundation of EN 50581:2012.

When it comes to RoHS compliance, particularly Europe RoHS, this standard is valuable for a product testing documentary approach. It avoids many of the costly RoHS analytical testing methods like XRF analysis at the homogeneous material level.

EN IEC 63000:2018

Finally, at the end of 2018, the European Union released the standard EN IEC 63000:2018, based on the 2016 edition to replace the previous EU standard EN 50581:2012. CENELEC has approved this standard.

European Union Product Environmental Compliance

Similarities and Differences Between Standards

All standards (EN 50581:2012, IEC 63000:2016, and IEC 63000:2018) share a common goal: to specify the documentation that a manufacturer must abide by to declare compliance with applicable substance restrictions such as RoHS.

Indeed, standards EN IEC 63000 and EN 50581 are almost the same concerning the requirements for technical documentation. However, IEC 63000 removed the details specific to the EU RoHS Directive.

Instead, it focuses on the different worldwide regulations for substances and ensures that manufacturers approach them similarly. In addition, it updated the analytical test methods and material declarations from EN 50581:2012 to include the latest developments.


Replacing EN 50581:2012 with EN IEC 63000:2018

It is important to note that as of November 18th, 2021, according to the decision (EU) 2020/659 on May 15th, 2020, the standard IEC 63000:2018 officially replaced EN 50581:2012. This new development involves Europe RoHS technical files and declarations of conformity (DoC).

Therefore, you must update your internal procedures and RoHS technical files accordingly if you have not already done so.

It should also be noted that IEC 63000 is subject to regular amendments. One should use its most recent version.

Which Standard to Use?

What IEC 63000 standard?

Since IEC 63000:2018 has replaced EN 50581:2012 as the appropriate harmonized standard to use, it is necessary to remove any mention of standard EN 50581 in the RoHS declaration of conformity.

This revision is critical for any products on the market still referring to the outdated standard in their Declaration of Conformity. Producers need to make the necessary changes and refer to EN IEC 63000 in order to comply with RoHS 2.

Should you have any questions, or need assistance building your technical file using the RoHS harmonized standards, don’t hesitate to contact Enviropass.