EUROPE ROHS COMPLIANCE

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Becoming EU RoHS Compliant

EU RoHS Enviropass

RoHS is the top requirement when it comes to product environmental compliance of electrical and electronic devices.

 

You can choose three types of services as needed for your Europe RoHS testing for CE marking certification, according to the current RoHS directive 2011/65/EU (RoHS 2), including the 2015/863/EU amendment (also called RoHS 3):

  • Classic EU RoHS
  • Deluxe EU RoHS
  • Documentary Review... Details below

Ask your free Demo!

Europe RoHS Certification and the Exemptions List

Most complex products benefit from Europe RoHS exemptions, that should be monitored by the manufacturers since they may be modified, replaced or removed like the expired RoHS exemption 7c-iii:

Download
General RoHS Exemptions List
EU RoHS list of general exemptions with applicable expiration dates
RoHS exemptions AH December 7th 2019.pdf
Adobe Acrobat Document 464.7 KB
Download
Medical Devices and Monitoring and Control Instruments RoHS Exemptions List
EU RoHS list of exemptions specific to Medical Devices and Monitoring and Control Instruments
RoHS exemptions Medical Monitoring and C
Adobe Acrobat Document 218.8 KB

CLASSIC EU ROHS

With Classic EU RoHS, you allow Expertise Enviropass to undertake the documentary assessment of your products. 

 

A Certificate of Conformity is issued for each product in compliance with the requirements of Europe RoHS.

DELUXE EU ROHS

Deluxe EU RoHS does not only provide you with fishes… but also teaches you how to fish! Indeed Deluxe EU RoHS includes:

  • Training in products auditing that will allow you to analyze more products yourself.
  • Adapting technical documentation procedures and making you a master in monitoring the compliance of your products in regards to the Europe RoHS.
  • Evaluating a product and issuing a Certificate of Conformity or a corrective action plan.

RoHS Consulting & Documentary Review

You have built the technical documentation for a product yourself, but you want to make sure that the data quality is sufficient to show due diligence? Let Enviropass:

 

  • Review your technical documentation
  • Advise you on potential gaps

  • Issue an applicable Certificate of Conformity


What Does it Mean to be RoHS Compliant?

RoHS Europe

The RoHS is an acronym that stands for the Restriction of the use of certain Hazardous Substances.

 

The current Europe RoHS applicable regulation is Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment and amendments. 

 

It is also called the recast version, or RoHS 2 since it replaces the first RoHS Directive 2002/95/EC.

 

Dozens of amendments have modified the initial version of Directive 2011/65/EU since then.  One of these amendments is the Commission Delegated Directive 2015/863 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances, with the addition of 4 restricted phthalate substances. Since it is a major amendment, the literature often calls it RoHS 3. However, we are still technically under the 2.0 2011/65/EU version of Europe RoHS.

 

RoHS imposes limitations for concentrations of the following substances contained in electrical and electronic equipment:

    • Lead (Pb) and lead compounds
    • Cadmium (Cd) and cadmium compounds
    • Mercury (Me) and mercury compounds
    • Hexavalent chromium (Cr 6+) - CAS # 18540-29-9
    • Polybrominated biphenyls (PBBs), and
    • Polybrominated diphenyl ethers (PBDEs)

From 22 July 2019 (or 2021 for products categories 8 and 9), the following 4 phthalates are also added to the restricted substances list, under delegated Directive 2015/863:

    • Butyl benzyl phthalate (BBP) - CAS # 85-68-7
    • Di-n-butyl phthalate (DBP), - CAS # 84-74-2
    • Di(2-ethylhexyl) phthalate (DEHP) - CAS # 117-81-7, and
    • Diisobutyl phthalate (DIBP) - CAS # 84-69-5
EU RoHS electronics

Importantly, the concentrations of the restricted substances are not regulated at the component level, but at the level of the homogeneous materials, which constitutes each component.


A homogeneous material is defined in article 3 of the directive 2011/65/EU as:

 

'one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes'.


Therefore, one to dozens of homogeneous materials should be analyzed within the same component (i.e. various plastics, metals, ceramics, epoxy finishes, painting, welding, etc.) one by one…


To confirm EU RoHS conformity of an assembly, you should not only consider each electronic component but also the materials of every cable, label, hardware (such as screws...), solder, paste, casing, chassis, etc... in other words, wherever restricted substances may be found.


Since 2013, by labeling an electrical or electronic product with "CE", you are implicitly declaring its compliance with RoHS 2 (RoHS recast) and RoHS 3 requirements according to the Europe RoHS directive, if your product falls in the RoHS scope, as defined in article 2.


If it is out of the RoHS scope, then CE marking may still be mandatory, according to other requirements - related to electrical safety or EMC (electromagnetic compatibility) for example.


RoHS allows restricted substances to be exempted for certain categories of products and applications. However, many of these RoHS exemptions are set to expire.


Therefore, the expiration dates on exemptions must be monitored as they are regularly updated - by default every 5 years.

Categories of EEE covered by Europe RoHS

Europe RoHS applies to most electrical and electronic equipment (EEE), as defined in article 3 of the Directive 2011/65/EU.  However, some products are out-of-scope, such as military, aerospace, or most automotive equipment.  The ELV (End of Life Vehicles) directive applies to most automotive products.

 

Active implantable medical devices, some devices designed for research and development, large-scale stationary industrial tools, or fixed installations are also out of the RoHS scope. 

 

Is my design exempted from RoHS if I only sell to R&D businesses?  And, what is considered 'large-scale'? etc.

 

Let Enviropass help you determine the scope of your products.

Here is, according to the RoHS annex I, the list of electrical and electronic equipment that are currently covered by Europe RoHS:

Europe RoHS scope example

1. Large household appliances.

2. Small household appliances.

3. IT and telecommunications equipment.

4. Consumer equipment.

5. Lighting equipment.

6. Electrical and electronic tools.

7. Toys, leisure, and sports equipment.

8. Medical devices.

9. Monitoring and control instruments including industrial monitoring and control instruments.

10. Automatic dispensers.

11. Other EEE not covered by any of the categories above

Europe RoHS - the Facts

RoHS product assessment

Statistically, manufacturers declare at least one RoHS exemption in 90% of their Printed Circuit Board Assemblies (PCBA) and Electrical and Electronic Equipment (EEE).


As per Directive 2011/65/EU, technical product documentation with procedures must now be prepared and provided upon request to surveillance authorities.


Asking your suppliers whether they are compliant with RoHS or finding a RoHS logo on a specification sheet is not sufficient.


Indeed, the manufacturer’s declarations of conformity (DoC) must be collected, specifying whether exemptions are used and if so, what they are.


Furthermore, it is highly recommended to perform risk assessments on your bill of materials (BOM), or parts list, according to standard IEC 63000  for 'technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances'.


Importantly, the assessed BOM must not only include electronic components, but also any parts or material that are used to manufacture your products, including:

RoHS BOM assessment of an electronic product
  • Solder
  • Finishes, paste, paints
  • Hardware, screws, nuts
  • Buttons
  • Fans
  • Customized parts
  • Screens
  • Cables
  • Connectors
  • PCBs, bare boards
  • Labels on the device
  • Chassis, casing, etc.

In other words, everything that constitutes a device must be considered, except batteriespackaging, and... software!  Specific regulations on heavy metals address batteries and packaging.


Complying with the European RoHS does not automatically imply that your design will conform to the China RoHS.  However, the information already gathered will be valuable and will simplify the compliance process with China RoHS.  The same comment applies to Taiwan RoHS.

How do I get a RoHS Certification?

RoHS Compliance

You must ensure compliance with restricted substances thresholds, and monitor any reported exemptions.

 

In the vast majority of cases for PCBA and complex products, the documentation review from suppliers and subcontractors is the best option because unlike chemical analysis or other analytical tests (i.e. XRF testing), it enables:

Europe RoHS parts list
  • Better money value for the assessment of all the homogeneous materials which constitute a product
  • To check and reuse the tests already carried out by the suppliers instead of redoing them
  • To find out which exemptions numbers have already been claimed
  • To monitor product compliance over the changing requirements (i.e. changes in exemptions) or new designs (i.e. replacement of suppliers, parts, etc.). Only the documents of affected parts will be reviewed
  • To build robust technical documentation.

Since its introduction, the standard EN 50581 / IEC 63000 - Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances - recommends the documentary approach with suppliers, which is recognized by both industry and enforcement authorities.

 

In the absence of sufficient documentation for a component, a risk analysis is conducted and recommendations are given (either chemical analysis or component replacement).

 

Chemical analysis is therefore taken as a last resort, only after a careful documentary review, and focuses on uncertain homogeneous materials only.

Europe RoHS Technical Documentation

With EU RoHS, it is mandatory to build technical file showing the method for verifying a product’s compliance.  

 

The technical documentation must contain specific information documented in the procedure.

Download
Technical Documentation - Table of Contents
Technical Documentation - Table of Conte
Adobe Acrobat Document 353.1 KB

Product Environmental Compliance: Beyond RoHS

For most devices, being EU RoHS compliance is not sufficient to comply with all your product's environmental compliance obligations in Europe.  Here are some of the main applicable EU regulations for your products:

REACH SVHC

RoHS REACH SVHC

Other than RoHS, REACH is another important mandatory obligation in Europe, which applies to chemicals, mixtures, but also products like electronic equipment.  Importantly, the Substances of Very High Concern (SVHC) list controls the use of dozens of substances that may be present in electronic devices.

WEEE

WEEE RoHS compliance

While RoHS tends to reduce the concentration of certain hazardous substances from the design, WEEE (Waste of Electrical and Electronic Equipment) deals with the product's end-of-life by making the producer responsible for the e-waste.

POP

ROHS POP Regulation

The Persistent Organic Pollutant (POP) regulation addresses brominated and chlorinated chemicals.  Like RoHS substances, the idea is to ban or limit the use of some POP hazardous substances that may be found in electrical and electronic equipment.

Is RoHS Testing Required in the USA?

Despite there is no USA RoHS regulation at this time at the federal level, RoHS-like regulations have been published in some US States, like California and New Jersey.  

 

Nevertheless, the federal US Environmental Protection Agency (EPA) makes an effort to control substances use via the Toxic Substances Control Act (TSCA).

 

RoHS-type of regulations in other countries than the European Union and the USA include:

RoHS around the world

As a result, if you design electrical or electronic products that are intended to be sold worldwide, chances are very high that you have to comply with RoHS. And it is always more cost-effective to start by choosing from the design process materials and parts that are compatible with the highest Europe RoHS standards.

 

Needs to know more about RoHS? Please contact Enviropass, get advice, and a Free Demo!

Enviropass Expertise Inc.

Suite 211 - 1750 St-Louis

Montreal, H4L 5N4, Quebec, Canada

Tel: +1 (514) 887-7871