EUROPE ROHS COMPLIANCE
Most complex RoHS compliant products benefit from EU RoHS exemptions, that should be monitored by the manufacturers since they may be modified, replaced or removed like the expired RoHS exemption 7c-iii.
EU RoHS Certification and the Exemptions Lists
Becoming EU RoHS Compliant
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 does not only provide you with fish… but also teaches you how to fish! Indeed Deluxe EU RoHS includes:
- RoHS 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.
What Does it Mean to be EU RoHS Compliant?
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 (Hg) and mercury compounds
- Hexavalent chromium (Cr 6+) and hexavalent chromium compounds
- 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
| Substance Name | Concentration Limit |
| Lead (Pb) and lead compounds | < 0.1% or 1000 ppm* |
| Cadmium (Cd) and cadmium compounds | < 0.01% or 100 ppm |
| Mercury (Hg) and mercury compounds | < 0.1% or 1000 ppm |
| Hexavalent Chromium (Cr6+) and hexavalent chromium compounds | < 0.1% or 1000 ppm |
| Polybrominated biphenyls (PBBs) | < 0.1% or 1000 ppm |
| Polybrominated diphenyl ethers (PBDEs) | < 0.1% or 1000 ppm |
| Butyl benzyl phthalate (BBP) – CAS # 85-68-7 | < 0.1% or 1000 ppm |
| Di-n-butyl phthalate (DBP) – CAS # 84-74-2 | < 0.1% or 1000 ppm |
| Di(2-ethylhexyl) phthalate (DEHP) – CAS # 117-81-7 | < 0.1% or 1000 ppm |
| Diisobutyl phthalate (DIBP) – CAS # 84-69-5 | < 0.1% or 1000 ppm |
*ppm: parts per million
7 potential RoHS hazardous substances in use in electrical and electronic equipment are being assessed for possible inclusion in the Europe RoHS list:
- Beryllium & its compounds
- Cobalt Dichloride & Cobalt Sulphate
- Diantimony Trioxide
- Indium Phosphide
- Medium Chain Chlorinated Paraffins (MCCPs)
- Nickel Sulphate & Nickel Sulfamate
- Tetrabromobisphenol A (TBBP-A)
MCCPs and TBBP-A, which are used in plastics, are already recommended for approval. Such an amendment to the RoHS directive should not be implemented before 2027.
‘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 one by one within the same component (i.e. various plastics, metals, ceramics, epoxy finishes, painting, welding, etc.).
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 the RoHS scope, such as some photovoltaic panels, 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‘?
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:
EU RoHS Compliant Products - the Facts
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 materials that are used to manufacture your products, including:
In other words, everything that constitutes a device must be considered, except batteries, packaging, and… software! Specific regulations on heavy metals address batteries and packages compliance requirements.
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 Certification of RoHS-Compliant Products?
RoHS Compliance
To avoid costly RoHS violations, 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:
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.
Once a product assessment is completed and positive, then the outcome is a declaration of conformity (DoC). The annex VI of the Europe RoHS directive shows what a DoC must contain. It is recommended to name the standard IEC 63000 under section 6 and to list the exemptions under section 7 of the DoC, if applicable. The DoC can, therefore, be provided on demand to surveillance authorities or any other stakeholder.
Europe RoHS Technical Documentation
Environmental Compliance: Beyond EU RoHS Compliant Products
For most devices, being EU RoHS compliant 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:
Is RoHS Testing Required in the USA?
Despite that there is no USA RoHS regulation at this time at the federal level, RoHS-like regulations have been published in some US States, like RoHS in 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:
EU RoHS FAQ
