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How to Comply with EU RoHS
Restricted Hazardous Substances and their Concentration Thresholds under Directive 2011/65/EU
Let's start by showing the basic EU RoHS rule:
|Lead (Pb) and lead compounds||< 0.1% or 1000 ppm|
|Cadmium (Cd) and cadmium compounds||< 0.01% or 100 ppm|
|Mercury (Me) 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|
Do you want to make sure that your product is EU RoHS compliant, but you don’t know where to start?
Knowing the general rule is a good start, but it is not enough... You need a practical approach and a deeper understanding of RoHS. Here is a 7-step guide towards RoHS Compliance to steer you in the right direction and help you achieve this goal.
1. Consider a Cost-Efficient and Eco-Friendly Method to Product Environmental Compliance: The Documentary Approach
While there are many techniques to establish compliance to EU RoHS, the most cost-effective and environmentally conscious solution would be the documentary approach, per Standard IEC 63000 for example, which is recommended by the environmental compliance industry as well as enforcement authorities.
2. Remember that RoHS applies at the Homogenous Material Level
Homogenous materials have a uniform composition that cannot be physically separated.
For example, a metal screw is often composed of two homogenous materials: The core metal and the finish. Both components will have to be assessed for compliance with EU RoHS.
Popular examples of homogenous materials are:
- Stainless steel
- An aluminum alloy
- A coating layer
As a result, an electronic devices typically have hundreds of difference homogeneous materials. For your product to comply with EU RoHS, every homogenous material must contain less than the allowed thresholds of restricted hazardous substances as shown in the table above, unless it has a valid exemption.
3. What do you Need to Establish RoHS Compliance?
The first step in establishing compliance would be to obtain a Bill of Materials (BOM), or parts list, which lists all components used in manufacturing your product and includes:
- The names of the relevant suppliers/manufacturers
- Supplier/Manufacturer part numbers
- Corresponding Internal part numbers
- Part descriptions
4. Obtain a Certificate of Conformity (CoC) from all Suppliers
Suppliers should provide a CoC which explicitly states that the parts in question are compliant with the latest RoHS restrictions.
This CoC, which can be in the form of a written statement or even a label, should mention whether a valid RoHS exemption is being used to establish compliance and should include all RoHS Restricted Substances.
A great way to ensure that all the required information is present and up to date is to use the Enviropass EPEC form which is available for free.
The EPEC form is useful as it includes many regulations such as EU RoHS, REACH, POP (Persistent Organic Pollutants), California Prop. 65, USA TSCA-PBT, the Battery Directive, and the Packaging Directive. Thus, if a supplier fills out this one form, documentation on all these regulations can be collected.
Is a Lead-free Statement Enough?
Unfortunately, a “Lead-free” statement is not sufficient to establish compliance to EU RoHS since it fails to mention the other restricted RoHS substances.
5. What if No Certificate of Conformity (CoC) is Available?
Under certain conditions, other valid forms of statements to establish environmental compliance include a safety data sheet (SDS). Specifically, Section 3 and Section 15 of SDS’ are useful to determine whether restricted substances are present in the product.
6. Build your RoHS Compliance Documentation
Collect and archive all Certificates of Conformity (CoCs), EPEC forms, material declarations, MSDS’ or analytical test results for every part in your BOM.
7. Audit your Product Environmental Compliance Documentation
It is paramount to possess proper and accurate environmental compliance documentation as inadequate or erroneous documentation can be considered to be a form of non-compliance in itself.
Therefore, you should audit and perform risk assessment, per IEC 63000 of your technical file.
Alternatively, full material disclosures (FMD) - or material declaration sheets - are useful to assess whether any of the restricted substances are present above the allowed thresholds.
As a last resort and following a risk assessment, selected samples of materials may need to be tested for RoHS compliance, and analytical test results will be required to confirm the absence of the 10 restricted substances above the allowed thresholds.
Your RoHS assessment procedure should also be documented.
What are the risks of non-compliance to EU RoHS?
While the penalties for EU RoHS non-compliance depend on multiple factors, companies are at a risk of facing potential fines and removal of their product from the EU market. This is why auditing your documentation and performing risk assessments is key!
Other Applicable Regulations in the EU
While it is imperative to be EU RoHS compliant to sell your product in the European market, it is not the only environmental regulation applicable. In fact, EU REACH, with SCIP notifications of substances of very high concern (SVHC), which applies at the component level, pertains to almost all devices sold in the EU.
Other predominant environmental compliance regulations include Persistent Organic Pollutants (POP), the Battery Directive, and Waste Electrical and Electronic Equipment (WEEE) which must also be considered.
Beyond EU RoHS
Similar regulations to EU RoHS exist all around the world. For example, there is China RoHS, UAE RoHS, UK RoHS, Taiwan RoHS, etc. Slight differences exist between these regulations. These variations can exclude the four restricted phthalates, can include differences in product labeling, and can even differ in scope. These are worth keeping in mind if you wish to integrate your product into the global market.
How can Enviropass Help?
Enviropass can assist you every step of the way! Having performed hundreds of quality documentary assessments and product auditing, our dedicated team of specialists can surely assist you by:
- Undertaking the documentary assessment of your products.
- Providing RoHS training in product auditing for you to be able to confidently perform documentary assessments on your own.
- Reviewing and auditing your technical documentation.
- Issuing corrective action plans or certificates of conformity when applicable.
Get your free Enviropass consultation!