How do I know if my product is required be RoHS certified?

#1
Dear Gentlemen,

I have a product for Automotive Industry which was questioned for RoHS, I know many Directives in EU are also harmonised with RoHS, so
following the RoHS guidelines for product composition is vital, however, how do I know if my component (Electronic assembly) needs a RoHS Certificate?

Thank you,

Best Regards

Marcel
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Good day Marcel, welcome to The Cove!

The easiest way to learn if your product is required to conform to RoHS is to ask your customer. If you have been provided with drawings/specifications or access to them, the requirement would likely be within them.

If you don't have access to these specifications or they do not provide this information, ask your Customer Service person to give you contact information for your customer(s) so you can inquire based on part numbers.

I hope this helps!
 
#3
Hi Jens, thank for the warm welcome.

In fact, our customer is aware of the RoHS, (but it seems they leave that to us) but as we assemble components and transform it into modular parts, we can have our suppliers (electronic components) to have RoHS certificates. Through the just google: mdsystem.com/imdsnt/startpage/index.jsp IMDS database it is possible to have a lot of info on materials used for Automotive industry, if we have suppliers who are RoHS certified, we are ok.

However, if we have any doubt we must test it, invidually as importers of products in Europe, our company is also responsible for not using the materials described in the RoHS catalogue. So to avoid liability, certificates must be documented and in case of doubt, we may require a test. That is what I learned from other Certification companies.

The good thing is that we really do not need a test or a certificate to comply, if all our assembly products and materials carry a RoHS certificate. However, if there are some materials, components, we are not sure, it would be better to change supplier.

That is what I found on it, but thank you for the input it helped to confirm what I found.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Good day Marcel,

The best way to manage this is through procurement of RoHS conforming materials with which to accomplish your assembly processes as per the requirements of your customers. Many of my suppliers provide documents declaring this due diligence has taken place. In the potential event of an audit, I recommend you retain RoHS certifications for your raw materials and to be prepared to show how those materials came to be included in your assemblies. Traceability is important.

I hope this helps!
 

Alex73

Involved In Discussions
#5
Hi Jens, thank for the warm welcome.

Through the just google: mdsystem.com/imdsnt/startpage/index.jsp IMDS database it is possible to have a lot of info on materials used for Automotive industry, if we have suppliers who are RoHS certified, we are ok.
Hi Marcel,

The IMDS database is related with the automotive EU ELV directive.

On the other hand, RoHS (2011/65/EU) applies to electrical and electronic equipment (EEE). See annex I of the directive to know which categories of EEE are covered. However, in my opinion, if you do not have feedback from your customer then the boundary is not clear. Take as an example a CD player (the hardware), if it is been used in a Walkman then RoHS applies but if it had been used in a car stereo then ELV applies. Thus, it is always a good idea to know your final product will be used.

As you mentioned, IMDS can provide a lot of information regarding the material composition. But please be aware that the IMDS (i.e. ELV) exemptions are different from the RoHS exemptions. An example of that is Cadmium that is allowed by RoHS but cannot be used any more on the automotive industry. On such situation either you have to contact the supplier to know the correct RoHS exemption or you take the responsibility to select.

For more details please check:
Waste - Environment - European Commission
Electrical and electronic waste - Environment - European Commission

Some customers may request RoHS because of the phthalates (mainly the DEHP that is a REACH SVHC).


Hope this can help you.

Alex.
 
#6
Good day Marcel,

The best way to manage this is through procurement of RoHS conforming materials with which to accomplish your assembly processes as per the requirements of your customers. Many of my suppliers provide documents declaring this due diligence has taken place. In the potential event of an audit, I recommend you retain RoHS certifications for your raw materials and to be prepared to show how those materials came to be included in your assemblies. Traceability is important.

I hope this helps!

Pretty good to know, that is one of the ways I was thinking about it, now I have one confirmation about it.
 
#7
Hi Marcel,

The IMDS database is related with the automotive EU ELV directive.

On the other hand, RoHS (2011/65/EU) applies to electrical and electronic equipment (EEE). See annex I of the directive to know which categories of EEE are covered. However, in my opinion, if you do not have feedback from your customer then the boundary is not clear. Take as an example a CD player (the hardware), if it is been used in a Walkman then RoHS applies but if it had been used in a car stereo then ELV applies. Thus, it is always a good idea to know your final product will be used.

As you mentioned, IMDS can provide a lot of information regarding the material composition. But please be aware that the IMDS (i.e. ELV) exemptions are different from the RoHS exemptions. An example of that is Cadmium that is allowed by RoHS but cannot be used any more on the automotive industry. On such situation either you have to contact the supplier to know the correct RoHS exemption or you take the responsibility to select.

For more details please check:


Some customers may request RoHS because of the phthalates (mainly the DEHP that is a REACH SVHC).


Hope this can help you.

Alex.

Thanks a lot, listing about the exceptions was really nice. I will check deeper into RoHS and ELV Direktive, in my case here we manufacure power components for E-vehicles. I have here a book that says it would apply to any EEE (Electrical and Electronic Equipment) not exceeding 1000 Vac and 1500 Vdc. In Automotive, not all CE directives are applied, because the automotive type approval is controlled by ECE norms, which are some in the DNA of CE directives. But I will go deeper into the differentes between ELV and RoHS. Thanks a lot for the valueable input.
 
Thread starter Similar threads Forum Replies Date
J Is Design Validation required for fixtures or test systems used to manufacture a product? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Is Certificate of Conformance required for an OEM released product? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M ISO 13485 Required for CE Mark on Class I product CE Marking (Conformité Européene) / CB Scheme 1
A Level of details required for Class IIb Product Verification and Validation CE Marking (Conformité Européene) / CB Scheme 1
R Are the ISO Standards actually required for health product registration on ANVISA? Other Medical Device Regulations World-Wide 4
M Is 510k Required for Adding a section on use of Disinfectants to Product Manual? US Food and Drug Administration (FDA) 3
K Is compliance to IEC 60601-1 Required for my Product? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
N Extent of Product Traceability Required by ISO 13485 (Low Level Class I Devices) ISO 13485:2016 - Medical Device Quality Management Systems 3
R New product testing for CE marking - Required FCC testing CE Marking (Conformité Européene) / CB Scheme 4
J AS9100 Clause 7.4.3 Verification of Purchased Product - OEM C of C required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J What is required in Product Specifications? ISO 13485:2016 - Medical Device Quality Management Systems 3
K What is required to sell a medical product in the US? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
V ISO 14971: 2007 Risk Management File - Separate file required for each product? ISO 14971 - Medical Device Risk Management 3
R Change Control Required? Changes during the product gamma phase IATF 16949 - Automotive Quality Systems Standard 3
R Final Product Prints - Are Final Product Prints required by ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A 6.2.2.1 Product Design Skills required for the personnel of Product Engineering Design and Development of Products and Processes 1
J Where traceability is required, the unique identification of the product is recorded ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Documentation required when doing a PPAP for a "Product Family" APQP and PPAP 6
Y NPI (New Product Introduction) Process Qualification System Required Document Control Systems, Procedures, Forms and Templates 8
A What is required to export Class I (non exempt) 510(k) approved product to Mexico ISO 13485:2016 - Medical Device Quality Management Systems 3
P New product Design & Development for automotive requirements - Documents required Design and Development of Products and Processes 4
S P-Chart Question - Need Guidance - 100% inspection of all product parts required? Statistical Analysis Tools, Techniques and SPC 11
J APQP - List of SKPC's (significant key product characteristics) Required? APQP and PPAP 1
V Product Audit - What is actually required to be audited during product audit? Various Other Specifications, Standards, and related Requirements 5
S Personnel safety to achieve product quality as required by TS 16949 Clause 6.4.1 IATF 16949 - Automotive Quality Systems Standard 4
Y New Japanese EMC/electrical safety standards - Additional product testing required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
A Software bug fixes after shipping a product EU Medical Device Regulations 3
S How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
S California Cleaning Product Right to Know Act - Product Label advice needed Miscellaneous Environmental Standards and EMS Related Discussions 1
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
H PCD remains valid for new product ISO 13485:2016 - Medical Device Quality Management Systems 11
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
E How do you determine if hipot is necessary for a cable product? Manufacturing and Related Processes 8
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
N Authorised Representative details on product label? EU Medical Device Regulations 1
D Importing a general wellness low risk product Other US Medical Device Regulations 3
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8

Similar threads

Top Bottom