The RoHS Directive restricts chemicals and heavy metals in electronic components, solder, and casing materials. Further, the RoHS Directive applies to essentially all electronic and electrical products imported or manufactured in the European Union.
The requirements of the directive go beyond that of substance restrictions. More specifically, it also covers CE marking and other labeling requirements, technical documentation, harmonised standards, and lab testing requirements.
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What is RoHS?
The RoHS Directive regulates the use of hazardous substances in electrical and electronic equipment (EEE). It also has set up rules regarding the collecting and recycling of EEEs. The purpose of RoHS is to restrict the use of hazardous substances to protect human health, animals, and the environment.
You can read more about the rules of the RoHS Directive, covered products, and lab testing requirements in our articles:
- List of Products Covered by RoHS: An Overview
- RoHS Product Lab Testing: A Complete Guide
- List of RoHS Lab Testing Companies: Our Top 9 Picks
How can I get a RoHS certificate?
There is no such thing as a RoHS certificate. RoHS compliance is primarily demonstrated by providing lab test reports, which in turn provide the following information:
- List of substance tests
- Detected limit or ND*
*ND = Not detected
The RoHS Directive applies to the following categories of electrical and electronic equipment (as listed in Annex I):
- Household appliances
- IT and telecommunications equipment
- Lighting products
- Electrical and electronic tools
- Electronic toys
- Electronic sports equipment
- Medical devices
- Monitoring instruments
- Automatic dispensers
- Other electronics
The RoHS exempts products that concern specific applications, such as:
a. Equipment that is designed for military purposes
b. Equipment that is designed to be used in space
c. Large-scale stationary industrial tools
d. Active implantable medical devices
e. Equipment specifically designed for research and development and only made available on a business-to-business basis
You can find the complete list of covered and exempted products in Article 2 and Annex I of the Directive. Also, if you want to know more about the RoHS substance restriction exemptions, please visit RoHS Directive Annex III and Annex IV.
Which substances are restricted by RoHS?
The RoHS Directive restricts a list of substances and sets the maximum concentration values (by weight) in the covered products as it follows:
- Lead < 0.1 %
- Mercury < 0.1 %
- Cadmium < 0.01 %
- Hexavalent chromium < 0.1 %
- Polybrominated biphenyls (PBB) < 0.1 %
- Polybrominated diphenyl ethers (PBDE) < 0.1 %
- Bis(2-Ethylhexyl) phthalate (DEHP) < 0.1 %
- Benzyl butyl phthalate (BBP) < 0.1 %
- Dibutyl phthalate (DBP) < 0.1 %
- Diisobutyl phthalate (DIBP) < 0.1 %
These restrictions should not apply to the following situations:
a. Mercury in single capped (compact) fluorescent lamps not exceeding (per burner) < 30 W
b. Lead, cadmium, and mercury in detectors for ionizing radiation
c. Lead, cadmium, and mercury in infra-red light detectors
d. Lead in solder in portable emergency defibrillators
Note that other exceptions might also apply.
Electronic components and casing materials are often available as both RoHS compliant components and non-RoHS compliant components. The former does not contain substances above the set limits, whereas the latter category may contain amounts above the set limits.
It’s therefore important to instruct component suppliers to only provide RoHS compliant components. Further, you should also consider requesting test reports or a bill of substances that support the claim that the components are actually RoHS compliant.
Using non-RoHS components can be extremely expensive, as it may not be economically viable to dissemble products that contain even a small number of non-RoHS components.
The RoHS Directive specifies EEE manufacturers’ responsibilities on technical specifications, product labeling, packaging, and more. The requirements are as follows:
a. Ensure that the products do not contain restricted substances over the allowable limit
b. Draw up the required technical documentation and carry out the internal production control procedure according to the requirements of Decision No 768/2008/EC
c. Draw up a Declaration of Conformity (DoC) and affix the CE marking on the finished product
d. Keep the technical documentation and the DoC for 10 years after the product has been placed on the market
e. Ensure that the product or the packaging bears a type, batch or serial number, or other information allowing the identification and tracing of the product source
f. Place the manufacturer’s name, trademark, and address on the product or product packaging
g. When suspecting that the EEEs do not comply with the RoHS Directive, manufacturers should withdraw or recall the products immediately and inform the relevant national authorities
h. When requested, provide necessary information and documentation to demonstrate the conformity of the EEEs with the RoHS Directive to the relevant national authorities
The RoHS Directive also specifies importers’ responsibilities in Article 9 as follows:
a. Make sure that the EEEs comply with technical and regulatory requirements before placing them in the EU market
b. Ensure that the products have technical documentation drawn up by the manufacturer(s)
c. Ensure that the products bear the CE marking and have been assessed according to the requirements of the applicable CE marking directive (s)
d. Indicate importer’s name, registered trade name or trademark, and address on the product or packaging
e. Keep a copy of the DoC for at least 10 years after the product has been placed on the market
f. When the importers suspect that the EEEs do not comply with the requirements of the RoHS Directive, they should not place the product in the EU market until they can confirm that the products comply with the requirements. They should at the same time inform the manufacturer and the market surveillance authorities to take corrective actions
The RoHS Directive requires that all the EEEs covered in the directive should bear a CE Mark and are accompanied by the required technical and administrative documents in the language of the destined market (in the EU).
The CE Mark shall be affixed visibly and legibly on the products or their packaging or accompanying documents when there is a space limit on the surface of the products.
Note that the CE Mark is only allowed to be affixed on the products when they comply with all technical and regulatory requirements set forth in the RoHS Directive, and other CE marking directives and regulations that might apply to the product.
Other Labeling Requirements
Other than the CE mark, it is also the responsibility of the importers or manufacturers to ensure that their products’ labels contain the following information:
a. Type, batch or serial number, or other information showing its identification
b. Manufacturer or importer’s name, registered trade name or registered trademark, and address
c. Manufacturer or importer’s contact information (e.g. email, phone number)
Declaration of Conformity (DoC)
A RoHS Declaration of Conformity (DoC) is a mandatory document that is self-issued by the manufacturer or authorized representative, declaring that the products comply with the directive’s requirements. Manufacturers are responsible for preparing the DoC and technical documentation before placing their products in the EU market.
The RoHS DoC should contain the following information:
a. Unique identification of the EEE (e.g. type number, serial number, batch number, or other identification code)
b. The manufacturer or authorized representative’s name and address
c. A statement that the DoC is issued under the sole responsibility of the manufacturer
d. The identification of EEE, such as product description and photo, when relevant
e. A statement that the EEEs comply with the RoHS’s requirements on substance restriction
f. A list of relevant harmonized or technical standards (e.g. EN IEC 63000:2018)
g. Place and date of issue
h. Signature of the issuer
The RoHS Directive requires that manufacturers should draw up the technical documentation for the EEEs, which is a document that exposes the details of product design, manufacture, and operation.
It also contains information showing the compliance of products to applicable EU regulations or technical standards. Manufacturers will need the technical documentation before they are allowed to affix the CE Mark to their EEEs.
Manufacturers of the EEEs have the responsibility to prepare the technical documentation before placing the products on the EU market. They should also keep a record of the technical documentation for at least 10 years after the products have been placed on the market.
When requested by the market surveillance authorities, manufacturers should provide the technical documentation for their inspection.
The technical documentation should also contain information such as the following:
a. Name and address of the manufacturer or authorized representatives
b. Product description
c. Product identification information (i.e. type number, serial number, batch number, or other code)
d. Name(s) and address(es) of the facilities involved in the design and manufacture of the product
e. A statement indicating that the relevant conformity assessment procedure has been followed
f. A copy of the Declaration of Conformity in accordance with Annex VI of the RoHS
g. Label information and user instructions
h. A statement explaining to which EU regulation(s) or technical standards the product complies
i. Parts list
j. Test reports and results
k. A risk assessment, which aims at identifying possible risks posed by the product, and in which way these risks are addressed (e.g. complying with relevant harmonized standards).
Manufacturers can choose in which language they prefer to prepare the technical documentation. However, the market surveillance authorities may request the manufacturer to translate the technical documentation to the language where the products are placed.
User instructions are documents or brochures that accompany the products, to explain and instruct the end-users on the methods to install, operate, and dispose of products and product applications.
Depending on the specific type of EEEs, the user instruction brochure may also include parts and components replacement methods, potential hazards, warning texts, images, and more.
Even though the RoHS Directive does not mention that manufacturers or importers of the EEEs to the EU should provide instructions to the users, we still recommend that you should provide a user instruction pamphlet or brochure when selling to consumers in the EU.