Table of Contents
- What Is RoHS?
- What Is the CE Marking?
- Origins of the RoHS CE Marking Requirement
- When Is a CE Marking Necessary?
- Why Is the RoHS CE Marking Important?
- RoHS 2 Requirements for the CE Marking
- What Does a CE Marking’s Technical File Include?
The EU Restriction of Hazardous Materials (RoHS) directive requires manufacturers to affix a visual CE marking on electronic products before they are put on the market.
This article briefly describes the RoHS directive itself before delving into the specifics of the CE marking, including what it is, why it’s important, and what requirements must be met to create a CE marking.
What Is RoHS?
The RoHS directive, issued in the European Union, restricts the use of ten hazardous materials in electronic and electrical equipment (EEE). A product is RoHS compliant if it does not exceed the allowable amounts of these restricted substances. All EEE sold in the EU must be RoHS compliant.
To be RoHS compliant, EEE must not contain any of the following hazardous substances in amounts larger than 1000 ppm. These materials are deemed to be hazardous to human health and the environment.
- Cadmium (Cd) [The allowable amount for cadmium is 100 ppm.]
- Mercury (Hg)
- Lead (Pb)
- Hexavalent Chromium (Cr VI)
- Polybrominated Biphenyls (PBB)
- Polybrominated Diphenyl Ethers (PBDE)
- Bis(2-Ethylhexyl) phthalate (DEHP)
- Benzyl butyl phthalate (BBP)
- Dibutyl phthalate (DBP)
- Diisobutyl phthalate (DIBP)
Read more: What is RoHS?
What Is the CE Marking?
The CE marking is a visible mark on the product in the shape of stylized C and E letters, which stands for Conformitè Europëenne. A CE marking represents the manufacturer’s declaration that their product complies with all EU directives requiring a marking, including RoHS.
The CE marking visually demonstrates to authorities and consumers that an EEE product meets all RoHS requirements. A CE marking must be put on a product before it is put on the EU market.
The CE marking also shows that the manufacturer has the appropriate documentation proving compliance. Before placing the CE marking on a product, a manufacturer must create a technical file, a set of data that includes information about the product and steps taken to ensure the product meets RoHS requirements.
Read more about what must be included in a technical file below.
Origins of the RoHS CE Marking Requirement
The CE marking on a product shows that the product complies with all European Union directives that require a CE marking, not just RoHS. RoHS became a ‘CE marking directive’ when RoHS 2 added a CE marking requirement with its passage in 2011. RoHS compliance is now required before a CE marking can be placed on a product.
Current RoHS restrictions are the result of one original directive, RoHS 1, and two updates known as RoHS 2 and 3. Businesses must comply with all requirements included in RoHS 2 and 3.
RoHS 1 and 3 are mainly concerned with the specific materials that are restricted under RoHS, listed above. RoHS 1 included six materials deemed to be hazardous to human health and the environment, and RoHS 3 added four more.
RoHS 2 includes more robust requirements that manufacturers must follow to achieve and demonstrate compliance, including affixing a CE marking and issuing a compliance statement.
RoHS 2 also created additional categories of appliances subject to RoHS, as well as a larger list of exemptions.
Learn what steps manufacturers must take to ensure compliance: What is ‘RoHS Compliant’?
When Is a CE Marking Necessary?
All EEE material and products imported or sold on the EU market must have a CE marking.
In addition to the CE marking, technical documentation must be kept by the manufacturer for ten years. In the event that compliance is challenged, the manufacturer must be able to produce this information.
Why Is the RoHS CE Marking Important?
The CE marking is a crucial part of RoHS’s emphasis on manufacturers’ self-regulation. By affixing the CE marking, manufacturers take on responsibility for compliance, including inspecting their own manufacturing processes and reporting or recalling violations.
The technical file is an important facet of manufacturers taking on the burden of documenting compliance. When authorities investigate a product, the necessary background information on steps taken to ensure compliance is already compiled.
RoHS 2 Requirements for the CE Marking
The RoHS 2 directive mentions the CE marking in Articles 14,15, and 16, and provides several descriptions and requirements for the marking (Directive 2011/65/EU).
Article 14 of RoHS 2 explains that CE markings are subject to the “general principles set out in Article 30 of Regulation (EC) No 765/2008.” This other regulation, Regulation No 765/2008, is concerned with protecting public health while ensuring the free movement of products.
General principles of the CE marking include requirements for how the CE marking should be affixed, and explains the significance of the CE marking. The regulation reads: “By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.”
Article 15 of RoHS 2 supplies several rules for affixing the CE marking:
- The CE marking must be affixed “visibly, legibly and indelibly to the finished EEE or to its data plate.” If this is not possible the CE marking should be put on the packaging and the product’s accompanying documents.
- The CE marking must be affixed before the EEE is placed on the EU market.
- Member States should ensure the CE marking is being used lawfully and should take action in the event of improper use of the CE marking. It is up to Member States to penalize infringements as they see fit, but the penalties should be proportionate to the offense.
Article 16 simply states, “In the absence of evidence to the contrary, Member States shall presume EEE bearing the CE marking to comply with this Directive.” In this way, a CE marking shows authorities that the product is in compliance with RoHS.
What Does a CE Marking’s Technical File Include?
The CE marking shows that a manufacturer has a technical file, a list of information showing how the manufacturer ensured RoHS compliance. The information should be collected throughout the manufacturing process, as well as during testing of the product after production.
The technical file must include:
- A description of the product and how it works
- Design and manufacturing drawings, and scheme drawings of all sub-assemblies or circuits. These drawings must include written descriptions.
- Manufacturing documentation and records, including design calculations
- A list of harmonized standards or other specifications and procedures used
- Test results (risk assessment of all materials and parts used)
Additional Requirement for Demonstrating Compliance: Declaration of Conformity
The CE marking works hand in hand with the Declaration of Conformity, also known as a compliance statement or certificate. The compliance statement is a legal document that contains information about the product and the measures taken to ensure compliance. The manufacturer signs the statement before the product is put on the market to certify that the product is RoHS compliant.
Read more: RoHS Compliance Statement