EU RoHS Directive

RoHS (Restriction of Hazardous Substances Directive 2002/95/EC) is a mandatory standard established by legislation of the European Union. Its full title is "Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment." The standard officially came into effect on July 1, 2006, and is primarily aimed at regulating the materials and technical standards of electrical and electronic products to make them more conducive to human health and environmental protection.

The RoHS directive applies to equipment with a working voltage of less than 1000V AC or 1500V DC. During manufacturing, it restricts the usage of six substances: lead, cadmium, mercury, hexavalent chromium, and polybrominated biphenyls (PBBs) and polybrominated diphenyl ethers (PBDEs), as outlined in Directive 2011/65/EU ANNEX II.

On March 31, 2015, the European Union issued a directive requiring the addition of restrictions on the usage levels of four phthalates in the RoHS directive. This directive is identified as Directive 2015/863 ANNEX II.

The table below outlines the 10 restricted substances and their concentration limits enforced as of July 22, 2019:

Restricted Substance	Concentration Limit(PPM)
Lead (Pb)	0.1% by weight (1000 ppm)
Mercury (Hg)	0.1% by weight (1000 ppm)
Cadmium (Cd)	0.01% by weight (100 ppm)
Hexavalent chromium (Cr6+)	0.1% by weight (1000 ppm)
Polybrominated biphenyls (PBBs)	0.1% by weight (1000 ppm)
Polybrominated diphenyl ethers (PBDEs)	0.1% by weight (1000 ppm)
Bis(2-Ethylhexyl) phthalate (DEHP)	0.1% by weight (1000 ppm)
Benzyl butyl phthalate (BBP)	0.1% by weight (1000 ppm)
Dibutyl phthalate (DBP)	0.1% by weight (1000 ppm)
Diisobutyl phthalate (DIBP)	0.1% by weight (1000 ppm)

Background

In recent years, the rapid development of emerging technologies has brought about a significant increase in short-lived consumer electronics products. The disposal of electronic waste, both within the EU and globally, has become a considerable environmental concern. The volume and cost of handling "e-waste" and discarded electrical appliances in EU countries have been steadily rising. Hazardous substances such as lead and cadmium from these wastes seep into water, soil, and air, causing substantial pollution to the environment and natural ecosystems, ultimately posing severe threats to both the environment and human health. Consequently, there has been a growing awareness among individuals and businesses about the importance of environmental protection. The manufacturing industry is now placing greater emphasis on developing production processes towards environmental sustainability. Additionally, there is a global trend towards regulating the usage of hazardous substances through laws and regulations, reflecting a commitment to environmental protection and ensuring the sustainable development of industries.

Applicable Regions

All countries within the European Union, including Finland, France, Germany, Greece, Sweden, Austria, Belgium, Czech Republic, Denmark, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Latvia, Estonia, Bulgaria, Croatia, Cyprus, Lithuania, Luxembourg, Malta, Romania, Slovakia, and Slovenia, are required to comply with this directive for any products exported to these countries. The directive is issued by the EU, and each member state subsequently enacts regulations based on this directive.

Prominent case

In 2001, SONY exported 1.3 million PlayStation game consoles and 800,000 accessories to the Netherlands. However, the cables contained excessive levels of cadmium (Cd), which violated the Cadmium Directive (91/338/EEC). As a result, Sony was fined 17 million euros by the Netherlands.
In California, 105 Japanese companies were accused of exceeding the lead (Pb) content limit of 300 ppm in electrical wires, as per California Proposition 65. The International Electrical Manufacturers Association (NEMA) acted as a coordinator on behalf of the manufacturers to mediate with the defendants. The settlement reached amounted to 3 million US dollars.

The history of the RoHS directive

On February 13, 2003, the European Union officially announced two environmental directives: RoHS and WEEE. RoHS focuses on the product design phase, while WEEE pertains to the product disposal phase. The ultimate goal is to reduce the pollution burden on the Earth caused by electronic products.
On August 19, 2005, the amended resolution 2005/618/EC further specified the "shall not contain" provision. It explicitly outlined that the restriction applies to all homogeneous materials in the products (a homogeneous material being one that cannot be mechanically separated into different materials). It also introduced maximum allowable weight percentage concentration requirements for each substance, with the exception of cadmium (Cd), which was set at 0.01%, while others were set at 0.1%.
On July 1, 2006, the directive officially came into effect, requiring that eight categories of electrical and electronic products placed on the EU market shall not contain lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers—six harmful substances.

RoHS 2.0

RoHS 2.0, commonly referred to in the industry, has the formal directive name of 2011/65/EU. It was published in the Official Journal of the European Union on July 1, 2011. The most significant difference is the addition of four hazardous substances, abbreviated as 4PBB.

Here are the relevant deadlines:：

July 21, 2011 - RoHS 2.0 comes into effect, requiring EU member states to transpose the new directive into domestic law.
January 2, 2013 - Member states may "begin" implementing RoHS 2.0 into law.
January 3, 2013 - Directive 2002/95/EC (amended by 2005/95/EC, also known as RoHS 1.0) is repealed.
June 4, 2015 - The Official Journal of the European Union (OJ) publishes RoHS 2.0 Amendment Directive (EU) 2015/863/EU, officially adding DEHP, BBP, DBP, and DIBP to the restricted substances list in Annex II.
December 31, 2016 - This directive is "mandatory" transposed into national regulations and enforced.
July 22, 2019 - All electrical and electronic products imported into the EU (except medical and monitoring equipment) must comply with these restriction requirements.
July 22, 2021 - Medical devices (including in vitro medical devices) and monitoring equipment (including industrial monitoring equipment) will also be included in the scope of this regulation. Additionally, toys already subject to the restriction of DEHP, BBP, and DBP under Annex XVII of REACH will be exempt from control under this directive.

The main updates in RoHS 2.0 include:

The scope of controlled products is expanding: all electrical and electronic equipment except those exempted under 2002/95/EC, such as medical devices (Category 8) and monitoring and control instruments (Category 9), are now included. Additionally, a new Category 11 has been added, covering all other electrical and electronic equipment not covered by Categories 1 to 10, including cables and other components.
Four new restricted substances have been added: DEHP (Di(2-ethylhexyl) phthalate), BBP (Benzyl butyl phthalate), DBP (Dibutyl phthalate), and DIBP (Diisobutyl phthalate). With the addition of these four phthalates, the RoHS restricted substances list is now updated to include a total of ten substances.
"CE marking requirement: Compliance with RoHS for electrical and electronic equipment must be included in the CE marking requirements. Manufacturers should ensure that their products comply with RoHS and be ready with corresponding declarations and technical documentation when affixing the CE marking.
Transitional provisions: To allow manufacturers of newly included products under ROHS 2.0 sufficient time to comply with the directive requirements, ROHS 2.0 sets out transitional periods for the relevant products.

RoHS 2.0 regulated product categories

Refer to 2011/65/EU ANNEX I for devices with AC voltage not exceeding 1000V and DC voltage not exceeding 1500V:

Large household appliances
Small household appliances
IT and telecommunications equipment
Consumer products
Lighting equipment
Electrical and electronic tools (excluding large industrial tools)
Toys, leisure, and sports equipment
Automatic dispensers
Medical devices
Monitoring and control instruments (including large industrial monitoring and control instruments)
Other electrical and electronic equipment not covered in 1-10, including cables and other components

Industry Practices

Supplier's Responsibilities

a) Design and manufacture products in compliance with the requirements of Article 4 of the directive, ensuring they do not contain restricted substances.

b) Draft technical documentation and implement internal production control procedures according to Module A of Annex II of 768/2008/EC.

c) If the conformity of the product with applicable requirements can be demonstrated using this module, prepare a "Declaration of Conformity" and affix the "CE" marking.

d) Keep technical documentation and EC Declaration of Conformity for at least ten years after the product has been placed on the market.

e) Ensure that procedures for series production are in place to maintain compliance. When making design changes, changes in characteristics, harmonization of standards, or changes in technical specifications referenced in the Declaration of Conformity, full consideration should be given.

f) Register complaints about non-compliant products and conduct product recalls. Inform distributors of information regarding such monitoring.

g) Ensure that products bear model, batch, and serial numbers or other elements that facilitate product identification. If not possible due to the nature or shape of the product, provide this information on the packaging or accompanying documents.

h) Mark the product with the company name, registered trademark name or symbol, and contact address, or provide this information on the product packaging or accompanying documents.

i) Take necessary corrective measures to ensure compliance, rectify, or recall products when the manufacturer confirms that products placed on the market do not comply with applicable EU regulations. Immediately inform the competent authorities of the member state where the product is located about the non-compliance and provide detailed information on the corrective actions to be taken when there is a risk associated with the product.

j) Provide all information and files available to prove product compliance upon reasonable request from supervisory authorities. Cooperate with regulatory authorities and take any measures requested by them to eliminate any risks associated with products placed on the market.

European Conformity Certification (CE Mark)

Products that comply with the RoHS directive and are intended for sale in the European Economic Area (EEA) must bear the CE marking. The CE marking is a self-certification scheme indicating that the production process of the product or the required third-party testing is the responsibility of the manufacturer or importer, who bears criminal liability. Authorities conduct periodic random inspections, and if any issues are found with the product, there may be consequences such as product recalls, fines, or even imprisonment of responsible individuals.

Rules and conditions for the CE Mark:

The CE Mark should be affixed visibly on the finished electrical or electronic equipment. If it's not possible to affix it directly on the product due to the nature of the equipment, it should be affixed on the packaging and accompanying documentation.
The CE Mark should be affixed before the electrical or electronic equipment is placed on the market.
Member states of the European Union should ensure the correct application of the CE Mark regulatory mechanism based on existing mechanisms.

What is the relationship between RoHS and REACH?

RoHS and REACH are two distinct EU regulations/directives that do not directly influence each other's implementation. However, when overlapping areas arise, substances need to be controlled in accordance with the stricter requirements.

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