Restriction on Hazardous Substances Directive

RoHS Directive 2011/65/EU

All products that fall under the scope of the RoHS Directive 2011/65/EU must bear a CE marking. RoHS (Restriction of Hazardous Substances) – is a European Directive that regulates the amount of hazardous substances in electrical and electronic equipment. There are six restricted substances that are mentioned in the RoHS Directive. Below is the list of those substances with maximum concentration values tolerated by weight in homogeneous materials:

• Lead (Pb – 0.1%)
• Mercury (Hg – 0.1%)
• Cadmium (Cd – 0.01%)
• Hexavalent chromium (Cr⁶⁺ – 0.1%)
• Polybrominated biphenyl (PBB – 0.1%)
• Polybrominated diphenyl ether (PBDE – 0.1%)

Be aware: in March 2015 there was an adaptation of RoHS Directive issued (2015/863/EU), where four additional substances were mentioned. There are:

• Bis (2-ethylhexyl) phthalate (DEHP – 0,1%)
• Butyl benzyl phthalate (BBP – 0.1%)
• Dibutyl phthalate (DBP – 0.1%)
• Diisobutyl phthalate (DIBP – 0.1%)

The new provisions should be applied from 22 July 2019.

Even though RoHS Directive is related to electrical and electronic equipment, there are different product categories that fall into the scope of the Directive. According to the Annex I RoHS Directive 2011/65/EU they are as following:

• Large household appliances
• Small household appliances
• IT and telecommunications equipment
• Consumer equipment
• Lighting equipment
• Electrical and electronic tools
• Toys, leisure and sports equipment
• Medical devices
• Monitoring and control instruments including industrial monitoring and control instruments
• Automatic dispensers
• Other EEE not covered by any of the categories above

Each product covered by ROHS 2011/65/EU must have technical testing and accompanying documents, a declaration of conformity, and the CE marking affixed to the product. The format of the declaration of conformity is outlined in Annex VI of the Directive.

How can we help you?

Our compliance specialists can perform complete CE certification of your equipment in accordance with RoHS Directive 2011/65/EU.

Besides our services for complete CE certification you can also contact us for the following services:

• Determine the amount of hazardous substances in an apparatus with an Material Safety Data Sheet (MSDS)
• Compile and verify Technical Files
• Compile and verify User Instructions manual
• Verification and drafting EU Declarations of Conformity
• Instruct in affixing the CE marking correctly

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