RoHS 2011/65/EU

RoHS Directive (2011/65/EU) in Details

I. Definition & Purpose of RoHS

RoHS Directive 2011/65/EU, known as well as RoHS 2 Directive, is a recast of the first EU RoHS Directive 2002/95/EC. The new Directive came into force on the 21st of July, 2011 and was aligned with the New Legislative Framework. It lays down the rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE). Such hazardous materials are, for example, mercury, lead, cadmium, polybrominated biphenyls, dibutyl phthalate, diisobutyl phthalate, hexavalent chromium, polybrominated diphenyl ethers, and others. They can be challenging to manage at the end of the product’s life cycle, and because of that the Directive restricts their use at the initial stage, i.e. during product’s manufacturing, and helps to keep them out of the waste stream. In the table below, you can see the maximum concentration allowance of the mentioned hazardous substances.

RoHS hazardous substances RoHS 2

The RoHS 2 Directive further provides regulations for protecting human health and the environment, along with the environmentally sound recovery and the disposal of waste EEE.RoHS 2011/65/EU has many goals, but one of the most important is to reduce administrative burdens and make sure there is coherency with the newer policies and legislation. For instance, those related to the new legislative framework for the marketing of products within the EU borders.

II. Scope of RoHS

In comparison to RoHS 2002/95/EC, RoHS 2 has not only an expanded scope of products but also imposes new obligations on EEE manufacturers regarding the preparation of EU Declaration of Conformity and placing the CE markings on finished products. The latter was included in the Directive’s scope because the original RoHS Directive didn’t have any formal marking requirements for illustrating CE compliance, which brought many manufacturers to design their own RoHS symbol and issue their version of a “Declaration of Conformity”.

Within the scope of RoHS 2011/65/EU are included electrical and electronic equipment from the following product categories:

  • Large and small household appliances;
  • IT and communications equipment;
  • Lighting equipment;
  • Consumer Equipment;
  • Electrical and electronic tools;
  • Automatic Dispensers;
  • Toys;
  • Leisure and sports equipment;
  • Medical devices, including In-Vitro diagnostic medical devices;
  • Monitoring and control Instruments, including those with industrial purpose;
  • Any other electrical and electronic equipment which is not covered by any of these categories – the deadline for adopting the change is the 22nd of July, 2019.

 

Currently, within the Directive’s scope are not included the following types of electrical and electronic equipment:

  • Equipment with specifically military purposes;
  • Space equipment;
  • Equipment specially designed to be a part of another kind of equipment outside of the scope of this Directive, and which can fulfil its function only if it is part of that equipment and can be replaced only by the same specially designed equipment;
  • Large-scale stationary industrial tools;
  • Transport vehicles for people or goods, except electric two-wheel vehicles which are not type-approved;
  • Active implantable medical devices;
  • Large-scale fixed installations;
  • Photovoltaic panels assisting in the production of solar energy for a public, commercial, industrial and residential applications;
  • Equipment which is designed explicitly for research and development;
  • And others.

III. Conformity and Legal obligations of economic operators

To demonstrate CE compliance with RoHS 2011/65/EU, manufacturers of electronic and electrical equipment must conduct conformity assessment, prepare a Declaration of Conformity, and affix the CE mark on their products before placing them on the EU market.

RoHS Directive places legal obligations not only on manufacturers but also on authorised representatives, importers and distributors, including retailers.

1.Manufacturers

As a manufacturer can be seen anyone who manufactures electrical and electronic equipment or market it under their name or trademark, no matter is it was designed or produced by someone else. Any manufacturer of electrical and electronic equipment who wants to place their product on the EU market have the following legal obligations:

  • Ensuring that the product’s design and manufacturing comply with RoHS 2011/65/EU;
  • Have effective production control systems to support compliance and review them to ensure that the equipment remains compliant over time;
  • Create a technical documentation, also known as a “technical file” (see an example of a technical documentation here);
  • Complete conformity assessment according to the regulations;
  • Create a Declaration of Conformity (see an example of a Declaration of Conformity);
  • Keep product’s technical documentation and the Declaration of Conformity for 10 years;
  • Affix the CE mark to the product;
  • Make sure that the equipment is marked with type, batch or serial number for identification;
  • Ensure your product’s compliance throughout its production life;
  • Place your name, trade name or trademark on the product and packaging;
  • Ensure that any non-compliant electronic or electrical equipment is withdrawn from the market, and take corrective action to make it comply with the regulations;
  • And others.

2.Authorised representatives

All authorised representatives must be established within the EU borders and can be sub-contractors, agents, importers or distributors. An authorised representative can be anyone who has received a written mandate from a manufacturer based within or outside the European Union to carry out specific administrative tasks related to placing electrical and electronic equipment on the EU market. Such tasks could be, for example, keeping the technical file and the declaration of conformity. The legal obligations of the authorised representatives are, as follows:

  • Holding the technical file and the Declaration of Conformity for 10 years after the product has been placed on the market;
  • Being able to comply with any requests for information regarding the product’s compliance;
  • Cooperating with the national authorities.

3.Importers

As an importer can be seen anyone who imports electrical or electronic equipment into the EU and places it on the EU market. They must ensure that the specific product complies with the requirements of the RoHS Directive 2011/65/EU. Anyone who is considered as an importer has the following obligations:

  • Placing only electronic and electrical equipment that complies with the RoHS requirements;
  • Ensuring that the manufacturer has carried out essential compliance tasks;
  • Making sure that their own trade name or trademark and address are indicated on the product or packaging;
  • Recalling all non-compliant equipment that has already been placed on the EU market;
  • Informing the national authorities and the manufacturer of any non-compliance and taking immediate measures to ensure that the product becomes compliant before placing it on the EU market;
  • Keeping a register of all recalled and non-compliant products;
  • Storing the product’s technical file and the Declaration of Conformity available for 10 years after the product has been introduced to the EU market;
  • Complying with national authorities’ requests for information when the product’s compliance is in question.

4.Distributors

A distributor can be anyone who is not a manufacturer or importer, and who makes the electrical and electronic equipment available on the EU market. For instance, a distributor can be any wholesaler or retailer of electrical products. The distributor’s legal obligations according to the RoHS regulations are, as follows:

  • Verifying that the CE mark has been affixed on the product, as well as the type, batch or serial number for identification, and ensuring that the all required documentation accompanies it;
  • Verifying that the manufacturer’s trade name or trademark and address are on the product or packaging, as well as the importer’s trade name and address if applicable;
  • Withdrawing or recalling any non-compliant products that have already been placed on the EU market;
  • Informing the national authorities and the manufacturer or importer of any non-compliance;
  • Ensuring that non-compliant equipment is not returned to the market before it complies with the RoHS regulations;
  • Complying with national authorities’ requests for information when the product’s compliance is in question.

V. How can CE Check help you?

With CE Check, you don’t have to worry about having the wrong directives or following the wrong conformity procedures! CE Check is a web-based service that helps you identify all CE directives and requirements needed for your product’s CE compliance. By using our online service, you will not only get to know what your product needs to comply with, but you will also be able to test your product in an accredited test laboratory with only three weeks of lead time. Moreover, you can store all of your product’s technical documentation in our system and create a Declaration of Conformity automatically.

Check out our video below to have a quick look at how our system works.

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