Overview of EU RoHS 2
In 2002, the European Union first introduced the concept of RoHS – the restriction on hazardous substances in electronic and electrical equipment (EEE). Directive 2002/95/EC, which came into effect from July 2006, required the demonstration of compliance with the six restricted substances: cadmium, chromium (VI), lead, mercury, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE).
However, since January 3, 2013, Directive 2011/65/EU, or RoHS 2, has replaced Directive 2002/95/EC. Besides expanding the scope and clarifying some definitions, RoHS 2 is now also a CE marking Directive. It is one of the first regulations to incorporate the New Legislative Framework (NLF) for the marketing of products, which lays down obligations for all operators within the supply chain. In addition, the new Directive also ensures that additional restricted substances to be included under RoHS 2 will be coherent with other chemical regulations such as REACH.
The EU RoHS 2 restricts the use of certain hazardous substances in electronic equipment. RoHS 2 extended the original RoHS 2002/95/EC regulations, which were introduced in 2002, and introduced the following changes:
- Scope expansion
- The scope of RoHS 2 has been expanded in two ways: clarification of definition and additional product categories. The definition of “electrical and electronic equipment (EEE)” now includes all EEE that require electrical currents or electromagnetic fields to fulfill at least one intended function. This means products that were previously excluded from the scope, such as talking teddy bears or a gas cooker with an electrical clock, are now included.
- The list of product categories has also increased from the previous eight to eleven. The new categories are highlighted in bold:
- Category 1 – Large household appliances
- Category 2 – Small household appliances
- Category 3 – IT and telecommunications equipment
- Category 4 – Consumer equipment
- Category 5 – Lighting equipment
- Category 6 – Electrical and electronic tools
- Category 7 – Toys, leisure and sports equipment
- Category 8 – Medical devices
- Category 9 – Monitoring and control instruments including industrial monitoring and control instrument
- Category 10 – Automatic dispensers
- Category 11 – Other EEE not covered by any of the categories above
- Technical documentation, Declaration of Conformity (DoC) and CE marking
- Products that fall within the RoHS 2 scope require CE marking. First, the manufacturer must ensure that the product meets the restricted substance requirements and that an internal production control has been carried out. Compliance with the restricted substance requirements must be supported by a technical documentation file in line with the general requirements in Decision 768/2008/EC. The Standard EN 50581:2012 has been published to provide guidance on fulfilling this requirement. Once these obligations have been fulfilled, a Declaration of Conformity (DoC) can be drawn up and the CE marking can be affixed on the finished product.
- Supply chain obligations
- RoHS 2 defines the specific obligations for each “economic operator” – the manufacturer, the authorized representative, the importer and the distributor (which includes the retailer).
- The manufacturer has to ensure that an EEE has been designed and manufactured to meet the restricted substances requirements. In addition, the manufacturer is to draw up the technical documentation, carry out the internal production control, draw up the DoC, affix the CE marking, ensure the product bears the required information for its traceability, as well as to keep the technical documentation and the DoC for 10 years after the product has been placed on the market.
- In addition, all economic operators have responsibilities for the compliance of the products they sell. For example, manufacturers and importers are required to keep records of non-conforming products and product recalls, and to keep their distributors informed. Upon discovery of non-conformity, they are required to apply corrective measures (including withdrawing or recalling the product) and inform the authorities immediately.
- Procedure for the addition of new restricted substances
- In order to achieve coherence with other EU regulations, the RoHS 2 Directive includes a procedure to ensure that new restricted substances will align with other chemicals legislation, especially REACH.
- Automatic expiry of exemptions
- There are now two lists of applications exempted from the substance restrictions: Annex III for all 11 categories of EEE and Annex IV for only categories 8 and 9 (i.e. medical devices and monitoring and controlling instruments). Different validity periods apply to differing categories.
- For exemptions in Annex III that are applicable to categories 8 and 9, and all exemptions in Annex IV, the maximum validity period is 7 years. Exemptions in Annex III that are applicable to categories 1 to 7 and 10 have a maximum validity period of 5 years. This means that unless an application for renewal has been submitted and approved, all exemptions will eventually expire.
- In addition to granting and renewing exemptions, any economic operator in the supply chain can also make an application to revoke existing exemptions.
Why ROHS Compliance Testing is Important
Becoming RoHS compliant is essential if you wish to sell any kind of electronic products on the EU and European Economic Area (EEA) market:
- An RoHS CE mark is a mandatory requirement – it is illegal to sell your product in the EU without this mark.
- An RoHS CE mark gives consumers and regulators confidence that your product is safe - testing helps you discover problems and avoid fines and expensive product recalls.
Our RoHS compliance testing services
TÜV SÜD is one of the largest providers of RoHS compliance testing and certification services, with a strong reputation for independence and impartiality. We have extensive experience in certification of electrical safety for electrical equipment, with several world-class testing laboratories.
Our scope of testing and compliance is widely known and our certification marks for product tests and certification are instantly recognized and trusted by the authorities. With an international network of laboratories and multidisciplinary experts, we offer a personalized one-stop solution designed to assist you with the complex processes of RoHS CE compliance.
Our experts have extensive knowledge and experience and are fully versed in every aspect of the regulations. Our efficient RoHS compliance testing supports you to confidently take your product to market fast.
TÜV SÜD provides RoHS compliance testing services according to the relevant standards to determine the content of hazardous substances in materials. Our testing covers materials, components, parts and finished products:
- Guidance on regulation – we advise you on the relevant regulations to your product and necessary steps to compliance
- CE mark – we provide all guidance on how to apply the CE mark to your product
- Testing and auditing – we conduct a wide range of tests to identify hazardous substances in your product and your supply chain