The Restriction of Hazardous Substances in Electronic Equipment Directive (2011/65/EU) came into force on the 21st July 2011. The application and enforcement were aligned with the New Legislative Framework.
The Directive is aimed at eradicating certain hazardous substances from new electrical and electronic equipment (EEE). Producers of EEE within the scope of the Directive are responsible for ensuring that their products meet the requirements of the Directive.
The RoHS requirements apply to end products that fall within the scope of the Directive. However, as a final product is made up of components and sub-assemblies it is inevitable that all components and sub-assemblies must not contain any of the restricted substances above the defined maximum concentration values. A technical file must be produced supporting compliance to the directive. There are specific exemptions from the RoHS directive as the Commission realizes that it may not be possible to manufacture some products without the use of banned substances. The RoHS Regulations in the UK are specifically worded so that any European Commission Decisions reflecting exemptions to the RoHS Directive become UK law as soon as they are officially published.
The RoHS enforcement agency for the UK is the Office for Product Safety and Standards. Contravening or failing to comply with the prohibition on hazardous substances in the RoHS Regulations could result in those held responsible facing a fine up to the statutory maximum (currently £20000) on summary conviction or an unlimited fine on conviction on indictment. Also, the 2008 RoHS Regulations gave the enforcement agency the further power to issue enforcement notices requiring non-compliant goods to be withdrawn from the market.
The RoHS (2011/65/EU) Directive prevents all new electrical and electronic equipment placed on the market in the European Economic Area from containing Lead, Mercury, Cadmium, Hexavalent chromium, Poly-brominated biphenyls (PBB) and Polybrominated diphenyl ethers (PBDE), except in certain specific applications, in concentrations greater than the values shown within the Directive.
On 31st March 2015 the RoHS Directive was amended by Directive 2015/863 which adds a further 4 restricted substances. The effective date of restriction for the additional substances is from 22nd July 2019 for products placed on the EU market. Medical devices have until 22nd July 2021 to comply with the additional restrictions. The GOV.UK website provides useful information.
These values have been established as 0.01% by weight per homogeneous material for Cadmium and 0.1% for the other nine substances.
The additional substances are:
- Bis (2-ethylhexyl) phthalate (DEHP)
- Butyl benzyl phthalate (BBP)
- Dibutyl phthalate (DBP)
- Diisobutyl phthalate (DIBP)
They are all Substances of Very High Concern (SVHC) as defined in 2015/863 Paragraph 5.
The restriction of DEHP, BBP and DBP does not apply to toys as this is already covered under Regulation 197/2006 entry 51 to Annex XVII.
We are also aware of the stakeholder consultation in the first part of 2018 covering the collection of information for seven substances to be subjected to an assessment with a view to the review and amendment of the RoHS Annex II list of restricted substances. The seven additional substances are:
- Diantimony trioxide
- Tetrabromobisphenol A (TBBP-A)
- Indium phosphide
- Medium Chain Chlorinated paraffins (MCCPs)
- Beryllium and its compounds
- Nickel sulphate and Nickel sulfamate
Cobalt dichloride and Cobalt sulphate
The RoHS Directive draws its scope from that of the Waste Electrical and Electronic Equipment (WEEE) Directive, with a few exceptions, as listed below. The WEEE Directive specifies ten broad product categories. Groups eight and nine “medical devices” and “monitoring and control instruments” were not within scope of the RoHS 1 but are being included within the scope of RoHS 2, these will be phased in completely by 2019. Also “Light bulbs and luminaries in households” have been included in the scope of the RoHS Directive, although they are not within the scope of the WEEE Directive.
- Large household appliances
- Small household appliances
- IT and telecommunications equipment
- Consumer equipment
- Lighting equipment
- Electrical and electronic tools (with the exception of large-scale stationary industrial 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.
Click for examples of products in each of the above categories. Although the above list covers a wide range of products and in most cases it is clear whether a product falls within the scope or not, there are many “grey area” products that are hard to classify. Helpful guidance can be found from a variety of sources regarding product classification (see links section below), but it is practically impossible to obtain any answer from a governmental organisation that does not carry a caveat along the lines of “Any guidance given is to be taken only as guidance. Only a court can decide authoritatively on the specifics of each case and manufacturers/importers are advised to obtain legal advice for themselves”.
A list of products that are deemed specifically outside the scope of the RoHS Directive is given below (for the full text refer to the Directive):
- Equipment for the protection of the essential interests of the security of Member States
- Equipment designed to be sent into space
- Equipment specifically designed and is to be installed as part of another type of equipment that is excluded or does not fall within the scope of the Directive
- Large scale stationary industrial tools
- Large scale fixed installations
- Means of transport for persons or goods
- Non road mobile machinery
- Active implantable medical devices
- Professional photovoltaic panels
- Equipment designed for research and development.
The RoHS Directive applies only to products “placed on the market” in the European Economic Area. The definition of “placed on the market” is taken in the sense implied by the European Commission's "Guide to the implementation of Directives Based on the New Approach and the Global Approach" (the "Blue Book").
The RoHS Directive makes provision for a number of specific exemptions. Because of the sweeping nature of the scope of the RoHS Directive and the large number of products it affects, the Commission realises that it may not be technically possible to feasibly manufacture some products without the use of some of the banned substances. As a consequence, some products have been granted specific exemptions where science has yet to formulate an alternative (mercury in some types of fluorescent lamps, for example) while two entire product groups have currently been exempted (medical devices and monitoring and control instruments), where the reliability of new component designs can have potentially life-critical consequences.
It must be noted that the “exemptions list” is liable to change as industry requests further products to be excluded (such requests may or may not be granted) or technological advances mean previous exemptions are withdrawn.
Producer Compliance, Responsibility and Requirements
Producers of EEE within the scope of the Directive are responsible for ensuring that their products meet the requirements of the Directive. Furthermore, the act of placing a product on the market is a declaration by the producer that the product complies with the Directive. It is of course important, therefore, that producers can demonstrate the compliance of any product that they place on the market by obtaining and maintaining sufficient technical documentation.
The term “producer” can refer to various people depending on the market situation. Irrespective of the selling technique used it can mean any person who..
- manufactures and sells EEE under his own brand
- Imports EEE
- Distributes EEE within the EU
- Is an Authorised Representative
The RoHS requirements apply to end products that fall within the scope of the Directive. The components and sub-assemblies within the final products are not specifically covered by the scope of the Directive and so do not of themselves need to comply with the Directive. However, as a final product is made up of components and sub-assemblies it is inevitable that all components and combinations of components put together to form sub-assemblies in the final product must themselves not contain any of the restricted substances above the defined maximum concentration values.
To demonstrate compliance, a producer must prove that all components, materials, sub-assemblies etc that comprise the product are RoHS compliant. To avoid expensive testing of all components, the simplest way to do this is to obtain certification from his suppliers that the parts supplied are compliant. Producers are also expected to perform selected analysis of components as necessary. A technical file must be produced as part of the CE Marking process.
CE Marking requirements
Requirements for CE Marking of EEE to attest conformity with RoHS 2 is effective from July 2013. As part of RoHS 2, all EEE within the scope of the directive must be CE marked and include reference to RoHS 2 on the declaration of conformity from the date the substance restrictions apply.
The RoHS and WEEE DirectivesEnforcement
From January 2018 the enforcement authority in the UK is the Office for Product Safety and Standards. This is part of the Department for Business, energy & Industrial Strategy.
Currently the penalties associated with failing to comply with the Directive are as follows;
- Contravening or failing to comply with the prohibition on hazardous substances in the RoHS Regulations could result in those held responsible facing a fine up to the statutory maximum (currently £5000) on summary conviction or an unlimited fine on conviction on indictment.
- Those failing to submit compliance documentation at the request of the enforcement authority may be liable to a fine up to level five on the standard scale (currently £5000).
The Enforcement body has powers to make test purchases, request compliance documentation, inspect processes and perform analytical tests, issue compliance notices requiring certain actions to be taken and, significantly, to issue enforcement notices requiring non-compliant goods to be withdrawn from the market.
There is provision in the RoHS Regulations for the defence of “due diligence”. To use this defence a person must show he took all reasonable steps and exercised all due diligence to avoid committing an offence. Unfortunately there is no definitive definition of what “due diligence” is and whether a particular defence stands or not will only ever be decided in court. This is because a variety of factors are important when deciding if due diligence has been followed and they are specific to each case.
Examples of these factors are the size of the business under investigation, the types of systems and safeguards implemented by the business, to what level the systems and safeguards are followed, what documentation is kept by the producer and what state it is kept in, how trusted various suppliers are and on what grounds this trust is based etc.
To have a reasonable defence of due diligence the courts suggest that some form of positive action is necessary. This could be in the form of assessing the risks specific to your products and creating a system proportionate to the size of your business, that appropriately deals with the risks and can be demonstrated to be kept up to date, fully implemented and documented. The system must demonstrate that all reasonable steps have been taken to ensure the correct information has been gathered for your particular products and that the sources of the information can be trusted.
Timetable for Extension of scope
|Implementation date||Products to be included|
|22nd July 2019||4 Additional substances banned|
|22nd July 2019||Extension to all EEE except those explicitly excluded|
Directive 2011/65/EU (RoHS 2) came into force on the 21st July 2011. Published in Official Journal L174, 1 July 2011. This came fully into force on 21st July 2011 and transposed into national law by member states by 2nd January 2013.
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012, implementing the European Directive, came fully into force in the UK on 2nd January 2013.
As with most Directives, the actual requirements for any particular product or producer are very specific. In the case of the RoHS Directive, these requirements are highly dependent on the type of product, the intended market and market size, the size of the producer's business, the suppliers involved in the product creation, etc.
For further advice specific to your products and requirements, please contact us at Conformance and we will be pleased to discuss your needs.