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 so-called 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. Furthermore, the act of placing a product on the market is a declaration by the producer that the product complies with 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 containing the analysis and component data and be kept for at least four years from the date the equipment was put on the market. 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 National Measurement Office (NMO). 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gave the enforcement agency the further power to issue enforcement notices requiring non-compliant goods to be withdrawn from the market.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 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) or polybrominated diphenyl ethers (PBDE), except in certain specific applications, in concentrations greater than the values decided by the European Commission. These values have been established as 0.01% by weight per homogeneous material for cadmium and 0.1% for the other five substances.
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.
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”.
Basically the view of the National Measurement Office who are the RoHS enforcement agency for the UK and the BERR (formerly the DTi) is that manufacturers should review their own products themselves, using a methodical and common sense approach and taking legal advice if necessary. A good “Decision Tree” walk-through of this process can be found on the NMO website. When assessing if products are included in the scope or not, it is recommended that all points, arguments, legislation, previous court rulings referred to, case specifics etc are written down. This will provide details of a clear, sensible and considered thought process that can be shown to enforcement bodies to demonstrate that serious effort has preceded any “in or out” scope decision.
A list of products that are deemed specifically outside the scope of the RoHS Directive is given below:
The RoHS Directive applies only to products “placed on the market” in the European Economic Area. The NWML 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"). This definition also has “grey areas” for certain circumstances, but in general is interpreted to mean the initial action of making a product available for the first time on the Community market. This takes place when the product is transferred from the producer to a distributor or final consumer or user in the Community market. Moreover the transfer can be when the physical hand-over or the transfer of ownership has taken place, can be for a payment of free of charge and can be based on any type of legal instrument. Again, the only way to determine whether a product has been “placed on the market” or not is to examine each case individually.
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.
The main exemptions are given below;
A comprehensive list of current exemptions can be found in the RoHS Directive and amendments, available from the NMO web site. The RoHS Regulations contains wording such that it automatically enacts any Commission decision into UK law, with regard to any exemption updates they produce
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..
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. So although technically excluded from the ultimate scope of the Directive, component and sub-assembly manufacturers must ensure that their products are RoHS compliant if they want their products to be purchased.
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 containing all the analysis and component data and must be kept for at least four years from the date the equipment was put on the market. If the compliance of a product is called into question by an authority, it is the technical file they will request first for assessment, and one must be produced within 28 days of the request.
There are at present no standard certificates of RoHS compliance or declarations that can be conveniently compiled into a technical file. However, this situation is under development and large suppliers such as Farnell and RS have already started selling components with their own “standard” RoHS compliance documentation. When requesting RoHS compliance information from a supplier, the minimum information required is a statement that the materials, parts or components may be used to produce RoHS compliant equipment. This should be in the form of a statement that the restricted substances by weight in homogeneous materials are within the maximum allowed limits.
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.
Currently the penalties associated with failing to comply with the Directive are as follows;
Although the NMO will not advise anyone to break the law with regard to RoHS if they are having difficulty meeting their obligations, they have stated that their approach to enforcement will be proportionate and based on an assessment of risk. Thus, if a large producer has a very high output of products with short life cycles and refuses point blank to do anything at all to meet his RoHS requirements, they are likely to be hit with the full force of the law very quickly. Conversely, if a small producer with a low output of products has obtained all certification documentation they reasonably can, are pursuing outstanding documentation and can demonstrate their efforts to any enforcement authority, they are likely to be given a reasonable amount of time to fully complete their RoHS obligations before further action is taken.
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. For a more detailed discussion of the practicalities of due diligence, go to the NWML website.
Timetable for Extension of scope
|Implementation date||Products to be included|
|22nd July 2014||Category 8: medical devices|
|22nd July 2014||Category 9: monitoring and control instruments|
|22nd July 2016||Category 8: In vitro diagnostic medical devices|
|22nd July 2017||Category 9: Industrial monitoring and control instruments|
|22nd July 2019||Extension to all EEE except those explicitly excluded|
The scope of RoHS 2 will be reviewed in July 2014.
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.
Directive 2002/95/EC (RoHS 1) of the European Parliament and of the Council, of 27 January 2003, on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) - Published in Official Journal L37, 13 February 2003
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.
The National Measurement Office (NMO) has been appointed as the UK's national RoHS enforcement body. Their website contains very useful information regarding all aspects of the RoHS Directive, including updates on exemptions, a Frequently Asked Questions section, what constitutes Due Diligence, a timetable of industry events and a “Decision Tree” to assist producers in assessing whether RoHS applies to their products or not.
The Department for Business, Innovation and Skills has a summary webpage on the RoHS Directive.
A list of all Legislation and stakeholder consultations at the European Commission level can be found on their Europa website - Waste Electrical and Electronic Equipment page.
The National Physical Laboratory website contains some information on their studies of lead-free solder investigations.
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.