Permanent exclusions from RoHS include: military equipment, space equipment, equipment intended to be part of another device that does not fall within the scope of RoHS, large-scale industrial tools, large-scale fixed installations, means of transport of persons or goods, machinery and mobile equipment, Active implantable medical devices, photovoltaic modules, research and development equipment intended only for companies is available. As noted above, the European Commission interprets very narrowly the product categories to which these exemptions apply. The editor of Conformity Magazine questioned in 2005 whether the transition to lead-free soldering would affect the long-term reliability of electronic devices and systems, especially in applications that are more critical than consumer products, citing potential violations due to other environmental factors such as oxidation.  The 2005 Farnell/Newark InOne “RoHS Legislation and Technical Manual” mentions these and other “lead-free” solder problems, such as: In 2012, a final report by the European Commission revealed that some EU Member States classified all toys within the scope of the primary RoHS 1 Directive 2002/95/EC, whether their primary or secondary functions use electric currents or electromagnetic fields. Once the recast of Directive 2011/65/EU has been implemented, all Member States concerned will have to comply with the new Regulation. Notifications can be sent to OPSS using the following form: RoHS is the EU directive that restricts the use of certain hazardous substances in electrical and electronic products (EEE). ROHS II, which was adopted in 2011, is an “Open Scope” directive, which means it will be in place until the 22nd. July 2019 applies to all EEE products that “depend on electricity or electromagnetic fields for at least one intended function. The current list of restricted substances is set out in Annex II to the Directive and currently includes: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butylbenzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl (DIBP). If your device is a component (e.g. sub-assembly, spare part) sold to an integrator of another product sold in Europe, or if you sell to a distributor or reseller that sells products in Europe, you will probably need to comply with the RoHS directive. In addition, several U.S. states as well as several other countries (including China, India, Japan, and Korea) now require RoHS compliance or have taken similar measures.
In the United States, California`s law most closely resembles the European RoHS Directive, which prohibits the sale of “covered electronic devices” — defined as a video display device with a screen larger than four inches — though it is also prohibited by European RoHS regulations. RoHS Directive 3 or (EU) 2015/863 entered into force on 22 July 2019 and is actually an amendment to RoHS Directive 2, which added four new restricted substances – all phthalates primarily used as insulating plasticisers – to the initial list of six. Medical devices have again been granted a two-year exemption and do not have to comply with RoHS 3 until July 22, 2021. It is closely linked to Directive 2002/96/EC on waste electrical and electronic equipment (WEEE), which sets targets for the collection, recycling and recovery of electrical equipment and is part of a legislative initiative to address toxic electronic waste. Some of these products, such as medical devices, also fall within the scope of other EU legislation, such as the EU Medical Devices Regulation. Compared to other consumer products, electric motors have fewer potential effects on human health through indirect contact. However, RoHS aims to reduce damage and impact on people and the environment. Until 31 December 2023, you have the option to affix the UKCA mark to the product, packaging or documents by means of a label or similar label, as required. From 1 January 2024, the UKCA mark must be affixed directly to the product. The maximum permissible concentrations in non-exempted products are 0.1% or 1000 ppm (with the exception of cadmium, which is limited to 0.01% or 100 ppm). The restrictions apply to each homogeneous material in the product, meaning that the limits do not apply to the weight of the final product or even to a component, but to any individual material that could (theoretically) be mechanically separated – for example, the sheath of a cable or the tinning of a component cable.
As safety-critical devices, medical devices sometimes benefit from exemptions from RoHS or similar laws due to concerns about the reliability of suitable alternative materials. Paul Goodman of ERA Technology – the UK consultancy tasked with revising the RoHS directive for the inclusion of medical devices – explains why restrictions on substances are of such concern to the industry: RoHS applies to all components contained in lighting products, including the bulb, material, coating and even packaging. Lighting products with Wi-Fi or Bluetooth capabilities must also comply with the Radio Equipment Directive (RED). Unless explicitly excluded, the EU RoHS Directive applies to all electrical and electronic equipment, including category 11, since 22 July 2019. Negative impacts on product quality and reliability, as well as high compliance costs (especially for small businesses), are cited as criticisms of the policy, as is early research suggesting that the life-cycle benefits of lead-free solder are mixed compared to traditional solder materials.  In 2011, the RoHS 2/RoHS Recast Directive (2011/65/EU) entered into force, replacing RoHS 1 and no longer excluding medical devices. RoHS 2 broadened the scope of the original directive and was developed to align with other EU legislation, including REACH and CE marking (i.e. a certification mark indicating that the manufacturer`s product complies with the requirements of the applicable EU directives). Medical devices, with the exception of in vitro devices, which were given an additional two-year grace period, were required by law to comply with the new RoHS Directive by 22 July 2014.
Only “active implantable devices” and a small subset of medical applications (e.g., devices that use or detect ionizing radiation) were and are currently exempt. A complete list is set out in Annex IV 2011/65/EU. In 2012, the Swedish Chemicals Agency (Kemi) and the Electrical Safety Authority tested 63 consumer electronics products and found that 12 were non-compliant. Kemi says this is similar to test results from previous years. “Eleven products contained prohibited lead levels and a polybrominated diphenyl ether flame retardant. Details of seven companies have been forwarded to the Swedish Public Prosecutor`s Office. Kemi says that non-compliance with the RoHS directive is similar to previous years and is still too high.  There is what is known as RoHS regulation. In each jurisdiction, there is a list of products that fall outside the scope. This is the case in the European Union under Directive 2011/65/EU and its amendments to: Therefore, good companies should clearly define their level of compliance in their key product data sheets (SD); Ideally, they should provide a Product Content Sheet (PCS) with a full mass declaration of the substance.
Similarly, good developers (and users) need to carefully validate product information to ensure they receive exactly the expected hardware security. RoHS compliance is mandatory for all electronic components of wristwatches such as quartz movements, induction chargers, heart rate sensors, chips and touchscreens (if applicable). Note that the battery of smartwatches is excluded from RoHS. RoHS 2 attempts to solve this problem by requiring the above-mentioned CE marking, the use of which is controlled by the Trade Standards Enforcement Authority.  It states that the only acceptable indication of RoHS compliance is CE marking.  The WEEE Directive (Waste Electrical and Electronic Equipment Directive), which entered into force at the same time as the RoHS Directive, displays a bin logo with an “X” and often accompanies the CE marking. RoHS restricts heavy metals such as lead and cadmium in all electronic products sold in the European Union. To ensure RoHS compliance, all electronic components, printed circuit boards, and solders must be RoHS compliant. On 4 June 2015, the European Commission published Directive (EU) 2015/863 (RoHS 3) amending Annex II to RoHS 2. With this new amendment, the following category 11 products and four phthalates have been added to the list of restricted substances: Despite the exceptions, most products, B2C or B2B, fall within the EU`s RoHS scope, which is particularly broad. Annex I to Directive 2011/65/EU lists the eleven RoHS categories in the table above.
Test and measurement providers, such as National Instruments, have also started manufacturing RoHS compliant products, although devices in this category are exempt from RoHS.  Depending on the category, an electrical or electronic product may require RoHS certification. Let`s take a look at the product categories: The RoHS directive covers headphone products, from Bluetooth headphones to bone conduction headphones, to reduce substances that are dangerous to users and the environment. Economic operators in Great Britain and Northern Ireland must take specific measures if they know or suspect that a product is not compliant, including: Another potential problem that some lead-free, high-tin tin solder may face is the growth of tin whiskers. These thin strands of tin can grow and come into contact with an adjacent track, creating a short circuit. In the past, tin whiskers have been linked to a handful of failures, including the shutdown of a nuclear power plant and a pacemaker incident that used pure tinning. However, these errors date back to before RoHS. They also don`t include consumer electronics and can therefore use RoHS restricted substances if desired.