The European Union (EU)'s Restriction of Hazardous Substances (RoHS) expands the list of prohibited substances from six to ten by adding four new types of phthalates (*). This directive has been adopted by the EU legislature and came into full force on the 22nd of July 2019 with a special provision for medical devices until 2021. On July 22, 2019, RoHS 3 was put into effect and now all electrical and electronic equipment on the EU market must act in accordance with the new restrictions. Imposition of the RoHS 3 regulations on medical devices and monitoring & controls instruments from categories 8 and 9 will go into effect on July 22, 2021. Category 8 in-vitro diagnostic medical devices (IVDs) exemption deadline is July 21, 2021. Category 9 industrial monitoring & control instruments; Category 11 products examption deadline is July 21, 2024.
Understand the RoHS Directive and its requirements. The RoHS Directive applies to all companies selling EEE finished products including components within finished products in Europe, regardless of where they were manufactured. Beyond this, any business selling applicable electronic products, sub-assemblies or components directly to EU countries, or to resellers, distributors or integrators that in turn sell those goods to EU countries will be impacted if they use any of the restricted materials.
Exemptions and their respective expiration dates. A capacitor containing lead attached to a circuit board contained within a device on a product assembly would be out of scope (ngoài phạm vi/tầm) because the device itself is out of scope (large scale healthcare commercical machines). However, that same capacitor attached to a circuit board contained in a desktop computer would be required to use the exemption 7(c)-I “Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectric devices, or in a glass or ceramic matrix compound” to be compliant with exemption, or reduce the lead content to a level below 0.1 percent to be compliant without the exemption. Understanding how a product is being used is key to determining whether or not it is out of scope or requires the use of an exemption to be compliant. For suppliers, exemptions should be included in their declarations as they have no way of knowing exactly how their supplied product will be used by the customer.
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The difference between exempted and out of scope substances and product categories. Permanent exclusions from RoHS includes military equipment, space equipment, equipment designed to be part of another piece of equipment falling outside the scope of RoHS, large scale industry tools, large scale fixed installations, means of transport for persons or goods, non-road mobile machinery. RoHS categories are:
How long is a RoHS certificate valid for? A RoHS certification is valid for five years. However, early re-certification may be required if a product undergoes significant changes in design, raw materials or sourcing procedures.
What is the difference between Reach and RoHS? REACH is a horizontal legislation controlling the risks associated with chemical substances throughout their whole life cycle, while RoHS is a product-specific vertical legislation focuses on hazardous substances in electrical and electronic equipment (EEE).
The RoHS Directive, also known as Directive 2002/95/EC, entered into effect on July 1, 2006. The directive restricted the use of six chemicals harmful to human and environmental health in electrical and electronic equipment (EEE) and was the original foundation of RoHS 2 and its amendments. RoHS is closely linked to the Waste Electrical and Electronic Equipment Directive (WEEE) (2002/96/EC) which outlines collection, recycling and recovery targets or electrical goods in an effort to help solve the problem of toxic electronic waste. These six chemicals and their accepted thresholds under RoHS 1 were:
RoHS Directive (2002/95/EC) Exemptions: The original RoHS Directive (2002/95/EC) included 36 exemptions applying within specific use cases for each restricted substance (this number is now closer to 150). These exemptions were given an expiry date, after which time that particular use would no longer be permitted. An exemption temporarily allows a restricted sub-stance to be used in certain applications in cases where a suitable alternative is not available. During the time period in which the exemption applies, industry experts research and test possible replacements for the exempted substances in various applications. If alternatives cannot be found during this period, manufacturers can request an extension or clarification of the exemption to allow further time for suitable replacements to be found. If a request for ex-tension is rejected, the exemption will expire between 12 and 18 months after the decision by the European Parliament is made. At this time, products containing the substance will become non-compliant with the RoHS Directive. However, certain applications may be exempt from RoHS restriction if it is technically or scientifically impracticable to prohibit the use of certain hazardous substances at present.
RoHS Directive (2011/65/EU), known 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 mercury (Hg), lead (Pb), cadmium (Cd), polybrominated biphenyls (PBB), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP), hexavalent chromium (Cr(VI)), polybrominated diphenyl ethers (PBDE), bis (2-ethylhexyl) phthalate (DEHP) and butyl benzyl phthalate (BBP). 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.
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.
Scope of RoHS. In comparison to RoHS 2002/95/EC, RoHS 2 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”. RoHS 2011/65/EU are included electrical and electronic equipment from the following product categories:
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.
‹•› Within the Directive’s scope not included are:
Conformity and Legal Obligations: 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.
‹•› Manufacturers: Any manufacturer of electrical and electronic equipment who wants to place their product on the EU market have the following legal obligations:
‹•› Authorised Representatives: All authorised representatives must be established within the EU borders and can be sub-contractors, agents, importers or distributors. An EU authorised representative is 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. The legal obligations of the authorised representatives are, as follows:
A further RoHS amendment (2015/863) followed in 2015, adding four more substances (all phthalates) to the list of restricted chemicals under Annex II. This brought the total number of restricted substances to 10.
The maximum allowable concentrations for these was set at 0.1 percent, weight by weight (w/w). As of July 22, 2019, the four substances cannot be placed on the EU market in concentrations above this threshold, with the exception of monitor and control equipment and medical devices (including in vitro devices), which cannot be put on the market after July 22, 2021.
China RoHS 2 is a "Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products (EEP)". Substances: Standard six by 2019 | Exemptions: 12 additional product types | Included Products: Electrical and Electronic Products (EEP, 12 types of aditional products required to be compliant as of March 2019 | Compliance: Labeling and declaration using a custom table in Chinese, additional labeling requirements come into effect in November 2019 for an additional 12 product types.
Japan RoHS is the "Law for Promotion of Effective Utilization of Resources in Japan (Japanese Recycling Law) and mandatory industry standard JIS C 0950 aka: J-MOSS ("The marking for presence of the specific chemical substances for electrical and electronic equipment” (effective July 1, 2006). Substances: Standard six | Exemptions: Similar to EU | Included Products: Seven specific categories, including batteries | Compliance: Labeling and declaration using a custom form.
South Korea RoHS is the "Act for Resource Recycling of Electrical and Electronic Equipment and Vehicles" (effective January 1, 2008, phthalates effective January 1, 2020). Substances: Standard six substances and four phthalates, plus four for vehicles | Exemptions: Similar to EU | Included Products: Five specific categories plus vehicles, broken out into specific product types | Compliance: Self-declaration through an online program or website disclosure. No marking or labeling requirements.
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Singapore RoHS is the "Second Schedule of the Environmental Protection and Management Act, Chapter 94A". Substances: Standard six | Exemptions: Same as the EU | Included Products: Six specific categories. | Compliance: Declaration of conformance to be included in the import documentation or presented before sale on the market when manufactured in Singapore.
India RoHS is the "E-waste (Management and Handling) Rules 2011" (effective May 1, 2014). Substances: Standard six | Exemptions: Same as the EU | Included Products: Consumer EEE, IT and telecom. | Compliance: Include information on RoHS in instruction manuals. No marking or labeling requirements.
Turkey RoHS is the "Regulation on the Restriction of Hazardous Substances in EEE" (effective June, 2009). Substances: Standard six | Exemptions: Similar to the EU but not as detailed. | Included Products: EEE, specific voltages (under 1,000 volts AC or 1,500 volts DC). | Compliance: Declaration of conformance submitted annually.
Requirements Companies of EEE in scope of the RoHS Directive are responsible for ensuring their products meet the requirements of the directive. Producres and manufacturers sells EEE products under their own brand on the market must be ready to demonstrate the compliance of these products with the RoHS Directive by ensuring they have the relevant technical documentation on hand to support this. Resells under their own brand equipment produced by other suppliers, a reseller not being regarded as the "producer" if the brand of the producer appears on the equipment, as provided for in subpoint (điểm phụ); or Imports or exports electrical and electronic equipment on a professional basis into a Member State. In order for the final product to remain compliant, these components and sub-assemblies must themselves not contain any of the 10 restricted substances in quantities above the threshold concentration values. A certificate from the suppliers that the parts supplied are RoHS compliant is required. Producers should also perform selected audits to confirm the compliance of these parts, as deemed necessary.
CE Marking: In addition, RoHS 2 (i.e. as of 2013) requires all EEE in scope to have a CE (Conformité Européene) marking, and to feature a reference to RoHS 2 on the product’s Declaration of Conformance. All CE marking directives require the manufacturer of the product to create a technical file containing the analysis and component data required to demonstrate that product’s compliance with the regulations relevant to it. This technical file must be kept for a minimum of 10 years after the product is put on the market (as per article 7d). Should a product’s compliance be questioned by enforcement authorities, this technical file must be produced within 28 days of the request. Manufacturers are not required to make this file available to the public or to customers.
Technical Files in Alignment with CE Marking Requirements: The support technical files to be maintained for ten years after the product has been placed on the market should include:
Declaration of Conformity (Tuyên bố về sự phù hợp) includes —›
Enforcement Action: The RoHS Directive gives the National Measurement & Regulation Office (NRMO) a range of powers, including:
The following explains how to assess the products for compliance with the RoHS Directive using appropriate documentation. The second part of this instruction shows the steps that could be taken by a RoHS enforcement body against a company demonstrating non-compliance with the directive. These have been adapted from the Environ-mental Protection Agency’s (EPA) RoHS Enforcement Guidance Document, and should not be viewed in isolation from it.
Product Outside the Scope of RoHS: No further action. —›
Product Within the Scope of RoHS: Carry out targeted XRF analysis of higher risk products to detect infringements (relevant only for some EU States and optional) —› Request technical documentation showing that the producer’s RoHS compliance assurance system is effective (within time limit specified by the enforcement authority) —› If —›
‹•› Process-based document exit: (Tài liệu dựa trên quy trình nếu có) Producer to provide process-based technical documentation —› if —›
Engage with your subject matter experts (SMEs) (chuyên gia vấn đề)) to identify potential in-scope products. Just because a particular product or part is not in scope of RoHS directly, does not mean we should ignore it when evaluating for RoHS-specific substances. The regulatory landscape is expanding, meaning other regulations, such as REACH, may capture that product in-scope and restrict the same substance in the future. By evaluating the product or part now, and proactively making changes to insulate your company from regulatory changes in the future —›
Reach out to suppliers for data:
Commence design change process: Changing a product’s composition can come with design changes that impact everything from specifications to certifications and manufacturing process compatibility. This is where the new design is conceptualized, rigorously tested, implemented and certified, all before moving on to manufacturing. Overlooking any of these steps, and the many others that are more industry-specific, can result in the failure of your new design to meet the product’s intended use, or its failure to live up to the user’s expectations in terms of durability, safety and use-ability. Even if your product now has market access, the new design still has to work as intended.
Manufacture the new product • Inventory and Stock Management: At the end of the process, you need to ensure all your outdated and non-compliant inventory has been moved out of your warehouses and replaced with the new product. To avoid stress and the risk of missing any inventory, aim to achieve this several months in advance of the deadline. Including factory line items used in the manufacturing process is vital to make sure nothing is missed that could otherwise affect the product’s compliance. This is a common gap in most programs and leads to inadvertent non-compliance.
RoHS Directive is a complex process that, without significant internal resources, cannot be achieved successfully without support. Complying with the RoHS Directive and similar regulations is entirely dependent upon your understanding of the product and its composition. That means we need to leverage data (both from internal sources and the suppliers) to gain that understanding, evaluate the product for compliance issues, and know what steps we must take to comply.
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