RoHS Compliance – FAQ
What is RoHS Compliance? RoHS (Restriction of Hazardous Substances) is a product-level compliance standard based on the EU Directive 2002/95/EC. It limits hazardous materials in electrical and electronic equipment to ensure environmental and human safety. What are the restricted materials mandated under RoHS? RoHS restricts the following hazardous materials in electrical and electronic products: lead (<1000 ppm), mercury (<100 ppm), cadmium (<100 ppm), hexavalent chromium (<1000 ppm), polybrominated biphenyls (PBB) (<1000 ppm), and polybrominated diphenyl ethers (PBDE) (<1000 ppm), with some limited exemptions. Why is RoHS compliance important? Hazardous materials that are restricted in RoHS are harmful to environment, humans and animals. Why were RoHS regulations created? To reduce the usage of hazardous chemicals and thus reduce its effect on environment, humans and animals. How are products tested for RoHS compliance? RoHS compliance is tested with the help of RoHS analyzers. They are also known as X-ray fluorescence or XRF metal analyzers and are used for screening and verification of the restricted metals. Is RoHS compliance mandatory throughout the world? No, it is not mandatory throughout the world. It is good if you follow RoHS, because following Europe, most of the countries are now bringing up their own RoHS. Which companies are affected by the RoHS Directive? Any companies that sells electronic products, sub-assemblies or components directly to EU countries, or sells to resellers, distributors or integrators that in turn sell products to EU countries, is impacted by chemicals banned in RoHS directive Metal industry is also affected, if there are any applications of metal plating, anodizing, chromating or other finishes on EEE components, heat sinks, or connectors. How do I know whether my products are RoHS compliant? RoHS compliance is measured by careful testing and documentation in accordance with RoHS Directive regulations. RoHS consultants help to oversee compliance. Companies can send their products to laboratories for conducting RoHS tests. The labs will test the company’s products and will return the results that will be needed for documentation. Another option is the use of handheld XRF analyzers, small devices instantly test for the presence of elements and substances controlled by the RoHS Directive It will offer instant results as well as saved results for RoHS documentation. How can I obtain a RoHS certification letter? RoHS certificate is a self-declaration letter. You can declare the compliance after checking for RoHS chemicals. The following steps are to be followed for RoHS certification. a. Testing: Through XRF testing and/or lab phthalate solvent extraction testing to be done to determine values of the ten restricted RoHS substances. b. Process Audit: Inspect all applicable manufacturing processes used towards RoHS compliance on-site. c. Documentation Review: Review the Bill of Materials, assembly drawings, materials declarations, test reports, and conformance/compliance certificates from all suppliers. d. Certification Statement: After a successful audit, a RoHS Certificate of Compliance (also known as a Certificate of Conformity or Declaration of Conformity) can be issued. What is the impact of RoHS non-compliance? Companies will not prefer to buy RoHS non-compliance products. Refusing to comply with requests or non-compliant products can result in fines that are £5000 or more. In some cases, businesses can be banned from export of their products. Specific penalties vary from state to state, but non-compliance is always far costlier for a business than compliance. What is RoHS 2 and how does differ from the original RoHS? RoHS 2 is called Directive 2011/65/EU The scope of original RoHS is expanded to cover all electrical/electronic equipment, cables, and spare parts with compliance required by July 22, 2019 or sooner depending on product category. Directive 2011/65/EU was published in 2011 by the EU, is known as RoHS-Recast or RoHS 2. RoHS 2 includes a CE-marking directive, with CE-marking of products, RoHS compliance is also required. RoHS 2 also added Categories 8 and 9 and has additional compliance recordkeeping requirements. What is RoHS 3 and how does it differ from RoHS 2? RoHS 3, or Directive 2015/863, adds four additional restricted substances (phthalates) to the original list of six. What is RoHS 5/6? RoHS 5/6 refers to compliance for 5 out of the 6 restricted substances (no compliance for lead (Pb)). Will there be a “RoHS 4”? / Are there additional substances that will be restricted in the future? Mostly yes. There are discussions (called RoHS Pack 15) taking place for the possible amendment and inclusion of seven new substances. The seven additional substances being assessed are: Beryllium, Cobalt (dichloride and sulphate), Diantimony trioxide, Indium phosphide, Medium-Chain Chlorinated Paraffins (MCCPs), Nickel (sulphate and sulfamate), and Tetrabromobisphenol A (TBBP-A). How are RoHS and REACH related? RoHS restricts substances present in electrical/electronic equipment (wiring, components, circuit boards, displays, sub-assemblies, cabling). REACH controls all chemicals that might be used to manufacture the product. All the RoHS restricted substances are also on the REACH restricted list. How are RoHS and WEEE related? RoHS regulates the hazardous substances used in the manufacture of electrical and electronic equipment (EEE), while WEEE regulates the disposal of this same equipment. WEEE compliance aims to encourage the design of electronic products with environmentally-safe recycling and recovery. RoHS compliance joins with WEEE by reducing the amount of hazardous chemicals used in electronics manufacture. How is RoHS compliance enforced and what are the penalties? By national enforcement bodies such as the NMO (National Measurements Office). Penalties and fines for non-compliance can vary between EU countries but include fines or products going to be banned in countries and also imprisonment in some member states. Is my business affected by RoHS? Yes, if you use any EEE component in your product. What is EU RoHS Directive 2011/65/EU? EU Directive 2011/65/EU (Restriction of the Use of Certain Hazardous Substances in Electronic and Electrical Equipment) restricts the amount of hazardous substances that can be used in the manufacture of electrical and electronic equipment (EEE). These hazardous substances can be difficult to manage at the end period of the product life cycle. Therefore, the regulations focus on restricting them at the beginning of the cycle in order
New Conflict Mineral Reporting template has released – Revisionv5.12
CMRT 5.12 was released on 26th April 2019 and is available on the RMI (Responsible Minerals Initiative) website. The new CMRT comes up with a few minor changes when compared to 5.11. CMRT is a free standard template that helps the manufacturers and smelters, to get the current detailed information on sourced minerals/3TG in supply chain and improve their compliance. CMRT is a free standard template that helps the manufacturers and smelters, to get the current detailed information on sourced minerals/3TG in supply chain and improve their compliance. Corrections to all bugs and errors. Enhancements which do not conflict with IPC-1755 (Updates to ISO short names to countries, states/provinces). Updates to the Smelter Reference List and Standard Smelter List (Changes to the smelter list as reflected in the standard smelter list as of February 27,2019. This 20th version of CMRT, can be downloaded from below RMI website The next revision of CMRT is expected to be released in 2020 with revisions that will reflect changes to the IPC-1755 standard. Talk to global compliance experts at ComplianceXL, to get more insights on the new CMRT requirements and its effect on your day to day business.
ComplianceXL partners with a leading global risk management solutions provider to help with a dedicated technical support team
Chicago, IL April 03, 2019 – ComplianceXL has entered into a strategical partnership with the leading global risk management solutions provider to help them with a team of dedicated technical support. The client is a world leader in technology-enabled global risk management solutions for product development, compliance, safety, regulatory, and market access. Their major customer base includes retailers, distributors, brands, manufacturers, and suppliers of products to the global market. Under the terms of the three-year agreement, ComplianceXL will provide dedicated technical support engineers to answer customer queries and provide clarifications on regulatory compliance. These engineers will capitalize on the thought leadership of ComplianceXL and provide their customers with the most appropriate details to meet global compliance regulations. ComplianceXL will analyse the performance periodically with monthly reports and provide process improvements and will absorb up to 30% volume spikes as necessary. ComplianceXL will manage the administration and infrastructure while the client will provide required training on a timely basis and continuously monitor the performance of the support engineers. The engineers hired for this role are multi-skilled with sufficient prior experience in Chemical, Biology and Natural sciences domains. The engineers provide support across time zones covering Asia, Europe, and US regions.’ “We look forward to providing the client with greater flexibility of support in its global operations,unlock the capability in innovative customer engagement and help evolve its application technical support practices by leveraging the potential of big data analytics.”, says CK Bharathan, Head of Compliance Solutions, ComplianceXL. About ComplianceXL: ComplianceXL is the Compliance Solutions Division of Enventure, a leader in the compliance business since 2003. ComplianceXL is a one-stop solution for all supply chain compliance requirements, ranging from consulting and training to collecting compliance certifications and documentation from suppliers. By implementing a transparent and well-structured compliance program, ComplianceXL enables clients to follow an integrated process, to meet their compliance obligations. Beyond aninitial implementation, ComplianceXL also provides ongoing support to maintain compliance to regulations such as RoHS, REACH, CA Prop65, Conflict Minerals, ELV, GHS/OSHA and several other global legislations.
ComplianceXL wins contract from a leading manufacturer of impact-mitigating products in the US, to formulate global material compliance strategy
Chicago, IL; April 05, 2019 – ComplianceXL has been awarded a contract to formulate a strategic roadmap for global material compliance regulations such as RoHS, REACH and CA Prop 65. The engagement will provide Compliance Training to supply chain stakeholders, Compliance Audit and Gap Assessment. The client is involved in the design and development of protective and impact-mitigating products in the US. They are known for leading-edge products that protect serious and potentially life-threatening impact-related injuries. ComplianceXL will work side-by-side with the client team, performing gap analysis to evaluate current compliance practices, assess documentation and reporting structure, policy statements legal risks and mitigation plan . The objective of this program is tailoring a robust platform to meet global compliance requirements across European and North American countries. Additionally, ComplianceXL will provide on-demand training and support services for the client’s internal compliance team and their suppliers based on a custom-made global compliance framework. The new framework will define proactive communication plan that covers on-site & off-site training, virtual interactive sessions, leadership guidance programs and e-learning sessions on global compliance regulations such as RoHS, REACH and CA Prop65. “Sustainability is the top priority in the client’s journey towards business success. With this engagement, we are helping the client to stay compliant with global compliance regulations and unleash the extra business value from new markets. We are proud to deliver this compliance consulting and training program and enable client’s supply chain sustainability,” says CK Bharathan, Head – Compliance Solutions, ComplianceXL. On successful completion of this program, the client is expected to sign up for tech-enabled Compliance Documentation and Supplier Engagement services with ComplianceXL. About ComplianceXL: ComplianceXL is the Compliance Solutions Division of Enventure, a leader in the compliance business since 2003. ComplianceXL is a one-stop solution for all supply chain compliance requirements, ranging from consulting and training to collecting compliance certifications and documentation from suppliers. By implementing a transparent and well-structured compliance program, ComplianceXL enables clients to follow an integrated process, to meet their compliance obligations. Beyond an initial implementation, ComplianceXL also provides ongoing support to maintain compliance to regulations such as RoHS, REACH, CA Prop65, Conflict Minerals, ELV, GHS/OSHA and several other global legislations.
ECHA Proposes To Restrict Intentionally Added Microplastics
ECHA (European Chemicals Agency) has submitted a proposal for a new regulation to restrict microplastic particles that have been added intentionally in consumer and commercial products. What are microplastics? Microplastics are tiny particles of plastic material, typically smaller than 5 mm including much smaller nano-plastics. They are deliberately manufactured and intentionally added to products for certain specific reasons and used in a variety of consumer, agricultural, professional, and industrial products such as: Cosmetics and personal care products – both rinse-off and leave-on products Detergents and cleaning products – encapsulation of fragrances in laundry detergents and cleaning products paints, inks and coatings Products used in the oil and gas industry abrasive blasting media Agricultural and horticultural products – fertilizers and plant protection products Apart from this, some products are designed to intentionally release microplastics as a part of their function; for example, products such as nutrient pills used in the agricultural sector. These microplastic particles accumulate in the environment and may get consumed by animals and fish, which eventually be eaten consumed by human beings, which can be hazardous. What has been done in the EU? Many EU states have either banned the intentional use of such microplastics or have proposed bans. The biggest concern with the impact of products is they adversely affect human health and the overall environment. Some of the consumer products that use ‘microbeads’ in ‘rinse-off’ cosmetics, which act as exfoliating and cleansing agents are expected to be banned. What is ECHA’s assessment? Intentionally added microplastics are likely to get accumulated in terrestrial and aquatic environments. The alarming factor is that the bio-accumulation of these microplastics is rather persistent and lasts for thousands of years and becomes practically impossible to remove. At present, it is nearly impossible to measure the long-term exposure of these microplastics and their impact on the environment. Limited availability of data The risk assessment of microplastics on the environment is highly challenging due to the inadequate availability of information on the after-effects. The food chain becomes more vulnerable to the negative effects of microplastics because of its size and their degradation will result in much smaller particles, which makes it very difficult to identify or control. The socio-economic impact of such restrictions ECHA has identified that the agricultural sector will be the most affected industry segment, and the restrictions are likely to result in a difference in the cost of the product. However, ECHA expects the entire activity to be cost-effective in all sectors in the long run, by using environmentally friendly alternatives at better costs. Labeling requirements In addition to the ban of microplastics, the new regulations also require manufacturers to provide warnings through labels about potential microplastics released during usage. Some of the products affected by this requirement include: Paints, inks, and coatings – both for professional and consumer applications Chemicals – esp. oil and gas processes Construction products – cement and adhesives Medicinal products and medical devices What does the restriction proposal not cover? At the outset, few of the naturally occurring polymers such as cellulose, polymers that meet the proposed interim biodegradability criteria, or fertilizing products, are not included. However, the upcoming Fertilizing Products Regulation will keep a check on such products. How would the restriction work? The regulation is expected to be effective starting in 2021, in a phased manner to give manufacturers enough time to redevelop, rediscover and find suitable environmental friendly alternatives to microplastics. By this regulation, the release of microplastics is estimated to reduce by 400,000 tons over 20 years. What do you need to do? With the enforcement of various environmental regulations, manufacturers have to be more cautious and remain up-to-date, to stay compliant. Ensuing compliance requires extensive efforts in understanding complete regulations, compliance documentation requirements, supplier engagement, finding alternatives and accurate compliance reporting. Are you affected by this upcoming restriction? Talk to one of our Compliance Experts to learn more and do an assessment.
ComplianceXL to help a world leader in musical instruments in Compliance Documentation, Training and Supplier engagement.
Chicago, IL; March 02, 2019 – ComplianceXL has signed a contract with a global leader in specialized musical instruments to perform compliance risk analysis, manage compliance documentation, supplier engagement and provide compliance training for various stakeholders across locations. The client is a leading manufacturer of percussion instruments, mostly made of wood. Designed and built in the US, their instruments are handcrafted and known for its patented innovations that inspire passion and creativity with perfect sounds. With this engagement, ComplianceXL will transform the compliance practices of the client by delivering superior supplier engagement and documentation processes, followed by dedicated training on global compliance regulations such as RoHS, REACH and Prop 65. The scope of this engagement includes risk analysis, training for internal stakeholders and suppliers, compliance documentation, and supplier engagement. “ComplianceXL understands that in today’s dynamic environment, compliance needs, company liabilities and the marketplace are constantly evolving. By gaining control over material compliance regulations, the client really expands their ability to enter new markets, as well as achieve leadership in existing markets they operate in. Having a forward looking compliance program ensures that companies are managing their risks well and not exposing themselves to avoidable penalties and issues.” says Kiran Sivadas, EVP, ComplianceXL. Under the terms of the contract, ComplianceXL will allocate a Compliance Solutions expert supported by a team of compliance experts and a multilingual supplier engagement team. About ComplianceXL: ComplianceXL is the Compliance Solutions Division of Enventure, a leader in the compliance business since 2003. ComplianceXL is a one-stop solution for all supply chain compliance requirements, ranging from consulting and training to collecting compliance certifications and documentation from suppliers. By implementing a transparent and well-structured compliance program, ComplianceXL enables clients to follow an integrated process, to meet their compliance obligations. Beyond an initial implementation, ComplianceXL also provides ongoing support to maintain compliance to regulations such as RoHS, REACH, CA Prop65, Conflict Minerals, ELV, GHS/OSHA and several other global legislations.
ComplianceXL wins contract from a leading valve communication solutions provider in the US, to strategize roadmap for global product compliance regulations
Chicago, IL; February 25, 2019 – ComplianceXL has been awarded a contract to develop and implement a comprehensive roadmap for product compliance to regulations such as RoHS, REACH and CA Prop 65. The engagement will provide compliance guidance and support to the client’s internal team, consisting of cross functional team members. The client has a wide array of solutions such as position sensing systems, environmental encapsulation of electronics and field-based communication integration for the US and European markets. The few areas of concern for the client are: ComplianceXL will dedicate a Senior Compliance Consultant to lead this engagement, to perform gap analysis and a compliance audit at the client site. Based on the initial discovery, a team of compliance experts will develop and implement a comprehensive roadmap covering various stages of the compliance program. This engagement is expected to ensure the client is able to meet their obligations for compliance to RoHS, REACH and Prop 65, as well as stay ahead of the curve in terms of upcoming new regulations and amendments to rules, in the US and European markets. “Staying up-to-date with global compliance regulations is critical for all manufacturers and suppliers. In this highly competitive industry, the client’s focus on sustainability and growth is a top business priority. Our core strength lies in enabling clients to seamlessly manage their compliance activities and we are as passionate about this journey as they are. We always keep in mind the fact that sustainability of a program, is as critical as an initial implementation” said Kiran Sivadas, EVP, ComplianceXL. About ComplianceXL: ComplianceXL is the Compliance Solutions Division of Enventure, a leader in the compliance business since 2003. ComplianceXL is a one-stop solution for all supply chain compliance requirements, ranging from consulting and training to collecting compliance certifications and documentation from suppliers. By implementing a transparent and well-structured compliance program, ComplianceXL enables clients to follow an integrated process, to meet their compliance obligations. Beyond an initial implementation, ComplianceXL also provides ongoing support to maintain compliance to regulations such as RoHS, REACH, CA Prop65, Conflict Minerals, ELV, GHS/OSHA and several other global legislations.
Do your products comply with the ROHS 2 delegated directive 2015/863?
Any business that sells electrical/electronic products, sub-assemblies or components directly to EU countries, or sells to resellers, distributors or integrators that in turn sell products to EU countries, are required to comply with EU RoHS Directive The European Commission published the first RoHS Directive 2002/95/EC on the restriction of the use of six hazardous substances in electrical and electronic equipment (EEE) is referred to as RoHS 1 and the recast Directive 2011/65/EU is referred to as RoHS 2. The Commission published the RoHS 2 delegated directive 2015/863 on 04 June 2015 by adding 4 phthalates to the list of restricted substances in Annex II to Directive 2011/65/EU (RoHS 2). All EEE manufacturers should comply with the RoHS recast requirements by 22 July 2019, except for medical devices and monitoring and control instrument manufacturers, for whom the compliance deadline is 22 July 2021. Major features of the RoHS 2 recast are: Addition of low molecular weight Orthophthalates: DEHP, BBP, DBP, DIBP restricted at 1,000 ppm in homogenous materials The restriction of phthalates DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, reuse, updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019 The restriction of phthalates DEHP, BBP and DBP shall not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006 (REACH). Manufacturers must ensure that EEE are CE marked and must prepare a declaration of conformity confirming that they have complied with the regulations. The general principles of CE marking are outlined in Regulation 768/2008/EC. Below are the broad categories of EEE that are covered under the RoHS 2 recast RoHS 2 is applicable to these categories Categories exempted from RoHS 2 Large household appliances Small household appliances IT and telecommunications equipment Consumer equipment Lighting equipment Electrical and electronic tools Toys, leisure and sports equipment Automatic dispensers Non-industrial monitoring and control instruments Medical devices and monitoring and control instruments from July 2021 In vitro medical devices, from July 2021 Industrial monitoring and control instruments, from July 2021. Equipment built for military purposes and needed for national security. Equipment designed for space travel. Transport for people or goods. Active medical implants. Photovoltaic panels (for public, commercial, industrial or residential use). Equipment specifically designed for research and development (for professional use). Non-road mobile machinery for professional use that has an onboard motor. Large-scale stationary industrial tools. Large-scale fixed installations. Equipment specifically designed to be part of another type of equipment that is exempted. (EEE is defined as any equipment with a voltage rating not exceeding 1,000V for AC and 1,500V for DC that requires electric currents or electromagnetic fields to work, or equipment used for the generation, transfer and measurement of electric currents and fields. EEE can be a component or assembly used in a finished product. Cables and spare parts for repairing, reusing, updating or upgrading a product are all EEE.) Do you want to learn more about how to comply with the RoHS 2 recast before the deadline? Talk to the compliance experts at ComplianceXL.
ComplianceXL awarded contract for Compliance Documentation and Maintenance in SAP EH&S, by a world leader in optical systems.
Chicago, IL; February 7, 2019 – ComplianceXL, the compliance solutions division of Enventure, today announced that they were awarded a contract to manage compliance documentation in SAP EHS, by a well reputed global optical systems manufacturing company. The multi-year engagement is primarily designed for the client’s compliance to the EU REACH and RoHS regulations. The client has a wide mix of parts and components sourced from suppliers spread across North America, Europe and Asia. The major challenges they have been facing arise from discrepancies in their parts database, making it very hard to build up a reliable database of compliance documentation. The scope of ComplianceXL’s engagement includes: ComplianceXL provides tailor-made solutions for compliance and has been a dependable partner to over 300 organizations worldwide. A Senior Compliance Specialist at ComplianceXL will lead the internal team of compliance experts, multilingual sourcing engagement team and SAP EHS experts. The Client saw several strengths in ComplianceXL, ranging from domain expertise in multiple compliance regulations, to comprehensive solutions covering consulting, vendor engagement, data validation, topped off with very good SAP EHS skills. This really set apart ComplianceXL from other competitors, leading the client to award the contract to ComplianceXL. “Our up-to-date knowledge and expertise in global product compliance regulations have enabled clients to meet their regulatory deadlines on time and within budget. A significant part of the overall effort is collecting due diligence documentation from suppliers and our multilingual vendor engagement team ensures that vendors understand the reporting requirements and we are able to maximize delivery of compliance data by vendors. I believe our strength in this area was a key factor in the client deciding to award this contract to ComplianceXL” said CK Bharathan, Head – Compliance Solutions, ComplianceXL. About ComplianceXL: ComplianceXL is the Compliance Solutions Division of Enventure, a leader in the compliance business since 2003. ComplianceXL is a one-stop solution for all supply chain compliance requirements, ranging from consulting and training to collecting compliance certifications and documentation from suppliers. By implementing a transparent and well-structured compliance program, ComplianceXL enables clients to follow an integrated process, to meet their compliance obligations. Beyond an initial implementation, ComplianceXL also provides ongoing support to maintain compliance to regulations such as RoHS, REACH, CA Prop65, Conflict Minerals, ELV, GHS/OSHA and several other global legislations.
Reach SVHC List updated – 6 new substances added
On the 15 January 2019, the European Chemicals Agency (ECHA) announced six new additions to the REACH candidate list of Substances of Very High Concern (SVHCs) having below properties Carcinogenic, toxic to reproduction, Persistent, bio-accumulative and toxic (PBT) Very persistent and very bio accumulative (vPvB) Endocrine-disrupting The inclusion of Polycyclic Aromatic Hydrocarbons (PAHs) was considered with the involvement of the Member State Committee (MSC). The PAH cases were referred to MSC based on submissions received during the REACH public consultation. With this addition, the total number of SVHCs under ECHA is increased to 197 from 191 substances. The new substances included in the Candidate List are: 2,2-bis(4′-hydroxyphenyl)-4-methylpentane (CAS no. 6807-17-6) Benzo[k]fluoranthene (CAS no. 207-08-9) Fluoranthene (CAS no. 206-44-0) Phenanthrene (CAS no. 85-01-8) Pyrene (CAS no. 129-00-0) 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (CAS no. 15087-24-8) These substances are found in a variety of products from electronic and electrical appliances, toys, paints, chemicals and plastics. The companies are required to verify and identify if such substances are present in both semi-finished and finished products. Any organisation involved in the manufacture or sales of products in the European Union (EU) will need to communicate the presence of SVHCs in their products above the concentration of 0.1% (weight by weight), within six months from the date of substance inclusion in the candidate list by ECHA, which for the latest update is January 15,2019. All manufacturers/suppliers need to keep an active check on this SVHC list to stay compliant and avoid business continuity risks. If the manufacturer’s articles or products contain any substance included in the SVHC list above accepted concentration level, they need to fulfil the following obligations: REACH article 33 : Communication of information on SVHCs to the entire supply chain REACH article 7(2) : Notification of SVHCs to ECHA Learn more about compliance best practices? Connect with our compliance specialists at [email protected].