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
Managing And Qualifying Your Suppliers On REACH And RoHS
Companies manufacturing products or consumer parts that contain hazardous materials in the manufacturing process must comply with RoHS regulation. RoHS and REACH are two regulations that require compliance if a company intends to sell their products in the European Union. Hence, it is very important to know your vendor compliance status with respect to these regulations. Supplier qualification Sometimes it’s tough to gauge which of your suppliers are compliant with these regulations and which ones are not compliant. Many vendors will have limited understanding of RoHS and REACH. Often, manufacturers claim that their components are compliant without having any supporting documentation. In our research, we have found 4 measures that guide companies on compliance. In order to ensure compliance with RoHS and REACH: Each supplier should send in a Certificate of Compliance (CoC) indicating that the components or products in question are compliant. A CoC can be a written statement, a label or a blanket statement of compliance to a product line, material or process offered by a supplier. If a CoC is not available, auditing a vendor or reviewing past audits is another way to ensure that the vendor is following the correct procedures. Another option is to ask the vendor for the material declaration. The material declaration is a list of all substances in the part, product or process. This list can be compared with the specifications of RoHS and REACH. If no banned substances are present, the item can be considered compliant. Suppliers must also include in the documentation any exemptions that have been taken. Anyone importing products into the European Union will be most affected. All manufactures in the European Union member states are also required to comply with the regulations. Who Needs to Comply? Compliance affects: Importers and manufacturers selling products in the EU OEMs sourcing materials globally Distributors handling products across the European market Whether you manufacture within or outside of the EU, RoHS and REACH compliance is non-negotiable if you want access to the European market. Best Practices for RoHS and REACH Compliance Maintaining compliance requires: Full visibility into your supply chain Accurate record-keeping Proactive supplier management Regular product testing, if necessary A strong compliance program not only protects your company from regulatory action—it also builds trust with your customers and partners. Partner with Compliance Experts Navigating the complexities of RoHS and REACH can be overwhelming. At ComplianceXL, our team of compliance experts helps businesses like yours: Assess supplier compliance Perform material analysis Develop and implement compliance programs Prepare for audits and regulatory filings Compliance with RoHS and REACH requires extensive knowledge of the supply chain, excellent record keeping, and in some cases testing. Whether you are an OEM or a supplier, understanding the restrictions on hazardous materials and compliance is critical to maintaining and expanding market share. For more information about how ComplianceXL can help your company respond to RoHS and REACH compliance, contact our experts. Contact us today to ensure your products meet EU regulations and maintain a competitive edge in the global market.
Additional Four Elements – ROHS 2015/863
Directive (EU) 2015/863 has Amended EU RoHS to Restrict 4 New Phthalates: DEHP, BBP, DBP and DIBP Bis(2-Ethylhexyl) phthalate (DEHP): max 0.1%: DIBP is an odorless plasticizer and has excellent heat and light stability. It is the lowest cost plasticizer for cellulose nitrate and is widely used in nitro cellulose plastic, nail polish, explosive material and lacquer manufacturing etc Benzyl butyl phthalate (BBP): max 0.1%: BBP is a phthalate that is mainly used as an additive for plasticising PVC , perfumes, hair sprays, adhesives, glues, automotive product and vinyl floor coverings etc. At present, BBP is banned in all toys and childcare articles ( European Directive 2005/84/EC) and in cosmetics which includes nail polish as it is considered to be carcinogenic, mutagenic and toxic to reproduction. Dibutyl phthalate (DBP): max 0.1%: Dibutyl phthalate (DBP) is a commonly used plasticizer and is found naturally in small quantities in cloves. It is soluble in various organic solvents, e. g. in alcohol, ether and benzene and suspected to be an endocrine disruptor. It is also used as an additive to adhesives,printing inks and as an ectoparasiticide (drugs which are used to kill the parasites that live on the body surface). Diisobutyl phthalate (DIBP): max 0.1%: DIBP is a phthalate and an additive used to keep plastics soft or more flexible (plasticiser), often in combination with other phthalates.DIBP has very similar properties to DBP which was banned in toys and childcare articles as well as in cosmetics, it may therefore be used as a substitute for instance in PVC, paints, printing inks and adhesives. Grace Periods are given to DEHP, BBP, DBP and DIBP as they will be restricted from 22 July 2019 for all electrical and electronic equipments apart from medical devices, monitoring and control equipment which will have an additional two years to comply by 22 July 2021.These are chemicals which are added on top of the existing list which consists of the following Cadmium(Cd): 0.01%;Mercury: 0.1%;Lead(Pb) : 0.1%;Hexavalent chromium (Cr6+) : 0.1%;Polybrominated biphenyls (PBB): 0.1 %;Polybrominated diphenyl ethers (PBDE): 0.1 %. It shall be noted that above maximum concentration values apply to each homogeneous material rather than a product or a part itself. Here for instance a homogeneous material means material of uniform composition throughout which cannot be mechanically separated into different materials.Some electrical and electronic products are out the scope of EU RoHS 2. Military equipment, large-scale stationary industrial tools, large-scale fixed installations, active implantable medical devices, and photovoltaic panels are excluded from RoHS.Batteries and package materials are also out the scope of RoHS since they are subject to different directives.In addition to that, certain applications are exempt from RoHS restrictions (For example, Cadmium in helium-cadmium lasers).
Amendment to RoHS 2 Directive: Alert for Electronics/Electrical & Medical manufacturers
On March 31st 2015, European Commission adopted a new directive (Directive (EU) 2015/863) to amend the existing EU RoHS 2 directive (2011/65/EU). The new directive adds 4 substances to the existing list of 6 restricted substances under RoHS2. The new directive was officially published on 4th June 2015 and entered in to force on 24thJune 2015, 20 days after publishing. The restrictions basis the directive will take effect beginning July 22, 2019 for all Electrical and Electronic equipment except Medical Devices (category 8) and Monitoring & Control equipment (category 9). Note: Category 8 & 9 will have an additional two years to comply (by 22 July 2021). At the time of adoption of 2011/65/EU directive in 2011, European Commission categorized 4 substances as priority substances to be assessed for next inclusion under RoHS2 restricted substances list. These 4 have now been included and are listed below: Substance Name CAS Number Maximum concentration in homogeneous material* Bis(2-ethylhexyl) phthalate (DEHP) 117-81-7 0.1% Benzyl butyl phthalate (BBP) 85-68-7 0.1% Dibutyl phthalate (DBP) 84-74-2 0.1% Diisobutyl phthalate (DIBP) 84-69-5 0.1% *The maximum concentration values apply to each homogeneous material rather than a product or a part itself. Where are the 4 substances used? DEHP, BBP, DBP and DIBP are primarily used as Plasticizers to soften PVC (Polyvinyl Chloride). PVC is commonly used for wires and cables and also can be found in some electronic components or plastic parts. Below are the areas where the 4 phthalates are commonly found. Cable and Wiring Flooring, wall covering and roofing Plastic films Bags, Brief-case, Gloves, blood bags Tablecloth, curtains, shower curtains & similar items Headphones Water beds & Air mattresses Wallpaper/Tapestry coated with PVC Footwear Bathing equipment Accessories on textiles Consumer goods packaging Car Care products Cosmetics (nail polish, hair spray, perfumes) Toys and childcare articles Paints and Seals Sealants and Adhesives Lacquer manufacturing Environmental pollutant Food chain and in the human diet Insulation for cables Solvent in glow sticks and hydraulic fluids Solvent in capacitor dielectric fluids Ceramics for electronics Building and Construction Dialysis equipment, dialysis bags and tubing Automotive products Food conveyor belts Coatings Printing inks Lubricants Plugs and Shock absorbers Suspension agent for solids Nitro cellulose plastic Explosive material Impact of Directive (EU) 2015/863 The new directive comes in as a release this year, but the substances in question had been already considered to be of hazardous impact since 2011, as per European Commission (RoHS2 & REACH). In the year 2011, European Commission had prioritized the above 4 substances to be analyzed for the next inclusion under RoHS 2. Also the REACH Candidate List by 2011, included DEHP, BBP, DBP and DIBP. Subsequent to these directives, manufacturers took steps to assess the parts and materials that require phthalates substitution from their products thereby reducing the demand for the chemicals in the market and initiating action for removal. As on date there are very few producers in Europe who manufacture or import these phthalates so the new directive comes in as a second chance for those who still haven’t prepared themselves to avoid these phthalates. EU has now given time till 2019 to implement the restriction. Thus the impact of the directive will not have an extreme effect but medical device manufacturers will need to give more attention to their product. The relative impact of the directive will also be seen more in case of medical device manufacturers rather than electronic and electrical manufacturers because the application of the above mentioned phthalates is mainly seen in the medical and consumer segment. This ensures that the impact of the new directive will not be extreme and manufacturers that have REACH SVHC information from their suppliers have a head start. So manufacturers have got enough time to start acting for avoiding these substances. What manufacturers should do? EEE manufacturers and their suppliers have over four years to prepare to become compliant to this secondary legislation on RoHS 2. They have to ensure that, in the manufacturing process/ supply chain, these phthalates are not used more than the allowable limit to keep the products compliant to EU’s RoHS 2. As of now most of the manufacturers have collected the RoHS 2 related certificates, supporting documents and also ensured preventive actions or found alternative options to make sure the 6 substances are not present in their products as per the previous requirement of RoHS 2. Now they have to go back and put the same effort to collect the documents and complete the procedures to avoid the new phthalates from the already compliant products. Most of them have a well-defined compliance management process and in certain cases have engaged with an expert data service provider to do the same, if not it’s the perfect time to make such arrangements. In any case, we would like reiterate that this particular directive will be easier to manage and implement, given that 70% of the market has already taken preventive steps.
The RoHS and WEEE directives – recent developments
Electrical and component engineering companies exporting products to the EU are heavily governed by ROHS/WEEE legislation. As this effects companies located outside of the Union, it is essential to keep up to date with the latest changes, and have an effective master data management scheme that includes obsolescence management tools. RoHS/WEEE legislation is a complex area, but an essential one for PCB designers and component manufacturers, as it covers areas like tin-lead solders and semiconductor finishes. Both directives are in the process of being revised. It’s important to realize that the laws simply act as a template, and that each European country may have its own specific regulations. These can vary considerably between borders and be changed at any time, so it’s vital you keep stringent, up to date records, especially when dealing with different export destinations. The US Department of Commerce has a web portal (Buy USA Gov) to assist US engineering companies and component engineering firms exporting EEE (electrical and electronic equipment) to Europe. A valuable resource, it has country-by-country information on RoHS/WEEE implementation, and issues regular news updates. The latest news concerns revisions to the RoHS directive, which took place on November 24, 2010. A key change was the extension of the directive to cover all electrical and electronic equipment, apart from that covered by exclusions, with a transitional period of 8 years. A 3-year impact assessment plan has been suggested with an 18-month period before the changes become legally binding, but the implications are obvious. We at Enventure Technologies have a number of enterprise data management solutions in the area of environmental compliance, covering ELV, GADSL, ROHS, WEEE and REACH regulations.
REACH EU and US Defense Exports – The Continuing Saga
ROHS, WEEE and REACH regulations may be European initiatives, but their influence is far-reaching. The EU is a major importer of products produced outside the European Union which come under its environmental compliance laws. These range from agricultural chemicals to FPGA designs. Here, we address the latest developments in REACH compliance as it applies to defence. REACH legislation governs the import and production of chemical substances within the EU. Certain products produced for the defence industry are exempt. However, exemption decisions were very much made on a national basis, and varied between member states. It became obvious to the EDA (European Defence Agency) that REACH compliance required a more harmonised approach. Creating a transparent, open European Defence Market aligning national exemption policies would considerably simplify matters for component manufacturers and other producers, not least those wishing to export into the European Union. In March 2010, the pMS (participating Member States) of the EDA agreed a Steering Board Decision which set common standards for REACH exemptions in the defence industry. A public web portal was also established to provide transparency over national policies and procedures. The PMS are now in the process of adopting the new international standards, which will be reviewed annually starting in 2011. In realisation of the fact that the REACH Regulation affects non-member countries of the EDA, such as the US and Canada, the Steering Board invited these “third member” states to adopt the new REACH legislation principles, further harmonising the process of supply. The Steering Board decision is a promising development in a controversial and confusing area. We at Enventure Technologies offer a number of solutions to help you cope with the complexities of ROHS, WEEE and REACH legislation.
What is RoHS All About?
RoHS Compliance, or more accurately EU Directive 2002/95 covering the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008 (the “RoHS Regulations”) is hard enough to pronounce (people tend to spell it out or opt for Ross, Roz or even sometimes, Rose) let alone to understand, so we thought we would try and sum up why it exists and why you should take notice of it in a couple of short paragraphs. Basically, what happens with EU directives is that they are passed for Europe as a whole and each member state has to implement the directive within its own laws. This law went live in July 2006 and anything made after this time must follow these environmental compliance laws. The topics covered in this directive are quite wide-ranging, for example, six hazardous substances have to be removed from all electrical and electronic equipment. These are Cadmium (Cd), hexavalent Chromium (CR VI), Lead (Pb), Mercury (Hg), polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). The directives also enforce recycling and safe disposal of old equipment that you have sold, these take-back schemes enforcing a duty of care upon the manufacturer and sometimes the distributor to either dispose of the item or to re-use parts. In Europe this comes under the WEEE Compliance Scheme which we cover elsewhere. Many other countries (such as the US, and China) are implementing their own version of RoHS and WEEE ,so even if you manufacture and ship outside the EU it would be well to at least learn the guidelines and stick with them as much as possible not only for the sake of the environment but also for your future ability to market products just about anywhere in the world.