Substances for possible futures restriction under RoHS-2!!
European commission has made a contract with Oeko-Institute to conduct consultations to support the review of the list in relation to the Substance Review and Substance Inventory under RoHS 2 (Pack 15). Stakeholder consultation for evaluation of restricted substance list and new exemption request under RoHS 2(Pack 15) has started on 05th December 2019 and until 30th January 2020. Substance Assessment:- There are seven substances to be assessed in the course of the study with a view to review and amen the RoHS Annex II list of restricted substances. In relation to RoHS restricted substances, the committee will be assessing 3 substances out of seven, in current consultation:- Tetrabromobisphenol-A (TBBP-A) Medium Chain Chlorinated Paraffin (MCCPs) Diantimony trioxide Below 4 substances has been already assessed in previous consultation closed on 7th November 2019:- Cobalt dichloride and Cobalt sulphate Nickel sulphate and Nickel sulfa mate Beryllium and its compounds Indium phosphide Substance Prioritization:- This consultation will collect the input on quantitative usage data for 43 priority substances that has been identified under EEE, the highest priority group of substance inventory. Following are the groups targeted by the consultation:- EEE industry EEE industry federations Research institutions & universities NGOs Consultancies Public administrations Conclusion:- The aim of the RoHS recast was, among other things, to reduce administrative burdens and ensure coherency with newer policies and legislation covering, for example, chemicals and the new legislative framework for the marketing of products in the European Union. The RoHS Recast Directive (RoHS 2) was published in the Official Journal on 1 July 2011. In January 2017, the Commission adopted a legislative proposal to introduce adjustments in the scope of the Directive, supported by the impact assessment. The preparatory RoHS 2 scope review studies are also available. The respective legislative act amending the RoHS 2 Directive, adopted by the European Parliament and the Council, has been published in the Official Journal on 21 November 2017.
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
RoHS Compliance Marking For Medical Devices
While the previous version of RoHS directive did not require any special mark to demonstrate RoHS compliance, under the recast, it became mandatory that all equipment covered by RoHS must now bear the CE mark. As a symbol, CE mark is familiar for everyone as it has been a mandatory requirement for many years on products sold in the European Union. After the recast of the RoHS directive, it has also become the proof of conformity of the product to the European RoHS directive. The mark must be displayed on the product visibly, legibly and indelibly. Manufacturers, importers and distributors are responsible for ensuring that the mark is properly placed on EEE. The CE marking indicates a product’s compliance with EU legislation. By affixing the CE marking to a product, a manufacturer declares his sole responsibility, that the product meets all the legal requirements, which means that the product can be sold across the European Economic Area. RoHS 2 brings about a few other significant changes related to the broader scope of the directive which has implications on the legal responsibilities of businesses. Some of these changes affect manufacturers directly, as they are required to: Issue a signed Declaration of Conformity (DoC). Create a technical documentation file as per EN 50581:2012 or equivalent standards that meet requirements of module A of Annex II to decision 768/2008/EC. Accept analytical material test results as per the IEC 62321 Standard. Keep the DoC and technical documentation file for a longer period after the product has been placed in the market. Obtain the CE marking, to prove RoHS 2 compliance. Obligations for medical device manufacturers Now, since the medical devices also fall within the scope of RoHS2 directive (2011/65/EU), Medical Device manufacturers are obligated to ensure and demonstrate compliance with the directive. If a medical device is properly CE marked and has the necessary documentation for verification, it does not require additional approval or certification to be marketed in the European Union (EU), European Economic Area (EEA), or Switzerland. RoHS compliance for medical devices ensures that the product meets environmental standards, and with CE marking, it allows for the free movement of goods across these regions. The CE mark is a legal designation that the manufacturer’s product has met the requirements of all relevant Medical Device Directives as laid down by EU (93/42/EEC or 90/385/EEC or 98/79/EC). In order to demonstrate compliance with the RoHS 2 recast, Medical Device Manufacturers are required to Define their product and identify the directives applicable to it. Source RoHS compliant material from suppliers, analyze and identify material changes needed to comply with the RoHS 2 directive. Show proof of RoHS 2 compliance by drawing up required technical documentation surrounding their product including conformity risk assessment reports, test reports for each part. Draw up an EC declaration of Conformity Affix the ‘CE’ mark on the finished product and start to sell. CE Marking is now a mandate for RoHS 2, manufacturers must draw up the required technical documentation, carry out an internal production control procedure, draw up an EC declaration of conformity and affix the ‘CE’ mark to their product. It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the declaration of conformity and to affix the CE marking to a product. Distributors must check that the product bears the CE marking and that the requisite supporting documentation is in order. If the product is being imported from outside the EEA, the importer has to verify that the manufacturer has undertaken the necessary steps and that the documentation is available upon request. According to the other Medical Device Directives in the EU, subject to the type of the device, manufacturers require to have their quality systems and technical documentation reviewed by a Notified Body before they can place their products on the market as part of the conformity assessment procedure. However, RoHS 2 outlines surveillance responsibilities of member states but does not contain a mandate for Notified Body assessment of compliance with the RoHS 2 provisions. Only products which are designated as high risk to public interest require conformity assessment by a Notified Body. Unless there are grounds for suspecting that a device may pose a risk to public health, member states must not create any obstacles to the placing on the market or the putting into service of any medical devices as defined under the Directive bearing a legitimate CE marking. Since most of the CE standards that apply to products are harmonized, entry of the product into EU market only requires conformance to a single set of standards, this simplifies the process of entering the EU market for medical device manufacturers and also demonstrates the importance of obtaining the ‘CE’ mark.