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.
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).
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.