All you need to know about New RoHS Project (Pack 25)
Oeko-Institut has been appointed by the European Commission to assist in reviewing requests for exemptions of Restricted Substances under the Directive 2011/65/EU, commonly known as RoHS 2. The purpose of this consultation is to collect contributions from stakeholders. Oeko is responsible for collecting and evaluating information provided by Stakeholders, whereas institutions of the European Union are solely responsible for making decisions. The Oeko-Institut has begun assessment of the two exemption requests for the new RoHS project – pack 25. Below are the exemptions requests raised with the EU for the RoHS Directive: Mercury in pressure transducers (Mercury in melt pressure transducers for capillary rheometers at temperatures over 300°C) DEHP in a PVC base material (Bis (ethylhexyl) phthalate (DEHP) as a plasticizer in polyvinyl chloride (PVC), is used to produce amperometric, potentiometric and conductometric electrochemical sensors, which are used in medical devices for the analysis of whole blood (i.e. in-vitro diagnostic medical devices). This study will provide information on exemption requests for two new exemptions that will be listed in Annex IV of Directive 2011/65/EU. It is important to note that this list of exemptions is specific to monitoring and control instruments for medical devices. The consultation period started on 30 November 2021 and will last for a period of 10 weeks, finishing on 8 February 2022. When submitting stakeholder contributions, it should clearly state if the exemption requests are justified or if there is no explanation. Your contribution must be supported by relevant technical and scientific evidence presented as part of the submission. The confidential information submitted during the consultation will be posted on the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens) website. Stakeholders will be given the opportunity to exchange further information after the consultation. Following the consultation period, the exchange of information or need for technical discussion will be identified. Consultations will be conducted with the following groups: EEE industry EEE industry federations Consultancies Research institutions & universities NGOs Public administrations To stay abreast of regulatory updates around material compliance, ask for a no-cost Compliance Gap Analysis with one of our global compliance specialists today!
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.
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.