Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK
Procedure No. EVL/ROHS/PC-A/1020/C-1
As per: DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE).
RoHS is a product level compliance based on the European Union's Directive 2011/65/EC, the Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment (EEE).
The EU RoHS Directive (2011/65/EU) restricts the maximum allowable levels of lead (Pb), cadmium (Cd), mercury (Hg), hexavalent chromium (Cr6+), polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants to 0.1% or 1000 ppm (except for cadmium, which is limited to 0.01% or 100 ppm) by weight of homogeneous material in electrical equipment and electronic products. In order to manufacture these products within or import into the European Union, manufacturers are responsible for providing due diligence documentation.
This Directive lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE) with a view to contributing to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE.
Categories of EEE covered by this Directive
1. Large household appliances.
2. Small household appliances.
3. IT and telecommunications equipment.
4. Consumer equipment.
5. Lighting equipment.
6. Electrical and electronic tools.
7. Toys, leisure and sports equipment.
8. Medical devices.
9. Monitoring and control instruments including industrial monitoring and control instruments.
10. Automatic dispensers.
11. Other EEE not covered by any of the categories above.
This Directive does not apply to:
(a) equipment which is necessary for the protection of the essential interests of the security of Member States, including arms, munitions and war material intended for specifically military purposes;
(b) equipment designed to be sent into space;
(c) equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment;
(d) large-scale stationary industrial tools;
(e) large-scale fixed installations;
(f) means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved;
(g) non-road mobile machinery made available exclusively for professional use;
(h) active implantable medical devices;
(i) photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications;
(j) equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.
EU declaration of conformity
1. The EU declaration of conformity shall state that it has been demonstrated that the requirements specified in Article 4 have been met.
2. The EU declaration of conformity shall have the model structure and shall contain the elements specified in Annex VI and shall be updated. It shall be translated into the language or languages required by the Member State on the market of which the product is placed or made available. Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4(1) of the Directive may be demonstrated within the context of that procedure. A single technical documentation may be drawn up.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EEE with this Directive.
RoHS 3 (EU 2015/863) Certification
RoHS 3 (EU Directive 2015/863) adds Category 11 (catch-all) products and adds four new restricted substances - all phthalates. The four phthalates are mainly used as insulation plasticizers, and are on the REACH list of SVHC (Substances of Very High Concern).
The expanded list for RoHS 3 is thus as follows:
Cadmium (0.01 %)
Lead (0.1 %)
Mercury (0.1 %)
Hexavalent chromium (0.1 %)
Polybrominated biphenyls (PBB) (0.1 %)
Polybrominated diphenyl ethers (PBDE) (0.1 %)
Bis(2-ethylhexyl) phthalate (DEHP) (0.1 %)
Butyl benzyl phthalate (BBP) (0.1 %)
Dibutyl phthalate (DBP) (0.1 %)
Diisobutyl phthalate (DIBP) (0.1 %)
Extension exemption: Medical devices have a two-year extension to meet RoHS 3 compliance:
"The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021."
Category 11 products include all other electronic and electrical equipment not covered under the other categories. Included are 2-wheeled vehicles, electronic nicotine delivery systems (ENDS) such as e-cigarettes, cannabis vaporizers and vape pens. Also included are electrical cables that are less than 250V working voltage.
RoHS Testing Methods
The 1st method used for RoHS compliance testing is by X-Ray Fluorescence Spectroscopy (XRF), as per ASTM F2617. XRF analyzers come in stand-alone, bench-top and handheld formats. Portable, on-site XRF testing using a handheld XRF analyzer is usually performed first and focuses on the parts of a product with the highest risk of containing restricted substances. Other RoHS testing methods used include Fourier Transform Infra-red Spectroscopy (FTIR) testing and sometimes Scanning Electron Microscope (SEM) testing.
With the advent of RoHS 3 and the four added phthalates, additional testing is required to ascertain levels of these compounds, which are extracted with a solvent. The extraction solvent is then analyzed for the presence of phthalates using gas chromatography coupled with mass spectrometry (GC/MS) or coupled with flame ionization detection (GC/FID).
Who can take this ROHS Certification?
Any business that sells applicable 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 if they utilize any of the restricted materials ROHS should be complied by any organization involved in the production, sale or distribution of electrical and electronic equipment destined for the EU market.
THIS INCLUDES
• Manufacturers
• Retailers
• Brand Managers
• Traders and Distributors
• Applicants & Responsible Entity.
The following steps are involved for RoHS certification: Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK
1. Testing: Either on-site testing and/or lab testing is done to determine values of the restricted RoHS substances.
2. Process Audit: Inspect all applicable manufacturing processes (to include Procurement, QA/QC as well) used towards RoHS compliance on-site.
3. Documentation Review: Review the Bill of Materials, Technical File, assembly drawings, materials declarations, test reports, and conformance/compliance certificates from all suppliers. The Technical File must contain the following:
• General product description and design structure information
• Risk assessment of materials, parts and subassemblies
• Conformity information on materials, parts, and subassemblies
• Manufacturing documentation and records
• Conformity with the EU Directive
• Harmonized standards, specifications, and conformity procedures
4. Certification Statement: After a successful audit, a RoHS Certificate of Compliance (also known as a Certificate of Conformity or Declaration of Conformity) is issued from Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK
RoHS Certification Services from Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK:
Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK does more than simply help our customers comply, we give them a competitive advantage by partnering with them every step of the way to establish a detailed product file upon application that contains:
• Declarations of Conformity (DoC)
• Test reports
• Materials declarations from the suppliers of materials and/or components
All compliance documents are subject to review and samples are required for RoHS 6-substance verification and testing of homogeneous materials. In addition, manufacturer site audits and surveillance for process management control will be implemented and executed to ensure compliance.
This unique Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK certification scheme as per Procedure No. EVL/ROHS/PC-A/1020/C-1 essentially offers:
• A trusted third-party partnership in RoHS self declaration
• Assurance that products and accompanying documentation has been independently reviewed and certified by a competent third party
• Time and cost savings reducing the client’s overall workload
• Reduced risk of being exposed to market surveillance
• An easier way to show compliance to your producers
• An environmentally positive profile to present to end-users and consumers
RoHS 2 Technical Documentation Services
Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK provides a RoHS 2 Technical Documentation creation service to assist EEE product manufacturers to comply with the new conformity assessment requirements of the recast RoHS Directive (2011/65/EU). Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK will develop and/or assemble existing documentation sections of technical information to create a technical documentation package based on requirements specified in the RoHS-2 Directive and related standards. Standards are now an important part of RoHS 2 compliance since RoHS 2 is now a CE Mark Directive. In instances where information is to be collected or conformity assessment performed, Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK can also help support these activities.
The technical documentation file will include:
• General description of the product
• Documentation of Product design structure and information showing the relationship of conformity documentation with material, parts, and subassemblies in the product
• Risk assessment of materials, parts and subassemblies
• Conformity information on materials, parts, and subassemblies
• Manufacturing documentation and records
• Harmonized standards, specifications, and conformity procedures that have been applied to ensuring the conformity of the product
RoHS Consulting Services
Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK
Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK, a global leader in restricted substances services, provides RoHS consulting services to help businesses understand and comply with local, regional, and global Restriction of Hazardous Substances legal requirements that may impact your electrical and electronic products. Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK consulting service provides companies access to our team of RoHS experts who can address your questions regarding your company's specific RoHS obligations, providing you guidance in regulatory, supply chain, and technical RoHS compliance requirements. Intertek’s consulting service also provides subscribers with access to continuously updated information on changes to and clarification of RoHS requirements.
Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK RoHS consulting services include:
• Monthly conference call to review impact of regulatory information and industry practices
• Regulatory and research Q&A style consulting support (as needed)
• Monthly reports on health and environmental requirements
• Real-time Information Change Notices (ICNs) on important changes to health and environmental requirements.
With [Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK] RoHS consulting and strategy services, companies can effectively:
• Manage RoHS compliance strategy and risks
• Ensure RoHS requirements are properly applied and met for your products
• Educate your employees on RoHS obligations and requirements
• Develop and sustain a competitive advantage
• Protect your brand
• Minimize business impacts such as loss of sales, product recall, and obsolete inventory
