RoHS Testing and Compliance (2011/65/EU)

RoHS (Restriction of Hazardous Substances, Directive 2011/65/EU) limits the use of ten hazardous substances in electrical and electronic equipment (EEE). RoHS compliance is one of the conditions for CE marking of electrical products. CE Danışmanı (CE Consultant) builds the test plan, coordinates the analyses with accredited laboratories and prepares the technical file for manufacturers in Turkey and for companies shipping products to or from Turkey.

The ten restricted substances and their limits

The limits apply to each homogeneous material, not to the product as a whole.

The four phthalates were added by Directive (EU) 2015/863, often called “RoHS 3”.

Which products are covered?

Large and small household appliances, IT and telecommunications equipment, consumer equipment, lighting, electrical and electronic tools, toys and leisure and sports equipment, medical devices including in vitro diagnostic devices, monitoring and control instruments including industrial ones, automatic dispensers and other EEE.

Outside the scope

• Military equipment and equipment designed to be sent into space
• Large-scale stationary industrial tools and large-scale fixed installations
• Means of transport for persons or goods (except electric two-wheel vehicles that are not type-approved)
• Non-road mobile machinery for professional use only
• Active implantable medical devices
• Photovoltaic panels for permanent energy-generation systems
• Equipment designed solely for research and development, available business-to-business only
• Equipment designed specifically as part of another product that is itself out of scope

Homogeneous material: the key concept

A homogeneous material is a single material that cannot be separated further by mechanical means such as unscrewing, cutting, crushing or grinding. A cable looks like one part but consists of at least three homogeneous materials: the copper conductor, the insulation and the outer sheath. Each is assessed separately.

This drives the scope of the work. The more homogeneous materials a product contains, the more analyses it needs. Samples sent to a laboratory without a test plan often produce results that are either more extensive than necessary or incomplete.

How RoHS testing is done

The international reference is the IEC 62321 series. In practice the work has two stages:

1. XRF screening. X-ray fluorescence scans the sample without destroying it and shows the presence of lead, cadmium, mercury, bromine and total chromium. It is fast, but not sufficient on its own for results near the limit, and it cannot distinguish hexavalent chromium or measure phthalates.
2. Confirmatory analysis. Wet-chemistry methods are used for doubtful results and for the substances XRF cannot resolve:
   • ICP-OES / ICP-MS: lead, cadmium, mercury
   • UV-Vis spectrophotometry: hexavalent chromium (IEC 62321-7)
   • GC-MS: the four phthalates (IEC 62321-8)
   • GC-MS / HPLC: PBB and PBDE

XRF screening results are typically available in 1–3 working days. Full confirmatory analysis takes 5–10 working days, depending on the number of materials. Phthalate analysis is usually the longest item.

What a valid test report contains

• Identity of the laboratory and its accreditation scope
• Description and photograph of the sample
• List of every homogeneous material tested
• Method applied (the relevant part of IEC 62321)
• Measured value and limit of detection for each substance, compared with the limit
• Report date and number

For the report to count as strong evidence, the laboratory should be accredited to ISO/IEC 17025 and its scope must include the IEC 62321 methods you need. If the scope does not include the phthalate or hexavalent chromium method, the report is not valid for that analysis.

Is there a “RoHS certificate”?

There is no mandatory certificate issued by an authority. Conformity is shown by the technical file the manufacturer prepares under Module A (internal production control) and by the EU Declaration of Conformity the manufacturer signs. What the market calls a “RoHS certificate” is usually the test report, or a voluntary certificate issued by a certification body. “RoHS compliant” on its own is not a document; test reports and a Declaration of Conformity must stand behind it.

The compliance process, step by step

1. Product and material inventory. The product is broken down and its homogeneous materials are listed.
2. Supplier declarations. RoHS declarations and existing test reports are collected from component suppliers. Part of the chain can be closed with these documents, so not every material needs retesting.
3. Test plan and sample preparation.
4. Analysis in an accredited laboratory.
5. Technical file. Test reports, material list, supplier declarations, product description and risk assessment in one file.
6. EU Declaration of Conformity and CE marking.

For a product with few components and supplier declarations at hand, the process can be completed in 2–3 weeks. For multi-component products or missing supplier documents it can take 6–8 weeks. Collecting documents from suppliers is usually what takes longest.

Obligations of manufacturers, importers and distributors

• Manufacturers prepare the technical file, carry out internal production control, draw up the EU Declaration of Conformity, affix the CE marking and keep the documents for 10 years. The product must carry a type, batch or serial number and the manufacturer’s name and address.
• Importers verify that the manufacturer has done the above, that the product bears the CE marking and is accompanied by the required documents, and put their own name and address on the product. They keep a copy of the Declaration of Conformity for 10 years.
• Distributors verify that the product bears the CE marking and is accompanied by the required documents before making it available.

RoHS in Turkey

Turkey applies RoHS through the Regulation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, published in the Official Gazette of 26 December 2022, No. 32055. If the EU Declaration of Conformity is drawn up in another language, a Turkish translation must be attached. Market surveillance is carried out by:

• the Ministry of Health for medical devices,
• the Ministry of Trade for toys and sports equipment,
• the Information and Communication Technologies Authority for radio and telecommunications terminal equipment,
• the Ministry of Industry and Technology for other EEE.

EEE imported into Turkey is also subject to the TAREKS import inspection.

RoHS and REACH

RoHS covers only electrical and electronic equipment and limits ten substances per homogeneous material. REACH is a much broader chemicals regulation covering all product groups; its SVHC list is updated regularly and creates a notification duty for SVHCs above 0.1% of the article’s weight. An electronic product is usually subject to both.

How CE Danışmanı helps

• Drawing up the homogeneous-material inventory of your product
• Building a test plan that avoids unnecessary analyses
• Coordinating sample shipment and reporting with accredited laboratories
• Preparing the technical file and the EU Declaration of Conformity

The tests are performed in independent laboratories whose accreditation scope includes the relevant IEC 62321 methods. We manage the whole process for you and build your technical file.