OnRule publications - Series 2

Publications

Series 2
  1. Saudi Arabia's Supplier Declaration of Conformity (SDoC) for Restriction of Hazardous Substances (RoHS)
  2. Australia Supplier's Declaration of Conformity (SDoC) & Regulatory Compliance Mark (RCM)
  3. Cybersecurity and Product Regulatory Compliance: Part 2
  4. Cybersecurity and Product Regulatory Compliance: Part 1
  5. Product Regulatory Compliance: Compliance Model Number and Product Tree
  6. Product Regulatory Compliance: UK Declaration of Conformity (DoC) & UKCA Marking
Special topic for Product Regulatory Compliance & Environmental Compliance

Saudi Arabia's Supplier Declaration of Conformity (SDoC) for Restriction of Hazardous Substances (RoHS)

By Tom Killam and Cyril Mecwan

July 10, 2023 | Series 2 / No. 6 | V1.0

Since its founding in 1972, Saudi Arabia’s Standards, Metrology and Quality Organization (SASO) ensures products introduced in the Kingdom of Saudi Arabia (KSA) protect health and safety of consumers, among many things. SASO also develops and updates technical regulations and standards in support of developing and manufacturing quality products.

A Technical Regulation related to the Restriction of Hazardous Substances (RoHS) for all Information Technology and Communication Equipment and their spare parts is a new compliance requirement that went into effect on December 31st, 2022. SASO has listed different dates of implementation for different categories of equipment.

Scope:

The in-scope items that are subject to the application of Hazardous Materials Limits include electrical and electronic equipment and spare parts for Large and small home appliances, Information and communication technology equipment, Lighting equipment, Electrical and electronic tools and equipment, Games, entertainment devices and sports equipment, and Control and monitoring instruments.

On the other hand, the list of excluded items includes Medical equipment, Military weapons and equipment, Equipment designed for use in space missions, Large-scale stationary industrial tools, Large-scale fixed installation, and Some control and monitoring instruments.

Essential Requirements:

It is the responsibility of the supplier to ensure that the electrical and electronic equipment and its spare parts adhere to the permissible percentage of hazardous materials as set out in Annex (1-C) of the Technical Regulation.

The five out of the six hazardous substances identified by Saudi Arabia (RoHS) – Lead, Mercury, Hexavalent Chromium, Polybrominated biphenyls, and Polybrominated biphenyls ethers – have an upper limit of 0.1% as permissible percentage.

The sixth hazardous substance – Cadmium – has an upper limit of 0.01% as permissible percentage.

Technical Requirements:

It is the responsibility of the supplier to fulfill the following technical requirements:

  1. The electrical and electronic equipment and their spare parts shall meet the technical requirements specified in the standards set out in Annex (2-a) of the Technical Regulation, which is a list of applicable SASO IEC standards. In absence of a relevant Saudi or Gulf standards, they shall meet the requirements of international standards.
  2. The electrical and electronic equipment and their spare parts shall pass the conformity assessment procedures and be accompanied by a technical file that includes all documents and information proving the product’s compliance.
  3. The manufacturer should have the availability of an effective quality management system, ISO 9001 or its equivalent.
Conformity Assessment:
  1. Test the product in accordance with the relevant requirements using an ISO 17025 accredited test lab. The test report must bear the accreditation logo. In-country testing is not a requirement.
  2. For the purpose of testing, the IEC based SASO standards are used in determining hazardous substances. However, equivalent IEC or EN standards are also accepted. This means that the European RoHS test reports are accepted.
    • SASO IEC 62321 or IEC 62321 or EN 62321 family of standards are used for the assessment of the hazardous substances in the materials used in the construction of the product.
    • SASO IEC 63000 or IEC 63000 or EN IEC 63000 defines the technical documentation required.
  3. Using the above test report, the supplier should obtain a Type Approval certificate, called Certificate of Conformity, from a notified body (NB) approved by SASO.
  4. To obtain the approval, in addition to the sample of the product for the purpose of evaluation, the supplier should submit a technical file including the following:
    • Supplier Declaration of Conformity
    • Test Report(s)
    • List of applied standards to the product
    • Risk Assessment Document
    • Certificate of Origin
    • The necessary warnings, cautions, and manuals
  5. Note that the spare parts placed on the market, for the purpose of repair or services, are exempted from the certificate of conformity if the targeted electrical and electronic equipment has a certificate of conformity. The supplier still has to submit a risk assessment for the spare part.
Supplier:

The SASO identifies supplier as below:

  1. A product manufacturer resident in KSA, or any entity linking the original product to its name (for example, a company rebranding a product to its name from the original manufacturer) and resident in KSA.
  2. A third-party agent, resident in KSA, and representing the product manufacturer resident outside KSA; or an importer of the product (in absence of an agent representing the manufacturer), resident in KSA.
  3. Any person in the supply chain, whose activities may affect the product properties.
A. The requirements for the SDoC:

The Annex (4) of the Technical Regulation provides the form for Supplier Declaration of Conformity (SDoC). This form is required to be filled out using the company letterhead.

The form requires the following key content while creating the SDoC:

  1. Supplier's data (manufacturer, importer or authorised agent):

    2. SASO is looking for the name of the supplier, who is residing in KSA – the product manufacturer, if resident of KSA, qualifies as a Supplier. Alternatively, a third-party agent who is residing in KSA and is representing the manufacturer, or an importer of the product in KSA (in the absence of a third-party agent), who is residing in KSA may also qualify as a Supplier.

    • The supplier’s name and address
    • The contact person’s name and contact information such as email, phone, fax etc.
  2. Product details:

    3. SASO is looking for the following product details:

    • The Trademark, Product Type, Batch or Serial number are generally available from the manufacturer's Product Manager; some of the information is readily available in the product table maintained by the manufacturer.
    • Reference standards/Technical Specifications are supplied by the Compliance Engineer or Compliance Specialist.
    • The Notified Body’s name and Acceptance Registration Number are also supplied by the Compliance Engineer or Compliance Specialist.
  3. Declaration statement:

    4. The standard Declaration statement requires the reference of the applicable Technical Regulation.

  4. Signature

    5. The signature block requires the name of the responsible supplier, her/his position in the company, the date of signature, and the signature. Although the responsible supplier must reside in KSA, the signatory could be an individual directly involved in the supply chain and can reside in a foreign country.

B. Record Keeping:

It is the supplier’s responsibility to maintain the complete records, such as the product technical file and Supplier Declaration of Conformity, etc. Besides, the information must be complete and correct.

The unavailability of the records may be the ground for the Market Surveillance Authorities and Regulatory Authorities to consider the product as non-conforming.

References: