1. Analysis

•       Have you reviewed the current regulations and their relevance to your product range?

•       Have you received any RSL (restricted substances lists) from customers with specific requests?

If not, you can use ComplyIntelligent: AI-powered software that can quickly identify compliance requirements, which saves time and resources at ( https://complymarket.com/intelligent )

 

2. Supplier & Material Assessment

• Supplier Assessment
• Material Assessment

2.1 Supplier Assessment:

1. Exclude suppliers that do not provide parts or components that are used in the end product or its accessories from the scope of consideration.
2. To assess the trustworthiness of suppliers within scope, you can consider factors such as your past experience with the supplier organization (such as quality management soft facts and audits) and the country of origin (EU/Non-EU) as well as external factors like the Corruption Perceptions Index (CPI). The CPI can be found at https://www.transparency.org/.
3. Manufacturer / part Risk assessment process overview

To categorize the manufacturer, there are three types:

• Type A: suppliers who have a thorough understanding of UAE RoHS, effective systems to ensure compliance, and conduct selective analysis of high-risk components/materials.
• Type B: suppliers who have a good understanding of UAE RoHS, have a compliance system in place, but may lack in some areas, such as not analyzing high-risk components/materials.
• Type C: suppliers who do not understand UAE RoHS requirements, do not have a system to ensure compliance, and do not check incoming components/materials or declarations.

How ComplyDoC do supplier assessment?

1. Suppliers with 50 or more in corruption index will get 10 points.
2. Suppliers with ISO 9001 or ISO 14001 or ISO 37301 will get extra 10 points.
3. Suppliers with RoHS Test report get 2 points.
4. Suppliers with REACH SVHC Test report get 2 points.
5. Suppliers with REACH Annex XVII Test reports get 2 points.
6. Suppliers with POP Test reports get 2 points
7. Suppliers with Packaging Test reports get 2 points.
8. Suppliers with MDR Test reports get 2 points.
9. Suppliers with Battery directive Test reports get 2 points.
10. Suppliers with TSCA ( Sec. 5(a)(2) ) Test reports get 2 points.
11. Suppliers with TSCA ( Sec. 6(h) ) Test reports get 2 points.
12. Suppliers with California Test reports get 2 points.

Check : www.transparency.org/en//cpi/2021

2.2 Material Assessment:

To conduct material assessments, it is permissible to use technical judgment as some substances are not expected to be present in certain materials (e.g., organic substances in metals). Such technical judgment may be based on technical information available in the electrical/electronics industry and/or literature research on the materials used in articles.

Example: How ComplyDoC Do Material Risk Assessment

3. Data Collection & Evaluation

• Determine the needed info
• Evaluation of collected declarations

3.1 Determine the needed info

The types of documents and evidence required to confirm conformity depend on two factors:

• The likelihood of restricted substances being present in the product
• The results of the supplier assessment, which includes an evaluation of their trustworthiness.

To determine the appropriate level of conformity documents:

• it is necessary to create a risk matrix.
• This matrix takes into account the probability of restricted substances being present and the trustworthiness of the supplier

 

3.2 Types of declaration:

1- Supplier declaration and/or contractual agreement:

• To ensure that materials, components, or assemblies do not contain excessive amounts of harmful substances, suppliers provide a declaration or contractual agreement specifying maximum substance limits and any applicable exemptions.
• Manufacturers sign these agreements to confirm compliance, which should be specific to a particular material or component.
• These agreements are crucial for confirming adherence to legal and proprietary requirements and are agreed upon by the supplier and/or customer.

2- Material Declaration based on a list of substances:

• A substance list-based declaration of materials provides information on the concentration of specific substances and any applicable exemptions.
• The IEC 63000 standard references the IEC 62474 standard, which is discussed in Section 4 of the same document.
• Material declarations based on substance lists, such as the one provided in the IEC 62474 database, identify all listed substances and their proportions in the product.
• Material declarations differ from supplier declarations or contractual agreements as they specify all substances of interest to the customer and their relevant proportions.

3- Full Material Declaration (FMD):

• There is no standardized definition of which substances must be included in a Full Material Declaration (FMD) or how they should be listed.
• FMDs can vary in terms of the specific substances included and the level of detail provided, as this is determined by each company's individual requirements.
• Companies use FMDs for various purposes and can address legal and proprietary requirements as long as there is a clear definition of how the FMD should be created.

3.3 The declaration should have the following elements:

1. Company letterhead
2. Correct regulation/guideline mentioned.
3. Legislative reference
4. Clear reference to the parts or products to be covered by the declaration.
5. Declaration of the compliance status
6. Declaration of any present substances
7. Signed by a suitable person.
8. Includes a reference date.

IEC 62474 is a standard for material declaration of products that are used in the electrical and electronic industry. It specifies the requirements for the disclosure of material composition information and the communication of this information along the supply chain.

A collection of documents and resources related to the classification and declaration of substances, including a list of declarable substances, a list of material classes, exemption lists, and additional information and resources.

3.4 Accepted & Recommended Testing Criteria (Check Accreditation ISO 17025)

3.4.1 RoHS (EN 62321-x) :

1- XRF-Screening

XRF-Screening refers to the process of analyzing chosen hazardous homogeneous materials by utilizing X-ray fluorescence (XRF) technology.

2- Evaluation of RoHS Status

The evaluation of RoHS status and additional chemical testing based on XRF-Screening results is the process of analyzing the RoHS compliance of the materials tested using XRF-Screening and performing further essential chemical testing as needed.

3- Testing for Phthalates

Testing for the presence of phthalate can be performed using gas chromatography-mass spectrometry (GC-MS) or chromatography, as XRF-Screening is not a reliable method for this particular test.

3.4.2 REACH and POP Testing

ComplyMarket Approach:

• Testing in the lab is the fastest way to get your company (non-competitive)
• You test only in extreme cases, when you have high risk supplier and you insist on keeping the supplier and when your material risk assessment is showing high risk as well

4. Data Administration:

• • Supplier Management
  • Data Collection Process

4.1 Supplier Management

• Brand Protection: Have peace of mind that you are meeting regulatory requirements with the support of a trusted and reliable partner.
  
• Ongoing Update Support: Stay proactive in complying with regulatory changes by utilizing compliance tools that are based on risk assessment.
  
• Focused Testing: Perform testing based on risk assessment to confirm compliance and address any identified gaps.
  
• Risk Assessment: Gain a clear understanding of your inherent risks and develop a prioritized strategy for mitigating those risks.
  
• Supplier Engagement: We can assist your business to quickly engage suppliers to comply with your requirements, enabling a smooth supply chain.

4.1.1 Data Collection Process

 

5. Data Maintenance

• Train and involve your supply chain
• Conduct random analytical compliance checks
• Utilize a suitable database for storage
• Practice horizon scanning and proactive action for upcoming changes
• Many regulations like REACH SVHC is being updated twice a year!
• Keep your technical file updated.

5.1 Content of the technical file according to IEC EN  63000

The manufacturer is responsible for creating technical documentation that can be used to evaluate whether the product complies with RoHS substance restrictions, including a thorough analysis and assessment of potential risks. This documentation should outline the substance restrictions and address the design and manufacturing of the products, including:

• General description of the product
• Unique identifier of the product (e.g. model number)
• Purpose of the declaration (including product identification for traceability)
• Conceptual design, manufacturing drawings, and plans of components, assemblies, circuits, etc.
• Descriptions and explanations are necessary to understand the drawings and plans.
• Technical documentation for materials, parts, and/or assemblies
• Results of design modifications, tests, etc.
• Declaration evidence of RoHS conformity

 

Ahmed Sakr

Product Compliance Consultant 

ComplyMarket UG (haftungsbeschraenkt)