Medical Device E-Waste (Management) Rules, India

On November 2, 2022, the Ministry of Environment, Forests, and Climate Change published the E-Waste (Management) Rules 2022. The regulations became effective on April 1, 2023. Under these rules, all producers, manufacturers, refurbishers, and recyclers of electrical and electronic equipment are required to register on the designated portal. They must also manage the collection, refurbishment, and recycling or disposal of e-waste generated from their products. The Extended Producer Responsibility (EPR) framework mandates that manufacturers take full responsibility for the end-of-life management of their products, ensuring safe and environmentally sound disposal. To facilitate this, manufacturers and distributors must provide designated collection points for consumers to return their e-waste. Additionally, the government has mandated the registration of recyclers and dismantlers to ensure compliance and proper e-waste management practices.?

To further clarify and support the implementation of these rules, the CPCB released a circular (File No: CP-22/40/2023-WM-III-HO-CPCB-HO) dated 13th May 2024. This circular outlines the requirements for the import and registration of 106 categories of electrical and electronic equipment (EEE) by producers, as specified in the E-Waste (Management) Rules, 2022. It primarily informs stakeholders about the extension of deadlines for compliance and the necessary procedural steps.

Key Points of the Circular:

1. Compliance Deadline Extension: Import consignments of the specified 106 EEE items can be released until 30th June 2024, provided producers submit an undertaking and proof of EPR registration.
2. EPR Portal Maintenance: The E-Waste EPR Portal has been under maintenance since 20th March 2024 and is expected to be fully operational soon.
3. Required Documentation: Producers must submit an undertaking to the CPCB and a copy of their online EPR Registration certificate to the Customs Authority by 30th June 2024.
4. Regulatory Oversight: The undertaking and proof of registration must be sent to the CPCB via email for verification and compliance.

E-Waste (Management Rules Applicable to What Type of Medical Devices?

These rules apply to every manufacturer, producer, refurbisher, dismantler, and recycler involved in the life cycle of electrical and electronic equipment listed in Schedule I of the E-Waste (Management) Rules, 2022. The table below lists the medical devices specified in Schedule I of the E-Waste (Management) Rules, 2022. These devices, except for all implanted and infected products, are covered under the rules for effective e-waste management.

Extended Producer Responsibility (EPR):

EPR targets are specified in Schedule III and IV of the E-Waste (Management) Rules, 2022, with different targets for new producers and those already in operation. The tables below outline the E-Waste Recycling Targets specified in Schedule III and Schedule IV of the E-Waste (Management) Rules, 2022. These targets are essential for ensuring compliance with the EPR framework.

Registration Process for EPR?

Entities must register on the portal under one of the following categories:

1. Manufacturer
2. Producer
3. Refurbisher
4. Recycler

If an entity falls into multiple categories, they must register separately for each category. Conducting business without registration is prohibited, and registered entities must ensure they do not engage with any unregistered manufacturers, producers, recyclers, or refurbishers. Providing false information or concealing details during registration or in reports may result in revocation of registration for up to three years by the Central Pollution Control Board (CPCB) and potential environmental compensation charges, following a hearing. Additionally, the CPCB may impose registration and annual maintenance fees based on the capacity of e-waste generated, recycled, or handled, as approved by the Steering Committee.

Steps for EPR Registration

1. Documentation: Complete all required paperwork with an EPR authorization plan.
2. Application Completion: Fill out the application with the EPR plan in the specified format.
3. Offline Submission: Submit the application offline with a producer profile and EPR plan.
4. Scrutiny: A CPCB official reviews the application and may request additional documents within 25 days.
5. Approval: The EPR plan must receive approval from the Chairman of the Central Pollution Control Board (CPCB). Following approval, relevant officials will examine the plan, and the divisional head will issue the EPR authorization based on the approval of the EPR plan.

List of Documents for EPR Registration

1. Address Proof Documents: Provide address proof of the importer.
2. GST Certificate Details: Include details of your GST certificate along with the address proof of your import business.
3. Company Registrar or Import Export Code (IEC) Letter: Submit a copy of the document or certificate from the Company Registrar or Directorate, or an Import Export Code letter.
4. Agreement Document: Provide a copy of the agreement document with all dealers, collection centres, dismantlers, recyclers, treatment, storage, and disposal facilities (TSDFs), etc.
5. RoHS Compliance: Submit a self-declaration for compliance with RoHS (Restriction of Hazardous Substances) in the prescribed format.
6. Technical Documents: Include copies of technical documents, such as supplier declarations, product descriptions, documents for materials, parts, and/or sub-assemblies, and analytical test results.
7. Permissions/Licences: Provide copies of permissions or licences from the relevant ministry or government department for marketing various products or for conducting business. The specific documents required include:
8. SPCBs/PCCs Authorization: Include a copy of the authorization issued by the State Pollution Control Boards (SPCBs) or Pollution Control Committees (PCCs).
9. EPR-related Documents: Provide all other documents related to EPR.
10. EPR Budget: Make an estimated budget for Extended Producer Responsibility (EPR).

Responsibilities of Manufacturers and Producers in EPR:

Manufacturers and producers have specific responsibilities under the E-Waste (Management) Rules, 2022. Both must register on the portal and file annual and quarterly returns by the end of the month following the respective quarter or year. Manufacturers are required to collect and ensure the recycling or disposal of e-waste generated during manufacturing. Producers must obtain and implement extended producer responsibility (EPR) targets via the portal, migrating plans from the 2016 rules as needed. Additionally, producers are responsible for creating awareness about e-waste management through media, publications, advertisements, posters, or other communication means.

Procedure for Storage of E-Waste

Every manufacturer, producer, refurbisher, and recycler is permitted to store e-waste for up to 180 days. They are required to maintain records of the sale, transfer, and storage of e-waste, ensuring these records are available for inspection. Additionally, storage must comply with applicable rules or guidelines in force. The Central Pollution Control Board may extend the storage period up to 365 days for developing a recycling or reuse process.

EPR Requirements:

Producers must meet their EPR obligations as outlined in Schedules III and IV of the rules (See Table 2 and Table 3 above). They can engage third-party organisations like Producer Responsibility Organizations (PROs), collection centres, and dealers to help fulfil these obligations. However, the ultimate responsibility remains with the producer. The EPR obligation for each product is calculated based on information provided by producers on the designated portal, considering the product's lifespan as determined by the Central Pollution Control Board (CPCB). The targets for EPR are specified in Schedules III and IV. To fulfil their EPR, producers must purchase EPR certificates from registered recyclers through an online system and submit these purchases online as part of their quarterly returns. The data provided by producers and recyclers is cross-checked on the portal, and if there are discrepancies, the lower figure is used to fulfil the producer's EPR obligation. EPR certificates are also subject to environmental audits by the CPCB or other authorised agencies to ensure compliance.

EPR Certificate Generation:

As medical device manufacturers, understanding and complying with India's EPR regulations is essential. Here’s a streamlined guide on how these regulations impact your business:

EPR Certificate for Recycling

• Certificate Generation: The Central Pollution Control Board (CPCB) issues EPR certificates through a designated portal for end-of-life products processed by registered recyclers.
• Eligible Quantity Calculation: Calculate the eligible quantity for certification using the formula QEPR = Qp x Cf. Here, QEPR is the quantity eligible for the certificate, Qp is the quantity of your manufactured products, and Cf is the conversion factor determined by CPCB, reflecting the material inputs per unit of output.

EPR Certificate for Refurbishing

• If your devices are suitable for refurbishing, you must register on the CPCB portal to generate refurbishing certificates, which can defer part of your EPR obligations based on the extended life of the refurbished products.
• Only 75% of the deferred quantity from refurbished devices is added back to your obligations after the product’s extended life ends, reducing your future recycling burden.

Validity and Final Obligation Fulfilment

EPR certificates are valid for two years from the end of the fiscal year in which they are issued and each certificate includes a unique identifier to aid in traceability, detailing the generation year and specific product and recycler codes. It's important to note that to fulfil your EPR obligations fully, your products must be properly recycled as documented by EPR certificates from registered recyclers; merely refurbishing the products does not meet these obligations.

Benefits of EPR Registration Certificate

1. Encourages E-Waste Recycling and Reuse: EPR promotes recycling and reuse of electrical and electronic waste, reducing raw material costs for producers and manufacturers.
2. Environmentally Responsible E-Waste Management: EPR ensures that e-waste is managed in an environmentally responsible manner, mitigating its negative impact on the environment.
3. Improves Market Reputation: EPR authorization from the Central Pollution Control Board (CPCB) enhances the market reputation of the product and brand.
4. Promotes Sustainable Development: EPR supports sustainable development by reducing waste production and resource usage.

Essential E-Waste Management Guidelines for Medical Device Manufacturers

Medical device manufacturers must navigate key aspects of India’s e-waste management rules:

1. Annual Reporting: Annually, the Central Pollution Control Board (CPCB) reports on e-waste management to the Ministry of Environment, which includes data from manufacturers. This must be submitted within one month of the financial year's end.
2. E-Waste Transportation: Compliance with the 2016 Hazardous and Other Wastes Rules is required for transporting e-waste, ensuring safety and environmental standards are met.
3. Accident Reporting: Immediate reporting to the State Pollution Control Board is mandatory if an accident occurs during e-waste processing or transportation.
4. Environmental Compensation: The CPCB imposes penalties for non-compliance with e-waste rules, including incorrect handling of EPR certificates. Timely correction of these issues may lead to a partial refund of levied fines.
5. Compliance Audits: The CPCB conducts random inspections and audits to ensure adherence to regulations. Cooperation during these audits is crucial to avoid penalties.
6. Legal Action: Manufacturers can appeal against adverse regulatory decisions and should be aware that providing false information can lead to prosecution.

Conclusion:

The E-Waste (Management) Rules, 2022, mark a significant step towards sustainable management of e-waste in India. Compliance with these rules is crucial for manufacturers, producers, and importers to operate legally and responsibly. The circular from the CPCB provides temporary relief by extending compliance deadlines but underscores the importance of adherence to the rules. Morulaa offers expert guidance and support to help manufacturers and importers navigate these regulations effectively. With in-depth knowledge of the CDSCO regulatory environment, Morulaa can assist in ensuring timely EPR registration, compliance with e-waste management protocols, and seamless import processes. For more information, visit Morulaa and stay ahead in regulatory compliance. To know more about how we can support you, Click Here or email us on [email protected].