Document Management for Clinical Waste Production and Handling Activities

Required Documentation: 

Treatment contract

The content of the treatment contract is defined in Article 5 of Royal Decree 553/2020 and constitutes the agreement between the operator and the manager of the waste treatment facility. This agreement must be in place prior to the commencement of any shipment and ensures that the waste is directed to an authorised treatment facility, where it will be processed upon acceptance. It is the responsibility of the authorised waste manager to issue this document for each type of waste, and it must include the applicable acceptance conditions.

Identification Document

This document accompanies and identifies the waste throughout its transport, from the point of origin to its receipt at the destination facility. It must be submitted at the start of the shipment and enables the Autonomous Communities to track the transfer. It includes detailed information on the operator, the waste manager, and the transporter, along with the type and quantity of waste transported. The consignee has 30 days from the date of receipt to conduct the necessary checks and issue either acceptance or rejection of the waste to the operator.

Prior notification of transfer

Article 8 of Royal Decree 553/2020. The transfer of hazardous waste requires the operator to notify the Autonomous Community of origin, which will forward the notification to the Waste Information System (eSIR). The system will archive the transfer and forward it to the Autonomous Community of destination. This notification must be submitted at least ten days prior to the scheduled shipment.

Chronological Archive (Logbook)

To comply with the provisions of Law 7/2022, of 8 April, on waste and contaminated soils for a circular economy (Article 64), waste producers are required to maintain an electronic chronological archive. This logbook must record all operations related to the generation and management of waste:

1. Quantity, nature, origin
2. Quantities of products, materials, or substances resulting from preparation for reuse, recycling, recovery, or disposal operations
3. Destination, frequency of collection, mode of transport, and intended treatment method of the resulting waste, as well as the destination of the resulting products, materials, and substances

The information recorded must be retained for a minimum of five years.

Annual Report

In accordance with Article 65 of Law 7/2022 of 8 April on waste and contaminated soils for a circular economy, producers of hazardous waste and producers of non-hazardous waste exceeding 10 tonnes per year must submit an annual summary report by 1 March of the year following the reporting period.

This report, which must be submitted to the competent authority of the Autonomous Community where the facility is located, must include at least the information required in Annex 15: quantities and characteristics of the waste managed, its origin, the treatment operations performed, its destination, and any incidents that may have occurred. The specific procedures and requirements outlined by each Autonomous Community must be observed when submitting the report.

Other documents

Documentary obligations:

1. Retain waste treatment contracts.
2. Retain identification documents and proof of waste delivery
3. Retain Transfer Notifications
4. Keeping the chronological file up to date.

In general, copies of all documentation required under current regulations relating to the generation, shipment, storage, and final management of hazardous waste must be retained for a period of five years.