Clinical Waste & The Regulations Explained

The Statutory Duty of Care

The statutory duty of care applies to everyone in the waste management chain. It requires producers and others who are involved in the management of the waste to prevent its escape, and to take all reasonable measures to ensure that the waste is dealt with appropriately from the point of production to the point of final disposal.

This is enforced through the “polluter pays” principle, making producers of waste responsible for its management and disposal.

A key element to the duty of care is the requirement for producers (other than householders) to ensure that a written description, adequately describing the type and quantity of waste, is provided for transfer of the waste as it is moved from point of production to point of final disposal.

Where an annual waste transfer note is used, as long as the initial note contains the details specified in Defra’s ‘Waste management: the duty of care – a code of practice’, the written description will only be required for the initial transfer.

In England and Wales, the "Hazardous Waste Regulations" require that most premises producing hazardous waste be registered with the Environment Agency. Premises are exempt from the requirement to register if they produce less than 500 kg of hazardous waste in any period of 12 months.

Guidance on registration can be found on the EA website. Premises registration does not apply in Scotland or Northern Ireland.

Hospitals and Complexes

Hospital complexes are often occupied by a number of different organisations that produce hazardous waste. These might for example include acute, primary care, mental health and ambulance trusts, private practices, shops and laboratories.

Where these organisations have their own discrete units or areas, they are considered to be separate individual premises for the purposes of producer registration under the Hazardous Waste Regulations. Those that produce 500 kg or more of hazardous waste per year will need to register each of their premises. Those that produce less will remain exempt from registration.

An acute Hospital Trust would not normally need to register more than once as its building, units and departments are likely to fall within a single continuous premises boundary.

Other organisations with two or more separated areas (for example two shops) may find that more than one registration is required unless they are adjacent or adjoining.

Each producer can store its own waste on site, or waste can be stored in a shared storage area. As long as it meets the conditions, this storage can benefit from an exemption from an environmental permit for temporary storage at the premises of production.

Waste in shared storage areas may be segregated by type rather than producer; however, it is important that clinical waste receptacles are labelled to identify the individual producer. If a producer stores and manages its own hazardous waste, it must complete its own consignment notes for each collection. If a producer transfers its waste to one on-site organisation, for example the acute hospital trust that manages the waste storage and collection, a single consignment note can be completed for a collection of waste. The other producers would need to be identified on part A5 of the consignment note. Each producer would need to ensure that it complies with its duty of care to provide the acute hospital trust with the information they need to complete the consignment note and manage the subsequent transport and disposal of the waste. This is best supported by a memorandum of understanding or partnership papers agreed between all the collaborating organisations.

Consignment notes

Consignment notes are required when transporting hazardous waste. The producer is legally responsible for ensuring the accuracy of a consignment note and in some instances it may be appropriate to seek advice from the waste contractor.

Controlled drugs

Controlled drugs are subject to special legislative controls as they are potentially harmful. The Misuse of Drugs Regulations lists the medicines that are classified as controlled drugs. There are five schedules that dictate the level of control applied to each medicine – Schedule 1 having the most controls and Schedule 5 the fewest.

The regulations set out the regime of control that governs the various legitimate clinical activities associated with controlled drugs, for example:

 • which professionals are allowed to prescribe, order, supply or administer the drugs;

• destruction and/or disposal procedures;

• associated record-keeping requirements.

The Misuse of Drugs (Safe Custody) Regulations list additional requirements in terms of safe storage (for example lockable cupboards of sufficient strength).


Under the Misuse of Drugs Regulations, all Schedule 1 and 2 stock-controlled drugs can only be destroyed in the presence of a person authorised under those regulations to witness destruction.

When a stock-controlled drug is destroyed, details of the drug must be entered into the controlled drugs register. This should include:

• the name of the drug;

• its form;

• its strength and quantity;

• the date it was destroyed; and

• the signature of the authorised person who witnessed the destruction, and the person witnessing it (that is, two signatures).

Once issued/dispensed to a patient, the requirements for witnessed destruction do not apply, although there is a general duty of care to ensure the appropriate disposal of waste medicines that are returned by patients to their local GPs.

Healthcare organisations should be aware of who within their organisation is authorised to witness destruction.

For more information on this or any other waste disposal enquiry contact us on 01638 815464 or email at

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Contact information

For all enquiries please send to:

The Vastum Group Ltd
9 Saxon Hall Road

Tel: 01638 815464