The key aim of the proposed Norms and Standards is to:

• regulate the management of HCRW throughout the duration of its life cycle in accordance with NEMWA to ensure ultimate safe disposal and third-party protection, which will be achieved through the assignment of responsibilities to both waste transporters and waste managers in respect of storage, transportation, treatment and post-treatment disposal of HCRW; and
• prescribe efficacy testing requirements for non-combustion treatment technologies (NCTTs) to secure proper levels of disinfection of HCRW.

Scope of application

The proposed Norms and Standards will be applicable to all HCRW, which is defined broadly to include the waste generated throughout the diagnosis, treatment or immunisation of humans or animals, with a particular focus on waste that has been contaminated with blood, bodily fluids or tissues of humans or animals.

This includes but is not limited to cytotoxic, genotoxic, infectious, isolation, laboratory, pathological, pharmaceutical, radioactive and heavy metal wastes.

The central emphasis derived from the proposed Norms and Standards is to implement measures that ensure control, traceability and accountability across the entire value chain. As such, while specific duties are prescribed for waste transporters and waste managers, general duties are also imposed on every holder of HCRW as well as in respect of every storage area used for the storing of HCRW. Considering this together with the definition of HCRW, the proposed Norms and Standards extend not only to waste service providers, but also stand to impact waste generators within the healthcare, pharmaceutical and veterinarian industries, amongst others. Certain general prohibitions are also imposed on all persons relating to the handling of HCRW.

Further, HCRW waste generators will also have to, by virtue of their duties of care under NEMWA, take reasonable measures to ensure that waste transporters and waste managers are compliant with the Norms and Standards.

Specific duties for waste transporters and managers

Waste transporters, meaning persons who transport HCRW from the point of generation to any temporary or permanent point of storage, treatment or disposal, will be required to comply with specific storage and transportation controls, including in respect of transport vehicles and time frames for storage and transport.

Waste managers, which includes people who manage the operation of waste treatment facilities, in turn will be subject to prescribed time frames, standards for the treatment of waste and record-keeping requirements. Where NCTTs are used in the treatment and destruction of waste, the Norms and Standards set out general efficacy requirements that will need to be complied with, with specific biological indicators prescribed. Extensive requirements are also prescribed in respect of validation testing for NCTTs, including commissioning, routine, independent and re-validation testing. Specific obligations will also rest on a waste manager in the event of a system failure.

It is noted that certain norms and standards relating to the handling, transport, storage and treatment of HCRW have already been prescribed under the National Health Act 61 of 2003 (Health Act) and gazetted in October 2025 as well as in terms of provincial legislation applied in both Gauteng and the Western Cape. The proposed NEMWA Norms and Standards do not expressly address their interaction with the Health Act Norms and Standards and existing provincial legislation, which should be clarified.

Conclusion

The draft Norms and Standards cater for transitional arrangements, providing that a person who lawfully operates a HCRW treatment facility must continue to operate under its existing waste management licence (WML). Upon renewal or review of the licence, the holder must ensure it complies with its WML and the Norms and Standards. HCRW treatment facilities that do not require a WML have six months from the date that the Norms and Standards take effect to comply.

It is important to note that any company operating in the value chain of HCRW, whether that be as a generator, holder, transporter or manager, will be imposed with a level of responsibility to comply with the proposed Norms and Standards. It is evident that the strict operational time frames create space for non-compliance to arise. Therefore it is essential that the necessary operations take note of the enforceable time frames to avoid the risk of non-compliance penalties, as section 67(1)(f) of NEMWA confirms that non-compliance with a norm or standard is an offence which can result in a fine not exceeding R5 million and/or imprisonment for a period not exceeding five years in terms of section 68(2) of NEMWA.

The draft Norms and Standards are open to public comment until 5 March 2026.