Remarks on the assessment process for HP 9
Toxins from micro-organisms have to be assessed analogously to chemical substances by considering their assigned hazard statement codes and associated hazardous properties. There are no hazard statement codes for infectious micro-organisms as they are not considered as hazardous substances under the CLP Regulation. The assessment of HP 9 depends on a reference to categories of specific risk groups of organisms according to their potential to cause and spread infection and their potential clinical treatment (23). The World Health Organisation (24) provides a widely recognized system categorising organisms according to four risk groups: Risk Group 4 (high individual risk, high community risk); Risk Group 3 (high individual risk, low community risk); Risk Group 2 (moderate individual risk, low community risk); Risk Group 1 (low individual and community risk). The UN has taken up this approach (25) and set up an indicative list of infectious substances (see Table 17). Table 17 Indicative examples of infectious substances included in category A (26) Infectious substances (including wastes contaminated with such substances, such as medical or clinical wastes) in category A (as well as cultures of infectious substances of category B) must be classified under transport regulations, as UN 2814 ‘infectious substance, affecting humans’, or UN 2900 ‘infectious substance, affecting animals only’. Considering the classification applied by the abovementioned UN document, without testing, a reasoned judgment can be made whether the waste under consideration has to be classified as hazardous waste by HP 9. In this regard, the UK Guidance mentions two general aspects for the assessment of HP 9: In case it has to be decided whether to assign the MH or MNH entry to the waste under consideration, the waste will be assigned the MH entry by virtue of HP 9 if it contains a toxin produced by a micro-organism in a concentration that the waste displays the hazardous property HP 5 (Specific Target Organ Toxicity/Aspiration Toxicity, see Section 3.5) or HP 6 (Acute Toxicity, see Section 3.6). Wastes that might be infectious due to microbial toxins include dredgings or skimmings from waterbodies where a cyanobacterial bloom has occurred. It needs to be identified whether relevant healthcare wastes can be associated with infection and have to be classified as infectious. Regarding the latter aspect, relevant entries in the LoW (MH and MNH entries) that are linked to HP 9 are: To distinguish between the mirror entries 18 01 03*/18 01 04 or respectively 18 02 02*/18 02 03 the UK Guidance uses the term ‘special requirement’ as decisive criterion. The following information is directly taken from the UK Guidance which states that special requirements apply when: the source person or animal (the patient), is known or suspected to have a disease / infection caused by a micro-organism or its toxin and the waste is likely to contain the viable infectious agent or toxin; or the waste is, or is contaminated with, a culture or an enrichment of a micro-organism or its toxin that may cause disease in man or other living animals; or the waste may cause infection to any person or animal coming into contact with it. According to the UK Guidance, special requirements should be determined by clinical assessment of each waste item and patient, as follows: clinical assessment should be carried out by a healthcare professional who is familiar with the type of waste generated, the current medical condition and, where feasible, the past medical history of the patient; it is unlikely that it will always be practical, or possible, to identify specific pathogens or toxins within the waste when a patient first presents symptoms as definitive laboratory identification requires time to undertake. The procedure for determining whether a waste is considered hazardous by HP 9 must therefore, where this is the case, assume that the disease causing agent has not been confirmed and should be based on clinical assessment of whether an unidentified infection of any type is suspected or known; all pathogens and microbial toxins should be included in the assessment. HP 9 does not consider the severity of the disease. Any waste classified as hazardous by virtue of HP 9 Infectious should be kept separately from other waste to prevent contamination.
Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.