Health and environmental risk assessment of microbial cleaning products. Scientific Opinion of the Panel on Microbial Ecology of the Norwegian Scientific Committee for Food Safety

In 2015, The Norwegian Environment Agency requested the Norwegian Scientific Committee for Food Safety (VKM) to provide a scientific assessment of the information requirements laid down in the declaration form for the Regulation on microbial products and its guidelines, if these are sufficient to conduct a health and environmental risk assessment of the use of microbial cleaning products in Norway. VKM appointed a working group consisting of members of the Panel on Microbial Ecology. The Panel on Microbial Ecology has reviewed and revised the draft prepared by the working group, and the assessment has been adopted. Based on scientific assessment of the information requirements laid down in the declaration form of the Regulation on microbial products, the VKM Panel recommends that the information requirements in their current form should be revised to facilitate health and environmental risk assessment of the use of microbial cleaning products in Norway. There seems to be a general lack of accuracy when it comes to specification of the microbial content and concentrations (metabolically active vs. inactivated or dead cells) in the product. Without proper taxonomic classification, no meaningful risk assessment is feasible. The taxonomic affiliation of the organisms present in the product should be specified to at least species, preferably strain level. The declaration should in our opinion not necessarily rely on specific methods, as long as the methods described are scientifically adequate. However, the identification should be based on new molecular methods, for e.g. the potential role of the microorganism in the product acting as a pathogen or an allergen, its association to intestinal dysbiosis or genes coding for antibiotic resistance can be identified. Rather than specifying a list of specific antibiotics one should employ generic classes of antibiotics as stipulated in the Nordic Ecolabelling guidelines. The Panel recommends a multiphasic approach to future assessments, as this allows for the implementation of current and most effective methods as they are developed and verified. There seems to be lack of emphasis on environmental impacts, especially on the potential for persistence and spread in the environment (terrestrial or aquatic), the potential for pathogenic effects on domestic or wild vertebrates, arthropods or plants. Furthermore, there is little emphasis on the effects with increased use and accumulation, persistence and spread, both indoor, in terrestrial and aquatic environments and on long-term effects on the microbial community. The state (living, dead, inactivated) and form (vegetative, viable spores (bacteria and fungi) or cysts (protozoans)) of the microorganism present should be specified. If the product contains organisms that form endospores, spores or cysts, procedures for activation of the spores or cysts and for further cultivation should be described. This makes it possible to test whether the spores or cysts are not viable. The method employed for eventual inactivation or sterilization such as heat or chemical treatment, radiation, or dose, and the exposure time and concentration of the micro- organism should be described. Information on how the product has been tested to ensure that it does not contain live microorganisms is also required. The declaration should provide information about the procedures and quality controls securing a product without contaminations, pathogens, or known relevant virulence or resistance factors that may increase health or environmental risks. The safety reassurances provided by producers of microbial cleaning products, should also cover properties related to allergenicity, sensitization, plant pathogenicity and environmental impacts. How the microbes in the product and their pathogenic properties develop with time through and after shelf life should also be described. In our opinion a declaration should include information about intended use and instructions for use, if specific precautions (personal protection, waste, containers etc.) need to be taken. Furthermore, information relating to user groups should be provided; for example if the product is suitable for use in certain settings and environments such as healthcare institutions, food facilities, and areas with vulnerable people (immunocompromised, infants, elderly, pregnant women etc.) or production animals. The term “Environmental Damage” is not sufficiently defined. What kind of shift in the microbial community and local community can be expected in the receiving environment, especially if exposure is chronic and frequent? The document focuses only on the introduction of foreign genes into the ecosystem. The environment can also be permanently altered (or damaged) if the introduction of the new organisms results in the extinction of the naturally existing closely related species. In addition, metabolic products that might affect resident microbial communities could be valuable information. A re-evaluation of current national and international regulatory and policy frameworks may be necessary. This can include an evaluation of the most appropriate instruments (e.g. product declaration forms, regulations, standards, codes of practice, etc.) to use for strengthening these frameworks to mitigate risks to human health and the environment.
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