Chinese NHFPC has finalized a mandatory standard for hygienic safety assessment of disinfection products. Universal implementation is expected by the end of 2017
China NHPFC has recently solicited internal comments from industry through its provincial institutes on a draft standard of the hygienic safety assessment of the Category I and Category II disinfection products. The NHFPC plans to promulgate the standard by the end of 2017, replacing the current “Provisions for the Hygienic Safety Assessment of Disinfection Products”. A comparison between the two versions reveals elevated enforceability, more defined product classification and more scientific testing requirements in the new draft.
Departmental Circular Vs Mandatory Industrial Standard
In 2014, the “provisions” were issued by the NHFPC in the form of a departmental circular to its provincial subordinates. In accordance with the “provisions”, the provincial department should supervise the completion of the hygienic safety assessment report by manufacturers, which should be submitted to the provincial department for filling. The new draft has been developed as a collaborative effort between NHFPC, provincial health department, CDC and domestic manufactures. The draft will be issued and will be a mandatory industrial standard and universally adopted by industry.
Product Definition and Classification
The provision offered only a general classification of disinfection products, resulting in ambiguity in company regulatory obligations and loopholes in supervision and enforcement. The draft provides a specific definition and classification on the scope and treatment of Category I and Category II disinfection products.
New claims to be identified as disinfection product
Gastrointestinal endoscope treatment will be included into the Category I disinfection products
Food processing tool and equipment treatment and decontamination purpose(treatment on excrement, excreta, bold and other stained articles and environment) will be included into the Category II disinfection products;
“Air” only refers to indoor air;
“Common surface and textile fabric “is further divided into” textile fabric and porous surface” and “hard surface”;
“Hand” will be subdivided into “surgical hand” and “hygienic hand”;
Some of the tests originally required by the provision are removed from the draft, while a clear requirements on product characteristics and efficacy are presented:
- Appearance test will be removed from all product category;
- The metal corrosiveness test on disinfection products for fruit and vegetable treatment would no longer be required;
- For sterilization efficacy evaluation, each product will be designated with definite microbial species and the efficacy test targeting these designated species should be included in hygienic safety assessment;
- test list and criteria for the evaluation of ethanol, glutaraldehyde, sodium hypochlorite and calcium hypochlorite groups are provided separately;
- For sterilization apparatus and instruments, if the apparatus or instrument was utilized in human environment, the determination on sterilization coefficient in ambient air will be required;
Additional Toxicological Test
In response to rising health concerns related to chemicals and increasing uses of disinfection products in China, the draft also broadens the scope of toxicological tests. If a Category I disinfectant product was used on skin and mucous membrane, subacute toxicology test will be required. Also, experts are discussing whether to require additional toxicological tests if a Category II disinfestation product was used in hand disinfection for surgery and other hand hygiene applications.
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