Compliance of your biocidal products in China
In China, biocidal products are regulated under different authorities according to the target organism and sectors of use, for example, hygienic disinfectant areas, drinking water-related areas, animal health areas, pesticide areas, chemicals, and others.
Hygienic biocidal products will apply to different regulatory levels depending on the microbial killing rate and safety level. In which disinfectants, sanitary products (directly contact with human body) and water-related biocidal products are administered by the National Health Commission (NHC). For new disinfections and water-related biocidal products, administrative licensing is required according to NHC Announcement No. 14 (2014) prior to launching the products in the market. For existing disinfectants, water-related products and sanitary products with high safety risks, testing and pre-market notification are also required. Hygiene products with low safety risks can be directly marketed after testing.
There are two compliance requirements that refer to water-related biocidal products, which are new biocidal products (new materials, new processes and technologies, and new sterilization principles) and the existing biocidal products. The regulatory obligations of these categories are different.
Products used to control pests in agriculture and animal husbandry are managed as pesticides. Pesticides are administered by the Ministry of Agriculture and Rural Affairs (MOARA) according to State Council Decree No. 677 (2017 and the amendments) on the management of pesticides. The technical material or concentrate and the formulation should be registered and the registration license must be obtained. Likewise animal health and relevant products are also administered by MOARA according to State Council Decree No. 404 (2004 and the amendments).
The product, which is not a pesticide (TC or TK and formulation), not a veterinary drug (raw material and product), not a food, not a food additive, not a feed or not a feed additive, it is administered by the Ministry of Ecology and Environment (MEE) and/or the Ministry of Emergency Management (MEM) if there is a new substance included in the product and/or the product belongs to a hazardous chemical. Any new substances (not listed in the national chemical inventory) should be registered according to MEE Order No. 12 of 2020 before the product is manufactured or imported into China.
Due to the different types of biocidal products and the relevant regulations, it might be unclear how to develop the compliance work in view of the complex regulatory scheme and several regulatory authorities in China. To ensure that your biocidal products will be in compliance with Chinese regulations, please contact us: firstname.lastname@example.org. We can help you achieve this.