In 2022, Chinese officials fined a company for violating multiple regulations related to disinfectant products. This incident serves as a reminder that the Chinese government has strict regulations that must be followed by companies operating in China. To avoid penalties and fines, enterprises targeting China should take into account key considerations.
In June 2022, the Hangzhou Health Commission imposed a fine of nearly 3.5 million CNY on a company for several violations, including adding lidocaine illegally to disinfectants, failing to conduct proper hygiene and safety evaluations before marketing, and providing false information on product packaging labels.
The company produced and sold several batches of disinfectant products containing lidocaine, which were detected in the bacteriostatic liquid products with batch numbers 2021120903, 2022011001, and 2022011702. The total value of the illegal products was 457,730.2 CNY, with an illegal income of 140,126.2 CNY. Additionally, the company sold 369 boxes of bacteriostatic liquid products with lidocaine (batch numbers 2021112603 and 2021110803) after December 1, 2021, with total sales amounting to 16,605 CNY.
What is lidocaine and why is it banned in disinfection products?
As is known lidocaine is a local anesthetic and antiarrhythmic drug that is used to numb the skin or mucous membranes. Lidocaine can cause skin irritation, allergic reactions, and even systemic toxicity if ingested or absorbed into the body through the skin. Illegal addition to disinfectant products may cause potential health risks.
Lacking hygiene evaluation and safety assessment
In addition, the other 15 kinds of bacteriostatic liquid products produced by this company were not evaluated for hygiene and safety before they were marketed.
As required in Articles 31 and 32 of the Measures for the Administration of Disinfection in China, the manufacturing enterprise or import agent shall apply for a license in accordance with the requirements of the provisions of China’s Ministry of Health on the declaration and acceptance of disinfection products. And enterprises are required to provide a copy of the certificate or the approved sanitary license when operating the product.
Wrong claims of ingredients on product packaging labels
One of the bacteriostatic liquids is labeled as containing dimethocaine, but instead, it contains trimecaine. Thus, the product packaging label information was not true. However, a small difference in the chemical structure will cause big differences in function. Therefore, it is crucial that companies take their responsibility seriously and prioritize the accuracy of their product labeling to ensure consumer safety and satisfaction.
To sum up, in order to ensure that disinfectants comply with regulations in the Chinese market, it is important to follow several key steps:
- Apply only approved ingredients in your disinfectant product.
- Complete the required hygiene and safety assessment in a timely and proactive manner.
- Ensure that the product label accurately and clearly lists all relevant information about the ingredients.
REACH24H, as a professional regulatory consulting firm, strongly advises enterprises against taking any chances with non-compliant disinfectant products. Companies should prioritize ensuring that the products they sell are compliant with regulatory requirements, to avoid the risk of facing severe penalties. The potential consequences of non-compliance could include costly fines, product recalls, loss of reputation, and even legal action.
REACH24H is a highly experienced regulatory consulting firm that has been closely monitoring the Disinfection Products Regulation since its introduction in 2013. The company has a comprehensive understanding of the regulation and can provide expert guidance and support to companies seeking to comply with its requirements. REACH24H provides a one-stop service for Chinese disinfection products filing, including：
- product type analysis,
- data gap analysis,
- compliance analysis report,
- trail supervision,
- dossier preparation and submission, etc.
If you need any help with disinfectant regulatory compliance, please feel free to contact us:
Tel: +86 (0)571 8700 6630
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