In China, biostimulants and fertilisers are regulated at the national level, under a unified central legislation.

There is not yet a separate regulation for biostimulants, they are currently dealt with under the existing fertiliser and pesticide frameworks, depending on the product.

If the product acts primarily through nutrients, it may be registered as a fertiliser.

If it contains microorganisms, it could be treated as a microbial fertiliser (微生物肥料).

If the product affects plant growth or stress resistance, it may fall under the plant protection regulation, and it will very much depend on the sort of claims made and how they are worded. Also, depending on the mode of Action, the product might be either classified as a fertiliser or Plant Protection Product. At the end, MARA (Ministry of Agriculture and Rural Affairs) will take that decision.

If you want to sell your biostimulant on the Chinese market, you will have to submit an application to MARA and have an appointed chinese legal representative.

The application would typically contain the following information: Product composition, manufacturing process, safety and efficacy data (watch out - data must be generated with Chinese certified institutes), and, of course, the label and technical data in Chinese. Field trials will also be necessary and once it is approved, you will get a Fertiliser Registration Certificate.

In terms of costs, the good news is that the formal application process is fee-free—there is no charge for filing the registration or change-of-registration requests.

However, you will have to plan for other fees, such as for chemical testing and field trials. The costs for field trials depend very much on the scale and the time needed, and can range from 6000,00 - 25000,00 per trial. And, other costs relate to document translation & notarisation (for foreign filings, labels, agency agreements) and consular/legalization of export certificates and registration documents.

So, while MARA does not charge an administrative fee for the evaluation, your budget should amount to about €35000 - 40000, should you wish to bring your biostimulant onto the Chinese market.

Need help with your product for the Chinese market ?

Don’t hesitate to reach out to us !

We are always happy to help,

The sciBASICS Team.