The import of biological materials has been strictly supervised under the Chinese import regulatory regime. On April 15, 2021, The Biosecurity Law of P.R.C. (“Biosecurity Law”) was officially implemented, which strengthens the supervision on the application of biology technology. The Biosecurity Law and other existing regulations and rules establish a national administration system for imported biological materials.
This article intends to highlight key regulatory requirements for importing biological materials and assist biotech companies in the compliance management related to importing biological materials.
I. Key Regulatory Requirements for the Import of Biological Materials
As preconditions for importing, the biological materials must be declared to the Customs and go through health and quarantine inspection, and the approval certificate issued by the Customs for Special Articles should be obtained.
1. Biological Materials under Regulation
According to the Administrative Provisions on Health Quarantine for Entry or Exit of Special Articles (the “Special Articles Quarantine Provisions”), the biological materials are defined as “Special Articles” including microbes, human tissues, biological products, blood and its products, etc., details as follows:
2. Quarantine Approval
According to the Implementing Rules of Border Health and Quarantine Law and the Special Articles Quarantine Provisions, the General Administration of Customs of PRC is uniformly in charge of the national supervision and administration of entry and exit health quarantine on Special Articles. The competent Customs shall be responsible for the supervision and administration of entry and exit health quarantine on Special Articles within their own jurisdictions.
Before the import of Special Articles, the importer shall submit the required documents to the Customs to apply for the approval of the Special Articles quarantine and obtain the Certificate of Approval of Health Quarantine for Entry or Exit of Special Articles (“Certificate of Approval of Special Articles”).
3. Quarantine Inspection and Examination
After the Special Articles arrive at the port of entry, the importer shall declare to the Customs at the port of entry with the Certificate of Approval of Special Articles and other documents. The Customs at the port of entry will release the Special Articles after they pass the inspection and examination of health quarantine.
4. Subsequent Supervision and Administration
For the imported Special Articles subject to subsequent supervision (including those containing or likely to contain microbes, toxins and other biological hazards), the organization which uses such Special Articles shall declare to the Customs at destination within 30 days after the import, and the Customs at destination shall implement the subsequent supervision and administration thereon.
II. Potential Implications
In recent years, Customs across the country have dealt with a number of cases of illegal import of biological materials. For example, in May of 2021, Shanghai Customs intercepted 247 items hiding human cells when inspecting imported goods named “laboratory medium”.
1. Risks of Administrative Penalties
According to the Special Articles Quarantine Provisions, the Customs shall order the biological materials without obtaining or inconsistent with the Certificate of Approval of Special Articles, to be returned or destroyed. In addition, the importers of the goods may also be imposed with a fine no more than RMB 30,000.
Although the amount of administrative fine is not overwhelmingly huge, the administrative penalties of the Customs will directly degrade the customs credit rating of the importer. Such degradation will bring serious supervision on the import and export activities of the importer, e.g. more port inspections.
2. Risks of Illegal Smuggling or Smuggling Crime
If the importers of goods have the intention to smuggle biological materials and bring the biological materials into the border of PRC, which do not comply with above requirements for quarantine approval and quarantine inspection, through the approaches of deliberately concealed declaration, misrepresentation or secret carry, etc., the activities may constitute illegal smuggling under Customs Law or the crime of smuggling under Criminal Law if the circumstance is serious.
Suggestion
In order to prevent legal risks related to importing biological materials, it is suggested that enterprises engaged in importing and/or using imported biological materials should strengthen compliance management, including:
1. The importer should faithfully declare the goods with Customs, apply for the approval, examination and quarantine for importing biological materials strictly in accordance with the Special Articles Quarantine Provisions and other relevant customs regulations. Enterprises must not conceal, falsely declare or secretly carry biological materials into the border of PRC.
2. The enterprise should (i) establish a security management system for the use, sale and scientific research of imported biological materials, (ii) produce, use or sell biological materials strictly in accordance with the purposes approved, and (iii) keep authentic records of production, use and sale of imported biological materials for no less than two years.
3. Enterprises purchasing imported biological materials in China should strictly conduct supplier audit, require the suppliers to provide the Certificate of Approval of Special Articles regarding the relevant batch of biological materials and require them to make compliance commitment for the imported biological materials.
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