Disinfection Product (Biocide) Regulations in China 2015

China Disinfection Product Regulations (or called disinfectant regulations or sterilize product regulations, includes parts of PT 1 and all PT 2 of EU BPR) were reformed by the end of 2014. Only New disinfection products will be required to be registered in National Level (to NHFPC). Any existing disinfection products just need to notify to local Authorities in Provincial Level (NHFPC local system/Bureau). We collected China main disinfection/disinfectant/Sterilize product Regulations and listed them as follows:

1. Measures on the Administration of Sterilizing 【2002】

News: Measures on the Administration of Sterilizing was amended in 2016.

This regulation entered into force on 1 July 2002. It can be divided into four parts: sanitary standards for sterilization, production and management requirements of disinfection product, regulation for sterilizing institutions and penalty.

2. Management Guidance for Labels and Instructions of the Disinfecting Products【2005】

This guidance entered into force on 1 May 2006. The main content of this regulation includes two parts: 1). Information on label and specification of disinfection product must be true; 2). Product cannot claim or impact it can treat any diseases or exaggerate efficacy.

3.Regulations on the Safety Evaluation Report of Disinfecting Products 【2014】

This regulation divides disinfection products into 3 Tiers. In accordance with this Regulation, Tier 1 and Tier 2 existing disinfection products shall prepare Safety Evaluation Reports and register them at local Health Inspection Centre (NHFPC System).

4. Regulations on the Hygienic Administrative License of New Disinfecting Products【2014】

New disinfection product shall obtain the hygiene license prior to making available in China. This Regulation specifies material requirement and administrative license procedure in detail.

The existing disinfection product shall complete Safety Evaluation Report and submit materials to local Health Inspection Centre for recording. Meanwhile, the new disinfectant product should prepare the dossiers to obtain hygiene license from NHFPC which may demand 9 months.

Scope of Disinfection Products in China

Any chemical with the following intended uses are regarded as disinfection products in China:

• To disinfect/sterilize medical and health consumable goods;
• To disinfect skin/mucosa;
• To disinfect hand;
• To disinfect tableware;
• To disinfect fruit and vegetable;
• To disinfect water;
• To disinfect environment;
• To disinfect the surface of an general object;
• To disinfect air;
• To disinfect the sewages including excrements, secretions

Note 1: Disinfection products that apply to above scope are inspected by National Health Family Planning Committee (NHFPC); disinfection products used for Veterinary hygiene are inspected by Ministry of Agriculture of the People’s Republic of China (MOA); disinfection products used for medicine are inspected by China Food and Drug Administration (CFDA). This article is not appropriate for disinfectants used for veterinary hygiene and medicine.

Note 2: Product claim will influence the judgement of disinfection product. For example, if a product claims it can remove bacteria, it doesn’t belong to disinfectant/ disinfection device so far; if a product claims it can kill 99% bacteria, it is identified as disinfection product.

Categories of Disinfection Products in China

There are 5 categories of Disinfection products in China.

Category 1: Disinfectant
Category 2: Disinfection device
Category 3: Chemical and biological indicator
Category 4: Packaging materials for disinfected and sterilized product
Category 5: Antibacterial and bacteriostatic agent

Note 1: If the disinfectant/ disinfection device is low risk hygienic product, such as disposable consumer, are not required to prepare Safety Evaluation Report or register product to Ministry of Health Inspection.

Note 2: Please find testing requirements in details here.

Comparison between EU BPR and China Biocides related regulations

In Europe, all of biocides are regulated by EU BPR. However, biocides are regulated by independent regulations and administrations in China. Please find below table to understand which Chinese Regulations will be applicable for different EU BPR Product Types. If you still have some questions on recognising the appropriate Regulations, please contact us at Service@cirs-reach.com for assistance.

Table1 Comparison Between EU BPR and CN regulations

Exsting Products Notification VS New Product Registration

Before prepare documents for registration, the product must be identified whether is new disinfection via Judging criterion for disinfectant and disinfecting device which use new active ingredient, new technique and new disinfecting mechanism (2013) (Original source: http://www.nhfpc.gov.cn/zhjcj/s9139/201309/ff222da7f4e54feb95f62476e536b7a0.shtml)

If the active ingredients of disinfectants are not listed in the Pharmacopoeia of China (2000), the disinfectants belong to new disinfection products. If disinfectants use new sterilizing technologies or the disinfecting factors which haven’t been approved, they should apply of new disinfection products hygiene license as well.

Notification Procedure for Existing Disinfection Products

Step 1: Identify the Tier of your product

In the Regulations on the Safety Evaluation Report of Disinfecting Products (2014), disinfection products are divided into 3 Tiers. If a product belongs to Tier 1 or Tier 2, it is required to complete a safety evaluation report and notify in local authority. If a product belongs to Tier 3, it is not required to notify to the provincial authority.

Step 2: Decide location of responsible entity in China

In order to import and sale products, company should find or establish a responsible entity in China, such as distributor or subsidiary. Trough the responsible entity, NHFPC can inspect and manage imported disinfection products easily. And the testing and notification must be performed in the same province, where the responsible entity is located.

Step 3: Conduct essential testing in qualified laboratories in China

Different type disinfection product is required to test different items (Please click here to get test requirements). All test items should be conducted in laboratories which have been certified by provincial authorities. Meanwhile, all product samples should be manufactured in the same batch.

Step 4: Prepare Safety Evaluation Report

Besides test report, Safety Evaluation Report demands some other significant information, for instance, formula, quality criterion and product specification. Data requirement has been listed at the following chapter.

Step 5: Notify to provincial authorities prior to making available in China market

The responsible body of the imported products should notify provincial authorities before imported disinfection products being made available on Chinese market.

Step 6: Release notification information at online disinfection product information service platform

Provincial health inspection authorities review the Safety Evaluation Report of disinfection product, and should release disinfection product information on notification information service platform. The public information for imported disinfection product includes product name, application scope, business license number, disinfectant category, test conclusion, safety evaluation conclusion and notification date.

CIRS Suggestions

Efficacy testing is the most significant test for all disinfection products. So company can perform a simple efficacy testing before formal detection to roughly analyze if the product meets the Chinese Standard. If yes, the product can start formal testing for safety evaluation report. If no, the product cannot enter into China Market, company should revise the formula or re-design the product at first.

Authority requires every disinfection product has its quality criterion, even the product has been designed in accordance with Chinese National Standard. The completed quality criterion should be notified in local Municipal Bureau of Quality Supervision or put it on Public Service Platform for Product Quality Criterion.

Registration Procedure for New Disinfection Product

Step 1: Conduct manufacturing capacity censor of new disinfection product (if products manufacture or sub package in China).

Step 2: Integrate Research and Development report.

R&D report should consist of development of product research, basic information of product, working mechanism, property report and so on.

Step 3: Prepare quality criteria of new disinfection product.

Authority requires every disinfection product has its quality criterion, even the product accord with Chinese National Standard. The completed quality criterion should be notified in Municipal Bureau of Quality Supervision or put it on Public Service Platform for Product Quality Criterion.

Step 4: List the detecting methods.

Test methods should be recorded in detail. NHFPC will conduct testing according to these test methods. Hence, accurate description of experiment steps can increase the success rate of test.

Step 5: Prepare and translate relevant documents.

Beside above data and reports, company needs to prepare some certificates. For instance, the imported new disinfection product should hand in business license or manufacturing license in original country/ region, Authorization for responsible company in China and so on.

Step 6: Fill the application form online.

Application for New disinfection administrative license is required to complete at Health administrative license online application system (http://slps.wsjd.gov.cn/ ). And then, hand in application dossier and samples.

Step 7: NHFPC review and approval dossier.

When authority receives the application material, they check whether the material is complete. And they will notice applicant that “some additional documents should be submitted” or “committee accept the application”. If the material is complete, it will be send to CNHIC (China National Health Inspection Centre) and start technique review. It demands 60 working days at least.

Step 8: Factory inspection and Answer technical question.

CNHIC may require visiting the plant to check the safety and sanitation of production. And the applicant needs to reply the question about manufacture on-site.

Step 9: Conduct product test according to CNHIC required.

If the committee doubt the test method or test result, they will ask applicant to detect product with their methods. Test items, test methods, test samples are decided by authority. And the tests should be performed in authorized laboratory.

Step 10: Get the new disinfection product administrative license.

NHFPC should decide whether approve the administrative license application in 20 working days when they receive the technique review conclusion from CNHIC. After making decision, the administrative license should be issued in 10 working days.

Data Requirements for Existing Disinfectant

The following documents are required for the existing disinfectant notification in provincial ministry of health inspection.

1. Application form
2. Testing report
3. Quality criterion
4. Certificate of sale in the country of origin
5. Customs declaration
6. Formula and raw material description
7. Main units description and structure diagram (Only for disinfection device)
8. Business License of responsible company
9. Product label and specification

Who could be the applicant ?

The applicants of new disinfection products registration and or existing product notification must be the Chinese Legal Entity. Those Chinese Legal Entities should guarantee the safety and property of disinfection products. If the product doesn’t reach the minimum limit of quality standard or doesn’t accord with the Safety Evaluation Report, they will be punished.

What other regulations should disinfectant comply with ?

Disinfectant (biocide) not only needs to be regulatory compliance with health related requirements, but also should comply with chemical regulations. The chemical regulations include:

• Hazardous Chemical Management Regulations
• China GHS
• China New Chemical Substance Notification

Contact Us

If you need more information for China Disinfection Product Regulations or want to try our services, please contact us at service@cirs-group.com.