In China, new chemicals are regulated by Ministry of Environmental Protection (MEP). The regulation is called Measures on the Environmental Management of New Chemical Substances (MEP Order No.7), which is enacted by China MEP on 15th Oct 2010. According to the ‘Measures’, the companies which intend to produce new chemicals in China mainland or import new chemicals into China mainland are required to notify new chemicals to Solid Waste and Chemicals Management Center of MEP (SCC-MEP) to get market approval.
- Applicable Substance Scope
| Existence form | pure substance
substance in the preparations substance intends to be released from articles |
| Applications | raw materials
intermediates functional additives: surfactants, plasticizers, preservatives, dispersing agents, flame retardants, etc. |
| Substance type | with unique chemical structure
with no unique chemical structure polymers |
- Applicable Substance Scope
| Existence form | pure substance
substance in the preparations substance intends to be released from articles |
| Applications | raw materials
intermediates functional additives: surfactants, plasticizers, preservatives, dispersing agents, flame retardants, etc. |
| Substance type | with unique chemical structure
with no unique chemical structure polymers |
- Exemptions
- Finished products regulated by other laws or regulations (i.e. cosmetics, pesticides, pharmaceuticals, veterinary medicine, foodstuffs, food additives, feedstuffs, feed additives, tobacco, military products, etc.)
- Naturally occurring substances;
- Impurities (<10% w/w);
- Non-isolated intermediates;
- Others (alloys, glass materials, ceramics, etc.);
- Who is Responsible for Notification in the Supply Chain?
- Companies produce new chemicals in China mainland
- Companies directly import new chemicals into China mainland (can be either Chinese local importer or overseas exporter)
*Non-China-mainland-located companies (including HongKong, Macau and Taiwan), shall appoint a China representative agent (similar to ‘OR’) to complete the notification work on their behalf.
- How to Check if the Product Contains New Chemical Substance?
Chemicals not listed in the Inventory of Existing Chemical Substance in China (IECSC) are regarded as new chemicals. The current IECSC 2013 contains 45,612 substances, among which 42,342 substances are released to public and the remaining 3,270 substances are listed as confidential. Hence, a formal inquiry to SCC-MEP is always preferred to confirm whether a substance is actually new chemical.
- Types of Notification
| Scientific Research Record Notification
(SRRN) |
<100kg/a | R&D purpose/ testing sample;
Requires no data. |
2-3 weeks to get approval |
| Simplified Notification | <1t/a | Eco-Tox test data are required except following situations:
· Manufacture in China for export only; · Intermediates; · R&D purpose; · Polymer of low concern (PLC), no tonnage limit; · Polymer with low new substance monomer content (<2%, w/w), no tonnage limit; · PPORD, < 10 t/a, valid no more than 2 years; |
3-7 months to get approval |
| Regular Notification | Level 1: 1-10 t/a,
Level 2: 10-100t/a, Level 3: 100-1000t/a, Level 4: 1000+ t/a; |
Depends on the data availability | |