The quest for regulatory approval in China

A revision known as Order No 7 overhauled chemical regulatory standards in China when it was announced by the country's Ministry of Environmental Protection in January 2010. Soon after coming into force in October that year, the rules became known as "China REACH", owing to the similarities between the guidance and the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations.

In addition, there are numerous supporting measures and a variety of national standards that must be adhered to, with eight government bodies involved in the implementation of the laws relating to China REACH and the 2011 revised Decree No 591 "Regulations on the control over safety of hazardous chemicals".

However, the documentation pertaining to that revision alone contains 102 articles spanning eight chapters: general provisions; safety management during manufacture and storage; safety management of use; safety management of transportation; registration of hazardous chemicals and emergency response; legal liabilities and supplementary provision.

All production activities, imports and exports of new chemicals in China have been affected, with producers now required to supply a much increased volume of complex data in order to satisfy the authorities. This has made it far more challenging for foreign enterprises involved in the Chinese chemical market.

Under these rules, companies are obligated to submit new chemical substance notifications to the Chemical Registration Centre (CRC) for all new chemicals, irrespective of annual tonnage.

This requirement for notification applies to all substances distributed as such or in articles, as well as any ingredients or intermediates used for pharmaceuticals, pesticides, veterinary drugs, cosmetics, food or feed additives.

Exemptions
The only exceptions to the regulations are the 45,000 or so products that are currently listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC), which is updated each year and can freely be accessed from the MEP's website.

Of these substances, just over 3,000 are confidential and despite being shown by category name, no CAS number or molecular structure is provided. To check whether or not a chemical is already listed in this section of the IESC, companies are required to submit a formal enquiry to the CRC, which will usually respond in writing within two weeks.
It is worth noting that polymers are not exempt from notification, even if all monomers are listed in the IECSC.

Timeframe
There are four types of notification that can be made to the CRC and the timeframe for approval varies with each.
Typical notification: This is for new chemical substances designed to be produced or imported at the annual volume of one or more tons, of which there are four further levels - first (one to ten tons), second (ten to 100 tons), third (100 to 1,000 tons) and fourth (greater than 1,000 tons). These notifications can take between eight months and three years to be approved.

Simplified notification basic condition: Any new chemical substance with a tonnage of less than one ton per year. A decision is likely to be made on this within three to four months.

Simplified notification specific condition: New chemical substances that fulfil any of the following criteria require this notification, which takes two to three months:
- for export only and with annual tonnage of less than one ton
- for scientific research with tonnage of between 0.1 and one ton per year
- for technological research with tonnage of less than ten tons per year
- for a polymer consisting of monomers already listed in the IECSC
- for polymers containing less than two per cent of the new chemical substance by weight
- for low-concern polymers

Scientific research record: Chemical substances used for scientific research with an annual quantity of less than 0.1 ton, or samples to be tested in Chinese laboratories, require this notification. It can be processed in three to ten working days.

Who is responsible for notification?
To satisfy the stringent China REACH regulations, it is necessary for all manufacturers, importers and foreign companies selling new substances in China to submit notifications to the CRC.

Domestic firms are able to do so of their own accord, but foreign businesses need to have a legal entity within the country or must appoint an agent who performs a similar role to the 'only representative' required under EU REACH.

While registering and gaining approval for the use of chemicals in China is undeniably a long, difficult and sometimes expensive task, the process can be made much easier by partnering with or utilising the services of companies that have experience of these issues. Robinson Brothers has extensive knowledge of the Chinese regulatory system, having completed the process on numerous occasions, ensuring all products, additives and agents we provide comply with the latest standards.