Industrial Chemical Control Law in the Peoples Republic of China
The Peoples Republic of China regulates the manufacture and importation of chemical products primarily through a notification and testing program for substances that are not listed on China's Inventory of Existing Chemical Substances (IECSC). China also has rules relating to the preparation of safety data sheets and precautionary labels for certain hazardous industrial products. China's system of labeling requirements merges United Nations' dangerous goods transportation (UNDGT) and workplace hazard communication (UNWHC) requirements with unique Chinese requirements.
China's regulation of the manufacture and importation of chemical products will be of interest to participants in the packaging industry and packaging suppliers, particularly, because of their need to know the regulatory status of ingredients in products and packaging, the effects of local Chinese standards, and the necessity for and means of obtaining pre-market clearance for their products.
This "Special Focus" on industrial chemical control law in the Peoples Republic of China briefly describes the procedure for introducing a new substance on the Chinese market, the special (reduced) notification procedures applicable to polymers, including polymers "of low concern," and various key exemptions and exclusions from the Chinese law.
By submitting a notification package to China's State Environmental Protection Administration's (SEPA's) Chemical Registration Center (CRC), manufacturers and importers of new chemical substances can obtain a "registration certificate" that is required for introducing a new substance on the market.
To avoid rejected notifications, notifiers must keep pace with rapid and unannounced changes in the most current forms and procedures for providing the specified information, including test data.
SEPA typically requires that at least one physicochemical, one toxicity, and one ecotoxicity study accompany a notification. The ecotoxicity study must be performed in China at a Chinese-accredited laboratory. All other tests may be conducted outside of China.
SEPA does not specify what additional tests it will require in any given case, leaving this to be developed in consultation with SEPA, as needed.
Once issued, a registration certificate authorizes the substance for approved uses and in quantities specified on the certificate.
The registration certificate remains valid until SEPA adds the substance to the IECSC. During this period, SEPA plans to track the movement of the new chemical substance in Chinese commerce.
SEPA requirements do not apply to the manufacture or import of chemical substances into Hong Kong, which has its own chemical control rules. They also do not apply in free trade zones—new chemicals in free trade zones in China are exempted from the new chemical regulations.
A polymer is subject to reduced notification if each of its monomers and reactants greater than two percent by weight is listed on the IECSC. Also, a polymer is eligible for reduced notification if:
- two or more of its monomers and reactants present at the highest concentration in the polymer (by weight) already exist in a polymer(s) listed on the IECSC;
- all of its blocks are included in a block copolymerization listed on the IECSC;
- the precursors and branched chains exist in graft polymers listed on the IECSC;
- the polymer is of low concern.
Polymers of low concern must meet the following conditions. For an average molecular weight (MW) of the polymer between 1,000~10,000 daltons, the oligomer content is less than 10 percent at MW < 500, and less than 25 percent at MW < 1,000.
Also, these polymers cannot have "an obvious content" of active functional groups. If the MW of the polymer is more than 10,000, the oligomer content must be less than two percent at MW < 500, and less than five percent at MW < 1,000.
Polyesters are also considered to be of low concern.
Certain other polymers qualify for "simplified notifications." These are polymers that are already included in the four or more existing chemical substance inventories, and polymers with molecular structures similar to a polymer(s) listed on the IECSC.
Again, the above polymer classifications all must be applied for and approved.
Even with a registration certificate in hand, new chemical substances are not immediately placed on the IECSC. The Inventory will be updated only every two to three years. Thus, any other company wishing to market a substance will need to notify until the substance appears on the IECSC.
Once a substance is placed on the IECSC, it may be freely manufactured or imported by others. SEPA does not intend to re-open its Inventory for additional "grandfathered" submissions. Alternative methods must be used to resolve the status of substances still in Chinese commerce, which are not listed on the IECSC.
SEPA-CRC apparently now provides a service for a "new chemical check" that will determine whether a substance is already on the inventory (i.e., where a notified substance identity was claimed confidential). The cost of the service is currently 200 RMB (~ 24 USD).
Exemptions and Exclusions
No notification is required for naturally occurring substances, glasses, frits, ceramic wares, metal alloys, articles, and certain substances that are regulated under other Chinese laws. Articles include batteries, fibers, thin film, leather, paper, and yarn.
Articles that generate a surface chemical reaction, but maintain their overall structure and shape, are deemed to retain their article status in China. Examples include reactions to increase strength, hardness, or fire resistance, and reactions to improve ion exchange, resilience, and antibiotic properties.
Chemicals used in the following types of products are regulated under other existing laws and regulations in China: pesticides, tobacco and tobacco products, radioactive substances, military industry products, pyrotechnics, pharmaceuticals, food, feed, feed additives, veterinary drugs, and biological substances.
Companies should seek guidance on whether their cosmetic components are intended to be covered by this law.
Impurities and waste products are not subject to notification under the category of "substances" without commercial purpose. Other, seemingly exempt, substances must be notified. These include polymers whose monomers and other reactants are listed on the IECSC, research and development (R&D) substances, and substances imported into China for the purpose of ecotoxicity testing.
Because these exemptions are not self-executing, these substances are better categorized as subject to reduced notification. A manufacturer or importer must make a formal application to SEPA.
There is currently no "low volume exemption" or reduced notification that applies to small quantities of manufactured or imported new chemicals. Further, although the regulatory treatment of intermediates is not clearly defined, SEPA may recognize, after consultation, that no notification is required for site-limited intermediates.
Who May Notify
Foreign or domestic companies may submit notifications to SEPA; a Chinese agent is not required, but assistance on-the-ground is advisable.
SEPA has not yet established a schedule of fees, so none are currently required. The review period lasts up to 140 days, although it may be completed sooner -- or later.
R & D Substances
Up to 1,000 kg of a new chemical substance for technological R&D is allowed subject to notification. The approval is valid for one year.
Scientific R&D in quantities of 100 kg or less is not subject to the one-year limitation, but must be approved.
Certain information in a notification may be claimed as confidential business information (CBI). This protection is not available for the identity of the notifier, common names of the chemical substance, and physicochemical, toxicity, and ecotoxicity assessments.
Challenges continue to exist concerning the ability to ensure CBI protection abroad.
Enforcement and Penalties
The enforcement provisions of China's new law provide for fines of up to RMB 30,000 (US ~$3,700) for each violation of the new chemical notification requirements. SEPA may also halt manufacture or import and refuse approval of future notifications for up to three years.
The General Rules for Preparation of Chemical Safety Data Sheets for hazardous chemicals were issued by the State Bureau of Quality and Technical Supervision and went into effect on June 1, 2000. Safety data sheets must be in Mandarin Chinese and follow the sixteen (16) section ISO 11014-1, 1994 Safety Data Sheet for Chemical Products-Part 1 model.
The General Rules for Preparation of Precautionary Label for Industrial Chemicals apply to chemicals with certain dangerous characteristics: explosive substances, compressed gasses and liquefied gasses, flammable liquids, flammable solids, spontaneously combustible substances and substances that are flammable when wet, oxidizers and organic peroxides, toxic and harmful substances and corrosives, as well as any other chemical substances that are dangerous to humans and the environment.
Labels must identify the chemical or its hazardous components, and include a U.N. Transport of Dangerous Goods (UNTDG) hazard symbol, a unique Chinese CN number (which must be on the Safety Data Sheet, as well), the appropriate signal words, a hazard summary and safety phrases, applicable reference(s), and an emergency telephone number.
Provisions on the Environmental Administration of New Chemical Substances (issued September 12, 2004 and effective October 15, 2004), http://www.crc-sepa.org.cn/newchem/enewchem.htm.
Inventory of Existing Chemical Substances manufactured or imported into China, http://www.crc-sepa.org.cn/zhengding/eDINGGOU.htm.
Guidelines for New Chemical Substance Notification, http://www.crc-sepa.org.cn/newchem/guidelines.doc.