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This regulation came into effect on June 1, 2007 and is the EU regulation governing all chemicals entering the market. The regulation stipulates that chemicals that do not submit for registration as required will not continue to be manufactured, imported or sold within the EU.

(1) Scope of REACH registration.
1. Chemical substances placed on the EU market exceeding 1 ton/year;
2. Chemical composition exceeding 1 ton/year in preparations placed on the EU market;
3. Chemical substances deliberately released in articles placed on the EU market, and the total amount exceeds 1 ton/year.
Note: Deliberately released substances in articles refer to substances that are intentionally released from articles under normal or reasonably foreseeable use, usually to achieve some auxiliary function of the article, such as air fresheners.
(2) Requirements for registration entities.
The EU only recognizes three entities:
1. Manufacturers in the EU;
2. Importers within the EU;
3. Non-EU producers must use a Only Representative (OR) within the EU to fulfill their registration obligations under EU REACH regulations.
After successful registration, some substances still need to continue to fulfill the obligations of evaluation, notification/authorization, and restriction.
(3) Specific registration channels.
Domestic exporters usually have three ways to register substances intended for export to the EU:
1. Establish a branch in the EU;
2. Entrusting legal or natural persons within the EU to register;
3. Entrust a domestic agency to register, which has a branch in the EU.
The costs and procedures of the three methods are different, and companies can choose according to their own circumstances.
Reminder: SIEF (Substance Information Exchange Forum), which is a substance information exchange forum, legal entities that complete REACH pre-registration of the same substance are members of the SIEF. SIEF members can be EU producers, importers, downstream users, OR of non-EU companies and owners of substance data of the substance.
(4) Post-registration requirements.
Some chemicals, especially dangerous chemicals, need to continue to fulfill the obligations of evaluation, notification/authorization, and restriction after registration.
The ECHA (European Chemicals Agency) and EU member states receive and evaluate the compliance of individual registrations to determine whether the hazards and risks of registered substances to human health or the environment are controllable. If the risk cannot be controlled, authorities can ban use. You can also decide to restrict use or subject it to prior authorization.
Restricted substances are substances whose amounts are restricted in certain products. Authorized substances refer to those substances that can only be put on the market and used after being officially authorized and approved.
2. U.S. TSCA Act
The Toxic Substances Control Act (TSCA) came into effect on January 1, 1977. It was implemented by the U.S. Environmental Protection Agency (EPA) and was revised in 2016.
According to TSCA regulations and U.S. customs requirements, a TSCA compliance or exemption statement must be provided with the relevant goods when entering customs. If a company violates this regulation, it may face consequences such as prohibiting entry into customs, withholding goods, detention fees, fines, and inclusion in the import blacklist.
(1) Management points
1. Classify substances into “existing substances” and “new substances” for management. Whether they belong to “new chemical substances” depends on whether the substance is included in the TSCA list.
2. Food, pesticides, drugs, tobacco and other substances are regulated by other U.S. regulations and are exempt from TSCA declarations.
3. For substances not included in the TSCA list, i.e. new substances, the manufacturer or importer of the substance must make a PMN (pre-production) declaration if the exemption conditions are not met.
4. For substances included in the TSCA list, i.e. existing substances, the manufacturer or importer of the substance must confirm whether the substance and the corresponding use comply with the Important New Use Rules (SNUR) and Chemical Data Reporting (CDR) requirements.
5. For products that fall within the scope of TSCA supervision or exemption, a TSCA compliance or exemption statement must be provided when the product enters customs.
(2) TSCA compliance or exemption statement issued.
Generally, importers in the United States make TSCA declarations or apply for exemptions; as exporters, they should actively cooperate and provide information such as chemical composition, tonnage, and test reports when necessary.
In addition, it is necessary to promptly understand whether chemicals exported to the United States contain substances of high concern that are restricted for use and their content, and whether they meet U.S. standards to avoid risks.
3. Japanese CSCL method
The full name of Japan’s Chemical Substance Control Law (CSCL) was promulgated on October 16, 1973. It is the world’s first regulation to control the risks of chemical substances. In 2017, the 17-year amendment to Japan’s Chemical Review Law passed a cabinet resolution and will be implemented in stages starting from April 1, 2018 and January 1, 2019.
(1) Management department and supervision key points
The Chemical Review Law stipulates that three departments of the Central Ministry of Japan: the Ministry of Health and social protection (MHLW), the Ministry of Environment (MOE), and the Ministry of Economy, Trade and Industry (METI) will jointly supervise industrial chemicals produced or imported in Japan. The key points are as follows:
1. Japan’s List of Existing Chemical Substances and New Chemical Substances (referred to as ENCS List) includes chemical substances produced, imported and used in Japan, and both new chemical substances and existing chemical substances are subject to supervision.
2. Whether it is a new substance can be confirmed by querying the ENCS list. Existing substances are included in the list and assigned a MITI number, otherwise they will be regarded as new chemical substances.
3. New chemical substances should be submitted for review according to their annual production or import volume.
(2) Regulatory requirements for existing and new substances
First specific chemical substance (refractory, highly cumulative, long-term toxic):
Strictly prohibited (except for licensed purposes)
·Import of some products is prohibited
·Recycling measures and labeling obligations
Monitoring chemical substances (refractory to decomposition, highly cumulative, unknown toxicity):
·Report production and import volumes, detailed uses (>1.0 kg/year)
·Examine hazard characteristics
Second specific chemical substance (with health and environmental hazard risks):
·Report production and import volumes (planned and actual), uses (>1.0 kg/year)
·Reduce tonnage if necessary
·Technical guidelines and labels used
Priority assessment of chemical substances:
·Report manufacturing, import volume, detailed use, and sales volume (>1 ton/year)
·Supplementary data if necessary
·Transfer information downstream
General chemical substances:
·Report manufacturing, import volume, detailed use, etc.(>1 ton/year)