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Regulatory Consultancy
  • Taiwan:
    New chemical substances and existing chemical substances registration
    New chemical substances registration and management approach
  • International norms:
    Globally Harmonized System of Classification and Labeling of Chemicals (GHS)
    International Maritime Dangerous Goods Code (IMDG Code)
  • EU:
    Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
    Restriction of Hazardous Substances Directive 2002/95/EC (RoHS)
    European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR)
  • Japan:
    Chemical Substances Control Law (CSCL)
    Industrial Safety and Health Law (ISHL)
  • South Korea:
    Act on the Registration and Evaluation of Chemicals (K-REACH)
  • America:
    Code of Federal Regulations:Title 49 (49 CFR)

International norms

Globally Harmonized System of Classification and Labeling of Chemicals (GHS):

The United Nations Committee of Experts transport of dangerous goods and Global Harmonized System of Classification and Labeling of Chemicals (UNCETDG / GHS) completed the development of the GHS in December 2002, and the United Nations Economic and Social Council formally adopted GHS and authorization translated into the official languages of the United Nations to facilitate the worldwide use in July 2003. GHS is the implementation of the classification and labeling of chemicals to reduce labor and users of chemicals on health hazards and environmental pollution, and barriers to cross-border trade, dominated by the United Nations. The implementation of GHS will provide easy understanding hazard communication systems internationally. It can not only improve human health and environmental protection, but also save the cost and time of production label and material safety data sheets by the multinational.

International Maritime Dangerous Goods Code, IMDG Code)

The implementation of the Code is mandatory in conjunction with the obligations of the members of united nation government under the International Convention for the Safety of Life at Sea (SOLAS) and the International Convention for the Prevention of Pollution from Ships (MARPOL). IMDG Code was adopted by the International Maritime Organization and the international community to comply with the requirements, which aims to protect the safety of the ship's personnel and property safety of the ship and the time of transport of dangerous goods, and to prevent the pollution of the ocean shipping in 1965. Its rule is divided into seven chapters:

  • General provisions, definitions, training
  • Classification
  • Dangerous Goods List, special provisions and exceptions
  • Packing and Tank Provisions
  • Consignment Procedures
  • Construction and Testing of packagings, IBCs, large packagings, portable tanks, MEGCs and road tank vehicles
  • Transport Operations

EU

Registration, Evaluation, Authorisation and Restriction of Chemicals REACH :

REACH is a regulation of Registration, Evaluation, Authorization and Restriction of Chemicals. The manufacturer or importers import chemicals, the annual amount of more than one ton (including 1 ton), are required to be registered to Helsinki, Finland European Chemicals Agency (ECHA) by EU. To protect the rights of non-EU manufacturers sell the EU shall be the sole agent of transmission (Only Representative, OR) in the European Union local, depending on the information to complete the payment process and obtain a registration number from ECHA, chemicals may import in the EU market.

Restriction of Hazardous Substances Directive 2002/95/EC (RoHS) :

RoHS is the regulation of Hazardous Substances Directive (2002/95 / EC) to limit the use in electrical and electronic products, lead and other hazardous substances in July 1, 2006. The aim is to limit the six substances in the electrical and electronic products, in order to protect the safety and health of people and the environment.

European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) :

ADR developed by the Economic Commission for Europe, a vehicle loaded with dangerous goods on EU roads must comply with this regulation content. The structure is consistent with that of the United Nations Recommendations on the Transport of Dangerous Goods: Model Regulations(URECN), the International Maritime Dangerous Goods Code (IMDG), the Dangerous Goods Regulations by Air (DGR) and the Regulations concerning the International Carriage of Dangerous Goods by Rail (RID). Its content includes dangerous goods classification, packaging, transportation-related provisions, as well as equipment and license files during transport of dangerous goods.

Japan

Chemical Substances Control Law (CSCL):

Three ministries for the common authority of CSCL currently are the Ministry of Economy, Trade and Industry (METI) from 1974, the Ministry of Health, Labor and Welfare (MHLW) in1987, and the sources of law delegated to the Ministry of the Environment (MOE) in 2004, but dominated by the METI. CSCL is the first regulatory to distinguish New Chemicals and Existing Chemicals in the world.

Industrial Safety and Health Law (ISHL):

ISHL were implemented in 1972 and the competent authority for the Ministry of Health, Labor and Welfare (MHLW).

Manufacture or import chemical substances must comply with both CSCL and ISHL regulations in Japan.

South Korea

Act on the Registration and Evaluation of Chemical Substances (K-REACH):

With officially implemented from January 1, 2015, chemical manufacturers, importers, trafficking must register the new chemical substances and the annual consumption of more than one ton of existing chemical substance to the Ministry of Environment (MOE). In addition, the existing chemical substances (priority list) will be released in different phase, while the new chemical substances must be registered before the operation. The joint registration and the only representative (OR) system are very similar both in K-REACH and EU REACH, manufacturers get the registration number after the registration, then the chemical substances may enter the Korean market.

America

Code of Federal Regulations:Title 49 (49 CFR)

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to Federal regulation. Title 49 is the principle set of rules and regulations issued by the Departments of Transportation and Homeland Security, federal agencies of the United States regarding transportation and transportation related security. In the United States by air, sea, water, rail and road transport units are required to comply with this specification. Transport of Dangerous Goods Regulations specification is included in this first chapter, section C. Its content includes transport of dangerous goods to apply for the documents and dangerous goods packaging requirements.

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