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REACH

Overview
REACH is the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007. It streamlines and improves the former legislative framework on chemicals of the European Union (EU).

Standards and Regulations

EU
REACH regulation divide the existing of substance into three forms: on their own, in mixtures and in articles. In principle, the regulation has an impact on most products input into EU (except for food, drug and pesticide). 
What’s SVHCs?
Substances with the following hazard properties may be identified as Substances of Very High Concern (SVHCs):
(1) Carcinogens, mutagens, reproductive toxins (CMRs) cat 1A and 1B 
(2) Persistent, Bioaccumulative and Toxic (PBT) 
(3) Very Persistent and Very Bioaccumulative (vPvB) 
(4) Substances of equivalent concern to the above
At present, eight batches of 163 substances were listed in the SVHC Candidate List, and ECHA will publish two batches every year.

SVHC requirement:
Substance SVHC(Article 31) SDS
Mixture Gaseous mixture: SVHC≥0,2 % by volume 
non-gaseous mixtures: SVHC ≥0.1%(w/w) Article 31
SDS
Article SVHC concentration≥ 0,1 (w/w) 
Article 33
Provide sufficient information about how to use safely, 
as a minimum, the name of that substance. (Within 45 days of receipt of the request)
SVHC may be included in the Authorisation list (Annex XIV of REACH) step by step. Once were listed into the list, the SVHCs become subject to authorization. These substances cannot be placed on the market or used after a given date (Sunset day), unless an authorisation is granted for their specific use, or the use is exempted from authorisation. 

The list of restrictions (Annex XVII of REACH) contains those substances (on its own, in a mixture or in an article) for which manufacture, placing on the market or use is limited or banned in the European Union. The list included 63 entries and will be updated continual. Restriction is the highest fire safety on substances limit, the enterprise must conform this restriction first during production process. 

China-REACH (New Chemical Registration in China)
On 19 Jan 2010, the Ministry of Environmental Protection (MEP) of China released the revised version (the Order No. 7) of the Provisions on Environmental Administration of New Chemical Substances. The new regulation replaced the old regulation issued in 2003 and came into force on 15 Oct 2010. This regulation is similar to EU REACH and is also known as "China REACH".

Under this regulation, companies shall submit new chemical substance notification to the Chemical Registration Centre (CRC) of the Ministry of Environmental Protection (MEP) for the new chemicals irrespective of annual tonnage, ie chemicals other than the approximately 45,000 substances currently listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). The notification not only applies to new substance on its own, in preparation or articles intended to be released, but also applies to new substances used as ingredients or intermediates for pharmaceuticals, pesticides, veterinary drugs, cosmetics, food additives and feed additives, etc.

The Amended Japanese Chemical Substances Control Law 
Introduction of the Law
"Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture etc” is well known as “Chemical Substances Control Law (CSCL)” which has imposed strict pre-marketing evaluation of chemical substances that were introduced on the market from 1973, and the latest amended law was published on 20 May 2009. The amended law had entered into force fully since 1 April 2011.
Scope of Japan CSCL
Japan CSCL covers general industrial chemical products only, which include both new chemicals and existing chemicals. Food or feed additives, pharmaceuticals, cosmetics, agricultural chemicals and fertilizers are subject to different laws and acts.
General industrial chemical products might also be subject to the requirements of the Industrial Safety and Health Law (ISHL), the Poisonous and Deleterious Substances Control Act, the Air Pollution Control Law, and the Water Pollution Control Act. 
The three government bodies responsible for the implementation of CSCL are the Ministry of Economy, Trade and Industry (METI), Labor and Welfare (MHLW), and the Ministry of the Environment (MOE).
Chemicals Regulated under Japan CSCL
The following categories of chemicals are regulated by Japan CSCL:
  • Class I Specified Chemical Substances (28 substances);
  • Class II Specified Chemical Substances (23 substances);
  • Monitoring Chemical Substances (39 substances);
  • Priority Assessment Chemical Substances(~139 substances);
  • New Chemical Substances(~6500 substances);
  • General Chemicals;
New Classification Scheme
Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (after amendment)
Classification Measures
Class I Specified Chemical Substance
-Persistent and bioaccumulative; and
-long-term toxicity to humans or top predators
-Technical ban of manufacture/import
-Ban of uses other than those specified (Essential Uses)
-Import ban of specified products
-Compliance with technical standards and labeling for substances and products containing them
-Various government orders (recall, etc.)
Class II Specified Chemical Substance
-Low bioaccumulation and ecotoxic or has long-term toxicity to humans
-Notify planned and actual quantity, uses, etc.
-Order to change planned quantity
-Publish technical standards for substances and products containing them
-Labeling obligation
Monitoring Chemical Substance
-Existing Chemical Substance that is
-Persistent and Bioaccumulative
-Notify manufacture/import quantity, uses, etc.
-Information sharing (supply chain)
-Report Usage
-Directive for hazard investigation
Priority Assessment Chemical Substance
-From Type II and III Monitoring
-Requires prompt assessment of risk
-Detailed Use: 30 Classifications
Manufacturers/Importers
-Notify manufacture/import quantity, detailed uses, etc.
-Information sharing (supply chain)
-Toxicity Testing/Hazard Investigation
-Report usage
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