Japan Chemical Substances Control Law

Overview Enacted on 16 October 1973, the Japan Chemical Substances Control Law (CSCL) was the world’s first to regulate chemicals and control risks. In 2017, the 4th amendment to the Japan Chemical Substances Control Law was passed and will be implemented in phases from April 1, 2018 and January 1, 2019. The Law is intended to manage risks of industrial chemicals both manufactured in Japan and imported, giving the Ministry of Health, Labor and Welfare (MHLW), Ministry of Environment (MOE) and Ministry of Economy, Trade and Industry (METI) oversight authority over these issues. Parties Covered by CSCL Japanese manufacturers and importers of chemical substances. Foreign companies selling chemical substances to Japan. Categorizing Chemical Substances under CSCL The categories of existing chemical substances and newly announced chemical substances    include most chemical substances manufactured, imported and used in Japan. The status of a substance, existing or new, can be confirmed by searching…

Mar. 25th, 2014

CAS Number Application

The CAS Registry database is the most authoritative collection of chemical substance information, containing more than 56 million organic and inorganic substances. CAS Registry covers substances identified from the scientific literature from 1957 to the present, with additional substances going back to the early 1900s. CAS Registry Number (CASRN) is a Registered Trademark of the American Chemical Society (ACS), which is a congressionally chartered independent membership organization that represents professionals at all degree levels and in all fields of chemistry and sciences that involve chemistry, and the gold standard for substance information worldwide.With the development of the times, many manufactures focus on advance scientific research worldwide and continue to develop completely new substance. How to identify these substances and get these substances accepted by others, applying CAS Registry Number would be a best choice. Our Services Include:>>Assist clients in gathering chemical substance identity information;>>Assist clients to confirm accuracy of substance…

Mar. 25th, 2014

DMF application and FDA certification

According to US Federal Administrative Law, there is a Drug Master File (DMF) must be provided for pharmaceutical ingredient entering into United States. It is a document that provides detailed interpretation of a drug manufacture process, which would help FDA to have a comprehensive understanding of the manufacturing plant. The latter will issue certification to allow the applying products to place on US market. Our Service Includes:>> Compilation and delivery of DMF to FDA>> Acquisition of DMF distribution number and NDC registration number>> DMF annual update>> Help company to prepare materials for obtaining FDA certification>> Assist company to confront regular random inspection About REACH24HREACH24H Group provides product stewardship & regulatory compliance service for global customers from its three offices – Ireland, Canada and China, assisting international companies to comply with global chemical regulations including the EU REACH, China new chemical substance notification, Global GHS, USA TSCA, etc. REACH24H in-house team…

Mar. 25th, 2014

U.S. TSCA

The Toxic Substances Control Act, namely TSCA, was enacted by the US Congress in 1976 and came into effect in 1977, implemented by the US Environmental Protection Agency (EPA). The Act intends to prevent unreasonable risks of injury to human health or the environment as well as to limit, prohibit, or ban chemical substances posing imminent hazards. With several amendments, TSCA has become a prominent regulation for effective chemical substance management. Much attention shall be paid to TSCA compliance by manufacturers and importers with regulatory obligations. Interpretation of TSCA Chemical substances under TSCA are clarified as either “existing substances” or “new substances”. Any substance that is not on the TSCA Inventory is classified as a new substance. Several categories of substances such as munitions, food, food additives, pesticides, drugs, cosmetics, tobacco, nuclear materials etc. are managed by other US regulations and exempt from TSCA regulation obligations. The TSCA Inventory is…

Mar. 24th, 2014

COS application and EDMF certification

“COS” is recognition to the quality of a product. Company that wish to enter EU market must first acquire a “COS” number to prove that their API has reached certain level according to relevant EU regulations. EDMF certification mainly aims to regulate manufacturers of preparation and finished goods. Without both companies may not be able to enter EU market. Our Service Includes: >> Help company to apply COS number application>> Help company to confront possible on-site audit>> Help manufacturer of preparation and finished good to complete EDMF certification>> Compilation of document covered in EDMF submission materials for API-related companies About REACH24HREACH24H Group provides product stewardship & regulatory compliance service for global customers from its three offices – Ireland, Canada and China, assisting international companies to comply with global chemical regulations including the EU REACH, China new chemical substance notification, Global GHS, USA TSCA, etc. REACH24H in-house team consists of global-regulatory…

Mar. 24th, 2014

EU Cosmetics

According to Article II of Regulation (EC) No 1223/2009, ‘a ‘cosmetic product’ shall meanany substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.’ EU Cosmetics Suppliers have to Comply with:>>EU Cosmetics Directive 76/768/EEC;>>New EU Cosmetic Products Regulation (EC) No 1223/2009;>>REACH Regulation (EC) No 1907/2006; The Cosmetic Directive 76/768/EEC entered into force in 1976 and provided the main rules for composition, labelling and packaging of cosmetic products. From 11 July 2013, Regulation (EC) No 1223/2009 will replace the Cosmetics Directive. However, some of the provisions of Regulation (EC) No 1223/2009 will apply to substances that are carcinogenic, mutagenic or toxic…

Mar. 24th, 2014

EU Cosmetics

According to Article II of Regulation (EC) No 1223/2009, ‘a ‘cosmetic product’ shall meanany substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.’ EU Cosmetics Suppliers have to Comply with:>>EU Cosmetics Directive 76/768/EEC;>>New EU Cosmetic Products Regulation (EC) No 1223/2009;>>REACH Regulation (EC) No 1907/2006; The Cosmetic Directive 76/768/EEC entered into force in 1976 and provided the main rules for composition, labelling and packaging of cosmetic products. From 11 July 2013, Regulation (EC) No 1223/2009 will replace the Cosmetics Directive. However, some of the provisions of Regulation (EC) No 1223/2009 will apply to substances that are carcinogenic, mutagenic or toxic…

Mar. 24th, 2014

EU BPR

EU BPR came into force on Sept. 1st 2013. It aims to harmonize the European Market for biocidal products and their active substance and at the same time to provide a high level of protection for humans, animals and the environment. BPR regulates strictly its authorization deadline, and EU commission, ECHA, and all members of EU are in preparation for BPR’s enforcement. Industries are working hard on studying BPR and preparing for compliance, because only products complying with BPR can have access to EU market. Our Service Includes:>>Compliance strategy formulation for biocidal product>>Product analysis and advice to constituent improvement>>Early regulatory warning>>Keep informed of active substance supplier list>>Biocidal product authorization application>>Label compilation of treated article>>Active substance search Why Choose Us?Since 2008, REACH24H has kept an eye on BPD, and all the time followed the newly enforced regulation——BPR. Since 2010, we have been the largest Chinese provider of chemical regulatory compliant service….

Mar. 24th, 2014

EU BPR

EU BPR came into force on Sept. 1st 2013. It aims to harmonize the European Market for biocidal products and their active substance and at the same time to provide a high level of protection for humans, animals and the environment. BPR regulates strictly its authorization deadline, and EU commission, ECHA, and all members of EU are in preparation for BPR’s enforcement. Industries are working hard on studying BPR and preparing for compliance, because only products complying with BPR can have access to EU market. Our Service Includes >>Compliance strategy formulation for biocidal products >>Product analysis and advice to constituent improvement >>Early regulatory warning >>Keep informed of the active substance supplier list >>Biocidal product authorization application >>Label compilation of treated article >>Active substance search Why Choose Us? Since 2008, REACH24H has kept an eye on BPD, and all the time followed the newly enforced regulation——BPR. Since 2010, we have been…

Mar. 24th, 2014

EU CLP

The CLP Regulation (Regulation (EC) No 1272/2008) is the new European regulation on classification, labeling and packaging of chemical substances and mixtures (preparations). This Regulation entered into force on 20th January 2009. CLP Regulation will replace Directive 67/548/EEC (short as DSD) relating to the classification, packaging and labeling of dangerous substances as well as Directive 1999/45/EC (short as DPD) relating to the classification, packaging and labeling of dangerous preparations.It introduces in the EU new criteria for classification and labeling, based on the United Nations’ Globally Harmonized System (UN GHS). From 1st December 2010, companies should apply the new classification regulation to substances, and from 1st June 2015 to mixtures (preparations). It also provides rules for the notification of substances to the Classification & Labeling Inventory established by the European Chemicals Agency (ECHA). Compliant Responsibility under EU CLPCompanies should classify substances or mixtures, submit C&L (Classification and Labeling) notifications, label and…

Mar. 24th, 2014
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TSCA Inventory Search Tool