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ECHA Releases First List of Substances Requiring Registration in 2013

On February 3, ECHA (European Chemicals Agency) released the first list of substances requiring registration by May 31, 2013. It is estimated that at least 2,300 phased substances will complete REACH registration, with 1,583 registrants currently preparing. Christel Musset, Manager of ECHA's Registration Department, emphasized that although this is only preliminary data, ECHA's timely release allows downstream users to determine whether the substances they use are being registered or will be registered by 2013. If necessary, downstream users should contact their suppliers to check whether the chemicals they use are covered in chemical safety assessments and exposure scenarios. Andreas Herdina, Manager of ECHA's Cooperation and Communication Department, pointed out that this data is better than the estimates before the 2010 registration deadline, and the number of SMEs participating in registration by the 2013 deadline will increase significantly, which is inconsistent with the original official expectation that "more SMEs will register by 2018." ECHA stated that they will update the data monthly, and therefore hope that more potential registrants will actively respond to the survey. Furthermore, Andreas Herdina stated that the ECHA Directors Liaison Group, established to resolve registration issues from 2010, will continue to exist, but at a reduced frequency, as most registration-related issues have been resolved, and communication within the supply chain and with downstream users will be less frequent.

Chesar, short for Chemical Safety Assessment and Reporting Tool, was first released in May 2010 and updated to version 1.2 in August 2011. (2010)

On March 16, 2012, ECHA noted that Denmark had submitted a report recommending several restrictions on leather goods. Because leather goods come into direct and continuous or repeated contact with the skin, restrictions were proposed if the hexavalent chromium (chromium VI) content in the leather was greater than or equal to 3 mg/kg. Hexavalent chromium is a substance that can cause severe allergies in humans; even very low concentrations can trigger dermatitis. Hexavalent chromium in shoes or other leather products can cause contact allergies. If the authorities adopt the restriction measures, hexavalent chromium will be included in the restricted substances list of Annex XVII of REACH, applicable throughout the EU, and this ban will cover shoes, gloves, watch straps, jackets, coats, trousers, hats, and toys. ECHA pointed out that although manufacturers do not intentionally add hexavalent chromium during the manufacture of leather and leather goods, trivalent chromium used in leather tanning (the leather soaking process) can oxidize to hexavalent chromium during oxidation. However, the formation of hexavalent chromium can be avoided by properly controlling the leather tanning process. Denmark's proposed list of restricted substances has entered the public consultation period, with relevant parties from within and outside the EU able to submit their comments by September 16, 2012. However, ECHA has stated that relevant parties should ideally submit their comments by June 1, 2012. The ECHA Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) will make a decision by March 16, 2013, based on all documents related to the proposed restricted substances and the comments received during the public consultation period.

ECHA will release statistics on tonnage ranges for substance registration in June.

ECHA will compile a total tonnage range for substances in its Registered Substances Database and publish the statistics on its website in June of this year. ECHA will obtain tonnage data from the latest complete registration files (non-intermediate use) for each substance, compile the total tonnage range, and publish it in the ECHA Registered Substances Database. Both jointly submitted and individually submitted tonnage ranges will be announced. It should be noted that tonnage information from certain files will not be used or calculated, including: • Intermediate registration files under Articles 17 or 18 of the REACH Regulation; • Complete registration files (non-intermediate use) for which commercial confidentiality has been requested under Article 119(2)(b) of the REACH Regulation, unless jointly submitted by four or more registrants, as the total tonnage of four or more registrants does not reveal the individual tonnage information of any one registrant. Since 2008, registrants have been able to apply for confidentiality of their tonnage information under section 119(2)(b) of the REACH Regulation; if a registrant has not previously submitted an application but wishes to maintain confidentiality of their tonnage information, they must promptly submit an updated file containing a confidentiality application. The confidentiality application is submitted on E...

ECHA has finally allowed ORs to submit C&L notifications on behalf of companies.

Whether a Sole Representative (OR) can substitute for an importer in submitting Classification & Labelling (C&L) notifications for producers outside the EU has been a point of contention within the European Chemicals Agency (ECHA) and the European Commission. However, on May 3rd, ECHA issued a statement on its website indicating that it accepts C&L notifications from suppliers other than producers and importers for the CLP (Category of Chemicals) regulations. This change means that a Sole Representative (OR) who is not an importer can finally submit C&L notifications on behalf of non-EU companies. Previously, ORs needed to import a small quantity of the chemical substance to qualify as importers before they could submit classification and labelling notifications. ECHA is currently adjusting the REACH-IT system interface to allow groups of suppliers (including ORs) who are not importers to submit group notifications. This adjustment is expected to be completed by the summer of 2012. In the coming weeks, ECHA will update relevant guidance manuals and support documents. ECHA also emphasizes that if the OR submits classification labels on behalf of companies (including manufacturers and importers), the OR needs to provide documentation proving that it is authorized by the company to submit the C&L notification on behalf of the manufacturer or importer; simultaneously, the manufacturer...

ECHA officially released the first batch of 90 assessment substances under the REACH regulation.

On February 29, 2012, ECHA officially published the first list of substances included in the Community Rolling Action Plan (CoRAP), identifying 90 substances for initial assessment. According to REACH regulations, member states will conduct assessment procedures for these substances in 2012, 2013, and 2014. The 90 substances included in the first CoRAP were suspected of being harmful to human health and the environment. This list was agreed upon and approved in consultation with the Member State Committee (MSC) on February 9, 2012. Substance assessment is a process under REACH regulations to clarify the risks of substances. During this process, if ECHA deems it necessary to clarify the harmful risks of a substance, the registrant will be required to provide further necessary information and data. The selection of substances for the first CoRAP is primarily based on the properties of the substances, especially their persistence, bioaccumulation and toxicity, endocrine disruption, carcinogenicity, teratogenicity, and reproductive toxicity, and also considers the substances' intended use. The substances in the first CoRAP generally have multiple uses, not limited to specific industrial, professional, or consumer applications. The initial 90 substances in the CoRAP list required assessment of 36 substances by 17 member countries in 2012; the remaining substances were assessed in 2013 and 2014, but the list may be updated at that time. Details of the initial CoRAP list (90 substances) Assessment

ECHA recommends adding 13 new substances of high concern

ECHA (European Chemical Agency) has added 13 new proposals for Substances of Very High Concern (SVHCs). ECHA has opened a 45-day public consultation period, ending on April 12, 2012. SVHCs refer to any substance that meets Article 57 of the REACH Regulation and is mutagenic, carcinogenic, or reproductively toxic (CMR). Specifically, the following four substances will be considered potential SVHCs if present at a concentration of 0.1% wt/wt or greater than 0.1% of milchler's ketone (EC Number: 202-027-5) or milchler's base (EC Number: 202-959-2): Basic Violet 3, Basic Blue 26, Solvent Blue 4, 4,4'-bis(N,N-dimethylamino)diphenyl ketone. Comments should include substance identification information, and information on the tonnage used per instance, the amount of substance released, and the intended use of the exposed substance is also welcome. Manufacturers can also provide information on safe alternative substances and technologies, as well as supply chain structures. ECHA will consider this information when drafting the list of SVHCs (Annex 14). At the request of the European Commission, Belgium, Poland, Finland, Germany, and ECHA have submitted proposals regarding Substances of Very High Concern (SVHCs). The substance names, reasons for being recommended as SVHCs, and usage information are now available on the ECHA website.

ECHA newly releases REACH registration dossier evaluation report - nearly 70% are unqualified

On February 27, 2012, ECHA released its assessment report on REACH registrations submitted in 2011. The report indicated that nearly three-quarters of the assessed REACH registration documents were non-compliant or unqualified. ECHA stated that most documents required review because the overall compliance was not high, and that over 70% of substance identification was incomplete; only a small number of documents did not require further review. Besides substance identification, ECHA also pointed out insufficient evidence in risk assessments and chemical safety reports. In 2011, ECHA completed compliance checks on 146 registration documents, of which 134 required further information, indicating significant room for improvement in the quality of information submitted by registrants. ECHA advised that "those who plan to complete registration in 2013 must read this report, and those who have already completed registration should take necessary actions." The report listed common deficiencies in the documents and made relevant recommendations: Ø Substance Identification: It is argued that registrants must clearly define substances. The composition and identification information in the registration documents must be supported by appropriate substance analysis. Unclear substance identification information may affect the accuracy of hazard information, leading to incorrect information regarding the safe use of the substance. Ø Test recommendations and hazard assessments: Information referencing research results for the substance must ensure that it represents standard testing methods, and

ECHA Risk Assessment Committee (RAC) adopted four proposals for a unified classification and labeling of substances.

On March 13, 2012, the ECHA Risk Assessment Committee (RAC) adopted a proposal for a harmonized classification and labelling of four substances in industrial chemicals and pesticides across Europe. The Global Harmonized System (GHS) is a global harmonized system for the classification and labelling of chemicals, spearheaded by the United Nations to reduce the health hazards and environmental pollution caused by chemicals to workers and users, and to reduce barriers to cross-border trade. Its main objectives are: (i) to provide an internationally recognized and easily understood hazard awareness system to improve the protection of human health and the environment; (ii) to provide a mutually recognized framework for countries that do not yet have such a system; (iii) to reduce the necessity of chemical substance testing and assessment; and (iv) to increase the facilitation of international trade for chemicals for which appropriate assessments and hazard confirmations have been made. The ECHA Risk Assessment Committee (RAC) adopted information on four substances as follows: Substance Name, CAS Number, Proposing Country, Adopted Classification, Uses. Proquinazid 189278-12-4 UK Possibly carcinogenic to humans and harmful to aquatic environments. Fungicide. Amidosulfuron 120923-37-7 Austria Harmful to aquatic environments. Herbicide. Tebufenpyrad 119168-77-3

The fourth batch of REACH authorized substances list is now open for public comment.

On June 20, the European Chemicals Agency (ECHA) released a fourth list of 10 substances slated for inclusion in the REACH mandate, with comments due by September 19. Details of the substances are as follows: Substance Name, CAS Number, EC Number, Main Uses: Pentazinc chromate octahydroxide (Zinc Yellow), 49663-84-5, 256-418-0; Metallic raw material: automotive coatings, aerospace coatings. 2,2'-dichloro-4,4'-methylenedianiline 4,4'-diamino-3,3'-dichlorodiphenylmethane (MOCA) 101-14-4 202-918-9 Plastics/rubber, wood: Primarily used in the production of resin curing agents and polymers, as well as in construction and art. Strontium chromate 7789-06-2 232-142-6 Used in paints, varnishes, and oil paints; anti-wear agents for metal surfaces or aluminum sheet coatings. N,N-dimethylacetamide (DMAC) 127-19-5 204-826-4 Plastics/rubber/coatings, adhesives, textiles: Used as a solvent, in the production of various substances and fibers. Also used in reagents, industrial coatings, polyimide films, paint removers, and ink removers.

Japan's Ministry of Health, Labour and Welfare updated the names of 55 new chemical substances.

On March 30, Japan's Ministry of Health, Labour and Welfare (MHLW) issued a statement revising the name of the Industrial Safety & Health Law (ISHL). This included changing the names of 51 substances, such as bis[(1S,4R)-4-[2-amino-6-(cyclopropylamino)purine-9-YL]-2-cyclopentenyl] methylalcohol], and deleting 4 substances, including 1-ethyl-2,3-dimethylimidazolium hydrogen phthalate. The MHLW also published a table comparing the original and revised names of the substances; for details, please refer to the following website (in Japanese): http://www.mhlw.go.jp/bunya/roudoukijun/anzeneisei06/dl/20120313.pdf. The MHLW stated that the production and import of these new substances will require registration certificates and small-scale new chemical substance confirmation. Therefore, companies that have already produced or imported these substances, or plan to produce or import them, need to immediately contact the Japanese Ministry of Health, Labour and Welfare for further information.

The US FDA rejected the bisphenol A ban.

In late 2011, the U.S. Food and Drug Administration (FDA) and the Natural Resources Defense Council (NRDC) reached an agreement requiring the FDA to provide a specific response by the end of March 2012 regarding restrictions on the use of bisphenol A (BPA) in food packaging containers and other food contact materials. On March 30, 2012, the FDA sent a letter to the NRDC, rejecting its request due to a lack of strong scientific evidence. It rejected the removal of regulations allowing the use of BPA in food contact containers and did not intend to ban BPA in food. It also questioned the evidence presented by the NRDC. However, the U.S. industry hoped the FDA would amend the legislation. The Endocrine Society, the world's oldest and largest endocrine association, accused the FDA of neglecting overall research on BPA. The society's leaders stated that they hoped the FDA would conduct small-dose tests to study the effects of BPA on the endocrine system before deciding whether to allow its continued use. Note: Bisphenol A, industrially known as polycarbonate, is widely used in the production of shatterproof plastics. It is one of the most widely used industrial compounds in the world, used in the manufacture of baby bottles, water bottles, sporting goods, medical devices, eyeglasses, CDs, DVDs, and household appliances.

The European Commission has added new regulations on the use of phosphates in cleaning agents.

On March 14, the European Commission published Regulation (EU) No. 259/2012 in the Official Journal of the European Union, amending the original Cleaning Agents Regulation (EC) No. 648/2004, adding restrictions on the use of phosphates and other phosphorus compounds in household laundry detergents and dishwashing liquids, with the aim of reducing phosphate emissions into water. The Official Journal of the European Union also provides a transition period before the effective date, summarized as follows: Cleaning Agents | Limits | Final Effective Date Laundry Detergent | The phosphate content in the standard dosage defined in Annex VII, Part II of the Regulation shall not exceed 0.5g | June 30, 2013 Dishwashing Liquid | The phosphate content in the standard dosage defined in Annex VII, Part II of the Regulation shall not exceed 0.3g | January 1, 2017 Official Journal of the European Union: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:094:0016:0021:EN:PDF Source: Chemical Watch (2012-03-30)

Japan takes action to halt the production and sale of pigments containing high concentrations of PCBs.

Polychlorinated biphenyls (PCBs) were successfully synthesized by German scientists in 1881. Japan did not begin production until 1954, but its consumption has continued to increase rapidly. Japan's consumption was only 200 tons in 1954, but reached over 50,000 tons by 1971, an increase of 250 times in 17 years. Because PCBs are not easily decomposed in the natural environment, they easily enter the air, soil, rivers, and oceans during production, processing, use, transportation, and waste disposal, causing serious pollution. For those poisoned by PCBs, the damage is permanent. Due to the stable nature of PCBs, they cannot be excreted from the body, causing not only organ damage but also, more alarmingly, vertical transmission to the fetus. The Environmental Regeneration and Conservation Organization (ERC), an independent administrative agency in Japan established by the "Public Pollution Health Victim Compensation and Prevention Association" and the "Environmental Project Group Earth Environment Fund Business," conducts research, education, and promotion of environmental protection, with a focus on PCB waste treatment. Japan discontinued the use of polychlorinated biphenyls (PCBs) in 1962 and enacted legislation in 2001 requiring those possessing PCBs to properly dispose of and dispose of them by July 17, 2016. The Japanese Ministry of Economy, Trade and Industry (METI) recently launched an initiative to identify pigments containing PCBs exceeding 50 ppm, as these pigments violate the PCB safety standards of the Stockholm Convention on Persistent Organic Pollutants.

Vietnam imposes environmental tax on eight types of polluting goods.

Vietnam's Environmental Tax Law came into effect on January 1, 2012. It regulates eight categories of goods subject to the tax, including fuels (gasoline, jet fuel, diesel, kerosene, heavy oil, lubricating oil, lubricants), coal, HCFC solutions, plastic bags, restricted pesticides, forestry chemicals, warehouse disinfectants, and termite control agents. According to the General Department of Taxation of Vietnam, the use of these eight items causes widespread environmental pollution; therefore, those using these goods should be taxed. To save the tax authorities the expense of collecting the environmental tax, it applies to households, individuals, and organizations engaged in the production of these goods. Vietnam's Environmental Tax Law also stipulates that the Standing Committee of the National Assembly will specifically regulate the following tax rates for the first eight categories of goods, and these rates may be adjusted as necessary: ​​1. Gasoline and aviation gasoline: 1,000 VND per liter; 2. Other fuels: 300 VND per liter; 3. Antraxit coal: 20 VND per metric ton; 4. Other coal: 10,000 VND per metric ton; 5. HCFC solution: 4,000 VND per kilogram; 6. Plastic bags: 40,000 VND per kilogram; 7. Pesticides: 500 VND per kilogram; 8. Other residual pesticides: 1,000 VND per kilogram. (Note: The current official exchange rate is 1 USD = 20,803 VND plus or minus 1%). Data recently released by the General Statistics Office of Vietnam shows that the country's GDP in 2011 increased compared to 2010.

The EU has announced eight new substances authorized under REACH, which will gradually be phased out in 2015.

On February 14, 2012, the European Union announced the addition of eight new authorized substances to Annex 14 of REACH, increasing the REACH authorized list from six to fourteen substances. Manufacturers wishing to continue using these substances after the expiration date must apply for authorization before the deadline. These eight newly added authorized substances are expected to be phased out within three and a half years. After the expiration date, substances on the list can only be used within the EU with authorization. The following table lists the 8 newly authorized substances and their official expiration dates: No. Chinese Name English Name CAS No. EC No Hazard Characteristics Application Deadline Expiration Date (Sunset Date) 1 Diisobutylphthalate (DIBP) 84-69-5 201-553-2 Reproductive Toxicity 1B 2013/8/21 2015/2/21 2 Diarsenic Trioxide 1327-53-3 215-481-4 Carcinogenicity 1A 2013/11/21 2015/5/21 3 Diarsenic Pentaoxide 1303-28-2 215-116-9 Carcinogenicity 1A 2013/11/21 2015/5/21 4 Lead Chromate &

South Korea plans to revise its safety and quality labeling standards.

The Korean Agency for Science, Technology and Standards (KATS) recently announced a proposal to revise the "Industrial Product Safety and Quality Labelling Standards" (Annex 1: Home Textile Products). According to a document issued by the Committee on Technical Barriers to Trade of the World Trade Organization, such requirements should be implemented by September 2012. The purpose of the revision is to: • Ensure children's safety from risks posed by hazardous materials or fire by revising the safety and quality labeling standards for children's clothing, restricting the use of hazardous materials, or adding warning information. Key revisions include: • Adding restrictions on the use of nickel in electromagnetic shielding fabrics. • Mandatory clear labeling of flame symbols ("Caution: Flame") on flammable children's pajamas. • Adding restrictions on the use of phthalate plasticizers in children's backpacks. • Product projects subject to safety management are identified: - Children's textile products: backpacks (including school bags); - Outdoor clothing: swimwear, sportswear, tracksuits, cold-proof masks; - Outerwear: warm arm warmers; - Bedding: hammocks; Table 1: Safety requirements under current textile safety and quality standards Test Item Requirements Children's textiles (under 12 years old)* Underwear Outdoor clothing Outerwear and bedding Formaldehyde (mg/kg) 75 or less 300 or less pH 4.0 to

EU Automotive Industry REACH Guidelines Version 3.1 Officially Released

On June 1st, the European Automobile Manufacturers Association (ACEA) announced the official release of version 3.1 of the new REACH Guideline for the automotive industry (AIG), by the automotive industry REACH working group (TR-REACH), and its translation into five languages: Chinese, French, German, Japanese, and Korean. The working group's members are primarily representatives from major automakers and the automotive supply chain. AIG version 3.1 adds content including the classification of substances and preparations, substance notification under CLP (classification, labelling, and packaging), substance authorization and restriction procedures, safety data sheet (SDS) requirements for downstream users, the impact of REACH and waste on the automotive industry, and more. Similar to chemicals, REACH regulations require the automotive industry to provide safety information on substances and effectively control the risks arising from their use. Note: Regulation 1272/2008, Classification, Labelling and Packaging of Substances and Preparations (CLP), aims to harmonize the European Commission's regulations and standards for the classification and labelling of substances and preparations, and takes into account the classification standards and labelling specifications of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The CLP regulation will contribute to achieving the goals of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.

The European Commission amended paragraphs 28-30 of Annex XVII to the REACH Regulation.

Following the consensus reached by the REACH Committee on a series of restrictions on CMR substances, on February 10, 2012, the European Union published Commission Regulation (EU) No 109/2012 on its official website, amending paragraphs 28-30 of Annex XVII to the REACH Regulation (EC) No 1907/2006. This regulation came into effect on June 1, 2012. Paragraphs 28-30 of Annex XVII to the REACH Regulation respectively added substances classified as carcinogenic in categories 1a and 1b of Annex VI of the EU Regulation (EC) No 1272/2008-CLP to parts 28-30 of Annex XVII to the REACH Regulation. Annexes 1-6 of Annex XVII of the REACH Regulation Description 1 Article 28—List of Class 1A/Class 1 Carcinogens 2 Article 28—List of Class 1B/Class 2 Carcinogens 3 Article 29—List of Class 1A/Class 1 Teratogens 4 Article 29—List of Class 1B/Class 2 Teratogens 5 Article 30—List of Class 1A/Class 1 Reproductive Toxicity Substances 6 Article 30—List of Class 1B/Class 2 Reproductive Toxicity Substances This revision mainly targets Articles 28-30 of Annex XVII of the REACH Regulation, which contain restrictions on CMR substances. Main revisions: (1)

Japan revises GHS standards

Japan has released a new version of the GHS standard (JIS Z 7253). This standard integrates two existing standards: the GHS Material Safety Data Sheet (MSDS) (Z 7250) and the GHS Labelling Regulations (Z 7251). The new standard is a revision based on the content of the fourth edition of the UN Purple Book. GHS stands for Globally Harmonized System of Classification and Labelling of Chemicals. In December 2002, the United Nations Expert Committee on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labelling of Chemicals (UNCETDG/GHS) developed the GHS system, which was officially adopted by the United Nations Economic and Social Council in July 2003, and authorized for translation into official UN languages ​​for worldwide use. The main revisions include: * Shortening the term "MSDS" to "SDS," which will be used in labeling and SDS preparation. * New standard requirements...

Dimethyl fumarate (DMF) was added to the list of restricted substances in Appendix 17 of the REACH regulation

On May 15, 2012, the Official Journal of the European Union promulgated Regulation (EU) No 412/2012, officially adding dimethyl fumarate DMF to Appendix 17 of the REACH Regulation (concerning hazardous substances, Mixtures and finished products, their manufacture and placement on the market are restricted) Item 61 of the list of substances. This regulation takes effect 20 days after publication in the European Journal and requires member states to unconditionally transfer it to their national laws. Prior to this, the EU issued revised regulations 2012/48/EU on the DMF ban on January 26, 2012, extending the effective date of the dimethyl fumarate ban (2009/251/EC) to March 15, 2013. . However, Regulation 2012/48/EU clearly states that if the proposal to list dimethyl fumarate in Appendix 17 of the REACH regulation for mandatory control is formally adopted earlier than the former, the ban on dimethyl fumarate will take effect immediately. That is to say, the 2012/48/EU directive "Extension of the Effective Date of Dimethyl Fumarate" issued by the EU will be invalidated at the same time as the effective date of (EU) No 412/2012, that is, starting from June 4, the entire EU will restrict Dimethyl fumarate is used. Substance name CAS number EC number restriction conditions 61. Dimethyl fumarate (DMF) 624-49-7 210-849-0 (1) The content of DMF used in articles and any component of articles shall not be

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