The European Commission of Member States (MSC) adopted the eighth batch of proposed Substances of Very High Concern (SVHC) candidate lists on December 17, 2012. These 54 substances were proposed by EU member states and ECHA because they are considered to pose a potentially serious hazard or impact on human health or the environment and meet the characteristics of Article 57, thus being included in the SVHC candidate list. Among them, azodicarbonamide (ADCA), hexahydrophthalic anhydride (HHPA), and methylhexahydrophthalic anhydride (MHHPA) are considered by the MSC to cause severe respiratory allergies, with a hazard level equivalent to carcinogenicity, mutagenicity, and reproductive toxicity (CMR), and are therefore classified as equivalent level of concern (EQC). To date, the REACH regulation has 138 SVHC candidate list substances. ECHA updated the SVHC candidate list on its website on December 19, 2012. Source of information

The European Commission recently published a research report on the overlap of the REACH Regulation, assessing whether the REACH Regulation overlaps with other relevant EU regulations and requires amendment. The 428-page report contains 38 practical action recommendations. Details are summarized below: "Dual Regulation" Some regulations contain restrictions on specific substances or uses that are similar to or contradictory to the restrictions in Annex 17 of the REACH Regulation. Examples include the PCBs/PCTs Directive, the Toys Directive, and the Packaging Directive. To address this, the report recommends amending the relevant regulations to avoid duplication or inconsistencies. It also recommends establishing a database of regulations restricting the use of specific substances for easy reference. "Lack of Risk Assessment Due to REACH Exemptions" The report notes that substances exempted from REACH regulations include medical products, cosmetics, and plant protection agents or pesticides. This exemption results in a lack of risk assessment because safety assessments during product manufacturing, mixing, and waste management are not subject to specific sectoral oversight. The report provides different revision recommendations for each industry regulation's gaps in risk assessment. "Multiple regulations increase response costs." In many cases, the documentation required by REACH regulations does not comply with the requirements of relevant industry regulations, leading to increased costs for businesses.

Following public consultation, the European Chemicals Agency (ECHA) published an updated REACH Registration Guidance on 2 May 2012. While the Guidance had undergone several revisions since its initial publication in 2007, a comprehensive revision was necessary as the second REACH registration deadline of May 31, 2013, approached, making it clearer, simpler, and easier for registrants, especially small and medium-sized enterprises (SMEs), to meet this need. ECHA drafted a revised version of the Guidance and issued a consultation, officially releasing Guidance 2.0 on May 2 after gathering feedback. Version 2.0 revised both the structure and content, placing the revised content in Annex III. The main changes are as follows: • Part I primarily explains and clarifies the registration requirements; • Part II provides practical guidance on how to use or refer to IT tools and manuals to prepare and submit registration documents. Furthermore, version 2.0 includes additional examples and case studies illustrating the experience gained since the implementation of the REACH regulation.

The European Union General Agency for Chemistry (ECHA) solicited public comment on May 14 on the harmonized classification and labelling (CLH) proposal for five substances for a period of 45 days, ending on June 28, 2012. The Committee for Risk Assessment (RAC) of the EHCA will seriously consider the opinions collected and make a final assessment, which will make a decision with reference to the views of the RAC whether to accept the uniform classification and labeling of these five substances; The five substances are as follows: Substance Name No. EC &nb

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.

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 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...

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...

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 (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.

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

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

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.