By Thuy Dang On September 15, 2016, Vietnam’s Ministry of Industry and Trade (MOIT) published a "National Chemical Inventory" for public feedback.  This "National Chemical Inventory" is still a work in progress and according to the Law of Chemicals, is defined as a “list of chemicals currently used in Vietnam under government regulations.” The draft will be generated from existing evaluations of regulated chemicals and newly collected data from public consultation. With the assistance of the Japanese Ministry of Economy, Trade and Industry (METI), the MOIT collected data from Vietnamese-based industrial companies who have been either manufacturing or importing chemicals.  From this survey, over 3000 chemicals (with CAS numbers) were identified for inclusion on the draft inventory. A first public consultation period, which ended on 30 October 2016, was held in order to gather additional information from enterprises.  For chemicals that were not in the draft inventory, enterprises had an opportunity to file a form with the government.  For mixtures with distinct features, lists of single substances with their relative percentage concentrations (to ensure confidentiality) could be reported.  It is not known if additional consultation periods will be held. According to MOIT, after the final National Chemical Inventory is issued, chemicals not listed on it will be considered new, and enterprises will have to perform assessments as well as register the new substance(s) prior to any public usage. Reference: Center of Data and Chemical Incident Support - CECHEDAR. Public comments on Draft Inventory Compilation. September 15th 2016. http://vcerc.com/lay-y-kien-cho-ban-du-thao-danh-muc-hoa-chat-quoc-gia/ (Vietnamese only)

by Tatjana Benko At the beginning of October, the European Chemical Agency (ECHA), the European Chemical Industry Council (Cefic) and the Downstream Users of Chemicals Coordination Group (DUCC) published a joint statement on how they want to improve the safe use of chemicals using Use Maps. The REACH Regulation moves responsibility to industry to demonstrate the safe use of chemicals. As part of the REACH registration, industry is required to generate substance data and assess exposure associated with each identified use of a substance. Industry associations like Cefic and DUCC are trying to help companies they represent with that task. Q: What are Sector use maps? A: Sector use maps are a tool for better communication up and down the REACH supply chain and are generated by Downstream user sector associations. Communication along the supply chain is vital for the safe use of chemicals. The use map gives a unique and structured overview of the common uses in a sector association and provides information on the chemicals' uses. Sector use maps describe the uses of the chemical and also have links to the information needed to carry out exposure assessments. Q:  Who creates and uses Sector use maps? A: Downstream users collect information about uses and conditions of use of chemicals and risk management measures in their sector; they also carry out exposure assessment(s). Downstream users have a key role in communicating all important information to their suppliers and customers. Manufacturers and importers use available Sector use maps developed by the downstream user sector associations to prepare their chemical safety assessments under REACH. Sector associations create Sector use maps by using the templates from the use map package for the information needed to carry out exposure assessments. Q:  What is a Use map package? A: The description of use and exposure assessment are designed to provide the registrant more realistic information from downstream sectors on uses/use conditions/Operational Conditions (OCs)/Risk Management Measures (RMM) to include in the Chemical Safety Assessment (CSA) for the registration dossier. Use map packages contain different contributing activities described in 4 different templates. These templates help Downstream user sector associations create Sector use maps: Description of uses - Each use is described by a use name and market information. Condition of use for environment (SPERC - Specific Environmental Release Category) – contains operational conditions and risk management measures and the corresponding release factors to water, air, soil and waste. Condition of use for workers (SWED - Sector-specific Worker Exposure Description) – includes standard phrases that help registrants to communicate the exposure scenarios attached to the safety data sheet to the downstream user. Condition of use for consumers (SCED - Specific Consumer Exposure Determinant) – includes information on the design of a consumer product type (e.g. package size and design) and information on the habits and practices of how consumers actually use the products. All of the templates include suitable standard phrases which help the registrant (manufacturer and importer) effectively communicate with the downstream user. Q: What are the benefits of Sector use map for Manufacturer/Importers and Downstream Users? A: Sector use maps include descriptions of uses as well as links to information needed to carry out Exposure Assessments. Benefits for Manufacturer/Importers: registrants are provided with input parameters for Exposure Assessment tools; harmonized Risk Management Measures (RMM) inside of the Sector association; same set of parameters will cover several companies inside of the Sector association (sharing of information); different registrants use the same input information in their Exposure Assessment; Sector use map format is comparable for different sectors; harmonized list of uses; Benefits for Downstream Users: understandable information; harmonized use descriptors and exposure parameters; simple way of checking if use of substance(s) is covered or not; improvement of dialogue between Manufacturer/Importer and Downstream User associations. The most important benefit for Manufacturers/Importers and Downstream Users is that Sector use maps can be integrated/imported into IT tools such as Chesar. The maps should be generated in Chesar XML format. Q: What is the collaboration between ECHA, Cefic, Concawe and DUCC in creating Sector use maps? A: Industry associations such as Cefic and Concawe (CONservation of Clean Air and Water in Europe) help companies implement Sector use maps in new registration dossiers and update previous registration dossiers.  DUCC supports downstream industry organizations in creating Sector use maps and, in this way, supports registrants in the generation of Exposure Scenarios.  ECHA provides tools and support to industry for good communication and dissemination of knowledge. REFERENCES: REGULATION (EC) No 1907/2006 -Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH): http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006R1907-20150601&from=EN ECHA - Use Maps: https://echa.europa.eu/csr-es-roadmap/use-maps/concept DUCC & Concawe – SCEDs- How to use the SCEDs for chemical exposure assessment under REACH – Guidance for SCEDs user: http://www.ducc.eu/documents/20140424-Guidance%20documents%20on%20SCEDs-Final-V1.pdf ECHA, Cefic & DUCC - Joint statement on Sector use maps: https://echa.europa.eu/documents/10162/13563/Joint+statement+on+use+maps/d76045c3-a4ad-40db-a617-e8c429130071

by June Kang On October 7, 2016, Korea’s Ministry of Environment (MOE) announced a revised draft of Designation of Product(s) of Risk Concerns and Safety and Labeling Standards (위해우려제품 지정 및 안전·표시기준) as Public Announcement No. 2016-0656.  In this revision, MOE designated three types of additional household chemical products, strengthened safety management on the existing products in the regulation and improved the inadequate current regulation. According to the revised draft, the three types of additional products that had not been previously regulated are Ironing auxiliaries in the Detergent product group, Ink cartridges and toners in the Dye product group and Algicides in the Biocidal product group.  Currently, there are a total of 15 types of household chemical products (Cleaners, Synthetic detergents, Bleaching agents, Fabric softeners, Coating agents, Anti-rust additives, Anti-fogging agents, Adhesives, Air fresheners, Deodorizing agents, Colorant/decolorant agents, Tattoo inks, Disinfectants, Insect repellents and Preservatives) which are regulated under the Designation of Product(s) of Risk Concerns and Safety and Labeling Standards as a part of K-REACH (The Act on Registration and Evaluation, Authorization and Restriction of Chemical Substances). To strengthen safety management, Methylisothiazolinone (MIT, CAS No. 2682-20-4) and Methylchloroisothiazolinone (CMIT, CAS No. 26172-55-4) will be prohibited for use in current spray products due to risk concerns for inhalation exposure when being used by consumers.  The permissible limit for Didecyldimethylammonium chloride (DDAC, CAS No. 7173-51-5), when used as a microbial inhibitor in Deodorizing agents, will be lowered to 0.18% for fabric use and 0.0015% for indoor air freshener.  Ethylene glycol (CAS No. 107-21-1), which possibly causes side effects such as respiratory irritation, will be limited to 0.2% or less.  1,4-Dichlorobenzene (CAS No. 106-46-7), known to be carcinogenic, will be prohibited when used in Deodorizing agents and Chloroethylene (CAS No. 75-01-4) will be limited to 0.04% or less when used in Coating agents.  In addition, Limonene (CAS No. 138-86-3) will be restricted to 1% or less when used in Fabric softeners based on the Korean FDA (Ministry of Food and Drug Safety, MFDS) risk assessment result. Labeling standards on the products will also be strictly enforced for public health and consumer’s safety.  When biocidal substance(s) are contained in a product, the signal word “Toxic” has to be included on the label along with the name of the substance, purpose of the substance and the percentage, regardless of the amount contained.  Also, MOE will be banning the use of false or misleading statements on the label such as low-risk, non-toxic (non-poisonous), harmless, environment friendly or other misbranded statements.  For the substances designated as hazardous substances under K-REACH, the name of the substance, purpose of the substance and the percentage have to be included on the label, regardless of its concentration.  For Deodorizing agents containing DDAC for clothes, textile products and shoes, the following statement “Hazardous when inhaled large amount.  Do not spray on human, animal or in the air” has to be included on the label. The public comment period is over on October 28, 2016.  The amended regulation is expected to be finalized in December 2016 and is proposed to enter into force on January 1, 2017.  A three-month grace period will be granted on safety standards and a six-month grace period will be allowed for labeling standards.  This is applicable to the products which have already cleared customs and been released after the official enforcement date has passed. Reference: Revised draft on Designation of Product(s) of Risk Concerns and Safety and Labeling Standards (위해우려제품 지정 및 안전·표시기준) as Public Announcement No. 2016-0656 on October 7, 2016.  http://www.me.go.kr/home/web/index.do?menuId=68 (available only in Korean)

by Karen Knutson The Montreal Protocol on Substances that Deplete the Ozone Layer is a universally ratified Multilateral Environmental Agreement (MEA) that restricts the consumption, production, importation and exportation of ozone-depleting substances to aid in the repair of the ozone layer and mitigate global warming. The 28th Meeting of the Parties to the Montreal Protocol convened on October 14, 2016 in Kigali, Rwanda.  After seven years of discussion, the Parties agreed on an amendment, known as the Kigali Amendment, to mitigate global warming by restricting Hydrofluorocarbons (HFCs). Highlights of the Kigali Amendment include, but are not limited to: 100-Year Global Warming Potential (GWP) values were added to Annex C, Group I. Eight HCFC’s were given GWP values, and the rest are considered to have a value of zero. Annex F, Group I and Group II were added. There are 18 HFCs in Group I and 1 HFC in Group II. Most countries will participate in the reductions of Group I and Group II HFCs by 2019. Each country that ratifies the Kigali amendment can decide on a specific reduction strategy from the newly amended Protocol that shall be implemented through their own rules and regulations.  Because HFCs are often used as refrigerants, some countries with High Ambient Temperatures can postpone their reductions until 2024.  The import and export restrictions will enter into force in 2029. However, it is important to note that countries may begin early enforcement of HFC restrictions on their own. Additional information can be found through the Ozone Secretariat’s website: ozone.unep.org. References: United Nations Environment Programme, Department of Public Information, Countries agree to curb powerful greenhouse gases in the largest climate breakthrough since Paris, 15 October 2016. http://www.unep.org/newscentre/Default.aspx?DocumentID=27086&ArticleID=36283&l=en Further Amendment of the Montreal Protocol, Decision XXVII/1, UN Environment Programme, UN DOC OzL.Pro28/CRP/10 (14 October 2016). Further Amendment of the Montreal Protocol, Decision XXVII/1, UN Environment Programme, UN DOC OzL.Pro28/CRP/11 (14 October 2016).

by Shanice Chia The Health Products (Therapeutic Products) Regulations 2016, under the Health Products Act, come into effect on November 1, 2016.  Health products (previously known as medicinal products or western medicines) originally regulated under the Medicines Act and Poisons Act will all be controlled under the Health Products Act; these products will also be renamed “therapeutic products” (TP).  The Singapore Government published the Health Products (Therapeutic Products) Regulations 2016 under the Health Products Act, on July 15, 2016.  This serves as a part of the Health Sciences Authority (HSA)’s strategy to standardize and streamline the regulatory control of these products. The following summarizes the key changes of the legislative control: "Product Registration:" The term “Product Registration’’ will replace the original term “Product Licence” and the licence holder will be recognized as the “Product Registrant.” The overall product registration process will remain unchanged; however, there will be some administrative changes to the online PRISM application form. These changes include, but are not limited to, updated existing product registration records and amended new drug application form.  For those who wish to import and/or wholesale their own registered TP, an Importer’s Licence (IL) and/or Wholesaler’s Licence (WL) will be required. "Licence Renewal:" Each TP on the register will have a retention fee due date, depending on the registration status. For the products registered under the Medicines Act, the due date will correspond to the expiry date of the licence; whereas the due date for new product registrations will be the anniversary of the TP's registration date.  All registered products will remain on the Register, with the following exceptions: "The registration is suspended or cancelled by HSA," "The registration is cancelled by the registrant," “The registrant has failed to pay for the annual retention fee within 60 calendar days after the due date” "Import for Re-export:" Notification will no longer be required for companies importing consignment for re-exporting purposes. For the existing companies 'with outstanding export clearance,' no export clearance notification will be required after November 1, 2016.  An Importer’s Licence for Restricted Activities will be needed for companies who have not already obtained an IL prior to conducting the import and export activities. "Import and Supply of Unregistered TP for Patients’ Use:" A valid IL and WL as well as an approval for the specific consignment will be needed for "companies importing unregistered TP on behalf of healthcare institutions". However, for healthcare institutions themselves, only consignment approval will be required prior to importation of these products for patients’ use.  For healthcare institutions that intend to inter-transfer stocks imported under “Unregistered TP for Patients’ Use”, no approval will be required from HSA. "Import and Supply of Registered TP on Consignment Basis:" A valid IL and WL, as well as approval for the specific consignment, will be necessary "for companies importing a registered TP on consignment basis for local supply." "Other Importation for Non-clinical Use, and Import for Supply to Vessels and Aircraft:" An Importer’s Licence for Restricted Activities will be required for companies prior to conducting any import activities, if the company does not have an existing IL. The reader should consult the full text of the Act(s) and/or Regulation(s) for complete details. References: For more information, please refer to the Health Sciences Authority (HSA) website and to the Singapore Statutes: HSA - http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/therapeutic-productsportover.html Singapore Statutes - http://statutes.agc.gov.sg/aol/search/display/view.w3p;orderBy=date-rev,loadTime;page=0;query=Id%3Af4a33790-9043-46b3-9105-95faf2c3c238;rec=0).

by Tammy J. Murphy On October 8, 2016, the proposed Environmental Emergency Regulations, 2016 were published in the Canada Gazette, Part I.  These proposed Regulations would "further enhance environmental emergency management in Canada" and would repeal and replace the current Environmental Emergency Regulations. The current Environmental Emergency Regulations (E2 Regulations) entered into force in November 2003 and were amended in December 2011.  These Regulations require that “effective environmental emergency plans are in place....” for “preventing, preparing for, responding to and recovering from an environmental emergency.”  The proposed Regulations would continue to do this as well as "clarify and strengthen existing regulatory requirements". Highlights of the proposed Regulations include, but are not limited to: The addition of 49 substances to the current Schedule; Consolidation of the three parts of Schedule 1 into a single list; Enhanced provisions relating to public notification; Provisions to ensure the "plan is adequate to address emergency situations"; Periodic reporting requirements; Modification of reporting thresholds for three current substances. There is a 60 day, from date of publication, public comment and/or notice of objection period. Readers should consult the full text of the proposed regulations for complete details. The full text can be found in the Canada Gazette, Part I, 8 October 2016 edition:  http://www.gazette.gc.ca/rp-pr/p1/2016/2016-10-08/pdf/g1-15041.pdf Additional information can also be found on Environment and Climate Change Canada’s Environmental Emergencies website:  https://www.ec.gc.ca/ee-ue/default.asp?lang=En&n=8A6C8F31-1

by Tammy J. Murphy On 5 October 2016, the “Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999” was published in the Canada Gazette, Part II.  This Order adds 44 petroleum and refinery gases (PRGs) to CEPA, 1999, Schedule 1, List of Toxic Substances.  The two proposed Orders addressing this were published in February 2014 and were open for a public comment period. The Canadian Environmental Protection Act (CEPA) authorizes the Ministers of Health and of the Environment to conduct research and collect information on a wide variety of substances that may contaminate the environment or cause adverse effects on human health and/or the environment.  If a substance is determined to be ''toxic,'' as per CEPA 1999, Environment & Climate Change Canada and Health Canada are then responsible for implementing preventive and/or control actions for any or all phases of that substance's ''life cycle.''  This is done to prevent or control the substance's release into the environment; the substance(s) are subsequently added to CEPA, 1999, Schedule 1, List of Toxic Substances. Canadian law also requires scientific information on any new chemical substances to be submitted for assessment prior to use of new substances in Canada.  However, many substances were in existence and in use prior to these laws being enacted.  The Chemicals Management Plan (CMP), an ongoing initiative, was formed in 2006 to address these chemicals.  Part of the CMP includes the "Petroleum Sector Stream Approach (PSSA)" which focuses on those substances used predominantly in the petroleum sector. Approximately 160 petroleum related substances were identified as high priority in regards to risk assessment in this sector.  As part of the PSSA, these substances were divided into 5 main "streams"; these "streams" were then divided into groups.  The main groups are based on uses while the further division is based on production similarities as well as physical and chemical properties.  The 44 substances added to the List of Toxic Substances include 40 PRGs ("site-restricted substances") from Stream 1 and 4 substances ("industry-restricted substances") that were part of Stream 2. Additional information, as well as a full list of substances, may be found on the Government of Canada's Chemical Substances website.  The full text of the amendment can be found in the respective issue of the Canada Gazette. Reference: Canada Gazette, Part II, October 5, 2016 edition: http://www.gazette.gc.ca/rp-pr/p2/2016/2016-10-05/pdf/g2-15020.pdf

by Tammy J. Murphy Pursuant to subsection 93(1) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Prohibition of Certain Toxic Substances Regulations, 2012 was established to 'prohibit the manufacture, use, sale, offer for sale and import of certain toxic substances listed in Schedules 1 and 2.'  The Minister of Health and the Minister of Environment & Climate Change oversee this Regulation.  "Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012" were published in the October 5, 2016 edition of the Canada Gazette, Part II.  Previously, the proposed amendments to this regulation were published in the April 4, 2015 edition of the Canada Gazette, Part I and were open to a public comment period and notice of objection filing period. Highlights of the amendments include, but are not limited to: The addition of Hexabromocyclododecane (HBCD) to Schedule 1; The addition of Polybrominated diphenyl ethers (PBDEs) to Schedule 1 and the subsequent repeal of the Polybrominated Diphenyl Ethers Regulations; A replacement of Schedule 2, Parts 1 and 2, with updated tables/parts, including, but not limited to: The addition of Perfluorooctanoic acid, its salts and its precursors (PFOAs); The addition of Long-chain Perfluorocarboxylic acids, their salts and precursors (LC-PFCAs); The addition of Perfluorooctane sulfonate (PFOS) and the subsequent repeal of the Perfluorooctane Sulfonate and its Salts and Certain Other Compounds Regulations Schedule 1 lists those toxic substances that are subject to total prohibition and Schedule 2 lists those toxic substances that are subject to total prohibition, but based on concentration and/or usage, may have designated permitted uses. These may also have annual reporting requirements and certain recordkeeping requirements.  Additionally, the amendments include phase-in periods for certain substances as well as exemptions. There are various coming into force dates as well as transitional provisions. The full text of the amendments should be consulted for complete details.  Additional information can also be found on Environment & Climate Change Canada’s CEPA Registry website. Reference: Canada Gazette, Part I, October 5, 2016 edition: http://www.gazette.gc.ca/rp-pr/p2/2016/2016-10-05/pdf/g2-15020.pdf

by Nathan Kongprachaya On February 19, B.E. 2558 (2015), the Notification of the Ministry of Industry Re: Notifications of Manufacturers and Importers of Hazardous Substances in Annex 5.6 was published in the Royal Government Gazette.  This notification requires manufacturers and importers of hazardous substances or mixtures found in Annex 5.6 of List of Hazardous Substances, whose volumes exceed 1000 kilograms per annum, to notify the Department of Industrial Works (DIW) within 60 days from the date of manufacturing or import. Notification can be done using form Wor Or/ Or Kor 20 (วอ./อก. ๒๐) or via the DIW’s webpage via: http://haz3.diw.go.th/hazvk/ These chemicals will be incorporated into the Thai Inventory and will not be considered as “new” when the final version of the Thai Inventory is published.  ChemADVISOR strongly urges manufacturers and importers who meet the above criteria to notify the DIW of their activities by December 31, 2016, as it is expected that new substances will be subjected to more stringent requirements relative to their counterparts present in Thailand’s Chemical Inventory. References: Notification of the Ministry of Industry Re: List of Hazardous Substances (No. 2) B.E. 2558 (in Thai): http://www.ratchakitcha.soc.go.th/DATA/PDF/2558/E/041/12.PDF Notification of the Ministry of Industry Re: Notifications of Manufacturers and Importers of Hazardous Substances in Annex 5.6 (in Thai):  http://www.ratchakitcha.soc.go.th/DATA/PDF/2558/E/041/15.PDF 

by June Kang The KCMA (Korea Chemicals Management Association) annual seminar 2016 hosted by KCMA and sponsored by the Ministry of Environment (MOE) took place on September 22 and 23, 2016 in Jeju, Korea.  K-REACH (officially named as the Act on the Registration and Evaluation of Chemical Substances) and related issues were covered on the first day and on the second day, the Chemicals Control Act (CCA) and the requirements to comply with its law and regulations were presented. On the first day of the KCMA seminar, the following topics were discussed:  the direction for the chemicals management policy and major ongoing issues, biocides management status and comparisons, current chemical registration status and low volume registration, joint registration and risk assessment report preparation guidelines.  Biocides are currently regulated under K-REACH.  However, it is being considered to be enacted as a separate law to regulate biocides more safely and efficiently.  The primary motivation for this is the numerous deaths and ongoing respiratory injuries associated with the use of a humidifier disinfectant. MOE implemented an authorization system to regulate certain hazardous chemical substances which is similar to the European Union (EU) REACH designated substances subject to Authorization.  The list has not yet been published, but MOE is reviewing the candidate substances and planning to announce the official list once the relevant regulation is finalized. Ms. Ahn, Jung-min from the National Institute Environmental Research (NIER) reviewed the details of the current status of chemical registrations and low volume registrations.  As of the end of August 2016, 4397 registrations have been accepted.  The majority (4237) were low volume registration (less than 1 ton/year).  Toxicity assessments have been completed for 40% of the registered substances and, as a result, 26 substances were notified as toxic chemical substances this year. On the second day, the major reporting system, strengthening surveillance, the items to be reviewed for facility inspections and the inspection results of existing facilities were covered.  Mr. Park, Joon-young of MOE went over the detailed cases that were caught with violations and also presented good examples to run chemical facilities. The KCMA seminar 2016 was held successfully with over 250 attendees from Korea’s chemical industry and multinational corporations, as well as ChemADVISOR.