Top International News in Chemical Policy and Regulation: October 25, 2018: OECD, Asia, Americas and Middle East
Technical Regulation On Degradable Plastics Products Released: The Kingdom of Bahrain’s Standards and Metrology Directorate has issued its “Technical Regulation on Degradable Plastics Products.” The Ministry of Industry, Commerce and Tourism, along with the Supreme Council for Environment, have collaborated to establish a National Technical Regulation (TR) to phase out the import, sale, or distribution of non-degradable plastic products. The proposed TR sets out the requirements with respect to specifications, licenses, labeling, and other requirements for such products. Specifically, the TR focuses on ethylene and polypropylene polymers for the conveyance or packing of goods not designed for prolonged use. Interestingly, this also includes degradable, biodegradable, and oxo-degradable single-use plastic products. The final date for comments is November 3, 2018.
Draft Regulation Of “Brazilian RoHS” Under Development: A working group comprised of representatives of federal government bodies, civil society entities, and industry, established by the Comitê Nacional Sobre Segurança Química (National Chemicals Safety Commission; CONASQ), has presented an internal draft of the regulation governing the use of hazardous substances used in electrical and electronic equipment (EEE). The draft is based on Directive 2011/65/EU, the “Restrictions on the use of Certain Hazardous Substances,” and as such is colloquially known as “Brazilian RoHS,” the work product of CONASQ’s “Brazilian RoHS Working Group.”
The draft sets forth proposed restrictions on the use of lead, cadmium, mercury, hexavalent chromium, binefil polybromate (PBB), diphenyl polybromate ether (PBDE), and four types of phthalates. No date is set at present for either publication of the draft or for a vote on the legislation.
Industrial Chemicals Regulation Development Continues: The draft Brazilian Regulamento Químico Industrial (Industrial Chemicals Regulation; Regulamento), the bill expected to serve as a national chemical substance inventory and notification process in the country, continues to wind its way through the legislative process. The final text of the Regulamento was agreed upon during the most recent meeting of CONASQ on September 4 and 5, 2018.
After the meeting, the Ministry of Environment announced it intends to send the final text to the Ministro-Chefe da Casa Civil da Presidência da República’s (Minister Chief of Staff of the Presidency of the Republic; Ministro-Chefe) office by the end of this year. The Ministro-Chefe is the second-highest ranking member of the Executive Office of Brazil, and a senior aide to the President.
The Regulamento is presently undergoing a judicial review of the text. Once completed, it is expected to receive signatures from the relevant Ministries (Environment, Health, Labor and Industry) before being sent to the Ministro-Chefe. The Ministro-Chefe will analyze the text again and, once it is validated, will send it to the Congress. Then the legislative voting process will start. We expect the text will be sent to the Congress early in 2019, when the new government will be in place.
IBAMA Releases Draft Revision To Agrochemicals Law: The Comitê Técnico de Assessoramento para Agrotóxicos (Technical Advisory Committee for Agrichemicals, CTA), a group comprised of the Ministries of Health, Agriculture, Livestock and Supply, and the Environment have proposed a revision to the Agrochemicals Law (Law No. 7.802/1989). Issued on behalf of the Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis (Brazilian Institute of Environment and Renewable Natural Resources, IBAMA), the CTA has noted an imbalance between the sheer number of registration requirements and the ability of the responsible agencies to evaluate submissions in a timely manner. Key among the proposed revisions is the setting of criteria for the technical evaluation of “priority products,” where having a more efficient review process would not harm the environment or public health.
Audit Reviews Canada’s Enforcement Of CEPA Regulations To Control Toxic Substances: On October 2, 2018, the Commissioner of the Environment and Sustainable Development tabled its audit of whether Environment and Climate Change Canada (ECCC) enforced regulations under the Canadian Environmental Protection Act, 1999 (CEPA) to control the risks of toxic substances. The audit included an examination of six substances -- lead, mercury, polychlorinated biphenyls, dioxins and furans, dichloromethane, and polybrominated diphenyl ethers -- to determine whether ECCC and Health Canada (HC) had evaluated their progress in meeting objectives for reducing risks to the environment and human health. The audit also examined whether ECCC and HC communicated the risks of toxic substances to the public. Overall, the audit found that ECCC and HC still had significant work to do in selected areas to control effectively the risks of toxic substances and to inform Canadians about those risks. According to the audit, ECCC has improvements to make in some aspects of its approach to enforcing toxic substance regulations under CEPA. ECCC conducted inspections and other enforcement activities to ensure that businesses complied with regulations on toxic substances, but in most cases, the audit states, it did not base its enforcement priorities on risks to human health and the environment. In addition, the audit notes that ECCC has not fully addressed selected recommendations from previous audits. ECCC lacked timely access to information about which businesses were regulated, had not yet set time frames to follow up on violations, and had not addressed all of the enforceability issues it had identified in regulations.
Canada Proposes To Amend Regulations Prohibiting Certain Toxic Substances: Canada published a notice in the October 13, 2018, Canada Gazette announcing its intent to amend the Prohibition of Certain Toxic Substances Regulations, 2012. The Department of the Environment and the Department of Health are initiating the development of amendments to the Regulations to restrict further the manufacture, use, sale, offer for sale, and import of two flame retardants (hexabromocyclododecane (HBCD) and PBDEs) and three oil and water repellents (perfluorooctane sulfonate (PFOS) and its salts and precursors, perfluorooctanoic acid (PFOA) and its salts and precursors, and long-chain perfluorocarboxylic acids and their salts and precursors (LC-PFCAs)). The notice states that if the final screening assessment reports for two additional flame retardants, dechlorane plus (DP) and decabromodiphenyl ethane (DBDPE), conclude that they are toxic under CEPA Section 64, notice is also given that the Departments will initiate the development of amendments to the Regulations to prohibit their manufacture, use, sale, offer for sale, and import. Comments on the notice of intent to amend the Prohibition of Certain Toxic Substances Regulations, 2012 are due November 12, 2018. According to the notice, a consultation document outlining the proposed regulatory approach to amending the Regulations will be published for public comment in fall 2018. Interested parties will also have an opportunity to make written comments on proposed amendments to the Prohibition of Certain Toxic Substances Regulations, 2012 during the mandatory consultation period that will follow their publication in the Canada Gazette, Part I, in winter 2019-2020.
NGOs Urge Introduction Of CEPA Amendments In Fall 2018 Session Of Congress: A number of non-governmental organizations (NGO) sent the Minister of Environment and Climate Change and Minister of Health draft legislation to amend CEPA to protect better human health and the environment from toxic substances. As reported in Acta’s August 2, 2018, Global Regulatory Update, on June 29, 2018, the Ministers submitted the Follow-Up Report to the House of Commons Standing Committee on Environment and Sustainable Development on the Canadian Environmental Protection Act, 1999. The Follow-Up Report describes the many areas where the government is committed to taking further action in the near-term. To address recommendations that require legislative reform, the ECCC stated that it would conduct a thorough review and consult widely with Canadians as it works toward updating the Chemicals Management Plan (CMP) and overhauling CEPA through amendments in a future Parliament. The NGOs state that CEPA has not been amended in 20 years and urge that the legislation be introduced in the fall 2018 session of Parliament. According to the October 16, 2018, Canadian Environmental Law Association (CELA) press release, the amendments presented to the Ministers address five areas of concern: (1) control over endocrine disrupting substances; (2) establishment of enforceable national ambient air quality standards; (3) protection of vulnerable populations from toxic substances; (4) substitution of safer alternatives to toxic substances; and (5) civil enforcement of CEPA by the public in the courts.
Canada Takes Measures To Ban Asbestos And Asbestos-Containing Products: Canada issued an October 18, 2018, press release announcing the Prohibition of Asbestos and Products Containing Asbestos Regulations “final step to prohibit asbestos and asbestos-containing products in Canada.” The Regulations prohibit the import, sale, and use of asbestos, as well as the manufacture, import, sale, and use of asbestos-containing products, with a limited number of exclusions. In addition, exports of asbestos and asbestos-containing products are now prohibited, with a limited number of exceptions, and the existing Export of Substances on the Export Control List Regulations and CEPA Schedule 3 were amended to reflect that. The new Regulations and related amendments will come into force on December 30, 2018.
Israel Continues Development of GHS Legislation: Israel has submitted two drafts of legislation that would implement the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) in the country to the World Trade Organization (WTO). The two drafts encompass aspects relating to substances and mixtures, and to transportation.
“SI 2302 Part 1 – Dangerous Substances and Mixtures: Classification, Labelling, Marking and Packaging” replaces the December 3, 2013, draft that was predominantly based on EU Regulation 1272/2008, colloquially known as CLP. There is, however, some uncertainty about the GHS version Part 1 is based upon; for example, Part 1 identifies “flammable aerosols” and not “aerosols” as an endpoint, which would appear to make it based on the Third Revision. Additionally, hazard classifications H229, H230, and H231, which were first introduced in the Fourth Revision, are included in Part 1. “SI 2302 Part 2 – Transportation: Classification, Labelling, Marking and Packaging” remains largely unchanged. At present, there is no official timeline for when the revised SI 2302 Part 1 standard will be issued in final.
Comments will be accepted until October 28, 2018. A three-year transition period is expected. During that time, compliance with either the existing SI 2302 Part 1 standard (promulgated in 2009) or the revised version of SI 2302 Part 1 will be permitted. At present, there is no official timeline for when the revised SI 2302 Part 1 standard will be issued in final.
Mexico’s GHS Regulation Enters Into Force: Mexico’s GHS regulation, NOM-018-STPS-2015, “The Harmonized Identification and Hazard Communication and Risk System of Workplace Hazardous Chemicals,” officially entered into force on October 9, 2018. NOM-018-STPS-2015 repeals the previous official Safety Data Sheet (SDS) standard NOM-018-STPS-2000 and addresses both substances and mixtures.
The Norma Oficial Mexicana (Official Mexican Standard; NOM) and its component requirements were detailed in Acta’s October 2016 webinar “Current Opportunities and Challenges with Chemical Substance Regulation in Mexico and Central and South America,” as well as in our January 2018 “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018.”
Six New NOMs Relating To Chemical Substances And Worker/Workplace Safety To Be Published: The Mexican Secretaría del Trabajo y Previsión Social (Secretariat of Labor and Social Welfare; Secretariat) has announced the pending issuance of six new NOMs. These six NOMs are expected to be issued as final in November, before the new President takes office.
The new standards to be issued are:
NOM-005-STPS-2017, Handling of hazardous chemical substances or their mixtures in the workplace -- Conditions and health and safety procedures;
NOM-014-1-STPS-2017, Diving, health and safety conditions. Occupational exposure to pressures different from absolute atmosphere;
NOM-006-STPS-2017, Storage and handling of materials through the use of machinery -- Occupational Safety conditions;
NOM-017-STPS-2017, Personal protective equipment -- Selection, use and handling in the workplace;
NOM-036-1-STPS-2017, Occupational ergonomic risk factors -- identification, analysis, prevention and control. Part 1 -- Manual loading; and
NOM-035-STPS-2017, Occupational psychosocial risk factors -- Identification, analysis and prevention.
Several Middle East Countries Implement Requirements For Cosmetics And Personal Care Products: The countries of Bahrain, Oman, Saudi Arabia, and the United Arab Emirates (UAE) have each announced that they plan to incorporate the Gulf Cooperation Council’s draft regulation (Regulation) for cosmetic products -- “Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products” -- into their respective national laws. This Regulation addresses the general safety requirements and parameters, as well as labeling and packaging requirements, for all cosmetics and personal care products. An illustrative list of such products is provided in Annex 1 of the Regulation.
The Regulation specifies six functions, or purposes, of use for cosmetic and personal care products, namely: to clean, to perfume, to change the appearance, to protect, to keep in good condition, and to correct body odors. The fields of application are to one or more of the following: the epidermis, hair, nails, lips, teeth, the mucous membranes of the oral cavity, and the external genital organs.
ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)
OECD Publishes Working Paper On Economic Valuation Of Benefits Of Regulating Chemicals: OECD published on October 22, 2018, an OECD Environment Working Paper entitled Assessing the economic valuation of the benefits of regulating chemicals: Lessons learned from life case studies. The Working Paper reviews and compares five case studies on quantification and economic valuation of benefits in cost-benefit analyses of regulating phthalates, mercury, PFOA and its salts, 1-methyl-2-pyrroloidine (NMP), and formaldehyde. The case studies were carried out as part of the Socio-economic Analysis of Chemicals by Allowing a better quantification and monetization of Morbidity and Environmental impacts (SACAME) Project, and the purpose of the Working Paper is to draw out cross-cutting findings from these studies. According to the Working Paper, the case studies show that there are major challenges in estimating the benefits of regulating chemicals. There are very few detailed applications of the full impact-pathway or damage-function approach, “even for mercury, which is the chemical with most available assessments among those covered here.” The Working Paper states that the case studies document that the values used for morbidity impacts are often incomplete, in most cases covering only lost productivity, lost earnings, or cost-of-illness, but mostly disregarding the disutility costs of pain and suffering from the illnesses. Finally, benefits transfer estimates are simplistically applied. The Working Paper highlights a need for: (1) identification of the potentially most important health and environmental impacts in term of aggregate economic benefits; (2) quantification of the consequences of these potentially most important impacts; (3) new economic valuation studies of these impacts, designed for benefit transfer and use in cost-benefit analyses; and (4) updated and improved guidance for benefit transfer and treatment of uncertainty in cost-benefit analyses of chemicals regulation.
Public Consultation Begins On CMR Substances To Be Registered Under K-REACH By 2021: South Korea notified WTO on October 16, 2018, of a proposed list of existing chemical substances that cause or may cause harm to humans and animals due to their CMR properties that should be registered under the Act for the Registration and Evaluation of Chemicals (K-REACH) by December 31, 2021. Persons who intend to manufacture or import a listed substance in an amount over one ton per year would be required to register the substance by December 31, 2021. The proposed date of adoption is January 1, 2019, and the proposed date of entry into force is also January 1, 2019. While the notice is in Korean, the chemical names are in English and Chemical Abstracts Service (CAS) numbers are provided. Comments to WTO are due November 5, 2018.
Designation Of K-REACH Priority Substances Available For Comment: On October 16, 2018, South Korea notified WTO of a notice that would designate chemical substances that have any of the following hazards as priority substances under K-REACH: (a) chemical substances that cause or may cause any harm to humans or animals due to their CMR properties; (b) chemical substances that cause or may cause endocrine disorders; (c) chemical substances that are highly bio-accumulative in humans or animals, and long-persistent in the environment; (d) chemical substances that may cause harm to human organs such as the lung, liver, and kidney through exposure; or (e) chemical substances that may cause harm equivalent to the abovementioned or may cause more severe damage. According to the WTO notification, the proposed date of adoption is January 1, 2019, and the proposed date of entry into force is also January 1, 2019. While the notice is in Korean, the chemical names are in English and CAS numbers are provided. Comments to WTO are due November 5, 2018.
Updated Draft National Chemical Inventory Available For Comment: On September 15, 2018, Vietnam issued a notice announcing the availability of an updated draft National Chemical Inventory. The draft Inventory currently includes 31,745 substances, a significant increase from the 4,927 substances included on Vietnam’s March 2017 draft Inventory. Comments on the draft National Chemical Inventory were due October 15, 2018.