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Top International News in Chemical Policy and Regulation: August 2,2018 - Americas, Asia and OECD


Restriction Of Hazardous Substances Law Moves Forward: The Brazilian Ministerio de Medio Ambiente (Ministry of Environment; MMA) has announced that the data received as part of its request for information from manufacturers and importers of electronic equipment will be considered in the development of the Authority’s late-2018 Restriction of Hazardous Substances (RoHS) regulation.

Brazilian Congress Takes Multiple Plastics Legislation: A pair of bills has been brought forward in the Brazilian Congress to regulate single-use plastics for consumer use. A bill in the lower house, the Câmara dos Deputados (Chamber of Deputies), Draft Law No. 10346/2018, “Cria regra para redução progressiva da utilização de plástico como matéria-prima de produtos de uso único” (“Creates rule for progressive reduction of the use of plastic as a raw material for single use products”), would develop a program to guide Brazil away from using plastic as the main raw material for single-use products, and to more sustainable and/or more environmentally-friendly ones.

A second bill in the Câmara dos Deputados, Draft Law No. 10409/2018, “Determina a progressiva redução e eliminação da produção, comercialização e importação de produtos plásticos descartáveis para uso único e outras medidas” (“Determines the progressive reduction and elimination of the production, commercialization and importation of disposable plastic products for single use and other measures”), would set forth requirements for progressively reducing, with the ultimate goal of elimination, the production, import, and sale of single-use plastics.


Canada Commits To Reforming CEPA: On June 29, 2018, the Minister of Environment and Climate Change and the Minister of Health 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. In its June 29, 2018, press release, Environment and Climate Change Canada (ECCC) states that the government is taking action to implement many of the Committee’s recommendations:

  • It is working to enhance how it protects vulnerable populations, including by developing a policy framework for considering vulnerable populations -- such as children, pregnant women, and the elderly -- in the assessment and management of chemicals;

  • It is taking action to protect Canadians from chemicals of high concern, such as endocrine disruptors, which can affect how hormones work and lead to long-term health issues; and

  • It is updating standards and developing new instruments to improve air quality and reduce air pollution from industrial sources, including oil refineries.

To address recommendations that require legislative reform, the press release states that ECCC will conduct a thorough review and consult widely with Canadians as it works toward updating Canada’s Chemicals Management Plan (CMP) and overhauling the Canadian Environmental Protection Act, 1999 (CEPA) through amendments in a future Parliament.


Chile Also Seeks To Regulate Single-Use Plastics: Similar to the Draft Laws pending in Brazil reported above, on June 12, 2018, the lower house of the Chilean Congress, the Cámara de Diputados (Chamber of Deputies), put forth Bill No. 11802-12 (the Bill). The “Prohíbe el uso de envases y embalajes plásticos en la comercialización de productos destinados al consumidor final” (“Prohibits the use of plastic containers and packaging in the marketing of products intended for the final consumer”) would set out a schedule to remove plastics from containers and related packaging designed for the end-use consumer. Per Section 1 of the Bill, it is designed as a corollary to Bulletin No. 9133-12, “Prohíbe la entrega de bolsas plásticas de comercio en todo el territorio nacional” (“Prohibits the delivery of plastic bags of commerce throughout the national territory”), that laid the groundwork for ending the use of plastic bags in the country. Interestingly, in the same section, the Congress notes it derives its authority for both the Bill and the Bulletin from Article 19, No. 8 of the Chilean Constitution. Specifically, “[t]he right to live in a pollution-free environment. It is the duty of the State to ensure that this right is not affected and to protect the preservation of nature[.] The law may establish specific restrictions on the exercise of certain rights or freedoms to protect the environment.”


Costa Rican Authority Decree Speaks To Pesticide Product Fees: The Costa Rican Ministerio de Salud (Ministry of Health) has recently promulgated Decree No. 41117-S, “Reglamento para la recopilación de procedimientos de registro y control de plaguicidas para uso doméstico y profesional” (“Regulation for the collection of procedures for registration and control of pesticides for domestic and professional use”). Per Article 1, the Decree “is to regulate the collection [of various fees] to be made by the Ministry of Health for the services it provides related to registration, renewal of the registry, subsequent changes to registration, control and monitoring of pesticide products for domestic and professional use…” Chapter II specifically enumerates the fees “for registration and control services of household pesticides or for professional use” in tabular format.


Mexican Authority Issues Official Standard Regulating Chemical, Pharmaceutical, Biological And Food Products For Animal Use Or Consumption: On July 14, 2018, the Mexican Ministerio de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food; SAGARPA) put forth its “Proyecto de Modificación a la Norma Oficial Mexicana NOM-012-ZOO-1993, Especificaciones para la regulación de productos químicos, farmacéuticos, biológicos y alimenticios para uso en animales o consumo por estos” (“Draft amendment to Mexican Official Standard NOM-012-ZOO-1993, Specifications for the regulation of chemical, pharmaceutical, biological and food products for animal use or consumption”).

The Draft Amendment establishes specifications relating to the production, storage, distribution, commercialization, quality control, and verification of products for the use or consumption of livestock. The manifest purpose is to ensure the efficacy and safety of the veterinary biologics and feedstuffs registered with SAGARPA, by more closely regulating the control of the production process and the raw materials. Further, the Draft Amendment specifies that the information provided in the labeling of all chemical, pharmaceutical, biological, and food products must provide a guarantee as to their effectiveness and safety. The NOM is applicable to establishments engaged in the production, import, export, conditioning, storage, distribution, and marketing of products for animal use or consumption.

The Draft Amendment will be available for comment 60 days following its publication in the Diario Oficial de la Federación.


OECD Invites QSAR Toolbox Users To Participate In Survey: In June 2018, OECD invited (QSAR) Toolbox users to participate in a survey. According to OECD, to understand the breadth of current usage of the QSAR Toolbox and its main applications, the survey focuses on the extent of the QSAR Toolbox usage and the collection of case studies (examples) of QSAR Toolbox application in a regulatory context. The survey consists of two sets of questions:

  1. Case studies (examples) of the QSAR Toolbox application in a regulatory context; and

  2. General questions regarding use of the QSAR Toolbox.

OECD states that the collected case studies should illustrate the following elements: ensuring protection for human health and the environment; the use and promotion of alternative methods; and enhancing competitiveness and innovation. OECD will use the results of the survey to improve the functionality and service of the QSAR Toolbox, as well as to promote the usage of the QSAR Toolbox in the regulatory context. Responses are due September 15, 2018.


Peru Considers Polymer Reduction Regulation: The Peruvian Congress is considering Bill No. 02976/2017-CR that would outline progressive and voluntary provisions for reduction of single-use polymers and their derivatives. The Bill is entitled “Ley De Reducción Progresiva Y Voluntaria Del Uso De Polímeros De Un Solo Uso Y Sus Derivados” (“Law Of Progressive And Voluntary Reduction Of The Use Of Single-Use Polymers And Their Derivatives”).


U.S. Responds To WTO TBT Notification Of Revised K-REACH Enforcement Decree And Rules: The U.S. World Trade Organization (WTO) delegation circulated a June 20, 2018, statement regarding South Korea’s June 11, 2018, Technical Barriers to Trade (TBT) notification of the revised Act for the Registration and Evaluation of Chemicals (K-REACH) enforcement decree and rules. The U.S. asks that the January 1, 2019, implementation date be delayed to allow companies adequate time to prepare. The U.S. “strongly encourage[s]” the issuance of English translations and comprehensive guidance in English for all industry stakeholders. According to the U.S., while South Korea has stated that companies can apply to the Ministry of the Environment (MOE) for confidential treatment of some information, U.S. industry reports that MOE is denying most confidential business information (CBI) claims. The U.S. is also concerned about MOE’s recent proposal for amendments to the Chemical Control Act and Presidential decrees to introduce a mandatory tracking and reporting system for chemicals from import to manufacturing and end-use. The proposed amendments “would impose a heavy new burden, particularly on non-Korean firms, as well impose inappropriate CBI disclosure requirements.” The U.S. delegation also notes MOE’s draft K-REACH implementation rules that, among other things, require companies by June 30, 2019, to “pre-report” the substances they manufacture or import, or face being banned from the market. The U.S. delegation “ask[s] you to notify this announcement, take industry comments into consideration, issue the guidance in English, and consider a longer implementation period.”

© 2018 The Acta Group All Rights ReservedNational Law Review, Volume VIII, Number 214

About this Author

The Acta Group (Acta®) is the consulting affiliate of Bergeson & Campbell, P.C. (B&C®), established to complement B&C’s legal services by providing a full-range of support for the process of marketing chemicals, biocides, and products of industrial biotechnology, nanotechnology, and synthetic biology. Acta knows that clients must function optimally in all jurisdictions in which they market and/or place products to remain competitive. We help them get there through our global reach....