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Global Chemical Product Innovation and Development: Asia, Americas, Australia


Institutional Coordination On Chemicals and Waste Management Under Development: The Argentinian Dirección de Sustancias y Productos Químicos (Directorate of Substances and Chemical Products; Directorate), a new Directorate created in 2018 with funding from the United Nations (UN) Environment’s Special Programme on Institutional Strengthening for Chemicals and Waste Management, has begun to settle more fully into its mandate of ensuring adequate personnel and infrastructure to implement various international conventions to which the country is a party.

The Directorate falls administratively under the Dirección de Productos Químicos y Residuos, (Directorate of Chemicals and Waste), a department that has been tasked with promoting cooperation and coordination among the relevant stakeholders, developing training plans, evaluating the country’s degree of compliance with the conventions, and designing strategies to effectively manage emerging regulatory actions and challenges. The establishment of the Directorate consolidates Argentina’s capacity to manage chemicals and wastes in a manner that is both efficient and cost-effective. The Directorate has identified the following challenges relating to chemical substance management in the country: limited access to information related to chemicals production, a lack of motivation for various types of stakeholders to participate in national and international goals, and a relatively “weak image” of chemicals in both the public agenda and the general public interest. The Directorate plans to release its work agenda for 2019 shortly.


Legislation To Implement NICNAS Reforms Awaiting Debate In Senate, Reforms Postponed To 2020: According to the December 18, 2018, National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Stakeholder Update, the legislation is awaiting debate in the Senate in 2019. On January 14, 2019, NICNAS announced that the government has considered options to address issues associated with the revised timeline. To assist regulated entities to prepare adequately for implementation of the Australian Industrial Chemicals Introduction Scheme (AICIS), it has decided to postpone commencement of the scheme to July 1, 2020. Government amendments to change the commencement date will be moved at the time of debate in the Senate.


Brazil Drafts Cosmetics Labeling Resolution: On November 23, 2018, the Agencia Nacional de Vigilancia Sanitaria (National Sanitary Surveillance Agency (ANVISA)) issued Resolution RDC 250/2018 (RDC 250), which set forth the requirements for labeling related to hygiene products, cosmetics, and perfumes. The main impetus for RDC 250 was to enhance the nimbleness of the cosmetics sector in Brazil and to reduce the cost of labeling processes within organizations. Prior to the passage of RDC 250, organizations were required to submit every label change for cosmetic products (including those that did not impact the efficacy of the product, such as promotional language or colors) to ANVISA for review. Additionally, ANVISA did not allow for multiple (different) labels for the same product to coexist. RDC 250 allows manufacturers of cosmetics and personal care products to more effectively manage different labeling variations for the same base product. Moving forward, only changes related to safety and addressing the benefits of products will require the submission of labeling to ANVISA.

Brazil Continues To Move Forward on Industrial Chemicals Law: The Brazilian Ministerio de Medio Ambiente (Ministry of Environment) has published a draft bill to establish a general regulatory scheme for chemical substances. The bill, “Sobre el Inventario, Evaluación y Control de Sustancias Químicas (On the Inventory, Evaluation, and Control of Chemical Substances”) is the revision of the initial draft from June 2016, the Regulación de Productos Químicos Industrials (Industrial Chemicals Regulation), and includes many of the comments and related items presented by industry, trade associations, and the public.


Canada Publishes Updates To Two-Year Rolling Work Plans (2018-2020): On December 14, 2018, Canada published updates to the two-year rolling work plans (2018-2020):

Canada Publishes Results Of 2017-2018 CMP Prioritization Exercise: On January 14, 2018, Canada announced the availability of the results of the 2017-2018 CMP prioritization exercise results. The Identification of Risk Assessment Priorities: Results of the 2017-2018 Review and its supporting document describe how the approach was applied to identify chemicals and polymers, beyond those identified through the Domestic Substances List (DSL) categorization, as risk assessment priorities under CEPA. Canada primarily focused on identifying new information that would constitute indicators of hazard and/or exposure for the following types of substances:

  • Substances on the DSL that have not been assessed within the last five years, and are not scheduled to be assessed under the CMP;
  • Previously assessed substances that were not found to meet the criteria under CEPA Section 64, depending on the time elapsed since data/information on the substance was last reviewed;
  • Substances that were nominated by CMP Program staff as being of potential concern based on knowledge acquired through research and/or expertise gained from previous assessments; and
  • Substances identified as potentially requiring review pursuant to CEPA Section 75.

After searching the pertinent sources of information, the process identified approximately 8,400 substances that fit the scope of the review and had at least one new piece of information representing potential indicators requiring further consideration. The analysis identified substances that are:

  • Unlikely to require further work based on information available (approximately 7,100 chemical substances);
  • New candidates for risk assessment (one chemical substance, 1-H-benzotriazole);
  • Likely to require further data gathering (58 chemical substances);
  • Likely to require further scoping/problem formulation (1,094 chemical substances); or
  • Subjects of ongoing international activities (77 chemical substances).

Canada Begins Consultation On Informed Substitution: Canada announced on January 16, 2019, a public consultation seeking comments for advancing informed substitution in Canada. Health Canada and Environment and Climate Change Canada are exploring ways to support informed substitution and drive Canadian innovation and the adoption of safer chemistry. Canada states that informed substitution “is the considered transition from a chemical of concern to safer chemicals or non-chemical alternatives, and is an internationally recognized strategy for reducing health and environmental risks posed by chemicals.” Canada commissioned the Lowell Center for Sustainable Production to conduct a study to identify potential ways for Canada to advance informed substitution in a future iteration of the CMP after 2020. The purpose of the consultation is to solicit feedback on the proposed elements and activities outlined in the study. The key questions for discussion include:

  • Who are the partners that have a role to play in considering informed substitution, and what role should each of them play;
  • Are there considerations or is there information missing from the study; and
  • Are there potential costs, benefits, or impacts of informed substitution on the health of Canadians, the environment, companies, or others.

Canada will consider this feedback when planning the next phase of chemicals management in Canada. Comments are due March 18, 2019.

Canada Announces Healthy Home Social Marketing Campaign: On January 18, 2019, Canada announced the launch of the Healthy Home social marketing campaign, a “key CMP public outreach initiative led by Health Canada.” The objective of Healthy Home is to raise awareness among Canadians about the health risks from chemicals and pollutants that might be in and around their home and to encourage them to take measures to make their home and families safer and healthier. Topics include:


Chamber of Deputies Proposes Update To Fertilizer Legislation: The lower house of the Chilean Congress, the Cámara de Diputados (Chamber of Deputies), has proposed Bulletin 12233 (Bulletin), which amends the requirements relating to the importation of fertilizers. This Bulletin updates Resolution 1035/10 of the Servicio Agrícola y Ganadero (Agriculture and Livestock Service (SAG)), enacted February 18, 2011. The Bulletin contains two key parts: in addition to setting out a series of specific definitions such as “biofertilizers,” “composition,” “label,” “amendment,” “manufacturer,” “fertilizer,” “quality parameters,” “traceability,” and “user,” among others, the Bulletin obligates those who produce, manufacture, formulate, market, pack, import, or export fertilizers that are used for non-agricultural purposes to register them in the Registro Único Nacional (National Single Registry). Such registration must be completed within 30 days.

The Bulletin also introduces quality parameters that must be followed by the aforementioned categories of entities, as well as the composition (to hundredths of a percent) of nutrients and “accompanying elements” in the product formulation. SAG is additionally empowered to set out the processes and procedures for sampling and analysis of fertilizers subject to its jurisdiction.


China Publishes Chemical Environmental Risk Assessment And Control Regulation To Update MEP Order No. 7 For Public Comment:After over a year of review and revision, on January 8, 2019, the Chinese Ministry of Ecology and Environment (MEE) published the “Chemical Environmental Risk Assessment and Control Regulation (Draft)” (Regulation) for public comment. The draft Regulation would update the “Environmental Management of New Chemical Substances” (MEP Order No. 7). The draft Regulation includes risk assessment and management of new and existing chemical substances; the key provisions include:

  • Scope: The scope of the Regulation is expanded from new chemical substances to all chemical substances, including both existing and new chemical substances;
  • Inventory and Lists: Risk assessment and control of chemical substances are managed under the lists based on priority and risk;
  • Registration of New Chemical Substances; and
  • Risk Assessment and Reporting of Chemical Substances.

The deadline to submit comments to MEE regarding the Regulation is February 20, 2019. Comments should be submitted to MEE via e-mail ([email protected]). More information is available in Acta’s January 16, 2019, memorandum, “China Publishes Chemical Environmental Risk Assessment and Control Regulation to Update MEP Order No. 7 for Public Comment.”


Mexico Promulgates New Regulation for Household Cleaning Products: On December 3, 2018, the Comisión Federal de Protección Contra Riesgos Sanitarios. (Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)) has issued NOM-189-SSA1/SCFI-2018, “Productos y Servicios. Etiquetado y Embalaje Para Productos de Limpieza del Hogar” (Products and services. Labeling and Packaging for Household Cleaning Products (NOM-189)). NOM-189 speaks specifically to “soaps, detergents, cleaners, bleaches, starches for external use, stain removers, disinfectants, deodorants and environmental flavorings, and others of an analogous nature,” and is directed to “establish the health and commercial information requirements for the labels of household cleaning products in order to choose a better purchase option, as well as the sanitary characteristics for their packaging and thus avoid their use representing a risk.”

In part, NOM-189 sets out requirements for generic and specific product names, mandating that the generic name must be “established by reference to the presentation or function of the product,” and the specific name must be “established by reference to the place where the product will be applied” (Section 6.1.1). Furthermore, for products produced within Mexico, “the name, denomination or company name and address (street, number, postal code, city, and state) of the producer or person responsible for manufacturing must be included” (Section 6.1.2). For imported products, the importer may provide this information to COFEPRIS.

Section 6.1.3, “Declaration of the List of Ingredients” requires that such must “appear on the information surface of the primary packaging” and that the “corrosive, toxic or flammable ingredients that give rise to the precautionary legends must be declared with the chemical or technical name most commonly used,” while Section 6.1.6 sets out the “precautionary legends” (pictograms) that must appear on the product label.

Various other requirements relating to packaging, commercial labeling, and country of origin are also found within NOM-189.


Registrations Under Amended K-REACH Due June 30, 2019: The amended Act on Registration and Evaluation, etc of Chemical Substances (K-REACH) came into effect on January 1, 2019. All existing chemical substances (i.e., substances that are listed on the existing chemical inventory in South Korea) manufactured in or imported to South Korea at greater than or equal to one ton per year are now subject to registration.

Existing chemical substances must be pre-registered prior to registration and pre-registration must be completed by June 30, 2019. Pre-registered substances benefit from registration grace periods that allow existing chemical substances to be imported without full registrations.

Substance Type Registration Deadline
>1,000 t/y existing substances
>1 t/y CMR substances
December 31, 2021
100-1,000 t/y existing substances December 31, 2024
10-100 t/y existing substances December 31, 2027
1-10 t/y existing substances December 31, 2030

As reported in Acta’s October 25, 2018, Global Regulatory Update, on October 16, 2018, South Korea submitted two notices to the World Trade Organization (WTO). The first notice concerned carcinogenic, mutagenic or reprotoxic (CMR) substances that must be registered by December 31, 2021, if manufactured or imported in quantities greater than one ton per year. South Korea published the final notice on December 28, 2018. The notice lists only 364 CMR substances compared to the 544 CMR substances in the WTO notification. The second notice submitted to WTO concerned the designation of priority management substances. MOE published the final notice on December 28, 2018. The notice includes two lists of 672 substances. Notification of products containing the priority management substance is required if the quantity is above one ton per year and the content exceeds 0.1 percent weight by weight. The first list will be implemented in July 2019, and the second list in July 2021.

More information on the upcoming registration deadline is available in Acta’s January 14, 2019, memorandum, “Information on the Upcoming Registration Deadline for Chemical Substances in South Korea -- June 30, 2019.”


President Signs Bill Amending The Toxic Chemical Substance Control Act: The full legislature passed on December 21, 2018, a bill amending the Toxic Chemical Substance Control Act. During the review by the Social Welfare, Health, and Environmental Protection Affairs Committee (Committee), the Committee revised the bill to include the creation of a National Chemical Substances Control Board. Under the legislation, the Board will be tasked with policy related to chemical substances; decision-making; and cross-ministerial policy coordination. The Committee also revised the legislation to strengthen the toxic chemical disaster response and reporting systems and improve the insurance and liability provisions. Under the bill, the Toxic Chemical Substance Control Act will be renamed the Toxic and Chemical Substances of Concern Control Act. A rider to the legislation calls for the Taiwan Environmental Protection Administration (Taiwan EPA) to draft a bill within one year to regulate the existing chemicals manufactured, imported, and used in Taiwan. Once the legislation is signed into law, Taiwan EPA is expected to review over 30 subordinate laws and proposed updates as necessary. President Tsai Ing-wen signed the Toxic and Chemical Substances of Concern Control Act on January 16, 2019.

© 2019 The Acta Group All Rights ReservedNational Law Review, Volume IX, Number 25

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....