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Top International News in Chemical Policy and Regulation: December 12, 2018: Americas and United Kingdom


Argentina Continues Inter-agency Coordination on Chemicals and Waste Management: In 2017, the Argentinian government, recognizing that there are multiple authorities and agencies within the country that manage a variety of international conventions (e.g., The Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal, The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, and the Stockholm Convention on Persistent Organic Pollutants), announced an effort to consolidate these activities. The manifest goal of the program was to provide a systematic and comprehensive mechanism to establish cooperation, coordination, and information exchange among the various entities.

Readers may recall that, through funding from the United Nations Environment’s Special Programme on Institutional Strengthening for Chemicals and Waste Management, a new directorate was created in 2017, the Directorate of Chemicals and Waste, to ensure that sufficient personnel and infrastructure exist to implement the requirements of the above and other chemical and waste management conventions to which Argentina is a party. In March 2018, the Directorate of Substances and Chemical Products was established, and tasked with promoting cooperation and coordination between the stakeholders, as well as developing a training plan, evaluating Argentina’s participation in the multilateral environmental agreements and the Strategic Approach to International Chemicals Management (SAICM), and designing strategies to combat new and emerging challenges. As of November 2018, the Directorate of Substances and Chemical Products has identified the following challenges: limited access to information related to chemicals production; stock and commerce among private and public actors; lack of motivation for certain stakeholders to participate in national and international goals; and a weak image of chemicals in the public agenda. As such, it has designed actions to generate new mechanisms to systematize information and develop new, cost-effective, and efficient mechanisms to further streamline interdisciplinary and interjurisdictional cooperation of all relevant partners and stakeholders. Work is expected to continue throughout 2019.


ANVISA Holds Discussions With ABIQUIM: The Brazilian Agência Nacional De Vigilância Sanitária (National Health Surveillance Agency (ANVISA)) has conducted meetings with the Associação Brasileira da Indústria Química (Chemical Industry Association (ABIQUIM)) to discuss the regulation of agrochemicals in the country. Señor Alessandra Bastos Soares, the Director of Sanitary Authorization and Registration, and Carlos Alexandre de Oliveira Gomes, General Manager of Toxicology, represented ANVISA at an extraordinary meeting of the Sectorial Committee of Chemicals for the Agribusiness at the headquarters of ABIQUIM. The Director of Technical Affairs, Andrea Carla Cunha, represented ABIQUIM.

The meeting focused on two public consultations, both of which were in the first half of this year. The first one, CP 484, addressed criteria for the evaluation and toxicological classification of agrochemicals, components, and preservatives of wood. The second one, CP 486, spoke to the non-active components of agrochemicals and related products as well as components not authorized for use in such products. ANVISA plans to hold conversations with industry on the two consultations to regulate products and components that help rural producers, ensure the health of workers, producers, and the population, and preserve the environment.


Canada Begins Consultation On Vulnerable Populations: On November 22, 2018, Health Canada announced the availability of a consultation document on the proposed definition of vulnerable populations within the context of chemicals management. According to Health Canada, “[t]his is a first step towards the development of a policy framework focused on enhancing the protection of vulnerable populations through the assessment and management of risks associated with certain chemicals,” in particular under the Canadian Environmental Protection Act, 1999. For the assessment and management of chemicals, Health Canada is proposing to define vulnerable populations as “a group of individuals within the general Canadian population who, due to either greater susceptibility and/or exposure, may be at greater risk than the general population of experiencing adverse health effects from exposure to chemicals.” Comments are due January 21, 2019.


House Of Lords Releases Report On Brexit And REACH: On November 7, 2018, a week prior to the UK-EU agreement on and public distribution of the draft Brexit withdrawal agreement and political declaration outline, the House of Lords issued a report entitled “Brexit: Chemical Regulation.” The 18-page report focuses on important REACH issues for UK-based companies and includes several sections, including “Chemicals and Brexit,” “Ongoing Participation,” “Replacing the REACH Database,” and “Costs to Businesses.”

The report states that while industry and government agree that the UK’s continued participation in the REACH regulation and continued membership of ECHA are the best Brexit outcomes, it is “far from certain that this is a possibility.” As a result, the UK government must:

  • Clarify its approach to chemical regulation in the future;

  • Create and populate a database of chemicals;

  • Prepare a UK body “to take on the role of chemical regulation in a way that is independent, transparent and scientifically robust”;

  • Enable businesses to take pre-emptive action to maintain valid registrations for the EU market; and

  • Mitigate the economic impact on the chemical industry that would result from leaving the EU system.

The report states “[n]one of these actions is easy or quick to accomplish,” and expresses concern regarding the UK Government’s preparations and “lack [of] a credible plan of action.” The report provides that, because of the “cliff-edge” the chemicals sector is facing due to Brexit, chemical regulation post-Brexit should be a higher priority for the Government.

The report outlines principles and procedures under EU REACH, and the desirability of the UK continuing to participate in EU REACH actively post-Brexit. Consistent with other industry discussions, the report states:

We welcome the Government’s aim to continue to participate in REACH and ECHA post-Brexit, but we note that its red line on the UK’s membership of the Single Market after Brexit casts significant doubt on the feasibility of this aim. As a consequence, the Government must be fully prepared to manage an independent UK regulatory regime for chemicals immediately post-Brexit.

The report emphasizes that “[t]he loss of access to 16,000 substances after Brexit would have a serious impact on the UK’s chemical industry and the many supply chains that rely on it.” In this regard, the report states “[w]e urge the Government to clarify as a matter of urgency whether it would automatically accept EU-27-led chemical registrations into a UK system in order to avoid such a cliff-edge, and if so how it would address concerns regarding the use of chemicals for which it cannot access the information that supports that registration.”

The report also urges the Government to clarify immediately the circumstances under which it is possible for UK-based chemical manufacturers and importers to transfer their EU REACH registrations to an EU-27 based party before exit day, and, where this is not currently possible, to work with ECHA to enable such transfers to take place. The report states that such measures would avoid a “trading hiatus” that would seriously affect both UK and EU businesses.

The report expresses concerns regarding the Government’s ability to populate the UK chemicals database with necessary data, and highlights copyright and data protection issues surrounding the proposed “copy and paste” of registration information from companies in the EU-27. Furthermore, the House of Lords’ report states “[w]e are deeply concerned that the Government has not started making preparations for equipping a UK body to take on the task of regulating chemicals post-Brexit. The Government must clarify what body will take on ECHA’s role if the UK ceases to participate in REACH, and the means by which independent, expert and transparent chemical risk assessments will take place post-Brexit.”

HSE Updates Brexit Web Pages: Following agreement between the UK and EU on a draft Brexit withdrawal agreement on November 14, 2018, the UK’s Health and Safety Executive (HSE) updated its Brexit web pages. As the draft withdrawal agreement requires ratification by UK and European Parliaments to hold legal standing, HSE’s webpages cover both “implementation period” and “no Brexit deal” scenarios and related guidance.

In its Brexit webpages, HSE provides that, working closely with the Department for Environment, Food, and Rural Affairs (DEFRA) and the Environment Agency (EA), HSE has an important role to play in the UK’s chemicals regulatory process. HSE provides that “[t]he UK is strongly committed to the effective and safe management of chemicals. This will not change after Brexit.” HSE’s stated Brexit-related priorities are to:

  • Ensure the continued effective and safe management of chemicals to safeguard human health and the environment; and

  • Respond to emerging risks and allow trade with the EU that is as frictionless as possible.

HSE states “[a] scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome, but as a responsible regulator HSE aims to provide support and advice in all outcomes.”

HSE provides that, subject to ratification of the draft withdrawal agreement, the implementation period will start on March 30, 2019, and last until December 31, 2020. The UK will no longer be a Member State of the EU during the implementation period, but market access will continue on current terms. HSE provides that during the implementation period, and subject to preparation in final of the draft withdrawal agreement:

  • Registrations, approvals, authorizations, and classifications in place before March 2019 will continue to be valid in the same way that they are now;

  • REACH will continue to apply to the UK;

  • The process for registering new chemicals under REACH will remain the same as it is now, which will require UK companies to register with ECHA; and

  • The UK will recognize all new registrations, approvals, authorizations, and classifications granted by the EU.

Regarding a no-deal scenario, HSE states that extensive work to prepare for such potential circumstances has been underway for almost two years. HSE indicates that the Government is taking steps to ensure that the UK continues to operate smoothly from “day one of Brexit.” HSE provides that “[a]n effective regulatory framework will be put in place for any outcome,” and states the EU (Withdrawal) Act converts current EU chemicals legislation into domestic law and ensures that chemical regulations work in the UK. HSE states “[t]his means that the requirements established through these regulations will continue to apply in the UK after Brexit.”

HSE states it is working with DEFRA, which is building a UK chemicals IT system to support the registration of chemicals placed on the UK market. HSE states “[t]his will guarantee continuity for businesses whatever the outcome of negotiations.” HSE refers in its Brexit webpages to the following technical notices prepared to allow businesses and citizens to understand what they would need to do in the “unlikely event that there’s no Brexit deal”:

© 2018 The Acta Group All Rights ReservedNational Law Review, Volume VIII, Number 347

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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....