Global Regulatory Update for December 2018


ARGENTINA

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.

BRAZIL

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. Senhora Alessandra Bastos Soares, the Director of Sanitary Authorization and Registration, and Senhor 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

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.

EUROPEAN UNION (EU)

Updated Biocides IT Tools Available: On October 23, 2018, the European Chemicals Agency (ECHA) issued a press release entitled “Updated biocides IT tools available.” In its press release, ECHA provides that the latest version of the biocides submission tool, Register for Biocidal Products (R4BP 3), which includes enhanced workflows and controls for applications. ECHA states further that the new version of the Summary of Product Characteristics (SPC) Editor improves the text search in SPCs.

The new features in R4BP 3 include:

  • A new “Cc” field that allows users to copy recipients in a message, and the corresponding possibility to “Reply to all.”
     
  • A workflow that allows authorities to request updated IUCLID files during the peer review phase of active substance applications.
     
  • Features to support Brexit-related database adaptations.
     

The new features in SPC Editor include:

  • A functionality for finding and replacing text in SPC files.
     
  • Enhanced text formatting options supporting the use of superscripts.
     
  • The possibility to export the content of the SPC in Word format.
     

If companies’ deadlines in R4BP 3 were during the tool’s maintenance break from October 20-23, 2018, the deadlines were extended automatically. Additional information regarding the updated biocides IT tools is available in the release note.

BPC Adopts Eight Opinions: On October 23, 2018, ECHA issued a press release entitled “[Biocidal Products Committee (BPC)] proposes not to approve three silver-containing active substances.” In its press release, ECHA indicates that the BPC “adopted eight opinions in total, including one on Union [Authorization] and one on a [European Commission (EC)] request related to a dispute between Member States in a mutual recognition procedure.”

The BPC concluded that the following active substances should not be approved because their efficacy is not sufficiently demonstrated:

  • Silver zeolite for product-types 2 and 7;
     
  • Silver copper zeolite for product-types 2 and 7; and
     
  • Silver sodium hydrogen zirconium phosphate for product-types 2 and 7.
     

The BPC adopted a positive opinion on an application for Union Authorization for a teat disinfectant biocidal product family in veterinary hygiene (product-type 3). The BPC also adopted an opinion addressing a request from the EC on unresolved objections during the mutual recognition of a biocidal product family in insecticides (product-type 18) containing 1R-trans phenothrin for use against ants. The BPC was able to address the EC’s questions, which means that the EC can take a decision leading to the authorization of the biocidal product family.

During the BPC’s meeting in October 2018, it also discussed draft opinions on the following active substances without reaching a conclusion:

  • Silver zinc zeolite for product-types 2, 4, 7, and 9;
     
  • Silver zeolite for product-types 4 and 9;
     
  • Silver copper zeolite for product-types 4 and 9; and
     
  • Silver sodium hydrogen zirconium phosphate for product-types 4 and 9.
     

The discussion on these opinions will continue in BPC meetings. The EC, together with EU Member States, will take the final decision on the approval of active substances and on Union Authorization of biocidal products. Additional information is available in the Annex to ECHA’s News Alert.

ECHA Urges Companies To Keep Registrations Up To Date: On November 6, 2018, ECHA issued a press release urging registrants to review their registration dossiers regularly and update them when information becomes available. ECHA stresses that a registration has to reflect the most up-to-date knowledge on how a substance can be used safely at production sites and through the supply chain, all the way down to the end user. The information in the registration dossier must be updated, for example, when a registrant learns something new about the composition of the substance, its properties, how it is used by clients, or the specific risk management measures needed. ECHA states that “[s]ignificant changes” in the production or import volumes and the company information must also be reported to ECHA. In addition, new information may become available when new companies want to join the joint submission, and this must also be reflected in the joint dossier. More information is available in ECHA’s November 6, 2018, press release, “Keep your registration up to date.”

EC Updates Strategy On EDCs: On November 7, 2018, the EC issued a press release entitled “Endocrine disruptors: A strategy for the future that protects EU citizens and the environment.” In its press release, the EC provides that it has adopted a Communication confirming its commitment to protecting citizens and the environment from hazardous chemicals. The EC provides that “[t]he Communication also outlines how the [EC] intends to ensure that the EU approach remains the most modern and fit-for-purpose in the world.”

The EC states that the Communication delivers on the commitment made by the EC last year, when working with Member States on the criteria to identify endocrine disrupting chemicals (EDC) in the areas of biocides and pesticides. The EC notes further that the Communication addresses “the concerns of the [European Parliament (EP)] and the Council and follows up from the 7th Environment Action Program.”

In the press release, the EC states that it “is updating its approach for the years to come.” The EC states that the EU’s strategic approach towards EDCs will continue to be based firmly on science and application of the Precautionary Principle. The approach aims at:

  • Minimizing our overall exposure to EDCs, paying particular attention to important life periods, such as pregnancy and puberty;
     
  • Accelerating the development of a thorough research basis for effective and forward-looking decision-making in the context of Horizon Europe, building on the existing research and paying particular attention to areas where knowledge gaps exist; and
     
  • Promoting active dialogue allowing all stakeholders to be heard and to work together.
     

For the first time, the EC will launch a comprehensive screening of the legislation applicable to EDCs through a Fitness Check that will build on the data already collected and analyzed. The EC states “[w]ithout putting into question the general science-based EU approach to the management of chemicals, the Fitness Check will involve an assessment of the current legislation on whether it delivers on the objectives of protecting human health and the environment.” As noted in the Communication, the Fitness Check will also include a public consultation.

The Communication “outlines initiatives currently considered by the [EC] to ensure that the implementation of existing policies on [EDCs] reaches its full potential.” This includes the identification of EDCs, improving communication throughout supply chains by using Safety Data Sheets (SDS), and taking forward the scientific assessment of EDCs with further regulatory action. Additional detail is available in the Communication and related Questions and Answers.

ECHA Launches New Web Pages To Prepare Companies For Brexit: On November 14, 2018, ECHA issued a press release entitled “New web pages to prepare companies for [the United Kingdom's (UK)] withdrawal from EU.” In its press release, ECHA states “[t]he UK’s withdrawal from the EU will affect companies including those that manufacture or use chemicals in the UK as well as in the EU-27 … ECHA’s updated web section aims to help affected companies who have registered substances or use [authorized] chemicals in supply chains.”

In its press release, ECHA indicates that the UK is withdrawing from the EU at the end of March 2019. ECHA states “[h]ow the withdrawal will affect companies depends on their role in the supply chain … For some companies the withdrawal can have significant consequences.” As an example, ECHA states that if a UK-based company registered a substance under the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the registration will no longer exist with ECHA after the UK’s withdrawal from the EU. ECHA provides that if a UK chemicals manufacturer wants to continue doing business in the EU after the UK’s withdrawal, it can:

  • Appoint an only representative within the EU Member States remaining after the UK’s withdrawal (EU-27) to manage registrations; or
     
  • Move operations related to the registered substance to a legal entity within the EU.
     

ECHA indicates that REACH, the Classification, Labelling, and Packaging (CLP) regulation, the Biocidal Products Regulation (BPR), and the Prior Informed Consent (PIC) regulation will no longer apply to UK companies that place chemical substances, mixtures, articles, biocidal products, or active substances on the market only in the UK. ECHA states “[t]his is also the case when companies export certain chemicals directly from the UK to non-EU/[European Economic Area (EEA)] countries.”

The EU and the UK are working towards a withdrawal agreement. The agreement needs to be concluded and ratified by both sides to take effect. ECHA states this could take until early 2019. ECHA indicates that “[i‌]f and only when this occurs, companies may benefit from a transition period, which gives them more time to prepare for the effects of the UK’s withdrawal.” ECHA will update its Brexit support pages in accordance with progress on the withdrawal agreement.

Further information is available in ECHA’s website section on the UK withdrawal from the EU.

EC Publishes Draft Brexit Agreement: The EC published the draft agreement on the withdrawal of the UK from the EU, as agreed at the negotiators’ level on November 14, 2018. The draft agreement does not include specific provisions addressing chemical substances. Instead, an article on non-regression in the level of environmental protection states that the EU and the UK shall ensure that the level of environmental protection is not reduced below the level provided by the common standards applicable at the end of the transition period in relation to several areas, including the prevention, reduction, and elimination of risks to human health or the environment arising from the production, use, release, and disposal of chemical substances. Under the draft agreement, the UK would be excluded from nominating, appointing, or electing members of EU agencies, including ECHA, and would not be allowed to participate in the decision-making and governance of EU agencies, including ECHA. During the transition period, the UK would not act as the leading authority for risk assessments, examinations, approvals, or authorizations.

The Chemical Industries Association (CIA) and European Chemical Industry Council (Cefic) issued a joint press release on November 15, 2018, welcoming the draft agreement but noting that ensuring continued participation in REACH through ECHA “is the best outcome for the chemical industry in both the UK and the Europe as well as the health and environment agenda across the continent.” The associations intend to continue to work with the EP and members of the House of Lords to ensure there is an agreement for the UK to leave the EU and trade with EU Member States “with minimum disruption to the chemical sector.”

EU-27 leaders met for a special meeting of the European Council on November 25, 2018. They endorsed the draft Brexit agreement, as presented by the negotiators of the EU and the UK. Leaders also approved the political declaration on future EU-UK relations, which accompanies and is referred to in the withdrawal agreement. Following the meeting, EU-27 leaders met with Prime Minister Theresa May to discuss the next steps.

EC Welcomes Industry Pledges To Boost Market For Recycled Plastics, Encourages Further Action: The EC announced on November 20, 2018, that a preliminary assessment of voluntary industry pledges shows that EU industry “is significantly committed to recycling plastics -- at least 10 million tons of recycled plastics could be supplied by 2025 if the pledges are fully delivered.” The EC notes that on the demand side, only five million tons are expected so far, however, “demonstrating that more will be needed to achieve the objective of a well-functioning EU market of recycled plastics.” The main pledges came from plastics recyclers, industry associations for Expanded Polystyrene, and brand owners mainly for polyethylene terephthalate (PET) packaging. Although the official pledging exercise announced in the Plastics Strategy is now closed, the EC states that it is “well aware that more companies are preparing their commitments -- which we strongly encourage.” According to the EC, “the demand for recycled plastics may increase quickly if good quality material becomes available in stable quantities and at competitive prices.” Based on the pledges received to date, the EC states that the demand for recycled plastics needs developing. The EC will publish a more detailed assessment in the first quarter of 2019. This analysis will help identify gaps between supply (recyclers) and demand (producers, converters, and manufacturers) for the different plastic types, and guide future actions, including the ongoing assessment of regulatory or economic incentives in targeted sectors such as the automotive, construction, and packaging sectors that were announced in the Plastics Strategy. The EC will continue to encourage strongly initiatives that contribute to boosting the market of recycled plastics in the EU. The EC will cooperate with stakeholders and facilitate close stakeholder collaboration across the supply chain to achieve this objective. A first stakeholder meeting will be organized in early 2019. More information is available in the EC’s November 20, 2018, press release, “EU Plastics Strategy: Commission welcomes voluntary pledges from industry to boost the market for recycled plastics and encourages further action.”

ECHA’s Enforcement Forum Starts Preparation For REF-8: On November 21, 2018, ECHA issued a press release entitled “Inspectors prepare for EU-wide control of chemicals sold online.” In its press release, ECHA provides that its Forum for Exchange of Information on Enforcement (Enforcement Forum) and the Forum’s BPR Subgroup (BPRS) held meetings in November. The Enforcement Forum and its BPRS “kicked off preparations for a coordinated project where inspectors will control the chemicals sold online in all EU and EEA countries” (i.e., REACH-EN-FORCE-8 (REF-8)), and discussed the quality of SDSs with stakeholder organizations in an open session.

REF-8 will “cover duties under REACH restriction, [CLP,] as well as BPR duties relevant to biocidal products sold online.” Preparations will run through 2019, where inspectors will identify common methods of targeting goods online and dealing with internet duty holders. Inspections will be carried out during 2020, and the REF-8 report is expected in 2021.

The Enforcement Forum also adopted its Work Program for 2019-2023. ECHA states that the Work Program lists clearly the enforcement priorities for the coming years for all pieces of legislation covered by the Enforcement Forum and BPRS. The Work Program will be published by the end of 2018. Additional information is available in ECHA’s Annex to the News Alert.

ECHA Finds That Intentionally Added Microplastics Are Likely To Accumulate In Terrestrial And Freshwater Environments: ECHA issued a November 22, 2018, press release announcing that, according to its assessment, “microplastics that are added to products are more likely to be released to, and accumulate in, terrestrial and freshwater environments rather than the oceans.” Peter Simpson, ECHA’s Senior Scientific Officer, spoke at the MICRO 2018 Fate and Impact of Microplastics conference, stating that the sources of microplastics in the environment include intentional uses in cosmetics, detergents, other household products, paints, and agricultural uses. According to Simpson, many microplastics are washed down the drain. Although they are not typically released directly to aquatic environments, they are more likely to concentrate in sewage sludge that is frequently applied to agricultural soils as a fertilizer. The EC asked ECHA to investigate whether an EU-wide restriction for intentionally added microplastics would be warranted. ECHA is assessing the risks that microplastics could pose to the environment once they are released, and states that it will “specifically address their extreme persistence in the environment and the difficulty in removing them once they are there.” According to ECHA, it expects to issue a final restriction proposal on microplastics at the beginning of 2019. ECHA’s scientific committees, the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC), typically take about 14 months to issue opinions. The RAC and SEAC opinions should be sent to the EC “around April 2020.” ECHA notes that it is separately examining the risks posed by oxo-degradable plastics. More information is available in ECHA’s November 22, 2018, press release, “Intentionally added microplastics likely to accumulate in terrestrial and freshwater environments.”

EC Begins Consultation Towards An EU Product Policy Framework Contributing To The Circular Economy: On November 29, 2018, the EC began a public consultation “Towards an EU Product Policy Framework contributing to the Circular Economy.” The EC seeks comments from the general public, businesses, non-governmental organizations, and national and regional authorities in EU Member States. The EC notes that EU policies affect the products on the EU market in many different ways. As such, all citizens, businesses, and other stakeholders are affected by these policies. Citizens in their role as consumers buy, use, and discard products. Businesses and industries are involved in all life-cycle phases including design, manufacturing, importing/exporting, purchasing, consumption, and recycling/waste handling at the end of the product lifetime. The EC states that all these parties make decisions related to products based on certain perceptions, under the influence of incentives and limitations set in (among others) EU policies. According to the EC, “[i‌]t is therefore vital to obtain views from a wide range of stakeholders on these perceptions and incentives, in particular those relating to EU product policies.” This will help identify how much the current EU product policy framework supports a circular economy and what potential there is to increase this contribution. The public consultation will end January 24, 2019.

EC Amends REACH To Require Information On Nanomaterials: The EC announced on December 3, 2018, that it adopted amendments to several REACH Annexes to clarify the information requirements for nanomaterials. The EC notes that REACH “has always applied to nanomaterials, but did not contain specific provisions for them, which is why companies often did not know how to register these ‘substances in nanoform.’” According to the EC, the modifications and new requirements will help close the knowledge gap concerning which nanomaterials are placed on the market and in what quantities. The EC states that “[t]he new provisions will have to be implemented for all substances in nanoform that fall within the scope of REACH, from the already widely used and registered ‘legacy’ nanomaterials in all their product grades and variations to the specifically engineered nanomaterials placed on the market by the newly founded SMEs.” ECHA’s December 3, 2018, press release states that nanoforms of substances are those covered by the EC’s recommendation for a definition of a nanomaterial. ECHA “strongly encourages registrants of nanoform substances to familiarise themselves with the amendments and assess what action they need to take to comply.” ECHA is currently assessing the need to update existing guidance or issue new guidance to help registrants comply with the new requirements. The information requirements will apply beginning January 1, 2020. More information is available in the December 3, 2018, press releases released by the EC, “REACH: Closing the gap for nanomaterials,” and ECHA, “Companies to provide more information on nanomaterials.”

Council Of The EU Agrees To Reduce Occupational Exposure To Five Carcinogens: The Council of the EU announced on December 6, 2018, that it adopted its position on a proposal that will update the existing rules on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Directive 2004/37/EC). The proposal, including the Council’s proposed amendments, would set the following new limits that “are in line with new scientific and technical data and evidenced-based practices for measuring exposure levels at the workplace”:

  • Cadmium -- 0.001 milligrams per cubic meter (mg/m3). This value will apply after a seven-year transitional period during which the limit value 0.004 mg/m3 should apply;
     
  • Beryllium -- 0.0002 mg/m3. This value will apply after a five-year transitional period during which the limit value 0.0006 mg/m3 should apply;
     
  • Arsenic acid -- 0.01 mg/m3. This value will apply for the copper smelting sector after a two-year transitional period;
     
  • Formaldehyde -- 0.37 mg/m3 for eight-hour exposure and 0.74 mg/m3 for a short-term exposure. These limit values will apply after a three-year transitional period; and
     
  • 4,4’-Methylene-bis(2-chloroaniline) (MOCA) -- 0.01 mg/m3 with a skin notation to indicate possible dermal uptake.
     

The press release states that with regard to cadmium, the EC “shall assess no later than five years from the entry into force of the Directive the option of a further amendment to Directive 2004/37/EC which would add the combination of an airborne occupational exposure limit with a biological limit value.” The proposal allows EU Member States to introduce at the national level more stringent binding limit values and does not prevent them from applying additional measures, such as a biological limit value. The agreement reached by the Council will serve as the basis for negotiations with the EP. More information is available in the Council of the EU’s December 6, 2018, press release, “More protection for workers: Council agrees to reduce the exposure to 5 carcinogens.”

EP Proposes Blueprint To Improve Approval Procedure For Pesticides: The EP issued a press release on December 6, 2018, announcing that the special committee on pesticides put forward plans intended to increase trust in the EU approval procedure by making it more transparent and accountable. According to the press release, the committee agreed that “the public should be granted access to the studies used in the procedure to authorise a pesticide, including all the supporting data and information relating to the applications.” Concerns were raised about the right of applicants to choose a particular EU Member State to report on the approval of an active substance to the European Food Safety Authority (EFSA), “as this practice is seen as lacking in transparency and could entail a conflict of interests.” The committee recommends that the EC allocate the authorization renewal to a different Member State. The press release states that during the procedure, applicants should be required to register all regulatory studies that will be carried out in a public register, and allow for a “comment period,” during which stakeholders are able to provide additional existing data to ensure that all relevant information is taken into account before a decision is made. Post-market evaluation should be strengthened, and the EC should launch an epidemiological study on the real-life impact of pesticides on human health. The committee also proposes to review existing studies on the carcinogenicity of glyphosate and to set maximum residue levels for soils and surface water. The committee “stress[es] the need to ensure political accountability when authorisation is adopted in the form of implementing acts -- in the so-called ‘comitology procedure.’” The committee states that the EC and Member States should publish detailed minutes and make their votes public. The committee adopted its recommendations by a vote of 23 to five with one abstention. The full House will vote on the report during its January 14-17, 2019, plenary session in Strasbourg. More information is available in the EP’s December 6, 2018, press release, “Pesticides: MEPs propose blueprint to improve EU approval procedure.”

UK

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”:


 
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