Global Regulatory Update for September 2019
SWA Accepting Public Comment On Workplace Exposure Standards (Release 2): On August 30, 2019, Safe Work Australia (SWA) began a public consultation on the recommendations for 50 chemicals ranging from acetaldehyde to benzoyl chloride. Release 2 includes current and new chemicals. The new chemicals are o-anisidine; benzidine; 1H-benzotriazole; and benzoyl chloride. SWA states that it seeks comments of a technical nature regarding:
- The toxicological information and data that the value is based upon, and
- The measurement and analysis information provided.
Comments on the chemicals in Release 2 are due September 27, 2019. SWA will consider the comments when making final recommendations regarding the workplace exposure standards. SWA will release the draft evaluation reports and recommendations for the remaining chemicals throughout 2019 and 2020.
Australia’s New Scheme For Introducing Industrial Chemicals Will Begin July 1, 2020: On July 1, 2020, the Australian Industrial Chemicals Introduction Scheme (AICIS) will replace the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The Industrial Chemicals Act 2019, which was passed by Parliament in February 2019 and received Royal Assent in March 2019, created AICIS, a new regulatory scheme for the importation and manufacture of industrial chemicals in Australia. Starting on July 1, 2020, through the implementation of AICIS, Australia’s regulatory efforts will be based on the likely risk of a chemical introduction. More information is available in The Acta Group’s (Acta®) August 28, 2019, memorandum, “Australia’s New Scheme for Introducing Industrial Chemicals Will Begin July 1, 2020.”
Brazil Updates GHS Implementation: On June 13, 2019, the Associação Brasileira de Normas Técnicas (Association of Technical Standards; ABNT), the normative body responsible for establishing technical standards in the country, published an amended version of its classification regulation, NBR 14725-2:2009, Produtos químicos — Informações sobre segurança, saúde e meio ambiente Parte 2: Sistema de classificação de perigo (Chemicals — Information on Security, Health and Environment, Part 2: Hazard Classification System). In ABNT NBR 14725-2: 2019, the changes primarily address classification groupings for substances and threshold value changes (e.g., concentrations of ingredients that would result in a specific hazard classification/classification change).
The purpose of the amendment is to align Brazil’s implementation with the latest (seventh) version of the United Nation’s (UN) Globally Harmonized System of Classification and Labeling (GHS). ABNT 14725-2: 2019, consolidated with its Amendment No. 1, is already in force.
ANVISA Relaxes Pesticide Approval Regulations: Brazil’s Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency; ANVISA) has recently adopted new rules designed to reduce the threshold for classifying pesticides as toxic in the country. Previously, a variety of other hazards, such as skin irritation, eye irritation, and dermal irritation, were to be considered when determining the hazard classification(s) of the product. Under the new regulation, the risk of death is now the sole means to classify the toxicity level of a product.
Carbendazim To Be Reevaluated Regarding Human Health Issues: ANVISA has been ordered by a federal judge in Brazil to re-assess the human health effects of a widely used fungicide, carbendazim, within 180 days. The re-assessment order came in place of a requested formal approval of one to suspend the registration of the product, sought by the public prosecutor’s office beginning in 2013. ANVISA argued that it had re-evaluated carbendazim in 2001-2002 and determined that there was no reason to deny approval at that time, largely due to a lack of scientific studies on the substance that would provide grounds for such action.
Brazil Approves Measures To Clarify Agrochemical Classification In Accordance With GHS: On July 23, 2019, ANVISA approved measures that clarify the toxicological classification of agrochemicals. Under the approved rules, the evaluation criteria of agrochemicals’ toxicity categories are established and label requirements are updated to include clearer warnings and pictograms. The changes established by ANVISA were based on the GHS, aligning Brazil’s regulations with European Union (EU) and Asian countries, among others. With the aim of strengthening the commercialization of national products abroad, the approved rules allow one year for stakeholders to begin implementation. Out of the 2,300 agrochemicals registered in Brazil, ANVISA has already received information for the reclassification of 1,981 products.
Brazil Amends Toxicological Information Label Requirements: ANVISA has issued in final its Draft Resolution No. 483, originally published March 16, 2018, now codified as RDC No. 296, on July 29, 2019. RDC No. 296 sets out the mandatory information relating to the protection of human health that must appear on labels of pesticides, related products, and wood preservatives. RDC No. 296 also extends to the “package leaflet,” defined in Article 3 as the “legal document containing technical-scientific information and guidelines for the proper use of pesticides, related products and wood preservatives”. Per Article 6, when developing the “medical information” (health and exposure) data, the company should consider the following items:
- — the qualitative and quantitative composition;
- — the toxicological characteristics submitted in the registration dossier;
- — the toxicologically relevant components, when in concentrations above the limits set in the GHS;
- — indications and precautions for use;
- — the updated scientific literature; and
- — the adequacy of information about medical procedures.
ANVISA reserves the right, in Article 8, to require changes to the labeling and leaflets at its discretion, although such changes must be based on “technical justification” by the Agency.
Canada Publishes Updates To Certain Two-Year Rolling Work Plans (2019-2021) For Third Phase Of CMP: On July 19, 2019, Canada published updates to certain two-year rolling work plans (2019-2021) for the third phase of the Chemicals Management Plan (CMP). The list of substances can be used to identify the substances found in each of the screening assessment reports published under the third phase of the CMP. Group names are subject to change as assessment activities advance. Assessment documents that have been published, or are close to being published at the time of release of the list, are identified in the Assessment Document column.
HC Publishes Guidance Document On Joint HC And U.S. OSHA Guidance: Under the Canada-United States Regulatory Cooperation Council (RCC), Canada and the United States have developed joint guidance on the labeling requirements for hazardous products under the Canadian Hazardous Products Regulations (HPR) and the U.S. Hazard Communication Standard (HCS). The guidance document contains three areas of focus and compares the requirements within each area:
- Joint U.S. Occupational Safety and Health Administration (U.S. OSHA)/Health Canada (HC) Guidance on Regulatory Processes for Hazardous Products in the Workplace:
- Comparison of U.S. and Canada’s Regulatory Process for Hazardous Products in the Workplace;
- Comparison of U.S. and Canada’s Regulatory Process for Hazardous Products in the Workplace;
- Joint U.S. OSHA/HC Comparison of Labeling Requirements for Hazardous Products:
- Label Comparison for Shipped Containers; and
- Label Comparison for Shipped Containers; and
- Joint U.S. OSHA/HC Guidance on Labeling Pictogram for Hazards Not Otherwise Classified, Physical Hazards Not Otherwise Classified, and Health Hazards Not Otherwise Classified:
- Labeling Pictogram for Hazards Not Otherwise Classified, Physical Hazards Not Otherwise Classified, and Health Hazards Not Otherwise Classified.
- Labeling Pictogram for Hazards Not Otherwise Classified, Physical Hazards Not Otherwise Classified, and Health Hazards Not Otherwise Classified.
China Notified Two Draft Chemical Regulations To WTO: The Chinese Ministry of Ecology and Environment (MEE) notified the World Trade Organization (WTO) of its “Environmental Risk Assessment and Control Regulation for Chemical Substances (Notification Draft)” (the draft Regulation) and “Measures on the Environmental Management of New Chemical Substances (Notification Draft)” (the draft Measures) on September 2, 2019. The draft Regulation is a revised version of the Consultative Draft of the Regulation published on January 8, 2019, and it is now more in line with the draft Measures, especially articles related to new chemical substances. The draft Measures is the same as the Consultative Draft of the Measures published on July 9, 2019. The draft Regulation and the draft Measures are intended to govern the environmental risk assessment and management of chemical substances and their mixtures, excluding medicines, pesticides, veterinary drugs, cosmetics, foods, food additives, feeds, feed additives, fertilizers, and radioactive materials. More information is available in Acta’s September 9, 2019, memorandum, “China Notifies WTO of Two Draft Chemical Regulations.”
EUROPEAN UNION (EU)
EC Study To Analyze Integration Of REACH In Customs Procedures: The European Commission (EC) will launch a “call for tender” in relation to Action 13 of the Second Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Review, which addresses enhancement of enforcement. In a document entitled “REACH and customs contract” issued following the 30th Meeting of the Competent Authorities for REACH and Classification, Labeling, and Packaging (CLP) (CARACAL), the EC indicates that “[s]trengthening the enforcement of the obligations on all actors, including registrants, downstream users and in particular [importers], is necessary to ensure a level playing field, meet the objectives of REACH and ensure consistency.”
As part of its goal under Action 13 of the Second REACH Review to “clarify and enhance” the role of enforcement and customs authorities in the enforcement of REACH, the EC will contract a study to analyze integration of REACH into customs procedures. The EC indicates that the main purpose of the study contract will be to elaborate a set of options and tools to further support the integration of REACH provisions into “Customs legislation/procedures.” The feasibility of the various options will be evaluated by the EC, and the “length of the contract shall be 16 months.”
The EC provides that the following “tasks are required to be performed in the contract”: (1) identify and review relevant information (e.g., REACH and customs legislation, enforcement projects, “ways of cooperation among REACH and customs authorities”); (2) identify REACH provisions and activities “that may be integrated in customs”; (3) develop procedures for each topic identified in task 2 and draft interlinks, classify and select clusters of activities, develop summary fact sheets; (4) discuss the preliminary results in an “ad-hoc Workshop”; and (5) elaborate the final report.
Cefic Offers Feedback On Implementing Regulation Regarding Duty To Update Dossiers: The European Chemical Industry Council (Cefic) issued a memorandum entitled “Cefic’s feedback on a draft Implementing Regulation on duty to update dossiers.” In its memorandum, Cefic indicates that REACH Article 22(1) defines cases when an update of a REACH registration dossier is needed. Cefic provides that it is fully behind the EC’s initiative, which seeks to clarify, via an Implementing Regulation, “how the provisions of article 22(1) should be understood.”
Cefic states “[a]ll actors involved will benefit from having a clearer understanding of the different elements of art. 22(1).” Cefic indicates that, at the CARACAL meeting of November 21-22, 2018, the EC presented time frames “clarifying the notice ‘without undue delay.’” Cefic states that it “fully supported this proposal” and that significantly revised time frames were presented at the July 1-2, 2019, CARACAL meeting. Cefic indicates the “[l]atest timeframes would be extremely challenging to meet,” stating that they merely seem to fit easy, straightforward updates of dossiers.
Cefic provides that, in reality, such “updates are rather exceptional” and typically complex, “simultaneous touching upon different elements and/or involving multiple actors.” In its memorandum, Cefic suggests alternative time frames for updating dossiers under REACH, indicating that it is convinced its proposal “strikes the right balance between workability and securing timely updates of dossiers.” Cefic also suggests “a few additional changes to avoid introducing a new layer of uncertainties via the implementing regulation.”
Cefic’s suggestions include a six-month time frame for updates in case of changes in a registrant’s status or identity, no mandatory update “in case a lower threshold is reached,” and an update requirement six months after receiving the final required test report in case “a higher tonnage band is reached.”
EC Proposes REACH Restriction For PVC Articles Containing Lead And Lead Compounds: On July 12, 2019, the EC notified WTO of a draft regulation and related Annex that would amend Entry 63 to REACH Annex XVII. The proposal from the EC “would prohibit the use of lead and lead compounds in articles produced from [polymers or copolymers of vinyl chloride (PVC)] as well as their placing on the market in articles produced from PVC if the concentration of lead (expressed as metal) is equal to or greater than [0.1 percent] by weight of the PVC material.” Time-limited exemptions from this limit are provided for rigid and flexible recycled PVC material and PVC-silica separators in lead acid batteries.
The “objective and rationale” section of the WTO notification states “[t]o reduce releases of lead during the service life of PVC articles thereby contributing to reducing direct and indirect exposure to lead, a toxic metal.” The European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) adopted its opinion on the proposed restriction in 2017, concluding that the proposal is “the most appropriate Union-wide measure to address the identified risks posed by lead compounds present as stabilisers in PVC articles in terms of effectiveness in reducing such risks, practicality and monitorability.” ECHA’s Committee for Socio-economic Analysis (SEAC) concluded that the proposed restriction, as modified by RAC and SEAC, is the most appropriate “Union-wide” measure to address the identified risk, in terms of its socioeconomic benefits and costs.
Comments on the proposed restriction were due “60 days from notification” to WTO, and the proposed date of adoption is the “3rd quarter of 2019.” The proposed date for entry into force of the restriction is 20 days from publication in the Official Journal of the EU. Application of the restriction on the placing on the market of articles would be deferred for 24 months after its entry into force.
RoHS 3 Restrictions For Four Phthalates Enter Into Force: An amended version of the Restriction of Hazardous Substances Directive (RoHS 3) entered into force in 2015, and the revised Annex II restrictions have applied since July 22, 2019. RoHS 3 includes in Annex II the following phthalates, with corresponding “maximum concentration values tolerated by weight in homogeneous materials”: (1) bis(2-ethylhexyl) phthalate (DEHP) — 0.1 percent; (2) butyl benzyl phthalate (BBP) — 0.1 percent; (3) dibutyl phthalate (DBP) — 0.1 percent; and (4) diisobutyl phthalate (DIBP) — 0.1 percent.
Since July 22, 2019, electrical and electronic equipment (EEE) containing the phthalates above specified concentration limits cannot be sold on the EU market. RoHS 3 includes the following exemptions:
- The restriction of DEHP, BBP, DBP, and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from July 22, 2021.
- The restriction of DEHP, BBP, DBP, and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities, or upgrading of capacity of EEE placed on the market before July 22, 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before July 22, 2021.
ECHA Addresses Public Concerns Regarding Intentionally Added Microplastics Restriction Proposal: On July 25, 2019, ECHA issued a press release entitled “Restriction proposal for intentionally added microplastics in the EU — update.” In its press release, ECHA indicates that “[s]everal media have recently reported that proposals to restrict the intentional use of microplastics under the REACH regulation will result in the closure of thousands of artificial turf pitches across the EU.”
ECHA states that the granular infill material typically used in artificial turf pitches is understood to be an “intentionally-added microplastic,” but neither ECHA nor the EC are proposing that these pitches should be closed. ECHA states that it was requested by the EC in 2018 to prepare a restriction proposal for intentionally added microplastics under the REACH regulation, and “[t]his is done in the wider context of the EU plastics strategy.” ECHA published its proposal in March 2019, and opened a public consultation that closes on September 20, 2019.
ECHA provides that the restriction proposal addresses a wide range of uses of intentionally added microplastics. ECHA states “further information has been requested on the use of granular infill material in synthetic turf in order to assess the implications and the possible need for a derogation.” ECHA indicates that as “[t]hese pitches are a substantial source of microplastics to the environment,” it is gathering information on the socioeconomic impacts of phasing out microplastic infill material.
ECHA provides that it is also gathering information on the effectiveness of technical measures to prevent the loss of infill material from artificial turf pitches into the environment. ECHA’s RAC and SEAC will review the information received “as they consider their opinions on the restriction proposal.” ECHA provides that the Committees’ final opinions are expected in early 2020, after which they will be sent to the EC for decision making.
ECHA states that all factors, including the important role that sports fields play in promoting physical exercise, health, and social inclusion, are taken into account in the decision-making process.
ZWE Publishes Study On Chemical Recycling, Offers Policy Recommendations To Ensure Chemical Recycling Complements Circular Economy: On August 29, 2019, Zero Waste Europe (ZWE) announced the availability of a study on chemical recycling that examines the state of implementation of the technologies in the European context. The study notes that plastic cannot be “endlessly mechanically recycled” without reducing its properties and quality, and not all types can be mechanically recycled. ZWE states that chemical recycling “could be a complementary solution to mechanical recycling where the latter is unsuited to materially recover plastic because it is too degraded, contaminated or too complex. On the flipside, it could also become the new plastics El Dorado if plastic to fuels is allowed.” The study emphasizes the importance of establishing a policy frame work to accommodate chemical recycling as complementary to mechanical recycling and to ensure that carbon stays in the plastic and is not released into the environment. ZWE offers policy recommendations intended to ensure that chemical recycling complements a “real” circular economy:
- Chemical recycling should be defined to exclude any operation that does not result in the production of new plastic;
- Only processes with a lower carbon footprint than the production of plastic from virgin feedstock can be classified as chemical recycling;
- Chemical recycling should be used to deal with degraded and contaminated plastics and never with plastics coming from separate collection;
- Verification systems should be established to ensure chemical recycling process outputs plastic and plastic feedstocks; facilities licensed for chemical recycling should not produce fuel as primary output;
- To avoid competition with mechanical recycling, but also to differentiate from recovery and disposal operations, a new level in the waste hierarchy should be added for those operations that recover materials from mixed waste that today would be burned or landfilled; and
- For coherence with the EU Climate and Circular Economy agendas, EU funding should only be allowed to finance plastic to plastic chemical operations.
ECHA Will Hold Biocides Day On October 29: ECHA will hold its annual Biocides Day on October 29, 2019, at its offices in Helsinki, Finland. Biocides Day will focus on active substance approval, endocrine disruptors, and biocidal product families. To attend in person, registration is required. ECHA will also stream it online. The conference is open to all, but according to ECHA will be particularly useful for companies, industry associations, public bodies, non-governmental organizations, and research institutions involved in biocides.
Israel Plans To Harmonize Migration Limits For Chemicals In Toys: On July 29, 2019, the Standards Institution of Israel (SII) notified WTO of its intent to revise Part 3 of its Mandatory Standard SI 562 “Safety of toys: Migration of certain chemical elements”, with the manifest goal of aligning SI 562 with the European Standards EN-71-3:2013 and A3:2018. The SII amended Part 2 (“Safety of Toys: Flammability”) and Part 7 (“Safety of Toys: Finger Paints — Requirements and Test Methods”) on April 21, 2018, with an entry into force of April 20, 2019. Part 3 speaks about toys that could “reasonably” be put by children into their mouths, as well as toys designed for children younger than six years of age.
Pending approval, the migration limits in SI 562 would be identical to those in the European Standard for the following elements: aluminum, antimony, arsenic, barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin, and zinc.
The final date for comments is September 27, 2019.
MERCOSUR Publishes List of Food Contact Material Additives: On July 15, 2019, the Mercado Común del Sur (Southern Common Market; MERCOSUR), the South American trading bloc composed of the countries of Argentina, Brazil, Paraguay, and Uruguay, has published its anticipated technical regulation addressing additives permitted in polymer coatings and plastics used as part of food contact materials, Resolution GMC 39/19 (Resolution). Some of the MERCOSUR countries have had similar types of regulation in place for some time. For example, Brazil has had its general safety standard, GMC Res. No. 03/92 (“General Criteria for Packaging and Articles to Come Into Contact with Foodstuffs: Terminology, General Criteria, and Classification of Materials”) in place since 1992. As with all MERCOSUR regulations, the member states must pass the Resolution into their respective national laws within six months, in this case by January 15, 2020.
The basis for the 1,150 approved substances listed in Resolution GMC 39/19’s “Cuadro 1. Lista positiva de aditivos con restricciones de uso y especificaciones” (Picture 1. Positive list of additives with restrictions of use and specifications) is largely United States and EU food contact legislation, although the Resolution reserves the right to include chemicals from other jurisdictions. Interestingly, several types of unintentionally added substances are exempted, such as impurities and reaction products, presumably because these products will be addressed in the perennially imminent Regulamento Químico Industrial (Industrial Chemicals Regulation) with respect to Brazil. Additionally, companies should be aware that, per Section 5.2.1 of the Resolution, they are required to provide the composition of the product to the “Competent Health Authority” upon their request. The Resolution is silent with respect to confidentiality provisions for these data.
New Zealand Begins Public Consultation On Proposed Improvements To Its Hazardous Substances Management System: The Ministry for the Environment announced on August 19, 2019, that it began a public consultation on proposed changes to New Zealand’s hazardous substances management system. The Ministry states that the aim is to improve the process for assessing new and existing hazardous substances, “thereby incentivising the introduction of beneficial and ‘greener’ substances.” The Ministry has identified a number of opportunities to improve their assessment. According to the Ministry, one of the options is to enable better use of overseas information to assess promptly any priority chemicals that the New Zealand Environmental Protection Authority (New Zealand EPA) has identified as being in need of review. The consultation web page states that under the proposed changes, a trusted regulator would be “an overseas regulator who the New Zealand government may choose to recognise as making comparable decisions on particular substances.” New Zealand may apply information used by an international trusted regulator to fill gaps in information. New Zealand seeks input from stakeholders and the public to form the criteria for choosing “trusted regulators.” Information from “trusted regulators” can include data, scientific information, hazard assessments, risk assessments, and decisions. The Ministry notes that data are not always available for sharing because of confidentiality requirements. The public consultation does not propose changes to any specific chemical approvals. Comments are due September 30, 2019.
New Zealand EPA Seeks Comment On Proposed Updates To Hazard Classifications For 79 Substances: On August 29, 2019, New Zealand EPA proposed to update the hazard classifications of 79 substances — including single chemicals and mixtures containing chemicals — to take into account new information such as study data and reviews or assessments by overseas chemical regulators. New Zealand EPA classifies substances based on their hazardous properties, and changes to hazard classifications may result in changes to the controls that apply to the substances. New Zealand EPA states that the chemicals listed below may be of particular interest to submitters, either because the hazard classification changes are extensive, or because they are widely used components of many products in New Zealand:
- Butylated hydroxytoluene (BHT);
- N-methylpyrrolidinone (NMP);
- Furfuryl alcohol;
- Propazine; and
New Zealand EPA states that suppliers, manufacturers, and users of chemical products should check their application documents to see whether their products are affected by the proposed changes. Comments are due September 25, 2019.
ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)
OECD Publishes Working Paper On Policy Approaches Intended To Incentivize Sustainable Plastic Design: On July 19, 2019, OECD published a working paper entitled Policy approaches to incentivise sustainable plastic design. According to the working paper, plastics are an important material in the global economy, but they present a challenge for waste management, resource efficiency, and the environment. The chemical composition of plastics, including their additives, creates physical and toxicological barriers to “closing the loop” on the material and creates risks such as low-quality secondary materials or ecological exposure to hazardous chemicals. The working paper states that a range of policy instruments can be applied to improve the sustainability of plastics, including regulations, market-based instruments, information, and voluntary tools. The working paper reviews the current use of instruments in each of these categories; provides a number of good practice examples, such as product taxes and charges, eco-design standards, extended producer responsibility, and environmental product labels; and discusses opportunities for their future applications.
Sierra Leone Works Toward Chemical Framework: The government of Sierra Leone is planning to implement an overarching chemical regulatory framework by the close of 2023 at the latest (Framework). The Framework will ultimately guide the development of legislation to evaluate chemical substances currently in commerce in the nation and to develop a registration process for those substances deemed hazardous. As part of the Framework, Sierra Leone plans to implement GHS within the next four years.
MoE Publishes Data Requirements For K-BPR Approvals: South Korea’s Ministry of Environment (MoE) has issued rules regarding data that companies are required to submit for biocidal substance and product approvals under the Consumer Chemical Products and Biocides Safety Act (K-BPR). The following information must be submitted for approval of substances under K-BPR:
- Applicant and manufacturer details;
- Names of substances, molecular formula, and chemical composition;
- Product types for use of substances;
- Purity level of substances; and
- Characteristics of, and impurities contained in, substances.
Entities are required under K-BPR to provide additional information on exposure, including details regarding the uses of substances and products containing the substances, categories of users of a substance (e.g., children), and the main route of exposure. Companies are required under K-BPR to submit testing data for human health and environmental issues in their applications. Entities may benefit from exemptions to the requirement for submission of hazard information if exposure levels are low or if relevant testing is technically impossible.
Under K-BPR, data requirements for products include:
- Details regarding substances in the product, including their regulatory status;
- Handling precautions;
- Methods of disposal;
- Details of the manufacturing process; and
- Labeling information.
UNITED ARAB EMIRATES (UAE)
UAE Looks To Further Develop Chemicals Management Strategy: UAE’s Ministry of Climate Change and Environment (MOCCAE) announced on July 28, 2019, that it has begun work on the implementation of its National Strategy for Integrated Chemicals Management (NSICM), a plan that had been approved in April 2019. The manifest purpose of the NSICM, which has yet to be made public, is to further coordinate and fortify regulations and administrative authorities responsible for the import, movement, and disposal of chemical substances in the UAE. No timetable for the completion of the NSICM has been announced.
UNITED KINGDOM (UK)
House Of Commons Environmental Audit Committee Publishes Final Report On Toxic Chemicals In Everyday Life: The House of Commons Environmental Audit Committee has published its final report entitled Toxic Chemicals in Everyday Life, completing its inquiry into the impact of toxic chemicals in everyday life on human health and the environment. The inquiry focused on how toxic chemicals are used in everyday products, such as furniture, food, and toys, current government regulation of these substances, and the environmental and human health problems associated with them. According to the report, the government has committed to publishing a Chemicals Strategy that is likely to be available in 2020-2021 “due to [the Department for Environment, Food, and Rural Affairs’] reprioritisation of staff to work on the UK’s departure from the EU.” The report notes that some of the content will be dependent on how the UK leaves the EU. According to the Resources and Waste Strategy, the Chemicals Strategy will strengthen the chemicals-waste interface by tracking chemicals in products across supply chains and work internationally to standardize assessment methods for chemical safety. It will also seek to define substances of concern that can create barriers to recycling, consider different rules for chemicals in primary and secondary materials, and facilitate better communication so that hazardous components are designed for safer recycling.
Parliament Issues Report On Consequences Of “No Deal” For UK Business: On July 19, 2019, the UK House of Commons’ Exiting the EU Committee published a report entitled “The consequences of ‘No Deal’ for UK business.” The detailed report includes several sections, including “Services,” “Automotive sector,” “Food and farming,” and “Pharmaceuticals and chemicals.” The “Pharmaceuticals and chemicals” section of the report includes multiple subsections, including “UK life sciences and chemical industries,” “Life sciences and regulatory divergence,” and “Chemicals and regulatory divergence.”
The report indicates that, according to figures published in January 2017, the UK chemical industry generated an annual turnover of £32 billion. The report provides further that the UK’s chemical industry employed 99,000 people directly and that the industry is “also at the top of the supply chains for many other sectors, including life sciences, aerospace and the automotive industry.” The report also states that, in recent times, 60 percent of the UK’s chemical exports “went to the EU” and 75 percent of UK chemical imports “came from the EU.”
In the “Chemicals and regulatory divergence” chapter, the report emphasizes the importance of REACH, and states “we were told that it is becoming the industry standard worldwide and that despite initial industry reservations, there is no appetite to diverge from its specifications.” The report emphasizes the implications of a “no deal” Brexit on EU REACH compliance for UK entities and discusses implementation of a post-Brexit UK REACH frame work, including its “grandfathering” provisions. The report highlights UK REACH criticisms and compliance challenges, including environmental campaign groups’ concerns regarding lower standards of chemical safety and data rights issues.
In the “Conclusions” section of the “Pharmaceuticals and chemicals” chapter, the report provides that “[u]nder no deal, chemical and pharmaceutical companies operating in the UK will be cut off from EU regulatory systems and databases, which protect the environment and patient safety. Companies operating in both markets will need to register chemicals or seek marketing approvals for drugs twice, in the UK and the EU, an expensive and bureaucratic process that will reduce the attractiveness of doing business in the UK.”
CBI Issues Report On No-Deal Brexit: The Confederation of British Industry (CBI) has issued a report entitled “What comes next? — The business analysis of no deal preparations.” CBI’s report addresses various issues, including movement of goods, regulated goods, tariffs and taxation, regulated services, and global regulations. In the foreword to the report, CBI states “[n]o one is ready for no deal.” CBI indicates that it has analyzed the no-deal preparations in the UK, the EU, and businesses in 27 key areas of the economy and “concluded that — despite existing mitigations — disruption is likely in 24 of those areas immediately after no deal.”
CBI’s report provides various recommendations pertaining to a potential no-deal Brexit for the UK and the EU, including “[r]ecommendations for joint action between the UK and the EU.” The report also provides recommendations for businesses, including immediately resuming no-deal preparations and prioritizing people in the event of a no-deal Brexit. Within the section of the report covering regulated goods, CBI offers various comments on chemicals in consideration of a potential no-deal Brexit. The report provides, in the context of post-Brexit UK chemicals legislation, that “no deal will mean some UK companies will be forced to duplicate testing to register EU substances in the UK, including in some cases through animal studies.”
CBI highlights data sharing issues for post-Brexit chemical regulatory compliance in the UK and indicates that “[t]he choice for chemicals firms in no deal is stark: pay more for the right to use chemicals they previously had access to or cease to use them altogether.” CBI offers the following recommendations, among others, for the UK and EU to mitigate the “disruption of no deal for chemicals businesses”: (1) guarantee that the new UK REACH-IT system will be ready on “Day 1” and expand related “trials and testing”; (2) provide a route for firms to have additional time to submit full UK REACH registrations in the event of the need to re-run testing; (3) reduce UK REACH registration fees “to ensure they reflect the UK’s smaller market size”; and (4) “[p]rovide a grace period of 180 days from no deal for UK manufacturers to transfer registrations to the EU market.”