Global Regulatory Update for June 2020
Join Bergeson & Campbell, P.C., The Environmental Law Institute, And George Washington University Milken Institute School Of Public Health For “TSCA Reform — Four Years Later” Virtual Seminar: From the current impacts of the Toxic Substances Control Act (TSCA) on science policies to challenges faced by industry, Lautenberg Implementation continues to evolve even four years after becoming law. Bergeson & Campbell, P.C. (B&C®), The Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health are pleased to present “TSCA Reform — Four Years Later,” a complimentary virtual seminar bringing together government and industry officials to reflect on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.
Panelists will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and regulatory policies, especially those concerning ensuring compliance and enforcement. Mark your calendar for Wednesday, June 24, 2020, 9:30 a.m. – 4:30 p.m. (EDT), to join ELI, B&C, the GWU Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA. Registration is free and open to the public, but an ELI account (no charge) is required.
SWA Posts Industry Guidance Regarding COVID-19: Safe Work Australia (SWA) has updated its website to provide a central hub of work health and safety (WHS) guidance and tools intended to help Australian workplaces manage the health and safety risks posed by COVID-19. The website provides stakeholders access to guidance that is directly relevant to their specific industry. It includes guidance about physical distancing, personal protective equipment (PPE), cleaning, workers’ compensation, and how to conduct risk assessments and design emergency plans, as well as providing case studies to help explain how to manage the risk of COVID-19 in the workplace. Stakeholders can choose from 23 industries to choose from, as well as general industry information if the industry is not listed.
SWA Delays Transition To GHS 7: A two-year transitional period to the seventh edition of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was due to begin July 1, 2020. SWA announced on June 5, 2020, that it has postponed the start of the transitional period due to the impact of COVID-19. The new start date is January 1, 2021. According to SWA, a full two-year transitional period will follow to allow manufacturers and importers time to prepare new classifications, labels, and safety data sheets (SDS) for hazardous chemicals to meet GHS 7 requirements. SWA states that to ensure that any importers and manufacturers that had already begun work on implementing GHS 7 are not disadvantaged, state and territory governments will put in place regulatory arrangements allowing businesses to begin classifying and labeling chemicals in accordance with GHS 7 from July 1, 2020. Suppliers and end users will also be able to supply and use GHS 7 labeled chemicals under these arrangements. SWA will publish details of the regulatory arrangements on its website when they become available. Manufacturers, suppliers, and users of hazardous chemicals will be able to continue to supply and use chemicals classified and labeled under GHS Revision 3 in the lead up to and during the transitional period. SWA states that it will “soon” publish guidance to support businesses to transition to GHS 7.
AICIS Will Begin July 1, 2020: The Australian Industrial Chemicals Introduction Scheme (AICIS) is still scheduled to begin on July 1, 2020. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has reminded companies that have already submitted an application for a NICNAS assessment certificate or permit, or are planning to apply before AICIS takes effect, that they must submit a completed application form and the relevant data and make full payment so that NICNAS receives it before July 1, 2020. Any application with an outstanding fee or missing forms or data will be canceled starting July 1, 2020. Companies must then categorize their introduction in accordance with legal requirements under AICIS. If NICNAS receives a complete application and full payment before July 1, 2020, it will be covered under the transitional arrangements, which means NICNAS will assess it similar to requirements under the current Act.
Chemicals listed on the Australian Inventory of Chemical Substances are available for industrial use in Australia. If a chemical is on the Inventory and a company’s introduction meets any terms specified in the Inventory listing, the introduction (importation or manufacture) is categorized as “listed.” Beginning July 1, 2020, all industrial chemical importers and manufacturers must categorize their chemical introduction. NICNAS has posted a step-by-step guide that takes companies through the process of categorizing their introduction. NICNAS is also publishing decision tools intended to help businesses categorize their chemical importation or manufacturer under AICIS. On June 30, 2020, the NICNAS website will retire and will be replaced by the AICIS website on July 1, 2020.
Canada Announces Interim Policy For Household Cleaning Products And Hand And Body Soaps: According to Health Canada, the COVID-19 pandemic “created an unprecedented demand for household cleaning products regulated under the Canada Consumer Product Safety Act (CCPSA) and hand soaps and body soaps regulated as cosmetics under the Food and Drugs Act (FDA).” Health Canada states that as an interim policy due to the COVID-19 pandemic, it is facilitating the access and sale of certain consumer products and cosmetics in Canada where:
- The label may only be in one official language; or
- The label may be different from what is required for sale in Canada.
To support the health and safety of Canadians, Health Canada published a list of the products being imported under the interim policy, including links to the complete label text, in both official languages, as required by the relevant regulations. The interim policy covers the following household cleaning products regulated under the CCPSA:
- Cleaning and furnishing care products used mainly to clean, bleach, or scour surfaces (products used to polish, protect, or improve the appearance of surfaces are excluded); and
- Laundry and dishwashing products used mainly to clean (fabric softeners or other products are excluded).
The interim policy covers hand and body soaps, regulated as cosmetics under the FDA, used mainly to clean the skin. It does not cover:
- Products that have a Drug Identification Number (DIN) or Natural Product Number (NPN); and
- Other products where skin cleaning is not the main function.
China Publishes Long-Awaited Revised MEP Order No. 7: The Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the long-awaited revision of MEP Order No. 7 in final, “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12), on April 29, 2020, which will become effective January 1, 2021. MEE Order No. 12 will replace the current MEP Order No. 7, strengthening the management of new chemical substances with persistent (P), bioaccumulative (B), and toxic (T) potential, including some concepts similar to the ones under the U.S. Toxic Substances Control Act (TSCA), reducing some registration burdens for new chemical substances, particularly for new chemical substances with annual production or import volume of less than ten metric tons. The key provisions in the final revision are summarized below:
- New chemical substances with annual production or import volumes of less than one metric ton and polymers with less than two percent of new chemical monomers or polymers of low concern (PLC) will only require a record filing, which does not require premarket approval;
- Regular registration is required only for new chemical substances with annual production or import volumes of ten metric tons and above. New chemical substances with annual production or import volumes of one to ten metric tons will only require a simplified registration, which does not require toxicology tests related to health hazards. Substances that meet all three criteria — P, B, and T — and with cumulative environmental risk will not be eligible for the simplified registration;
- New chemical substances with regular registration will be added to the Inventory of Existing Chemical Substances in China (IECSC) five years from the date of approval and PB, PT, or BT substances will include a use restriction;
- Substances on the IECSC with a use restriction will require new use registration, similar to the significant new use rule (SNUR) under TSCA;
- Introduces a maximum five-year protection period for confidential information on the identity of new chemical substances; and
- Annual reporting will only be required for highly hazardous, PB, PT, or BT substances with regular registration, which will be specified in the registration certificate.
More information on MEP Order No. 7 is available in The Acta Group’s (Acta®) May 8, 2020, memorandum, “China Publishes Long-Awaited Revised MEP Order No. 7.”
China Publishes Draft Notice On Convergence Matters Related To Transition From MEP Order No. 7 To MEE Order No. 12: MEE released a Notice on Convergence Matters Related to Environmental Management Registration of New Chemical Substances (Draft for Consultation) on June 3, 2020. The deadline to submit comments to MEE regarding the draft Notice is June 20, 2020. Comments can be submitted to MEE via e-mail (firstname.lastname@example.org). The key points in the draft Notice are summarized below:
- After January 1, 2021, new chemical substances that have completed regular registration under MEP Order No. 7 but that have not yet been added to the IECSC will be managed as follows:
- Annual reporting of the registered new chemical substances will follow the requirements under MEE Order No. 12;
- New chemical substances registered with classification of priority management of environmental risk will be added to IECSC with a use restriction five years after the approval date of regular registration; and
- Any changes of information in the registration certificate will require re-registration.
- Annual reporting of the registered new chemical substances will follow the requirements under MEE Order No. 12;
- After January 1, 2021, new chemical substances with simplified registration under MEP Order No. 7 will be managed as follows:
- Simplified registration for research and development (R&D) of process and product will be valid for two years from the date of the first activity; and
- Any changes of information in the registration certificate will require new record filing or simplified registration.
- Simplified registration for research and development (R&D) of process and product will be valid for two years from the date of the first activity; and
- Registrations submitted under current MEP Order No. 7 for which technical review and approval are not completed before January 1, 2021, will have to register according to MEE Order No. 12.
Acta recommends that all registration holders check all existing new chemical substance registration certificates to ensure that any changes of the registrations will be filed at least three months before the end of this year to avoid re-registration obligations. More information is available in Acta’s June 4, 2020, memorandum, “China Publishes Draft Notice on Convergence Matters Related to Transition from MEP Order No. 7 to MEE Order No. 12.”
EU Postpones New Requirements For Medical Devices: On April 24, 2020, the European Commission (EC) published a notice in the Official Journal of the European Union that postpones the application of the Medical Devices Regulation by one year, until May 26, 2021. The EC states in its April 23, 2020, press release that the postponement will allow all key players — EU Member States, health institutions, and economic operators — “to give priority to the fight against the ongoing coronavirus pandemic, forming a key position in the timing of the lifting of confinement measures as Member States return to the road of recovery.” The EC states that the adopted amendment takes into consideration the need for an increased availability of “vitally important medical devices” and at the same time continues to guarantee patient health and safety until the new legislation becomes applicable.
EFSA Publishes First Cumulative Risk Assessments Of Pesticides: The European Food Safety Authority (EFSA) announced on April 29, 2020, that it published the results of its two pilot assessments on the risks posed to humans by residues of multiple pesticides in food. The assessments — one on chronic effects on the thyroid system and the other on acute effects on the nervous system — are the culmination of a multi-year collaboration between EFSA and the Dutch National Institute for Public Health and the Environment (RIVM). EFSA states that the overall conclusion for both assessments is that consumer risk from dietary cumulative exposure is, with varying degrees of certainty, below the threshold that triggers regulatory action for all the population groups covered. EFSA published frequently asked questions (FAQ) that provide more information, including the data and methodologies used, the threshold for regulatory consideration, the margin of exposure, and information on the use of uncertainty analysis in the assessments.
EC Holds Public Consultation On Roadmap Regarding Chemicals Strategy For Sustainability: On May 9, 2020, the EC began a public consultation on a roadmap for “Chemicals Strategy for Sustainability.” The roadmap states that the regulatory framework on chemicals needs to be strengthened to increase further the level of protection of human health and environment — in particular from exposure to endocrine disruptors; combinations of chemicals; hazardous chemicals in products, including in imports; and very persistent chemicals. The roadmap notes that production of safer chemicals, products, and materials in Europe is not sufficiently incentivized, and frontrunners developing and using safer and more sustainable chemicals and modernizing existing or developing alternative technologies and business models are struggling to be competitive. According to the roadmap, the Chemicals Strategy for Sustainability will help to protect citizens and the environment better against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives. The EC will review how to use better the EU’s agencies and scientific bodies to move toward a process of “one substance — one assessment” and to provide greater transparency when prioritizing action to deal with chemicals. The roadmap states that the Strategy “will also support EU’s strategic autonomy in the production of essential chemicals across key sectors and promote research and development for the sustainable transformation of the chemical industry and the creation of green and sustainable manufacturing capacity in Europe.” Comments were due June 20, 2020.
The European Environmental Bureau (EEB) issued a position paper on June 16, 2020, listing its priorities for the Chemicals Strategy for Sustainability:
- Develop an ambitious overarching regulatory framework for chemicals to reduce pollution effectively at the source;
- Ensure a high level of protection for people and the environment;
- Rapid and complete implementation and enforcement of Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and other chemical laws;
- Transparency on substances in products along the life cycle;
- Clean the circular economy: end toxic recycling;
- Accelerate EU plans for substitution, innovation for safe alternatives, and green chemistry;
- Plug funding gaps by applying the polluter pays principle; and
- Ensure EU global leadership for a toxic-free environment.
Five European States Call For Evidence On Broad PFAS Restriction: On May 11, 2020, the European Chemicals Agency (ECHA) announced that the national authorities of Germany, the Netherlands, Norway, Sweden, and Denmark invite interested parties to send in evidence and information on the use of per- and polyfluoroalkyl substances (PFAS). The authorities of the five countries have agreed to prepare a joint Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) restriction proposal to limit the risks to the environment and human health from the manufacture and use of a wide range of PFAS. ECHA states that companies producing or using PFAS, selling mixtures or products containing these substances, and those using alternatives to PFAS “are especially invited to take part.” ECHA also encourages scientists and non-governmental organizations (NGO) to participate. The five countries will use the information received through the call for evidence to refine the scope of the proposal and analyze the effectiveness and socio-economic impact of different restriction options. Submissions are due July 31, 2020.
Annual Report On Integrated Regulatory Strategy Finds Grouping Of Chemicals Speeds Up Regulatory Action: ECHA issued a press release on May 13, 2020, announcing the availability of its second report on the Integrated Regulatory Strategy. The report provides an overview of the progress in addressing substances of concern and in the “mapping of the chemical universe.” It includes recommendations to authorities and industry on managing chemicals’ risks. In 2019, ECHA moved from a substance-by-substance approach to addressing structurally similar chemicals in groups. The aim is to speed up the identification of hazardous substances and get their risks controlled more quickly. The report covers an overview of the pre-regulatory steps (screening of groups by ECHA or Member States, expert group assessment, and regulatory management option analysis), the evaluation processes, and the regulatory risk management activities under REACH and the Classification, Labeling, and Packaging (CLP) regulation. The report includes the following recommendations:
- Screening groups of substances, data generation, and assessment should be further optimized to ensure substances are progressed to regulatory risk management without delay;
- Harmonized classification and labeling should become a priority, as it has a direct impact on company-level risk management, and is often the step before restriction, authorization, or other measures under other pieces of legislation are taken;
- The priority and appropriateness of previously identified, but still pending, follow-up actions should be reviewed and those substances that need further regulatory risk management should be progressed without delay;
- The compliance of registration information needs to be improved, in particular, for substances with a high potential for exposure and currently lacking appropriate hazard data;
- Compliance of dossiers, their systematic review, and updates of registrations based on new information remains industry’s responsibility. ECHA welcomes the initiative of industry associations to develop review programs to help registrants review chemical safety data; and
- Further enhance cooperation and coordination between authorities.
Survey Begins On Impacts From REACH 2018 Registration Deadline On Economic Operators: Under REACH, all manufacturers and importers of chemical substances in the EU had to submit information to ECHA on the properties and uses of all substances above one metric ton per year by May 2018 (hereafter 2018 REACH registration deadline). The EC Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) has contracted a study to understand better the impacts on businesses of the 2018 REACH registration requirements. A key element of the study is feedback on the costs and benefits from the REACH 2018 registration exercise. A survey to collect this feedback will close August 10, 2020.
ChemRecEU Publishes Position Paper Calling For Faster Recognition And Legislation Review Of Chemical Recycling: Chemical Recycling Europe (ChemRecEU) published a position paper on June 2, 2020, that calls for the “faster recognition and legislation review to unlock the potential of chemical recycling.” ChemRecEU states that the sustainable management of waste and use of resources is central to the European Green Deal. While the Circular Economy Action Plan aims at accelerating transformational change required by the EU Green Deal, to achieve the goals and to reach the recycling targets in the EU Plastics Strategy, “there is an urgent need to develop and implement new technologies for the recycling of polymeric waste, going beyond the limitations of traditional mechanical recycling.” According to ChemRecEU, chemical recycling complements the current recycling approaches and has the potential to be an environmental game-changer by processing polymeric wastes that are currently difficult to recycle. Investment in developing chemical recycling technologies and infrastructure will lead to the creation of new jobs and the protection of the environment by curbing carbon dioxide emissions and increasing EU recycling capacity.
ECHA Safer Chemicals Conference Held Online: On June 2, 2020, ECHA held the Safer Chemicals Conference 2020. The program focused on the following three main topics:
- Safer chemicals for a greener Europe;
- Tracking substances of concern; and
- Harmonized information for poison centers.
The Conference presentations, which are all available online, offer practical advice, demonstrations, and company case studies on reporting to European poison centers and to the new Substances of Concern In articles as such or in complex objects (Products) (SCIP) database to help stakeholders meet the new obligations on harmful chemicals in 2021.
EC Will Develop New Pharmaceutical Strategy For Europe: The EC intends to design a plan that will address the current issues of access, availability, and affordability of medicines, while still promoting sustainable innovation and supporting the EU industry to remain an innovator and world leader. The EC also aims to strengthen the current system and help it respond to public health threats such as the coronavirus pandemic, without compromising patient safety. This plan will be a new Pharmaceutical Strategy for Europe, scheduled for adoption by the end of the year. It will address:
- The life cycle of medicines from R&D to authorization and patient access;
- How to put scientific and technological advances into practice;
- How to fill market gaps (e.g., new antimicrobials); and
- Lessons learned from COVID-19 on how to prepare better for future pandemics.
Comments on the roadmap are due July 7, 2020. To ensure that all possible views are considered in the design of the Strategy and to ensure transparency and accountability, the EC invites all interested individuals or organizations to share their views and experiences. Responses on the questionnaire are due September 15, 2020.
EU Member States Create Website Listing Endocrine Disrupting Chemicals: The National Authorities in Belgium, Denmark, France, the Netherlands, and Sweden created a website intended to inform stakeholders about the current status of substances identified as endocrine disruptors or under evaluation for endocrine disrupting properties within the EU. The intention is to improve knowledge about endocrine disruptors and increase transparency, coherence, consistency, and coordination across legislative areas. The information is detailed in two separate lists (Lists I and II), based on the EU regulations for REACH, the Biocidal Products Regulation (BPR), Plant Protection Products Regulation (PPPR), and cosmetic products. A third, hazard-based list (List III) details substances that may have endocrine disrupting properties and that have been proposed by an individual National Authority.
EU Member States Report Illegal And Ineffective Disinfectants: ECHA announced on June 5, 2020, that several EU Member States have indicated to ECHA and the European Commission (EC) that the COVID-19 pandemic has led to an increased number of non-compliant hand disinfectants on the market. Of the 20 EU Member States that have reported an increase in non-compliant disinfectants, many of them reported disinfectants that do not have the required authorization or permit or lack hazard labeling. EU Member States also found products claiming to be disinfectants that had a formulation that cannot be sufficiently effective against viruses — for example, due to insufficient concentrations of active substances with virucidal activity that stops the spread of viruses. ECHA states that when the Member States deem these products a serious risk to the health of both professionals and consumers, they communicate the measures taken against them in the Rapid Alert System for Non-Food Products (RAPEX). National enforcement authorities continue to perform market inspections, including controls of online sales, to avoid ineffective products marketed to consumers as disinfectants being used against COVID-19. Enforcement actions include fines and the withdrawal of the products from the market.
ECHA Publishes Fourth Report On The Use Of Alternative Methods To Animal Testing Under REACH: ECHA announced on June 8, 2020, the availability of its fourth report on the use of alternative methods to animal testing under REACH. According to ECHA, the findings show, in general, relatively few changes in the use of alternatives since the last report in 2017. ECHA states that the most common adaptation was the use of information on similar substances (read-across, 25 percent), followed by justifications for omitting data (data waiving), combining information from different sources (weight of evidence), and predicting properties from structurally similar substances using computer models (quantitative structure-activity relationships (QSAR)). ECHA notes that data collected in the REACH registration database “is a good starting point for developing a unique chemicals knowledgebase that could be used to develop alternative approaches to animal testing and lend support to increasing the production and use of sustainable chemicals and the goals of the European Green Deal and the Digital Agenda.” ECHA states that since many registration dossiers still need to be updated to be compliant with REACH, it “urges companies to make use of all guidance and tools at their disposal to strengthen their use of alternative approaches when reviewing and updating their registrations.” More information is available in ECHA’s press release, “Alternatives to animal testing continue to be widely used.”
RAC Adopts Opinion Supporting Restriction Of Intentional Uses Of Microplastics: ECHA announced on June 10, 2020, that its Committee for Risk Assessment (RAC) adopted its opinion on ECHA’s proposal to restrict the use of microplastics that are intentionally added to products on the EU/European Economic Area (EEA) market, in concentrations of more than 0.01 percent weight by weight. RAC considered the proposal appropriate for reducing releases to the environment. In its opinion, RAC recommended:
- Biodegradable polymers: ECHA’s proposal set out specific test methods and pass criteria for identifying biodegradable polymers, which are excluded from the restriction. RAC wanted to see greater evidence that microplastics are biodegradable in the environment (e.g., soils, marine environment, freshwater);
- Use of microplastics as infill material on artificial turf fields: RAC recommended a complete ban after a transition period of six years as there was incomplete information on the effectiveness of risk management measures. A ban would also be more effective than risk management measures in preventing environmental releases in the long term; and
- The definition of a “microplastic”: ECHA proposed a lower size limit of 100 nanometers for a microplastic as analytical methods for detecting microplastics in products (i.e., mixtures) are still in development. RAC recommended that a lower size limit is not necessary as the potential restriction can also be enforced in other ways, such as by looking at raw materials in supply chains.
ECHA’s Committee for Socio-Economic Analysis (SEAC) agreed on its draft opinion on the costs and benefits of the proposal for society. ECHA states that SEAC supports the wide scope of the proposal and the transition periods for different product groups to give companies time to prepare. According to ECHA, for practical reasons and to ease enforcement, SEAC recommends a lower size limit of 100 nanometers until suitable analytical methods are available. SEAC also noted that risk management measures to contain synthetic infill material on artificial turf fields cost less than a complete ban, but a ban would be more effective in preventing releases in the long term. Based on the available information, SEAC does not prefer one option over the other. ECHA notes that a 60-day consultation on SEAC’s draft opinion will start “soon.” The consolidated opinion of both RAC and SEAC is expected to be ready by the end of 2020. The decisions on REACH restrictions are made in the EC by the EU Member States and scrutinized by the Council and the European Parliament. More information is available in ECHA’s press release, “RAC backs restricting intentional uses of microplastics.”
EC’s REACH Committee Will Make Final Decision Regarding Whether Resorcinol Is An SVHC: ECHA announced on June 16, 2020, that its Member State Committee (MSC) did not agree to identify resorcinol as a substance of very high concern (SVHC) due to its endocrine-disrupting properties. The EC’s REACH Committee will now make a final decision. At its June 10-12, 2020, meeting, the MSC did not unanimously support France’s proposal to identify resorcinol as an SVHC. The MSC acknowledged that there is scientific evidence that resorcinol is an endocrine disruptor as defined by the World Health Organization (WHO), however. After receiving the MSC’s opinion, the EC has three months to prepare a draft proposal on the identification as an SVHC and will then make a final decision in its committee procedure. According to ECHA, resorcinol is used to manufacture rubber compounds, resins, and coatings, as well as cosmetics. ECHA notes that it is the first substance proposed as an SVHC because of its thyroid-disrupting effects in humans. ECHA states that “[a] majority of the committee members concluded that there is scientific evidence of probable serious effects to human health due to hypothyroidism and potential neurodevelopmental effects during pregnancy. However, a few members expressed different views on whether the substance is of equivalent level of concern.” More information is available in ECHA’s June 16, 2020, press release, “Resorcinol not identified as a substance of very high concern.”
SEAC Supports Proposal To Restrict PFHxS: On June 17, 2020, ECHA announced that SEAC recently adopted its final opinion supporting the proposal to restrict the manufacture or placing on the market of perfluorohexane-1-sulfonic acid (PFHxS), its salts, or related substances in mixtures and articles. According to ECHA, “SEAC concluded that the expected benefits and costs to society of the restriction proposal are proportionate and would, therefore, be the most appropriate EU-wide measure to address the identified risks to the environment.” The proposed restriction “aims to avoid the regrettable substitution” of perfluorooctanoic acid (PFOA), which is scheduled to be banned from July 4, 2020, under the Persistent Organic Pollutants (POP) Regulation, as well as of perfluorooctane sulfonate (PFOS), which has already been eliminated under the Regulation. ECHA states that once adopted, the restriction would reduce the environmental emissions from products and mixtures imported to the EU/EEA (e.g., from water-repellent outdoor textiles), minimize exposure of future generations to PFHxS, and prevent further irreversible contamination of drinking water. Following SEAC’s adoption, the opinions of both RAC and SEAC will be sent to the EC, which will make the decision on the proposal together with the EU Member States.
In their June meetings, RAC and SEAC also discussed other restriction proposals, applications for authorization, occupational exposure limits (OELs), and harmonized classification and labeling. ECHA states that the main conclusions were:
- Both RAC and SEAC supported ECHA’s proposed restriction of intentionally added microplastics, with RAC adopting its opinion as reported above. ECHA expects to launch the 60-day consultation on SEAC’s draft opinion in early July 2020;
- Both RAC and SEAC supported ECHA’s proposal to restrict the placing on the market of calcium cyanamide used as a fertilizer. The 60-day consultation on SEAC’s draft opinion will begin June 24, 2020;
- SEAC agreed on its draft opinion on France and Sweden’s proposal to restrict skin-sensitizing substances in textiles, leather, hide, and fur articles placed on the market for the first time. The 60-day consultation on SEAC’s draft opinion will begin June 24, 2020;
- Both RAC and SEAC adopted their opinions on applications for authorization on one use of sodium chromate, five uses of octylphenol ethoxylates, and one use of nonylphenol ethoxylates;
- In response to an EC request, RAC adopted its opinions on the scientific evaluation of OELs for lead and its compounds and for diisocyanates; and
- RAC adopted 11 opinions on harmonized classification and labeling.
More information is available in ECHA’s June 17, 2020, press release, “ECHA’s committees recommend restricting a subgroup of PFAS.”
ECHA Announces Results Of “Fourth And Final” Market Survey On Use Of BPA And Other Developers In Thermal Paper: ECHA announced on June 18, 2020, that its fourth and final market survey on the use of bisphenol A (BPA) and other developers in thermal paper confirms that paper manufacturers have continued to replace BPA with bisphenol S (BPS). ECHA states that by 2022, “it is expected that 61% (or 307 kilotonnes) of all thermal paper in the EU will be BPS-based.” According to ECHA, the wide use of BPS in thermal paper “raises concern as BPS is suspected to affect human reproductive and hormonal systems.” ECHA notes that Belgian authorities are currently evaluating whether the use of BPS poses a risk to human health or the environment. Their conclusions are expected by 2021. In addition, Belgium made a proposal in 2019 to harmonize the classification and labeling of the substance as toxic to reproduction. RAC is expected to give its opinion on this proposal in spring 2021. Moreover, ECHA states that it is currently looking at bisphenols as a group, rather than as individual substances, to collect information for a more comprehensive regulatory strategy concerning these chemicals. More information is available in ECHA’s June 18, 2020, press release, “Bisphenol S has replaced bisphenol A in thermal paper.”
Consultation Resumes On Proposal To Adopt GHS 7: On June 8, 2020, the New Zealand Environmental Protection Authority (New Zealand EPA) announced that it is seeking comment on proposed changes required to adopt the seventh edition of the GHS, replacing New Zealand’s current hazard classification system, which was implemented in 2001. New Zealand EPA states that using GHS will mean less complexity and better quality information for users of hazardous substances. It will also help simplify processes for importers and manufacturers, and increase the effectiveness of chemical management under the Hazardous Substances and New Organisms Act. According to New Zealand EPA, comments from the first round of consultation were generally in favor of moving to GHS. New Zealand EPA is seeking comment on some of the specifics of the changeover, such as the new proposed GHS classification of hazardous substances, the updating of individual approvals, group standards, and the mapping of controls in the new system. Comments are due August 4, 2020.
OECD Summarizes Emergency Responses For Supply Of Disinfectants Against COVID-19: OECD is collecting and providing available information regarding emergency procedures intended to increase the availability of disinfectant products from different competent authorities and industry organizations. OECD notes that as the situation is “fast evolving,” countries are submitting information on a rolling basis. OECD’s summary includes whether there are emergency procedures in place; whether adequate efficacy methods have been identified; the products that are approved; whether biocides are registered for use via fogging or fumigation and if yes, a list of these products, including active ingredients and/or copy of approved labels; and any other relevant topics.
Global Forum On Environment Will Be Held In November: The “Global Forum on Environment: Towards cost-effective management systems for industrial and consumer chemicals” will be held November 3-4, 2020. According to OECD, the Global Forum on Environment will discuss the challenges posed by chemicals and provide knowledge on effective and sustainable policies for the sound management of chemicals. OECD states that leading actors in the field of chemical management, including regulators and relevant stakeholders, will promote effective engagement, collaboration, and action on the sound management of chemicals and waste. OECD states that production and consumption of chemicals “is rapidly increasing in emerging economies while the design of chemical management policies, the establishment of legal and institutional frameworks and the implementation of risk assessment methodologies and risk management decisions require a great deal of efforts in terms of time and resources from governments and industry.” The Global Forum is intended to serve as a tool for fostering networking and cooperation between partner and member countries. OECD organized the Global Forum as part of the activities of the OECD Joint Meeting on the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology and in relation to development cooperation in the area of sound chemical management.
Available On-Demand: “Eurasia REACH: Achieving Timely Compliance with New Chemicals Requirements,” Webinar: On May 27, 2020, representatives from The Acta Group (Acta®) and EPPA’s Moscow offices presented “Eurasia REACH: Achieving Timely Compliance with New Chemicals Requirements,” a webinar on what businesses must do to maintain an uninterrupted supply chain in the Eurasian Economic Union (EAEU) and support EAEU customers. The strategic importance of the Russian market is undeniable. Anticipating and addressing regulatory provisions that impact business opportunities is essential, as are securing and appointing an Authorized Representative (AR) and monitoring future developments with EAEU REACH. A full recording of this webinar is available now.
Russian Federation Publishes Interim Inventory Of Existing Chemicals, Extends Nomination Period: As reported in our April 2, 2020, memorandum, “Russian Federation Accepting Nominations to New Chemical Inventory,” the Russian Federation opened the Governmental Industry Information Exchange Platform (GISP) for the submission of substance information for an inventory of existing chemicals in November 2019. The initial submission deadline of January 1, 2020, has now been extended to August 1, 2020. Information requirements include:
- Chemical identification information;
- Use information;
- Volume as a three-year average or planned deliveries;
- Hazard classification according to Russian Gosudarstvennyy Standart (GOST) classification standards; and
- Company data.
An interim inventory is available, although it may not include recent nominations. The Russian Federation will publish a final inventory of existing chemicals after the nomination period closes and it process all nominations.