China: Implementation of the “Stockholm Convention on Persistent Organic Pollutants” Prohibiting the Production and Use of Hexabromocyclododecane, Notice No. 237, 2021

On 4 June 2021, the China Ministry of Ecology and Environment, the China Ministry of Industry and Information Technology (MIIT), the China State Administration for Market Regulation (SAMR) and the Chinese Ministry of Housing and Urban-Rural Development jointly published a notice about the relevant management action on implementation of the “Stockholm Convention on Persistent Organic Pollutants” prohibiting the production and use of hexabromocyclododecane.

In accordance with this Notice, and with Announcement No. 84 of 2016, the production, use, import, and export of hexabromocyclododecane should be banned from 26 December 2021.

This Notice describes measures put in place to ensure that compliance goals are achieved as scheduled. These include:

  • Further investigation on companies producing or using hexabromocyclododecane: the production and use of hexabromocyclododecane in each region will be investigated and tracked in a register, to be dynamically and rigorously managed;
  • Relevant departments should clarify the responsibility of the enterprises, and ensure the production and use of hexabromocyclododecane will be completely stopped from 26 December 2021;
  • Strengthen the supervision and management of illegal production and sale of HBCD and products containing HBCD;
  • Strengthen the environmental supervision and management of the disposal of waste stocks of hexabromocyclododecane: the remaining hexabromocyclododecane stocks on 26 December 2021, must be disposed of as hazardous wastes in accordance with the “National Catalogue of Hazardous Waste (2021 Version)”.

The relevant actions taken by local authorities need to be reported to the China Ministry of Ecology and Environment before 31 March 2022, and a copy shall be submitted to the China Ministry of Industry and Information Technology (MIIT), the China State Administration for Market Regulation (SAMR) and the Chinese Ministry of Housing and Urban-Rural Development.

EU Environmental Policy to 2030: A Systemic Change

What are the goals of the new EU Environment Action Plan to 2030 and what has to be done to achieve them?

As Europe, along with the rest of the world, faces the economic and societal impact of climate change, ecosystem degradation and overconsumption of natural resources, MEPs will vote on the EU’s Environment Action Programme 2030, which aims to tackle some of the issues.

Find out about EU responses to climate change

Towards a climate-neutral EU

In November 2019, Parliament adopted a resolution declaring a climate emergency and urged the European Commission to ensure that future legislative and budgetary proposals are aligned with the objectives of the Paris Climate Agreement.

The first EU Environment Action Programme in 1973 aimed to reduce pollution, improve natural and urban environments and promote awareness of ecological problems. The 8th environmental action programme, which will be discussed by MEPs during July’s plenary session, will focus on accelerating the transition to climate neutrality, to clean and efficient energies and to a circular economy.

A sustainable economy is key

In its State of the Environment report, the European Environment Agency said that economic activities and lifestyle are Europe’s most important environmental challenges.

According to Parliament’s environment committee, the EU should shift towards a sustainable well-being economy with the Sustainable Development Goals as the foundation. A wellbeing economy is one where public interest determines economics and not the other way around.

The priorities in the action plan proposal include:

  • Environmental damage should be seen as a priority, rectified at source and damage paid for by the polluter
  • Mid-term evaluation by the Commission in March 2024
  • Data technologies should be used to support environment policy, ensuring transparency and public accessibility of the data
  • The phase out of all direct and indirect fossil fuel subsidies by 2025 and subsidies which fund environmentally harmful activities to be phased out by 2027.

Transparency and monitoring 

The new Environment Action Programme, which will support the European Green Deal, will include a new monitoring mechanism. The Commission is expected to come up with indicators to monitor and track progress by 31 December 2021.

California’s identification and ranking of substances for hazard assessment under Proposition 65 included PFOS and PFDA, PFHxS, PFNA, and PFUnDA and related substances

In March, the OEHHA (Office of Environmental Health Hazard Assessment) selected for hazard assessment several per- and polyfluoroalkyl substances (PFAS) for review and possible listing.  The chemicals are under review by two expert committees: the Carcinogen Identification Committee (CIC) and the DARTIC (Developmental and Reproductive Toxicant Identification Committee).  Under evaluation as carcinogenic and/or reproductive hazards are PFOS and its salts and transformation and degradation precursors; and PFDA and its salts, PFHxS and its salts, PFNA and its salts, and PFUnDA and its salts.

In a summary released this spring, OEHHA listed 22 substances reviewed and ranked by DARTIC from High Priority to No Priority for assessment.  OEHHA has discretion to determine which if any will be considered for listing under Prop 65:

Chemical Recommended Priority
Benzophenone 3 High priority
Bisphenol S (BPS) High priority
Diazinon High priority
Glyphosate and its salts High priority
Perfluorodecanoic acid (PFDA) High priority
Perfluorohexanesulfonic acid (PFHxS) High priority
Perfluorononanoic acid (PFNA) High priority
Imidacloprid Medium/High priority
Acetamiprid Medium priority
Butyl paraben Medium priority
Clothianidin Medium priority
Domoic acid Medium priority
Manganese Medium priority
Methyl paraben Medium priority
Perfluorodecanoic acid (PFUnDA) Medium priority
Titanium dioxide nanoparticles Medium priority
Zearalenone Medium priority
Thiamethoxam Medium priority/No priority
Vinpocetine Medium priority/No priority
Diethyl phthalate No priority
Isobutyl paraben No priority
Propyl paraben No priority

EU REACH – Simplified applications for authorisation for legacy spare parts

The European Commission has published an implementing regulation simplifying applications to use authorized chemicals to produce legacy spare parts or to repair products that are no longer manufactured. The application requires a simplified format for the analysis of alternatives and socio-economic analysis. No substitution plan is needed. The application fee will also be 50 % lower than normal.

New REACH Annex XIV Authorization List Substances

Authored by Emily Tyrwhitt Jones of RINA Apr 15, 2021

ECHA recommends for the European Commission to add seven substances to the REACH Authorisation List (Annex XIV), which when included cannot be used in the EU without authorisation after the relevant sunset date. Interestingly the recommendation comes 6 months prior to deadline where ECHA is obliged to submit such recommendations, which may be part of the ‘Stronger EU legal framework to address pressing environmental and health concerns’ published under the EU chemicals strategy published in October 2020.

Proposed Substances and their Uses:

Octamethylcyclotetrasiloxane (D4) (EC 209-136-7) is used in washing and cleaning products, processing aid in the semiconductor industry, polishes and waxes. Also used to manufacture silicones such as sealants that are widely used by many industries. The last application date is proposed to be 24 months after the substance inclusion in Annex XIV.

Decamethylcyclopentasiloxane (D5) (EC 208-764-9) is used in washing and cleaning products, polishes and waxes. Also used to treat textiles and as a dye additive. Also used to manufacture silicones such as sealants that are widely used by many industries. The last application date is proposed to be 24 months after the substance inclusion in Annex XIV.

Dodecamethylcyclohexasiloxane (D6) (EC 208-762-8) is used in washing and cleaning products, polishes and waxes. Also used to manufacture silicones such as sealants that are widely used by many industries. The last application date is proposed to be 24 months after the substance inclusion in Annex XIV. It is worthwhile noting at this point that in applications where substances are used as intermediates, such as use of D4 in the manufacture of ultra-pure thin layers of silicon dioxide, are not subject to authorisation.

Terphenyl, hydrogenated (EC 262-967-7) is widely used additive in tapes, electrical insulating coating compounds, epoxy resins and coatings, polyurethane potting and moulding compounds, and electric cables. It is also used in polysulphide sealants and as a plasticiser, such as in high voltage power cables and in aircraft sealants. It is also used as a heat transfer fluid. Due to its wide ranging uses many industry sectors may be impacted by its inclusion in Annex XIV. The last application date is proposed to be 21 months after the substance inclusion in Annex XIV.

Dicyclohexyl phthalate (DCHP) (EC 201-545-9) is used as a plasticiser in a wide range of polymers including PVC. Also used as an additive in resins, paints, lacquers and varnishes to aid flexibility and to provide water-resistance in ink. The last application date is proposed to be 18 months after the substance inclusion in Annex XIV.

Disodium octaborate (EC 234-541-0) is used in paints, lubricant, adhesives and construction materials. The last application date is proposed to be 24 months after the substance inclusion in Annex XIV.

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride, TMA) (EC 209-008-0) has no uses in the scope of the authorisation but it is included to avoid regrettable substitution in epoxy resin hardeners. The last application date is proposed to be 18 months after the substance inclusion in Annex XIV.

EU REACH – Enforcement Forum Agrees on Scope of Checks for Consumer Products and Biocides in 2022

The Forum’s 10th major enforcement project (REF-10) will focus on integrated controls of consumer products. The Forum agreed that inspectors will be able to check that products comply with many different restrictions for hazardous substances under REACH.

Among those that inspectors could check are new entries such as restrictions for carcinogenic, mutagenic and reprotoxic substances in textiles, the siloxanes D4/D5 in wash-off cosmetic products, or bisphenol A in thermal paper.

Controls will also check whether products comply with restrictions for the presence of persistent organic pollutants defined under the POPs Regulation. Here, inspectors could check PFOA in water repellent textiles or ski waxes, or short chain chlorinated paraffins in soft plastic articles.
The lists of REACH and POP restrictions that will be covered in the project are still under development but will provide much choice to the inspectors resulting in wide-ranging controls of products in the EU-EEA countries.
Enforcers will also check REACH duties for substances in articles requiring that information on substances of very high concern in products is being communicated in the supply chain.

To promote the integrated enforcement of chemicals legislation, the controls of the project will also allow inspectors to cooperate with authorities responsible for enforcing requirements of the Toy Safety and RoHS directives, which are complementary to REACH and POPs and restrict the presence of certain substances in toys, and electronic and electrical equipment.

The BPR Subgroup of the Forum agreed that inspections in its BEF-2 project will focus on controls of biocidal products for the presence of approved and non-approved active substances. The controls will be wide covering all types of biocidal product types and include both products already authorized under the BPR as well as products covered by pieces of national biocides legislation (i.e. transitional measures under Article 89 of BPR). Checks in the project may also include control labelling of biocides, online advertising, verifying that the active substance in the product is coming from an approved distributor, verifying active substances by chemical analysis, and targeted controls of disinfectants.

REF-10 and BEF-2 project will both be prepared in 2021, with inspections carried out in 2022 and reports to be published in 2023.

The Forum for Exchange of Information on Enforcement met virtually on 16-18 March 2021, while the BPRS met virtually on 23 March 2021.

India: Management and Handling of Chemicals and Hazardous Waste, Handbook, March 2021

The Handbook on Chemicals and Hazardous Waste Management and Handling in India endeavors to give a broad overview of the legislative and regulatory framework governing the chemical sector in India. Designed to serve as a ready reckoner for stakeholders working in the field of chemicals and hazardous waste, such as members and officers of the Pollution Control Boards, allied institutions of the Ministry of Environment, Forest and Climate Change, other regulatory authorities, officials and employees of hazardous waste management companies and chemical industries, importers and exporters of chemicals and waste, the Handbook outlines the core objectives of the different Acts, Rules and Regulations that regulate different aspects of chemicals and hazardous waste.

Much of the legislative framework in India that governs chemicals and hazardous waste owes its origin to different Multilateral Environmental Agreements on hazardous waste, to which India is a signatory. The Handbook also delineates the core principles of five major Conventions on hazardous waste and the obligations that the country has to fulfil in furtherance of their objectives. Spread across six chapters, the Handbook presents to its readers a holistic picture of the chemical sector in India and attempts to apprise them about the fundamental concepts that influence and govern chemical and hazardous waste management and handling in the country.

For more information see here.

EU REACH – 2020 SVHC Roadmap Complete

As part of the SVHC 2020 Roadmap launched by the Council of the EU in 2013, all relevant, currently known substances of very high concern have been identified and included on the Candidate List. Systematic screening of registered substances has been key in identifying new chemicals of concern.

ECHA has today published a brochure summarizing the achievements of the SVHC 2020 Roadmap, following its completion.

The goal of the SVHC Roadmap was to identify all relevant, currently known substances of very high concern (SVHCs) and include them on the Candidate List by 2020. SVHCs are chemicals that are carcinogenic, mutagenic or toxic to reproduction (CMRs), persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (PBTs/vPvBs) and chemicals that pose an equivalent level of concern like endocrine disruptors (EDs) and sensitizers. The Candidate List now contains 211 substances.

The roadmap also aimed to efficiently identify new chemicals of concern. EU Member States and ECHA have systematically screened information on registered substances. By the end of 2020, Member States had carried out regulatory management option analysis (RMOA) on around 220 chemicals of potential concern and identified a need for further regulatory action for about 80 % of them.

As an example, dibutylbis(pentane-2,4-dionato-O,O’)tin, which is used as a catalyst and an additive for producing plastics, was first picked up as a potential carcinogenic, mutagenic or reprotoxic (CMR) substance through screening and RMOA. Its human health hazards were then confirmed by harmonized classification and labelling and it was included in the Candidate List in 2020.

For a large proportion of screened chemicals, more information from registrants is needed for authorities to be able to conclude on their hazards. When the information becomes available through substance or dossier evaluations, some of the substances are expected to have SVHC properties and will be addressed with the best regulatory instrument (e.g. authorization, restriction, or other legislation).

The SVHC Roadmap has increased the speed at which new chemicals of concern are identified as ECHA and Member States have started focusing on groups of chemically similar substances. It has also made the work of authorities more transparent by, for example, providing an overview of their work on chemicals of concern through the public activities coordination tool (PACT).

Jack de Bruijn, Director for Risk Management sums up: “While the SVHC 2020 Roadmap is complete, work will continue within ECHA’s Integrated Regulatory Strategy, which brings together various EU regulations to manage the risks of hazardous chemicals. The next goal has been set for 2027. By then, we aim to have screened all substances registered under REACH. This work contributes directly to the EU’s Chemicals Strategy for Sustainability and to the United Nations’ Sustainable Development Goals concerning chemicals.”

Progress on the Integrated Regulatory Strategy is provided in annual reports, with the next one published in April 2021.

EU REACH – 2021 Work Programme Published

ECHA’s 2021 priorities focus on its core mandate – REACH compliance, restrictions, authorization, harmonized classification and labeling, and biocides active substance approval. The Integrated Regulatory Strategy guides the work in prioritizing, evaluating and managing the risks of chemicals. The aim is to show ECHA’s impact in protecting European citizens and the environment from effects of harmful chemicals.

On 27 March 2020, the European Commission Directorate-General for Neighborhood and Enlargement Negotiations (DG NEAR) and ECDC signed an agreement for the implementation of the EU Initiative on Health Security.

This will enable tailor-made support to strengthen public health systems’ preparedness and response capacities of the European Union candidate and potential candidate and the European Neighborhood Policy partner countries, and improve health security in the European neighborhood. ECDC has developed a comprehensive programme for 2021 to enhance regional cooperation in the fields of epidemic intelligence, rapid risk assessment, preparedness and response. The goal is to empower partner countries’ professionals to better face the threats public health systems have to fight against. Several thematic events based on specific interests will be organized.

More guidance from ECHA can be found here.

EPA Seeks Public Input on Draft Guidance for PFAS Significant New Use Rule

Aggressively addressing per- and polyfluoroalkyl substances (PFAS) in the environment continues to be an active and ongoing priority for the U.S. Environmental Protection Agency (EPA). As part of these efforts, EPA is asking for public input on new draft guidance that outlines which imported articles are covered by the agency’s July 2020 final rule that prohibits companies from manufacturing, importing, processing, or using certain long-chain PFAS without prior EPA review and approval. More specifically, this guidance provides additional clarity for stakeholders that are importers of articles that may contain long-chain PFAS as part of a surface coating.

Comment deadline is January 15, 2021.

The draft guidance:

  • Provides additional clarity on what is meant by a “surface coating.”
  • Identifies which entities are regulated.
  • Describes the activities that are required or prohibited.
  • Summarizes the notification requirements of the final rule.

Upon publication of the Federal Register notice, EPA will accept comments on the guidance for 30 days in docket EPA-HQ-OPPT-2020-0621 on www.regulations.gov. EPA will use feedback received from the public comment process to inform the final guidance.

The July 2020 final rule is part of EPA’s PFAS Action Plan issued in February 2019. The cross-agency plan is the most comprehensive effort ever to address an emerging chemical of concern. Through the plan, EPA has made significant progress to help states and local communities address PFAS and protect public health.

Find a link to the draft guidance and learn more about the PFAS final rule.

Background on Draft Guidance

In July 2020, EPA issued a final rule strengthening the regulation of PFAS by requiring notice and EPA review before the use of long-chain PFAS (LCPFAC) that have been phased out in the United States could begin again. Additionally, products containing certain long-chain PFAS as a surface coating and carpet containing perfluoroalkyl sulfonate chemical substances can no longer be imported into the United States without EPA review.

This action means that articles like textiles, carpet, furniture, electronics, and household appliances that could contain certain PFAS chemicals cannot be imported into the United States unless EPA reviews and approves the use or puts in place the necessary restrictions to address any unreasonable risks.

For more information on the final rule: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-and-polyfluoroalkyl-substances-pfas

Background on PFAS Action Plan

EPA continues to make progress under its PFAS Action Plan to protect the environment and human health, including:

Drinking Water

  • In December 2019, EPA accomplished a key milestone in the PFAS Action Plan by publishing a new validated method to accurately test for 11 additional PFAS in drinking water. Method 533 complements EPA Method 537.1, and the agency can now measure 29 chemicals.
  • In February 2020, EPA took an important step in implementing the agency’s PFAS Action Plan by proposing to regulate PFOA and PFOS drinking water.
  • EPA also asked for information and data on other PFAS substances, as well as sought comment on potential monitoring requirements and regulatory approaches.
  • In November 2020, EPA issued a memo detailing an interim National Pollutant Discharge Elimination (NPDES) permitting strategy for PFAS. The agency also released information on progress in developing new analytical methods to test for PFAS compounds in wastewater and other environmental media.

Cleanup

  • In December 2019, EPA issued Interim Recommendations for Addressing Groundwater Contaminated with PFOA and PFOS, which provides guidance for federal cleanup programs (e.g., CERCLA and RCRA) that will also be helpful to states and tribes.
    • The recommendations provide a starting point for making site-specific cleanup decisions and will help protect drinking water resources in communities across the country.
  • In July 2020, EPA submitted the Interim Guidance on the Destruction and Disposal of PFAS and Materials Containing PFAS to OMB for interagency review. The guidance would:
    • Provide information on technologies that may be feasible and appropriate for the destruction or disposal of PFAS and PFAS-containing materials.
    • Identify ongoing research and development activities related to destruction and disposal technologies, which may inform future guidance.
  • EPA is working on the proposed rule to designate PFOA and PFOS as hazardous substances under CERCLA. In the absence of the rule, EPA has used its existing authorities to compel cleanups.

Monitoring

  • In July 2020, EPA transmitted the Unregulated Contaminant Monitoring Rule 5 (UCMR 5) proposal to the Office of Management and Budget (OMB) for interagency review. EPA anticipates proposing nationwide drinking water monitoring for PFAS that uses new methods that can detect PFAS at lower concentrations than previously possible.

Toxics

  • In September 2019, EPA issued an advanced notice of proposed rulemaking that would allow the public to provide input on adding PFAS to the Toxics Release Inventory toxic chemical list.
  • In June 2020, EPA issued a final regulation that added a list of 172 PFAS chemicals to Toxics Release Inventory reporting as required by the National Defense Authorization Act for Fiscal Year 2020.
  • In July 2020, EPA issued a final regulation that can stop products containing PFAS from entering or reentering the marketplace without EPA’s explicit permission.

Scientific Leadership

  • EPA continues to compile and assess human and ecological toxicity information on PFAS to support risk management decisions.
  • EPA continues to develop new methods to test for additional PFAS in drinking water.
  • The agency is also validating analytical methods for surface water, groundwater, wastewater, soils, sediments and biosolids; developing new methods to test for PFAS in air and emissions; and improving laboratory methods to discover unknown PFAS.
  • EPA is developing exposure models to understand how PFAS moves through the environment to impact people and ecosystems.
  • EPA is working to develop tools to assist officials with the cleanup of contaminated sites.
  • In July 2020, EPA added new treatment information for removing PFAS from drinking water.

Technical Assistance

  • Just as important as the progress on PFAS at the federal level are EPA efforts to form partnerships with states, tribes, and local communities across the country.
  • EPA has provided assistance to more than 30 states to help address PFAS, and the agency is continuing to build on this support.
  • These joint projects allow EPA to take the knowledge of its world-class scientists and apply it in a collaborative fashion where it counts most.

Enforcement

  • EPA continues to use enforcement tools, when appropriate, to address PFAS exposure in the environment and assist states in enforcement activities.
  • EPA has already taken actions to address PFAS, including issuing Safe Drinking Water Act orders and providing support to states. See examples in the PFAS Action Plan.
  • To date, across the nation, EPA has addressed PFAS in 15 cases using a variety of enforcement tools under SDWA, TSCA, RCRA, and CERCLA (where appropriate), and will continue to do so to protect public health and the environment.

Grants and Funding

  • Under this Administration, EPA’s Office of Research and Development has awarded over $15 million through dozens of grants for PFAS research.
  • In May 2019, EPA awarded approximately $3.9 million through two grants for research that will improve the agency’s understanding of human and ecological exposure to PFAS in the environment. This research will also promote a greater awareness of how to restore water quality in PFAS-impacted communities.
  • In September 2019, EPA awarded nearly $6 million to fund research by eight organizations to expand the agency’s understanding of the environmental risks posed by PFAS in waste streams and to identify practical approaches to manage potential impacts as PFAS enters the environment.
  • In August 2020, EPA awarded $4.8 million in funding for federal research to help identify potential impacts of PFAS to farms, ranches, and rural communities.

Highlighted Action: Risk Communications

  • EPA is working collaboratively to develop a risk communication toolbox that includes multimedia materials and messaging for federal, state, tribal, and local partners to use with the public.

Additional information about PFAS can be found at: www.epa.gov/pfas