Recent Chemical Watch summary

Neil Plumridge (Chair of the Environmental Working Party) has provided the following summary of recent Chemical Watch developments. In order to access links, you will need an account with Chemical Watch.

 

UK

• Northern Ireland will continue to apply EU REACH rules under the new ‘Windsor Framework’ deal Prime Minister Rishi Sunak has signed with the European Commission, the UK’s Department for Environment, Food and Rural Affairs (Defra) has confirmed. – ‘Windsor Framework’ deal keeps Northern Ireland within EU REACH But many EU laws will stop applying in the territory.
• In what is seen as a major victory for industry, the UK’s Department for Environment, Food and Rural Affairs has agreed to propose legislation to extend current UK REACH submission deadlines by three years for each tonnage band. NGO bemoans decision but further win for industry on statutory dates for compliance checks.
• The UK’s Department for Environment, Food and Rural Affairs has confirmed it will publish its belated chemicals strategy this year and provided further details at what is a time of great regulatory uncertainty for industry – Long-awaited plan, due this year, should cement approach for tackling PFASs, EDCs.
• Planned changes to UK REACH have been thrown into disarray following a new Brexit bill that aims to tear up and replace all retained EU laws, sowing fresh uncertainty about the country’s policy direction nearly two years after it implemented an independent regime. The bill comes as the Department for Environment, Food and Rural Affairs (Defra) is working on changes to UK REACH to address problems that emerged after it was copied from the EU law.
• The UK’s Health and Safety Executive (HSE) has called for comments on applications for authorised uses of three SVHCs. The requested review period is ten years. Interested parties can submit scientific and technical information on possible alternatives or technologies to these substances by 3 November 2022.

 

Europe

CLP

• European Commission tweaks resorcinol SVHC proposal to consider outcome of CLP revision  Draft EU law to face further scrutiny from member states, industry.
  • The European Commission has updated the draft text for its delegated Act for new hazard classes under CLP to clarify that non-animal tests can be used to identify endocrine disrupting chemicals (EDCs). It has also extended the time the law would allow companies to classify substances in accordance with the new criteria from 18 months to 24 months. – EU Industry calls for longer transition for proposed CLP hazard classes Clear guidance also needed, trade groups say in comments on proposed delegated Act – The European Commission has published its highly anticipated final proposal to revise the CLP Regulation, as well as a Delegated Regulation and Annex that would add new hazard classes for endocrine disruptors and other harmful substances. – The European Commission said it has set in motion a fast-track written procedure in order to adopt a draft delegated Act that will add new hazard classes to the CLP Regulation. The move, which has agitated both industry and animal rights NGOs, confirms a controversial plan to adopt and implement the hazard classes much faster and without the full period of scrutiny from the European Parliament and Council. All other elements of the CLP revision will be subject to the lengthier ordinary legislative procedure. – The European Commission has begun consulting on its fast-tracked plans to add new hazard classes to the CLP Regulation, including a category for ‘suspected’ endocrine disrupting chemicals. Proposal for new CLP hazard classes opens for public consultation Deadline of 18 October 2022 to comment on the Commission’s ‘fast-track’ delegated Act.
  • France has appealed the EU General Court’s decision to annul the European Commission’s classification of titanium dioxide as a carcinogen, in the latest twist over the strongly disputed classification that France initiated more than a decade ago.  France appeals EU court’s annulment of titanium dioxide classification Action suspends General Court’s judgment; Commission labelling rules back in place. – EU General Court annuls titanium dioxide carcinogen classification Momentous ruling says scientific study did not justify decision.
  • The European Commission has formally asked ECHA’s risk assessment committee to review its 2019 opinion on silanamine, a surface-treated synthetic amorphous silica (SAS). It has tasked RAC with analysing additional industry data that suggests an acute toxicity classification is unwarranted.
  • Greater regulatory acceptance of newer test methods is being held up by a chronic shortage of funding for validation, this week’s International Congress of Toxicology 2022 in Maastricht has heard. – Regulatory uptake of NAMs hampered by validation funding shortage.

REACH

• Sweden is prepared to prioritise starting negotiations on the revision of REACH during its six-month presidency of the Council of the European Union, the country’s recently appointed environment minister has said.- Swedish EU presidency: minister to prioritise REACH. revision talks Country wants progress on chemicals strategy
• Ministers from eight EU and EEA countries have joined others in calling on the European Commission to press ahead with the REACH revision, amid growing concerns the economic fallout from the war in Ukraine might lead the executive to put its plans on hold. – MEPs assail European Commission with demands for earlier REACH revision proposal. European Commission officials yesterday faced a fresh barrage of criticism for delaying the publication of the REACH revision proposal, with MEPs accusing the EU executive of ‘cheating’ citizens and ‘giving in’ to lobbyists by pushing back urgent chemical reforms possibly for another two years. Commission working as fast as possible but timing is political, officials say.
• PFCA restriction now applies in EU.
• The EU executive has shelved its controversial plan to identify resorcinol as an endocrine disrupting SVHC under REACH, and will wait for new CLP hazard classes to enter into force before potentially tabling another proposal.
• Inspectors from EU and European Economic Area authorities will embark on a campaign to check how importers of substances, mixtures and articles from outside the bloc comply with REACH obligations.
• Scope of proposed EU bisphenols ban is too narrow, NGOs say – Plastics Europe’s second appeal against BPA SVHC identification suffers setback
• Inspectors from EU and European Economic Area authorities will embark on a campaign to check how importers of substances, mixtures and articles from outside the bloc comply with REACH obligations.- EU industry to face scrutiny over REACH import obligations Major Enforcement Forum project to implement key chemicals strategy action.
• Germany has set forth three main options for its proposed group restriction of bisphenols under REACH. The alternatives differ primarily in how they treat polymers that incorporate bisphenols as monomers, for example in polycarbonate and epoxy resins. – Treatment of polymers is key factor in eagerly awaited ‘pre-publication’ version.
• European Commission may face another major legal defeat over its past authorisation decisions after an EU court expert recommended the annulment of an approval granted for uses of chromium trioxide. The outcome could spark big changes for industry and the REACH process currently under review.
• European Commission has adopted its 2023 work programme, confirming reports that the REACH revision will be delayed until the fourth quarter of next year, although some plans may be unaffected by the delay. – NGOs concerned revision now open to being ‘modified or withdrawn’.
• The European Commission has published its long-awaited draft proposal to restrict intentionally added microplastics, increasing the size of particles covered and allowing a transition period of up to 12 years for certain products.
• Analysis shows non-standard studies are ‘indispensable’ to REACH restrictions.
• Trade bodies representing producers and downstream users of polyvinyl chloride (PVC) have urged ECHA to take a “holistic and science-based” approach when gathering information on the potential risk to human health and the environment from the polymer and its additives. At the request of the European Commission, the agency is also looking at circular economy and societal impacts of a possible restriction. ECHA expects to deliver its results in May 2023.
• Industry groups have warned that changes to the REACH definition of intermediates proposed by the European Commission could have far-reaching consequences, halting product flows and supply chains and potentially jeopardising efforts to streamline the authorisation process.
• The European Commission has opened a call for evidence ahead of a proposal for a new standalone Regulation to redefine ECHA’s financing and operating model, which could introduce new fees for industry. A key plank of the EU’s ‘better regulation’ agenda, the call for evidence outlines the aims and objectives of the new initiative. If approved, the Regulation would supersede the ‘agency’ chapter in title X of REACH which sets out the way ECHA and its committees operate within the law.
• The European Commission has signalled that changes to the main body of REACH on nanomaterials may be on the cards, following a revised definition and amid concerns that current information requirements are ineffective. Responding to a question from Chemical Watch on potential changes to REACH, the EU executive said it was presently “analysing the inputs and the new developments”. It is considering “minor changes” to Annex VI to fully reflect the new definition of nanomaterials adopted in June, said a spokesperson.

PFAS

• ECHA has published full details of the highly anticipated EU REACH restriction proposal that aims to place limits on all uses of more than 10,000 PFASs – significantly more than the 4,700 previously identified. Industry has expressed concern that the proposal could eliminate some key applications critical for society, but the key details of the text are likely to be under scrutiny in the weeks to come. – Two options give industry from 18 months to 12 years to transition.
• Manifesto published amid concerns European Commission is delaying legal proposals. A group of more than 50 NGOs is calling on EU countries to ban PFASs in consumer products such as food packaging, cosmetics and clothing by 2025, and across all uses by 2030. On 12 October 2022, the group published a manifesto, in the form of a website, setting out its demands on how EU authorities should address existing ban per- and polyfluoroalkyl substances (PFAS) issues and stop adding to the pollution problems related to the chemicals.
• Germany, Denmark, Netherlands, Norway and Sweden have prepared a comprehensive restriction covering all PFASs, which was originally expected to enter into force in 2025. However, the group of countries delayed the proposal’s submission by six months to early 2023, prompting concern from NGOs over the timeline for an EU-wide ban.
• France has published a PFAS action plan that includes establishing safe environmental concentration limits, increasing monitoring and significantly reducing industrial emissions.
• Industry groups warn against PFAS alternatives in EU firefighting foams restriction consultation.

Green Deal

• The European Commission has adopted its framework on the safe and sustainable by design concept that foresees a commitment from industry to boost research and innovation, as laid out in the bloc’s landmark chemicals strategy.
• First tested substances fail to pass EU SSbD framework – SSbD (Sustainable Substance by design) – Obtaining and generating data, gathering internal and external expertise and identifying the right tools are the main challenges of carrying out an assessment using the EU’s safe and sustainable by design (SSbD) framework, according to the first three chemical companies to test it. – BASF, Clariant, Novozymes share challenges of applying EU SSbD framework  Commission workshop reveals initial findings from first case studies. – European industry groups have broadly welcomed the European Commission’s recently adopted framework on the safe and sustainable by design (SSbD) concept, but say the additional reporting requirements would hit resources hard. The text outlines comprehensive methods for assessing the safety and sustainability aspects of a chemical or material.
• The European Commission, in cooperation with stakeholders, has published a sweeping plan that lists more than 150 actions to help industry and authorities meet the Green Deal and digital goals by 2050. The ‘Transition Pathway for the Chemical Industry’ document, which was published on 27 January, proposes steps that support the Union’s move towards a ‘toxic free’ environment, climate neutrality, circularity and digitalisation.
• Essential use: Proposed EU criteria from consultancy limit health and safety exemptions Only uses upon which health and safety are ‘dependent’ should be allowed, WSP says.
• The EU’s chemical strategy for sustainability (CSS) will simplify and improve the bloc’s regulatory framework, benefitting companies in the long term, representatives from the European Commission and ECHA told delegates at a Chemical Watch conference this week. – EU Commission, ECHA try to relieve industry’s chemicals strategy concerns changes are challenging but will bring ‘simplification and improvements’ for companies.
• The European Commission has delayed the publication of its proposal on the revision of the EU’s Directive on the restriction of hazardous substances (RoHS) in electrical and electronic equipment (EEE). Before completing the review, the Commission is considering other processes underway, including the REACH Review and the recently presented legislative proposal for a Regulation on ecodesign for sustainable products. The proposal to revise REACH has been delayed until the first quarter of 2023.

SCIP

• Companies in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway will be obliged from 7 November to submit notifications on their products that contain SVHCs to ECHA’s substances of concern in products (Scip) database. The obligation follows the incorporation of the amendment to the EU’s Waste Framework Directive into the EEA Agreement.

RoHS

• German body to assess cadmium quantum dot RoHS exemption.

Biocides

• ECHA’s Biocidal Products Committee has concluded that iodine and polyvinyl-pyrrolidone (PVP) iodine meet the criteria for being endocrine disruptors, meaning the biocides can no longer be approved for use in the EU unless they qualify for a derogation. – Iodine could face non-approval in EU after identification as endocrine disruptor.
• ECHA biocides committee approves ozone, sulphur dioxide uses at September meeting.

Other

• The European Commission is seeking research proposals for a new €40m project on the health impacts of endocrine disrupting chemicals (EDCs) that aims to bridge science–policy gaps by addressing “persistent scientific uncertainties”. A representative from the Commission presented details of the funding call at the annual meeting of the European Cluster to Improve Identification of Endocrine Disruptors (Eurion) on 30 January.
• Polymers and plant extracts may pose a “unique challenge” for testing using new approach methodologies (NAMs), according to a skin sensitisation study by German chemical company BASF. The availability of appropriate NAMs has become increasingly important because of the EU ban on animal testing for cosmetic materials and plans to extend REACH registration to polymers, said the researchers in the journal Regulatory Toxicology and Pharmacology.
• EU Taxonomy to require companies, investors to report on ‘sustainable’ chemicals activities.
• Researchers at the Dutch National Institute for Public Health and the Environment (RIVM) have developed a computational screening tool for persistent, mobile and toxic (PMT) substances. They hope that regulators and drinking water suppliers will be among those to use it to identify potential PMT and very persistent, very mobile (vPvM) substances for further action.
• Dutch study suggests PFOA from past atmospheric emissions is mobile in soil.
• French NGO finds ‘alarming’ proportion of nano substances in consumer products.
• Smaller-than-expected budget for Sweden’s Kemi sparks NGO alarm – Sweden’s Competent Authority have been active contributors to proposals under CLP and REACH etc.
• The Centre for Research on Multinational Corporations (SOMO) has called on the EU to strengthen upcoming due diligence legislation to require supply chain disclosure by leather companies working in low- and middle-income countries. The lack of corporate transparency persists despite multiple international guidelines aimed at safeguarding humans and the environment, according to SOMO.
• Global interest in the EU’s chemicals work growing – Commission official.
• NGOs are questioning whether new EU legislation, which enables the use of recycled plastics in food contact materials (FCMs) with less regulatory scrutiny, can adequately protect consumers from exposure to hazardous chemicals. The regulation on recycled plastic materials and articles intended to come into contact with food entered into force on 1 October and supersedes a previous law of the same name. It removes the requirement for the European Food Safety Authority (Efsa) to issue a full scientific opinion on a recycling process before it can be used to place recycled plastics on the market.

 

Turkey

• Turkey plans measures to help KKDIK registrants struggling to access data – Only 504 dossiers received so far, the ministry says, as December 2023 deadline looms.
• Cost of data in focus as Turkey KKDIK registrations trickle in Around 100 substances may have been registered so far.
• Turkey has relaxed requirements for foreign-based suppliers to provide information on their Turkish importers as part of their KKDIK registration dossiers, in an attempt to accelerate submissions which have remained sluggish in the run up to the end of December deadline. The Ministry of Environment, Urbanisation and Climate Change (MoEUCC) took the step following a meeting in October with lead registrants, where companies blamed major problems with access to data for an exceptionally low number of registrations submitted under the REACH-like law.
• Turkey’s environment ministry is preparing new measures to give KKDIK registrants a leg up in the race to submit dossiers before a December 2023 deadline, after companies blamed major problems with access to data for an exceptionally low number of registrations received under the REACH-like law. The Ministry of Environment, Urbanisation and Climate Change (MoEUCC) told a meeting with industry representatives last week that it would publish a circular within days to help bolster registrations, with new guidance on data sharing, potentially including a cap on costs, and a delay for certain information requirements.

 

Eurasia Union

• The invasion of Ukraine continues to throw up questions for members of the Eurasian Economic Union (EAEU) who have missed a key deadline for the proposed technical regulation on the safety of chemical products.- War sanctions, supply chain shortages hamper central inventory finalisation.

 

Ukraine

• Ukraine’s cabinet of ministers has approved a draft law that if adopted would see the creation of a national chemicals management framework in line with European and UN standards.

 

US

TSCA

• The US EPA has released a collection of principles for studying substances’ cumulative risks under TSCA, alongside a proposal for applying the strategy to several phthalates subject to risk evaluation under the statute. – US EPA unveils preliminary TSCA cumulative risk assessment plan.
• Agency prepares to apply method to six phthalates under review.
• The US EPA has denied a TSCA citizen petition requesting it to use its authority under federal chemicals legislation to regulate greenhouse gas (GHG) emissions. – Agency has now rejected ten of the 11 section 21 petitions it has received since 2016.
• TSCA Snur restricting carbon nanotubes poses ‘challenges’ for renewable battery sector.
• The US EPA has proposed an update to its TSCA fees rule that would more than double the cost of filing a pre-manufacture notice to $45,000, narrow exemptions and change how companies divide fees for existing chemical reviews.
• TSCA 6(g) requests set stage for tussles over risk management exemptions EPA’s discretion to provide regulatory relief may face scrutiny.
• US EPA researchers update read-across framework to include non-animal tests.
• Pushback continues to grow over Washington state’s proposal to pursue the world’s broadest prohibition against organohalogen flame retardants (OFRs) in electronics, with representatives from three Asian nations joining industry’s call for a scaled-back approach – South Korean, Chinese governments join industry opposition to class-based proposal.
• Concentrated products highlight need for New York 1,4 dioxane rule, according to industry.
• US EPA finalises ‘whole chemical’ TSCA risk determination for Perc.
• The US EPA has announced it will release draft principles for conducting cumulative risk assessments (CRAs) under TSCA and signalled plans to apply that approach to certain phthalates undergoing agency review.
• Sephora, importer face titanium dioxide Prop 65 lawsuit.
• US speciality chemicals companies are “strongly considering” shifting their new chemical introductions to the European market due to the consistency of the REACH review process relative to that of TSCA, the Society of Chemical Manufacturers and Affiliates (Socma) has said.
• The US EPA has awarded more than $7.7m in grants to 11 institutions to research health risks that could result from chemical mixture exposure. The research will focus on the “development and improvement, evaluation and integration” of predictive toxicology methods to evaluate environmental chemical mixtures.
• The US EPA has proposed an update to its TSCA fees rule that would more than double the cost of filing a pre-manufacture notice to $45,000, narrow exemptions and change how companies divide fees for existing chemical reviews.- Proposed TSCA fees hike calls for $45k for new chemical submissions.
• Risk evaluations face $5m price tag, revised approach for splitting cost.
• Industry seeks rule changes to speed TSCA new chemical reviews.
• California’s LA region amends VOC limits for adhesives and sealants, restricts two solvents.
• Aerospace firm Boeing and several battery manufacturers have asked the US EPA to exempt specialised uses of four solvents expected to see proposed TSCA risk management rules next year, according to documents obtained by Chemical Watch. – Companies highlight ‘critical’ conditions of use for methylene chloride, NMP, TCE, Perc.
• Trade associations call for review of latest US pipeline safety rule.
• Scientific standards could take centre stage in future TSCA litigation.
• Changes to California’s Prop 65 ‘short form’ warnings still in the works.
• Colorado proposes nation’s toughest consumer product VOC limits outside California.
• Expertise shortage is ‘barrier’ to US EPA’s cumulative impacts research.
• The US EPA has launched a “new, more efficient” process for conducting TSCA premarket reviews of mixed metal oxides (MMO), in support of the Biden administration’s effort to scale up production of electric vehicle batteries and other clean energy sector products. The initiative, announced by chemicals office head, Michal Freedhoff, at the Chemical Watch US Regulatory Summit, builds on the agency’s effort to develop targeted approaches to streamline new chemical reviews, amid ongoing industry frustration at the programme’s slow pace.
• Insufficient evidence to support strict limits on BPA, industry tells US FDA.
• ‘Misleading’ Prop 65 warning for DEHP violates First Amendment, US textile company says.

PFAS

• In California, lawmakers have sent two unparalleled PFAS bills to the governor’s desk: one to limit the substance class in most fabrics and another to require annual reporting on the compounds in all sorts of goods.
• How the US EPA has fired a ‘warning shot’ on enforcement of PFAS requirements (5 April 2022) – North America managing editor, Kelly Franklin, looks at how an ‘open letter’ on fluorinated HDPE containers signals tighter examination of per- and polyfluorinated substances under the agency’s strategic roadmap. A recent policy interpretation on the fluorination of high-density polyethylene (HDPE) containers could be a “warning shot” that the US EPA will be tightly enforcing rules related to PFASs as it works to execute a strategic roadmap released late last year, according to some industry experts. The notice to industry also serves as a timely reminder that TSCA obligations extend beyond substance manufacturers and importers, and of the agency’s stance that all companies should be aware of the chemicals present in their products and supply chains. The interpretation, issued in an ‘open letter’ to the HDPE industry, warned that the generation of long-chain per- and polyfluorinated substances (PFASs) as unintentional byproducts during the fluorination of containers may constitute a TSCA violation. The March letter flows from an investigation the agency began after the discovery of PFASs in mosquito control pesticides that apparently leached into the products after being stored and transported in fluorinated HDPE containers. And in some respects, there has been little surprise at the agency’s view that the generation of certain PFASs during the fluorination of polyolefins – including polyethylene – is an activity covered under the 2020 long-chain perfluoroalkyl carboxylate (LCPFAC) TSCA significant new use rule (Snur). The LCPFAC Snur has been around since 2020, so this is “hardly a new development”, says law firm Bergeson & Campbell. “That it could apply to substances in polyolefins is a predictable and logical extension of the rule, and the EPA’s letter is a reminder to stakeholders to be mindful of this fact.” ‘Warning shot’ on PFASs Instead, the law firm says, the letter “is more a reflection of the agency’s commitment to its PFAS strategic roadmap than it is anything else”. Released last October, the ‘roadmap’ for addressing PFASs sets out an agency-wide approach for researching, restricting and remediating the substance class. TSCA-specific actions outlined in the plan largely involve section 5 of the law – the new chemicals programme, where the agency’s Snur authority lies – to address both newly introduced and existing PFASs. Under the roadmap, the EPA committed “to improve approaches for tracking and enforcement of PFAS requirements in new chemical consent orders and Snurs”. Its letter to industry is intended to support this goal “by ensuring that manufacturers, processors, distributors, users and those that dispose of these containers are aware of and are complying with the Snur requirements”. According to attorneys at Hunton Andrews Kurth, the letter is “just the latest in a series of aggressive actions taken by the agency” under the PFAS roadmap. This extract is from a news feature written by North America managing editor, Kelly Franklin. The full article is available to Chemical Watch News & Insight members.
• US EPA considers new enforcement programmes on PFAS, HFCs Industry stakeholders have voiced their support for suggestions from small business advocates to reduce the burden of the US EPA’s upcoming TSCA PFAS reporting rule, but environmentalists argue these modifications could invite litigation. Environmental NGO disputes legality of article importer exclusion, further floated changes.
• Maine PFAS rule expected months after disclosure requirements start in January State environmental department targets April for final rule. Maine has revealed that it intends to issue a rule in April to set out notification obligations for PFAS-containing goods, at least three months after the mandated reporting deadline takes effect on 1 January. The timeline, announced during a 27 October stakeholder meeting, adds to longstanding concerns regarding implementation of the US state’s expansive 2021 law. The measure mandates disclosure of goods containing per- and polyfluoroalkyl substances to better understand their use and eliminate non-essential applications by 2030.
• ASTM to develop testing standards for PFASs in consumer products – International standards organisation ASTM has set up a subcommittee to develop standards for determining the presence and levels of PFASs in consumer products. Per- and polyfluoroalkyl substances (PFASs) “are intentionally added or inadvertently present” in a significant number of products, co-chair of the subcommittee, Rock Vitale, said. The ASTM’s new standards would “provide guidance on how to prepare and analyse a wide variety of consumer product samples for PFAS”. The standards will help consumers, manufacturers and legislative and regulatory bodies understand the presence of PFASs in consumer products, the ASTM said. The new subcommittee will operate under the ASTM’s consumer products committee. Its work will focus on PFAS compounds most relevant to human and environmental health. The organisation is also calling on “chemical engineers, analytical chemists and advocacy group technical personnel” to participate in the development of the standards by joining the subcommittee.
• The US EPA has proposed a TSCA significant new use rule (Snur) to restrict the resumed use of more than 300 PFASs that have not been manufactured, imported or processed in more than a decade. The action would give the EPA the opportunity to review and potentially regulate any new applications of ‘inactive’ per- and polyfluoroalkyl substances (PFASs). But it may also present compliance hurdles for those who import or process articles containing the substances, or produce them as byproducts.
• An NGO coalition has called on the US EPA to impose TSCA restrictions on PFASs that 3M voluntarily plans to stop manufacturing. Snurs for voluntarily phased-out substances would shut door on future manufacturing.
• The US EPA has removed 12 PFASs from its list of non-food inert ingredients approved for use in antimicrobials and other pesticide products. Companies wanting to use the chemicals as inert ingredients in the future will need to supply a full and up-to-date set of data, in line with the 40 CFR 158 information requirements for pesticides.
• The European PFAS restriction proposal released last week could augment growing class-based action in US states to require disclosure or elimination of goods containing the substance class. – Europe’s proposed PFAS ban could boost US state-level prohibitions Plans would have less effect on EPA, FDA regulations, but could inform their work.
• Maine formally releases draft rule on PFAS-containing articles – Maine’s Board of Environmental Protection (BEP) has authorised a long-awaited proposal for gathering data on PFAS-containing goods, clearing the way for its formal publication. The draft rule, informally released earlier this week, explains manufacturers’ PFAS disclosure obligations under a 2021 state statute. The notification scheme seeks to obtain information – including on which PFAS applications are essential to health or safety and lack reasonably available alternatives – to shape a 2030 ban on most applications of the substance class.
• Maine has released for public comment the second iteration of a draft rule intended to clarify notification obligations and sales prohibitions for PFAS-containing articles set to begin on 1 January 2023.
• Maine proposes fees, further details for PFAS product regulations US state to hold meeting next week to discuss requirements slated for 2023.
• Organisations representing a wide array of downstream sectors have implored the US EPA to exempt article importers from forthcoming PFAS reporting requirements. Many groups, particularly those in the electronics industry, have told the agency the requirements would unduly fall on article importers, despite those entities being the least likely to have valuable information. –TSCA PFAS reporting would yield ‘unreliable data’ at huge cost, article importers say Trade groups press US EPA for exemption from coming disclosure mandate.
• US FDA cannot review PFASs as a class, according to agency official.
• In California, governor Gavin Newsom has approved two bills to ban PFAS-containing fabrics and personal care items. He also signed into law an update to the state’s green chemistry scheme intended to streamline the programme and increase the Department of Toxic Substances Control’s authority to collect product ingredient information.
• A Texas company has asked a federal court to throw out a lawsuit the US EPA filed late last year over its alleged violation of a TSCA significant new use rule (Snur) for long-chain PFASs. The company’s claims raise questions about whether the agency exceeded its statutory authority by using a Snur to regulate an ongoing activity and could lead to a court ruling with far broader legal implications. 22 September 2022 An industry coalition has urged California’s governor to veto legislation that would restrict PFASs in an array of fabrics from 2025 onwards. The alliance aims to block the broadest prohibition on per- and polyfluoroalkyl substance-containing textiles cleared by a US state legislature, and stall nationwide impacts expected due to California’s economic might. In their 13 September letter, the American Apparel & Footwear Association (AAFA), American Chemistry Council (ACC) and six other trade groups said Governor Gavin Newsom should veto the measure (AB 1817) because “additional work is needed to make this bill workable”. Lawmakers declined to incorporate some changes favoured by industry before advancing the legislation to Mr Newsom’s desk in August. For instance, the final phaseout deadline should have been delayed to 2027, the organisations said. The 2025 cutoff “for certain products does not provide enough time for manufacturers, retailers and others to transition product lines, research and develop potential alternative materials, design new products to utilise those materials, evaluate performance characteristics [and] establish consumer and environmental safety”.
• Washington state has proposed restricting or imposing reporting requirements on organohalogen flame retardants, PFASs, phthalates and phenolic compounds in a range of consumer products. The proposed rule kicks off the formal rulemaking phase under the Safer Products for Washington programme with potentially precedent-setting restrictions on the use of concerning substances in ten priority product categories where alternatives exist.

Biocides

• US EPA biocide actions raise concerns over lack of economic considerations.
• Biocides authorities place concentration limit on isothiazolinones in detergents.

 

Canada

• Canada proposes adding cyanides to toxic substances list.
• Industry groups, NGOs push for changes in Canada’s Cepa reform bill  Businesses want risks narrowly defined; NGOs seek greater transparency, environmental protections.
• Canada to update dangerous goods regulations to align with international rules.
• Canada’s rule restricting DBDPE, long-chain PFASs expected ‘late 2023’.
• Canada proposes class-based PFAS drinking water limit.
• Canada Modernises its Biocide and Pesticide Device Regulations  – changes to Canada’s Pest Control Products Act (PCPA) regarding pesticide devices; efficacy and safety requirements for pesticide devices; biocides regulations in Canada and exemptions from these regulations.
• Canada consults on update to VOC rules for paints and coatings.
• Applications open soon for alternative compliance options to Canada’s VOC limits.
• Canada prioritises methylene chloride for further risk assessment.

 

Brazil

• New life for Brazil’s chemicals bill after election – Bill 6120/2019 ‘undoubtedly’ more likely to become law next year, observers say.
• Brazil to launch project to monitor hazardous chemicals.

 

LATAM

• Industry, governments to meet to discuss regulatory action across Latin America.

 

Australia

• Australia consults on improving classification information for dangerous goods transport.
• The Australian Industrial Chemicals Introduction Scheme (AICIS) has proposed changes to simplify companies’ record-keeping requirements for chemicals manufactured or imported in quantities of 10kg or less. – Australia looks to simplify record-keeping rules for low-volume substances AICIS gives industry until 11 October to comment.

 

China

• China has reported an increase of more than a quarter in conformity assessment submissions on its RoHS2 online compliance platform since July 2021. – China sees RoHS2 conformity assessment submissions increase by more than a quarter – Six substances are restricted under China’s RoHS, but this may change in 2023.
• The China National Coatings Industry Association has released a document previewing 73 chemicals used in paints and coatings that are expected to form part of the first batch of priority chemicals requiring environmental risk assessment under China’s new chemical pollutants control plan. – China coatings industry previews 73 expected priority substances.
• Chemicals likely to be among first batch to see environmental risk assessments.
• Importers into China should prepare for information requests and be ready to assess business risk as the country gets ready to release the first batch of pollutants under its New Pollutants Control Action Plan, experts say. –Importers advised to prepare for China’s new pollutants lists Detailed records and business strategy will be key considerations, say experts.
• China seeks input on draft GHS labelling standard. 

 

Japan

• Japan enforces new requirements for export of PFOA and decaBDE – Companies to comply with prior informed consent (Pic) procedures. New requirements for the export of perfluorooctanoic acid (PFOA), its salts and related compounds – and decabromodiphenyl ether (decaBDE) – have come into force in Japan. Since 21 October, under the Export Trade Control Order, companies have been required to obtain permission from the Ministry of Trade, Economy and Industry (Meti) to export the substances and comply with the Rotterdam Convention’s export restrictions such as the Prior Informed Consent (Pic) procedures. That means countries receiving goods containing these substances must be informed of their import and are able to refuse them. The substances are listed under the Stockholm Convention, which requires countries to eliminate their production and use.
• Japan publishes 2023 schedule for new chemical notifications.

 

New Zealand

• New Zealand to streamline hazardous substance assessment process.
• New Zealand seeks industry input on phasing out fluorinated gases in refrigerants.
• New Zealand consults on persistent organic pollutant PFHxS.  

 

Singapore

• Singapore publishes standard aligning country with GHS 7.

 

South Korea

• The South Korean National Institute of Chemical Safety (NICS) has revised a standard covering the storage of hazardous chemicals at ports to improve safety. The revised standard, which came into force on 23 December, aims to strengthen safety management and improve congestion at ports. It applies to facilities that store hazardous chemicals for customs inspections.
• South Korea’s Ministry of Environment (MoE) has called for stakeholder comments on a list of potential chemicals to be designated as substances subject to permission under K-REACH. The consultation will run from 12 December to 2 February.
• South Korea urges industry to prepare SDS and CBI protection submissions as deadline looms  Grace period for companies handling 100-1,000 tonnes per year of existing substances ends 16 January 2023.
• South Korea to ease chemical regulation measures to attract foreign investment.
• One third of new substances in South Korea hazardous to workers’ health, government says.
• Inspectors find SDS violations in more than half of South Korea facilities.
• South Korea plans radical changes to the regulation of toxic substances under both K-REACH and the country’s Chemical Control Act (CCA), ushering in a more differentiated system based on hazard types and toxicity levels. – South Korea prepares overhaul of toxic substance regulation
• Draft reforms expected by end of this year.
• South Korea identifies new hazardous substances for workers’ health; eases PPE rules.
• South Korea enacts Regulation for designating ‘permitted substances’  New selection system will enter into force on 15 October.

 

Taiwan

• Taiwan’s EPA has published the final version of amendments to the country’s labelling requirements for toxic substances and chemicals of concern. Taiwan’s EPA has published the final version of amendments to the country’s labelling requirements for toxic substances and chemicals of concern.- Implementation of Articles 3 and 4 pushed back to 31 October next year.
• Taiwan’s proposed EPA restructure may pave the way for OR inclusion, says consultant.

 

Thailand

• Thailand approves the addition of eight PFOA compounds to hazardous substances list. 

 

Vietnam

• Vietnam’s Ministry of Industry and Trade has amended implementation regulations for the country’s Law on Chemicals. The measure includes updates to the rules on licences, labelling, transport and reporting. – Certificates of approval now valid for five years – Vietnam updates chemicals law implementation rules.
• Vietnam publishes second draft to limit POPs in specified products.
• Vietnam proposes restricting four phthalates in electrical and electronic equipment.

 

Africa

• African countries propose international code of conduct for chemicals.

 

India

• India to commence international chemical safety cards training ‘early next year’.
• India is consulting until 5 November on revised standards for enamel used in interior undercoating and finishing paint. The draft standards, published by the Bureau of Indian Standards (BIS) on 30 September, set out the specification for enamels, as well as testing methods, preparation of samples for testing, quality of reagents, and standardised packaging and labelling.
• India’s Department of Chemicals and Petrochemicals (DCPC) has delayed the implementation of quality control orders (QCOs) for six substances. The QCOs, issued by the Bureau of Indian Standards (BIS), will now enter into force in March, instead of this month as planned.

 

Pakistan

• Pakistan’s Ministry of Climate Change is in the final stages of formulating a plan to establish a Directorate for Chemicals and Hazardous Waste. Depending on funding, it is expected that the approval process will take approximately six months.

 

Global

• Add gene expression to OECD test guidelines for thyroid effects, suggest EPA researchers.
• OECD’s chemicals work will focus on risk assessment, data exchange over next five years.
• OECD calls for ‘urgent mobilisation’ of funding for test method validation.
• The OECD, in cooperation with the US, Canada and EU, is developing a global database of publicly available information on chemicals. – EU, US, Canada take first steps in the development of a global chemicals database  Pilot project will inform OECD’s ‘vision’ for its own international platform.
• Global chemicals framework negotiations extended to a fifth meeting.

 

Other

• Metabolic effects of flame retardant TDCPP seen in mice The flame retardant tetrabromobisphenol A (TBBPA) may affect the immune system, according to a gene study for the EU endocrine project, ERGO. The study adds to the scrutiny of TBBPA, which is commonly used in electronics to meet fire safety standards, as well as in printed circuit boards, paper and textiles.
• Multinational chemicals conglomerate, 3M, has said it will phase out the production and use of PFASs across its product portfolio by the end of 2025.
• Almost 50 investment firms have come together to demand chemical companies disclose more information on the hazardous substances they produce and use and set phase-out plans for persistent chemicals.- Investors join forces to push for more chemicals transparency, substitution   Group wants phase-out timelines and disclosure of hazardous substances.
• African countries launch pilot project to implement GHS  Kenya, Ghana, Côte d’Ivoire and Nigeria to get help from international partners.
• Israel to present delayed draft chemicals law ‘soon’ Government had expected to adopt a final version in 2021.
• Global managing editor Kate Lowe caught up with Chemical Watch reporters to find out about developments in Brazil, the biggest changes in transport and storage regulation, and news on the regulation of PFASs in the US.
• Phthalate substitute plasticiser may cause thyroid disruption in fish, study finds – BPA may increase thyroid cancer risk for obese people, study suggests.
• Unep has published a report that provides policy makers with guidance and recommendations on how to integrate chemicals management into electronics public procurement policies. It recommends, among other things, that public sector organisations explicitly define their approach to chemicals management and the mitigation of impacts.
• Green Seal ecolabel to extend PFAS-free requirements.
• Scientists pinpoint exposure hotspots with georeferenced data in environmental risk assessments.
• Some regions, particularly those without well-established chemicals legislation, are showing strong interest in how the EU is progressing with plans to manage substances under its strategy for sustainability (CSS), according to the European Commission’s head of sustainable chemicals. In particular, countries are interested in the development of the EU’s safe and sustainable by design (SSbD) framework.
• Regulators urged to follow clinical view of thyroid anomalies.
• Genomics study finds shared disease pathways for humans and environmental test organisms.
• An industry study based on the ‘next generation risk assessment’ (NGRA) concept has found no evidence of endocrine disruption for widely used antioxidant butylated hydroxytoluene (BHT). BHT, or 2,6-di-tert-butyl-4-methylphenol, is used to extend the shelf life of many products, including personal care items and cosmetics.
• Robo-regulator? Experts suggest switching to AI for environmental risk assessment.