AUSTRALIA

Australia Updates HCIS, Including Amended GHS Classifications: Safe Work Australia (SWA) announced on May 9, 2018, that it completed an update of the Hazardous Chemical Information System (HCIS), a web-based system that provides information on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classifications, as well as workplace exposure standards. The update incorporates classification information published in tranches 8 to 20 of the Inventory Multi-Tiered Assessment and Prioritization (IMAP) Program run by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The update comprises the addition of 755 new chemicals and amendments to classifications for 672 listed chemicals. To see new and amended chemicals, use the advanced search feature to show chemicals that were revised the week of May 7, 2018.

SWA Publishes Methodology For Review Of Workplace Exposure Standards: On June 14, 2018, SWA announced that it published the methodology that it will use to review the regulatory framework for workplace exposure standards for airborne contaminants. The purpose of the review is to develop a list of health-based recommendations for workplace exposure standards in Australia. SWA states that it will base recommendations for changes on an evaluation of available information from trusted domestic and international sources. It will use only publicly available information. The list of trusted primary sources includes:

• American Conference of Governmental Industrial Hygienists (ACGIH^®) -- Threshold Limit Values (TLV^®);
• Deutsche Forschungsgemeinschaft (DFG) -- Maximum workplace values (MAK values);
• European Union (EU) Scientific Committee on Occupational Exposure Limits (SCOEL) -- Occupational exposure limits (OEL);
• American Industrial Hygiene Association/Occupational Alliance for Risk Science (AIHA/OARS); and
• Health Council of the Netherlands (Dutch Expert Committee on Occupational Safety).

The list of trusted secondary sources includes:

• The United Kingdom (UK) Health and Safety Executive;
• Australian Institute of Occupational Hygienists (AIOH) position papers -- recommendations for workplace exposure standards;
• Nordic Council: The Nordic Expert Group for Criteria Documentation of Health Risks of Chemicals;
• NICNAS;
• Australian Pesticides and Veterinary Medicines Authority (APVMA);
• European Chemicals Agency (ECHA);
• International Agency for Research on Cancer (IARC);
• National Toxicology Program (NTP);
• U.S. Environmental Protection Agency (U.S. EPA);
• Organization for Economic Cooperation and Development (OECD); and
• U.S. National Institute for Occupational Safety and Health (NIOSH).

According to SWA, the review will result in recommendations for the workplace exposure standard values, notations, and the list of chemicals. SWA will publish the recommendations and supporting information in individual evaluation reports for each chemical. The methodology includes criteria developed to identify chemicals to be added or removed from the workplace exposure standards list to ensure it is reflective of contemporary Australian workplaces. It lists chemicals that will be evaluated as part of the review of the workplace exposure standards and chemicals that have been identified as potential candidates to be removed from the workplace exposure standards list. The evaluations of individual chemicals will commence in the second half of 2018 and include an independent peer review process.

BRAZIL

MAPA Establishes Specifications For Organic Plant Protection Products: The Ministerio de Agricultura, Ganadería y Abastecimiento (Ministry of Agriculture, Livestock and Supply, MAPA) has issued its Instrução Normativa Conjunta SDA/SMC N° 01 (Instrução). The Instrução, a Technical Regulation that amends Annex II of SDA/SDC N° 02 (12 July 2013), establishes the reference specifications for plant protection products approved for organic agriculture.

Anexo II of the Instrução lists the 33 substances, by name and Chemical Abstracts Service (CAS) number, as well as the minimum and maximum levels approved for such use.

Industrial Chemicals Regulation Moves Forward -- Slowly: In previous issues of this memorandum, The Acta Group (Acta^®) has provided updates on the development of Brazil's Regulação de Substâncias Químicas Industriais (Industrial Chemicals Regulation, Regulação), as it moves through the legislative process. During the most recent meeting of the Comissão Nacional de Segurança Química (National Commission of Chemical Safety, CONASQ), the group completed the review of comments submitted with respect to how new substances would be managed under the Regulação (Article 2) and began discussing Article 3, the article related to exemptions. The next CONASQ meeting is scheduled for June 25 and 26, 2018, where the Commission expects to complete discussion on Article 3 and begin the discussion of “Cost Recovery” (Article 12).

COLOMBIA

Colombia Issues Draft Decree Regarding Industrial Use Chemicals Management: On May 25, 2018, the Ministerio de Salud y Bienestar Social (Ministry of Health and Social Welfare) issued its Proyecto de Decreto (Draft Decree) entitled “Por el cual se reglamenta la gestión integral de las sustancias químicas de uso industrial y se toman otras determinaciones” (Draft Decree Regulating The Integral Management of Chemical Substances for Industrial Use And Containing Other Determinations).

The Draft Decree defines “instruments of management” (Instruments) for chemicals designed for industrial use. The Instruments are essentially rules and processes for the handling of such substances, and include categories such as risk reduction and management programs, environmental risk assessments, and monitoring of specific chemical substances for industrial use, among others. In addition, the Draft Decree contains obligations for importers, manufacturers, transporters, and users, as well as specific sections relating to data management and use (e.g., mutual acceptance of data, exchange of confidential business information (CBI)), and inspection, monitoring and control aspects.

Comments must be received by July 22, 2018.

EU

DCG Calls For Companies To Continue Their Cooperation After The Registration Deadline: On May 31, 2018, ECHA issued a press release announcing that the Directors’ Contact Group (DCG) has published a recommendation urging registrants of phase-in substances to continue their current cooperation arrangements from June 1, 2018, onwards to ensure compliance with the post-deadline legal obligations. These obligations include:

• Keeping the joint part of the registration up to date, reflecting the most recent information on hazards, uses, and risk management measures;
   
• Coordinating joint responses to regulatory requests; and
   
• Managing data and cost sharing with new registrants joining the registration.
   

According to ECHA, the recommendation states that registrants are free to agree on the form of cooperation, but that they should have a contract in place to manage the chosen collaboration platform. The contract should ensure that only information that is necessary to complete the regulatory task is shared among the co-registrants, and that administrative costs for managing the platform are fairly distributed. More information is available in ECHA’s press release, “Call for companies to continue their cooperation after the deadline.”

Over 21,000 Chemical Substances Registered Under REACH: On June 1, 2018, ECHA issued a press release entitled “21 551 chemicals on EU market now registered.” In its press release, ECHA states “[t]he 10-year registration period for existing chemicals is now complete following the last REACH registration deadline on [May 31, 2018]. 13 620 European companies have submitted information to ECHA in nearly 90 000 registrations for chemicals manufactured in or imported to the EU and [European Economic Area (EEA)] at above one tonne a year.”

ECHA indicates that more is known today about chemicals used in Europe than ever before. This knowledge, generated by industry, is stored and published by ECHA in the world’s largest public regulatory database on chemicals and forms the basis for protecting citizens and the environment from the risks posed by chemicals. ECHA provides that over the first ten years of REACH, the EU has established a fair and transparent internal market for chemicals with strict safety rules, thereby promoting innovation towards safer substances and strengthening EU competitiveness.

ECHA’s REACH Registration Results indicate that registrations for 21,551 substances were submitted to ECHA, and 20,608 of these registrations were completed. The total number of completed registrations, including joint submissions for the same substance and Notification of New Substances (NONS) notifications, is 82,874. The highest number of REACH registrations was submitted by Germany and the UK. The registrations are distributed among REACH tonnage bands as follows:

• 1-10 tonnes per year = 14,865 completed registrations;
• 10-100 tonnes per year = 11,080 completed registrations;
• 100-1,000 tonnes per year = 12,489 completed registrations; and
• 1,000 tonnes per year and more = 20,113 completed registrations.

ECHA Begins Public Consultation On Updating The Authorization List Entries For Four Phthalates With Endocrine Disrupting Properties: In 2011 and 2012, bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), and diisobutyl phthalate (DIBP) were identified as substances of very high concern (SVHC) due to their classification as toxic for reproduction and subsequently added to the Authorization List. In 2014 and 2017, the four phthalates were identified as SVHCs for authorization due to endocrine disrupting properties with effects on human health and, in the case of DEHP, also on the environment. ECHA updated the Candidate List entries for these substances accordingly. According to ECHA, later in 2018, the European Commission (EC) intends to amend the current entries of these substances in the Authorization List to include the endocrine disrupting properties as intrinsic properties referred to in REACH Article 57. ECHA has begun a public consultation targeted at the sectors affected by such amendment of the Authorization List. ECHA states that in particular, it seeks information about the uses that might no longer be covered by generic exemptions from the authorization requirement, such as uses in food contact materials and in medical devices, as well as transitional arrangements, exemptions, and review periods. The EC will examine separately uses already subject to authorization. Comments are due August 6, 2018. More information is available in ECHA’s June 5, 2018, press release, “Consultation on four phthalates for updating their Authorisation List entries with endocrine disrupting properties.”

NGOs Criticize ECHA’s Microplastics Restriction Proposal: In January, the EC requested that ECHA prepare an Annex XV restriction dossier “in view of a possible restriction of synthetic water-insoluble polymers of 5mm or less in any dimension (i.e., microplastic particles).” In its request, the EC stated:

ECHA’s call for evidence on the microplastics restriction proposal closed in May 2018. Non-governmental organizations (NGO) have been critical of ECHA’s efforts in terms of, and approach towards, developing a suitable restriction for microplastics. On June 5, 2018, ClientEarth issued a press release entitled “ECHA favouring microplastics industry opinion over scientific evidence of environmental damage.” In its press release, ClientEarth expresses that ECHA has been favoring industry during its initial gathering of evidence on microplastics, prompting environmental organizations to remind ECHA not to overlook or underestimate the risks for health and the environment when preparing the proposal to restrict the use of this pollutant.

ClientEarth’s press release refers to a letter sent to ECHA by ClientEarth, the European Environmental Bureau (EEB), the Health and Environmental Alliance (HEAL), the International Chemical Secretariat (ChemSec), Women Engage for a Common Future (WECF International), and Greenpeace, with the support of the Rethink Plastic Alliance. The letter raises concerns that ECHA “will unduly limit the scope of upcoming restriction proposals, by taking on board industry concerns before [ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC)] are in a position to give their scientific opinions.” In particular, the NGOs criticized ECHA’s management of the call for evidence, stating that they witnessed ECHA, “in its external communication”:

• Lacking the objectivity required by its role in the restriction process; and
• Misinterpreting the conditions that may justify the addition of derogations to the restriction.

The NGOs express concern regarding the “long overdue” restriction on microplastics being undermined by ECHA’s current approach, and state that ECHA has not fully integrated the lessons learned from the REACH review. The NGOs suggest in the letter that ECHA was excessively focused on protecting the interests of industry, rather than human health and the environment. Furthermore, the NGOs suggest that ECHA misinterpreted REACH and did not apply appropriately the Precautionary Principle.

Consequently, the NGOs “ask the Management Board to correct this maladministration and misinterpretation of REACH” by ensuring that ECHA gives “a proper weight” to the evidence showing risks to human health and the environment versus other factors and does not require a higher level of proof to demonstrate a risk than to demonstrate the justification for a derogation. The NGOs request further clarifications in public on specific issues, and express that “ECHA needs to adopt an approach fit to meet the original expectations of the restriction process, which involve ensuring that no information on risk is overlooked and that derogations are considered only when the risk is proven to be adequately controlled.”

On June 11, 2018, ECHA responded to the NGOs’ letter, stating:

EDC Identification Criteria Under BPR Come Into Effect: On June 7, 2018, the scientific criteria for identification of endocrine disrupting chemicals (EDC) came into force under the Biocidal Products Regulation (BPR). ECHA’s Biocidal Products Committee is required to assess biocidal active substances against the new criteria. ECHA, in its press release entitled “Guidance on identifying endocrine disruptors published,” states “[a] drafting group consisting of scientific staff from ECHA and the European Food Safety Authority (EFSA), with the support of the Joint Research Centre (JRC), have developed scientific guidance to enable the identification of endocrine disruptors. The guidance advises applicants and assessors of the competent regulatory authorities on how to identify endocrine disruptors in accordance with the endocrine disruptor criteria.”

The EC tasked ECHA and EFSA to develop the guidance to support harmonized implementation of the EDC identification criteria across the EU for the assessment of biocides and plant protection products. The guidance has been reviewed by stakeholders, ECHA’s EDC expert group, and Member States’ biocides and pesticides Competent Authorities. ECHA hosted a webinar on June 19, 2018, to explain the practical implementation of the criteria and the new guidance to affected companies and authorities with obligations under BPR. Additional information on EDCs in Europe is available on ECHA’s Hot Topics web page.

JRC Science For Policy Brief Addresses Safety Of Chemical Mixtures:JRC has published a May 2018 JRC Science for Policy Brief entitled “Something from nothing? Ensuring the safety of chemical mixtures.” The Policy Brief includes the following headlines:

• Humans and the environment are exposed to a cocktail of chemicals from different sources;
• Combined exposure to multiple chemicals can lead to health/environmental effects even if single substances in the mixture do not exceed safe levels;
• The assessment and management of mixtures is only partly covered by current legislation, which focuses on single substances in isolated sectors;
• Methodology to address mixture risks is available, yet many knowledge gaps need to be filled. In particular, real co-exposure patterns are mostly unknown; and
• JRC is performing research on new strategies to assess the combination effects of chemicals.

ClientEarth States EC’s Delayed Decisions On Chemicals Are Endangering Human Health And Environment: ClientEarth, an NGO, issued a press release on June 11, 2018, stating that “human health and the environment are being put at risk because of excessive delays in chemical regulatory decisions by the [EC].” ClientEarth states that “[‌i]n many cases companies are free to use chemicals, some known to be dangerous – in some cases for up to four years – while decisions to restrict or [authorize] their use have been sitting on Commission desks.”

ClientEarth states that according to its research, EC decisions are “delayed unreasonably in a whopping 96 [percent] of all [authorization] cases and in 89 [percent] of all restriction cases.” In a footnote to its press release, ClientEarth indicates that delays were calculated by considering applicable procedures and the time already spent by ECHA to provide its in-depth scientific assessment. ClientEarth suggests that “those highlighted to be most at risk are workers, as the majority of decisions relate to chemicals in production and manufacturing processes.”

Under REACH, ECHA’s scientific committees are responsible for assessing the risks of chemicals. On the basis of these assessments and with support from Member States, the EC decides whether companies should be granted authorizations to use SVHCs. The EC also decides whether to restrict uses of chemicals where risks are not adequately controlled. While the EC’s decisions are pending, companies may continue to use the chemicals in question. ClientEarth lawyers Alice Bernard and Apolline Roger were critical of the EC’s delayed decision-making, and highlighted disparities in time frames required to make decisions under seemingly similar circumstances.

As an example, ClientEarth cites DEHP, a plastic-softening chemical found to be a “hormone-disrupting substance toxic for human reproduction – that is used to make plastic PVC items.” ClientEarth indicates that ECHA’s scientific committees concluded in 2014 and 2015 that the companies requesting authorization for DEHP were using it without adequately controlling its risks for workers exposed during production. ClientEarth states that “[as] of June 2018, the Commission has still not yet adopted a final decision on these cases, meaning companies remain free to continue using the chemical as they see fit.”

ClientEarth has written to the EC sharing the detailed findings of its study “showing a clear trend of unreasonable delay,” and “calls on the [EC] to use its power and resources to correct its maladministration and speed up the [authorization] and restriction processes under the [REACH regulation].”

ECHA And Cefic Sign Joint Statement Outlining Their Future Cooperation To Implement REACH: On June 15, 2018, ECHA and the European Chemical Industry Council (Cefic) signed a cooperation agreement intended to contribute to improving REACH implementation. ECHA states in its June 15, 2018, press release, “ECHA and Cefic sign joint statement to work on effective implementation of REACH,” that the agreement “is a commitment from both industry and ECHA to focus on improving the scientific assessment of some substances or groups of substances, further enhancing safety information and its communication across the supply chain.” ECHA and Cefic have also agreed to work jointly to solve scientific and technical challenges by facilitating technical discussions between experts and to improve the transparency on the quality of dossiers. According to the Joint Statement, ECHA and Cefic will “[a]gree on the identification of specific substances or groups of substances which require discussion on critical issues.”

IARC

Advisory Group Will Meet In 2019 To Recommend Priorities For IARC Monographs: IARC announced that its Advisory Group will meet March 25-27, 2019, to recommend priorities for the IARC Monographs during 2020-2024. IARC is seeking scientists who wish to be considered for membership in the Advisory Group to Recommend Priorities for the IARC Monographs. The call for experts will close August 12, 2018. IARC states that it is interested in nominations of agents for future evaluation by the IARC Monographs, for consideration by the Advisory Group. IARC will make pertinent nominations available to the Advisory Group, and no material will be treated as confidential. The call for nominations of agents will close December 23, 2018. In the interest of transparency, IARC welcomes observers with relevant scientific credentials to attend its meetings. IARC notes that observers should not attempt to influence it, and this includes a requirement not to contact participants before the meeting or to lobby them at any time. Requests for observer status are due October 24, 2018.

ISRAEL

Israel Considers Updates to Hazardous Substances Law: The Israeli Ministry of Environmental Protection has informally commented that there are plans to update the Hazardous Materials List, which is in Annex I and Annex II of the Hazardous Substances Law (1993) to align it with the EU’s Classification, Labelling and Packaging (CLP) regulation, but neither a time frame nor official notification has been put forth by the Ministry.

OECD

OECD Assesses Alignment Of Industry Programs With OECD Minerals Guidance: In 2016, OECD launched a project to develop and pilot test an assessment methodology for evaluating the extent to which industry programs align with the recommendations of the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas. On April 17, 2018, OECD published a report presenting the findings of the pilot alignment assessment of the following five industry programs against the recommendations of the OECD Due Diligence Guidance:

• Connflict Free Smelter Initiative;
• International Tin Supply Chain Initiative;
• London Bullion Market Association;
• Responsible Jewelry Council; and
• Dubai Multi Commodities Center.

When reassessed in early 2018, most of the programs’ standards were in, or close to, full alignment. OECD plans a full reassessment of the implementation of the revised standards in 2019/2020. According to OECD, without reassessing the implementation, “it was impossible for any of the programmes to improve their rating to ‘fully aligned’ in this pilot assessment, given the shortfalls observed in programme implementation identified during the 2016 assessment activities.” OECD states that the “challenge now will be to ensure that the revised due diligence requirements are effectively implemented across the industries covered by the programmes.”

OECD Calls For Data On PFASs And Alternatives: OECD is collecting data on per- and polyfluoroalkyl substances (PFAS) for a new report entitled PFASs and Alternatives -- Commercial Availability and Current Uses. OECD has posed a questionnaire for stakeholders to provide information on current uses of alternatives to PFASs, specifically on the three following sectors:

• Textile and shoes: Covering apparel and outerwear, workwear (worker protection, uniforms), and other textiles. Shoes include casual and protective shoes;
• Firefighting foam; and
• Food packaging, including paper and paperboard.

OECD invites industry (chemical manufacturers and downstream users), public authorities, NGOs, and academia to complete the questionnaire. The deadline for response is July 31, 2018.

SOUTH KOREA

MOE Begins Public Consultation On K-BPR And K-REACH Proposals:On May 30, 2018, the Ministry of Environment (MOE) began a public consultation on draft proposals of the enforcement decree and enforcement rule of the Consumer Chemical Products and Biocides Safety Act (K-BPR). According to MOE’s press release, when applying for approval of a biocidal substance, applicants would be required to submit 13 kinds of data, including physical and chemical characteristics, biological characteristics, effects and efficacy, and human and environmental hazards, as well as a representative sample of the product containing the biocidal substance. Biocidal products are divided into four categories: bactericides (disinfectants); detergents; preservatives; and other. Existing biocidal substances would be those on the market as of December 31, 2018. The grace period would range from three to ten years for existing biocidal substances, depending on the type of biocidal product for which the biocidal substance is used.

In the same press release, MOE announced a public consultation on draft rules to implement the K-REACH amendments reported in Acta’s March 16, 2018, memorandum, “K-REACH Amendments Expected to Be Promulgated Shortly and Be Enforced January 2019.” The draft rules provide details on pre-reporting substances, tonnage band registration dates, simplified registration, and CBI exemptions for manufacturers and importers. Companies must pre-report the substances that they manufacture or import by June 30, 2019. Companies that fail to do so will be banned from manufacturing or importing beginning July 1, 2019. The first registration deadline of December 31, 2021, is for substances manufactured or imported in total volumes of 1,000 tonnes or more annually and high concern substances, such as carcinogenic, mutagenic, or reprotoxic (CMR) substances, manufactured or imported in total volumes of one tonne or more annually. Substances can qualify for a simplified registration if they are low concern substances or intermediate substances that are completely used up in production.

Comments are due July 9, 2018.

UK

DEFRA Begins Public Consultation On Environmental Principles And Governance After EU Exit: On May 10, 2018, the Department for Environment, Food and Rural Affairs (DEFRA) began a public consultation on the development of an Environmental Principles and Governance Bill. According to DEFRA, this legislation “will mark the creation of a new, world-leading, statutory and independent environmental watchdog to hold government to account on our environmental ambitions and obligations once we have left the EU.” The new body “will work alongside a new policy statement setting out the environmental principles that will guide successful and sustainable policy-making, marking the beginning of a new era for our environment.” The consultation document addresses some of the key questions around how environmental principles should be embedded into law, public policy-making, and delivery, and what functions and powers the new environmental watchdog should have to oversee environmental law and policy. DEFRA notes that the consultation proposals apply to England and reserved matters only. Comments are due August 2, 2018.

Irish HSA Launches Brexit Web Pages: Ireland’s Health and Safety Authority (HSA) has launched web pages intended to assist businesses in managing the potential impacts of Brexit. HSA states “[t]he UK continues to play a full role within the European regulatory network during the on-going negotiations in relation to its withdrawal from the EU. Although we do not yet know the eventual outcomes of these negotiations, potentially significant implications for Ireland and Irish companies are anticipated due to our shared market with the UK. While we [recognize] that there is still some uncertainty over the outcome of the Brexit negotiations, we are nonetheless planning on the basis that the UK becomes a third country as of [March 30, 2019,] and we now encourage businesses and stakeholders to do the same.”

HSA indicates that it is preparing for the impacts of Brexit on its “key policy and operational areas,” and that it has established an internal committee to ensure that it is prepared for the UK’s withdrawal from the EU. HSA states:

On its web page regarding REACH and CLP, HSA states that REACH registrations currently in place by UK companies will be invalid once the UK withdraws from the EU, as only EU legal entities can register under REACH. HSA indicates that at present, if an Irish company sources chemical substances from a UK supplier, its role under REACH is as a Downstream User. As a result, the Irish company currently does not face registration obligations. HSA indicates that following Brexit, the UK will be regarded as a “third country” with the consequence that Irish companies sourcing chemicals from UK suppliers following its withdrawal will lose their Downstream User status -- and be regarded under REACH as importers with registration obligations.

HSA advises Irish companies “finding themselves in such a situation” to speak to their UK suppliers and determine plans for Brexit. If the UK supplier does not intend to appoint an Only Representative, and if Irish companies wish to avoid registration under REACH, HSA advises that Irish companies consider sourcing the chemicals from another supplier based within the EEA.

HSA also highlights on its REACH and CLP web page that Irish registrants under REACH that are in a joint submission for which the Lead Registrant is based in the UK “need to be aware that the UK company’s registration will be non-existent following the UK withdrawal.” In such a situation, HSA provides that it should be ensured that the Lead Registrant moves to the EEA or that a legal entity change is completed “so that the current [Lead Registrant] becomes an EU-27/EEA based [Only Representative].” HSA indicates that alternatively, a new Lead Registrant can be appointed and the Lead Registrant role transferred before the date of the UK withdrawal.