Global Regulatory Update for September 2014

AUSTRALIA

Australia Publishes Tenth Tranche Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published for public comment the tenth tranche of human health and environmental assessments for chemicals identified as part of the Stage One implementation of the Inventory Multi-tiered Assessment and Prioritization (IMAP) Framework. NICNAS states that it seeks comments where information that has the potential to affect the outcome of an assessment has not been considered in the assessment. Comments provided should be evidence-based and the relevance of submitted information should be highlighted. Comments are due October 31, 2014. More information is available online.

CANADA

Canada Publishes Proposed Hazardous Products Regulation: On August 9, 2014, the Government of Canada published in Gazette I (Vol. 148, no. 32) a proposal for adopting the Globally Harmonized System for Classification and Labeling of Chemicals (GHS). The regulatory proposal seeks to align current systems for classification, material safety data sheets (MSDS), and labels with the U.S. Occupational Safety and Health Administration (OSHA) Hazard Communications Standard published on May 26, 2012 (HCS 2012) and the approaches used in other countries that have similar GHS legislations. In order to align with the U.S. HCS 2012, the proposed implementation would come into force no later than June 1, 2015. More details are available online and in The Acta Group’s September 3, 2014, memorandum.

Canada’s Energy And Mines Ministers Discuss Priorities For 2015, Including Reporting Requirements For Extractive Companies: On August 26, 2014, Natural Resources Canada issued a press release entitled “Our Resources, New Frontiers: Canada’s Energy and Mines Ministers Discuss Responsible Resource Development and Priorities for the Upcoming Year,” which highlights the outcomes of the Energy and Mines Ministers’ Conference in Sudbury, Ontario. The press release states that, in particular, the Ministers emphasized the need to continue working collaboratively over the coming year on several issues, including implementing mandatory reporting standards for payments made by the extractive sector to governments. The press release states that all provinces and territories support the principle of mandatory reporting standards for the extractive sector on payments to governments. With this support, the Government of Canada intends to enact legislation. According to the press release, the federal government will defer by two years the requirement for industry to report their payments made to Aboriginal governments and continue engaging Aboriginal groups regarding mandatory reporting standards. The press release is available online.

EUROPEAN UNION (EU)

ECHA Begins Consultations On Alternatives To The Uses Of Trichloroethylene And Diarsenic Trioxide: On August 13, 2014, the European Chemicals Agency (ECHA) began a public consultation on alternatives to trichloroethylene and diarsenic trioxide for the following specific uses:

The Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) will review and consider the comments in their opinion-making process. Based on RAC and SEAC’s final opinions, the European Commission (EC) will decide whether to grant the applicants an authorization for the uses for which they applied. Comments are due October 8, 2014. More information is available online.

ECHA Publishes New eGuide On SDSs And Exposure Scenarios: ECHA announced on August 18, 2014, the availability of a new eGuide on safety data sheets (SDS) and exposure scenarios. ECHA states that the eGuide is an interactive online publication that aims to provide information on SDSs and exposure scenarios in a user friendly way. According to ECHA, “ts simple structure makes it suitable as both a training tool and reference tool to help employees use chemicals safely.” The eGuide includes:

• Short informative video tutorials;
   
• Examples of SDSs and exposure scenarios;
   
• Clear descriptions of what information is contained in each section of the SDS and exposure scenario;
   
• Advice on what to do to promote safe use and regulatory compliance;
   
• A toolbox that allows the user to compare how they use the substance with the conditions contained in the exposure scenario;
   
• Answers to the most frequently asked questions;
   
• Annotated templates for exposure scenarios; and
   
• Supplementary information and useful links to other relevant sources.

ECHA states that this development forms part of its contribution to support processing and use of information related to chemical safety report and exposure scenarios at the end user level. More information is available online.

Non-EU Companies To Be Indicated In The List Of Biocidal Active Substances And Suppliers: ECHA announced on August 18, 2014, that it has formally agreed with the EC to publish the company names of non-EU entities together with their EU representatives in the Article 95 list of the Biocidal Products Regulation (BPR). ECHA states that, to ensure equal treatment, all non-EU manufacturers will from now on have the possibility to appoint an EU representative for the purposes of the Article 95 list. ECHA will contact non-EU companies participating in the Review Program for more information about their EU representatives. For those companies planning to make a submission representing non-EU entities, ECHA states that it has modified the supporting document to include this information. Beginning September 1, 2015, a biocidal product cannot be placed on the EU market if the substance supplier or product supplier is not included in the list for the product type to which the product belongs. More information is available online.

ECHA Updates Guidance On Testing For Mutagenicity: ECHA announced on August 19, 2014, that it published an update of the Guidance on Information Requirements and Chemical Safety Assessment — Chapter R.7a. According to ECHA, it updated the Guidance to take into account the recent adoption or revision of several Organization for Economic Cooperation and Development (OECD) test guidelines for genotoxicity testing. The update involved a complete revision of sub-sections R.7.7.1 to R.7.7.7, which are related to mutagenicity. The revised text also reflects the status of development of other test methods, as well as non-testing methods for mutagenicity. Further to this, ECHA updated the recommended testing strategy for mutagenicity. More information is available online.

EC Adds Nine Substances To Authorization List: On August 19, 2014, the EC published a notice in the Official Journal of the European Union adding nine substances to the Authorization List (Annex XIV of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation). ECHA prioritized these substances of very high concern (SVHC) in January 2013. The latest application dates range from February 2016 to July 2017. The substances are: formaldehyde, oligomeric reaction products with aniline (technical MDA); arsenic acid; bis(2-methoxyethyl) ether (diglyme); 1,2-dichloroethane (EDC); 2,2′-dichloro-4,4′-methylenedianiline (MOCA); dichromium tris(chromate); strontium chromate; potassium hydroxyoctaoxodizincatedichromate; and pentazinc chromate octahydroxide. The Authorization List is available online. The notice is available online.

EC Begins Online Consultation On Implementation Of The Minamata Convention: The EC is conducting an online consultation on issues related to the ratification and implementation by the EU of the Minamata Convention on mercury. The EU signed the Minamata Convention and intends to become a party. The EC notes that while the Minamata Convention largely contains measures similar to or identical to existing EU legislation, certain additional measures will be needed, however. In addition, certain elements of EU legislation need to be amended. According to the EC, gaps exist in EU legislation in the following areas:

• Import restrictions for metallic mercury from non-Parties;
   
• Export ban for certain products containing mercury;
   
• Mercury use in products and processes not yet placed on the market;
   
• Restrictions on certain processes where mercury is used; and
   
• Mercury use in artisanal and small-scale gold mining.

The consultation asks citizens, public authorities, businesses, and non-governmental organization (NGO) for their views. The EC will consider responses in the preparation of a ratification package by the EC services. The consultation will end on November 14, 2014. More information is available online.

ECHA Releases Data Sharing Dispute Decisions Under REACH And BPR: ECHA recently released 25 decisions on data sharing disputes under the REACH program and two decisions on data sharing disputes under the Biocides Product Regulation (BPR). Compensation for data sharing is to be determined under REACH and BPR by the same standard, that is, in a “fair, transparent and non-discriminatory manner,” and as such there are similar issues in the ECHA decisions under REACH and BPR. The decisions are available online. The Acta Group memorandum discussing data compensation and sharing under the BPR can be found online and an article is available online. More information regarding the decisions is available in The Acta Group’s August 25, 2014, memorandum.

ECHA Begins Public Consultation On Proposal To Add New Substances To The Authorization List: ECHA announced on September 1, 2014, that it has begun a public consultation on its draft recommendation of new substances to be included in the Authorization List. In parallel, ECHA is facilitating a call by the EC on the possible socio-economic consequences of the inclusion of these substances in Annex XIV. ECHA states that, based on an assessment of the data from the registration dossiers and other available information, and the initial consultation of the Member State Committee, it is considering recommending the following priority substances:

• Two substances obtained from coal tar: anthracene oil; and pitch, coal tar, high temp.;
   
• Seven lead substances: orange lead (lead tetroxide); lead monoxide (lead oxide); tetralead trioxide sulphate; pentalead tetraoxide sulphate; silicic acid, lead salt; pyrochlore, antimony lead yellow; and acetic acid, lead salt, basic;
   
• Four boron substances: boric acid; disodium tetraborate, anhydrous; diboron trioxide; and tetraboron disodium heptaoxide, hydrate;
   
• Seven phthalates: diisopentylphthalate; 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich; 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters; 1,2-benzenedicarboxylic acid, dipentylester, branched and linear; bis(2-methoxyethyl) phthalate; n-pentyl-isopentylphthalate; and dipentyl phthalate;
   
• 4-Nonylphenol, branched and linear, ethoxylated; and
   
• 1-Bromopropane (n-propyl bromide).

The recommendation also specifies the proposed conditions of the authorization requirement for each substance, including the latest application and sunset dates. ECHA states that the information obtained during the public consultation will be used to assess further the workload associated with the recommended substances and, where relevant, to refine the priority assessment using the agreed prioritization approach. ECHA expects that a subset of the above substances will be selected for its final recommendation to the EC. This will also take into account the capacity of ECHA and the EC to handle the applications within the timelines defined in the legislation. The EC will eventually decide which of the substances from ECHA’s recommendation to include in the Authorization List and on the respective conditions applicable for each substance. During the public consultation, there is also an opportunity to provide input for a call for information, by the EC, on the possible socio-economic consequences of the inclusion of the substances in Annex XIV. ECHA will pass such information directly on to the EC and will not consider it in the recommendation process. Comments are due November 30, 2014. More information is available online.

ECHA Begins Public Consultation On Identification Of SVHCs: On September 1, 2014, ECHA began a public consultation on ten proposals to identify new SVHCs:

Information is due October 16, 2014. More information is available online.

ECHA Announces New Restriction Q&As (Annex XVII To REACH): In its September 3, 2014, issue of e-News, ECHA announced that it prepared, in collaboration with the EC services, both new and updated Questions and Answers (Q&A) on restrictions related to toys and childcare articles. According to ECHA, the Q&As provide general definitions that apply for all restriction entries of REACH Annex XVII. In addition, clarifications are provided for phthalates restrictions. The new and updated Q&As are: 748, 982, 983, 984, and 985. The restriction Q&As provide guidance concerning the implementation of the restriction entries in REACH Annex XVII. The Q&As are available online.

President-Elect Juncker’s EC Will Move Biocides From DG Environment To DG Health And Consumers: On September 10, 2014, President-elect Juncker announced his team and the new shape of the next EC. According to Juncker, the new EC “will be streamlined to focus on tackling the big political challenges Europe is facing: getting people back to work in decent jobs, triggering more investment, making sure banks lend to the real economy again, creating a connected digital market, a credible foreign policy and ensuring Europe stands on its own feet when it comes to energy security.” The September 10, 2014, press release includes the allocation of portfolios and supporting services for 2014-2019. Within the portfolio for Environment, Maritime Affairs and Fisheries, the parts of Unit ENV A3 (Chemicals) dealing with biocides will move from Directorate-General (DG) Environment to DG Health and Consumers. The press release states that the structural changes in the services listed will be implemented within three months following the entry in office of the new EC. The European Parliament (EP) must give its consent to the entire College of Commissioners, including the President and the High-Representative Representative of the Union for Foreign Affairs and Security Policy/Vice-President of the EC. This is preceded by hearings of the Commissioners-designate in the relevant Parliamentary committees. The hearings will be held September 29-October 7, 2014. Once the EP has given its consent, the European Council will formally appoint the EC. The press release is available online.

ECHA Announces RAC And SEAC Support 16 Uses Of SVHCs: On September 17, 2014, ECHA announced that RAC and SEAC have issued opinions in support of authorizing the use of SVHCs. ECHA states that the opinions are based on eight applications for 16 specific uses from companies in which they gave reasons for continuing use of the substance and described their plans to replace the SVHCs with safer alternatives in the future. RAC also adopted its opinion on a proposal to restrict the use of cadmium and its compounds in paints. SEAC reached agreement on that same proposal to restrict the use of cadmium, as well as a proposal to restrict the use of 1-methyl-2-pyrrolidone (NMP). SEAC also adopted an opinion on the restriction proposal on nonylphenol and nonylphenol ethoxylates. ECHA states that it will send the following draft opinions to the applicants for their comments before RAC and SEAC prepare their final opinions:

RAC adopted its opinion and SEAC agreed on a draft opinion in support of the ECHA proposal to restrict cadmium and its compounds in paints. The proposed restriction is an amendment to an existing restriction. In the current entry, only “use” is restricted, and there is no concentration limit. ECHA states that the reason for the amendment is that “use” could be interpreted to mean intentional use only, thus the restriction might be understood as not covering potential cadmium impurities. In addition, as the current entry does not provide a limit value for cadmium in those paints, according to ECHA, the enforcement of the restriction is challenging. SEAC agreed on a draft opinion on the Dutch proposal to restrict the manufacturing and use of NMP. SEAC concluded that the proposed restriction, adjusted by RAC in line with its opinion of June 2014, is the most appropriate EU-wide measure to address the identified risks in terms of cost-effectiveness. Comments on SEAC’s draft opinions are due November 14, 2014. SEAC intends to adopt its final opinions by December 2014. SEAC adopted by consensus its final opinion on the Swedish proposal to restrict nonylphenols/nonylphenol ethoxylates in textile articles, or textile parts of articles, that can be washed in water. SEAC confirmed its draft opinion of June 2014 that the proposed restriction is justified and not disproportionate, provided that the scope and conditions are modified as stated in the RAC opinion. ECHA states that, having considered the two comments received during the public consultation on the draft opinion agreed in June 2014, SEAC did not introduce any changes to its opinion. More information is available online.

ECHA Will Hold Webinar On Mixture Classification And Communicating Safe Use Of Mixtures — Advice For Formulators And Importers: On November 5, 2014, ECHA will hold a webinar on the classification of mixtures and how information on the safe use of mixtures can be communicated in the supply chain. The webinar is intended to help formulators and importers understand and implement their obligations according to the REACH and Classification, Labeling, and Packaging (CLP) regulations relating to mixtures. ECHA states that, in anticipation of the 2015 deadline for classifying mixtures according to CLP, the webinar will describe the steps a supplier should take to (re)classify mixtures. It will also describe how formulators can handle and communicate the information they receive in exposure scenarios for hazardous substances. The related REACH and CLP obligations will be outlined and participants guided to the range of support material that is available to help fulfil these obligations. Registration is available online.

ECHA Will Provide Advance Notice On Substances Being Considered For Risk Management: ECHA announced on September 23, 2014, that its website now provides advance notice on the substances being considered by authorities for regulatory risk management, together with the routes that are being considered. ECHA states that this information was agreed as part of the roadmap to include all relevant SVHCs on the Candidate List by 2020. According to ECHA, the advance notice is intended to increase the predictability and transparency of the process by which substances are considered for regulatory risk management action. Registrants of those substances will have “the opportunity to make sure that their registration data is up to date and to consider their business strategy in addressing these substances of potential concern.” All stakeholders will have the chance to gather information and prepare for possible future public consultations. The Public Activities Coordination Tool (PACT) lists the substances to be addressed and the risk management options being considered. Once completed, it will include the conclusion of the Risk Management Option Analysis (RMOA). The RMOA aims to identify whether further regulatory risk management activities are needed for a substance and if so, to identify the most appropriate instrument to address the concern. The responsibility for the content of an RMOA lies with the authority that produced it. Once a risk management route has been decided upon, the usual consultation processes and decision making will take place, as defined in REACH. More information is available online.

JAPAN

NITE Publishes Brochure On Chemical Management Center In English: The National Institute of Technology and Evaluation (NITE) published a brochure, in English, that provides an operational overview of the Chemical Management Center. The brochure describes its operations related to enforcing laws on chemical management, including the Chemical Substances Control Law (CSCL), Chemical Weapons Act, and Pollutant Release and Transfer Register Law. The brochure also describes the provision of information and arrangement of technology infrastructures on chemical management. The brochure is available online.

Japan Introduces Simplified Notification System For Small Volume New Chemical Intermediates: The Ministry of Health, Labor, and Welfare (MHLW) is amending the CSCL to introduce a simplified system for the manufacture or import of small amounts of new chemical intermediates. Effective October 1, 2014, “the small amount intermediate new substance confirmation system” will be available for new chemical intermediates that are manufactured or imported in volumes of one tonne or less per company annually. More information is available, in Japanese, online.

OECD

OECD Posts Report On Workshop On Children’s Exposure To Chemicals: On September 15, 2014, OECD posted a document entitled Report on OECD Workshop on Children’s Exposure to Chemicals. The Report outlines the results of an October 7-8, 2013, expert workshop on estimating children’s exposure to chemicals. The Report provides summaries of the presentations, the results of group discussions, and recommendations of possible follow-up actions. According to the Report, the main outcomes of the workshop are: (1) a draft decision tree to provide risk assessors in deciding when to perform children-specific exposure and risk assessment; and (2) a gap analysis with recommendations for further work on specific exposure assessment issues such as hand-to-mouth contact. The Report states: “It is expected that the decision tree will be elaborated by being applied to some cases and possible actions will be considered for initiating further activities.” The Report is available online.

SOUTH KOREA

K-REACH Joint Registration Pilot Project Announced: The Korea Chemical Management Association (KCMA) and the Korea National Cleaner Production Center (KNCPC) will oversee a pilot project to test tools and procedures for the joint registration of substances under the Act for the Registration and Evaluation of Chemicals (K-REACH). The project, which will end in May 2015, is intended to produce registration dossiers by April 2015 for seven substances that will be included in the first registration priority list: m-tolylidene diisocyanate; dibenzoyl peroxide; 4,4’methylenedianiline; hydrogen bromide; methyl-m-phenylene diisocyanate; trichloroethylene; and butyl glycidyl ether. Each substance will be assigned to a different consultancy. More information is available, in Korean, online.

TAIWAN

Taiwan Announces Draft Rules For The Registration Of New And Existing Chemical Substances: The Environmental Protection Administration announced on August 25, 2014, draft rules for the registration of new and existing chemical substances. The draft rules are part of the implementation of the revised TCSCA, which will take effect December 11, 2014. The draft rules include the following:

• Registrants, including a legal entity, unincorporated body, or administrative agency, would be able to register a new or existing chemical substance directly or appoint a representative;
   
• A “standard registration” would be required for new chemical substances manufactured or imported in annual quantities of one tonne or more and for substances manufactured or imported for scientific R&D or for product or process-oriented R&D in quantities of over 100 tonnes per year;
   
• Substances classified as carcinogenic, mutagenic, or toxic for reproduction would be subject to standard registration;
   
• Standard registrations would be valid for five years, while simplified registration and small quantity registrations would be valid for two years;
   
• Prospective registrants of the same chemical substances would be allowed to file a joint registration; and
   
• Registrants could apply for five-year permits to retain the confidentiality of some information for demonstrable reasons involving national security or commercial secrets.

A spokesperson for the Department of Environmental Sanitation and Toxic Substance Management suggested comments be submitted by October 15, 2014. More information is available, in Chinese, online. Taiwan submitted a copy of the draft rules, in English, to the World Trade Organization, and the draft is available online.

UNITED KINGDOM (UK)

UK Publishes Draft Regulations For Extractive Industries Reporting: On August 21, 2014, the Department for Business, Innovation and Skills (BIS) published the government response, impact assessment, and draft regulations for extractive industries reporting. The government response sets out how the government will implement Chapter 10 of the Accounting Directive (2013/34/EU) requirements in the UK. BIS states that the government has decided that:

• In line with the Prime Minister’s Group of Eight (G8) commitment, it will introduce regulations later in 2014;
   
• Companies will be required to report payments to governments for financial years from January 1, 2015; and
   
• The regulations will detail the penalty regime, which is based on existing offences in the Companies Act 2006.

Under the draft regulations, large energy, mining, and forestry companies would be required to disclose payments made to foreign governments. Companies subject to the regulation would have 11 months after the end of the financial year to file reports detailing information about project-level payments totaling more than £86,000, including payment amounts and types, as well as how much of the money went to individual projects. More information is available online.

UK Will Comply With 365-Day Phase Out Period Under EU BPR: The UK Health and Safety Executive (HSE) published a notice on September 16, 2014, concerning the impact of the EU Biocides Regulation amending Regulation (334/2014) on Certificates of Exemption issued under the UK Biocidal Products and Chemicals Regulation. The original text of the EU BPR did not include a provision to allow a phase out period for existing stocks of biocidal products that did not comply with the conditions of authorization granted under the EU BPR. In the absence of such a phase out period, the UK continued to apply the existing 18-month phase out period it used prior to the EU BPR as an interim measure. The UK highlighted the absence of a phase out period to the EC, and a 365-day phase out period has been included in Article 89(4) of the recent update of the EU BPR. In the notice, HSE states that any product authorized in the UK on or after October 1, 2014, will receive the 365-day phase out, which consists of:

• 180 days in relation to making available on the market of existing stocks; and
   
• 365 days in relation to the use of existing stocks.

The HSE notes that the 180-day period for continuing to make the product available on the market relates to all making available of the biocidal products from the top of the supply chain (e.g., manufacturer or formulator) down to when the user receives it (e.g., from a distributor or retail store/website). According to the HSE, in “the next few days,” holders of Certificates of Exemption affected by this change will receive letters outlining the change.