Global Regulatory Update for June 2015

AUSTRALIA

APVMA Seeks Stakeholder Input Into The User Of International Data, Assessments, Standards, And Decisions: The Australian Pesticides and Veterinary Medicines Authority (APVMA) began a public consultation on April 15, 2015, on the formation of its policy on the use of international data, assessments, standards, and decisions. APVMA developed criteria intended to indicate clearly how international data, standards, and assessments can be better used as part of the risk assessment processes that it is required to undertake as part of the approval of an active constituent, registration of a product, or approval of a label. These criteria are listed in the draft policy document, which also outlines:

• Existing standards already in use;
   
• Circumstances in which international standards may not be used;
   
• APVMA’s position on the use of overseas regulatory decisions; and
   
• Requirements for the protection of intellectual property.

Comments are due July 10, 2015.

Australia Reforms NICNAS To Simplify Chemical Assessments: The Department of Health (DOH) announced on May 26, 2015, that there will be reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to streamline the assessment process for industrial chemicals. The reforms are intended to reduce the regulatory burden on the sector while ensuring Australia’s robust safety standards are maintained, and to ensure that the level of assessment of industrial chemicals is proportionate to the potential risks they pose. The reforms will include:

• Rebalancing pre- and post-market regulatory requirements to match the indicative risk profile of a new chemical;
   
• Streamlining the existing risk assessment process for new and existing chemicals;
   
• Greater use of international assessment materials; and
   
• More appropriate compliance tools.

Assistant Minister for Health Fiona Nash stated that DOH will work with all stakeholders to draft the new assessment framework before legislation is submitted to Parliament. According to Nash, although the reforms will be fully implemented by September 1, 2018, the government will make an upfront investment of $7 million so that the full costs of the reforms can be recovered from industry over a seven-year period. Questions and answers regarding the NICNAS reforms are available online.

CANADA

Canada Posts Information Regarding Canada-U.S. RCC On Chemical Management: On May 28, 2015, Environment Canada posted information concerning chemical regulation, with a focus on risk assessment, under the Canada-U.S. Regulatory Cooperation Council (RCC). The Regulatory Partnership Statement provides a general description of how Environment Canada and the U.S. Environmental Protection Agency (EPA) will work together going forward. The Regulatory Partnership Statement “outlines a consistent and predictable mechanism for engaging with stakeholders bi-nationally, with an aim to facilitate opportunities and reduce barriers to alignment, including minimizing the duplication of effort on key assessment and scientific tools.” The scope of work to be undertaken under the Regulatory Partnership will vary over time, but will center on work that will support chemical risk assessment including, but not limited to, the following areas:

• Information gathering;
   
• Information sharing;
   
• Technical work-sharing;
   
• Scientific collaboration;
   
• International collaboration; and,
   
• Risk assessment methodology.

According to the Regulatory Partnership Statement, the agencies “are open to other areas of potential cooperation, including areas of cooperation based on input from stakeholders.” Environment Canada, Health Canada, and EPA have developed a work plan describing medium-term collaboration activities in two areas:

• Approaches for regulatory reporting requirements for new uses of chemical substances, and
   
• Approaches for chemical risk assessment.

New FAQs Addresses SNAc Provisions: On June 3, 2015, Canada posted frequently asked questions (FAQ) regarding the significant new activity (SNAc) provisions under the Canadian Environmental Protection Act, 1999 (CEPA). The FAQs, which are intended to provide Canadians and businesses with basic information about the requirements under the SNAc provisions, address:

• What is the purpose of these provisions?
   
• What are the key elements of these provisions?
   
• How do these provisions affect Canadian businesses?
   
• What is the timeline for implementation?
   
• Where can I get more information?

CHINA

MIIT Releases Final Draft RoHS 2 For Public Comment: On May 18, 2015, the Ministry of Industry and Information Technology (MIIT) released for public comment its final draft of the Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products (RoHS 2), which would make a number of changes to the Management Methods for the Control of Pollution from Electronic Information Products (RoHS 1). Under RoHS 1, China restricts the level of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE) in electronic information products (EIP). The final draft includes the following provisions:

• Product scope would be expanded to electrical and electronic products (EEP) (reflected in the changed name of the regulation). The definition of EEP is similar to the European Union’s (EU) definition, which refers to devices and accessory products with a voltage rating not exceeding 1,000 V for alternating current and 1,500 V for direct current and function by means of current or electromagnetic fields and generate, transmit, and measure such currents and electromagnetic fields, excluding power generation, transmission, and distribution equipment;
   
• The scope of the restricted substances would be expanded from lead, cadmium, mercury, and hexavalent chromium to include their compounds;
   
• A Compliance Management Catalog that includes the EEP categories, the classes of restricted hazardous substances, the restricted use times, and the exemption requirements would be drafted. Listed EEP must comply with RoHS 2 requirements for restricted use of hazardous substances;
   
• Products listed in the Compliance Management Catalog would be managed under a national conformity assessment regime, restricting hazardous substances in EEP;
   
• The exemption for products manufactured in China for export would be removed; and
   
• Products must be marked with information, including the name and amount of hazardous substances and their location in products and recyclability, as well as the possible impact of inappropriate use or disposal to the environment and human health.

Comments were due June 17, 2015. No timeline has yet been set for the release of the Compliance Management Catalog.

EU

Deza’s Case To Suspend The Identification of DEHP As An Environmental Endocrine Disruptor On The Candidate List Was Rejected By The European Court Of Justice on May 6, 2015: Deza submitted an Application for Authorization for Bis (2-ethylhexyl)phthalate (DEHP) when it was only listed on Annex XIV as a reproductive toxic substance. It remains to be seen how the new listing as an environmental endocrine disruptor will affect the ongoing applications.

ECHA Publishes Consumer Exposure Example To Help Companies Comply With REACH: The European Chemicals Agency (ECHA) published on May 11, 2015, an illustrative example of consumer exposure to substances in articles to help companies comply with their obligations under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Under REACH, registrants must assess exposure and risk from a substance that becomes part of an article. They also must report the conditions of safe use in the exposure scenario. ECHA states that it published the example “as registrants have often not addressed this assessment in their registration dossiers.” According to ECHA, the example illustrates the level of knowledge and expertise required to make sure that exposure estimation tools are correctly used. It also demonstrates how the limitations within the models can be addressed, and how they can be reflected in the exposure scenarios for the chemical safety report. The example’s main objectives are:

• To emphasize the relevance of the article service life in the context of the chemical safety assessment;
   
• To show how the article service life can be assessed and how meaningful exposure scenarios can be generated from the assessment; and
   
• To explain what type of considerations are needed within such an assessment.

More information is available in ECHA’s press release, New consumer exposure example helps companies to comply with REACH.

EC Releases Report On Study Proposing 50 Enforcement Indicators For REACH And CLP: The European Commission (EC) announced on May 19, 2015, the publication of a report on the results of a study concerning developing enforcement indicators for REACH and the regulation on the classification, labeling, and packaging of substances and mixtures (CLP). The objective of the study was to propose a set of indicators that can be used to monitor and measure the performance of REACH and CLP enforcement. The report proposes a set of 50 enforcement indicators at the levels of the individual Member States, the Forum for Exchange of Information on Enforcement of REACH and CLP, and the EU as a whole. The report includes the following conclusions:

• The three levels for which indicators have been developed are not isolated from each other;
   
• Member State level indicators cover mostly the Organization for Economic Cooperation and Development (OECD) principles of good enforcement that relate to “selectivity” and “risk focus and proportionality,” followed by “clear and fair process” and “professionalism”;
   
• The proposed indicators and the systems for implementing them have been validated in terms of their costs and benefits; and
   
• Existing documentation contains many examples of other REACH and CLP enforcement indicators.

The report recommends several points of attention for the implementation of the enforcement indicators:

• Start the implementation of the indicators on all levels on the short term and further refine them in the course of using them. This will also allow further refinement of the indicators in the course of using them. The involvement of all parties (i.e., Member States, Forum, and the EC) is vital for the success of the implementation of the indicators.
   
• Further develop definitions for key terms that apply EU-wide and are used in the enforcement indicators. The Forum — together with National Enforcement Authorities for REACH and CLP, Member State Competent Authorities, the EC, and the relevant stakeholders — could contribute to develop shared definitions for these terms.
   
• Disseminate the Enforcement Indicators for REACH and CLP (ENFIND) results. The enforcement indicators can provide an effective tool for measuring and communicating the state of affairs of the enforcement of REACH and CLP to the regulations’ stakeholders and the general public.
   
• Further develop the additional indicators proposed in Annex C, including the EU level indicator to measure the extent to which the playing-field of enforcement of REACH and CLP is level in the EU.
   
• Develop consolidated indicators at the Member State and Forum level. These may be inspired by the consolidated indicator developed at the EU level (indicator EU12). The Forum can play an important role in developing these consolidated indicators at the levels of the Forum and the Member States.
   
• Leverage on the work done on the enforcement indicators by applying the proposed indicators to other regulations. The EC and the Member States can play an important role in this area.

EP Adopts Position On EC’s Conflict Minerals Proposal, Would Require Mandatory Compliance: On May 20, 2015, the European Parliament (EP), by a vote of 400 to 285, with seven abstentions, voted to overturn the EC’s conflict minerals proposal, as well an amended proposal adopted by the EP Committee on International Trade, and requested mandatory compliance for “all Union importers” sourcing in conflict areas. In addition, downstream companies would be required to provide information on the steps they take to identify and address risks in their supply chains for tin, tungsten, tantalum, and gold. The EP’s May 20, 2015, press release includes the following summary:

• Request for mandatory certification: As metal smelters and gold refiners are the last point at which the minerals’ origin can be effectively traced, the EP goes beyond the EC’s self-certification approach and calls for smelters and refiners to undergo a compulsory, independent, third-party audit to check their due diligence practices;
   
• Strengthened review clause: The EP “insists” on tougher monitoring of the scheme, with a review two years after it is applied and every three years thereafter (instead of after three and six years respectively, as proposed by the EC); and
   
• Geographical scope: The regulation would apply to all conflict-affected high risk areas in the world, of which the Democratic Republic of the Congo and the Great Lakes area “are the most obvious example.” The draft law defines conflict-affected and high-risk areas as those in a state of armed conflict, with widespread violence, the collapse of civil infrastructure, fragile post-conflict areas, and areas of weak or non-existent governance and security, characterized by “widespread and systematic violations of human rights.”

In a vote of 343 votes to 331, with nine abstentions, the EP chose not to close the first reading position and instead to enter into informal talks with the EU Member States to seek agreement on the final version of the law. In a May 19, 2015, speech, EU Trade Commissioner Cecilia Malmström stated that mandatory tracking for downstream companies was flawed and that the results of the U.S. Dodd-Frank Act proved it. After the EP’s vote, the EC stated: “Our first assessment shows that some amendments diverge widely from our proposal which focuses on the choke point of the supply chain (i.e. smelters and refiners).” According to the EC, the feasibility of the amendments adopted “will need to be assessed thoroughly.”

Appeal Submitted To ECHA To Annul Decision On Extended One-Generation Reproduction Toxicity Study May Be Precedent Setting: The Contested Decision was adopted in 2014 by the French Competent Authority, requesting to conduct an Extended One Generation Reproduction Toxicity Study (EOGRTS) by inhalation route under the Substance Evaluation process. The Appeal was submitted by Registrants of carbon tetrachloride: Akzo Nobel Industrial Chemicals GmbH (Germany), Dow Deutschland Anlagengesellschaft mbH (Germany), KEM ONE (France), INEOS ChlorVinyls Ltd (United Kingdom), Solvay Chimica Italia S.p.A. (Italy), and Solvay Electrolyse France SAS (France). The Appellants claim the following:

• The Contested Decision breaches the principle of proportionality as the requested study is not the least onerous measure to attain the pursued objective since it is excessive in terms of the number of animals sacrificed, and there is insufficient likelihood that it will provide meaningful results.
   
• The OECD 443 study is not introduced in the EC test methods (that has changed with the fifth Adaptation to Technical Progress of the EU Test Methods Regulation, Commission Regulation (EU) 900/2014 implemented), nor is it an internationally recognized test method. The EOGRTS has been adopted into the REACH information requirements with the EC Regulation (EU) 2015/282 and is applicable from March 13, 2015, EU-REACH being the first jurisdiction in the world to change the golden standard of reproductive toxicity testing, the OECD 416 study. The Regulation states only two-generation reproductive toxicity studies (B.35, OECD TG 416) that were initiated before March 13, 2015, shall be considered appropriate to address these standard information requirements under REACH. Even in this case, if the data show triggers for developmental neurotoxicity or developmental immunotoxicity, those concerns shall be addressed in different studies, which are addressed by Cohort 2 and Cohort 3 in the OECD 443 study.
   
• The Contested Decision breaches REACH Article 25(1), i.e., to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.
   
• ECHA infringed its duty to state reasons by failing to provide reasons why it changed its request from a two-generation reproduction toxicity study which was requested in the draft decision.
   
• ECHA breached the Appellant’s right to be heard; the Appellants were not able to review and comment on certain data submitted by the evaluating Member State Competent authority before the Member State Committee meeting’s Contested Decision was agreed upon.
   
• The Contested Decision breaches the principle of legal certainty and non-retroactivity as they were only notified about the deadline after which updates of their registration dossier were not taken into account after the deadline passed.

The result is expected 90 days from the hearing, which took place on May 20, 2015.

EC Asks For Ideas To Develop The Circular Economy: On May 28, 2015, the EC began a public consultation to collect views on the main policy options for developing a new approach on the circular economy. Stakeholders’ input will help feed the preparation of the new action plan, to be presented by the end of 2015. According to the EC, the policy options for developing a competitive circular economy in Europe will look at waste policy and beyond, and address the full product lifecycle, taking into account the situation in all Member States. It will include actions on intelligent product design, reuse and repair of products, recycling, sustainable consumption, waste policy, recycling levels, smart use of raw materials, stronger markets for secondary raw materials, and specific sectorial measures. The EC invites citizens, public authorities, businesses, and all other interested governmental and non-governmental parties to answer questions on the various parts of the economic cycle and their role in the transition to a circular economy. The EC states that it will open a separate public consultation on waste market distortions, and more information on this consultation is below. The EC will hold a stakeholders’ conference on June 25, 2015. The consultation will run until August 20, 2015.

Well-attended Endocrine Disruptor Workshop With Significant Press Representation: The EC finished a series of roundtable sessions with stakeholders regarding the “scientific criteria for the determination of endocrine-disrupting properties,” that culminated in a workshop on June 1, 2015. After a public consultation about the proposed options finished earlier this year, an external consultant was enlisted to conduct an Impact Assessment “which will assess the options outlined in the Roadmap for Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation and will consider the potential effects on health, environment, trade, agriculture and socio-economic aspects in general.” Parties from academia/research, industry, and regulatory authorities were invited to the workshop to share their opinions; the workshop also was followed with significant interest and representation by the press. The main topics were discussed in separate sessions as follows: scientific debate on criteria to identify endocrine disruptors; endocrine disruptors under EU legislation; potential impacts on industry and consumers; potential impacts on trade; and potential impacts on agriculture, health and the environment. The presentations were charged with heated debates, with emotions sometimes hindering agreement on common points. The EC presented on the status of the Impact Assessment. The EC plans to screen 700 substances (pesticides, biocides, cosmetics, and substances addressed under the Water Framework Directive and REACH) in a tight, ten-month period to compare how many and which substances would meet the endocrine disruptor criteria following the different options proposed by the Roadmap. The methodology for this evaluation is currently under development, beginning with a pilot project involving the screening of 5 percent of the 700 substances. The results of the pilot project will be presented during the next public workshop in Fall 2015. This evaluation by the EC is expected to be completed by the end of 2016. The ongoing activities under the umbrella of various governmental bodies such as the European Food Safety Authority (EFSA), the Ad-hoc Working Group under the Directorate General Environment and the Endocrine Disruptor Expert Advisory Group led by the Joint Research Centre (JRC), with regards to specific scientific topics (e.g., endocrine disruptor mixtures (EDC-MixRisk), non-monotonic dose-responses and low-dose effects), and test method development were also briefly introduced. The presenters emphasized the EU bodies’ commitments to define the criteria for endocrine disruptors, one of them under the 7th Environment Action Programme to 2020 to “tackle hazardous chemicals, including nanomaterials, chemicals that interfere with the endocrine system and chemicals in combination, as part of a broader, strategic approach for a non-toxic environment.” ECHA has also committed in the SVHC Roadmap to “have all currently known SVHCs included in the candidate list by 2020,” including endocrine disrupting chemicals. The legal deadline to define the criteria for endocrine disruptors as required by the Biocidal Products Regulation (EU) No. 528/2012 (BPR) and Plant Protection Product Regulation (EC) No. 1107/2009 (PPPR) by the end of 2013 has been missed already and, consequently, the EC faces legal actions from Sweden and various other parties. Participants asked for more clarity and transparency from the EC with regards to differentiating between hazard identification, hazard characterization (potency) and assessment based on risk, and also between the identification of endocrine disruptors and the legal implications thereof.

EC Adjusts REACH Fees For Inflation: The June 5, 2015, Official Journal of the European Union includes a regulation amending the regulation on fees and charges payable to ECHA, pursuant to REACH. The new fees and charges, which have been increased 1.5 percent, will enter into force on June 25, 2015. According to a June 8, 2015, ECHA press release, all REACH invoices will automatically reflect the new fees as of that date.

ECHA Asks Registrants To Consider New OECD Data On Nanomaterials: ECHA issued a June 9, 2015, press release reminding registrants to consider OECD’s dissemination of hazard information on the following nanomaterials, and to update their dossiers accordingly:

• Cerium oxide;
   
• Dendrimers;
   
• Fullerenes (C60);
   
• Gold nanoparticles;
   
• Multi-walled carbon nanotubes;
   
• Nanoclays;
   
• Silicon dioxide;
   
• Silver nanoparticles;
   
• Single-walled carbon nanotubes;
   
• Titanium dioxide (NM100-NM105); and
   
• Zinc oxide.

ECHA “encourages registrants of these substances to carefully assess the new data. When relevant, they should take this information into account and update their registration dossiers accordingly to ensure the safe use of their substances.” More information is available in the press release, OECD releases new data on nanomaterials — registrants asked to consider the information.

ECHA’s Management Board Adjusts Administrative Charge Levels: On June 12, 2015, ECHA issued a press release announcing that the Management Board revised the levels of the administrative charge. According to ECHA, the new scales of the charge take into account the financial gain made from an incorrect declaration of company size. The review leads to reduced levels of the administrative charge being applied in certain cases where a wrong company size is established, and where the difference between the incorrectly claimed fee and the applicable fee is small, such as for joint submissions in the low tonnage bands. The administrative charge is levied by ECHA on registrants that, in the process of verification, cannot prove their declared small- and medium-sized enterprises (SME) size category. More information is available in ECHA’s press release, Verification of fee reductions — ECHA’s Management Board adjusts administrative charge levels.

ECHA Provides New Summary Table For Applications For Authorization: ECHA announced on June 12, 2015, that companies applying for authorization for their substances need to fill in a summary table of their risk management measures and operational conditions. According to ECHA, the table, which summarizes the representative and relevant risk management measures (RMM) and operational conditions (OC) set out in the exposure scenario (ES) from the chemical safety report (CSR), will facilitate the enforcement process and provide authorization holders and downstream users with a simple format easily translatable into the local national language where the authorized use takes place. ECHA states: “The summary needs to be clear, unambiguous and presented in a tabulated manner, describing the RMMs/OCs for safe use of the substance.” The applicant will compile the information required for the table from the full set of conditions that should be described in the exposure scenarios included in the CSR. ECHA notes that there are no additional information requirements due to the new document. The table is now a mandatory document to be completed and submitted as a part of the application for authorization dossier. More information is available in ECHA’s press release, New summary table available for applications for authorisation.

EC Begins Public Consultation On The Functioning Of Waste Markets In The EU: On June 12, 2015, the EC began a public consultation on the functioning of waste markets in the EU. The EC states that the goal of the consultation is to obtain a better understanding of the nature and the extent of regulatory failures causing undue distortions to EU waste markets for recycling and recovery. Under existing rules, waste to be prepared for re-use, recycled, or subject to other recovery activities should move freely within the EU, without any unjustified restrictions. Only certain specific reasons may be used to restrict the free movement of waste for recycling and recovery. The EC notes that in some cases, however, “the regulatory environment may hamper the efficient functioning of waste markets and fail to ensure optimal implementation of the waste hierarchy.” According to Article 4(1) of the EU waste framework directive, the following waste hierarchy shall apply as a priority order: prevention; preparing for re-use; recycling; other recovery, e.g., energy recovery; and disposal). In January 2015, the EC launched a study to examine obstacles and regulatory failures affecting the functioning of waste markets in the EU. The EC will use the information obtained from the public consultation to prepare the final study. The EC will also consider the information in preparing the new circular economy initiative reported above. Comments are due September 4, 2015.

ECHA Encourages Registrants To Re-Assess Information On Reproductive Toxicity: According to a June 17, 2015, press release, beginning October 1, 2015, ECHA will start the decision making on testing proposals on the reproductive toxicity endpoint, i.e., EOGRTS. ECHA states that it will soon contact registrants with pending testing proposals under examination through REACH-IT and encourage them to update their testing proposal on reproductive toxicity to correspond with the REACH annexes. ECHA will also start addressing the EOGRTS information requirement in its compliance check decisions. ECHA invites registrants to re-assess whether the information they provided on reproductive toxicity fulfills the current requirement and adequate justifications are in place when omitting studies. ECHA intends to issue final updated guidance on reproductive toxicity by the end of July 2015. More information is available in ECHA’s press release, Registrants encouraged to re-assess information on reproductive toxicity.

EP Committee Passes Resolution On Circular Economy: On June 17, 2015, the EP Committee on Environment, Public Health, and Food Safety passed a resolution calling for binding waste-reduction targets, revamped ecodesign legislation, and measures to break the link between growth and the use of natural resources. The resolution calls for the EC to table a new proposal by the end of 2015. The Committee’s June 17, 2015, press release states that the new proposal should include waste prevention measures; binding waste-reduction targets for municipal, commercial, and industrial waste to be achieved by 2025; application of the “pay as you throw” principle; targets for recycling and preparation for reuse to be raised to at least 70 percent of municipal solid waste and 80 percent of packaging waste by 2030; incineration to be strictly limited by 2020 to non-recyclable and non-biodegradable waste; and a binding, gradual reduction of all landfill waste. The full EP will vote on the report at its July 6-9, 2015, session.

OECD

OECD Announces New Version Of IOMC Toolbox: On May 12, 2015, OECD announced the availability of a new version of the Inter-Organization Program for the Sound Management of Chemicals (IOMC) Toolbox for Decision-Making in Chemicals Management. According to OECD, the IOMC Toolbox enables countries to identify the most relevant and efficient national chemicals management actions. OECD states that the IOMC Toolbox “takes into account the resources available and guides users towards cost-effective solutions adapted to the country.” At each implementation step, the IOMC Toolbox presents the relevant IOMC resources, guidance documents, and training material. The IOMC Toolbox identifies appropriate actions and guidance for:

• A national management scheme for pesticides;
   
• An occupational health and safety system;
   
• A chemical accidents prevention, preparedness, and response system for major hazards;
   
• An industrial chemicals management system (new);
   
• A classification and labeling system (new);
   
• A system to support health authorities that have a role in the public health management of chemicals (new); and
   
• Pollutant release and transfer registers (coming soon).

The IOMC Toolbox also provides links to five new online toolkits:

• OECD Environmental Risk Assessment Toolkit;
   
• The World Health Organization (WHO) Human Health Risk Assessment Toolkit;
   
• Food and Agriculture Organization of the United Nations (FAO) Toolkit for Pesticides Registration Decision Making;
   
• United Nations Industrial Development Organization (UNIDO) Toolkit on Chemical Leasing; and
   
• UNIDO Toolkit on Innovative, Safe, and Resource Efficient Application of Chemicals in Industry.

OECD Updates eChemPortal To Offer Better Access To GHS Chemical Classifications: OECD announced on June 15, 2015, that it updated the Global Portal to Information on Chemical Substances (eChemPortal) to offer better access to chemical classifications according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). OECD states that the new search by GHS classification allows users, for an individual chemical, to view GHS classifications that have undergone a review by a regulatory body or intergovernmental organization. The first data sources linked to eChemPortal via this search are ECHA’s classification and labeling (C&L) Inventory and the GHS classification results by the Japanese government. The eChemPortal provides access to information of regulatory relevance on industrial chemicals, pesticides, and biocides. Users can search simultaneously for data contained in multiple data sources via searches by chemical identity, certain properties, or effects.

SOUTH KOREA

Voluntary Notification Period Begins For New Chemicals With Incomplete Hazard Evaluations: The Ministry of Environment (MOE) and Ministry of Justice (MOJ) announced on May 22, 2015, a voluntary notification period for manufacturers and importers who did not register and complete a hazard evaluation for a new chemical substance under the Toxic Chemical Control Act (TCCA), which was replaced by the Act for the Registration and Evaluation of Chemicals (K-REACH) on January 1, 2015. Under TCCA Article 10, manufacturers and importers of new chemical substances in volumes greater than 0.1 tonnes per year were required to complete a hazard evaluation and notify the appropriate authorities prior to manufacture or import. If the hazard evaluation was not completed, then the manufacturer or importer was subject to five years’ imprisonment or a fine of up to 50,000,000 KRW. Under K-REACH, all new chemical substances and existing chemicals subject to registration that will be manufactured or imported in one tonne or more must be registered before manufacture or import. The voluntary notification period runs from May 22, 2015, through November 21, 2015.