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December 1, 2015

Global Regulatory Update for December 2015

The ACTA Group

The Acta Group (Acta®) extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, and peaceful New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.


Comment Period On First Consultation Paper On Reforms To NICNAS Ends Soon: As reported in Acta’s November 9, 2015, memorandum, “Australia Implementing Reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS),” the Australian government is implementing reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). NICNAS held consultation workshops in Sydney and Melbourne during November 2015 to discuss issues raised in the first consultation paper, which was released in October 2015. The consultation paper provides the following list of reforms:

  • NICNAS will continue to maintain the Australian Inventory of Chemical Substances (AICS);
  • For chemicals not on the AICS, there will be three classes of chemicals based on risk. Categorization of chemicals will be self-determined by industry, in accordance with criteria developed by NICNAS based on indicative risk:
    • Class 1: Very low risk chemicals;
    • Class 2: Low risk chemicals; and
    • Class 3: Medium-high risk chemicals.
  • The regulatory outcomes of a Class 3 chemical assessment include:
    • Issuance of an assessment certificate that is subject to a defined assessment scope; and
    • Refusal of a certificate where conditions of use or existing risk management frameworks cannot manage the risk.
  • Should an assessment certificate be granted, the introducer may also apply for early listing on the AICS;
  • NICNAS may assess or re-assess any existing chemical on its own initiative. The existing Priority Existing Chemical process will be replaced by a streamlined, more concise assessment process, focused on particular concerns about a chemical;
  • NICNAS will have access to more contemporary tools to enable it to monitor compliance and take action in the event of non-compliance. For example, NICNAS will be able to: issue improvement notices and prohibition notices in response to non-compliance; require introducers to produce documents where necessary; and revoke assessment certificates as necessary (based on non-compliance or risk);
  • The reforms will be rolled out progressively between September 1, 2016, and September 1, 2018; and
  • The cost of the reforms will be recovered from the regulated industry. NICNAS estimates that the reforms will cost $12.4 million to implement.

Comments on the consultation paper are due December 14, 2015.

Australia Begins Public Consultation On Chemical Exposure Standards: Safe Work Australia (SWA) has begun a public consultation on the role of workplace exposure standards and how they could be reviewed and maintained. According to the discussion paper, Australia’s workplace exposure standards were first adopted from the standards set by the American Conference of Governmental Industrial Hygienists (ACGIH®) in the 1980s by the National Health and Medical Research Council. The standards were first published by SWA’s predecessor, the National Occupational Health and Safety Commission (NOHSC), in 1990. NOHSC updated about 80 of the 644 standards 1995-2005, but the “vast majority” have not been updated since they were adopted. The discussion paper examines the role of exposure standards in the regulatory framework and considers how they could be reviewed and maintained. The discussion paper lists the following ways SWA could review exposure standards and keep them up to date in a timely and efficient way:

  • Reinstating the NOHSC fast-track process;
  • Replacing exposure standards in line with international updates;
  • Adopting international exposure standards; or
  • Keeping a smaller number of mandatory exposure standards up to date.

Comments are due December 18, 2015.

SWA Updates Hazardous Substances And Chemicals Lists: SWA announced on December 3, 2015, that it has updated the Hazardous Substance Information System (HSIS) and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Hazardous Chemical Information List (HCIL) to incorporate assessments made by NICNAS. SWA states that these changes represent human health assessments made as part of tranches one through seven of the Inventory Multi-tiered Assessment and Prioritization (IMAP) framework. The update includes approximately 300 new entries and approximately 130 amendments to existing entries for both datasets.


Canada Announces Approach For The Prioritization Of Substances On The Revised In Commerce List: Canada announced on November 27, 2015, the availability of the approach for the prioritization of substances on the revised in commerce list (ICL), a list of substances in Canadian commerce used in products regulated by the Food and Drugs Act between January 1987 and September 2001. After September 2001, new substances used in these products became subject to the new substances notification regulations of the Canadian Environmental Protection Act, 1999 (CEPA). Substances on the revised ICL include substances in pharmaceuticals, veterinary drugs, cosmetics, biologics, food products, natural health products, and medical devices. As part of the Chemicals Management Plan, Health Canada is prioritizing substances on the revised ICL to identify substances not expected to pose a risk to human health or the environment. Canada states that substances identified for further evaluation to determine whether they may pose a significant risk will be subject to a more rigorous assessment, which may include further information gathering following the completion of this prioritization exercise.


China Releases Draft Revisions To Order No. 22 For Public Comment: The Ministry of Environmental Protection (MEP) held a public consultation on draft revisions to Order No. 22, the measures for the environmental administration registration of hazardous chemicals. The proposed changes would simplify the process for companies to use existing hazardous chemicals in China. The changes would apply to substances listed in the Catalog of Hazardous Chemicals. Substances listed in the Catalog of Priority Hazardous Chemicals for Environment Management would still be subject to more stringent registration guidelines. Chemical risk would be calculated based on the ratio of hazard and exposure.


CIEL, ECOS, And Öko-Institut e.V. Issue Position Paper On Revision Of REACH Annexes For Nanomaterials: In October 2015, the Center for International Environmental Law (CIEL), European Environmental Citizens Organization for Standardization (ECOS), and Öko-Institut e.V. issued a position paper on revising the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annexes to address nanomaterials. The position paper discusses the proposed amendments that the European Commission (EC) presented in May 2014. The position paper states that registrants should be required to describe the test material and sample preparation and to justify why the selected test material and test method is the most appropriate form for the test and whether the results are significant across multiple forms. Registration dossiers should include physicochemical and (eco-) toxicological information when “nanoforms are used in consumer preparations or incorporated into consumer articles.” Registrants should be required to characterize fully all nanoforms before grouping them for (eco-) toxicological assessment. The supplier should provide information on nanomaterials in the following categories of the safety data sheet (SDS): composition, handling, exposure controls, physical and chemical properties, and toxicological information.

ECHA Proposes To Update CoRAP For 2016-2018: On October 28, 2015, the European Chemicals Agency (ECHA) announced that it prepared a proposal to update the Community Rolling Action Plan (CoRAP) for 2016-2018. The Member States are planning to evaluate 138 substances, including 53 that are newly selected. ECHA states that the final CoRAP will be adopted in March 2016. The 138 substances are allocated for evaluation during 2016, 2017, and 2018. ECHA prepared the draft CoRAP in close cooperation with the Member States, taking into account risk-based criteria for the selection of substances. The draft CoRAP includes the tentative year of evaluation, contact details of the proposed evaluating Member State, as well as a brief indication of the initial area of concern. ECHA’s Member State Committee will prepare an opinion on the draft plan in February 2016. Based on the opinion, ECHA will adopt the final CoRAP update for 2016-2018 and publish it in March 2016. ECHA states that it encourages registrants of the listed substances to start coordinating their actions and to contact the evaluating Member States. From the publication of the final CoRAP update, Member States will have one year to evaluate the substances specified for 2016. Where necessary, they will prepare a draft decision for requesting further information to clarify the suspected risks. More information is available in ECHA’s press release, “Draft CoRAP to evaluate 138 substances in 2016-2018 published.”

ECHA Asks Registrants To Show How They Considered Alternative Methods Before Consulting On Testing Proposals: On November 2, 2015, ECHA announced that, to ensure that testing on animals is only done as a last resort, it has started requesting additional information from registrants who submit new testing proposals for vertebrate animal tests. This follows the European Ombudsman’s recent decision about ECHA’s role in evaluating testing proposals. ECHA stated that it has sent the first requests to registrants asking them to inform ECHA of their considerations of alternative methods to support their testing proposals involving vertebrate animals. This affects testing proposals made since September 11, 2015. According to ECHA, it will publish the information received together with the testing proposals on its testing proposals consultation web page. Third parties can take this into account when deciding whether to submit relevant information about the substance from alternative methods that may avoid the test. Registrants could consider this information instead of testing on vertebrate animals to fulfill the REACH information requirements. In such cases, the registrant must show that the main objectives of REACH, to ensure a high level of protection of human health and environment, can be achieved without the performance of a vertebrate test. ECHA states that it has started a consultation with the Member States and stakeholders on the further practical steps to implement the Ombudsman’s conclusions. According to ECHA, the aim is for companies to be able to show their considerations in registration dossiers following the next update of the IUCLID tool in 2016. In the meantime, registrants will be contacted through REACH-IT. More information is available in ECHA’s press release, “ECHA asks registrants to show how they considered alternative methods before consulting on testing proposals.”

EC Organizes Meeting On The “Impact Assessment On Criteria to Identify Endocrine Disruptors — Technical Meeting On The JRC Methodology”: The European Commission (EC) hosted a technical meeting to introduce the methodology developed by the Joint Research Center (JRC) for screening endocrine disruptors. The meeting started with a detailed and comprehensive introduction of the methodology that the JRC developed for the screening of the approximately 700 substances selected in the scope of the Plant Protection Product Regulation (EC) No. 1107/2009 (PPPR), Biocidal Products Regulation (EU) No. 528/2012 (BPR), REACH, Regulation (EC) No. 1223/2009 on Cosmetic Products and Water Framework Directive (EC) No. 2000/60 (WFD) to compare the four options of the endocrine disruptor criteria proposed by the EC. The methodology will be applied by a contractor, whose identity was not revealed, and the results will provide the basis for the EC’s 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” in 2016. Participants also heard about the data sources used for the screening exercise and the principles for the selection of these substances. While all active substances approved under PPPR and BPR were initially considered, in the case of REACH, WFD and Cosmetic Regulation, only substances with already existing endocrine disruptor concerns were considered. The full list of the 700 substances, along with the rationale for selecting them, were promised to be published soon. Participants also had a chance to make comments and ask questions. Almost every participant representing industry, non-governmental organizations, Member State Competent Authorities, or European Parliament (EP) asking questions in the Q&A session started their questions by thanking JRC for the tremendous work they are undertaking. It was also repeated several times, however, that due to the short time available to complete the screening, a pragmatic approach with several limitations had to be taken. It was also emphasized that the result of the screening will not have or trigger any regulatory consequences whatsoever. It was stated during the Q&A session that the contractor already applied the methodology to a subset of substances (35) that took several months, but that the exercise is not expected to be proportionally long for the rest of the substances. In the concluding remarks, the EC included an estimated timeline, admitting that they are already facing delays compared to previous estimations: PPPR active substances would be finalized by end of December, substances under BPR by end of January, and the rest in Q2 of 2016, by which time also the full report will be published.

ECHA Announces Enforcement Pilot Projects For 2016 And 2017: On November 10, 2015, ECHA announced the two new pilot programs that the Forum for Exchange of Information on Enforcement selected during its November 2015 meeting. The 2016 pilot project will focus on Internet sales of chemicals. According to ECHA, the intention is to enforce that legal provisions are complied with (e.g., appropriate information is provided to customers) when substances and mixtures are offered for sale on the Internet. The 2017 pilot project will focus on enforcing the provisions for substances in articles in REACH. The press release states: “The Forum is committed to coordinating enforcement of these provisions following the recent judgment of the Court of Justice (10 September 2015 in case C-106/14) clarifying the obligations under Articles 7(2) and 33 of REACH.” During its meeting, the Forum also specified the scope of the fifth coordinated REACH enforcement project, which will focus on obligations related to extended SDSs, exposure scenarios, risk management measures, and operational conditions. The project will be executed in 2017 and addresses the entire supply chain covering obligations of first-level suppliers (e.g., manufacturers or importers), actors in the supply chain (e.g., distributors), and actual users (e.g., formulators or end users). According to the press release, to prepare further inspectors for the project, the Forum’s annual training for enforcement trainers in 2016 will also focus on enforcement of extended SDSs. The press release states that the Forum also held an open session with ECHA’s accredited stakeholder organizations. They brought forward a number of items for discussion, including an industry initiative for complying with provisions for liquid laundry detergent capsules, enforcement of information requirements in dossiers, and intermediate uses in the metal industry. More information is available in ECHA’s press release, “Forum starts projects on internet trade of chemicals and on substances in articles.”

ECHA Urges Companies Find Their Co-Registrants: ECHA issued a November 17, 2015, press release urging companies preparing for the 2018 REACH registration deadline to find their co-registrants and establish substance sameness as early as possible. According to ECHA, companies need to find each other, agree that they are registering the same substance, and organize in a Substance Information Exchange Forum (SIEF). If the substance is already registered, the SIEF has already organized data sharing. A company should contact the existing registrants in that particular SIEF and confirm that the substance as agreed in that SIEF is the same. Afterwards, the company can begin data-sharing negotiations for the joint registration. If the substance is not registered, companies will first need to establish that they intend to register the same substance. Companies should contact each other to see who will register and if their substances are in fact the same. If the substances are the same, then the companies are part of the same SIEF. ECHA has posted step-by-step instructions on how to find the other SIEF members. More information is available in ECHA’s press release, “REACH 2018: Find your co-registrants.”

ECHA Begins Consultation On 11 Substances Proposed For Authorization: On November 18, 2015, ECHA began a public consultation on a proposal to include 11 new substances in the Authorization List (examples of uses in parentheses):

  • Dihexyl phthalate and 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (plasticizer in polyvinyl chloride);
  • Hexahydrophthalic anhydride (HHPA) and hexahydromethylphthalic anhydride (MHHPA) (hardener for epoxy resins);
  • Trixylyl phosphate (in lubricants, hydraulic fluids, and plastics production);
  • Two boron compounds: sodium perborate; perboric acid, sodium salt and sodium peroxometaborate (in detergents and bleaching products); and
  • Four lead compounds: orange lead (lead tetroxide); lead monoxide (lead oxide); and tetralead trioxide sulphate and pentalead tetraoxide sulphate (batteries and rubber production, in adsorbents).

ECHA’s draft recommendation specifies the proposed conditions of the authorization requirement for each substance, including the latest application and sunset dates. ECHA invites comments on the priority of the substances, their uses, possible exemptions from the authorization requirement, and on the proposed transitional arrangements. At the same time, the European Commission (EC) seeks information on the possible socio-economic consequences of including these 11 substances in the Authorization List. Any information received on the socio-economic impact will be passed on directly to the EC and will not be considered by ECHA in the recommendation process. Comments are due February 18, 2016. More information is available in ECHA’s press release, “ECHA consults on 11 substances to be proposed for authorisation.”

EC Begins Consultation, Holds Workshop On Streamlining Monitoring And Reporting Obligations In Environment Policy: The EC began a public consultation on November 18, 2015, on “Streamlining monitoring and reporting obligations in environment policy.” The EC states that the Fitness Check of monitoring and reporting obligations in environment policy is intended to ensure that environmental monitoring and reporting is “fit for purpose: delivering the right information, at the right time and in an efficient way.” According to the EC, it is likely to identify some additional information that is required but also some existing reporting requirements that can be scaled back or met in a more efficient and less burdensome manner. The objective of the consultation is to help the EC to validate principles such as proportionality, accessibility, and relevance that it should use for assessing environmental reporting requirements; gather views regarding whether reporting requirements are in line with those principles; and gather evidence on current shortcomings, overlaps, and potential improvements that should be examined during the process. On November 19-20, 2015, a joint EC and Make it Work workshop was held to discuss principles for smart monitoring and reporting. Information concerning this workshop is provided below. According to the EC website, the EC intends to publish a planned communication on reporting in 2016. Comments on the public consultation are due February 10, 2016.

EU Court Of Justice Hearing in Sweden’s Case Against The EC on November 17 in Luxembourg: Sweden presented its arguments against the EC along with the EU Council of Ministers, the EP, Denmark, France, and the Netherlands over the delay in defining criteria for endocrine disruptors. The Court did not indicate when a verdict is expected in the case.

“Recycling Should Not Justify The Perpetuation Of The Use Of Hazardous Legacy Substances”: says a Resolution the EP’s Environment Committee presented and the EP agreed by 603 votes to 86, with five abstentions on November 25. The non-binding resolution demands the EC to reject Application for Authorizations for using recycling plastics containing bis(2-ethylhexyl) phthalate (DEHP).

EC Adopts “Ambitious” New Circular Economy Package: The EC announced on December 2, 2015, that it adopted “an ambitious new Circular Economy Package to help European businesses and consumers to make the transition to a stronger and more circular economy where resources are used in a more sustainable way.” The proposed actions are intended to contribute to “closing the loop” of product lifecycles through greater recycling and re-use, and to bring benefits for both the environment and the economy. The proposals cover the full lifecycle, from production and consumption to waste management and the market for secondary raw materials. Key actions adopted or to be carried out under the current EC’s mandate include:

  • Funding of over €650 million under Horizon 2020 and €5.5 billion under the structural funds;
  • Actions to reduce food waste, including a common measurement methodology, improved date marking, and tools to meet the global Sustainable Development Goal to halve food waste by 2030;
  • Development of quality standards for secondary raw materials to increase the confidence of operators in the single market;
  • Measures in the Ecodesign working plan for 2015-2017 to promote reparability, durability, and recyclability of products, in addition to energy efficiency;
  • A revised regulation on fertilizers to facilitate the recognition of organic and waste-based fertilizers in the single market and support the role of bio-nutrients;
  • A strategy on plastics in the circular economy, addressing issues of recyclability, biodegradability, the presence of hazardous substances in plastics, and the Sustainable Development Goals target for significantly reducing marine litter; and
  • A series of actions on water reuse, including a legislative proposal on minimum requirements for the reuse of wastewater.

The EC states that its revised legislative proposal on waste sets clear targets for reduction of waste and establishes “an ambitious and credible long-term path for waste management and recycling.” To ensure effective implementation, the waste reduction targets in the new proposal are accompanied by concrete measures to address obstacles on the ground and the different situations across Member States. Key elements of the revised waste proposal include:

  • A common EU target for recycling 65 percent of municipal waste by 2030;
  • A common EU target for recycling 75 percent of packaging waste by 2030;
  • A binding landfill target to reduce landfill to maximum of ten percent of all waste by 2030;
  • A ban on landfilling of separately collected waste;
  • Promotion of economic instruments to discourage landfilling;
  • Simplified and improved definitions and harmonized calculation methods for recycling rates throughout the EU;
  • Concrete measures to promote re-use and stimulate industrial symbiosis, turning one industry’s by-product into another industry’s raw material; and
  • Economic incentives for producers to put greener products on the market and support recovery and recycling schemes (e.g., for packaging, batteries, electric and electronic equipment, vehicles).

More information is available in the EC’s press release, “Closing the loop: Commission adopts ambitious new Circular Economy Package to boost competitiveness, create jobs and generate sustainable growth.”

The EP welcomed the EC’s proposals for a circular economy but criticized the proposals for “aim[ing] too low” on waste recycling, reducing food waste, and landfill. In its press release, the EP notes that in a July 2015 resolution, it advocated strictly limiting incineration of recyclable and biodegradable waste by 2020, phasing in a ban on landfilling by 2030, and raising targets for recycling and preparation for re-use to at least 70 percent of municipal solid waste and 80 percent of packaging waste by 2030. The EP states that the Environment, Public Health, and Food Safety Committee will appoint rapporteurs in the coming weeks on the various pieces of legislation proposed. More information is available in the EP’s December 2, 2015, press release, “MEPs welcome new circular economy proposals but regret weaker waste targets.”


Mandatory GHS Standard Clarified: On November 11, 2015, the Ministry of Labor and Social Welfare published a clarification to Standard NOM-018-STPS-2015 in the Official Gazette. As reported in our October 2015 Global Regulatory Update, under the Standard, the GHS will be mandatory after a three-year transition period.


South Korea Publishes Revised Ministerial Decree Concerning K-REACH: South Korea published a revised Ministerial Decree concerning the Act for the Registration and Evaluation of Chemicals (K-REACH) in the October 30, 2015, Korean Gazette. The Ministerial Decree took effect immediately. Changes include:

  • To protect confidential business information (CBI), companies can now list a product name rather than provide chemical information;
  • Foreign manufacturers and producers can prepare and submit annual reports;
  • Figures on handled volume can now be provided in ranges when reporting manufactured volumes;
  • The test requirements for biocidal products have been simplified, requiring “usage and efficacy-related test data” rather than a “test analysis of active ingredients”; and
  • Documents required for exemption from registration of research and development (R&D) substances can be prepared and submitted by R&D personnel.