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Global Regulatory Updates
March 1, 2016

Global Regulatory Update for March 2016

The ACTA Group

AUSTRALIA

Australia Issues Second Consultation Paper On Reforms To National Regulatory Framework: On February 18, 2016, the Australian government published Consultation Paper 2 outlining proposals for reform of the country’s chemical regulatory framework. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is consulting on the paper until March 30, 2016. The paper proposes allowing use of international assessment materials to self-categorize against hazard bands.

Consultation Paper 2 suggests that the U.S. Environmental Protection Agency (EPA) is not considered a “trusted source” for international assessment materials due to “issues relating to transparency … and differences in regulatory coverage.” It expresses the opinion that EPA does not publish assessment reports or assess the public health risks from the use of cosmetics. Therefore, the paper suggests, U.S. assessments do not fulfill the criteria proposed for Australian chemical management. NICNAS invites stakeholders to comment on how these criteria could be met by other international regulators (such as EPA) through information being made available in addition to those articulated in Consultation Paper 1.

NICNAS proposes to change words used to describe the matrix banding to avoid confusion with those used for Dangerous Goods Classification. The suggestions would change categories from:

  • Class 1 to Exempted;
     
  • Class 2 to Reported; and
     
  • Class 3 to Assessed.

A simplified registration process will be implemented for polymers of low concern and very low risk chemicals.

Other suggested changes include:

  • Increasing the transition time for new chemicals under exemptions, permits, or certificates to greater than six months;
     
  • Measures to reduce animal testing (i.e., information requirements will include greater acceptance of data from similar chemicals and non-animal test methods); and
     
  • Proposals to reduce the assessment time from 120 days to 90 days.

CANADA

Canada Seeks Early Stakeholder Engagement To Address Remaining Substances Under CMP: Canada published on February 6, 2016, a notice of intent seeking early stakeholder engagement to help inform the plan to address the remaining 1,550 substances under the Chemicals Management Plan (CMP). Environment and Climate Change Canada and Health Canada invite stakeholders to provide information that will inform the path forward for the next phase (2016-2020) of the CMP. The CMP is an initiative aimed at reducing the risks posed by chemicals to Canadians and their environment. The notice states that information obtained will help tailor assessment and management approaches and inform the implementation plan for the next phase of the CMP, which will be made available in spring 2016. The types of information being sought may include:

  • Information that could influence the timing and complexity of an assessment;
     
  • Composition data for unknown or variable composition, complex reaction products, or biological materials;
     
  • Information on releases of a substance to the environment;
     
  • Information on the fate of the substance in the environment;
     
  • Information on industrial facility processes, operating conditions and practices, and handling of the substance;
     
  • Information on controls (e.g., on-site wastewater treatment) relevant to limiting the release of a substance to the environment;
     
  • Information on products (industrial, commercial or consumer) that contain the substance, as well as the concentration of a substance in a given product; information regarding the function of a substance in a product that could influence potential exposures or releases;
     
  • Data on hazard potential (human health, ecotoxicity);
     
  • Data on the function of the substance (e.g., whether it is consumed in reactions during industrial use; if it is designed to be released to the environment due to its use);
     
  • Data on migration or release of the substance from products;
     
  • Data that could help refine substance-specific assumptions (such as dermal absorption data);
     
  • Access to existing information, such as data shared within a Substance Information Exchange Forum (SIEF) under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation; and
     
  • National and international research activities related to a substance, including monitoring.

According to the notice, Canada plans to begin assessment activity on the remaining 1,550 substances in spring 2016. Canada will periodically publish more detailed notifications as it updates the work plan to specify the substances for which additional information is needed, the associated timelines, and details on how to provide this information.

CHINA

China Publishes Long Awaited RoHS2 Regulation: On January 21, 2016, China’s Ministry of Industry and Information Technology (MIIT) published its final version of the Administrative Measures for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products (China RoHS2). China RoHS2 will enter into force on July 1, 2016. An English translation of China RoHS2 provided by the EU Chamber of Commerce is available online.

Since 2010, the Chinese government has endeavored to update its RoHS Regulation, and MIIT has released several draft revisions. None, however, has been enacted. China RoHS2 will replace the existing “China RoHS” promulgated in 2006 and will significantly align the scope of coverage with the European Union’s (EU) RoHS2 (EU RoHS2).

The enactment of China RoHS2 is an important milestone in the ongoing harmonization and development of global regulatory frameworks. The Chinese Regulation relies significantly on the pre-existing measures in China’s RoHS1 and shares many similarities with the EU RoHS2. Maintaining compliance with China RoHS2 includes substantial efforts to remain compliant with other relevant national standards. More information is available in The Acta Group’s (Acta®) January 28, 2016, memorandum, “China Publishes Long Awaited RoHS2 Regulation.”

EU

ECHA Makes It Easier To Find Information On 120,000 Chemicals: On January 20, 2016, the European Chemicals Agency (ECHA) announced that it is “now easier to find information on 120,000 chemicals used in Europe today.” The information is available in three layers of complexity — the simple infocard, the more detailed brief profile, and the full source data:

  • The infocard gives a summary of the key information on a chemical substance in plain English. Users can read about the chemicals they are exposed to, where they are commonly used, whether they are hazardous, and the precautions that they might need to take;
     
  • The brief profile goes deeper into the environmental, human health, and physico-chemical properties of the chemical. It provides a user-friendly overview of the information collected for each substance under the different chemical regulations. This will be most useful for employers, workers, academics, and regulators; and
     
  • The third level, source data, includes the raw data submitted by companies to ECHA in REACH registration dossiers and notifications to the classification and labeling inventory.

ECHA notes that the three-level approach “improves the transparency and traceability of data on chemicals.” ECHA states that it is not reducing the amount of information, adding or approving the collected data, but “making it much more accessible.” More information is available in ECHA’s press release, “Know more about the effects of the chemicals we use in Europe.”

ECHA Applies New Rules To Biocidal Substance Approval Process: On January 20, 2016, ECHA’s Biocidal Products Committee (BPC) issued two important documents. The first, “Applicability Time of New Guidance and Guidance-Related Documents in Active Substance Approval,” provides details on how and when new guidance applies.

The BPC agreed that new guidance will apply:

  • To an applicant if it is published at least six months before it submits its dossier to the evaluating competent authority (eCA); and
     
  • To an eCA if it is published at least six months before it submits its draft competent authority report to ECHA.

In some cases, however, new guidance will apply immediately (e.g., guidance corrects major mistakes of former guidance).

The second document issued by BPC, “Introducing New Information During the Peer Review Process of Active Substance Approval,” addresses the “problem definition” under the Biocidal Products Directive (BPR), stating: “[t]he BPR contains no provision on the possibility to submit new information during the peer review process. It therefore can be assumed that it is the intention of the BPR that after the submission of the evaluation by the eCA no new information is requested and incorporated.” Following “analysis of possible options,” the document concludes that new information can be submitted during the peer review process when the following conditions are met:

  • The relevant 270-day time limit must be adhered to;
     
  • During the peer review, the outcome of the evaluation of the eCA is significantly changed. For example, where the conclusions lead instead of a proposal for approval to non-approval (or vice-versa) or severe restrictions are imposed on the use of the active substance that were not included in the original proposal from the eCA;
     
  • The new information is readily available and can be submitted by the applicant or a [Member State Competent Authority] directly after the Working Group. The new information must be submitted ten working days after the Working Group; and
     
  • The Working Group has agreed that new information is required and which information is required.

Both of the documents take effect immediately.

ECHA Updates REACH-IT Tool To Reject Submissions Outside Of A Joint Registration: ECHA issued a January 25, 2016, press release noting that the new implementing regulation on joint submission of data and data sharing adopted by the European Commission (EC) requires ECHA to ensure that all companies registering the same substances are part of the same registration. To implement this requirement, ECHA adapted REACH-IT to reject registration dossiers if a registration for the same substance already exists. Companies will also not be able to update registrations that were submitted individually if another registration for the same substance is in REACH-IT. ECHA is revising its guidance documents and other support materials to reflect the changes. More information is available in ECHA’s press release, “Registrants of the same substance must be part of the same registration.”

ECHA Shortlists Nearly 300 Substances For Possible Regulatory Action: ECHA announced in a January 27, 2016, press release that it has selected nearly 300 substances from REACH registrations for further scrutiny by the Member State competent authorities. According to the press release, the shortlisted substances are registered by nearly 1,500 companies in 2,500 registration dossiers. ECHA states that the selection is based on an automated IT screening focusing on substances with potential carcinogenic, mutagenic, or toxic to reproduction (CMR), persistent, bioaccumulative, and toxic (PBT), endocrine-disrupting, sensitizing, or specific target organ toxicity following repeated exposure properties. According to the press release, a subset of substances are then further prioritized based on uses that are likely to lead to exposure to humans or release to the environment. The Member State competent authorities will then prioritize substances for their manual examination. Companies affected have received or are about to receive a letter from ECHA informing them of the potential examination of their registrations. ECHA invites companies to update their dossiers to address any shortcomings as soon as possible. If the Member States or ECHA take action on a substance, ECHA states that it will publish this information on its website, for example, in the list of substances potentially subject to compliance checks, the Registry of Intentions, draft Community Rolling Action Plan (CoRAP), and Public Activities Coordination Tool (PACT), which lists substances under hazard assessment or risk management option analysis. Companies can check the status of their substance through the “Search for Chemicals” available on ECHA’s homepage. More information is available in ECHA’s press release, “ECHA shortlists substances for possible regulatory action.”

EC Publishes Inception Impact Assessment Concerning Possible REACH Annex Amendments For Registration Of Nanomaterials: On February 2, 2016, the EC published an inception impact assessment concerning “Possible amendments of Annexes to REACH for registration of nanomaterials.” According to the inception impact assessment, the EC identified a need for more specific requirements for nanomaterials to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers to attain the aims of REACH. This initiative intends to solve how nanomaterials should be addressed and safety demonstrated in REACH registration dossiers. The inception impact assessment identifies the following options:

  • Baseline scenario — no EU policy change;
    • Option 1: No change;
       
  • Options of improving implementation and enforcement of existing legislation or doing less/simplifying existing legislation:
    • Option 2: Clarifying the existing information requirements;
       
    • Option 3: Soft law measures;
       
    • Option 4: Scientific-technical recommendations tailoring information requirements;
       
    • Option 5: Reduced information requirements; and
       
    • Option 6: Exhaustive information requirements.

The chosen option, if different to the baseline scenario, will take the form of a draft EC implementing regulation amending certain REACH Annexes, and the EC will submit it to the REACH Committee for opinion in accordance with REACH Article 133(4) before its adoption by the EC. The inception impact assessment states that work on the impact assessment was expected to conclude by the end of 2015.

French MSCA Notifies ECHA Of Its Intention To Propose BPA As An SVHC: On February 8, 2016, the French Member State Competent Authority (MSCA) notified ECHA that it plans to submit an Annex XV dossier by August 8, 2016, for classification of bisphenol A (BPA) as a Substance of Very High Concern (SVHC). The reasons for adding BPA to the Candidate List of SVHCs are its endocrine disrupting and carcinogenic properties. BPA is proposed for a toxic for reproduction Category 1B classification; its current harmonized classification for reproductive toxicity is Category 2. If this happens, it will strengthen the French MSCA’s case for classifying BPA as an SVHC. More information is available in ECHA’s “Current SVHC Intentions.”

Two Disinfectants Lose Support In Biocides Review Program: On February 10, 2016, ECHA added citric acid and chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidification to its list of Open Invitations for Notifications. This was a consequence of withdrawal by two companies that supported citric acid and chlorine dioxide generated from TDCO.

The company supporting citric acid under product-type one withdrew because the biocidal product it had applied for, an anti-viral tissue impregnated with citric acid, belongs to product-type two. The EU Standing Committee on Biocidal Products decided this in September 2015 based on the product’s intended use for the disinfection of surfaces and materials. The reason behind withdrawal of support for chlorine dioxide generated from TDCO is unknown.

Participants may withdraw from the Biocides Review Program by choice. Participants are also considered to have withdrawn if there is a problem with their approval application (e.g., late submission). Companies backing citric acid or chlorine dioxide generated from TDCO must inform ECHA by February 9, 2017, of an interest to be included in the review program.

ECHA Begins Public Consultations For Applications For Authorization: ECHA announced on February 10, 2016, that it began a public consultation on 27 applications for authorization covering 39 uses of:

  • Chromium VI compounds used in surface treatment, hard and functional chrome plating, cooling systems, passivation of tin plates, production of copper foils, production of colored stainless steel, and manufacture of sodium chlorate/chlorite. These uses take place in various industry sectors such as chemical industry, aerospace, automotive, electronics, and lithography;
     
  • 1,2-dichloroethane (EDC) used as solvent in the production of a polymer; and
     
  • Diglyme used as solvent in the manufacture of an active pharmaceutical ingredient.

Comments are due April 6, 2016. More information is available in ECHA’s press release, “Public consultations launched for applications for authorisation.”

Cefic AMBIT Tool To Access ECHA Database: On February 11, 2016, ECHA announced that it will provide the European Chemical Industry Council (Cefic) access to data from its chemicals database to improve its AMBIT tool for predicting toxicity of chemicals. The tool was developed by Cefic’s long-range research initiative and was launched in 2009. AMBIT’s purpose is to give registrants access to all available information and avoid unnecessary testing on animals when addressing data gaps in chemical safety reports. ECHA stated that Cefic will only be given access to “carefully selected parts of the non-confidential registration data, to protect the rights of owners.” ECHA indicated that it wants to make data more readily available to academia, regulators, and other companies. It recognizes, however, that it must respect the rights of data owners. More information is available in ECHA’s press release, “ECHA gives out registration data to support development of non-test methods.”

Danish Researchers Claim Urgent Need For Nano-Guidance In BPR: A team of Danish researchers has stated that the lack of nano-specific guidance on data requirements under the BPR is an obstacle to manufacturers and importers wanting to introduce new nano-biocides to the market. The team from the University of Copenhagen and the Technical University of Denmark suggests that appropriate data requirements are missing from the BPR. As a result, the team suggests in its paper, biocidal products containing nanomaterials could be placed on the market without sufficient hazard assessment, compromising health and environmental protection. The paper highlights that the BPR is the first regulation to include specific testing requirements for nanomaterials as a part of the information requirements.

The researchers indicate that although the BPR requires competent authorities to include nano-specific test requirements and specific nanobiocide risk assessments of biocidal nanomaterials, “there is no guidance accompanying the BPR on how to provide nano-specific test results, or how to justify the scientific appropriateness of the current test methods for the testing of nanomaterials.”

The Danish team suggests that for nano-specific risk assessments to be conducted, best practices must be developed on:

  • Stock suspension preparation and characterization;
     
  • Exposure suspensions preparation; and
     
  • Conducting ecological tests.

Report Assesses Current Substance Evaluation Process Under REACH: ECHA announced on February 18, 2016, the availability of a report entitled Assessment of the current substance evaluation process under REACH. The report presents the findings of a survey conducted among MSCAs and relevant stakeholders (e.g., the EC, Member State Committee (MSC) observers, and registrants) on workability, efficiency, effectiveness, and transparency. The report proposes the following areas for “fine-tuning” substance evaluation:

  • Tackling the short deadlines under the legislation that both registrants and authorities struggle to comply with improving the communication to registrants of the time schedule for decision making;
     
  • Accelerating the referral process to avoid creating a backlog of old cases;
     
  • Ensuring that CoRAP addresses substances that matter in light of the increasing workload and available resources; and
     
  • Improving the interplay between substance evaluation and compliance check, i.e., always having a compliance check to address data gaps in support to substance evaluation.

According to ECHA, the report suggests that further improvements can be made to substance evaluation under REACH. While significant advances have been made, the report recommends changes to improve workability and efficient use of resources for registrants and authorities. More information is available in ECHA’s press release, “Improving how substances are evaluated.”

ECHA Warns Of False LRs: On February 22, 2016, ECHA announced that “some companies have been claiming to be the lead registrant in situations where their nomination has not been agreed between co-registrants, where another lead registrant has already been selected or even where a joint REACH registration has been already submitted to ECHA.” ECHA indicates that if approached by such a company, offers to prepare a joint registration should be declined. Instead, the real lead and other registrants must be located.

ECHA provides the following guidance for situations where companies are contacted by a lead registrant before co-registrants have been identified:

  • Ask for details on the identity of the substance to establish substance sameness;
     
  • Ask for evidence that they have the consent of the co-registrants to act as a lead registrant; and
     
  • Ask for evidence that they have sufficient information for a compliant dossier.

More information is available in ECHA’s press release, “Be aware of false invitations – check that the lead registrant is credible.”

ChemSec Claims Chemical Regulation Is Economically Beneficial For Many Companies: The International Chemical Secretariat (ChemSec) announced on February 23, 2016, the availability of a report entitled The bigger picture: Assessing economic aspects of chemicals substitution. According to ChemSec, the report “shows that the business world is bursting with innovative solutions to chemical issues.” ChemSec acknowledges that regulation “might cause a negative economic impact for a company that has to substitute a substance it is dependent on,” but states that “there are also opportunities and benefits for other companies that have already phased out the substance in question.” The report outlines the following four main aspects of the economic benefits of substitution, “which must not be forgotten if we are to see the bigger picture and make the most accurate assessments”:

  1. Prices are not static: New alternatives are often expensive initially, while prices tend to decline as supply increases;
     
  2. Using hazardous chemicals is costly: Typically, the use of hazardous chemicals is accompanied by additional costs. These can include setting up protective measures/equipment for workers, including healthcare, handling of hazardous waste, etc. At the same time, new innovations may bring additional benefits, such as reduced energy or water consumption;
     
  3. Regulation sets the stage for innovation: New and better products are being developed quickly and continuously. Anticipation of regulation efficiently drives the process further. What seems to be impossible or too expensive today may very well be possible tomorrow; and
     
  4. The market for safer alternatives is growing: Sustainability is here to stay. Safer products not only have the advantage of remaining safe from potential future regulations, but are also increasingly requested by consumers and other stakeholders, including investors.

ECHA Issues 2015 Evaluation Report: On February 25, 2016, ECHA issued its “Evaluation under REACH Progress Report 2015.” The proportion of compliance checks where ECHA decided further information was needed to bring REACH registration dossiers into compliance rose in 2015 from 60 percent to 82 percent. ECHA stated that this statistic is not representative of the quality of all dossiers. ECHA suggests this increase is because certain substances were deliberately selected as ECHA believed they were likely to have data gaps. In the introduction to the report, ECHA Executive Director Geert Dancet states that he encourages industry associations “to convince and support their members in filling the knowledge gaps, rather than seeking to delay addressing the identified gaps that stop us from concluding whether a substance is a concern or not.”

In addition to compliance checks, the report addresses the review of testing proposals and substance evaluation. It includes recommendations for first-time registrants and companies updating their dossiers on how to ensure the dossiers are of sufficient quality. The compliance checks focused on the eight higher-tier endpoints addressed in the compliance check strategy adopted by ECHA in 2014.

ECHA suggests in the report that the most common areas of non-compliance are substance identification and composition; issues related to the CSR; pre-natal developmental toxicity; and effects on terrestrial organisms.

ECHA’s key recommendations for registrants addressed in the report are:

  • Animal testing must be a last resort;
     
  • Familiarity with ECHA’s read-across assessment framework is essential for building a successful read-across case;
     
  • Maintenance of efficient communication and planning throughout the substance evaluation process; and
     
  • Accurate substance identification is imperative.

Third Data Sharing Appeal Lodged Against ECHA Under BPR: Troy Chemical Company B.V. (Troy) has requested ECHA’s Board of Appeal to annul a contested decision taken under the BPR. Troy lodged its appeal in January 2016 after ECHA granted a company permission to reference studies owned by Troy on the active substance 3-iodo-propynylbutylcarabamate for the purpose of Article 95 of the BPR. Troy stated that the contested decision does not follow the procedure addressed in Article 63(3) of the BPR as ECHA adopted a data-sharing decision even though the prospective applicant had not made a payment to Troy before initiating the data-sharing dispute. Troy submits that ECHA has breached Article 63 of the BPR and its own guidance on data-sharing by permitting the company to reference the studies.

Troy suggests the other company failed to make every effort to reach an agreement per the requirements of the BPR. Additionally, Troy claims that ECHA breached Article 95 of the BPR by stating that the payment Troy received for the same studies in a previous data-sharing agreement under the Biocidal Products Directive should be taken into account “for a fair and non-discriminatory cost-sharing under the BPR.”

This is the third data-sharing appeal lodged against ECHA under the BPR; the previous two were withdrawn or dismissed by the Board of Appeal. More information is available in ECHA’s “Announcement of Appeal.”

ITALY

Legislation On Green Economy Includes Incentives For Producing Green Products: On February 2, 2016, a law entitled Provisions on the Environment to Promote the Green Economy and to Restrict the Excessive Use of Natural Resources took effect. The law, which was passed on December 28, 2015, requires the government to adopt and update every three years a National Strategy for Sustainable Development. It also creates a National Agency for New Technologies, Energy, and Sustainable Economic Development to provide services to companies and individuals in those areas. Under the provision concerning incentives for the generation of green products, the government will approve specific agreements and contracts establishing programs that create incentives for products derived from recycled materials and for the recovery of waste from the disassembly of complex products. Incentives will be provided for the production of electricity from installations running on renewable sources other than photovoltaic sources and for the use of certified compostable plastic waste and fertilizers.

SOUTH KOREA

List Of LRs For 121 PECs Published: In January 2016, the Task Force for The Act on the Registration and Evaluation of Chemicals (K-REACH) published a list of 121 Lead Registrants for the 510 Priority Existing Chemical Substances (PEC) subject to registration under K-REACH. This list was a result of the first voting period that ended on December 17, 2015. A second voting period for LRs ended on February 5, 2016, and results for 35 PECs were made public on February 22, 2016. The deadline for registering PECs in South Korea is June 30, 2018.

South Korea Publishes Guidance On Annual Reporting For Overseas Companies: The Ministry of the Environment (MOE) published on February 26, 2016, a notice concerning the “Summary Guidance on Reporting by Overseas Manufacturer or Producer.” Under K-REACH Article 8, a person who manufactures, imports, or sells non-phase-in substances or one ton or more of a phase-in substance must complete the first report on the use and amount of the relevant substances by June 30, 2016. A phase-in substance is defined as any of the following:

  1. Chemical substances domestically distributed for commercial purposes prior to February 2, 1991, and publicly announced by the Minister of Environment after consultation with the Minister of Employment and Labor; or
     
  2. Chemical substances examined with respect to hazards after February 2, 1991, pursuant to the former Toxic Chemicals Control Act and publicly announced by the Minister of Environment.

A non-phase-in substance is defined as “all chemical substances excluding phase-in substances.” The scope of the report is the previous year (in this case, January 1, 2015, through December 31, 2015). The purpose of reporting is to provide a basis for MOE to designate and announce phase-in substances subject to registration.

TURKEY

Turkey Catching Up With The EU’s REACH Regulation: Turkey has been swiftly aligning its chemical regulatory system to that of the EU since its EU membership negotiations commenced in 2005. KKDIK, described below, is Turkey’s new chemical regulation, currently in draft. Widely referred to as Turkey REACH, KKDIK will further Turkey’s vision of enacting EU REACH-like legislation. It is available in Turkish online.

The name is taken from the first letters of Registration (Kaydi), Evaluation (Değerlendirilmesi), Authorization (İzni) and Restriction (Kısıtlanması) of Chemicals (Kimyasalların). KKDIK has been drafted by the Ministry of Environment and Urbanization (MoEU), which is the Turkish Competent Authority responsible for its implementation and enforcement.

Turkey’s previous Chemical Inventory Control Regulation is best regarded as a scaled down version of EU REACH, whereas KKDIK is more comparable in many respects. Turkey has legislation in place addressing the classification, labelling, and packaging (CLP) of dangerous substances and preparations, and a regulation on safety data sheets (SDS) for dangerous substances and preparations. More information is available in Acta’s January 27, 2016, memorandum, “Turkey Catching Up with the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation.”

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