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Global Regulatory Updates
June 1, 2017

Global Regulatory Update for June 2017

The ACTA Group

ARGENTINA

Argentina Introduces Pair Of Corporate Social Responsibility Bills: Legislators have introduced two bills in the Argentinian Chamber of Deputies (Cámara de Diputados), the lower house of the Argentine National Congress, that would serve to require socially responsible conduct by organizations. Among the “socially responsible conduct” the bills aim to foster would be aspects such as sustainable development, environmental preservation, and citizen access to “environmental and social information” that may be the property of Argentinian and/or other companies.

Should the proposed bills be signed into national law, entities subject to the regulation would be required to develop what is being termed a “Social Balance Report.” The Social Balance Report would be required to contain a comprehensive evaluation of the entity’s socially responsible conduct, although the specific details required and the frequency of reporting have yet to be fully defined.

AUSTRALIA

Industrial Chemicals Bill 2017 Would Replace NICNAS With New Scheme: The Australian government has presented the Industrial Chemicals Bill 2017 to Parliament. The bill describes the legislative framework for a reformed, risk-based regulatory scheme for Australia to continue to regulate the introduction of industrial chemicals in Australia. The core elements of the reformed scheme, the Australian Industrial Chemicals Introduction Scheme (AICIS), include:

  • Rebalancing the regulatory burden through the revision of industrial chemical introduction categories, with regulatory effort focused on assessing higher risk chemicals;
     
  • Improved approaches to reviewing chemicals on the market by replacing an overly prescriptive post-market assessment process with a more responsive and flexible evaluation process;
     
  • Greater transparency by striking a balance between confidentiality and publicly available information through publication of more meaningful information, with confidentiality achieved through masking the chemical name or end use; and
     
  • A new statutory power for the Executive Director of the scheme to refuse introduction of an industrial chemical if its risks to human health or the environment cannot be managed.
     

AICIS will replace the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) effective July 1, 2018. The bill also implements a national ban on the use of new animal test data for chemicals used exclusively as cosmetic ingredients, as part of the Australian government’s 2016 election commitment.

Bill Would Amend ICNA Act: The Australian government introduced the Industrial Chemicals (Notification and Assessment) (ICNA) Amendment Bill 2017 in Parliament. The amendments to the ICNA Act include:

  • Revising the definition of a new synthetic polymer to align more closely with international approaches;
     
  • Revising the notification requirements for new chemicals, such that polymers of low concern would be exempt from notification;
     
  • Removing the requirement for introducers to provide annual reports to NICNAS for permits and self-assessed assessment certificates;
     
  • Removing the requirement for introducers to provide a final statement of the value of relevant industrial chemicals actually introduced in a registration year; and
     
  • Making consequential changes to the ICNA Act related to these changes.
     

These amendments enable the early introduction of certain aspects of the Australian government’s NICNAS reforms.

NICNAS Reform Consultation Paper 5 Available For Comment, Public Meetings Will Be Held: Consultation Paper 5 seeks feedback from stakeholders on the detail to be included in delegated legislation made under the framework established by the Industrial Chemicals Bill. The paper and supporting material focus on technical matters related to the categorization and assessment of unlisted chemical introductions into Australia:

  • Part 1: Provides a general overview of the NICNAS reforms;
     
  • Part 2: Focuses on the development of the technical detail to be set out in the delegated legislation and guidance material;
     
  • Part 3: Describes the objective hazard and exposure criteria. These criteria will provide a structured and transparent approach to self-categorization of industrial chemical introductions. The chemical categorization outcomes (Exempted, Reported, or Assessed) will allow risk-based regulation;
     
  • Part 4: Describes the requirements for information that an introducer must consider in categorizing their chemical introduction and that Australia will need as part of an assessment certificate application;
     
  • Part 5: Provides the detail of the hazard information required to categorize chemical introductions the right way for both human health and environmental risks. The level of hazard characterization required will vary with the predicted level of exposure;
     
  • Part 6: Describes additional information requirements. These will apply for a limited set of specified chemical introductions where minimum information requirements will not be enough to determine the indicative risk, and thus the appropriate introduction category;
     
  • Part 7: Proposes the categorization of industrial chemicals introduced at the nanoscale. It presents options for the properties of nanoscale chemicals that should be used as criteria to define the chemicals that require pre-introduction assessment;
     
  • Part 8: Describes the criteria for the commercial evaluation authorization pathway that will be prescribed in the delegated legislation. It will include the volume threshold and the circumstances related to public exposure;
     
  • Part 9: Presents the details to be included in the delegated legislation to implement the national ban on the use of new animal test data for chemicals used exclusively as cosmetic ingredients; and
     
  • Part 10: Discusses other matters to be included in the delegated legislation, including prescribed bodies for consultation; prescribed bodies for disclosure of confidential business information (CBI); definitions to be elaborated on in the delegated legislation (including article and industrial chemical); and requirements for the annual compliance declaration.
     

NICNAS will hold two public workshops on June 16, 2017, and June 28, 2017. Comments are due July 12, 2017. The Department of Health will review feedback received on the Consultation Paper and use it to develop advice to the Australian government on drafting the delegated legislation.

BRAZIL

Brazil Continues To Experience Delays With Industrial Chemicals Regulation: In a series of 2016 articles on The Acta Group’s (Acta®) website (“Brazil Moves Closer to National Chemical Inventory,” “A Critical Review of Brazil’s Just-Published Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais),” and “Brazil Delays Promulgation of Final Industrial Chemicals Regulation”), as well as in two webinars (“Current Opportunities and Challenges with Chemical Substance Regulation in Mexico and Central and South America,” and “Chemical Substance Regulation in Central and South America: A Deeper Dive”), Acta has closely followed the development of the Industrial Chemicals Regulation in Brazil, the Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais, or Regulação).

On May 22, 2017, it was announced that, due to changes inside the Brazilian Ministry of Environment (Ministério do Meio Ambiente, or MMA), the extraordinary meetings of the National Commission of Chemical Safety (CONASQ) were rescheduled for the end of June. As part of the development of the Regulação, all of the comments received during the public consultation period were to be discussed at a meeting of CONASQ. This delay means the earliest the comments may be reviewed and addressed will be at the close of June, however, looking at the developmental history of the Regulação, additional delays should be expected.

Brazilian Chamber Of Deputies Approves Chemical Protective Packaging Amendment: The Brazilian Chamber of Deputies (Câmara dos Deputados), the lower house of the National Congress of Brazil, has passed a series of amendments that will define the situations and products for which special protective packaging must be used — generally for chemicals and medications used in the home environment for which child-resistant packaging is required. The Constitutional, Justice, and Citizenship Committee’s amendments specifically require that the associated packaging would need to be difficult for a child under five years old to open.

CANADA

Canada Seeks Comment On Proposed Approach To Promote Transparency In CMP Risk Assessment Activities: Canada has begun a public consultation on a proposed approach to promote transparency in Chemicals Management Plan (CMP) risk assessment activities. The approach outlines the steps to achieve an appropriate balance between transparency and the right of stakeholders to protect confidential information. Of particular relevance, Canada states, is the aim to publish a robust rationale for supporting decisions in risk assessments while protecting confidential information. Canada reviewed best practices in other jurisdictions and, based on this review, set out procedures in the proposed approach when claiming confidentiality for information provided to inform risk assessment activities. Canada is currently exploring opportunities for alignment of the process for reviewing confidentiality claims with the U.S. Environmental Protection Agency (EPA). Canada states that it will update the approach to reflect the alignment potential and comments received on the proposed approach. Comments are due June 30, 2017.

Canada Delays June 1 WHMIS Deadline: Canada published a notice on May 31, 2017, in the Canada Gazette to extend the first two transition milestones for Workplace Hazardous Materials Information System (WHMIS) 2015 to provide additional time for Health Canada to consider an industry proposal to protect CBI. Currently, according to the notice, all suppliers have the option of complying with either the Controlled Products Regulations (CPR) or the Hazardous Products Regulations (HPR). To protect ingredient concentrations or concentration ranges as CBI once suppliers transition to compliance with the HPR, they must use the mechanism provided by the Hazardous Material Information Review Act (HMIRA). Since manufacturers and importers of hazardous products were required to comply with the HPR by June 1, 2017, they would have had to submit any CBI claims before that date. To avoid the burden of protecting CBI under HMIRA, industry stakeholders proposed that prescribed concentration ranges be permitted in HPR and used to replace actual concentrations and concentration ranges of ingredients, rather than having to use HMIRA to protect CBI. The notice states that this proposal would allow the supplier to choose whether to disclose the actual point of concentration or concentration range of the ingredient or to make use of the prescribed concentration ranges. Health Canada will consider this proposal through consultations with stakeholders, including labor representatives. The amendments delay the transition deadline for manufacturers, importers, and distributors to become compliant with WHMIS 2015. More specifically, the June 1, 2017, transition deadline for manufacturers and importers is delayed to June 1, 2018, and the June 1, 2018, transition deadline for distributors to become compliant is delayed to September 1, 2018.

CHILE

Chilean Chamber Of Deputies Approves Resolution Requesting Elimination Of Pesticides: The Chamber of Deputies, the Lower House of the Chilean Congress, has approved a resolution adopting a national plan that would require the elimination of synthetic pesticides. If signed into national law, the plan, which has not yet been published, would establish specific goals and deadlines to replace existing chemical pesticides with those of natural origin. Additionally, the proposed plan would establish a product label, to be used on various foods, that would attest to the absence of pesticides (somewhat analogous to the “natural” food labeling used in other jurisdictions). Finally, the plan would encourage the research and development of organic pesticides, with the manifest goal of determining whether such could be used on a wide scale in Chile.

Chilean Authority Lays Out Requirement To Disclose Fertilizer Ingredients: The Chilean Ministry of Agriculture (Ministerio de Agricultura) has opened the comment period for its regulation “Provisions Concerning the Declaration of the Physico-Chemical Composition of Fertilizers, and Repeal of the Resolution Indicated” (Regulation) (Establece disposiciones para declaración de composición fisico química de los fertilizantes y deroga resolución que indica). The comment period closes June 18, 2017.

The Regulation sets out the requirement for the declaration of the physico-chemical composition of fertilizer products, both imported into and domestically manufactured in the country, with the professed goal of improving the quality of fertilizer products available in the country. The Regulation mandates that manufacturers, importers, and distributors of fertilizers must disclose, either on product containers or product labels or, for bulk products, on the commercial invoice. In addition to the physico-chemical composition, these entities must also declare other parameters, which will depend on the type and nature of the specific fertilizer. These other parameters will include solubility, granulometry, and pH.

CHINA

China Developing Standards Concerning Hazardous Chemicals In Consumer Products And SVHCs: A Chinese recommended national standard, “Safety Requirements for Hazardous Chemicals in Consumer Products (Draft for Public Comments), was issued on March 28, 2017. The standard would create limit values for 103 chemical substances, listed with Chemical Abstracts Service (CAS) numbers, including heavy metals and hazardous chemicals. Another Chinese recommended national standard, “List of Substances of Very High Concern (SVHC) in Consumer Products (Submitted Draft)” was released in March 2017, in which 205 SVHCs with CAS numbers and uses are reportedly listed. This submitted draft for official review has not been released to the public. On April 24, 2017, the Standardization Administration of China (SAC) published a list of 209 national standards to be established (2nd batch of 1017) for public comments. According to the list, SAC plans to establish a recommended national standard, “Guidelines on Identification and Evaluation of SVHCs” in 24 months. The technical standard will provide guidelines for determination, classification, risk assessment, restrictions, and management of SVHCs.

European Union (EU)

PlasticsEurope Files Action Against ECHA’s SVHC Listing For BPA: On March 21, 2017, PlasticsEurope, an important trade association, filed an action against the European Chemicals Agency’s (ECHA) inclusion of bisphenol A (BPA) in the Candidate List of SVHCs. BPA was added to the Candidate List on January 12, 2017, due to its reprotoxic properties following a proposal by French authorities. Additionally, the Member State Committee will discuss at its meeting scheduled for June 12-16, 2017, a proposal to identify BPA as an endocrine disruptor for humans.

PlasticsEurope’s action claims that the European Court of Justice should: (1) declare the application admissible and well-founded; (2) annul ECHA’s decision, published on January 12, 2017, to include BPA in the Candidate List; (3) order ECHA to pay the costs of the proceedings; and (4) take such other or further measure as justice may require. PlasticsEurope emphasized widespread use of BPA as an intermediate and raised the following pleas in law:

  • The Contested Decision breaches Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Article 2(8)(b) because intermediate uses are “exempt from the entire Title VII pursuant to Article 2(8)(b) of the REACH Regulation, and are thus outside the scope of Articles 57 and 59 and outside the scope of [authorization].”
     
  • The Contested Decision breaches the principle of proportionality because inclusion of intermediate uses in the Candidate List exceeds the limits of what is appropriate and necessary to attain the objective pursued and is not the least onerous measure to which ECHA could have had recourse.
     
  • ECHA committed a “manifest error of assessment” by failing to take into account the information made available in the REACH Annex XV dossier for BPA, which described uses of BPA as an intermediate.
    ​

A court hearing for this case is likely to commence in late 2017-early 2018.

ECHA Continues Development Of Its Transparency Approach: ECHA’s “Update of the ECHA Transparency Approach” following the 45th Meeting of the Management Board on March 30-31, 2017, provides that ECHA’s “efforts towards openness and transparency remain focused” on the following three pillars:

  • ECHA clearly explains activities and processes in a way that is understandable by a general audience. ECHA, therefore, describes its role, its activities, how it works, who works there, and how it achieves its results.
     
  • ECHA practices open decision-making. It describes clearly who makes decisions, who is involved, how and when it consults the public, how stakeholders can observe and contribute, and how bias is avoided.
     
  • ECHA makes information available in a timely manner. It makes information available proactively and provides it in such a way that citizens can easily understand and reuse it, in whole or in part.
     

Annex 1 of ECHA’s Update provides a report on transparency improvements in 2015-2016. These improvements include: (1) further developing ECHA’s work to improve the dissemination of information on chemicals and extending it to cover ECHA’s decisions; (2) improved communications; and (3) improving the transparency of Committee meetings by providing more explanation and information on the processes and decision-making, and by reviewing observer and third party involvement.

Annex 2 of ECHA’s Update provides its goals for further improvement in transparency in 2017-2018, which include: (1) further developing the dissemination of information on chemicals; (2) improving communication, including more focus on specific target groups; and (3) continual improvement of the transparency of Committee meetings, regulatory decision-making, and third party involvement therein.

As part of its efforts to develop further the dissemination of information on chemicals, ECHA has launched a study on extending its dissemination website with an “EU chemicals legislation finder” that provides an overview of how a substance is regulated at the EU level. Subject to the outcome of the study and its reception, ECHA may be asked to develop the finder in 2018.

More information is available in “ECHA’s Approach to Transparency.”

ECHA States All Known SVHCs Are “Being Tackled”: On April 25, 2017, ECHA announced the availability of the third annual report on implementing the SVHC Roadmap. ECHA states that each year since 2013, it has screened the full REACH/Classification, Labeling, and Packaging (CLP) regulation substance database to identify substances of concern. This resulted in around 900 substances being put forward for further manual screening by the EU Member States, of which more than 600 have now been screened. According to ECHA, identifying substances of potential concern is becoming more and more difficult because of the lack of information on their hazards and on how they are used. Information is being requested for 540 substances. ECHA and the Member States have started to look more at groups of structurally similar substances. ECHA states that this will speed up the process of identifying substances of concern by enabling conclusions to be drawn on a larger number of substances at the same time. Since 2013, ECHA and the EU Member States have decided on the best risk management option for a total of 67 substances of potential concern. Approximately half are being listed as SVHCs.

ECHA Updates List Of Biocidal Active Substances In The Review Program: ECHA announced on April 27, 2017, that the list of biocidal active substances to be evaluated by Member States has been updated. The updated Annex II to the Review Program Regulation includes a list of the active substances for which companies have requested approval for a specific product-type. If a substance is on the list for a particular product-type, that product can remain on the EU market until the substance is approved. If a substance is no longer included in the Review Program for a specific use, it means that no company has expressed an interest in keeping it there or the notification has not fulfilled the requirements. The European Commission (EC) has adopted a non-approval decision for these substances. According to the decision, the substances can no longer be made available on the EU market after November 4, 2017, and no longer used after April 4, 2018.

Chemical Product Labels Must Comply With CLP As Of June 1: On April 28, 2017, ECHA issued a press release reminding companies that hazardous chemicals must be classified, labeled, and packaged appropriately before being placed on the market. Beginning June 1, 2017, all chemical products placed on the market have to be labeled in accordance with CLP. ECHA notes that this marks the end of the transitional period for labeling mixtures. Companies that still have products on the shelves with labels following the requirements of the previous legislation must now make sure that the products are either no longer placed on the market, or re-classified and re-labeled in accordance with CLP.

EC Adopts Guidance On Access To National Courts On Environmental Cases: The EC announced on April 28, 2017, the availability of a guidance document on access to justice in environmental matters. According to the EC, the guidance document clarifies how individuals and associations can challenge decisions, acts, and omissions by public authorities related to EU environmental law before national courts. The guidance is intended to help individuals and non-governmental organizations to decide whether to bring a case before national courts. The EC states that national courts can use it to help identify all the EU Court of Justice cases that they should take into account when they are faced with questions related to access to justice in environmental cases. With the guidance, national administrations are made aware of possible shortcomings in their justice systems, and businesses are provided with greater clarity on what EU rights and obligations are at stake in the decisions, acts, and omissions that concern them. More information is available in the EC’s press release, “New guidelines help citizens gain better and fairer access to their national courts on environmental cases.”

BPC Adopts Six Opinions Supporting Approval Of Active Substances: On April 28, 2017, ECHA announced that the Biocidal Products Committee (BPC) adopted opinions supporting the approval of two active substances for use in biocidal products used as disinfectants for human and veterinary hygiene. The active substances and related product-types are:

  • L(+) lactic acid for product-types 2, 3, and 4; and
     
  • Propan-1-ol for product-types 1, 2, and 4.
     

L(+) lactic acid is an existing active substance evaluated in product-types 1, 2, 3, 4, and 6. BPC has already adopted an opinion on product-type 1. The products containing L(+) lactic acid are used for the disinfection of surfaces in bathrooms by the general public in product-type 2, for disinfection of cow teats after milking in product-type 3, and for the disinfection of tanks in the brewery industry by professional users in product-type 4.

Propan-1-ol is an existing active substance. The products containing propan-1-ol are used for hand disinfection by non-professional and professional users in product-type 1, and for the disinfection of surfaces, objects, material, and equipment in private, public, health, and industrial areas by non-professional and professional users in product-types 2 and 4.

The evaluating competent authority for these active substance applications was Germany. Further information is available in the Annex to ECHA’s news alert.

JRC Publishes NANoREG Framework For The Safety Assessment Of Nanomaterials: The EC Joint Research Center (JRC) has published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials. The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.” The NANoREG framework represents the project’s proposal for a common understanding in the field of environmental health and safety (EHS) assessment of nanomaterials under the current European regulatory framework, with focus on REACH. The key conclusions note that the EC, ECHA, the Organization for Economic Cooperation and Development (OECD), and the scientific community “have worked closely together in recent years to improve the knowledge on EHS of [nanomaterials], remove hurdles and concretely help stakeholders in addressing regulatory requirements for [nanomaterials].” The report states that the NANoREG partners, including JRC, “believe that the proposed framework will be useful for scientific experts and stakeholders, such as regulatory authorities and industry.”

Tenth ATP To CLP Regulation Published: On May 4, 2017, Commission Regulation (EU) 2017/776 was published in the Official Journal of the EU to amend the CLP Regulation. This publication is the tenth Adaptation to Technical and Scientific Progress (ATP), and introduces new or revised entries for the harmonized classification and labeling of 37 substances. The amendments introduced include new harmonized acute toxicity estimates (ATE) values. The Regulation entered into force on May 24, 2017, and will apply from December 1, 2018.

ECHA Creates Web Page For NMEP: ECHA created a web page for the Nanomaterials Expert Group (NMEP), which was created in October 2012. NMEP aims to seek common ground among experts on scientific and technical issues regarding the implementation of REACH, CLP, and the Biocidal Products Regulation (BPR) for nanomaterials. ECHA states that the page includes information on NMEP’s mandate and activities, the list of the members, and the meeting schedule, which will also include the minutes of the meetings in the future. According to the web page, NMEP met May 16-17, 2017, and will meet November 7-8, 2017.

ECHA Opens Consultation On Chromates Authorization Applications: On May 10, 2017, ECHA commenced consultation on four applications for authorization submitted by Saes Getters S.p.A. The authorization applications submitted by Saes Getters S.p.A. relate to the following uses of potassium chromate and sodium chromate:

  • Use in the fabrication of alkali metal dispensers for production of photocathodes; and
     
  • Use of alkali metal dispensers containing either substance for production of photocathodes.
     

The requested review period for these four authorization applications is seven years. ECHA’s consultation period for the authorization applications ends on July 5, 2017.

ECHA Provides Information On Union Authorization Of Biocides: On May 17, 2017, ECHA issued a press release entitled “Check the 2018 deadlines to apply for Union authorisation of biocides.” The press release states “[a] list of active substance and product-type combinations for which a Union [authorization] should be applied for in 2018 has been published. Check the deadlines and apply in time to keep your product on the market … In 2018, you should apply for product [authorization] to keep your existing products on the market if they contain the active substances for which legal deadlines happen in that year. A convenient way to make the product [authorization] applications is to use Union [authorization].”

ECHA recommends that a pre-submission is made at least six months prior to an application for Union authorization because this “free-of-charge consultation” by Member States provides useful information on the chances of success of the Union authorization application, and helps in identification of any potential issues that may need to be addressed.

More information on upcoming 2017 and 2018 deadlines is available on ECHA’s “Deadlines for Union authorisation applications” web page.

EC Publishes Final Conflict Minerals Regulation: On May 19, 2017, the EC published the final conflict minerals regulation in the Official Journal of the European Union. The regulation establishes a system for supply chain due diligence intended to “curtail opportunities for armed groups and security forces to trade in tin, tantalum and tungsten, their ores, and gold.” Beginning January 1, 2021, importers, smelters, and refiners of tungsten, tin, tantalum, and gold will have to conduct mandatory due diligence checks when annual import volumes exceed set thresholds. While there will be no mandatory requirements on downstream companies in the supply chain, they will be encouraged to carry out voluntary checks. The EC posted questions and answers (Q&A) in March 2017 regarding the regulation. The Q&As address the countries and companies covered, due diligence, implementation, and the institutions and countries involved.

ChemSec Launches Marketplace For Safer Alternatives: The International Chemical Secretariat (ChemSec) has launched the “Marketplace,” an interactive online portal that allows manufacturers to advertise safer alternatives to hazardous products. ChemSec states: “Do you want to replace a chemical that is harmful to health or the environment with a better alternative? Search our database to find an alternative product from the suppliers presenting their offerings on the site. A quick and simple way to find the substitute you need.”

The Marketplace features a number of manufacturers of “alternatives,” including Chemours, Clariant, Valspar, Beyond Surface Technologies, Bio Gen Active, Nordic Paper, Organoclick, and Rivertop Renewables. The Marketplace’s Frequently Asked Questions (FAQ) include responses to a number of important questions. In addition, the Marketplace provides certain regulatory information that will be expanded upon progressively.

ECHA Publishes REACH Guidance for Nanomaterials: ECHA announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 REACH registration deadline. ECHA published two new guidance documents:

In addition, ECHA published updates to three of its existing guidances on nanomaterials — the appendices for nanomaterials to Chapters R.7a, R.7b, and R.7c of the Guidance on IR&CSA (endpoint specific guidance). ECHA states that these three documents provide nano-specific advice to help registrants meet the information requirements set out in REACH Annexes VI-XI. ECHA notes that the scope of the updates covers human health and environment related endpoints and incorporates new developments in the scientific understanding of hazard/risk assessment of nanomaterials. It also takes account of ECHA’s experience from compliance checks and substance evaluation.

First Appeal By DU Dismissed By Board Of Appeal: On May 30, 2017, ECHA’s Board of Appeal dismissed an appeal against a substance evaluation decision for N,N- dicyclohexylbenzothiazole-2-sulphenamide (DCBS). The Appellant, Manufacture Française des Pneumatiques Michelin, is a French tire manufacturer and Downstream User (DU) of DCBS. The appeal by Manufacture Française des Pneumatiques Michelinagainst the substance evaluation decision is the first appeal to be filed by a DU. The Appellant uses DCBS, “which is an accelerator of [vulcanization] for certain types of rubber compounds, in the manufacture of internal components of [tires].”

Following evaluation of DCBS by Germany, ECHA requested that registrants of DCBS submit an updated Chemical Safety Report (CSR) containing additional information on environmental exposure assessment, including: (1) assumptions underlying the environmental exposure estimation; (2) “[e]nvironmental exposure assessment for the sediment compartment from manufacturing the Substance”; (3) environmental exposure assessment for the production and use of tires and general rubber products; and (4) environmental releases from the use of tires.

Manufacture Française des Pneumatiques Michelinraised two pleas in law in support of its appeal. The first plea alleged that ECHA breached REACH Article 46 and “went beyond its margin of discretion”: (1) by failing to examine carefully and impartially the facts of the case; and (2) “by failing to ensure that the requested information on exposure for the use of the Substance in [tires] is obtained from the relevant [DUs].” In its second plea, the Appellant argued that ECHA should have conducted a compliance check prior to the substance evaluation to request the information required in the Contested Decision.

ECHA challenged the admissibility of the appeal, and submitted that the Contested Decision had only “remote effects” on the legal situation of DUs and new registrants of DCBS, and that these remote effects did not demonstrate the Appellant’s “direct or individual concern vis-à-vis the Contested Decision.” ECHA also questioned the date upon which the Appellant became aware of the Contested Decision and whether the appeal was correctly lodged within the timeframes under REACH Article 92(2).

The Board of Appeal dismissed the appeal as inadmissible because the Appellant did not have legal standing to challenge ECHA’s decision. In reaching this conclusion, the Board of Appeal considered whether the Contested Decision was of “direct and individual concern” to the Appellant. The Board of Appeal concluded that the Contested Decision was not of direct concern to the Appellant, and that a determination on individual concern was not needed as the requirements are cumulative. The Board of Appeal decided that the appeal fee shall not be refunded.

ECHA Publishes Illustrative Examples To Guide Companies In Preparing Registrations: On May 31, 2017, ECHA announced that it published eight new illustrative examples to guide registrants. ECHA states that the examples illustrate situations companies may face when preparing their REACH registrations and are intended to complement the practical advice given through the REACH 2018 web pages. In addition, ECHA posted four new video tutorials to help companies manage IUCLID and use it to prepare technical dossiers.

  • Phase 1: Know your portfolio:
    ​
    • How to plan your registration;
       
    • How to identify a substance on the borderline of a mono- and multi-constituent;
       
    • How to identify a substance produced in different qualities;
       
    • How to identify a substance that consists of a “mixture of isomers”; and
       
    • How to identify a substance that includes a stabilizing solvent;
       
  • Phase 3: Get organized with your co-registrants:
    • Sharing the costs of an individual study; and
       
    • Cost sharing between co-registrants with different data requirements;
       
  • Phase 4: Assess hazards and risks of substances:
    • Steps to gather information for low tonnage substances;
       
  • Phase 5: Prepare your registration as a IUCLID dossier:
    ​
    • How to install IUCLID 6 desktop;
       
    • How to run the Validation Assistant in IUCLID 6;
       
    • How to update IUCLID 6 desktop; and
       
    • How to backup and restore IUCLID 6.
       

More information is available in ECHA’s press release, “REACH 2018: Practical help to prepare your registration.”

ECHA’s Report Indicates Alternatives To Animal Testing Are Widely Used: On June 1, 2017, ECHA issued a press release entitled “Alternatives to animal testing widely used.” The press release states: “ECHA’s report on the use of alternatives to animal testing shows that registrants [under REACH] have used alternatives for at least one endpoint in [89 percent] of the substances [analyzed]. However, industry needs to improve the quality and robustness of alternative data.”

ECHA’s press release indicates that data sharing is a significant contributor to minimizing animal testing because 98 percent of substances are registered jointly. As a result, registrants make extensive use of existing information and alternative methods before conducting new studies. ECHA’s analysis, which is based on individual registration dossiers submitted between 2008 and 2016 for 6,290 substances, indicates that 89 percent of the substances have at least one endpoint where an alternative was used instead of a study using animals. The most common alternative method was using information on similar substances (i.e., read-across), used in 63 percent of the analyzed substances, followed by combining information from different sources (i.e., weight-of-evidence), used in 43 percent of analyzed substances, and computer modelling (i.e., QSAR prediction), used in 34 percent of analyzed substances.

The report indicates that read-across data have been particularly useful for human health endpoints (e.g., developmental and reproductive toxicity). For skin and eye irritation, REACH registrants largely use existing data, read-across, and in vitro studies. For environmental endpoints such as bioaccumulation, long-term toxicity to fish, and toxicity to birds, data waiving (i.e., justification to omit studies) is the most commonly used alternative to animal testing. Considering all of the endpoints and substances analyzed that can be filled by tests on vertebrate animals, ECHA’s report indicates that registrants used data from new vertebrate animal studies in 11 percent of the cases.

ECHA uses the report’s findings to promote alternative methods through its guidance, web pages, webinars, and events. More information is available in ECHA’s third report under REACH Article 117(3) entitled “The use of alternatives to testing on animals for the REACH Regulation” or the summary of the report.

OECD

OECD Publishes Report On Economic Features Of Chemical Leasing: OECD on May 11, 2017, published a new report, Economic Features of Chemical Leasing. OECD describes chemical leasing as “a service-oriented business model that aligns the interests of the chemical supplier with those of the chemical user by compensating the service of the chemical rather than the chemical volume sold and used.” The report presents a review of the literature on the economic features of chemical leasing and of similar business models, focusing on the drivers and barriers and comparing their functioning to traditional contracts. The report provides:

  • An overview of the potential market of chemical leasing and examples of practical implementation;
     
  • A description of the stakeholders involved;
     
  • A description of the costs and benefits, drivers, and barriers of implementing the model;
     
  • An analysis of the functioning of chemical leasing versus traditional contracts; and
     
  •  Proposed initiatives that could be undertaken to facilitate the take-up of the model.
     

SWEDEN

KEMI Will Focus Enforcement And Market Surveillance On Chemical Products, Pesticides, And Articles: KEMI published in April 2017 its 2017 enforcement and market surveillance plan, describing the enforcement activities that will be prioritized in 2017. According to the summary, which is available in English, KEMI has divided the operational enforcement into three main areas:

  • Chemical Products: Enforcement will focus on continued regional-based systematic control, supplemented with risk minimization measures in prioritized substance or product category areas, such as eyelash adhesives and chemical products in toys. Together with other authorities, KEMI will also monitor exposure scenarios in accordance with REACH;
     
  • Pesticides: Enforcement will focus on monitoring disinfectants in accordance with new legislation. KEMI will also do follow-ups with companies that showed shortcomings during previous enforcement of plant protection products; and
     
  • Articles: Enforcement will focus on follow-ups with companies that during previous inspections have shown repeated occurrence of hazardous chemicals in their products. KEMI will also monitor articles frequently used in the home environment, including articles children might put in their mouths. KEMI will inspect personal hygiene products and control articles treated with biocides, focusing on sportswear and shoe soles.
     

TAIWAN

Taiwan EPA Begins Consultation Period On Proposed TCSCA Revisions: The Taiwan Environmental Protection Administration (Taiwan EPA) has begun a public consultation on proposed changes to the Toxic Chemical Substance Control Act (TCSCA). Changes include:

  • Coordinating central and local government agencies by establishing a national chemical regulation advisory reporting system;
     
  • Removing Class 4 toxic chemical substances (substances deemed to endanger human health or the environment);
     
  • Introducing a “chemical substances for investigation” category;
     
  • Generating a chemical substances regulation fund to introduce new regulatory fees; and
     
  • Provisions to improve emergency response procedures for toxic chemical incidents.
     

Comments on the proposed revisions are due June 16, 2017.

UNITED KINGDOM (UK)

Environmental Audit Committee Issues Report On Chemicals Regulation: On April 29, 2017, the House of Commons Environmental Audit Committee published a report entitled “The Future of Chemicals Regulation after the EU Referendum.” The report states “[‌i]t is crucial that the EU negotiations and any future domestic legislative framework allow the UK chemicals industry to continue to provide value to the economy whilst also protecting public health and the environment.” The Environmental Audit Committee’s “key findings” in the report are:

  • The chemicals regulation framework established by the EU through REACH would be difficult to transpose directly into UK law;
     
  • Companies face significant uncertainty over the validity of current REACH registrations after the UK leaves the EU, and the Government must clarify its position on the future regulatory framework as a matter of urgency;
     
  • In deciding the future of the UK’s relationship with the EU’s single market for chemicals, the Government should take a pragmatic approach. The most important element of REACH, which the Government should seek to remain involved in as a minimum, is the registration process for chemicals;
     
  • Establishing a fully stand-alone system of chemicals regulation for the UK is likely to be expensive for both the taxpayer and for industry; and
     
  • The experiences of the U.S. as it introduces an improved system of chemicals regulation could be useful for the Government when planning the UK’s approach.
     

The report elaborates upon these findings, provides information on consultations with important actors in industry (e.g., Chemical Industries Association), and describes additional REACH-related challenges for the UK. These challenges include financial and practical problems industry may face in complying with “two sets” of regulations, and issues the UK Government may encounter in establishing and financing a new regulatory framework and responsible authority.

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