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October 1, 2015

Global Regulatory Update for October 2015

The ACTA Group


NICNAS Will Publish Reforms Implementation Plan Consultation Paper And Consultation Workshops: The October 6, 2015, issue of The NICNAS Bulletin includes an item on the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) reforms implementation plan. According to the item, the implementation plan outlines opportunities for community and industry consultation; timing of legislation and information technology (IT) system changes; proposed improvements to NICNAS’s registration and payments processes; and the process for developing new procedures and guidance. NICNAS will hold consultation workshops in Sydney and Melbourne during November/December 2015 to discuss issues raised in a consultation paper to be published in October 2015. According to the September 2015 implementation plan, this consultation paper will likely describe the criteria proposed to distinguish new chemicals in Classes 1, 2, and 3. The consultation paper will detail the proposed criteria, and seek stakeholder comments regarding how the criteria might be improved, without losing the policy intent agreed by government. The implementation plan states that subsequent consultation papers, expected to be released in January, March, and May 2016, will address the detailed data requirements for each class. Additional workshops in other capital cities will be dependent on the level of interest.

NICNAS Publishes Overview Of Comments On IMAP Assessments, Will Publish Tranche 15: NICNAS published an overview of public comments suggesting amendments to the Inventory Multi-tiered Assessment and Prioritization (IMAP) Tier II assessment reports for tranches 10 through 14. NICNAS states that it considered the suggested amendments and, where appropriate, amended the assessment reports as part of an ongoing process of refinement and improvement of IMAP outputs. NICNAS intends to publish tranche 15 IMAP assessments during the week of October 26, 2015. Once NICNAS publishes the assessments, an eight-week comment period will begin.


Proposed Legislation Will Address Industrial Chemicals: The fourth session of the International Conference on Chemicals Management (ICCM4) included a presentation on “The Brazilian Path to Establish Legal and Administrative Infrastructure to the Sound Chemicals Management” at an event on September 30, 2015. According to the presentation, which was part of “Implementing the Overall Orientation and Guidance for Achieving the 2020 Goal: Elements of Legislation on Chemicals Management — Experiences in Brazil and Serbia,” there is a lack of comprehensive legislation on industry chemicals, including an inventory of existing chemicals and measures to assess and manage their risks. Proposed legislation, which will be presented to the National Congress, will include:

  • A national inventory of chemicals;
  • The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) as the classification and labeling system;
  • Use of available and reliable national and international database and substance information sources to reduce costs;
  • Industry to provide data to contribute in assessing hazards and, when necessary, risks to health and environment;
  • Substance prioritization based on risk; and
  • Risk management measures.


ECHA Publishes Nanomaterials Workshop Proceedings: The European Chemicals Agency (ECHA) published the proceedings of its October 23-24, 2014, “Topical Scientific Workshop: Regulatory Challenges in the Risk Assessment of Nanomaterials.” According to ECHA, the anticipated outcome was early emergence of new and/or improved approaches in the context of risk assessment of nanomaterials. ECHA states that the result “clearly matched the expectations and the output from this workshop will form a cornerstone in the guidance developments for the implementation of” the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Classification, Labeling and Packaging (CLP), and Biocidal Products Regulations (BPR).

ECHA Executive Director Asks EP Committee To Address The Two “Remaining Headaches,” Nanomaterials And Endocrine Disruptors: Geert Dancet, ECHA Executive Director, in his annual speech to the European Parliament (EP) Committee on the Environment, Public Health and Food Safety, repeated his request to address the two “remaining headaches”: nanomaterials and endocrine disruptors. Dancet urged the European Commission (EC) to address information requirements for nanomaterials by amending the REACH Annexes and to define the criteria for endocrine disruptors. The recording of the Committee meeting is available online.

Technical Meeting On Endocrine Disruptors Will Be Held In November: The EC will host a technical meeting to introduce the methodology developed by the Joint Research Center (JRC) for screening endocrine disruptors. The JRC developed the methodology in the context of the Impact Assessment on criteria to identify endocrine disruptors and aims to estimate which chemicals may fall under the different options for criteria to identify endocrine disruptors, as outlined in the roadmap. This meeting will take place in Brussels on November 6, 2015. The registration is already closed, but the meeting will be web-streamed live.

ChemSec Updates SINimilarity Tool, “Empowers Non-Chemists”: The International Chemical Secretariat (ChemSec) announced on September 27, 2015, the availability of “a much-improved version of SINimilarity” that will “empower non-chemists who previously had to rely solely on the information provided by their chemical suppliers.” ChemSec describes SINimilarity as a “free of charge web-based tool that can identify if a substance has structural similarity to a known hazardous chemical, which in turn is an indication of similar hazardous properties.” According to ChemSec, SINimilarity “serves as a first screening tool when investigating the safety of a replacement chemical in a substitution process.”

JRC IHCP Publishes Status Report On Alternative Methods And Approaches: The JRC Institute for Health and Consumer Protection (IHCP) published the EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches. The European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM) Status Report provides an update on: the progress since May 2014 in the research and development of alternative testing methods; the evaluation and validation of alternative test methods and promoting their regulatory acceptance; and contribution to various international projects like developing Integrated Approaches to Testing and Assessment (IATA) and Adverse Outcome Pathways (AOP). According to the Status Report, “(i)n the framework of the OECD programme on the development of Adverse Outcome Pathways (AOP), EURL ECVAM has developed AOPs relevant to neurotoxicity, toxicity via disruption of the endocrine system and liver toxicity.”

ECHA Will Update Guidance On Substances In Articles: ECHA issued a September 30, 2015, press release entitled “ECHA will update the Guidance on substances in articles.” According to the press release, ECHA will update its guidance on requirements for substances in articles in two stages:

  1. A quick update in the coming months restricted to correcting the parts with references to the 0.1 percent limit that are no longer consistent with the conclusions of the court judgment. This will be carried out using a fast-track procedure — only the Competent Authorities for REACH and CLP (CARACAL) will be consulted on the update; and
  2. A more comprehensive exercise to allow for a general update and re-structuring of the document. ECHA expects to include a review of the current examples against the experience gained and questions received by ECHA since the guidance was published, as well as development of new examples that are fully aligned with the court judgment. This update will be subject to the normal three-step guidance consultation process, including consultation of accredited stakeholders.

Materials Now Available From Workshop On Soil Risk Assessment: ECHA announced on October 7, 2015, that materials from an October 7-8, 2015, scientific workshop on soil risk assessment are now available. The primary objective of the workshop, hosted by ECHA and the European Food Safety Authority (EFSA), was to review the state of the art regarding soil risk assessment in view of developing updated scientifically-sound principles and approaches for assessing the ecological risks of chemical substances (i.e., industrial chemicals, pesticides, and biocides) that are released to or reach the soil. The workshop also provided a platform for academia, regulators, and other stakeholders to address how the main long-term challenges from the regulatory perspective can be reflected and employed in current and future research topics on soil risk assessment. Discussions were reinforced by information on recent developments and on risk assessment methodologies applied in chemicals management both within and outside the EU. According to ECHA, a video recording of the workshop is “coming soon.”

Danish Chemicals Forum Calls For Sharper Focus On EU Chemicals Initiatives: On October 14, 2015, the Danish Chemicals Forum sent a letter calling for a sharper focus on EU chemicals initiatives to the EC, ECHA, authorities, non-governmental organizations (NGO), and the business community concerning five areas in which it believes “it is necessary to strengthen and improve REACH and EU chemicals initiatives”:

  1. The quality of REACH registrations; 
  2. Phase-out of substances of very high concern (SVHC);
  3. Endocrine disruptors;
  4. Nanomaterials; and
  5. Imports of articles containing substances subject to registration.

EC And Member States Repeal Manual Of Decisions Concerning Old Biocidal Products Directive: ECHA issued an October 23, 2015, press release, “Manual of Decisions repealed: check the status of products formerly excluded from biocides legislation with the national helpdesk,” announcing that the EC and Member States repealed on October 1, 2015, the Manual of Decisions for implementation of Directive 98/8/EC concerning the placing on the market of biocidal products. Companies that, on the basis of the Manual, considered their product excluded from the scope of the former biocides legislation, or covered by a different product-type, can check with their national helpdesk whether their product could now fall within the scope of the BPR. According to ECHA, if the national authority or the EC indicates that the product can be considered biocidal, companies can declare an interest to notify an active substance/product-type combination for inclusion in the Review Program until October 3, 2016. The EC will then assess the declarations of interest and provide ECHA with a list of notifiable active substance/product-type combinations. Once ECHA publishes the list, companies will have six months to notify their intention to submit an application to get their active substance/product-type combination in the Review Program. ECHA states that if an active substance/product-type combination is notified successfully, the full application for approval must be submitted within two years.


Mandatory GHS Standard Will Take Effect In 2018: On October 9, 2015, the Ministry of Labor and Social Welfare (MLSW) published Standard NOM-018-STPS-2015 in the Official Gazette. Under the Standard, GHS will be mandatory after a three-year transition period. The Standard will not apply to finished products such as pharmaceuticals, food additives, cosmetics articles, pesticide residues in food, and hazardous waste. During the transition period, employers must comply with Standard NOM-018-STPS-2000 or NOM-018-STPS-2014. These Standards will be repealed in 2018, when Standard NOM-018-STPS-2015 takes effect.


IT System Available To Help Joint Registration Under K-REACH: The Ministry of Environment (MOE) posted on its website a system intended to help companies that are jointly registering existing chemicals under the Act for the Registration and Evaluation of Chemicals (K-REACH). The system will allow companies to view the information of other companies registering the same chemical substance. It will also help joint registrants determine the lead registrant for each chemical. The lead registrant will be elected by a vote. Companies that manufacture or import existing chemicals, subject to registration, may use the system. It is also available to companies that wish to join.

South Korea Releases English Version Of Joint Submission Guidance: On September 22, 2015, South Korea released an English version of the Guidance on Joint Submission Procedure. The Guidance recommends that manufacturers, importers, or Only Representatives (OR) on behalf of foreign manufacturers sign in to the Joint Registration Information System by September 30, 2015, and begin joint registration after identifying those manufacturing or importing the same chemical and complete the registration within the three-year grace period. The Joint Registration Information System is available online.


ICCM4 Concludes With Commitment To Assure Sound Chemicals Management By 2020: ICCM4 was held September 28-October 2, 2015. According to an October 2, 2015, UNEP press release, delegates committed “to step up action to safeguard people and the environment from the risk posed by inadequately managed chemicals.” ICCM4 concluded with a commitment to invest in efforts to prevent deaths and illnesses from environmental causes by assuring sound chemicals management throughout their life cycle by 2020. ICCM4 focused on “five priority policy issues requiring urgent action to protect human health and lives — lead in paint, endocrine-disrupting chemicals, chemicals in products, nanotechnology, and hazardous substances in the lifecycle of electronics and electrical products.” Delegates added environmentally persistent pharmaceutical pollutants as a priority policy issue. Discussions on highly hazardous pesticides (HHP), which “pose particular risks to children and have caused health problems and fatalities in many parts of the world,” led delegates to agree to promote ecological alternatives and strengthen national legislation regarding the use of HHPs. ICCM4 closed by adopting a global plan of action for sound management of chemicals by 2020 that proposes concrete interventions, promotes implementation of existing legal instruments, and addresses emerging policy issues.