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June 1, 2014

Global Regulatory Update for June 2014

The ACTA Group


NICNAS Will Hold Training And Outreach Sessions: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) will be conducting stakeholder training and awareness sessions in major capital cities and selected regional areas in coming months, and it seeks expressions of interest from those wishing to attend. According to NICNAS, the topics to be discussed include:

  1. Who is NICNAS?;
  2. What does NICNAS do?;
  3. Industrial chemical introducers’ regulatory obligations;
  4. NICNAS registration;
  5. Australian Inventory of Chemical Substances (AICS);
  6. New industrial chemicals;
  7. Existing chemicals;
  8. Prior Informed Consent (PIC) chemicals;
  9. Nanomaterials;
  10. NICNAS compliance and enforcement functions; and
  11. Cosmetic introducers’ regulatory obligations.

The sessions are intended for new registrants and those unfamiliar with the NICNAS scheme. More information is available online.

NICNAS Will Conduct Workshops For New Chemical Notifiers: In August 2014, NICNAS will conduct workshops for new chemical notifiers in Sydney and Melbourne. NICNAS has arranged the topics to be covered into two sessions: in the morning, an overview of new chemical notification categories and NICNAS’ approach to risk assessment; and in the afternoon, a more detailed look at the new chemical submissions process, including common issues, use of analogues, and environmental assessments. Space is limited. More information is available online.


RoHS Directive Amended To Allow Certain Exemptions: The May 20, 2014, issue of the Official Journal of the European Union includes several European Commission (EC) delegated directives amending the Restriction of Hazardous Substances (RoHS) Directive to allow the following exemptions:

  • Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments;
  • Lead in micro-channel plates;
  • Lead in solder in one interface of large area stacked die elements;
  • Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems;
  • Lead in platinized platinum electrodes used for conductivity measurements;
  • Lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments;
  • Mercury in cold cathode fluorescent lamps (CCFL) for backlighting liquid crystal displays, not exceeding five milligrams per lamp, used in industrial monitoring and control instruments placed on the market before July 22, 2017; and
  • Mercury in hand crafted luminous discharge tubes (HLDT) used for signs, decorative or architectural, and specialist lighting and light-artwork.

The directives are available online.

EC Issues Second Progress Report On The Implementation Of The EU Raw Materials Initiative: On May 26, 2014, the EC announced a revised list of Critical Raw Materials and issued its second progress report on the implementation of the EU Raw Materials Initiative. The list of Critical Raw Materials still includes antimony, beryllium, cobalt, fluorspar, gallium, germanium, indium, magnesium, natural graphite, niobium, platinum group metals, heavy rare earths, light rare earths, and tungsten. The EC has removed tantalum, and added borates, chromium, coking coal, magnesite, phosphate rock, and silicon metal. The EC states that the list should help to incentivize the European production of critical raw materials and facilitate the launching of new mining and recycling activities. The EC states that it will produce a Communication on the European Innovation Partnership (EIP) to explain how the EC, Member States, industry, academia, and non-governmental organizations (NGO) intend to work together to put the strategic implementation plan of the EIP into practice. More information is available online.

ECHA Publishes Three Transitional Guidance Documents Concerning Biocides: The European Chemicals Agency (ECHA) announced on May 28, 2014, that it published three Transitional Guidance documents for the Biocidal Products Regulation (BPR):

  • Efficacy Assessment for Product Type 21 Antifouling Products;
  • Efficacy Assessment for Preservatives; and
  • Mixture toxicity assessment for biocidal products for the environment.

ECHA and the Member States’ competent authorities developed the Transitional Guidance documents, taking into account the elements described in the Technical Notes for Guidance for Biocides under the former legislation, the Biocidal Products Directive (BPD). ECHA states that a “Transitional Guidance” is a document that has been initiated under the “old” BPD and because it has been issued in final before the relevant new BPR guidance document has been fully developed, it is being made available as a Transitional Guidance document until such time as the relevant new document is ready for publication. More information is available online.

ECHA Announces New Rules On The Renewal Of Biocidal Product Authorizations Subject To Mutual Recognition: On June 4, 2014, ECHA issued a press release announcing that an EC delegated regulation entered into force providing supplementary rules for the renewal of authorizations that are subject to or granted through mutual recognition. They apply when a Member State has granted the first authorization and a different Member State has granted an authorization through mutual recognition of the first authorization. ECHA states that the new procedures affect the authorization of biocidal products or biocidal product families with the same terms and conditions in all the relevant Member States. A single application for renewal should be made that covers all the linked national authorizations. In particular, the rules specify:

  • The content of the application;
  • The procedures for the submission of applications by companies and their validation and evaluation by competent authorities;
  • The timelines for a competent authority’s decision on renewal; and
  • The period of grace for existing stocks of the biocidal product to be made available on the market if no application for renewal is submitted.

ECHA notes that, as with all national authorizations, companies have to submit an application for renewal at least 550 days before the expiry date of the authorization. Product authorizations can be granted for an initial maximum period of ten years and the renewal should not be granted for a longer period than the initial authorization. More information is available online.

Final Report Available On Analysis Of Impacts From Possible Restriction Of New Substances Under RoHS 2: On June 10, 2014, the Oeko-Institut e.V. posted a final report entitled Study for the Review of the List of Restricted Substances under RoHS 2: Analysis of Impacts from a Possible Restriction of Several New Substances under RoHS 2. The objectives of the project were to:

  • Prepare a substance assessment of diisobutylphthalat (DIBP), based on the methodology for substance assessment prepared by the Austrian Umweltbundesamt GmbH; and
  • Provide input concerning quantitative usage data for the 21 priority substances in electrical and electronic equipment (EEE) identified by the Austrian Umweltbundesamt GmbH, or where this is not possible, a magnitude ranking, with a view to a refined prioritization for future review cycles.

The criteria used as the basis of the refined prioritization includes quantities in which the substance is in use in EEE manufacture; quantities present in EEE end products (in cases where substances are used as intermediates or reactive chemicals); and possible differences in the use trend of a substance between EU manufacturers and other manufacturers in light of the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation authorization processes. The final report includes recommended priorities for assessing the various substances, as well as commentary to indicate aspects of interest that should be considered in future assessments of the substances in the context of RoHS. The recommended priorities for substance assessment are:

1High use volume in EEEHigher priority to assess if environmental benefits justify restriction — check if there are sub-substances that need to be reviewed as with polyvinyl-chloride (PVC) rigid, soft, and recycled.PVC
2Medium use volume in EEEMedium priority to assess if environmental benefits justify restriction — check if there are sub-substances that need to be reviewed as with PVC rigid, soft, and recycled.Medium chained chlorinated paraffins (MCCP)
antimony trioxide
tetrabromo-bisphenol A (TBBPA)
3Low use volume in EEELower priority to asses if environmental benefits justify restriction — check if there are sub-substances that need to be reviewed as with PVC rigid, soft, and recycled.indium phosphide
beryllium metal and containing alloys
beryllium oxide
4Annex XIV substance assumed not to be in use in light of EU use trends — needs to be confirmed in the supply chain, particularly of articles imported from outside the EU. Restriction may be more relevant to ensure that substance is not brought in through import of components and products.Assessment can be made at a later stage in light of the lower relevance to EEE. Main focus would be to realize if there is an impact to competitiveness in light of the Authorization requirement or if manufacture has just moved elsewhere. It may be beneficial to have a survey of the supply chain in cooperation with industry, to clarify if its use in EEE is relevant and would justify a restriction to ensure the level of environmental safety is the same and whether the different trend of use causes impacts on competition between EU and non-EU manufacturers.di-arsenic trioxide
di-arsenic pentoxide
tris (2-chloroethyl) phosphate (TCEP)
Annex XVII substance with restrictions applying both to EU and non-EU productionAssessment can be made at a later stage in light of the lower relevance to EEE. Main focus would be to realize if there is an environmental impact still expected from restriction.nonylphenol
5Varying use volume with low anticipation for presence in final product in light of intermediate applicationsAssessment can be prepared at later stage as restriction aimed at quantities present in end product and thus impact on use needs to be revisited.nickel sulphate
nickel bis (sulfamidate)/nickel sulfamate
Varying use volume with low anticipation for presence in final product in light of intermediate applications; Annex XIV definition pending. cobalt dichloride
cobalt sulphate
6Low use volume in EEELower priority to assess if environmental benefits justify restriction — check if there are sub-substances that need to be reviewed as with PVC rigid, soft, and recycled.cobalt metal
Assumed not to be in use in light of EU use trends — needs to be confirmed in the supply chain, particularly of articles imported from outside the EU.Assessment can be made at a later stage. It may be beneficial to have a survey of the supply chain in cooperation with industry, to clarify if its use in EEE is relevant and would justify a restriction to ensure the level of environmental safety is the same and whether the different trend of use causes impacts on competition between EU and non-EU manufacturers.diethyl phthalate (DEP)
dibromoneopentyl glycol

The final report is available online.

ECHA Adds Four New SVHCs To Candidate List: ECHA announced on June 16, 2014, that it added cadmium chloride, a phthalate, and two boron substances to the Candidate List, which now contains 155 substances. ECHA states that cadmium chloride is a carcinogenic, mutagenic, or toxic for reproduction (CMR) substance and is also identified as being of an equivalent concern based on probable serious effects to human health, specifically due to the effects on kidney and bone. ECHA identified the other three substances as being toxic for reproduction. According to ECHA, it added one boron substance directly to the Candidate List because it did not receive any comments relevant for the identification as an SVHC during the public consultation. Concerning the remaining three substances, the Member State Committee reached unanimous agreement to their identification as SVHCs in written procedure. ECHA states:

Legal obligations that companies may have resulting from the inclusion of substances in the Candidate List apply to the listed substances on their own, in mixtures or in articles. Producers and importers of articles, containing any of the four substances included in the Candidate List by 16 June 2014, have six months from today to notify ECHA if both of the following conditions apply:

  • the substance is present in those articles in quantities over one tonne per producer or importer per year, and
  • the substance is present in those articles above a concentration of 0.1% weight by weight.

There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded. More information is available online.

EC Publishes Endocrine Disruptors Roadmap: The EC published on June 17, 2014, a Roadmap entitled Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation.

The main policy objectives are:

  • General objective within the Treaty:
    • Ensuring a high level of protection to human health and the environment; and
    • Strengthening the functioning of the internal market.
  • Specific objective for the Plant Protection Product Regulation (PPPR) and BPR:
    • Providing for legal clarity, predictability and coherence in the identification of endocrine disruptors;
    • Providing for scientific criteria that are operational in terms of regulatory decision-making; and
    • Ensuring possibility to apply these criteria across all relevant EU legislation.

The Roadmap lists the following policy options to identify endocrine disruptors: (1) no policy change; (2) World Health Organization (WHO)/International Program on Chemical Safety (IPCS) definition to identify endocrine disruptors (hazard identification); (3) WHO/IPCS definition to identify endocrine disruptors and introduction of additional categories based on the different strength of evidence for fulfilling the WHO/IPCS definition; and (4) WHO/IPCS definition to identify endocrine disruptors and inclusion of potency as element of hazard characterization (hazard identification and characterization). The Roadmap provides an initial assessment of the impacts of each of the policy options. The Roadmap states that the EC will hold a public consultation, which is expected to start in 2014, to collect views of all interested parties. The Roadmap is available online.

ECHA Publishes New Practical Guide On Intermediates: ECHA announced on June 25, 2014, that it published a new practical guide entitled “How to assess whether a substance is used as an intermediate under strictly controlled conditions and how to report the information for the intermediate registration in IUCLID.” Intermediates may benefit from special derogations under REACH, such as reduced registration requirements and exemption from authorization. ECHA states that the practical guide is intended to support registrants and downstream users of intermediates in checking if their use of the substance complies with the definition of intermediate under REACH. The practical guide provides examples of use as an intermediate and of strictly controlled conditions that are required for reduced registration. It also shows how registrants and downstream users can check that these conditions are implemented on site. The practical guide also illustrates what should be included in the registration dossier in relation to intermediate use, and is complementary to ECHA’s 2010 guidance on intermediates. More information is available online.

ECHA Announces New Partners Service For Authorization Applicants: ECHA invites companies, consortia, industry associations, and consultants to use its partners service to find partners for their authorization applications. ECHA states that the service may also be used to communicate between suppliers, clients, or to inform other companies about potential alternatives. ECHA notes that its use is limited to the substances on the Authorization List (Annex XIV of REACH) and the substances recommended for inclusion in the Authorization List. More information is available online.

Registration Open For Biocides Stakeholders’ Day: ECHA has begun registration for its September 24, 2014, Biocides Stakeholders’ Day, which will provide key biocides stakeholders with information about the BPR, including the tools and support available for companies. ECHA’s objective is to make sure that companies are aware of their roles and obligations to assist them in meeting the relevant BPR requirements. ECHA will organize one-to-one sessions between participants and ECHA staff on key topics. ECHA states that it will provide further information about booking a session closer to the event date. Registration closes on July 31, 2014, and space is limited. Registration is available online.

ECHA Will Begin Consultation On Draft Sixth Annex XIV Recommendation On September 1: ECHA announced that it will hold a public consultation on the draft sixth Annex XIV recommendation from September 1, 2014, through November 30, 2014. ECHA states that it postponed the start of the public consultation to allow interested parties more time to prepare their input. ECHA intends to submit the sixth Annex XIV recommendation to the EC in summer 2015. ECHA states that to support the EC in its decision-making, interested parties will also be invited to submit information on possible economic, social, health, and environmental impacts (costs and benefits) of the inclusion of the substances in Annex XIV.


Taiwan Holds Second Supplementary Nomination Period For Existing Substances Inventory: Taiwan began a second “supplementary nomination and correction” period on June 1, 2014. Substances eligible are those imported to Taiwan, or manufactured, handled, used, or sold domestically between January 1, 1993, and December 31, 2011. Substances that are already on the draft existing chemical substance inventory do not have to be nominated. Nominations will be accepted until July 31, 2014. Nomination tools and guidance documents are available online.