Global Regulatory Update for February 2015

AUSTRALIA

NICNAS Publishes New Guidelines On Applying For Confidential AICS Listing And Exempt Information: NICNAS announced in the January 2015 NICNAS Bulletin the availability of new guidelines on applying for confidential Australian Inventory of Chemical Substances (AICS) listing and exempt information. NICNAS states that, following consultation with a number of stakeholders, it has now published Guidelines – Applying for certain information to be exempt from publication by NICNAS and Establishing a case for confidential listing of chemicals on the Australian Inventory of Chemical Substances. The guidelines contain detailed information about applying for confidential AICS listing and procedures to follow when seeking certain information to be exempt from publication, under the Industrial Chemicals (Notification and Assessment) Act 1989.

CANADA

Environment Canada Announces Availability Of Non-Confidential Summary Of Information From Phase 2 Of The DSL IU: Environment Canada announced on January 9, 2015, that a non-confidential summary of information received from the second phase of the Domestic Substances List (DSL) Inventory Update (IU) is now available. Environment Canada states that the summary refers to both information provided in mandatory responses to its December 2012 notice, and information provided on a voluntary basis. Environment Canada will use information collected for the 2011 calendar year to update the commercial status of remaining priority substances, inform priority setting, support risk assessment and risk management activities, and inform the next phase of the DSL IU. Environment Canada asks users to note that the information presented is limited to what was requested in the notice and throughout the document confidential business information (CBI) has been protected (i.e., by providing quantity ranges, or excluding data elements that were designated by submitters as CBI). Consequently, Environment Canada states, this may have led to underestimates, so conclusions should be drawn with care.

Canada Begins Review Of SNAc Orders And Notices: On January 28, 2015, Environment Canada announced that, with Health Canada, it has initiated a review of significant new activity (SNAc) orders and notices currently in place under the Canadian Environmental Protection Act (CEPA). According to Environment Canada, since publication of the first SNAc in 2001, policies and practices have evolved, particularly with respect to the nature and scope of SNAcs, as well as the wording used to identify “significant new activities.” The SNAc review is intended to ensure that SNAcs are in step with current information, policies, and approaches. Environment Canada states that, following the review process, there may be no changes needed for certain SNAcs or, for others, rescissions or amendments may be warranted. As the review will be implemented via a phased approach, Canada will publish information on the results of the review process on an ongoing basis as elements of the review are completed. Elements of the review may be subject to external consultation. Below is the list of SNAc review groups in order of priority:

EU

Austrian, Belgian, Danish, German, French, Dutch, And Swedish Delegations, And Norway Send Information Note To Environment Council: The Austrian, Belgian, Danish, German, French, Dutch, and Swedish delegations and Norway sent an information note to the Environment Council concerning key issues in chemicals policy on the road to a non-toxic environment for discussion during the Environment Council’s December 17, 2014, meeting. The information note identified key issues to be addressed:

• Minimizing or substituting the use of substances of concern;
   
• Endocrine disruptors;
   
• Nanomaterials;
   
• Substances in articles and imported products; and
   
• Improving the quality of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registrations.

The initiative was supported by the Croatian and Luxembourg delegations, subsequently joined by the Greek delegation. The press release for the Environment Council’s December 17, 2014, meeting states: “According to these delegations, the key issues to be addressed with priority relate to minimising or substituting the use of substances of concern, endocrine disruptors, nanomaterials, substances in articles and imported products and improving the quality of REACH registrations.”

ECHA Adds Six SVHCs To Candidate List And Updates Entry: On December 17, 2014, the European Chemicals Agency (ECHA) announced that it added six new substances of very high concern (SVHC) to the Candidate List, based on the agreement of the Member State Committee (MSC), and updated an existing entry to address an additional reason for inclusion. According to ECHA, cadmium fluoride and cadmium sulphate were added to the Candidate List as being carcinogenic, mutagenic, toxic for reproduction, and were also identified as being of “equivalent level of concern based on probable serious effects to human health” (specifically due to the effects on kidney and bone). Two benzotriazole substances, UV-320 and UV-328, were identified as being persistent, bioaccumulative, and toxic (PBT)/very persistent and very bioaccumulative (vPvB), and 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannate tradecanoate (DOTE) and the reaction mass of DOTE:2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4- octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MOTE) are identified as being toxic for reproduction. ECHA states that the MSC also unanimously agreed that bis(2-ethylhexyl) phthalate (DEHP) meets the criteria for identification as an SVHC under Article 57(f) due to its endocrine disrupting properties causing probable serious effects to the environment. As DEHP is already included in the Candidate List based on its toxic for reproduction properties, ECHA will update the entry to address the additional reason for inclusion. ECHA notes that, as DEHP is already included on the Authorization List, companies that were initially exempt from the authorization requirement may, in the future, be subject to authorization. Before this could happen, however, the EC would need to amend the corresponding entry for DEHP on the Authorization List. Legal obligations that companies may have resulting from the inclusion of substances on 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 six substances newly added to the Candidate List by December 17, 2014, have six months to notify ECHA if both of the following conditions apply: (1) the substance is present in those articles in quantities totaling over one tonne per producer or importer per year; and (2) the substance is present in those articles above a concentration of 0.1 percent weight by weight, unless exemptions apply. More information is available in ECHA’s press release, “Six new substances of very high concern (SVHCs) added to the Candidate List and one entry updated.”

Draft Delegated Directive Would Add Four Phthalates To RoHS 2: On December 17, 2014, the European Union (EU) submitted to the World Trade Organization (WTO) a draft EC delegated directive concerning the addition of four phthalates (SVHCs) to the list of restricted substances under the Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) 2. The objective of the draft directive is to adapt existing legislation to scientific and technical progress, and phase-out SVHCs in electrical and electronic equipment (EEE) to facilitate recycling and reduce possible negative impacts on human health and the environment, while granting economic operators adequate transition time for compliance. The draft directive would add DEHP, butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP) to Annex II to RoHS 2. The proposed date of adoption is February to March 2015. The directive would take effect 20 days after publication in the Official Journal of the EU. Member states would have until July 22, 2019, to apply the provisions of the directive. The restriction of DEHP, BBP, DBP, and DIBP would apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from July 22, 2021 forward. More information is available in the European Commission’s (EC) notification detail.

ECHA Publishes 2018 Roadmap: ECHA announced on January 14, 2015, the publication of its REACH 2018 Roadmap, which outlines its milestones planned in the run up towards the final REACH registration deadline for existing chemicals, which is May 31, 2018. ECHA states that, for the last REACH registration deadline, it is expecting a significantly larger amount of small- and medium-sized enterprises (SME) to register for the first time. Large companies may also have hundreds of chemicals in their portfolios to register. The REACH 2018 Roadmap describes the different milestones and support services that ECHA plans to provide registrants from now until the deadline. According to ECHA, the Roadmap is based on the seven phases of a successful registration process. For each phase, the Roadmap presents the relevant milestones and an estimated timing for them. More information is available online.

ECHA Prioritizes CMR Substances For Risk Management: ECHA announced in a January 19, 2015, press release, “ECHA is prioritising CMR substances for risk management,” that its new report on substances that are carcinogenic, mutagenic, or reprotoxic (CMR), “shows that companies are adhering well to the harmonised classification of substances.” The report identifies over a thousand CMR substances that potentially merit further regulatory action such as harmonized classification and, where relevant, identification as an SVHC. ECHA, together with Member State competent authorities, is now prioritizing such substances for appropriate risk management actions. ECHA will refer 12 registrations for individual substances on Annex VI to the national enforcement authorities for follow-up as they are not in line with the requirements of the Classification, Labeling, and Packaging (CLP) Regulation. According to ECHA, it found that a further 48 registrations for the group entry for lead compounds do not adhere to the regulation. In the follow up of these, the first step is to clarify the exact nature of the compounds. ECHA is contacting the registrants directly to ask them to clarify their classifications. ECHA urges all companies to check and update their notifications if needed. ECHA states that, as part of this study, it also screened its databases to identify substances on the EU market with CMR properties that do not currently have a harmonized CMR classification. ECHA identified 5,675 substances classified as CMR substances by at least one notifier or registrant, of which 1,169 have been registered under REACH. These substances will now be prioritized to help Member State competent authorities conclude on appropriate risk management measures such as harmonized classification and, where relevant, identification as SVHCs.

EP Committee Holds Hearing On Protecting Trade Secrets: On January 20, 2015, the European Parliament (EP) Committee on Legal Affairs held a hearing on protecting trade secrets. The purpose of the hearing was to consider why trade secrets should be protected and analyze the instrument put forward by the EC. The hearing program included:

• Trade secrets: Why should they be protected?
  
  • The vulnerability of trade secrets in commercial chains: Alain F. Berger, Vice President European Affairs and Head of Brussels office, Alstom;
     
  • Unlawful acquisition of trade secrets: Massimo Amenduni Gresele, Managing Director, and Valter Viero, Deputy Financial Director, Acciaierie Valbruna Spa; and
     
  • The difficulty in protecting trade secrets of SMEs: Dimitri Stoffels, Finance, Intellectual Property (IP), and Legal Manager, Nanocyl.
     
• Towards a better protection of trade secrets in the EU:
  
  • An academic’s perspective: Alain Strowel, Professor Université catholique de Louvain, Université Saint-Louis Brussels, Munich IP Law Center;
     
  • A practitioner’s perspective: Wouter Pors, Bird & Bird; and
     
  • An employee’s perspective: Byrial Rastad Bjorst, Teknisk Landsforbund (Danish Association of Professional Technicians).

The presentations and speeches are available on the Committee’s website.

EC Announces Pesticide Candidates For Substitution: On January 27, 2015, the EC issued a press release entitled “Pesticides: Experts endorse new EU list of candidates for substitution.” The EC announced that the EU Member State experts endorsed an EC proposal to establish an EU list of 77 candidates for substitution (CfS). CfSs are pesticides for which national authorities need to carry out an assessment to establish whether more favorable alternatives to using the plant protection product exist, including non-chemical methods. According to the EC, the aim is to encourage more sustainable crop protection. The EC states that the new list of 77 CfSs is the result of a comprehensive review of the active substances that are currently on the market and extensive consultation with stakeholders, and is based on an independent study tasked by the EC. The EC notes that the list “is neither to be misconstrued as a list of banned substances, nor as a ranking of CfS[s].” All listed active substances will still be available on the market and are deemed safe, but could be substituted in time when a viable alternative is made available. Approval periods for CfS are limited to a maximum of seven years. Current approval periods will not be affected.

ECHA Publishes List Of Substances potentially subject to compliance checks during 2015: On January 28, 2015, ECHA published a press release entitled “ECHA tightens its practice on dossier updates,” announcing that it has started publishing a list of likely cases for compliance checks and tightened and clarified deadlines for dossier updates to reduce processing times once dossier evaluation has been started. According to ECHA, publishing the list of substances for which a compliance check would in all probability be conducted gives registrants the possibility for early dossier updates before ECHA begins the compliance check. ECHA notes that the list is indicative and non-exhaustive, and that it “reserves the right to open further compliance checks on any dossier at any time and without prior notice to the registrants.” The compliance check will focus mainly on eight key endpoints that are outlined in the new compliance check strategy: genotoxicity; repeated-dose toxicity; pre-natal developmental toxicity; reproduction toxicity; carcinogenicity; long-term aquatic toxicity; biodegradation; and bioaccumulation. To shorten processing times, ECHA will no longer take into account dossier updates made after ECHA has sent its draft decision on a compliance check to the registrant for comments. ECHA states that the change does not affect the 30-day period given to registrants to submit comments on the draft decision. ECHA will take comments into account in the decision making. According to the press release, ECHA continues to offer informal interaction with registrants to clarify the process and content of the draft decision. Registrants are expected to update their dossier after the final decision, before the given deadline. ECHA will evaluate whether the requirements of the decision are met after this deadline. When registrants receive a draft decision on a testing proposal, they will have 30 days to comment and a further 30 days to update their dossier, where relevant.

Ask ECHA About Authorization Applications: On February 25, 2015, ECHA will offer support to SMEs planning to apply for authorization to use an SVHC. ECHA states: “We will be at your service on 25 February 2015, from 10:00 and 12:00 Central European Time, and we will provide support in your own language (where there is more than one official language for your country, we will offer at least one of them).” Interested SMEs should book a time for a telephone discussion online and submit their question in advance. ECHA will then call at the agreed time. More information is available in ECHA’s press release, “Ask ECHA about authorisation applications.”

OECD

OECD Announces Launch Of Substitution And Alternatives Assessment Toolbox: The Organization for Economic Cooperation and Development (OECD) announced on January 30, 2015, the availability of its Substitution and Alternatives Assessment Toolbox. The Toolbox is a compilation of resources relevant to chemical substitution and alternatives assessments. It includes the following resource areas:

• Alternatives Assessment Tool Selector: A filterable inventory of chemical hazard assessment tools and data sources to help identify tools most relevant to substitution and alternatives assessment goals. A listing of non-hazard assessment tools is also available;
   
• Alternatives Assessment Frameworks: A summary of the current frameworks that can be used to assess alternatives. Guides and other resources for conducting a chemical substitution or alternatives assessment are included;
   
• Case Studies and Other Resources: Links to case studies, toolkits, and product rating systems that provide examples, insights, and lessons learned on substitution and alternatives assessment approaches; and
   
• Regulations and Restrictions: A list of regulations and restrictions throughout OECD member countries that are driving the increased need for chemical substitution and alternatives assessment approaches.

SOUTH KOREA

What You Need to Know Now That K-REACH Is in Effect: South Korea’s Act on the Registration and Evaluation, etc. of Chemical Substance, commonly referred to as K-REACH, is now in effect. The Ministerial Decree implementing K-REACH was published in the Official Gazette on December 24, 2014. K-REACH requires that any entity that manufactures, imports, or sells new and/or existing chemicals in South Korea, at greater than or equal to one ton per annum, report annually volume and use details unless otherwise exempt. In addition, all non-exempt new chemicals and designated existing substances must be registered and reported annually under K-REACH. Companies must submit information regarding the manufacturer/importer, chemical identification, intended uses, classification and labeling, physical and chemical properties, hazard and risk information, safety data, and use-related exposure information when applying for registration.

The Acta Group (Acta^®), along with our partner in Seoul, South Korea, Sustainable Health, Environment, and Safety Chemical Consulting (SHES), presented a webinar in December to assist companies in preparing for the new regulation, and we have posted a number of valuable, in-depth resources from that webinar on our “Chemical Regulation in South Korea” web page:

• An online English translation of “The Act” establishing K-REACH;
   
• A Draft List of Chemicals for Registration under K-REACH;
   
• Information on requesting the audio recording of the webinar and presentation slides from the Acta webinar “K-REACH: What You Need to Know to Do Business in South Korea in 2015”; and
   
• Questions & Answers from Acta’s K-REACH webinar — We had many more questions from participants than we were able to address in the time allotted, so we have provided the answers to the additional questions we received.

Information on complying with K-REACH can also be found in the book Global Chemical Control Handbook: A Guide to Chemical Management Programs, written by the attorneys, scientists, and regulatory professionals of Acta and affiliated law firm Bergeson & Campbell, P.C. and others, and published by the American Bar Association. Visit our website for more information about this regulatory handbook, which includes a chapter on K-REACH and other Asian regulatory programs.