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May 1, 2014

Global Regulatory Update for May 2014

The ACTA Group


Australia Publishes Eighth Tranche Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published for public comment the eighth tranche of human health and environmental assessments for chemicals identified as part of the Stage One implementation of the Inventory Multi-Tiered Assessment and Prioritization (IMAP) Framework. NICNAS states that it seeks comments where information that has the potential to affect the outcome of an assessment has not been considered in the assessment. Comments provided should be evidence-based and the relevance of submitted information should be highlighted. Comments are due May 30, 2014. More information is available online.


Canada Tables Legislation Intended To Improve Labeling And Classification Of Workplace Chemicals: Canada announced on March 28, 2014, that it tabled new legislation intended to improve the level of protection for workers handling hazardous materials in the workplace. According to Canada, the proposed legislative changes to the Hazardous Products Act are an important step in Canada’s implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Canada has committed to implementing the GHS by June 1, 2015. In a fact sheet, Health Canada states that the GHS would improve how information on hazardous products is communicated, by implementing changes to the current Workplace Hazardous Materials Information System (WHMIS):

  • The standardized hazard symbols, signal words and hazard statements are expected to improve the communication of hazard information;
  • The GHS identifies hazards not addressed under the current system; and
  • More detailed information on hazardous products would be provided to employees and employers.

Under the proposed legislation, the GHS would apply to sectors currently under WHMIS. Additionally, eight sectors — consumer products, pest control products, explosives, cosmetics, medical devices, drugs, food, and wood and products made from wood — are currently excluded from WHMIS in Canada but included by the U.S. and other jurisdictions. Under the proposed legislation, these sectors would be moved to a Schedule to the Hazardous Products Act. If and when Canada moves forward on excluded sectors, any of the sectors listed in the Schedule could be brought under all or some of the provisions of the Act through the normal regulatory process, including full consultation with impacted sectors. According to the fact sheet, a key objective of implementation of the GHS is to create a system that would allow the use of a single North American label and safety data sheet (SDS) for each hazardous product. The fact sheet notes that although Canada and the U.S. are working to keep variances to a minimum, there will be some regulatory variances, such as bilingual labels in Canada, between the two countries. Once Canada adopts the changes to federal legislation, provinces and territories would be required to make their own legislative and regulatory amendments. More information is available online.

Canada Announces Final Screening Assessment Of Substances From Phase One Of The Domestic Substances List Inventory Update: Canada announced in a March 29, 2014, Canada Gazette notice the release of its Final Screening Assessment of Substances from Phase One of the Domestic Substances List Inventory Update. The Final Screening Assessment, which used the rapid screening approach, concludes that 117 of the 140 substances do not meet any of the criteria set out under Section 64 of Canadian Environmental Protection Act, 1999 (CEPA). The remaining 23 substances were identified as needing further assessment. The notice is available online. The Final Screening Assessment is available online.

Canada Begins Public Consultation On Approach For A Subset Of Substances Prioritized During Categorization: Canada began on March 29, 2014, a pubic consultation concerning the approach for a subset of substances prioritized during categorization. Canada proposes that 249 substances on the Domestic Substances List (DSL) identified as priorities through categorization that, upon further analysis, can be associated with other risk assessment or risk management initiatives under CEPA do not require further risk assessment at this time. Canada notes that this does not preclude further data collection, risk assessment or risk management activities triggered through other initiatives such as:

  • Identification of new hazard or exposure information that may impact previous analyses of risk;
  • International activities;
  • Inclusion in future substances grouping or other assessment initiatives; or
  • As may be required to support risk management activities including performance evaluation and subsequent changes to risk management.

Comments are due May 28, 2014. The consultation document, Proposed Approach for a Subset of Substances Prioritized during Categorization, is available online. More information is available online.

Canada Issues Substances Management Advisory Note Regarding Application Of The SNAc Provisions Of CEPA To “Special Category” Substances: Canada issued Substances Management Advisory Note 2014-01, “Application of the Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 to ‘Special Category’ Substances.” The Advisory Note explains to manufacturers, importers, and users of substances how a Significant New Activity (SNAc) notice or order applies to special category substances. A special category substance is defined as any substance that is manufactured or imported as: (a) a research and development substance; (b) a contained site-limited intermediate substance; or (c) a contained export-only substance. The Advisory Note states that Canada will consider inclusion or exclusion of special category substances from the notification requirements of a SNAc on a case-by-case basis. For SNAcs describing the new activities by inclusion (i.e., specifically identifying the significant new activities), special category substances would not be subject to the notification requirements of the SNAc unless explicitly described therein. Similarly, for SNAcs describing new activities by exclusion (i.e., identifying activities for which the notice or order does not apply), special category substances would be subject to the notification requirements of the SNAc, unless those activities are explicitly identified as being excluded. The Advisory Note includes examples demonstrating how the definition of significant new activities may be written in a SNAc notice or order either to include or exclude special category substances. The list is to be taken only as an example of possible wording, and any questions concerning the activities subject to notification under a SNAc should be directed to the Substances Management Information Line. The Advisory Note is available online.


China Publishes Catalog Of Priority Hazardous Chemicals For Environment Management: In early April, the Ministry of Environmental Protection (MEP) published the final Catalog of Priority Hazardous Chemicals for Environment Management, which includes 84 substances. Companies that manufacture listed chemicals or use listed chemicals to manufacture products must submit an environmental administration registration to provincial environmental authorities. These companies must obtain an environmental risk assessment report, prepared by a qualified third party, and submit it to the authorities, as well. By January 31 of each year, companies must submit a pollutant release and transfer register form and environmental risk management plans to county-level authorities. Companies must conduct environmental monitoring of listed chemicals and their waste. MEP stated that most of the 84 substances are persistent, bioaccumulative, and toxic (PBT); manufactured in large quantities and pose possible risks to human health or the environment; or covered by international conventions on hazardous chemicals. MEP’s notice is available, in Chinese, online. The notice includes a link to the list of 84 substances. Although the substance names are in Chinese, Chemical Abstracts Service (CAS) Numbers are included.


ECHA Report Includes Recommendations For Exposure Assessment And Risk Characterization Of Nanomaterials Under REACH: On March 26, 2014, SAFENANO announced that the European Chemicals Agency (ECHA) published a report entitled Human health and environmental exposure assessment and risk characterisation of nanomaterials: Best practice for REACH registrants. The report summarizes the outcomes of the third (and last) meeting of the Group Assessing Already Registered Nanomaterials. The September 30, 2013, meeting focused on discussing the approach and challenges faced by participant registrants when documenting the human health and environmental exposure assessment and risk characterization of their substances while registering them under REACH. The report states that the outcomes of the discussion “can be viewed as generic recommendations for the exposure assessment and risk characterisation of NMs under REACH, while considering the present scientific knowledge on the field of nanotoxicology and practice, as well as challenges from participating registrants.” The report states that the provisions that apply to the registration of nanomaterials are the same as those for any other chemical substance, but notes that, “in line with scientific developments, there are specific considerations that registrants should report in specific endpoint sections, as this information will facilitate the evaluation of the adequacy of the tests performed and data obtained with regard to the safety assessment of NMs.” The report is available online.

ECHA Adopts CoRAP For 2014-2016: On March 26, 2014, ECHA published the Community Rolling Action Plan (CoRAP) for 2014-2016 on its website. The update contains 120 substances that will be reviewed by 21 Member States under the substance evaluation process of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The CoRAP list now includes 53 newly selected substances, and 67 substances from the update published last year. From the date of publication of the CoRAP update, the respective Member States have one year to evaluate the 51 substances specified for 2014. In addition to the initial grounds for concern, other concerns on the substance may be identified and addressed during the evaluation. Where necessary, within this time they will prepare a draft decision for requesting further information to clarify the suspected risks. The draft decisions will be reviewed by the other Member States and ECHA and when necessary agreed to by the Member State Committee before ECHA issues the final decision. Registrants of substances listed on the CoRAP will be given an opportunity to comment before any decision to request further information is taken. More information is available online.

ECHA Forum Begins Authorization Pilot And Presents Preliminary Results Of The Third Enforcement Project: ECHA announced on March 28, 2014, that the Forum for Exchange of Information on Enforcement, during its March 25-27, 2014, meeting, decided to undertake a pilot project on authorization and discussed preliminary results of its third coordinated enforcement project. The pilot project will address substances with sunset dates that will soon elapse. The focus will be on gathering experience and building practice and processes for enforcing the authorization-related obligations. The project will be set up in 2014 with inspections taking place in early 2015. The third coordinated enforcement project, REF-3, focuses on checking the registration obligations of manufacturers, importers, and only representatives in close cooperation with customs authorities. Preliminary results show that inspectors checked 528 companies and 3,065 substances across European countries. Three percent of the checked companies did not register any of the substances that they were supposed to register, and 14 percent of companies were incompliant only with some registration duties. According to ECHA, non-compliance was found most frequently among only representatives and least frequently among manufacturers. ECHA states that the final report of the first phase of REF-3 is expected to be published in mid-2014. More information is available online.

EC Adds Substances To Annex XVII: The European Commission (EC) published in the March 28, 2014, Official Journal of the European Union, an amendment to REACH, adding the following substances to Annex XVII:

  • Effective April 1, 2014:
    • Indium phosphide;
    • Trixylyl phosphate; and
    • 4-tert-butylbenzoic acid;
  • Effective January 1, 2015:
    • Gallium arsenide;
    • Epoxiconazole (ISO); (2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane;
    • Nitrobenzene;
    • Dihexyl phthalate;
    • N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one;
    • Ammoniumpentadecafluorooctanoate;
    • Perfluorooctanoic acid; and
    • 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa- 3,5-dithia-4-stannatetradecanoate;
  • Effective April 1, 2016:
    • Pitch, coal tar, high-temp.

The notice is available online.

ECHA Publishes First Substance Evaluation Decisions: ECHA announced on April 1, 2014, that the first decisions on substance evaluation are now available on its website. These are the decisions on 14 substances taken by ECHA based on evaluations carried out by Member States. ECHA states that a decision on substance evaluation means that there is a need for further information to conclude on the concern on a substance. From the substances listed in the CoRAP for 2012, there were 32 substances for which the evaluating Member States originally proposed a draft decision. After the Member States’ review and discussions and unanimous agreement in the Member State Committee, ECHA has taken final decisions on 14 substances. Decisions are now available for the following substances:

Bisphenol A, 4,4′-isopropylidenediphenol
A mixture of: cistetrahydro-2-isobutyl-4-methylpyran-4-ol; transtetrahydro-2-isobutyl-4-methylpyran-4-ol
Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol
Carbon tetrachloride
Hexyl salicylate
2-Ethylhexanoic acid
Alkanes, C14-17, chloro (MCCP, Medium chained chlorinated paraffins)

ECHA notes that, for some substances, more than one decision is attached as in these cases some registrants of the substance were addressed separately for confidentiality reasons. Each decision defines a deadline by which the registrants subject to the decision must deliver the requested data in a IUCLID dossier update to ECHA. The evaluating Member State will then review the data and conclude on the risks and follow up actions, if deemed necessary. In future, ECHA will continue publishing the decisions in batches without separate communications upon publication of each batch. More information is available online.

Board Of Appeal’s Decision Emphasizes Various Roles In The Registration Process: On April 2, 2014, ECHA announced that the Board of Appeal decision in Case A-008-2012 “highlights that it is the responsibility of the registrant to decide which substance(s) it is required to register (its registration strategy) and to act accordingly (e.g. by submitting compliant registrations).” ECHA is responsible for verifying whether the information provided by the registrant meets the REACH requirements. The Member State enforcement authorities are responsible for taking action if they consider that a manufacturer or importer has failed to register a substance in accordance with REACH. In the ECHA decision challenged in the appeal, ECHA found that the appellant’s registration dossier contained information on more than one substance. While the Board of Appeal’s decision confirmed that registration dossiers should contain information on only one substance, ECHA states that “the appeal was upheld as the Board of Appeal considered that the ECHA decision appeared to direct the registrant as to the substance that should be included in the registration dossier when this decision is the sole responsibility of the registrant. The risks of ECHA directing a registrant in this way was clearly illustrated in this case as information made available during the appeal proceedings showed that ECHA’s assumptions on the substance that the registrant needed to register may have been based on a false premise.” More information is available online.

ECHA Announces Registrants Should Get Ready To Comment On Draft Substance Evaluation Decisions: On April 3, 2014, ECHA announced the timing for the availability of draft decisions on requests for further information for 37 substances evaluated under CoRAP in 2013. ECHA planned to distribute draft decisions to the registrants between April 28-May 2, 2014. Registrants will have 30 days to consider and submit their joint or individual comments. A notification letter will contain the deadline by when the comments must be submitted. This deadline will include an extra seven-day period as addressed in the latest update of point 9(d) of the Terms and Conditions of REACH-IT. Additional information on the announcement is available online.

ECHA Announces Board Of Appeal Decision Examining Substance Identity Requirements For UVCB Substances: ECHA announced on April 9, 2014, that in case A-001-2013, the appellant requested the annulment of an ECHA decision requiring the submission of additional information on substance identity. The case focused on the information requirements for a unknown or variable composition, complex reaction products, or biological materials (UVCB) substance consisting of a phenate constituent and a lubricating oil constituent that together formed a colloid. The Board of Appeal decision examines a number of issues, such as whether the lubricating oil can be considered to be a stabilizer for registration purposes, whether the information required for substance identity purposes was in accordance with REACH and the relevant ECHA guidance, and whether ECHA gave the registrant reasons to expect that registration updates would be taken into account in the final version of the contested decision. The appeal was rejected. More information is available online.

ECHA Invites Companies To Check Provisional List Of Biocidal Active Substance Suppliers: ECHA announced on April 14, 2014, that it launched an exercise to verify the correctness of the information contained in the provisional list of biocidal suppliers. Companies can request by June 30, 2014, a modification by filling in a form made available on ECHA’s website. ECHA states that it will verify the information provided in collaboration with the EC, the relevant Member State competent authorities, and industry, as necessary. Based on the verification, ECHA plans to publish in summer 2014 the formal list of active substances and product suppliers in application of Article 95 of the Biocidal Products Regulation (BPR). The Article 95 list will also include the names of companies that submit dossiers under Article 95(1) of the BPR that are found to be compliant with the BPR requirements. ECHA notes that since companies who are located outside the EU cannot be included on the list as substance or product suppliers, they are invited to contact their importers to apply for inclusion on the list of substance and product suppliers. More information is available online.

New Version Of REACH-IT Clarifies Communication Between ECHA And Companies: ECHA announced on April 16, 2014, that the new version of REACH-IT (2.7) introduces new terms and conditions that clarify how companies receive decisions and other communications from ECHA. The new terms and conditions state that if a message received through REACH-IT has been opened by one user in the company, it has been legally received. According to ECHA, all messages are considered to be received seven days after they are sent and can set deadlines in motion. ECHA states that this applies even if the messages have not been opened. Certain messages, however, can set deadlines in motion as soon as the message is sent, such as in the case of decisions on incomplete registrations and Product and Process Orientated Research and Development (PPORD) dossiers. ECHA encourages users to regularly log into REACH-IT and to check their message boxes. ECHA recommends that companies identify an “ECHA Regulatory Contact” to receive e-mail alerts and initiate the follow-up actions required by any important message sent by ECHA. In addition, the REACH-IT update now allows the submission of applications for authorization through REACH-IT. At the same time, a new version of IUCLID launched. More information is available online.

EU Ombudsman Closes Three Complaints In ECHA’s Favor: ECHA announced that the EU Ombudsman has closed three complaints and found no maladministration in ECHA’s activities. The first complaint (1826/2010/VL) was based on what information from registration dossiers can be disclosed under Access to Document (ATD) requests. The Ombudsman found that ECHA correctly applied the ATD rules but also indicated that the minimum of five working days needs to be respected when ECHA consults third parties and that national holidays should be taken into account. The second complaint (2469/2011/VL) related to the information that is published from registration dossiers. In May 2011, ECHA informed of the Ombudsman’s intention to publish the names of registrants. The complainant challenged this. The Ombudsman concluded that ECHA’s interpretation of the legislation was reasonable since the Court of Justice had not offered its own interpretation. The third complaint (2185/2013/EIS) concerned the need for candidates to submit an ECHA CV during selection procedures following ECHA’s decision to reject a candidate’s Europass CV. Since the vacancy notices clearly state that an ECHA CV is required and as the ECHA CV is more detailed than the Europass CV, the Ombudsman found in favor of ECHA. More information is available online.

ECHA April 23, 2014, Newsletter Focuses On Substitution And Innovation: The April 23, 2014, newsletter includes case studies, interviews, and guest columns that show how industry, authorities, and organizations are working for safer chemicals and greener innovation. ECHA notes that it includes how Spanish small and medium-sized enterprise (SME) Incusa has found a new technology to replace hexavalent chromium used in leather tanning; how Dutch multinational AkzoNobel keeps stock of their substances; and how the biocides regulation promotes safer alternatives. The newsletter is available online.

New BPR Amendments Enter Into Force: ECHA announced on April 25, 2014, that the amending regulation (334/2014) entered into force, addressing a number of aspects of the BPR to give further clarification to the regulation. According to ECHA, the key aspects of the revised BPR include:

  • A new definition of the concept of biocidal product families to include product variants with similar levels of risk and efficacy in the same family;
  • Clarification of a transitional period to allow new treated articles to be placed on the market as long as the application for approval of the active substance or product type used is made by September 1, 2016;
  • The introduction of the concept of “substance supplier” and “product supplier” in the framework of Article 95, which allows formulators to apply to be included on the Article 95 list, which will also be product type specific;
  • The extension of mandatory data sharing for review program active substances, in the framework of Article 95, to include data on environmental fate and behavior in addition to toxicological and ecotoxicological data (non-vertebrate);
  • The establishment of data protection periods for data submitted for products under simplified authorization; and
  • An extension of the role of the ECHA secretariat to provide support and assistance to the Member States with regards to control and enforcement activities.

More information is available online.


DOSH Updates Industry Code Of Practice On Chemicals Classification And Hazard Communication: Malaysia published a notice in the April 16, 2014, Federal Government Gazette entitled “Notification of the Approval and Revocation of the Approval of Industry Code of Practice.” The notice announces the approval of an updated Industry Code of Practice on Chemicals Classification and Hazard Communication (ICOP) and revokes the 2012 edition. The ICOP contains a list of chemical substances that have been classified and guidance on chemical classification and hazard communication. The ICOP provides guidance to the principal suppliers on self-classification of chemicals according to method and classification criteria of the third edition of the GHS. The ICOP can also assist suppliers in preparing labels and SDSs according to the Department of Occupational Safety and Health’s (DOSH) Classification Labeling, and SDS of Hazardous Chemicals Regulations. The 2014 ICOP is available online.