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January 1, 2016

Global Regulatory Update for January 2016

The ACTA Group


Stakeholder Roundtables Discuss Supply Chain Communication And SNUR And SNAc Programs: Under the Regulatory Cooperation Council (RCC) work plan for chemicals management, Environment Canada, Health Canada, and the U.S. Environmental Protection Agency (EPA) are collaborating to develop common approaches for regulatory reporting requirements for new uses of chemical substances. The initiative involves work to support supply chain communication on chemicals in the significant new use rule (SNUR) and significant new activity (SNAc) programs. In September 2015, The Horinko Group in cooperation with Noblis hosted two roundtable meetings in Toronto and Washington, D.C., to discuss challenges and solutions related to sharing information on chemicals throughout supply chains. The Horinko Group and Noblis published a November 30, 2015, proceedings report that “reflects the information exchanged at the roundtables as understood by The Horinko Group and Noblis,” but the report is “not an official representation of the agencies or companies present.” According to the report, the discussions identified “numerous opportunities for regulators and stakeholders to pursue and collaborate on,” including:

  • Industry cross-sector information exchanges to facilitate efficiency in supply chain data management and communication solutions;
  • Collaboration across environment, health and safety, and procurement silos within companies and between government agencies; and
  • Chemical tracking and regulatory monitoring systems, practices, and tools to improve compliance efficiency.

Canada Will Discontinue Conditional Pesticide Registrations: Health Canada announced on January 19, 2016, that it intends to stop granting new conditional registrations of pesticides as of June 1, 2016. According to Health Canada, “[t]his is an important step in improving the openness and transparency of Canada’s pesticide regulatory system.” Health Canada states that discontinuing conditional registrations, which have been granted when the scientific review determines that the risks are acceptable but that additional confirmatory information is required and do not undergo a public consultation, “will provide reassurance that all pesticide registration decisions are made with the same high level of scientific and public scrutiny.” Health Canada published a Notice of Intent and will accept comments until March 19, 2016. It will publish a final decision following the consultation once all comments have been considered.


Chinese Due Diligence Guidelines For Responsible Mineral Supply Chains Adopted In December: On December 2, 2015, at a workshop hosted by the Chinese Chamber of Commerce for Metals, Minerals, and Chemicals (CCCMC) and the Organization for Economic Cooperation and Development (OECD), the Chinese Due Diligence Guidelines for Responsible Mineral Supply Chains were adopted. The Guidelines will apply to all Chinese companies that are extracting and/or using mineral resources and their related products and are engaged at any point in the supply chain of minerals. The implementation of the Guidelines will initially be voluntary. The Guidelines state that CCCMC will prioritize releasing audit protocols and supplementary materials covering the supply chains of gold, tin, tungsten, and tantalum.


Brussels Publishes List Of Substances Used In EDC Screening Exercise: The European Commission (EC) has published a list of almost 700 substances that have been screened for available evidence on endocrine disruption. The aim of the screening is to be able to estimate which chemicals would fall under the different options for the criteria outlined in the roadmap of the impact assessment. This exercise is part of the process of gathering information necessary for the impact assessment. The EC held a public consultation on different options for defining the criteria for the identification of endocrine disrupting chemicals (EDC) and is conducting an impact assessment of the options. It also launched a study to estimate which chemicals would be identified as EDCs under the different options. The EC uses a screening methodology developed by its Joint Research Center. This screening exercise started in May 2015, using the substances in the recently published list. A rationale included with the list emphasizes that presence on the list does not mean the substance should be considered, “even on a working hypothesis basis,” as an actual or suspected EDC. The document also makes it clear that the screening process using these substances does not replace an in-depth regulatory assessment. The listed substances include 324 substances covered by the Plant Protection Product Regulation (PPPR); 95 substances covered by the Biocidal Products Regulation (BPR); 201 substances covered by the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH); and 45 substances covered by the Cosmetic Products and Water Framework Directive (WFD). The final criteria for identifying EDCs will be applied across the EU chemical regulatory frameworks, including the Regulations on cosmetics, biocides, and pesticides.

Phthalates To Be Considered SVHCs Because Of Endocrine Effects: The EC is moving ahead with its initiative to designate four phthalates as substances of very high concern (SVHC) due to their endocrine disrupting properties. In early December 2015, the EC sent the World Trade Organization (WTO) a draft Decision that applies to bis (2-ethylhexyl)phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), and diisobutyl phthalate (DiBP). The EC stated that it will be adopted in March 2016, and come into force three days after its publication in the Official Journal of the European Union. The four phthalates are already considered SVHCs due to their classification as Category 1B substances toxic to reproduction. Last year, however, the European Chemicals Agency’s (ECHA) Member State Committee concluded the substances have endocrine disrupting properties whose health effects give rise to an “equivalent level of concern” under REACH Article 57(f).

Many Companies Still Miss Registration Duties: According to a December 10, 2015, ECHA press release, 13 percent of companies did not fulfill some of their registration obligations. In most cases, the non-compliant companies failed with registration duties related to one or two substances from their portfolio. ECHA states that two percent of companies had not registered any substances at all, however. ECHA’s Enforcement Forum coordinated the third REACH-EN-FORCE project, and the goal was to investigate the registration obligations of manufacturers, importers, and only representatives (OR). ECHA states that ORs “are more likely to be in breach of their REACH-related obligations than other registrants.” According to ECHA, it carried out a dedicated investigation of supply chains involving more than one Member State by inspecting 104 ORs. A third of them (32 percent) did not comply with their specific OR information duties as described by REACH Article 8. ECHA states that the flow of information in the supply chain between ORs and importing downstream users was also poor. ECHA often found it difficult to establish the structure of the supply chain as the respective importers could not specify the correct OR and the ORs did not keep reliable records of represented importers. ECHA Executive Director Geert Dancet “strongly advise[s]” third country exporting companies to keep their ORs informed annually of the exported volumes to all their importers in the EU/European Economic Area (EEA) so that registration obligations are correctly identified. More information is available in ECHA’s press release, “Many companies still miss their registration duties.”

Sweden Wins Case Over EDC Criteria Delay: On December 16, 2015, the General Court of the EU sided with Sweden in a landmark ruling, which concludes that the EC failed to fulfil its obligations under the BPR by not adopting criteria for EDCs. In the judgment, the court stated that the EC had a “clear, precise and unconditional obligation,” under the BPR, to adopt the criteria by December 13, 2013. The EC had previously argued that it was open to interpretation whether the deadline was a binding one. Additionally, the EC had expressed that, considering the scientific controversy around the topic, it should not have been expected to review the criteria in the timeframe it was originally given. The court concluded that the criticism over criteria is irrelevant to the EC’s duty to uphold the deadline, and that the regulator never proposed the BPR should be amended to defer it. While the EC reiterated in November 2015 that an impact assessment is the appropriate way to proceed, the court concluded that no provision under the BPR requires such an analysis. The decision has been welcomed by Sweden and various non-governmental organizations (NGO).

Sweden And NGOs Criticize EC’s Reaction To EDC Criteria Ruling: The EC was criticized by the Swedish government and NGOs over its work on criteria for EDCs. Following the judgment of December 16, 2015, in Sweden’s favor, the EC stated that the first phase of the impact assessment is ongoing and others will start this year. The EC stated that its objective is “to conclude the impact assessment in 2016, and the criteria will follow thereafter.” Sweden’s Minister for Climate and the Environment, Åsa Romson, expressed her disappointment to the Health and Environment Commissioners, stating: “I expect that the Commission will take the measures necessary to comply with the treaties and to meet the legitimate expectation of citizens that the EU will protect human health and the environment against the threat of endocrine disruptors.” NGOs sent a joint letter to EC President, Jean-Claude Juncker, criticizing the press conference statement. The NGOs call for the “immediate” adoption of the EDC criteria and a review of how the EC’s use of impact assessments is causing delays in regulatory action.

ECHA Updates List Of Substances Potentially Subject To Compliance Checks: ECHA announced on December 16, 2015, that it updated the list of substances that might be chosen for compliance checks. The list now includes 50 new substances. ECHA recommends registrants check the list and, if needed, update their related registration dossiers by February 29, 2016. More information is available in ECHA’s press release, “Update to the list of substances potentially subject to compliance checks.”

ECHA Adds Five SVHCs To Candidate List: On December 17, 2015, ECHA announced that it added the following five new SVHCS to the Candidate List due to the carcinogenic, toxic to reproduction, persistent, bioaccumulative, and toxic (PBT), and very persistent and very bioaccumulative (vPvB) properties of the substances:

Substance nameReason for inclusionExamples of use(s)
NitrobenzeneToxic for reproduction (Article 57 c)Manufacture of other substances
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)vPvB (Article 57 e)Ultraviolet (UV)-protection agents in coatings, plastics, rubber, and cosmetics
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)vPvB (Article 57 e)UV-protection agents in coatings, plastics, rubber, and cosmetics
1,3-propanesultoneCarcinogenic (Article 57 a)Electrolyte fluid of lithium ion batteries
Perfluorononan-1-oic-acid and its sodium and ammonium saltsToxic for reproduction (Article 57 c) PBT (Article 57 d)Processing aid for fluoropolymer manufacture/lubricating oil additive/surfactant for fire extinguishers/cleaning agent/textile antifouling finishing agent/polishing surfactant/waterproofing agents and in liquid crystal display panels

ECHA notes that the decision to include perfluorononan-1-oic acid and its sodium and ammonium salts was taken with the involvement of the Member State Committee. Substances on the Candidate List are candidates for possible inclusion in the Authorization List. Once they are on the Authorization List, industry will need permission to continue using the substance after the sunset date. More information is available in ECHA’s press release, “Five new substances of very high concern added to the Candidate List.”

ECHA Updates Guidance On Substances In Articles: ECHA announced on December 17, 2015, that it updated its guidance on requirements for substances in articles. The update corrects the parts of the guidance with references to the 0.1 percent limit that are no longer consistent with the Court of Justice of the EU’s September 10, 2015, decision. The court clarified the scope of the notification and communication obligations of companies in relation to articles containing substances included in the Candidate List of SVHCs in a concentration above 0.1 percent weight by weight. According to the court, the legal obligations also apply to articles that are present in complex products (i.e., products composed of several articles) as long as these articles keep a special shape, surface, or design, or as long as they do not become waste. ECHA states that it will issue a “more comprehensive update” of the guidance in 2016. The update will be subject to the typical three-step guidance consultation process, which will include a consultation with ECHA’s accredited stakeholders. More information is available in ECHA’s press release, “Guidance on substances in articles updated.”

ECHA Consults On Classification And Labeling For Two Biocides: ECHA is consulting on harmonized classification and labeling proposals for two biocidal active substances used to control anthropods. The substances are:

  • D-trans-tetramethrin. Germany is proposing a classification of acute toxicity 4, carcinogen 2, STOT SE 2, aquatic acute 1 and chronic 1; and
  • Tetramethrin. Austria is proposing a classification of acute toxicity 4, carcinogen 2, STOT SE 2, aquatic acute 1 and chronic 1.

ECHA seeks input for both substances on all hazard classes for physical, health, and environmental hazards. The deadline for submission of comments is February 5, 2016.

ECHA Announces Clarification Of REACH Data-Sharing Principles: ECHA announced on January 7, 2016, that a new implementing regulation adopted by the EC defines more clearly what the terms “fair, transparent, and non-discriminatory” mean for data sharing under REACH. The regulation gives ECHA the mandate to ensure that all registrants of the same substance are part of one joint registration and sets rules to make sure that the data-sharing agreements in Substance Information Exchange Forum (SIEF) are clear and comprehensive. Potential registrants joining a SIEF are given the right to request a breakdown of the study and administrative costs that make up the price for the joint registration. ECHA states that registrants are only required to share the costs of information they need to submit to ECHA. Therefore, they need to clarify how the data they share satisfy the relevant information requirements. The regulation will enter into force on January 26, 2016. More information is available in The Acta Group’s (Acta®) January 11, 2016, memorandum, “EU Publishes Regulation Regarding REACH Joint Submission of Data and Data Sharing.”

ECHA Compliance Checks Focus On “Substances That Matter The Most”: ECHA issued a January 13, 2016, press release concerning its new compliance check strategy, which focuses on checking the dossiers of substances that matter the most for the protection of people and the environment. According to ECHA, this meant high-tonnage registration dossiers with important data gaps and with a high potential for worker, consumer, or environmental exposure. ECHA states that it checked the dossiers of 107 high priority substances for compliance. In most cases, ECHA drafted a decision requesting the registrant for the missing information. ECHA states that it will provide more statistics in the annual evaluation report that it will publish in February 2016. ECHA notes that it identifies these substances of potential concern in collaboration with Member States and through an integrated screening that also serves to identify candidates for substance evaluation.

France To Introduce New Rules For Healthcare Disinfection Appliances: France is introducing new provisions for the placing on the market of appliances used to disinfect healthcare waste. The new rules are in the form of a standard — “Reduction of Microbiological and Mechanical Risks from Potentially Infectious and Other Comparable Healthcare Waste by Disinfection Pretreatment Appliances.” The standard specifies the tests and approval conditions for these products. It also includes a mutual recognition clause for appliances originating elsewhere in the EU. France has proposed to the EC that it implement the standard on July 1, 2016.


OECD Publishes Report On Substitution And Alternatives Assessment Of Harmful Chemicals: In January 2016, OECD posted the Synthesis Report from the OECD Workshop on Alternatives Assessment and Substitution of Harmful Chemicals. The OECD Ad Hoc Group on Substitution of Harmful Chemicals organized a May 2015 expert workshop on substitution and alternatives assessment. The expert workshop aimed to identify where gaps remain in terms of possible missing tools, guidance, and research to support stakeholders engaged in alternatives assessment and substitution of harmful chemicals. The Report summarizes the workshop conclusions. OECD states that the Report’s conclusions support the development of future activities of the OECD Ad Hoc Group. Issues associated with the way alternatives assessment and substitutions are taking place today emerged from workshop discussion, including:

  • Past alternatives assessment and substitution cases are generating a large amount of expertise and experience. Efforts should be made to collect and compile this “real life” experience. This would serve as a critical source of knowledge to identify and address common challenges, as well as to identify and share good practices and success stories, and to make the business case for substitution;
  • There is a recognized complexity of the alternatives assessment and substitution processes. Providing flexible guidance and best practices to help manage the complexity and uncertainties in the process would support companies, in particular small- and medium-size companies (SME), to engage in alternatives assessments and substitution processes. It was also acknowledged that the level of complexity of the assessment and the attributes addressed should fit the purpose of the assessment, and avoid “paralysis by analysis”; and
  • There is a large variety of approaches used by countries to support substitution. It is important to learn from each others’ experiences in this area to strengthen public policy and programs for substitution.


KCMA Publishes Guidance For Importers On K-REACH Compliance: The Korea Chemicals Management Association (KCMA) published on January 13, 2016, Guidance on Compliance Procedures of the Act on Registration and Evaluation, etc. of Chemical Substances. The Guidance, which is English, includes:

  • An overview of the Act for the Registration and Evaluation of Chemicals (K-REACH);
  • Glossary of key terms;
  • Confirmation of phase-in substances and substances under regulation;
  • Report of substance manufacturing;
  • Registration of chemicals;
  • Declaration of products containing hazardous substances;
  • Information offering;
  • Registration by OR (overseas manufacturers or producers);
  • Competent authorities by work; and
  • Frequently asked questions (FAQ).