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December 1, 2013

Global Regulatory Update for December 2013

The ACTA Group


Australia Seeks Comment On Sixth Tranche Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has published for public comment the sixth 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 requests comments where information that has the potential to affect the outcome of an assessment has not been considered. NICNAS states that for certain chemicals it is seeking information from any party, particularly companies introducing products with biocidal ingredients, which identifies industrial uses. Comments provided should be evidence-based and the relevance of submitted information should be highlighted. Comments are due January 17, 2014. More information is available online.


EU General Court Orders Disclosure Of CBI Submitted As Part Of The Authorization Process: On October 8, 2013, the General Court ordered that non-governmental organizations (NGO) be granted access to confidential business information (CBI) submitted by a pesticide manufacturer to a Member State agency as part of the authorization process for the active substance glyphosate. Stichting Greenpeace Nederland and Pesticide Action Network Europe v. European Commission. On December 20, 2010, the NGOs requested access from the European Commission (EC) to several documents relating to the first authorization of the placing of glyphosate on the market as an active substance. On August 10, 2011, the EC issued its response to the NGOs. The EC stated that the Federal Republic of Germany opposed disclosure of the document at issue to protect the commercial interests of a natural or legal person. According to the court’s decision, Germany believed the document at issue contained confidential information relating to the intellectual property rights of the operators — namely the detailed chemical composition of the active substance produced by each of them, detailed information concerning the process by which each of them produced the substance, information on the impurities, the composition of the finished products, and the contractual relations between the various operators who had sought the inclusion of glyphosate. Noting that the German authorities did not consider there to be an overriding public interest to justify the disclosure of the document at issue, the EC then examined whether such an overriding public interest could be invoked. The EC determined that, on balance, the need to protect the intellectual property rights of the operators outweighed the public interest in disclosure of the information. In the EC’s opinion, disclosure of the information would allow competitors to copy the operators’ production method, leading to “considerable loss” for the operators and leaving their commercial interests and intellectual property rights unprotected. The EC determined that the public interest in disclosure of the information had already been taken into account, since the possible effects of glyphosate emissions were shown in other parts of the draft report that had already been disclosed to the public, in particular those concerning relevant impurities and metabolites. Regarding the information relating to the non-relevant impurities, the EC considered it to relate to elements that do not present risks to health or the environment, but that make it possible to reconstitute the manufacturing process of each product. The NGOs filed suit in the General Court, appealing the EC’s August 2011 decision and seeking access to information relating to the identity and quantity of impurities present in the glyphosate; the analytical profile of the batches, in particular their composition; the identity and quantity of chemical substances added during the tests; the duration of those tests; and the actual effects on the active substance. The NGOs argued there was an overriding public interest in disclosure where information relates to emissions into the environment. According to the court, the EC erred in rejecting the NGOs’ application for access to the document at issue, “to the extent that the request in question concerned information relating to emissions into the environment, namely, first, the ‘identity’ and the quantity of all of the impurities contained in the active substance notified by each operator, . . . secondly, the impurities present in the various batches and the minimum, median and maximum quantities of each of those impurities, . . . and, thirdly, the composition of plant protection products developed by the operators.” The court agreed with the NGOs’ second plea in law, that “the exception to the right of access designed to protect the commercial interests of a natural or legal person must be waived, because of an overriding public interest in disclosure of the information requested, which relates to emissions into the environment,” and annulled the EC’s August 2011 decision. The court’s decision is available online.

EC Issues Call For Commitments For EIP On Raw Materials: The EC issued on October 31, 2013, a public “Call for Commitments” that allows all potential stakeholders to express their concrete intention to contribute to the implementation of the Strategic Implementation Plan (SIP). The EC states that it anticipates that “the call will trigger a number of individual commitments (referred to as Raw Material Commitments — RMCs) where the partners jointly commit to co-operate and take actions that will contribute to achieving the objectives” of the SIP in the different action areas. The call is intended “to mobilise a substantial part of the European raw materials community thus significantly increasing the positive impacts of the EIP.” Commitment proposals are due January 31, 2014. A Communication will follow in 2014, to explain how the EC, Member States, industry, and academia intend to implement the SIP. The SIP is available online.

ECHA Announces Draft CoRAP Update: On November 4, 2013, the European Chemicals Agency (ECHA) announced the availability of the draft update of the Community Rolling Action Plan (CoRAP) for 2014-2016. It includes 56 substances newly allocated to the Member States, and 69 substances already included in the March 20, 2013, CoRAP update. The substances are tentatively divided for evaluation in years 2014, 2015, and 2016. ECHA has submitted the draft update to the Member State competent authorities and the Member State Committee. The Committee will prepare an opinion on the draft plan in February 2014. ECHA intends to adopt and publish the final CoRAP update for 2014-2016 in March 2014. The final CoRAP update will indicate the Member State responsible for the evaluation of each substance and the initial reasons of concern. From the publication of the final CoRAP, the respective Member States have one year to evaluate the 56 substances specified for 2014 and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. Such draft decisions will be reviewed by the other Member States and ECHA and when necessary agreed by the Member State Committee before ECHA issues a final decision. Registrants of substances listed on the final CoRAP will be given an opportunity to comment before any final decision to request further information is taken. More information is available online.

SAFENANO Publishes Article Concerning Options For Changing REACH Requirements For Nanomaterials: On November 8, 2013, SAFENANO published an article by Karin Aschberger, Scientific Officer, EC Joint Research Centre, entitled “Development of options for changing REACH requirements for nanomaterials and assessment of their consequences for industry, consumer human health and the environment.” According to Aschberger, the results of the project will have an impact on the forthcoming modifications of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annexes, which are intended to address better the properties and risks of nanomaterials. The article is available online.

ECHA Begins Public Consultations On Applications For Authorization For DEHP And DBP: ECHA announced on November 13, 2013, that it received seven applications for authorization for uses of bis(2-ethylhexyl) phthalate (DEHP) and dibutyl phthalate (DBP):

Substance nameUses applied for
DEHPFormulation and use of DEHP in production of polyvinyl chloride (PVC) articles;
Use of DEHP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements;
Use of DEHP in manufacture of solid propellants and motor charges for rockets and tactical missiles; and
Formulation and use of recycled PVC containing DEHP in production of PVC articles.
DBPUse of DBP in the manufacture of maleic anhydride;
Use of DBP in propellants in manufacture of ammunition for military and civilian uses, and pyrocartridges for aircraft ejection seat safety systems;
Use of DBP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements;
Use of DBP in manufacture of solid propellants and motor charges for rockets and tactical missiles; and
Use of DBP within a specialty paint in manufacture of motors for rockets and tactical missiles.

The Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will review all information on alternatives submitted during the public consultation. Based on the final opinions of the two committees, the EC will decide whether to grant the applicants an authorization. Information is due January 8, 2014. More information is available online.

MSC Agrees ECHA Should Request More Information On Six Substances: ECHA announced on November 14, 2013, that the Member State Committee (MSC) agreed that ECHA should request more information on six substances because the currently available information is insufficient to assess the risks they pose to human health and/or the environment. These six substances listed in the CoRAP were evaluated by Germany, France, Denmark, the United Kingdom, Belgium and Spain:

  • Bisphenol-A (BPA): The MSC agreed to request a new in vitro skin absorption study to assess the risk to consumers from, for example, toys and PVC articles. Secondly, information on the emissions and environmental exposure of BPA will be requested to assess the impact on the environment. The information will help to prepare the final risk assessment and to decide whether further risk management measures are needed. There are on-going studies on BPA in the U.S. that the German authority will also take into account in the next step of the assessment on endocrine disrupting properties for humans;
  • Carbon tetrachloride: The MSC agreed to request further information on the reproductive toxicity in an extended one-generation reproductive toxicity study. More information on the exposure of workers to carbon tetrachloride will also be requested;
  • Oligomerization and alkylation reaction products of 2-phenylpropane and phenol (previously registered as phenol, methylstyrenated): The MSC agreed to request a bioaccumulation study in fish to clarify the concern for potential persistent, bioaccumulative, and toxic (PBT) properties. A combined repeated dose toxicity and reproductive toxicity study is also requested to investigate endocrine disrupting effects;
  • Imidazole: The MSC agreed to ask for further information on workers’ exposure and on its reproductive toxicity effects. Information will also be requested on short-term toxicity in the environment and on mutagenicity through an in vitro study;
  • N,N’-bis(1,4-dimethylpentyl)-p-phenylenediamine: The MSC agreed to request further information to clarify the concerns relating to PBT properties of the substance. A soil simulation test will be requested to look at aerobic and anaerobic transformation in soil; and
  • A mixture of cis- and trans- tetrahydro-2-isobutyl-4-methylpyran-4-ol: Information will be requested to clarify concerns relating to the environment. The requested study will be a short-term growth inhibition study, followed if necessary, by a long-term toxicity study in the aquatic environment.

More information is available online.

ECHA Publishes Updated Guidance On The Application Of The CLP Criteria: On November 25, 2013, ECHA announced the availability of an update of the Guidance on the Application of the CLP Criteria for Part 2: Physical hazards and Part 3: Health hazards. According to ECHA, the update was necessary to take account of the second Adaptation to Technical Progress (ATP) to the Classification, Labeling, and Packaging (CLP) Regulation, which entered into force in April 2011. The update also takes account of the fourth ATP, which entered into force in June 2013. In addition, a corrigendum of Part 1: General principles for classification and labeling and Part 4: Environmental hazards and its related Annexes I-V has been made. More information is available online.

EC Releases Study On Certain CMR 1A And 1B Substances In Articles: On November 25, 2013, the Directorate General (DG) Enterprise and Industry released a final report entitled The potential impact on industrial competitiveness of restrictions on certain CMR 1A and 1B substances in articles — Scoping study for the application of art. 68.2 of REACH to CMR substances requiring priority action. The DG contracted ICF International to gather information on the presence of specific carcinogenic, mutagenic, or toxic for reproduction (CMR) substances 1A and 1B in articles and to investigate the current market distribution, including the availability of alternatives and the potential socio-economic impact for industry of potential restriction(s). According to the DG, the main objective of the project is to elaborate criteria for the implementation of REACH Article 68(2), which foresees a special restriction procedure for CMRs 1A and 1B present in articles that might be used by consumers. In the next phase of the project, the EC will use the findings to define, in agreement with Member State Competent Authorities, the criteria for the implementation of Article 68(2). The report is available online.

ECHA Publishes First Four Conclusion Documents On Substance Evaluation: On November 26, 2013, ECHA published the substance evaluation conclusion documents for ethylene oxide, tributyl phosphate, m-tolylidene diisocyanate, and toluene. ECHA states that, in these cases, the designated evaluating Member State decided not to ask for further information, and hence no draft decision was prepared. The evaluating Member State instead finalized its assessment and drew conclusions about the suspected risks. The conclusion document summarizes the evaluating Member State’s view on the potential need for risk management. ECHA notes that this conclusion alone does not begin any new regulatory process, and is not binding to the Member States or the EC. The registrants, Member State Competent Authorities, and EC are “invited to take note of the conclusions drawn by the four Member States, and to consider if further actions for ensuring the safe use of the substances is necessary.” More information is available online.

EC Draft Directive Would Protect Against Theft Of CBI: On November 28, 2013, the EC proposed a draft directive that would introduce a common definition of trade secrets, as well as means through which victims of trade secret misappropriation could obtain redress. The EC states that the draft directive would make it easier for national courts to address the misappropriation of CBI, to remove the trade secret infringing products from the market, and help victims to receive damages for illegal actions. The EC’s proposal on the protection against misappropriation of trade secrets will be transmitted to the Council of Ministers and the European Parliament for adoption under the ordinary legislative procedure. More information is available online.

ECHA Launches First Public Consultation on a New Active Substance under the Biocidal Products Regulation: In what may be a test case for the future of neonicotinoids, the first public consultation launched by ECHA for a new active substance under the 2013 Biocidal Products Regulation (BPR) will address dinotefuran (CAS Number 165252-70-0), a neonicotinoid insecticide. According to ECHA’s November 29, 2013, announcement, dinotefuran will be considered as a candidate for substitution under criteria set out in Article 10 of the BPR that are based on the intrinsic hazardous properties in combination with the use and potential exposure. Biocidal products containing an active substance that is a candidate for substitution will be subject to a comparative assessment and will be authorized only if there are no better alternatives. After a period of time (typically ten years), the substance would no longer be approved for the specified use. More information is available in The Acta Group’s December 9, 2013, memorandum.

ECHA Announces Updated Guidance For Downstream Users And Guidance On The Compilation Of SDSs: ECHA announced on December 5, 2013, the availability of updated guidance for downstream users and guidance on the compilation of safety data sheets (SDS). ECHA states that it updated the guidance for downstream users to take into account and implement the experience and best practices developed and established since the original version of the guidance was drafted in 2008. The update addresses the need to provide more and up-to-date guidance on the application of scaling when checking whether a downstream user’s use of a substance is covered by the supplier’s exposure scenario, as well as the communication of information on the safe use of mixtures. ECHA amended the guidance on the compilation of SDSs by updating and including as an appendix information on extending the SDS that was already contained in Part G of the Guidance on Information Requirements and Chemical Safety Assessment. More information is available online.

ECHA Website Allows Users To Monitor Progress On The Implementation Of The SVHC Roadmap: ECHA announced on December 9, 2013, that its website now includes a designated section providing stakeholders and the general public regularly updated information on how ECHA, the EC, and EU Member States plan to implement the SVHC Roadmap to 2020. ECHA states that the SVHC Roadmap 2020 focuses on finding new potentially relevant substances of very high concern (SVHC) with CMR, sensitizing, PBT/very persistent and very bioaccumulative (vPvB), and/or endocrine disrupting properties. The best regulatory risk management option should then be identified to manage their risks, using either REACH or CLP (authorization, restriction, or harmonized classification and labeling), or another piece of legislation. Substance evaluation may also be needed to clarify the concern before regulatory risk management action is taken. More information is available online.

ECHA Will Hold Webinar In 2014 On How To Ensure The Safe Use Of Nanomaterials Under REACH: In the first quarter of 2014, ECHA intends to hold a webinar on “How to ensure the safe use of nanomaterials under REACH — Part III: Exposure and risk assessment.” ECHA will announce the exact date once it is available. ECHA states that the webinar will provide feedback to registrants on how to submit information on chemical substances in the technical dossier to ECHA in compliance with REACH. More information is available online.


FDA Issues Guidelines On Notification Of Selected HUHS Products: The Food and Drug Administration (FDA) issued on November 14, 2013, FDA Memorandum Circular No. 2013-045, “Guidelines on Notification of Selected Household/Urban Hazardous Substances (HUHS) Products.” According to FDA, this simplified approach places the responsibility for ensuring the safety and quality of the products primarily on the companies. FDA states that it will strengthen post-marketing surveillance, however, to ensure compliance with FDA safety and quality standards. The guidelines apply to the following products: paints, lacquers, and varnish; solvent paint, lacquer thinner, and mineral spirits; adhesives (contact cement); polishes and waxes (metal polish, wood polish, and shoe polish); bleaches; cleaners; disinfectant sprays; detergents (bar, liquid, and powder); dishwashing (liquid and paste); glues/paste; fabric (dyes, softeners, and conditioners); educational set and miscellaneous chemistry set (paste, crayons, pencils, water colors, glue stick/glues, correction fluid/rubber eraser, crayons, oil pastels, air paints, chalk, and molding clays); stationeries/art paper (colored and/or scented); air fresheners (deodorizer, fabric freshener, aromatherapy product, scented candles, gels, oil, spray); and “the like.” The guidelines state that product notification is applicable per formulation per packaging presentation. The guidelines are available online.


Legislature Approves Amendments To TCSCA: On November 22, 2013, the national legislature unanimously approved amendments to the Toxic Chemical Substances Control Act (TCSCA). The amendments, which revise 17 articles and create a system for the registration, evaluation, and control of chemicals, will take effect one year after being officially promulgated. Promulgation is expected by the end of 2013 or early 2014. According to an Environmental Protection Administration (EPA) statement, the amended TCSCA will require companies that want to manufacture or import chemicals designated as priority chemicals to submit applications for registration. The applications would need to include information on the plans for production or importation, physico-chemical properties, and evaluation of toxicity and risk. Companies can produce or import such substances only after EPA approves their applications. Implementation of the TCSCA is scheduled to coincide with the formation of the Ministry of Natural Resources and Environmental Protection (MNREP), which will include a chemicals and pollution control agency. The MNREP will replace the EPA. The official text of the amendments is not yet available. EPA’s November 22, 2013, notice is available, in Chinese, online.