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September 1, 2015

Global Regulatory Update for September 2015

The ACTA Group


Guidance On The Catalog Of Hazardous Chemicals Includes Mandatory GHS Classifications: On August 19, 2015, the State Administration of Work Safety (SAWS) released guidance on the Catalog of Hazardous Chemicals. The guidance includes mandatory Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classifications for all 2,828 listed chemicals. It also provides instructions on how to determine if a mixture is listed in the Catalog and whether firms producing or handling listed chemicals require licenses or hazardous chemical registrations. If listed chemicals are present by 70 percent or more by weight or volume, the mixture is deemed as listed in the Catalog, and administrative licenses may be required.


EC Begins Public Consultation On Evaluation Of The E-PRTR: The European Commission (EC) has begun a public consultation to obtain input into an ongoing evaluation of the European Pollutant Release and Transfer Register (E-PRTR) regulation, including delivery of objectives, efficiency, effectiveness, and relevance of the E-PRTR requirements, and whether they reflect the current needs of European citizens, businesses, and policy makers. The EC states that the public consultation will be one important part of the evaluation, which will also be supported by independent analysis, workshops, and interviews. The regulation requires some 28,000 industrial facilities across the EU to report their annual emissions of specified pollutants and waste transfers to national authorities, for forwarding to the E-PRTR. The consultation includes substantive questions structured around the following themes:

  • Scope of the E-PRTR;
  • Providing data to the E-PRTR;
  • Checking and forwarding data;
  • Understanding the E-PRTR website; and
  • Usefulness of the E-PRTR.

Responses are due October 15, 2015.

Companies Appeal ECHA’s Decision On Silicon Dioxide: On August 19, 2015, the European Chemicals Agency (ECHA) announced appeals of its March 11, 2015, decision on substance evaluation for silicon dioxideCase A-015-2015 was filed by Evonik Degussa GmbH and 34 others, while Case A-014-2015 was filed by Grace GmbH & Co. KG and Advanced Refining Technologies GmbH. The appellants in Case A-015-2015 challenge ECHA’s decision to include silicon dioxide on the Community Rolling Action Plan (CoRAP) “due to initial grounds for concern relating to ‘the substance characterisation, nanoparticles and toxicity of different forms of the substance.'” The appellants argue that none of the alleged grounds for concern are criteria for inclusion of a substance on the CoRAP, and as a result, ECHA’s decision to include silicon dioxide on the CoRAP was adopted in breach of Article 44 of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and must be set aside. In addition, the appellants claim further that, since the decision to include the substance on the CoRAP was illegal and must be set aside, the March 11, 2015, decision lacks legal basis as only substances appearing on the CoRAP can be evaluated. In Case A-014-2015, the appellants’ arguments include: “The Agency has based its decision very largely on its own classification of [synthetic amporphous silica] as a nanomaterial, a classification that the Agency is not empowered to make and that in any event is irrelevant to the toxicity of [synthetic amporphous silica].” In the March 11, 2015, decision, ECHA requires silicon dioxide registrants to provide specified data by March 20, 2017.

JRC Report On Identification Of SVHCs Under Equivalent Level Of Concern Route Includes Aluminum As Example: The Joint Research Center (JRC) published a report on August 21, 2015, entitled Identification of Substances of Very High Concern (SVHC) under the ‘equivalent level of concern’ route (REACH Article 57(f)) — neurotoxicants and immunotoxicants as examples. The report analyzes whether substances classified for specific target organ toxicity according to the Classification, Labeling, and Packaging (CLP) regulation, in particular those causing immunotoxic or neurotoxic effects, would be eligible to be identified as substances of very high concern (SVHC) under the “equivalent level of concern” route set out in REACH Article 57(f). The report states that the assessment suggests that some substances showing immunotoxic or neurotoxic effects could present an equivalent level of concern to carcinogens, mutagens, and/or reproductive toxicants (CMR) and potentially be identified as SVHCs according to REACH Article 57(f). According to the report, neurotoxicity or immunotoxicity effects occurring at dose ranges that are critical for the respective specific target organ toxicity classification should be primarily considered for SVHC identification. Annex III of the report includes examples for chemicals with potential neurotoxic effects.

Stakeholder Consultation For New RoHS Project Includes 29 Requests For Renewal Of Exemptions Listed In Annex III: Öko-Institut e.V. announced on August 21, 2015, a new stakeholder consultation for the evaluation of applications for exemptions to be included in or deleted from Annex III of the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive Recast. Renewal/amendment requests have been submitted for 29 exemptions. Öko-Institut e.V. notes that, for some exemptions, multiple applications have been submitted. Comments are due October 16, 2015.

ECHA Publishes Guidance On Active Micro-Organisms And Biocidal Products: ECHA published a new guidance document on active micro-organisms and biocidal products. The guidance is for the Biocidal Products Regulation (BPR) in Volume V, “Specific Guidance,” of the new BPR guidance structure. The guidance provides technical advice on the information requirements, the hazard and exposure assessment, the risk characterization, and the evaluation of the active substances and biocidal products in accordance with Annex II, Title 2, and Annex III, Title 2 of the BPR for micro-organisms.

ECHA Begins Public Consultation On Seven Proposals To Identify SVHCs: On August 31, 2015, ECHA began a public consultation on seven proposals to identify new SVHCs. The substances proposed to be identified and examples of their uses include:

  • 1,3-propanesultone: Electrolyte fluid of lithium ion batteries;
  • UV-327 and UV-350: UV-protection agents in coatings, plastics, rubber, and cosmetics;
  • Dicyclohexyl phthalate: Plastisol and in polyvinyl chloride (PVC), rubber, and plastic articles, and as a phlegmatizer and dispersing agent for formulations of organic peroxides;
  • Hexamethylene diacrylate: Manufacturing formulations of coatings and inks, and as a cross linking agent in polymerization processes in the production of resins, rubbers, and polymers;
  • Nitrobenzene: Production of chemicals and as a processing aid; and
  • Perfluorononan-1-oic acid and its sodium and ammonium salts (group entry): A processing aid for fluoropolymer manufacture, and also as a lubricating oil additive, surfactant for fire extinguishers, cleaning agent, textile antifouling finishing agent, polishing surfactant, waterproofing agents, and in liquid crystal display panels.

ECHA Posts Recordings And Presentations From Biocides Stakeholders’ Day: On September 1, 2015, ECHA held Biocides Stakeholders’ Day, which was intended to provide key biocides stakeholders with information about the BPR, including the tools and support available for companies. The focus of the day was on case studies and experiences from companies on the various aspects of the regulation. The overall objective was to provide companies with information about their roles and obligations to assist them in meeting their BPR requirements. Video recordings of and presentations from the event are available on the Biocides Stakeholders’ Day web page on ECHA’s website.

Article 95 List Of Active Biocidal Substance And Product Suppliers Became Enforceable September 1: In a September 2, 2015, press release, “The Article 95 list of active biocidal substance and product suppliers becomes enforceable,” ECHA reminds stakeholders that as of September 1, 2015, a biocidal product consisting of, containing, or generating a relevant substance cannot be made available on the EU market unless the substance supplier or product supplier is included in the list for the product type(s) to which the product belongs. Exceptions exist for biocidal products where the active substance dossier has not yet been validated by a Member State Competent Authority, such as due to transitional arrangements for biocidal products that were not covered by the previous Biocides Directive and substances where the original substance identity has been changed. ECHA states that by the deadline, it received 158 applications. ECHA already concluded positively on 99 and negatively on 3. ECHA states that it will update the Article 95 list monthly to include suppliers whose application is decided upon after September 1, 2015 (late applications, new market entrants, and new relevant substances).

ECHA Posts Practical Guide On How To Prepare A Downstream User Chemical Safety Report: ECHA posted a September 7, 2015, press release announcing the availability of a new practical guide on how to prepare a downstream user chemical safety report. If a downstream user’s use of a substance is not covered by the supplier’s exposure scenarios, it has an option to prepare a downstream user chemical safety report. The guide provides advice and examples on how to prepare one, including how to:

  • Gather information on the substance;
  • Perform a chemical safety assessment;
  • Document the downstream user chemical safety report;
  • Communicate the outcome of the report to customers; and
  • Report to ECHA.

More information is available in ECHA’s press release, “How to prepare a downstream user chemical safety report.”

ECHA Announces Board Of Appeal Decision, Highlights Difference Of Scientific Opinion Not Sufficient To Invalidate ECHA Decision: Case A-004-2014 concerned an ECHA decision following the substance evaluation of medium-chain chlorinated paraffins (MCCP). In ECHA’s September 9, 2015, e-News, ECHA states that its decision was primarily aimed at clarifying whether MCCP had persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) properties. ECHA states that the Board of Appeal “noted that a difference of scientific opinion is not sufficient to invalidate an Agency decision as long as the Agency applied its discretion correctly.” The Board of Appeal found that the evaluating Member State competent authority (eMSCA) and ECHA examined and considered all relevant information on MCCP. Furthermore, the Board of Appeal found that the detailed scientific assessment, reasoning, and conclusions given by the eMSCA and ECHA were well founded, justified, and addressed the arguments put forward by the appellants. The Board of Appeal also concluded that a constituents-based fractionation testing approach can be appropriate in certain circumstances to assess the PBT/vPvB properties of complex substances of unknown or variable composition, complex reaction products, or biological materials (UVCB). The Board of Appeal dismissed the appeal.

Court Finds Articles Incorporated As Components Of A Complex Product Must Be Notified To ECHA: The Court of Justice of the EU announced in a September 10, 2015, press release, “Articles incorporated as components of a complex product must be notified to the European Chemicals Agency when they contain a substance of very high concern in a concentration above 0.1%,” that each of the articles incorporated as a component of a complex product is covered by the relevant duties to notify and provide information when the articles contain an SVHC in a concentration above 0.1 percent of their mass. As reported in our March 2015 Global Regulatory Update, in 2014, two French trade bodies initiated legal proceedings to resolve the issue. The Federations of Commerce and Distribution Undertakings and of Do-It-Yourself (DIY) and Home Improvement Stores lodged a request for a preliminary ruling with the French Council of State, challenging the position of the French Ministry of Ecology, Sustainable Development, and Energy. The parties sought a ruling on whether REACH applies only with regard to the assembled article or to each of the elements that meet the definition of’ “article.” The EC, supported by a majority of the Member States, has maintained that the proportion of the SVHC should be calculated by reference to the assembled article. Some Member States, including the majority of the parties to the case, contended that it is sufficient if the proportion is reached in the individual components. In its September 10, 2015, decision, the court rules that each of the articles incorporated as a component of a complex product is covered by the relevant duties to notify and provide information when they contain an SVHC in a concentration above 0.1 percent of their mass. The court found that the producer’s duty to notify covers only those articles that the producer itself has made or assembled and is not applicable to an article that, although used by the producer as input, was made by a third party. The court stated that the third party is also subject to the duty to notify in respect of the article that it makes or assembles. Similarly, according to the court, the importer of a product, the composition of which comprises one or more of the objects falling within the definition of the term “article,” must also be considered to be the importer of that article or those articles. The court noted that the fact that it can be difficult for importers to obtain the required information from suppliers based in non-EU countries does not alter their duty to notify. The court found that the duty to provide information with regard to the recipients and consumers of the product is not restricted to the producers and importers, but applies to all operators along the supply chain when that person supplies an article to a third party. The press release states: “It is therefore for the person supplying a product one or more constituent articles of which contain(s) a substance of very high concern in a concentration above 0.1% to fulfil his duty to provide information and provide the recipient and the consumer of the product, as a minimum, with the name of the substance in question.” The duty to communicate information on articles containing SVHCs is not limited to direct EU importers or producers. It is the responsibility of the supplier of the article containing an SVHC above 0.1 percent to provide at least the substance name of the SVHC to all members of the supply chain, not limited to the importer and/or consumer.

ECHA Will Hold Webinars To “Inspire” Companies To Substitute Hazardous Chemicals: On September 22, 2015, ECHA will hold a webinar entitled “Why opt for substitution.” The summary states:

Replacing hazardous chemicals with safer alternatives can bring substantial benefits to the company, the environment and the health of workers and consumers — all good reasons to substitute them. An additional driver comes from the chemicals legislation. Companies using substances that have been identified as SVHCs under REACH[] have to decide whether to apply for [] permission to continue using these toxic substances for a limited period of time or to substitute them with safer alternatives.

According to ECHA, it has organized with a group of accredited stakeholder organizations a series of webinars intended to inspire companies to substitute hazardous chemicals and explain how it can be done. ECHA states that all webinars include examples of real life substitution projects. The September 22, 2015, webinar is the first in the series.


Phase 1 Notification Began September 1, 2015: Taiwan’s phase 1 notification activities in association with the Toxic Chemical Substance Control Act (TCSCA) began on September 1, 2015. Notification of all existing substances imported in quantities greater than 100 kilograms (kg) per year or 100 kg in one of the past three years must be completed prior to March 31, 2016. The notification does not require hazard information to be generated, but serves to function as a pre-registration phase. Taiwan does not have provisions for an Only Representative (OR), but it does allow for a Third Party Representative (TPR) to be appointed to assist non-Taiwanese companies by appointing an Agent on behalf of the importer to protect confidential substance/formulation details. A three-year volume average is considered to support the volume to be notified. Basic use information is also required to be reported.

MOL And EPA Harmonize Inventory Of Existing Chemical Substances: The Ministry of Labor (MOL) has updated the Taiwan Chemical Substance Inventory (TCSI), which now contains over 100,000 existing chemical substances. MOL and the Environmental Protection Administration (EPA) worked together to create a harmonized list. Previously, MOL maintained a list of substances registered under the Occupational Safety and Health Act (OSHA), while EPA maintained a list of substances registered under TCSCA. Following the release of the TCSI, EPA announced the availability of the Guidance for the Regulation of New and Existing Chemical Substance Registration. The Guidance was based on MOL’s January 1, 2015, Guidance of New Chemical Substance Registration. EPA’s Guidance includes minor amendments and clarifications.