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May 1, 2013

Global Regulatory Update for May 2013

The ACTA Group


Australia Seeks Comment On Third Batch Of Stage One IMAP Assessments: On May 16, 2013, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published for public comment the third batch 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 June 28, 2013. More information is available online.


Canada Releases Final Screening Assessment Of Substances Of Low Concern: Canada published in the April 20, 2013, Canada Gazette a notice concerning the final screening assessment of substances of low concern. Canada concluded, based on available information, that 533 of the substances do not meet the criteria set out under Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). Canada states that it “is committed to identifying and addressing all substances that may pose risks to the environment or to human health.” To validate the assumptions made under the rapid screening approach, it will obtain further information regarding the current quantities of these substances that are in commerce in Canada through the Domestic Substances List (DSL) Inventory Update program. Canada identified the remaining 472 of the 1,005 substances that underwent rapid screening as requiring further screening assessment to evaluate their potential to cause harm. Canada will address these substances with other substances moving forward in the Chemicals Management Plan. More information is available online.


Catalog Of Hazardous Substances Could Be Reduced: At an April 2013 industry training seminar in Hangzhou, a National Registration Center for Chemicals (NRCC) official stated that the forthcoming revised Catalog of Hazardous Chemicals may include just 3,000 substances, not the 7,000 substances that were expected, and fewer than the current 3,800 substances. According to the official some ministries are reluctant to add substances to the Catalog because it will create new obligations for industry, such as additional registrations, special permits, and possibly inspections. The Catalog is being revised under Decree 591, which regulates hazardous chemicals through the entire supply chain, including import, manufacture, storage, distribution, and use. The Decree is the main law regulating existing substances in China and implementing the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Before the Catalog is issued in final, it will be released in draft for public consultation, as well as evaluation by an expert panel.

NRCC Launches Online Hazardous Chemical Registration System: NRCC recently launched its new online registration system for hazardous chemicals. Companies importing hazardous chemicals should create user accounts and begin the registration work through the “Information Management System for Hazardous Chemicals (new)” by June 30, 2013. Hazardous chemical manufacturers who apply for registration extensions should submit their applications through the old version of the registration system, which is still available. The new online registration system includes a list of 3,466 hazardous chemicals that reportedly could be regarded as the draft of the revised Catalogue of Hazardous Chemicals.


EC Announces Communication On Building the Single Market for Green Products: On April 9, 2013, the European Commission (EC) announced the Communication on Building the Single Market for Green Products and a Recommendation on the use of the methods. According to the EC, the proposal:

  • Puts forward two methods to measure environmental performance throughout the lifecycle, the Product Environmental Footprint (PEF) and the Organization Environmental Footprint (OEF);
  • Recommends the voluntary use of these methods to Member States, companies, private organizations, and the financial community;
  • Announces a three-year testing period to develop product- and sector-specific rules through a multi-stakeholder process, including provision for organizations with other methods to have them assessed;
  • Provides principles for communicating environmental performance, such as transparency, reliability, completeness, comparability, and clarity; and
  • Supports international efforts towards more coordination in methodological development and data availability.

According to the April 9, 2013, press release, the EC expects to launch the three-year testing period “soon after the adoption of the Communication.” The EC will publish an open call for volunteers on the web portals for the PEF and OEF, inviting companies and industrial and stakeholder organizations to participate in the development of product-group specific and sector-specific rules. The EC states that a second phase will build on an evaluation of the results of the three-year testing and additional actions carried out under the Communication and the Recommendation. Based on this evaluation, the EC will decide on further policy applications of the PEF and OEF methods. More information is available online.

Conference Participants Discuss Need For EU Register Of Nanomaterials: On April 11-12, 2013, the Netherlands Ministry of Infrastructure and the Environment hosted an invitation-only conference entitled “Building Blocks for Completing EU Regulation of Nanomaterials.” The conference was intended to identify areas where current EU legislation on nanomaterials is insufficient. Participants include representatives from Member States, the EC, European Parliament (EP), industry, and a number of non-governmental organizations (NGO). According to the April 29, 2013, Chairman’s Report, during the meeting, many participants “considered that databases or registries will be indispensable for gathering the necessary information on (products with) nanomaterials.” While France has already created a national registry, and other Member States, such as Denmark and Belgium, have taken steps towards creating their own, participants “agreed that a[n] EU-registration on nanomaterials is preferred over a series of varying national databases,” which could “create[] more problems than solutions in improving a harmonised European policy on nanomaterials.” The Chairman’s Report states that an EC official noted that “the main problem on the table is to define the level of information on nanomaterials that is required.” According to the Report, the current EC “(which will be in office until the second half of 2014) is unlikely to take a decision on setting up a community-wide EU-database for (products with) nanomaterials.” Industry participants acknowledged that an EU-wide registry could increase public confidence in the safety of nanomaterials, but expressed their concern that a registry could also stigmatize nanoproducts and increase the costs for small- and medium-sized enterprises. The Majority Agreements states: “There is a need to further discuss the goals, costs/benefits and outcome of a register of (products with) nanomaterials. Such discussion should address:

  1. Public concern;
  2. Consumers choice;
  3. Traceability;
  4. Information (for authorities, in the supply chain, for consumers); and
  5. Proportionality, etc.

The Chairman’s Report is available online. The Majority Agreements are available online.

EC Amends REACH Annex XIV: The EC published a notice in the April 18, 2013, Official Journal of the European Union that amends Annex XIV of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, commonly referred to as the Authorization List. The substances added include:

SubstanceTransitional Arrangements
Latest Application DateSunset Date
TrichloroethyleneOctober 21, 2014April 21, 2016
Chromium trioxideMarch 21, 2016September 21, 2017
Acids generated from chromium trioxide and their oligomers group containing: chromic acid; dichromic acid; and oligomers of chromic acid and dichromic acidMarch 21, 2016September 21, 2017
Sodium dichromateMarch 21, 2016September 21, 2017
Potassium dichromateMarch 21, 2016September 21, 2017
Ammonium dichromateMarch 21, 2016September 21, 2017
Potassium chromateMarch 21, 2016September 21, 2017
Sodium chromateMarch 21, 2016September 21, 2017

The cobalt compounds cobalt (II) sulphate, cobalt dichloride, cobalt (II) dinitrate, cobalt (II) carbonate, and cobalt (II) diacetate have been prioritized for inclusion in Annex XIV. According to the notice, the EC considers that at least one of the uses of those substances (i.e., surface treatment) poses a risk to human health that is not adequately controlled and needs to be addressed. The notice states that the EC should ask the European Chemicals Agency (ECHA) to prepare a dossier on restrictions in accordance with the requirements of Annex XV and that the decision on the inclusion of any of these substances has been postponed. The notice is available online. More information is available in our April 26, 2013, memorandum.

EU Votes To Restrict Neonicotinoid Products: The EU voted April 29, 2013, on a proposal to restrict the use of three neonicotinoid substances for agricultural uses. The substances are clothianidin, imidacloprid, and thiamethoxam. The proposal failed to gain sufficient support from the 27 EU Member States Appeal Committee and was passed to the EC, which has confirmed that the proposal will be adopted in the coming weeks. Restriction upon the agricultural use of the three neonicotinoid substances will apply from December 1, 2013. More information is available in our May 8, 2013, memorandum.

EC Posts Assessment Of Consequences Of Changing The REACH Requirements For Nanomaterials: In May 2013, the EC posted a January 2013 report entitled Examination and Assessment of Consequences for Industry, Consumers, Human Health and the Environment of Possible Options for Changing the REACH Requirements for Nanomaterials. According to the report, 12 of the 21 originally suggested options are considered already implemented with existing legislation and guidance. The other nine options were considered relevant for an adaptation of REACH and thus build the basis for the assessment. The report states that the total costs for implementing the nine options range from €11 million to €73 million as a cumulative effort for all concerned companies for a time period until 2022. These costs result from extensive application of grouping and read-across approaches under REACH. Without this approach, the costs would multiply up to €100 million and €600 million. The report states: “The overall conclusion of this impact assessment shows that additional costs for companies lead to a reduced uncertainty about potentially adverse effects of nanomaterials to human health and the environment. These may lead to considerable benefits, especially if combined with appropriate risk reduction measures.” The report is available online.

EC Proposes To Amend Biocidal Products Regulation: The EC approved a May 16, 2013, proposal to amend the Biocidal Products Regulation. According to the proposal, an analysis showed that certain provisions would lead to unforeseen consequences, with the main problem being that “the transitional rules of the Biocidal Products Regulation will introduce an un-intended market freeze of up to eleven years for articles treated with biocidal substances which are legal on the EU market, but which have not yet been evaluated at EU level.” The proposal states that other un-intended market barriers for certain companies have also been identified. Finally, the Biocidal Products Regulation “fails to define a protection period for data relating to those products with the most favourable risk profile.” The proposal will now go through the co-decision procedure with the Council and the European Parliament and could be adopted by the end of the year. An EC spokesperson stated that the EC has informally approached the EP to explain the importance of a quick adoption of the proposed amendments. The proposal is available online.

Consultation Begins On Draft Methodology Manual For The Identification And Assessment Of Substances For A Potential Restriction Under RoHS 2: Environment Agency Austria has begun a public consultation on the draft methodology manual for the identification and assessment of substances for potential restriction under the recast of the Restriction of Hazardous Substances Directive (RoHS 2). According to Austria, the methodology developed will be used in future reviews of the list of restricted substances under RoHS. The application of the methodology should allow for decision making concerning the inclusion of substances in Annex II, based on scientific evidence and taking into account principles established under REACH. Comments are due June 10, 2013. More information is available online.

ECHA Will Hold Biocides Stakeholders’ Day: ECHA will hold a Biocides Stakeholders’ Day on June 25, 2013. ECHA intends to engage key stakeholders regarding the Biocidal Products Regulation. According to ECHA, the event is intended to ensure that companies are aware of their roles and available tools and resources to assist them in meeting their obligations. ECHA states that the content of the event “will be of particular relevance to European and national trade associations, SMEs, large companies, alternative suppliers and environmental as well as health NGOs.” Participation is free. The event will be streamed live online. More information is available online.

EC Will Hold Technical Workshop On The Follow-Up To The Review Of REACH: The EC will hold a workshop on June 27, 2013, to present the main findings of its report on the operation of REACH and to discuss priorities for actions to follow-up on the report’s recommendations. According to the EC, the workshop aims to discuss with the stakeholders some of the main recommendations and possibilities for concrete actions. Participation is free, and registration is open until June 10, 2013. The EC states that if there are more than 200 registrations, it will select participants “with a view to obtain a balanced representation of stakeholders and geographical origin of participants.” The workshop will be streamed live online. More information is available online.


Indonesia Amends C&L Framework To Align With The GHS: The Ministry of Industry amended the classification and labeling (C&L) framework to align with the fourth revised edition of the GHS. Updates include provisions on confidential business information and rules on risk-hazard communication. The updated framework requires companies to comply with GHS requirements for substances by July 12, 2013, and for mixtures by December 31, 2016.


National Assembly Approves Korean REACH: The National Assembly unanimously enacted on April 30, 2013, the Act on the Registration and Evaluation of Chemicals, which would implement a REACH-like system of chemical regulation. Companies manufacturing, importing, using, and selling chemicals would be required to report annual volumes and purposes. Existing chemicals manufactured, sold, or imported in quantities greater than one tonne annually would be subject to the filing requirements for that chemical. Manufacturers and importers would be required to register with the Ministry of Environmental Protection (MEP) before the manufacture or import of regulated chemicals. MEP would determine whether a registered chemical requires a toxicity evaluation. Evaluations would be mandatory for chemicals with an annual aggregate manufacturing or import volume of ten tonnes or more. The proposed legislation would have required biennial reporting, rather than annual. MEP drafted the proposed legislation, which was modified by the National Assembly’s Environment and Labor Committee, and then revised again to incorporate some provisions from MEP’s proposal and make other technical changes. The Law will take effect on January 1, 2015. A translation of the Act is available online. This translation is provided as a courtesy and is not an official document. The complete text of the Act is available, in Korean, online. More information is available in our May 17, 2013, memorandum.

National Assembly Amends The Toxic Chemicals Control Act: On May 7, 2013, the National Assembly passed a bill that would amend the Toxic Chemicals Control Act. Under the amendments, companies responsible for leaking chemicals would face fines of up to five percent of annual sales. The fines would be based on sales at an individual workplace rather than on company sales as a whole. The MEP would have the authority to increase or reduce fines by half, depending on the number and severity of offices and the size of the workplace. Executives and employees held responsible for chemical-related worker fatalities could face up to ten years in prison. The amendments would introduce new safety requirements, including off-site consequence analysis on the spillover effects of a potential chemical incident, as well as on-site rapid response emergency-handling procedures. The Toxic Chemicals Control Act would be renamed the Chemicals Control Act to indicate the broader scope of chemical controls under the law. President Park Geun-hye is expected to sign the bill in the next month or two, and the amendments would take effect January 1, 2015. The bill is available, in Korean, online.


Vietnam Issues Registration Requirements For Hazardous Substances: On April 22, 2013, the Vietnamese Ministry of Industry and Trade published a circular for the registration of hazardous substances used to produce products and goods in the industrial sector. The Ministry listed 117 chemicals that are subject to mandatory reporting and registration requirements. Under the requirements, which will take effect January 1, 2014, companies just report uses of the listed chemicals twice a year, by June 10 and December 31. More information is available, in Vietnamese, online.