Global Regulatory Update for April 2013


AUSTRALIA

NICNAS Releases Second Batch Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) began a public comment period on the assessment outcomes of the second batch Inventory Multi-tiered Assessment and Prioritization (IMAP) assessments. NICNAS released the following information:

  • Tier I -- Human Health Assessments: These chemicals are not considered to pose an unreasonable risk to the health of workers and public health on the basis of the Tier I assessment (high throughput assessments). The Tier I assessment takes into account both potential human health hazard and the potential for exposure;
     
  • Tier II -- Human Health Assessments: These chemicals have been assessed at Tier II (individual chemical evaluation) because the Tier I assessment indicated a need for further investigation; and
     
  • Tier I -- Environment Assessments: These chemicals are not considered to pose an unreasonable risk to the environment on the basis of the Tier I assessment (high throughput assessments).

NICNAS states that comments provided should be evidence-based and highlight the relevance of submitted information. Comments are due May 7, 2013. More information is available online.

CANADA

Canada Announces Stakeholder Engagement And Outreach For Phase Two Of The DSL Inventory Update: As part of the second phase of the Chemicals Management Plan (CMP), Canada published a notice in the December 1, 2012, Canada Gazette that applies to approximately 2,700 substances in Phase 2 of the Domestic Substances List (DSL) Inventory Update. Canada seeks to obtain updated information on the commercial status of substances that are remaining priorities, and to support any subsequent risk assessment and risk management activities, if applicable. To support this work, Canada will host the following outreach activities and events:

  • Web-based conferencing (WebEX) sessions to walkthrough the on-line reporting tool and DSL Section 71 Notice;
     
  • Webinars providing background information and important information for compliance and reporting; and
     
  • A series of stakeholder workshops across four Canadian cities designed to provide a basic overview of the CMP, and concentrate on the DSL Inventory Update initiative.

More information is available online.

CHINA

China Releases 12th Five-Year Plan Of Chemical Environmental Risk Prevention And Control: On February 20, 2013, the Ministry of Environmental Protection (MEP) published the 12th Five-Year Plan for Chemical Environmental Risk Prevention and Control (2011-15). The Plan includes a list of 58 priority chemicals for prevention and control. Under the Plan, China intends to publish by the end of 2015 a list of restricted substances and a list of substances to be phased out. The Plan designates seven manufacturing industries as sectors to be brought under priority risk prevention and control: chemical materials and products; chemical fibers; textiles; non-ferrous metal smelting and calendering; pharmaceuticals; coal; and petroleum refining, coking, and nuclear fuel processing. The Plan is available, in Chinese, online.

MEP Publishes Forms To Register Hazardous Chemicals: MEP published on April 1, 2013, four supporting documents related to the trial measures for the environmental management of hazardous chemical registration (MEP Order No. 22), which took effect on March 1, 2013. The supporting documents include:

  • Registration form;
     
  • Change of registration certificate;
     
  • A sample registration certificate; and
     
  • Guidelines for the preparation of the environmental risk assessment report for priority hazardous chemicals for environmental management, which describes how substances should be classified, and environment exposure and risks reported.

The trial measures require entities producing, using, and importing or exporting hazardous chemicals to register with the local environmental protection department at the county level and above. More information is available, in Chinese, online.

EUROPEAN UNION (EU)

EC Proposes To Amend Existing Directives To Improve Workers' Protection Against Exposure To Hazardous Chemicals: On February 26, 2013, the European Commission (EC) issued a press release concerning its proposal to amend five existing EU health and safety Directives concerning protection of workers from exposure to harmful chemicals. The amendments are intended to align the Directives with the latest rules on classification, labeling, and packaging of chemicals (Regulation (EC) 1272/2008). The EC states that the amendments would ensure that manufacturers and suppliers of chemical substances and mixtures would have to provide harmonized labeling information on hazard classification. According to the EC, employers use this information when carrying out workplace risk assessments, and harmonized labeling would allow employers to implement appropriate risk management measures to protect workers' health and safety. The European Parliament (EP) and the EU's Council of Ministers will now consider the proposal. The five Directives that would be amended by this proposal (92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC, and 2004/37/EC) all currently refer to existing EU chemical classification and labeling legislation that will be repealed on June 1, 2015, in accordance with Regulation (EC) 1272/2008. More information is available online.

ECHA Announces Results Of REACH Evaluation Report 2012: The European Chemicals Agency (ECHA) announced on February 27, 2012, the results of its Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Evaluation Report 2012, stating that quality information is required for REACH compliance. According to ECHA, "a large part of the examined registration dossiers still raise quality and subsequently compliance concerns." ECHA "strongly encourages registrants, in particular if they are preparing registration dossiers for the second REACH registration deadline, to read the recommendations of the report and act accordingly." The Report lists the most common shortcomings found in the dossiers and provides recommendations for registrants concerning the following topics:

  • Identifying your substance;
     
  • Identifying the test material;
     
  • Making full use of all relevant information;
     
  • Providing clear use and exposure information; and
     
  • Making use of ECHA support.

More information is available online.

ECHA Offers Support To Registrants In "Exceptional Cases": ECHA announced on March 1, 2013, that it is offering help for companies affected by four scenarios identified by the Directors' Contact Group (DCG) where companies face difficulties regarding the upcoming registration deadline of May 31, 2013. The DCG identified the following instances where such pressing and exceptional circumstances could apply:

  • Difficulties in providing data required in Annex VII and Annex VIII in due time or difficulties for importers of mixtures to obtain compositional and analytical data of the substances in the mixture from their suppliers (Issue No. 10);
     
  • Impossibility of submitting a late pre-registration due to legal entity changes (Issue No. 15);
     
  • Failure by the lead registrant to submit a fully REACH compliant dossier (Issue No. 20); or
     
  • Downstream users being obliged to become importers, as a substance is not registered by any EU-based supplier (Issue No. 21).

ECHA states that every affected company will need to contact it as far ahead of the deadline as possible, providing detailed justification of its situation and an explanation of the measures that it has taken to comply with its obligations under REACH. Upon receiving this information, ECHA can provide instructions on how to submit a registration by the deadline. More information is available online.

ECHA Begins Public Consultation On Ten Potential SVHCs: ECHA began a public consultation on March 4, 2013, on proposals to identify ten chemicals as substances of very high concern (SVHC). ECHA notes that, for the first time, substances are proposed to be identified as SVHCs based on their specific target organ toxicity after repeated exposure. ECHA states that comments may be submitted on the persistent, bioaccumulative, and toxic (PBT)/very persistent, very bioaccumulative (vPvB) or "equivalent level of concern" properties of the proposed substances, as well as information on their identity. The Member State Committee will take these comments into account when seeking agreement on the identification of a proposed substance as an SVHC. Information on the uses of the substances may be provided to ECHA, including data on tonnages per use, exposures or releases resulting from these uses, the availability of safer alternative substances/techniques, and the structure of supply chains. ECHA states that it will consider this information later in the process when recommending SVHCs for inclusion in the Authorisation List (Annex XIV). The substances proposed for identification as SVHCs and the reasons for their proposal are below:

Substance name Proposed SVHC property
Cadmium Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f)
Cadmium oxide Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f)
Dipentyl phthalate (DPP) Toxic for reproduction (Article 57 c)
4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof] Equivalent level of concern having probable serious effects to the environment (Article 57 f)
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) vPvB (Article 57 e)
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) PBT (Article 57 d); vPvB (Article 57 e)
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) vPvB (Article 57 e)
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) PBT (Article 57 d); vPvB (Article 57 e)
Ammonium pentadecafluorooctanoate (APFO) Toxic for reproduction (Article 57 c); PBT (Article 57 d)
Pentadecafluorooctanoic acid (PFOA) Toxic for reproduction (Article 57 c); PBT (Article 57 d)

Comments are due April 18, 2013. More information is available online.

ChemSec Publishes Information Concerning Producers Of SIN List Chemicals: On March 5, 2013, the International Chemical Secretariat (ChemSec) announced that it compiled information about the companies that have registered production or imports of Substitute It Now! (SIN) List chemicals. According to ChemSec, the information was recently made publicly available by ECHA following a ChemSec and ClientEarth lawsuit. ChemSec states that the SIN List "contains chemicals identified by ChemSec as fulfilling the criteria for Substances of Very High Concern as defined in the REACH regulation, and therefore likely to face future EU bans." ChemSec added information about the producers of SIN List chemicals, and in which countries they operate, to its SIN List database. ChemSec also released two new publications, including one that lists the stock-exchange-listed companies that put the SIN List chemicals on the EU market. More information is available online.

ECHA "Welcomes" Court's Confirmation Of PBT Assessment Of Substances: In a March 8, 2013, press release, ECHA "welcomed" the EU General Court's conclusions that confirm ECHA's approach in identifying PBTs and vPvBs as SVHCs. ECHA states that the ruling confirms that ECHA's approach in identifying unknown, or variable composition, or of biological origin (UVCB) substances and other multi-constituent substances as PBTs or vPvBs on the basis of their constituent ingredients present in a concentration of 0.1 percent or more is lawful. The court also upheld that ECHA's decisions were proportionate and did not breach the principle of equal treatment. ECHA notes that the court further ruled that after a substance has been identified by ECHA as having PBT and/or vPvB properties, suppliers "are legally required to update their safety data sheets with this information." ECHA states that it follows that all registrants of such substances will also need to update their chemical safety report with such information. ECHA reminds companies that, under REACH, companies that have already concluded in their chemical safety assessment that a substance meets the criteria for identification as a PBT/vPvB are required to update their safety data sheet (SDS) with this information, "even if ECHA has not yet formally identified such substances as PBTs/vPvBs and included them in the Candidate List." ECHA considers the ruling "a clear reminder" to registrants that in their chemical safety assessment of UVCBs and other multi-constituent substances, they must identify and take into account the properties of the constituents of these substances. More information is available online.

SEAC Agrees On How To Evaluate Economic Feasibility: On March 12, 2013, ECHA announced that, during the Committee for Socio-economic Analysis's (SEAC) 18th meeting in Helsinki, it agreed to publish an explanatory note that clarifies how it will evaluate economic feasibility within the context of the application for authorization procedure. In the socio-economic analysis, the applicant needs to examine whether there are suitable alternatives for the application through an analysis of alternatives. ECHA states that a suitable alternative should be both technically and economically feasible, and its risks should be lower than those of the substance for which the applicant is seeking authorization. ECHA suggests applicants read SEAC's explanatory note in conjunction with the ECHA guidance on preparing applications for authorization. More information is available online.

ECHA Publishes Annual Update Of The CoRAP: On March 20, 2013, ECHA published the first annual update of the Community Rolling Action Plan (CoRAP) for 2013-2015. It contains 115 substances, of which 62 are newly allocated, and 53 come from the first CoRAP adopted in 2012. Member States will evaluate the substances under the REACH substance evaluation process in 2013, 2014, and 2015. In the update, ECHA provides justification documents to explain the grounds for the initial concerns for each substance. ECHA states that, in many cases, the concerns are related to potential PBT, endocrine disruption, or carcinogenic, mutagenic or toxic for reproduction (CMR) qualities, in combination with wide dispersive or consumer use. According to ECHA, in general, the use of these substances covers various areas and does not focus on any particular industrial, professional, or consumer uses. From the publication of the CoRAP update, the respective Member States have one year to evaluate substances specified for 2013 and, where justified, to prepare a draft decision requesting registrants submit further information to clarify any possible risk. The decision will be taken by ECHA, after consultation with the Member State competent authorities and the Member State Committee, or by the EC if there is no unanimity at the Member State Committee. ECHA notes that, as for other evaluation decisions, registrants will have opportunities to comment before any final decision is taken. More information is available online.

EC Lowers REACH Fees For SMEs: The EC recently implemented Regulation 254/2013. The regulation amends Regulation 340/2008 on the fees and charges payable to ECHA pursuant to Regulation 1907/2006 on REACH.

From March 20, 2013, the fees payable to ECHA for the registration of chemical substances in the EU have changed. In general, a decrease in fees payable by micro, small and medium sized enterprises (within the meaning of Regulation 2003/361/EC) (or "SME fees") and an increase in "Standard fees", the fees payable by large companies are outlined.

The changes implemented in the revised ECHA fees regulation (254/2013) are illustrative of the commitment the EC and ECHA have to SME companies as well as the current financial climate. ECHA has often reiterated its commitment to reducing the financial burden for SME companies, while ensuring strict compliance that large companies do not take advantage of reduced SME fees. (ECHA (2012) ECHA protects SME privileges, ECHA Press, Helsinki, November 16 2012.)

The EU currently subsidizes the REACH and Classification, Labeling and Packaging (CLP) Regulation (EC Regulation 1272/2008) work conducted by ECHA, due to a shortfall in registration fees collected. This is currently being reduced by the EU, however, and ECHA is therefore seeking to gain additional income from fees.

Within the meaning of Regulation 2003/361/EC, SME companies are generally defined using Table 1 below. This table is intended as a guide only, and Regulation 2003/361/EC should be fully reviewed before stating that a company is an SME for the purposes of REACH registration. The revision to the fees regulation does not amend this definition.

Table 1. General definition of SMEs

Enterprise category Headcount Turnover or Balance sheet total
Medium-sized < 250 ≤ € 50 million ≤ € 43 million
Small < 50 ≤ € 10 million ≤ € 10 million
Micro < 10 ≤ € 2 million ≤ € 2 million
Table taken from ECHA (2012) SMEs and REACH, Lead Registrant Workshop, February 2, 2012.

The pricing structure for ECHA fees is calculated using Table 2 (below). This table shows the breakdown between the "Standard fee," payable by all large companies and the reduced fees for SME companies, based upon their size. A further 30% reduction is applicable if the submission is being made jointly, that is, more than one registrant is registering the substance at the time of submission.

Table 2. Fees from the Fee Regulation by Company Size

Company size Large Medium Small Micro
Percentage of Standard fee applicable to each registrant 100% 70% 40% 10%
After ECHA (2012) SMEs and REACH, Lead Registrant Workshop, February 2, 2012.

Additional fees have been added to cement the REACH regulation with regards to updates to existing registrations. The full text of the revised ECHA fees regulation can be found on the ECHA website. All revised fees are listed in the Annex to this regulation.

Registration submission fees are reproduced below. These revisions are likely to be the most commonly encountered by submitting legal entities, as many registrants will be submitting dossiers for the May 31, 2013, deadline.

Table 3. Standard fees for registration submissions

  Individual submission (Euros) Joint submission (Euros)
Fee for substance in the range of 1 to 10 tonnes 1,714 1,285
Fee for substance in the range of 10 to 100 tonnes 4,605 3,454
Fee for substance in the range of 100 to 1000 tonnes 12,317 9,237
Fee for substance above 1000 tonnes 33,201 24,901

Table 4. Reduced fees for registration submissions from SMEs

  Medium enterprise (Euros) Small enterprise (Euros) Micro enterprise (Euros)
Individual Joint Individual Joint Individual Joint
Fee for substance in the range of 1 to 10 tonnes 1,114 835 600 450 86 64
Fee for substance in the range of 10 to 100 tonnes 2,993 2,245 1,612 1,209 230 173
Fee for substance in the range of 100 to 1000 tonnes 8,006 6,004 4,311 3,233 616 462
Fee for substance above 1000 tonnes 21,581 16,185 11,620 8,715 1,660 1,245

While the changes listed in the revised ECHA fees regulation are unlikely to impact the ability to perform REACH registrations being submitted for the 100 to 1000 tonnes deadline on May 31, 2013, company finances will be impacted.

While the regulation has been expected for some time, the timing of the release (a mere two and a half months before the 2013 deadline), is likely to upset regulatory managers in large companies. This is especially true for those who had planned specific budgets for REACH registration, especially where multiple registrations are anticipated. Many registrants are now re-aligning budgets to accommodate the regulation and perform registrations prior to the May 31, 2013, deadline.

Biocidal Products Committee Holds First Meeting: The Biocidal Products Committee held its first meeting on March 26-27, 2013. The Committee began work on the working methods, procedures, and priorities for future work. The Biocidal Products Committee gives an opinion on all active substances that will be used in biocidal products. According to ECHA, the Committee expects to have the first discussions on active substances in early 2014, when ECHA takes over the review program of existing active substances from the EC. ECHA will forward the Committee's opinions to the EC for its decision making. After that, companies can choose whether to apply for an authorization for their biocidal products for all European markets through ECHA, or to apply on a national level and subsequent mutual recognition to other countries. ECHA states that discussions on product authorizations will therefore start later, as the active substances need to be approved before the product authorization can start. More information is available online.

EC Publishes New Data Requirements For Plant Protection Products: The EC published two regulations in the April 3, 2013, EU Official Journal concerning new data requirements for the authorization of plant protection products and active substances. In addition, the EC also published two complementary EC Communications on test methods and guidance documents on how to fulfill the new data requirements. The EC states that the new data requirements are intended to strengthen the EU authorization process for plant protection products/substances used in plant protection products. The new requirements request additional data in areas of concern such as potential effects of plant protection products on bees, and additional data regarding neurotoxicity, endocrine disruptors, or potential residues in food, while considering the replacement, reduction, and refinement of animal testing. The new data requirements will apply from 2014 for active substances and from 2016 for plant protection products. More information is available online.

JAPAN

Japan Updates Chemical Notification Manual: The Ministry of Economy, Trade, and Industry has published an updated version of the chemical notification manual, which includes the submission and documentation requirements for notifications. Under the Chemical Substances Control Law (CSCL), companies manufacturing or importing existing chemicals included on the lists below and above certain thresholds must notify Japanese authorities each year of the previous year's production and importation quantities. The manual covers substances on the following lists:

  • List of General Chemical Substances;
     
  • List of Priority Assessment Chemical Substances; and
     
  • List of Monitoring Chemical Substances.

Under the CSCL, new substances must also be notified. The notification period for 2012 began in April 2013, and will end in June 2013. The updated manual is available, in Japanese, online.

SOUTH KOREA

Korean REACH Expected In 2013: A Ministry of Environment (MOE) spokesperson stated during the 2013 Global Chemical Regulations Conference that she expects a law authorizing a new chemical regulatory system to be passed during the first half of 2013. The law, modeled after EU's REACH, would expand the government's regulation of chemicals to approximately 6,500 existing chemicals manufactured or imported in Korea in volumes over one tonne per year. The new system would require high-volume chemicals to be registered and undergo a risk assessment to determine whether they pose a risk to human health. According to the spokesperson, there will be a "grace period" of up to eight years to allow for the registration of existing chemical substances. The spokesperson stated that enforcement of Korea's REACH, including registration and chemical evaluation, would not begin until June 2015 at the earliest.


 
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