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Global Regulatory Updates
June 1, 2012

Global Regulatory Update for June 2012

The ACTA Group

AUSTRALIA

Australia Announces 3,000 Chemicals To Be Assessed In IMAP Framework: On June 15, 2012, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced the 3,000 existing chemicals that it will assess through its new Inventory Multi-tiered Assessment and Prioritization (IMAP) framework. NICNAS has designated the chemicals in the first group to be assessed as “Stage One chemicals.” NICNAS identified the Stage One chemicals based on characteristics agreed by stakeholders as priorities for early consideration and sources subsequently identified by NICNAS and stakeholders. These characteristics and sources of information include:

Category
Chemicals for which NICNAS holds exposure dataChemicals reported in the NICNAS 2006 High Volume Chemical Survey;Chemicals on the NICNAS Candidate list; andChemicals for which NICNAS holds data as a result of various other information gathering activities or technical projects.
Chemicals identified as a concern or for which action has been taken overseasChemicals assessed as part of the Canadian Challenge program;Chemicals assessed as part of the Canadian Petroleum Sector Stream Approach;Chemicals classified as CMR Chemicals;INCI listed chemicals listed on Annex II of the Cosmetic Regulation EC No 1223/2009 (banned);INCI listed chemicals listed on Annex III and V of the Cosmetic Regulation EC No 1223/2009 (restricted);Chemicals with EPA Action Plans;Chemicals included in the EU REACH Substances of Very High Concern Candidate List;Chemicals listed in Annex VXII of EU REACH Regulation 2006; andOECD Perfluorinated chemicals.
Chemicals detected in international studies analyzing chemicals present in the blood in babies’ umbilical cordsChemicals detected in umbilical cord blood in a study conducted by the Environmental Working Group; andChemicals detected in umbilical cord blood in a study conducted for Greenpeace and World Wildlife Fund UK by TNO.

NICNAS states that the IMAP framework is a science- and risk-based model designed to align the assessment effort with the human health and environmental impacts of chemicals. It consists of three levels (tiers) of assessment, with the assessment effort increasing with each tier. Assessment outcomes from Stage One will determine whether a chemical:

  • Poses no unreasonable risk to human health or the environment; or
     
  • Requires risk management measures to be instituted for safe use; or
     
  • Requires more in-depth assessment to determine fully its impact on human health and/or the environment.

According to NICNAS, it will screen and assess Stage One chemicals over the next four years, up to at least Tier II. It intends to publish the outcomes (including recommendations for risk management measures) in several batches on the NICNAS website. NICNAS has identified 800 chemicals for assessment in 2012-13, and “welcomes the provision of information by introducers and users of the Stage One chemicals that will be assessed in the first year.” Information is due September 15, 2012. More information is available online.

CHINA

Chinese Ministry Releases RoHS Proposal: The Chinese Ministry of Industry and Information Technology (MIIT) proposed amending the Restriction on the use of Hazardous Substances in electrical and electronic equipment (RoHS) on June 4, 2012. The proposed revisions would align the definition of electrical and electronic equipment (EEE) with the European Union’s (EU) RoHS Directive; clarify the definition of hazardous substances; provide MIIT more authority to implement RoHS; and create a voluntary certification process for EEE in China. The proposal is based upon the restriction of the content of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers, which are the same chemicals restricted by the EU. Comments on the proposed revisions are due July 10, 2012. More information is available, in Chinese, online.

Under the proposed amendments, EEE products subject to certification would be grouped into four product types:

  • Devices: Computers, monitors, TVs, mobile phones, etc.
     
  • Peripherals: Keyboard, mouse, sound card, graphics card, Backlight components, remote control, print head, toner, power adapter, etc.
     
  • Parts and Components: Capacitor, resistor, connector, microphone, shock absorber, light-emitting diode (LED), battery, compact disc (CD), optical head, cartridge, etc.
     
  • Materials: Insulation board, piezoelectric materials, liquid crystal materials, quartz products, ink, glue, solder, toner (masterbatch), glass products, flame retardant, etc.

As with the EU RoHS II, the proposed revisions identify specific exemptions from voluntary certification based upon the hazardous substance, the product type, and the concentration of the hazardous substance.

Voluntary certification (where necessary) is split into four types, with selection based upon the product type (above) unless otherwise stated. The four certification types are:

  • Type 1 (applicable to Materials and Parts and Components): This is a basic screening test that identifies and characterizes the product and its hazardous substance content. The products are analyzed for hazardous substance content by X-Ray Fluorescence (XRF), and, in the event of uncertainty of result, a chemical test is performed. A follow-up inspection is performed after certification.
     
  • Type II (applicable only to certain Parts and Components): This certification includes the screening test defined above and, where necessary, disassembly of the finished product to perform a more thorough identification and characterization of hazardous constituents.
     
  • Type III (applicable to Devices and Peripherals and therefore considered to be applicable for the majority of finished EEE): Considered the “optimal test” level as it combines a high level of hazard information with a reduced level of testing (compared to Type IV). This certification includes the basic screening test (as above) with a self-declaration and a follow-up inspection. There is no disassembly of the finished product as set out in Type II.
     
  • Type IV (intended only for those products that have been included in the implementation rules): This certification includes a full disassembly test (as set out in Type II) with a self-declaration. It also includes an initial factory test and a follow-up inspection after certification. This is the largest and more complex of the types of certification.

Testing must be conducted at a laboratory mutually accredited by the Certification and Accreditation Administration of China and MIIT. This means that all testing for Chinese Voluntary RoHS Certification must be conducted in China. Sampling must be performed by the testing laboratory at a location mutually agreed by the certification body and the applicant. The applicant may submit its voluntary certification to any certification body accredited by both the Certification and Accreditation Administration of China and MIIT. This suggests that Chinese laboratories are likely to function as both the testers and certifiers of the voluntary RoHS legislation.

In addition to the product-specific exemptions for substances outlined in the proposed revisions, in the case of multiple product models in the same series containing the same hazardous substances, a “primary model” may be defined that represents all products in the series. This can include a ten percent difference in the amount of hazardous substances in the products of the series. While no more than ten product models may be included in the same series utilizing the same “primary model,” where all product models share the same percentage hazardous substances, this can be increased to include all in the hazard profile.

China Asks Industry To Submit Information On Substitution Of Priority Hazardous Substances: MIIT has asked chemical companies that use certain priority hazardous substances to submit information on the substitution of those substances. MIIT intends to use the information to draft national policies for existing hazardous chemicals and substitution. Priority substances include certain heavy metals, organic pollutants, and pesticides. MIIT is considering two types of substitution, both of which would be implemented without affecting an original product’s performance and reliability: complete substitution and partial substitution. Three types of substitutes are proposed, based on technical stages: development (safe alternatives in urgent need of development); application (safe alternatives that have been developed and expect promising marketing promotion); and promotion (safe alternatives of mature promotion and in need of expanding range of application). The information is due June 30, 2012.

China Seeks Public Comment On Revised Draft Work Safety Law: The Legislative Affairs Office of the State Council issued a June 4, 2012, notice seeking public comments on the revised draft Work Safety Law. The revisions would increase the punishment and supervision provisions for violations concerning illegal production, operation, storage, and transportation of dangerous goods, including hazardous chemicals. The revisions include:

  • Article 45 would require entities producing, operating, and storing dangerous goods to participate in insurance to cover third-party, emergency, and incident investigation expenses;
     
  • Article 98 would impose penalties one to three times the insurance premium for entities producing, operating, and storing dangerous goods if they do not participate in any insurance; and
     
  • Article 59 would include a provision stating that dangerous goods illegally produced, used, operated, and transported will be seized; and workplaces with illegal production, storage, use, and operation will be closed down.

Under the revisions, fines for illegal production, operation, and storage of dangerous goods, or for not meeting national or industrial standards or not passing inspections, would increase from RMB20,000-100,000 to RMB50,000-200,000. Comments are due July 5, 2012. More information is available, in Chinese, online.

China Issues Guidance On Non-Pharmaceutical Precursor Chemicals: The State Administration of Work Safety (SAWS) issued guidance on Further Advancing the Supervision Work of Non-pharmaceutical Precursor Chemicals on June 21, 2012. The guidance addresses the following issues:

  • Strict administration for issuing certificates for manufacturing and operating non-pharmaceutical precursor chemicals;
     
  • Supervision of certified enterprises;
     
  • Establishing and increasing administrative responsibility systems;
     
  • Ensuring that manufacturing equipment, storage facilities, and packaging comply with national standards or relevant regulations;
     
  • Observing the rules of the licensing and filing system; and
     
  • Tracking sales and maintaining archival records.

The guidance is available, in Chinese, online.

COLUMBIA

Colombia Publishes National Guide To Chemicals Management: Colombia’s Ministry of Environment and Sustainable Development, in conjunction with the United Nations Industrial Development Organization (UNIDO), published a national profile of chemicals on May 31, 2012. The document is intended to serve as an information source on all areas of chemical management in Colombia, and includes information on the production, import, export, and use of chemicals; the legal requirements for chemicals; national agencies involved in this area; and available resources. The press release is available, in Spanish, online. The full National Profile of Chemicals document is available, in Spanish, online.

EUROPEAN UNION (EU)

ECHA Publishes “Illustrative” CSR: The European Chemicals Agency (ECHA) announced on May 21, 2012, that it has developed an illustrative chemical safety report (CSR) to help companies comply with their obligations under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Registrants are required to submit a CSR as part of their registration dossier for substances manufactured or imported in quantities of ten tonnes or more per year. According to ECHA, its illustrative CSR demonstrates the assessment of a hypothetical monoconstituent organic substance used principally in coating applications. The CSR includes an introductory note with hints and tips to consider when planning and writing CSRs and an example CSR that is consistent with the format set out in REACH Annex I. ECHA states that the illustrative CSR “exemplifies how to describe uses for a substance in an efficient manner; assess the hazards, including a [persistent, bioaccumulative, and toxic (PBT)] assessment; estimate exposure to the environment and human health using a range of estimation methods and build exposure scenarios for manufacture and industrial, professional and consumer uses.” More information is available online.

ECHA Publishes Information On Substances Notified Under Directive 67/548/EEC: ECHA announced on May 31, 2012, that it has started to make available information received from notifications submitted under Directive 67/548/EEC (Notifications of New Substances (NONS)), which was in effect before REACH entered into force. According to ECHA, the NONS information will increase the number of publishable substances made available on the ECHA website from 78 percent to almost 100 percent. ECHA intends to release the information in a stepwise approach, to give NONS registrants time to adapt the different parts of their dossier to the REACH format. The information in the first publication includes the majority of the dossier content, including classification and labeling of the substance, physicochemical data, data on pathways and fate, results of toxicological and ecotoxicological studies, the derived no-effect level (DNEL) and predicted no-effect concentrations (PNEC), and the guidance on safe use. ECHA intends to publish in autumn 2012 the safety data sheet (SDS) related information to its registered substances database. In the third publication for the NONS dossiers, ECHA will publish the remainder of the information according to REACH Article 119, after the 2013 registration deadline. According to ECHA, industry should “review their dossiers and consider whether an update is needed in respect of the information to be disseminated.” According to ECHA, some NONS dossiers have been and will continue to be fully published ahead of the 2013 registration deadline. These NONS dossiers have undergone a tonnage band update or contain a testing proposal requiring a public consultation. The registered substances database is available online.

EC Postpones REACH Review Communication: On June 1, 2012, the EC announced that its REACH Review Communication, which was due that day, will be postponed. According to an EC spokesperson, the EC intends to make the Communication publicly available in early September 2012. The EC also postponed a September workshop on the review. The workshop will be held in late October 2012 or early November 2012. An EC spokesperson stated that the reason for the delay was not due to any problems, but rather the size of the project. Once the EC completes its review, it may, if appropriate, propose legislative revisions to REACH. In parallel, the EC will consider practical approaches to implement better the current legislation, e.g., by improving existing guidance documents and/or by preparing new ones, where necessary.

ECHA Publishes First Report On CMR Substances Registered Or Notified After The 2010 Registration Deadline: ECHA published on June 4, 2012, a report entitled CMR substances from Annex VI of the CLP Regulation which are registered under REACH and/or notified under CLP. According to ECHA, the report is a screening of the information available as of April 2012 and is the first opportunity to review CMR substances that have been registered and/or notified. ECHA conducted a raw data analysis of more than 25,000 registration dossiers and three and a half million classification, labeling, and packaging (CLP) notification records, which have been matched with the EC and Chemical Abstracts Service (CAS) number of around 1,100 individually identified CMR substances listed in Annex VI of the CLP regulation. ECHA found that 60 percent of the CMR substances have either been registered under REACH or notified to the Classification & Labeling (C&L) Inventory under the CLP regulation. ECHA found no match for approximately 40 percent of the substances, but states that some substances on Annex VI are very rare and unlikely to be on the market, while others have been replaced by less hazardous substances. ECHA intends to analyze further some of the information gaps highlighted by the report, focusing on those substances that industry has self-classified as CMRs, but which have not been included on Annex VI to the CLP regulation. The report is available online.

ECHA Creates An Online Form For Downstream User Report Submission: On June 6, 2012, ECHA announced its development of an online form to facilitate downstream users in reporting unsupported uses. Downstream users whose uses of a registered substance are not covered by the exposure scenario provided by their supplier may complete the online form. More information is available online.

ECHA Publishes Q&A Document On Dissemination & Confidentiality Of SDS Information: ECHA announced on June 7, 2012, the publication of a questions and answers (Q&A) document that provides detailed information on the new fields of the SDS that will be disseminated, how the information will be published, and how confidentiality can be claimed. It also covers questions regarding confidentiality claims, the expected timetable, and the potential need to update registration dossiers. The document clarifies that uses of the substance, uses advised against, and generic exposure potential will be disseminated according to the new IUCLID format. According to ECHA, companies will have a three-month window following the launch of the new REACH-IT version (scheduled for July 2012) to submit updated registration dossiers with new confidentiality claims. ECHA states that it intends to begin publishing the SDS information from dossiers submitted in IUCLID 5.4 format in November 2012. The Q&A document is available online.

Substance Evaluation Workshop Leads To Agreement On Interaction With Registrants: During a June 4-5, 2012, substance evaluation workshop, participants Member States’ Competent Authorities (MSCA), ECHA, and observers from stakeholder organizations agreed on preferred ways to interact early with registrants during the substance evaluation process. Participants agreed that the evaluating Member State should initiate informal interaction with the registrants of the concerned Community Rolling Action Plan (CoRAP) substance as early as possible. The general principles agreed upon include:

  • The evaluating Member State should be in contact with the lead registrant to start the interaction as soon as it is evident that the Member State will be the evaluating Member State;
     
  • Registrants should organize themselves for the dialogue so that one registrant, presumably the lead registrant, is coordinating the views and handling the contacts with the evaluating Member State;
     
  • Interaction during the evaluation phase should focus only on the technical information of the substance; and
     
  • If the registrants plan to update their dossier, they should do so before the substance evaluation begins due to the stringent legal timelines making it difficult to take new information into account during the process. If it is not possible to update the dossier before the substance evaluation starts, the lead registrant should clearly communicate to the evaluating Member State the plans for the update and the type of new information.

Workshop participants also agreed to recommend that, for the formal commenting steps in the decision making process, registrants of the same substance should coordinate their views and submit only one set of comments. Participants also discussed the preparation of the next CoRAP update, allocation of substances to the Member States, and the selection criteria for substances that will be evaluated. The workshop participants concluded there was no immediate need to revise the prioritization criteria for the selection of CoRAP substances. ECHA intends to publish a draft CoRAP update by the end of October 2012, and the adopted CoRAP update by the end of March 2013. ECHA notes that the substances on the list are not proposed for restriction or to be banned; the only purpose of the evaluation is to clarify whether their use poses a risk to human health or the environment. If necessary, the evaluation could result in a request for further information. The evaluation could conclude that the risks are sufficiently under control with measures already in place, or may lead to a separate proposal for EU-wide risk management measures. More information is available online.

Member State Committee Agrees On Identification Of Five SVHCs, Prepares In Final 41 Dossier Evaluation Cases: During its June 6-8, 2012, meeting, the Member State Committee (MSC) unanimously agreed on the five substances of very high concern (SVHC) to be added to the Candidate List. One, diborontrioxide, was decided through written procedure. The other four substances, all dyes, were discussed at the meeting, and it was decided that the entry will be made explicit so that it is evident that the dyes (C.I. Basic Violet 3, C.I.Basic Blue 26, C.I. Solvent Blue 4, and 4,4′-bis(dimethylamino)-4″-(methylamino)tri tyl alcohol) are identified as SVHCs only if the concentration of the impurities, Michler’s ketone or Michler’s base, is equal to or higher than 0.1 percent. Eight substances that did not require the MSC’s involvement will also be included in the updated Candidate List, which ECHA will publish “in due course” on its website. The MSC also agreed on 41 draft dossier evaluation decisions, agreeing unanimously on nine of them. Though the majority of MSC members supported a draft decision in the tenth case, giving the registrant the choice between a two-generation study and an extended one generation reproductive toxicity study (EOGRTS) with the second generation, a minority of MSC members considered that only an EOGRTS with extra cohorts on immunotoxicity and neurotoxicity and without the second generation should be requested. In addition to the ten cases of dossier evaluation addressed at the meeting, the MSC agreed in written procedure on 23 draft dossier evaluation decisions. The MSC did not reach unanimous agreement on written procedures regarding eight draft decisions addressing testing proposals for meeting the information requirements for two-generation reproductive toxicity studies where the EOGRTS was involved. According to ECHA, the disagreement is due to legal uncertainty regarding the status of the EOGRTS under REACH. The cases where MSC failed to reach unanimous agreement will be referred by ECHA to the EC for decision making. More information is available online.

RAC Concludes Proposal To Restrict Four Phthalates Not Justified: ECHA announced on June 15, 2012, that the Committee for Risk Assessment (RAC) adopted by consensus an opinion concluding that the proposed restriction of four phthalates in articles is not justified. The Danish competent authorities proposed the restriction to limit exposure to humans from the four phthalates in consumer articles. According to RAC, the available data do not indicate there is currently a risk from combined exposure to the four phthalates. REACH concluded that the existing regulatory measures and reduction in use would further reduce exposure, and that the proposed restriction is not justified. RAC recommended biomonitoring and following use trends for the four substances, due to the uncertainties regarding future exposure. The Committee for Socio-Economic Analysis (SEAC) concluded, following RAC’s conclusion that the proposed restriction was not justified, that they would have no basis for a supportive opinion, as risk was not demonstrated. SEAC’s draft opinion will be submitted for public consultation for 60 days, and their final opinion will be adopted in December 2012 at the latest. RAC’s opinion and SEAC’s draft opinion will be posted online.

ECHA Announces 13 New SVHCs Added To Candidate List: ECHA announced on June 18, 2012, the addition of 13 new SVHCs to the Candidate List. According to ECHA, all are classified as CMR. Four were identified as SVHCs under the precondition that they contain certain carcinogenic constituents above the concentration limit for classifying these substances as carcinogenic. Five were included in the Candidate List following a scrutiny of the comments received during the public consultation and the unanimous agreement of the MSC. The other eight substances, which did not receive comments challenging their identification as SVHCs during public consultation, were directly added to the Candidate List. ECHA states that the Candidate List update also includes a consolidation of the entries of aluminosilicate refractory ceramic fibers and zirconia aluminosilicate refractory ceramic fibers included in the List in January 2010 and December 2011. Producers and importers of articles containing any of the 13 substances added to the Candidate List have until December 17, 2012, to notify ECHA if both of the following conditions apply: (1) the substance is present in those articles in quantities totaling over one tonne per producer or importer per year; and (2) the substance is present in those articles above a concentration of 0.1 percent weight by weight. ECHA notes that there are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded. The new SVHCs are:

Substance NameSVHC PropertyMain Uses
1,2-bis(2-methoxyethoxy)ethane (TEGDME; triglyme)Toxic for reproduction (Article 57 c)Mainly used as a solvent or as a processing aid in the manufacture and formulation of industrial chemicals. Minor uses in brake fluids and repair of motor vehicles.
1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME)Toxic for reproduction (Article 57 c)Mainly used as a solvent or as a processing aid in the manufacture and formulation of industrial chemicals, including use as an electrolyte solvent in lithium batteries.
Diboron trioxideToxic for reproduction (Article 57 c)Used in a multitude of applications, e.g. in glass and glass fibres, frits, ceramics, flame retardants, catalysts, industrial fluids, metallurgy, nuclear, electrical equipment, adhesives, inks/paints, film developing solutions, detergents and cleaners, reagent chemicals, biocides and insecticides.
FormamideToxic for reproduction (Article 57 c)Mainly used as an intermediate in the manufacture of agrochemicals, pharmaceuticals and industrial chemicals. Minor uses as a solvent, as a laboratory reagent for quality control purposes in forensic laboratories, hospitals, pharmaceutical companies, food and drinks manufacturers and research laboratories. The substance seems to also be used as a plasticiser.
Lead(II) bis(methanesulfonate)Toxic for reproduction (Article 57 c)Mainly used in plating processes (both electrolytic and electroless) for electronic components (such as printed circuit boards). The substance seems to also be used for batteries in special applications.
1,3,5-tris(oxiranylmethyl)
-1,3,5-triazine-2,4,6
(1H,3H,5H)-trione (TGIC)		Mutagenic (Article 57 b)Mainly used as a hardener in resins and coatings. Also used in inks for the printed circuit board industry, electrical insulation material, resin moulding systems, laminated sheeting, silk screen printing coatings, tools, adhesives, lining materials and stabilisers for plastics.
1,3,5-tris[(2S and 2R)
-2,3-epoxypropyl]-1,3,5-triazine-
2,4,6-(1H,3H,5H)-trione (ß-TGIC)		Mutagenic (Article 57 b)Mainly used as a solder mask ink in the EU. Also used in electrical insulation material, resin moulding systems, laminated sheeting, silk screen printing, coatings, tools, adhesives, lining materials and stabilisers for plastics.
4,4′-bis(dimethylamino)
benzophenone (Michler’s ketone)		Carcinogenic (Article 57 a)Used as an intermediate in the manufacture of triphenylmethane dyes and other substances. Further potential uses include use as an additive (photosensitiser) in dyes and pigments, in dry film products and as a process chemical in the production of electronic circuit boards.
N,N,N’,N’-tetramethyl-4,
4′-methylenedianiline (Michler’s base)		Carcinogenic (Article 57 a)Used as an intermediate in the manufacture of dyes and other substances.
[4-[[4-anilino-1-naphthyl] [4-(dimethylamino)phenyl] methylene]cyclohexa-2,5-
dien-1-ylidene] dimethylammonium
chloride (C.I. Basic Blue 26) [with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)]		Carcinogenic (Article 57 a)Used in the formulation of inks, cleaners, and coatings, as well as for dyeing paper, packaging, textiles, plastic products, and other types of articles. It is also used in diagnostic and analytical applications.
[4-[4,4′-bis(dimethylamino) 2,5-dien-1-ylidene] dimethylammonium chloride ( C.I. Basic Violet 3) [with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)]Carcinogenic (Article 57 a)Used mainly for paper colouring and inks supplied in printer cartridges and ball pens. Further uses include staining of dried plants, use as a marker for increasing the visibility of liquids, staining in microbial and clinical laboratories.
4,4′-bis(dimethylamino)-4”
-(methylamino)trityl alcohol [with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)]		Carcinogenic (Article 57 a)Used in the formulation of writing inks and potentially other inks, as well as for dyeing a variety of materials.
a,a-Bis
[4-(dimethylamino)phenyl]-4
(phenylamino)naphthalene-
1-methanol (C.I. Solvent Blue 4) [with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)]		Carcinogenic (Article 57 a)Mainly used in the formulation of printing and writing inks, for dyeing paper and in mixtures such as windscreen washing agents.

More information is available online.

ECHA Launches Chesar 2.0: ECHA announced on June 20, 2012, the availability of version 2.0 of the Chemical Safety and Reporting Tool (Chesar). ECHA states it “invested in the redesign of the IT technology of Chesar in order to enhance its stability and make it a better platform for further developments as part of the long term strategy for Chesar.” Other improvements include a redesigned user interface, more transparency in determining the scope of the required exposure assessment, a simplified risk characterisation and an updated version of the Targeted Risk Assessment (TRA) developed by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), and the extension of the possibilities for importing and exporting complete chemical safety assessments (CSA) or CSA building blocks. ECHA states that, through Chesar, industry organizations can make available generic exposure assessments for the conditions of use in their sector, which single registrants may then import and use as a starting point for their own substance specific assessment. ECHA “strongly recommends” potential registrants use Chesar for making chemical safety reports and exposure scenarios. The Chesar website is available here.

ECHA Begins Public Consultation On Draft Recommendation To Add Substances To Authorization List: ECHA announced on June 20, 2012, that it intends to recommend the following ten substances from the Candidate List for inclusion on the Authorization List (Annex XIV):

  • Formaldehyde, oligomeric reaction products with aniline (technical MDA);
     
  • Arsenic acid;
     
  • Dichromium tris(chromate);
     
  • Potassium hydroxyoctaoxodizincatedichromate;
     
  • Pentazinc chromate octahydroxide;
     
  • Bis(2-methoxyethyl) ether (diglyme);
     
  • N,N-dimethylacetamide (DMAC);
     
  • 1,2-dichloroethane (EDC); and
     
  • 2,2′-dichloro-4,4′-methylenedianiline (MOCA).

ECHA invites comments on the draft recommendation, “in particular on the uses that should be exempted from the authorisation requirement.” ECHA’s recommendation also specifies the proposed conditions to the authorization requirement for each selected substance, including the latest application and sunset dates and any specific exemptions of uses from the authorization requirement. ECHA states that it will consider comments when preparing its final recommendation. The EC will make the final decision concerning which of the substances from ECHA’s recommendation will be included on the Authorization List and on the respective conditions applicable for each substance. Comments are due September 19, 2012. More information is available online.

GERMANY

UBA And NGO Provide Online Service For SVHCs In Consumer Products: Germany’s Federal Environment Agency (UBA) and Friends of the Earth Germany (BUND) created an online service for consumers wanting information on SVHCs in products. The service allows consumers to enter the number under a product barcode into an online form to send an information request to the manufacturer or importer. According to UBA, the barcode service will soon be available as an app for smart phones. Any supplier of a product containing an SVHC at a concentration of more than 0.1 percent by weight is required to respond to consumer requests for information within 45 days of a request, at no charge. UBA’s press release is available online.

JAPAN

Japan Releases Requirements For Reporting Workplace Exposures: The Ministry of Health, Labor, and Welfare released the manual for the Report of Workplace Exposure to Harmful Substances for 2012. The manual requires that operators in workplaces manufacturing and handling the listed 15 substances in volumes of 5,000 kg and above must report their operations for 2012 between January 1, 2013, and March 31, 2013. This requirement is in accordance with the Industrial Safety and Health Act and Ordinance on Industrial Safety and Health. The manual lists the 15 substances by CAS number and also includes detailed guidance on how to complete the report form. The manual is available, in Japanese, online. More information is available, in Japanese, online.

MEXICO

Mexico Outlines Progress Towards Chemical Inventory: Mexican officials announced at the Commission for Environmental Cooperation Chemicals Management Forum that they expect to release a draft inventory of chemicals in commerce by October 2012 and a revised recommended legal framework for such an inventory by March 2013. Mexico has been working to compile a chemicals inventory since 2008, using data from lists of chemicals regulated nationally, the customs office, and national chemical industry reports. According to Leonor Cedillo Becerril, Director of Chemical Research and Ecotoxicological Risk at Mexico’s National Institute of Ecology, the inventory currently contains about 6,000 chemicals.

SERBIA

Serbia Amends Chemical Legislation: On May 8, 2012, Serbia amended the chemicals legislation to harmonize various pieces of legislation and include a list of substances of concern. Serbia also amended the rules governing legal experts carrying out training for chemicals consultants. The amendments entered into force on May 16, 2012. More information is available, in Serbian, online.

Serbia Amends Chemical Restriction Regulations: Serbia published on June 5, 2012, an ordinance amending the rules on chemical restrictions. The amendment bans the production, marketing, and use of chemicals that represent an “unacceptable risk to human health and the environment.” The amendments entered into force on June 13, 2012. The ordinance is available, in Serbian, online.

Serbia Provides Information On Inspection Process: The Serbian Chemicals Agency (Shema) published a press release concerning the inspection process for substances on the Register of Chemicals, including information on obligations. Shema noted that failure to submit an application for registration of chemicals in the Register of Chemicals will be treated as an economic offense and subject to a significant monetary fine. More information concerning the inspection process is available, in Serbian, online.

Serbian Chemicals Agency Signs MOU: Shema signed a memorandum of understanding (MOU) with nine consumer organizations on June 14, 2012. The MOU covers a series of joint actions and initiatives, including: regular cooperation and information exchange on the preparation, adoption, and implementation of laws and strategies in the field of chemicals and biocidal products; rights, obligations, and consumer protection in the safe management and use of chemicals and biocidal products; and the preparation and implementation of programs, projects, and seminars on the safe management and use of chemicals and biocidal products. As part of the MOU, the consumer organizations will become more involved in drafting new laws for chemical management. The announcement is available, in Serbian, online.

SWEDEN

Swedish Companies Fall Short On Information Requirements Under REACH: The Swedish Chemicals Agency (KemI) published a document entitled Enforcement of the information duty in REACH: Inspection project 2011-2012, which reports the results of an enforcement project focused on checking compliance by companies with the REACH rules on information duty. The project consisted of three parts, one of which focused on analyses of articles regarding substances on the Candidate List. KemI then followed up on the inspections by letter. KemI also visited ten general retailers, supplementing these inspections by analyses of articles. In addition, KemI published information for consumers on its website to make it easier for them to request information on SVHCs in articles. KemI reports that its analyses showed that 18 of the 50 purchased articles contained more than 0.1 percent by weight of one or more substances on the Candidate List. In most cases, according to KemI, this was unknown to the companies, partly because of inadequate procedures at the companies and partly because of incorrect information from suppliers. KemI determined that half of the ten companies visited “were deemed to have relatively good knowledge of the rules contained in REACH.” Some issues where deficiencies were common were knowledge of the requirement of notification in REACH Article 7, information to professional customers in stores, information about safe use, and knowledge about the two differing interpretations of how 0.1 percent is to be calculated. The report is available online.

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