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November 1, 2011

Global Regulatory Update for November 2011

The ACTA Group


MEP Publishes Draft Guidelines For Risk Assessment And Hazard Identification Under China REACH: The Ministry of Environmental Protection (MEP) recently published draft guidelines concerning the risk assessment of chemicals and hazard identification of new chemical substances. The draft guidelines are intended to provide guidance on the hazard identification methods and categorization of environmental management under China Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). Comments were due October 30, 2011.

China Submits Notifications For Draft Dangerous Goods Standards To WTO: On October 10, 2011, the Standardization Administration of China (SAC) submitted notifications for draft standard GB 12268 (List of Dangerous Goods) and draft standard GB 6944 (Classifications and Codes of Dangerous Goods) to the World Trade Organization (WTO) Committee on Technical Barriers to Trade. According to the notification for the List of Dangerous Goods, the mandatory contents of the List are the categories and items of dangerous goods, as well as the list of dangerous goods. This standard would apply to the transport, storage, selling, and related activities of dangerous goods. The notification for the Classifications and Codes of Dangerous Goods states that the mandatory contents include the classification, fatalness sequence, and code of dangerous goods. The standard would apply to the transport, storage, selling, and related activities of dangerous goods. The WTO Committee on Technical Barriers to Trade has until December 10, 2011, to comment on the notifications.

SAWS Begins Consultation On Draft Rules Concerning Registrations Of Existing Hazardous Chemicals: On October 11, 2011, the State Administration of Work Safety (SAWS) proposed draft revised requirements and procedures for the registration of hazardous chemicals. A revised version of the Measures for the Administration of Registration of Hazardous Chemicals will replace the 2002 version, and is scheduled to enter into force on December 1, 2011. Manufacturers and importers of chemicals listed in the Catalogue of Hazardous Chemicals must register with SAWS prior to manufacture or importation for the first time. Registration certificates will be valid for three years and must be renewed three months before the expiry date. The registrations will require legal entity information; classification and labeling; physiochemical properties; main uses; hazard classes; conditions for safe storage, use, and transport; and emergency responses.

MEP Announces State Council’s Suggestions On Strengthening Environmental Protection: On October 21, 2011, the MEP announced 16 suggestions in three categories intended to strengthen major environmental protection activities. The categories and suggestions include:

  1. Improve environmental protection supervision and management:
    1. Strictly carry out the environmental impact assessment process;
    2. Continuously strengthen total reduction of discharge of major pollutants;
    3. Intensify supervision of environmental enforcement; and
    4. Effectively prevent environmental risk and properly handle sudden environmental accidents.
  2. Make more efforts to address pre-eminent environmental issues affecting scientific development and threatening public health:
    1. Practically strengthen prevention and control of heavy metals pollution;
    2. Carry out strict environmental management on chemicals;
    3. Ensure nuclear and radiation safety;
    4. Deepen comprehensive prevention and control of pollution in key areas;
    5. Vigorously develop environmental industry;
    6. Accelerate environmental protection in the countryside; and
    7. Make more efforts in ecological conservation.
  3. Carry out reforms and make innovative schemes and mechanisms for environmental protection:
    1. Continue facilitating the historical transformations for environmental protection;
    2. Carry out economic policies conducive to environmental protection;
    3. Continuously improve the capacity in environmental protection;
    4. Improve environmental management system and work mechanisms; and
    5. Strengthen the leadership and performance evaluation for environmental protection work.

Regarding item 6 concerning strict environmental management of chemicals, the MEP states that the environmental protection authority should phase out chemicals with high toxicity and environmental hazards or hard to degrade; limit the production and use of chemicals with high environmental risk; promote eco design of industrial products; improve whole-process environmental management of chemicals; strengthen supervision and management of key industries that discharge persistent organic pollutants; and establish the life-long liability and accountability system and whole-process of administrative accountability system for chemical pollution accidents. The MEP’s announcement is available in English online.

U.S. And China Will Hold Technical Dialogue On China RoHS Voluntary Certification: On November 15, 2011, the U.S. Department of Commerce and the Certification and Accreditation Administration of China will convene a technical dialogue in Beijing, China, on China’s restrictions on hazardous substances (RoHS) voluntary certification program. U.S. government and industry representatives will have an opportunity to gain an understanding of the most recent developments to China’s RoHS voluntary certification program, including China’s RoHS voluntary certification product catalogue and exemption list, as well as certification models and basic requirements of certification implementation. Representatives of U.S. companies and industry associations are welcome, however, space is limited; registration will be accepted on a first-come, first-served basis. More information is available online.


Ecuador Will Draft Mandatory Dangerous Goods Regulation: The Ecuadorian Standards Institute (INEN) technical committee will meet on November 16, 2011, to draft a legally binding regulation for manufacturers and importers of dangerous goods. The 2010 voluntary standard, NTE INEN 2266, covers manufacturing, marketing, transporting, storing, and managing dangerous goods in Ecuador. The regulation is expected to include provisions on classification, labeling, and packaging, requirements for containers, dangerous goods certification, and enforcement.


EP Committee Approves Legislation That Would Tighten Regulations On Biocides: The European Parliament (EP) Committee on Environment, Public Health and Food Safety announced on October 4, 2011, that it approved proposed legislation that would tighten safety checks for pest and germ control products and require more approvals to be managed at the European Union (EU) level. The proposed update to existing legislation would cover a wide range of biocides, excluding those covered by other legislation, such as agricultural pesticides. The Committee’s second reading resolution was adopted “almost unanimously,” with 57 votes in favor, one against, and two abstentions. The Committee’s press release states that the use of the most problematic substances, such as carcinogens, should not be allowed except where absolutely necessary, such as in the absence of effective alternatives and the need to prevent a wider risk to health or the environment. Further attention should be paid to endocrine disruptors, and the Committee asked the European Commission (EC) to define better criteria for them by the end of 2013. The Committee wants biocides to be reviewed regularly, suggesting approvals or renewals should be for a maximum of ten years, and less for “problematic” substances. More products would be assessed at the EU level to ensure a simpler and more consistent application process. The Committee suggested that applications for products with new active substances could be submitted to the European Chemicals Agency (ECHA) from 2013 and for other categories from 2017. The Committee stated that products treated with biocides are not covered by existing rules, leading to problems, “such as rashes from imported sofas that had been sprayed with fungicide.” The Committee wants to ensure this loophole is closed and that all treated products are labeled in the future. Finally, the Committee notes that nanotechnology is an emerging area in biocides. To ensure that the use of nanoparticles does not constitute a risk, the Committee wants specific checks to be devised and carried out on products that contain nano-ingredients. More information is available online.

Highlights Of Forum’s Tenth Plenary Meeting Include Enforcement Projects: According to an October 10, 2011, ECHA press release, during the Forum’s 10th Plenary meeting, Forum members reviewed the results of the prolongation of the first Forum coordinated enforcement project and agreed on the subject of the third enforcement project. According to ECHA, the results of the first coordinated enforcement project on registration obligations for phase-in substances and on safety data sheets (SDS) from substance suppliers indicate that there is a clear need for industry to improve the quality of these documents. ECHA intends to publish the final report by mid-November 2011. The Forum’s third harmonized enforcement project will once more focus on registration obligations. Its scope will cover the verification of the registrations by Only Representatives and the cooperation with custom authorities controlling imports of substances. Separately from this project, some member states will pilot the verification of registrations for intermediates. More information is available online.

ECHA Submits Draft Plan For First Substance Evaluation: ECHA submitted on October 21, 2011, the first draft Community Rolling Action Plan (CoRAP) to the member state competent authorities and ECHA Member State Committee. The draft CoRAP lists 91 substances proposed for review under the REACH evaluation process. The substances are divided for evaluation during 2012, 2013, and 2014. The plan addresses substances suspected of posing risk to human health or the environment. The Committee will prepare an opinion on the draft plan in February 2012. From the publication of the final CoRAP, the respective member state responsible for the evaluation of each substance and the initial reasons of concern will have one year to evaluate substances specified for 2012 and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. The other member states, ECHA, and the Member State Committee will review and agree on the draft decisions before they become effective. Registrants of substances listed on the final CoRAP have an opportunity to comment before any final decision to request further information will be taken. More information is available online.

ECHA states that, in many cases, the initial concerns are related to potential persistent, bioaccumulative, and toxic (PBT) properties, suspected endocrine disruption, or carcinogenic, mutagenic, and reprotoxic properties in combination with wide dispersive or consumer use(s). In general, the uses of the substances cover various areas and are not focused on any particular industrial, professional, or consumer uses. The 91 substances are:

2012carbon tetrachloride
2012ethylene oxide
2012Tributyl Phosphate
20122-Ethylhexanoic acid
2012dimethyl phosphonate
2012N-(1,4-dimethylpentyl)-N’-phenylbenzene-1,4- diamine
2012tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
2012hexyl salicylate
2012Silicon dioxide
2012m-Tolylidene diisocyanate
2012Phenol, methylstyrenated
2012Alkanes, C14-17, chloro
2012A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4- methylpyran-4-ol
2013Carbon disulphide
2013Furfuryl alcohol
20134,4′-methylenediphenyl diisocyanate
20131,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3- dicarboxylic anhydride
2013Diallyl phthalate
2013di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide
2013[1,3(or 1,4)-phenylenebis(1- methylethylidene)]bis[tert-butyl] peroxide
2013diisotridecyl adipate
2013Phenol, dodecyl-, sulfurized, carbonates, calcium salts, overbased
2013mixture of two components: 1. N-(1,3- dimethylbutyl)-N´-phenyl-p-phenylenediamine 2. N1-(1,3-dimethylbutyl)-N4-(4-(1-methyl-1- phenylethyl)phenyl)benzene-1,4-diamine
2013Public name to be agreed with the registrant
2013Public name to be agreed with the registrant
2013Mono- and/or di- and/or tri(1-phenylethyl)-m-cresol and p-cresol
20142-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether
2014diethyl phthalate
2014methyl 4-hydroxybenzoate
20144-hydroxybenzoic acid
2014Allyl alcohol
2014triphenyl phosphate
2014Gallium arsenide
2014tris(methylphenyl) phosphate
2014tert-butyl methyl ether
2014diundecyl phthalate
20142-ethylhexyl 4-methoxycinnamate
2014titanium dioxide
2014Ditolyl ether
2014diisodecyl azelate
20142-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2- oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3 ,5-dithia-4- stannatetradecanoate
20141,2-Benzenedicarboxylic acid, benzyl C7-9- branched and linear alkyl esters
20141,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters
20141,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl es-ters, C13-rich
2014Phenol, 4-nonyl-, branched
2014diundecyl phthalate, branched and linear

ECHA Will Hold Lead Registrant Workshop In February 2012: ECHA will hold a “Lead Registrant Workshop” on February 2-3, 2012, in Helsinki. According to ECHA, preliminary topics include feedback and lessons learned from 2010; registration management: case studies related to data sharing, substance identity, and data quality; and Substance Information Exchange Forum (SIEF) formation and challenges. There are 300 spots available for lead registrants who have informed ECHA of their role using the lead registrant notification web form available online. ECHA states that it will give priority to lead registrants with no previous experience in SIEF formation. The workshop will be streamed online. More information is available online.


Japan Issues Hazard Information For Existing Chemicals Designated As PACs: The Ministry of Economy, Trade, and Industry (METI) issued on October 31, 2011, the first hazard information for existing chemicals that were designated as priority assessments chemicals (PAC) in April 2011. The hazard information includes two data sets. For the first, METI invites companies to fill in missing data gaps, while in the second, METI provides the sources of data and invites companies and academics to check the accuracy of information and respond to it. METI also issued two appendices containing notes with instructions for respondents, definitions, and flow charts. All documents are in Japanese. The provisional translation of the April 2011 list of PACs is available online. Appendix 1 hazard information is available online; Appendix 2 documents are available online; Appendix 2 materials are available online; Appendix 1 notes are available online; and Appendix 3 notes are available online.

Japan Intends To Comply With GHS Requirements By 2020: During the CHEM 2011 conference on November 4, 2011, Yuriko Kashio, Section Chief of the Chemical Management Division of METI, stated that Japan intends to comply with Globally Harmonized System of Classification and Labeling of Chemicals (GHS) requirements by 2020. Under the amendments to the Chemical Substance Control Law (CSCL), new chemical substances manufactured or imported in amounts of less than ten metric tons per year are subject to a simplified system of three tests, as opposed to nine tests for materials made or imported in higher amounts. Companies that produce or import more than one metric ton of chemicals per year must file an annual report. According to Kashio, new rules for risk assessment narrow the focus to mainly prioritized chemicals. In addition, some data collected for REACH can be used for Japanese reporting and evaluation. Evaluation of new chemical substances is jointly handled by the Ministries of Environment; Economy, Trade, and Industry; and Health, Labor, and Welfare. The National Institute of Technology and Evaluation is the official evaluator.


South Korea Publishes Updated List Of Banned Chemicals: The Ministry of Environment published in the October 5, 2011, Korean Official Gazette an updated list of chemical substances banned under the Toxic Chemical Control Law (TCCL). Listed substances are banned from manufacture, import, sale, keeping and storage, transportation, or use. The list includes specific substances within the following categories:

  • Benzene and its salts;
  • Strychnine and its salts;
  • Chlordimeform and its salts;
  • Paraquat salts;
  • Pentachlorophenol and its salts;
  • 2-Naphthylamine and its hydrochloride; and
  • 4-Aminobiphenyl and its hydrochloride.