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October 1, 2012

Global Regulatory Update for October 2012

The ACTA Group


Chile Invites Pesticide Registration Applicants To Apply Online: The Department of Environmental Health invited pesticide registration applicants to begin the registration process by applying for authorization online. The Department made public its electronic records for disinfectant products since September 2010, so that registration applicants could see what data the Department already has. More information is available, in Spanish, online.


ECHA Begins Consultation On 54 Potential SVHCs: On September 3, 2012, the European Chemicals Agency (ECHA) announced the beginning of a public consultation on 54 potential SVHCs. According to ECHA, the European Commission (EC) requested ECHA prepare Annex XV dossiers for 37 substances on their behalf, while Austria, Germany, the Netherlands, Poland, Slovakia, Sweden, and the United Kingdom put forward proposals for the identification of 17 substances. Comments should provide information concerning the identity of the substances or on their persistent, bioaccumulative, and toxic (PBT)/very persistent and very bioaccumulative (vPvB) or “equivalent concern” properties. The Member State Committee will consider comments when seeking agreement on the identification of all proposed substances as substances of very high concern (SVHC). ECHA states that the Committee will not consider comments on carcinogenic, mutagenic, and/or toxic for reproduction (CMR) properties where harmonized classification is laid down in Annex VI of the regulation on classification, labeling, and packaging of hazardous substances and mixtures. ECHA invites the submission of information on the uses of the substances, including data on tonnages per use and exposures or releases resulting from these uses, as well as on the availability of safer alternative substances and techniques and the structure of supply chains. ECHA will consider this information when recommending SVHCs for inclusion in the Authorization List (Annex XIV). ECHA notes that 84 SVHCs are currently included in the Candidate List. According to ECHA, the proposed SVHCs “may take the total number above the policy target of 136 set for the end of 2012. Inclusion on this list imposes new information requirements on manufacturers and importers of listed substances and on suppliers of preparations and articles containing the substances.” Below is a list of substances proposed for identification as SVHC and reasons for their proposal:

Substance NameProposed SVHC Property
Bis(pentabromophenyl) ether (DecaBDE)PBT; vPvB
Pentacosafluorotridecanoic acidvPvB
Tricosafluorododecanoic acidvPvB
Henicosafluoroundecanoic acidvPvB
Heptacosafluorotetradecanoic acidvPvB
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated — Covering well-defined substances and UVCB substances, polymers and homologuesEquivalent level of concern – probable serious effects on the environment
4-Nonylphenol, branched and linear — Substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereofEquivalent level of concern – probable serious effects on the environment
Diazene-1,2-dicarboxamide (C,C’-azodi(formamide))Equivalent level of concern – probable serious effects on human health
Cyclohexane-1,2-dicarboxylic anhydride (Hexahydrophthalic anhydride – HHPA)Equivalent level of concern – probable serious effects on human health
Hexahydromethylphathalic anhydride, Hexahydro-4-methylphathalic anhydride, Hexahydro-1-methylphathalic anhydride, Hexahydro-3-methylphathalic anhydrideEquivalent level of concern – probable serious effects on human health
Methoxy acetic acidToxic for reproduction; equivalent level of concern -probable serious effects on human health and the environment
1,2-Benzenedicarboxylic acid, dipentylester, branched and linearToxic for reproduction
Diisopentylphthalate (DIPP)Toxic for reproduction
N-pentyl-isopentylphtalateToxic for reproduction
1,2-DiethoxyethaneToxic for reproduction
N,N-dimethylformamide; dimethyl formamideToxic for reproduction
Dibutyltin dichloride (DBT)Toxic for reproduction
Acetic acid, lead salt, basicToxic for reproduction
Basic lead carbonate (trilead bis(carbonate)dihydroxide)Toxic for reproduction
Lead oxide sulfate (basic lead sulfate)Toxic for reproduction
[Phthalato(2-)]dioxotrilead (dibasic lead phthalate)Toxic for reproduction
Dioxobis(stearato)trileadToxic for reproduction
Fatty acids, C16-18, lead saltsToxic for reproduction
Lead bis(tetrafluoroborate)Toxic for reproduction
Lead cynamidateToxic for reproduction
Lead dinitrateToxic for reproduction
Lead oxide (lead monoxide)Toxic for reproduction
Lead tetroxide (orange lead)Toxic for reproduction
Lead titanium trioxideToxic for reproduction
Lead Titanium Zirconium OxideToxic for reproduction
Pentalead tetraoxide sulphateToxic for reproduction
Pyrochlore, antimony lead yellowToxic for reproduction
Silicic acid, barium salt, lead-dopedToxic for reproduction
Silicic acid, lead saltToxic for reproduction
Sulfurous acid, lead salt, dibasicToxic for reproduction
TetraethylleadToxic for reproduction
Tetralead trioxide sulphateToxic for reproduction
Trilead dioxide phosphonateToxic for reproduction
Propylene oxide; 1,2-epoxypropane; methyloxiraneCarcinogenic; Mutagenic
Diethyl sulphateCarcinogenic; Mutagenic
Dimethyl sulphateCarcinogenic
3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidineToxic for reproduction
DinosebToxic for reproduction
4,4′-oxydianiline and its saltsCarcinogenic; Mutagenic
4-Aminoazobenzene; 4-PhenylazoanilineCarcinogenic
4-methyl-m-phenylenediamine (2,4-toluene-diamine)Carcinogenic
6-methoxy-m-toluidine (p-cresidine)Carcinogenic
o-Toluidine; 2-AminotolueneCarcinogenic
N-methylacetamideToxic for reproduction
1-bromopropane; n-propyl bromideToxic for reproduction

Comments are due October 18, 2012. More information is available online.

ECHA Posts Webinar On Dissemination And Confidentiality Claims: ECHA posted a September 6, 2012, webinar on key concepts on the rules of confidentiality and the dissemination of information post-registration. The webinar included presentations on dissemination filter rules, claiming confidentiality under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, and safety data sheet (SDS) information. This webinar serves as a reminder to registrants on data that will be made publicly available by ECHA on its dissemination portal. The presentations are available online.

EC And U.S. Seek Public Comment On How To Coordinate Regulations: The EC and the U.S. issued a joint notice on September 7, 2012, seeking public comment on how to promote greater transatlantic regulatory compatibility generally. The notice asks for concrete ideas on how greater compatibility could be achieved in a particular economic sector by providing detailed information for that sector, including:

  • Names of the relevant regulatory agencies in the EU and the U.S.;
  • Citations to the relevant regulatory and/or statutory provisions for each jurisdiction (this is not meant to exclude potential cooperation in areas where neither jurisdiction has yet adopted such provisions);
  • A description of the regulatory differences to be addressed, including any information on negative effects of these differences and on the entities or stakeholders affected by them;
  • Possible solutions for bridging these differences, including both the substance of the solution and the proposed procedure for reaching it;
  • Any steps that the EU and/or the U.S. should consider to address horizontal and/or sectoral differences between the two jurisdictions that may be impeding deeper regulatory compatibility in the sector, such as differences with respect to technical regulations or in respective approaches to standards; and
  • An assessment of the effects of enhanced regulatory compatibility (quantified benefits and costs, if possible, or else qualitative descriptions), the likelihood of these effects occurring, and the time period over which they would occur.

The High Level Regulatory Cooperation Forum will consider comments as it defines its priorities and explores next steps. According to the joint notice, the EU and U.S. intend to hold a meeting in the fall involving EU and U.S. regulators, economic policy agencies, and stakeholders. Comments are due October 31, 2012. The joint notice is available online.

ECHA Urges Registrants Of Intermediates To Improve Their Dossiers: ECHA announced on September 14, 2012, that it has undertaken a more systematic IT-screening of the approximately 5,500 registrations for intermediates. According to ECHA, its analysis of the reported uses in these dossiers revealed that 2,388 dossiers included uses that do not, or are very unlikely to, fulfill the definition of intermediates and/or are used under strictly controlled conditions. These dossiers with deficiencies and a potential for incompliance represent 760 substances. ECHA sent letters to 574 registrants with potentially non-compliant intermediate registrations, asking them to review carefully the reported uses and update their registration dossiers within three months. ECHA states that the letter also includes practical advice for registrants on how to report better intermediates in IUCLID 5.4 or how to update the registration to a full Article 10 Registration. After the end of the three-month period, ECHA intends to undertake a new screening of dossiers and identify those that require regulatory action. More information is available online.

ECHA Introduces Targeted Compliance Checks: On September 17, 2012, ECHA announced a new systematic targeting of compliance checks based on specified concerns. According to ECHA, this will increase the chances for dossiers of insufficient compliance to be scrutinized, and ensure higher compliance of REACH registrations. In a full compliance check, ECHA addresses the full dossier content in a single evaluation exercise, especially for randomly selected registration dossiers. Where a dossier is non-compliant with an information requirement, ECHA will request the information in a single decision taken in cooperation with the Member States. In a targeted compliance check, ECHA evaluates only a specific part of the registration dossier based on specified concerns. ECHA states that selected areas of concern have been identified that are in particular relevant for the safe use of substances, and it will emphasize PBT, CMR, or sensitizing properties of a substance. According to ECHA, the chances of non-compliant dossiers being picked up for compliance check are now higher. Dossiers submitted individually outside an existing joint submission and dossiers with obviously incomplete essential elements will be automatically selected for compliance check. ECHA notes that the consequence of the targeted compliance check is that if the dossier contains several non-compliances, registrants may receive more than one draft decision per registration dossier at different moments in time. ECHA invites registrants who receive a first draft decision as a result of these targeted compliance checks to re-assess the overall quality of their registration dossier and prepare updates where necessary. More information is available online.

EC Notifies WTO Of Intent To Add Substances To Annex XIV: The EC sent a September 18, 2012, notification to the World Trade Organization (WTO) announcing its intent to amend REACH Annex XIV to include trichloroethylene, chromium trioxide, acids generated from chromium trioxide and their oligomers, sodium dichromate, potassium dichromate, ammonium dichromate, potassium chromate, and sodium chromate. The notification states that, once the EC promulgates the regulation and it enters into force, the placing on the market and the use of these substances will be possible, after the date specified for each substance, only for those operators who have been granted an authorization and for those who have submitted an application for authorization before a given date but a decision has not yet been adopted. According to the notification, the EC intends to adopt the regulation in March 2013, and it would enter into force three days after publication in the Official Journal of the European Union. Comments are due to the WTO 60 days from the date of notification.

EC Adds Cadmium, Lead, Mercury, And Phenylmercury Compounds To REACH Annex XVII: The EC published notices in the September 19, 2012, Official Journal of the European Union adding restrictions concerning cadmium and lead to REACH Annex XVII, and notices in the September 20, 2012, issue adding mercury and phenylmercury compounds to Annex XVII. The restrictions include:

  • Cadmium: Shall not be used in mixtures and articles produced from the listed synthetic organic polymers (hereafter referred to as plastic material). Mixtures and articles produced from plastic material as listed shall not be placed on the market if the concentration of cadmium is equal to or greater than 0.01 percent by weight of the plastic material. By November 19, 2012, the EC shall ask ECHA to prepare a dossier conforming to the requirements of Annex XV to assess whether the use of cadmium and its compounds in plastic material, other than that listed, should be restricted. The notice is available online.
  • Lead: Shall not be placed on the market or used in any individual part of jewelry articles if the concentration of lead in such a part is equal to or greater than 0.05 percent by weight. The restriction does not apply to jewelry articles placed on the market for the first time before October 9, 2013, and jewelry articles produced before December 10, 1961. By October 9, 2017, the EC shall re-evaluate the restriction in the light of new scientific information, including the availability of alternatives and the migration of lead from articles and, if appropriate, modify the entry accordingly. The notice is available online.
  • Mercury: The following mercury-containing measuring devices intended for industrial and professional uses shall not be placed on the market after April 10, 2014: (a) barometers; (b) hygrometers; (c) manometers; (d) sphygmomanometers; (e) strain gauges to be used with plethysmographs; (f) tensiometers; and (g) thermometers and other non-electrical thermometric applications. The following mercury-using measuring devices intended for professional and industrial uses shall not be placed on the market after April 10, 2014: (a) mercury pycnometers; and (b) mercury metering devices for determination of the softening point. The restrictions shall not apply to: (a) measuring devices more than 50 years old on October 3, 2007; or (b) measuring devices which are to be displayed in public exhibitions for cultural and historical purposes. The notice is available online.
  • Phenylmercury: The listed phenylmercury compounds shall not be manufactured, placed on the market, or used as substances or in mixtures after October 10, 2017, if the concentration of mercury in the mixtures is equal to or greater than 0.01 percent by weight. Articles or any parts thereof containing one or more of these substances shall not be placed on the market after October 10, 2017, if the concentration of mercury in the articles or any part thereof is equal to or greater than 0.01 percent by weight. The notice is available online.

EC Publishes Update To REACH Baseline Study: On September 20, 2012, the EC posted a report entitled The REACH baseline study — 5 years update, which follows up on the 2009 Eurostat study that was published with data before REACH was in place. The report is intended to answer two questions on the effectiveness of REACH: (1) does REACH lead to a reduction of the risks posed by chemicals to humans and the environment, and (2) does REACH lead to an improvement of the data. The report concludes that the results of the five-year update “show a marked decrease in the nominal risk associated with the registered reference substances which is largely believed to be due to REACH.” The results also “show a marked increase in the quality of the data, which are available for the chemical assessment of the registered reference substances.” The report is available online.

ECHA Announces Two-Week Interruption Of Inquiry Process In November: On September 25, 2012, ECHA announced that it will release the last version of REACH-IT at the end of November 2012, before the 2013 registration deadline. According to ECHA, the main benefit for users will be to access the contact details of existing registrants directly within REACH-IT once ECHA has ascertained the identity of the substance. In parallel, ECHA will enhance its technical completeness check plug-in tool to allow potential registrants to check their inquiry dossier and increase its overall quality prior to submission. ECHA notes that the new release will not affect the main requirements to prepare and submit inquiry dossiers. Implementation of the improved inquiry process will require a two-week interruption of the service of processing inquiry dossiers in ECHA. ECHA will update the REACH-IT homepage regularly to provide more details closer to the release date. More information is available online.

C&L Inventory Contains All Information On Hazardous Substances On The EU Market: ECHA announced on September 27, 2012, that it updated the public Classification and Labeling (C&L) Inventory with information on substances that notifiers have indicated as not classified. The Inventory also includes all notifications for European Inventory of Existing Commercial chemical Substances (EINECS). The Inventory shows all notifications for substances for which there is at least one notification classifying it as hazardous according to REACH Article 119(1). In addition, all notifications for substances on the EC Inventory are also now provided. ECHA states that the current version of the Inventory contains approximately 5.3 million notifications relating to 120,000 substances. More information is available online.

ECHA Reminds Companies To Update Dossiers According To Second ATP To CLP: On September 28, 2012, ECHA issued a press release reminding companies that the classification, labeling, and packaging (CLP) provisions of the second Adaptation to Technical and scientific Progress (ATP) amending the CLP regulation must be applied to substances by December 1, 2012. The second ATP includes amendments concerning new subcategories for the hazard classes of respiratory and skin sensitization, a revision of the classification criteria for aquatic chronic toxicity, and a new hazard class for classification, “hazardous to the ozone layer.” ECHA requests companies classify, label, and package their substances in compliance with the new provisions, as well as update their REACH registration dossiers and notifications to the C&L Inventory, by December 1, 2012. ECHA states that substances placed on the market before December 1, 2012, and classified, labeled, and packaged according to the CLP regulation, do not require relabeling and repackaging until December 1, 2014. The second ATP applies to mixtures only from June 1, 2015. Mixtures placed on the market before June 1, 2015, and classified, labeled, and packaged in accordance with the CLP regulation or the Dangerous Preparations Directive are not required to be relabeled and repackaged until June 1, 2017. ECHA notes that companies can voluntarily apply all provisions contained in the second ATP before the set deadlines. More information is available online.

EFSA Will Review Scientific Information On Endocrine Disruptors: The European Food Safety Authority (EFSA) announced on October 1, 2012, that it is reviewing all available scientific information on endocrine active substances, with a view to evaluating possible approaches for their identification and methods to assess the hazards they may pose. The EC requested EFSA prepare a scientific opinion on the human health and environmental risks associated with the possible presence of endocrine disruptors in the food chain. According to EFSA, the opinion will take stock of the available scientific information and seek to answer three key questions: (1) what scientific criteria are used for identifying endocrine disruptors; (2) what criteria can be applied to distinguish potential adverse effects of an endocrine disruptor from the normal regulation of body function in humans and the ecosystem; and (3) do existing toxicity testing methods appropriately cover the effects of endocrine active substances. EFSA intends to release its opinion in March 2013. More information is available online.


Japan Considering Combining Chemical Inventories: According to the mid-term report of the Joint Review Committee, Japan is considering combining the chemical inventories created by the Chemical Substances Control Law (CSCL) and Industrial Safety and Health Law (ISHL). The CSCL inventory includes substances manufactured in or imported into Japan, in categories such as existing substances, specified substances, and priority assessment substances. The ISHL inventory includes substances manufactured in or imported into Japan and used in the workplace. The inventories use different forms and procedures for the notification and assessment of new chemical substances. The Joint Review Committee includes members of the Ministry of Economy, Trade, and Industry (METI), Ministry of Environment, and Ministry of Health and Labor Welfare. The mid-term report is available, in Japanese, online.


Russian Consumer Rights Protection Agency Will Administer State Registration Of Certain Products, Including Hazardous Chemicals And Food Contact Substances: Under an August 28, 2012, decree, which revised the national product registration framework, Rospotrebnadzor, the consumer rights protection agency, will administer state registration of certain products, including hazardous chemicals and food contact substances. According to the Rospotrebnadzor website, the decree will not change the legal status of the state registration certificates it currently issues. The decree entered into force seven days after its publication. More information is available, in Russian, online.


Taiwan Proposes To Amend Guidelines For Regulated Toxic Chemical Substances: Taiwan began a 14-day public comment period on proposed amendments to the Guidelines on Regulated Toxic Chemical Substances and the Management of Their Handling. The Environmental Protection Agency (EPA) has proposed, based on the eight substances in association with the EU’s REACH Authorization List in February 2012, to add four substances to Taiwan’s Regulated Toxic Substances List and adjusted one toxic substance’s toxicity level. The amendments, which are in accordance with the Toxic Chemical Substances Control Act, include:

  • Arsenic pentaoxide, lead chromate molybdate sulphate red (CI Pigment Red 104), lead sulfochromate yellow (CI Pigment Yellow 34), and tris (2-chloroethyl) phosphate would be added to the regulated toxic substances list;
  • Di-isobutylphthalate would be adjusted as toxicity class 1, 2;
  • The allowed usage of the above five toxic substances has been added;
  • Beginning February 1, 2013, asbestos would be prohibited to be used in the manufacturing of asbestos tiles. Firms with permits obtained before February 2, 2012, would be able to manufacture until the expiration date; and
  • Deadlines for various operations of the toxic substances would be adjusted.

Taiwan Finds Violations Concerning Hazardous Substance Labeling And Communications: The Council of Labor Affairs announced that, in a recent inspection of hazardous substance labeling and communications, it found that approximately 40 percent of the inspected companies violated regulations. The inspection, which ended August 31, 2012, included over 2,000 companies. Violations concerned classification and labeling, material safety data sheets (MSDS), and hazardous communications. More information is available, in Chinese, online.


MOI Signs MOC On Chemicals Management With Japan’s METI: The Thai Ministry of Industry (MOI) signed a memorandum of cooperation (MOC) with Japan’s METI. Under the MOC, which will last for three years and can be extended, Japan will help Thailand to build a chemicals management system that will include the following:

  • Research and analyze the status of the industrial chemicals management system and existing laws and regulations;
  • Develop guidelines for risk assessment and chemicals management;
  • Provide training courses to the Thai government and industries on risk assessment and management;
  • Develop database systems to support risk management;
  • Make proposals to improve hazardous chemicals-related laws and regulations; and
  • Assist the set-up of an implementation plan for developing a risk management system.

More information is available, in Japanese, online.