Global Regulatory Update for April 2012
OECD Announces Availability Of Modified Environmental Risk Assessment Toolkit: The Organization for Economic Cooperation and Development (OECD) Environmental Risk Assessment Toolkit describes the work flow for environmental risk assessment and management of chemicals with links to available OECD material relevant for the different steps in risk assessment and management. OECD announced on March 19, 2012, that it has revised the Toolkit to include resources other than OECD products, and to incorporate three examples (i.e., textile dye, pesticide, and environmental quality standard setting) that show the risk assessment steps involved in each case. More information is available online.
Safe Work Australia Reports Progress On Implementing The Model Work Health And Safety (WHS) Laws: At its March 16, 2012, meeting, Safe Work Australia members endorsed six further Codes of Practice as part of the harmonized WHS laws:
- Safe design of structures;
- Excavation work;
- Demolition work;
- Spray painting and powder coating;
- Abrasive blasting; and
- Welding processes.
After final technical and editorial changes, Safe Work Australia will forward the above codes with the six codes previously agreed upon to the Ministerial Council:
- First aid in the workplace;
- Managing risks in construction work;
- Preventing falls in housing construction;
- Managing electrical risks at the workplace;
- Managing risks of hazardous chemicals; and
- Managing risks of plant in the workplace.
If approved, these 12 codes will become model Codes of Practice. Members agreed by majority to release five further Codes of Practice for a 12-week public comment period commencing early April 2012:
- Safe design, manufacture, import, and supply of plant;
- Working in the vicinity of overhead and underground electrical services;
- Traffic management in workplaces;
- Scaffolding work; and
- Formwork and falsework.
Members agreed that a package seeking public comment on proposed changes to the workplace exposure standard for airborne contaminants for synthetic mineral fiber will be released for an eight-week period beginning April 16, 2012. Members agreed the title for the new strategy be Australian Work Health and Safety Strategy 2012-2022: Healthy, Safe and Productive Working Lives. Members also agreed that the draft strategy be released for public comment for an eight-week period beginning March 26, 2012. More information is available online.
U.S. And Canada Regulatory Coordination Council Will Work On GHS Implementation: According to Maureen Ruskin, Director of the U.S. Occupational Safety and Health Administration’s (OSHA) Office of Chemical Hazards, the U.S. and Canada have formed a Regulatory Coordination Council and implementation of the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) is included on its current work plan. The Council has agreed on four actions to coordinate GHS implementation, which include developing:
- A mechanism to coordinate implementation between the two countries;
- A mechanism to provide input on GHS issues at an international and national level;
- Technical coordination to ensure that consistent results are reached based on the underlying data; and
- Stakeholder involvement as implementation of GHS in the workplace moves forward.
The Council is planning a stakeholder meeting in the Spring to discuss the work plan, as well as other practical issues, including the scope of the agreement between the U.S. and Canada and potential guidance. According to Ruskin, while Canada is expected to be at least a year behind the U.S. in GHS implementation, once both countries implement GHS, the Council intends to work to ensure alignment, particularly on technical issues and the interpretation of data to ensure companies in the U.S. and Canada classify chemicals in the same way.
Canada Publishes Proposed Polymer Approach For Public Consultation: On March 19, 2012, as a part of the Chemicals Management Plan, Canada published its proposed approach to assess and manage, where appropriate, the potential health and ecological risks associated with certain polymers under the Canadian Environmental Protection Act, 1999 (CEPA 1999). Canada proposes a tiered approach, taking into account the data requirements in the New Substances Program under CEPA and the timing of upcoming information gathering initiatives. Details of the proposed approach, as well as a list of polymers falling within the scope of this initiative, are in the Proposed Polymer Approach Consultation Document, which is available online. Canada anticipates that the initiative will take place over several years, with high level information gathering and its analysis occurring over the next two years, followed by the start of polymer specific surveys in 2014/2015. Canada intends to hold further consultations on additional elements of the initiative throughout the process. Comments on the proposed polymer approach are due May 18, 2012.
New Rules Of Entry And Exit Inspection For 160 Specific Hazardous Chemicals: The General Administration of Quality Supervision, Inspection and Quarantine of People’s Republic of China (AQSIQ) released a notice of entry and exit inspection for hazardous chemicals and packages. The notice identifies new requirements of entry and exit inspection for 160 specific hazardous chemicals and came into force on February 1, 2012. The new requirements include:
- Specific substances on the 2002 List of Hazardous Chemicals, inspection declaration, and listed on the National Inspection List; and
- The submitted documentation is different between import declaration and export declaration.
Previously, on December 29, 2011, AQSIQ and the General Administration of Customs (GAC) jointly issued the 2012 Catalog of Entry and Exit Goods Subject to China’s Entry-Exit Inspection and Quarantine Administrations (Legal Inspection Catalog). The 160 hazardous chemicals listed in the 2002 Catalog of Hazardous Chemicals have been added to the Legal Inspection Catalog. In China, any entry/exit goods listed in the Legal Inspection Catalog shall receive compulsory inspections by China’s entry-exit inspection and quarantine administrations. Shipments into China of a substance on the Legal Inspection Catalog should be accompanied by a declaration of conformity; safety data sheet (SDS) and label compliant with China GHS; and usual customs declarations forms. More information is available, in Chinese, online and online.
EUROPEAN UNION (EU)
ECHA Launches C&L Inventory: On February 13, 2012, the European Chemicals Agency (ECHA) announced the availability of the Public Classification and Labeling (C&L) Inventory, which provides information from industry on how they have self-classified chemicals and, ECHA notes, shows how some companies have classified the same substance differently. ECHA has not filtered or quality checked the information provided. ECHA encourages industry to use the Inventory data as a common ground for discussions between companies to reach agreement on the self-classification and labeling of hazardous substances. To provide support for the hazard communication process, ECHA intends to develop an IT platform to facilitate contacts among notifiers of chemicals to give them the opportunity to discuss reasons for differences and, where appropriate, agree on a uniform classification. A number of options are available for searching the Inventory, based on both the substance identity and its classification. According to ECHA, future updates of the Inventory “will continuously improve the search functions in order to enhance access to the information.” ECHA states that the data “will be refreshed on a regular basis with incoming and updated C&L information.” More information is available online.
EC Adds Eight Substances To REACH Annex XIV: The European Commission (EC) published a regulation in the February 15, 2012, Official Journal of the European Union that adds eight substances to Annex XIV of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Once the substances are phased out, they may be used only if authorizations are granted for specific uses. The substances and their phaseout dates are:
- Di-Isobutylphthalate (DIBP), February 21, 2015;
- Diarsenic trioxide, May 21, 2015;
- Diarsenic pentaoxide, May 21, 2015;
- Lead chromate, May 21, 2015;
- Lead sulfochromate yellow (CI Pigment Yellow 34), May 21, 2015;
- Lead chromate molybdate sulphate red (CI Pigment Red 104), May 21, 2015;
- Tris(2-chloroethyl)phosphate (TCEP), August 21, 2015; and
- 2,4-Dinitrotoluene (2,4-DNT), August 21, 2015.
Authorization requests for DIBP are due August 21, 2013. Authorization requests for diarsenic trioxide, diarsenic pentaxide, lead chromate, lead sulfochromate yellow (CI Pigment Yellow 34), and lead chromate molybdate sulphate red (CI Pigment Red 104) are due November 21, 2013. Authorization requests for TCEP and 2,4-DNT are due February 21, 2014. The regulation is available online.
ECHA Publishes 2011 Evaluation Report: ECHA announced on February 27, 2012, the availability of its 2011 evaluation report. According to ECHA, the main finding of the report is that a large part of the examined registration dossiers raise compliance or quality concerns to different degrees and require ECHA to address the shortcomings by regulatory action. In 2011, ECHA issued 187 draft or final decisions on testing proposals; adopted 22 final decisions on testing proposals; and closed the examination of 58 cases that were either inadmissible or withdrawn by the registrant. ECHA states that a significant share of the proposals could not be examined or properly concluded due to substance identity problems. In 2011, ECHA completed 146 compliance checks, and 134 resulted in ECHA requesting the registrant to provide further information. Ten of the cases were already closed after the registrant had updated his dossier with the information required, and in twelve cases, no action was needed. The report includes recommendations for registrants concerning the relevance of particular tests, the test material for the specific substance, substance identity, and reproductive toxicity testing. There are also tips to avoid shortcomings in the chemical safety assessment, hazard assessment, persistent, bioaccumulative, and toxic (PBT) assessment, exposure assessment and its scope, risk characterization, and classification and labeling. More information is available online.
ECHA Begins Public Consultation On 13 Potential SVHCs: On February 28, 2012, ECHA published new proposals to identify 13 chemicals as substances of very high concern (SVHC). ECHA states that the 13 substances “are classified as carcinogenic, mutagenic or toxic for reproduction and appear to fulfil Article 57 of the REACH Regulation, defining the identification of an SVHC.” ECHA notes that, for four of the substances (C.I. Basic Violet 3, C.I. Basic Blue 26, C.I. Solvent Blue 4 and 4,4′-bis(dimethylamino)-4″‘-(methylamino)trityl alcohol), the potential SVHC identification is based on the presence of the carcinogenic constituents Michler’s ketone or Michler’s base above the concentration limit for classifying the substances as carcinogenic (≥ 0.1 percent weight/weight). The substances are:
- 1,2-bis(2-methoxyethoxy)ethane (TEGDME; triglyme);
- 1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME);
- Diboron trioxide;
- Lead(II) bis(methanesulfonate);
- TGIC (1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1 H,3H,5H)-trione);
- ß-TGIC (1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5 H)-trione);
- 4,4′-bis(dimethylamino)benzophenone (Michler’s ketone);
- N,N,N’,N’-tetramethyl-4,4′-methylenedianiline (Michler’s base);
- [4-[4,4′-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimet hylammonium chloride (C.I. Basic Violet 3);
- [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl ]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26);
- α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4); and
- 4,4′-bis(dimethylamino)-4″-(methylamino)trityl alcohol.
ECHA requests comments include information concerning the identity of the substances. The Member State Committee will consider these comments when seeking agreement on the identification of a proposed substance as an SVHC. ECHA also requests information on the uses of the substances, including data on tonnages per use and exposures or releases resulting from these uses. ECHA states that information on the availability of safer alternative substances and techniques, and the structure of supply chains is also welcome. ECHA will consider this information when recommending SVHCs for inclusion in the Authorization List. Comments are due April 12, 2012. More information is available online.
ECHA Announces First CoRAP: On February 29, 2012, ECHA announced the first Community Rolling Action Plan (CoRAP), which includes 90 substances that Member States will evaluate under the REACH substance evaluation process. The substances are scheduled for evaluation in 2012, 2013, and 2014. Following the evaluation, further information may be requested from the registrants of the substances when additional data are considered necessary to clarify the suspected risk. The CoRAP includes the grounds for the initial concerns, and indicates the Member State that is responsible for the evaluation of each substance. In 2012, 36 substances will be evaluated by 17 Member States. The remainder have been listed for 2013 and 2014, but ECHA states that it expects to amend the number and selection of substances listed for those years in the annual updates of the CoRAP. From the publication of the CoRAP, the respective Member States have one year to evaluate substances specified for the year 2012 and, where justified, to prepare a draft decision requesting the registrant(s) to submit further information to clarify any possible risk. The decision will be taken by ECHA after consultation of the Member State Competent Authorities and the Member State Committee, or by the EC if there is no unanimity at the Member State Committee. For other evaluation decisions, registrants of the substances listed on the CoRAP will have opportunities to comment before any final decision is taken. The 90 substances are:
- Carbon tetrachloride;
- Ethylene oxide;
- 4,4′-isopropylidenediphenol (Bisphenol A);
- 2-(4-Tert-butylbenzyl)propionalde hyde;
- Tributyl phosphate;
- 2-Ethylhexanoic acid;
- Dimethyl phosphonate;
- Tris(2-ethylhexyl) benzene-1,2,4- tricarboxylate;
- Hexyl salicylate;
- Silicon dioxide;
- M-tolylidene diisocyanate;
- Phenol, methylstyrenated;
- 1,1′-(ethane-1,2-diyl)bis[pentabromoben zene];
- Alkanes, C14-17, chloro (MCCP, Medium chained chlorinated paraffins);
- A mixture of: cis- tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4- methylpyran-4-ol;
- 2- (Phenylmethoxy)naphthalene;
- Carbon disulphide;
- Furfuryl alcohol;
- 4,4′-Methylenediphenyl diisocyanate;
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3 -dicarboxylic anhydride;
- Diallyl phthalate;
- 1,3,5- Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H, 5H)-trione;
- [1,3(or 1,4)-phenylenebis(1- methylethylidene)]bis[te rt-butyl] peroxide;
- Diisotridecyl adipate;
- Phenol, dodecyl-, sulfurized, carbonates, calcium salts, overbased;
- Mixture 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-d iamine;
- Reaction mass of mixed (3,3,4,4,5,5,6,6,7,7,8,8, 8-tridecafluorooctyl) phosphates, ammonium salts;
- Ammonium salts of mono- and bis[3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl and/or poly (substituted alkene)] phosphate;
- Mono- and/or di- and/or tri(1-phenylethyl)-m-cresol and p-cresol;
- 2-(2-Butoxyethoxy)ethyl 6-propylpiperonyl ether;
- Diethyl phthalate;
- Methyl 4- hydroxybenzoate;
- 4-Hydroxybenzoic acid;
- Allyl alcohol;
- Triphenyl phosphate;
- 1,1,1,3,3,3- Hexamethyldisilazane;
- Gallium arsenide;
- Tris(methylphenyl) phosphate;
- Tert-butyl methyl ether;
- Diundecyl phthalate;
- 2-Ethylhexyl 4- methoxycinnamate;
- Titanium dioxide;
- Ditolyl ether;
- Diisodecyl azelate;
- 2-Ethylhexyl 10-ethyl-4-[[2-[(2- ethylhexyl)oxy]-2- oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3 ,5-dithia-4-stannatetradecanoate;
- 1,2-Benzenedicarboxylic acid, benzyl C7-9-branched and linear alkyl esters;
- 1,2-Benzenedicarboxylic acid, di-C9-11- branched and linear alkyl esters;
- 1,2-Benzenedicarboxylic acid, di-C11-14- branched alkyl esters, C13-rich;
- Phenol, 4-nonyl-, branched; and
- Diundecyl phthalate, branched and linear.
More information is available online.
ECHA Publishes Data On Candidate List Substances In Articles: On March 5, 2012, ECHA published data on Candidate List substances in articles, stating that the data provide examples of articles available for consumer use on the EU market that contain SVHCs that are included on the Candidate List. The data are based both on the notifications that companies have submitted to ECHA, as well as on the information contained in the registration dossiers. Importers and producers of articles must notify ECHA if a Candidate List substance is present in their articles above one tonne per year and in a concentration above 0.1 percent weight by weight. ECHA states that, in some cases, in particular for articles produced in the EU, the use of the SVHC in articles will already have been covered in the registration dossier for the substance. In such cases, no separate notification by the article producer needs to be made to ECHA. According to ECHA, the data do not provide a comprehensive picture of the presence of Candidate List substances in articles on the EU market. The majority of notifications received so far relate to four phthalates that are on the Candidate List due to their toxicity to reproduction. Examples of such notified articles are cables, bags, packaging material, waterproof garments, and polyvinyl chloride flooring. The second most common notification is for the brominated flame retardant hexabromocyclododecane, which is PBT. This substance can be found in articles used by the construction and building sectors, such as plastic panels for the thermal insulation of buildings. It has also been notified in polystyrene foam used for packaging and in the plastic housing of electronic appliances. ECHA states that it is providing this information to add to the general increase in knowledge on the use and presence of hazardous substances in consumer articles, as well as to remind importers and producers of their legal obligations, under certain conditions, to notify when their articles contain substances on the Candidate List. From April to December 2011, the Agency received only 203 notifications. The deadline for producers and importers of articles to notify ECHA of the presence in articles of the 20 SVHCs that were included in the Candidate List in December 2011 is in June 2012. ECHA intends to update the data every six months. More information is available online and online.
Japan Updates GHS Information To Include Classification Results In English: The National Institute of Technology and Evaluation (NITE) announced that, on March 16, 2012, it updated the GHS information website, which now includes the following GHS classification results:
- GHS classification results of about 1,500 chemicals by Inter-Ministerial Committee (fiscal year (FY) 2006);
- GHS classification results of 145 chemicals by the Ministry of Economy, Trade and Industry (METI) (FY 2007); and
- GHS classification results of about 145 chemicals by METI and the Ministry of the Environment (MOE) (FY 2008).
According to NITE, the classification results are intended to help enterprises that are producing material safety data sheets (MSDS) and/or labels under the requirements of the GHS. The classification results are not mandatory and could be revised. More information is available online.
Japan Publishes Summary Of Release And Transfer Amounts Of Chemical Substances: Earlier this month, METI announced that, together with MOE, it totaled the release and transfer amounts of chemical substances in FY 2010 on the basis of notification by companies pursuant to the Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (Chemical Substances Management Act), estimated the release amounts other than those notified, and compiled the results. According to the Ministries, the number of business operators for which notification was required in FY 2010 was 36,491 (decreased by 4.9 percent from the previous FY), and the total of notified release amounts (183,000 tons) and transfer amounts (198,000 tons) was 381,000 tons. In accordance with the Chemical Substances Management Act, the number of chemical substances that require notification increased from 354 to 462, and the medical business was added to the industries subject to notification from FY 2010. This is the first release of data after the change of the chemical substances and industries subject to the Act. More information is available online.
Norway Proposes To Increase National Registration Requirements: On February 13, 2012, the Norwegian Climate and Pollution Agency (Klif) proposed revisions to the national regulations concerning the registration of hazardous chemicals. The proposed changes include keeping the requirement to declare chemicals to the National Product Register following national implementation of the EU legislation on the classification, labeling, and packaging of substances and mixtures (CLP) on June 1, 2015. The Norwegian regulations are currently set to expire on June 1, 2015. The proposed changes also include extending the declaration requirements to chemicals not currently included in the regulation and requiring that Norwegian manufacturers and importers submit SDSs to a public website for chemical information that is hosted and developed by Klif. Comments on the proposed changes are due May 13, 2012. More information is available, in Norwegian, online.
Presidential Decree Revises TCCA: Under a February 1, 2012, Presidential decree, the Toxic Chemical Control Act (TCCA) has been revised to include a provision stating that the government will begin issuing “pre-notices” before designating certain chemicals as banned or restricted, thereby providing time for industry to comply. The pre-notices will include chemical names and timelines for inclusion in the lists of banned and restricted chemicals. The amended TCCA authorizes the government to adopt emergency measures to ban any chemical proven to harm human health or the environment. Chemicals banned by way of emergency measure, however, are not subject to the pre-notice provision. The revisions also provide a new exemption from the TCCA’s chemical identification requirement for substances created during a manufacturing process that remain in the finished product. The changes become effective one year after the amendment’s publication.
Sweden Calls For Improved EU Rules For Chemicals: The Swedish Chemicals Agency (KemI) announced on March 1, 2012, the availability of a report entitled Improved EU Rules for a Non-Toxic Environment, which identifies gaps and opportunities for improvement in EU chemicals legislation. The report, which contains the views of KemI and eight other central governmental authorities, examines EU legislation in ten areas linked to chemicals control and the Swedish environmental objective of “A Non-Toxic Environment.” Suggestions for improvement include:
- Integrating rules on chemicals, articles, and waste in a lifecycle perspective in a new EU strategy;
- Developing EU legislation on pharmaceuticals to include environmental aspects, such as resistance to antibiotics and disturbance of the hormonal system more efficiently when testing and producing pharmaceuticals;
- Improving environmental inspections and environmental monitoring within the EU;
- Elaborating a plan of action to handle risks connected with organic fluorinated substances;
- Improving the protection of children by assuring that articles children come in contact with are safe;
- Introducing new EU rules on chemicals in textiles; and
- Strengthening the information requirements for low volume chemicals in the REACH regulation and developing it to improve risk management with regard to groups of substances.
The report includes proposals for improved information about chemicals to users, consumers, and those handling waste by establishing a new information strategy. The report also considers how the rules on food and cosmetics should be developed and improved. More information is available online.
KemI Proposes Amendment To Rules On The Sale Of Particularly Hazardous Chemical Products: KemI announced on March 1, 2012, that it reviewed the Swedish regulations applicable to permits relating to the sale of particularly hazardous chemical products, and presented proposed revisions to the Swedish government. According to KemI, the most significant change concerns the proposal to remove the permit requirement regarding professional sale and replace it with notification and knowledge requirements. Under the proposal, anyone who sells or in any other way supplies particularly hazardous chemical products shall notify the activity to the municipality and appoint a responsible chemical representative, who must have documented knowledge about the risks with the products and be aware of applicable rules. KemI states that particularly hazardous chemical products are those that may be lethal if swallowed, inhaled, or by skin contact, such as hydrogen cyanide and fluoric acid. Among particularly hazardous chemical products are also products that in a longer perspective are very hazardous and might cause cancer, cause heritable genetic damage, fetal damage or impaired fertility, or other serious health damage. Highly corrosive products are also part of this group. Other revisions include:
- Keeping the permit requirement for consumer use of particularly hazardous chemical products. A consumer should receive a permit to handle a particularly hazardous chemical product if he or she can prove that the product can be handled safely and that there is a need for the product for an artistic, technical, scientific, or similar purpose; and
- Highly corrosive products should also in the future be subject to rules that apply to the sale of particularly hazardous chemical products. The rules on corrosive products vary depending on professional or consumer use.
More information is available online.
Turkey Updates Inventory Of High Production Volume (HPV) Substances: The Turkish Ministry of Environment and Urbanization updated the list of HPV substances, manufactured or imported in quantities above 1,000 tonnes per year, for which it received notifications under the 2008 Bylaw on the Inventory and Control of Chemicals. The Ministry published an earlier inventory of HPV substances, in 2011, but stakeholders complained that it failed to include substances that were successfully notified before the March 31, 2011, deadline. The updated inventory includes an additional nine substances, for a total of 597 chemicals. When the Ministry released the inventory of low production volume chemicals in December 2011, stakeholders raised similar concerns regarding missing substances, and called for an update to include missing substances and remove exempt chemicals listed on the first inventory. The Ministry responded by stating: “Companies don’t need to be concerned about substances that are not listed on the published inventory as it is subject to update as it was for the HPV inventory publication.” The HPV inventory is available online.
Vietnam Publishes Guidance On SDS And Label Requirements: On February 13, 2012, Vietnam’s Ministry of Industry and Trade published detailed guidance on compliance with the 2008 law intended to implement the GHS on classification and labeling (Decree 108/2008). Circular 04/2012/TTBCT, which is scheduled to take effect on March 30, 2012, provides details on the requirements for SDSs and labeling. The requirements appear to follow the third revision of the UN “Purple Book,” and give companies until March 30, 2014, to comply for substances, and until March 30, 2016, to comply for mixtures. At this time, no official translation is available. The Ministry announcement is available online.