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April 1, 2011

Global Regulatory Update for April 2011

The ACTA Group


China Issues Fines For Non-Compliance With Requirements For Notification Of New Substances: China’s Ministry of Environmental Protection (MEP) announced on February 9, 2011, that it fined six companies belonging to a U.S.-based corporation Yuan 30,000 (€3,300) for allegedly failing to provide ecotoxicological test reports by an MEP-approved laboratory. Beginning in October 2010, companies wishing to manufacture or import a new substance in China must comply with a new notification regime that requires the use of risk assessments, compliance with explicitly stated minimum data requirements, and the use of certified Chinese laboratories for ecotoxicity tests. Some non-Chinese companies are concerned that the latter requirement could mean that sensitive product information will have to be shared with Chinese testing laboratories and that data generated under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) may not be accepted as part of Chinese notification dossiers. The companies must correct the alleged violation and have 60 days to apply for a re-evaluation. While the maximum amount of the fine for such violations is low, China could withdraw notifications if, for example, it determined that a company concealed information during its application. The corporation issued a statement that it “accepted the penalty and regrets what has happened,” and that the fine was imposed “for the misreporting of our chemicals which was due to an oversight in our chemical registration process.” The corporation has been “working very closely with the MEP and Chinese authorities during the investigation to resolve this.”

China Introduces Classification And Labeling Rules: On March 12, 2011, the State Administration of Work Safety (SAWS) published a revised version of the Regulation on the Safe Management of Dangerous Chemicals. The revised Regulation, which will enter in force on December 1, 2011, gives legal force to two national standards that concern rules under the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS) — GB 13690-2009 on the general rules for the classification and hazard communication of chemicals, and GB 12528-2009 on precautionary labeling. China implemented the national standards on May 1, 2010, and they are scheduled to enter into force on May 1, 2011. The December 1, 2011, date is the significant one, however, as that is the date recognized by the implementation authority. China has previously issued supplementary guidance, after promulgating final regulations, that contain transitional periods, and it is possible that the December 1, 2011, deadline will change. Under the Regulation, companies must classify chemical hazards and communicate those hazards in compliance with GHS requirements, and provide examples of precautionary labels, transport symbols, and precautionary statements for different categories of chemicals.


EC Announces The Addition Of Six Substances To Annex XIV: On February 17, 2011, the European Commission (EC) announced that six substances of very high concern (SVHC) will be banned within the next three to five years unless an authorization is granted to individual companies for their use. According to the EC, the substances are carcinogenic, toxic for reproduction, or persist in the environment and accumulate in living organisms. The substances, which were moved from the Candidate List to Annex XIV, are 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene); 4,4′-diaminodiphenylmethane (MDA); hexabromocyclododecane (HBCDD); bis(2-ethylexyl) phthalate (DEHP); benzyl butyl phthalate (BBP); and dibutyl phthalate (DBP). More information regarding the substances is available online.

Companies wishing to sell or use the substances will need to demonstrate that the required safety measures were taken to control the risks adequately, or that the benefits for the economy and society outweigh the risks. Where feasible alternative substances or techniques exist, a timetable for substitution will also have to be submitted. For each substance listed, a “sunset date” is provided, ranging from 2014 to 2015. From this date the substance may be placed on the market or used only if an authorization was granted or an application for authorization was made before the “latest application date.” These requirements apply regardless of the tonnage at which the substance is placed on the market or used, as no lower limits are provided for the authorization requirement. The EC notes that some uses of substances, such as intermediates, are excluded from the authorization requirement.

Companies must submit their authorization applications to the European Chemicals Agency (ECHA), whose Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) will consider each application and submit their opinions to the EC. The EC will make the final decision regarding the authorization application. Guidance documents on the preparation of an application for authorization and on preparing a socio-economic analysis are available online. The EC states that it “aims to put forward a greater number of known substances of very high concern for inclusion in the candidate list,” and that, together with ECHA, it is “fully committed to achieve this goal with the active engagement of the Member States.”

ECHA Posts Proposals To Identify Seven Chemicals As SVHCs And To Amend One Candidate Substance: On February 21, 2011, ECHA announced the availability of proposals to identify seven chemicals as SVHCs and possible candidates for authorization, as well as a proposed amendment to a Candidate List substance. The seven new substances are 2-ethoxyethyl acetate; strontium chromate; 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters; hydrazine; 1-methyl-2-pyrrolidone; 1,2,3-trichloropropane; and 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich. According to ECHA, the substances are carcinogenic and/or toxic for reproduction. There is an additional proposal to align the SVHC identification of cobalt dichloride with its revised classification as both carcinogenic and toxic for reproduction. Cobalt chloride was originally identified in October 2008 as SVHC only because of its carcinogenic properties. ECHA asks that comments focus primarily on the hazard properties that qualify the chemicals as SVHCs. ECHA also welcomes comments and further information on the market, uses of, and exposures to these substances, and on the availability of safer alternatives. The Member State Committee will review comments on hazard properties when seeking agreement on the identification of the proposed substances as SVHC. Substances with agreed SVHC status will be included by ECHA in the Candidate List. Comments were due April 7, 2011. More information is available online.

Forum For Exchange Of Information On Enforcement Holds Ninth Meeting: During the Forum for Exchange of Information on Enforcement’s March 1-3, 2011, meeting, participants discussed the second enforcement project, REACH-En-Force-2, which will lead to inspections of formulators between May and December 2011. National coordinators were trained at ECHA in January and are now sharing information with inspectors at the national level. ECHA has translated the project manual into national languages and is producing a leaflet on downstream user obligations that inspectors can distribute when visiting companies. The Forum agreed on a proposal to work towards a third enforcement project to control the import of chemical substances in European Union (EU) and European Economic Area (EEA) countries working in conjunction with customs authorities. ECHA will work on designing a coordinated project that will involve cooperation with customs officials so that the proposal can be tested in practice in a number of countries. The Forum is expected to agree on the scope of the project at its next meeting, in October 2011.

ECHA Scientific Committees Adopt First Opinions On Restriction Proposals: ECHA announced on March 14, 2011, that the RAC and SEAC each adopted their first opinions on restriction proposals. France submitted proposals to restrict dimethylfumarate in articles and to restrict lead and its compounds in jewelry. Regarding dimethylfumarate, RAC considered that there is a serious risk to consumers and that the suggested restriction on the production and placing on the market of articles containing dimethylfumarate is appropriate to reduce the risk to consumers. SEAC concluded in its draft opinion that a restriction of dimethylfumarate is the most appropriate EU-wide measure, and that the action is justified from a socio-economic point of view. Under the REACH program, ECHA will publish the SEAC’s draft opinion for comment. Comments on the draft SEAC opinion are due May 17, 2011, and the final SEAC opinion is scheduled to be adopted in June 2011. Regarding lead and its compounds in jewelry, RAC considered that it may significantly contribute to the exposure of children to lead by them putting it in their mouths, and that a restriction is therefore appropriate. RAC agreed in principle with the French proposal to have a restriction for lead in jewelry; after assessing the dossier and the information submitted during the public consultation, however, RAC suggested basing the restriction on the content of lead in articles unless it could be demonstrated that lead is not released should a child put a piece of jewelry in his or her mouth. SEAC concluded in its draft opinion that the benefits for human health of the restriction of lead in jewelry appear proportionate to the costs of the restriction. SEAC proposed the restriction to be based only on the content of lead in jewelry articles instead of release, as it is easier to measure in practice. Comments on the draft SEAC opinion are due May 28, 2011. Due to the differences between the RAC opinion and the original proposal from France, ECHA decided to postpone the adoption of the SEAC opinion until September 2011. More information is available online.

EC Publishes Second ATP For CLP Regulation: The EC published the second adaptation to technical progress (ATP) of the Regulation on Classification, Labeling and Packaging of Substances and Mixtures (CLP) in the March 30, 2011, Official Journal of the European Union. The CLP Regulation takes into account the GHS, and the third revised edition of the GHS was adopted in December 2008. The revised edition of the GHS includes amendments concerning the provisions for the allocation of hazard statements and for the labeling of small packaging; new subcategories for respiratory and skin sensitization; the revision of the classification criteria for long-term hazards (chronic toxicity) to the aquatic environment; and a new hazard class for substances and mixtures hazardous to the ozone layer. The EC notes that the GHS allows authorities to adopt supplemental labeling provisions to protect individuals already sensitized to a specific chemical that may elicit a response at very low concentration, and that requirements should be introduced to add the name of such chemical on the label, even if present at very low concentration in a mixture. The Second ATP enters into force on April 19, 2011. Manufacturers and importers of substances may already implement the new CLP provisions as of April 19, 2011. Although manufacturers and importers of substances have until December 1, 2012, to implement the labeling and packaging requirements, they do not have to relabel and repackage substances placed on the market before December 1, 2012, until December 1, 2014. Manufacturers and importers of mixtures have until June 1, 2015, to implement the labeling and packaging requirements. Manufacturers and importers do not have to relabel and repackage mixtures placed on the market before June 1, 2015, until June 1, 2017.

ECHA Updates Guidance On Substances In Articles: On April 1, 2011, ECHA announced the availability of an update to the Guidance on Requirements for Substances in Articles. The update replaces the previous Guidance. Beginning June 1, 2011, companies must notify to ECHA substances present in articles they produce or import that were included on the SVHCs Candidate List before December 1, 2010, if both of the following conditions are met:

  • The SVHC is present in those articles at a volume of >1 metric ton per manufacturer/importer per year; and
  • The SVHC is present in those articles above a concentration of 0.1 percent weight by weight (w/w).

The Guidance describes the registration, notification, and communication requirements related to substances in articles, and is intended to help producers, importers, and suppliers of articles to identify and fulfill their legal obligations. The Guidance explains how to check if a substance is already registered for a use and therefore whether a registration or notification is needed. Examples of borderline cases, such as blasting grits and wax crayons, are provided. The Guidance also explains how companies can predict the inclusion of substances in the Candidate List for authorization.

According to ECHA, the updated Guidance further clarifies the decision-making process as to whether an object is an article. The updated Guidance maintains the EC’s view, as well as that stated in the previous Guidance, that the threshold of 0.1 percent w/w applies to the article as a whole. Six member states (Germany, France, Sweden, Austria, Belgium, and Denmark) and Norway advocated a dissenting minority view pertaining to the threshold of each component in an article. The updated Guidance includes a letter from ECHA Executive Director Geert Dancet noting that it “did not find full support by consulted national authorities of EU/EEA Member States in the stage of its final consultation,” and, consequently, “companies may face diverging enforcement practices as to some of its aspects.” More information is available online.

ECHA Announces Availability Of REACH And CLP Terminology: On April 5, 2011, ECHA announced the availability of a test version of a multilingual terminology database that provides the main REACH and CLP terms in 22 EU languages, including the CLP pictograms, hazard, and precautionary statements. The database is available for final testing. Users can provide feedback by carrying out simple exercises and reporting their experiences between April 5-13, 2011. More information is available online.


Japan Posts Documents Concerning Amended Chemical Substance Control Law: Japan’s Ministry of Economy, Trade, and Industry (METI) has recently published several documents concerning the amended Chemical Substance Control Law (CSCL), which came into force on April 1, 2011. Under the amended CSCL, chemical safety management will shift from a hazard-based to a risk-based approach that takes exposure into account. Beginning April 1, 2011, companies producing or importing chemicals in annual quantities above one tonne are required to report hazard and use data annually. METI will conduct a screening assessment based on estimated environmental exposure and available hazard information, and create a list of priority assessment chemical substances for which further data will be requested and risk management measures proposed. On April 1, 2011, Japan announced the first priority assessment chemicals. The available documents include:

  • Revised CSCL, available online;
  • Guidance on Implementation, available online;
  • Guidance on Notification, available online;
  • Main Points of the Amended CSCL, available online;
  • Use Categories Under the Amended CSCL, available online; and
  • List of Priority Assessment Chemical Substances (PACs) Notified on April 1st 2011, available online.

Japan Begins First Round Of EXTEND 2010: Japan’s Ministry of the Environment (MOE) is currently reviewing data on the endocrine disrupting properties of 13 substances: acrylamine, acrylic acid, alachlor, 2-4-D, dinocap, tetrachlorobenzene, TBBP-A, trichlorobenzene, naphthalene, dibutyl phthalate, mercaptoacetic acid, molinate, and triphenyl phosphate. Japan expected to complete its review of the substances in March 2011. Japan intends to review 100 chemicals for endocrine disrupting properties by 2015 as part of the Extended Tasks on Endocrine Disruption (EXTEND 2010), which MOE launched in July 2010. MOE will note substances that require further research, and substances flagged for further testing may be prioritized for biological assays or undergo in vitro tests. If the results of EXTEND 2010 suggest that a substance has endocrine disrupting properties, it will be regulated under Japan’s CSCL.


Malaysia Releases New Version Of EHS Notification And Registration Scheme: On March 2, 2011, Malaysia’s Department of Environment announced the availability of a new version of the online Notification and Registration Scheme of Environmentally Hazardous Substances (EHS) in Malaysia. The new system has been enhanced with the following additions and changes:

  • Option for Malaysian importers to request overseas suppliers to make detailed notification of EHSs;
  • A module for overseas suppliers to undertake detailed notification of EHSs on behalf of Malaysian importers, with login using user ID and password after nomination by Malaysian companies;
  • Change in data entry format during detailed notification of EHSs — from the existing left-right format to a top-down format;
  • Option to select hazard classes based on the UN GHS or the Malaysian Classification, Packaging and Labeling (CPL) during the detailed notification of EHSs; and
  • Provision for industry to report different GHS hazard classifications for chemicals on EHS Reference List during basic notification of EHSs.

On March 25, 2011, the Department announced on its website the availability of a guidance document for industry on the notification and registration scheme. The guidance document is available online. In February 2011, the Department stated that a draft regulation for EHS notification and registration was “at the final stage.” Malaysia introduced a voluntary notification scheme in January 2009, which will be replaced once the regulation takes effect. EHSs are defined as those classified as hazardous under the GHS, or appearing on an internationally recognized list of chemicals of concern. More information is available online.

The Department of Environment previously published guidelines for industry on notification and registration. According to the guidelines, if the substance is on the EHS reference list and already has an agreed GHS hazard classification, the company can submit a basic notification. A basic notification is not required if the annual tonnage of the substance is below the tonnage trigger point currently enforced by the Department. If a substance is on the EHS reference list, and already has an agreed GHS hazard classification, a basic notification is required, irrespective of the annual tonnage produced or imported by the company. If the substance is not on the EHS and carcinogenic, mutagenic, and reprotoxic substances (CMR) reference lists, or does not have an agreed GHS classification, the company must assess the substance against the GHS classification criteria. If the substance is assigned a GHS classification, the company must then supply the information it used to carry out the classification, the classification itself, and data on tonnage per annum. If the substance is determined to be an EHS, a company must submit a detailed notification.


South Korea Issues “Korean REACH” For Comment: On February 25, 2011, the South Korea MOE made a preannouncement of the draft of the Act on the Registration and Evaluation of Chemicals, or “Korean REACH.” The Act would amend the current Toxic Chemicals Control Act (TCCA) and introduce many similar regulatory elements from the EU REACH, including priority chemicals, chemicals for authorization, chemicals for restriction, pre-registration of priority chemicals, and communication of information throughout the supply chain. Under the draft bill, toxicology evaluation would become mandatory for new and existing chemicals manufactured or imported in annual amounts exceeding 500 kilograms. The current threshold is 100 kilograms and applies only to new chemicals. The registration and evaluation requirements would not immediately apply to all 37,000 existing chemicals. Selections would be made, and factors including the industrial purpose and environmental exposure of different chemicals would be considered to avoid an undue burden on manufacturers and importers. A system of preliminary registrations would allow companies up to eight years before full compliance kicks in with official registrations. Manufacturers and importers of controlled chemicals would be required to notify their customers about any known hazards and regulatory restrictions on use.

Korean REACH would use the same enforcement mechanism as the current TCCA, and would impose authorization, restriction, and prohibition measures on highly toxic substances, including human carcinogens. Violations would incur criminal penalties, including jail terms and fines. TCCA would be amended to cover safety management, chemical incident prevention, and chemical inventories.

The draft bill is available in Korean online. Comments are due April 26, 2011. MOE intends to submit the bill to the National Assembly in September 2011, after pre-legislation procedures, including public comments and cabinet-level reviews. The Act will enter into force two years after publication in the Official Journal.

South Korea Issues Draft GHS Classifications: On March 16, 2011, MOE’s National Institute of Environmental Research released draft classifications for 315 substances for a ten-day comment period. The draft classifications were based on the GHS, and the list is the third issued by MOE under its GHS classification project. MOE intends to release the final version in the near future. The GHS classification list is scheduled to become mandatory on July 1, 2011, when the transitional period ends. More information is available in Korean online.


Turkey Implements Legislation Concerning Dangerous Substances And Preparations: On December 26, 2009, Turkey implemented chemical legislation concerning the CLP of dangerous substances and preparations and safety data sheets (SDS) for the same. As implemented, the law is identical to the EC’s Dangerous Substances Directive and Dangerous Preparation Directive. Implementation of CLP in Turkey will remain in place until 2012, when Turkey plans to implement the GHS. Until then, suppliers to entities located in Turkey must ensure that all labels conform to the requirements of the CLP legislation.

The SDS regulation is intended to standardize the format in which safety information is presented. It applies to any dangerous substance or dangerous preparation placed on the Turkish market. A dangerous substance or preparation is one that is classified as: physical chemical hazard: explosive, oxidizing, extremely flammable, highly flammable, or flammable; health hazard: irritant, harmful, corrosive, toxic, very toxic, or as a CMR; or environment: very toxic, toxic, or harmful to the environment. When classification is complete, the hazard information and control measures must be presented in a standard format, typically in an SDS. The regulation states that certain substances and preparations are exempt from being provided on an SDS to the end user. Specifics are located within the regulation, however, exemptions seem to follow closely those allowed under REACH.

If a preparation does not meet the CLP criteria for classification, a user of the preparation may still request an SDS. The supplier will have to honor this request if individual substances, within the preparation, are greater than or equal to 1 percent w/w for non-gaseous preparations and greater than or equal to 0.2 percent by volume for gaseous preparations and are:

  • Hazardous to human health or the environment; or
  • Have been assigned a permissible workplace exposure limit.

The SDS must be supplied in Turkish, including the chemical names that appear anywhere in the document. The Turkish SDS must be compiled by a certified person within Turkey. The SDS will follow the standard format that is set out in the regulation. Sixteen headings are identified for inclusion in the SDS. No sections of the SDS are to remain blank. In the event that no data are available, a statement must be inserted that will indicate the reason that no specific data are provided. A statement such as “not applicable” or “data lacking” is sufficient and required. Once completed, a hard copy version of the SDS must be sent to users. In addition, the SDS must be submitted in electronic form to the Ministry of Environment and Forestry.

The full text of the legislation is available in Turkish online.


UK Publishes New Green Claims Guidance: On February 2, 2011, the United Kingdom’s (UK) Department for Environment Food and Rural Affairs (Defra) announced the availability of its new Green Claims Guidance, which it intends to help companies describe the environmental credentials of their products in a way that people find easier to understand. The Guidance builds on the principles of Defra’s original Green Claims Code (2000), and replaces Defra’s Green Claims Practical Guidance (2003). The Guidance “represents good business practice to be followed on a voluntary basis, and is not regulated or enforced by the Government.” The Guidance applies to all forms of communication, marketing, or advertising relating to the environmental attributes of products, services, or organizations, including all types of statements, information, symbols and graphics on packaging, labeling, and advertising, in all media (including websites) and made by any organization. The Guidance encourages businesses to follow three key “steps” to build consumer confidence in the environmental attributes of their products:

  • Ensure the content of the claim is relevant and reflects a genuine benefit to the environment;
  • Present the claim clearly and accurately; and
  • Ensure the claim can be substantiated.

In developing the Guidance, Defra sought to align it with the following standards, guidance, and codes: the international standard on self-declared environmental claims ISO 14021; the UK Code of Non-Broadcast Advertising, Sales Promotion, and Direct Marketing and Code of Broadcast Advertising; the EC Guidance for Making and Assessing Environmental Claims; and Guidelines on the EU Unfair Commercial Practices Directive. More information is available online.