Global Regulatory Update for October 2011

ARGENTINA

Argentina Issues Regulation Concerning Registration Of Fertilizers: On June 7, 2011, Argentina’s Servicio Nacional de Sanidad y Calidad Agroalimentaria/National Service of Agri-Food Health and Quality (SENASA) issued Regulation 359, the “Regulation on the Registration of Fertilizers, Substrates, Conditioners, Protectors and their Raw Materials.” The Regulation was published in the Boletin Oficial de la Republica Argentina on June 10, 2011. Regulation 359 sets forth the requirement for entities to take (three) samples of products listed in the National Register of Plant Therapeutics (Active Principles and Formulated Products) and/or in the Register of Fertilizers, Amendments, Substrates, Conditioners, Protectors and Raw Materials, for analytical testing, in order to certify the quality of the representative product(s). The entity must inform the Directorate of Agrochemicals and Biological Substances at least 48 hours prior to import/export of the product(s) listed. If the analytical results of the samples taken do not correlate with the data already on hand in the aforementioned Registers, a “control procedure” for verification or rejection must be applied. In addition, the Regulation establishes penalties for noncompliance. The Regulation is available in Spanish online.

CANADA

Canada Announces Next Phase Of The Chemicals Management Plan: Canada announced on October 3, 2011, the renewal of its commitment to protect Canadian families and consumers by updating its Chemicals Management Plan. According to Canada, the next phase of the Plan will focus on:

• Further improving product safety in Canada;
   
• Completing assessments of 500 substances across nine categories including phthalates, primarily used in plastics; and
   
• Investing in additional research for substances like bisphenol A, flame retardants, substances that affect hormone function, and substances that affect the environment.

Canada states that it will address approximately 1,000 additional substances in the next five years through other initiatives, including rapid screening of substances which pose little or no risk. More information on the Chemicals Management Plan is available online.

CHINA

China Confirms Criteria For Substances With Grace Period Under New Substance Notification: The Chemical Registration Center of China’s Ministry of Environmental Protection confirmed the criteria for substances that will have an extra 12 months to comply with China’s New Chemical Substance Notification. The criteria are:

• New chemical substances manufactured or imported in Export Processing Zones (EPZ) and Free Trade Zones (FTZ) before October 15, 2010;
   
• New chemical substances intended to be released from articles which were manufactured or imported before October 15, 2010; and
   
• Raw materials and intermediate products related to new chemicals listed in Article 2 of Order Number 7 which were also manufactured or imported before October 15, 2010.

Substances that meet any of the above three conditions will have until October 15, 2011, to conform to the new requirements. More information is available in Chinese online.

China Announces National Chemical Safety Campaign: The Ministry of Environmental Protection (MEP) announced on September 15, 2011, that China will launch a national safety campaign to inspect companies producing or using hazardous chemicals and will issue new limits on expansion of the chemical industry. Limits will include bans on the expansion or construction of chemical production facilities outside designated industrial parks. MEP also will be stricter about requiring environmental impact assessments for new chemical facilities in the industrial parks and enforcing existing requirements that chemical manufacturers register with local environmental protection bureaus.

ChemSec Promotes SIN List In China: The International Chemical Secretariat (ChemSec) announced in a September 20, 2011, press release that it “is taking the [Substitute It Now! (SIN)] List to China.” ChemSec representatives are meeting with Chinese authorities, public interest organizations, domestic corporations, and multinational companies to discuss the SIN List and chemicals management in general, and endocrine disrupting chemicals in particular. ChemSec states: “Public awareness about hazardous chemicals is growing and many Chinese companies are increasingly seeing the benefits of having forward-thinking strategies with regards to the chemicals used in the products they market. The Chinese government is in the process of upgrading its chemicals management regulations, especially in the area of existing chemicals.” ChemSec organized the meetings in collaboration with organizations such as Greenpeace China and Global Village Beijing, as well as Business for Social Responsibility. ChemSec’s press release is available online.

EU

ECHA Begins Public Consultation On 20 Potential SVHCs: The European Chemicals Agency (ECHA) published on August 29, 2011, proposals to identify 20 chemicals as substances of very high concern (SVHC) and thus as possible candidates for authorization. Nineteen substances are proposed because of their potentially serious effects on human health. They are classified as carcinogenic and/or toxic for reproduction. In addition, one substance is proposed to be identified as a substance of equivalent concern in accordance with Article 57(f) of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation because of its endocrine disrupting properties and potential for serious effects to the environment. ECHA states that, for two of the substances, aluminosilicate refractory ceramic fibres and zirconia aluminosilicate refractory ceramic fibres, proposals to identify them as SVHC were submitted previously and they have been included in the Candidate List in January 2010. The substance definitions in the Annex XV dossiers supporting the identification of these fibres as SVHCs were too narrow to cover the composition of all types of refractory ceramic fibres on the European market, however, and the new SVHC proposals for these fibres therefore provide a wider substance definition intended to cover all types of refractory ceramic fibres used in the European Union (EU). The substances are:

According to ECHA, comments should focus primarily on the hazardous properties that qualify the chemicals as SVHCs and on the substance identity. Interested parties can provide comments and further information on the uses, exposures, and availability of safer alternative substances or techniques. ECHA notes that they should be aware that these aspects “will mainly be considered at the next stage of the process (i.e. selection of substances for authorisation), which includes a new round of public consultation.” The Member State Committee will review the comments when seeking an agreement on the identification of the proposed substances as SVHCs, and before ECHA includes the agreed substances on the Candidate List. Substances on the Candidate List may be selected for authorization. Comments are due October 13, 2011. More information is available online.

ECHA Publishes New Guidance On The Scope Of Exposure Assessment: ECHA announced on August 31, 2011, that it published a new chapter in the guidance on information requirements and chemical safety assessment: Chapter B8 – Scope of Exposure Assessment. ECHA states that the new chapter is intended to help registrants determine the scope of the exposure assessment and when it is necessary to conduct it, based on the outcome of the hazard assessment for their substance. Guidance on how to assess the exposure and on the subsequent risk characterization is already contained in other chapters of the guidance on information requirements and chemicals safety assessment. Exposure assessment for subsequent risk characterization is required for substances registered above ten tonnes if the substance is classified as dangerous and/or has persistent, bioaccumulative, and toxic (PBT)/very persistent and very bioaccumulative (vPvB) properties. The new guidance on the scope of exposure assessment clarifies that:

• The scope of the exposure assessment should address the toxicological effects, routes of exposure, and environmental protection targets identified from the outcome of the hazard assessment; and
   
• The exposure assessment should cover all hazards identified and is not only limited to classified hazards or adverse effects observed at doses/concentrations where classification is triggered.

More information is available online.

ECHA Publishes New Example Exposure Scenarios: ECHA announced on August 31, 2011, that, to support companies in complying with one of their new obligations under REACH, it developed practical examples of how to generate exposure scenarios together with the cleaning products industry and the construction chemicals industry. The new example exposure scenarios are featured in two publications that are now available on the ECHA website. The publications provide descriptions of both professional and consumer use of the substances. One document presents an example exposure scenario that refers to the widespread use of a substance in floor coatings applied by workers. The other document contains an example exposure scenario on the use of cleaning products by consumers. In both example exposure scenarios, the substances are classified as hazardous to human health but with a relatively low hazard level. ECHA notes that each publication includes:

• Exposure scenarios, exposure estimations, and risk characterizations for the chemical safety report (CSR) and for communication via the safety data sheet (SDS);
   
• A description of the methodologies applied;
   
• Learning points and conclusions from the exemplification process; and
   
• Open questions where further work is needed.

More information is available online.

ECHA Publishes New Guidance On SDSs: ECHA announced on September 8, 2011, the availability of new guidance on the compilation of SDSs. According to ECHA, the guidance provides information on:

• What is new in SDSs according to REACH by comparison with the previous legislation;
   
• Issues to consider when compiling an SDS;
   
• Details of the requirements for information to be included in each Section of an SDS, in particular detailing the changes arising from the revisions of Annex II of REACH;
   
• The timetables for implementation of Annex II and its amended Annexes; and
   
• Who should compile the SDS and what competences the author should have.

The guidance is available online.

EC Conducting Online Survey On The Impact Of REACH On Innovation: The European Commission (EC) announced on September 14, 2011, that it is carrying out “an extensive review” of REACH “that will report on the first lessons learnt from the implementation of REACH.” The study includes an online survey of businesses across the EU to obtain feedback on key issues related to the implementation of REACH. The survey targets manufacturers and importers of chemical substances, as well as downstream users, distributors of chemicals, and other firms involved in the different stages of the chemicals supply chain and which may be affected by REACH. The survey looks at innovation from product conception through testing and piloting to production. Within the interpretation of the term “innovation” is included product, process, marketing, and organizational innovation. The survey will end October 7, 2011. It is available online.

ECHA Opens Public Consultation On Proposed Restriction For Four Phthalates: On September 19, 2011, ECHA opened a public consultation on a report submitted by Denmark that proposes a restriction for the placing on the market and use of certain articles containing four classified phthalates — di(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP). ECHA states that the phthalates are found primarily in polyvinyl chloride (PVC) as softeners, but they can also be found in low concentrations in other plastics and also in dispersions, paints, and varnishes. The phthalates are all reported to affect reproductivity. According to ECHA, the widespread use of phthalates is raising concern regarding human exposure from consumer articles, and the dossier addresses the combined exposure based on common effects seen with exposure to these phthalates. Denmark proposes a ban for the placing on the market of articles intended for indoor use and articles that may come into direct contact with the skin or mucous membranes, containing one or more of these four phthalates in a concentration greater than 0.1 percent by weight of any plasticized material. DEHP, DBP, and BBP are in the list of substances subject to authorization (Annex XIV). DIBP is included in ECHA’s second recommendation of substances to be included in that list. ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) will review and consider comments. The final opinions of the Committees on the proposed restriction are scheduled for September 2012. Based on these opinions, the EC will decide whether to introduce additional restrictions. ECHA notes that, although the six-month public consultation concludes on March 16, 2012, the Rapporteurs of RAC and SEAC would appreciate receiving comments by December 16, 2011, “to assist them in the detailed discussion of the restriction proposal in January 2012.” More information is available online.

SEAC Adopts Scientific Opinions On Lead, Mercury, And Phenylmercuries: During the SEAC’s September 13-15, 2011, meeting, it adopted the following opinions on restriction proposals:

• Lead: SEAC proposed the restriction to be based only on the content of lead in jewelry articles as it is easier to measure in practice. Derogations for crystals and precious and semi-precious stones were proposed, as well as for jewelry more than 50 years old. SEAC’s draft opinion was submitted for public consultation for 60 days. Following the comments received, SEAC included additional derogations for vitreous enamels and non-accessible parts of watches in its opinion. The final opinion has now been adopted.
   
• Mercury in measuring devices: At the request of the EC, ECHA reviewed the availability of safer alternatives to measuring devices containing mercury and, as a result, proposed to restrict mercury in several measuring devices that are used in industrial and professional setting. RAC adopted its opinion in support of ECHA’s proposal with some modifications in June 2011. At the same time, SEAC agreed on its draft opinion, which concluded that suitable alternatives to the measuring devices are available and that the restriction (with some minor derogations) is considered to be proportionate to the risks. No comments were received during the public consultation that lead to changes to the final opinion, which has now been adopted.
   
• Phenylmercury compounds: Norway proposed a ban on the manufacture, placing on the market, and use of five phenylmercury compounds, as well as a ban on placing articles containing these substances on the market. RAC adopted its opinion in support of Norway’s proposal with some modifications in June 2011. At the same time, SEAC agreed on its draft opinion, which also supported the proposal and concluded that a restriction on the five phenylmercury compounds was proportionate. No comments were received during the public consultation that lead to changes to the final opinion, which has now been adopted.

More information is available online.

ECHA Removes Invalid Pre-Registrations From Database: ECHA announced on September 21, 2011, that it has removed outdated or irrelevant pre-registration information from the REACH-IT database. After consultation with the concerned pre-registrants, ECHA removed the following:

• Pre-registrations for which the deletion was requested by the pre-registrant during the pre-registration period;
   
• Pre-registrations corresponding to Annex IV entries;
   
• Based on inspection reports issued by the member state competent authorities, pre-registrations that are considered invalid because the pre-registrant is not lawfully established in the EU or the pre-registrant could not be identified, because its postal address is not correct and it did not reply to electronic and postal inquiries; and
   
• All pre-registrations made by legal entities whose REACH-IT accounts were blocked and the use of the account was never reclaimed.

ECHA advises importers, potential registrants, and downstream users to consult the list of invalid pre-registrations on ECHA’s new dedicated website. ECHA also reminds pre-registrants who do not intend to register a given substance to deactivate themselves in the corresponding pre-SIEF page of REACH-IT. More information is available online.

ECHA Analyzes Substances Not Registered By The First Deadline: According to ECHA, despite the reported intentions, some 1,500 substances were not registered by the first registration deadline. The Directors’ Contact Group (DCG) agreed to conduct an analysis of the reasons, and ECHA published the results on September 21, 2011. DCG carried out a survey in spring 2010 to obtain estimates of substances intended to be registered by the first registration deadline. After the registration deadline, ECHA reported a gap of about 1,500 substances, which represented 30 percent of all the intentions. ECHA has published the list of those substances that were identified to be registered by the first registration deadline but have not been registered yet. According to ECHA, its coordinated efforts with industry associations and member state competent authorities have to date produced information for over 1,200 substances, and the explanations are given in the list. ECHA was unable to trace the reason for non-registration for the remainder of the substances due to lack of feedback. ECHA states that the list will not be updated and that downstream users interested in the status of their substance(s) should first check the list of registered substances, which is updated regularly. Only following this check should they look for a potential explanation for non-registration in the list published on September 21, 2011. More information is available online.

ECHA Urges Companies To Begin Preparing For 2013 Registration Deadline: On September 23, 2011, ECHA announced the launch of its “REACH 2013 — Act Now!” campaign. Companies manufacturing or importing chemicals in quantities at or above 100 tonnes per year are required to register these substances with ECHA by May 31, 2013. ECHA organized the campaign to promote the best practice in fulfilling the obligations and also to publicize the various services and tools that can help companies comply with the REACH registration requirements. ECHA’s website includes a dedicated webpage on which there is an agenda for the events that ECHA is rolling out in relation to the REACH 2013 deadline. All relevant materials and links can also be found there. More information is available online.

EC Publishes DCG Report: The EC has published a report presenting achievements, lessons learned, and recommendations from the DCG between the EC, ECHA, and industry associations on meeting the first REACH registration deadline. During 2010, the DCG monitored the overall preparedness of companies in meeting the registration deadline. The DCG identified and addressed a total of 28 issues, contributing to the successful completion of registration by the first deadline according to the ECHA’s September 23, 2011, press release. The practical cooperation between the EC, ECHA, and industry associations proved fruitful. The EC published a report analyzing the work of the DCG in 2010. ECHA states that the success of the DCG’s efforts in 2010 made the group decide to continue its work under a new and revised mandate, thus continuing its support in facilitating the registration process through to the next major registration deadline of May 31, 2013. More information is available online.

ECHA Sets Up ENES: ECHA announced on September 26, 2011, the creation of an Exchange Network on Exposure Scenarios (ENES), which is intended to identify good industry practices on drafting exposure scenarios and build a dialogue between supply chain actors to improve the protection of human health and the environment. ECHA created ENES together with the European Chemical Industry Council (CEFIC), Eurometaux, CONCAWE (the oil companies’ European association), the European Association of Chemical Distributors, and the International Association for Soaps, Detergents and Maintenance Products on behalf of the Downstream Users of Chemicals Coordination Group. The first meeting will be held in Brussels, on November 24-25, 2011. Sectors of industry, non-governmental organizations (NGO), member state authorities, and other stakeholders will be invited to participate. ENES will share the approaches and practical experience of industry and other stakeholders from the first REACH registration deadline, the areas that are working well, and the areas where improvements are needed. More information is available online.

ECHA Announces New Procedure For Submitting Alternative Chemical Name Requests: ECHA announced on September 30, 2011, the availability of a new online form that allows manufacturers, importers, and downstream users to request the use of alternative chemical names. ECHA states that they may choose to do this if they believe that the disclosure of a substance name on the label of their mixtures or in the SDSs reveals business secrets. Producers of mixtures are obliged to inform the users of any relevant hazardous ingredient in the mixture by disclosing its chemical identity. Under certain conditions, ECHA or EU member state authorities may grant exemptions from this obligation. Before such exemptions are granted, ECHA examines whether the safe use of the mixture may be compromised. Manufacturers, importers, and downstream users can submit their application only if the mixture(s), which contains the substance for which the alternative name will be used, is classified and labeled according to the Classification, Labeling and Packaging (CLP) Regulation. If the mixture is classified and labeled according to the Dangerous Preparations Directive (DPD), the alternative name request has to be submitted to a competent authority in one of the EU member states where the substance is placed on the market. More information is available online.

JAPAN

METI Posts Guidance In English On Notification Rules And CBI: The Ministry of Economy, Trade, and Industry (METI) has posted guidance in English on the special procedure to submit notifications of manufactured or imported substances under the Chemical Substance Control Law (CSCL). METI notes that, as a rule, manufacturers and importers are legally obliged to submit annual notifications of manufactured and/or imported quantities of the previous fiscal year of substantially all chemical substances under the CSCL. If a notifier has “extreme difficulties” in identifying a certain chemical substance or its concentration rate in mixture (e.g. because an exporter claims the chemical identity as confidential), however, the notifier is currently allowed to notify the annual volume of general chemical substances jointly with a chemical supplier. METI states that this procedure does not intend to exempt the notifier from its legal obligations as a notifier, and, therefore, this procedure may not be used without the consent of the notifier. More information is available online.

MHLW Adds Substances To ISHL Inventory: The Health, Labor and Welfare Ministry (MHLW) announced on September 27, 2011, that it added 316 substances to the Industrial Safety and Health Law (ISHL) inventory. Japan has two substance inventories, the one established under the ISHL and another established under the CSCL. The CSCL inventory applies to substances manufactured in or imported into Japan, while the ISHL inventory applies to chemical substances manufactured in or imported into Japan and used in the workplace. While the purpose of the CSCL is to determine if chemical substances are safe to be manufactured, imported, and used without causing environmental pollution or harm to humans, the purpose of the ISHL scheme is to protect workers from illness. Because the CSCL and ISHL each has its own inventory of existing substances, and forms, procedures, and requirements for the notification and assessment of new chemical substances, companies should check both inventories to see if their chemical substances are listed and comply separately according to the different laws.

MALAYSIA

Malaysia Updates Status Of Voluntary EHS Notifications And Registrations: On September 28, 2011, the Department of Environment updated the status of voluntary environmentally hazardous substance (EHS) notifications and registrations. According to the Department, the number of companies identified for EHS notification is 1,130. To date, 304 companies have registered, mainly in the following sectors: resins, electronics, oilfied, petrochemicals, paints, printing, oleochemicals, sewage and water treatment, gas, construction, rubber, lubricants, adhesives, textiles, leather, and detergents. The number of EHS entries officially notified (basic notification) is 1,173, and 615 EHS have been officially notified. The number of EHSs not in the EHS reference list, for which detailed notification is required, is 156, and 125 EHSs have been officially notified in detail. The Minister has reviewed and profiled in detail 141 EHSs. The Ministry plans to use information submitted by industry to create a chemical register containing information about the identity of substances that have been notified, their uses, and their hazard classification. While the notification and registration scheme is currently voluntary, it will become mandatory once Malaysia passes secondary legislation. The regulation is expected in late 2011.

MEXICO

Mexico Preparing Chemical Inventory: According to the Secretaría de Medio Ambiente y Recursos Naturales/The Ministry of Environment and Natural Resources (SEMARNAT) Direction of Research on Chemicals and Ecotoxicological Risks, the long-rumored Mexican chemical inventory is scheduled for release in June 2012. The inventory, which is still in development, will contain a list of the chemical substances identified as being in commerce in Mexico. For some substances, the list will also include the amount of the substance produced or/and imported. All information is being collected by the Mexican government from existing sources of information. Most importantly for the chemical industry, the pending regulation will define what chemicals need to be approved and/or submitted to the authority prior to placing substances on the market in Mexico. As of yet, however, SEMARNAT has not provided a timetable for publication. As a result, the publication of the June 2012 inventory will likely contain only a list of chemical substances, without an infrastructure that outlines a chemical control program, i.e., data requirements. The list will, however, help to identify the chemicals most likely to be managed in some way in the future by the Mexican authorities.

OECD

OECD Releases New Emission Scenario Document On The Chemical Industry: The Organization for Economic Cooperation and Development (OECD) announced on September 28, 2011, the availability of a new emission scenario document on the chemical industry. OECD states that the document is intended to provide information on the sources, use patterns, and release pathways of chemicals used in the chemical industry to assist in the estimation of releases of chemicals to the environment. More information is available online.

OECD Publishes Summary Of Public Availability Of National/Regional GHS Classifications: OECD has published a table summarizing the availability of United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classifications from OECD countries and other organizations. According to OECD, the table outlines the current status based on a survey performed in 2011. The table includes whether a country or organization classifies and labels chemicals according to GHS; whether the results are publicly available on the Internet; whether the underlying dataset is available to the public; whether a rationale is available to the public; and comments. The table is available online.

RUSSIA

Russia To Adopt Chemical Regulations Similar To REACH: The Russia Ministry of Industry and Trade released earlier in 2011 a proposed regulation, On the Safety of Chemical Products, that would create a unified system of chemical regulation in line with the EU’s REACH program and the GHS. The proposed regulation would apply to chemical products already in circulation, as well as new products that are imported into or transiting through the Customs Union, regardless of country of origin. The legislation defines rules for market access, chemical product identification, classification, safety, consumer disclosure, and registration. Under the Customs Union agreement, which removed customs borders between Russia, Kazakhstan, and Belarus as of July 1, 2011, Kazakhstan and Belarus would also adopt the regulation. As of January 1, 2012, the three countries will become a single economic space and will allow freer movement of goods, services, and labor under common policies and smoothed border procedures. The same technical regulations will apply in the Eurasian Economic Community, which includes Kyrgyzstan, Tajikistan, and Uzbekistan, as well as Russia, Kazakhstan, and Belarus, under an agreement to coordinate policy. The draft text of the regulation is available, in Russian, online.

TAIWAN

Taiwan Announces Seminars Focused On Registration Of New Chemical Substances: The seminars are being sponsored by Safety and Health Technology Center (SAHTEC) under the Council of Labor Affairs. The seminars are designed to allow for manufacturers and importers to gain a better understanding of chemical substance management policy and planning. The seminars are intended to provide an overview of this year’s briefings and introductions of the envisioned path forward, allow for stakeholder involvement, and facilitate the promotion of the proposed amendments to the current regulation and communicate these amendments to manufacturers/importers. We anticipate that the sessions will be conducted in Taiwan’s native language. A member of The Acta Group EU, Ltd (Acta EU) team will be in attendance and updates will be provided accordingly. More information on the seminars can be found online.

TURKEY

Turkey Publishes Inventory Of Notified HPV Chemicals: Turkey has published a list of high production volume (HPV) chemicals, defined as those manufactured or imported in quantities above 1,000 tonnes per year, for which it received notifications by March 31, 2011. The inventory includes 588 chemicals. Under the Bylaw on Inventory and Control of Chemicals, manufacturers and importers of chemicals above one tonne per year were required to notify certain data by March 31, 2011. Approximately 2,000 companies submitted about 40,000 notifications. The inventory is available online.

VIETNAM

Vietnam Limits Toxic Substances In Electrical Products: In August 2011, Vietnam’s Ministry of Industry and Trade issued a circular placing limits on the concentrations of hazardous substances, including lead, cadmium, mercury, chromium, PBB, and PBDEs in electrical products. The limits took effect on September 23, 2011. More information is available in Vietnamese online.