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February 1, 2013

Global Regulatory Update for February 2013

The ACTA Group


China Publishes Catalogue Of Substitutes For Hazardous Substances: On January 14, 2013, the Ministry of Industry and Information Technology (MIIT) published a catalogue of information on possible alternatives to 81 hazardous substances, including heavy metals, organic pollutants, and pesticides. The catalogue includes three sections, based on stage of substitution: development of alternatives; application; and promotion. More information is available, in Chinese, online.

China Publishes Updated Version Of Existing Substances Inventory: On January 14, 2013, Ministry of Environmental Protection (MEP) published an updated version of China’s inventory of existing chemical substances. The list includes 45,612 substances, with their Chinese and English names and Chemical Abstracts Service (CAS) number. Substances not on the inventory are considered to be new substances and must be notified to the government prior to manufacturing or importing. More information is available, in Chinese, online. The inventory is available for purchase from the MEP’s Chemical Registration Center (CRC). More information is available, in Chinese, online.

SAWS Updates List Of Priority Hazardous Chemicals: In February 2013, the State Administration of Work Safety (SAWS) released the second batch of hazardous chemicals for priority management. The chemicals are:

Chemical NameCAS Number
Sodium chlorate7775-09-9
Potassium chlorate3811-04-9
2-butanone peroxide1338-23-4
Dibenzoyl peroxide94-36-0
Guanidine nitrate506-93-4
Ammonium perchlorate7790-98-9
Tert-Butyl peroxybenzoate614-45-9

Companies who use listed chemicals to manufacture products are required to obtain a safe use permit from the administrative department of work safety at the city level when the quantity of usage exceeds certain threshold volumes. SAWS will prioritize and strengthen inspections of companies that manufacture, store, sell, or use listed chemicals. Companies that manufacture or store listed chemicals must be equipped with automated instruments to monitor parameters such as temperature and pressure. Manufacturers must prepare sound emergency response plans to address possible chemical accidents. More information is available, in Chinese, online.


Ecuador Publishes Draft Regulation On Mandatory Chemical Standards: Under a draft technical regulation, companies would be required to comply with national technical standards when placing chemicals on the market. The requirements concern the scope, definition, classification, labeling, and packaging requirements, and specify the documents necessary to sell chemicals on the Ecuadoran market. The standards are currently voluntary. The proposed adoption date is 90 days from November 13, 2012, with an effective date six months later. Comments were due February 11, 2013.


EP Approves Revisions To Dangerous Preparations Directive: The European Parliament (EP) voted on January 16, 2013, to update the 1999 Dangerous Preparations Directive, which regulates the classification, labeling, and packaging (CLP) of chemical mixtures. The revisions would bring the Directive into line with the current treaty governing the EU and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Dangerous Preparations Directive will be replaced on June 1, 2015, by the CLP Regulation, which implements the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) in the EU. The CLP Regulation will apply to the classification and labeling (C&L) of mixtures effective June 1, 2015. It has applied to chemical substances since December 1, 2010. The revisions to the Directive will become final after adoption by the EU Council.

ECHA Recommends Ten SVHCs For Authorization: The European Chemicals Agency (ECHA) announced on January 17, 2013, that it recommended ten substances of very high concern (SVHC) for authorization. According to ECHA, the recommended chemicals are classified as carcinogenic or toxic to reproduction and are used in applications where there is potential for worker exposure. For each substance recommended for inclusion in Annex XIV, a deadline is suggested after which companies will only be able to use it within the EU if an authorization has been granted. The final decision on the inclusion of the substances in Annex XIV and on their sunset dates will be made by the European Commission (EC), in collaboration with Member States and the EP. The ten SVHCs and examples of their uses in the scope of authorization, are listed below:

Substance name and SVHC propertyUses in the scope of authorization (examples)
Formaldehyde, oligomeric reaction products with aniline (technical MDA) (carcinogenic)Hardener for epoxy resins; curing agent for polymers
Arsenic acid (carcinogenic)Used to modify properties of glass and in the production of printed circuit boards
Dichromium tris(chromate) (carcinogenic)Anti-corrosion surface treatments of steel and aluminium in the construction and the aeronautic sectors
Strontium chromate (carcinogenic)Anti-corrosion coatings in the aeronautic/aerospace, coil coating and vehicle coating sectors
Potassium hydroxyoctaoxodi-zincatedichromate (carcinogenic)Anti-corrosion coatings in the aeronautic/aerospace and vehicle coating sectors
Pentazinc chromate octahydroxide (carcinogenic)Anti-corrosion coatings in the vehicle coating and the aeronautic/aerospace sectors
Bis(2-methoxyethyl) ether (Diglyme) (toxic for reproduction)Primarily used as a reaction solvent or process chemical in distillation applications; further in batteries and in the production of plastics
N,N-dimethylacetamide (DMAC) (toxic for reproduction)Solvent in synthesis, the production of synthetic fibres, in industrial coatings, paint strippers, insulation paper, films and membranes
1,2-dichloroethane (EDC) (carcinogenic)Solvent in the manufacture of fine chemicals and pharmaceuticals and in mixtures for biochemical applications
2,2′-dichloro-4,4′-methylenedianiline (MOCA) (carcinogenic)Curing agent in resins and in the production of polymer articles

More information is available online.

ECHA Seeks Stakeholders To Work On Biocides: On January 29, 2013, ECHA encouraged umbrella organizations, whose members represent biocide-related sectors, to indicate their interest in having an active role in ECHA’s work. According to ECHA, cooperation might include participating in the meetings of the Biocidal Products Committee, HelpNet, scientific consultations, updating guidance documents, reaching out to target audiences, and other collaborative activities. ECHA states that, to qualify, organizations must become an ECHA Accredited Stakeholder Organization. Accreditation is based on a set of criteria that includes being not-for-profit and operating at an EU-wide level, and representing its field of competence. Currently, there are 64 Accredited Stakeholder Organizations, representing industry, non-governmental organizations (NGO), trade unions, and academia. More information is available online.

ECHA Announces C&L Platform: ECHA announced on January 31, 2013, the availability of the C&L Platform, which is a web-based discussion forum intended to allow C&L notifiers and REACH registrants of the same substance to discuss and agree on the C&L of their substance. Discussion features are available for each substance that has different notifications in its C&L Inventory summary page. ECHA notes that each discussion room is accessible only to those registrants and notifiers who have submitted a notification for that particular substance. Once agreement is reached on a common C&L, companies must notify ECHA and update their notifications in REACH-IT. ECHA states that the changes will be subsequently reflected in the public C&L Inventory on its website. More information is available online.

EC Completes REACH Review And Finds “No Major Overhaul Is Required”: On February 5, 2013, the EC announced that it completed its five-year review of REACH, and, while some adjustments are needed, “no major overhaul is required.” The EC states that the main findings include:

  • Recommendations to improve REACH implementation, including improving the quality of registration dossiers, enhancing the use of safety data sheets (SDS) as a central risk management tool, and addressing issues related to cost sharing within Substance Information Exchange Forums (SIEF);
  • A recommendation to reduce the financial and administrative burden on small- and medium-sized enterprises (SME) to ensure the proportionality of legislation and to assist them to fulfill all their REACH obligations;
  • There are no major overlaps with other EU legislation;
  • Considerable efforts to develop alternative methods to animal testing have been made and will continue: since 2007, the EC has made available € 330 million to fund research in this area;
  • Enforcement could be improved. As this is the responsibility of the Member States, the report recommends that Member States reinforce coordination amongst them; and
  • Although the report identifies a need for some adjustments to the legislation, the EC wants to ensure legislative stability and predictability for European businesses. No changes to REACH’s main terms are proposed at present.

Regarding next steps, the EC will discuss the outcomes of the REACH review with the Member States and stakeholders. In cooperation with Member States and ECHA, the EC is developing a roadmap to assess and identify SVHCs. The EC states that the roadmap will set out clear milestones, deliverables, and the division of work between the EC, Member States, and ECHA to place all relevant known SVHC on the candidate list by 2020. The EC intends to look into greater fee reductions to SMEs to spread the financial impact of registration more evenly. The EC notes that the next deadline under the REACH regulation is May 31, 2013, by when industry must register all phase-in substances manufactured or imported in the EU at or above 100 tonnes a year. More information is available online.

EC Releases SVHCs Roadmap: The EC released a document entitled Roadmap on Substances of Very High Concern, which is intended to define a process to identify and assess the following categories of potential SVHCs: carcinogenic, mutagenic, or toxic to reproduction (CMR); persistent, bioaccumulative, or toxic for the environment (PBT); very persistent and very bioaccumulative (vPvB); and substances of equivalent concern (such as endocrine disruptors or sensitizers). The EC intends to include all currently known SVHCs in the candidate list by 2020. The Roadmap describes how to examine the substances that may belong to one of the categories, by giving priority to those that have been registered and are not used only as chemical intermediate. According to the Roadmap, potential SVHCs excluded by this selection could still be considered after 2020. Regarding next steps, the Roadmap states: “The Commission considers that the 2020 objective can only be met if all actors involved co-operate to ensure an appropriate sharing of the workload. The Commission therefore invites Member States to work together with the Commission and ECHA on SVHC identification. ECHA and the Commission will continue to contribute by providing assistance, coordination and sharing experiences with the Member States.” The Roadmap is available online.

ECHA Asks Registrants And Downstream Users To Clarify List Of Substances For Which Lead Registrant Is Unknown: On February 11, 2013, ECHA published the list of substances to be registered by May 31, 2013, for which the lead registrant is unknown. According to ECHA, there are approximately 700 substances on the list. ECHA “strongly encourages” downstream users and potential registrants to check the list to ensure that their substances manufactured or imported at or above 100 tonnes a year will be registered on time. ECHA states that substances on the list that will not be registered “may unexpectedly disappear from the market.” ECHA recommends that, if your substance is on the list, “you should contact your supplier if you are a downstream user or your SIEF members if you are a manufacturer or importer.” More information is available online.

CIEL Report Claims Stronger Chemical Regulation Will Increase Innovation: The Center for International Environmental Law (CIEL) released on February 13, 2013, a report entitled Driving Innovation: How stronger laws help bring safer chemicals to market, which claims that tougher rules to manage chemicals at the global, regional, and national levels “have sparked the continuous invention of safer chemicals, accelerating the pace at which safer alternatives are developed, and pulled them into the market.” CIEL examined the impact of laws governing hazardous chemicals in terms of their effect on innovation. According to CIEL, stricter laws enable safer chemicals to overcome barriers to entry, such as economies of scale enjoyed by the current mix of chemicals, the externalization of costs, and the lack of information about chemicals and products on the market today. CIEL cautions that policies must be in place to ensure that alternatives do not also have intrinsic hazards. The report includes the following recommendations for policy makers in Europe, the U.S., and other countries and regions:

  1. Ensure the burden of proving chemical safety falls on chemical manufacturers;
  2. Phase-out chemicals with certain intrinsic hazards;
  3. Recognize endocrine disruption as an intrinsic hazard that cannot be soundly managed;
  4. Internalize the costs of hazardous chemicals;
  5. Promote access to information; and
  6. Craft stronger international laws to ensure a level playing field at the global level.

The report is available online.

ChemSec Announces SIN List 2.1: On February 14, 2013, the International Chemical Secretariat (ChemSec) announced version 2.1 of the Substitute It Now! (SIN) List. According to ChemSec, the additions are mainly substances newly classified as CMRs under the CLP Regulation, as well as substances recently agreed by EU Member States as SVHCs. With the addition of 249 substances and substance groups, the SIN List now includes 626 entries. ChemSec describes the SIN List as “highly hazardous chemicals in use in a wide range of everyday consumer products, posing a threat to the health of people in Europe and elsewhere, as well as to the environment.” ChemSec notes that while the SIN List includes 626 SVHCs, the REACH Candidate List includes only 138, and “[a] lot of work still remains before the most hazardous substances are regulated in the EU.” The SIN List database includes updated hazard classification data, new information about uses, and the quantities in which chemicals are produced. More information is available online.

ECHA Receives Updates For Intermediate Dossiers And Announces Further Follow-Up Actions: ECHA announced on February 14, 2013, that letters sent to registrants based on the IT-based screening of REACH intermediate dossiers in fall 2012 “has lead to promising results.” Of the 5,500 dossiers that were screened, an analysis of the reported uses revealed that 2,388 dossiers included uses that do not, or are very unlikely to, fulfill the definition of intermediates and/or strictly controlled conditions. ECHA sent letters to 574 registrants, indicating the observed issues for their dossiers and asking them to review the reported uses and update their registration dossiers within three months. According to ECHA, 1,844 dossiers were updated, of which 39 were updates into Article 10 registrations, meaning full registration dossiers. For 107 dossiers, registrants have indicated they were preparing an update, of which approximately half will become a full registration. For approximately 437 dossiers that have not yet been updated or indicated as dossiers for which an update is imminent, ECHA is beginning follow-up actions. First, ECHA sent a final reminder to the registrants of 183 dossiers, who failed to read the communication ECHA sent via REACH-IT. ECHA states that, if it does not receive an update in the coming weeks, it will initiate “legally binding actions,” including a formal request for information that would lead to compliance check decisions and the submission of complete datasets. ECHA will also inform national enforcement authorities and start discussions on possible actions that they could take in support of ECHA’s measures. More information is available online.

ECHA Offers Instructions To Request Extension Of PPORD Exemption: On February 15, 2013, ECHA announced that, as of February 25, 2013, product and process oriented research and development (PPORD) notifiers will be able to submit, via REACH-IT, their requests for an extension by updating their PPORD International Uniform Chemical Information Database (IUCLID) dossier. REACH allows an exemption from registration for substances manufactured or imported at or above one tonne per year, for the purpose of PPORD. The exemption is limited to five years, unless companies can demonstrate that a prolongation of their PPORD program is required. ECHA notes that the first five-year exemptions will expire in June 2013. ECHA states that for PPORD notifiers to benefit from an extension, companies that submitted a PPORD notification in 2008 and that wish an extension must submit a request at least four months before the expiry date of their original exemption. According to ECHA, this timeline will allow it to process the request on time, and ensure no interruption of the PPORD exemption. ECHA states that the companies must justify their requests for extension by providing a documented research and development (R&D) program. More information is available online.


Philippines Publishes Draft Rules Implementing GHS Requirements For Consumer Products: The Philippines Food and Drug Administration published draft procedural rules and regulations implementing the GHS for classification and labeling of household hazardous chemicals and consumer products regulated by the Department of Health. Under the draft, importers, distributors, manufacturers, users, and transporters of toxic chemicals and mixtures would be required to: adopt harmonized criteria for classifying substances and mixtures based on the GHS; prepare SDSs and labels, as necessary; and place the appropriate pictograms, signal words, and hazard and precautionary statements at the storage or warehouse facility/premises and on transport. The requirements would apply to chemicals classified under RA 6969 within two years of the draft coming into force; high volume toxic chemicals after four years; toxic chemicals under the International Air Travel Association (IATA) list of dangerous goods and International Maritime Dangerous Goods (IMDG) code after five years; and mixtures after seven years.