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August 1, 2011

Global Regulatory Update for August 2011

The ACTA Group


Brazil Revised Standard Requires Chemicals Be Classified And Labeled: The May 24, 2011, revised edition of Brazil’s Health and Safety Labor Standard includes provisions requiring that chemicals in the workplace be classified and labeled. The Standard also requires that safety data sheets (SDS) be prepared in accordance with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) provisions in Brazil’s Technical Standard NRB 14725. Technical Standard NRB 14725 is based on the first edition of the GHS, but is being revised in accordance with the provisions of the third revised edition. Both standards have the same implementation deadlines of February 2011 for substances and June 2015 for mixtures, although companies may implement the standards sooner on a voluntary basis.


China Requires Notification For New Chemicals Used In Food Packaging: In June 2011, a requirement to notify new chemicals used in food packaging entered into force under Article 2 of China’s 2009 Food Safety Act. Companies need to ensure that substances are on one of several updated approved lists for additives, resins, detergents, and disinfectants. The notification requirement applies to several categories of food-related products, including packaging materials, containers, tools and equipment, disinfectants, and detergents. For substances imported into China, companies will need to have approval and certification from the competent authorities in their own countries for food contact applications.

China Seeks Comment On Proposed Revisions To Pesticide Regulation: The Ministry of Agriculture drafted proposed revisions to the pesticide management regulation, which were released on July 20, 2011. The revisions would require authorities to standardize pesticide application procedures; require manufacturers to keep detailed records of raw materials, productions processes, and sales; and require detailed and clear labeling on packages. The authorities would establish a pesticide licensing system, improve inspection systems, including tracking of purchases and sales, and conduct training and provide guidance on the safe use of pesticides. Comments are due August 31, 2011. More information is available in Chinese online.

SAWS Releases Revised Regulations For Operating Licenses For Hazardous Chemicals: The State Administration of Work Safety (SAWS) released for public comment revised regulations concerning operating licenses for hazardous chemicals. The revised regulations:

  • More clearly define the scope;
  • Do not differentiate between all hazardous chemicals, previously denoted as “Type A” substances, and general hazardous chemicals other than highly toxic substances, “Type B” substances; and
  • Require companies to submit more documentation to support their applications for operating licenses, including proof of employment injury insurance and personal protective equipment meeting the requirements of relevant legislation.

Comments are due September 15, 2011. The revised regulations are scheduled to take effect December 15, 2011. More information is available in Chinese online.


EC Begins Public Consultation On The Preliminary Opinion Concerning Toxicity And Assessment Of Chemical Mixtures: The European Commission (EC) is holding a public consultation on the July 4, 2011, paper on the toxicity and assessment of chemical mixtures, which was prepared by the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER), and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). EC asked the Committees to issue a joint opinion. According to the EC, the key conclusions of this preliminary opinion are:

  • Chemicals with common modes of action may act jointly to produce combined effects that are larger than the effects of each mixture component alone;
  • For chemicals with different modes of action (i.e. acting independently), no robust evidence is available that exposure to a mixture of such substances is of health concern if each individual chemical is present at or below their no effect levels; and
  • For chemicals that interact, interactions (including antagonism, potentiation, synergies) usually occur at medium or high-dose levels (relative to the lowest effect levels). At low exposure levels, they are either not occurring or toxicologically insignificant.

Comments are due September 9, 2011. More information is available online.

EP Committee Releases Draft Recommendation For Second Reading Of Biocides Proposal: On July 19, 2011, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety published its draft recommendation for second reading of the regulation concerning the making available on the market and use of biocidal products. According to rapporteur Christa Klass, the European Union (EU) Council incorporated almost half of the EP’s amendments when it achieved political agreement in 2010. Klass stated, however, that the proposed legislation is still “in considerable need of improvement in order to achieve the stated purposes, such as eliminating the shortcomings in the existing authorisation directive, 98/8/EC, improving the authorisation procedure and streamlining decision-making while further developing the high level of protection.” The EP Committee proposed that low-risk products that would be eligible for authorization from 2013 be specified, while the EC proposed a more general definition. The EP Committee also proposed that authorization be introduced in stages and that most biocides should be eligible for authorization after 2017. Member states want this deadline to be pushed back to 2020. The EP Committee also urged “clear and transparent rules on fees” for the European Chemicals Agency (ECHA) and member states, recommending that the new regulation avoid duplicating labeling requirements made by other legislation, and the inclusion of a more detailed definition of nanomaterials. The EP Committee will discuss the proposed legislation in September 2011. Its draft recommendation is available online.

ECHA Rejects Danish EPA’s Annex XV Proposal For Four Phthalates Based On Combined Exposure: ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC) reviewed Denmark’s April 4, 2011, dossier calling for the restriction of di(2-ethylhexyl) phthalate, butyl benzyl phthalate, dibutyl phthalate, and diisobutyl phthalate, based in part on the risks posed by the combined exposures to all four substances, based on a dose addition calculation. According to RAC and SEAC, the dossier did not meet the conformity check requirements in terms of some of the information it contained, or the explanation of that information. The Danish Environmental Protection Agency (EPA) has 60 days from receipt of the letter to resubmit an updated dossier; which it says it is confident will be achieved, and has already scheduled a teleconference with ECHA and the dossier rapporteurs with the aim of ensuring the resubmitted dossier meets the necessary requirements. A spokesperson for the Danish EPA said that while the scope of the proposed restriction was broad, this in itself was not the problem. According to the spokesperson, it is a matter of providing additional explanation and redrafting the dossier. The spokesperson stated that the data and calculations on which the proposed restriction is based — which uses dose addition to estimate impacts from combined exposures of the phthalates — had not been challenged, although it was acknowledged that a full discussion of the dossier would take place in the future if it is accepted. The Danish EPA intends to resubmit the dossier in time to be discussed by the next RAC and SEAC meetings in September 2011.

ECHA Urges Registrants To Verify Compliance With Data Sharing And Joint Submission Obligations: According to an August 10, 2011, press release, ECHA has noted that for some substances companies have submitted registrations possibly without taking part in a single Substance Information Exchange Forum (SIEF). ECHA “strongly encourages” such registrants to verify their compliance with data sharing and joint submission obligations. ECHA states that, under the Registration, Evaluation, Authorization and Restriction of Chemicals regulation (REACH), companies have to share existing information on the same substance and submit one joint dossier. Compliance with these obligations must take place before registration dossiers are submitted to ECHA, and is facilitated through the SIEF and inquiry processes. ECHA acknowledges that, in some cases, “the pre-SIEF and SIEF formation process may not have worked as expected, and multiple separate (joint) registrations for the same substance have been submitted.” To support registrants in ensuring compliance, ECHA now facilitates contact between existing registrants in the event that the contact details cannot be found via the normal channels, i.e. the (pre-)SIEF or inquiry process, as appropriate. If companies become aware that other separate registrations exist for their substance, they can contact ECHA to obtain the contact details of the other registrants, subject to the verification of certain information. ECHA notes that this process is recommended only to registrants who become aware of other registrations of the same substance outside of their SIEF and/or joint submission (e.g. via the dissemination portal). More information is available online.

EU REACH Committee Sent Second List Of Chemicals For Prioritization Under REACH: On August 1, 2011, the second list of chemicals to be prioritized under the REACH authorization process was sent to the EU REACH Committee. ECHA proposed eight substances — diisobutyl phthalate, diarsenic trioxide, diarsenic pentaoxide, lead chromate, lead sulfochromate yellow (C.I. Pigment Yellow 34), lead chromate molybdate sulphate red (C.I. Pigment Red 104), tris(2-chloroethyl) phosphate, and 2,4-dinitrotoluene — in December 2010. The EU REACH Committee will decide whether to list the chemicals in REACH Annex XIV at its September 28, 2011, meeting. Addition to the Annex would mean companies would have to seek authorization for these chemicals in the future. More information is available online.

EC Sends Communication On WEEE Directive To The EP: In an August 11, 2011, communication concerning the position of the EU Council on the adoption of a Directive of the EP and EU Council on waste electrical and electronic equipment (WEEE), the EC states that not all changes introduced by the Council are consistent with the objectives of the EC’s proposal, “in particular with regard to resource-efficiency, the need to recover secondary raw materials, and the need to reduce unnecessary administrative burdens. Therefore, the Commission can not accept the Council’s position in its entirety.” According to the EC, the EU Council proposed the following main changes to its proposal:

  • Open scope: The Council proposes that, starting six years after entry into force, the scope include all “large equipment” and “small equipment,” rather than be limited to a list of closed categories as is currently the case. The EC considers that equipment falling into the scope of the Directive currently should not be excluded in the future, and that extensions of the scope should be undertaken only if the benefits exceed the costs;
  • Definition of categories of WEEE: The Council replaces the current ten categories in the Annex of the Directive by a new set of five categories;
  • Extension of scope to include photovoltaic panels: The Council proposes to extend the scope of the Directive from the date of entry into force to include photovoltaic panels. The EC agrees that the collection, proper treatment, and recovery of photovoltaic panels should be ensured;
  • National approach to producer obligations: The Council applies a definition of producer that builds on the concept of national markets. This national concept, according to the EC, can lead to a situation of multiple registration, multiple payments for the same product, multiple requirements for treatment information and marking of products, as well the obligation for producers to be legally represented in more than one member state;
  • Collection target: The Council requires member states to achieve the collection target of 65 percent of electrical and electronic equipment placed on the market eight years after entry into force of the Directive. The EC notes that, compared to its proposal, this implies a delay of about four years. The EC states that it “cannot accept to delay the year the collection target needs to be achieved,” but that it “can agree to the Council’s intention to treat mercury containing fluorescent lamps as priority products for separate collection, for which a dedicated collection target could be established in the future”;
  • Development of standards: The Council requires that the EC shall develop minimum standards for the treatment of WEEE. The EC “does in principle see benefits in establishing standards for the treatment of WEEE,” and considers that the new text on standards can be in conflict with those parts of the text not subject to the recast procedure; and
  • Adaptations related to the Treaty on the Functioning of the European Union and other issues: The Council foresees implementing acts for Articles 7, 16, 23 and Annex VI. The Commission considers that these should be delegated acts in line with the Commission proposal.

The communication is available online.


India Issues Draft Classification, Labeling, And Packaging Rules For Hazardous Substances: The Ministry of Environment and Forests posted the July 8, 2011, draft “Hazardous Substances (Classification, Packaging and Labelling) Rules, 2011.” The Ministry states that:

  • The rules apply to hazardous substances, hazardous chemicals, and dangerous goods, as specified in Schedule I appended to the draft;
  • The occupier (person in possession of the substance) and consigner (any person or organization which prepares a consignment for shipment) are required to assign hazard classes, use proper shipping names, suitable packaging, requisite labels, marking, and use of updated SDSs for transportation. The draft rules mandate training of persons engaged in handling, storage, and transportation of dangerous goods;
  • Various classes of hazardous substances have been specified, such as explosives, gases, flammable liquids, flammable solids, oxidizing substances, toxic and infectious substances, radioactive materials, corrosive substances, and miscellaneous dangerous substances; and
  • The assignment of United Nations (UN) number and proper shipping names has been prescribed as per its hazard classification and composition. Packaging provisions have been assigned for handling of hazardous substances. Labeling provisions, including trade name, substance name, Chemical Abstracts Service (CAS) Number, gross weight, name and address of manufacturer, importer, supplier, emergency contact number, hazard class, packing group, and play card, have been provided.

Comments are due 60 days from publication in the Gazette of India. More information is available online and the draft rules are available online.


Japan Updates CSCL Inventory: The Ministry for Economy, Trade and Industry, the Ministry of Health, Labor, and Welfare, and the Ministry of the Environment have published a list of 166 substances new to the Chemical Substance Control Law (CSCL) inventory of existing and new chemical substances. The list is available in Japanese online.


Mexico Adopts Voluntary GHS Standard: Mexico published a June 3, 2011, notice in the Official Gazette concerning standard NMX-R-019-SCFI-2011, which allows companies to use GHS on a voluntary basis to comply with NOM-018-STPS-2000, the existing standard for classification, labeling, and SDSs in the workplace, while also meeting GHS requirements in Europe, Asia, and South America. The standard sets out the criteria for classifying chemicals according to their physical, health, and environmental hazards, and provides the elements of a uniform hazard communication system for chemical products, labeling requirements, and SDSs. The standard entered into force on June 3, 2011. The notice is available online.


Serbia Amends Chemical Regulations: In the July 27, 2011, Official Gazette, Serbia published three notices amending Serbia’s chemicals management regulations:

  • A regulation establishing fees for registering chemicals;
  • A chemicals register ordinance; and
  • An ordinance regulating permits for placement on the market and usage of very hazardous chemicals.

The amendments create a tiered system of fees, based on tonnage thresholds; clarify provisions concerning the registration of multiple chemicals as a group; and clarify which substances are hazardous and which require permits for their sale or use in Serbia. The amendments entered into force on August 4, 2011. More information is available online.