Global Regulatory Update for December 2011

OECD Publishes Schedule Of Chemicals Assessments: The Organization for Economic Cooperation and Development (OECD) announced on December 12, 2011, the availability of a webpage created on eChemPortal that provides links to existing scheduling information of national/regional and international assessments notified to the OECD by OECD member countries and stakeholders. OECD states that the links are provided “with the aim to assist in avoiding duplication across national/regional programmes in the area of chemical assessment.” At this time, the page includes only links to pages under Canada’s Chemicals Management Plan and the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, but a “project is underway to provide a more integrated access to this information in the future.” The page is available online.

EU

Proposed EU Biocidal Products Regulation Moves Forward: On November 23, 2011, the EU Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for “problematic” substances. While companies would be able to apply to the European Chemicals Agency (ECHA) for EU-wide authorization of some classes of products from 2013, other product types would only become eligible for EU-wide authorization in 2017 and 2020. Companies would also be able to continue to apply for national authorizations, and then mutual recognition in other EU countries, which is the current practice. EU countries can approve only those biocides whose active ingredients have been judged safe at the EU level. The proposed legislation incorporates the European Commission’s (EC) recent recommendation on the definition of a nanomaterial, and would require that, where nanomaterials are used in a product, the risk to the environment and to health be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word “nano” in brackets. Both the EU Council and the EP must approve the proposed legislation. The EP is scheduled to vote on the proposed legislation in January 2012.

ECHA Publishes Guidance On Identification And Naming Of Substances: On November 30, 2011, ECHA announced the availability of a new Guidance in a Nutshell and an updated Guidance Fact Sheet on identification and naming of substances under REACH and the Classification, Labeling, and Packaging of Chemical Substances and Mixtures (CLP) regulation. According to ECHA, the objective of the Guidance in a Nutshell is to provide guidance for manufacturers and importers on recording and reporting the identity of a substance within the context of the REACH and CLP. It briefly explains how to name the substance and also gives guidance on whether substances may be regarded as the same in the context of those regulations. The Guidance in a Nutshell was drafted according to the corrigendum on guidance for identification and naming of substances under REACH and CLP, which has been published at the same time. The corrigendum includes editorial corrections, the replacement of outdated information, the correction of examples, and references intended to improve readability. The Guidance Fact Sheet has also been updated to reflect the content of the corrigendum. The Guidance in a Nutshell, Fact Sheet, and corrigendum are available on the guidance section of ECHA’s website.

RAC Adopts 13 Scientific Opinions On Harmonized C&L: ECHA announced on December 9, 2011, that the Committee for Risk Assessment (RAC) has adopted opinions on proposals for harmonized classification and labeling (C&L) for the following 13 substances:

• Pitch, coal tar, high temperature;
   
• N-ethyl-2-pyrrolidone;
   
• 1-Octadecanamine;
   
• (Z)-octadec-9-enylamine;
   
• Hydrogenated tallow alkyl amine;
   
• Coco alkyl amine;
   
• Tallow alkyl amine;
   
• Aluminium phosphide;
   
• Trimagnesium diphosphide;
   
• Ammoniumpentadecafluorooctanoate (APFO);
   
• Perfluorooctanoic acid (PFOA);
   
• 1,3-cyclohexanedione,
  2-[2-chloro-4-(methylsulfonyl)benzoyl]; and
   
• Gallium arsenide.

More information is available online.

EC Announces Eco-Innovation Action Plan: On December 15, 2011, the EC announced the availability of its new Eco-Innovation Action Plan (EcoAP), which it intends to boost innovation that reduces pressure on the environment, and bridge the gap between innovation and the market. According to the EC, the EcoAP expands the focus from green technologies to the broader concept of eco-innovation, targeting specific challenges, and opportunities for achieving environmental objectives through innovation. The EcoAP “recognizes the key role of environmental regulation as a driver of eco-innovation and foresees a review of environmental legislation,” while stressing the importance of research and innovation to produce more innovative technologies and bring them to the market. Key aspects of the EcoAP include:

• Using environmental policy and legislation to promote eco-innovation;
   
• Supporting demonstration projects and partnering to bring operational technologies to market;
   
• Developing new standards to boost eco-innovation;
   
• Mobilizing financial instruments and support services for small- and medium-sized enterprises (SME);
   
• Promoting international co-operation;
   
• Supporting the development of emerging skills and jobs and related training programs to match labor market needs; and
   
• Promoting eco-innovation through European Innovation Partnerships.

The EC states that it will implement the EcoAP through partnerships with stakeholders and the private and public sector. New efforts will focus on product development and demonstration activities to fill the gap between technology and market uptake. More information is available online.

New Information On Emergency Contact Numbers To Be Included In EU Safety Data Sheets: ECHA on December 15, 2011, made available information regarding EU emergency contact telephone numbers for chemical emergencies on its website. The list of National Helpdesks now contains links to the emergency contact telephone numbers for official advisory bodies, which are to be identified in Section 1.4 of EU Safety Data Sheets (SDS), for each EU member state. This update can be found online. Below is a comprehensive list of EU member state advisory bodies and contact details.

In accordance with EC Regulation 453/2010, Annex I, Section 1.4 (which replaces the EU REACH regulation, Annex II, Section 1.4), the SDSs for substances and mixtures must contain the emergency contact telephone number for the official agency of the EU member state where the substance is placed on the market.

The legal definition of “placed on the market” is not provided within EC Regulation 453/2010 and is the subject of controversy and interpretation. The Acta Group EU, Ltd (Acta EU) believes that there are two ways to interpret the legislation: contact details for the emergency agency for each EU member state where the substance is placed upon the market are required in Section 1.4 of the SDS; or the contact details for the EU member state where the substance is registered, imported, or manufactured are required in Section 1.4 of the SDS.

Acta EU is researching appropriate and pragmatic approaches for interpretation of this requirement. Prior to contacting ECHA, who will more than likely refer Acta EU to each respective member state competent authority for interpretation, Acta EU is further consulting with European legal counsel. Acta EU is specifically assessing the prudence of providing SDSs that follow a regional approach in lieu of preparing SDSs on a per country basis. An issue that must be addressed under one approach over the other is the desire of each country upon import wishing that its contact details be presented first. There is also questionable benefit in providing numerous individual country contact details in Section 1.4, when all contact details can be further supported in Section 16 of the SDS.

Acta EU hopes to provide clarification shortly.

Emergency Contact Numbers to Be Included in Section 1.4 of SDSs

ECHA Delays Launching C&L Inventory: ECHA announced that it has “decided to delay” launching the C&L Inventory “to ensure that the information provided by industry will be made publicly available in an accurate way that allows easy and functional access and navigation.” ECHA intends to announce the new launch date by mid-January 2012. ECHA states that the C&L Inventory “is a key milestone project for ECHA because the public will have, for the first time, access to information on the self-classification of chemical substances by Industry.”

ECHA Adds 20 SVHCs To Candidate List: ECHA announced on December 19, 2011, that it added 20 substances of very high concern (SVHC) to the Candidate List, which now includes 73 substances. Of the 20 substances, 12 were added following the unanimous agreement of the Member State Committee, while the other eight, which did not receive comments challenging the identification as SVHC during public consultation, were directly added to the Candidate List. Nineteen of the SVHCs are carcinogenic and/or toxic for reproduction. Additionally, for the first time a substance — 4-tert-octyl phenol — has been identified as an SVHC because of its endocrine disrupting properties, which ECHA states “give rise to an equivalent level of concern due to its probable serious effects to the environment.” The 20 SVHCs are:

• Zirconia Aluminosilicate Refractory Ceramic Fibres;
   
• Calcium arsenate;
   
• Bis(2-methoxyethyl) ether;
   
• Aluminosilicate Refractory Ceramic Fibres;
   
• Potassium hydroxyoctaoxodizincatedichromate;
   
• Lead dipicrate;
   
• N,N-dimethylacetamide;
   
• Arsenic acid;
   
• 2-Methoxyaniline; o-Anisidine;
   
• Trilead diarsenate;
   
• 1,2-dichloroethane;
   
• Pentazinc chromate octahydroxide;
   
• 4-(1,1,3,3-tetramethylbutyl)phenol; 4-tert-octyl phenol;
   
• Formaldehyde, oligomeric reaction products with aniline;
   
• Bis(2-methoxyethyl) phthalate;
   
• Lead diazide, lead azide;
   
• Lead styphnate;
   
• 2,2′-dichloro-4,4′-methylenedianiline;
   
• Phenolphthalein; and
   
• Dichromium tris(chromate).

ECHA notes that companies “may have legal obligations resulting from the inclusion of substances in the Candidate List which may apply to the listed substances on their own, in mixtures or in articles.” ECHA states that producers and importers of articles have until June 19, 2012, to notify ECHA if both of the following conditions apply: (1) the substance is present in those articles in quantities totaling over one ton per producer or importer per year; and (2) the substance is present in those articles above a concentration of 0.1 percent weight by weight. There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded. More information is available online.

ECHA Offers Support Activities For Lead Registrants: To help lead registrants in their Substance Information Exchange Forum (SIEF) activities and preparation for the next registration deadline, May 31, 2013, ECHA is offering a series of support activities, including two lead registrants’ workshops in 2012, a series of webinars, and other training opportunities. ECHA published the preliminary schedule for the webinars and a dedicated webpage for the first lead registrant workshop, which will be held February 2-3, 2012. ECHA states that, as an additional incentive for SME lead registrants facing the challenges of leading a SIEF, it is offering to reimburse the travel and accommodation costs of SMEs wishing to attend the lead registrant workshop, subject to the availability of places and an eligibility check. These events will be by invitation only to lead registrants who have first identified themselves via the ECHA website. ECHA emphasizes that companies notifying themselves as lead registrants do not take any extra responsibilities beyond the ones already outlined by REACH. ECHA will publish the identity of the nominated lead registrants, subject to their individual agreement, to further facilitate SIEF formation. More information is available online.

ECHA Recommends 13 SVHCs For Authorization: ECHA announced on December 21, 2011, that it submitted to the EC a recommendation that 13 SVHCs should in the future not be used without authorization. ECHA states that the substances are all classified because of their carcinogenic, mutagenic, or toxic to reproduction (or a combination thereof) properties, and they are used in applications where there is potential for worker exposure. ECHA provides the following list of the 13 SVHCs and their main uses within the scope of authorization:

• Trichloroethylene (carcinogen): A substance mainly used in surface cleaning, in textile scouring, in adhesives and as a heat transfer fluid;
   
• Chromium trioxide (carcinogen, mutagen): A substance mainly used for metal finishing and as a catalyst;
   
• Acids generated from chromium trioxide and their oligomers (group containing: chromic acid, dichromic acid, oligomers of chromic acid, and dichromic acid) (carcinogen): A substance that could be used to replace chromium trioxide in many of its uses;
   
• Sodium dichromate (carcinogen, mutagen, toxic for reproduction): A substance mainly used in metal surface treatment;
   
• Potassium dichromate (carcinogen, mutagen, toxic for reproduction): A substance mainly used in metal surface treatment and as a processing aid;
   
• Ammonium dichromate (carcinogen, mutagen, toxic for reproduction): A substance with currently no uses in the scope of authorization. It could, however, be used to replace other chromium(VI) substances;
   
• Potassium chromate (carcinogen, mutagen): A substance mainly used in metal surface treatment;
   
• Sodium chromate (carcinogen, mutagen, toxic for reproduction): A substance mainly used in metal surface treatment;
   
• Cobalt(II) sulphate (carcinogen, toxic for reproduction): A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger, and corrosion inhibitor;
   
• Cobalt dichloride (carcinogen, toxic for reproduction): A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger, and corrosion inhibitor;
   
• Cobalt(II) dinitrate (carcinogen, toxic for reproduction): A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger, and corrosion inhibitor;
   
• Cobalt(II) carbonate (carcinogen, toxic for reproduction): A substance mainly used in fertilizers and in surface treatment processes; and
   
• Cobalt(II) diacetate (carcinogen, toxic for reproduction): A substance mainly used as a catalyst and in surface treatment processes.

The EC will make the final decision on the inclusion of the substances in Annex XIV, following the committee procedure with scrutiny. Then, as of a specific date, substances on the Authorization List can only be used within the EU for those uses for which an authorization has been granted. More information is available online.

JAPAN

METI Publishes Survey Regarding Communication In International Supply Chains: In November 2011, the Ministry of Trade, Economy and Industry (METI) began a survey concerning the communication of information on chemical substances between different countries and industries. The survey is intended to facilitate discussions on how to improve and harmonize communication in the future. More information is available, in Japanese, online.

METI Publishes Information On The Notification Procedure For Small Amounts Of New Chemicals: METI posted on its website on December 13, 2011, information concerning the notification procedure for small amounts of new chemicals, in volumes of one ton or less, under the Chemical Substances Control Law. The notice is available in Japanese online.

SERBIA

Serbia Announces Changes And Amendments To Laws On Chemicals And Biocidal Products: The Serbian Chemicals Agency (SHemA) announced on December 13, 2011, changes and amendments to the Law on Chemicals and the Law on Biocidal Products. According to SHemA, the main change is the introduction of sanitary inspectors to supervise the implementation of the legislation regulating chemicals and biocidal products. Besides this change, SHemA states, the latest amendments more clearly define the powers of the inspectors, and also more precisely define sampling in the procedure of inspection supervision, as well as costs of sampling and testing of the chemical and biocidal product. In a case where the sample corresponds to the prescribed properties, SHemA would bear the costs of sampling and testing, and if it is determined that the sample does not correspond to the prescribed properties, the costs shall be borne by the business entities from which the sample is taken. Under the amendments, active substances for which SHemA rejects the application for inclusion in List I — List of Active Substances or List Ia — List of Active Substances Contained in Low-Risk Biocidal Products will be included in List II — List of Active Substances for which the Inclusion into List I or List Ia Is Rejected. SHemA notes that “[t]hese are so called negative lists that did not exist in the basic law, where we had only so called positive lists. Negative lists of substances are result of the rejection of inclusion of active substances into the positive lists.” More information is available online.

TURKEY

Turkey Presents Draft CLP Regulation At Stakeholder Workshop: During a November 16-17, 2011, workshop, the Ministry of Environment and Urbanization presented proposals for a draft regulation intended to bring Turkey’s C&L provisions in line with the EU CLP. As presented during the workshop, the regulation would include the following provisions:

• Exemptions listed in the EU CLP would be identically applied;
   
• Terminology for formulations would be changed from preparations to mixtures;
   
• The forecast publication and adoption execution date is the first half of 2012;
   
• In response to requests from industry, the deadline for substance labeling and notifications to the proposed C&L inventory for substances would be pushed back 12 months, to January 1, 2014. Mixtures would have to start using the new C&L requirements beginning June 1, 2015, while mixtures already on the market as of June 1, 2015, would have to be relabeled by June 1, 2017; and
   
• Substances placed on the market after January 1, 2014, would have to be notified within one month.

Turkey Publishes Chemical Inventory: On December 14, 2011, Turkey published a list of chemicals manufactured and imported in the country above one ton per year for which notifications were received before March 31, 2011. The list, which includes 2,887 substances, provides substance names in both Turkish and English. The list is available online.