Global Regulatory Update for February 2014
NICNAS Seeks Feedback On Proposed Draft Guidelines On The Confidential Section Of The AICS: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is seeking comment on draft guidelines relating to listing chemicals on the confidential section of the Australian Inventory of Chemical Substances (AICS). NICNAS seeks stakeholder views on the clarity and practicality of the draft guidelines, and the proposed approach to handle applications currently awaiting a decision on confidential listing. Comments are due February 14, 2014. More information is available online.
Canada Posts Chemicals Management Plan Progress Report: On December 20, 2013, Canada posted online the first issue of the Chemicals Management Plan Progress Report, which is intended to keep stakeholders and other interested parties up to date on the activities and programs related to Canada’s Chemicals Management Plan. The report will include updates on advances in major initiatives and highlight key activities related to recent work under the Chemicals Management Plan. According to Canada, of the 4,300 substances identified as priorities for assessment by 2020, it has addressed approximately 1,100 and initiated risk management action when necessary through such initiatives as the Challenge to Industry, the Petroleum Stream Sector Approach, and the rapid screening of substances of low concern. The report states that approximately 1,500 additional substances are on track to be addressed, with risk management initiated by 2016. The report is available online.
Canada’s PMRA Releases Proposed Special Review Process: On December 30, 2013, Health Canada’s Pest Management Regulatory Agency (PMRA) released a consultation document entitled Proposed Approach to Special Reviews — Consultation Document. The Consultation Document outlines the Pest Control Products Act legislative requirements for special reviews and PMRA’s proposed approach to conduct such special reviews. Comments were due January 29, 2014. More information is available in our January 21, 2014, memorandum, which is available online.
EUROPEAN UNION (EU)
ECHA Publishes Fact Sheet On Toll Manufacturer Responsibilities Under REACH: The European Chemicals Agency (ECHA) published on December 12, 2013, a fact sheet that explains the concept of toll manufacturers and the responsibilities they may have under the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). ECHA states that a toll manufacturer is typically understood to be a company providing manufacturing services (for a fee) to another company, on the basis of a contract for provision of those services. Although REACH does not have specific provisions on toll manufacturing, toll manufacturers may have obligations. The fact sheet describes relevant REACH requirements that may apply to toll manufacturers, and provides advice on how compliance may be facilitated for toll manufacturers and for companies who are contracting others to toll manufacture on their behalf. More information is available online.
ECHA Adds Seven SVHCs To Candidate List: On December 16, 2013, ECHA added the following seven substances of very high concern (SVHC) to the Candidate List: cadmium sulphide; disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis(4-aminonaph thalene-1-sulphonate) (C.I. Direct Red 28); disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo][1,1′-biphenyl]- 4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulp honate (C.I. Direct Black 38); dihexyl phthalate; imidazolidine-2-thione (2-imidazoline-2-thiol); lead di(acetate); and trixylyl phosphate. ECHA states that the legal obligations that companies may have resulting from the inclusion of substances in the Candidate List may apply to the listed substances on their own, in mixtures, or in articles. Producers and importers of articles containing any of the seven SVHCs have six months to notify ECHA if the SVHC is present in articles in amounts that total more than one tonne per producer or importer per year and above a concentration of 0.1 percent weight by weight. ECHA notes that 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 Publishes New Biocides Guidance Document: ECHA announced on December 17, 2013, that it published a new guidance for the Biocidal Products Regulation (BPR) on human health risk assessment, Volume III, Part B. According to ECHA, it developed the guidance with the Member State competent authorities, taking into account the elements described in the technical notes for guidance for biocides under the former legislation, as well as the technical guidance on hazard assessment developed for REACH implementation and the guidance on the Classification, Labeling, and Packaging (CLP) Regulation. ECHA states that the guidance provides technical advice on how to perform the hazard and exposure assessment and risk characterization for biocidal active substances and products with respect to human health risk assessment. ECHA intends to publish other Part B guidance documents, such as Part B for Volume IV (Environment), in 2014. More information is available online.
EC Begins Public Consultation On Restriction Of Hazardous Substances (RoHS) Exemption Request For Lead And Hexavalent Chromium In Reused Spare Parts: The European Commission (EC) began a public consultation on December 20, 2013, for Exemption Request 2013-6, “Lead and hexavalent chromium in reused spare parts, recovered from industrial monitoring and control instruments placed on the global market before July 22, 2017 and used in category 9 equipment placed on the market before July 22, 2024, provided that use and reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer.” Comments are due February 28, 2014. More information is available online.
RAC And SEAC Adopt Opinions On Application For Authorization For DEHP: ECHA announced on January 3, 2014, that the Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) have adopted their opinions on an application for authorization to use bis(2-ethylhexyl) phthalate (DEHP), an SVHC. Rolls-Royce plc. submitted an application concerning specific uses of DEHP in the manufacture of aero engines. ECHA states that, in their opinions, the RAC and SEAC conclude that adequate control has been demonstrated for the specific use. According to ECHA, given the risks posed by the use in question, the analysis of alternatives, and the substitution plan provided by the applicant, RAC and SEAC propose to review the authorization in seven years. The EC will make the final decision on the application, based on ECHA’s opinions. More information is available online.
EC Publishes RoHS Exemption Directives: The January 9, 2014, issue of the Official Journal of the European Union includes 16 directives adding exemptions to the RoHS Directive. The directives implement the following exemptions:
- Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionizing radiation;
- Cadmium in phosphor coatings in image intensifiers for X-ray images until December 31, 2019, and in spare parts for X-ray systems placed on the European Union (EU) market before January 1, 2020;
- Lead acetate marker for use in stereotactic head frames for use with Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) and in positioning systems for gamma beam and particle therapy equipment;
- Lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers;
- Lead in solders on printed circuit boards, termination coatings of electrical and electronic components, and coatings of printed circuit boards, solders for connecting wires and cables, solders connecting transducers, and sensors that are used durably at a temperature below – 20°C under normal operating and storage conditions;
- Lead in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20°C under normal operating and storage conditions;
- Lead in solders, termination coatings of electrical and electronic components, and printed circuit boards, connections of electrical wires, shields, and enclosed connectors that are used: (a) in magnetic fields within the sphere of a one meter radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere; or (b) in magnetic fields within a one meter distance from the external surfaces of cyclotron magnets, magnets for beam transport, and beam direction control applied for particle therapy;
- Lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards;
- Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, Superconducting Quantum Interference Device (SQUID), Nuclear Magnetic Resonance (NMR), or Fourier Transform Mass Spectrometer (FTMS) detectors;
- Lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments;
- Hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until December 31, 2019, and in spare parts for X-ray systems placed on the EU market before January 1, 2020;
- Lead in solders on printed circuit boards of detectors and data acquisition units for Positron Emission Tomographs that are integrated into MRI equipment;
- Lead in solders on populated printed circuit boards used in Directive 93/42/EEC Class IIa and IIb mobile medical devices other than portable emergency defibrillators;
- 3.5 milligrams mercury per lamp in single capped compact fluorescent lamps for general lighting purposes < 30 W with a lifetime equal to or above 20,000 hours;
- Lead, cadmium, and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before July 22, 2014, and used in category 8 equipment placed on the market before July 22, 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer; and
- Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BaSi2O5b (BSP) phosphors.
Each directive entered into force January 29, 2014. EU Member States have six months to bring into force the laws, regulations, and administrative provisions necessary to comply with the directives.
EC Seeks Additional Input To Impact Assessment For Review Of The Scope Of RoHS: The EC began a stakeholder consultation on January 13, 2014, to obtain additional input for the impact assessment for its review of the scope of RoHS. The consultation includes two areas of review: (1) electric bicycles — technical and socio-economic considerations concerning a possible exclusion for electric bicycles; and (2) electrical and electronic equipment (EEE) newly in scope — technical and socio-economic considerations relevant for assessing the impacts of various possible amendments to RoHS Articles 2(2), 4(3), and 4(4). ECHA notes that, under RoHS, it must present a report by July 22, 2014, on the need to amend the scope of the Directive. If appropriate, the report must be accompanied by a legislative proposal with respect to any additional exclusions related to that EEE. Comments are due March 7, 2014. More information is available online.
ECHA Meets Five Percent Compliance Check For 2010 Registration Dossiers: On January 15, 2014, ECHA announced that, by the end of 2013, it concluded 1,130 compliance checks, or 5.7 percent of the total number of registration dossiers over 100 tonnes submitted for the first registration deadline. According to ECHA, it found 69 percent of all evaluated dossiers to be non-compliant. ECHA states that the two main reasons for shortcomings were deficiencies in the information regarding identification and composition of the substance, and insufficient justification for not submitting the required studies or missing information in the chemical safety report. Under REACH, ECHA is required to check at least five percent of registrations per tonnage band for compliance. ECHA notes that it set its own target to check five percent of the over 100 tonnes dossiers submitted for the 2010 deadline, at least partially, by the end of 2013. ECHA states that it used both concern-based and random selection to choose registration dossiers for evaluation. For the selected dossiers, ECHA conducted either an overall compliance check (approximately 30 percent of the cases) or a targeted one (70 percent of the cases). More information is available online.
ECHA Publishes Recommendations On Best Practice For Interaction During Substance Evaluation: ECHA announced on January 21, 2014, that it agreed with the EC and Member States on recommendations regarding harmonizing the interaction between the evaluating Member State and the registrants under substance evaluation. The recommendations, which are addressed to Member States performing the evaluations for Community Rolling Action Plan (CoRAP) substances and their registrants, are intended to aid open and efficient interaction between the evaluating Member States and the registrants. Evaluating Member States are recommended to make contact with the concerned registrants shortly after publication of the CoRAP for the first year substances. Where there are a large number of registrants, evaluating Member States should contact the lead registrant in the first instance. ECHA notes that registrants “are also encouraged to be proactive.” ECHA states: “The registrants should speak with one voice and it is recommended that one representative, the registrants’ contact point, should coordinate the communications and send consolidated comments on the draft decisions on behalf of all registrants.” The recommendations are not legally binding and are not meant to be exhaustive. More information is available online.
ECHA Offers Chemical Similarity Check For Biocidal Active Substances: According to the January 22, 2014, issue of ECHA e-News, beginning February 2014, ECHA will offer a chemical similarity check to industry. According to ECHA, the chemical similarity check is an assessment similar to the technical equivalence assessment described in Article 54 of Regulation (EU) No 528/2012, but is applicable only for substances where no final decision on the approval of the active substance has yet been adopted, and is performed solely on the substance identity and chemical composition. ECHA states that the intent is to establish the similarity between two or more sources of the same substance. The service is designed for the following situations:
- The comparison of one source of an active substance to a biocidal active substance that has been submitted for assessment under the Biocidal Products Directive 98/8/EC or Regulation (EU) No 528/2012 but for which no final decision on the approval has yet been adopted; and
- The comparison of two or more sources of the same active substance (which are generally not under evaluation, under the Biocidal Products Directive 98/8/EC or Regulation (EU) No 528/2012), in view of a prospective joint application for active substance approval under Regulation (EU) No 528/2012.
ECHA notes that the chemical similarity check is voluntary and subject to a charge that depends on the scope of the assessment. ECHA will publish instructions for applying for the chemical similarity check on its website.
EC Calls For Information On In-Situ Generated Biocidal Active Substances: The EC has issued a “Call for information on in-situ generated biocidal active substances” that is intended for companies placing on the market or using biocidal products generating active substance(s) and falling within the scope of the EU BPR. The EC seeks to obtain information on in-situ generated biocidal active substances, as well as on those chemical substances (i.e., the precursors), that may be used to generate them. In the context of the BPR, chemical substances generated at their place of use from various devices, equipment, or systems, with a view to exerting a biocidal function, are referred to as in-situ generated biocidal active substances. The EC asks for the following information:
- If your company is a participant in the review program, please specify:
- What you are currently supporting under the review program (i.e., the precursor(s), the active substance(s), or the combination “precursor(s)/active substance(s)”);
- Whether you envisage to seek product authorization for other combinations “precursor(s)/active substance(s)” than the ones currently supported; and
- Whether you are aware of other precursors for the generation of the active substance you support being made available or used on the market.
- What you are currently supporting under the review program (i.e., the precursor(s), the active substance(s), or the combination “precursor(s)/active substance(s)”);
- If your company is not a participant in the review program, please provide details of the product, device, equipment or system, including of the combination “precursor(s)/active substance(s)” involved and of the methods used to generate the active substance(s) in situ, as well as of the area of use.
Responses are due March 31, 2014. According to the EC, it will use the information to decide how to manage in-situ generated biocidal active substances in the context of the BPR. The note is available online.
South Korea Provides Information Concerning Implementation Of Korean REACH: During a December 27, 2013, Ministry of Environment hearing, officials stated that the draft secondary legislation, which will include a presidential and ministerial decree, will be issued later in January 2014. The draft legislation has not yet been released, however. The first batch of existing substances that will be subject to registration, which will include fewer than 500 chemicals, will be announced by October 2014. South Korea will announce every three years existing substances subject to registration, and manufacturers and importers will have three years to submit their registrations.
KCMA Creates Online K-REACH Help Desk: The Korea Chemicals Management Association (KCMA) has created an online K-REACH Help Desk, which includes information in both Korean and English. The help desk includes information regarding substances subject to registration. Other sections of the website, such as the K-REACH Joint Registration Support System and Test Data Trading System, are still in preparation. The help desk is available online.
Taiwan Promulgates Amendments To TCSCA: On December 11, 2013, President Ma Ying-jeou promulgated legislation amending the Toxic Chemical Substances Control Act (TCSCA). On November 22, 2013, the national legislature unanimously approved the amendments, which revised 17 articles and created a system for the registration, evaluation, and control of chemicals. According to an Environmental Protection Administration statement, the amended TCSCA will require companies that want to manufacture or import chemicals designated as priority chemicals to submit applications for registration. The applications would need to include information on the plans for production or importation, physico-chemical properties, and evaluation of toxicity and risk. Companies can produce or import such substances only after the Environmental Protection Administration approves their applications. The Environmental Protection Administration is preparing to formulate regulations implementing the amended TCSCA. The President’s December 11, 2013, press release is available, in Chinese, online. The Ministry of Justice has published an unofficial English translation of the amended TCSCA, which is available online.
Taiwan Publishes List Of 1,020 Chemicals And Mixtures Subject To Third Stage Of GHS Implementation: On December 23, 2013, the Council of Labor Affairs (CLA) published a list of 1,020 chemicals that pose physical, health, or environmental hazards as specified in Taiwan’s national standards, the Chinese National Standards (CNS) 15030 serial of Classification and Labeling of Chemicals, and will be subject to the third stage of United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) implementation on January 1, 2014. The transition period ends December 31, 2014. On December 31, 2008, Taiwan implemented the first stage, covering 1,062 substances, and on January 7, 2011, implemented the second stage, covering 1,089 substances. Under the Regulation of Labeling and Hazard Communication of Dangerous and Harmful Materials, industries must examine the compliance status of safety data sheets (SDS), labeling, and other required hazardous communication measures. More information is available, in Chinese, online.
CLP Legislation Enters Into Force: Turkey published in the December 11, 2013, Official Gazette legislation intended to align its implementation of the GHS with the EU CLP Regulation. The legislation entered into force on December 11, 2013. Under the legislation, manufacturers and importers must notify substances placed on the market before June 1, 2015, between June 1, 2014, and June 1, 2015. After June 1, 2015, notification must be made within a month of substances being placed on the market. Substances must be classified and labeled as required by the legislation by June 1, 2015, and mixtures by June 1, 2016.