Global Regulatory Update for March 2014
Canada Begins Consultation On Potential Amendments To The E2 Regulations: On March 10, 2014, Canada began a public consultation on potential amendments to the Environmental Emergency (E2) regulations. Canada states that the amendments are intended “to better protect Canadians and their environment from environmental emergencies, and to provide the regulated community with clarity on existing regulatory requirements.” Canada lists the following key elements of the amendments, which include the addition of 49 substances to Schedule 1 of the E2 regulations and the amendment of thresholds for three existing substances:
- 20 substances from the Chemicals Management Plan (CMP) Challenge;
- 16 substances from the CMP Petroleum Sector Stream Approach;
- 12 strong acids and bases, plus revising the threshold for three substances that are already regulated under the E2 regulations;
- One additional substance;
- Clarifications for regulatory requirements regarding E2 plans and measures to notify the public;
- The identification of reporting notification triggers related to minimum substance quantity releases;
- Modifications to Schedule 1 of the E2 regulations to consolidate all three parts under a single list; and
- Administrative corrections or minor changes.
Environment Canada will host webinars on March 25 and March 28, 2014, on the potential amendments. Comments are due April 7, 2014. More information is available online.
EUROPEAN UNION (EU)
ECHA Proposes Five Substances Of Very High Concern (SVHC) For Authorization: The European Chemicals Agency (ECHA) announced on February 10, 2014, that it recommended a new batch of substances for authorization to the European Commission (EC). The EC, in collaboration with the Member States and European Parliament (EP), will make the final decision on the inclusion of the substances in Annex XIV and on the dates by which companies will need to apply for authorization to ECHA. The recommended substances, including examples of their uses in the scope of authorization, are:
|Substance name and SVHC property||Uses in the scope of authorization (examples)|
|1||N,N-dimethylformamide (DMF) (toxic for reproduction)||Solvent for synthesis and for production of coated textiles and synthetic fibers|
|2||Diazene-1,2-dicarboxamide (C,C’-azodi(formamide)) (ADCA) (equivalent level of concern due to its respiratory sensitizing properties)||Blowing agent in the rubber and plastics industry|
|3||Aluminosilicate Refractory Ceramic Fibers (Al-RCF)  (carcinogenic)||Insulation for high-temperature industries; ceramic and metal composite reinforcement; electrical and acoustic insulation|
|4||Zirconia Aluminosilicate Refractory Ceramic Fibers (Zr-RCF)  (carcinogenic)||Insulation for high-temperature industries; ceramic and metal composite reinforcement; electrical and acoustic insulation|
|5||4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-Octylphenol ethoxylates) (4-tert-OPnEO)  (equivalent level of concern due to its degradation to a substance with endocrine disrupting properties)||Paints and coating products, emulsion polymerization|
More information is available online.
ECHA Begins Public Consultation On Applications For Authorization: ECHA announced on February 12, 2014, that it received four applications for authorization for the uses of diarsenic trioxide, lead sulfochromate yellow (C.I. Pigment Yellow 34), and lead chromate molybdate sulphate red (C.I. Pigment Red 104):
|Substance name||Uses applied for|
|Diarsenic trioxide||Use of diarsenic trioxide in the purification of metal impurities from the leaching solution in a zinc electrowinning processIndustrial use of diarsenic trioxide to produce a copper concentrate in the purification of the leaching solution in a zinc electrowinning processFormulation of diarsenic trioxide into a mixtureIndustrial use of diarsenic trioxide as a processing aid in gold electroplating|
|Lead sulfochromate yellow (C.I. Pigment Yellow 34)||Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer useIndustrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating)Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture) or as road markingDistribution and mixing pigment powder in an industrial environment into liquid or solid premix to color plastic/plasticized articles for non-consumer useIndustrial use of solid or liquid color premixes and pre-compounds containing pigment to color plastic or plasticized articles for non-consumer useProfessional use of solid or liquid color premixes and pre-compounds containing pigment in the application of hot melt road marking|
|Lead chromate molybdate sulphate red (C.I. Pigment Red 104)||Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer useIndustrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating)Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture) or as road markingDistribution and mixing pigment powder in an industrial environment into liquid or solid premix to color plastic/plasticized articles for non-consumer useIndustrial use of solid or liquid color premixes and pre-compounds containing pigment to color plastic or plasticized articles for non-consumer useProfessional use of solid or liquid color premixes and pre-compounds containing pigment in the application of hot melt road marking|
The Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) will review and consider the comments in their opinion-making process. Based on the committees’ final opinions, the EC will decide whether to grant the applicants an authorization. The consultation closes on April 9, 2014. ECHA states that “[c]ontributions on feasible alternatives to the uses applied for are welcome as soon as possible.” More information is available online.
Board Of Appeal Emphasizes The Importance Of Fully Justifying Read-Across Proposals: On February 13, 2014, ECHA announced that the Board of Appeal decided that for a read-across adaptation to be assessed and potentially accepted by ECHA, registrants must show with clear reasoning and supporting data that the substances involved are structurally similar and are likely to have similar properties (or follow a regular pattern). According to the Board of Appeal, registrants should also explain how and why the similarity of properties is as a result of the structural similarity. The decision clarified ECHA’s role in verifying whether read-across adaptations are in compliance with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Board of Appeal found that the appellant had not demonstrated that ECHA, in rejecting the appellant’s read-across approach, had incorrectly interpreted the REACH requirements on read-across. The Board of Appeal also found that the other pleas made by the appellant were unfounded and the appeal was therefore rejected. More information is available online.
ECHA Asks Unresponsive Registrants Of Intermediates To Provide More Information: ECHA announced on February 14, 2014, that it has started sending out legally binding letters to registrants who have registered their substances as intermediates but have not responded to ECHA’s requests to correct the inconsistencies found in their dossiers. ECHA states that companies receiving the letter have one month to update their registration before ECHA sends the case to the Member States enforcement authorities. ECHA identified 118 dossiers from 46 registrants who have not reacted to its earlier communication in any way. According to ECHA, these registrations may be in breach of REACH. The letters request tonnage information for the uses that remain inconsistent with the intermediate definition or strictly controlled conditions. The registrants must update their dossier by submitting a full registration, by reconsidering the reported uses, or by providing information on the tonnage. If a company provides the tonnage information, ECHA will initiate a compliance check. ECHA states that it will use the tonnage information to establish the information requirements for the non-intermediate use. More information is available online.
EU Amends Health And Safety Directives On Protection Of Workers From Exposure To Harmful Chemicals: On February 20, 2014, the EU Council of Ministers adopted a directive amending five existing health and safety directives on protection of workers from exposure to harmful chemicals to align them with the latest rules on classification, labeling, and packaging (CLP) of chemicals (Regulation (EC) 1272/2008). In its February 20, 2014, press release, the EC states that Member States have until June 1, 2015, to implement the new directive in their national legislation. According to the EC, manufacturers and suppliers of chemical substances and mixtures will have to provide harmonized labeling information on hazard classification, alerting the user to the presence of hazardous chemicals, the need to avoid exposure, and the associated risks. The EC states that, “[t]o assist employers and workers in managing the practical implications of the new system for chemical packaging and labelling, the Commission has published some guidance materials, available, free of charge.” The guidance materials are available online. The EC’s press release is available online.
ECHA Announces New Procedure Allowing Companies To Apply To Include Active Substances In Annex I Of The BPR: ECHA announced on February 21, 2014, that following the publication of the Commission Implementing Regulation (EU) No 88/2014, it has developed a new procedure using the register for biocidal products (R4BP 3) that allows industry to submit requests to amend the current list of active substances in Annex I of the Biocidal Products Regulation (BPR). The regulation defines the data requirements for applications for inclusion in Annex I dossiers and establishes the relevant evaluation procedure. ECHA states that applicants need to demonstrate conclusively that the substance falls into the description of the relevant category for which the authorization is sought and that there is a robust consensus of expert opinion that the substance does not give rise to concern. ECHA notes that, in some cases, it is necessary to submit a data package allowing a full risk assessment of the substance. The evaluating competent authority (eCA) will prepare the draft assessment report and the conclusions of its evaluation. ECHA’s Biocidal Products Committee then adopts and submits its opinion to the EC based on the conclusions of the eCA. The EC makes the final decision on the amendment of Annex I. More information is available online and in The Acta Group’s February 18, 2014, memorandum.
ECHA Publishes 2013 Annual Evaluation Report: On February 26, 2014, ECHA announced the availability of the annual evaluation report for 2013, which includes recommendations to all registrants on how to improve the quality of their dossiers. According to ECHA, in 2013, the focus of its dossier evaluation activities was on compliance checks: it concluded 928 checks during the year. In 61 percent of the cases, ECHA found that the dossiers did not comply with one or more REACH information requirements and sent draft decisions to the registrants. ECHA notes that, due to its “selection of dossiers with clear indications of potential non-compliance, this proportion is not a reliable indicator of data quality in all dossiers.” Most of the information requests were related to substance identity, physicochemical properties, sub-chronic toxicity studies, pre-natal developmental toxicity studies, and exposure assessment. The specific recommendations for both future registrants for the 2018 deadline and existing registrants who may need to update their dossiers include:
- Improving the chemical safety report to reflect actual uses and risks;
- Knowing how to react to (draft) decisions;
- Keeping the dossier up-to-date; and
- Substantiating the reasoning when adapting the standard testing regime.
More information is available online.
RoHS 2 2014 Review And Amendments To Exemptions: Key differences in the scope of the EU Restriction of Hazardous Substances (RoHS 2) (2011/65/EU) directive, and the RoHS 1 (2002/95/EC) directive are the gradual extension of the former to encompass types of electrical and electronic equipment (EEE) not covered by the original directives, and also the provision for a review of the scope of RoHS 2 no later than July 2014. In keeping with the gradual extension of the scope of RoHS 2, the following exemptions are proposed, and are expected to be enacted in March 2014. These changes have been notified to the EU by the EC:
- Exemption for mercury in hand crafted luminous discharge tubes (HLDT) used for signs, decorative or architectural, and specialist lighting and light-artwork;
- Exemption for lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments;
- Exemption for lead in micro-channel plates (MCP);
- Exemption for lead in solder in one interface of large area stacked die elements;
- Exemption for lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems;
- Exemption for lead in platinized platinum electrodes used for conductivity measurements;
- Exemption for lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments, and;
- Exemption for mercury in cold cathode fluorescent lamps (CCFL) for backlighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before July 22, 2017.
The EC is also running a consultation on two areas of review:
- Substance assessment of diisobutylphthalate (DIBP); and
- Quantitative usage data for the 21 priority substances in EEE.
The EC aims to collect information on DIBP (a candidate substance for restriction), as well as information to allow prioritization of a first shortlist of substances to be added to the restricted list. Dossiers have so far been created on brominated flame retardants and phthalate plasticizers as candidates for restriction under RoHS 2. The consultation closes April 4, 2014. Interested stakeholders can view further information via the EC website.
EC Proposes Responsible Trading Strategy For Minerals From Conflict Zones: The EC announced on March 5, 2014, a proposed integrated approach intended to stop profits from trading minerals being used to fund armed conflicts. The EC states that the focus of the approach is to make it easier for companies to source tin, tantalum, tungsten, and gold responsibly and to encourage legitimate trading channels. The EC proposed a draft regulation that would create a voluntary EU system of self-certification for importers of tin, tantalum, tungsten, and gold who choose to import responsibly into the EC. The self-certification would require EU importers to exercise due diligence by monitoring and administering their purchases and sales in line with the five steps of the Organization for Economic Cooperation and Development (OECD) Due Diligence Guidance. To increase public accountability of smelters and refiners, enhance supply chain transparency, and facilitate responsible mineral sourcing, the EU aims to publish an annual list of EU and global “responsible smelters and refiners.” The EC also announced a proposed Communication and other incentives intended to encourage supply chain due diligence, such as:
- Public procurement incentives for companies selling products such as mobile phones, printers and computers containing tin, tantalum, tungsten, and gold;
- Financial support for Small- and Medium-Sized Enterprises (SME) to carry out due diligence and for the OECD for capacity building and outreach activities;
- Visible recognition for the efforts of EU companies who source responsibly from conflict-affected countries or areas;
- Policy dialogues and diplomatic outreach with governments in extraction, processing, and consuming countries to encourage a broader use of due diligence;
- Raw materials diplomacy including in the context of multi-stakeholder due diligence initiatives;
- Development cooperation with the countries concerned; and
- Support by EU Member States through their own policies and instruments.
More information is available online.
EU Council Amends BPR: The EU Council adopted on March 10, 2014, a regulation amending the BPR. The EU Council states that the objective of the BPR “is to improve the functioning of the internal market in biocidal products whilst ensuring a high level of environmental and human health protection.” The amendment is intended to remedy problems related to provisions of the BPR. The EU Council states that the amendment “removes unintended market barriers for suppliers of new articles treated with biocidal products and for a large number of suppliers of biocidal active substances.” The EP approved the amendment on February 25, 2014.
ECHA Begins Consultations On Proposals To Identify Four Substances As SVHCs: ECHA has begun public consultations on proposals to identify the following four substances as SVHCs: (1) 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear; (2) cadmium chloride; (3) sodium perborate; perboric acid, sodium salt; and (4) sodium peroxometaborate. Comments are due April 17, 2014. More information is available online.
SIEF Members Could Be Affected By Draft Compliance Check Decisions Concerning Substance Identity: ECHA announced on March 17, 2014, that it is sending informative letters to the members of joint submissions in which the lead, or any other member, has received a draft compliance check decision concerning substance identity. ECHA states that it intends to make all the members aware of the ongoing process, which may eventually have an impact on the identification of the substance agreed in the Substance Information Exchange Forum (SIEF). The letters inform registrants that a draft decision has been sent to one or more members of the joint submission. They include the date on which the draft decision has been sent and the deadline by which the recipient has to provide comments. According to ECHA, even if the draft decision does not affect the registration of other members, it may impact the substance sameness assessment made in the SIEF and ultimately the joint submission. ECHA encourages each member of the joint submission to contact the lead registrant and other members to assess whether the draft decision has implications for their registration. More information is available online.
ECHA Begins Public Consultations On Two Proposals For Restrictions: On March 19, 2014, ECHA began public consultations on a proposed restriction of cadmium and its compounds in artists’ paints and chrysotile. Sweden submitted a report proposing a restriction on the placing on the market and use of cadmium and its compounds in artists’ paints. ECHA submitted a report to amend the current asbestos fibers restriction (entry 6 in Annex XVII to the REACH legislation). The proposal would introduce a time limit to the current derogation on the use of chrysotile until 2025 and new duties for companies. Although comments on the proposals are due September 19, 2014, ECHA states that its “Committees welcome early comments by 29 May 2014 to assist them in the first discussions of the proposal[s] in June 2014.” More information is available online.
ECHA Will Hold Webinar On How To Ensure The Safe Use Of Nanomaterials Under REACH: On March 31, 2014, ECHA will hold a webinar entitled “How to ensure the safe use of nanomaterials under REACH — Part III: Exposure and Risk Assessment.” The description states that the webinar will provide feedback to registrants on how to submit information on chemical substances in the technical dossier to ECHA in compliance with REACH. More information is available online.
Department Of Labor And Employment Posts Guidelines For GHS Implementation In Workplace Chemical Safety Programs: On March 6, 2014, the Department of Labor and Employment posted Department Order No. 136-14, “Guidelines for the Implementation of Globally Harmonized System (GHS) in Chemical Safety Program in the Workplace.” The Guidelines are intended to protect workers and properties from chemical hazards and to prevent or reduce the incidence of chemically induced accidents, illnesses, injuries, and death resulting from the use of chemicals at work. The Guidelines apply “to all workplaces engaged in the manufacture, use, storage of industrial chemicals, in the private sector, including their supply chain.” The Guidelines define industrial chemicals to include:
- Chemical manipulations carried out even in small scale;
- Multiple chemical procedures and/or chemicals used in the manufacturing or production process;
- The storage process and handling; and
- Chemical wastes collection and disposal.
Under the Guidelines, employers must ensure the development, implementation, and monitoring of the workplace policy and program on safety in the use of chemicals. All chemicals must be labeled or marked, and accurate safety data sheets (SDS) must be provided. Confidential business information (CBI) claims should be limited to the names of chemicals and the concentration in mixtures. The Guidelines will take effect within 15 days after publication in two newspapers of general circulation. The Guidelines are available online.
Draft K-REACH Decrees Available For Comment: On February 18, 2014, the Ministry of Environment (MOE) issued for comment a draft Presidential Decree and Ministerial Decree. Under the draft Presidential Decree, manufacturers and importers of existing substances would have three years to compile and submit their registrations for a particular substance from the date that a particular batch of substances subject to registration is announced. R&D substances and polymers of low concern would be exempt from registration. Simplified registration would be available for substances deemed to be non-hazardous, and new substances produced or imported in annual quantities below one tonne. Existing and new substances over one tonne would be fully registered, while existing substances below one tonne would not have to be registered. The draft Ministerial Decree would require annual reporting of substance tonnages and use by April 30 of the following year. The reporting requirement would apply to new and existing substances produced or imported in annual quantities of one tonne or more. The reporting data will be used, together with information on substance hazards and risks, to designate substances subject to registration. Every three years a list of designated existing substances subject to registration would be announced. More information is available, in Korean, online. Comments are due March 31, 2014.
Taiwan Will Hold Second Nomination Period For Existing Substances Inventory: According to a spokesperson for Taiwan’s Safety and Health Technology Center, Taiwan will hold a second “supplementary nomination and correction” period in 2014, possibly as early as May or June. The spokesperson stated that the process and tools will be almost identical to those used in 2012. As in the earlier nomination period, substances eligible will be those imported to Taiwan, or manufactured, handled, used, or sold domestically between January 1, 1993, and December 31, 2011.
Update To Aerosol Labeling Directive: The United Kingdom (UK) Department for Business Innovation and Skills (BIS) proposes an amendment to the UK Aerosol Dispensers Regulations (2009) to bring it in line with the amended Aerosol Dispensers Directive (75/324/EEC) (ADD). Amendments to the ADD change the labeling requirements, in line with industry best practice, and the CLP (1272/2008) regulation.
The ADD annex, “2.2 Labelling” will now read:
Without prejudice to Regulation (EC) No 1272/2008, each aerosol dispenser must visibly bear the following legible and indelible marking:
- Whatever its contents:
- the hazard statement H229: “Pressurised container: May burst if heated”;
- the precautionary statements P210 and P251 provided for in Part 1, Table 6.2 of Annex IV to Regulation (EC) No 1272/2008;
- the precautionary statement P410 + P412 provided for in Part 1, Table 6.4 of Annex IV to Regulation (EC) No 1272/2008;
- the precautionary statement P102 provided for in Part 1, Table 6.1 of Annex IV to Regulation (EC) No 1272/2008, where the aerosol dispenser is a consumer product;
- any additional operating precautions which alert consumers to the specific dangers of the product; if the aerosol dispenser is accompanied by separate instructions for use, the latter must also reflect such operating precautions.
- Where the aerosol is classified as “non-flammable” according to the criteria of point 1.9, the signal word “Warning.”
- Where the aerosol is classified as “flammable” according to the criteria of point 1.9, the signal word “Warning” and the other label elements for “Flammable Aerosols Category 2” provided for in Table 2.3.2 of Annex I to Regulation (EC) No 1272/2008.
- Where the aerosol is classified as “extremely flammable” according to the criteria of point 1.9, the signal word “Danger” and the other label elements for “Flammable Aerosols Category 1” provided for in Table 2.3.2 of Annex I to Regulation (EC) No 1272/2008.
Certain derogations are provided for in the new labeling requirements for aerosol dispensers containing mixtures. More information is available online.