Global Regulatory Update for April 2016
Canada Publishes Notice With Respect To Substances In The NPRI For 2016 And 2017: On February 27, 2016, Environment and Climate Change Canada published a Canada Gazette notice with respect to substances in the National Pollutant Release Inventory (NPRI) for 2016 and 2017. Under the authority of the Canadian Environmental Protection Act, 1999 (CEPA), owners or operators of facilities that meet published reporting requirements are required to report to the NPRI. Companies that meet reporting requirements but fail to report, do not report on time, or knowingly submit false or misleading information, face penalties as listed under CEPA Sections 272 and 273. Environment and Climate Change Canada suggests that facilities that in previous years did not meet the reporting criteria or were exempt should review their status to determine whether they are required to report for the current reporting year. The notice applies to the calendar years 2016 and 2017. Information pertaining to the 2016 calendar year must be provided no later than June 1, 2017. Information pertaining to the 2017 calendar year must be provided no later than June 1, 2018.
Canada Developing Recommendations For Procedures To Exchange Information On Chemical Substances: CEPA Section 75 instructs the Minister of the Environment to cooperate and develop procedures with non-federal governments in Canada and with the governments of the Organization for Economic Cooperation and Development (OECD) member states for the exchange of information on substances that are prohibited or substantially restricted by their legislation(s) for environmental or health reasons. In addition, the Minister of the Environment and the Minster of Health are to review decisions made by these other jurisdictions to prohibit or restrict substantially substances for environmental or health reasons to determine whether the substances are harmful to Canadians and their environment. On April 1, 2016, Environment and Climate Change Canada published a draft document that describes the implementation of procedures for the exchange of information within the requirements set out under CEPA Section 75(2). The draft document also describes steps to identify when a review is required under CEPA Section 75(3). The draft document lists the following Toxic Substances Control Act (TSCA) actions that would be included in the procedure for exchanging information with the U.S.:
- TSCA Section 5(b)(4) authorizes the U.S. Environmental Protection Agency (EPA) to compile and keep current a list of chemical substances with respect to which it finds that the manufacture, processing, distribution in commerce, use, disposal, or any combination of such activities, presents or may present an unreasonable risk of injury to health or the environment;
- If EPA determines that a new chemical will present unreasonable risk before a TSCA Section 6 rule can be promulgated, EPA may (1) limit the amount or impose other restrictions on the substance via an immediately effective proposed rule; or (2) completely prohibit the substance by issuing a proposed order or applying to a U.S. District Court for an injunction. Section 5(f) actions are communicated using the “F” flag on the TSCA Inventory;
- TSCA Section 6 gives EPA the authority to protect against unreasonable risk of injury to health or the environment from chemical substances. Section 6 actions are communicated using the “R” flag on the TSCA Inventory; and
- Section 7 authorizes EPA to commence a judicial action for seizure of a chemical substance, mixture, or article containing such a chemical substance or mixture that EPA has determined is imminently hazardous, and/or for other relief against any person who manufactures, imports, processes, distributes in commerce, uses, or disposes of an imminently hazardous chemical substance or mixture. Concurrently with filing a civil action under Section 7, EPA would initiate proceeding for promulgation of a rule under TSCA Section 6(a). If EPA determines that a chemical is likely to present an unreasonable risk of serious or widespread injury to health or the environment before normal rulemaking procedures can be completed, EPA may declare a proposed rule under TSCA Section 6 immediately effective upon publication and until the effective date of the final action. Section 7 decisions are communicated using the “R” flag on the TSCA Inventory.
Canada will not undertake reviews under CEPA Section 75(3) for all decisions notified under the procedures. Before such a review is performed, the criteria below must be met:
- The decision is on a substance “severely restricted” or “specifically prohibited”;
- The decision originates from an OECD member state;
- The substance has non-pesticidal uses in Canada;
- The decision is based on a risk or hazard evaluation; and
- The notification contains information that was not previously considered as part of an assessment by relevant Canadian authorities.
Comments are due May 31, 2016.
31 Substances Supplemented To IECSC: On March 10, 2016, China’s Ministry of Environmental Protection (MEP) published a list of 31 substances that were supplemented to the Inventory of Existing Chemical Substances (IECSC). These substances were registered previously under New Chemical Substance Notification (NCSN) and five years have passed since they were first manufactured, imported, or exported. The chemicals will be regulated as existing chemical substances and there will be no tonnage limit.
Nine of the 31 chemicals are classified as hazardous chemicals of priority environmental concern. As a result, their use is explicitly specified (e.g., used as an intermediate in herbicide manufacture or used as a component in fragrances).
More information is available, in Chinese, in MEP’s Notice of Supplementation.
Danish EPA Highlights Risk Of EDCs In Recycled Textiles: In March 2016, the Danish Environmental Protection Agency (Danish EPA) announced that the recycling of outdoor clothing may have the potential to increase human and environmental exposure to hazardous chemicals such as perfluorinated substances (PFC). This conclusion was reached through a project assessing outdoor clothing and plastic components in electrical and electronic equipment, with the aim of investigating if hazardous chemicals could impede the potential for recycling products and materials.
The Danish EPA suggests that such hazardous chemicals may be present in outdoor clothing (e.g., rain jackets), and include PFCs used as impregnation agents and phthalate softeners in polyvinyl chloride (PVC). The report indicates that some phthalates found in textiles have been identified as reproductive toxins and endocrine disrupting chemicals (EDC), while PFCs have been found to be carcinogenic and reproductively toxic, and persistent and bioaccumulative in the environment. The Danish EPA emphasizes the potential risk of human exposure for workers and the potential of PFC emissions contributing to accumulation in the environment. The report suggests that inhalation and dermal exposure are risks when unraveled material is used in products such as mattresses, rags, and insulating materials.
More information is available, in Danish, in the Danish EPA’s report, “Kemiske stoffer i forbrugerprodukter, der kan hindre genanvendelse.” A summary is available in English at pages 10-13 of the report.
EUROPEAN UNION (EU)
Disinfectant Uses For Two Biocides Lose Review Program Support: On February 26, 2016, the European Chemicals Agency (ECHA) added Pyridine-2-thiol 1-oxide, sodium salt (sodium pyrithione) and Cetylpyridinium Chloride (CPC) to its list of Open Invitations for Notifications. The substances have lost support in the Biocides Review Program.
Sodium Pyrithione is no longer supported for product-type three, veterinary hygiene products, and CPC is not supported for product-type two, disinfectants and algaecides not intended for direct application to humans and animals. ECHA stated that it does not know the reason for withdrawal of support for the chemicals.
For the substances to remain on the EU market, new supporting companies need to express support to ECHA via the Registry for Biocidal Products by February 25, 2017. If the role of participant is not assumed by another company, the substances will be subject to a non-approval decision. Consequently, products containing the chemicals for the affected product types will need to be removed from the market.
ECHA Urges 2018 Registrants To Organize Their SIEFs: On March 1, 2016, ECHA urged companies that intend to register substances before the 2018 deadline to contact other registrants and organize their substance information exchange forums (SIEF) as soon as possible. ECHA reminded companies of the steps they need to take and the information, tools, and guidance available on its website.
Geert Dancet, Executive Director of ECHA, stated “[t]he important thing is we want to get people, in the coming months, to start doing all their contact and interactions with their co-registrants in order to make sure who will co-register, be part of the SIEF and be the Lead Registrant so that SIEF formation and first agreement on how it will operate will actually happen this year.” Dancet expressed concerns regarding Small- and Medium- Sized Enterprises’ (SME) compliance, stating “there are many small companies that don’t even know – if they are importing a substance, for example — that they need to register.”
ECHA hosted a webinar, “Get organised with your co-registrants – SIEF management and data sharing,” on March 2, 2016, providing companies with an overview of the tasks needed to be performed by SIEFs to prepare a registration dossier. The webinar explained what “fair, transparent and non-discriminatory data and cost sharing” means in the context of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation and the Implementing Regulation on Joint Submission of Data and Data-Sharing.
More information is available in ECHA’s March 1, 2016, press release, “REACH 2018: Work together to share data and its costs.”
Beginning May 31, ECHA Will Refrain From Updating REACH Guidance Documents: On March 2, 2016, ECHA announced that beginning May 31, 2016, it will apply a two-year moratorium on updates to the majority of its REACH guidance before the May 31, 2018, deadline. ECHA states that the moratorium concerns any guidance that explains the registration requirements. According to ECHA, the purpose of the moratorium “is to provide a sufficiently long period of stability for future registrants to undertake their preparations and negotiations in [SIEFs] undisturbed.” ECHA will update guidance documents during the moratorium only in rare cases, e.g., when REACH legislation has been modified or IT tools updated. ECHA notes that it “recognises that some aspects of guidance directly related to registration (such as the Guidance on Registration itself and the Guidance on data sharing) will still be under consultation” after May 31, 2016, however. ECHA will provide further updates on which documents will be subject to change during the moratorium before May 31, 2016. More information is available in ECHA’s March 2, 2016, press release, “ECHA stabilises guidance two years ahead of the 2018 REACH deadline.”
ECHA Assessing Feasibility Of EU Substance Regulation Database: ECHA will assess the feasibility of developing a “central EU navigator” that provides information on how individual substances are affected by EU regulations. ECHA stated that following discussion in 2015 with the European Commission (EC) and industry associations, it will carry out a study to understand the scope of the legislation to be covered, technical feasibility, and the resources needed to develop the system. ECHA did not provide a date for commencement of this work.
The study will be performed in collaboration with the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), the Directorate-General for Environment (DG Environment), and other stakeholders.
The German Chemicals Industry (VCI) and the European Chemical Industry Council (Cefic) encouraged development of the database. In a September 2014 position paper, Cefic stated that ECHA’s substance database is insufficient because it does not “cover the entire regulatory framework on chemicals in the EU/member states nor the results from the European research programmes.” The position paper did suggest, however, that the database could form a good basis for the navigator.
Member States Criticize EC For EDC Criteria Delay: On March 4, 2016, the Environment Council urged the EC in a Council Meeting to “respect its legal obligations” and propose scientific criteria for EDCs. Pressure to implement such criteria is steadily increasing after the General Court of the EU ruled in December 2015, in a case brought by the Swedish government, that the EC had failed to specify criteria by the deadline of December 2013 set under the Biocidal Products Regulation (BPR). The General Court of the EU disagreed with the EC’s view that socio-economic costs and benefits merit consideration, stating that the criteria for EDCs should be based on science alone, independent of all other considerations.
Scientists from the Endocrine Society met EU Health Commissioner Vytenis Andriukaitis before the March 4, 2016, Council Meeting and suggested that EDCs are “an important public health threat, and that governments need to design regulations to protect vulnerable populations from irreversible effects.”
A coalition of environment, consumer, and health non-governmental organizations (NGO) wrote to national environment ministers shortly before the meeting, urging them to adopt a strong statement. The coalition argued that criteria for EDCs should not consider any issues related to hazard characterization, such as potency, a factor the chemical industry has pressed hard to include.
Environment ministers noted the General Court of the EU’s judgment, and stated that the EC is legally required to comply. A background brief on the Council Meeting, drafted by the Dutch EU presidency, stated the Environment Council’s statement aimed “at underscoring the importance of urgent action by the Commission to comply with the General Court’s judgement and its legal obligations.”
French Environment Minister Ségolène Royal suggested the EC should propose three categories of EDCs corresponding to the degree of certainty relating to the danger posed. Royal added that governments should support companies seeking to find alternatives to chemicals of concern, such as EDCs. The French Minister stated that she “agreed with her European partners” that Bisphenol A (BPA) should be banned from all food containers and till receipts.
Sweden’s Minister for Climate and the Environment, Åsa Romson, stated EDCs may be found in baby food jars, canned foods, skin creams, and cash register receipts. Romson highlighted the health risks associated with EDCs and stated it is a “grave situation that the EU must take very seriously.”
More information is available in the “Outcome of the Council Meeting.”
EC Consults On Chemicals Legislation Outside REACH: On March 4, 2016, the EC launched a public consultation on the effectiveness of chemicals legislation, excluding REACH, which will be evaluated separately in 2017.
All citizens and organizations are welcome to contribute to the consultation. In particular, input is sought from Member State public authorities responsible for the implementation and enforcement of the legislation; companies and industry associations in the chemicals and downstream industries; workers employed by the aforementioned industries; trade unions; NGOs; consumer associations; academia; and research/educational institutes.
The public consultation is conducted in support of the fitness check on “the most relevant chemicals legislation (excluding REACH), as well as related aspects of legislation applied to downstream industries.” The objective is to obtain stakeholder views on the functioning of the legislative framework for chemicals. This framework covers legislation governing the hazard identification and classification of chemicals and legislation governing risk management measures for chemicals (excluding REACH). This includes chemical-related provisions in worker safety legislation, transport legislation, environmental protection legislation, and supporting legislation.
The results of the consultation will be included in the EC’s regulatory fitness program, REFIT. The deadline for responses to the consultation is May 27, 2016. More information is available in the EC’s “Consultation on the regulatory fitness of chemicals legislation (excluding REACH).”
EC Rejects Idea Of EU Nano Register: The EC has informed Member State officials that its preferred option for improving transparency on nanomaterials is a public website listing existing information, rather than an EU register. During the March 10-11, 2016, meeting of the Competent Authorities for REACH and Classification, Labelling and Packaging (CLP) (CARACAL) Subgroup on Nanomaterials (CASG Nano), EC officials confirmed that the introduction of new REACH information requirements for nanomaterials will not affect pre-2018 substance registrations.
ECHA will develop the website to provide existing information on nanomaterials. ECHA stated that different sections of the website “may have different key audiences,” and that it faces a unique challenge to present information in a user-friendly way for consumers.
BoA Upholds OSOR Principle: In a landmark ruling upholding the principle of “One Substance, One Registration” (OSOR), the ECHA Board of Appeal (BoA) agreed with a Lead Registrant’s appeal for it to annul ECHA’s decision to accept a separate registration dossier because ECHA “failed to adequately examine” the dossier’s completeness. The BoA stated ECHA should not have deemed the separate registration dossier to be complete, as it was not part of the existing joint submission for the substance.
REACheck Solutions (REACheck), the Lead Registrant for charcoal, urged the BoA to reject a registration dossier for the same substance submitted by Bulgarian company Nikimol OOD (Nikimol), that ECHA had accepted as complete on July 19, 2013. In its appeal in 2013, REACheck suggested that several individual submissions had been made for charcoal outside the joint submission, and that some individual dossiers were “devoid of any real content.” REACheck had asked ECHA to revoke the registration numbers assigned to those registrants.
ECHA initially suggested there was no legal basis to revoke the registration numbers because the completeness check process specified in REACH Article 20(2) does not include ensuring that a registrant has permission to use data included in its registration documents. ECHA also indicated that the completeness check does not require it to verify the quality or adequacy of provided information.
The BoA disagreed with ECHA, stating it had failed to examine the completeness of Nikimol’s dossier adequately with regard to REACH Articles 10, 12, and 20(2). The BoA ruled that REACH Article 11(3) only permits a partial “opt-out” for certain endpoints, rather than a full opt-out from a joint submission.
ECHA stated that it is “[analyzing], in light of the decision, the regulatory and technical mechanisms available to require existing registrants to re-negotiate with each other by becoming part of the same registration.”
More information is available in the “Decision of the Board of Appeal of the European Chemicals Agency.”
EU Biocides Committee Approves 19 Substance Uses: On March 17, 2016, the Standing Committee on Biocidal Products approved 19 active substance/product-type combinations. These included ampholyt for use in product-types two, three, and four; biphenyl-2-ol for use in product-type three; formaldehyde for use in product-type three; tolylfluanid for use in film preservatives (product-type seven); cyrpomazine for use in insecticides (product-type 18); and dicopper oxide for use in product-type 21. The EC will formally adopt the proposals. More information is available in the Standing Committee on Biocidal Products’ Draft Agenda for its 47th Meeting.
ECJ Rules In Favour Of Swedish Product Register: On March 17, 2016, The European Court of Justice (ECJ) overruled an indictment against Sweden relating to the legality of its product register. The ECJ judgment was a consequence of charges being brought against Canadian Oil Company in Sweden for importing 392 tons of chemical products in 2009 without fulfilling reporting obligations required by the Swedish Chemicals Agency, Kemikalieinspektionen’s (KEMI) product register by the 2010 deadline. KEMI suggests that the product register facilitates Swedish supervision of chemicals and provides the basis for Sweden to propose new substances for restriction and authorization under REACH.
Following imposition of a fine by the Court of Appeal for Skåne and Blekinge, Canadian Oil Company appealed to the Swedish Supreme Court, expressing its view that the obligation to notify KEMI’s product register hinders the free movement of substances covered by REACH. Canadian Oil Company argued that the register serves the same purpose as REACH and is incompatible with REACH Article 128 and the Treaty of the Functioning of the European Union (TFEU).
The case was referred to the ECJ, as the Swedish Supreme Court was not clear on the requirement for chemical product importers to notify KEMI for inclusion in the Swedish product register. The ECJ ruled that REACH does not preclude national legislation that makes it mandatory for chemical importers to register substances with the competent national authority. More information is available in the Judgment of the Court.
EC Report Declares BPR Is Sufficient: On March 17, 2016, the EC issued a report indicating the existing provisions of the BPR are sufficient to ensure sustainable use of biocides. The report emphasizes the importance of distributing best practice guidelines on the use of biocidal products and raising awareness among end users regarding risk mitigation measures, use of non-chemical alternatives, and unnecessary applications.
For professional users, the report concludes that the control measures applied under EU health and safety legislation and chemicals legislation, combined with the risk mitigation measures specified at the stage of biocidal product authorization, are sufficient to address risk from exposure.
The EC states it will be taking several precautionary measures, and invited EU Member States to do the same. These include ensuring that once active substances are approved, product authorizations are granted, amended, or cancelled within three years; investing additional resources on enforcement activities; and encouraging the development and implementation of standards that could contribute to the sustainable use of biocidal products.
More information is available in the “Report from the Commission to the European Parliament and the Council on the Sustainable use of Biocides Pursuant to Article 18 of Regulation (EU) No 528/2012 of the European Parliament and of the Council Concerning the Making Available on the Market and Use of Biocidal Products.”
EC Report States TTIP Negotiations On Priority Chemicals Are Useful: The 12th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP) took place in Brussels from February 22-26, 2016. The EC’s report on the 12th round of negotiations states “[s]everal Member States are now actively engaged in exchanges with US technical experts on individual priority chemicals. So far, Member States have indicated that they find these exchanges useful and have confirmed that this has not led to either additional work or to any delays in the planning and execution of their own activities.”
The EC issued a revised proposal on regulatory cooperation for TTIP. This proposal states that it is undecided whether certain sectors (e.g., chemicals) will be covered under the proposed “horizontal” provisions or will have their own specific chapters in the agreement. NGOs have expressed their disappointment, stating that the EC should ensure TTIP negotiations do not affect REACH-related issues.
More information is available in the EC’s Public Report on The Twelfth Round of Negotiations for TTIP.
ECHA Adopts Updated CoRAP, Will Evaluate 39 Priority Substances In 2016: ECHA announced on March 22, 2016, that it adopted the updated Community Rolling Action Plan (CoRAP) for 2016-2018. According to the CoRAP, 22 Member States will carry out substance evaluations in the coming three years for 54 newly-selected substances and 84 substances from the previous CoRAP update. Member States have 12 months from March 22, 2016, to evaluate the 39 substances specified for 2016. ECHA encourages registrants of these substances to coordinate their actions and to interact early with the evaluating Member States. ECHA states that the initial concerns about CoRAP substances are, “in many cases,” related to potential persistent, bioaccumulative, and toxic (PBT) properties, suspected endocrine disruption, or carcinogenic, mutagenic, and reprotoxic (CMR) properties in combination with wide dispersive or consumer uses. Justification documents explain the grounds for the initial concerns for each substance. The registrants of substances listed on the CoRAP will have an opportunity to comment before any decision to request further information is taken. Such draft decisions will be reviewed by the other Member States and ECHA and, when necessary, agreed by the Member State Committee before ECHA issues the final decision. More information is available in ECHA’s press release, “Member States to evaluate 39 priority substances in 2016.”
Endocrine Society Report States EDCs Cost EU €1.4 Billion: On March 22, 2016, the Endocrine Society released a report suggesting that EDCs may contribute significantly to general reproductive disorders in women, costing the EU €1.4 billion annually.
The most robust EDC-related data in terms of female reproductive disorders concerns the diphenyldichloroethene (DDE)-attributable fibroids and phthalate-attributable endometriosis. Cost estimates were deduced from direct costs (e.g., treatment) and indirect costs (e.g., productivity loss). The report estimates that in the EU 56,700 women suffer from DDE-attributable disorders and 145,000 women suffer from phthalate-attributable disorders. Combined calculated economic and healthcare costs amounted to €163 million and €1.25 billion respectively. The report advises that public health costs should be considered as part of the EU’s regulatory action regarding EDCs.
More information is available in the Endocrine Society’s report, “Female Reproductive Disorders, Diseases, and Costs of Exposure to Endocrine Disrupting Chemicals in the European Union.”
ECHA Announces New Approach On Hazard Assessment For Nanoforms: ECHA announced on March 23, 2016, a new publication co-authored with the Dutch National Institute for Public Health and the Environment (RIVM) and Joint Research Center (JRC) that illustrates how to use data for different nanoforms within the same substance registration. According to ECHA, this approach “will form a cornerstone in the future guidance development on hazard assessment for nanoforms” at the European Union (EU) and OECD level. ECHA describes the paper, “Usage of (eco)toxicological data for bridging data gaps between and grouping of nanoforms of the same substance: Elements to consider,” as a scientific reference paper. ECHA states that at the EU level, it offers regulators, researchers, industry, and NGOs an approach of how to justify scientifically that studies on one nanoform of a substance can be used to predict the hazard properties of other forms of the same substance. The paper outlines a stepwise approach to identify opportunities for using data between nanoforms within the same substance registration. The identification is based on grouping through an assessment of physicochemical properties and in vitro screening methods. According to ECHA, this may allow for a hazard assessment of several nanoforms of the same substance, minimizing the testing needed, including testing on animals, and therefore also minimizing costs. More information is available in ECHA’s press release, “New approach on hazard assessment for nanoforms.”
ECHA Forum Makes Progress On Internet Sales Of Chemicals: On March 23, 2016, ECHA announced that a task force established by its Forum for Exchange of Information on Enforcement will prepare the manual and methodology for a pilot project on how CLP is addressed for internet sales. The project, with an operational phase starting at the end of 2016, intends to assess companies’ obligations to mention substance hazards in advertising as stated in Article 48 of the CLP Regulation.
ECHA has released new tools to assist national enforcement authorities. These include a portal dashboard for national enforcement authorities (PD-NEA), which replaces the REACH Information Portal for Enforcement (RIPE). PD-NEA provides enforcement authorities with new search features, including searching for revoked registrations; finding dossiers according to the classification and labeling of a substance; and finding dossiers in terms of substances’ presence on authorization or restriction lists. This instrument complements ECHA’s pre-existing ePIC tool and has been made available to inspectors to allow them to access directly Prior Informed Consent (PIC) information submitted to ECHA.
More information is available in ECHA’s press release, “Forum starts to liaise with the Biocides Enforcement Group.”
ECHA Urges Registrants To Prepare To Comment On 2015 Substance Evaluation Draft Decisions: On March 30, 2016, ECHA announced that, during the last week of April 2016, it intends to send draft decisions on 32 substances to registrants. Registrants will have 30 days to consider and submit comments. ECHA recommends that one representative, the registrants’ contact point, send consolidated comments on the draft decision on behalf of all addressed registrants of a substance. According to ECHA, in 2015, Member States evaluated 48 registered substances under the substance evaluation process. ECHA states that in 32 cases, further information is considered necessary to assess the safety of the substance, and a draft decision was prepared to request this data. The registrants receiving a draft decision will be those with active, standard registrations for a substance on the date when the draft decision is first sent. Registrants who, after having received an ECHA draft decision, cease manufacture or import of the substance before the decision is adopted by ECHA will not receive the decision and their registrations will become invalid. ECHA notes that registrants who have registered the substance exclusively as an on-site isolated intermediate or as a transported isolated intermediate under strictly controlled conditions will typically not be addressed in the (draft) decision under substance evaluation. Where there are specific grounds of concern for intermediate uses, however, registrants of transported isolated intermediates may be requested to provide further information under substance evaluation. For 14 substances, the evaluating Member State is concluding the substance evaluation without the need to request further data. The evaluating Member State will submit a conclusion document that ECHA will publish on its website. In two cases, the evaluating Member State could not conclude the evaluation as information related to the standard information requirements was missing. A compliance check process will be used to request the missing data. In those cases, the substance evaluation process is suspended, and will resume once the necessary information is submitted. ECHA states that the concerned registrants will have an opportunity to comment on the compliance check draft decisions once they are issued. More information is available in ECHA’s press release, “Registrants should get ready to comment on 2015 substance evaluation draft decisions.”
EC Publishes Inception Impact Assessment On Initiative To Amend Directive On Protection Of Workers From The Risks Related To Carcinogens And Mutagens At Work: ECHA recently published an inception impact assessment for a legislative initiative to amend Directive 2004/37/EC on the protection of workers from the risks related to carcinogens and mutagens at work (CMD). According to the assessment, the EC will propose occupational exposure limit values (OEL) for a limited number of “recognized human carcinogens.” In addition, the EC will propose to bring within the scope of the CMD a limited number of process generated substances (PGS) that are recognized as human carcinogens in other countries or by international organizations like the International Agency for Research on Cancer (IARC) but that are not classified under the current EU system, as a consequence of which workers exposed to these substances are protected by neither the CMD nor REACH. Two amendments to the CMD would cover four of these PGSs: respirable crystalline silica; diesel engine exhaust emissions; mineral oils and used engine oils; and rubber process dust and fumes. For some of them, the EC also intends to propose an OEL in Annex III (e.g., respirable crystalline silica), for the others, the EC currently intends only to establish an entry in Annex I, until robust scientific data are available to allow the establishment of an OEL. The assessment states that the initiative would be divided in two steps:
- The first amendment of the CMD will aim to extend its scope as regards PGSs and establish OELs for a number of substances. Currently, Annex III to the CMD contains three OELs, out of which two (hardwood dust and vinyl chloride monomer) need to be revised due to new scientific evidence; and
- A second amendment of the CMD will aim to extend its scope to include additional PGSs, and will establish OELs for additional substances for which only limited data is currently available pending the results of another targeted study.
The assessment states that, with regard to the content of the initiative proposed, the EC will take into account that certain substances under the scope of the CMD either are already, or will soon be, covered by restrictions or authorization requirements under REACH. Both the CMD and REACH aim at controlling exposure to chemicals that pose particular risks, but REACH regulates inter alia the conditions for putting a substance on the market or its use, whereas the CMD regulates the employer’s obligations to protect workers against those substances. The impact of the measures under REACH will be taken into account in the impact assessment report.
ECHA Issues Second Progress Report On SVHC Roadmap: ECHA announced on April 4, 2016, release of its second report on the implementation of the Substances of Very High Concern (SVHC) Roadmap. The report describes the main achievements in 2015 on activities covered by the SVHC Roadmap to 2020, and provides an update on regulatory risk management activities under REACH and CLP. ECHA states in the report that its screening, generation and assessment, and risk management option analysis measures “are now well in place and support the identification of substances that matter most.” ECHA suggests that its change in focus from CMR substances to identification of and further regulatory action on other substances (i.e., EDCs and PBT substances) is beneficial.
The report is divided into three sections: “Part 1 — Activities carried out in 2015”; “Part 2 — Outline of activities planned for 2016“; and “Part 3 — Report on regulatory risk management activities.” ECHA’s efforts in 2016 will concentrate on further developing and enhancing the common screening approach.
More information is available in ECHA’s report, “Roadmap for SVHC identification and implementation of REACH risk management measures.”
ECHA Will Review Completeness Of Certain REACH Registrations: ECHA announced on April 8, 2016, that it will reopen certain REACH registration dossiers for a new completeness check. The first set will be the charcoal dossiers, which were recently subject to a decision by the Board of Appeal, as reported above. ECHA states that it will look at the completeness of information and whether the joint submission obligation has been fulfilled. According to the press release, ECHA will prepare to check retroactively all dossiers that may be in breach of the “one substance, one registration” principle of REACH. This means that approximately 700 individual REACH registrations will be reopened, representing 1.5 percent of all registrations. ECHA states that at the same time, it will recheck the completeness of the dossiers in its database with regard to the information requirements to verify that the information provided is meaningful. ECHA recommends companies check the relevance of the information that they have submitted and make sure that the “one substance, one registration” principle is followed. ECHA encourages companies to update their registrations proactively as soon as possible if needed. If ECHA finds a dossier to be incomplete after the retroactive completeness check, ECHA will give the registrant a “reasonable” amount of time to update their dossier with the missing information. This may also require discussions on joining the joint submission for the same substance. If they provide the information within the deadline and fulfil the joint submission obligation, they can remain on the market without interruption. Otherwise, ECHA states, the registration will lose its validity and the company will lose market access.
JRC Publishes Report On Harmonized Terminology For EHS Assessment Of Nanomaterials: JRC recently published a report entitled NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials, developed within the NANoREG project: “A common European approach to the regulatory testing of nanomaterials.” The report states that it represents the project’s attempt at bringing common understanding and consistency in the use of key terms in the environmental health and safety (EHS) assessment of nanomaterials. The objective of the report is to publish the harmonized terminology that has been developed and used within NANoREG. According to the report, all project partners have agreed upon and adopted the terminology in their activities and related documents. The report specifically includes: (1) the methodology used to select key terms that form the harmonized terminology and to develop harmonized definitions; (2) the existing literature definitions that have been used as a starting point to develop for each key term a harmonized definition; and (3) the reason(s) behind the choices that have been made in drafting a definition. The discussion on the key terms to be considered for the harmonized terminology led to the selection of 43 key terms. The list includes terms with international regulatory relevance, such as those defined at the OECD level, as well as terms that have a specific meaning and use under REACH. According to the report, it has “already proven very useful” in the context of OECD work, as a support document to the April 13-14, 2016, OECD Expert Meeting on “Grouping and read-across for the hazard assessment of manufactured nanomaterials,” and in a regulatory context, as a support document to the work recently released by RIVM, ECHA, and JRC on using (eco)toxicological data for bridging data gaps between nanoforms of the same substance.
ChemSec Updates SIN List And More: The International Chemical Secretariat (ChemSec) announced on April 8, 2016, several new features intended to increase the user friendliness of the Substitute It Now! (SIN) List, the SIN Producers, and the Textile Guide. According to the press release, the SIN List and SIN Producers have new background data, and ChemSec added 18 new SVHCs to the SIN List, bringing the total number of substances listed to 862. ChemSec added new filtering options to the Textile Guide, “making it easier to identify unwanted chemicals in your supply chain, build of chemicals and share them with your colleagues and suppliers.” ChemSec updated several industry restricted substance lists (RSL) and manufacturing RSLs (mRSL) to their latest versions. More information is available in ChemSec’s press release, “Update of the SIN List, and more.”
Late Pre-registration Commenced On April 1: Taiwan launched Phase 1 Registration for existing chemical substances manufactured or imported in amounts over 100 kg/year on September 1, 2015. Pre-registration for these substances ended on March 31, 2016. For companies that manufacture or import substances in amounts greater than 100kg/year for the first time after March 31, 2016, late pre-registration will be applied.
Two key differences between pre-registration and late pre-registration are:
- The volume information required for pre-registration included data from previous years. For late pre-registration, however, only the estimated volume for the year when the application is made is required.
- For pre-registration, no proof was required for the previous years’ volume. In contrast, for late pre-registration, registrants are required to provide proof that the manufacture or import of the substance has exceeded 100kg/year.
The information gathered from Phase 1 Registration will facilitate the designation of priority existing substances subject to Phase 2 Registration.
GHS Requirements Extend To Mixtures: The Ministry of Industry and Trade (MOIT), through Circular 4/2012/TT-BCT, requires chemical substances manufactured or imported by enterprises in Vietnam to be classified and labeled based on the United Nations’ (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Since March 30, 2016, the GHS requirements extend to all mixtures.
Circular 4/2012/TT-BCT adopts 17 physical hazards, seven health hazards, and two environmental hazards. The following substances are exempt from the GHS requirements:
- Temporarily imported chemicals for re-export; non-commercially imported chemicals; chemicals used for research and development; and chemicals imported for national security purposes, defense, disaster response, emergency disease response, or other special cases.
- Chemicals as gifts or donations; luggage of people on exit.
- Chemicals under the jurisdiction of the Ministry of Science and Technology, Ministry of Health, and Ministry of Agriculture and Rural Development.