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May 1, 2015

Global Regulatory Update for May 2015

The ACTA Group


Australia Publishes Thirteenth Tranche Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published for public comment the thirteenth tranche of human health and environmental assessments for chemicals identified as part of the Stage One implementation of the Inventory Multi-tiered Assessment and Prioritization (IMAP) Framework. NICNAS states that it seeks comments on information that has the potential to affect the outcome of an assessment, but has not been considered in the assessment. Comments provided should be evidence-based and the relevance of submitted information should be highlighted. Comments are due June 19, 2015.


ECHA Releases Annual Report On Roadmap For SVHC Identification And Implementation Of REACH Risk Management Measures: The European Chemicals Agency (ECHA) announced on March 24, 2015, the release of its Annual Report on the Substances of Very High Concern (SVHC) Roadmap 2020, which involves screening, assessment, and the analysis of further risk management options for substances of concern. ECHA states that it reviewed hundreds of substances in 2014, and “lots of work” concentrated on substances that are already known to be carcinogenic, mutagenic, and toxic for reproduction (CMR). This work resulted in 145 substances being included in the Candidate List due to their CMR properties, out of which 29 are included in the Authorization List. ECHA and the Member States are now working to identify new CMRs either by proposing new harmonized classification and labeling (based on available data) or, where further information is needed, through substance evaluation. ECHA is also examining potential persistent, bioaccumulative, and toxic (PBT) substances, but according to ECHA, for many of these substances, more information is necessary to determine whether the substances are PBTs. ECHA states: “Consequently, the number of potential PBT substances in the assessment phase is high. Where further testing is needed, it will obviously take a substantial amount of time before work on the substances can progress.” ECHA states that it included 20 PBT/very persistent and very bioaccumulative (vPvB) substances on the Candidate List, and two of them are on the Authorization List. ECHA has also begun work on identifying endocrine disruptors, and has included five substances on the Candidate List due to their endocrine disrupting properties. More information is available in ECHA’s press release, ECHA focuses on substances that matter most.

Enforcement Forum Agrees On Pilot Project On Authorized Substances: ECHA announced on March 27, 2015, that during the March 24-26, 2015, meeting of the Forum for Exchange of Information on Enforcement, the Forum decided on a second pilot project on the use of substances subject to authorization. The pilot project will focus on substances with a sunset date before 2016. ECHA states that in addition to enforcing that substances subject to authorization are not on the market without an authorization, inspectors will also check whether the authorization holders comply with the conditions of the granted authorization. According to ECHA, the inspections will target manufacturers, importers, other suppliers, and downstream users of substances subject to authorization. This includes authorization holders and their downstream users. ECHA expects results at the end of 2016. The Forum also decided to choose specific restriction entries for the fourth coordinated enforcement project. The entries will be chosen so that they are relevant for consumer articles, professional use, and protection of the environment. Each Member State will be free to choose restrictions that are most relevant to their national priorities and market situation from a list of entries. ECHA states that the list will be published in the second quarter of 2015. Inspections will then take place during 2016, and the final report will be available in 2017. More information is available in ECHA’s news item, Forum starts a pilot project on authorised substances.

ECHA Suggests Registrants Prepare To Comment On Substance Evaluation Draft Decisions: ECHA announced on March 30, 2015, that it will soon send requests for further information on 39 substances evaluated in 2014 under the Community Rolling Action Plan (CoRAP) to registrants for comments. In 2014, Member States evaluated 51 registered substances under the substance evaluation process. If further information is needed to assess the safety of the substance, the Member States have prepared a draft decision. The deadline for submitting a draft decision to ECHA was March 26, 2015. ECHA states that it has received draft decisions on 40 substances, and registrants should prepare to provide their consolidated comments on the draft decisions addressed to them. ECHA plans to send out the draft decisions to the relevant registrants the week of May 4, 2015. Registrants will have 30 days to consider and submit their comments. The registrants receiving a draft decision will be those with active registrations for a substance on the date when the draft for the decision is first sent. ECHA states that two categories of registrants will be excluded, however: registrants who exclusively use the substance as an on-site isolated intermediate and under strictly controlled conditions; and those who have ceased manufacture or import of the substance in accordance with Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Article 50(3) before the decision is adopted by ECHA. Registrants of one substance received the draft decision in 2014. For 11 substances, there are no draft decisions and thus no consultation with the registrants. In such cases, ECHA has asked the evaluating Member State to submit a conclusion document, typically within four months from the end of the evaluation period. When available and cleared for confidential information, ECHA will publish the documents on its website. More information is available in ECHA’s press release, Registrants should get ready to comment on substance evaluation draft decisions.

ECHA Publishes List Of Pending Article 95 Applications: ECHA announced in a March 31, 2015, press release that to increase transparency ahead of the September 1, 2015, deadline for the compliance with Biocidal Products Regulation (BPR) Article 95, it has published a list of all pending Article 95 applications. The list contains applications for which ECHA has not yet taken a decision, and ECHA will update it regularly. ECHA will synchronize its publication with the list of relevant substances and suppliers. ECHA states: “It is important to note that the presence of a company for a given active substance/product type/role on the list of pending applications does not guarantee that the corresponding application will be successful and that the company will ultimately be included in the ‘Article 95 list.'” More information is available in ECHA’s press release, ECHA publishes list of pending Article 95 applications.

EP Committee Votes On Draft EC Legislation Concerning Conflict Minerals: The European Parliament’s (EP) International Trade Committee passed an amended version of the European Commission’s (EC) proposal to create a voluntary scheme concerning conflict minerals. The amended proposal would require EU smelters and refiners importing tin, tantalum, and tungsten, their ores, and gold from conflict-affected and high-risk areas to be certified by the EU. The Committee rejected amendments regarding mandatory certification of all downstream operators; a proposal to extend the scope of the regulation to include other minerals and metals was also voted down. The amended proposal would establish requirements that EU importers must meet if they choose to be self-declared “responsible importers.” According to the Committee press release, the certification schemes to which many EU importers and refiners already belong would be brought into the EU system, without imposing any additional burdens upon them. An EP plenary vote will be held on the amended proposal in May 2015.

ECHA Will Correct Information On Biocidal Product Authorizations: On April 22, 2015, ECHA announced that some companies have had difficulties managing their product authorizations since their assets have erroneously expired and “disappeared” from the R4BP 3 system preventing the companies from updating any information. ECHA states that it has now asked the Member State Competent Authorities that grant authorizations for biocidal products “to urgently send information to the Agency on the expired assests for authorisation that are still valid.” Once ECHA receives this information, it will activate the assets and correct the expiry date in the R4BP 3 database. ECHA expects to complete this “by end of May at the latest.” More information is available in ECHA’s press release, Member States and ECHA to update information on biocidal product authorisations.

ECHA Redefines In Situ Generated Biocidal Active Substances: ECHA announced on April 27, 2015, that to improve consistency in the evaluation of active substances, ECHA will evaluate potential risks of both the precursor(s) and the substance it generates. To take this change into account, ECHA has redefined the in situ generated active substances to refer consistently to both the substance generated in situ and its precursors presently included in the review program. ECHA notes that this may lead to situations where other precursors that are used by industry are not covered by the review program. ECHA invites companies using other precursors to notify it within one year if they wish to have their precursor-active substance system also included in the review program. More information is available in ECHA’s press release, In situ generated biocidal active substances redefined.

Roadmap Published For Defining Criteria For Identifying Endocrine Disruptors: Under Plant Protection Product Regulation (EC) 1107/2009 (PPPR) and BPR, “the co-legislators empowered the Commission to establish scientific criteria to identify substances with endocrine disrupting properties.” This Roadmap, published by DG ENV and DG SANCO in June 2014, defines criteria for identifying endocrine disruptors and is closely aligned with the guidance issued by the World Health Organization International Program on Chemical Safety (WHO IPCS) (2002). The EP and Council requested the EC to establish a horizontal hazard-based scientific criteria so it could be used in other EU legislation as well, namely REACH, Regulation (EC) No. 1223/2009 on Cosmetic Products, and the Medical Devices regulatory framework and Water Framework Directive 2000/60/EC.

The Roadmap introduces four policy options: the baseline, i.e., no policy change, the interim criteria set in BPR and PPPR continue to apply; hazard identification based on the WHO IPCS definition ; the WHO IPCS definition completed with categories based on strength of evidence; or completed with the introduction of potency. The three options for regulatory actions are the following: no policy change; considering further risk-related aspects; and considering further socio-economic aspects. To gather information on the potential economic impact of the above scenarios, a public consultation started in 2014 and concluded in January 2015. The EC released in February 2015 the non-confidential responses submitted on-line during this consultation and is expected to issue a detailed report on the consultation and possibly organize a stakeholder conference in summer 2015. The impact assessment will be conducted by the EC through mid-2016. The anticipated schedule for final criteria is a proposal in late 2016, adoption in early 2017, and entry into force in the second quarter 2017.

The Most Prominent Endocrine Disruptor Title Is Shared By BPA And DEHP: Bisphenol A (BPA) has been among the most well-studied endocrine disruptors, and not without controversy. A recent European Food Safety Authority (EFSA) assessment of over 450 scientific studies found the consumer exposure to BPA to be lower than the tolerable daily intake (TDI) of four micrograms per kilogram body weight per day (µg/kg bw/day). The exposure assessment covers both dietary and non-dietary exposure routes. Industry questioned the national ban on using BPA in food contact materials in France. The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) concluded its final opinion on the safety of BPA in medical devices, i.e., whilst accepting the TDI proposed by EFSA, “risk for adverse effects may exist from systemic exposure to BPA via non-oral exposure routes, especially for neonates in intensive care units, infants undergoing prolonged medical procedures and for dialysis patients. Although the benefit of medical devices has also to be considered, the SCENIHR recommends that, where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials.”

Bis (2-ethylhexyl)phthalate (DEHP) is relatively new to the endocrine disruptor discussion, but causes considerable headache to the EC lately following Denmark’s proposal to identify DEHP as an SVHC due to its reported endocrine disrupting properties in the environment. DEHP was already on the candidate list (and on the Authorization list with a sunset date of February 21, 2015) as toxic to reproduction category 1B. In fact, it was the first substance for which an Authorization has been granted; several other applications are awaiting the EC’s decision. One of the concerned parties, Deza, submitted a case to the EU General Court against this decision. It is uncertain at the moment what will happen with the already submitted applications [Case number: Case number = T-115/15]. Based on the Competent Authorities for REACH and Classification, Labeling, and Packaging (CLP) (CARACAL) meeting in April 2014, applicants need to prove whether a safe threshold exists and determine that threshold for endocrine disrupting substances, which is the basis for determining whether an applicant can apply on the “adequate control” route rather than the “Socio-economic Analysis (SEA-)” route. The original Danish proposal addressed both human and environmental endocrine disrupting properties, and included three further phthalates: dibutyl phthalate (DBP), diisobutyl phthalate (DiBP), and benzyl butyl phthalate (BBP), which have been removed subsequently, however. The Member State Committee decided the proposal would not result in additional regulatory benefit, as human risk is already covered by the existing listing on the Authorization List.

ECHA And The Danish Competent Authority Working On Compilation Of Annex XV Dossier To Restrict Use Of Four Phthalates In Imported Articles: This would be the first restriction under Article 69(2) to level the playing field between articles imported and manufactured in the EU, i.e., article importers benefit from the advantage that service life (use in imported articles) is not in the scope of Authorization. The expected date of submission is 2016. A similar legal procedure started when the Swedish Competent Authority, the Swedish Chemicals Agency (KEMI), identified dicyclohexyl phthalate (DCHP) as endocrine disruptor, asking for written comments for the fourth meeting of ECHA’s Endocrine Disruptor Expert Group. In the future, if a substance is undergoing hazard assessment under the substance evaluation process and discussed in the PBT or endocrine disruptor expert groups, this link will be visible in ECHA’s Public Activities Coordination Tool (PACT). PACT lists the substances for which a risk management option analysis (RMOA) or an informal hazard assessment for PBT/vPvB properties or endocrine disruptor properties is either under development or has been completed since the implementation of the SVHC Roadmap commenced in February 2013.

Stakeholder Consultation Begins On RoHS Exemption Request: On April 24, 2015, a stakeholder consultation began on six exemption requests from the Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS). Three are requests for renewal of exemptions listed in Annex III, and three are requests for new exemptions:

  • Exemption renewal request 9b: Lead in bearing shells and bushes for refrigerant-containing compressors with a stated electrical power input of only nine kilowatts or lower for the heating, ventilating, air conditioning, and refrigeration industry with requested expiry date three years after publication of the amended RoHS Annex;
  • Exemption renewal request 13a: Lead in white glasses used for optical applications;
  • Exemption renewal request 13b: Cadmium and lead in filter glasses and glasses used for reflectance standards;
  • Exemption request 2015-1: Lead in thin film electronic sensor elements such as pyroelectric sensors or piezoelectric sensors;
  • Exemption request 2015-2: Lead in high voltage cables and cable assemblies for a rated voltage higher than 250 kilovolt direct current, containing up to four percent lead by weight (for industrial monitoring and control instruments, Annex IV); and
  • Exemption request 2015-3: Lead as activator in the fluorescent powder (one percent lead by weight or less) of discharge lamps when used as phototherapy lamps containing phosphors such as barium silicate phosphor (BaSi2O5:Pb) (Annex IV).

Comments are due June 19, 2015.

ETUC Calls For Occupational Exposure Limits For Priority List Of Chemicals: On April 28, 2015, the European Trade Union Confederation (ETUC) announced that it “condemns the European Commission for delaying since October 2013 the adoption of legally binding exposure limits for chemicals that cause cancer, or are toxic for male and female fertility and the unborn child, because it is conducting a review of ‘red tape.'” According to ETUC, this means that 150,000 people have died while EC evaluates “better regulation.” ETUC “demands legally enforceable exposure limits for a priority list of 50 of the most harmful chemicals as a first step.” ETUC “call[s] on the European Commission to unblock the revision of the Directive on Carcinogens or Mutagens at work and include substances that are toxic for reproduction.”


List Of Priority Existing Substances Submitted For Consultation: On April 1, 2015, the Korean Ministry of Environment submitted the list of priority existing substances for consultation in accordance with Article 9 of Korea’s Registration, Evaluation, Authorization, and Restriction of Chemicals (K-REACH) regulation. The list identifies in Korean and English 518 phase-in (existing) substances that are considered a priority and thus part of the first phase of registration under K-REACH. The deadline for submitting comments was April 30, 2015. South Korea intends to publish the final list of priority existing substances in June 2015. Once the final list is published, companies manufacturing or importing listed substances will have three years to prepare their registration dossiers, for submission by June 30, 2018.


Taiwan Publishes Draft List Of Priority Management Chemical Substances: The Ministry of Labor (MOL) issued on April 13, 2015, a draft list of the Phase I Designated Priority Management Chemical Substances. Under the Occupational Safety and Health Act, a manufacturer, importer, supplier, or employer must submit relevant handling information, including exposure data, for listed substances. A public consultation on the draft list ended on April 24, 2015. The list will be effective May 31, 2015, following a public announcement by MOL.


UNEP Publishes Trade And Green Economy Handbook: The United Nations Environment Program (UNEP) announced on April 28, 2015, publication of the Trade and Green Economy Handbook, which is intended to increase the interaction between trade and the green economy, opening up new opportunities to drive sustainable development. The Handbook, prepared by UNEP and the International Institute for Sustainable Development, “covers a wealth of new information, including the emergence of the Green Economy concept, the latest World Trade Organization (WTO) jurisprudence and the increasingly important linkages between trade and inclusive Green Economy policies and practices.” These developments are considered amid the changing dynamics of international trade with the increased importance of global value chains and the rise of regional trade agreements. According to UNEP, the green economy presents a model for reversing environmental degradation and pollution by altering economic structures and incentives in a way that supports growth, social equity, and welfare through the preservation and sustainable use of natural resources and vigilant control of pollution. UNEP states that the Handbook is aimed at those policy makers interested in the transition to a green economy who require a better understanding of the relevant trade rules, as well as trade negotiators who want to learn about the environmental implications of their decisions. The Handbook is intended to increase coordination and reduce tension between the international trade and environment agendas to open new pathways to achieve sustainable development.