Global Regulatory Update for August 2016
SWA Announces New Chemical Database: On July 5, 2016, Safe Work Australia (SWA) announced the Hazardous Chemical Information System (HCIS), a new database that provides information on chemicals that have been classified in accordance with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The database features classification and labeling information for over 4,500 chemicals, including pictograms, and a searchable database of workplace exposure standards. The HCIS replaces the Hazardous Substances Information System (HSIS), a database of information on substances classified in accordance with Australia’s previous hazardous substance classification system, the Approved Criteria for Classifying Hazardous Substances. SWA states that the HCIS will make it easier for manufacturers, importers, suppliers, and end-users of chemicals to meet the GHS requirements. The GHS will become mandatory January 1, 2017. Manufacturers, importers, and suppliers of hazardous workplace chemicals are responsible for ensuring that correct GHS labels and safety data sheets (SDS) are prepared for hazardous chemicals. Users of workplace hazardous chemicals can keep using, handling, and storing hazardous chemicals labeled in accordance with a previous labelling code if the product was supplied before January 1, 2017. Beginning January 1, 2017, users should not accept new hazardous chemical products that are not GHS labeled.
NICNAS Publishes IMAP Review: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published on July 11, 2016, a review of the Inventory Multi-Tiered Assessment and Prioritization (IMAP) framework to determine if it had achieved its original purpose and to identify any areas for improvement. NICNAS established the IMAP framework to accelerate the assessment of risks to human health and the environment posed by chemicals listed on the Australian Inventory of Chemical Substances (AICS) that have not previously been assessed. The publication summarizes the review, including key data analysis; contains feedback from stakeholders; and highlights opportunities for applying the results to NICNAS-initiated assessments proposed by the NICNAS Reforms. The review found that the IMAP framework has been “very effective overall in accelerating high quality assessment outputs for chemicals.” By the end of December 2015, NICNAS had published 4,315 human health and/or environment assessments for a total of 3,215 chemicals in 15 tranches. The review also found that the IMAP framework has been successful in supporting risk management, with risk management measures implemented or being considered for a “significant number of chemicals” as a result of their assessment under the IMAP framework. The review identified opportunities to improve the assessment and prioritization processes. The review states that the improvements should contribute to a more robust and efficient framework that can be applied to the large number (approximately 34,000) of unassessed chemicals remaining on the AICS. More information about the IMAP framework review is available in a frequently asked questions (FAQ) web page.
NICNAS Updates Guidelines On Applying For Confidentiality: NICNAS published on July 12, 2016, updated guidelines on applying for information to be exempt from publication by NICNAS and establishing a case for confidential AICS listing. The guidelines are intended to assist:
- Applicants to prepare applications for:
- Listing/re-listing of an industrial chemical on the confidential section of the AICS; and
- Certain information given to NICNAS to be treated as exempt from publication;
- Listing/re-listing of an industrial chemical on the confidential section of the AICS; and
- NICNAS staff to review applications for exempt information and confidential listing/relisting; and
- The Director of NICNAS to make decisions on these applications.
Canada Begins Consultation On Proposed Prioritization Approach For Nanoscale Forms Of DSL Substances: On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL). Canada will use the proposed approach to: (1) establish a list of existing nanomaterials in Canada for prioritization; (2) identify how the information available will be used to inform prioritization of nanomaterials for risk assessment; and (3) outline the proposed outcomes of the prioritization process. In 2015, Canada conducted a mandatory survey under Section 71 of the Canadian Environmental Protection Act, 1999 (CEPA). The survey applied to persons who manufactured or imported any of 206 nanomaterials at a quantity greater than 100 kilograms during the 2014 calendar year. Based on the results of the survey, ECCC and HC will prepare a final list of confirmed existing nanomaterials in Canada and will use the list for subsequent prioritization. ECCC and HC propose that, where possible, the substances identified via the survey be “rolled up into” their broader parent nanomaterial groups for the purposes of prioritization. According to ECCC and HC, this will allow, when possible, a more robust look at the hazard, volume, and use data as appropriate, rather than considering an individual substance-by-substance approach. Comments on the proposed prioritization approach are due September 25, 2016. More information is available in Bergeson & Campbell, P.C.’s (B&C®) August 4, 2016, blog item, “Canada Begins Consultation on Proposed Prioritization Approach for Nanoscale Forms of DSL Substances.”
Catalog Of Hazardous Wastes Enters Into Force: On August 1, 2016, an updated Catalog of Hazardous Wastes entered into force. Companies must use qualified professional hazardous waste disposal companies to treat wastes listed in the Catalog, which are officially categorized as hazardous. The updates to the 2008 Catalog include the addition of 117 types of hazardous wastes; a list of categories exempt from waste management; and all 2,828 chemicals listed in the State Administration of Work Safety’s (SAWS) Catalog of Hazardous Chemicals are categorized as hazardous waste at the end of their lives.
China Implements Requirements For Shipments From Zika-Infected Countries, Including The U.S.: In March 2016, the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) began requiring all countries on its Zika-infected list to comply with disinsection requirements. The United States Department of Agriculture (USDA) Foreign Agricultural Service’s (FAS) August 19, 2016, “Update on China’s Requirements for Shipments from Zika-Infected Countries” reports that following the World Health Organization’s (WHO) August 2, 2016, listing of the U.S. as a country reporting mosquito-borne Zika virus transmission, China now requires mosquito disinsection for all U.S.-origin shipments to China. As of August 5, 2016, 40 other countries, including Mexico and Brazil, are subject to these requirements. FAS states that on August 18, 2016, staff from the U.S. Embassy in Beijing met with AQSIQ’s Department of Supervision and Health Quarantine. FAS provides the following summary of its understanding of AQSIQ’s responses during that meeting:
- Chinese authorities require all cargo shipments originating from the U.S. to provide proof of disinsection upon arrival at the Chinese port, both either air or sea. This applies to all vessels that left the U.S. on or after August 5, 2016, with the exception of containers kept at or under a temperature of 15°C (59°F).
- Disinsection treatment may be carried out by either physical or chemical means, and does not require fumigation. Physical means could include trapping, air curtains, or other integrated pest-management techniques. Chemical means could include surface spraying, space spraying, or fumigation, depending on the shipper’s choice. The treatment used should take into account human health and safety.
- Treatment can be carried out at any point during the shipping process. For example, it is acceptable for containers to be disinsected before loading, certified as mosquito free, then loaded in a mosquito-free environment.
- Proof of disinsection does not need to be government-issued.
- Either the vessel or the container must be certified, not the goods themselves.
- The information to be included on the certificate has already been provided in the notice sent out by AQSIQ. If you do not have a copy, FAS can share with you.
- All shipments found to contain live mosquito eggs, larvae, or mosquitoes during inspection at the Chinese port will be subject to disinsection, including shipments that are chilled below 15°C (59°F). Chinese authorities will direct a third party to perform any required disinsection in accordance with WHO guidelines as outlined in the AQSIQ announcement. The cost will vary at each port of entry, but AQSIQ estimates that it will be about RMB 200 ($30) for a 20-foot container and RMB 400 ($60) for a 40-foot container.
- All WHO member countries where Zika is present will be treated in the same manner.
- AQSIQ has not contacted airlines, shipping lines, exporters, etc., about the mosquito treatment requirements. Rather, AQSIQ leaves it up to each CIQ (branch office) at the port of entry to give out this information.
- AQSIQ will perform a Zika risk assessment for Florida and neighboring states, based in part on the U.S. Centers for Disease Control and Prevention (CDC) documentation of control measures. AQSIQ will use the assessment to determine whether to apply a regional approach in its Zika response.
- China’s policy applies to Zika and yellow fever, and will remain in effect until March 2017, subject to adjustment or renewal depending on the situation.
EUROPEAN UNION (EU)
BoA Rules On CSA Obligations: On June 28, 2016, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) supported ECHA’s decision to require a registrant to conduct an environmental exposure assessment although the relevant substance is not classified under the Classification, Labeling, and Packaging (CLP) Regulation as hazardous to the environment.
BASF, the Appellant, performed a Chemical Safety Assessment (CSA), including an exposure assessment and associated risk characterization, for the substance, 2-ethylhexyl acetate. The exposure assessment and associated risk characterization were limited to human health hazards, on the basis that the substance is classified as hazardous only in relation to human health under the CLP Regulation.
ECHA conducted a compliance check of BASF’s registration dossier for 2-ethylhexyl acetate, and notified a draft decision to BASF for comments on November 19, 2013. The draft decision contained requests for inclusion in the Chemical Safety Report of an environmental exposure assessment and risk characterization. BASF claimed that the environmental exposure assessment and risk characterization were not required by Article 14 and Annex I of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation as the substance is not classified under Annex I of the CLP Regulation as hazardous to the environment.
BASF commenced the appeal before BoA on December 15, 2014, and requested that BoA annul the Contested Decision and make an order for refund of the appeal fee. BASF raised two pleas in law in support of its appeal: (1) the Contested Decision lacks legal basis; and (2) the Contested Decision breaches the principle of legal certainty.
BoA observed that examination of the first plea requires it to interpret REACH Article 14. BoA stated that “[o]n the basis of the literal, contextual and teleological interpretation of Article 14 … [BoA] finds that the scope of the exposure assessment and [risk characterization] provided for by Article 14(4) is not limited to hazards which lead to classification under the CLP Regulation.” Regarding BASF’s second plea, BoA stated: “Insofar as the plea relating to the principle of legal certainty overlaps in part with the first plea raised in this appeal, alleging the lack of a legal basis, it must be rejected as unfounded for the same reasons as the first plea.”
Under BoA’s decision, BASF is required to meet the information requirements of the Contested Decision by January 2, 2017, and the appeal fee will not be refunded.
EC Denies 2014 Petition Seeking EU-Wide Ban On Nanoparticles: On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament (EP) regarding its response to a 2014 petition calling for an EU-wide ban on microplastics and nanoparticles. In its response, the EC states that the general regulatory framework on chemicals, along with the sectoral legislation, “are appropriate to assess and manage the risks from nanomaterials, provided that a case-by-case assessment is performed.” The EC notes that the need to modify REACH to include more specific requirements for nanomaterials was identified. According to the EC, a final impact assessment of the proposed changes is being prepared, and the modification of technical REACH Annexes to include specific considerations for nanomaterials is planned for early 2017. The EC states that it created a web portal intended to improve communication regarding nanomaterials, and that this web portal will soon be superseded by the EU Nano Observatory, which will be managed by ECHA. The EC concludes that it has “no plans for a generic ban of nanomaterials,” and as it states in the petition response, “[n]anotechnology has a considerable potential to develop tools that protect human health and the environment and address other societal challenges, and the Commission supports its responsible development and use.”
BPA Banned In Thermal Paper: The EC’s proposed Regulation and Annex thereto, which amend REACH Annex XVII by creating a new entry to include a restriction for Bisphenol A (BPA) in thermal paper with a limit of 0.02 percent by weight, were supported by a committee of Member State officials on July 6, 2016. The ban was initially proposed by France in 2014, and was supported by ECHA’s Committees for Risk Assessment and Socio-economic Analysis.
Member State officials supported the proposed Regulation without any changes to the text. According to the World Trade Organization (WTO) Notification, the draft Regulation is proposed to be adopted in the “[s]econd half of 2016,” and will enter into force 20 days after publication in the Official Journal of the European Union. The restriction on BPA in thermal paper will apply three years after the Regulation enters into force.
Scientists Issue Letter Criticizing EDC Criteria: On July 6, 2016, a group of 15 European and U.S. researchers wrote to the EU’s Health and Food Safety Directorate, criticizing recent proposals for the identification of endocrine disrupting chemicals (EDC) under the Plant Protection Products (PPP) Regulation and the Biocidal Products Regulation (BPR).
The scientists addressed two major concerns relating to the proposed criteria:
- The criteria place an “under-defined, potentially unprecedentedly high, burden of proof” on identifying problem compounds as having endocrine-disrupting properties, with the result that the identification process will be either conducted inconsistently, or only a very small proportion of EDCs may be classified as such; and
- The criteria present a “confused set of processes for identifying, evaluating and integrating scientific evidence,” and these processes unnecessarily privilege certain types of data, and cannot be operationalized adequately for regulatory identification of EDCs.
The researchers’ suggestions to “resolve the issues” include: (1) a clear, unambiguous definition of “known to cause adverse effects relevant for human health”; (2) allowance for regulatory identification of a chemical substance as an EDC in the absence of “sufficient” evidence of harm from epidemiological studies; (3) the introduction of a hierarchy of categories for EDCs; (4) the articulation of a systematic and coherent process for integrating evidence across the three components of the WHO definition of EDC; and (5) ensuring all evidence is assessed on merit without privileging certain study types.
REACH Committee Approves Authorization For Lead Pigments Despite NGOs’ Efforts: On July 6-7, 2016, the majority of REACH Committee members voted to approve the EC’s draft Implementing Decision, which granted authorization for uses of two lead chromate pigments, lead sulfochromate yellow and lead chromate molybdate sulfate red. The draft Implementing Decision provided Dominion Color Corporation, the applicant, a review period of seven years for all uses of the substances. This timeframe has been reduced to four years for use in road markings.
IPEN and the International Chemical Secretariat (ChemSec), and the Health and Environmental Alliance (HEAL), ClientEarth, the European Environmental Bureau (EEB), and several other non-governmental organizations (NGO) issued letters to the REACH Committee discouraging authorization of the lead chromates ahead of the REACH Committee meeting.
In its July 5, 2016, press release, NGO IPEN stated “[the EC] has issued a draft decision to the REACH Committee that would authorize use of two toxic lead pigments in the EU for non-consumer use, despite the availability of well-known alternatives.” IPEN expressed that the REACH Committee should not have approved the Implementing Decision because:
- The EC’s draft Implementing Decision disregards that there are known alternatives to lead chromates available;
- The health and environmental risks associated with the authorization are high; and
- The authorization creates an unacceptable precedent for REACH, and harms the global movement to eliminate lead chromates in paint.
Industry Sends Letter On TTIP To EP President: On July 7, 2016, 67 organizations, including EEB, HEAL, and Greenpeace, issued a joint letter to EP President Martin Schulz on the Transatlantic Trade and Investment Partnership (TTIP).
The letter states: “In anticipation of the 14th round of negotiations between the EU and US for [TTIP] planned to start on 11 July in Brussels, we are writing to you on behalf of over 65 [organizations] representing consumers, farmers, not-for-profit health insurers, environmental and general public interest groups to express our serious concerns that the [EC] is failing to respect the [EP’s] 2015 Resolution on TTIP.”
The letter references “A Compliance Check of the [EP]’s TTIP Resolution,” a joint report prepared by the Center for International Environmental Law, ClientEarth, and HEAL. Three key recommendations of the report are: (1) “[d]o not negotiate on areas where the EU and the US have very different rules and do not allow regulatory cooperation to affect standards that have yet to be set in such areas”; (2) “[p]revent TTIP from affecting the EU regulatory process”; and (3) “[s]ubstantially reform the investor-state dispute settlement (ISDS) mechanism.”
In their letter, the organizations state that it is “particularly worrying” that the EC has continued to negotiate on issues that will affect European legislation on chemicals, pesticides, and cosmetic products. Additionally, the organizations expressed discontent with the EC’s proposal to “codify regulatory tools in TTIP that have already led to delays in introducing legislation that would protect human health.” In conclusion, the letter states “we strongly urge you to use your influence to ensure that the [EC] complies with the [EP’s] recommendations on TTIP.”
EC Suggests Lower Migration Limit For BPA In Toys: The EC has published a proposal, in the form of a draft Commission Directive, to lower the migration limit for BPA in toys from 0.1 milligrams per liter to 0.04 milligrams per liter. The EC’s proposal states: “In the light of available scientific evidence and considering the differences between toys and materials which come into contact with food, the currently applicable specific limit value for [BPA] in toys is too high and should be revised.” The EC indicated that Appendix C to Annex II of the Toy Safety Directive should be amended to reflect the revised migration limit.
According to the EC’s Notification to the WTO, the proposed date of adoption for the draft Commission Directive is the “[f]ourth quarter of 2016,” and the “[p]roposed date of entry into force” is the “[s]econd quarter of 2018.”
EC Issues Report On Costs For Chemicals Industry: On July 11, 2016, the EC issued a report entitled “Cumulative Cost Assessment for the EU Chemical Industry.” The report was prepared as part of the EC’s Better Regulation Agenda and includes a number of chapters, including “[p]anorama of the EU chemical industry,” “[m]ethodology,” and “[r]esults of the cumulative cost assessment.”
The report states “[w]hen all legislation relevant to chemical companies is cumulated, the estimated average annual total direct cost borne by the subsectors covered by the study during the period 2004-2014 approaches €9.5 billion, representing around [two percent] of their turnover and [12 percent] of the value added. Comparing cost with Gross Operating Surplus (GOS), which can be used as a proxy for profit, the cost represents as much as [30 percent] of this value, indicating that legislation cost is among the important factors shaping the profitability of the EU chemical industry … [C]ost is mainly driven by the chemicals legislation package, responsible for [75 percent] of the administrative burden, and more specifically by REACH, PPPs, biocides and CLP regulation.”
The European Chemical Industry Council (Cefic), which provided support for the preparation of the Cumulative Cost Assessment, stated that Europe’s complex regulatory framework poses a significant burden on EU chemical companies. Furthermore, Cefic stated “[t]he picture is very clear. Europe needs to focus on its competitiveness, of which the regulatory burden is a big factor … Cefic will continue to explore with the EU institutions how the regulatory framework can be made more cost-effective and fit for purpose while upholding the same high level of safety, health and environmental protection.”
More information is available in Cefic’s press release, “New Commission study shows high regulatory costs for EU chemical industry.”
Fourteenth Round Of TTIP Negotiations Concluded: The 14th Round of Negotiations for TTIP took place in Brussels on July 11-15, 2016. During these discussions, the EU advanced proposals on chemicals and cosmetics, and the U.S. raised a number of preliminary questions in this regard.
In its proposal for an Annex on Chemicals, the EU stated that the objectives of the Annex are to: (1) “[e]nhance cooperation on the review and assessment of chemicals of common priority to enable governments and stakeholders, including in particular small and medium-sized enterprises, to better use their limited resources”; (2) enhance scientific cooperation related to hazard identification and risk assessment methodologies; (3) improve exchange and/or availability of information and data on chemicals for regulatory purposes; (4) promote alignment in classification and labeling of chemicals based on GHS; (5) enhance cooperation on new and emerging issues of common interest; (6) strengthen cooperation in relevant international organizations and bodies; and (7) promote regulatory cooperation to facilitate the coordination of regulatory initiatives on chemicals, avoid unnecessary duplicative requirements, and if possible, identify and implement actions that can reduce unnecessary costs.
The EU’s proposal for an Annex on Cosmetics states that it seeks to promote convergence of technical requirements and relevant standards for cosmetics; alignment for labeling of ingredients; use of validated alternative methods to animal testing; and cooperation related to safety assessment methodologies.
Discussions on chemicals and cosmetics will continue “ahead of the next round” of TTIP negotiations, “which will most likely take place in the autumn.”
BPA Classified As Category 1 CMR Under CLP Regulation: On July 19, 2016, Commission Regulation (EU) 2016/1179 was published in the Official Journal of the European Union. The Regulation provides numerous changes to Annex VI of the CLP Regulation. These changes include revised mandatory classification of BPA as a Category 1B substance toxic for reproduction. The revised classification of BPA brings it into the Carcinogenic, Mutagenic, and Reprotoxic (CMR) Category 1 group. As a consequence, BPA can be nominated as a Substance of Very High Concern (SVHC) and added to the REACH Candidate List.
The revised classification of BPA will apply from March 1, 2018, when Commission Regulation (EU) 2016/1179 enters into force.
EU Takes Legal Action Against China’s Restrictions On The Export Of Raw Materials: The EC issued a July 19, 2016, press release, “EU takes legal action against export restrictions on Chinese raw materials,” announcing its third case against China concerning restrictions on the export of raw materials. According to the EC, China currently imposes a set of export restrictions, including export duties and export quotas, that limit access to graphite, cobalt, copper, lead, chromium, magnesia, talcum, tantalum, tin, antimony, and indium for companies outside China. The EC claims that these measures have distorted the market and favored Chinese industry at the expense of companies and consumers in the EU, in violation of general WTO rules and also of China’s specific commitments from the time of its accession to the WTO. The EC states that China’s “alleged aim to support an environmentally friendly and sustainable production of raw materials could be achieved more effectively with other measures, without negative impact on trade.” Formal consultations between the EU and China — the first step in the WTO dispute settlement process — will be conducted in parallel to a similar procedure initiated by the U.S. In absence of a satisfactory solution within 60 days, the EU may request the WTO to set up a panel to rule on the compatibility of China’s measures with WTO rules.
MIT Banned In Leave-On Cosmetics: The EC has banned the use of Methylisothiazolinone (MIT) in “leave-on” cosmetic products, following public consultation, due to its sensitizing potential. The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on MIT on December 12, 2013, which concluded that, based on clinical data, a concentration of 100 parts per million (ppm) of MIT in cosmetic products is not safe for consumers. For leave-on cosmetic products, SCCS concluded that no safe concentrations of MIT for induction of contact allergy or elicitation have been adequately demonstrated.
The ban on MIT, through amendment of the Cosmetics Regulation, allows for a transition period until February 12, 2017. By this date, industry is required to make necessary adjustments to product formulations and withdraw non-compliant products from the market.
EC Publishes Updated Blue Guide On The Implementation Of EU Product Rules: On July 26, 2016, the EC published a notice announcing the availability of the 2016 Blue Guide on the implementation of EU products rules. In 2000, the EC published the Guide to the implementation of directives based on the New Approach and the Global Approach, more commonly known as the Blue Guide. Since then, according to the EC, the Blue Guide has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework. The EC states that much of the 2000 edition is still valid, but it requires updating to cover new developments and to ensure the broadest possible common understanding on implementation of the New Legislative Framework for the marketing of products. It is also necessary to take account of the changes introduced by the Lisbon Treaty with regard to the legal references and terminology applicable to EU-related documents and procedures. The new version of the Blue Guide builds on the past edition, but includes new chapters, for example on the obligations of economic operators or accreditation, or completely revised chapters such as those on standardization or market surveillance. The EC notes that the Blue Guide has also been given a new title reflecting the fact that the New Legislative Framework is likely to be used, at least in part, by all types of EC harmonization legislation and not only by the so-called “New Approach” directives. The Blue Guide lists EU legislation to which it primarily relates, including the restriction of the use of certain hazardous substances in electrical and electronic equipment (Directive 2011/65/EU) (RoHS); ecodesign requirements for energy-related products (Directive 2009/125/EC); toys’ safety (Directive 2009/48/EC); active implantable medical devices (Directive 90/385/EEC); medical devices (Directive 93/42/EEC); in vitro diagnostic medical devices (Directive 98/79/EC); equipment and protective systems intended for use in potentially explosive atmospheres (Directive 94/9/EC and Directive 2014/34/EU); personal protective equipment (Directive 89/686/EEC). The Guide states that it “does not attempt to cover” the Directive on General Product Safety, for which the EC services have provided specific guidance, or the EU legislation on motor vehicles, construction products, REACH, and chemicals.
ClientEarth Suggests EC’s EDC Plan Is Illegal: In its July 28, 2016, press release entitled “Commission endocrine disruptor plan is illegal,” ClientEarth stated “[the EC’s] call for reaction to its [EDC] plan [closed on July 28, 2016] … In saying that only EDCs known to harm people should be outlawed, the [EC] is ignoring [BPR and the PPP Regulation]. These two laws require that chemicals presumed to cause harm are outlawed.”
ClientEarth Lawyer Vito Buonsante stated “[the EC’s] plan makes people the lab rats in a hugely dangerous experience. EDCs cause cancer, development problems and infertility. Under the [EC’s] proposal, the only way to outlaw them would be to wait for human health to suffer.” ClientEarth suggests that the EC wants to change the way risks are managed, and that such a major change in law should be negotiated between the EP and the Council of the EU. Furthermore, ClientEarth stated that if the EC “forces through its proposals,” the European Court of Justice can reject them on the grounds that the EC has overstepped its powers.
In the legal opinion on behalf of ClientEarth, the authors state “[g]iven the BPR and the [PPP Regulation] are ‘underpinned by the precautionary principle,’ the scientific criteria, too, need to reflect the precautionary principle … Based on [the] findings the conclusion can be drawn that the [EC] is not legally entitled to use its powers mandated by the BPR and the [PPP Regulation] to implement the [EDC] criteria as defined by the draft proposals.”
More information is available in ClientEarth’s analysis summary, “How will the EU identify EDCs and ban or approve their use? — The Commission cannot change the scope and basis of the mechanism through the back door.”
EC Expands Furniture Ecolabel Criteria: On July 28, 2016, the EC established via Commission Decision (EU) 2016/1332 ecological criteria for the award of its EU Ecolabel for furniture. The Commission Decision states “[t]he revised ecological criteria aim at using materials produced in a more sustainable way (considering a life cycle analysis approach), limiting the use of hazardous compounds, the levels of hazardous residues, the contribution of furniture to indoor air pollution and promoting a durable and high-quality product that is easy to repair and disassemble.”
Although such criteria already exist for wooden furniture, the EC decided that to reflect better the range of furniture products on the market and the state of the art for these products, and to account for innovation in recent years, it is appropriate to extend the scope of the product group to include non-wooden furniture, and to establish a revised set of ecological criteria.
The Commission Decision states: “It is appropriate to allow a transitional period for producers whose products have been awarded the EU Ecolabel for wooden furniture on the basis of the ecological criteria set out in Decision 2009/894/EC, so that they have sufficient time to adapt their products to comply with the revised ecological criteria and requirements … EU Ecolabel licenses awarded in accordance with the criteria set out in Decision 2009/894/EC may be used for 12 months from the date of adoption of this Decision.”
EC Issues Evaluation Roadmap For Batteries Directive: On August 16, 2016, the EC issued an Evaluation Roadmap for the Batteries Directive. The evaluation is intended to assess if the Batteries Directive meets its objectives and contributes to the general objectives of the EU’s environmental policy. The results of the evaluation will be used to identify measures to improve the Directive and its implementation. The evaluation will pay particular attention to aspects for which implementation has been challenging. The relevance, coherence, effectiveness, efficiency, and added value of the Directive’s provisions and its implementing legislation will be considered in the evaluation.
The planned start date for the evaluation is the fourth quarter of 2016, and the planned completion date is the fourth quarter of 2017.
Germany Notifies EC Of Draft Amendment Concerning Printing Inks For Food Contact Materials: On July 5, 2016, Germany notified to the EC a draft of the “Twenty-First Ordinance amending the Consumer Goods Ordinance (Bedarfsgegenständeverordnung).” The draft amendment generally applies to printed food contact materials and articles. To protect consumers from possible health risks involving printed food contact materials and articles, the draft amendment makes provision for a list of substances permitted for use in printing inks for printing food contact materials and articles, including toxicologically derived maximum quantities for the transfer of these substances to foodstuffs (positive list). Only those substances for which a risk assessment or suitable and adequate toxicological data is available to this end are included in the positive list. Substances may also be used for which insufficient documentation for the purposes of a health assessment is available. CMR substances may not be used if a safety assessment that would justify their use or the derivation of limit values for transfer to foodstuffs is unavailable and, hence, facilitate inclusion in the positive list.
RIVM Issues Report On Microplastics Emissions: The Dutch National Institute for Public Health and the Environment (RIVM) issued a report entitled “Emission of microplastics and potential mitigation measures.” In its report, RIVM states “[t]yres, paints and abrasive cleaning agents can release microplastic particles, which are distributed in soil, water and air. Tyre wear is the largest of these three sources, with a total emission in the Netherlands of 17,300 tons per year, followed by paint particles at approximately 690 tons per year. The abrasive cleaning agents are a much smaller source, at approximately [three] tons per year.”
To “create awareness amongst consumers and professionals in order to induce a change in behavior,” RIVM’s report analyzes the impact of abrasive cleaning agents, paints and coatings, and rubber tires on releases of microplastics into the environment. The report states “[v]alid reasons for reducing microplastics are the precautionary principle and the ambition to close loops of materials in order to achieve a circular economy and improve resource efficiency.”
RIVM’s report provides measures to reduce microplastics emissions (e.g., national and international approaches, command and control instruments, and economic instruments), and recommends “further socio-economic analysis” to determine the effectiveness, viability, costs, and benefits of the measures.
Amended K-REACH Decree And Enforcement Rules Enter Into Force: The Ministry of the Environment (MOE) published an amended version of the Act for the Registration and Evaluation of Chemicals (K-REACH) enforcement decree and enforcement rules, which have both entered into force. The amendments include some exemptions from reporting for new chemicals, and an extended 14-day grace period for substances used only for research and development (R&D) purposes. The final amendments do not include a proposal to remove a provision that states quantitative structure-activity relationship (QSAR) data can be used only for substances imported or manufactured in volumes below ten tonnes per year. This means these restrictions are still in place. To help small- and medium-sized enterprises (SME) with their increasing obligations, the enforcement decree stipulates that MOE will provide:
- Administrative, technical, and financial support;
- Education and promotion of related law; and
- Research support in finding alternative technologies to hazardous chemicals.
Sweden Bans BPA In Water Pipe Linings: The Swedish government announced, in Swedish, that it is banning BPA use in epoxy resins in water pipe linings, starting September 1, 2016. The announcement provides that studies suggest drinking water pipes renovated with epoxy may leak BPA into the water. The Swedish government stated that high levels of BPA have been measured in hot water from pipes that use epoxy material, and that more environmentally friendly methods exist in Sweden for repairing water pipes.
Swedish Environment Minister, Carolina Forest, highlighted that citizens need to be confident of their drinking water, and mentioned the special importance of this for parents of young children. The Swedish government stated that baby formula mixed with lukewarm water from pipes containing epoxy material may contain BPA at levels that are potentially harmful for infants.
In its announcement, the Swedish government highlighted key concerns with BPA’s endocrine-disrupting properties, and suggested that if small children or fetuses are exposed to BPA, risks of cancer, diabetes, obesity, and cardiovascular disease in adulthood increase. Carolina Forest emphasized that the Swedish government prioritizes protection of its citizens from EDCs, particularly as the chemicals spread across national borders via air, water, and supplies.
Thailand Publishes Preliminary Inventory Of Existing Chemicals: The Department of Industrial Works (DIW) recently published a preliminary inventory of existing chemicals that it has since taken offline due to server issues. The preliminary inventory combined the hazardous substance list; the most recent hazardous chemical notification list; chemicals listed in DIW’s consultation database; and the national single window list from the Customs Department. DIW expects to publish a final inventory of existing chemicals in 2017. Chemicals not listed on the inventory would be considered new chemicals. More information is available, in Thai, on DIW’s website.
CIA Issues Open Letter To Candidates For Next Prime Minister: On July 1, 2016, the Chemical Industries Association (CIA) issued an “Open Letter to All Candidates for the UK’s Next Prime Minister from the UK’s Number One Manufacturing Exporter.” In its letter, CIA stated “[t]he chemical and pharmaceutical industry, ranging from small companies to large multi-nationals, is the UK’s largest manufacturing export earner. The products and technologies we make deliver clean water, vital medicines, modern communications and so much more for society.” The letter provides that the chemical sector contributes £200 billion every year (£3.8 billion every week) to the UK economy and involves 150,000 women and men. Additionally, CIA stated “[e]very successful economy has a strong manufacturing base, with a chemical sector at its heart.”
CIA stated that, in leaving the EU, “three key priorities” must be secured to ensure economic success:
- Access to the single market;
- Availability of skilled people; and
- The supply of competitive and secure energy.
In conclusion, CIA stated that as the UK builds its future relationship with Europe, “politicians, the business community and others” should work together to deliver the best possible outcome for the UK’s population.
IPCP Issues Report On EDCs: The International Panel on Chemical Pollution (IPCP) issued a report entitled “Overview Report I: A Compilation of Lists of Chemicals [Recognized] as [EDCs] or Suggested as Potential EDCs.” The report is the first of a series of reports that the UN Environment Program (UNEP) commissioned IPCP to prepare.
The report states “[EDCs] are chemicals that may interfere with the endocrine system(s) and cause adverse effects. Over the past three decades, international concern regarding [EDCs] and research efforts to better understand them have intensified. Numerous efforts by the global scientific and regulatory communities have revealed substantial evidence of increasing trends of endocrine-related disorders linking to exposure to EDCs in humans and related effects in wildlife and raised serious concern about EDCs.”
The report provides a compilation of lists of chemicals that have been recognized as EDCs based on the WHO/International Program on Chemical Safety (IPCS) 2002 definition, or have been suggested as potential EDCs by various stakeholders. Some of the report’s general observations include that: (1) the purpose of individual lists varies considerably; (2) the selection criteria used to justify the inclusion of chemicals in a list vary considerably; and (3) comparing the lists highlights inconsistencies in methods being used, the lack of input from “developing and transition countries,” and the need for further clarification of the meaning and purposes of the lists. The report states that the following lists have the “most justified and robust selection criteria”:
- REACH SVHC Candidate List;
- The list of substances evaluated using the Danish criteria for identifying EDCs by the Danish Environmental Protection Agency; and
- Substitute it Now! (SIN) List by ChemSec.
Accordingly, IPCP stated that it considers the 77 chemicals identified in these lists as “identified EDCs or potential EDCs with high certainty.” The comment period on IPCP’s report ended on August 20, 2016.
UN Group Publishes Report On Sound Chemicals Management: The UN Environment Management Group published a report entitled United Nations and Sound Chemicals Management: Coordinating delivery for Member States and sustainable development. The report reviews how the UN and related agencies can support Member States in addressing the issue of sound management of chemicals and chemical waste. The report provides conclusions regarding the state of system-wide efforts to achieve the 2020 goal of producing and using chemicals in ways that lead to the minimization of significant effects on human health and the environment. The report recommends:
- Those organizations that have not already done so issue a declaration or joint statement signaling commitment to promote the importance of sound chemicals management both within and outside of their organizations;
- Identify and promote the multiple benefits of greater cross-sectoral coordination, and engage as standard practice to invite other sectors/organizations to relevant meetings;
- Increase and broaden efforts to organize joint capacity-building workshops for key sectors with involvement of relevant UN and other agencies, and include chemicals modules in relevant training and capacity building workshops for “non-chemicals” topics and Conventions;
- Build on the work of the Inter-Organization Program for the Sound Management of Chemicals and prepare a detailed assessment of other UN organisations’ contributions to the Strategic Approach to International Chemicals Management (SAICM) and the 2020 goal by reviewing the full SAICM Global Plan of Action;
- Examine and develop linkages with initiatives linked to the green economy and cleaner production, green jobs, greening the health sector, and other similar programs;
- Capitalize on existing opportunities to promote the importance of sound chemicals management issues at key meetings and participate at or convene high-level events during major international meetings to highlight the UN system contribution to sound chemicals management and its co-benefits for sustainable development; and
- Continue to coordinate, promote synergies, and work with authorities at the national level and encourage countries to integrate sound chemicals management issues in national development plans.