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Top International News in Chemical Policy and Regulation-June 2017: Europe

European Union (EU)

PlasticsEurope Files Action Against ECHA’s SVHC Listing For BPA: On March 21, 2017, PlasticsEurope, an important trade association, filed an action against the European Chemicals Agency’s (ECHA) inclusion of bisphenol A (BPA) in the Candidate List of SVHCs. BPA was added to the Candidate List on January 12, 2017, due to its reprotoxic properties following a proposal by French authorities. Additionally, the Member State Committee will discuss at its meeting scheduled for June 12-16, 2017, a proposal to identify BPA as an endocrine disruptor for humans.

PlasticsEurope’s action claims that the European Court of Justice should: (1) declare the application admissible and well-founded; (2) annul ECHA’s decision, published on January 12, 2017, to include BPA in the Candidate List; (3) order ECHA to pay the costs of the proceedings; and (4) take such other or further measure as justice may require. PlasticsEurope emphasized widespread use of BPA as an intermediate and raised the following pleas in law:

  • The Contested Decision breaches Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Article 2(8)(b) because intermediate uses are “exempt from the entire Title VII pursuant to Article 2(8)(b) of the REACH Regulation, and are thus outside the scope of Articles 57 and 59 and outside the scope of [authorization].”

  • The Contested Decision breaches the principle of proportionality because inclusion of intermediate uses in the Candidate List exceeds the limits of what is appropriate and necessary to attain the objective pursued and is not the least onerous measure to which ECHA could have had recourse.

  • ECHA committed a “manifest error of assessment” by failing to take into account the information made available in the REACH Annex XV dossier for BPA, which described uses of BPA as an intermediate.

A court hearing for this case is likely to commence in late 2017-early 2018.

ECHA Continues Development Of Its Transparency Approach: ECHA’s “Update of the ECHA Transparency Approach” following the 45th Meeting of the Management Board on March 30-31, 2017, provides that ECHA’s “efforts towards openness and transparency remain focused” on the following three pillars:

  • ECHA clearly explains activities and processes in a way that is understandable by a general audience. ECHA, therefore, describes its role, its activities, how it works, who works there, and how it achieves its results.

  • ECHA practices open decision-making. It describes clearly who makes decisions, who is involved, how and when it consults the public, how stakeholders can observe and contribute, and how bias is avoided.

  • ECHA makes information available in a timely manner. It makes information available proactively and provides it in such a way that citizens can easily understand and reuse it, in whole or in part.

Annex 1 of ECHA’s Update provides a report on transparency improvements in 2015-2016. These improvements include: (1) further developing ECHA’s work to improve the dissemination of information on chemicals and extending it to cover ECHA’s decisions; (2) improved communications; and (3) improving the transparency of Committee meetings by providing more explanation and information on the processes and decision-making, and by reviewing observer and third party involvement.

Annex 2 of ECHA’s Update provides its goals for further improvement in transparency in 2017-2018, which include: (1) further developing the dissemination of information on chemicals; (2) improving communication, including more focus on specific target groups; and (3) continual improvement of the transparency of Committee meetings, regulatory decision-making, and third party involvement therein.

As part of its efforts to develop further the dissemination of information on chemicals, ECHA has launched a study on extending its dissemination website with an “EU chemicals legislation finder” that provides an overview of how a substance is regulated at the EU level. Subject to the outcome of the study and its reception, ECHA may be asked to develop the finder in 2018.

ECHA States All Known SVHCs Are “Being Tackled”: On April 25, 2017, ECHA announced the availability of the third annual report on implementing the SVHC Roadmap. ECHA states that each year since 2013, it has screened the full REACH/Classification, Labeling, and Packaging (CLP) regulation substance database to identify substances of concern. This resulted in around 900 substances being put forward for further manual screening by the EU Member States, of which more than 600 have now been screened. According to ECHA, identifying substances of potential concern is becoming more and more difficult because of the lack of information on their hazards and on how they are used. Information is being requested for 540 substances. ECHA and the Member States have started to look more at groups of structurally similar substances. ECHA states that this will speed up the process of identifying substances of concern by enabling conclusions to be drawn on a larger number of substances at the same time. Since 2013, ECHA and the EU Member States have decided on the best risk management option for a total of 67 substances of potential concern. Approximately half are being listed as SVHCs.

ECHA Updates List Of Biocidal Active Substances In The Review Program: ECHA announced on April 27, 2017, that the list of biocidal active substances to be evaluated by Member States has been updated. The updated Annex II to the Review Program Regulation includes a list of the active substances for which companies have requested approval for a specific product-type. If a substance is on the list for a particular product-type, that product can remain on the EU market until the substance is approved. If a substance is no longer included in the Review Program for a specific use, it means that no company has expressed an interest in keeping it there or the notification has not fulfilled the requirements. The European Commission (EC) has adopted a non-approval decision for these substances. According to the decision, the substances can no longer be made available on the EU market after November 4, 2017, and no longer used after April 4, 2018.

Chemical Product Labels Must Comply With CLP As Of June 1: On April 28, 2017, ECHA issued a press release reminding companies that hazardous chemicals must be classified, labeled, and packaged appropriately before being placed on the market. Beginning June 1, 2017, all chemical products placed on the market have to be labeled in accordance with CLP. ECHA notes that this marks the end of the transitional period for labeling mixtures. Companies that still have products on the shelves with labels following the requirements of the previous legislation must now make sure that the products are either no longer placed on the market, or re-classified and re-labeled in accordance with CLP.

EC Adopts Guidance On Access To National Courts On Environmental Cases: The EC announced on April 28, 2017, the availability of a guidance document on access to justice in environmental matters. According to the EC, the guidance document clarifies how individuals and associations can challenge decisions, acts, and omissions by public authorities related to EU environmental law before national courts. The guidance is intended to help individuals and non-governmental organizations to decide whether to bring a case before national courts. The EC states that national courts can use it to help identify all the EU Court of Justice cases that they should take into account when they are faced with questions related to access to justice in environmental cases. With the guidance, national administrations are made aware of possible shortcomings in their justice systems, and businesses are provided with greater clarity on what EU rights and obligations are at stake in the decisions, acts, and omissions that concern them. More information is available in the EC’s press release, “New guidelines help citizens gain better and fairer access to their national courts on environmental cases.”

BPC Adopts Six Opinions Supporting Approval Of Active Substances: On April 28, 2017, ECHA announced that the Biocidal Products Committee (BPC) adopted opinions supporting the approval of two active substances for use in biocidal products used as disinfectants for human and veterinary hygiene. The active substances and related product-types are:

  • L(+) lactic acid for product-types 2, 3, and 4; and

  • Propan-1-ol for product-types 1, 2, and 4.

L(+) lactic acid is an existing active substance evaluated in product-types 1, 2, 3, 4, and 6. BPC has already adopted an opinion on product-type 1. The products containing L(+) lactic acid are used for the disinfection of surfaces in bathrooms by the general public in product-type 2, for disinfection of cow teats after milking in product-type 3, and for the disinfection of tanks in the brewery industry by professional users in product-type 4.

Propan-1-ol is an existing active substance. The products containing propan-1-ol are used for hand disinfection by non-professional and professional users in product-type 1, and for the disinfection of surfaces, objects, material, and equipment in private, public, health, and industrial areas by non-professional and professional users in product-types 2 and 4.

The evaluating competent authority for these active substance applications was Germany.

JRC Publishes NANoREG Framework For The Safety Assessment Of Nanomaterials: The EC Joint Research Center (JRC) has published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials. The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.” The NANoREG framework represents the project’s proposal for a common understanding in the field of environmental health and safety (EHS) assessment of nanomaterials under the current European regulatory framework, with focus on REACH. The key conclusions note that the EC, ECHA, the Organization for Economic Cooperation and Development (OECD), and the scientific community “have worked closely together in recent years to improve the knowledge on EHS of [nanomaterials], remove hurdles and concretely help stakeholders in addressing regulatory requirements for [nanomaterials].” The report states that the NANoREG partners, including JRC, “believe that the proposed framework will be useful for scientific experts and stakeholders, such as regulatory authorities and industry.”

Tenth ATP To CLP Regulation Published: On May 4, 2017, Commission Regulation (EU) 2017/776 was published in the Official Journal of the EU to amend the CLP Regulation. This publication is the tenth Adaptation to Technical and Scientific Progress (ATP), and introduces new or revised entries for the harmonized classification and labeling of 37 substances. The amendments introduced include new harmonized acute toxicity estimates (ATE) values. The Regulation entered into force on May 24, 2017, and will apply from December 1, 2018.

ECHA Creates Web Page For NMEP: ECHA created a web page for the Nanomaterials Expert Group (NMEP), which was created in October 2012. NMEP aims to seek common ground among experts on scientific and technical issues regarding the implementation of REACH, CLP, and the Biocidal Products Regulation (BPR) for nanomaterials. ECHA states that the page includes information on NMEP’s mandate and activities, the list of the members, and the meeting schedule, which will also include the minutes of the meetings in the future. According to the web page, NMEP met May 16-17, 2017, and will meet November 7-8, 2017.

ECHA Opens Consultation On Chromates Authorization Applications: On May 10, 2017, ECHA commenced consultation on four applications for authorization submitted by Saes Getters S.p.A. The authorization applications submitted by Saes Getters S.p.A. relate to the following uses of potassium chromate and sodium chromate:

  • Use in the fabrication of alkali metal dispensers for production of photocathodes; and

  • Use of alkali metal dispensers containing either substance for production of photocathodes.

The requested review period for these four authorization applications is seven years. ECHA’s consultation period for the authorization applications ends on July 5, 2017.

ECHA Provides Information On Union Authorization Of Biocides: On May 17, 2017, ECHA issued a press release entitled “Check the 2018 deadlines to apply for Union authorisation of biocides.” The press release states “[a] list of active substance and product-type combinations for which a Union [authorization] should be applied for in 2018 has been published. Check the deadlines and apply in time to keep your product on the market … In 2018, you should apply for product [authorization] to keep your existing products on the market if they contain the active substances for which legal deadlines happen in that year. A convenient way to make the product [authorization] applications is to use Union [authorization].”

ECHA recommends that a pre-submission is made at least six months prior to an application for Union authorization because this “free-of-charge consultation” by Member States provides useful information on the chances of success of the Union authorization application, and helps in identification of any potential issues that may need to be addressed.

More information on upcoming 2017 and 2018 deadlines is available on ECHA’s “Deadlines for Union authorisation applications” web page.

EC Publishes Final Conflict Minerals Regulation: On May 19, 2017, the EC published the final conflict minerals regulation in the Official Journal of the European Union. The regulation establishes a system for supply chain due diligence intended to “curtail opportunities for armed groups and security forces to trade in tin, tantalum and tungsten, their ores, and gold.” Beginning January 1, 2021, importers, smelters, and refiners of tungsten, tin, tantalum, and gold will have to conduct mandatory due diligence checks when annual import volumes exceed set thresholds. While there will be no mandatory requirements on downstream companies in the supply chain, they will be encouraged to carry out voluntary checks. The EC posted questions and answers (Q&A) in March 2017 regarding the regulation. The Q&As address the countries and companies covered, due diligence, implementation, and the institutions and countries involved.

ChemSec Launches Marketplace For Safer Alternatives: The International Chemical Secretariat (ChemSec) has launched the “Marketplace,” an interactive online portal that allows manufacturers to advertise safer alternatives to hazardous products. ChemSec states: “Do you want to replace a chemical that is harmful to health or the environment with a better alternative? Search our database to find an alternative product from the suppliers presenting their offerings on the site. A quick and simple way to find the substitute you need.”

The Marketplace features a number of manufacturers of “alternatives,” including Chemours, Clariant, Valspar, Beyond Surface Technologies, Bio Gen Active, Nordic Paper, Organoclick, and Rivertop Renewables. The Marketplace’s Frequently Asked Questions (FAQ) include responses to a number of important questions. In addition, the Marketplace provides certain regulatory information that will be expanded upon progressively.

ECHA Publishes REACH Guidance for Nanomaterials: ECHA announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 REACH registration deadline. ECHA published two new guidance documents:

  • Nano-specific appendix to Chapter R.6 of the Guidance on information requirements and chemical safety assessment (IR&CSA) (quantitative structure-activity relationships (QSAR) and grouping of chemicals); and

  • How to prepare registration dossiers that cover nanoforms -- best practices: ECHA states it originally intended this to be a guidance document, but as a consequence of the Board of Appeal decision in Case A-011-2014, ECHA is publishing it as an advisory best practice document.

In addition, ECHA published updates to three of its existing guidances on nanomaterials -- the appendices for nanomaterials to Chapters R.7a, R.7b, and R.7c of the Guidance on IR&CSA (endpoint specific guidance). ECHA states that these three documents provide nano-specific advice to help registrants meet the information requirements set out in REACH Annexes VI-XI. ECHA notes that the scope of the updates covers human health and environment related endpoints and incorporates new developments in the scientific understanding of hazard/risk assessment of nanomaterials. It also takes account of ECHA’s experience from compliance checks and substance evaluation.

First Appeal By DU Dismissed By Board Of Appeal: On May 30, 2017, ECHA’s Board of Appeal dismissed an appeal against a substance evaluation decision for N,N- dicyclohexylbenzothiazole-2-sulphenamide (DCBS). The Appellant, Manufacture Française des Pneumatiques Michelin, is a French tire manufacturer and Downstream User (DU) of DCBS. The appeal by Manufacture Française des Pneumatiques Michelinagainst the substance evaluation decision is the first appeal to be filed by a DU. The Appellant uses DCBS, “which is an accelerator of [vulcanization] for certain types of rubber compounds, in the manufacture of internal components of [tires].”

Following evaluation of DCBS by Germany, ECHA requested that registrants of DCBS submit an updated Chemical Safety Report (CSR) containing additional information on environmental exposure assessment, including: (1) assumptions underlying the environmental exposure estimation; (2) “[e]nvironmental exposure assessment for the sediment compartment from manufacturing the Substance”; (3) environmental exposure assessment for the production and use of tires and general rubber products; and (4) environmental releases from the use of tires.

Manufacture Française des Pneumatiques Michelinraised two pleas in law in support of its appeal. The first plea alleged that ECHA breached REACH Article 46 and “went beyond its margin of discretion”: (1) by failing to examine carefully and impartially the facts of the case; and (2) “by failing to ensure that the requested information on exposure for the use of the Substance in [tires] is obtained from the relevant [DUs].” In its second plea, the Appellant argued that ECHA should have conducted a compliance check prior to the substance evaluation to request the information required in the Contested Decision.

ECHA challenged the admissibility of the appeal, and submitted that the Contested Decision had only “remote effects” on the legal situation of DUs and new registrants of DCBS, and that these remote effects did not demonstrate the Appellant’s “direct or individual concern vis-à-vis the Contested Decision.” ECHA also questioned the date upon which the Appellant became aware of the Contested Decision and whether the appeal was correctly lodged within the timeframes under REACH Article 92(2).

The Board of Appeal dismissed the appeal as inadmissible because the Appellant did not have legal standing to challenge ECHA’s decision. In reaching this conclusion, the Board of Appeal considered whether the Contested Decision was of “direct and individual concern” to the Appellant. The Board of Appeal concluded that the Contested Decision was not of direct concern to the Appellant, and that a determination on individual concern was not needed as the requirements are cumulative. The Board of Appeal decided that the appeal fee shall not be refunded.

ECHA Publishes Illustrative Examples To Guide Companies In Preparing Registrations: On May 31, 2017, ECHA announced that it published eight new illustrative examples to guide registrants. ECHA states that the examples illustrate situations companies may face when preparing their REACH registrations and are intended to complement the practical advice given through the REACH 2018 web pages. In addition, ECHA posted four new video tutorials to help companies manage IUCLID and use it to prepare technical dossiers.

  • Phase 1: Know your portfolio:

    • How to plan your registration;

    • How to identify a substance on the borderline of a mono- and multi-constituent;

    • How to identify a substance produced in different qualities;

    • How to identify a substance that consists of a “mixture of isomers”; and

    • How to identify a substance that includes a stabilizing solvent;

  • Phase 3: Get organized with your co-registrants:

    • Sharing the costs of an individual study; and

    • Cost sharing between co-registrants with different data requirements;

  • Phase 4: Assess hazards and risks of substances:

    • Steps to gather information for low tonnage substances;

  • Phase 5: Prepare your registration as a IUCLID dossier:

    • How to install IUCLID 6 desktop;

    • How to run the Validation Assistant in IUCLID 6;

    • How to update IUCLID 6 desktop; and

    • How to backup and restore IUCLID 6.

ECHA’s Report Indicates Alternatives To Animal Testing Are Widely Used: On June 1, 2017, ECHA issued a press release entitled “Alternatives to animal testing widely used.” The press release states: “ECHA’s report on the use of alternatives to animal testing shows that registrants [under REACH] have used alternatives for at least one endpoint in [89 percent] of the substances [analyzed]. However, industry needs to improve the quality and robustness of alternative data.”

ECHA’s press release indicates that data sharing is a significant contributor to minimizing animal testing because 98 percent of substances are registered jointly. As a result, registrants make extensive use of existing information and alternative methods before conducting new studies. ECHA’s analysis, which is based on individual registration dossiers submitted between 2008 and 2016 for 6,290 substances, indicates that 89 percent of the substances have at least one endpoint where an alternative was used instead of a study using animals. The most common alternative method was using information on similar substances (i.e., read-across), used in 63 percent of the analyzed substances, followed by combining information from different sources (i.e., weight-of-evidence), used in 43 percent of analyzed substances, and computer modelling (i.e., QSAR prediction), used in 34 percent of analyzed substances.

The report indicates that read-across data have been particularly useful for human health endpoints (e.g., developmental and reproductive toxicity). For skin and eye irritation, REACH registrants largely use existing data, read-across, and in vitro studies. For environmental endpoints such as bioaccumulation, long-term toxicity to fish, and toxicity to birds, data waiving (i.e., justification to omit studies) is the most commonly used alternative to animal testing. Considering all of the endpoints and substances analyzed that can be filled by tests on vertebrate animals, ECHA’s report indicates that registrants used data from new vertebrate animal studies in 11 percent of the cases.

ECHA uses the report’s findings to promote alternative methods through its guidance, web pages, webinars, and events. More information is available in ECHA’s third report under REACH Article 117(3) entitled “The use of alternatives to testing on animals for the REACH Regulation” or the summary of the report.

SWEDEN

KEMI Will Focus Enforcement And Market Surveillance On Chemical Products, Pesticides, And Articles: KEMI published in April 2017 its 2017 enforcement and market surveillance plan, describing the enforcement activities that will be prioritized in 2017. According to the summary, which is available in English, KEMI has divided the operational enforcement into three main areas:

  • Chemical Products: Enforcement will focus on continued regional-based systematic control, supplemented with risk minimization measures in prioritized substance or product category areas, such as eyelash adhesives and chemical products in toys. Together with other authorities, KEMI will also monitor exposure scenarios in accordance with REACH;

  • Pesticides: Enforcement will focus on monitoring disinfectants in accordance with new legislation. KEMI will also do follow-ups with companies that showed shortcomings during previous enforcement of plant protection products; and

  • Articles: Enforcement will focus on follow-ups with companies that during previous inspections have shown repeated occurrence of hazardous chemicals in their products. KEMI will also monitor articles frequently used in the home environment, including articles children might put in their mouths. KEMI will inspect personal hygiene products and control articles treated with biocides, focusing on sportswear and shoe soles.

UNITED KINGDOM (UK)

Environmental Audit Committee Issues Report On Chemicals Regulation: On April 29, 2017, the House of Commons Environmental Audit Committee published a report entitled “The Future of Chemicals Regulation after the EU Referendum.” The report states “[i]t is crucial that the EU negotiations and any future domestic legislative framework allow the UK chemicals industry to continue to provide value to the economy whilst also protecting public health and the environment.”  The Environmental Audit Committee’s “key findings” in the report are:

  • The chemicals regulation framework established by the EU through REACH would be difficult to transpose directly into UK law;

  • Companies face significant uncertainty over the validity of current REACH registrations after the UK leaves the EU, and the Government must clarify its position on the future regulatory framework as a matter of urgency;

  • In deciding the future of the UK’s relationship with the EU’s single market for chemicals, the Government should take a pragmatic approach. The most important element of REACH, which the Government should seek to remain involved in as a minimum, is the registration process for chemicals;

  • Establishing a fully stand-alone system of chemicals regulation for the UK is likely to be expensive for both the taxpayer and for industry; and

  • The experiences of the U.S. as it introduces an improved system of chemicals regulation could be useful for the Government when planning the UK’s approach.

The report elaborates upon these findings, provides information on consultations with important actors in industry (e.g., Chemical Industries Association), and describes additional REACH-related challenges for the UK. These challenges include financial and practical problems industry may face in complying with “two sets” of regulations, and issues the UK Government may encounter in establishing and financing a new regulatory framework and responsible authority.

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