EUROPEAN UNION (EU)

EC Posts Comments Received On Draft Regulation To Amend REACH Annexes To Address Nanomaterials: On October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances. Comments were due November 6, 2017. The EC has posted the comments online. In all, 36 comments were submitted. The comments received fall into the following categories: business associations; public authorities; non-governmental organizations; company/business organizations; environmental organizations; academic/research institutions; and other.

PlasticsEurope Brings Second Lawsuit Against ECHA Regarding BPA: On November 13, 2017, details regarding PlasticsEurope’s lawsuit against the European Chemicals Agency (ECHA) for Bisphenol A (BPA) were published in the Official Journal of the EU. PlasticsEurope’s case concerns ECHA’s decision to update the REACH Regulation Candidate List entry for BPA to include endocrine-disrupting properties affecting human health. The case, filed with the European General Court on September 15, 2017, constitutes the second legal action brought by PlasticsEurope against ECHA for BPA. PlasticsEurope’s first case against ECHA for BPA was initiated on March 21, 2017, due to BPA’s inclusion in the Candidate List because of its reprotoxic properties.

The first case is pending, however, PlasticsEurope provides that ECHA’s decision in July 2017 to update the classification for BPA infringed the principle of legal certainty by applying inconsistent and unforeseeable criteria to assess the endocrine disrupting properties for human health of BPA. PlasticsEurope regards identification of BPA as a Substance of Very High Concern (SVHC) due to endocrine disrupting properties as not sufficiently substantiated, and raised concerns regarding REACH Article 57 “routes” towards identification as a SVHC. PlasticsEurope cites concerns and issues related to intermediate uses of BPA and principles of proportionality.

In its second lawsuit against ECHA, PlasticsEurope claims that the Court should: (1) declare the application admissible and well-founded; (2) annul the decision to update the existing entry of BPA in the Candidate List as a SVHC on the basis of Article 57(f) REACH; (3) order ECHA to pay the costs of the proceedings; and (4) take such other or further measures as justice may require.

PlasticsEurope raised the following pleas in law:

• ECHA infringed the principle of legal certainty by applying inconsistent and unforeseeable criteria to assess alleged endocrine disrupting properties for human health of BPA.

• ECHA committed a manifest error of assessment and infringed its duty of care.

• The contested decision infringes the principles of legal certainty and protection of legitimate expectations by failing to take into consideration expected studies that were acknowledged as relevant for the assessment of BPA’s alleged endocrine disrupting properties, and in particular the CLARITY-BPA study, and by not considering the derivation of a safe level as a factor relevant for the establishment of the equivalent level of concern.

• The contested decision breaches REACH Articles 59 and 57(f) by identifying BPA as a SVHC on the basis of criteria referred to in Article 57(f), since Article 57(f) only covers substances that have not yet been identified under Article 57(a)-(e).

• The contested decision breaches REACH Article 2(8)(b) because intermediates are exempt from Title VII, 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 BPA in the Candidate List when it is a non-intermediate exceeds 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.

Biocides IT Tools Improved Based On User Feedback: On November 15, 2017, ECHA issued a press release entitled “Biocides IT tools improved based on user feedback.” In its press release, ECHA provides that a new version of the biocides submission tool, R4BP 3, is now available with improvements in the user interface and search and communication functionalities. ECHA also indicated that the Summary of Product Characteristics Editor (SPC Editor) has been updated.

New features in R4BP 3 include:

• The possibility to apply for mutual recognition of the same biocidal product in market areas where the original product has already been authorized;

• The possibility for the evaluating competent authorities to redefine active substances;

• The possibility for companies to provide scientific data after active substance approval;

• Enhanced search filters and export functions; and

• The possibility to group multiple products in one application for notification to other markets when they are eligible for simplified authorization.

The SPC Editor now includes the possibility to select multiple product-types for each use and improved support for special characters.

Enforcement Forum Discusses Preliminary Results Of REF-4: According to ECHA’s November 16, 2017, press release, during the November 7-10, 2017, meeting of the Forum for Exchange of Information on Enforcement, the Forum endorsed the preliminary results of REACH-EN-FORCE-4 (REF-4), focusing on compliance with the conditions set out for selected restrictions in Annex XVII of the REACH regulation. ECHA states that the results of REF-4 “revealed relatively high incidence of products that are incompliant with conditions of restriction for phthalates, cadmium, and asbestos.” During its March 2018 meeting, the Forum will discuss the REF-4 project report, which will be published by the end of 2017. The Forum will also consider how to address the “relatively high degree of infringements found.”

At its November 2017 meeting, the Forum also held an open session with stakeholder organizations and discussed potential actions related to the duty to use animal testing as a last resort. ECHA notes that it identified a number of cases where registrants submitted results of tests carried out on animals, although REACH only required results from in vitro studies. According to the press release, ECHA will inform Member States about the cases, and the national enforcement authorities will consider which of the cases inspectors will investigate. During the annual session involving accredited stakeholder organizations (ASO), the topics discussed included enforcing duties for importers of substances, mixtures, or articles, including textiles, the risk of withdrawal of critical substances after the 2018 registration deadline, new test methods for upcoming REACH restrictions, and enforcing the duty to consider alternatives to animal testing. ECHA states that many ASOs joined the initiative to work with the Forum on improving the quality of the safety data sheets (SDS). The activity aims to identify frequently occurring problems with SDSs and will engage ASOs to address them in voluntary industry initiatives. The Forum also invited the ASOs to submit new proposals for the 2018 enforcement project selection cycle.

The Biocidal Products Regulation (BPR) Subgroup decided that its first coordinated enforcement project dedicated solely to BPR requirements will focus on duties related to treated articles. The project will focus on substances, mixtures, or articles that have been treated with or that incorporate a biocidal product. ECHA states that it will be prepared during 2018, executed in 2019, and the report will be published in 2020.

More information is available in ECHA’s press release, “Forum for enforcement reviews results of its restriction project and agrees on new actions.”

ECHA Screens SIN List For Substances Not Yet Under Regulatory Scrutiny: ECHA’s November 16, 2017, Newsletter includes an article, “How are SIN List substances being addressed?,” that includes the results of ECHA’s screening of the “Substitute It Now” (SIN) List. The SIN List includes carcinogenic, mutagenic, or reprotoxic (CMR) substances; persistent, bioaccumulative, and toxic (PBT) substances; and substances of equivalent concern. ECHA notes that “[t]hese hazard criteria alone are not enough to consider if a substance matters according to the integrated strategy and would require further action.” Authorities have agreed on how to set priorities among these hazardous substances and to focus resources where they can expect to have the highest impact on the protection of human health and the environment. Therefore, the substances that matter are those with a hazard concern and potential for exposure, either to human health or the environment. Substances that are considered hazardous but do not meet the exposure criteria may be considered as a low priority for further work by authorities, which is reflected in ECHA’s analysis of the SIN List. ECHA grouped substances on the SIN List into four categories:

1. Substances already regulated or in the process of being regulated: This covers substances that are restricted under REACH (Annex XVII), subject to authorization (Annex XIV), on the Candidate List, or listed on ECHA’s Registry of Intentions as being considered for inclusion in any of these lists. ECHA also included substances listed as persistent organic pollutants under the Stockholm Convention for which regulatory risk management measures are already in place at the global level. ECHA found that more than 270 substances are already regulated in the EU or in the process of being regulated;

2. Substances currently under scrutiny by ECHA or EU Member States: This covers those substances that are currently under Substance Evaluation or are listed on the Public Activities Coordination Tool (PACT) as undergoing risk management option analysis (RMOA) or informal hazard assessment of PBT/very persistent and very bioaccumulative (vPvB) and/or endocrine disrupting properties. ECHA also included substances that are under manual screening, for which an intention or proposal for harmonized classification and labeling is available or those that are addressed under the Petroleum and Coal Stream Substances Working Group, which deals with petroleum and coal stream substances. According to ECHA, approximately 280 substances on the SIN List are currently under scrutiny by ECHA or EU Member States;

3. Substances considered of low priority for regulatory action at present (scrutinized by EU Member States): Substances are included here if they have been assessed by EU Member States (or ECHA) under Substance Evaluation, RMOA, or manual screening and have been concluded not to warrant further regulatory action at the moment in view of the SVHC Roadmap prioritization criteria. This group also includes substances that are not (actively) registered under REACH even though they are not scrutinized by EU Member States. About 240 of the substances on the SIN List are in this group. Around 40 have been examined and have been concluded not to warrant further regulatory scrutiny at this time. The other 200 low priority substances in this group are substances that are not (actively) registered under REACH. They are either not on the market or in very low amounts and therefore the need for regulatory action is of low priority at present; and

4. Substances without further action at present (IT screened): This group covers substances that are registered under REACH and are not covered by any of the three groups above. The majority of these substances are of low priority for further scrutiny based on SVHC Roadmap criteria (i.e., low potential for exposure). The remaining substances may warrant further scrutiny. This group includes less than 80 substances. ECHA examined the priority for action on these substances against exposure criteria to humans and release to the environment using automated algorithms. According to ECHA, almost a third of these substances are registered only as intermediates and, due to the low exposure potential, have never been prioritized as candidates for further scrutiny by EU Member States in the context of manual screening. Most of these 80 substances already have a harmonized classification as CMR 1A/1B and are therefore restricted for consumer uses. Out of the 80 substances, ECHA identified seven with high potential for exposure to humans or release to the environment based on the registered uses. ECHA states that, together with EU Member States, it will investigate whether those substances warrant further action.

EDC Identification Criteria To Apply Under BPR Starting June 2018: On November 17, 2017, the EC published in the Official Journal of the EU Commission Delegated Regulation (EU) 2017/2100 regarding scientific criteria for determination of endocrine-disrupting properties pursuant to the BPR. These legal criteria for identification of endocrine disrupting chemicals (EDC) under the BPR will apply from June 7, 2018.

As reported in Acta’s earlier Updates, the EDC identification criteria under the BPR and Plant Protection Products (PPP) Regulation were subject to extensive debate and criticisms by non-governmental organizations (NGO) and others. Typical criticisms of NGOs included that the criteria would effectively delay substantially or prevent identification of chemical substances as EDCs due to the high evidentiary thresholds under the proposed laws. Various groups stated that the EDC identification criteria presented unacceptable risks for human health.

The EDC criteria for the PPP Regulation were rejected by the European Parliament (EP) in October 2017. The criteria for identification of EDCs under the BPR were approved by the EP, however. The BPR will be the first EU regulatory program to apply such EDC criteria, and similar criteria are expected to extend to sectors such as cosmetics, toys, and food contact materials.

As requested by the EC in the interests of “ensuring for an immediate, consistent and transparent implementation of the new criteria,” ECHA and the European Food Safety Authority (EFSA) have issued a draft guidance document for the identification of EDCs. ECHA and EFSA are currently inviting public comments on the draft guidance document, with a deadline of January 31, 2018. In its press release, ECHA states “[a]ll received comments will be taken into consideration in [finalizing] the guidance, which is scheduled to be available by June 2018.”

Pilot Project Will Target Suppliers Of Consumer Articles: ECHA announced on November 20, 2017, that the Forum for Exchange of Information on Enforcement began a pilot project to verify compliance with the notification and communication obligations of substances in articles under REACH. According to ECHA, the project is being launched as a result of national enforcement actions, reports from authorities or NGOs, and a low number of notifications being made to ECHA. ECHA states that “[t]hey all indicate that the obligations of industry would not be adequately met.” The pilot project aims to:

• Check compliance of producers, importers, and suppliers of articles with their obligations;

• Contribute to raising awareness and understanding of the legal obligations and in turn raise the level of compliance among duty holders;

• Build a better picture of the actual level of compliance by suppliers of articles;

• Identify the reasons for non-compliance and whether further actions are required by ECHA, the EC, and/or competent authorities of the Member States; and

• Gather experience and establish enforcement methods for potentially checking these obligations on a larger scale in the future.

The pilot project will target article distributors and producers or importers of articles for inspection. ECHA notes that articles that are likely to contain Candidate List substances to which consumers may be exposed are a particular focus point. Examples of consumer articles that may be inspected are electrical products, building materials, and interior articles. According to ECHA, the following specific substances that will be targeted include:

• Brominated flame retardants;

• Phosphorous flame retardants;

• Short-chain chloroparaffins;

• Phthalates;

• Aprotic polar solvents;

• Perfluorinated substances; and

• Phenolic benzotriazoles.

The operational phase of the project started in October 2017 and will run until the end of June 2018. A report of the results is expected by the end of November 2018. More information is available in ECHA’s press release, “Enforcement project to check compliance with the obligations of substances in articles.”

ECHA Issues Report On Animal Tests Under EU Chemical Laws: On November 22, 2017, ECHA issued a press release entitled “More progress needed to replace animal tests under EU chemicals laws.” In its press release, ECHA states “[t]he report on the regulatory applicability of non-animal approaches reviews their current status under the three EU chemicals regulations coordinated by ECHA (REACH, [the Classification, Labelling, and Packaging (CLP) Regulation] and BPR). It states there have been significant scientific developments in the past [ten] years regarding the replacement of animal testing for chemical safety assessment with non-animal approaches. Concepts such as the integrated approach to testing and assessment and the adverse outcome pathways now enable a better use of data from non-animal approaches. This has already reduced the need for animal testing.”

ECHA stated that for lower tier endpoints such as skin corrosion/irritation, serious eye damage/eye irritation, and skin sensitization, companies already use in vitro tests as the default method. For more complex endpoints such as repeated dose toxicity or reproductive toxicity, ECHA states “non-animal approaches are not yet foreseeable.” ECHA states that methods such as grouping and read-across or weight of evidence use existing data to predict toxicity of substances, and can therefore reduce the need for new tests on animals.

ECHA provides that “new approaches,” such as in vitro microsystems and high-throughput/high-content methods, are under development. ECHA states “[t]hey aim to provide better insight into the mechanisms of toxicity. However, they require further [standardization] and validation before they can be accepted for regulatory use. A continuous dialogue between researchers and regulatory authorities is necessary to ensure that innovations in non-animal approaches to chemical safety assessment can be considered for regulatory use without undue delay.”

ECHA encourages industry to use reliable non-animal approaches to comply adequately with the information obligations of regulations, and provides tools and advice through guidance, practical guides, IT tools, case studies, and webinars to support this effort.

ECHA Asks Companies To Communicate Their Registration Intentions For 2018: The Directors’ Contact Group (DCG) met on November 27, 2017, to discuss solutions for issues concerning the May 31, 2018, REACH registration deadline for low-volume chemicals. ECHA states DCG “identified a need to call upon suppliers to communicate their registration intentions to their customers to avoid crucial substances not being registered and supply chains being disrupted.” Suppliers should let their customers know of their plans to register both individual substances and substances in mixtures. For the ten to 100 tonne registrations, they should also identify the uses their registrations intend to cover and communicate them downstream. DCG recommends companies increase their efforts to communicate their registration intentions. According to the press release, industry associations represented in DCG are committed to passing this recommendation on to their members. DCG also agreed to publish a fact sheet on access to EU finance. The fact sheet provides advice to companies that need to find resources to ensure safe handling of their substances and to those that choose to substitute their chemicals with more sustainable alternatives. DCG revoked its advisory document on data sharing as it has been superseded by the January 2016 EC Implementing Regulation. More information is available in ECHA’s November 29, 2017, press release, “Companies asked to communicate their registration intentions for 2018.”

ECHA Publishes Interactive Infographic For Following Progress Of REACH Registrations: On November 30, 2017, ECHA announced the availability of an interactive map of Europe that will allow users to check ECHA’s statistics on registered chemicals and follow the progress towards the May 31, 2018, registration deadline. ECHA states that users can see:

• The number of unique substances registered, their registration type (full or intermediate), the substance type (existing or new substance), and the approximate total tonnage on the EU/European Economic Area (EEA) market;

• The number of registrations, their type (full or intermediate), and the role of the company that submitted the registration (manufacturer, importer, etc.);

• The most commonly registered chemicals;

• The number of unique companies that have registered chemicals, their company size, and role in the supply chain;

• All of the above by individual EU/EEA country and by year, month, or week; and

• A searchable list of lead registrants for the 2018 deadline, who have declared their role in the dossier submission tool REACH-IT.

More information is available in ECHA’s November 30, 2017, press release, “New interactive infographic for following the progress of REACH registrations.”

Presentations Available From ECHA Webinar On REACH Guidance For Nanomaterials: On November 30, 2017, ECHA held a webinar to explain the support documentation available for registrants that cover nanoforms in their REACH registration dossier. The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements for human health and the environment. ECHA has posted the following presentations from the webinar:

• Introduction -- Celia Tanarro, ECHA;

• Registration dossiers covering nanoforms: best practice -- Bernadette Quinn, ECHA;

• Human health endpoints -- Camelia Constantin, ECHA;

• Grouping and read-across for nanoforms -- Valeria Amenta, ECHA; and

• Environmental endpoints -- Laurence Deydier, ECHA.

EC Publishes Study On Impacts Of REACH Authorization: The EC announced on December 12, 2017, the availability of the final report from a study to assess the performance of the REACH authorization system and to provide evidence of its effects. The EC states that the study indicates that the system is achieving its objectives. The authorization system is progressively promoting substitution of SVHCs by available alternatives and reducing risks associated with the use of SVHCs. The final report lists the following key observations from the study:

• There is evidence of substitution of SVHCs within the EU due to REACH authorization;

• There is evidence of substitution despite applying for authorization being a cheaper option. This seems to be linked to the perceived business continuation risks/uncertainties associated with having to rely on applying for authorization to continue operating;

• The authorization process is resulting in improvements in risk management measures at every stage of the process; and

• It is still too early to be able to quantify the benefits of authorization due to a lack of publicly available historical exposure data. This should improve over time but further work (requiring substantial effort and resources) is needed to collect the relevant information required.

SCOPAFF Adopts Revised EDC Criteria For Pesticides: On December 13, 2017, representatives from European Member States in the Standing Committee on Plants, Animals, Food, and Feed (SCOPAFF) voted in favor of a revised EC proposal on identification criteria for EDCs under the PPP Regulation. The SCOPAFF meeting was convened due to the EP veto on an earlier version of the criteria. Members of the EP vetoed the earlier proposal because, in their opinion, the EC had exceeded its mandate by proposing to exempt certain substances designed to attack an organism’s endocrine system from the criteria, even when the substances caused harm to non-target organisms of the same group of species.

The criteria agreed upon in SCOPAFF do not include this exemption. In this regard, the Health and Environment Alliance (HEAL) stated “[t]he criteria agreed today partly took into account the EP’s demand by removing a problematic exemption that would have left numerous endocrine disrupting pesticides unaddressed. However, [HEAL] reiterates concerns stated earlier – alongside numerous public health voices and respected scientific societies - about the very high burden of proof required in the criteria that have now been adopted to identify EDCs. This is of particular concern in the context of growing evidence that human exposure to environmental pollutants such as endocrine disruptors are weighing heavily on public budgets.”

The proposal approved in SCOPAFF will now undergo three months of scrutiny by the Council of Ministers and the EP. The proposal can be vetoed or adopted.

UNITED KINGDOM (UK)

Cefic And CIA Issue Joint Brexit Statement: On November 14, 2017, The European Chemical Industry Council (Cefic) and the Chemical Industries Association (CIA) issued a joint statement on “Brexit and the Future.” The statement includes several sections, including “Importance of EU Chemicals Industry”; “Supply Chains”; “Tariffs”; “Customs Procedures”; “Free Movement of People”; “Investment”; “Regulatory Consistency”; and “Transition and Legal Certainty.”

The joint statement provides, in summary, that Cefic and CIA:

• Consider that the UK’s exit from the EU without a new trade agreement in place is the worst possible outcome for companies and their employees in both the UK and EU-27;

• Consider that a transitional period between Brexit and the new trade relationship should be adopted to avoid disruption of chemical markets;

• Call for the least disruptive agreement in terms of customs procedures;

• Stress the need for the continued free movement of skilled labor between the EU-27 and the UK;

• Call for concrete measures to avoid further investment leakage in the European chemical industry;

• Call for regulatory consistency upholding the level playing field between the EU-27 and the UK;

• Stress that a healthy and viable chemical industry is essential for the preservation of the social model that has been built up in Europe in the past 50 years;

• Call on the authorities of the EU-27 and of the UK to develop forward looking industrial policy strategies that ensure that Europe remains an attractive place to invest; and

• Emphasize the need for a well-managed transition that addresses the need for commercial reassurance and legal certainty over market access, jurisdiction, and dispute resolution.