EU REACH – Endocrine Disrupting Chemicals – EU Classification

By Paul Goodman, RINA

Substances that are classified as endocrine disruptors are believed to be some of the most harmful to human health or the environment, however it is notoriously difficult to determine whether a substance should be classified as an endocrine disruptor. In 2016, the EU announced that it would consider about 600 substances regarding their endocrine disrupting properties, but at present there are only 16 substances that are classified as endocrine disruptors under the REACH Regulation and only two as biocides. All of the REACH endocrine disrupting chemicals have been added to the Candidate List with 14 of the 16 being classified as environmental endocrine disruptors and 6 as human endocrine disruptors.

One of the main approaches used by the EU to assess chemicals is via the Community Rolling Action Plan (CoRAP). This currently lists about 289 substances of which 87 are being considered for endocrine disrupting properties. Of the potential endocrine disruptors listed; 16 have not yet started investigation, 19 have concluded assessment and 25 assessments are on-going. The list on the ECHA website is out of date, however, as several of the substances listed as “on-going” have now been confirmed to be endocrine disruptors and have been added to the REACH Candidate List. Being included in the CoRAP list by no means guarantees that a substance will be confirmed to be an endocrine disruptor and in fact many are determined to not meet the criteria or at least there is insufficient evidence to classify them as endocrine disruptors.

The CoRAP list is useful as it alerts industry of the types of substances that are being considered by the EU, however it should not be regarded as a “black list” as many of the assessments conclude that the substances do not meet the hazard classification criteria that are being assessed. However, if a substance is confirmed to be a CMR, PBT/vPvB or an endocrine disruptor, regulation in some form is likely to be considered.

For more information about EPA’s efforts under the PFAS Action Plan: https://www.epa.gov/pfas

USA: EPA Takes Next Step to Implement PFAS Legislation – Certain PFAS to be added into the Code of Federal Regulations for the Toxics Release Inventory

13 May, 2020

The U.S. Environmental Protection Agency (EPA) took the next step to implement an important per- and polyfluoroalkyl substances (PFAS) requirement of the National Defense Authorization Act (NDAA). The NDAA added 172 PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) and established a 100-pound reporting threshold for these substances. The agency is publishing a final rule that officially incorporates these requirements into the Code of Federal Regulations for TRI.

“EPA continues to prioritize and make progress to protect the health and well-being of communities across the country that are working to address PFAS,” said EPA Administrator Andrew Wheeler. “The inclusion of these 172 PFAS on the TRI list will provide EPA and the public with important information on these emerging chemicals of concern.”
As this action is being taken to conform the regulations to a Congressional legislative mandate, this rule is effective immediately. Per the NDAA requirements, the PFAS additions became effective as of January 1, 2020. Reporting forms for these PFAS will be due to EPA by July 1, 2021, for calendar year 2020 data. EPA expects to release the 2020 TRI data by July 31, 2021.

To provide clear information on which chemicals fall under the NDAA requirement, in February 2020, EPA released a list of 172 PFAS chemicals that are subject to TRI reporting. Facilities in TRI-covered industry sectors should track and collect data on these PFAS during 2020. All TRI reporting requirements apply to these PFAS (e.g., supplier notification) and TRI reporting exemptions, if applicable, are available for these PFAS. Note that TRI reporting requirements state that a facility should use readily available data collected pursuant to other provisions of law or, where such data are not readily available, reasonable estimates of the amounts involved.
EPA’s TRI is an important tool that provides the public with information about the use of certain chemicals by tracking their management and associated activities. U.S. facilities in different industry sectors must report annually how much of each chemical is released to the environment and/or managed through recycling, energy recovery, and treatment. TRI helps support informed decision-making by companies, government agencies, non-governmental organizations, and the public.

To view the final rule, visit: https://www.epa.gov/toxics-release-inventory-tri-program/implementing-statutory-addition-certain-an…

Learn more about the addition of PFAS chemicals to TRI, including a list of the 172 PFAS subject to TRI reporting: https://www.epa.gov/toxics-release-inventory-tri-program/addition-certain-pfas-tri-national-defense…

EU: Chemicals Strategy for Sustainability Roadmap, May 2020

The Chemicals Strategy for Sustainability will both help to protect citizens and the environment better against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives It will set a vision and a comprehensive framework for action where all parties – including industry – should work together to combine better health and environmental protection and increased global competitiveness.

This can be achieved by simplifying and strengthening the legal framework. The Commission will review how to better use the EU’s agencies and scientific bodies to move towards a process of ‘one substance – one assessment’ and to provide greater transparency when prioritizing action to deal with chemicals. In parallel, the regulatory framework will need to rapidly reflect scientific evidence on the risk posed by endocrine disruptors, hazardous chemicals in products including imports, combination effects of different chemicals and very persistent chemicals.

The Strategy will also support the EU’s strategic autonomy in the production of essential chemicals across key sectors and promote research and development for the sustainable transformation of the chemical industry and the creation of green and sustainable manufacturing capacity in Europe.

This Strategy is delivered within the framework of the European Green Deal, as a first step to move towards a zero pollution ambition for a toxic-free environment, in synergy with the Zero Pollution Action Plan (planned in 2021). The zero pollution ambition complements initiatives foreseen under the European Green Deal to protect biodiversity and to move towards a climate-neutral and circular economy. The Chemicals Strategy for Sustainability will also support other priorities of the European Commission, in particular the digital transition, strengthening the EU’s competitiveness as well as its industrial and strategic autonomy, fighting cancer, ensuring Europe’s manufacturing and supply of safe and affordable medicines, developing markets for innovative companies, exploiting digitization for societal solutions, ensuring strict enforcement of EU’s legislation and promoting the highest standards of environmental and health protection globally to also ensure safety and sustainability of chemicals and products imported into the EU.

EU REACH – Authorizations granted for various uses of five substances

By European Chemicals Agency (ECHA)

The European Commission has granted authorizations (review period expiry dates in brackets) for:

  • two uses of potassium dichromate(EC 231-906-6, CAS 7778-50-9) by Gentrochema BV (21 September 2024);
  • three uses of sodium dichromate(EC 234-190-3, CAS 10588-01-9) by Gentrochema BV (21 September 2024 (for uses 1 and 2) and 14 April 2024 (for use 3));
  • three uses of sodium dichromate(EC 234-190-3, CAS 10588-01-9) by Brenntag UK Ltd; Henkel AG & Co. KGaA and AD International BV (21 September 2024 (for uses 1 and 2) and 14 April 2024 (for use 3));
  • two uses of dichromium tris(chromate)(EC 246-356-2, CAS 24613-89-6) by Henkel AG & Co. KGaA and Henkel Global Supply Chain B.V. (22 January 2026);
  • two uses of potassium hydroxyoctaoxo-dizincate dichromate(EC 234-329-8, CAS 11103-86-9) by PPG Industries (UK) Ltd., Finalin GmbH, PPG Europe B.V., PPG Coatings SA, Boeing Distribution, Inc. (22 January 2026);
  • two uses of strontium chromate (EC 232-142-6, CAS 7789-06-2) by Akzo Nobel Car Refinishes B.V; Habich GmbH; Henkel Global Supply Chain B.V.; Indestructible Paint Ltd.; Finalin GmbH; Mapaero; PPG Europe B.V.; PPG Industries (UK) Ltd., PPG Coatings SA and Boeing Distribution, Inc. (22 January 2026)

BSEF requests Court of Justice annulment of Regulation (EU) 2019/2021 laying down ecodesign requirements for electronic displays

Authored by Joyce Costello, Compliance & Risks

In an action brought on 20 February 2020, Case T-113/20, the Bromine Science Environmental Forum (BSEF) lodged an application for an order of annulment of Commission Regulation (EU) 2019/2021 of 1 October 2019 laying down ecodesign requirements for electronic displays pursuant to Directive 2009/125/EC of the European Parliament and of the Council, insofar as it bans halogenated flame retardants.

The applicant, global representative of the bromine flame retardant industry, has presented 7 pleas of law in a bid to overturn the Regulation’s ‘unprecedented’ and ‘unwarranted’ restriction on halogenated flame retardants (HFRs) for electronic display enclosures.

In essence, BSEF contends that this ban is unlawful, and that the Commission exceeded the limits of its competence under the EU Ecodesign Directive by imposing restrictions on an entire class of substances that are within the scope of and controlled by other specific EU legislations (such as the EU RoHS Directive 2011/65/EU).

Pleas set out by BSEF in its application:

  1. The Commission breached Article 1(4) and Article 15(2)(c)(i) of the Ecodesign Directive, acted ultra vires and exceeded the limits of its competence, as well as prevented the effet utileof other EU law measures.
  2. The Commission breached the applicant’s rights of defence by banning the halogenated flame retardants for use in electronic displays through the Contested Regulation.
  3. The Commission manifestly erred in its assessment and failed to take all information into account, breached Article 15(1) of the Ecodesign Directive and failed in its duty to undertake an appropriate impact assessment when banning the substances
  4. Regulation (EU) 2019/2021 breaches the principle of legal certainty in that the applicant is placed in a position of unacceptable legal uncertainty.
  5. Regulation breaches the principle of proportionality.The ban  exceeds the limits of what is appropriate, is not necessary to achieve the objectives pursued and is not the least onerous measure to which the Commission could have had recourse.
  6. Regulation breaches the principle of equal treatment – the ban is discriminatory vis-à-vis other categories of products and vis-à-vis other substances.
  7. The Commission breached Article 15(1) of the Ecodesign Directive and Article 5a(1) to (4) and Article 7 and 8 of Decision 1999/468/EC and acted ultra vires.

The contested ban is scheduled to come into force in March 2021. 

Case T-113/20 may be tracked at http://curia.europa.eu/juris/fiche.jsf;jsessionid=C0176D2121C8E0C9CAAD8834C0C02221?id=T%3B113%3B20%

EU: Restrictions on CMRs 1A and 1B in Textiles and Clothing, Guidance Document, June 2018

“The purpose of this explanatory guide is to clarify the scope of the articles intended to be covered by the Commission Regulation Commission Regulation (EU) 2018/1513 of 10 October 2018 amending Annex XVII to REACH Regulation as regards certain substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B (entry 72 of REACH, Annex XVII).

The list of articles below is not exhaustive but aims to give illustrate examples of products available for use by consumers that are considered as being covered by the restriction, in particular by paragraph 1(a) clothing and related accessories, and paragraph 1(b) textiles other than clothing which, under normal or reasonably foreseeable conditions of use, come into contact with human skin to an extent similar to clothing.

The restriction covers products of the categories in paragraphs 1(a) – 1(c) that consumers acquire themselves, but also products they use in a private capacity or when using a product within the context of a service provided to the general public (e.g. bed linen in a hospital or upholstery in a public library).

For deciding whether other articles not listed below are to be interpreted as being covered (point 1 below), or not covered (point 2 below), by the restriction, a case-by-case assessment is necessary.

Such a case-by-case assessment is to be undertaken considering the wording of the restriction; the examples given can provide useful elements for this assessment.

With regards to concentration limits in Appendix 12, where different concentration limits are set in other entries in Annex XVII to REACH or in other EU legislation, the stricter limits always apply. This refers, amongst other, to the limits set in entry 50 on Polycyclic-aromatic hydrocarbons (PAH) and in the Toy Safety Directive 2009/48/EC.

Finally, in point 3, this guide also provides for a list of available analytical methods in certain matrixes that can be used for the determination of the different substances. It is suggested to use the most performant method. The list is not exhaustive and some of the methods might require some adaptations depending on the matrix.”

Oko Institut Completes RoHS Pack 15 Substance Assessments

by Joyce Costello, Compliance & Risks

On 8 April, Oko announced completion its Substance Assessment on seven different substances and substance groups (cobalt dichloride and cobalt sulphate, nickel sulphate and nickel sulfamate, beryllium and its compounds, indium phosphide, tetrabromobisphenol-A, medium chain chlorinated paraffins, diantimony trioxide) and advised that resulting dossiers will soon be published on its website.

Oko will also hold a final stakeholder webinar on 27 April 2020 from 14 to 18 CEST, to be hosted by EU Commission DG Environment. A draft agenda is circulating in advance of the meeting, showing, as expected, that there will be discussion of the substance inventory, followed by discussion of each of the substances, for a period ranging from 15-25 minutes per substance. Before DG Environment delivers concluding remarks, Öko-Institut will give a presentation of the exemption methodology .

RoHS Pack 15 from inception to conclusion:

On 1 February 2018, EU Commission DG Environment assigned a seminal project to a consortium led by Oko Institut, to:

  1. Provide technical and scientific support for the review of the list of RoHS restricted substances;
  2. Assess a new exemption request under RoHS 2 for cadmium in luminescent material for on-chip application on LED semiconductor chips.

The project, now known as ‘Pack 15’, is mandated by Article 6 of RoHS 2 which requires that the list of restricted substances in Annex II be reviewed periodically and further sets rules for amending the list. The project was designed by the Directorate as follows:

 Part 1: Substance restriction:

‒Task 1: Update the existing methodology to identify and assess substances for possible restriction;

‒Task 2: Assess substances with a view to their possible future restriction;

‒Task 3: Determination of the quantitative usage data for substances used in EEE;

Part 2: Exemption evaluation:

‒Task 4: Exemption methodology;

‒Task 5: Exemption assessment.

The project is now concluding after over 2 years of work, and the completion of the major milestones below:

February 2018 – Pack 15 launched

April 2018 – stakeholder consultation commences on task 2 assessment of 7 substances

October 2018 – new stakeholder consultation explores the substance assessment methodology and substance inventory

September 2019 – stakeholder consultation focuses on 4 substances and a revised substance inventory

December 2019 – stakeholder comments sought on 3 remaining substances, along with data from manufacturers on 43 priority substances identified as highest priority in the inventory

January 2020 – Oko extends deadline for submission of contributions to 13 February.

Oko now hands over to the EU Commission which must decide whether or not the conditions under Article 6 have been fulfilled to enable the addition of further substances to Annex II, following which it may commence work on a draft amending Directive.

China MIIT published Catalogue of Demonstration Guide for Key New Materials (2019)

On 25 November 2019, China MIIT published Catalogue of Demonstration Guide for Key New Materials (2019).

In 2016 China MIIT established an insurance compensation mechanism to promote the production and application of new materials in industry, and which would benefit companies using these listed materials. The scheme requires the regular release of an application demonstration guidance directory for key new materials, and the construction of a new material production and application demonstration platform. This platform is intended to reduce the risk to downstream users and improve the efficiency of insurance compensation work.

This catalogue covers 331 types of new materials that widely used in different industries and products. The industries and products include, among others: vehicles, new energy vehicles, pressure vessels, chemical industry, IT equipment, medical devices, 3D printers, textiles.
The 331 types of materials are separated into advanced basic materials, key strategic materials and cutting-edge new materials.

The advanced basic materials cover the following types of materials:

  • Advanced Steel Materials;
  • Advanced Nonferrous Metals;
    • Aluminium
    • Magnesium
    • Titanium
    • Copper
    • Other Nonferrous Metals
  • Advanced Chemical Materials;
    • Special rubber and other polymer materials
    • Engineering plastics
    • Membrane material
    • New electronic chemical materials
    • Other advanced chemical materials
  • Advanced Inorganic Nonmetallic Materials;
    • Special glass and high-purity quartz products
    • Green building materials
    • Advanced ceramic powder and products
    • Artificial Crystal
    • Mineral Functional Materials
  • Rare metals;
  • High-performance targets materials;
  • Other new materials.

Key strategic materials cover the following types:

  • High-performance fibres and composite materials,
  • Rare earth functional materials,
  • Advanced semiconductor materials and new display materials,
  • New energy materials.

This 2019 catalogue entered into force on 1 January 2020.

EU Packs 19 and 20, Consultation request for New and Renewal RoHS Annex IV for DEHP, Lead and Cadmium

Overview

The scope of the current consultation concerns two exemption requests: one for exemption renewal and one for a new exemption.

The application for the renewal of exemption 12, Annex IV was submitted under the project “Pack 19”, the application for the new exemption is being evaluated under the project “Pack 20”. The requests of both packages are to be consulted upon together, under the current stakeholder consultation.

Oeko-Institut and Fraunhofer IZM, on behalf of the European Commission, has published the requests as worded by the applicant, therefore the applicant is solely responsible for the wording and supporting evidence it has provided.

How to submit a stakeholder contribution

The following general guidelines should be taken into account:

• Refer to the exemption request listed in Table 2-1 and have a clear reference as to the exemption number

• Take the questionnaires on the exemption requests into account (questionnaires available under the exemption request specific pages, accessible through this link, and select exemptions through the tabs on the left.)

• Clearly state whether the exemption requests are supported or whether no justification is apparent. To support your contribution, it is required to provide relevant technical and scientific evidence in accordance with the criteria listed in Article 5(1)(a). Explain the reasons why potential alternative materials, designs or processes are unsuitable with quantitative data wherever possible. If possible, provide photographs or diagrams to illustrate claims. Provision of third party data and information may be beneficial to further support your view. Sources of information should be referenced where possible.

• Provide your input to the consultation as early as possible in order to allow other stakeholders to comment.

• Exemptions to RoHS Directive cannot be justified on the basis of confidential information.

New RoHS Stakeholder Consultation

This article was authored by Mike Kirschner of Design Chain Associates. 

Last week the Öko-Institut opened up a new stakeholder consultation on the three remaining substances proposed for restriction under the RoHS Directive:

  • Antimony Trioxide (ATO; a synergist for halogen-based flame retardants);
  • Medium-chained chlorinated paraffins (MCCPs) – Alkanes, C14-17, chloro; and
  • Tetrabromobisphenol-A (TBBPA)

Öko-Institut’s bottom line and rationale for these three substances is interesting but not unexpected.

ATO: if ATO on its own is restricted, there is a risk of regrettable substitution since – as a consequence of this restriction – an increased amount of halogenated flame retardants is expected to be used, bringing along their predominant negative impacts on health and the environment. In order to avoid this, the consultant proposes not to exclusively restrict ATO, but instead to carry out an assessment of the system of halogenated flame retardants and the ATO synergist with high priority.

MCCPs: Öko-Institut recommends restricting a range of MCCPs, describing that this entry covers chlorinated paraffins containing paraffins with a chain length of C14-17 – linear or branched.

TBBPA: it is recommended to include this substance in the list of restricted substances with a limit value of 0.1 % per weight due to the described risks of TBBP-A and the availability of alternatives. Assuming good and controlled manufacturing conditions, reactive applications and in particular its use as a component of FR4 PWB would not be affected by this restriction, because the residual levels of TBBP-A would be below the proposed limit in this case.

Note that, In light of the upcoming ban of organohalogen flame retardants (OHFRs) in displays/monitors/TVs under the Eco-design Directive, as well as the relatively non-impactful restriction of TBBPA, this should be interesting. In my opinion, in order to effectively restrict ATO, they have to restrict the entire sub-class of OHFRs that ATO would be used with in polymers including PVC and others.

Not to be too overshadowed, another stakeholder consultation is concurrently open on “substance prioritization” for 43 substances that could represent upcoming restriction proposals under RoHS. Öko-Institut is asking for quantitative usage data on these 43 substances.

Both stakeholder consultations are open until January 30, 2020.