Bureau REACH - Annual report 2022

Foreword by Richard Luit

For Bureau REACH, activities in 2022 focused on preparatory work, taking initiative and reaping results. Ongoing themes in our work are the European Commission’s plans regarding the Chemicals Strategy for Sustainability (CSS) and in particular, the adjustments to the REACH and CLP Regulations set out in those plans. The highlights we will present in this annual report give an accurate picture of our tasks and responsibilities within the purview of the Bureau REACH work programme and international chemicals policy.

Preparatory work

We can look back on successful preparatory work in connection with the proposal for a European ban on PFAS substances. It was an enormous task that required a great deal of work from us and the four other Member States involved. We have also contributed to the objectives of the CSS on a variety of fronts by means of technical-scientific and policy recommendations. As the adjustments to the CLP Regulation took shape in 2022, we assisted in the preparatory stage of defining the new types of hazards and criteria for endocrine-disrupting and persistent chemicals. The European Commission is expected to introduce proposed adjustments to the REACH Regulation somewhere in the course of 2023. To prepare for this, we contributed on behalf of the Netherlands to the discussions in working groups, workshops and public consultations of the European Commission that took place in 2022.

Initiatives

In 2022, we once again undertook many initiatives to improve the hazard and risk assessment and socio-economic analyses in connection with REACH and CLP. A few of these are highlighted in this annual report. We contributed to improvements in the European Chemicals Agency (ECHA) guidelines for evaluating PBT substances. We were also active in the UN’s Globally Harmonised System of Classification and Labelling (GHS) compilation efforts, aimed at adjusting the hazard classification criteria for skin sensitization in order to facilitate non-animal testing. And we worked on scientific research into the practical application of the concept of ‘essential use’.

Reaping results

In addition to all that preparatory work, we were fortunately able to reap some results in 2022 as well. PFAS is not the only restriction dossier we are working on. In April, we submitted a restriction proposal for the solvents Dimethylacetamide (DMAc) and N-ethyl-2-pyrrolidone (NEP). Exposure to excessive concentrations of these substances in the workplace carries an unacceptable risk of harmful effects. Among other things, we uncovered risks to workers in the textile industry. We also identified the most suitable options for managing risks in connection with styrene and PFHpA (a PFAS compound) and we were closely involved in the harmonised classification and labelling procedures for carbon nanotubes and barium chromate.

Bureau REACH does more than will fit into this overview. Our work will continue in 2023 as well. To keep abreast of what we are doing, you can follow us on LinkedIn. This, too, was one of our focus areas in 2022: to communicate even more clear, up-to-date information regarding the risks of chemicals.

Richard Luit, Head of Bureau Reach

While this annual report looks back at 2022, we also want to take this opportunity to look ahead to 2023.

One important moment has already occurred. In January 2023, the restriction dossier for PFAS was submitted to ECHA and published. This was followed shortly thereafter by the evaluation procedure involving ECHA’s scientific committees. This procedure will conclude in 2024. The final scope and form of the ban will be established through decision-making at the European level at the behest of the European Commission. The ban will enter into force in 2026 at the earliest.

The European Commission is currently working to revise the REACH and CLP Regulations. We will once again actively contribute to those efforts. The work of the various scientific committees will continue as well.

Bureau REACH intends to begin the substance evaluation for chlorobenzene in order to identify any potential harmful properties, including endocrine-disrupting effects.

Bureau REACH will also compile a RMOA for 6PPD. This substance is added to rubber tyres to make the rubber more resistant to wear and deterioration. There is evidence in the literature that this substance and its conversion products lead to fish die-off after heavy rain, when rubber particles enter surface water through run-off.

Finally, we plan to update both the content and layout of the website chemischestoffengoedgeregeld.nl.

About Bureau REACH

Bureau REACH helps ensure that chemicals are used safely in the Netherlands and Europe.

On behalf of the Dutch Government, Bureau REACH carries out tasks in connection with the EU’s REACH and CLP Regulations. These are important European laws designed to ensure the safe use of chemicals in Europe,

with a particular focus on protecting consumers, workers and the environment. Other important aims include ensuring equal opportunities for businesses, reducing animal testing and enhancing the sustainability of both the chemical industry and the environment in general.

Bureau REACH plays a central role on behalf of the Dutch Government in implementing the tasks and powers granted to the Netherlands as a Member State of the European Union. Among other things, we take part in discussions on how to elaborate and implement regulations, as well as on how to improve them. Our involvement with the European Commission’s Chemicals Strategy on Sustainability (CSS) is one example of how we do this.

We submit dossiers on behalf of the Netherlands and comment on proposals submitted by other Member States and ECHA. That means that we make suggestions based on scientific research about banning specific substances, regulating their use or assigning them to a particular risk category.

Bureau REACH also answers companies’ questions about what they must do in order to comply with the REACH and CLP Regulations.

Bureau Reach is an implementing organisation of the Dutch Government and part of RIVM. Clients of Bureau REACH include the Dutch Ministries of Infrastructure & Water Management, of Health, Welfare & Sport, and of Social Affairs & Employment.

For more information about Bureau REACH’s duties and responsibilities, and our contributions to a wide range of working groups and committees in Helsinki, Brussels, Paris, Geneva and The Hague, see:

How to deal properly with chemicals! | Chemicals..

What is the current status of…

Projects often last longer than one year. As we look back on 2022, there are several projects that began earlier, but still deserve further attention. To that end, here is an update: What is the current status of…

The PFAS restriction dossier

Since 2020, we have been working on the proposal for a European ban on the use of some 10,000 PFAS substances. We have concluded that the production and use of all PFAS in this group yields an unacceptable level of risk. By enacting a single European ban on all these PFAS, we want to eliminate these risks and prevent one PFAS from being replaced by another. The preparation of this proposal was our main focus in 2022 and the project was as good as finished by the end of the year. We drafted the proposal in cooperation with Germany, Sweden, Norway and Denmark.

More information: Ban on use of PFAS | RIVM and Special edition about the ban on PFAS | PFAS rivmmagazines.nl

PFHpA identified as a substance of very high concern

The PFAS compound PFHpA is a degradation product of HGC-TLF. The Netherlands has identified the most suitable options in a risk management option analysis (RMOA). For PFHpA, this resulted in both a harmonised classification and labelling and a substance of very high concern (SVHC) dossier being created for this substance in order to identify it as a substance of very high concern (due to reprotoxic effects). We compiled this dossier and submitted it in mid-2022. ECHA published the dossier on 9 August. The Member State Committee has since approved the classification of PFHpA as a SVHC. The hazard identification process for PFHpA was unusual because the substance has been categorised as both persistent, bioaccumulative and toxic (PBT) and persistent, mobile and toxic (PMT).

Substance evaluation for EIK completed

There is concern about the carcinogenic and genotoxic properties of 4,4'-bis(diethylamino)benzophenone (EIK). This substance is used in products such as glue, caulk, paint and printer ink. In 2022, Bureau REACH completed the substance evaluation for EIK and submitted it to ECHA. Due in part to this evaluation, EIK will no longer be manufactured in the EU or imported in larger volumes. All registrants have decided to cease producing and importing the substance, meaning its use will decline from here on out.

Restriction proposal for DMAC and NEP

In April, we submitted a double restriction proposal to ECHA with the goal of protecting workers from the risks associated with exposure to the aprotic solvents DMAC and NEP. These solvents are frequently used in the chemical industry, for instance in the production of cosmetics and medicines. The dossier was opened in December 2019 with a call for evidence. Now, over two years later, the dossier is complete and the sections on alternatives, evidence to support the most suitable measure and the impact assessment have been added. ECHA’s scientific committees will now evaluate the dossier. The next step will be the European decision-making procedure in order to formalise the restriction as a matter of law.

Classification of barium chromate as a carcinogen

The Netherlands has submitted a proposal for harmonised classification and labelling (CLH) in order to ensure that the substance barium chromate is classified as carcinogenic (category 1B carcinogen). Applications of this substance include use as a pigment in paints, ceramics, coloured glass and porcelain. All other known chromates and chromium salts containing chromium(VI) have already received this classification. In addition, many chromates require authorisation for use, despite the fact that this group of substances is quite common in connection with chrome-plating metals. The Netherlands wants to prevent barium chromate from being used as a replacement for other, prohibited chromates. The Dutch view is that harmonised classification and labelling, along with inclusion on the SVHC list, is the best way to achieve this end.

Carbon nanotubes classified as carcinogenic and toxic to organs

Germany has submitted a proposal for the harmonised classification and labelling of carbon nanotubes. These tubes are used in an extremely wide range of applications, including electric cables and wires, batteries and solar cells. A Dutch member of the ECHA Risk Assessment Committee (RAC) has drafted an opinion on behalf of the RAC. This opinion was adopted during the RAC’s plenary meeting in 2022. Due to the nanoscale dimensions and the physical form of the material, reaching a consensus regarding this dossier proved exceptionally challenging. Depending on their dimensions, particles are classified as a carcinogen (1B) and as having specific organ toxicity in the event of repeated exposure (STOT RE 1).

RMOA for styrene completed and submitted

At the start of 2022, we completed an RMOA for the substance styrene. Styrene is a building block for the plastic known as polystyrene, which is used to make things like disposable plates and styrofoam. ECHA published the conclusions on its website on 13 May 2022. The Netherlands suggests the gradual implementation of additional legal measures. Efforts to draft a proposal for harmonised classification and labelling will follow in 2023. This CLH will be for specific organ toxicity in the event of repeated exposure and for carcinogenic and mutagenic properties. Once the classification has been established, the substance can be identified as a SVHC and could potentially be added to the list of substances with an authorisation requirement under the REACH Regulation. The Netherlands also recommends establishing an exposure limit for workers.

Contributions to the European Chemicals Strategy on Sustainability

The Chemicals Strategy on Sustainability (CSS) figured prominently in much of the work carried out by Bureau REACH in 2022.

Throughout 2022, there was much discussion regarding which adjustments to legislation are needed in order to achieve the CSS objectives. Such changes might entail reviews of authorisations and restrictions, the expansion of the generic approach to risk management (GRA) or the introduction of new SVHC hazard classifications in the CLP Regulation. Safe and Sustainable by Design, essential use and criteria for an environmental footprint were addressed as well.

Bureau REACH contributed to various proposals for adjustments to the CLP Regulation. One issue we felt was important, for instance, was adequate implementation of the desired new hazard classifications in the CLP Regulation (endocrine-disrupting and PBT/vPvB and PMT, vPvM).

Bureau REACH has a coordinating and policy-advising role in connection with submitting comments from the Netherlands. We comment on all these topics via consultations, workshops and interviews. For some topics, Bureau REACH took part in interviews and completed specific questionnaires in order to explain the positions taken by the Netherlands. This work is slated to continue in 2023 and 2024.

Agreement reached in connection with proposal on alternatives to laboratory animals

An interview with Marjolein Woutersen

Substances must be tested in order to assign them a skin sensitisation (allergy) classification. In many cases, laboratory animals are used for this purpose. Under Dutch leadership, the GHS criteria for this classification have been adjusted. As a result, it has become possible to make use of other methods as well, such as in vitro (in the cells of a laboratory animal), in chemico (based on chemical reactivity) and in silico (by means of a computer simulation). This adjustment will eventually be adopted in the legislation of over 80 countries, as well as in the EU’s CLP Regulation. The adjusted criteria will greatly reduce the number of laboratory animals needed. Marjolein Woutersen was closely involved in this project.

What results were achieved in 2022?

In the past two years, we have worked hard to see that alternatives to animal testing were added to the criteria for skin sensitisation applied by the United Nations. And our efforts have been rewarded! In other words, it will no longer be necessary to conduct animal testing or human studies to determine whether a substance can cause allergic reactions on skin.

What role did the Netherlands play in this success?

Together with the United Kingdom, the Netherlands led the UN working group for the implementation of alternative methods for classifying skin allergies. This working group was established within the framework of the GHS. It is vital to ensure that the hazardous properties of chemicals are classified in the same way all around the world. To that end, the United Nations is working to establish and publish criteria for classification at a global level. These criteria, in turn, provide part of the basis for European legislation in this area.

What was the highlight for you personally?

This project was quite special to me, because it was the first time I was involved so directly in this process. For the last six months, I had the privilege of co-chairing this working group. Leading these meetings is an incredibly intensive undertaking. The working group includes leading experts who are highly experienced, well-spoken and sometimes a bit idiosyncratic. And even though everyone supports the intentions of this working group, it is still a challenge to find a text that is both scientifically accurate and useful for everyone’s policy purposes. I found it very interesting and educational and am proud that we succeeded in submitting this adjustment ahead of the tight deadline.

New scientific publications

A number of projects and studies resulted in scientific publications in 2022.

We published a scientific article from RIVM in Environmental Pollution, for example, which dealt with the role and suitability of toxicity tests involving amphibians as a means to identify the mechanism for disruption of thyroid hormone in the environment.

We published about the impact of international guidelines for evaluating the safety of chemicals with a letter to the editor published in Critical Reviews in Toxicology. In many cases, animal testing is used to determine whether a given chemical is carcinogenic. Sometimes there is reason to suspect that a chemical will behave differently in the human body than it does in rats or mice. Only when there is convincing evidence that no harmful mechanism will occur in humans can such a substance be considered safe. Even so, we frequently encounter cases where this evidence is insufficiently substantiated.

We also published an article in Regulatory Toxicology and Pharmacology about the maximum dose that may be administered in animal testing, with an eye to preventing unbearable suffering among laboratory animals. We found that guidelines are sometimes misinterpreted or may themselves contain inaccuracies.

In the Journal of Industrial Ecology, we published an article about the stock pollution assessment of persistent chemicals. RIVM experts worked on this in 2022 as a follow-up to the research project on the SEA of PBT and vPvB substances. The results of the analysis offer insight into the long-terms effects of persistent chemicals such as PFAS. These insights can be used to evaluate the cost-effectiveness of restriction options.

Improvements to ECHA guidelines for evaluating PBT substances and nanomaterials

With support from the RIVM knowledge team, the Dutch member of ECHA’s PBT Expert Group took part in the revision of the PBT guidelines. This included efforts to compile background information on growth dilution in bioaccumulation studies. In addition, we made suggestions for dealing with volatilisation and the formation of non-extractable residue (NER) during degradation studies. Lastly, we helped draft the guideline for bioaccumulation in air-breathing organisms (especially mammals and birds).

Individual sections of existing nano-specific guidelines were adjusted and are expected to be published in early 2023. These adjustments pertain to solubility in water, granulometry, the octanol-water partition coefficient and adsorption/desorption. An RIVM expert participated in the Partner Expert Group for this guideline at Bureau REACH’s request. The various REACH committees (MSC, RAC, CARACAL) have since submitted their comments and their input has been incorporated into a preliminary public version.

Elaboration of the concept of essential use

Essential use is a central and vital concept in the CSS. The European Commission has plans to increase its use of general bans on the most hazardous substances in the future, with exceptions permitted only for essential use. Essential use could therefore be integrated into the REACH policy framework and other European legal frameworks for chemicals. To clarify this concept, we conducted a study into perceptions and elaborated the results into a framework in 2022. Our SEA team presented the initial findings of this study during a SETAC Europe conference. We also designed and distributed a questionnaire in 2022. The data have now been collected and interpreted. Publication of the results will follow in early 2023.

Revision of CLP with new criteria

An interview with André Muller

Together with international partners, Bureau REACH firmly committed itself to including new hazard classifications in the updated version of the CLP Regulation in 2022. André Muller made a key contribution to this in his capacity as coordinator.

What did we achieve in 2022?

Last year, we committed ourselves to including new hazard classifications in the updated version of the CLP Regulation. Our efforts focused primarily on endocrine-disrupting chemicals and chemicals that are both persistent and (very) bioaccumulative and/or (very) mobile and toxic. And with success: these substances were added to the proposed legislation and, when it was adopted on 19 December 2022, the Commission took many of our comments and suggestions to heart.

What role did the Netherlands play in this success?

The Netherlands is a small country with a relatively large chemical industry. This makes it vital to ensure a high level of protection for people and the environment. To that end, we are extremely active in a variety of international partnerships. We also have access to RIVM’s wealth of technical and scientific knowledge relating to toxicology. As a result, the lines of communication are short and we are in a position to judge effectively how the various laws and procedures relate to one another.

We achieve the CSS goals through discussion and consultation in many areas and subsectors. This, in turn, should eventually lead to legislative amendments – which is why we offer advice to the relevant ministries for the purpose of public consultations and why we take part in meetings and working groups in the technical/scientific sector. This enables us to make significant contributions at the international level as well.

What was the highlight for you personally?

Personally, I am proud that we were able within a very short period of time to provide advice for the public CLP consultation. The additional points we suggested are reflected in the proposal. It feels great that I can make a real contribution to improving these protections in this way.

Active input for CARACAL and with regard to the CCS

Bureau REACH assists CARACAL and contributes to policy discussions on the CSS in a number of ways, for example in working groups on endocrine disruption (CASG-ED), information (CASG-IR) and polymers (CASG-polymers). We also undertook a multitude of activities in connection with the CSS in 2022. Employees of Bureau REACH and their RIVM colleagues participated in workshops, interviews and discussions on many different topics.

Bureau REACH took the lead in drafting the Dutch comments during many consultations arranged by the Commission and consultants. The consultation on the review of the REACH Regulation turned out to be the most extensive task in this regard. This was particularly true of our RIVM colleagues’ contributions in the working groups. Based on our technical expertise and practical experience with different parts of REACH and CLP 1.0, we were able to make suggestions for making version 2.0 better than its predecessor.

In many cases, this involved existing and standing working groups such as those which a focus on exposure, nanomaterials and information requirements. Temporary working groups were sometimes convened for purposes such as determining new criteria for SVHC hazard classes under the CLP Regulation.

Informal knowledge exchange with other experts in REEG

The REACH Exposure Expert Group (REEG) is a network of experts from EU Member States and ECHA. In 2022, RIVM drafted a guideline for this network, in which we described the desired level of user and exposure information (according to REEG) in connection with various REACH processes. The guideline also describes how we will obtain the necessary information if it cannot be found in existing sources. By extension, we discussed what is desirable in terms of user and exposure information. This may apply to complex restriction dossiers, ‘new’ dossiers concerning nanomaterials and polymers, or evaluation-related issues such as aggregation and cumulative exposure. Recent experiences with the group approach to restriction dossiers has shown that the current standard is far from sufficient.

REEG is therefore working informally to harmonise opinions in connection with user and exposure information within the Member States and ECHA.

Its efforts are expected to yield a concrete product in the form of templates for official requests for information. These templates will make it clearer which information is being requested. In this way, Member States and ECHA aim to enhance the quality and usability of user and exposure information. We began designing these templates at the end of 2022. The templates concerning exposure information for workers will be finished in 2023.