Bureau REACH - Annual report 2021

The Netherlands composes in close collaboration with Denmark, Germany, Norway and Sweden a so-called restriction dossier for a European ban on the use of PFAS. The countries draft this restriction proposal to reduce the risks of the large group of PFAS for people and the environment. The proposal is aimed at a group of approximately 4000 PFAS. This is to avoid that one PFAS will be replaced by another one. For a good restriction proposal, it is important to have as much information available as possible. Companies and other parties have therefore been asked to provide information by a public consultation. This information will be supplemented by scientific studies and processed into a proposal. The Netherlands and Germany will submit the proposal to the European Chemicals Agency (ECHA) presumably in January 2023. After submission, the proposal will be assessed by two Scientific Committees of ECHA. Their opinion, together with the proposal, goes to the European Committee for decision-making on inclusion in Annex XVII of the REACH Regulation. More information: Prohibition of use PFAS | RIVM and Special on the ban on PFAS | Pfas (rivmmagazines.nl)

On behalf of the Netherlands, Bureau REACH submitted six dossiers focusing on a harmonised classification for hazardous chemicals and harmonised labelling to ECHA this year. Four of these proposals focused on the industrial chemicals trimethyl borate, glycerol formal, alpha, alpha’-propylenedinitrilodi-o-cresol and 1,4-dichloronitrobenzene. The other two proposals concerned two crop protection products, colza oil and bixlozone. It is vital that these chemicals be classified and labelled in a harmonised manner, as this will create a level playing field for all users of these chemicals and ensure binding and uniform communications regarding their hazards at the European level. This will in turn allow professional users of these chemicals and consumers to take those precautionary measures that will enable them to use the products safely.

Talc is a mineral that may have harmful and irreversible effects on the respiratory tract when humans are exposed to it repeatedly. Bureau REACH received indications from certain industries that exposure to talc might be putting their workers at risk of occupational disease, which prompted us to perform a so-called ‘Regulatory Management Options Analysis’ (RMOA). This RMOA identified the potential health hazards and made several proposals designed to minimise adverse effects on workers’ health. A draft version was submitted to the manufacturing industry, along with questions. Following consultation of people working in the industry and receipt of their answers to our questions, the RMOA was revised and shared with other member states, as well as with the Dutch ministries involved: Social Affairs and Employment; Public Health, Welfare and Sport; and Infrastructure and Water Management. The RMOA was submitted in December 2021. The document outlining the conclusions can be found on ECHA’s website: PACT - Public Activities Coordination Tool - ECHA (europa.eu)

The RMOA draws the conclusion that the first step to be taken should be a proposal for harmonised classification and labelling. Bureau REACH is currently drafting this proposal, on behalf of the Netherlands. The proposal is expected to be finalised in mid-2022. One recommendation outlined in the RMOA is to determine a Binding Occupational Exposure Limit (BOEL). This will allow Europe to set a more harmonised exposure limit for respirable talc.

Dimethylacetamide (DMAC) and N-ethyl-2-pyrrolidone (NEP) are so-called aprotic solvents, which are used in the production of textile fibres and membranes among other things. Both substances have been identified as reprotoxic in the harmonised system of classification, meaning they are substances of very high concern. Workers who are exposed to excessive concentrations run an unacceptably serious risk of danger to their health. We examined the available information on the health hazards and risks outlined in REACH registrations and came to the conclusion that the Derived No-Effect Levels (DNELs) in the risk calculation were set too high, meaning that the risks proved insufficiently manageable at the calculated exposure rate in several applications. We hope the submission of our restriction proposal will make the scientifically robust and well-substantiated DNELs legally binding on all registrants and users of these substances, and that it will ensure that companies be required to take measures to reduce the amount of their workers’ exposure to below the DNEL. The proposal regarding DMAC and NEP is similar to a restriction proposal for N-methyl-pyrrolidone (NMP) submitted previously by the Netherlands. This restriction was laid down in Annex XVII of the REACH Regulation and entered into effect on 9 May 2020, with one exemption governing the electromagnetic coil wire coating industry, which will expire on 9 May 2024.

The DNEL derivation for workers subject to inhalation and skin exposure took a long time due to the availability of a large number of reports on the substances’ toxicity in animals and epidemiological data for both substances, and due to discussions on how to interpret the data. The National Institute for Public Health and the Environment (RIVM) also looked into the feasibility of applying so-called benchmark dose modelling as an alternative to deterministic derivation of DNEL involving safety factors. The RIVM sought to be particularly thorough in its dossier with respect to this, so as to allow for a proper discussion by the Risk Assessment Committee (RAC). Partly due to the additional time required for this, we were unable to submit a sufficiently high-quality dossier on the intended submission date, 1 October 2021. The timeline was revised, and the dossier was submitted on 8 April 2022.

In 2021, Bureau REACH started preparing a so-called Annex XV SVHC dossier for a PFAS called PFHpA. The purpose is to have this substance identified as a ‘substance of very high concern’ (SVHC) based on the fact that it is persistent, bioaccumulative and toxic (PBT) and/or has very persistent and very bioaccumulative (vPvB) properties. If the substance is granted SVHC status, we will have greater clarity on when substances can be considered bioaccumulative in humans. It is absolutely vital that PFHpA be identified as an SVHC, since the substance can exist on its own but also be formed by other PFAS compounds which do not come under the PFHxA restriction proposed by Germany. Furthermore, if PFHpA is identified as an SVHC, it will be easier to define the nature of the concern in the Annex XV restriction dossier, which will support the ban on a wide range of PFAS, which the Netherlands is working on in association with other member states.

Two substance evaluations initiated by the Netherlands were concluded with ECHA’s publication of the conclusions. The previously adopted decision on silicon dioxide included a request for information on a 90-day sub-chronic toxicity study (OECD 413) in rats which had been subjected to inhalation exposure, performed with four different forms of the substance. In June 2020, the Netherlands received the report on the study and evaluated the results. The results of the study confirm the original concern, particularly with regard to the granulomas and fibrosis/fibrogenesis observed in the lungs and lymph nodes. We propose that a dossier be prepared for a harmonised classification for the toxicity endpoint with repeated exposure. Bureau REACH will prepare this dossier itself.

TCP is a reaction mixture of 3-methylphenyl di-4-methylphenyl phosphate and 4-methylphenyl di-3-methylphenyl phosphate and tris(3-methylphenyl) phosphate. For obvious reasons, we prefer to use the abbreviation ‘TCP’ in our communications. The Netherlands requested additional information on the toxicity of TCP (dermal absorption and inhalation neurotoxicity) and on how the DNEL (Derived No-Effect Level) was established. It also requested an evaluation of worker exposure. The requested information was received in the spring of 2019, by means of an update to the dossier. During the evaluation of the information thus provided, the Netherlands, in its capacity as the evaluating member state, requested an additional analysis of the histopathological examination performed. The final components of this additional analysis were submitted in February 2021 and evaluated. As a result, the initial concern was addressed satisfactorily and a conclusion document was drawn up and published on ECHA’s website. The evaluation of the available data shows that the estimates of the exposure concentrations in the registration dossiers were too low and that DNELs may be exceeded. The Netherlands will assess in 2022 what follow-up measures will be required and will be best suited to address the concern.

Read the conclusion document on ECHA’s website: SiO2 & TCP

In 2021, Bureau REACH coordinated the contribution made by RIVM staff to the implementation of the targets specified in the CSS at the technical, scientific, policy-supporting and advisory levels. RIVM experts attended working groups, committees, meetings, workshops and consultations on subjects identified as priorities in the CSS. In 2021, the European Commission started having discussions on a great number of subjects, such as reviews of authorisations and restrictions, the identification of new hazardous properties of substances classified as substances of very high concern (SVHC), amendments of the CLP Regulation by including new types of hazards in these categories of SVHC, the introduction of a so-called ‘One Substance One Assessment’ approach, which sees more collaboration between legal frameworks with a view to chemical safety, and the implementation of a method that takes into account mixture effects. Bureau REACH made its contribution in close consultation with the three Dutch ministeries involved: Infrastructure and Water Management; Public Health, Welfare and Sport; and Social Affairs and Employment.

Three centres affiliated with RIVM (VSP, DMG and VPZ) and ECHA published a scientific article on the effects of mixtures of chemical agents that were analysed in European surface water bodies (including many water bodies in the Netherlands). The information was compiled to give effect to the plan for the introduction of a substantiated MAF in the REACH Regulation as referred to in the Chemical Strategy for Sustainability. We chose to focus in the publication on providing factual information on the likely extent of the effects of mixtures, analysing the relative dominance of a small number of substances and using that to derive some general insights on their potential meaning for the MAF concept. Despite the in-depth data analyses, no quantitative MAF was proposed, due to available data on measurements performed in European surface water bodies being limited both in terms of quantity and in terms of quality. Since environmental monitoring was never geared towards measuring complete mixtures, even the very best field data sets are only fit for purpose to a limited extent. A follow-up study, based on a broader set of modelled water concentrations obtained as part of the SOLUTIONS project, may help us gain the knowledge we currently lack. RIVM will write a follow-up article on this subject in 2022.

Bureau REACH contributed to an amendment of criteria in the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), a standard managed by the United Nations, which has allowed us to make significant progress in terms of reducing animal testing. The United Nations working group focussing on the application of non-animal testing methods, led by the Netherlands and the United Kingdom, has arrived at an agreement on the inclusion of criteria for in-vitro and in-silico methods for the assessment of eye irritation and eye corrosion in the GHS in full. The amendment was then adopted in the plenary session of the sub-committee for amendments to the GHS. Milestones achieved in this amendment include the agreement on the application of the pH rule, the inclusion of in-vitro methods and ‘defined approaches’, and the expansion of the ‘background guidance’. A brief article on this work and its consequences was published in an RIVM newsletter on 3R activities in September (3R s Quarterly).

In the CSS, the European Commission identified the ‘essential use’ concept as a potential way to exclude certain socially important applications of substances of very high concern from a ban in future. In 2020, Bureau REACH embarked on a project designed to gain a better understanding of the essential use concept as part of the work it was conducting in relation to the broad REACH restriction of PFAS. This work is also in line with the innovative work we do in relation to the development of socio-economic analysis methods. In 2021, we made progress in this regard in the form of three participatory thinking sessions held under the guidance of Amsterdam’s Argumentenfabriek. Fourteen to seventeen representatives of various industries (manufacturing industry, government, science, interest groups) took part in the sessions and discussed the criteria that would make persistent substances essential. The results of these sessions were used to develop a ‘mind map’ outlining criteria (sectors or societal objectives where the use of persistent substances might be deemed essential). The mind map shows that the list of potential criteria for essential use is highly diverse and far exceeds the list of categories identified in policy documents (health, security). In order to gain a better understanding of which kinds of use of persistent substances (including PFAS) the people of the European Union consider essential, we developed a survey that will be conducted in seven European countries in early 2022. This survey will provide us with information on the industries and types of use that are considered most essential and about any potential differences in the opinions given by people in different countries and in different population groups. The results of this survey will be presented to the Ministries of Infrastructure and Water Management, Social Affairs and Employment, and Public Health, Welfare and Sport, as well as to the European Commission and ECHA, in the course of 2022.

The project designed to improve the socio-economic analysis of PBT substances was completed in 2021. This project resulted in an integral method for improved estimation of the extent of environmental pollution caused by emissions of PBT or vPvB substances (the so-called ‘cumulative environmental stock’). This method can be used to quantify the effectiveness of measures (e.g. restriction options) in a socio-economic analysis. This method is compared with existing methods in a scientific article submitted to the Journal of Industrial Ecology in May 2021.

The concept of ‘Maximum Tolerated Dose’ (MTD) is used in more and more regulatory studies and is often defined incorrectly. In carcinogenicity studies, the MTD is the highest dose that results in clearly harmful effects in animals used in experiments, in animals who did not die of any other causes than cancer. In the 1970s, the MTD was defined as the dose that could be expected to result in a 10% loss of body weight, so as to prevent false negative results.

Over the course of time, the definition of MTD was revised in various guidelines. It is now defined as a maximum body weight loss limit of 10%. When the MTD is misused in experiments involving animal testing, the experiments are carried out at a highest dose that is too low. As a result, the toxicity of chemicals cannot be properly determined, and the reliability and applicability of the results of the studies concerned are compromised. This in turn results in more animals being used in experiments than necessary. In this article, we argue in favour of (1) removing the MTD criterion from regulatory guidelines that are not related to carcinogenicity, and (2) reintroducing the 10% body weight loss definition as the definition for MTD in carcinogenicity studies. The article was submitted to Regulatory Toxicology and Pharmacology and is currently in revision.

In 2021, Bureau REACH embarked on a project focussing on the 3Rs (replacement, reduction and refinement) of experiments involving animal testing. The project was outsourced and focuses on the application of so-called kinetic models as an alternative to animal testing. As part of this project, sensitivity analyses were performed and the impact of variation on in-vitro data was illustrated by means of several commonly applied kinetic models. This knowledge is important in helping us arrive at experimental methods that do not involve animal testing and helps us understand which components of the kinetics must be further refined or standardised before being able to be applied in regulatory studies. The project is on schedule and the findings are expected to be presented in early 2022.

A group of 35 experts representing several organisations in Europe, Canada and Japan is working on an initiative designed to promote knowledge harmonisation in human biomonitoring research to allow for the use or reuse of these data in statutory risk assessment processes. This idea was voiced in an opinion piece which was accepted for publication by the International Journal of Hygiene and Environmental Health (special edition on the Human Biomonitoring Network). The ‘Human Biomonitoring Global Registry Framework’ (HBM GRF) received a great deal of attention from various stakeholders. The authors were invited to prepare a reaction to the keynote manuscript and submit it to the journal. In accordance with a description of a project drawn up in 2021, 2022 will see the preparatory stages necessary to be able to include this work into the PARC project in the coming year.

In 2021, Dutch RAC and SEAC members, supported by other RIVM experts, drew up opinions on seven proposals for harmonised classification and labelling, three authorisation requests and two restriction proposals. In performing these rapporteurs’ duties, the Dutch members played a major role in the scientific assessment of proposals for thorough risk management of substances of very high concern under the REACH and CLP Regulations.

In addition to the ‘Application for Authorisation’ (AfA) working group that prepares the decision-making process for authorisation requests for the RAC, two new working groups were established this year to support the RAC and ensure that its workload remains manageable. One working group was established to advise on decisions on restriction proposals, while the other was established to help the RAC make decisions on harmonised classification and labelling. RIVM appointed ecotoxicologists and environmental experts who will serve on the working groups in question as consultants to the two current RAC members.

In the summer of 2021, the RAC’s recommendation on a proposal submitted by Germany for a ban on a substance called PFHxA was finalised. The complex dossier proved to be hard to assess and guidance was a slow process. As a result, the process required a great deal of extra effort on the parts of the Dutch RAC member and five consultants. Since the dossiers lacked sufficiently robust data and clarity, the rapporteurs and the RAC chose to perform a qualitative assessment of the effectiveness of the proposed restriction. Emissions were used as a qualitative indicator for the risk associated with specific applications, along with information on the extent of the emissions and the feasibility of preventing or reducing them by means of measures other than the proposed restriction. Paper, textile and fire extinguishers are the main emission sources. During the process, requests for exemption were filed for a range of applications. The RAC’s opinions on the requests for exemption were based on the principle of emission minimisation. This proposal for a ban on PFHxA follows previous proposals for bans on other PFAS compounds (C9-C14 PFCAs, PFHxS, PFOS and PFOA).

For years now, Bureau REACH has actively contributed to discussions held in the Member State Committee with a view to enabling ECHA to decide on registrations’ level of compliance and on test proposals submitted by companies. The Netherlands has mainly focussed on decisions with regard to the ‘Extended One-Generation Reproductive Toxicity’ study (EOGRT), in vivo mutagenicity and PBT/vPvB properties. As far as the EOGRT study is concerned, Bureau REACH is also contributing to a scientific project carried out by ECHA, whose purpose is an evaluation of whether new rules for requesting a more extensive test design under certain circumstances are actually complied with, and whether they provide us with sufficient information.

In 2021, Bureau REACH has designed and shared an online annual report with the clients. On the basis of concise texts and infographics, the reader included in the most important results and cases who have played in 2020: View the PDF here. It is also provided an overview of our work in terms of numbers of files at the request of our clients. The reactions to this were purely positive. Also for 2021 Bureau REACH follow this procedure for the annual report and digital design.

The Helpdesk website http://www.chemischestoffengoedgeregeld.nl is by a external party converted to a future-proof operating system. This party also has the content transferred and the quality control of this has now been round. After implementing the final corrections, the new website went live at the end of September 2021. Hereafter the updating of the content of the website has started gone. As part of the additional SZW project (on informing small SMEs about REACH, CLP and working conditions), is after the go-live of the website also an infographic aimed at garage owners added.

On Monday 29 November 2021, Bureau REACH shared the announcement of its own birth via LinkedIn. Bureau REACH’s Communications working group, in close collaboration with the National Institute for Public Health and the Environment’s Communications department, has drawn up a communication plan which will gradually raise the general public’s awareness of the organisation. The communications will share Bureau REACH’s message, as well as milestones and other subjects that crop up over the course of the year. Bureau REACH hopes they will reach a fixed number of followers and will help the organisation build a network in which knowledge and information about chemicals can be shared and exchanged.

In collaboration with the communications department, we have created an online magazine (in Dutch): Special edition about the ban on PFAS | PFAS (rivmmagazines.nl). An English-language version is also available: 01 | PFAS (rivmmagazines.nl). 

In March and April 2021, Bureau REACH coordinated and organised an online REACH and CLP course for inspectors and senior executives of the regulatory bodies. In all, we designed seven different modules about the REACH and CLP Regulations. Experts affiliated with RIVM and an external consultant held training sessions. Each module was attended by 30 to 50 participants. The course was evaluated afterwards, with attendees proving very satisfied with what they had learned.