POSITION | ENVIRONMENT | CHEMICAL REGULATION

REACH-Revision

Contribution to the public consultation

13.04.2022

Summary

In the revision of the REACH regulation envisaged by the EU Commission, serious changes with considerable tightening of the regulation of chemicals are planned. This includes, among other things, additional registration requirements, the introduction of a "mixture assessment factor (MAF)”, the extension of the "generic approach to risk management (GRA)” and the establishment of an "essential use concept". The measures proposed by the Commission are intended to make chemicals regulation more hazard-based in the future.

German industry views the paradigm shift from risk-based chemicals legislation to hazard-based chemicals legislation with great concern, as it can be assumed that this will massively restrict the availability of substances. This will severely impair the innovative capacity of European industry and the possibility of further technological developments. It must still be possible to produce and use hazardous chemicals in the future if there is no unacceptable risk to humans or the environment. This is a crucial prerequisite for the continued production of sustainable products and value creation in Europe. In order not to jeopardize the sovereignty of European industry against the backdrop of the current challenges, the revision of the REACH Regulation must be carried out with a sense of proportion. In particular, the following aspects should be considered.

➢ Risk-based regulation of chemicals must be maintained. Hazardous chemicals must be allowed to be used in Europe in the future if there is no unacceptable risk for humans or the environment.

➢ Registration and information requirements must be based on a tiered approach and be designed to be practicable and implementable.

➢ The risk-based approach of the restriction procedure allows for appropriate regulation of chemicals and should be maintained. Switching the restriction process to the hazard-based "generic approach" is disproportionate.

➢ Positive aspects of the authorization procedure should be retained but the scope should focus on cases where non-REACH measures and restrictions are less suitable, and the process must be simplified.

➢ In order to always select the best and most efficient risk management measure/regulatory option, a transparent procedure must be established right at the beginning of the regulatory process (e.g. RMOA)

➢ We reject the comprehensive application of an "essential use concept". The production and use even of hazardous substances must remain possible - regardless of whether they are essential for society - if there is no unacceptable risk.

Introduction

As announced in the Chemicals Strategy for Sustainability (CSS), the EU Commission has launched a targeted revision of the REACH Regulation. The revision provides for comprehensive adjustments in key areas of the EU chemicals regulation. This includes the extension of registration requirements, a reform of the authorisation and restriction procedure as well as the incorporation of new fundamental concepts such as the essential use concept (EUC) and the general risk assessment (GRA) In addition, the introduction of a mixture assessment factor (MAF), the extension of the DMEL approach and measures to improve communication in the supply chain are planned.

The measures proposed by the European Commission represent a fundamental shift of paradigm in EU chemicals legislation, away from a proven risk-based approach towards an unproven hazard-based approach. The targeted revision will include many tightened and extended requirements in EU chemicals legislation. Such a comprehensive revision will have far-reaching consequences for industry. It must be clearly pointed out that these consequences will not be limited to the chemical industry alone but will affect all sectors across the supply chains. However, at this stage, the impact of the reform of the risk management for chemicals cannot yet be assessed holistically, as the Commission does not clearly describe the foreseen interaction between the proposed approaches, e.g. the general approach to risk management (GRA), the essential use concept (EUC) and the reform of authorisation and restriction procedures

With the current REACH Regulation, the EU has one of the most comprehensive and safest regulatory frameworks for chemicals in the world. In addition, the safe and sustainable use of chemicals in workplaces is enshrined with existing occupational health and safety regulations such as the Chemical Agents Directive and the Carcinogens Directive. In order not to burden companies unnecessarily, not to hinder their ability to innovate and to further promote the sovereignty of European industry, the revision of the REACH Regulation must be carried out with great caution and a sense of proportion. Against the background of the current political and economic challenges, changes must not go beyond what is clearly necessary.

From the industry's point of view, the move away from a risk-based approach and the comprehensive regulation of entire groups of substances are particularly critical. In order to be able to develop and use innovative solutions and socially relevant technologies in the future, it must remain possible to produce and use hazardous chemicals if there is no unjustified risk to human health or the environment. Only if the broad availability of substances is maintained, the production of sustainable products and value creation may continue to take place in Europe.

The way in which the questions are posed in many parts of the questionnaire is unfortunate and provokes inconsistent and misleading answers. For example, the BDI and its members do of course support an internationally harmonised and yet rapid development of non-animal test methods. But unless the procedures are internationally harmonised and recognised, a European go-it-alone approach would lead to a duplication of the necessary tests within and outside the EU and of corresponding expenses, while unfortunately not saving any animal testing.

In this contribution to the public consultation, BDI discusses the individual options proposed by the EU Commission for revising the REACH Regulation. In our view particularly the following aspects should be taken into account in order not to place an unreasonable burden on European industry

Registration requirements

To better protect human health and the environment, the European Commission proposes within the Chemical Strategy for Sustainability to increase the information requirements under REACH for all chemicals. For so-called critical hazards such as carcinogenicity, mutagenicity and reproductive toxicity, endocrine disruption, data requirements mandatory in the registration procedure should be enhanced. This may imply the need for companies (registrants of substances, manufacturers and importers of substances) to test more chemicals for more hazardous properties.

In addition, the data requirements for substances produced in the lowest tonnage band of 1-10 tonnes/year are planned to be extended. Here, the Commission is assessing the obligation to prepare a chemical safety report (CSR) in this tonnage band as well. Up to now, polymers have been exempted from the obligation to register. The European Commission now is planning to extend the obligation so that certain polymers would also fall under the obligation to register.

Endocrine disruptors

The current REACH regulation already allows the identification of endocrine disruptors as Substances of Very High Concern (SVCH) As part of the registration obligation, manufacturers must submit information and data on the intrinsic properties of their substances. If further data are required, e.g. in the case of concerns about certain properties, these can already be requested by the authorities as part of the substance evaluation process.

Information and data requirements must be proportionate and consider animal welfare aspects. In our view, the general demand for further data as standard information is not justified. Especially in the case of low tonnages and low exposure potentials, extensive vertebrate testing is not appropriate.

A tiered approach is the most suitable for additional data requirements where necessary,

• if there is a reasonable suspicion of endocrine effects

• based on available information

• related to individual substances

• using internationally accepted and validated test methods

For this approach, as well, existing REACH procedures such as dossier and substance evaluation should be used and there should be no general demand for further data provision

Low tonnages

Especially in the volume band of 1 to 10 tonnes per year the information requirements must remain proportionate. If data requirements at the lowest tonnage level become too high, respective substances will disappear from the market due to disproportionate costs. If further data are needed to assess specific concerns, existing REACH procedures such as substance evaluation should be used.

We do not consider it appropriate to draw up a general chemical safety assessment for all substances in the 1-10 tonne range. Rather, depending on the use and exposure, it should be examined on a caseby-case basis whether the preparation of a CSA is necessary.

Polymer registration

We do not see any need to introduce a registration obligation under REACH for all polymers. For the registration of certain polymers ("polymers requiring registration" (PRR)), a practicable and cost-efficient concept, based on appropriate technical and scientific criteria must be established. When developing registration approaches for certain polymers (PRR), the requirements of Article 138 (2) should be considered

According to Article 138, the registration of polymers must take into account the following aspects:

• practicable and cost-efficient way of selecting polymers

• application of sound technical and valid scientific criteria

• selection of polymers based on reports, that demonstrate that certain types of polymers pose an increased risk compared to others (reports should consider competitiveness and innovation aspects and the protection of human health and the environment).

In order to identify "polymers requiring registration " (PRR) and "polymers of low concern" (PLC), appropriate criteria must be established. These criteria must be efficient and practicable Potential criteria should be tested under real conditions, e.g. in pilot studies. Furthermore, it is important that the chosen criteria are in line with other European and global regulations.

To make the registration of certain polymers practicable and cost-efficient, it is necessary to develop adequate grouping approaches for PRR. A grouping approach based on "hazard similarity" might provide a suitable frame for assessing heterogeneous groups of polymers.

Additionally, a robust impact assessment must be carried out by the European Commission on polymer registration Only in this way will it be possible to adequately assess the full consequences of a potential polymer registration. Within the impact assessment, all costs within the supply chain must be taken into account and differentiated. Baseline of any impact assessment should be the current situation, where polymers are exempted from registration and monomers are registered.

Information Requirements on Use and Exposure

Related to use information under REACH a balance must be maintained between what the registrant can consider for the totality of users during registration and what is specific to certain users or workplaces. It is important to keep the effort and benefit in a reasonable ratio. Therefore, only a change in the relevant information specified in REACH Art. 22 should trigger a mandatory update of the dossier. We see no need for substantial changes to the REACH Regulation at this point. If more or different information is needed in special cases, e. g. if a substance has been prioritized for further regulatory action a targeted approach considering registrants as well as downstream users should be chosen.

Derived Minimal Effect Level (DMEL) for non- threshold substances

Within the targeted revision of the REACH regulation the European Commission assesses the wider application of DMELs for non-threshold substances. The Commission aims to extend the DMEL approach from carcinogenic and cell mutagenic substances to other hazard endpoints such as respiratory sensitizers, immunotoxicants, neurotoxicants and endocrine disruptors. The introduction of DMELs for more non-threshold substances, based on dose-response relationships, coupled with the application of politically acceptable risk levels, would mean that registrants would be required to quantitatively demonstrate that risks are adequately controlled instead of the current qualitative demonstration of minimised exposure and emissions.

BDI supports the risk-based approach for non-threshold carcinogenic and cell mutagenic substances. If certain prerequisites such as a comprehensive database, detailed knowledge about "Mode of Action (MoA)" and studies to derive a dose-response relationship, are given, DMEL calculation is in principle an appropriate option.

However, we are very critical of an extension of the DMEL approach to further hazard-categories (e.g. endocrine disruptors, neurotoxicants, immunotoxicants and respiratory sensitizers), as these substances are not per-se non-threshold substances. Even if it may be - in some cases - difficult to quantify the threshold, they should not be treated systematically as non-threshold substances. DMELs should thus only be used for carcinogenic 1A and 1B and no other additional endpoints.

The DMEL-approach is meant for non-threshold endpoints and should not be used without the explicit knowledge that a substance exerts a non-threshold toxicity. Appropriate and comprehensive data are necessary to derive a dose-response relationship and, consequently a DMEL. Decisions, whether scientific dose-response relationships allow for a sound DMEL calculation must be made carefully and on a case-by-case basis.

Mixture Assessment Factor (MAF)

In order to consider adverse (eco)toxicological effects when humans or other organisms are exposed to several substances together or subsequently, the Commission intends to introduce a "Mixture Assessment Factor (MAF)". When applying a MAF, exposure levels that are considered sufficiently safe for single chemicals are reduced by a certain generic factor (i.e. by a MAF).

The introduction of a MAF is neither scientifically justified nor appropriate. MAF-Studies and assessments, e.g. in the MAF-Workshop of the Commission have shown, that combination effects of chemicals only occur in a limited number of cases.

Thus, the general introduction of a MAF would massively curtail all substances and uses even without relevant combination effects. This would have considerable consequences for the safe use of chemicals without being associated with an improvement in the level of protection. Already under the current requirements of the REACH regulation, enough parameters such as exposure pathways, exposure levels, relevant endpoints and mode of action are collected that allow to estimate and limit combination effects. For these reasons, we reject the introduction of a general assessment factor for registered substances.

Simplifying communication in the supply chain

In order to enhance the efficiency of supply chain communication on chemical substances and mixtures the European Commission plans to introduce the application of improved tools for communication, including, harmonised electronic formats for safety data sheets.

The BDI welcomes the digitalisation of the data exchange in the supply chain. Electronic data exchange leads to a considerable improvement in the quality of safety data sheets and reduces possible sources of error. In addition, harmonised exchange standards can considerably reduce the effort and costs of information processing.

When introducing harmonised formats, existing formats and standards should be taken into account. Special consideration should be given to the standards developed by industry - e.g. eSDSxml (former SDScom XML and EScomXML). Furthermore, harmonisation should not be limited to the EU-Market, also the global dimension should be considered.

Essential Use Concept (EUC)

The European Commission is pursuing the goal of establishing an "Essential Use Concept (EUC)" for the "most harmful substances" in the REACH regulation. To this end, criteria for essential uses will be defined to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health The Commission's EUC-approach is based on the essential use concept of the Montreal Protocol, where the approach was applied to a limited group of homogenous substances, which pose an unacceptable risk.

Now, the European Commission plans to apply the approach of "essentiality" to all "most harmful substances" in the context of exemptions from restrictions (following Art. 68), admitting only the use of substances that are needed for health and safety and the functioning of society.

Definition of essential uses

The definition of the term "essential use" will be crucial to the concept and its implications. However, this is not an easy task. For example, it will be difficult to determine ex-ante what is considered essential today and what might become essential later. We cannot know with certainty today which technologies and innovations will underpin the progress of our society decades from now.

The definition of the term "essential use" should not simply be prescribed by the legislator. Rather, a comprehensive societal discussion and a political decision is needed. In order to achieve this, it could be helpful to discuss the definition in an independent expert committee with representatives of all stakeholder groups (civil society, industry, public authorities).

An appropriate EUC must be based on scientific risk management and underpinned with comprehensive and workable criteria. Here, beside the functionality and wellbeing of the society, societal and cultural aspects should be considered as well as sustainability criteria. In addition, safe use aspects must be integrated. In order to promote substitution appropriately, the evaluation of possible alternatives should also take into account technical aspects and economic feasibility.

Potential risks and targeted implementation

Applying the EUC independently of a risk assessment and only based on the hazardous properties will lead to the fact that safe products can no longer be manufactured or recycled, even if they are not associated with a risk to human health and the environment This shift away from risk-based chemical management can lead to important substances no longer being available on the market without any benefit being achieved. Thus, the international competitiveness of EU’s industry could be severely hampered. An unfounded ban of the use of a hazardous substance means reducing the technological toolkit available to European manufacturers. This would lead to a substantial performance gap between products manufactured in Europe and those manufactured outside the EU, thus reducing the competitiveness of the former on the global market. In addition, an essential use exemption/derogation could result into severely reduced volumes and therefore question the economically reasonable production within the EU. This would lead to higher vulnerability in case of disruptions of the supply chain.

We also see a risk that the application of the EUC will lead to regrettable substitution and that products will be replaced by materials that are less sustainable from a broader perspective. Thus, the inadequate selection of alternatives with a limited focus on essentiality could make it more difficult to achieve the EU's sustainability goals and endanger the other objectives of the European Green Deal (e.g. carbon neutrality)

Another aspect that is critical from our point of view is that the application of the EUC will lead to a considerable slowing down of the regulatory processes. The broad application of the EUC to all substances with certain hazardous properties will be of very high complexity and would lead to the need to assess the different uses of all these substances. Considering the different uses of each substance, in many different applications, the regulatory process will be delayed extremely, as a detailed assessment of "essentiality" is required for each substance and all its subsequent uses along different value chains. If the EUC is introduced in the way envisaged in the CSS, the already limited regulatory resources would be deployed to assess essentiality of uses and would not be dedicated in a focused manner

From our point of view an EUC can be useful in identifying exemptions to restrictions or in granting authorisations. However, it only makes sense if it is used in a targeted manner at the very end of the process The EUC should only be applied if an unacceptable risk has been identified in a scientific risk assessment, if suitable protective measures are lacking, and if technically and economically suitable alternatives are not available.

Reform of authorisations and restrictions

The EU Commission concludes that the authorisation procedure is too complex and inflexible, and the current restriction process is too slow to sufficiently protect consumers and professional users against risks from the most hazardous substances. Therefore, the authorisation and restriction procedures are to be reformed. To reform the procedures, the EU Commission proposes 3 options:

• Option 1: Keeping the authorisation process, with clarification and simplifications

• Option 2: Merge the authorisation and restriction processes by allowing authorised uses of restricted substances

• Option 3: Remove the authorisation title from REACH

Assessment of possible options and general aspects of the reform of the procedures

As the EU Commission has announced that further sub-options to the three options will be examined, we do not evaluate the individual options as such, but provide an overview of the aspects which, in the view of the BDI, must be taken into account in a revision of the authorisation and restriction procedure

From BDI's point of view, some positive aspects of the authorisation procedure should be maintained in future and not be replaced completely by a generic restriction process. In the past, the authorisation process has led to a balanced substitution of substances. In addition, the authorisation process offers companies the possibility to maintain uses if they are adequately controlled and no suitable alternatives are available. This must also be possible in future.

Numerous experiences from the past clearly show that the authorisation process would benefit substantially from simplification and clarification. The procedure has proven to be too lengthy and too resource-intensive for all parties involved. Furthermore, particularly short review periods pose a challenge for companies. In order to limit the burden of the authorisation and restriction procedure, all realistic simplification options should be considered without limiting scientific justification, risk assessment and consultations.

If the authorisation process is maintained, simplifications of the authorisation process for small quantities (e.g. 100 kg/year) are urgently needed. Furthermore, it should be evaluated how efficiency, transparency and workability of the procedure could be enhanced, particularly for SME.

For spare parts, the principle of "repair as produced" should be introduced. A simplified approval procedure for a few spare parts for very long-lived and complex products is still associated with too high barriers for the companies concerned and is not proportionate. We also suggest, like in EU RoHS, to introduce a possibility, to apply for exemptions even after the latest application date (as known in today´s authorization process) to take latest developments and information into account).

Regarding the other options, we urge that any combination must be done very carefully and that the advantages of the two procedures must be clearly maintained., This is especially important when the procedure is combined with the "Generic Risk Assessment GRA)" approach and the EUC Under these conditions, it can be possible to establish a level playing field between EU and Non-EU-companies and to maintain the well-functioning parts of the processes. In order to always select the best and most efficient risk management measure/regulatory option, a transparent procedure must be established right at the beginning of the regulatory process (e.g. RMOA).The authorisation procedure should only be chosen as a regulatory option if a restriction procedure is not suitable. In principle, regulatory measures outside REACH should be assessed as an equivalent option (e.g. operation health and safety regulation)

Reform of the Candidate List

Within ECHA's regulatory screening approach it is planned to transform the candidate list into a tool to prioritise substances for regulatory action, in particular for restrictions, but also for non-REACH regulatory measures. In order to support decision making on regulatory measures and collect further data on uses and exposures, the European Commission suggests a mandatory notification for all actors in the supply chains using substances on the candidate list (SVHC).

BDI understands that in order to make more tailor-made regulatory decisions and confirm potential concerns and regulatory needs, more data may be required. However, it would be too early in the process, and too inefficient to collect additional data for all substances on the candidate list and from all downs stream users on a regular basis. In order to keep the bureaucratic burden as low as possible for all parties involved, other approaches for extended data collection must be identified. An important prerequisite would be, for example, to reduce the number of substances on the candidate list and to collect further data only for prioritised substances.

Generic Risk Assessment (GRA)

The CSS announced extending the "Generic Risk Assesment (GRA)" approach to further hazard classes and uses. Until now, the GRA-approach has been used to restrict CMR substances in consumer products (Article 68 (2) The EU Commission now is planning to apply the approach to several other hazard classes (endocrine disruptors, PBT-substances, vPvB-substances, STOT SE-substances, STOT RE-substances, immunotoxic substances, neurotoxic substances and respiratory sensitizers). In this context, it is planned that restrictions should increasingly take place within the framework of group approaches for entire groups of substances.

In addition, the procedure would no longer be used only to restrict consumer uses, but also to restrict professional uses without risk assessment. This means that in a first step, the use of carcinogenic substances of category 1 A and 1 B in professional applications (e.g. in workshops) will be no longer be possible.

Maintenance of the risk-based approach

The current (regular) registration process under REACH allows for an appropriate risk management, targeting in particular those substances and uses that pose an unacceptable risk. The existing procedure should therefore not be replaced by a generic approach, whereby substances and uses can be banned and restricted solely based on their intrinsic hazardous properties, irrespective of whether there is a risk to human health or the environment. Regulatory decisions must continue to consider benefits, risks and (safe) use conditions. The safe use of substances and not their intrinsic properties must continue to be decisive for the regulation of substances. Scientific risk assessments must remain the core element for the application of the precautionary principle and decision making in chemicals risk management.

Furthermore, there is an urgent need to keep restriction procedures transparent and comprehensible. Affected companies and industries must therefore be included in all steps of the process and be involved in comprehensive consultations.

Group approaches

The use of group approaches can be reasonable in individual cases. However, it is particularly important that substances or groups of substances are not banned independently of any proven risk. In order to make group approaches transparent and comprehensible, it is necessary that it is clear which substances fall under the regulation (e.g. via substance lists with CAS numbers). Group approaches are also only justified if the substances in a group have homogeneous properties and a homogeneous risk profile. In order to be able to consider the effects of far-reaching group approaches in advance, impact assessments, in which socio-economic and technical aspects are also taken into account, are of particular relevance.

Extension on professional uses

From the industry's point of view, the GRA should not be extended to the area of professional use. Even if professional uses do not take place in industrial sites, the conditions of professional uses can be very similar or even identical to those on industrial sites Professional use in most cases requires specific education and training, including trainings on how to safely manage hazardous materials. Furthermore, professional uses are additionally regulated by occupational health and safety regulations.

This contributes to a significantly different risk profile and increased risk awareness compared to consumer uses. Companies with business models on professional uses are responsible that the uses in their responsibility are in line with use conditions described in registrations, communicated in the supply chain (e.g. in safety data sheets) or given by OHS-regulations.

In view of these different framework conditions, an equal treatment of consumer use and professional uses would not be justified. If regulation is necessary in individual cases, professional uses can be regulated within an individual restriction based on the existing REACH provisions. Only in this way it can be prevented that professional uses are massively restricted without this being associated with a benefit for human health and the environment. In areas where there is a need for further action and, where current legislation is not yet being complied with, mandatory training measures and improved enforcement will be more effective than general substance bans.