POSITION | CHEMICALS POLICY | REACH Chemicals policy guidelines 2025
Revision of the REACH Regulation
May 20, 2025
General
In its communication on the "Clean Industrial Deal" from February 26, 2025, the European Commission announced a "Chemicals Industry Package" (CIP) for the fourth quarter of 2025, which will include targeted initiatives to improve competitiveness, modernization, and the promotion of production and innovation in Europe. Key components of the CIP will be the revision of the REACH regulation and the clarification of the regulatory situation regarding Per- and polyfluorinated alkyl substances (PFAS). Additionally, initiatives to promote innovation and enforcement are planned. In its work programme for 2025, the Commission also announced a targeted revision of the REACH Regulation. With the measures announced in the Clean Industrial Deal, the Commission is concretizing the objectives formulated in Ursula von der Leyen's political guidelines for 2024 - 2029 (July 2024) to make Europe more sustainable, innovative, competitive, resilient, and independent. Existing and new regulations should be simplified and bureaucratic hurdles reduced. To achieve the goal of "Making Europe simpler and faster," Ursula von der Leyen outlined important general guidelines in her Mission Letters to the Commission candidates (September 2024) to ensure that existing regulations are fit for purpose and that new measures focus on reducing bureaucracy and simplifying regulation. Simplification of the regulation is also mentioned as a key goal with regard to the REACH regulation (Mission Letters, September 2024). In April 2025, the EU Commission specified its plans for the revision of the REACH regulation in CARACAL (Competent Authorities for Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) and Classification, Labelling and Packaging (CLP)). These show that the Commission intends to adhere to the approaches and plans discussed under the Green Deal, contrary to the announced simplification.
With recent international developments, the need for clear and efficient European regulation to strengthen the competitiveness and resilience of the European economy and its companies is becoming even more prominent. The availability of chemicals plays a central role in this.
With this position paper, we outline the chemical policy measures and guidelines that we believe should be implemented in future from the perspective of German industry to ensure that the CIP is designed and, in particular, that the REACH Regulation is revised in an appropriate, effective and targeted manner.
Ensuring the Availability of Chemicals and Value Creation in the EU
The availability of chemicals is a key prerequisite for the competitiveness and innovative capacity of the industry and is therefore of crucial importance for Germany and Europe as a business location. The design of chemical policy measures and the revision of the REACH Regulation are therefore highly relevant not only for the chemical industry but for the entire industry, including downstream user sectors. Chemical policy has an impact on all manufacturing companies in almost all sectors. Innovations, Europe's strategic sovereignty, and the implementation of important political and societal goals of the EU require chemical diversity and value creation in Europe. These include, for example, digitalization, the implementation of the EU Chips Act, as well as achieving the goals of the EU Green Deal and the sustainable transformation of the economy. Without the sufficient availability of chemicals, these goals would no longer be fully achievable.
Apply existing Chemicals Regulation effectively, avoid new burdens
The announced chemicals policy measures are closely linked to the objectives and initiatives of the “Chemicals Strategy for Sustainability” (CSS). However, against the background of the Commission’s new guidelines to make Europe more innovative, competitive, and independent and to simplify existing rules, the original concepts of the CSS must be questioned and reassessed in terms of their necessity.
Experience over the past years has shown that the REACH Regulation works. With REACH, Europe has a legal framework that sets the highest safety standards worldwide. Adaptation measures and new initiatives in the area of chemicals regulation must therefore be well considered and carried out with a sense of proportion:
Quality must take precedence over speed. All procedures must be implemented with thorough involvement of the affected industry and evaluated in advance with comprehensive impact assessments.
Necessary amendments and simplifications should primarily be achieved within the existing legal framework.
Future initiatives should not aim at new regulation. Rather, the focus should be on the efficient implementation and enforcement of existing rules.
The revision of the REACH Regulation must therefore remain limited to simplification for all parties involved. The existing requirements should be adjusted and simplified in a targeted manner to make them more effective, predictable, transparent, and (resource)efficient, and to reduce unnecessary burdens for companies – especially SMEs. Additional measures must not lead to further bureaucratic hurdles. New or expanded reporting, notification, or registration obligations (e.g. for polymers) in principle should be avoided. Furthermore, chemicals regulation should be limited to REACH. Parallel or additional chemicals regulations in other legal areas (e.g. ESPR or EU-Taxonomy) lead to confusion and contradictory approaches that should be avoided
Maintain and strengthen risk-based approaches
Generic approaches and general bans on whole groups of substances do not constitute a simplification from the industry's perspective and are not efficient. The regulation of chemicals must therefore continue to be based on the proven concept of science based risk assessment. Purely hazard-based approaches are counterproductive and lead to an unjustified restriction of the availability of chemicals,
negatively impacting innovation capacity and the possibility of technological development. It must also be possible in the future to produce and use hazardous chemicals if there is no unacceptable risk to humans and the environment. This is a crucial prerequisite for the continued production of sustainable products and value creation in Europe.
Future Direction of EU Chemicals Policy
German industry fully supports the goals pursued by the REACH Regulation to protect people and the environment from risks posed by chemicals while simultaneously strengthening the competitiveness of the EU industry. Since REACH came into force, companies have made an immense achievement to improve chemicals management in Europe and are implementing the complex requirements of EU chemical regulation with considerable effort. They continuously aim to substitute hazardous chemicals and reduce the associated risks to the environment and health, as well as facilitating a better circular economy. Experience in recent years has shown that REACH works well and sets the highest safety standards worldwide, but also that there is potential for improvement in certain areas.
The BDI therefore welcomes the aim of making REACH more efficient and effective and simplifying existing regulation. However, the approaches for revising REACH as presented by the Commission in April 2025 in CARACAL do not reflect this objective from the industry's perspective. The plans are therefore disappointing and should be viewed critically.
To address the existing improvement potentials of REACH and simplify European chemicals regulation, industry believes that, in addition to protecting people and the environment, the competitiveness of companies and other overarching EU goals (e.g. resilience, sovereignty, economic transformation, digitalization, etc.) should also be considered. To this end, the following chemical policy guidelines and aspects should be taken into account in the upcoming measures. It is essential that the intended improvements and simplifications benefit not only the authorities, but also companies in particular:
1. Strengthening Risk-Based Chemical Regulation
The proven concept of scientific risk assessment must continue to be maintained as the central element for the application of the precautionary principle and for decisions in chemicals management. It is necessary to continue considering both the properties of substances and their potential exposures when evaluating chemicals and their uses. Additionally, it is important that risk assessments cover the entire lifecycle and evaluate the individual phases separately.
Regulation based solely on the intrinsic hazard properties of chemicals is not appropriate and leads to unnecessary restrictions on safe uses, which then are no longer available for safetyrelevant or innovative applications. Regulatory decisions in chemical management must continue to consider the benefits, risks, and safe use conditions.
2. Implementation of Comprehensive Impact Analyses
Chemicals regulation affects all manufacturing companies from a wide range of industries. Consequently, it has significant impacts on entire supply chains and the whole industry. To avoid undesirable effects and negative consequences, comprehensive impact assessments should be carried out prior to any chemicals policy initiative (e.g. with extensive restrictions such as for PFAS).
It is important that these assessments consider different criteria and always evaluate regulatory measures in terms of their impact on chemical diversity, resilience, innovation capacity, competitiveness, and attractiveness of the EU as a business location. Proposed approaches such as the announced SME check, which analyses the impact of regulatory measures on small and mediumsized enterprises, should be mandatorily applied here.
3. No additional burdens due to further registration requirements
A notification and registration requirement for polymers should be abandoned. The existing registration system in REACH is tailored to substances, not to polymers. Due to the specific characteristics of polymer chemistry compared to small molecules, the established procedures under REACH cannot be transferred 1:1 to polymers. For this reason and because of the immense number of polymers on the market (200,000 to 400,000), the introduction of new obligations for polymers would lead to a significant burden both on industry, especially SMEs and in innovative applications, and on the regulatory authorities.
Polymers are already subject to regulation in a wide variety of different ways, for example through the registration of their components/the monomers, and the mandatory classification of products containing polymers under CLP. In addition, polymers are handled in industrial practice through technical, organizational and personal measures (TOP), supported by safety data sheets (SDS). Furthermore, polymers, like other substances, can also be regulated within the framework of authorisation and restriction.
Further regulations regarding polymers have been adopted in the context of the European Green Deal or are in the legislative procedure (e.g. Packaging Regulation, Drinking Water Directive, Taxonomy, CLP). It is therefore essential to avoid double regulation and to review the efficiency of the approaches. To this end, a well-founded stocktaking should first be carried out and an analysis conducted to identify existing problems in data collection and the handling of polymers.
This analysis must consider the entire supply chain, in particular the needs of polymer users and the interaction between REACH, CLP and other regulations. Based on this, targeted measures could be developed with the involvement of the affected stakeholders.
In addition, the introduction of a limited validity period for registrations of max. 10 years should be rejected, as this would lead to considerable additional bureaucratic burdens for companies. The current REACH framework already obliges registrants to keep their dossiers up to date (see Article 22). Companies that comply with this obligation should not be burdened with additional administrative load.
The introduction of a limited validity period is primarily aimed at those dossiers that are not systematically kept up to date and that have not been updated over longer periods of time. However, this is a question of implementation and enforcement. The existing legal framework provides ECHA with sufficient tools to identify and address non-compliant dossiers through compliance checks, evaluations and enforcement tools.
4. Improvement of Authorisation and Restriction Procedures
Since the introduction of REACH, regulatory risk management of chemicals has significantly expanded and now includes more substances and uses than the authorities can handle. This has led to problems with authorization procedures and has caused significant planning uncertainties for the affected companies.
From the industry's perspective, previous experiences clearly show that the authorisation procedure would benefit considerably from simplification and clarification. The procedure has proven to be too lengthy and resource-intensive for all parties involved. Better prioritisation is needed in the future. Additionally, the short review periods pose a particular challenge for companies. To limit the burden of the authorisation procedure, all realistic simplification options should be considered without compromising scientific justification, risk assessment, and consultations.
In general, the positive aspects of the authorization procedure should be maintained and not completely replaced (e.g. by a generic restriction procedure). The authorisation procedure has led to balanced substitution of hazardous chemicals in the past. Furthermore, the authorization procedure offers companies the possibility to maintain uses if they are adequately controlled and no suitable alternatives are available. This must also be possible in the future.
In recent years, the existing problems in processing authorisation applications have led to increasingly broad restrictions in combination with temporary exemptions. This has resulted in a policy of "regulation by derogation". Ongoing restriction procedures clearly show that the restriction procedure also reaches its limits here, making regulations difficult to implement and causing high planning uncertainty for companies (e.g. PFAS, microplastics, skin sensitizers, etc.).
Restrictions should continue to be used as a targeted measure for regulating uses that pose unacceptable risks, as provided for in the REACH Regulation (see next point). Broad bans (of entire groups of substances in all use areas) contradict the risk-based principles of REACH and lead to ambiguities and planning uncertainty in the affected industries, which can have significant socioeconomic impacts even long before the respective restriction comes into force (e.g. PFAS) (see also point 6).
The EU Commission is considering using the candidate list more as a tool for prioritising regulatory risk management measures in the future. However, a prerequisite for this should be that, before substances are included on the Candidate List, a CLH classification is carried out and a mandatory RMOA is conducted.
To enable industry to provide informed input in the subsequent procedures, an information obligation within the supply chain should also apply to substances in articles that are candidates for restriction procedures (after RMOA and CLP classification), as this is the only way to achieve the necessary transparency regarding the sectors and products affected. For this reason, it should also be mandatory in these cases to pass on information on the presence of these substances in articles above a content of 0.1 % w/w to industrial recipients. This is because substitutes can only be identified for known uses.
The information requirement should be based on a definitive list of these substances with globally accepted numerical identifiers, preferably CAS numbers. Already established reporting procedures should be used; additional reporting processes or data points should be avoided.
If substitution is the goal of regulatory measures, an evaluation of suitable alternatives must always be holistic (“regrettable substitution”). This should include a comprehensive comparison of the substances and technologies to be replaced with their potential alternatives, covering the entire lifecycle. At the same time, it should be avoided that identified alternatives are themselves prevented from being made available by regulatory approaches under REACH. Especially in relation to the assessment of alternatives, all measures need to be consistent in order to ensure planning certainty as well as resource optimization for authorities and industry.
5. Avoidance of Generic Regulatory Approaches
The current REACH Regulation provides for a generic approach to restricting CMR substances in consumer products (Art. 68 (2)). The EU Commission has announced under the CSS that it intends to extend the application of the generic approach to risk management (GRA) to additional hazard classes (endocrine disruptors, PBT substances, vPvB substances, STOT SE substances, STOT RE substances, immunotoxic substances, neurotoxic substances, and respiratory sensitizers). Additionally, the extension of the GRA to professional applications is being discussed.
The current (regular) restriction process under REACH allows for appropriate risk management, targeting at particular those substances and uses that pose an unacceptable risk. Therefore, the existing procedure should not be replaced by a generic approach, where substances and uses can be banned and restricted solely based on their inherent hazard properties, regardless of whether there is a risk to human health or the environment. An extension of the GRA to additional hazard classes is therefore rejected. Extending it to commercial and industrial applications is also not appropriate. Workplace risks should continue to be addressed through occupational safety measures. The relevant European and national occupational safety regulations (OHS) ensure a high level of protection here.
6. Implementing the Essential Use Concept only in Combination with Risk-Based Approaches
The implementation of the Essential Use Concept (EUC) also carries the risk of moving away from the risk-based approach. The approach of allowing hazardous chemicals only for essential uses falls too short and cannot be implemented in reality. Applying the EUC independently of a risk assessment and solely based on hazard properties will result in safe uses no longer being possible and safe products no longer being manufactured or used, regardless of the existence of an actual risk.
If an EUC is to be implemented in the REACH regulation, this should only be done in combination with risk-based approaches and only based on understandable and practical decision criteria. The assessment of essentiality should always be used only as an additional evaluation criterion and never as the main criterion. Therefore, in addition to functionality and societal well-being, sustainability criteria as well as technological and economic aspects must also be considered. It is still unclear which institution should make the decision, how those involved and affected (ultimately society) should be involved and what legal measures the subject of law can take.
7. Avoid integrating MAF in REACH
A generic Mixture Allocation Factor (MAF) would create considerable bureaucracy without effectively addressing combined exposures. A blanket MAF applied to all chemicals is not the right solution as MAF studies and assessments, e.g. in the Commission's MAF workshop, have shown that combination effects of chemicals only occur in a limited number of cases and the majority of unintentional mixtures of chemicals are harmless. Therefore, the introduction of a MAF is neither scientifically justified nor appropriate.
The general introduction of a MAF would massively restrict all substances and uses, even without relevant combination effects. This would have serious consequences for the safe use of chemicals without any improvement in the level of protection.
8. Development and Implementation of Adequate Criteria for the Regulation of Entire Groups of Substances
Recent examples, such as the proposed universal restriction of PFAS, highlight the problems associated with regulating entire groups of substances and applications without a sufficient data basis. General bans on entire groups of substances are not appropriate, and the complexity of these approaches cannot be adequately managed by either the regulating authorities or the companies. This undermines legal certainty and predictability of regulatory measures and leads to considerable planning uncertainties and bottlenecks in supply chains.
In cases where grouping of substances appears necessary and appropriate, it is recommended to do so based on a comprehensive set of criteria that should all be comparable, such as (eco-)toxicological and physicochemical properties, similar toxicokinetics, environmental behavior, and common adverse effects, and not just based on structural similarities. This would lead to more practical, scientifically sound, and enforceable regulatory measures. To ensure that affected companies can adequately assess and support upcoming regulatory measures with appropriate data, broad restrictions must be supplemented by the provision of clearly defined substance lists including CAS numbers.
9. Increase Predictability and Transparency in Regulatory Measures/Mandatory Implementation of RMOA
Predictable and transparent chemicals regulations are crucial for the competitiveness of European industry. This enables early adaptation to new requirements and to promote innovation. Early and transparent involvement of all stakeholders must be ensured in both the authorization and restriction procedures. However, very broad-based restriction procedures have shown that, particularly in the context of dossier preparation and scientific assessment in RAC and SEAC, industry is not always sufficiently involved. Here, more continuous publication of procedural statuses and the extension of consultation periods would be helpful.
Approaches based on the principle of "inform first - then regulate" could also lead to significant improvements in the processes. Substances should mandatorily undergo an Assessment of Regulatory Needs (ARN) before regulation (and entry into the Registry of Intentions) and be classified according to the criteria of the CLP regulation.
To ensure efficient and effective risk management, a transparent and comprehensible procedure is required that is suitable for identifying the best regulatory option and ensuring sufficient involvement of the affected parties (e.g. RMOA). Such a procedure should be established at the beginning of each regulatory process and be mandatory for all member states and ECHA. Regulatory measures outside of REACH should fundamentally be considered as equivalent options (e.g. occupational safety regulations).
10. Simplifying Communication in the Supply Chain
To increase the efficiency of communication about chemicals in the supply chain, improved communication tools such as harmonized electronic formats for safety data sheets should be used. The digitalization of data exchange in the supply chain could significantly improve the quality of safety data sheets and reduce potential sources of error. Additionally, harmonized exchange standards can significantly reduce the effort and costs of information processing. Existing formats and standards should be considered when introducing harmonized formats. Special consideration should be given to industry-developed standards, such as eSDScom. Furthermore, synergies with
other approaches, such as the Digital Product Passport (DPP), should be used efficiently and without contradiction when digitizing supply chain communication.
11. Develop chemicals legislation in the context of circular value creation
The aim of the European circular economy agenda is to preserve natural resources and the climate, increase the supply security of raw materials and enable new business models for companies. Closing material loops through recycling contributes directly to all or some of these goals, depending on the material flow. However, before recycled materials can be reused as new goods in production, the source material often has to undergo extensive testing to ensure that it is compliant to the current legal substance requirements. With the stricter limit values and the increasing number of bans and restrictions, recycling can therefore not only become more difficult, but in some cases even impossible. This particularly affects additives and other auxiliary substances, such as flame retardants or alloying agents. It is therefore crucial to design the interface between waste and chemicals legislation in such a way that, based on a risk-based approach, the political goals of circular value creation can be implemented by companies in a legally secure manner. Future substance restrictions should therefore systematically consider the real material cycles from the beginning. It is important to take into account the different product lifespans and the associated time lag with which material flows enter the recycling process for recyclates.
In addition to recyclability, end products must be as durable as possible and, where necessary, capable of being repaired or maintained. It also needs to be possible to replace parts. This significantly reduces costs and preserves natural resources. The function, safety, and reliability of replacement parts must not be compromised. Furthermore, replacement parts must meet the same quality and safety standards as the original series parts. This is also confirmed, for example, by the decision of the EU Commission of February 23, 2010 to amend Annex II of Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles (“repair-asproduced principle”). For this reason, replacing individual substances in materials or entire materials is always associated with great difficulties and can lead to functional, geometric or thermic changes. Complex tests may be necessary in order to comply with product licenses. For these reasons, the Commission should consider establishing a general exemption from REACH for spare parts.
12. Harmonise Enforcement across Europe
Before introducing additional new measures, the focus should be on achieving harmonized enforcement across Europe. This is necessary to create a level playing field for all market participants and to avoid competitive disadvantages. Additionally, there is currently significant potential for improvement regarding imported products. An important prerequisite for appropriate enforcement is always the way regulations are designed. Therefore, it is essential to consider the enforceability of regulations already during the regulatory process. Regulations that are too complex on one hand and too generic on the other make it difficult for enforcement authorities to implement targeted measures and inspections. To avoid these problems, the assessments of the "ECHA Enforcement Forum" (which, for example, are available in the form of a report for each restriction procedure) should be taken into account in all regulatory decisions.
Imprint
Bundesverband der Deutschen Industrie e.V. (BDI)
Breite Straße 29, 10178 Berlin www.bdi.eu
T: +49 30 2028-0
German Lobbyregister Number R000534
Editorial
Dr. Mirjam Merz
Senior Manager Environment, Technology and Sustainability
T: +49 30 2028-1466 m.merz@bdi.eu
BDI Document number: D 2092