PFAS Restriction - BDI Contribution A to the SEAC-Consultation (main contribution) by Bundesverband der Deutschen Industrie e.V.

Statement

PFAS Restriction – BDI Contribution A to the SEAC-Consultation (main contribution)

Langtitel, Beispiel: (Arial, 20 Pt, fett)

Referentenentwurf/ Regierungsentwurf

Gesetzzur Modernisierung der Netzentgeltstruktur

Federation of German Industries e.V.

Date: 12 05 2026

Inhaltsverzeichnis

BDI Contribution to the SEAC-Consultation (EUSurvey Questions) .......................................................................................5

Question 2.17: Choose all sectors that are relevant or covered by your responses in this general survey..........................................5

Question 2.18: Please provide a general description of the use(s) of PFAS (or alternatives) you are providing comments on [2000 characters].......................................................................................5

Question 2.19: Please provide your comments on section 1.2. SEAC opinion [5000 characters]....................................................6

Question 2.20: Please provide your comments on section 2.2 Summary of the opinion and 2.2.2 SEAC opinion summary [5000 characters].......................................................................................8

Question 2.21: Please provide your comments on section 3.2. Justification that action is required on a Union-wide level [5000 characters].....................................................................................10

Question 2.22: Please provide your comments on section 3.3.1 Availability and technical and economic feasibility of alternatives [5000 characters]...........................................................................11

Question 2.23: Please provide your comments on section 3.4.1 Regulatory risk management options other than restriction [5000 characters].....................................................................................13

Question 2.24: Please provide your comments on section

3.4.2.2.1 Socio-economic analysis: Approach [5000 characters] 15

Question 2.25: Please provide your comments on section 3.4.2.2.2 Socio-economic analysis: Costs [5000 characters]....17

Question 2.26: Please provide your comments on section

3.4.2.2.3 Socio economic analysis: Benefits [5000 characters] 18

Question 2.27: Please provide your comments on section

3.4.2.2.4 Socio‑economic analysis: Other relevant impacts [5000 characters].....................................................................................19

Question 2.28: Please provide your comments on section

3.4.2.2.5 Socio-economic analysis: Proportionality [5000 characters].....................................................................................21

Question 2.29: Please provide your comments on section 3.4.2.3 Practicality, including enforceability [5000 characters].............22

Question 2.30: Please provide your comments on section 3.4.2.4 Monitorability [5000 characters] ..................................................23

Question 2.31: Please provide your comments on section 3.4.3.2.1 Conclusion whether the suggested restriction is the most appropriate EU‑wide measure: (i) PFAS definition [1000 characters].....................................................................................24

Question 2.32: Please provide your comments on section 3.4.3.2.1 Conclusion whether the suggested restriction is the most appropriate EU wide measure: (ii) Exclusion of PFAS from the scope [1000 characters].........................................................25

Question 2.33: Please provide your comments on section 3.4.3.2.2 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Scope of the proposed restriction [1000 characters] ........................................................25

Question 2.34: Please provide your comments on section 3.4.3.2.3 Conclusion whether the suggested restriction is the most appropriate EU‑wide measure: Concentration limits [1000 characters].....................................................................................26

Question 2.35: Please provide your comments on section 3.4.3.2.4 Conclusion whether the suggested restriction is the most appropriate EU wide measure: General 18 month transition period [1000 characters] 26

Question 2.36: Please provide your comments on section 3.4.3.2.5 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Derogations [5000 characters].....................................................................................27

Question 2.37: Please provide your comments on section 3.4.3.2.6.1 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Reporting requirements [1000 characters]...........................................................................28

Question 2.38: Please give an indication of the costs related to the reporting requirements. .........................................................29

Question 2.39: Please provide your comments on section 3.4.3.2.6.2 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Site specific PFAS management plan [1000 characters] ...........................................29

Question 2.40: Please provide your comments on section 3.4.3.2.6.3 Conclusion whether the suggested restriction is the

most appropriate EU wide measure: Additional conditions considered by RAC.......................................................................30

Question 2.41: Please give an indication of the costs related to monitoring of PFAS emissions at industrial sites......................30

Question 2.42: Please provide your comments on section 3.4.3.2.6.3 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Additional conditions considered by RAC [1000 characters].........................................30

Question 2.43: Please give an indication of the costs related to the additional conditions considered by RAC............................31

Question 2.44: Please provide your comments on section 3.4.3.2.7 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Interaction with other relevant legislation [1000 characters] .........................................31

Question 2.45: Please provide your comments on section 3.5.2 Uncertainties evaluated by SEAC [5000 characters]..................31 About BDI.......................................................................................34

BDI Contribution A PFAS SEAC-Consultation

BDI Contribution to the SEAC-Consultation (EU-Survey Questions)

Question 2.17: Choose all sectors that are relevant or covered by your responses in this general survey

BDI response:

PFAS manufacturing, 22 sectors and others

Question 2.18: Please provide a general description of the use(s) of PFAS (or alternatives) you are providing comments on [2000 characters]

BDI response:

In this submission, we address general aspects of the proposed PFAS restrictions from the perspective of German industry. Please also refer to the second submission of BDI (ID: eae19ac4-45db-40b9-86df-8dbc2867540d), in which we address procedural aspects. These are based on a legal opinion that we commissioned (see the BDI website under “Legal Opinion PFAS Restriction”).

PFAS are highly relevant in almost all industrial sectors. Due to their functional properties, PFAS are used as high-performance materials/process substances whenever extreme conditions such as high or low temperatures, high frictional resistance or aggressive chemical conditions require it. In many areas, the functionality of PFAS (e.g. chemical, physical, thermal stability) cannot be achieved by other substances.

PFAS often are key components in modern high-technology applications (e.g. semiconductors, fuel cells, medical devices, electronics) and they are used in research/ development of innovative and sustainable technologies. Here fluoropolymers are particularly important for industry

In all industrial plants, PFAS (especially fluoropolymers) contribute to safe /efficient operation, for example seals and gaskets, valves and other pressurebearing components, coatings/ linings, membranes/diaphragms, lubricants, electrical insulators, and protective/safety clothing.

Furthermore, PFAS are important for climate relevant technologies, here for example PFAS are used in membranes which are inevitable for electrolysis (e. g. hydrogen-electrolysis, fuel cells, chlor-alkali electrolysis, lithium ion and lead based batteries etc.)

PFAS are integral to the EU’s pursuit of strategic autonomy. They underpin a broad range of critical applications across key sectors (e.g. aerospace and defense, medical equipment). In this context, ensuring the continued manufacturing and use of PFAS is essential to strengthening EU defense Federation of German Industries

German Lobbyregister Number R000534

Address

Breite Straße 29 10178 Berlin

Postal Address 11053 Berlin Germany

Internet www.bdi.eu

E-Mail: m.merz@bdi.eu

capabilities, reducing strategic dependencies on external supply chains, and protecting EU industries from unfair competition.

Question 2.19: Please provide your comments on section 1.2. SEAC opinion [5000 characters]

BDI response:

SEAC considers the proposed restriction (ban with use-specific derogations) to be the most appropriate Union-wide measure to address the identified risk while taking into account the proportionality of its socio-economic benefits and costs. From the industry's perspective, it is not clear how SEAC comes to this assessment, especially since SEAC repeatedly states that there is insufficient information available to comprehensively evaluate the total costs and, consequently, the overall proportionality of the restriction.

In our view, a broad ban on PFAS with only limited – albeit numerous application-specific derogations is not an appropriate regulatory measure. The approach is too complex and not enforceable. Since PFAS will continue to be needed for manifold applications for the foreseeable future and no alternatives are available, it will not be possible to adequately identify all necessary exceptions, to map them out and to monitor their implementation in practice.

An appropriate regulatory approach for PFAS should differentiate between the different categories of PFAS, consider the availability of alternatives and be based on risk assessments and scientific evidence, as provided for in REACH.

If a restriction is pursued as an EU wide measure, it should be accompanied by clear, workable conditions to ensure proportionality, legal certainty, and continuity of critical uses where alternatives are not available. In order to limit the negative impact on the business location and its sovereignty of the European economy, the following points should be urgently taken into account:

Implement a risk-based approach

This requires a differentiated assessment/regulation of the substances or at least of PFAS subcategories based on their properties/risk profiles Thus, the regulatory approach should be reversed and, instead of a broad ban with numerous derogations, a targeted restriction of substances that verifiably pose an “unacceptable risk” which cannot be adequately controlled by other regulatory means should be implemented.

Exclude fluoropolymers from the scope of the restriction

This would significantly reduce and appropriately limit the negative economic consequences Concerning the exclusion of FP SEAC made the

statement that fluoropolymers need to be in scope of the restriction when considering the whole lifecycle. This argument does not fit to SEACs own conclusion that PFAS manufacture can be maintained under strict conditions (=no issue)andthat fluoropolymersin usephasedonot poseanunacceptable risk (=no issue). Taking into account new data on the extremely high efficiency of waste incineration (KIT study, Schweinfurt study) it needs to be concluded that also in the waste stage fluoropolymers can be handled safely. Based on the established body of evidence, it is clear that fluoropolymers do not present an unacceptable risk

Implementation of appropriate derogations with realistic transition periods

We generally support SEAC’s conclusion that a full ban with an 18-month transition period is unlikely to be proportionate. This is best addressed by a targeted restriction of individual, risk-prone uses instead of a broad ban. Where required in addition, broad and long-term derogations should be granted, that cover all uses that are critical for society, industrial safety and essential functions in complex products. To avoid undermining derogations, they should apply also to the upstream supply-chain of derogated uses (e. g intermediates, upstream inputs) for.

We support the SEAC proposal that the granting of derogations should consider a more comprehensive view of the associated emissions and the socioeconomic impacts related to those derogations, i.e. including costs and benefits of granting derogation, e.g. lower energy/CO2). Based on this logic, lowemission uses (=low benefit) that would cause severe socio-economic impacts if restricted, should receive a long term/time-unlimited derogation (as long as no suitable alternatives are foreseeable)

Finally, transition periods must be realistic and use specific. They should allow sufficient time to develop, validate, approve, and implement adequate replacement materials and processes Transition timelines should reflect technical complexity and regulatory certification needs in sensitive sectors ensuring that substitution leads to genuinely sustainable solutions rather than rushed changes with lower safety, performance and/or negative impact on the environment.

Implement review mechanism for reassessment and extension of derogations

Given the technical relevance of PFAS, this is the only way to ensure that it is possible to respond appropriately to necessary technical developments or thelackofavailabilityofsuitablealternativesdespiteacomprehensivesearch for alternatives.

Question 2.20: Please provide your comments on section 2.2 Summary of the opinion and 2.2.2 SEAC opinion summary [5000 characters]

BDI response:

General aspects

The summary of the SEAC opinion contains important acknowledgement that a comprehensive PFAS ban combined with a uniform 18-month transition period would not be proportionate and that a restriction can only be considered proportionate if use-specific derogations are granted where the socioeconomic costs outweigh the benefits.

PFAS are indispensable for a wide range of uses. They enable safe, reliable and efficient industrial processes and are integral to numerous high-technology sectors. In many of these applications, PFAS are essential for their unique combination of chemical stability, durability, purity and performance. Adequate alternatives are often not available.

Given the wide range of applications, the significant importance of this class of substances, and the varying risk profiles of PFAS, even a restriction approach that provides for a ban with numerous derogations does not constitute a suitable regulatory approach. Such an approach is inherently complex, difficult to implement and enforce in practice, and creates significant legal and planning uncertainty as in several cases it is unclear if a specific use is covered by the drafted derogations. Moreover, there is a substantial risk that important PFAS uses (that would need a derogation) are overlooked/ insufficiently captured due to incomplete information and the limitations of use-mapping exercises. We are concerned because the use-mapping does not include end uses that are critical e.g. the electricity and data infrastructure like power plants, the power grid, cell phone towers. It is unclear if all PFAS uses that are required for these end uses have been adequately addressed. The proposed restriction would not lead to a sustainable transition, but would risk interrupting industrial processes, weakening strategic value chains and shifting production/innovation to regions outside the EU.

Incomplete evidence base and unassessed uses (See also contribution ID: eae19ac4-45db-40b9-86df-8dbc2867540d))

The summary of the opinion also shows the incomplete knowledge base. SEACnotesthatjustifiedderogationsarenecessary,butmaynotbesufficient on their own, and that uncertainties as well as unidentified or insufficiently assessed uses prevent the specification of all necessary derogations at this stage. This point should be given even greater weight. Where uses have not yet been fully assessed and where information on alternatives, feasibility and socio-economic impacts is limited, restrictive conclusions shall be avoided.

This concern is particularly relevant for those sectors that were added at a later stage and for which no detailed sector-specific SEAC analysis has been carried out. Here the summary should clearly reflect that no judgment can be

made without a thorough assessment of technical feasibility, availability of alternatives, economic impacts and broader socio-economic consequences.

Applying the restriction to these sectors that were not assessed fails to meet the requirements of Art. 68 (1), Art. 69 (4) and Annex XV no, II. 3. REACH aswell asthegeneralproportionalityrequirement ofArt.5(4)TEU,asSEAC has not demonstrated that the benefits outweigh the costs for those uses. In the absence of clear guidance from ECHA/SEAC for these sectors, decision making authorities, in particular the European Commission, lack a robust basis for applying the restriction.

Therefore, these sectors shall be completely excluded from the scope of the restriction until a substantiated conclusion on the legal requirements as well as on proportionality is available (s also contribution ID: eae19ac4-45db40b9-86df-8dbc2867540d)

Additional conditions for continued use

The summary reflects SEAC’s cautious position regarding additional conditions for continued use, including site‑specific management plans, monitoring and reporting requirements. While such measures may in principle contribute to emission control, SEAC itself acknowledges uncertainties regarding their proportionality and enforceability. From an industry perspective, these are crucial considerations.

Additional risk-management measures may in principle contribute to emission reduction, but derogations must remain workable in practice. They should not be undermined by cumulative compliance obligations that are overly burdensome, legally uncertain or difficult to implement consistently across highly diverse industrial applications. Otherwise, such conditions risk increasing enforcement challenges and compliance costs without delivering commensurate benefits.

Socio‑economic impacts/investment uncertainty

The summary underestimates the scale of potential socio‑economic impacts. Uncertainty regarding unexamined sectors, combined with unclear timelines (“as soon as possible”), prologs regulatory uncertainty. This uncertainty affects investment decisions and may deter companies from maintaining/expanding production and innovation activities in the EU.

Question 2.21: Please provide your comments on section 3.2. Justification that action is required on a Union-wide level [5000 characters]

BDI response:

All regulatory measures implementedregardingPFAS (andothersubstances) must be on a union-wide level to guarantee the harmonisation of the European single market. Purely national approaches would conflict with this principle and hamper international supply chains.

Alignment

with international developments

While recognising the need for EU-wide action, it is important that PFAS regulatory measures are designed to align, as far as possible, with international regulatory developments and globally available alternatives. The proposed restriction would affect entire supply chains and production processes. It is likely to make production processes in the EU impossible or increase the cost of manufacturing within the EU, whereas the continued use of non-restricted PFAS or fluoropolymers outside the EU may allow production of functionally identical products (at lower cost). Without international alignment, this creates a risk of trade distortions, supply-chain disruption, and relocation of production outside the EU. A globally aligned approach is therefore necessary, as also acknowledged in SEAC’s draft opinion.

Focus on risk-based measures

Overall, it is essential that any EU-wide restriction must be risk-based. The current restriction proposal is not risk-based and therefore does not meet the requirements of the REACH Regulation.

Instead of a blanket ban on all PFAS, PFAS uses should be regulated only where an unacceptable risk is scientifically demonstrated, as required by Art. 68REACH.Thesoleassumptionthatallsubstanceswithinsuchalargegroup of substances have the same hazard characteristics is not sufficient to prove an "unacceptable risk" for the entire group. The argument that persistence is thesoleand decisive reasonfor regulation is also not adequate. Justifying this approach with the precautionary principle is still not conclusive, as the proposed restriction contradicts the principle of proportionality, which must always be taken into account when applying the precautionary principle (s. Communication from the Commission on the precautionary principle, Com (2000) 1 final). To ensure balanced and proportionate regulation, a scientific riskassessmentofallsubstances–oratleastofeachPFASsubgroup–should be carried out instead.

Focus on differentiated measures

As there is no adequate differentiation between the different PFAS categories and their properties in the restriction dossier, substance groups that do not pose an "unacceptable risk" during use are incorrectly included in the restriction proposal.

This is true in particular for the group of fluoropolymers, for which a general derogation should be provided, as they do not pose an “unacceptable risk” within the meaning of REACH, which is the basis for imposing a restriction. The risks attributed to fluoropolymers are related to non-polymer PFAS used during manufacturing or resulting from inappropriate disposal conditions Emissions of non-polymeric PFAS arising from the manufacture of fluoropolymers can be effectively regulated, controlled, and monitored under existing environmental emissions legislation (e.g. the IED), including through permitting requirements and the application of Best Available Techniques (BAT). In addition, available scientific evidence indicates that, under controlled conditions, incineration constitutes an effective waste management method that does not lead to significant PFAS emissions. Trade associations and numerous companies across a wide range of sectors have repeatedly emphasised that a full and undifferentiated ban on all PFAS (even with specific and time-limited) derogations, regardless of their risk assessment, would have significant negative impacts on EU industries, as well as on innovation, competitiveness and the EU’s pursuit of strategic autonomy. BDI therefore strongly recommends that SEAC carefully consider the contributionssubmittedbyBDImembersrepresentingvariousindustriesduring the stakeholder consultation and duly reflect these considerations in the final SEAC opinion.

Question 2.22: Please provide your comments on section 3.3.1 Availability and technical and economic feasibility of alternatives [5000 characters]

BDI response:

SEAC approves the Dossier submitter with a sector by sector assessment (except for the new eight sectors). While such an approach may appear appropriate to reflect the specificities of the various industries affected by the restriction proposal, there are significant concerns that, given the extremely broad scope of the restriction (both in terms of substances and end uses) technical misconceptions and overgeneralisations are difficult to avoid (e g. in assessing alternatives and possible substitution of PFAS).

Relevance of PFAS in high-tech applications and availability of suitable alternatives

Despiteextensiveresearchanddevelopment activitiesin manyindustrial sectors and applications substitution of PFAS in all applications is currently not possible. PFAS (and in particular fluoropolymers) are used precisely where materials must withstand extreme temperatures, high friction, aggressive chemical environments, or corrosive media. In such applications, alternative high-performance materials with comparable functionality are not available today. Where alternatives exist in principle, they often fail to meet the

performance or safety requirements for long term operation. In many applications, fluoropolymers remain the only materials capable of meeting the required combination of properties regarding safety, durability, and purity standards.

PFAS constitute a very heterogeneous group, spanning gases, liquids, and solids with widely varying functional properties and exposure scenarios. Consequently, the assessment of alternatives is highly application specific and different industrial sectors face very different starting points regarding the state of alternative technologies and the technical requirements of their applications. Thus, the feasibility of substitution cannot be assessed generically, but requires use-specific, case by case evaluation. For many critical uses (e.g. industrial seals, valves, linings, membranes, gaskets, and components exposed to aggressive media) analyses confirm that adequate substitutes are either unavailable or technically inferior.

Evaluating alternatives holistically

Even where theoretical substitutes exist, they must be assessed holistically. Technical feasibility is not determined by functional similarity alone Also, safety relevant performance aspects, service life and durability as well as maintenance needs and compatibility with existing technical components must be taken into account. In highly regulated sectors additional legal requirements or approval or certification standards must be met.

The SEAC opinion does not sufficiently reflect current technical limitations in several sectors, and the overall impact of alternatives are not considered (e.g. increased energy consumption, loss of reliability, durability or safety aspects.)

From an economic standpoint, substitution is often not feasible in the short to medium term even if a technical substitute is identified, due to major investment needs for redesigning equipment, qualifying new materials, passing through regulatory product certification and/or approval procedures and modifying industrial installations. Substitution very often means replacing or retrofitting functioning installations associated with high capital cost. Furthermore, implementing alternative solutions often leads to a potential increase in operating costs due to shorter lifetimes, higher maintenance demands, or reduced availability and reliability of substitutes.

Considering supply chains aspects

Substitution is therefore a value-chain challenge: developing PFAS-free alternatives requires close cooperation along the entire value chain (component and system suppliers, and users), including defining application-specific requirement profiles and accounting for processing compatibility in manufacturing, as well as recyclability and (eco)toxicological aspects.

Considering realistic timelines when evaluating alternatives

Within an application-specific regulatory approach the assessment of the availability of alternatives is of great importance. The specific situations of different applications and sectors should therefore also be reflected by the derogations and transition periods Thus the final regulation should provide for unlimited derogations where necessary and allow for use-specific transition periods. In this context, it is particularly important in highly regulated sectors with strict safety requirements to take into account the time required for approval and certification procedures

Enabling reevaluation of alternatives

In order to remain operational even if alternatives cannot be identified in a given transition period and to avoid unintended socio-economic consequences, it is imperative that the final regulation includes a review mechanism forreviewing and, if necessary, extending derogations (ina timelymanner before they expire).

Question 2.23: Please provide your comments on section 3.4.1 Regulatory risk management options other than restriction [5000 characters]

BDI response:

A broad and undifferentiated PFAS restriction is not the right regulatory approach. It is neither risk-based nor proportionate, and it creates massive socio-economic impacts, legal uncertainty, and implementation problems.

Instead of a general ban with many application-specific derogations other approaches are possible:

A) risk-based approach/targeted restrictions for uses with “unacceptable risk “

Asforeseen in REACH Article68,a moretargeted restriction ofthose PFASuses where an “unacceptable risk” which cannot be adequately controlled by other regulatory means is scientifically identified should be implemented instead of a blanket ban with many use-specific derogations.

This implies a more differentiated assessment and regulatory approach that considers safe and sustainable use along the product life cycle. Furthermore, a better differentiation between the PFAS categories is necessary. Substances and/or uses where no unacceptable risk is given and where emissions can be controlledbyotherriskmanagementoptions(s.BandC)shouldbeexempted from the restriction.

Based on the view that for fluoropolymers risks in the use phase are not “unacceptable” and risks occurring in manufacturing and the end-of-life phase

can be addressed through existing EU-regulatory control measures, fluoropolymers should be completely removed from the scope of the restriction.

Removing fluoropolymers from the dossier would not only make sense for scientific reasons but would also significantly reduce the undue complexity of the restriction and the number of necessary derogations. This, in turn, would lead to better enforceability, a higher probability of timely implementation and support for strategically important sectors.

B) restriction with broad time-unlimited derogations under controlled conditions (RO3 Approach)

The discussion of time-unlimited RO3-type approaches shows that a more realistic middle way is available. Here, the manufacture, placing on the market, and use of PFAS would remain possible under strict and enforceable conditions, unless risks cannot be adequately controlled by these means.

A time-unlimited RO3-approach offers a flexible approach between a complete ban (RO1/RO2) and unrestricted use. It allows the continued use of certain PFAS applications under strict conditions, rather than relying on blanket bans plus complex exemption lists. This mitigates this risk because use can continue under controlled conditions as long as risks remain manageable.

RO3 links further use directly to measurable emission reduction measures and substitution incentives.

However, in the current dossier, the specific design of a possible RO3 approach remains very unclear and many questions about its concrete implementation remain open. In addition, the RO3 approach always involves more/additional recurring information and documentation requirements (e.g. inventories, monitoring, substitution plans). Against the current economic situation and the European Commission's efforts to reduce bureaucracy, the regulations on reporting obligations must be designed with a great emphasis on proportionality Furthermore, the sharing of information on quantities used and derogations claimed, particularly in safety-related areas, must be viewed critically, as this requires the disclosure of sensitive company information.

Reporting requirements associated with RO3 conditions should be proportionate and clearly purpose driven. They shall not be of prohibitive character. While basic reporting may give a good overview of derogated uses, requirements that go beyond what is necessary could lead to unnecessary administrative burdens for both industry and authorities. Reporting obligations should therefore be limited to information that meaningfully supports compliance verification and contributes to the protection of human health and the environment.

C) Emission control measures and end-of-life management measures

Existing instruments already aim to keep emissions “as low as technically possible,” notably frameworks linked to industrial emission controls and implementing rules, including requirements to prevent releases to water and air and to ensure leak-tightness of installations. These regimes can function as risk management tools by preventing releases and requiring high technical standards.

For end-of-life, high-temperature thermal treatment and robust waste management standards are key measures to minimise environmental impacts of products and processes. Furthermore, additional measures like guidance, traceability initiatives and improved reporting can close information gaps in waste chains.

Consistency and the avoidance of double regulation play an important role in any regulatory approach. In this regard, duplicate or conflicting requirements in different regulatory regimes must be avoided and risk management measuresshouldbeappliedwithintheexistingframeworkwhereverpossible.

Question

2.24: Please provide your comments on section

3.4.2.2.1 Socio-economic analysis: Approach [5000 characters]

BDI response:

As part of the socio-economic analysis, both direct and indirect economic impacts must be assessed. In order to obtain a comprehensive picture and to capture system wide effects, a comprehensive socio-economic analysis must comprise:

Direct economic impacts/costs

Companies directly affected by the restriction may encounter direct costs due to lost sales,substitutioncosts,andtransition costs (assessedfor each directly affected application).

Indirect impacts/costs within the supply chain

AcomprehensiveSEAmustcovertheentiresupplychainbecausePFASmay be used as process aids or intermediates during manufacturing. Methodologically, the SEA should therefore assess impacts along the full supply and value chain (raw materials, precursors, intermediates, auxiliary products, components and downstream users). Exemptions only on specific end uses while overlooking upstream inputs and the wider supply chain can render exemptions ineffective and may shift production out of the EU, with consequences for jobs, imports and strategic autonomy-effects that SEA should explicitly account for.

Market effects

Such a far-reaching restriction on PFAS will not only have an impact on directly affected applications but will also have market effects on applications for which derogations are foreseen. From our point of view a time-unlimited derogation for the production of polymeric PFAS in compliance with certain emission requirements, combinedwith massivelimitations oronly temporary derogations for specific uses, will not reduce the risk of a shortage of these materials or the preservation of domestic production. From a business perspective, it makes little sense to operate plants for materials whose areas of application are increasingly restricted by regulatory requirements. The economic viability of such plants is at risk if key sales markets disappear. This can lead to a gradual shift of production to foreign countries and further weaken the supply security in Europe.

Broader effects on strategic policy goals, societal services /societal costs

A comprehensive PFAS restriction would not only have economic consequences but would also trigger far-reaching societal and systemic effects:

- Impeding the achievement of industrial transformation/climate/energy goals (with significant additional costs)

- Shortages of essential medical technologies, disruption of pharmaceutical manufacturing and a reduced resilience of healthcare systems.

- Loss of European sovereignty (associated follow-up costs). In order to assess economic costs in a reliable manner it must be ensured that affected stakeholders can provide all relevant information.

We support SEAC’s conclusion that the socio-economic analysis conducted by the dossier submitters shows significant shortcomings, both in its overall approach and in the assessment of proportionality. These deficiencies should be addressed and resolved before any restriction is implemented.

WithintheongoingSEACconsultation,submissionsarecollectedviaastructured/predefined questionnaire, and no attachments can be uploaded. Limiting input to predetermined fields risks preventing relevant information from being brought into the restriction process. The survey’s narrow scope significantly constrained public input. (see also contribution ID: eae19ac4-45db40b9-86df-8dbc2867540d)

Furthermore, a questionnaire-based consultation creates unnecessary administrative burdens across complex value chains, as multiple actors may need to submit separate/repeated submissions. The process shows that a restriction of this scale can become much too complex/ difficult to implement, making it harder to capture all relevant uses and impacts in a reliable way.

This problem becomes particularly clear in the use-mapping that forms the basis of this consultation. For many sectors/applications, it is impossible to

classify them appropriately in the use-mapping. This makes it very difficult for companies to provide the information that is in the right place.

Many applications are excluded from the assessed sectors or proposed derogations on the assumption that they are covered in “other parts” of the restriction dossier. However, it remains unclear whether these excluded applications have been comprehensively and consistently assessed in those other parts of the dossier. This concern is also reflected in RAC’s opinion.

Furthermore, several of these “other parts” of the restriction proposal have not been subject to a dedicated evaluation by the ECHA Committees. This reinforcesconcernsthattheassessmentofalternatives,economicimpactsand proportionality has not been applied consistently.

The significant process delays, repeated acknowledgements of insufficient evidence, simplifying assumptions and the complexity of use‑mapping indicate that the current scope is overly broad, difficult to implement effectively and likely to result in unintended consequences.

Question

2.25: Please provide your comments on section 3.4.2.2.2 Socio-economic analysis: Costs [5000 characters]

BDI response:

We support SEAC’s assessment that the dossier submitters did not provide a robust or reliable cost estimation. Even the qualitative sector level assessments lack comparability, as the methodologies applied vary significantly in scope and quality, likely reflecting limited alignment among contributors. More detailed and consistent analysis is required, particularly for complex and industry near sectors, in order to adequately assess potential impacts and costs before any decision on a restriction is taken.

Considering the different socio-economic effects of a PFAS-restriction different types of costs must be taken into account within the SEA. In particular, the following costs should be covered:

- Loss of revenue

- Substitution costs

- Transition costs

- Cost for retrofitting

- Additional maintenance costs

- Additional operating costs

- Morefrequent replacementcostsduetolostperformanceordurability

- Compliance Costs/Costs due to information and documentation requirements

In light of EU objectives to reduce bureaucracy and the current economic situation, additional costs due to bureaucratic requirements are particularly critical.

Against this background reporting and labelling requirements should thereforebedesignedwithproportionality,sothatcompliancecostsdonotbecome a major socio-economic burden in themselves.

Finally, the cost analysis should also reflect the potential macro-economic impacts of an undifferentiated approach: a blanket ban could disrupt industrial production across multiple sectors and value chains, with knock on effects on jobs, planning certainty, and investment decisions for a large number of companies. (s. B-D in question 2.27).

Question 2.26: Please provide your comments on section 3.4.2.2.3 Socio‑economic analysis: Benefits [5000 characters]

BDI response:

Socio economic benefits should be framed in terms of the benefits of effective, risk-based management that ensures safe and sustainable use across the product life cycle. While PFAS are persistent and some PFAS may pose risks to humans and the environment when they are not handled or disposed of properly robust risk management measures help to keep these risks low by ensuring safe handling and controlled practices throughout the life cycle.

For an appropriate and realistic assessment of suitable alternatives, it is always important to consider not only the benefits of emission reductions but also possible costs and negative effects, e.g. through losses in safety or sustainability.

In particular, the section addressing particle emissions from fluoropolymers is largely descriptive and lacks a quantitative and holistic assessment. This is despite the fact that emissions from fluoropolymer uses are relatively minor and result in particles that have effects comparable to those of other polymer microparticles, as also acknowledged by SEAC.

We support SEAC’s conclusion that the effectivity assessment should be based on absolute emission quantities (e.g. kilograms or tonnes). Strong relative reduction of emissions in sectors with very low emissions provide limited environmental benefit, while potentially resulting in substantial socioeconomic impacts.

Question 2.27: Please provide your comments on section 3.4.2.2.4 Socio economic analysis: Other relevant impacts [5000 characters]

BDI response:

As already explained, in addition to direct and indirect costs in companies and supply chains, broader effects on strategic policy goals, societal services and market effects must be considered. In this context, the impact on climate protection, sustainability, and secure medical care plays a particularly important role. Furthermore, the restriction is likely to reduce European sovereignty and innovation capacity as well as reducing investments.

Impacts on climate protection and sustainability:

PFAS-enabled materials and components are used in several technologies that are central to decarbonisation andthe energytransition. Ifthese materials were no longer available in the EU before technically equivalent solutions are ready, development timelines and scale up of key climate technologies could be delayed, with knock on effects on investment planning and the pace of industrial transformation.

Impacts on circular economy

Strict limit values for PFAS in products can hinder the use of recyclates, as these substances may appear with a time delay in waste and cannot always be removed. Consequently, once stricter limit values apply, certain recyclates may no longer be usable in production. But the promotion of the circular economy is essential for achieving climate goals. Therefore, transitional periods for recyclates and recycled raw materials to phase out PFAS in order to comply with stricter limit values.

Impacts on the health sector and supply with medical products

PFAS are used throughout medical and pharmaceutical manufacturing chains (including in process equipment and in production steps for important precursors). If access to such uses is cut off without workable derogations and realistic transition periods, this could reduce the EU’s ability to manufacture essential medicines and medical products-creating risks of shortages and increasing dependency on imports.

Impacts on European competitiveness and strategic autonomy

European sovereignty relies on preserving essential technological capabilities in strategically critical sectors (e.g. semiconductors, aerospace and defence), where PFAS enable high precision, highly controlled manufacturing processesthatcurrentlyhavenofeasiblesubstitutes.AbroadPFASrestriction could disrupt these key functionalities and weaken Europe’s ability to maintain or expand strategic production capacities, thereby undermining competitiveness, innovation and the resilience of downstream industries. The broad

scope of the PFAS proposal intensifies this risk byextending regulatory pressure across almost all industrial sectors, increasing the likelihood that sudden material constraints will erode Europe’s technological sovereignty and longterm strategic autonomy.

Impacts on innovative capacity

If regulation relies on a fixed set of specific derogations, new or still-developingusescannotbeproactivelyexemptedbecausetheyarenot yetidentified and mapped. This can create a chilling effect on R&D, piloting and early industrialisationinEurope,sinceinnovators cannot relyonpredictableaccess to necessary materials during development phases.The result can be substantial negative effects on future innovation, including in emerging climate, health and strategic technologies.

Impacts on investments

Finally, there are cross cutting implications for industrial operations and investment behaviour: if restrictions are perceived as unpredictable or not practicable, companies may postpone investments, relocate parts of production, or redesign supply chains outside Europe.

Impacts on overarching impacts on trade and competitiveness

We welcome that SEAC recognized that the Dossier submitters assumption, (according to which negative implications on trade and competitiveness will overall be mitigated by the proposed derogations as well as an effective enforcement) is highly uncertain.

Instead SEAC states that cumulative impacts, overarching impacts on trade and competitiveness, a potential for derogated uses lost due to low market volumes as well as forderogations in theupstream supplychain forderogated uses have not been properly evaluated. Since these effects will be significant, they must be taken into account in a socio-economic assessment.

These effects show, that the REACH restriction process is not suitable to adequately consider a large group of substances, such as fluoropolymers, which play an important enabling role in pursuit of technological advancement. Such technological advancement is undeniably part of current global competitiveness landscape.

Question 2.28: Please provide your comments on section 3.4.2.2.5 Socio-economic analysis: Proportionality [5000 characters]

BDI response:

In terms of proportionality, any regulatory measure should be appropriate to the demonstrated risk and feasible to be implemented. The proposed PFAS restriction, however, does not meet these fundamental requirements. To a large extent the precautionary principle is used to justify the current approach. However, proportionality must also be ensured when applying this principle.Arestriction that captures very different PFAS categories and uses in a blanket manner without sufficiently differentiated, evidence-based risk assessments risks going beyond what is necessary to address the identified problems.

In addition, proportionality requires that procedural and evidentiary requirements imposed on stakeholders be realistic.The current approach is problematic in this regard, as it expects companies to provide detailed information for a wide range of applications within very short deadlines. For many sectors and complex value chains, it is not possible to compile comparable, use specific data in the required depth and speed. As a result, there is a risk that relevant uses will not be adequately identified or represented.

A more proportionate approach should focus on targeted regulation of uses that are relevant from arisk perspective.Furthermore,adequate timelinesand practical formats for data submission should be provided to ensure that the requirements reflect the practical realities of industrial supply chains and the availability of robust evidence.

In addition, the proportionality assessment is materially affected by the assumptions used to quantify environmental benefits. For fluoropolymers, a substantial share of the modeled benefits is driven by assumed emissions at the waste and end‑of‑life stage, in particular from incineration. These estimates are based on highly precautionary default release factors that are not derived from measured incinerator performance and therefore likely significantly overestimate real‑world emissions.

Recent empirical evidence (see GKS study – summary available on the website of VCI Bayern) indicates that under representative and conservative incineration conditions, theformation andreleaseof non‑polymericPFAS from fluoropolymer waste is several orders of magnitude lower than the default values applied in the restriction dossier. This suggests that the environmental benefit baseline relevant for the socio‑economic analysis may be overstated. Where regulatory benefits are systematically overestimated, while costs and broader socio‑economic impacts remain highly uncertain or underestimated, the resulting proportionality assessment cannot be considered robust.

In light of these developments, SEAC should reassess the underlying emission assumptions for end‑of‑life treatment and, at a minimum, conduct

sensitivity analyses reflecting realistic release factors. Without such correction, conclusions on proportionality risk being distorted and may lead to regulatory outcomes that gobeyondwhat is necessary andappropriateto address actual risks.

Question 2.29: Please provide your comments on section 3.4.2.3 Practicality, including enforceability [5000 characters]

BDI response:

The restriction dossier (background document) remains highly complex and is not enforceable due to its sector-specific approach Due to the broad scope of the restriction approach and the large number of relevantuses,thesector-specificapproachisnotimplementableandtherefore inappropriate. From the industry's point of view, it is not possible to identify all relevant uses without suitable alternatives, to take these into account in the restriction proposal by means of derogation and thus to ensure necessary further uses. Instead, as repeatedly called for by industry, there should be a reversaloftheregulatory approachand, insteadofabroadbanwithnumerous derogations, targeted regulation of individual, high-risk uses of PFAS should be provided for.

The chosen approach will require a large number of derogations, which will make the restriction enormously complex. It is not clear how this is to be monitored and enforced in practice (e.g. also with regard to imports). The issues of lack of feasibility and high complexity have already become apparent in the context of incomplete use mapping. Despite its significant scope and broad differentiation of uses, it is not suitable to categorize all relevant products and applications in which PFAS are used.

Against this background, removing fluoropolymers from the dossier would not only make sense for scientific reasons (see above), but would also significantly reduce the undue complexity of the restriction and the number of necessary derogations. This, in turn, would lead to better enforceability, a higher probability of timely implementation and support for strategically important sectors.Still, removing fluoropolymers from the dossier would be only the first step; reversing the approach of the PFAS dossier in general would still be necessary to ensure proportionality.)

Enforceability is particularly challenging with regard to imports. Effective control would require reliable information on whether imported articles contain PFAS in a concentration exceeding the threshold and, if so, which PFAS In many cases, however, enforcement faces two structural obstacles:

(1) limited availability of standardised analytical methods for a wide range of PFAS in complex matrices, and (2) incomplete or inconsistent information obligations along global supply chains.

This makes it hard to verify compliance at the border or in market surveillance. For complex end products (e.g., vehicles or other assembled goods), it is often unclear how authorities could practically determine whether specific components (such as seals, hoses or other parts) contain PFAS.

In addition, legal certainty and enforceability suffer when definitions and exemption wording are not sufficiently precise, or when key terms are difficult to interpret consistently across sectors. This increases the risk of uneven implementation, disputes, and loopholes while also raising compliance costs and uncertainty for economic operators.

Overall, the overly broad restriction approach, the necessity of numerous exemptions, the limited traceability and testability in global supply chains, and the difficulty of controlling PFAS content in imported complex articles all point to a high risk that the measure would be difficult to implement and enforce in a predictable, consistent and effective way.

Question 2.30: Please provide your comments on section 3.4.2.4 Monitorability [5000 characters]

BDI response:

Monitoring of a regulatory measure requires, clear and measurable parameters, standardised analytical methods, and reliable information flows even within complex and global supply chains. These prerequisites are only partially available for PFAS. This results in inconsistent and uncertain monitoring capabilities.

Measurement of PFAS/StandardisedAnalytical Methods

For specific, well defined PFAS lists with validated methods, monitoring can work. However, for broader concepts - such as “total PFAS” or PFAS detection in complex matrices and articles - monitoring becomes difficult due to a lack of harmonised methods, incomplete data on measurement uncertainty, and insufficiently defined limits of quantification. Furthermore, the methods intended to determine ‘total PFAS’(e.g. TOF) are not PFAS‑specific. They also detect fluorinated substances that do not fall under the PFAS definition used here, which leads to misinterpretations and miscommunication

This reduces the ability of authorities and companies to verify compliance consistently and comparably across Member States.

For this reason, it would be very difficult for both authorities and companies to prove that the restriction requirements are being complied with.

Moreover, detecting very low concentrations of hazardous substances in recyclates/recycled raw materials requires significant technical effort. Limit valuesshould allowmeasurements to becarriedout with reasonabletechnical effort and should be complemented by testing methods initially detecting indicator substances rather than specific chemicals, allowing targeted followup testing only when necessary.

Information flow within global supply chains

Monitorability for complex products and articles is limited due to missing information flows within the supply chain.At present, there is only very limited transparency regarding which PFAS are contained in which components or products.As a result, even where legal thresholds and standards exist, it is difficult to trace and verify compliance. This creates the risk that, due to the lack of harmonised standards and insufficient information transfer along the supply chain, monitoring in practice may become inconsistent or only very narrowly achievable.

Overall, the current situation suggests that there remain major limitations for broad PFAS groupconcepts andforcomplexproducts -especially wheresupply-chain information and validated analytical tools are lacking.

Question 2.31: Please provide your comments on section

3.4.3.2.1 Conclusion whether the suggested restriction is the most appropriate EU wide measure: (i) PFAS definition [1000 characters]

BDI response:

The PFAS definition used in the restriction proposal is extremely broad, covering more than 10,000 substances (e.g. non-polymers, polymers with fluorinated side chains and fluoropolymers) despite major differences. in persistence, mobility, bioavailability, (eco)toxicity and exposure

Such heterogeneity makes a single EU-wide restriction scientifically difficult to justify and in practice requires numerous derogations and exclusions, increasing complexity and reducing legal certainty and enforceability.

A more appropriate approach would differentiate PFAS into subgroups with comparable properties and realistic emission and exposure scenarios, allowing regulation to focus on risk-relevant uses rather than the entire group.

We support SEAC’s position that the OECD PFAS definition is a structural terminology framework for identification and communication, not a basis for

regulatory action. It is not a hazard classification and does not imply equal levels of concern for all substances.

BDI response:

To ensure proportionality and workability of the PFAS restriction, certain PFAS categories/uses must be exempted where a restriction would not effectively address risk - in particular fluoropolymers. Fluoropolymers are mainly used as high-performance materials and are not intended for dispersive uses. Theirrisk profileand exposurepathways differsignificantlyfrom manyother PFAS. Relevant risks mainly arise during manufacturing and end-of-life phases and can be effectively addressed through existing emission-control/waste-management legislation. A exclusion of fluoropolymers would significantly reduce complexity, improve legal certainty and enforceability and allow regulatory focus on uses where a EU-wide restriction is justified. In addition, a general exemption for PFAS in spare parts is essential to ensure repairability/maintenance of long-lived products/equipment. Furthermore, exemptions must cover all supply chain stages; otherwise, exemptions are ineffective in practice.

BDI response:

The proposed scope of the PFAS restriction is extremely broad and does not sufficiently account for the diversity of PFAS substances, uses and exposure scenarios. By covering manufacture, placing on the market and use of PFAS in substances, mixtures and articles across almost all sectors, the restriction risks capturing many applications where exposure is limited and risks are adequately controlled.

In practice, this broad scope necessitates a large number of specific derogations to maintain uses without suited alternatives. This increases complexity and undermines legal certainty and enforceability.

A more appropriate approach would define the scope in a more targeted manner, focusing on PFAS uses with relevant emissions or exposure that lead to unacceptable risks. This would reduce the need for extensive derogation

systems and allow regulatory efforts to be concentrated where they are most effective. Within such approach at least Fluoropolymers should be completely excluded.

Question 2.34: Please provide your comments on section 3.4.3.2.3 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Concentration limits [1000 characters]

BDI response:

The proposed concentration limits raise significant concerns regarding both practicability and enforceability. In many cases, the limits are difficult to verify, particularly for complex articles and imported products, due to the lack of harmonised and validated analytical methods for a broad range of PFAS.

In addition, concentration-based thresholds do not adequately reflect actual exposure or emission scenarios, especially for PFAS used in solid matrices or as integral components of industrial equipment with minimal release during use.

Setting concentration limits without a clear link to risk-relevant exposure pathways may therefore lead to disproportionate regulatory outcomes. Any concentration limits should be technically measurable, enforceable in practice and closely linked to demonstrated risks, taking into account the function and use phase of the relevant products.

BDI response:

The general 18-month transition period foreseen in the proposed restriction is insufficient for most PFAS uses. Given the complexity of industrial production processes and value chains, substitution or phase-out of PFAS typically requires significantly longer timeframes.

Developing and qualifying alternatives, adapting production processes, obtaining regulatory approvals and redesigning equipment often take several years. In many cases, suitable alternatives are not yet available.

A uniform transition period does not reflect these practical realities and risks disrupting established supply chains and industrial activities. Transition periods should therefore be aligned with realistic technical, regulatory and

investment cycles. Where substitution is not feasible within foreseeable timeframes, appropriate derogations must remain available.

Question 2.36: Please provide your comments on section 3.4.3.2.5 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Derogations [5000 characters]

BDI response:

General Aspects/ Relevance of derogations

From an industry perspective, a broad and undifferentiated PFAS ban combined with many highly specific derogations is not an appropriate regulatory approach. Such a structure is inherently complex, inflexible and difficult to beimplementedand enforcedin practice. It creates legal uncertaintyfor companies and authorities alike and risks excluding relevant uses simply because they have not been fully identified or sufficiently characterised at an early stage of the process.

If an approach with a broad ban with application-specific derogations nevertheless is pursued, well-designed, evidence-based and reviewable derogations are a central prerequisite for a proportionate, practical and effective PFAS restriction.

In particular derogations are indispensable for applications that rely on PFAS as high-performance materials, where no equivalent alternatives exist. This applies inter alia to fluoropolymer-based uses, where risks during the use phase are typically low and can be effectively managed, while emissions from manufacturing and end-of-life can be addressed through existing environmental legislation. For such uses, broad and unlimited derogations are necessary to avoid disproportionate impacts and unnecessary complexity.

Assessment of derogations by SEAC

Given the critical importance of derogations for the proportionality and feasibility of the restriction approach, it is highly concerning that the SEAC supports only 34 derogations, either in full or in part. Without derogations that have reasonable transition periods and which are not overly fragmented, the restriction cannot function and will result in massive impacts Thus, from the industry’s perspective, the following aspects should be taken into account regarding derogations:

Scope and time-frame of derogations

For many PFAS uses, information on the availability, technical feasibility and socio-economic impacts of alternatives remains incomplete or uncertain. In such cases, it is not appropriate to apply narrow or rigid derogation concepts. Instead, time-limited derogations should be understood as remaining

valid until a comprehensive, use-specific assessment has been completed, rather than as fixed deadlines that apply irrespective of technological progress or remaining uncertainties.

From an industry perspective, derogations must provide sufficient legal certainty and continuity for critical uses. This requires clearly defined eligibility criteria, transparent and predictable review mechanisms and the possibilityto extend derogations where updated evidence demonstrates that suitable alternatives are still not available or that substitution would result in disproportionate socio-economic impacts.

The transition periods of derogation should be aligned with realistic development, qualification (including regulatory approval) and investment cycles.

Consideration of the full supply chain within derogations

Derogations must also be coherent along the entire value chain. An exemption for a specific use or application is ineffective if upstream materials, intermediates or production steps required to supply the derogated use remain prohibited. To prevent supply disruptions, plant closures or relocation of production outside the EU, derogations should therefore explicitly cover all indispensable elements across the value chain that are necessary to maintain the exempted use.

In addition, a general exemption for PFAS in spare parts is essential to ensure repairability/maintenance of long-lived products and equipment.

Review mechanism for derogations

Furthermore, derogations should include a review mechanism that allows exemptions to be reassessed, extended or adapted based on technological developments and newly available evidence. Such a mechanism has to be simple and effective. Hence, it must be different to the regular procedure of Art. 69 – 73 REACH. In general is essential to ensure that regulation remains dynamicandresponsive, ratherthancreatingregulatorydeadendswherenecessary uses are forced out of the EU despite continued lack of alternatives.

Question 2.37: Please provide your comments on section 3.4.3.2.6.1 Conclusion whether the suggested restriction is the most appropriate EU‑wide measure: Reporting requirements [1000 characters]

BDI response:

For a practical and proportionate PFAS restriction, the associated bureaucratic effort is crucial. Additional administrative burdens caused by the restriction play an important role. The proposed approach would lead to new

information/documentation obligations for companies - especially when exemptions are used, leading to significant additional bureaucratic burden. Overall, the reporting obligations must be designed to be lean and feasible, so that they do not become a dominant burden that undermines the practicality of the derogations.

Especially reporting on potential emissions is critical. Besides increasing administrative burden, the quality and usability of the data is questionable, as model base assumptions need to be applied to calculate theoretical downstream emissions. In addition, emissions are highly dependent on the specific processes, raising questions onconfidentiality. For all reporting requirements clear rules for data confidentiality must be taken into account.

Question 2.38: Please give an indication of the costs related to the reporting requirements.

BDI response: Very High

BDI response:

In the context of PFAS derogations, the proposal requires the development of a management plan. From the industry’s perspective, this can contribute to effective emission control.

However, it must be ensured that the requirement is designed in a lean/ practical way. Otherwise, feasibility might be impaired, and companies will be additionally burdened by unfounded bureaucratic hurdles. Thereforea PFAS management plan should demonstrably contribute to improving the protection of human health and the environment. It should be limited to uses which have been clearly identified as posing a risk, not universal.

Updates should only be required when conditions change significantly. It should also be noted that as long as the details of a putative reporting requirement are not defined it is impossible to estimate costs. Here, especially the proposals of RAC would lead to an unproportionate high administrative burden and costs that are not even closely linked to reduction of emissions.

Question 2.40: Please provide your comments on section 3.4.3.2.6.3 Conclusion whether the suggested restriction is the most appropriate EU wide measure: Additional conditions considered by RAC.

BDI response: Very High

Question 2.41: Please give an indication of the costs related to monitoring of PFAS emissions at industrial sites.

BDI response: Very High

BDI response:

Additional conditions may in principle contribute to emission reduction where PFAS uses continue under derogation. However, their application must be strictly risk-based, proportionate and demonstrably effective.

Inparticular, site-specific managementplansas well as additionalmonitoring and reporting obligations can lead to significant administrative and financial burdens. Without robust evidence that such measures deliver a meaningful additional risk-reduction benefit across the wide range of PFAS uses, it is difficult to justify their uniform application.

Additional conditions should thus be limited to situations where there is a clear link between the measure and a relevant reduction of emissions or exposure, where such reduction is necessary in the first place, and where implementation and enforcement are feasible in practice. Accumulating multiple requirements without sufficient differentiation risks legal certainty, practicality and investment planning, rather than improving risk management.

Question 2.43: Please give an indication of the costs related to the additional conditions considered by RAC

BDI response: Very High

BDI response:

For an EU-wide measure, its interaction with existing EU-legislation is of central importance. PFAS-related risks are already addressed under several regulatory frameworks, including existing REACH provisions, the POPs Regulation, industrial emissions legislation, occupational safety rules and sector-specific product requirements.

To be proportionate and effective, the proposed restriction must be coherent with these instruments and avoid overlapping or duplication. Where risks are already adequately managed through established, sector-specific requirements, the additional benefit of horizontal restriction measures should be clearly demonstrated.

A lack of regulatory coherence may increase administrative burden, reduce legal certainty and complicate enforcement. Clear definition of scope, consistency with existing legislation and avoidance of double regulation are thereforeessential to ensurethatthe restriction complements theexisting regulatory framework rather than weakening it.

Question 2.45: Please provide your comments on section 3.5.2 Uncertainties evaluated by SEAC [5000 characters]

BDI response:

We agree with the assessment of SEAC that the uncertainties of the proposed restriction are overall substantial. As assessed by the SEAC the uncertainties encompass such crucial parts of the restriction as scope, costs and benefits of the dossier

This hinders a clear and reliable assessment of proposed derogations and the overall proportionality of therestriction which actually form the basis of each REACH based restriction. Due to the complexity and broad character of the proposed restriction, it is highly doubtful if those uncertainties can be

resolved and whether a restriction in its current form can be placed on a sufficiently reliable basis.

From our point of view the proposed approach is associated with various uncertainties that have been repeatedly criticized by industry. These include:

Uncertainties in mapping all relevant uses/uncertainties in the assessment of derogations

The main uncertainty from the industry’s perspective is that a use-specific approach cannot successfully identify all relevant uses and, where necessary, cover them through appropriate derogations. In complex supply chains, information is often lacking, and additional uses may emerge that have not yet beenidentified.Thecurrentrestrictionproposaldoesnotsufficientlytakethis reality into account, creating a risk that urgently needed uses (for which no suitable alternatives exist) are overlooked or not properly represented in the use-mapping process. Within the broad PFAS restriction, to prevent massive impacts all uses without suitable alternatives must be covered and well-designed, evidence-based and reviewable derogations are necessary. Thus, also the uncertainties addressed by SEAC regarding the assessment derogations which result in a very low number of supported derogations are critical.

Uncertainties for sectors not assessed fully

For the eight sectors which were added at a later stage and for which no detailed sector-specific SEAC analysis has been carried out, the uncertainties are very high. Without a thorough assessment of technical feasibility, availability of alternatives, economic impacts and broader socio-economic consequences no final judgement on a regulatory measure should be made Applying the general ban to these sectors would not be in line with the legal requirements for a restriction since it is not proven that an unacceptable risk is linked with the uses in these sectors. The fact, that SEAC proposes a general exemption for all uses in these sectors until they are specifically assessed, cannot overcome this deficit. Such sectors can therefore not be subject to the restriction (s. contribution ID: eae19ac4-45db-40b9-86df-8dbc2867540d)

Uncertainties in the assessment and identification of alternatives

There are also significant uncertainties regarding the assessment and identification of suitable alternatives. There is a risk that not all relevant criteria for evaluating alternatives will be considered, or that insufficient time will be available for their identification and further development (particularly in the context of approval and certification procedures).

Uncertainties in the quantification of socioeconomic impacts

Furthermore, there are major uncertainties in quantifying socioeconomic impacts. Often, even at the company level, sufficient information on the costs arising from the restriction is not available. These uncertainties are further amplified when estimating indirect costs and systemic effects, meaning that coarse approximations with corresponding uncertainties must be used.

Uncertainties due to legal objections to the procedure (s. Contribution ID: eae19ac4-45db-40b9-86df-8dbc2867540d)

There are uncertainties due to legal objections to the procedure. A legal opinion commissioned by various industry associations and submitted to the consultation bythe Federation of German Industries highlights significant uncertainties arising from procedural errors, which render the process and its results open to challenge. These errors include, amongst other things, the inadmissible group-based approach, the reversal of the burden of proof to the detriment of those affected, insufficient consultation, excessively short deadlines, excessive demands placed on small and medium-sized enterprises in particular, and the lack of assessments of individual sectors (s. Contribution ID: eae19ac4-45db-40b9-86df-8dbc2867540d)

About BDI

The Federation of German Industries (BDI) communicates German industries’interests to thepolitical authoritiesconcerned.Sheoffersstrongsupport for companies in global competition. The BDI has access to a wide-spread network both within Germany and Europe, to all the important markets and to international organizations. The BDI accompanies the capturing of international markets politically. Also, she offers information and politico-economic guidance on all issues relevant to industries. The BDI is the leading organization of German industries and related service providers. She represents 40 inter-trade organizations and more than 100.000 companies with their approximately 8 million employees. Membership is optional. 15 federal representations are advocating industries’ interests on a regional level.

Imprint

Federation of German Industries e.V. (BDI) Breite Straße 29, 10178 Berlin, Germany www.bdi.eu T: +49 30 2028-00

German Lobbyregister Number: R000534

Contact Dr. Mirjam Merz m.merz@bdi.eu

BDI document number: D (D2274)