Keemiatööstuse pakett sh REACH määruse muutmine

15th of April 2025 REACH REVISION: Position paper Cosmetics Europe Cosmetics Europe is the cosmetics and personal care association. Through its network of active corporate and association members, Cosmetics Europe represents at least 80% of the European cosmetics industry in value, including more than 9,000 SMEs. Our sector provides approximately 3 million direct and indirect jobs across the continent. Cosmetics are an integral part of the lives and identity of European citizens, used by people of all ages to take care of their personal hygiene and to improve their well-being – from soap to skincare, toothpaste, perfume, hair dyes, sunscreens, and makeup. Cosmetics Europe is pleased to provide its comments on the upcoming revision of REACH. In line with the mission letter to Commissioner Jessika Roswall and the recently published Competitiveness Compass, this revision should ensure that the principles of Proportionality and Better Regulation are respected, including through wide consultations, impact assessments, a review by the independent Regulatory Scrutiny Board and a new SME and competitiveness check. The implementation of the REACH regulation over the past 18 years has demonstrated its effectiveness while also revealing some limitations, such as delays in revisions and enforcement. Cosmetics Europe supports the revision of REACH, provided that it takes into account the valuable lessons learned over the past years, is based on robust scientific principles, is proportionate and aligned with the principle of Better Regulation. 1. Impact assessment REACH regulation revision was paused after a 2022 public consultation and initial impact assessment. Now, with the revision restarting and a target adoption date of late 2025, the old impact assessment needs to be revisited. This refresh will account for the Commission's new focus on competitiveness and simplification, as well as changes in the regulatory and political environment since 2022. Ask (1): Cosmetics Europe asks for the reassessment and interpretation of the conclusions of the previous impact assessment for the revision of REACH regulation in light of the new priorities of competitiveness and simplification. 2. Generic Risk Management Approach (GRA) under REACH Under the current GRA regime in REACH, CMR category 1 substances with a harmonized classification are banned in consumer products. We understand that the classification of a substance with one of the new hazard classes can signal the need for swift and effective risk management. However, a CLP classification – regardless of the type of hazard – does not automatically mean that all uses of the substance pose an unacceptable risk. In order to ensure better predictability, and preserve industry competitiveness and innovation capacity, it must be assured that safe uses of the substance can be maintained. An efficient and effective system of restrictions, when necessary, including fast, quasi-automatic steps is a better option than a 1 simple extension of GRA that risks unjustified and disproportionate bans of safe uses which can lead to regrettable substitution. The concept of such system is described in section 3 (see hereafter). Ask (2): Cosmetics Europe is opposed to the extension of GRA. 3. Grouping of substances Cosmetics Europe acknowledges that grouping of substance can in principle be used to make regulatory processes more efficient, however, grouping is not a ‘one off exercise’ that is only done at the beginning of the process, when identifying substances of interest. Grouping must be a ‘stepwise’ approach that is repeated according to the regulatory question at hand (e.g., identification of substances of possible interest → chemical classification → restrictions). As an example: substances may be grouped according to their chemical similarities as a first step. In a second step, depending on the regulatory actions foreseen the relevant endpoints have to be assessed for each substance and grouping is only done on the basis of scientifically valid read- across approaches. Indeed, experience has shown that two “chemically similar” substances can have significantly different hazard properties. Ask (3): Cosmetics Europe asks for efficient and effective grouping of substances when used as a streamlining tool to ensure sufficient time and predictability for industry to work on the different suggested regulatory actions listed for the substances. 4. Streamlining the Authorisation and Restriction Processes Cosmetics Europe recognizes the pressing need to streamline the restriction process and reduce the number of authorisation dossiers under REACH. We support the objective of shortening delays and reducing the administrative burden, while allowing robust scientific decisions and enhancing the efficiency and predictability of risk management for harmful substances. Experience under sector specific legislations show that targeted restrictions of specific “substance/use combinations” do not have to become a resource-intensive, slow system. A key aspect is that gathering of data and preparation of safety dossiers is the responsibility of industry. The role of ECHA and Members States experts should be one of peer reviewing this information rather that generating/ compiling it. Such system can also include quasi-automatic fast track elements where, in a full reversal of burden of proof, failure of industry to unambiguously demonstrate safety will lead inevitably to a ban of certain substance/use combinations. To achieve this, Cosmetics Europe strongly advocates that: The REACH revision should amend Article 68(2) and the respective entries in Annex XVII to include a safety-based derogation system that is based on ‘demonstrated safe use’. Indeed, a GRA mechanism that does not consider safe uses goes beyond the legitimate safety objective of REACH and leads to disproportionate bans of safe uses of chemicals and possibly to regrettable substitutions while impeding innovation and competitiveness of the EU market. Such an 2 approach cannot be put in place in a product-specific or company-specific manner, but it is based on aggregated information collected across industry, thus representing all sectors’ uses of interest in a single sector dossier. This allows to reduce the burden on the evaluating scientific bodies and on the competent authorities which receive a smaller number of dossiers. In addition, by better prioritising substances the approach will also result in clear timetables/roadmap allowing high degree of predictability and legal certainty for all stakeholders. The concept of the approach is described hereafter: Starting point: Chemical universe defined by REACH registration. Step 1: Filter REACH chemical universe for substances of possible concern using as criteria the outcomes of ARN, CORAP, SVHC, CLH etc. → Outcome: List of substance of potential concern. Step 2: Screening and First Prioritisation: For resulting substances, ECHA/ Member States uses data from the REACH registration dossiers (uses, tonnages) to screen and prioritise substance for follow-up. - Fast track: Substances in consumer use with a CLH classification as CMR 1 are automatically considered as priority for potential follow-up and added to that list. → Outcome: List of prioritised substances published and updated annually. Step 3: On prioritised substances, Industry provides detailed information (beyond REACH information) on sector specific uses, exposures, tonnages. Information should be collected/aggregated at sector level rather than submitted on individual company/use level. - Fast track: Substances in consumer use with a CLH classification as CMR 1, the information to be provided includes an analysis of suitable alternatives (AoA). Failure of industry to submit information would automatically lead to a ban in the following steps (reversal of burden of proof). → Outcome: Detailed information available to ECHA and Member States on specific substance/use combinations on the prioritised substances including information on availability of suitable alternatives for substance/use combinations of CMR 1. Step 4: Second Prioritisation: Based on that information, ECHA/ Member States identifies which specific substance/use combinations require regulatory risk management, including potentially restrictions. - Fast track: Substances in consumer use with a CLH classification as CMR 1 are automatically considered as requiring regulatory follow-up. For substance/use combination without submitted AoA or where suitable alternatives exist, a ban is recommended as regulatory risk management. → Outcome: List of substance/use combination requiring regulatory risk management including identification of uses, that will automatically be banned. 3 Step 5: Determine the most appropriate regulatory risk management tool for each identified substance/use combination, taking into consideration socio economic impacts. Specific timelines are being set to allow workability, predictability and forward planning. Note that for some substance/use combination the regulatory risk management tool may be in sector specific legislation (e.g. BPR, PPP, CPR) or OSH or IED rather than REACH. - Fast track: Substances in consumer use with a CLH classification as CMR 1 – where the AoA showed that: i. there are suitable alternatives for a particular use → ban of that substance/use combination; ii. there are no suitable alternatives for a particular use → safety evaluation of this substance/use combination. There is a reversal of burden of proof. No need for authorities to demonstrate an unacceptable risk. Rather industry needs to submit a safety dossier (sector aggregated) on substance/ use combinations of interest for peer-review by ECHA (RAC, SCCS, BPC, etc.). o If safety is confirmed or unsafe exposure can be excluded a continued use is allowed under a substitution plan until availability of suitable alternatives. o If not safe the substance/ use combination is banned unless there is an overriding benefit (last resort use of authorisation process). → Outcome: Annual publication of a Regulatory Roadmap leading to comprehensive regulatory risk management that prioritises substances of concern, allows targeted restrictions based on substance/use combinations, fast tracks the ban of substances of most concern without automatic bans of safe uses. Throughout all steps above, it is important to note that identification of individual substances (e.g.: CAS or EC number) especially in the case of grouping approaches should be available. This is necessary to allow companies and in particular SMEs to prepare for restrictions. It also minimises the risk of misunderstandings and uncertainties and increases the effectiveness and efficiency of enforcement. The current restriction of PFAS shows the risks of insufficiently defined broad restrictions of a group of substances. Very broad restrictions that group a wide range of substances without distinction causes a high degree of uncertainty and burden. Ask (4): Cosmetics Europe asks for amending Art 68 (2) and respective entries of Annex XVII to introduce an efficient and effective system of restrictions, including automatic fast track processes accompanied by exceptional safety-based derogation mechanisms. Furthermore, restrictions should always provide a clear list of substances in scope. 5. Non-Animal Methods (NAMs) The current REACH legislative framework requires animal tests only as a last resort. The upcoming REACH revision is a unique opportunity to prioritize use of Non-Animal Methods (NAMs) in replacing animal tests, recognize the rapidly evolving state of the science on NAMs, and drive the regulatory acceptance and uptake of NAMs and NAMs data for hazard identification and risk assessment/ management of chemical substances. This can be achieved by use of 4 NAMs, particularly through application of Annex XI. Furthermore, strengthening a risk-based approach drawing on use-specific exposure data and in combination with NAMs would ensure an equal or higher level of safety, while avoiding animal testing. It is crucial that REACH facilitates scientific progress and regulatory acceptance of NAMs to ensure animal testing is, indeed, mandated by ECHA only as a true and demonstrable last resort. Ask (5): Cosmetics Europe asks to: • Enforce animal testing strictly as a last resort, ensuring that "last resort" truly means only when there are no other possibilities. • Implement a scrutiny process when animal testing is deemed necessary by ECHA. This process should involve a committee of NAMs experts and/or public consultation. 6. Consistency among chemical legislations Ensuring efficient enforcement of the regulations is a key aspect for the revision of the REACH regulation. To achieve this, firstly there is a need for coherence between REACH and other horizontal pieces of legislation. REACH should be strengthened in terms of setting the horizontal definitions and concepts used in other horizontal chemicals legislation to avoid overlaps and contradictions. Secondly, these concepts should then be translated and adapted into sector legislation taking into account their specificities. Ask (6): Cosmetics Europe asks for the revision of REACH to consider the current sectoral regulations already in place, to encourage the enforcement of the chemical regulations and ensure a level playing field. 5 CHEMICALS INDUSTRY PACKAGE: AN OPPORTUNITY TO SIMPLIFY REACH Position of A.I.S.E. April 2025 The European association representing detergents, disinfectants and maintenance products (A.I.S.E.) emphasises the importance of a targeted and effective revision of the REACH Regulation ((EC) No 1907/2006) through the Chemicals Industry Package. In line with the political guidelines from President von der Leyen and the mission letters to Commissioners Séjourné and Roswall, there will be an opportunity to revise and simplify the REACH Regulation for the first time in twenty years. This will set the stage for the coming decades. Besides ensuring a high level of protection for human health and the environment – already being delivered by REACH, as the most comprehensive and advanced chemicals management legislation in the world – the revision must have the goal to reduce administrative burden for both industry and authorities, and to enhance the competitiveness of European industry as highlighted in the Draghi and Letta reports, the Competitiveness Compass and the Clean Industrial Deal. In this context, A.I.S.E. believes that the Commission’s new ‘SME and competitiveness check’ for new legislative proposals must be applied to the critically important revision of REACH and that a level playing field and competitiveness for EU companies that invest in compliance should be preserved. A.I.S.E.’s priorities can be summarised as follows:  Predictability to enable investment: A.I.S.E. calls for the establishment of a binding regulatory roadmap, assigning priorities and clear timings for regulatory action on (groups of) substances. This will enable industry and authorities alike to plan strategically for the necessary tasks and resources, fostering innovation and facilitating the transition to new methods and alternatives.  A holistic approach to risk management options: Assessment of substances in the above roadmap must take into account all available regulatory tools to identify the most practicable and cost-effective route to manage the identified risk. This means considering not only the options provided by REACH, but also those under legislation on Occupational Safety and Health (OSH), industrial emissions and so on. Identifying the best regulatory route upfront will save time and resources for all parties and be more efficient in the long run.  Targeted rather than generic risk management: A.I.S.E. calls for a regulatory framework based on science and evidence, including assessments of exposure/risk and of socio- economic considerations. Restricting or banning chemicals based purely on their hazards, or a generic approach to risk management (GRA), would have a significant detrimental effect on the product offer and competitiveness of the European cleaning products industry, as shown by a 2022 economic analysis of business impacts. A key example of this would be ethanol, for which products such as hand sanitisers could be unnecessarily and automatically  removed from the market despite their safe use if ethanol were to be classified as CMR (Carcinogenic, Mutagenic and/or Toxic to Reproduction) Cat. 1.  Avoid excessive precaution on combined exposures: industry studies, such as A.I.S.E.’s case study and those from other downstream user sectors, indicate that applying a blanket Mixture Allocation Factor (MAF) to chemical safety assessments would have substantial negative impacts on formulators, on valuable applications and on animal testing, through additional compliance work to demonstrate the safety of well-established uses. More targeted risk management measures, making use of other regulatory tools such as industrial emissions controls, should be applied for the small proportion of substances that can actually contribute to the toxicity of unintentional mixtures – many of which fall outside the scope of REACH in any case.  Avoid burdensome new obligations for polymers: introducing registration obligations for polymers would represent the antithesis of simplification. Many downstream users would become registrants for the first time if they produce or modify polymers for their product formulations. Targeted risk management would be more appropriate for the small subset of polymers that represent a potential risk to human health or the environment.  Ensure measures are enforceable and enforced: effective management of chemicals depends on the ability and capacity to enforce rules in practice. Regulatory measures must be designed to be proportionate and enforceable; the advice of industry experts and enforcing authorities should be taken into account in this regard. A.I.S.E. supports enhanced cooperation between the EU and Member States to ensure effective control of imports, to preserve a level playing field and competitiveness for EU companies that invest in compliance.  Phase out animal testing: the REACH revision is a unique opportunity to advance the phase-out of animal testing for chemical safety assessments, as proposed through the Commission Roadmap and EU Test Method & Validation strategy. Maximising regulatory use of New Approach Methodologies (NAMs) facilitates sustainable innovation and achieves a higher level of protection for human health and the environment whilst avoiding unnecessary animal testing. A.I.S.E. is concerned that without coordinated actions to accelerate regulatory use of NAMs, new REACH information requirements may significantly increase the need for new animal testing with no additional benefit for protecting human health or the environment.  Last, but definitely not least - let’s keep talking: A.I.S.E. calls for more scientific dialogue between economic operators and regulators/agencies to be (re-)introduced into regulatory processes for chemicals. For example, agreeing on targeted and effective adaptations of standard information requirements in registration dossiers will help to reduce animal testing as well as administrative burden for companies; whilst the ability to comment on opinions from scientific committees after they have been developed (not only before) will lead to higher quality decision-making. ***** Conclusion 2 A.I.S.E. emphasises the importance of maintaining the fundamental principles of REACH whilst advocating for targeted improvements. The association calls for science-based approaches, increased dialogue and strategic risk management to ensure the regulation continues to protect human health and the environment without compromising the competitiveness of the European cleaning products industry. About A.I.S.E. A.I.S.E. represents the detergents & maintenance products industry in Europe. Based in Brussels, A.I.S.E. has been the voice of the industry to EU regulators since 1952. Membership consists of 29 national associations across Europe, 19 corporate members and 23 value chain partners. Through this extensive network, A.I.S.E. represents over 900 companies supplying household and professional cleaning products and services across Europe. Committed to promoting sustainable practices and innovation, A.I.S.E. collaborates closely with European institutions, industry stakeholders, and the public to enhance the sector's environmental protection, consumer safety, and regulatory compliance efforts. Contact information : [email protected] 3 A 10-POINT ACTION PLAN TO SIMPLIFY REACH The EU chemicals industry is at a critical juncture as it faces high energy costs, a slow economic recovery, and an increasingly complex regulatory landscape. As Professor Draghi highlighted, reducing regulatory burden is essential for Europe’s resilience. Among the many regulations affecting the sector, REACH remains a cornerstone framework. REACH is the most comprehensive and advanced piece of legislation governing chemicals. Despite gaps in its implementation and enforcement, it has proven to be fit for purpose, ensuring a high level of protection for people’s health and the environment. Any action on REACH must deliver real simplification without compromising the protection of human health and the environment. Simplification means making regulations more effective: reducing unnecessary burdens while ensuring regulations achieve their intended goals. In line with the EU’s commitment to restore competitiveness, the announced REACH simplification must build on a stress test of the EU acquis. It should cut complexity, improve implementation, reduce costs and uncertainty - particularly for SMEs - and strengthen Europe’s industrial base and strategic resilience. The result must be a clear, predictable and effective REACH that boosts competitiveness, avoids regulatory fragmentation across Member States, and aligns with a broader industrial strategy to secure investment in the EU and boost Europe’s industrial resilience. Outlined below are actions that can deliver this, several of which can be implemented immediately by improving the implementation and enforcement of the current framework. Action 1: Ensure simplified rules that align with Europe's political guidelines and competitiveness objectives The issue: A simplified REACH must serve a dual purpose: send clear signals to drive investments and innovation in Europe and improve the protection of human health and environment. This can only work if industry needs are mapped out, the initiatives actually bring simplification on the ground, and their impacts are measured against both objectives. The solution: The result: Engage in dialogue with industry to understand its needs. A simplified regulatory framework that is aligned with Update the previous impact assessment to integrate the the European Commission’s political guidelines. changed economic circumstances and regulatory burdens. Identification of quick wins that can be achieved under Assess what can be improved under the current system the current acquis. versus introducing new initiatives. A regulatory system based on reality checks, trust and Explore additional options for simplification within other EU incentives rather than “detailed control”. legislations governing chemicals. Action 2: Increase predictability for regulatory risk management The issue: The EU regulatory system includes 40+ regulations and directives governing chemicals. The result is a maze of overlapping rules. Once a chemical enters the system, it becomes unclear if, when, or how it will be regulated. This also includes redundant and overlapping rules, which can be a result of fragmentation across Member States. This lack of clarity creates inefficiencies and uncertainty, while also contradicting the objectives of the Single Market. The solution: The result: An upfront analysis of available data on chemicals would help Clear identification of "problematic uses of substances" to identify priority substances and uses for which regulatory and appropriate regulatory tools to control identified control is needed. The result would be a clear regulatory plan risks. which enables authorities to align actions under REACH or Greater clarity for industry, enabling smarter other legal frameworks, maximises resources across the EU investment and prioritisation of resources for and Member States, and facilitates discussions on strategic substitution. applications of chemicals. Enable authorities to prioritise resources where it matters the most. Enhance the Single Market by predictable, harmonised and coordinated actions in line with the spirit of One Substance One Assessment (OSOA). The European Chemical Industry Council, AISBL Belliard, 40 - 1040 Brussels - Belgium Transparency Register n°64879142323-90  A 10-POINT ACTION PLAN TO SIMPLIFY REACH Action 3: Improve the Authorisation and Restriction Processes The issue: Since REACH was introduced, the regulatory risk management of chemicals has expanded significantly, covering more substances and uses than authorities can handle. Over the past few years, the restriction route has increasingly used broad scope bans combined with time-limited derogations. This has led to issues like "policy by derogation", enforcement gaps, and inefficiencies e.g. the ongoing PFAS and skin sensitisers restrictions, and the microplastics restriction. The current authorisation system cannot cope with the number of applications, causing a significant backlog of work for the authorities and uncertainty for industry. The solution: The result: Have a strategic discussion at EU level before restriction Greater clarity, predictability and feasibility for proposals are submitted to the system (see action 2). restriction proposals. Limit the use of the authorisation scheme by adjusting the Keep critical value chains operating in Europe. prioritisation criteria and creating more possibilities for Adopt a more agile system that accommodates granting exemptions when risks are adequately company and sector specific needs. controlled. Limit excess workload for authorisations. Clarify and tailor the required information submitted in the application for authorisation. Go back to the original intent of the restriction process i.e. take action when unacceptable risk is identified and restriction is the most suitable approach (see action 2). Exclude chemicals used in the manufacturing processes (intermediates) from the scope of restrictions that are seeking to phase out chemicals. The primary focus of restrictions should be consumer use, final goods and end uses. Implement more flexible derogations, with review periods to account for timing of alternative development. Have a robust and transparent framework for grouping chemicals that require regulatory action. Action 4: Avoid Overly Simplistic Assessments - Use Targeted Restrictions instead The issue: Simplified assessment does not always lead to faster decision-making. Overly simplified restrictions, based on generic risk considerations and hazard classifications, risk overregulating substances without adequately assessing exposure and alternatives. This can prolong discussions on derogations and cause disruptions and uncertainties over (un)availability of chemicals for the value chains. Already today, under the current rules, many existing products could be automatically and unnecessarily removed despite safe use, for instance, hand sanitisers, if ethanol were to be classified as “Reprotox 1B”. The solution: The result: Do not add more semi-automatic links between hazard Avoid retroactively fixing issues caused by an overly classification and regulatory measures. Regular restrictions, simplified approach. including full-fledged risk and socio-economic assessments, A balanced, evidence and science-based framework ensure a balanced as well as evidence and science-based for managing harmful substances. approach to regulate the most severe hazards (SVHCs). Improved regulatory coherence and credibility This would provide a more targeted response, while also through targeted, well-designed restrictions. addressing the regulatory and societal needs without Prevent banning of critical applications through the overregulating. hazard classification route.  A 10-POINT ACTION PLAN TO SIMPLIFY REACH Action 5: Avoid Additional Requirements for Polymers - Develop a Holistic Strategy First The issue: Polymers are different from traditional substances because of their unique properties. Estimates count between 200,000–400,000 on the EU market. The current REACH system indirectly addresses polymers by managing their monomers (the smaller building blocks) used in their production and additives used in their application. While the existing registration system under REACH is tailored for individual substances, it does not work for polymers. Introducing new notifications and/or registration requirements for polymers under REACH would create unnecessary complexity, redundancy and inefficiencies in the chemicals management. It would require significant additional resources both for the industry and the European Chemicals Agency (ECHA). The industries’ administrative workload would increase, particularly putting SMEs under pressure. ECHA would need to add new expertise and resources to process the vast amount of notifications and registrations. Current fragmented attempts to address polymers across multiple frameworks risk creating redundancies and inefficiencies, i.e. Packaging and Packaging Waste Regulation (PPWR), End-of-Life Vehicles Regulation (ELVR) and product regulations. The solution: The result: Before taking any action on polymers, a clear problem A unified, efficient policy for polymers. definition for polymers resulting in a coherent, holistic Eliminate unnecessary notifications, testing for strategy is needed to streamline the regulatory approach for polymers and administrative complexity. polymers, ensuring alignment with simplification and burden-reduction goals, while also tackling the identified problems. Action 6: Avoid integrating MAF in REACH The issue: Industry studies e.g. the Ricardo case study and examples from downstream users, reveal that a generic Mixture Allocation Factor (MAF) would impose significant administrative burdens without effectively addressing combined exposures. Evidence suggests that a blanket MAF applied to all chemicals is not the right solution since the majority of unintentional mixtures of chemicals present no concern. The solution: The result: Existing measures seeking to reduce emissions to the A more focused, meaningful and effective approach to environment i.e. Industrial Emissions Directive, Urban Waste managing combined exposure. Water Treatment Directive, or assess real-life combined Greater alignment with existing legislation, exposures i.e. Water Framework Directive and Chemicals improving efficiency and environmental Agents Directive, offer more targeted and impactful ways to outcomes. address harmful combined exposures. Action 7: Ensure a continuous dialogue between industry and ECHA during dossier evaluation process The issue: Generating necessary safety data and filling REACH registration dossiers can be a difficult and time-consuming process (some safety studies take 3-4 years to complete) and information requirements may vary from case to case. The solution: The result: An open dialogue and agreeing with ECHA in advance are Safety data is generated faster. key for the smooth updating or development of new Clearer expectations on what is required from the registration dossiers. industry. Dossiers fulfill the expectations of authorities.  A 10-POINT ACTION PLAN TO SIMPLIFY REACH Action 8: Introduce a new safety assessment scheme that supports an increased uptake of reliable animal-free safety assessment methods (New Approach Methodologies or ‘NAMs’) The issue: Current data requirements under REACH still heavily rely on animal testing. The European Commission has ambition to phase out animal testing in chemical safety assessments. The solution: The result: Reduce the hazard focus of REACH, allowing more More targeted data requirements leading to reduced flexibility in achieving a high degree of safety. use of animal testing. Remove default requirements for animal testing wherever possible. Regulators should justify why concerns cannot be addressed using exposure-based approaches or NAMs, such as when rejecting proposals for read-across, grouping, or NAMs to avoid animal tests. Adapt data requirements to utilise NAMs together with exposure considerations: a chemical can only cause harm if it can reach a target and interact with it. Action 9: Smoothen the registration process The issue: Currently, data requirements are too often applied as a tick-box exercise. Waiving tests based on Annex XI is almost impossible. The added value of certain tests for assessing safety of chemicals is questionable. Each time a dossier is updated with new data, the full dossier must be revised in line with the latest ECHA IT software (IUCLID) in order to pass a technical completeness check. This creates significant workload and delays in keeping dossiers up to date. The solution: The result: Simplify data requirements by improving the use and Reduces redundant administrative workload for effectiveness of adaptations to the standard information companies. requirements and allowing data waiving under Annex XI. Facilitates uptake of latest science and data in Allow targeted updates of registration dossiers. dossiers. Put a freeze on updating IT formats for registration Reduces the use of animals in chemical safety dossiers. assessment. Action 10: Ensure rules are enforced and enforceable The issue: Evidence of enforcement of EU chemical laws shows a high rate of non-compliance, particularly in imported goods/products and online sales. The advice on enforceability developed by the ECHA Enforcement Forum is not fully considered in the final decision-making. The growing complexity of legislation and simplistic assessments mentioned in Action 4, make it difficult for enforcement authorities to target inspections where needed the most especially when faced with significant number of imports. Weak enforcement risks jeopardising human health and environment protection, as well as competitiveness of EU companies that are investing in compliance but are facing unfair competition. The solution: The result: Enforcement and enforceability must be considered at the very New rules can be properly enforced including for beginning and throughout all stages of the decision-making online sales. process. The ECHA Enforcement Forum should have a stronger Enhanced protection of human health, environment role and voice when it comes to enforceability assessment; if and EU competitiveness. enforceability gaps are identified, the European Commission Strengthen the effectiveness of the EU Single Market. should find a solution how to solve it e.g. launching a CEN request for harmonised test method development, ensuring there is laboratory capacity to check imports. Online platforms should become legally responsible and be considered as a responsible economic operator. The European Chemical Industry Council, AISBL Belliard, 40 - 1040 Brussels - Belgium Transparency Register n°64879142323-90 Saatja: "Eesti Keemiatööstuse Liit" <[email protected]> Saaja: [email protected], "Erkki Keldo - MKM" <[email protected]>, [email protected] Teema: EKTL seisukohad REACH läbivaatamise kohta Kuupäev: 2025-04-21 09:32 Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Tere ! Austatud Pr. Karmen Joller Hr. Erkki Keldo Hr. Peeter Tali 3. aprillil 2025 toimunud CARACAL-54 -l esitas Euroopa Komisjon oma lõpliku nägemuse REACH-määruse läbivaatamiseks. Komisjoni avatud konsultatsioon REACH-i ülevaatamise kohta lõpeb 25. aprillil 2025. Eesti Keemiatööstuse Liit palub, et Eesti avatud konsultatsioonil arvestaks keemiatööstuse peamiste prioriteetidega. Manuses EKTLi seisukohad REACH läbivaatamise osas + kõigi meie kolme katusorganisatsiooni (CEFIC, Cosmetics Europe, AISE) positsioonipaberid. Lugupidamisega/With kind regards Hallar Meybaum Peterburi tee 46 <http://www.keemia.ee/> www.keemia.ee 5169925; 6139775 Pr. Karmen Joller Sotsiaalminister 21.04.25 Sotsiaalministeerium Edastatud e-postiga: [email protected] [email protected] Hr. Erkki Keldo majandus- ja tööstusminister Meie 07.04.25 Majandus- ja Kommunikatsiooniministeerium Edastatud e-postiga: [email protected] [email protected] Hr.Peeter Tali Euroopa Liidu asjade komisjon Edastatud e-postiga: [email protected]; [email protected] Keemiatööstuse pakett sh REACH määruse muutmine Komisjoni 2025. aasta tööprogrammi kohaselt on REACH-määruse sihipärane läbivaatamine kavandatud aasta viimasele kvartalile pealkirja „lihtsustamine” all. Lihtsustamine tähendab eeskirjade tõhusamaks muutmist: tarbetu koormuse vähendamist, tagades samas, et eeskirjad saavutavad seatud eesmärgid. Kooskõlas ELi kohustusega taastada konkurentsivõime, peab väljakuulutatud REACH-määruse lihtsustamine vähendama keerukust, parandama rakendamist, vähendama kulusid ja ebakindlust – eriti VKEde puhul – ning tugevdama Euroopa tööstusbaasi ja strateegilist vastupanuvõimet. Tänu ELis juba kehtivale kemikaalide reguleerimise süsteemile on kogu elanikkonna, sealhulgas tundlike alampopulatsioonide praegune kaitse kemikaalide ohu eest maailmas üks kõrgemaid. Oleme seisukohal, et kõik REACH-määruse ajakohastamise muudatused peavad tingimata olema sihipärased, vähendama tööstuse halduskoormust ja suurendama konkurentsivõimet, ilma et see kahjustaks inimeste tervise ja keskkonna kaitset. 3. aprillil 2025 toimunud CARACAL-54 esitas Euroopa Komisjon oma lõpliku nägemuse REACH-määruse läbivaatamiseks. Kui regulaatorid kirjeldasid muudatusi kui lihtsustusi REACH jõustamise ajakohastamiseks ja tugevdamiseks, siis keemiatööstus nimetab ettepanekuid koormavateks ning Euroopa majanduse ja tööstuse tegelikkusele mittevastavateks. Keemiatööstuse peamised prioriteedid Eesti Keemiatööstuse Liit +372 613 9775 Peterburi tee 46, 11415 Tallinn [email protected] www.keemia.ee Tuleb vältida igasugust GRA laiendamist: Keemiatööstus ei toeta üldise riskijuhtimise lähenemisviisi (GRA – Generic Risk management Approach) laiendusi. Teaduspõhised lähenemisviisid piirangutele, sealhulgas riski- ja sotsiaalmajanduslikud hinnangud, on kõige tõhusam viis suurimat muret tekitavate ainete reguleerimiseks. Laiaulatuslikud ja ohupõhised piirangud (st GRA) mõjutaksid oluliselt tootepakkumist ja Euroopa keemia- ning seotud tööstuste konkurentsivõimet. „Üldine lähenemine riskijuhtimisele” (mida tuleks pigem nimetada „üldiseks ohujuhtimiseks”, kuna see ei hõlma tegelikku riski hindamist) loob automatismi, mis toob kaasa põhjendamatud, ettekavatsematud ja ühiskondlikult soovimatud tagajärjed. Juba praegu võidakse kehtivate eeskirjade kohaselt paljud olemasolevad tooted, näiteks kätedesovahendid, automaatselt ja asjatult keelustada, hoolimata ohutust kasutamisest, kui etanool otsustatakse klassifitseerida kategooriasse kantserogeenne ja reproduktiivtoksiline 1B. Tulemuseks võivad olla absurdsed tagajärjed, kus nt etanool on de facto kõigis tarbijatoodetes keelatud, aga mitte inimeste toidulaual. Probleem ei ole ainult riskijuhtimise liigeses lihtsustamises või puudumises, vaid sageli ka ohuhindamise (ehk CLP klassifikatsiooni määramise) liigses lihtsustamises (näiteks ei võeta arvesse ainete ohtlikkuse erinevat potentsust – st negatiivse mõju erinevat tugevust/ulatust) ning kriteeriumide rakendamisel ettevaatusprintsiibist lähtudes igal sammul ohutuse poole kaldu olevate otsuste tegemises, mis kuhjudes annavad tulemuseks vale (ülepaisutatud) ohuprofiili. Automaatsed keelud ja ebaproportsionaalsed piirangud ei pruugi soodustada pikaajalist sisulist innovatsiooni, mis parandab toote jätkusuutlikkust, jõudlust või tarbijakogemust. Selle asemel juhivad niisugused keelud ja piirangud teadus- ja arendustegevuse investeeringud eemale tulevikku suunatud teaduslikest edusammudest (nt biopõhised materjalid või täiustatud ohutuse hindamise meetodid) ning asendavad need reaktiivsetele lühiajalistele asendustele lahenduste leidmisega, mis ei pruugi anda olulist kasu ohutusele ega keskkonnale. Tuleb vältida MAFi integreerimist REACH-määrusesse Oleme vastu segu jaotusteguri (MAF – mixture allocation factor) kehtestamisele, kuna see avaldaks märkimisväärset negatiivset mõju kõigile keemiatööstuse allkasutus-sektoritele, väärtuslikele rakendustele ning suurendaks vajadust loomkatsete järele. MAF tooks kaasa suure halduskoormuse, ilma kombineeritud riskide tõhusa käsitlemiseta. See mõjutaks kõiki registreerimistoimikutes esitatud riskihinnanguid ja praegust riski iseloomustust. Selle tulemusel peetaks paljusid üksikuid aineid edaspidi „paberil mitte-ohututeks”, kuigi tegelikkuses ei tekita need ained muret. Tõendid näitavad, et kõikidele kemikaalidele rakendatav üldine MAF ei ole õige lahendus, kuna enamik tahtmatuid kemikaalide segusid ei tekita probleeme. Selle asemel tuleks rakendada sihipärasemat riskijuhtimist nende üksikainete suhtes, mis võivad kaasa aidata soovimatute segude toksilisusele. Tuleb vältida polümeeride ülereguleerimist Polümeerid juba on REACH alusel kaudselt reguleeritud monomeeridele rakendatud kohustuste kaudu. Polümeeridele uute teavitus- ja/või registreerimisnõuete kehtestamine REACH-määruse alusel tooks kaasa tarbetu keerukuse, liiasuse ja ebatõhususe kemikaalide haldamisse. See nõuaks nii tööstuselt kui ka Euroopa Kemikaaliametilt (ECHA) märkimisväärseid lisaressursse. Tööstusharude halduskoormus suureneks, pannes eriti surve alla VKEd. Hinnangute alusel võib erinevaid polümeere EL turul olla 200 000 – 400 000. Tuleb parendada (teaduslikke) dialooge Vajame täiendava (teadus)dialoogi (taas)sisseviimist REACH-i protsessidesse, nt. RACi arvamuste ja rühmitamise ning registreerimistoimikute kohta. Avatud dialoog ja ECHA-ga eelnevalt kokku leppimine on registreerimistoimikute sujuva ajakohastamise või uute väljatöötamise võtmeks. Tuleb tasandada mänguvälja Regulatiivsed meetmed peavad enne vastuvõtmist olema jõustatavad ja proportsionaalsed, et säilitada võrdsed võimalused. Jõustamist ja jõustatavust tuleb kaaluda otsustusprotsessi alguses ja kõigis etappides. Järjekindlam lähenemine jõustamisele, eriti e-kaubanduse ja impordi osas, on vajalik, et tagada õiglus ELis toodetud ja väljastpoolt ELi pärit toodete vahel. Ühtlustatud tõlgenduste ja praktikate tagamiseks on oluline tõhustatud koostöö ELi liikmesriikide täitevasutuste vahel. Koostöös tööstusega tuleks jätkata kooskõlastatud jõustamisprojekte. Kokkuvõte Rõhutame REACHi aluspõhimõtete säilitamise tähtsust, kuid toetame samal ajal sihipäraseid parandusi ja lihtsustusi. Soovime näha teaduspõhiseid lähenemisviise, tihedamat dialoogi ja strateegilist riskijuhtimist, et määrus kaitseks jätkuvalt inimeste tervist ja keskkonda, ilma et see kahjustaks Euroopa (keemia)tööstuse konkurentsivõimet. Lisaks juhime tähelepanu, et tervitame komisjoni uut algatust “VKEde ja konkurentsivõime kontroll”, mis on osa tulevaste seadusandlike ettepanekute mõjuhinnangutest. Seda uut mehhanismi tuleb rakendada ka kriitilise tähtsusega REACH-määruse läbivaatamisel. Enne uute rangete nõuete kehtestamist on vaja läbi viIa põhjalik VKEde ja konkurentsivõime mõjukontroll, et tagada proportsionaalsus ja teostatavus. Komisjoni avatud konsultatsioon REACH-i ülevaatamise kohta lõpeb 25. aprillil 2025. Eesti Keemiatööstuse Liit palub, et Eesti avatud konsultatsioonil arvestaks keemiatööstuse peamiste prioriteetidega. Lugupidamisega /allkirjastatud digitaalselt/ Hallar Meybaum tegevdirektor