Re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

AESGP, the Association of the European Self-Care Industry, is a non-profit organisation that represents the manufacturers of non-prescription medicines, food supplements, and self-care medical devices in Europe, an area also referred to as self-care or consumer healthcare products, takes the opportunity to share its views on the One Substance, One Assessment (OSOA) package of legislative proposals published on 7…

AESGP, the Association of the European Self-Care Industry, is a non-profit organisation that represents the manufacturers of non-prescription medicines, food supplements, and self-care medical devices in Europe, an area also referred to as self-care or consumer healthcare products, takes the opportunity to share its views on the One Substance, One Assessment (OSOA) package of legislative proposals published on 7…

Many of the substances placed on the market by AMFEP members serve both food/feed and ‎technical applications, thus falling under legislations (e.g. REACH, CLP, the Food Enzymes ‎Regulation) positioned across food and chemicals regimes, therefore potentially subject to ‎assessments conducted by both the European Chemicals Agency (ECHA) and the European Food ‎Safety Authority (EFSA) separately.‎ Thus, AMFEP has a…

Eurogroup for Animals, Cruelty Free Europe and the European Coalition to End Animal Experiments welcome the opportunity to share their views on the Commissions proposal to re-attribute scientific and technical tasks and improve cooperation among EU agencies in the area of chemicals.

On behalf of the Company/Business organizations/Business associations listed in the attached document, participants in the RoHS Umbrella Industry Project (the Umbrella Project). The Umbrella Project contribution to the consultation is attached as a pdf document.

The Nederlandse Cosmetica Vereniging (NCV) is the Dutch trade organization for the cosmetics industry. From deodorants, makeup and perfumes to toothpastes, shampoos, soaps, and sunscreens, cosmetics are indispensable in every aspect of our lives.

The European Environmental Bureau (EEB) welcomes the Commissions proposals for One Substance, One Assessment (OSOA) which aim to enhance the level of protection of the environment and human health against hazardous chemicals.

We support the reattribution of scientific and technical tasks to the ECHA under the RoHS directive. ECHA would be a neutral and highly competent party, but would need allocated resources to perform this specific task. It must be ensured that transferring this work to ECHA will not hamper the exemption request process. Oslo, 3 April 2024. Norwegian Environment Agency on behalf of the Norwegian authorities.

The planned re-attribution of scientific and technical work to EU agencies is key to fulfil the ambitions of the Chemicals Strategy for Sustainability, and also the Zero Pollution Action Plan and the Circular Economy Action Plan. Re-attribution of tasks to EU-agencies will contribute to increased transparency, harmonisation, coherence and efficiency of assessment of chemicals.

The Polih Union of the Cosmetics Industry supports the objectives of the Chemical Strategy for Sustainability (CSS) to improve effectiveness, efficiency, and coherence of safety assessments across EU legislation. However, the Union would like to reiterate that the SCCS needs to continue being a stand-alone committee within ECHA.

The Japan Cosmetic Industry Association, JCIA, appreciates the opportunity to comment on this proposal. JCIA welcomes the operational proposal to accelerate hazard and risk assessment in the EU. At the same time, we would like to request that the system be designed to derive appropriate risk assessments, taking full account of the fact that products are used in different ways for different purposes including…

The main chemical attack on humans comes from teeth material. Biomaterials leaking plastic. BPA, Tegdma, Udma, bisgma, SiO2, etc. plus cement that leak into the oral cavity and contributes to all diagnosis. People are not protected by these chemicals that are routinely sold globally in the dental industry.

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Being a cross-sector association with member companies operating in different industries and stages in the supply chain (electronics, chemicals, polymers, automotive, machinery, semiconductors, wholesale trade, precision instruments, pharmaceutical, steel, nonferrous metal, textiles, ceramics, and glass products), JBCE welcomes the opportunity to contribute to the discussion regarding the proposal for Chemicals…

Introduction Since our founding in 1959, SMC has grown as a comprehensive manufacturer of automatic control equipment. Our products are used in many different industries such as semiconductor, automotive, machine tools, food machinery and medical equipment to produce the many millions of products necessary for the modern world as it is today.

On a general note, SEMI understands that this proposal is part of the one substance one assessment (OSO) approach to improve the efficiency, effectiveness, coherence and transparency of issuing safety assessments of chemicals across different pieces of EU legislation, as proposed in the Chemicals Strategy for Sustainability (CSS) under the European Green Deal.

ESIA is a cosignatory of the submission of the RoHS Umbrella Project. In addition, ESIA would like to express its supports for the allocation of responsibilities to the European Chemicals Agency. However, ESIA appreciates the criteria for review and amendment of the list of restricted substances as it is currently set out in Article 6 and would recommend not changing these criteria.

Currently, various agencies and scientific committees provide advice and risk assessment to the Commission due to the diverse uses of substances and chemicals, leading to different laws and agencies responsible for their assessment. This approach of conducting risk assessments under specific legislation makes sense but can result in conflicts when the hazard assessment is not aligned or conducted simultaneously.

Being a cross-sector association with member companies operating in different industries and stages in the supply chain (electronics, chemicals, polymers, automotive, HVACR, machinery, semiconductors, wholesale trade, precision instruments, pharmaceuticals, steel, non-ferrous metals, textiles, ceramics and glass products), JBCE welcomes the opportunity to contribute to the discussion regarding the amendment of RoHS…

RUCODEM comments on several aspects of the legislative proposals on the establishment of a CDPC and on the re-attribution of scientific and technical work to ECHA regarding: Definitions - some need to be clarified: definition of environmental sustainability related data (too broad and is not clear to which information it refers to); definition of chemicals data; the definitions of duty holder and business operators…

We will support ECHA to cover the assessments on additional substances to be restricted and applications to be exempted under the RoHS Directive, provided that due consideration is fully given to the characteristics of EEE as complex articles.

The text below is the excerpt from 20240402_Japan_Cat89_RoHSRecast_BetterRegulation.pdf, which contains the completed our comment. Please find the attachment. We, electric equipment manufacturers' associations of category 8 and 9 products in Japan, would like to express the gratitude of having the opportunity of stating our opinion to the RoHS Directive.

Slovak Associations for Branded Products (SZZV) represents the brand manufacturers in Slovakia on key issues which affect the manufacture, sale, distribution and marketing their brands. Our mission is to protect and support the common interests of manufacturers and distributors of branded products. Our statement regarding the given public consultation is available in the attachment.

On 7 December 2023 the European Commission published two proposals for a Regulation as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals, and for a Directive as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency as part of the One Substance One Assessment package.

HSI welcomes efforts to improve and enhance the safety assessment of chemicals across EU legislation with the One Substance, One Assessment (OSOA) approach. We appreciate the ambition to centralize safety assessment activities for multiple regulatory frameworks within the European Chemicals Agency.

PSVAK on behalf of the Greek industry supports the "One Substance, One Assessment" approach under the CSS to enhance the efficiency and transparency of chemical safety assessments in the EU. We express our support for proposals establishing a common data platform on chemicals (CDPC) and re-attributing scientific tasks to ECHA.

The fact that ECHA will in future adopt the new and existing exemptions and the list of substances are neutral. It should be noted that in this context only these two articles 5 and 6 of the RoHS Directive will be amended and no more.

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The fact that ECHA will in future adopt the new and existing exemptions and the list of substances are neutral. It should be noted that in this context only these two articles 5 and 6 of the RoHS Directive will be amended and no more.

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Please receive in attachment the FEFANA's feedback on the proposal for a Regulation amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals.

We thank for the opportunity to comment on the European Commission's Draft COM(2023) 781. ZVEI considers the RoHS Directive to be effective in its central function and to promote a circular economy. We are neutral with regard to the transfer of the RoHS evaluation procedures to ECHA.

Federchimica acknowledges that the reallocation of tasks will have a significant impact on ECHA, which will see its workload considerably increased; calls, therefore, for all necessary measures to be taken to enable the agency to operate at full speed despite the increase in work: these measures could be both organisational and budgetary.

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Novonesis is supportive of the intention behind the One Substance, One Assessment initiative. Novonesis supports the European Commissions ambition about streamlining of substances across EU legislations and strengthening the knowledge about substances and act on new chemical risks when they occur. This initiative will make better risk assessment and increase transparency for consumers and researchers.

The fact that ECHA will in future adopt the new and existing exemptions and the list of substances are neutral. It should be noted that in this context only these two articles 5 and 6 of the RoHS Directive will be amended and no more.

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Merck welcomes the opportunity to comment on the proposals by the Commission to streamline regulatory processes and to improve cooperation between the agencies responsible for chemical management in the EU. Merck develops, manufactures, and markets high-quality medicines, innovative products for the biotech and pharmaceutical industries and for academic research as well as specialty chemicals for high-tech…

The German Social Security Fund (DSV) welcomes and supports the objective of this proposal for a Directive, which is to address the methodological and procedural differences in substance restrictions and authorisations between Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive) and Regulation (EC) No 1907/2006 on the Registration…

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The German Social Security Fund (DSV) welcomes the Commission’s initiative for a regulation to reallocate existing tasks and assign new tasks to EU agencies. This will ensure good cooperation between EU agencies, avoid duplication of work and achieve efficient functioning in the field of chemical evaluation.

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Thank you for the chance to provide input on this consultation. We have the following comments: 1. Avoid increased administrative burdens for business operators: The administrative burden on companies and the Agency has proven to be more time- and resource-intensive than initially anticipated.

MedTech Europe, the European industry association representing manufacturers of medical technologies (medical devices and in vitro diagnostic medical devices- IVDs), takes the opportunity to share its views on the One Substance, One Assessment (OSOA) package of legislative proposals published on 7 December 2023.

The Test & Measurement Coalition (TMC) welcomes the proposed reattribution of the scientific assessment of the RoHS processes to ECHA. By adopting a REACH-like process for both the evaluation of exemption applications and the restriction of new substances, the functioning of the RoHS system is improved as it offers clear process timelines and thus enhances the predictability and clarity for manufacturers of EEEs.

Feedback from the European Chemical Industry Council (CEFIC) on the proposals for the re-attribution of scientific and technical tasks to the Agencies: Cefic welcomes the Commission's efforts to improve and enhance the safety assessment of chemicals across EU legislation with the One Substance, One Assessment legislative package.

As an Expert for the European Commission (EC) with a focus on the Pharmaceutical, Healthcare and Health sectors, I am eager to contribute to the ongoing social dialogue initiated by the EC. This pertains to the Proposal for Regulation COM(2023)783 and Staff working document SWD(2023)850.

Concerning the Commission's ambition of: "establishing a common, open data platform on chemicals and tools for accessing relevant academic data." ...perhaps you could also propose that the data produced by academia be evaluated across all the legislation that you will be modifying (that which requires evaluation of the safety of petrochemicals (which includes medicines).

The European Biodiesel Board (EBB) is pleased to have the chance to contribute to the call for evidence and supports the principle of making more efficient use of expertise and resources by proposing a “one substance, one assessment” approach to chemical safety assessments.

Novozymes welcomes the opportunity to provide feedback to the Commission’s call for evidence on chemicals – making best use of EU agencies to streamline scientific assessments. Novozymes is the world leader in biological solutions. Together with customers, partners and the global community, we improve industrial performance while preserving the planet’s resources and helping to build better lives.

Cruelty Free Europe supports closer alignment of EU agencies tasked with chemicals management, and the streamlining of substance assessments, in order to ensure a high level protection of human health and the environment. As part of these efforts, the avoidance of animal testing must be a common, shared goal across all agencies.

Tronox supports the European Commission’s Chemicals Strategy for Sustainability and its overarching Chemicals Strategy with constructive input drawing on our expertise as a chemical manufacturer and market participant. The approach of ‘one substance, one assessment’ (OSOA) can help build trust between society and industry, whilst improving efficiency, and sound science-based regulatory and political decision-making.

TDMA see an added value in having more streamlined scientific assessments though having a more detailed description of one substance one assessment (OSOA) would be helpful. The current information we have on OSOA is limited to the general documents on the Chemicals Strategy for Sustainability (CSS), the short description in this consultation, and the presentation to the Advisory Committee for the Competent…

A.I.S.E., the International Association for Soaps, Detergents and Maintenance Products, welcomes the opportunity to comment on the European Commission call for evidence for an initiative on “Chemicals – making best use of EU agencies to streamline scientific assessments”.

We support the development of “ One substance, one assessment” and the idea of simplify and reduce the administrative burdens, not meaning that the high level of protection for the human health and the environment is jeopardised. If currently the burden of the proof relay on the applicants, it should continue as it is.

PPAM de France welcomes the European Commission’s initiative to make best use of EU agencies to streamline scientific assessments of chemical substances. In particular we strongly support the proposal to introduce new tools for the One Substance One Assessment (OSOA) approach, which would further improve the work of the Industry and Scientific Committees in ensuring consumer safety by: • extending the use of the…

EFPIA response to the Commission Call for Evidence on Chemicals – making best use of EU agencies to streamline scientific assessments The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe.

We consider that the “one substance one assessment” (OSOA) approach could be a useful starting point for sector-specific risk assessments, but cannot replace them. The specific risk assessment process for cosmetics requires a sector-specific scientific committee — SCCS — that upholds the principles of scientific excellence, independence and effectiveness and has significant experience in the use of alternative risk…

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The European Flavour Association (EFFA) is the voice of the European flavour industry in Europe, leading a Europe-wide strategy to the benefit of the flavour industry, its customers and consumers alike. Our members are Flavour Houses and National Flavour Associations from across Europe, representing 12 European countries.

IVc welcomes the move towards “One Substance — One Assessment” and supports close cooperation between EU agencies and academic institutions. A fit-for-purpose “one substance — one evaluation” approach should lead to the following results.

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The Polish Chamber of Chemical Industry supports the initiative to move to the ‘one substance — one assessment’ process, where the possibility of improving technical and scientific work through EU agencies will prevent inconsistencies in results across legislation, slow procedures and unnecessary costs.

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The PIPC supports the initiative to move towards a ‘one substance — one assessment’ process, where the possibility to improve technical and scientific work through EU agencies will prevent inconsistencies in results across legislation, slow procedures and unnecessary costs.

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CIRFS welcomes the move towards "One Substance - One Assessment" and supports close cooperation between EU agencies and scientific institutions. A fit-for-purpose "One Substance - One Assessment" approach should lead to the following outcomes.

The PIPC supports the initiative to move towards a ‘one substance — one assessment’ process, where the possibility to improve technical and scientific work through EU agencies will prevent inconsistencies in results across legislation, slow procedures and unnecessary costs.

Filed in Polish · English published by the European Commission

The Polish Chamber of Chemical Industry supports the initiative to move to the ‘one substance — one assessment’ process, where the possibility of improving technical and scientific work through EU agencies will prevent inconsistencies in results across legislation, slow procedures and unnecessary costs.

Filed in Polish · English published by the European Commission

CIRFS welcomes the move towards "One Substance - One Assessment" and supports close cooperation between EU agencies and scientific institutions. A fit-for-purpose "One Substance - One Assessment" approach should lead to the following outcomes.

Japan Business Council in Europe (JBCE) is a cross sector organisation representing the interests of more than 90 multinational companies of Japanese parentage active in Europe. We support EU law aimed at protecting human health and the environment. We are also pleased to be able to contribute to “Chemicals-making best use of EU agencies to streamline scientific assessments”.

BSEF – the International Bromine Council - welcomes the opportunity to contribute to the call for evidence and welcomes this initiative to make the use of expertise and resources more efficient by proposing the reattribution of technical and scientific work on chemicals performed under the relevant pieces of legislation to European agencies (ECHA, EFSA, EMA), including work of the Scientific Committee on Health…

EFEO thanks the Commission for the opportunity to provide comments on the document Ref. Ares(2022)1871487 - 14/03/2022: "Chemicals – making best use of EU agencies to streamline scientific assessments". Essential Oils are natural complex substances (NCSs) originating from botanically defined plant source material. They are obtained by physical processes like distillation or cold pressing.

The Food Contact Regulatory Experts Panel (FREP) is a sector group organized by European Plastics Converters (EuPC) consisting of a panel of plastics converters experts in food contact material regulation. On this occasion, we are providing this feedback to the “one substance, one assessment” (OS-OA) process for chemical safety assessments, in the context of the European Green Deal (please find it attached).

IBMA, the International Biocontrol Manufacturers Association with its over 230 members of which 85% SMEs, welcomes this public consultation. It regards a crucial matter for the future, in particular when it comes to PPPs such as biocontrol solutions, and therefore for the transition to a future more sustainable agriculture using agroecological farming practices, as per the EU Green Deal and Strategies objectives.

The idea of a single evaluation of a substance is attractive. It may lead to savings and more cost-effective procedures, provided that they are tailored to the groups of substances with adapted data requirements. The companies organised in the association produce and register biological active substances and products that are authorised to enter the market under different legislation.

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The International Fragrance Association (IFRA) welcomes the opportunity to comment on the European Commission Call for evidence for an initiative on “Chemicals – making best use of EU agencies to streamline scientific assessments”.

Eurocolour welcomes the opportunity to comment on the initiative to steamline scientific assessment in the EU. As umbrella association for the manufacturers of pigments, dyes, fillers, frits, ceramic and glass colours, and ceramic glazes in Europe, the products represented by us go into various applications subject to different scientific assessments.

VdMi welcomes the opportunity to comment on the initiative to steamline scientific assessment in the EU. As representer of German manufacturers of inorganic (e. g. titanium dioxide, iron oxides), organic and metallic pigments, fillers (e. g.

AESGP welcomes the consultation initiative and the stakeholder engagement on the principle of ‘One Substance – One Assessment’ as part of the commitment in the ‘European Green Deal’. It is essential for AESGP that the implementation of the ‘One Substance - One Assessment’ (OSOA) concept which aims to reduce the administrative burden, duplication of efforts and to optimize resources does not have a negative impact on…

UBA appreciates the initiative of streamlining the technical and scientific work through EU agencies by an omnibus regulation. Environmental safety data already assessed by one of the European agencies should be available for procedures under different EU regulations. This should also apply to environmental data from the veterinary and human pharmaceutical legislation.

AnimalhealthEurope represents the manufacturers of animal health products and services across Europe. The call for evidence refers to the “Fitness Check of all Chemicals Legislation” (COM(2019)264 final). We understand that the REACH Regulation, the pharmaceutical, veterinary and food additives legislations were excluded from the scope of this Fitness Check.

Food Contact Additives (FCA), a Sector Group of the European Chemical Industry Council (Cefic), welcomes the opportunity to provide input to the Commission’s call for evidence “Chemicals – making best use of EU agencies to streamline scientific assessments” and would like to provide the attached comments

EuPIA agrees with the assessment that the EU regulatory framework for hazard and risk assessment and management of chemicals consists of many pieces of legislation and that it involves various actors, at different points in time, using different data and various EU agencies like the European Chemicals Agency (ECHA) or the European Food Safety Authority (EFSA).

FoodDrinkEurope represents the food manufacturing industry. Made up of 294,000 businesses and 4.7 million workers, the food and drink industry buys 70% of all EU agricultural produce and is Europe’s largest manufacturing industry.

LANXESS welcomes the initiative by the European Commission to streamline the assessment of chemicals towards “one substance, one assessment” in order to increase transparency and coherence. However, this can only be achieved, if the following aspects are taken into account when implementing the “one substance, one assessment” principle: - Transparency of the assessment must be ensured: All information regarding the…

The Association of Enzyme Manufacturers and Formulators of Enzyme Products (AMFEP) is an EU-‎based association created in 1977 and consisting of 30 members. Members of AMFEP produce and sell ‎enzyme products for use in food, feed and technical industries.

Fecc acknowledges the consultation for the upcoming initiative on streamlining scientific assessments (link). At the same time, we would like to raise the following points in this consultation: 1. Risk assessment should be maintained at the corresponding level of expertise for each agency.

Norway supports the development of a "one substance, one assessment" (1S1A) approach under the CSS. The 1S1A initiative addresses needs for coordination of scientific assessment of chemicals as described in CSS. A main goal of the changes in legislation in all fields affected by OSOA should be to ensure that the level of protection for the human health and the environment remains high.

CEPE believes that a better use of resources and avoidance of duplication of work could be done but only for the derivation of hazard endpoints. With regard to the open data platform on chemicals, the repository of health-based limit values, or tools to improve access and uptake of academic data in regulatory work, CEPE would like to stress the importance of maintaining a high level of scrutiny on the quality of the…

The Japanese electric and electronic industrial associations, JEITA, CIAJ, JBMIA and JEMA, respect the accomplishment achieved by EU laws for the safety and environment. We appreciate the ongoing collaborative approach and are pleased to contribute to this assessment. We agree that the toxicity of the substance itself should be assessed by ECHA.

We support the streamlining and optimisation of the EU’s public administration in general, but also in the area of chemicals legislation. Existing resources should be used more efficiently. Cooperation between EU and national agencies is crucial for a better usage of resources. So are identifying synergies and overlaps in their line of work.

Streamlining and optimising public administration structures is always a useful approach. Particularly in the area of chemicals legislation, it is very good to do so. We fully agree on the need to use existing resources more efficiently. Optimising cooperation between EU and national authorities is crucial for savings. Synergies and overlaps need to be clearly identified.

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The Chemical Strategy for Sustainability (CSS) envisions better coordination and distribution of tasks between EU agencies like EFSA and ECHA concerning the hazard and risk assessment of substances. This translates in the aspirational approach of ‘one-substance, one-hazard-assessment’ (OSOA) followed by a tailored risk assessment as suggested by various stakeholders of the packaging and food value chain.

EU Specialty Food Ingredients represents the European manufacturers of specialty food ingredients, a wide range of functional carbohydrates, vitamins, specific proteins and fats, minerals, fibers, food improvement agents such as food additives and food enzymes, cultures, etc.

This initiative is positive as having a more efficient harmonization among the EU agencies, with optimization of resources and expertise is important. Just a couple of issues: 1. It is not clear why the fitness check of all chemicals legislation should exclude REACH which is THE chemical legislation by definition 2.

BUND (FoE Germany) welcomes the Commission's initiative to implement the principle of 'one substance - one assessment' that was declared in the ‘Chemicals Strategy for Sustainability’ within the framework of an omnibus regulation. Currently, the different legal provisions often lead to duplication of work and to different results and risk management measures.

My first proposal concerns the rules: In France, we have ACD (dangerous chemical agents) and CMR (carcinogenic, mutagenic and reprotoxic) regulations and to have intervened (very modest in Professor Frimat’s report) I think that for better ownership and, above all, applicability, it would only be necessary to have one. I propose that everything be repatriated under the banner of the Chimic Dangereux Agents.

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