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Food Supplements Europe

FSE

Food Supplements Europe is the trade association for the European food supplement industry.

Lobbying Activity

Food Supplements Europe seeks distinction from addictive products

22 Oct 2025
Topic — The Digital Fairness Act addresses gaps in online consumer protection and unfair practices.
Message — FSE urges the EU to distinguish food supplements from addictive products like tobacco. They want a focus on enforcing existing laws rather than creating new regulations.123
Why — This avoids new regulatory costs and protects the industry's reputation and competitiveness.45
Impact — Foreign companies that currently bypass EU safety and marketing standards through digital sales.6
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Food Supplements Europe urges broader EU food rule simplification

14 Oct 2025
Topic — This consultation concerns a proposal to simplify food and feed safety marketing authorization procedures.
Message — The organization calls for expanding the simplification omnibus to include the Transparency Regulation and mandatory impact assessments. They argue current hurdles create "massive administrative burdens" that delay innovation.123
Why — This would improve market competitiveness by accelerating product approvals and reducing unnecessary bureaucracy.45
Impact — Public health groups may lose oversight if study notification and data disclosure rules are relaxed.6
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Meeting with Pablo Arias Echeverría (Member of the European Parliament) and Seldia - The European Direct Selling Association and European Federation of Associations of Health Product Manufacturers

3 Oct 2025 · Protection of minors online

Meeting with Claire Bury (Deputy Director-General Health and Food Safety) and

17 Sept 2025 · EFSA’s performance evaluation

Meeting with Flavio Facioni (Cabinet of Commissioner Olivér Várhelyi) and European Federation of Associations of Health Product Manufacturers

2 Jun 2025 · Food supplements

Response to EU Start-up and Scale-up Strategy

17 Mar 2025

We strongly welcome the efforts the Commission is undertaking to foster innovation and are pleased to provide our contribution on the three questions included in the Call for Evidence on the Strategy for Start-ups and Scale-ups in the attached document.
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Meeting with Ariane Vander Stappen (Head of Unit Health and Food Safety) and FoodDrinkEurope and

4 Mar 2025 · Discussion on the ongoing harmonisation of maximum permitted limits for vitamins and minerals in food

Response to Evaluation of the European Food Safety Authority (EFSA) 2017-2024

8 Apr 2024

The work of EFSA has undeniably contributed to an environment where food and food ingredients can be safely consumed. EFSA's activities are crucial for the safety and innovative capacity in the food supplements sector. Food Supplements Europe thanks the Commission for the opportunity to contribute to this call for evidence. Drawing upon our long experience of working with EFSA, our contribution is presented in the attached file. We thank the Commission for considering our suggestions and remain available for further discussion and input.
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Response to Evaluation of the Regulation 2019/515 on the Mutual Recognition of Goods

29 Jan 2024

Food Supplements Europe represents manufacturers and sellers of food supplements and food supplement ingredients in Europe. Our membership is composed of national food supplements associations and both large and small companies, for whom the application of the Mutual Recognition Regulation is a crucial tool for accessing markets in other Member States. Please find attached the input from Food Supplements Europe.
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Response to Revision of the definition of engineered nanomaterial in food

12 Jan 2024

Food Supplements Europe welcomes the opportunity to comment on the newly proposed definition of engineered nanomaterial. The new proposed definition will be useful as it brings much clarity and also incorporates the experience gathered by EFSA and included in the relevant two EFSA guidance documents. Please find our comments attached.
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Response to Import conditions and border controls of trade samples and certain composite products

23 Nov 2021

Food Supplements Europe welcomes the opportunity to comment on the proposed legislation amending Regulation (EU) 2019/625. We fully support that imports of foods and food ingredients in the EU comply with the same food safety standards that apply to European manufactures, but want to draw the European Commission’s attention to the possibly unintended consequences the proposed legislation will have for two types of ingredients that are of crucial importance for food supplements and all finished foods manufactured in the EU in which these ingredients are used. We would invite the European Commission to consider the attached comments, given that if these proposed changes become effective, this legislation will have an immediate suspensive effect on the supply of Vitamin D3 and empty gelatine capsules. We are committed to assist the Commission in looking for appropriate solutions to maintain the imports of safe products into the EU. Our detailed comments are attached.
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Food Supplements Europe seeks threshold and transition for green tea

3 Nov 2021
Topic — Proposed EU safety restrictions on green tea catechins in food supplements.
Message — The association requests a transition period and a 300mg daily threshold. They argue some warning labels are redundant and may cause unnecessary consumer fear.123
Why — Companies would avoid immediate product recalls and minimize costly packaging redesigns.456
Impact — Vulnerable groups might lack information regarding potential health risks from extracts.78
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Food Supplements Europe seeks flexibility on red yeast rice restrictions

17 Jun 2021
Topic — The EU proposes restricting monacolins in red yeast rice due to safety concerns.
Message — Limit the scope of restrictions specifically to the substance Monacolin K. Set the daily limit at 3 mg to avoid unnecessary product reformulation. Allow use by adults over 70 and provide a transition period for businesses.123
Why — A transition period allows companies to reformulate products and avoid immediate market withdrawal.4
Impact — Elderly consumers lose access to supplements that help them manage high cholesterol levels.5
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Response to Amending the rules concerning the addition of vitamins & minerals to foods in view of the new Transparency Regulation

9 Apr 2021

Food Supplements Europe appreciates the possibility for submitting views on the Commission Implementing Regulation amending Implementing Regulation (EU) No 307/2012 as regards transparency and confidentiality requirements for the EU risk assessment of substances under scrutiny. This process is an important tool for assessing the safety of foods and food ingredients that often have a long history of use. It is therefore important that risk assessment and risk management are transparent and that interested companies can submit data and comments. Although we do not believe that an update of this Regulation was required under the provisions of Regulation (EU) 2019/1381, we nevertheless welcome that pre-submission advice will be possible and that the timeline for submission of data is extended.
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Response to List of composite products exempted from official controls at border control posts

2 Feb 2021

Food supplements Europe welcomes the elimination of the 20% and 50% rules and the clear criteria for food supplements that would no longer require inspection at BCP but are subject to controls at the point of destination. This is a good example of administrative simplification and reduced burden for economic operators without decreasing the standard of safety. This risk-based approach should also be extended to non-composite food supplements that meet the same criteria and thus, do not represent a risk. We would also remark that for certain products “controlled temperature conditions” are required for reasons other than food safety (e.g. to avoid melting or degradation of quality). It would therefore be more appropriate to define shelf-stable composite products in article 2(2)) as “ ‘shelf-stable composite products’ means products that can be transported or stored under ambient temperatures. ”
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Response to Amending the rules concerning the re-evaluation of approved food additives in view of the “Transparency Regulation”

2 Nov 2020

Food Supplements Europe thanks the Commission for allowing comments on this draft proposal. Our comments are detailed in the attached document.
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Response to Amending the rules for applications for food additives, enzymes & flavourings in view of the “Transparency Regulation"

20 Aug 2020

Food Supplements Europe thanks the Commission for giving us the opportunity to submit comments on this proposal. The proposal aims to implement the requirements of the Transparency Regulation 2019/1381 and this appears to be properly done. We would nevertheless want to indicate that the Food Additives Regulation is important for innovation in our sector. Given that this legislation only foresees generic authorisations, with no possibility for proprietary data protection, the protection of intellectual property of applicants by means of confidentiality is crucial for the competitiveness of our companies and to avoid that European innovations can be easily copied. There are two primarily crucial aspects that must be considered: Firstly, the way in which requests to keep the information that is accepted as eligible for confidential treatment under Regulation 2019/1381 will be applied in practice and secondly, what verifiable justification will be accepted to justify how the disclosure of such information would potentially harm the interests of the applicant to a significant degree. The proposed changes cannot therefore be seen separate from the Practical Arrangements that EFSA is developing on these aspects. We trust that also these Practical Arrangements will be open to a similar public consultation as is the case with this proposal. In addition, since over 95% of the companies in the sector are SME’s to which the Regulation applies, it is important to limit the administrative burden of the application procedure and in particular keep the electronic submission system as simple as it currently is. This is of particular importance when and if standard data formats will be developed for this kind of application. We consider that formats that are currently being considered for other legislative procedures are not appropriate for food additive applications. We consider that there are also other elements of the Transparency Regulation that are of importance and require further clarification as to their scope and practical implementation, so as to ensure they stimulate innovation and can be applied by all companies in a simple and easy way. This is in particular the case for the notification of studies and the provision of pre-submission advice by EFSA. We look forward to providing our input also on these matters whenever given the opportunity.
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Response to Amending the administrative and scientific requirements for traditional foods in view of the “Transparency Regulation”

20 Aug 2020

Food Supplements Europe thanks the Commission for giving us the opportunity to submit comments on this proposal. The proposal aims to implement the requirements of the Transparency Regulation 2019/1381 and this appears to be properly done. We would nevertheless want to indicate that the Novel Foods Regulation is of crucial importance for innovation in our sector. Given that this legislation has moved to generic authorisations, with no possibility for proprietary data protection for traditional foods, the protection of intellectual property of applicants by means of confidentiality is crucial for the competitiveness of our companies and to avoid that European innovations can be easily copied. There are two primarily crucial aspects that must be considered: Firstly, the way in which requests to keep the information that is accepted as eligible for confidential treatment under Regulation 2019/1381 will be applied in practice and secondly, what verifiable justification will be accepted to justify how the disclosure of such information would potentially harm the interests of the applicant to a significant degree. The proposed changes cannot therefore be seen separate from the Practical Arrangements that EFSA is developing on these aspects. We trust that also these Practical Arrangements will be open to a similar public consultation as is the case with this proposal. In addition, since over 95% of the companies in the sector are SME’s to which the Novel Foods Regulation applies, it is important to limit the administrative burden of the application procedure and in particular keep the electronic submission system as simple as it currently is. This is of particular importance when and if standard data formats will be developed for this kind of application. We consider that formats that are currently being considered for other legislative procedures are not appropriate for novel foods applications. We consider that there are also other elements of the Transparency Regulation that are of importance and require further clarification as to their scope and practical implementation, so as to ensure they stimulate innovation and can be applied by all companies in a simple and easy way. This is in particular the case for the notification of studies and the provision of pre-submission advice by EFSA. We look forward to providing our input also on these matters whenever given the opportunity.
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Response to Amending administrative & scientific requirements for applications for novel foods in view of “Transparency Regulation

20 Aug 2020

Food Supplements Europe thanks the Commission for giving us the opportunity to submit comments on this proposal. The proposal aims to implement the requirements of the Transparency Regulation 2019/1381 and this appears to be properly done. We would nevertheless want to indicate that the Novel Foods Regulation is of crucial importance for innovation in our sector. Given that this legislation has moved to generic authorisations, with only limited possibilities for proprietary data protection, the protection of intellectual property of applicants by means of confidentiality is crucial for the competitiveness of our companies and to avoid that European innovations can be easily copied. There are two primarily crucial aspects that must be considered: Firstly, the way in which requests to keep the information that is accepted as eligible for confidential treatment under Regulation 2019/1381 will be applied in practice and secondly, what verifiable justification will be accepted to justify how the disclosure of such information would potentially harm the interests of the applicant to a significant degree. The proposed changes cannot therefore be seen separate from the Practical Arrangements that EFSA is developing on these aspects. We trust that also these Practical Arrangements will be open to a similar public consultation as is the case with this proposal. In addition, since over 95% of the companies in the sector are SME’s to which the Novel Foods Regulation applies, it is important to limit the administrative burden of the application procedure and in particular keep the electronic submission system as simple as it currently is. This is of particular importance when and if standard data formats will be developed for this kind of application. We consider that formats that are currently being considered for other legislative procedures are not appropriate for novel foods applications. We consider that there are also other elements of the Transparency Regulation that are of importance and require further clarification as to their scope and practical implementation, so as to ensure they stimulate innovation and can be applied by all companies in a simple and easy way. This is in particular the case for the notification of studies and the provision of pre-submission advice by EFSA. We look forward to providing our input also on these matters whenever given the opportunity.
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Food Supplements Europe demands rethink of Aloe extract ban

23 Apr 2020
Topic — EU proposal to prohibit or restrict certain hydroxyanthracene derivatives in food supplements.
Message — The association requests the proposal be withdrawn and revised using updated safety data. They call for a residue threshold and placing substances under scrutiny instead of a ban.123
Why — This would prevent the immediate loss of over 300 million euros in annual sales.4
Impact — Small businesses face significant turnover losses and the forced destruction of existing product stocks.5
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Response to Farm to Fork Strategy

16 Mar 2020

Food Supplements Europe welcomes the opportunity to provide input to the Roadmap for a Farm to Fork Strategy. We acknowledge the importance of the challenges of our society ahead, including the consequences of climate change, the need for sustainable food production and waste reduction and the problematic situation of nutritional adequacy, in particular in vulnerable population groups, such as the elderly. Food Supplements Europe and its members support the Commission in its overall goals and are committed to collaborate with our contributions. We understand that the aim of the Farm to Fork strategy is to secure a fair, healthy and environmentally-friendly food system and that the focus of policy actions, both regulatory and non-regulatory, for the next 5 years will be on sustainability and circular economy. We would however want to stress two policy areas that in our view are also essential to make this strategy a success: The need to address nutritional inadequacies and the promotion of innovation. We consider this roadmap a starting point and ask the Commission to proceed with further steps after duly considering the comments received and accompany any proposed legislative measure by an economic impact assessment. Please find attached more details on the input from Food Supplements Europe.
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Response to Draft Impl Regulation establishing the list of animals and goods to be subject to official controls at BCPs

16 Aug 2019

Food Supplements Europe is the European Trade Association of the food supplements sector, representing national associations and companies involved in the manufacturing, sales and distribution of food supplements and ingredients used therein in the EU. We would request clarification on the requirements for border control of food supplements containing ingredients of animal origin and composite products as described in the attached document.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

18 Jan 2019 · courtesdy visit, presentation of activities

Response to Transparency and sustainability of the EU risk assessment model in the food chain

23 Jun 2018

Food Supplements Europe represents the manufacturers of food supplements and food supplement ingredients. In our sector, innovation is key and this proposal should not undermine the objectives of the Commission laid down it its better regulation programme. With this in mind, we are surprised that no impact assessment was performed on this proposal which, if not improved or adjusted, may have a profound negative impact on the competitiveness of the EU industry and thus on its economic performance and employment. It is our firm belief that an impact assessment is necessary and will help strengthen the effectiveness of the measures envisaged. We understand that the objective of this proposal is to increase the transparency and sustainability in the EU risk assessment process, given the particular issues surrounding pesticides and GMOs. However, we believe that the proposal should be adapted in two areas in order to avoid serious negative consequences for EU food operators, and their ability to innovate: - Applicant knowhow, research and development and business strategies must be protected; they must not be disclosed until the moment that the risk assessment outcome is published. - The pre-submission general advice on applications provided for in Article 32a must include advice on scientific principles and the outcomes of such meetings should not be made public until the outcome of the scientific risk assessment has been published.
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Response to More and better mutual recognition for the single market for goods (revision Regulation (EC)764/2008) (Goods package)

19 Mar 2018

We would like to thank the European Commission for its efforts in strengthening the application of Mutual Recognition and offering us the possibility to comment on the proposed revision of the Mutual Recognition Regulation. We support the measures foreseen and in particular the introduction of a self-declaration and the establishment of a problem-solving system. However, we are concerned that the current procedure in place for Member States to follow in case they want to deny mutual recognition is no longer maintained. The current procedure (Regulation 764/2008), foresees structured communication between authorities and operators to enable arguments to be exchanged, with short deadlines and not meeting these deadlines results in a legal confirmation that the product can be legally marketed. Without such formal process, the possibility is very real that no formal discussion takes place any longer between operators and authority. We therefore strongly believe that the procedure currently foreseen in Article 6 of Regulation 764/2008 needs to be retained. The problem-solving system should be put in place after that procedure being completed. We also believe that a systematic assessment of the underlying reason for cases to refuse mutual recognition is essential for the effectiveness of the Regulation. This would include: - Strengthening the TRIS system by systematically making a thorough assessment of the compatibility of notified measures with the Treaty and the principles of necessity and proportionality. - Including in any assessment of a mutual recognition infringement an assessment of the appropriateness of the underlying law or measure in terms of compliance with the Treaty, legitimacy of the pursued objectives and proportionality of the outcome measures, in the same way as new legislation would be scrutinised under the TRIS notification and make this process transparent to society. More detailed comments can be found in the attached document.
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Response to Transparency and sustainability of the EU risk assessment model in the food chain

16 Jan 2018

Food Supplements Europe welcomes the opportunity to comment on the proposed roadmap. A revision of the General Food Law Regulation requires a coherent approach integrating all necessary changes into the framework that has already demonstrated its effectiveness, as confirmed in the Fitness Check. The questions that are addressed are focused on a narrow field of activities (transparency and scientific capacity of EFSA) and specifically address aspects that relate to EFSA and risk assessment, which, as is clear from assessments already carried out, are already at a very high level of transparency and independence. We strongly believe that also the transparency in the risk management process should be covered, as trust in risk analysis can only be achieved when all components of the process are addressed. The risk management component is as critical as the risk assessment one. Given that the outcome of the Fitness Check of the General Food Law Regulation was only published this week, there may be a merit to take more time to address all aspects that should be covered and consult in detail with the stakeholders on the nature and effectiveness of the measures that are required. Our detailed comments are attached.
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Response to Implementing act on the Union list

1 Nov 2017

Please find attached our comments on behalf of Food Supplements Europe.
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Response to Implementing act on procedures for novel food status

14 Aug 2017

Please find attached the comments of Food Supplements Europe on this draft implementing act.
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Response to Commission Impl. Reg. laying down administrative & scientific requirements for traditional foods from a Third Country

14 Aug 2017

Please find attached the comments of Food Supplements Europe on this draft implementing act.
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Response to Commission Implementing Regulation laying down administrative and scientific requirements for novel food applications

14 Aug 2017

Please find attached the comments of Food Supplements Europe on this draft implementing act.
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Response to Evaluation of the Regulation on the functioning of the internal market

29 Mar 2017

Food Supplements Europe represents the manufacturers and sellers of food supplements and food supplement ingredients in the European Union. Food Supplements Europe welcomes the evaluation and fitness check roadmap on the evaluation of the Regulation on the functioning of the internal market. This is particularly important as the food supplements sector is one of the sectors where mutual recognition is often not applied between certain Member States and as a consequence the internal market in safe products is hindered. We have provided extensive comments into the REFIT assessment of the Mutual Recognition Regulation No 764/2008, which we attach to these comments. We wonder if and how the evaluation of the Internal Market Regulation will be considered in the light of the REFIT of the Mutual Recognition Regulation, as both fundamentally cover aspects of the same problem. In this respect we wonder to what extent Regulation No 2679/98 is known and applied by the Member States as it is Member State practice that is at the basis of most of the obstacles that hinder the free movement of goods in our sector in the first place. Whether such obstacles are considered as serious of sufficiently serious to warrant action, is another element that could be investigated. In this respect it would be good to see actual examples in which the procedure has actually been used or triggered by the Commission. The obvious conclusion today from experience from our sector would be that this legislation is not applied and thus does not meet its objective. We are available to provide further input into the consultations that are foreseen.
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Meeting with Vytenis Andriukaitis (Commissioner) and

29 Apr 2016 · International Workshop on Botanicals: how botanicals are regulated in third countries

Meeting with Vytenis Andriukaitis (Commissioner) and

14 Jan 2016 · Rules applicable to botanicals

Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

16 Jul 2015 · Botanicals