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The European Federation for Cosmetic Ingredients AISBL

EFfCI

EFfCI, established in 2000, represent the manufacturers of chemicals and natural ingredients for the cosmetics industry and advocate the collective interests.

Lobbying Activity

Meeting with Paul Speight (Head of Unit Environment) and Cosmetics Europe and PETA Science Consortium International e.V.

22 Jan 2026 · The CE – EFfCI Joint Position on Animal Testing Under EU REACH

Meeting with Christophe Clergeau (Member of the European Parliament, Rapporteur) and European Chemical Industry Council and

3 Dec 2025 · ENVI - ECHA

Response to Biotech Act

10 Jun 2025

The European Federation for Cosmetic Ingredients welcomes the opportunity to respond to the call for evidence for an impact assessment on the European Biotech Act. PLease refer to the appended file. We remain at your disposal for further discussions and look forward to contributing to the next phases of the Biotech Act development.
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Response to Evaluation of the Cosmetic Products Regulation

21 Mar 2025

EFfCI is the European Federation for Cosmetic Ingredients, a trade association representing European manufacturers of synthetic and natural ingredients for the cosmetics and personal care industry. Our membership comprises large multinational organizations and SME EFfCI welcomes the opportunity to contribute to the review of the EU Cosmetic Products Regulation (CPR) in line with Better Regulation guidelines. The CPR is at the core of our business, together with REACH. The CPR has two main objectives: 1. Protect consumer health 2. Ensure functioning of the internal market for cosmetic products Consumer Health Overall, the CPR has been effective in maintaining consumer health since its entry into force, with the SCCS playing a vital role in this. The CPR is often seen as the 'gold standard' in cosmetic legislation globally, with many countries adopting the legislation as is. SCCS expert opinions and guidance are recognized as world-leading and adopted globally. Global adoption of CPR is valuable to the industry as it offers a level of harmonisation. To ensure continuation of this high standard, it is imperative the expert knowledge of the SCCS, required to perform expert risk assessments, is retained. Independence within the EU Commission is essential to this. It is also critical, for innovation, EU competitiveness, effectiveness and coherence with other regulations, the SCCS can use all data available when completing risk assessments, including animal test data generated for purposes other than cosmetic safety. The discrepancy between the CPR and REACH concerning animal testing stems from differences in chemical and risk assessment methodologies. The CPR, which includes a marketing ban on ingredients tested on animals, inadvertently stifles innovation, blocking new additions to the annexes (colorants, preservatives, and UV filters) where alternatives to animal testing are lacking. Increasingly, the SCCS are unable to conclude their opinions due to lack of data. Acceptance of data from other regions or applications would address this. Additionally, clear guidance on assessing new annex ingredients using Non-Animal Methodologies would foster innovation and maintain global competitiveness. By aligning chemical and risk assessment processes under CPR and REACH, we can uphold consumer safety principles while promoting ethical and scientific advancements. EFfCI believes the current scope of the CPR is sufficient and strongly urge against the addition of an environmental assessment, as this is already comprehensively covered under REACH through rigorous hazard assessments. Duplication of work would only serve to create a barrier to innovation and obstruct competition within the market. Aligning CPR with the existing REACH framework will ensure efficient use of resources while maintaining high standards of safety and competitiveness. Internal Market EU-level legislation is absolutely critical to the functioning of the internal market. National-level legislation can form a barrier to the free movement of goods and adds complexity to the regulatory landscape, resulting in barriers to trade and additional costs for industry and consumers. This undermines the benefits of the internal market, which aims to facilitate trade, stimulate growth, and boost competition, while offering citizens more choices and opportunities. Examples of such situations include the avoidance of placing safe and effective nanomaterials on the market in France for fear of legal action resulting from unclear and divergent legislation. Industry would also welcome the introduction of a cost sharing mechanism, similar to that in REACH, to ensure all manufacturers and importers contribute equally to costs incurred during ingredient defence programs. Generation of safety data and SCCS dossiers can be extremely costly. Today, costs are not shared equally amongst all companies placing ingredients onto the internal market, generating a commercial disadvantage
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Response to Commission Roadmap to phase out animal testing

11 Oct 2024

European Commissions Roadmap to phase out animal testing in chemical safety assessments- Call for Evidence EFfCI comment EFfCI, as an association for manufacturers of cosmetic ingredients, welcomes the opportunity to provide feedback on the "European Commissions roadmap to phase out animal testing in chemical assessments" and emphasizes to support the roadmap content-wise through our expertise in the regulatory and scientific field. As manufacturers of cosmetic ingredients, we are bound by the obligations of global chemicals legislation, but we must also consider the needs of our customers and consumers of cosmetic products regarding animal testing and the pressing need for alternatives. European legislation (i.e. EU REACH and EU Cosmetic Product Regulation or EU CPR) presents a conflict and significant challenge in this regard. The EC roadmap can help clarify short-term, medium-term, and long-term milestones for the use of alternative methods and alternative assessment approaches, also on a global level. In this context, prompt recognition by authorities (e.g., ECHA) and implementation for hazard-based classification and labelling are also important. Significant scientific progress has been made within the past decade whereby a plethora of non-animal methods have been developed and deployed to move towards a new risk assessment paradigm. Next Generation Risk Assessment (NGRA) has emerged as a novel exposure-based approach to ensure human health protection without the need for animal testing. A fundamental premise of NAMs-based NGRA is that safety assessments should be protective for those exposed to the chemical, but not necessarily predictive of the specific adverse effects that may be seen in animal studies, sometimes at high doses completely irrelevant to human exposure(s). As a result of consumer preference and animal testing bans enforced in EU Cosmetic Product Regulation, NGRA approaches are now being frequently used for consumer safety assessments, especially for new cosmetic ingredients (due to the animal testing ban under EU CPR). However, it is noted that protective (or risk-based) approaches are currently not compatible with predictive hazard-based regulations like EU REACH and CLP. New (and even existing) cosmetic ingredients are completely stuck in the middle of this conflict between legislative requirements and customer/consumer preferences. To accelerate the adoption and acceptance of NAMs and NGRA the key question is whether the current EU regulatory system(s) and the wider society is prepared to embrace and accept approaches that are protective rather than predictive for human health, at least if we want to make meaningful progress in in the short-to medium-term. In this regard, perhaps cosmetic ingredients offer a low-hanging fruit to reconsider the conflict that exists between the regulatory systems required to ensure their safety for workers and environment (EU REACH) and consumers (EU CPR). EFfCI acknowledges that animal tests have served, and in some specific circumstances (e.g. using historical animal data in weight of evidence approaches etc) continue to serve, us well. However, in parallel, EFfCI considers the enhanced development of alternative methods and alternative assessment approaches to be urgently necessary to achieve animal testing free safety assessments for cosmetic ingredients in Europe (and on a global level due the influence European chemicals legislation has on a global stage). For this purpose, close collaboration and engagement among all involved European and international partners in the fields of science, politics and regulation is essential. Several initiatives such as the European PARC NGRA route and the ASPA framework, and global organizations such as the International Collaboration on Cosmetics Safety (ICCS) where EFfCI is a founding member, are proactively working on advancing development and adoption of animal-free science, and the Commission roadmap will certainly be
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Response to EU Chemicals Strategy for sustainability - Revision of the Cosmetic Products Regulation

1 Nov 2021

Extending the generic approach to risk management to cosmetics. The safety of cosmetic formulations and the ingredients they contain is of paramount importance to industry. Before ingredients and finished cosmetic formulations are placed on the market, their safety and suitability for use must be assessed. For any form of consumer risk assessment associated hazards (“potential for harm”) and how the consumer will be exposed to the hazard must be assessed to evaluate potential risks for the consumer. In cosmetic applications, exposure to humans is intentional through direct application to the body. Under normal conditions of use, consumer exposure varies greatly between cosmetic applications and is far more complex than industrial. Therefore, assessing exposure is elemental for determining the need for risk management measures and they should not be derived based on hazard alone. In fact, to apply generic risk assessment measures to cosmetic ingredients would be to ban ingredients based on their hazard, which is application of the precautionary principle. In guidance published by the Commission (2000)1 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52000DC0001) it was made clear that, “…the precautionary principle can under no circumstances be used to justify the adoption of arbitrary decisions.” and that a risk assessment should be considered where feasible, using “…..reliable scientific data and logical reasoning, leading to a conclusion which expresses the possibility of occurrence and the severity of a hazard's impact on the environment, or health of a given population including the extent of possible damage, persistency, reversibility and delayed effect”. Risk assessment of cosmetic formulations and their ingredients is possible within the existing system. To restrict ingredients on hazard alone (i.e. generic risk management measures, GRM) would be to invoke the precautionary principle. Reattribution of tasks from SCCS to ECHA Whereas the use of GRM for cosmetic ingredients is not an option without invoking the precautionary principle, a specific risk assessment for cosmetics is feasible as demonstrated over the past decades. The SCCS is a group of experts with specialist toxicological knowledge and a vast experience in cosmetic risk assessment and they take into account hazard as well as exposure during application. The process in place today is both effective and efficient. Whereas the initiative “One Substance, One Assessment” as a process” may require a reorganisation of experts to an ECHA body to further enhance the dialogue between experts in different groups, expertise in evaluating exposure and risk for cosmetic products should be maintained. Nanomaterial Definition Review We support a harmonized definition but must remember why the nano-definition was needed: to define a limit where hazard may arise from the nano-fraction of a product. Harmonization aligned with the most restrictive definition would make no sense: common ingredients in powder form without any specific properties having a distribution particle size tail in the range of the nano dimension would be considered as a nanomaterial. That’s why the notion of intentionally manufactured is crucial to embrace the real ‘’nanomaterials’’. Therefore, a link to any nano-specific property of the materials should be introduced to efficiently identify hazardous properties not known from the bulk form. If no hazard can be connected to the nano fraction of the material, requirements for an extensive set of data, restrictions and nano labelling should not apply which would thus avoid efforts that do not reflect a potential risk. Reference: 1. Commission of the European Communities. (2000). Communication from the Commission on the precautionary principle.
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Response to Fitness Check on endocrine disruptors

10 Jul 2019

Please find in the attached document the comments from the European Federation for Cosmetic Ingredients (EFfCI) on the EC´s Roadmap “Towards a more comprehensive EU framework on endocrine disruptors”
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