SCCS Ingredient Reviews Continue to Drive Reformulation Activity

Introduction

The Scientific Committee on Consumer Safety (SCCS) serves as the EU’s independent scientific advisory body for cosmetic ingredient safety, issuing opinions that form the basis for regulatory decisions regarding ingredient authorization, restriction, or prohibition [1]. By October 2025, the SCCS had issued hundreds of opinions covering preservatives, UV filters, colorants, hair dyes, nanomaterials, and other ingredient categories, with each opinion potentially triggering reformulation activity across the cosmetic industry [2]. The SCCS’s rigorous, evidence-based approach to safety assessment—grounded in the Notes of Guidance (10th Revision, SCCS/1602/18, with 11th Revision anticipated)—ensured that only ingredients with demonstrated safety under specified conditions of use remained authorized [3]. However, the SCCS’s frequent conclusions that submitted data were insufficient to demonstrate safety, coupled with the lengthy timelines for opinion development and regulatory implementation, created ongoing uncertainty and compliance challenges for manufacturers and Responsible Persons [4].

The SCCS opinion process, established under Article 32 of Regulation (EC) No 1223/2009, involves submission of a dossier by industry or Member States, evaluation by the SCCS according to the Notes of Guidance, public consultation on draft opinions, and adoption of final opinions [5]. The Commission then considers SCCS opinions when amending Annexes II-VI through implementing acts under Article 31 [6]. This process ensures scientific rigor and stakeholder input, but can take several years from initial dossier submission to final regulatory implementation, during which time industry faces uncertainty regarding ingredient status [7].

Regulatory Framework and Legal Analysis

Article 32 of Regulation (EC) No 1223/2009 establishes the SCCS as an independent scientific committee providing opinions on questions concerning the safety of cosmetic products and substances used in cosmetic products [8]. The SCCS operates under the framework established by Commission Decision 2008/721/EC, which sets out rules for the operation of scientific committees [9]. The SCCS comprises independent scientific experts in toxicology, dermatology, and related disciplines, appointed by the Commission for renewable three-year terms [10].

The SCCS evaluates ingredients according to the Notes of Guidance, which specify data requirements for demonstrating safety [11]. For new ingredients seeking authorization in Annexes IV (colorants), V (preservatives), or VI (UV filters), comprehensive dossiers must be submitted including: identity and specification, function and proposed uses, maximum concentration, physicochemical properties, toxicological profile (covering all endpoints specified in the Notes of Guidance), efficacy data (for preservatives and UV filters), and exposure assessment [12]. For existing ingredients under review, the SCCS evaluates available data from published literature, industry submissions, and regulatory databases [13].

The SCCS opinion process typically involves several stages. First, the dossier is submitted to the Commission, which forwards it to the SCCS [14]. Second, the SCCS appoints a working group of experts to evaluate the dossier and prepare a draft opinion [15]. Third, the draft opinion is adopted by the SCCS plenary and published for public consultation, typically for 8-12 weeks [16]. Fourth, the SCCS considers comments received during consultation and adopts a final opinion [17]. Fifth, the Commission considers the SCCS opinion when preparing amendments to the relevant Annex [18].

SCCS opinions typically conclude in one of several ways: (1) the ingredient is safe at the proposed concentration and conditions of use; (2) the ingredient is safe at a lower concentration or with additional restrictions; (3) the ingredient cannot be considered safe due to insufficient data; or (4) the ingredient should be prohibited due to unacceptable risks [19]. Conclusions of insufficient data are common, particularly for novel ingredients, nanomaterials, and ingredients with complex toxicological profiles [20]. In such cases, the applicant may submit additional data and request re-evaluation, but this process can take years [21].

Article 31 establishes the procedure for amending Annexes II-VI, requiring the Commission to adopt implementing acts after consulting the Standing Committee on Cosmetic Products [22]. The Commission typically follows SCCS opinions when amending Annexes, but the timeline for implementation varies depending on the complexity of the issue, the need for transition periods, and the political and economic considerations [23]. For example, the SCCS opinion on methylisothiazolinone (MI) recommending prohibition in leave-on products (SCCS/1557/15) was adopted in 2015, but the regulatory amendment was not implemented until 2016, with a transition period extending to 2017 [24].

Toxicological and Safety Science Considerations

The SCCS’s approach to safety assessment is grounded in the principles of toxicology and risk assessment, emphasizing the distinction between hazard (the inherent property of a substance to cause harm) and risk (the probability of harm occurring under specified exposure conditions) [25]. The SCCS evaluates all relevant toxicological endpoints, including acute toxicity, irritation, corrosivity, skin sensitization, dermal absorption, repeated-dose toxicity, mutagenicity, genotoxicity, carcinogenicity, reproductive toxicity, and photo-induced toxicity [26]. For each endpoint, the SCCS considers the quality and relevance of available data, applying weight-of-evidence principles to integrate results from multiple studies [27].

Dermal absorption is a critical parameter because it determines systemic exposure and forms the basis for margin of safety (MoS) calculation [28]. The SCCS requires in vitro dermal absorption studies using validated methods (OECD TG 428) with human or porcine skin, and specifies that the highest dermal absorption value from multiple studies should be used for SED calculation unless scientifically justified otherwise [29]. If in vitro data demonstrate significant dermal absorption (>10%), in vivo studies may be required to confirm systemic bioavailability and toxicokinetics [30].

Systemic exposure dosage (SED) is calculated using the formula: SED (mg/kg bw/day) = (A × C × DAp) / BW, where A is the amount of product applied per day, C is the concentration of the ingredient in the product, DAp is the dermal absorption percentage, and BW is body weight [31]. The SCCS provides default values for product application amounts based on product type and application site, and requires that exposure assessment consider realistic use scenarios, including use by vulnerable populations (infants, children, pregnant women) [32].

Margin of safety (MoS) is calculated as: MoS = NOAEL / SED, where NOAEL is the No Observed Adverse Effect Level from the most sensitive relevant toxicity study [33]. An MoS ≥100 is generally considered acceptable, providing a 10-fold safety factor for interspecies extrapolation and a 10-fold safety factor for intraspecies variability [34]. If the MoS is below 100, the SCCS typically concludes that the ingredient cannot be considered safe at the proposed concentration, unless additional data or scientific justification support a lower MoS [35].

The SCCS frequently identifies data gaps that prevent definitive safety conclusions [36]. Common data gaps include: lack of dermal absorption data, absence of repeated-dose toxicity studies, insufficient genotoxicity testing, lack of reproductive toxicity data, and inadequate characterization of impurities and contaminants [37]. For nanomaterials, additional data gaps include insufficient physicochemical characterization, lack of particle size distribution data, and absence of inhalation toxicity studies for spray applications [38]. When data gaps are identified, the SCCS typically concludes that safety cannot be demonstrated and recommends that additional data be generated [39].

The SCCS’s emphasis on data quality and completeness reflects the precautionary principle embedded in Article 3 of Regulation (EC) No 1223/2009, which requires that products be safe for human health [40]. The burden of proof rests with the applicant to demonstrate safety, and the SCCS will not approve ingredients based on incomplete or inadequate data [41]. This rigorous approach ensures consumer protection but can create challenges for industry, particularly for novel ingredients or ingredients with complex toxicological profiles [42].

Practical Compliance Guidance

For Responsible Persons, managing the impact of SCCS opinions requires proactive monitoring, strategic planning, and flexible reformulation capabilities. First, companies should systematically monitor SCCS opinion pipelines, including calls for data, draft opinions under consultation, and final opinions [43]. The SCCS publishes its work program and meeting agendas on the European Commission website, and industry associations such as Cosmetics Europe provide updates on SCCS activities [44]. Early awareness of SCCS reviews enables proactive planning and reduces the risk of market disruption [45].

Second, companies should assess their product portfolios to identify products containing ingredients under SCCS review [46]. If an SCCS opinion concludes that an ingredient cannot be considered safe or should be restricted, affected products must be reformulated or withdrawn from the market [47]. Portfolio assessment should prioritize high-volume products, products with long development timelines, and products where reformulation is technically challenging [48].

Third, reformulation strategies should be developed in advance of regulatory implementation, recognizing that SCCS opinions typically precede regulatory amendments by 12-24 months [49]. Reformulation should identify suitable alternative ingredients, conduct stability and compatibility testing, update safety assessments, and prepare for CPNP notification updates and labelling changes [50]. Article 10 requires that reformulated products undergo safety assessment, and the CPSR must document the safety rationale for replacement ingredients [51].

Fourth, companies should engage with SCCS consultations on draft opinions, providing comments and additional data that may influence final opinions [52]. The SCCS considers all comments received during consultation, and well-substantiated comments can result in modifications to draft opinions [53]. Industry associations often coordinate collective responses to SCCS consultations, and individual companies should participate in these efforts [54].

Fifth, companies should maintain comprehensive ingredient safety dossiers, including all toxicological data, dermal absorption studies, exposure assessments, and SCCS opinions [55]. These dossiers support CPSR preparation, facilitate reformulation planning, and enable rapid response to SCCS data requests or regulatory inquiries [56]. Article 11 requires that the PIF contain the CPSR and supporting documentation, and comprehensive ingredient dossiers ensure that this requirement is satisfied [57].

Sixth, companies should invest in alternative testing methods and data generation strategies that align with the EU’s commitment to replacing, reducing, and refining animal testing (the 3Rs principle) [58]. The SCCS increasingly accepts data from validated in vitro methods, read-across, and QSAR predictions, provided these approaches are scientifically justified and adequately documented [59]. Investment in alternative methods not only supports ethical objectives but also accelerates data generation and reduces costs [60].

Conclusion

SCCS ingredient reviews continue to drive reformulation activity across the cosmetic industry, reflecting the Committee’s rigorous, evidence-based approach to safety assessment and the EU’s commitment to precautionary consumer protection. The SCCS opinion process, established under Article 32 of Regulation (EC) No 1223/2009, ensures scientific rigor and stakeholder input, but can create uncertainty and compliance challenges due to lengthy timelines and frequent conclusions of insufficient data. Responsible Persons must proactively monitor SCCS activities, assess portfolio impacts, develop reformulation strategies, engage with consultations, maintain comprehensive ingredient dossiers, and invest in alternative testing methods. As the SCCS continues to evaluate ingredients and the Commission implements regulatory amendments based on SCCS opinions, the cosmetic industry must maintain flexibility, scientific expertise, and commitment to consumer safety while navigating the ongoing evolution of the EU’s science-based regulatory framework.

References

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