Microplastics in Cosmetics: Regulatory Pressure Intensifies Across the EU
Introduction
The regulatory landscape surrounding microplastics in cosmetic products underwent significant transformation during 2021, driven by mounting scientific evidence of environmental persistence and accumulation in aquatic ecosystems. Microplastics—defined as synthetic polymer particles smaller than 5 mm—have been widely used in cosmetic formulations as exfoliants, film formers, and viscosity modifiers [1]. The European Commission’s commitment under the EU Green Deal and the Chemicals Strategy for Sustainability signaled a fundamental shift toward precautionary restriction of intentionally added microplastics, creating substantial compliance obligations for cosmetic manufacturers and Responsible Persons operating under Regulation (EC) No 1223/2009 [2].
This regulatory pressure emerged from the intersection of cosmetic product safety obligations under Article 3 of Regulation (EC) No 1223/2009—which requires that products placed on the market be safe for human health under normal or reasonably foreseeable conditions of use—and broader environmental protection objectives under the REACH framework (Regulation (EC) No 1907/2006) [3]. The European Chemicals Agency (ECHA) initiated a restriction proposal targeting intentionally added microplastics across multiple product categories, including cosmetics, with implications extending far beyond traditional ingredient safety assessment [4].
Regulatory Framework and Legal Analysis
The primary legal instrument governing microplastics in cosmetics derives from REACH Article 69, which empowers ECHA to prepare restriction dossiers for substances posing unacceptable risks to human health or the environment [5]. ECHA’s restriction proposal, published in January 2019 and refined through extensive stakeholder consultation, defined “microplastics” broadly to encompass synthetic polymer microparticles below 5 mm that are organic, insoluble, and resistant to degradation [6]. This definition captured not only traditional microbeads used in rinse-off exfoliating products but also polymers in leave-on formulations, encapsulated ingredients, and film-forming agents.
Under Regulation (EC) No 1223/2009, Article 4 designates the Responsible Person as the entity ensuring compliance with all applicable requirements, including ingredient restrictions listed in Annexes II through VI [7]. While microplastics were not historically listed in Annex II (prohibited substances), the REACH restriction process operates independently and, once adopted, becomes directly applicable across all EU Member States without requiring transposition into national law [8]. This creates a dual regulatory framework where cosmetic-specific provisions under Regulation 1223/2009 intersect with horizontal chemical restrictions under REACH.
Article 11 of Regulation (EC) No 1223/2009 requires the Product Information File (PIF) to contain a cosmetic product safety report (CPSR) addressing not only human health endpoints but also, where relevant, environmental considerations that may inform the overall safety assessment [9]. The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (10th Revision, SCCS/1602/18) emphasize that safety assessors must consider the totality of available evidence, including environmental fate and persistence data, when evaluating ingredient safety [10]. Although environmental risk assessment is not formally mandated for cosmetic ingredients under Article 10, the precautionary principle embedded in Article 3 requires Responsible Persons to consider reasonably foreseeable risks, including those arising from environmental release and subsequent human exposure pathways [11].
The ECHA restriction proposal included transition periods recognizing the technical complexity of reformulation. For rinse-off products containing microplastic exfoliants, a four-year transition was proposed; for leave-on products and encapsulated ingredients, longer periods of six to twelve years were contemplated to allow development and validation of alternative technologies [12]. These timelines directly impact compliance planning under Article 13 (CPNP notification) and Article 19 (labelling), as reformulated products require updated notifications and revised ingredient declarations [13].
Toxicological and Safety Science Considerations
From a toxicological perspective, microplastics present a unique challenge because the primary concern is environmental persistence and bioaccumulation rather than acute human toxicity [14]. Traditional cosmetic safety assessment focuses on dermal absorption, systemic exposure dosage (SED), and calculation of the margin of safety (MoS) by comparing the No Observed Adverse Effect Level (NOAEL) to human exposure levels, with an MoS ≥100 generally considered acceptable for non-sensitizing ingredients [15]. However, microplastics are typically designed to be non-absorbable and inert, resulting in negligible dermal penetration and minimal systemic exposure [16].
The SCCS has consistently concluded that microplastic particles used in cosmetics, such as polyethylene (PE) and polypropylene (PP) microbeads, pose minimal direct risk to human health when used in rinse-off formulations at concentrations up to 10% w/w, based on their high molecular weight (typically >10,000 Da), lack of dermal absorption, and absence of systemic bioavailability [17]. Dermal absorption studies using Franz diffusion cells and ex vivo human skin models have demonstrated that particles above 100 nm do not penetrate the stratum corneum barrier, and even smaller particles show limited transdermal flux [18].
Despite this favorable human safety profile, the hazard-versus-risk paradigm central to modern toxicology requires consideration of indirect exposure pathways. Microplastics released into wastewater systems persist through sewage treatment processes, accumulate in aquatic sediments, and enter the food chain through ingestion by marine organisms [19]. Human dietary exposure to microplastics via seafood consumption has been documented, though the toxicological significance remains uncertain due to limited absorption from the gastrointestinal tract [20]. The SCCS Notes of Guidance (10th Revision) acknowledge that safety assessors should consider “the overall exposure from all sources” when evaluating ingredient safety, implicitly recognizing that environmental release may constitute a foreseeable exposure pathway [21].
Quantitative structure-activity relationship (QSAR) modeling and read-across approaches have limited applicability to microplastics because their environmental behavior is governed by physical properties (particle size, density, surface chemistry) rather than molecular structure [22]. In vitro alternatives to animal testing, such as 3D skin models and reconstructed human epidermis, confirm the lack of dermal penetration but do not address environmental fate endpoints [23]. Consequently, safety assessment of microplastics requires integration of environmental science data—including persistence, bioaccumulation, and toxicity (PBT) criteria—alongside traditional toxicological endpoints [24].
Practical Compliance Guidance
For Responsible Persons and manufacturers, compliance with emerging microplastic restrictions requires a systematic, multi-phase approach. First, comprehensive ingredient audits must identify all synthetic polymers in current product portfolios, including those not traditionally considered “microplastics” but potentially captured by ECHA’s broad definition [25]. This includes film-forming polymers (e.g., acrylates copolymers), rheology modifiers (e.g., carbomers), and encapsulation systems (e.g., polymethyl methacrylate capsules) [26].
Second, reformulation strategies must balance regulatory compliance with product performance and consumer acceptance. Alternative exfoliants include natural materials (e.g., jojoba esters, cellulose beads, walnut shell powder) and biodegradable synthetic polymers meeting specific degradation criteria [27]. However, Article 10 safety assessments must address potential allergenicity and irritancy of natural alternatives, as botanical materials may contain sensitizing proteins or essential oils [28]. The CPSR must document the safety rationale for replacement ingredients, including dermal absorption data, repeated-dose toxicity studies, and skin sensitization testing consistent with SCCS guidance [29].
Third, supply chain verification becomes critical, as many cosmetic ingredients are complex mixtures where microplastic content may not be immediately apparent from INCI nomenclature [30]. Article 5 of Regulation (EC) No 1223/2009 imposes obligations on distributors to verify that products bear required labelling and that the Responsible Person has fulfilled documentation requirements, creating shared responsibility throughout the supply chain [31]. Manufacturers should implement supplier declarations confirming absence of restricted microplastics and conduct analytical verification using techniques such as Fourier-transform infrared spectroscopy (FTIR) or pyrolysis-gas chromatography-mass spectrometry (Py-GC-MS) [32].
Fourth, CPNP notification updates under Article 13 must be submitted for reformulated products, including revised ingredient lists and updated safety assessments [33]. Article 19 labelling requirements mandate accurate ingredient declarations in descending order of weight, and removal of microplastics may necessitate artwork changes if the ingredient appeared prominently in marketing communications [34]. Article 20 claims substantiation becomes particularly important if products are marketed with environmental or sustainability claims such as “microplastic-free” or “ocean-friendly,” as Commission Regulation (EU) No 655/2013 requires that all claims be supported by adequate and verifiable evidence [35].
Finally, market surveillance authorities increasingly coordinate enforcement actions across Member States under Article 25 (non-compliant products) and Article 27 (safeguard clause) [36]. The Administrative Cooperation (AdCo) group facilitates information exchange regarding non-compliant products, and Responsible Persons should anticipate requests for documentation under Article 21 (access to information) and Article 22 (sampling and analysis) [37]. Proactive compliance, including voluntary phase-out ahead of mandatory deadlines, reduces enforcement risk and supports corporate sustainability commitments aligned with the EU Green Deal [38].
Conclusion
The intensification of regulatory pressure on microplastics in cosmetics during 2021 exemplified the evolving intersection of product safety, environmental protection, and precautionary regulation. While traditional toxicological assessment demonstrates minimal direct human health risk from microplastic ingredients, the REACH restriction framework prioritizes environmental persistence and long-term ecological impact. Responsible Persons must navigate this dual regulatory landscape by conducting comprehensive portfolio reviews, implementing science-based reformulation strategies, and maintaining robust documentation systems that satisfy both cosmetic-specific requirements under Regulation (EC) No 1223/2009 and horizontal chemical restrictions under REACH. The microplastics case study underscores the broader trajectory of EU cosmetic regulation toward holistic sustainability assessment, where ingredient safety encompasses not only human health endpoints but also environmental fate and life-cycle considerations.
[1] Prata, J. C., da Costa, J. P., Lopes, I., Duarte, A. C., & Rocha-Santos, T. (2020). Environmental exposure to microplastics: An overview on possible human health effects. Science of the Total Environment, 702, 134455.
[2] European Commission. (2019). The European Green Deal. COM(2019) 640 final.
[3] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union, L 342/59.
[4] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[5] Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union, L 396/1.
[6] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[7] Regulation (EC) No 1223/2009, Article 4.
[8] Regulation (EC) No 1907/2006, Article 73.
[9] Regulation (EC) No 1223/2009, Article 11.
[10] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.
[11] Regulation (EC) No 1223/2009, Article 3.
[12] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[13] Regulation (EC) No 1223/2009, Articles 13 and 19.
[14] Prata, J. C., da Costa, J. P., Lopes, I., Duarte, A. C., & Rocha-Santos, T. (2020). Environmental exposure to microplastics: An overview on possible human health effects. Science of the Total Environment, 702, 134455.
[15] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.
[16] Ferreira, M. S., Magalhães, M. C., Oliveira, M. B. P. P., & Sousa-Lobo, J. M. (2023). Nanomaterials in cosmetics: An outlook for European regulatory requirements and a step forward in sustainability. Cosmetics, 10(2), 53.
[17] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.
[18] Ferreira, M. S., Magalhães, M. C., Oliveira, M. B. P. P., & Sousa-Lobo, J. M. (2023). Nanomaterials in cosmetics: An outlook for European regulatory requirements and a step forward in sustainability. Cosmetics, 10(2), 53.
[19] Prata, J. C., da Costa, J. P., Lopes, I., Duarte, A. C., & Rocha-Santos, T. (2020). Environmental exposure to microplastics: An overview on possible human health effects. Science of the Total Environment, 702, 134455.
[20] Prata, J. C., da Costa, J. P., Lopes, I., Duarte, A. C., & Rocha-Santos, T. (2020). Environmental exposure to microplastics: An overview on possible human health effects. Science of the Total Environment, 702, 134455.
[21] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.
[22] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[23] Ferreira, M. S., Magalhães, M. C., Oliveira, M. B. P. P., & Sousa-Lobo, J. M. (2023). Nanomaterials in cosmetics: An outlook for European regulatory requirements and a step forward in sustainability. Cosmetics, 10(2), 53.
[24] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[25] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[26] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[27] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[28] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.
[29] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.
[30] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[31] Regulation (EC) No 1223/2009, Article 5.
[32] European Chemicals Agency. (2019). Annex XV restriction report: Proposal for a restriction on intentionally added microplastics. ECHA.
[33] Regulation (EC) No 1223/2009, Article 13.
[34] Regulation (EC) No 1223/2009, Article 19.
[35] Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products. Official Journal of the European Union, L 190/31.
[36] Regulation (EC) No 1223/2009, Articles 25 and 27.
[37] Regulation (EC) No 1223/2009, Articles 21 and 22.
[38] European Commission. (2019). The European Green Deal. COM(2019) 640 final.