The EU Microplastics Ban in Cosmetics: What Manufacturers Must Do Before October 2027
The REACH restriction on synthetic polymer microparticles in rinse-off cosmetics takes effect October 2027. Here's what EU manufacturers must do now.
Punto chiave
The REACH restriction on synthetic polymer microparticles in rinse-off cosmetics takes effect October 2027. Here's what EU manufacturers must do now.
October 17, 2027 is less than 17 months away. For European cosmetics manufacturers producing rinse-off products — exfoliating scrubs, cleansing gels, shampoos, toothpastes, any format that goes down the drain — that date marks the point at which Commission Regulation (EU) 2023/2055 becomes enforceable in your production line. After it, any rinse-off personal care product containing intentionally added synthetic polymer microparticles (SPMs) at concentrations ≥ 0.01% w/w cannot legally be placed on the EU market.
We’ve been reviewing formulations with manufacturers across France, Germany, and the Benelux for the better part of two years. The pattern that keeps repeating is this: brands removed polyethylene microbeads sometime between 2015 and 2020 — often ahead of any legal obligation — and concluded the job was done. In most cases, it isn’t. The scope of Entry 78 in REACH Annex XVII is substantially broader than the old “microbeads in scrubs” conversation, and a surprising number of otherwise well-managed formulations contain ingredients that fall squarely within it.
What Commission Regulation (EU) 2023/2055 Actually Restricts
The restriction is inserted as Entry 78 in Annex XVII to REACH Regulation (EC) No 1907/2006. It prohibits the manufacture, placing on the market, and use of synthetic polymer microparticles — either on their own or in mixtures — above a concentration of 0.01% w/w.
A synthetic polymer microparticle is defined as a solid particle of synthetic polymer where at least 1% of the particles by number have at least one dimension in the range of 1 nm to 5 mm (or, for fibrous particles, 3 nm to 15 mm in length with a length-to-diameter ratio above 3:1). Four categories are explicitly excluded from that definition:
- Natural unmodified polymers — cellulose, starch, natural waxes. These fall outside the SPM definition entirely, provided they haven’t been chemically modified in a way that alters their fundamental structure.
- Biodegradable polymers — materials that mineralise under specified OECD-method conditions documented in the regulation. Note that “biodegradable” under this regulation has a precise technical meaning, not a marketing one.
- Fully water-soluble polymers — substances that dissolve completely in water rather than forming colloidal or stable particle dispersions.
- Permanently incorporated polymers — where physical release into the environment is technically prevented by the product’s design (rarely applicable in cosmetic formats).
The transition timeline for REACH regulation compliance is staggered by product type. For cosmetics and personal care:
- Rinse-off products: 4-year transition from entry into force → October 17, 2027
- Leave-on products: 6-year transition → October 17, 2029
- Microencapsulated fragrances in rinse-off products: also October 17, 2027
- Microencapsulated fragrances in leave-on products: October 17, 2029
ECHA’s impact assessment estimated that intentional microplastic additions across all EU product sectors amount to approximately 42,000 tonnes per year. Personal care products and cosmetics contribute roughly 3,600 tonnes of that figure annually — one of the higher-volume target sectors of the restriction. The Commission expects the cumulative reduction in environmental releases to reach approximately 500,000 tonnes over a 20-year period.
Which Cosmetic Ingredients Fall Within the SPM Definition
This is where many manufacturers discover their exposure goes further than expected. The list extends well beyond the polyethylene microbeads that were phased out years ago.
Clearly within scope — no exclusion applies:
- Polyethylene (PE) — still present in some conditioning bead systems and a handful of colour cosmetics on the market
- Nylon-12 (Polyamide-12) and Nylon-6 (Polyamide-6) — among the most widely used functional polymers in prestige cosmetics; found in loose powders, setting powders, foundations, mascaras, and blushes for their skin-feel and light-diffusion properties
- Polymethyl Methacrylate (PMMA) — a ubiquitous soft-focus texturiser in primers, BB creams, serums, and sunscreens; particle size is typically 5–15 µm, placing it squarely within the SPM definition
- Polypropylene (PP) — exfoliants and some bead texturisers
- Synthetic glitter (PET and PET-coated particles) — body lotions, highlighters, nail varnishes, bath products
Frequently overlooked ingredients:
- Microencapsulated fragrances — where the capsule shell is a synthetic polymer (polyurea, polyacrylate, urea-formaldehyde condensate). Many fragrance suppliers use polymer-shell encapsulation as standard. For rinse-off applications, these are restricted as of October 2027. Fragrance houses are required to disclose shell composition, but not all do so proactively — you need to ask specifically.
- Acrylates copolymer in particulate form — some film-forming and texturising agents are supplied as aqueous dispersions of discrete particles rather than true solutions. Whether a given acrylates copolymer constitutes an SPM under the regulation depends on particle size and dispersion state; this cannot be assumed from the INCI name alone.
- Certain silicone elastomers and cross-polymers — dimethicone/vinyldimethicone crosspolymer and similar materials, when supplied as discrete particles, may fall within scope depending on their characterisation.
Likely excluded — but verify in writing:
- Microcrystalline cellulose (MCC) — natural polymer, unmodified, generally excluded
- Carnauba wax beads, candelilla wax — natural waxes, excluded
- Fumed and precipitated silica — inorganic mineral, not a polymer, unaffected by this restriction
- Hydroxyethylcellulose, hydroxypropyl methylcellulose — natural backbone, not chemically synthesised
That last column matters as much as the first. A raw material that is confirmed compliant should be documented as such. A REACH Certificate of Conformance that states general “compliance with REACH Regulation (EC) No 1907/2006” without addressing Entry 78 specifically is not adequate documentation for this restriction.
Building Your Reformulation Roadmap Before the Deadline
With the rinse-off deadline 17 months out, the formulation review process needs to start now — not in Q3 2026. Here is the practical sequence.
Step 1: Conduct a full SPM ingredient audit across your rinse-off portfolio
Go ingredient by ingredient through every INCI declaration for every rinse-off SKU. Flag any synthetic polymer listed without confirmation of particle size exclusion, water solubility, or biodegradability. This is a documentation exercise, not a chemistry exercise — it can be completed quickly and tells you exactly where you’re exposed before any reformulation cost is incurred.
For most mid-size manufacturers, this audit reveals that 15–30% of their rinse-off portfolio contains at least one ingredient requiring further assessment, the majority of which is not polyethylene.
Step 2: Request SPM-specific declarations from raw material suppliers
A standard Safety Data Sheet will not confirm SPM status under Entry 78. Contact each supplier of a flagged ingredient and request a written declaration confirming whether the material constitutes a synthetic polymer microparticle as defined under Commission Regulation (EU) 2023/2055, Entry 78 of Annex XVII to REACH. Suppliers who cannot provide this within a reasonable timeframe present a supplier qualification issue in their own right — and an indication that they haven’t yet worked through their own compliance obligations.
Step 3: Qualify alternative ingredients
The alternatives market has developed substantially since 2020, and for most affected ingredient categories, compliant replacements with comparable functional performance exist.
- Exfoliants: jojoba wax beads (INCI: Simmondsia Chinensis Seed Wax), cellulose microbeads (various botanical sources), pumice, rice bran wax spheres
- Powder slip and soft-focus (Nylon-12 replacement): this is technically the hardest substitution. Synthetic fluorphlogopite (a boron-modified mica), hollow silica microspheres, and certain biodegradable polyester systems are being evaluated across the industry — but particle morphology, skin-feel, and oil absorption characteristics differ from Nylon-12, and each requires independent toxicological assessment
- Soft-focus texturisers (PMMA replacement): silica-based spherical particles, starch-derived spheres (e.g. Tapioca starch), naturally derived acrylate alternatives that meet biodegradability criteria
- Encapsulated fragrances: fragrance houses are increasingly offering biodegradable shell systems; transition planning should include fragrance reformulation discussions alongside cosmetic formulation work
Step 4: Run stability and preservation testing on reformulated products
A formulation change — even a direct swap of one powder for another — constitutes a material change under EU Cosmetics Regulation 1223/2009. It requires stability verification (typically 12 months under accelerated and real-time conditions), and depending on the change, re-assessment of preservative efficacy. This is the step that most compresses available time. Stability testing has a fixed duration; it cannot be shortened retrospectively to meet a regulatory deadline.
The Knock-On Effect on Your Product Information File and CPSR
Reformulation doesn’t stop at purchasing a different raw material. Under Article 11 of Regulation (EC) No 1223/2009, the Product Information File (PIF) must be maintained and kept up to date for the entire period the product is on the market, plus ten years thereafter. Any change to the quantitative or qualitative composition triggers a PIF revision.
That revision requires:
- An updated formulation document with corrected INCI list and ingredient concentrations
- Revised raw material specifications and updated supplier documentation for the alternative ingredient
- A revised Cosmetic Product Safety Report (CPSR), both Part A (safety profile) and Part B (safety assessment), signed off by a qualified safety assessor meeting the criteria of Annex I to the Regulation
- Updated stability and challenge (preservative efficacy) test data where relevant
- Updated labelling review, particularly where INCI list changes affect consumer-facing information
For manufacturers reformulating 20, 30, or more SKUs simultaneously against a common deadline, safety assessor availability is a genuine constraint. Qualified assessors with bandwidth to process a batch of revised CPSRs within a 6-month window are already receiving enquiries — this is not a Q1 2027 problem to solve.
Finally, the CPNP (Cosmetic Products Notification Portal) record for each reformulated product must be updated before the product with the new formulation is placed on the EU market. The notification itself is the final step, but it cannot proceed until the PIF is complete and the CPSR is signed.
The One Thing to Do Before Any of This
Run the SPM audit. Before contacting alternative suppliers, before engaging a safety assessor, before reviewing fragrance supplier agreements — know exactly which products in your rinse-off portfolio contain ingredients that require action. It is a bounded exercise, it produces a clear action list, and it gives you the information needed to scope timelines and costs with precision rather than assumption.
Manufacturers who started this process in 2024 or early 2025 are now in reformulation and stability phases, on track for October 2027 with time to spare. Those starting in mid-2026 are manageable but tight. Those waiting until late 2026 will face compressing options and increasing pressure on stability testing timelines, safety assessor availability, and procurement lead times for alternatives.
The regulation is clear. The deadline is fixed. And 17 months, while it sounds like a long time, is roughly one stability study cycle away.
Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team
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Scritto da
Nour AbochamaQuality & Regulatory Advisor, Care Europe | VP Operations, Qalitex
Chemical engineer with 17+ years of experience in laboratory operations, quality assurance, and regulatory compliance across Europe and North America. VP of Operations at Qalitex (ISO/IEC 17025 accredited US laboratory). Through Care Europe, leads the European entry point to a partner-lab network across the USA, Canada, and local Europe — specialising in USA FDA + Health Canada compliance for European exporters and herbal & supplement testing (a rare expertise on the European continent).
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