REACH Regulation Compliance and Microplastics: What Every EU Cosmetics Brand Needs in Their PIF Right Now

Three years after Commission Regulation (EU) 2023/2055 entered the Official Journal, a significant number of the cosmetics brands we work with are still treating the microplastics restriction as a future compliance task. It isn’t. For certain product categories, the transition windows are closing — and the labelling obligation that runs during those windows is already in force.

The restriction operates as an amendment to REACH Annex XVII, creating Entry 78 for intentionally added microplastics. It spans dozens of product categories. Cosmetics sit firmly in scope. And unlike some EU regulations that leave interpretation to Member State authorities, this one is directly applicable and enforceable across all 27 markets where your products are placed.

If your formulation contains synthetic polymer particles ≤5mm that do not biodegrade under the criteria set out in the regulation, you have a documentation and reformulation issue that belongs in your Product Information File today — not on next quarter’s agenda.

What REACH Entry 78 Actually Restricts — And the Definitions That Matter

Entry 78 restricts the placing on the market and use of substances consisting of synthetic polymer microparticles no larger than 5mm, provided those polymers are not biodegradable, not naturally occurring, and not soluble in water. The word intentionally carries significant weight. Secondary microplastics — particles generated through product wear, abrasion, or degradation during normal use — fall outside this restriction. Only those deliberately incorporated into a formulation to serve a function are in scope.

For cosmetics formulators, that covers more ingredients than most assume at first glance:

• Polyethylene (PE) microbeads in facial and body exfoliating cleansers
• Polymethyl methacrylate (PMMA) microspheres used as texture agents in primers and foundations
• Polyester and PET-based glitter in colour cosmetics, body lotions, and bath products
• Nylon-12 and Nylon-6 particles used as slip agents and smoothing powders in pressed products
• Synthetic polymer microcapsules encapsulating fragrance components in rinse-off formulations

And critically — what is not captured. Naturally occurring polymers such as cellulose, starch, and chitosan are excluded. Synthetic polymers that meet the biodegradability criteria established in the regulation — tested using OECD 301, 302D, 310, or equivalent methods — are also outside the restriction’s scope. Certified biodegradable alternatives from both biobased and synthetic sources are available, but the biodegradability must be substantiated with data. A supplier’s marketing claim does not satisfy that burden.

ECHA’s Annex XV Restriction Report, which formed the basis of the legislative process, estimated that approximately 36,000 tonnes per year of intentionally added microplastics are used in products sold in the EU across all sectors. Cosmetics and personal care products rank among the highest-volume end uses — which is precisely why regulators prioritised this category.

The Transition Timeline: Not One Deadline, But Several

One reason brands miscalculate their exposure here is the assumption that there’s a single compliance date. There isn’t. Entry 78 operates on staggered timelines based on product category and the functional role of the microplastic in the formulation.

Rinse-off cosmetics containing microplastics as exfoliants or abrasives face the earliest deadlines. This is the classic microbeads use case — PE beads in facial scrubs, exfoliating body washes, and cleansing polishes. Given the direct aquatic exposure pathway from rinsing down drains, regulators set the shortest transition windows here. If your rinse-off exfoliant is still formulated with synthetic polymer abrasives and you haven’t initiated a reformulation programme, you’re likely in or approaching non-compliance territory.

Leave-on cosmetics — including foundations, primers, setting powders, body lotions, and eyeshadow formulations containing synthetic polymer texture agents — benefit from a longer transition window, extending to 6 years in certain categories. Six years from October 2023 is October 2029. But reformulating a colour cosmetics range is not a six-month exercise. Product development, safety assessment by a qualified assessor, CPNP re-notification, stability and compatibility testing, and packaging updates combine to make 18–30 months a realistic minimum for complex ranges. Brands that start that process in 2026 are already working against a compressed schedule.

Fragrance encapsulants — the microcapsules that rupture on skin contact and release scent during or after use — carry the longest transition period, up to 12 years in some configurations. The technical complexity of replacing encapsulation systems justifies the extended window, but ECHA has flagged this category for ongoing monitoring. A 12-year transition is not a 12-year reprieve from planning.

Cosmetic glitter sits in its own regulatory space. Plastic-based glitter in rinse-off products faces tighter deadlines than the same ingredient in a leave-on nail product, where technical substitution challenges are greater. If your product range includes bath bombs, body shimmer washes, or glitter-containing shower gels, the pressure is already on to substantiate your transition timeline or demonstrate reformulation progress.

During any applicable transition period, a labelling obligation applies: products that still contain intentionally added microplastics must carry the on-pack statement “This product contains microplastics.” That is a live, enforceable obligation right now — not something that applies only after the transition deadline passes. We are seeing some enforcement interest from national market surveillance authorities, and a missing label statement on an in-transition product is a straightforward violation to cite.

What Your Product Information File Must Document

Here’s where REACH Entry 78 and EU Cosmetics Regulation (EC) No 1223/2009 converge — and where we see the most gaps in practice. The PIF, required under Article 11 of Regulation 1223/2009, must be complete, up to date, and available to competent authorities on request. Microplastics compliance is now a substantive component of that file.

Ingredient-level polymer assessment. Every synthetic polymer in your INCI list must be evaluated against the Entry 78 definition. This goes beyond the obvious microbeads. Film formers, fixatives, binding agents, and encapsulants that consist of or contain synthetic polymer particles within the ≤5mm size range all require active evaluation. Many brands discover during formulation audits that certain performance ingredients they assumed were exempt are not.

Biodegradability substantiation. If you are relying on the biodegradability exemption to retain an ingredient in your current formulation, that claim requires test data. The accepted test methods under Entry 78 include the OECD 301 series (ready biodegradability), OECD 302D (inherent biodegradability), and OECD 310 (CO₂ in sealed vessels). A supplier Safety Data Sheet that mentions biodegradability, or a certificate from an unnamed internal method, does not satisfy this requirement. The test reports, or a documented reference to them, need to be in your PIF.

Particle size characterisation. For ingredients used as coatings, dispersants, or carrier systems rather than as discrete particles, particle size analysis determines whether Entry 78 applies. Laser diffraction or dynamic light scattering data from your supplier — or from third-party testing — provides the characterisation your safety assessor needs to make a reasoned determination. If your supplier’s CoA does not include particle size distribution data, request it before your next audit.

Transition period eligibility and labelling compliance. If a product is still formulated with in-scope microplastics while relying on a transition window, the PIF should document that eligibility clearly: which transition provision applies, the product category justification, the applicable deadline, and evidence that the on-pack labelling obligation is being met. This creates an auditable record — and demonstrates to any inspecting authority that the Responsible Person is managing the transition actively, not passively.

The Responsible Person under Article 4 of Regulation 1223/2009 — whether that is your in-house EU legal entity or an appointed RP — bears the obligation to ensure the PIF reflects current regulatory requirements. An incomplete or outdated PIF is a standalone violation, independent of the underlying microplastics status of the formulation.

Reformulation Options Worth Evaluating

The alternatives market has matured significantly since the restriction was first proposed. Several substitution paths have proven viable at commercial scale:

Cellulose-based particles derived from wood pulp or agricultural residue are now widely available with established INCI designations. Performance as a physical exfoliant is comparable to polyethylene microbeads for most face and body applications. Biodegradability data is available from major ingredient houses, and particle size distribution can be controlled to match formulation targets.

Amorphous silica and calcium carbonate particles are unrestricted by Entry 78 and have decades of safety data behind them. They function effectively as mild abrasives in cleansers and toothpaste. If your brief is gentle exfoliation rather than the very fine spherical texture of PMMA, these are often the fastest reformulation route.

Biodegradable polyhydroxyalkanoates (PHAs) represent a more technically sophisticated option for applications where the spherical morphology of PMMA or nylon particles is required. PHAs are biosynthesised by microorganisms and biodegrade in both soil and aquatic environments under standard test conditions. Cost premiums remain above petrochemical equivalents, though the gap has narrowed as production scale has increased over the past two years.

For synthetic glitter substitution, cellulose-based and mica-based alternatives have improved substantially. Biodegradable glitters based on regenerated cellulose with metallic coatings now achieve colour depth and reflectivity acceptable for most colour cosmetics applications. Very specific optical effects — deep holographic or fine iridescent finishes — remain more technically challenging to replicate, and those are the cases where the longer transition windows become genuinely relevant.

One practical point worth emphasising: reformulation triggers CPNP re-notification. A change to the qualitative or quantitative composition of a cosmetic product — removing an INCI ingredient, substituting one polymer for another — constitutes a notification-triggering modification under the Cosmetic Products Notification Portal. Your regulatory timeline and your formulation development timeline need to be coordinated from the start, not reconciled at the end.

Start With Your Rinse-Off Range, and Start Now

Entry 78 compliance is not theoretical risk management. It’s active enforcement territory, and the labelling obligation is already in scope for any product that still contains intentionally added microplastics regardless of transition status.

The right first step is a formulation-level inventory: pull every synthetic polymer from your INCI declarations, assess each against the ≤5mm size and biodegradability criteria, identify those that require reformulation, and map your transition timelines by product category. For brands with mixed ranges — some rinse-off, some leave-on, some colour — that inventory will quickly surface where the priority effort needs to go.

Rinse-off exfoliants first. Then colour cosmetics relying on PMMA or nylon texture particles. Fragrance encapsulants last — but not forgotten.

The brands we see managing this well started the formulation review 12 to 18 months ago. If you’re beginning now, there’s still time to get compliant within most transition windows — but not time to be casual about it.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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• ISO 17025-accredited ingredient testing and polymer characterisation for REACH compliance documentation — Qalitex Laboratories supports EU cosmetics brands with particle size analysis, biodegradability substantiation data, and supplier ingredient verification to build a complete PIF.
• Cosmetics compliance and GMP support for brands entering the North American market — Androxa helps European brands navigate Health Canada’s Cosmetic Ingredient Hotlist and Canadian GMP requirements alongside their EU compliance obligations.