REACH is not a cosmetic regulation, & that single fact explains most of the confusion that surrounds it on a brand side. The European cosmetic regulation governs what a cosmetic product may contain, how it must be labelled, who the responsible person is & what file must be held before placement on the market. REACH governs substances as such, in whatever mixture or article they travel, & it places duties on manufacturers, importers & downstream users rather than on brands as such. A cosmetic shipment sits in both regimes at once, & the second one is the reason a buyer finds themselves asking a factory for documents that have nothing to do with the product's performance.
This note sets out where the two systems overlap in practice, who normally carries the registration duty for a substance imported into the European Union, which categories of cosmetic ingredient most often attract questions, what the 0.1% communication threshold for substances of very high concern actually means in arithmetic terms, how the restriction list differs from the authorisation list & why that distinction matters to a formulator, which document set a brand should ask a manufacturer to hold or provide, what separates a usable declaration from an unusable one, how the duties change once the substance is blended rather than imported, & the gaps most often found when a brand reviews a supplier file for the first time. It describes what the paperwork typically looks like rather than what any particular product's position is, & nothing here should be read as a statement that any product meets a given rule.
Where REACH meets a cosmetic shipment
A cosmetic product entering the European Union is a mixture of substances. Each of those substances has its own status under REACH, decided by who manufactured it, where it was manufactured, & whether it was registered for that use. The mixture itself is not registered. That is the structural point most miss: there is no registration certificate for a finished cosmetic, & any document presented as one should be examined closely to see what it actually attests.
The duties attach to roles rather than to companies in the abstract. A manufacturer is a legal or natural person established in the Union who manufactures a substance there; an importer is one established in the Union who is responsible for import; a downstream user is one established in the Union who uses a substance, in the course of industrial or professional activities, other than the manufacturer or importer. A brand established outside the Union & shipping to a distributor is none of those, which means the duties it worries about belong primarily to whoever imports.
That allocation is why the conversation usually runs through the importer. The importer needs data to support its own position, it asks the supplier for that data, & the supplier asks the raw material producer. The chain therefore starts at the substance manufacturer & travels forward, & a break anywhere along it produces the familiar situation where nobody can answer a simple question about one component of one raw material.
The penalty for discovering this late is measured in product rather than in paperwork. If a substance turns out to be unregistered for the imported tonnage, the practical remedy is to source elsewhere, which means re-formulating, re-running stability & possibly re-assessing. Doing that check while a brief is still open costs very little next to doing it after the first commercial run has been filled.
Registration status & the importer's position
Whether a given substance needs registration depends on tonnage, on whether it has been registered already by another party, & on whether any exemption applies. Several exemptions matter to cosmetic work. Substances used in a cosmetic product within the scope of the cosmetic regulation have historically benefited from provisions that moved or waived certain registration duties for that end use, & those provisions have changed over time, so the correct answer depends on the date the duty is being assessed as well as on the substance. The honest formulation for a buyer is to ask which substances in the formula are registered for which uses, by whom, & at what tonnage band, rather than to ask whether the product is registered.
For a manufacturer based outside the Union, the usual route is either to rely on the importer having covered the substance, or to appoint an only representative — a legal or natural person established in the Union who takes on the registration & related duties for a specified set of substances & importers. Where an only representative exists, the downstream importers are regarded as downstream users rather than importers, which changes their obligations. A brand should be able to obtain the identity of that representative & the list of substances it covers, because the coverage is specific & not universal.
The practical questions to put to a supplier are then short & answerable. Which substances in this formula were manufactured or sourced outside the Union? For those, is there registration for the tonnage & use involved, & who holds it? Is there an only representative covering them, & can the declaration be produced? Are any of them covered by an exemption that is specific to cosmetic end use? A supplier who cannot answer those four is not necessarily non-compliant, but is definitely not able to support an importer's file.
Timelines are worth building into a project plan. Assembling declarations for every component of a multi-ingredient formula is a matter of weeks rather than days, because each raw material supplier has its own form & its own response time. Some charge for the work. Some will only release volume-banded statements. Waiting until the goods are ready to ship to ask for the file is the version of this that ends badly.
Substances that most often raise questions
Not all ingredients attract the same attention, & it is worth knowing which categories generate friction so the right ones get checked first. Certain solvents & glycol ethers have been restricted or moved onto the authorisation list over successive updates; cyclic siloxanes have been subject to restriction on the grounds of persistence & mobility, with conditions & transition periods attaching to particular uses; certain phthalates & some plasticiser-type materials have long carried restrictions in some applications; per- & polyfluoroalkyl substances have attracted a wave of restriction proposals across several jurisdictions; some preservatives sit both on a cosmetic annex & on a substance restriction; & certain ultraviolet filters & stabilisers appear in the candidate list or have been assessed under related programmes.
Fragrance is the difficult case, because a fragrance compound is itself a mixture, sometimes containing dozens of components, & it is the place where a composition gap most often appears. Suppliers handle this differently: some release full composition to a confidential third party, some release a restricted list, some release only the components above a stated threshold. A brand importing at meaningful volume needs to know which of those it will get, because the downstream arithmetic cannot be performed without the composition.
Botanical extracts & fermentation products add their own layer. An extract is a mixture within a mixture, sometimes carried in a solvent that is itself a regulated substance; the part of the material that is actually the active substance may be a small fraction of what is delivered, & the concentration declared on a specification may refer to the raw material rather than to the substance of interest. Getting that ratio right is what makes the percentage arithmetic possible.
Then there is the category nobody budgets for: impurities, residuals & reaction by-products. Monomer residues in a polymer, heavy metal traces carried in a mineral pigment, 1,4-dioxane present as a residual from an ethoxylation step, nitrosamine precursors from certain amine combinations, & pesticide residues in a plant-derived material all sit below the headline numbers & all can carry obligations. A specification that only declares the nominal composition does not support these checks, which is why the requirement belongs in the raw material specification rather than in a general quality document.
Substances of very high concern & the 0.1% threshold
The candidate list of substances of very high concern is maintained & updated at intervals, & inclusion triggers communication duties rather than an automatic prohibition. The figure to remember is 0.1% weight by weight. Where an article supplied by one party to another contains a candidate list substance above that concentration, the supplier must provide sufficient information to allow safe use, which in practice means identifying the substance & saying where it sits.
Where the candidate substance is present in a mixture rather than an article, the relevant duty is different: a safety data sheet has to be supplied for mixtures meeting the classification criteria, & where a non-classified mixture contains a listed substance individually at or above 0.1% w/w (or lower where a specific entry sets a lower specific concentration limit), that substance should be identified on request. The distinction between the two framings is technical & it decides which route applies, so it belongs in front of whoever prepares the file rather than being assumed.
The arithmetic itself is where most errors occur. The threshold is 0.1% of the article or mixture as supplied, not 0.1% of the raw material, so a component used at five percent in a finished product that itself contains two percent of a listed substance delivers 0.1% in the finished product & lands exactly at the boundary. Doing that sum for every component requires the full composition of every component, which is why the composition request in the previous section is not a formality.
The list also moves. A substance absent at the time a file was compiled can appear at the next update, which is why the file should carry the date of the check & the version of the list it was checked against. Re-checking the candidate list is cheap; discovering that a launched product now triggers a communication duty is not.
Annex XVII restrictions & the conditions attached
Restrictions are the part of the framework that directly tells a formulator what cannot be done. Each entry names a substance or a group, specifies the use or the concentration that is limited, sets the conditions, & sometimes provides a derogation for certain applications with a sunset date. The important habit is to read the conditions rather than the substance name, because the restriction frequently applies to particular uses, particular concentrations or particular routes of exposure rather than to presence as such.
Restrictions overlap with cosmetic annexes in a way that surprises people. A material may be permitted as a cosmetic ingredient for one function & at one concentration while being restricted for a different function or route of exposure by a restriction entry. The two lists are maintained separately, they do not reference each other consistently, & the answer to any specific question comes from reading both rather than either.
The most common practical failure is not a deliberate breach but an inherited one: a raw material specification unchanged for years that no longer matches either the current annexes or the current supplier composition. Because both move, a check that passed three years ago is not evidence today. Building a re-check into the specification review cycle is the low-effort answer.
Authorisation is a different instrument & worth distinguishing. Where a substance moves onto the authorisation list, use after the sunset date requires an authorisation granted for a specific use, & that authorisation belongs to whoever applied for it, extending to their downstream users under defined conditions. A downstream party cannot simply assume coverage; it must establish that its own use falls within an authorisation held somewhere up its supply chain. This is a question to ask rather than to assume, & the answer is usually found at the raw material supplier rather than at the formulator.
The document set a brand should request
What follows is what such a file typically contains, & it is what a brand is normally entitled to request from a manufacturing partner; it is not a statement that any particular factory holds all of it, & the exact contents depend on the role each party plays in the chain. The usual starting point is a full qualitative & quantitative composition of the finished product, with each raw material identified by its INCI name, its CAS or EC number where one exists, its supplier, & its percentage at the upper & lower ends of the permitted range. Without the identities, nothing else in the file can be checked.
The second item is the declaration set from the raw material suppliers: statements addressing whether each material contains candidate list substances above the relevant threshold, whether it is subject to any restriction entry, whether it was produced or imported into the Union & by whom, & whether any animal-derived content or any nanomaterial form is present. Some suppliers provide all of this on one form, others need several requests, & a few will only answer through the brand rather than to the factory.
The third is the safety data sheet set. Whether a finished cosmetic requires one depends on its classification; where one is produced for a raw material it must be dated, in the language of the destination, & in the current format. Collecting the set is only half the job — checking that the revision date on a raw material sheet matches the composition actually being used is the other half, & it is where discrepancies are usually found.
The fourth is the change history & the trigger mechanism, which is described below. Then come the supporting pieces: the specification & certificate of analysis per raw material, the allergen declaration for any fragrance, a residual solvent statement where a relevant process step is used, statements on nanomaterial content & on animal testing position, & where a claim or a particular ingredient standard is involved, the evidence behind it. Broader context on how these pieces fit together for export work is set out in our guide to European Union compliance for manufacturers based in China, & the product-level evidence that travels alongside it is covered in our note on stability work for export programmes.
Supplier declarations: what makes one usable
A declaration is only useful if it is specific, dated, signed by a named function, & traceable to a material identity. Vague statements — "contains no restricted substances" without a stated list, without a version date, without a material reference — cannot be checked & therefore cannot support anything. The three attributes worth insisting on are the exact material identity (trade name & grade, not just supplier name), the version of the regulation or list the declaration was made against, & the date.
Confidentiality is the predictable obstacle. A raw material supplier will often decline to release full composition to a brand directly, because the composition is its intellectual property. The usual resolution is release to a named third party under a confidentiality agreement, or release of a threshold declaration — confirming that nothing above a stated concentration is present — without identifying every component. Both work; neither is as good as full composition, & the difference should be understood rather than ignored.
Then there is the distinction between a one-off statement & a maintained one. A declaration produced once for a specific order does nothing for the next order. What supports an importer's position over time is a standing arrangement in which the supplier notifies changes, & the buyer should ask whether that notification commitment exists, in writing, rather than assuming it does.
Finally, watch the scope wording. A statement covering "the European Union" may not address Great Britain, Switzerland, Turkey, the United States, Canada, ASEAN member states, Japan or Korea, each of which maintains its own inventory, its own thresholds & its own forms. Asking which jurisdictions a declaration covers often reveals that the answer is narrower than the heading suggested.
Downstream user duties & exposure scenarios
Once a registered substance has been imported, anyone using it in the Union in the course of a professional activity is a downstream user. The obligations that follow are conditional rather than universal: they apply where the registration has identified use & exposure scenarios that must be complied with, & they amount to using the substance in a manner consistent with what the registration covers. Where the use falls outside the identified conditions, the downstream user has either to inform the supplier so that the exposure can be assessed, or to carry out the assessment itself.
For cosmetic blending this usually resolves into three checks. Is the quantity used within the identified scenario? Is the route of exposure comparable — mixing in a closed vessel with local extraction is not the same as an open transfer in a room without extraction? Is the concentration in the mixture within the identified band? Each is answerable from process knowledge rather than from laboratory work, & each should be documented, because the alternative is a claim of compliance that rests on nothing.
Where a brand blends nothing & only fills, its own position is simpler. Its obligation centres on what it places on the market & on the file it holds as responsible person under the cosmetic regulation rather than on industrial exposure. Mixing the two identities up is a common source of wasted effort: brands assemble elaborate downstream user documentation they do not need, & overlook the responsible person file they do.
The third case is the one that catches out mixed businesses: a party that both imports & blends, or that fills for several brand owners, may occupy more than one role at once for different products. Roles are assessed per substance & per activity rather than per company, so the correct answer for such a business is a matrix rather than a single statement.
Components, articles & the packaging side
REACH also reaches articles, & an article is an object whose shape, surface or design determines its function to a greater degree than its chemical composition. Packaging components clearly qualify: a moulded closure, an extruded laminate, a printed carton, an applicator tip. An article has no safety data sheet unless it is classified, & it triggers the 0.1% candidate list communication duty when a listed substance is present above the threshold in the article as supplied.
For a cosmetic pack the substances of interest sit in a short list: plasticisers & other additives in a flexible polymer, residual monomers in a moulding, substances in a coating or a lacquer, components of a printing ink & its photoinitiator package, substances in an adhesive, silicone-based release coatings on a liner paper, & historically certain substances in metal & in glass formulations. Each of those needs a declaration from whoever produced the component, which means asking the component supplier rather than asking the cosmetic factory.
Recycled content adds an unpredictable variable. A recycled polymer stream may carry legacy additives that were lawful when the material was first made & that are no longer acceptable in some applications. This is why recycled content should be accompanied by a declaration addressing the candidate list rather than merely by a recycled-percentage claim, & why the supplier of that material should be asked for its own upstream sources.
Coverage by another regime is the last point. Where a component is regulated as a food contact material, as a toy, or under a sector specific rule, that regime may set its own rules that sit alongside rather than replace what is required here. Assuming one covers the other is the error; asking whether both apply is the cheaper habit.
Common gaps found during a file review
The gaps that show up repeatedly when a brand reviews a supplier or factory file are predictable enough to list. A composition document without CAS or EC numbers, so nothing can be checked against any list. An out-of-date safety data sheet set, where several component sheets are three or four years old. A supplier declaration with no material identity attached, making it impossible to bind the statement to a specific purchase. A fragrance declared as a single line item with no component information available at any threshold. A raw material specification that has never been re-checked against the current annexes.
The second cluster concerns version control. Two documents describing the same raw material with different concentrations. A certificate of analysis whose test parameters do not match the specification it is supposedly testing against. A composition held in a development document rather than in the released manufacturing document, with the two having diverged at some point nobody recorded.
The third cluster is about people & responsibility. No named owner for keeping the file current. No defined trigger for revisiting it when something upstream changes. No route by which the component supplier's change notifications reach the party that needs to act on them. Each of those is cheap to fix before a shipment & expensive after one.
The last is common & least discussed: a file assembled against one destination market & reused for another. The European Union, Great Britain, Switzerland & Turkey maintain inventories & lists that are related but not identical, & the differences are exactly in the fields a buyer is most likely to copy across.
REACH data items at a glance
The table below sets each item a brand normally asks for against what it supports, who typically holds it, & the point most often overlooked. The rows describe how such files usually work rather than what is required of any particular product; the applicable duties depend on the substance, the role each party plays & the market, & should be confirmed with the competent authority.
| File item | What it supports | Who normally holds it | Watch point |
|---|---|---|---|
| Full qualitative & quantitative composition | Every downstream check that follows | Factory as the formulator | Identifiers absent make it unusable |
| Candidate list statement by raw material | The 0.1% communication arithmetic | Raw material supplier | Threshold is of what is supplied |
| Restriction & authorisation declarations | Whether the intended use is permitted | Raw material supplier | Conditions not just the substance name |
| Registration & only representative details | The importer's own position | Importer or representative | Coverage is per substance, not general |
| Safety data sheet set with revision dates | Hazard communication down the chain | Supplier of each material | Revision dates drift quietly |
| Fragrance composition at a stated threshold | Allergen & candidate list arithmetic | Fragrance house under confidentiality | Suppliers vary widely in what they release |
| Article declarations for pack components | The 0.1% duty for the components | Component manufacturer | Recycled content carries legacy additives |
Read the rows as a dependency chain. The composition unlocks the candidate list arithmetic; the candidate list arithmetic decides whether a communication duty arises; the registration details decide who carries what; & the article declarations cover everything that is not the formula. A gap in the first row makes every later row impossible to complete properly, which is why it is the one to insist on first.
What to put in the brief
A regulatory brief is not a request for a certificate. It is a request for data & for declarations that can be checked, & it works best when it names the destination markets, the role the factory is being asked to play, & the identities that have to accompany every line of the composition. Vague requests produce vague documents, which are worse than none because they give false comfort.
- The destination markets, named individually rather than as a region.
- Whether the brand or a nominated importer is established in the European Union.
- Whether full composition will be released to the factory or only to a third party.
- The identifiers required per component: trade name, grade, CAS or EC number, supplier.
- Which jurisdictions each supplier declaration must cover, & against which list version.
- Whether a safety data sheet set is required, in which languages, & at what revision age.
- How change notifications will reach the party responsible for updating the file.
- Who owns keeping the file current after the first shipment has gone out.
Then agree the practical mechanics before the first order rather than after it: who writes to which supplier, who pays for supplier declarations that are chargeable, how long the collection has to be allowed for, & what happens when a requested declaration cannot be obtained for one component. Those four answers decide whether the file gets assembled in time to inform the formulation or only in time to delay the shipment.
Where our capability fits
We regard the compliance file as part of the development deliverable rather than as an export formality. That means the composition is captured with identifiers at the point a formula is frozen, raw material specifications are requested with the declarations attached rather than without them, the fragrance route — full composition, threshold declaration or third party release — is agreed while the material is still selectable, & a named revision date is stamped on every document so that a future check knows which list version it succeeded against. Where a request depends on our suppliers rather than on us, we say so at the start rather than at the shipping date.
We work with brands on private label (your brand on a proven base), OEM/ODM contract manufacturing & full custom formula development, & we are clear about which parts of the regulatory position belong to the role we play & which belong to the importer or the responsible person. The same file discipline applies across a vitamin E serum softgel programme, a lotion filled into a pump bottle & a cleanser filled into a tube, where the composition, the raw material declarations & the component declarations all sit in one file per project.
Tell us the markets you are planning for, the volume band & how the goods will be imported, & we will come back with the list of documents we can provide, the list that has to come from our suppliers, & the parts that belong to your importer. Start at our inquiry page, email capsulebiotech@163.com, or message us on WhatsApp at +86 158-7655-5319.
General manufacturing information, not regulatory or legal advice. The duties described depend on the substance, the role each party holds in the supply chain, the tonnage band & the destination market; the candidate list, the restriction entries & the applicable exemptions change over time; & the resulting position for any specific product must be confirmed with the competent authority in the market where the product will be placed.