Key takeaways
A specification defines acceptance criteria; a certificate of analysis reports information about a particular lot.
Request composition information for the whole supplied mixture, including carriers and preservatives, not just the advertised active.
An SDS supports chemical handling and hazard communication. It does not replace the finished cosmetic's safety assessment.
Link supplier approval, delivery records and ingredient lots to the finished batches that use them.
Request documents for the exact ingredient grade you intend to buy. You need its specification and composition, relevant safety and impurity information, storage instructions and a certificate of analysis (CoA) for the delivered lot. A brochure and an ingredient name are not enough to approve a material for production.
Your formulator and safety assessor need to know what enters the finished product. Your quality team must also check whether the shipment matches the approved material. Agree who collects and reviews the documents when choosing a cosmetic lab, before ordering ingredients for production.
Legal requirements and purchasing standards
For EU cosmetics, the responsible person must ensure a safety assessment and cosmetic product safety report before placing the product on the market. Annex I requires information on composition, physical and chemical characteristics, microbiological quality, purity and toxicological profiles. The regulation requires this information but does not prescribe a universal set of supplier documents. See Regulation (EC) No 1223/2009, Article 10 and Annex I.
The Commission’s guidelines on the cosmetic product safety report, sections 3.1 and 3.2.1, state that specifications should be available for each raw material actually used, and substances within supplied mixtures need appropriate identification and quantification.
The receiving checks and supplier request below are recommendations, not prescribed legal procedures. Adapt them to the material, intended use and market. For US products, FDA describes a separate requirement to maintain records supporting adequate safety substantiation; an EU dossier should not be treated as a substitute for assessing US obligations. See FDA’s MoCRA overview.
Request documents by purpose
Use the supplier’s product code and grade on your request. Documents for a different concentration, extraction solvent or manufacturing site may describe a different material despite a similar trade name.
| Document or information | What to request | What it does not establish |
|---|---|---|
| Controlled specification | Grade, revision, acceptance limits and test methods for relevant identity, physical, chemical and microbiological attributes | Whether the delivered lot meets those limits |
| Lot-specific certificate of analysis (CoA) | Supplier lot, results or defined conformity statements, units, applicable specification and authorization | The complete formulation’s safety or every possible contaminant |
| Composition statement | Ingredient identities and quantitative information sufficient for formulation and safety assessment, including carriers and preservatives | Permission to use every component in every market |
| Safety data sheet (SDS), where applicable | Current version for the supplied material, covering hazards, handling and storage | A cosmetic product safety report or finished-product approval |
| Technical and safety information | Processing conditions, storage, shelf life or retest basis, relevant toxicology and impurity data | Guaranteed performance in your formulation |
| Claim or certification evidence, if needed | Scope, applicable grade, validity and supporting records for the intended claim | General cosmetic compliance or batch release |
An SDS communicates a material’s properties and hazards, along with handling, disposal, transport and protective measures. ECHA explains that the duty to supply one depends on the substance or mixture; not every ingredient requires an SDS. If none is supplied, request the reason and sufficient safe-use information. See ECHA’s safety data sheet guidance.
Check what the trade ingredient actually contains
A botanical extract may arrive as a mixture of extract, water, glycerin and preservative. The advertised INCI name or marketing description may omit constituents the formulator needs to calculate the final composition.
Ask for the identity and quantity of constituents needed by your assessor, with a confidential disclosure route where necessary. The Commission’s section 3.1 guidance explicitly covers solvents, antioxidants and preservatives introduced through raw materials. It treats fragrance compositions separately: request the composition code, supplier identity, regulated-substance information and safety-relevant disclosure rather than assuming a public fragrance recipe is required.
Record the manufacturing grade, source and relevant process information too. For a plant extract, useful questions include species, plant part, extraction solvent and carrier. For a dispersion, ask about active content and the dispersing medium. Resolve inconsistent identities across the specification, composition statement and CoA before approving the material.
Record the information and document versions in your product information file workflow. Keep copies rather than relying on a supplier portal whose contents can change without notice.
Ask about risks specific to the material
Request evidence for plausible concerns rather than sending every supplier the same contaminant list. The Commission’s section 3.4.1 guidance explains how origin, manufacturing process and solvents inform the evaluation of impurities and traces.
For an aqueous plant ingredient, ask about microbiological specifications, preservation and storage after opening. For an ingredient made using solvents, ask which residual solvents are relevant and how they are controlled. Mineral ingredients may need information on relevant elemental impurities. Particulate ingredients may require particle-size information. The safety assessor should decide what evidence is necessary for the intended product.
Ask whether each reported value comes from testing that lot, periodic checks or process knowledge. The supplier should distinguish declarations based on process knowledge from analytical results.
Claims need a separate review. An origin declaration or natural-content calculation may support a specific sourcing claim, but it cannot replace the underlying safety information. Nor does a quality-system certificate establish that the delivered lot meets your specification.
A supplier request you can adapt
Send this after agreeing the intended grade and use:
Please provide the following for [trade name, product code and grade], intended for [product type and target markets]:
- Current specification, revision identifier, acceptance limits and referenced test methods.
- A representative CoA for qualification, followed by the actual CoA for each delivered lot; identify tests performed per lot versus periodically.
- Composition information sufficient for our formulator and safety assessor, including carriers, preservatives and other additives. Please propose a confidential disclosure route if needed.
- Current SDS where applicable, safe handling instructions, storage conditions and shelf-life or retest basis.
- Relevant impurity, microbiological and toxicological information, including the basis and scope of declarations.
- Evidence for any sourcing or certification claim we have specifically agreed to use.
- Your process for notifying us of changes to composition, source, manufacturing site, process, specification or test methods, and a technical contact for discrepancies.
Use the representative CoA to assess the supplier’s reporting, then obtain the CoA for the lot you receive.
Check each delivery before use
At receipt, match the purchase order, supplier grade and lot on the sealed package to the delivery record and CoA. Check package integrity, transport concerns, dates and required storage conditions. Keep material on hold until the designated reviewer completes the agreed checks and any required sampling or testing.
Define your own sampling plan, identity checks, retained-sample arrangements and acceptance authority. FDA’s 2013 draft cosmetic GMP guidance, sections on records, raw materials and laboratory controls, offers useful examples of these controls. It is historical, nonbinding draft guidance, not a current legal release rule.
Hypothetical example: a preserved extract
Suppose a supplier’s composition statement says its extract contains 0.8% of a preservative. Your formula uses the supplied extract at 5%. The raw material therefore contributes 0.04% preservative to the finished formula: 0.008 × 0.05 × 100.
Those numbers are invented solely to illustrate the calculation. They are not permitted-use limits or a safety conclusion. The formulator must combine that contribution with any other sources of the preservative, and the assessor must review the actual substance, use conditions and applicable restrictions.
If the shipment’s CoA uses a different product code, there is a separate identity problem. Keep the lot on hold until the supplier explains and documents the discrepancy. A correct composition calculation does not resolve uncertain material identity.
Keep the approval current
Assign an owner for supplier document review and preserve superseded versions with their effective dates. Agree how the supplier will notify you of changes before ordering commercial quantities. A changed carrier or preservative can require reformulation, a new label review or additional testing even when the supplier retains the trade name.
Before accepting a substitution, compare it with the approved material and decide whether your stability and packaging compatibility evidence still applies. Record which ingredient lots entered each finished batch so the team can investigate a later complaint without reconstructing production from invoices.
Sources and references
Frequently asked questions
Is an SDS enough to approve a cosmetic ingredient?
Is an SDS enough to approve a cosmetic ingredient?
No. An SDS addresses chemical hazards and safe handling. To approve the ingredient, you also need its identity, composition, specification and information relevant to its intended cosmetic use. The finished EU cosmetic requires its own safety assessment under Article 10; the ingredient SDS does not replace it.
Must every CoA contain numerical results for every attribute?
Must every CoA contain numerical results for every attribute?
Not necessarily. Agree which attributes need measured results, which qualitative tests can report conformity, and which controls rely on periodic testing or other evidence. Ask the supplier to identify the basis of each statement rather than assuming every listed attribute was tested on that lot.
What if the supplier will not disclose a proprietary mixture?
What if the supplier will not disclose a proprietary mixture?
Ask whether it can disclose safety-relevant composition directly to the assessor under confidentiality arrangements. If the assessor cannot obtain enough information to evaluate the ingredient in your product, do not approve it solely because the supplier calls it cosmetic grade.