--- title: "Cosmetic Reformulation and Change Control" description: "Review cosmetic changes after launch: decide which evidence still applies, update safety records and trace the revised formula into production." image: "https://cosmetic-labs.com/wp-content/uploads/cosmetic-reformulation-pilot-comparison-square1200x1200.webp" --- # Cosmetic Reformulation and Change Control > Review cosmetic changes after launch: decide which evidence still applies, update safety records and trace the revised formula into production. Source: https://cosmetic-labs.com/articles/cosmetic-reformulation-change-control Created: 2026-10-25T18:26:15+00:00 Modified: 2026-10-25T18:26:15+00:00 Author: Emilie SCHOL Cosmetic Reformulation and Change Control | Cosmetic Labs ## **Key takeaways** Record proposed ingredient, packaging and manufacturing changes before approving them. Choose additional studies according to the change and the relevance of existing evidence; there is no universal retest package. Review EU safety, PIF and notification records and US safety, label and listing duties separately. Link the approved change to the first revised batch and follow complaints by product version. A supplier discontinues an emulsifier. Purchasing finds a replacement with the same INCI name, and the manufacturer expects the next batch to look unchanged. Before approving the substitution, the brand needs to compare the material’s composition, impurities and behaviour with the approved grade. Before the revised product enters production, brand and quality teams need to decide which evidence still applies and what further work is needed. For a cosmetic reformulation, document that review, the release approvals and the affected batches in a change-control record. This does not mean repeating every launch test. ## Open a change record before authorising the purchase Give the proposal a change number and an owner. Record the reason, affected products and markets, proposed implementation date, and current formula, process and packaging versions. Attach a precise comparison: ingredient grade and concentration, supplier specification, processing conditions, contact materials, or intended use, as applicable. Ask the manufacturer to identify related changes. Replacing a supplied blend may also change its solvent or preservative. A new pump can change the amount dispensed even when the bulk formula stays the same. Describe those differences explicitly in the change record, even if the supplier calls the replacement equivalent. The quality agreement should state which changes require advance notification and written brand approval, who supplies confidential composition data to the safety assessor, and who pays for additional work. Use the original [cosmetic formulation brief](https://cosmetic-labs.com/articles/cosmetic-formulation-brief) to check which sensory, performance and packaging requirements still apply. ## Decide what the change could affect Compare the proposal with the approved product for safety, preservation, physical stability, packaging, manufacturing reproducibility, claims and market compliance. Classify the change by these technical consequences, regardless of the substitution’s cost. The [European Commission’s Annex I guidelines](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013D0674), section 4.3, call for review and, where necessary, updating of the safety assessment when formulation or raw-material specifications change. They also identify changes in use, relevant scientific findings and rising undesirable-effect trends as review triggers. The required review determines which new laboratory studies, if any, are needed. The table suggests questions and evidence for the review; it is not a statutory testing schedule. Proposed changeQuestion to resolveEvidence to considerNew supplier or grade under the same INCIAre composition, impurities, microbiological quality and function comparable?Detailed specifications, composition disclosures, relevant lot data and targeted comparison workPreservative, pH or water-phase changeDoes the preservation rationale remain valid?Microbiologist review, relevant preservative-efficacy evidence and new challenge testing where neededFragrance or botanical substitutionHave exposure, allergens, contaminants or formula interactions changed?Updated supplier documentation, assessor review, label review and justified stability workNew product-contact pack or dispenserCould interaction, protection or delivered dose change?Material information, compatibility and dispensing studies appropriate to the new packMixing, heating or production-scale changeCan the revised process reproduce the approved product?Pilot or production verification, in-process controls and relevant finished-product resultsNew use directions or performance claimDoes existing evidence cover the revised use or promise?Exposure review, safety-assessment review and claim-specific substantiation ## Agree an evidence plan before testing The formulator, quality lead and relevant specialists should agree on the questions, methods and acceptance criteria before evaluating samples. Include the EU safety assessor where safety-assessment assumptions may change. Purchasing can supply documents, but a supplier’s equivalence statement does not replace the product-specific review. For each existing report, record whether it covers the revised product and explain why. Identify the exact versions compared and how the change affects the result’s relevance. Obtain further information or carry out additional work where the existing evidence is insufficient. The Commission’s guidelines allow data from reliable sources, including similar formulations, but require an explanation of their relevance to the product. If particular safety data are considered unnecessary, the justification for omitting them must be accepted through the safety assessment. In the US, [FDA’s MoCRA overview](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra) says no specific tests are prescribed for individual cosmetic products or ingredients, but the responsible person must ensure and maintain adequate safety substantiation. For a preservation change, a passing microbial-limits result does not answer the same question as preservative efficacy. Consult the [challenge-test and microbial-limits guide](https://cosmetic-labs.com/articles/cosmetic-challenge-test-microbial-limits). For a pack change, define which conditions and observations matter using the [stability and packaging-compatibility guide](https://cosmetic-labs.com/articles/cosmetic-stability-packaging-compatibility-testing). Avoid adopting a stock test duration simply because it appeared in the original project plan. ## Update the documents that the change affects For EU products, the responsible person must keep the cosmetic product safety report current in light of additional relevant information and update the product information file as necessary. [Articles 10 and 11 of Regulation 1223/2009](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02009R1223-20260518) establish these duties. The revised assessment must cover the product being supplied, including relevant composition, packaging, exposure and manufacturing information. Check the CPNP record against the change. Article 13(7) requires an update without delay when information covered by paragraphs 1, 3 or 4 changes. Also review the submitted labelling and packaging information, and whether the revised product needs a different notification treatment. Do not assume that every substitution requires a new notification, or that an unchanged retail name means the record remains correct. Review ingredient declarations, warnings, use instructions and claims for each market. Check whether performance studies on the previous formula still support the claims; document the reasoning or obtain new evidence. The [claims-substantiation guide](https://cosmetic-labs.com/articles/cosmetic-claims-substantiation) explains how to connect the promised effect to the evidence. For US products, review safety-substantiation records and labelling separately from FDA product listing. Where listing applies, [FDA requires updates annually](https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products); this is not the EU’s notification-update timetable. Check whether a product or business exemption applies. Listing is not FDA approval of a reformulation. ## Control the production changeover Approve a specific formula and process version, not an informal instruction to “use the new ingredient”. Link that approval to material codes, specifications, artwork and the first affected batch. Where a pilot is needed, use the proposed commercial materials and relevant production conditions; a successful laboratory sample cannot establish every aspect of factory performance. Before release, confirm that: The evidence plan is complete, with unresolved results assessed and the decision recorded. - Safety and regulatory reviewers have approved their relevant parts of the change. - The manufacturer is using the approved formula, process, materials and packaging versions. - Labels match the product, and affected notification or listing actions have assigned owners and deadlines. - Old materials, artwork and work instructions cannot enter the revised production by mistake. - Batch records identify the changeover, retained samples and distribution destinations. Decide what to do with old stock. A commercial reformulation does not automatically make compliant existing stock unsuitable for sale. A safety concern or ingredient restriction needs a separate decision based on the facts, applicable dates and corrective-action duties. ## Hypothetical example: replacing an emulsifier grade Suppose a body-lotion supplier withdraws an emulsifier blend. The proposed replacement has the same INCI declaration but a different compositional range. The brand opens a change record and obtains the full specifications and composition for specialist review. The formulator compares pilot batches against the current product and identifies which stability and manufacturing questions remain. The safety assessor reviews the changed raw-material information; the microbiologist decides whether the preservation evidence still applies or needs additional work. Quality records those decisions before approving the commercial version. If the comparison fails an agreed criterion, the team revises or rejects the proposal. If the evidence supports release, the first revised batch remains traceable to the approved change. Customer care can then distinguish complaints about the old and new versions. ## Keep the change open through the first market review Set a review point appropriate to the change and available sales data. Compare complaints by version and batch, check production deviations, and verify any continuing study commitments. Record quantities sold when interpreting complaint counts: a larger number of reports alone does not establish a higher complaint rate. Once the agreed work and follow-up are complete, the quality lead can close the record. Keep the closure approval with the supporting evidence and the references to affected batches. Author: Emilie SCHOL Founder of Cosmetic Labs, the B2B platform connecting cosmetic brands with labs, CROs and raw-material suppliers. Former Business Development Manager at QIMA Life Sciences (cosmetic & pharma CRO). Based in Toulouse, France. Updated on October 25, 2026 First posted on October 25, 2026 Sources ## Sources and references References supporting this page are listed below. Source access dates and supported claims are recorded in the evidence notes where available. [Consolidated text: Regulation (EC) No 1223/2009 on cosmetic products (18 May 2026)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02009R1223-20260518) URL [https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02009R1223-20260518](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02009R1223-20260518) Publisher European Union / EUR-Lex [Commission Implementing Decision 2013/674/EU on Guidelines on Annex I to Regulation (EC) No 1223/2009](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013D0674) URL [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013D0674](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013D0674) Publisher European Commission / EUR-Lex Date November 25, 2013 [Modernization of Cosmetics Regulation Act of 2022 (MoCRA)](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra) URL [https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra) Publisher US Food and Drug Administration [Registration & Listing of Cosmetic Product Facilities and Products](https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products) URL [https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products](https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products) Publisher US Food and Drug Administration FAQ ## Frequently asked questions ### Does the same INCI name mean a replacement ingredient is equivalent? No. Grades can differ in composition, impurities, physical characteristics or supplied blends despite sharing an INCI name. Obtain the relevant documentation and assess the differences against the finished product. ### Does every reformulation need a new challenge test? No. A specialist should assess whether the existing preservation evidence covers the change and what additional testing is needed. Record the justification; the size of the change alone does not establish its effect on preservation. ### Must the old formula be recalled when a revised version launches? A commercial reformulation does not automatically require recall of compliant old stock. Assess safety concerns, regulatory changes and any applicable transition dates separately, and document the stock decision. 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