When a supplier sends a revised specification, compare it with the previous issue before accepting the change. Establish whether it concerns the material, an acceptance limit, a test method, or the document’s wording.
Those are different events. An unchanged trade name does not prove the material is unchanged, and a changed limit does not necessarily mean its composition has changed.
Compare the documents first
Keep the old and new specifications together with their issue dates and the supplier’s explanation. Ask which deliveries or lots are affected and when the change took effect. The document’s issue date may differ from the first affected material lot.
Describe the difference in plain terms before circulating it: for example, “the declared solids-content range has changed; the supplier has not yet confirmed whether the process changed.” Ask the supplier to resolve the uncertainty about its process before completing that part of the review.
EU Annex I guidance addresses raw-material identification, specifications, and relevant impurities. It also discusses information exchange between the responsible person and safety assessor when the safety report needs updating.1
Decide who needs to review this change
| Reviewer | Question for their part of the business |
|---|---|
| Purchasing | Which orders and deliveries fall under the new specification? |
| Formulation | Could the difference affect the material’s use in an active formula? |
| Quality | Do incoming checks, limits or material status need to change? |
| Safety and regulatory | Does supporting product information need reassessment? |
| Manufacturing | Do handling or processing instructions need adjustment? |
| Customer or brand contact | Is a customer approval or commitment affected? |
Not every change needs every role. Assign a coordinator and ask the relevant people for a conclusion, supporting information, and any conditions on use. “Please see attached” does not tell anyone what they are expected to decide.
Find the material already on site
Search the internal material code and supplier product code across stock, orders, and active formulas. Include duplicate entries or aliases. Separate material already received from future deliveries, and identify any existing batches potentially affected by the new information.
FDA’s longstanding cosmetic self-inspection checklist addresses raw-material identity, lot identification, control status, and material outside acceptance specifications.2 These are helpful reference points for connecting the review to physical stock; this is not a new MoCRA GMP checklist.
Two lots can require different instructions
In a fictional example, lot A is held under the old botanical specification and lot B arrives under a revised solids-content range. Development reviews both against two formulas. One use can proceed on the available evidence; the other needs a trial.
The resulting instruction must identify the permitted lot-and-formula combinations. “Supplier approved” cannot communicate that difference. A certificate showing conformity to the revised specification also cannot establish suitability for every formula using the ingredient.
Confirm which internal documents changed and send the resulting lot-and-formula instructions to purchasing, stores, and production. Check the next planned batch against those instructions before closing the review.
Sources
European Commission / EUR-Lex. Commission Implementing Decision 2013/674/EU: Guidelines on Annex I to the Cosmetics Regulation. ↩︎
US Food and Drug Administration. Good Manufacturing Practice Guidelines/Inspection Checklist for Cosmetics. Relevant sections of the legacy self-inspection checklist. ↩︎
