Tranylcypromine (INN) and its salts: EU cosmetic annex conditions and formula evidence

Exact legal-entry matches and product-use conditions

Exact checksum-valid CAS and/or exact EC identifier in preserved legal identity cells. Group and substance scope are still conditional.

Each line below retains its own concentration basis, conditions and warnings. Blank source cells mean no condition was recorded in that cell; they do not establish unrestricted use.

The consolidated text is a dated reference. Current amendments, corrigenda and applicability dates must be checked. EU evidence does not resolve Great Britain rules.

Known facts and deciding inputs

Known context: EU. Ingredient identity is recorded; concentration, intended use, exposure and current legal conditions still need checking.

Resolve the entry against your actual formula

Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.

1. Does the supplied material fall within these exact entries?

   Put your supplier CAS/EC, substance composition, salt/group membership, purity, physical form and intended function beside each matched entry. A matching identifier does not resolve every group or impurity condition.

   Useful evidence: Supplier specification, composition and certificates of analysis; the exact annex rows above.

2. Which row governs the finished-product use?

   Compare the finished-product concentration, body site, rinse-off/leave-on use, consumer/professional setting and any exposure restrictions with each row. Preserve the units and calculation basis; do not transfer a limit from a different product-use row.

   Useful evidence: Quantitative formula and use instructions; a row-by-row condition and warning worksheet.

3. Is a prohibition or trace question involved?

   For Annex II matches, review Article 14 before formulation decisions. Article 17 concerns a separate, conditional non-intended trace situation; it does not grant blanket permission to intentionally add a prohibited substance. Record origin and technical-avoidability evidence for specialist review.

   Useful evidence: Ingredient/impurity origin, manufacturing controls, trace quantities and the cited Article 17 text.

4. What must reach the safety assessor and Responsible Person?

   Send the reconciled identity, condition table, exposure facts, supplier evidence and unresolved amendment/date questions. Agree formula, assessment and PIF responsibilities before notification or manufacturing handoff.

   Useful evidence: A dated formula-evidence matrix, supplier data, exposure description and document ownership list.

Work packages and dependencies

• Conditional: Formula-condition reconciliation and EU safety/PIF handoff — Resolve the matched annex entries against supplier identity, function, concentration basis, product use, warnings and linked notes. Agree assessment, PIF and Responsible Person responsibilities after the findings.
• Optional: Manufacturing and supplier-evidence handoff — If manufacturing support is needed, prepare material specifications, quantitative formula, batch controls and the condition/warning evidence matrix for the assessor and Responsible Person.

What needs to happen first

• EU+UK Cosmetics Compliance → Cosmetic Contract Manufacturers & Private Label: Resolve the formula-condition and warning questions before agreeing manufacturing release evidence; coordinate the assessor, Responsible Person and manufacturer handoff.

Questions for providers

• Which exact annex entry and product-use subrow matches our material and finished-product use, and which alternatives should be excluded?
• What evidence resolves group/salt, impurity, concentration-basis and warning conditions in the matched rows?
• Which amendments or applicability dates change this dated reference, and how will EU and GB evidence be checked separately?