SODIUM BUTYLPARABEN: EU cosmetic annex conditions and formula evidence
SODIUM BUTYLPARABEN has identifier matches to Annex V in the acquired 18 May 2026 EU Cosmetics Regulation text. The table distinguishes the substance identity, product-use conditions and recorded limits. Confirm the exact substance/group scope, formula concentration and intended use before applying an entry. This does not certify formula safety or settle Great Britain requirements. The informative CosIng metadata and legal-table references differ; this page does not treat them as interchangeable.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
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.
Annex V · Entry 12a
Recorded identity: Butyl 4-hydroxybenzoate and its salts Propyl 4-hydroxybenzoate and its salts
Matching CAS: 36457-20-2 · Matching EC: 253-049-7
Product use / body site
Maximum concentration and basis
Other conditions
Warnings
Source
Blank in source
0,14 % (as acid) for the sum of the individual concentrations 0,8 % (as acid) for mixtures of substances mentioned in entry 12 and 12a, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0,14 %
Not to be used in leave-on products designed for application on the nappy area of children under three years of age.
For leave-on products designed for children under three years of age: ‘Do not use on the nappy area’
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.
Check identity, concentration, exposure and use against the current legal annex and any amendments.
SCCS opinion reference
Extended Opinion on the Safety Evaluation of Parabens, Opinion on Parabens, underarm cosmetics and breast cancer, Opinion on Parabens, Opinion on Parabens, Opinion on Parabens, Opinion on Parabens updated request for a scientific opinion on 'propyl-and butylparaben' [1]
Check identity, concentration, exposure and use against the current legal annex and any amendments.
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.
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.
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.
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.
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?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
[2] HTML table[6] in substantive document container (extraction legal-html-tables-2) / own tr[29] · record f4ab71ffeaf8cdbe7ff911254e35dfec35af6dffe549431910b5164cf6afd239
[3] #art_14 · record 9ffeb5c563a32fe8d532de5d352c05f8a9062e1c5d21fd326d5e6c2ea42a84f4
[4] #art_17 · record 8ad3194ae1fc45e70495aa637f90457139a0023680e2b880fc4c8a8b4d202c43
[5] #art_10 · record 49eb173406b736d6f0b855572abc53b0f52d9543a4d170affa8ae68d6e809718
[6] #art_11 · record ba70c2a84c1d6c70eb57a0fd892fcdf584f6142281b03c29be4bd20e6e83844d
Prepare an editable project brief
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.
