2,2'-Methylene bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) / Bisoctrizole: EU cosmetic annex conditions and formula evidence
2,2'-Methylene bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) / Bisoctrizole has identifier matches to Annex VI 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.
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 VI · Entry 23
Recorded identity: 2,2′-Methylene- bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole
►M26 ( 5 ) In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g. ◄ [3]
Annex VI · Entry 23a
Recorded identity: 2,2′-Methylene- bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole
Not to be used in applications that may lead to exposure of the end user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — Purity ≥ 98,5 %, with 2,2′-methylene-bis-(6(2H-benzotriazol-2-yl)-4-(isooctyl)phenol) isomer fraction not exceeding 1,5 %; — Solubility < 5 ng/L in water at 25 °C; — Partition coefficient (Log Pow): 12,7 at 25 °C; — Uncoated; — Median particle size D50 (50 % of the number below this diameter): ≥ 120 nm of mass distribution and/or ≥ 60 nm of number size distribution.
►M26 ( 5 ) In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g. ◄ [3]
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
Opinion on 2,2'-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol), Opinion on 2,2’-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) nano form (S79) Revision of 23 July 2013, Opinion on 2,2’-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) (nano form) [1]
Check identity, concentration, exposure and use against the current legal annex and any amendments.
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[7] in substantive document container (extraction legal-html-tables-2) / own tr[35] · record 9e962bdec384832665128a3961e3a8fa68dcfa2b5659d0df4ee7572c9c9e0203
[3] #E0095 / containing div (linked annex note) · record 86348a1333f2e27fe43abcd3035e5b1d42ffe4a7cee5cff4f8df4cfa3e928cd7
[4] HTML table[7] in substantive document container (extraction legal-html-tables-2) / own tr[37] · record d462ee8d75cb539f15f14007936686b8ca7420bf977b65dd02fa88c39cb02ca0
[5] #art_14 · record 9ffeb5c563a32fe8d532de5d352c05f8a9062e1c5d21fd326d5e6c2ea42a84f4
[6] #art_17 · record 8ad3194ae1fc45e70495aa637f90457139a0023680e2b880fc4c8a8b4d202c43
[7] #art_10 · record 49eb173406b736d6f0b855572abc53b0f52d9543a4d170affa8ae68d6e809718
[8] #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.
