Ingredient Safety & Annexes

The ASEAN Cosmetic Directive controls ingredient safety through a system of **annexes** harmonised with — but not identical to — the EU Cosmetic Regulation (EC) No 1223/2009. The annexes are transposed into Vietnamese law through Circular 06/2011/TT-BYT and ongoing DAV official letters that incorporate ACSB updates. **Annex II — Banned substances.** Substances that must not form part of the composition of cosmetic products. The list contains over 1,300 entries, including: • Mercury and its compounds (high acute toxicity). • Hydroquinone (skin-lightening; banned for cosmetic use following EU SCCS opinion). • Lead and lead compounds. • Most CMR Category 1A/1B/2 substances per CLP/GHS classification. • Certain hair-dye intermediates (e.g., specific aromatic amines). • Formaldehyde above the trace-level threshold (free formaldehyde). **Annex III — Restricted substances.** Substances allowed only under specified conditions (max concentration, product type, mandatory warning): • Salicylic acid — max 2% in most products (lower in oral hygiene); not for use in products for children under 3 years except shampoos. • Boric acid in talc — max 5%, not for use on damaged skin or broken skin. • Retinol — concentration limits under ACSB review, with strict limits in leave-on products. • Specific hair-dye actives — concentration and warning labelling. **Annex IV (or III Part 2) — Colourants.** Permitted colourants by Colour Index (CI) number with restrictions on product type (rinse-off / leave-on / mucous-membrane) and use levels. **Annex VI — Preservatives.** Permitted preservatives, with max concentrations and exclusions: • Methylisothiazolinone (MI) — banned in leave-on cosmetics; restricted to 0.0015% in rinse-off following EU/ACSB action. • Parabens — methyl- and ethylparaben permitted; propyl- and butylparaben restricted; isopropyl-, isobutyl-, pentyl-, phenyl- and benzylparaben banned. • Phenoxyethanol — max 1%. • Triclosan — restricted use in specific product types. **Annex VII — UV filters.** Permitted UV filters with max concentrations. Octinoxate, oxybenzone, avobenzone and titanium dioxide / zinc oxide (nano forms with specifications) are commonly used. The list is periodically updated as new safety opinions are issued by ACSB/EU SCCS. The responsible company must verify that every ingredient is: 1. Not listed in Annex II; 2. If listed in Annex III/IV/VI/VII, used within the stated conditions; 3. Supported by a documented safety assessment in the PIF, prepared by a qualified safety assessor (toxicologist, pharmacist, or chemist with relevant training). Because ACD annex updates can lag the EU by 6–18 months, companies should track both the DAV notice archive and current EU SCCS opinions to anticipate forthcoming changes.

Core annex framework: • Circular 06/2011/TT-BYT, Appendices — Vietnamese version of ACD Annexes II, III, IV, VI, VII. • ASEAN Cosmetic Directive, Annexes — original harmonised lists. • ACSB and ACC meeting reports — current scientific opinions and pending substance reviews. Substance-specific Vietnamese transposition (illustrative): • DAV Official Letter on methylisothiazolinone (MI/MCI) restrictions in cosmetics. • DAV Official Letter on isopropyl- and isobutylparaben ban. • DAV Official Letter aligning Lilial (Butylphenyl methylpropional) classification. • DAV Official Letter on titanium dioxide nano-form specifications. Safety assessment reference: • ASEAN Cosmetic Guidelines for Safety Assessment — sets out the minimum format and scope for the Part 3 (safety) section of the PIF. • ASEAN Guidelines on Stability Testing of Cosmetic Products. • ASEAN Guidelines on Limits of Heavy Metals and Microbiological Contamination.

EU-driven annex updates (typical ACSB lag 6–18 months): • Lilial (Butylphenyl methylpropional) — banned in the EU as a CMR substance (Reg. 2021/1902, effective 1 March 2022); transposed into the ACD annex and noticed by DAV. • Methyl-N-methylanthranilate, kojic acid and certain UV filters (homosalate, octocrylene) are under ACSB review following updated EU SCCS opinions. • Per- and polyfluoroalkyl substances (PFAS) in cosmetics — under regulatory consideration in both EU REACH restriction and ACSB discussion. Vietnam-specific enforcement: • Skin-whitening cosmetics with undeclared hydroquinone, mercury, or corticosteroids remain a recurring enforcement target. DAV has recalled multiple products following provincial inspection lab findings. • Imported cosmetics whose foreign-language INCI declaration cannot be reconciled with the Vietnamese supplementary label are subject to suspension of notification number pending clarification.