卸売特殊化学品：検証済みサプライヤー

Food additives: emulsifiers (lecithin E322, mono- and diglycerides E471, polysorbates E432–436), preservatives (sodium benzoate E211, potassium sorbate E202, nisin E234), antioxidants (BHA E320, BHT E321, tocopherols E306–309), thickeners and stabilisers (xanthan gum E415, carrageenan E407, pectin E440), acidulants (citric acid E330, lactic acid E270). Flavours and fragrances: natural extracts (vanilla oleoresin, essential oils), nature-identical, and synthetic aroma chemicals; IFRA compliance required for fragrance compounds. Pharma excipients: binders (MCC, HPC, PVP), disintegrants (crosslinked PVP, sodium starch glycolate), lubricants (magnesium stearate), coating polymers (HPMC, EC, Eudragit). Personal care actives: retinol (Vitamin A palmitate), niacinamide, hyaluronic acid, peptides, alpha-arbutin, zinc pyrithione. Construction chemicals: superplasticisers (PCE), shrinkage-reducing admixtures, crystalline waterproofing agents.

Food additives in the EU must have E number authorisation under Regulation (EC) 1333/2008. Authorization requires a positive EFSA (European Food Safety Authority) scientific opinion establishing ADI (Acceptable Daily Intake) and maximum permitted levels per food category. In the USA, food additives are regulated under FFDCA (21 USC 321) and must be FDA-approved (Petition process) or GRAS (Generally Recognised As Safe) — GRAS substances can be self-affirmed by qualified experts or notified to FDA (GRAS notification program). Buyers importing food additives into the EU must confirm: the E number is authorised for the food category; the maximum permitted level is respected; source country GMP certificate; Certificates of Analysis per lot.

Pharmaceutical active ingredients (APIs) and excipients for GMP-regulated markets (FDA, EMA, TGA, PMDA, Health Canada) must be manufactured under ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients. Key GMP requirements: site master file (SMF); qualified person (QP) oversight; full batch records and traceability; impurity profiling per ICH Q3A and Q3B; pharmacopoeial testing (USP, Ph.Eur., BP, JP); change control and deviation management; regular regulatory inspections. For EU-bound APIs: EDQM CEP (Certificate of Suitability) or EMA registration dossier required. Buyers must conduct supplier qualification audits and request current GMP certificates issued by national regulatory authorities.

IFRA (International Fragrance Association) publishes the IFRA Standards — limits for fragrance ingredient concentrations in 12 product categories based on dermatological risk assessment. Categories range from Category 1 (lip products, highest restriction) to Category 12 (non-skin-contact — air fresheners, least restriction). Key restricted ingredients: oakmoss (Evernia prunastri), treemoss, Peru balsam, hydroxycitronellal, lily aldehyde. EU Cosmetics Regulation 1223/2009 requires labelling of 26 specific allergens above 0.001% (rinse-off) or 0.01% (leave-on) and imposes individual restrictions (lilial BMHCA now banned). Buyers of fragrance compounds should request a Certificate of Compliance confirming IFRA 51st Amendment compliance and EU Cosmetics Regulation 1223/2009 compliance.