Latin America · Argentina
What does it take to sell cosmetics in Argentina? Entry route, responsibility, labeling
Pre-market product admission/inscription with ANMAT — Grade I (low-risk) products by auto…; Responsible person: The ANMAT-enabled Argentine manufacturer or importer (estab…; Labeling: Spanish labelling per Res.
Latest change 2026-05-21 — Dispositions 2599/2026 and 2601/2026 (BO 2026-05-21) incorporated Mercosur GMC 06/25 (restricted list, replacing the 2011/2022 lists) and GMC 07/25, after Disposition 2820/2026 (BO 2026-05-15) banned TPO and N,N-dimethyl-p-toluidine with 60 days to adapt; 2025 deregulation removed ANMAT prior intervention on cosmetic imports (Disp. 4033/2025, from 2025-07-10) and allowed establishment enabling by sworn declaration (Disp. 7939/2025). Sumber
Ringkasan pihak pabrik; teks resmi tetap berlaku; bukan nasihat hukum.
- Otoritas
- National Administration of Drugs, Food and Medical Technology (ANMAT) — INAME
- Regulasi utama
- Resolución MSyAS 155/98; Disposiciones ANMAT 1107/99 and 1108/99; Ley 16.463 · Resolution (ex-MSyAS) No. 155/98 on personal hygiene products, cosmetics and perfumes, with ANMAT Dispositions 1107/99 and 1108/99 on product admission
- Berlaku
- 1998
- Masuk pasar
- Pre-market product admission/inscription with ANMAT — Grade I (low-risk) products by automatic admission via sworn declaration and Grade II products (e.g., sunscreens, hair straighteners, antiperspirants, fluoride oral care) by evaluation — before manufacture or import.
- Orang yang bertanggung jawab
- The ANMAT-enabled Argentine manufacturer or importer (establishment with a registered technical director) is the product holder; foreign makers must work through such an importer.
- Dokumen keamanan
- Formula, specifications, microbiological and stability data and safety substantiation kept by the holder and declared under oath for admission; no formal PIF/CPSR.
- Pelabelan
- Spanish labelling per Res. 155/98 and Mercosur rules (name, INCI ingredients, holder and technical director, ANMAT establishment and product admission numbers, lot, expiry, warnings); no fragrance-allergen declaration requirement.
- Pengujian pada hewan
- No national ban in force; proposed bills have not been enacted.
- Daftar bahan
- Mercosur technical regulations internalised by ANMAT dispositions: GMC 27/25 and 07/25 prohibited list (Disp. 2820/2026 and 2601/2026), GMC 06/25 restricted list (Disp. 2599/2026), plus lists of permitted preservatives, UV filters and colorants.
- Catatan
- official_url points to Disp. 1108/99 on Infoleg (Res. 155/98 text not fetched); the absence of a national animal-testing ban was not positively verified against a primary source.
- Teks resmi
- https://servicios.infoleg.gob.ar/infolegInternet/anexos/55000-59999/56703/norma.htm
Perubahan 2025–2026
- Argentina adopts Mercosur GMC 27/25, 06/25 and 07/25 lists and deregulates imports
Disp. 2820/2026 melarang TPO dan N,N-dimethyl-p-toluidine dengan masa adaptasi 60 hari; Disp. 2599/2026 dan 2601/2026 (BO 2026-05-21) menggantikan daftar pembatasan dan larangan tahun 2011/2014; Disp. 4033/2025 sebelumnya menghapus intervensi sebelumnya ANMAT pada impor kosmetik mulai 2025-07-10 dan Disp. 7939/2025 mengizinkan pendirian melalui pernyataan sumpah. Sumber
FAQ
Does Argentina require notification or registration before sale?
Pre-market product admission/inscription with ANMAT — Grade I (low-risk) products by automatic admission via sworn declaration and Grade II products (e.g., sunscreens, hair straighteners, antiperspirants, fluoride oral care) by evaluation — before manufacture or import.
Is a local responsible person mandatory in Argentina?
The ANMAT-enabled Argentine manufacturer or importer (establishment with a registered technical director) is the product holder; foreign makers must work through such an importer.
What are the labeling requirements in Argentina?
Spanish labelling per Res. 155/98 and Mercosur rules (name, INCI ingredients, holder and technical director, ANMAT establishment and product admission numbers, lot, expiry, warnings); no fragrance-allergen declaration requirement.
What changed recently in Argentina cosmetic regulation?
2026-05-21 Dispositions 2599/2026 and 2601/2026 (BO 2026-05-21) incorporated Mercosur GMC 06/25 (restricted list, replacing the 2011/2022 lists) and GMC 07/25, after Disposition 2820/2026 (BO 2026-05-15) banned TPO and N,N-dimethyl-p-toluidine with 60 days to adapt; 2025 deregulation removed ANMAT prior intervention on cosmetic imports (Disp. 4033/2025, from 2025-07-10) and allowed establishment enabling by sworn declaration (Disp. 7939/2025).
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