The regulatory regime that gates what Via Pureza can sell, when, and how (source).
Initial research
Cost figures and timelines are indicative; treat them as planning numbers, not contracts. The Lei 15.154/2025 artisanal criteria are still being defined by ANVISA as of mid-2026 (see below).
Grade classification
ANVISA divides cosmetics into two grades:
| Grade | Risk | Examples | What’s required |
|---|---|---|---|
| Grade 1 | Low | Shampoos, conditioners, body lotion, deodorant, nail polish, basic moisturizers | Notification only — online, fast |
| Grade 2 | High | Sunscreens, anti-aging with retinol / AHA / BHA, hair colorants, chemical straighteners, anti-dandruff | Full registration — safety data, clinical tests, formula docs, ~120-day review |
Implication for Via Pureza: the product-direction start-with set (moisturizers, serums, lip balms, lip tints, tinted moisturizers, mascaras) is all Grade 1. Grade 2 only enters if/when the SKU plan adds sunscreens or active-ingredient anti-aging.
Who files
A licensed manufacturer is already registered with ANVISA as a fabricante. When they produce under your brand, they typically handle notification / registration as part of their service.
- You become the empresa responsável (responsible company) — needs a CNPJ.
- For Grade 1, many contract manufacturers handle the whole flow; you provide brand details and labeling copy.
- For Grade 2, a Responsável Técnico (RT) — licensed pharmacist or cosmetic chemist — must sign off on the formulation. Contract manufacturers usually have one in-house.
Mandatory label content
Regardless of grade:
- INCI ingredient listing (international nomenclature)
- Lote (batch number)
- Validade (expiration — best-before or manufacture + shelf life)
- Responsável Técnico name and CRF registration number
- Manufacturer CNPJ and address
- Cosmetovigilância — mandatory adverse-event monitoring since 2025-08
The artisanal exemption — Lei 15.154/2025
In effect from 2025-08-30. Production exempt from ANVISA registration if:
- Manual, small-scale, no industrial automation
- Sold direct to end consumers
Still required:
- INCI labeling, lot, expiration, manufacturer info
- Basic sanitary hygiene
- Company registration (MEI or ME minimum)
Criteria pending
Revenue caps, production limits, and detailed rules for what counts as “artisanal” were still pending ANVISA regulation as of mid-2026. Viable as an MVP path (Stage 1 in manufacturing); do not build a large business on this exemption until the framework is final.
Why this matters for Via Pureza: Stage 1 MVP can launch a small skincare line under the exemption — no ANVISA fees, no consultant costs, just labeling discipline. Saves an estimated R$ 2,000–8,000 per SKU in notification costs during validation.
RDC 907/2024
Published 2024, in effect 2025. Tightened safety requirements across the board:
- More rigorous safety-assessment documentation
- Extended cosmetovigilance obligations
- Applies to small businesses, not just large manufacturers
A reputable contract manufacturer should already be compliant — confirm before signing.
Decision flow
Is the SKU artisanal-scale and Grade-1-equivalent?
yes → Lei 15.154/2025 exemption (Stage 1 MVP)
no → Is it Grade 1?
yes → Online notification via manufacturer (Stage 2+)
no → Grade 2 registration: RT signoff, ~120-day review (avoid early)
Cross-links: manufacturing (staged path), product-direction (which SKUs trigger which path), channels-overview (marketplaces require Grade 1 notification minimum).