1. Two different questions
When assessing a cosmetic for Brazil, two separate questions need answering. The first is the grade: what level of sanitary surveillance the product requires, Grade 1 or Grade 2. The second is the procedure: whether the product will be notified (exempt from registration) or registered.
It's common to read that "Grade 1 is notified and Grade 2 is registered." Since RDC 907/2024, that is not accurate: most Grade 2 products are also exempt from registration. Registration is required only for the groups listed in art. 34 of the regulation, regardless of grade.
2. What defines the grade
The regulation defines the grades by combining four factors: area of application, the product's target audience, specific formulation conditions, and the sanitary impact of the declared uses. Grade 1 products initially require a lower level of surveillance; Grade 2 products, a higher one (RDC 907/2024, art. 3, XVII and XVIII).
The lists of groups for each grade are in Annex I, as amended by RDC 949/2024, which incorporated Mercosur GMC Resolution 18/2023. The new classification has applied since April 7, 2025 (the deadline set by RDC 966/2025), and products already regularized have until January 2, 2030 to comply. The lists are indicative, not exhaustive: Anvisa may create other groups.
Two formulation rules bound Grade 1 (art. 7): the product cannot contain substances from the restricted list that are specific to Grade 2, nor ultraviolet filters for skin protection, because their presence alone already characterizes Grade 2.
3. Examples of Grade 1
Among the 71 groups in the indicative Grade 1 list:
- Perfumes, colognes and scented waters
- Shampoos, conditioners and leave-in styling products
- Facial and body soaps, bath products
- Moisturizers for the face, hands, feet and body
- Anti-wrinkle and anti-cellulite preparations
- Mechanical exfoliants
- Makeup: foundation, concealer, powder, blush, lipstick, eyeshadow, mascara, eyeliners
- Underarm, body and foot deodorants without antiperspirant action
- Regular toothpaste and flavored mouthwash
- Shaving products, pre- and after-shave
- Anti-hair-loss and hair-strengthening preparations
- Talcum powders, hygiene wet wipes, nail polish and removers
4. Examples of Grade 2
Among the 46 groups in the indicative Grade 2 list:
- Sunscreens and products with sun-protective action as an added benefit
- Tanning products, self-tanners and tan activators
- Underarm and foot antiperspirants
- Skin-lightening products and stretch-mark preparations
- Products for acne-prone skin and sensitive skin
- Anti-dandruff products, rinse-off or leave-in
- Hair dyes, bleaches, straighteners and perming products
- Chemical exfoliants and chemical depilatories
- Products intended for children and for pregnant women
- Products for intimate hygiene and for the hygiene of bedridden patients
- Antibacterial and antiseptic products, including hand soaps and wipes
- Anti-cavity, anti-plaque, anti-tartar and whitening toothpastes; products for sensitive teeth
- Products for artificial nail systems and insect repellents
5. Claims that change the grade
Annex I contains a rule that often surprises foreign brands: any product on the Grade 1 list moves to Grade 2 if it declares an indication:
- for pregnant women or for children;
- for people with acne-prone or sensitive skin;
- for sensitive teeth, anti-cavity, anti-plaque, anti-tartar or tooth whitening;
- for the hygiene of bedridden patients or for intimate hygiene;
- antiperspirant, anti-stretch-mark or skin-lightening;
- antibacterial or antiseptic;
- sun-protective, tanning, tan-activating or self-tanning;
- anti-dandruff;
- for dyeing, lightening or bleaching hair;
- as personal protective equipment (PPE) for work.
In practice: a regular body moisturizer is Grade 1. The same product labelled "for sensitive skin" or "for pregnant women" becomes Grade 2, requiring safety data consistent with the claim.
6. Notification or registration
Only the groups in art. 34 are subject to registration: tanning product, hand sanitiser gel, hair straightening product, hair straightening-and-dyeing product, perming product, sunscreen, children's sunscreen, insect repellent and children's repellent. All other groups are exempt from registration and follow the prior-notice procedure, notification (art. 35).
The base dossier is the same for both procedures (art. 8). The difference lies in the depth: safety or efficacy claims require summaries and complete data available to the authority, and sunscreens, repellents, straighteners and perming products must state acceptance ranges for their main functional substances (art. 8, §§ 3 and 10).
7. What changes for an international brand
Skincare, makeup and fragrance lines generally enter through notification, with a short gap between filing and sale. Sun-care, children's and technical haircare lines (straighteners, perming products) require registration, more documentary evidence and months of review.
That is why each SKU's classification should be locked in before defining labels, the commercial timeline and the volume of the first shipment. A marketing claim added late in the process can change the grade and reopen regularization.
Sources
- Anvisa. RDC No. 907, of September 19, 2024, arts. 3, 7, 8, 32, 34, 35, 40 and 41, and Annex I.
- Anvisa. RDC No. 949, of December 12, 2024: new wording of Annex I and incorporation of Mercosur GMC Resolution No. 18/2023.
- Anvisa. RDC No. 966, of February 26, 2025: sets the effective date of RDCs 949/2024 and 951/2024 as April 7, 2025.
- Anvisa. RDC No. 951, of 2024: migration of cosmetics notification to the Solicita/Datavisa platform.