OFFICIAL GAZETTE OF THE UNION
Published on: 08/20/2025 | Edition: 157 | Section: 1 | Page: 52
Body: Ministry of Health/National Health Surveillance Agency/Collegiate Board
COLLEGIATE BOARD RESOLUTION ANVISA No. 989, OF AUGUST 15, 2025

Provides for the regularization and classification of sanitizing products according to health risk.

THE COLLEGIATE BOARD OF THE NATIONAL HEALTH SURVEILLANCE AGENCY, using the powers conferred upon it by articles 7, item III, and 15, items III and IV, of Law No. 9,782, of January 26, 1999, and considering the provisions of article 187, item VI and §1 of the Internal Regulations, approved by Collegiate Board Resolution - RDC No. 585, of December 10, 2021, resolves to adopt the following Collegiate Board Resolution, as deliberated in a meeting held on August 13, 2025, and I, Substitute Director-President, determine its publication.
CHAPTER I
INITIAL PROVISIONS
Section I
Objective
Art. 1 This Resolution establishes the regularization and classification of sanitizing products according to health risk.
Single paragraph. The regularization of sanitizing products encompasses both registration and notification.
Art. 2 This Resolution incorporates into the national legal framework MERCOSUR/GMC Resolution No. 36/2022, which provides for the Technical Regulation for the regularization of sanitizing products.
Section II
Scope
Art. 3 This Resolution applies to all sanitizing products.
Section III
Definitions
Art. 4 For the purposes of this Resolution, the following definitions are adopted:
  1. free sample: product distributed among consumers free of charge;
  2. biodegradability: biodegradation capacity of surfactant agents;
  3. biodegradation: molecular degradation of the surfactant agent, resulting from a complex action of living organisms in the environment;
  4. complementary formulation component: substance used in the formulation to help obtain the desired qualities in the product;
  5. minor component: substance in concentration less than 1% w/w (one percent, expressed in weight by weight), which does not constitute active ingredient, complementary component or preservative;
  6. Lethal Dose 50 (LD₅₀) oral for rats: amount of substance necessary, in single ingestion, to cause death of 50% (fifty percent) of the total individuals exposed experimentally by said route of administration;
  7. adequacy label: complementary label for imported products containing information in the language of the destination country, which must be adhered to the primary packaging before commercialization;
  1. serious eye injury: damage to eye tissues or significant physical deterioration of vision, as a result of applying a test product to the anterior surface of the eye, not completely reversible within 21 (twenty-one) days following application;
  2. main panel: most prominent and visible area of the label for the consumer;
  3. secondary panel: area of the label less prominent than the main panel;
  4. active principle, active ingredient or active substance: component that defines the function of the product, according to its purpose, and that contains a defined percentage of purity;
  5. corrosive product: one that produces destruction of skin tissue, visible necrosis that crosses the epidermis and reaches the dermis, in at least 1 (one) animal subjected to exposure of up to 4 (four) hours after an observation period of 14 (fourteen) days, whose corrosive reactions are characterized by ulcers, bleeding and/or bloody scabs;
  6. over-the-counter product: one that can be sold directly to the public;
  7. professional sale product: one that cannot be sold directly to the public and must be acquired, handled and applied exclusively by trained person, professional or specialized company;
  8. sanitizing product: substance or preparation intended for application on inanimate surfaces, textiles, objects and environments, for cleaning and related purposes, with antimicrobial action and for disinfestation, for use at home and in collective, public and/or private environments, including products for disinfection of water for human consumption and swimming pool water;
  9. label: identification printed, lithographed, painted, flame-engraved, self-adhesive and/or by pressure, applied directly to the primary or secondary packaging, when applicable, which must not be removed or modified during use, transport or storage of the product; and
  10. version: product, under the same name and/or brand, with the same qualitative-quantitative base formula regarding active ingredients and complementary components, differing from each other only by minor components.
§1 Included in item IV of the caput of this article are solvents, diluents, stabilizers, additives, adjuvants, enzymes, synergists, inert substances, among others.
§2 The minor components indicated in item V of the caput of this article are substances with functions of fragrance, masking agent, colorant and low foam agent.
CHAPTER II
CLASSIFICATION
Art. 5 The products covered by this Resolution are classified according to sale and use condition, purpose of use and risk.
Section I
Sale and use
Art. 6 Sanitizing products are classified by sale and use condition into:
  1. over-the-counter products; and
  2. products for professional sale.
Section II
Purpose of use
Art. 7 Sanitizing products are classified by purpose of use into:
  1. products for general cleaning and related purposes;
  2. products with antimicrobial action;
  3. disinfectant products; and
  4. products for treatment and disinfection of water for human consumption and swimming pool water.
Section III
Risk
Art. 8 Sanitizing products are classified by risk into:
  1. risk 1 (notification); and
  2. risk 2 (registration).
Subsection I
Risk 1
Art. 9 Risk 1 products must have oral LD₅₀ for rats, considering the product without dilution, greater than 2000 mg/kg (two thousand milligrams per kilogram) of body weight for liquid products and greater than 500 mg/kg (five hundred milligrams per kilogram) of body weight for solid products, regardless of their type of sale.
§1 The method of calculating oral LD₅₀, according to the World Health Organization (WHO) is accepted.
§2 The health authority may request oral LD₅₀ by experimental determination, if there is any bibliographic report and/or toxicological reports that alert to a potentially high risk of acute oral toxicity.
Art. 10. Cleaning and related products, whose pH value in pure state, at a temperature of 25°C (twenty-five degrees Celsius), is greater than 2 (two) and less than 11.5 (eleven and five tenths), are considered risk 1.
Single paragraph. In the case of solid products, including powders, pH determination must be made in dilution between 1% (one percent) and 10% w/v (ten percent, expressed in weight per volume).
Subsection II
Risk 2
Art. 11. Risk 2 products must have oral LD₅₀ for rats greater than 2000 mg/kg (two thousand milligrams per kilogram) of body weight for liquid products and greater than 500 mg/kg (five hundred milligrams per kilogram) of body weight for solid products.
§1 The determination of oral LD₅₀ for rats for over-the-counter products must consider the product without dilution.
§2 The determination of oral LD₅₀ for rats for professional sale products must consider the product in final use dilution.
§3 The method of calculating oral LD₅₀, according to the World Health Organization (WHO) is accepted, except for disinfectant products established by Collegiate Board Resolution - RDC No. 682, of May 2, 2022, and its updates.
§4 The health authority may request oral LD₅₀ by experimental determination, if there is any bibliographic report and/or toxicological reports that alert to a potentially high risk of acute oral toxicity.
Art. 12. The following are considered risk 2:
  1. products whose pH value in pure state, at a temperature of 25°C (twenty-five degrees Celsius), is less than or equal to 2 (two) or greater than or equal to 11.5 (eleven and five tenths);
  2. products with antimicrobial action;
  3. disinfectant products;
  4. products formulated based on microorganisms;
  5. products corrosive to skin or that cause serious eye injuries;
  6. products containing hydrofluoric acid (HF), sulfuric acid (H₂SO₄), nitric acid (HNO₃) or their salts that release them under product use conditions;
  7. non-pressurized liquid products containing hydrocarbons (petroleum distillates) and chlorinated hydrocarbons in their composition at a concentration greater than or equal to 10% w/w or w/v (ten percent, expressed in weight by weight or weight by volume) and with kinematic viscosity, measured at 40°C (forty degrees Celsius), less than or equal to 20.5 mm²/s (twenty and five tenths square millimeters per second); and
  8. products for disinfection of water for human consumption and swimming pool water.
§1 In the case of solid products, including powders, indicated in item I of the caput of this article, pH determination must be made in dilution between 1% (one percent) and 10% w/v (ten percent, expressed in weight per volume).
§2 If acid or alkaline reserve suggests that products indicated in item I of the caput of this article may not be corrosive to skin or not cause serious eye injury, despite the low or high pH value, an assay should be presented, preferably in vitro or ex vivo, determined through experimental methodology accepted and internationally recognized, so that they are considered risk 1.
§3 Products indicated in item VI of the caput of this article must be registered exclusively under professional sale and use condition and industrial application.
CHAPTER III
REGULARIZATION
Art. 13. Products covered by this Resolution are subject to regularization, according to risk classification.
Single paragraph. Regularization can only be requested by companies that have Operating Authorization (AFE) to manufacture or import sanitizing products.
Art. 14. Companies legally authorized to perform activities related to manufacturing, fractionation, importation or exportation of sanitizing products are subject to verification of compliance with good manufacturing and control practices by the competent health authority, through inspection.
Art. 15. Regularization of sanitizing products with versions shall be performed under the same number, provided that mode of use, action, functions of base formula components and product risk classification are maintained.
§1 Versions are not permitted for disinfectants, products formulated based on microorganisms and products for treatment and/or disinfection of water for human consumption and swimming pool water.
§2 Versions of products whose active ingredient is a fragrance may be registered under the same number.
§3 Products whose formulation is 100% (one hundred percent) fragrance cannot have versions.
CHAPTER IV
REQUIREMENTS
Art. 16. For the purposes of this Resolution, sanitizing products must present the following minimum requirements for their regularization:
  1. product data: product description, complete qualitative-quantitative composition and physical-chemical data;
  2. test results required by specific standards;
  3. label model(s), colored and to scale;
  4. packaging design(s), sketch or photo;
  5. Operating License or Health Permit or renewal request (both from the current year) of the manufacturing, importation and/or distribution establishment(s) and outsourced or subcontracted companies; and
  6. stability test.
§1 In the case of imported products, in addition to the requirement indicated in item V of the caput of this article, documentation must be presented that proves authorization of intervening establishments and product registration, if this has been issued by the competent authority of the country of origin.
§2 The stability requirements indicated in item VI of the caput of this article will be subject to regularization through specific regulation.
Art. 17. Any modification in the conditions under which the product was regularized must be communicated to the health authority through changes in notification or registration.
Art. 18. Distribution of free samples of risk 1 and risk 2 sanitizing products that are not properly regularized is not permitted.
Art. 19. For over-the-counter sanitizing products, whose petroleum hydrocarbon concentration exceeds 10% (ten percent), the analysis certificate issued by the raw material supplier must be presented proving that the concentration of total aromatics is not greater than 25% (twenty-five percent) and that of benzene is not greater than 100ppm (one hundred parts per million).
Art. 20. The use, in sanitizing products, of substances classified by the International Agency for Research on Cancer of the World Health Organization (IARC) as group I carcinogenic agents for humans, as well as substances that have proven mutagenic or teratogenic effects in mammals, is prohibited, being tolerated only as impurities, if accepted as such by IARC.
Art. 21. The association of disinfectants with any other type of product covered by this Resolution is prohibited.
Art. 22. Anionic surfactant agents used in sanitizing product formulations must be biodegradable.
§1 Manufacturing companies of products that use anionic surfactants whose biodegradability is known must have technical information from the supplier as support for their biodegradability.
§2 If new generation anionic surfactants are used, for which information regarding their biodegradability is not yet available, this must be proven by international methodology of the Organization for Economic Cooperation and Development (OECD) and/or the European Union (EU), in which the minimum acceptable value is 80% (eighty percent).
Art. 23. Over-the-counter sanitizing products may have a maximum liquid content of 10L or Kg (ten liters or kilograms) and must have packaging that facilitates their safe use.
Art. 24. Any product covered by this Resolution, to be advertised and/or displayed, must be regularized with the health authority.
Single paragraph. Advertisement, display and supplementary leaflets must be in accordance with approved conditions for the product.
Art. 25. Sale of products for restricted use to professionals is not permitted in places where consumers have direct access.
Art. 26. The holder of notification or registration of products intended for use by professional users must have at their disposal the Chemical Product Safety Data Sheet or Safety Data Sheet (SDS), according to ABNT NBR 14725:2023 and its updates.
CHAPTER V
PACKAGING
Art. 27. The primary packaging material must have adequate composition and porosity to prevent the occurrence of:
  1. chemical reactions between the product and packaging;
  2. product color change;
  3. odor transfer; and
  4. migration of substances to the product and/or migration of the product to the external environment.
Art. 28. The container must be well sealed, with closure that prevents leaks or possible accidents and in such a way that it can be closed several times during use, without risk of contact with the product, making accidental or casual opening during its use difficult, throughout the entire validity period.
Art. 29. The use of packaging and labeling that allows false interpretation, error or confusion regarding origin, provenance, nature, composition or quality attributed to the product for purposes or characteristics different from those for which it is intended is prohibited.
Single paragraph. Packaging must not simulate, nor have presentation or resemblance to food products, beverages, cosmetics, medicines and toys or any children's motif that may be attractive to children.
Art. 30. Reuse of containers for food, beverages, dietary products, medicines, personal hygiene products, cosmetics and perfumes, and any other type for packaging sanitizing products is prohibited.
Art. 31. Transfer of sanitizing product contents to other containers, different from the original packaging, is not permitted, except in cases of risk 1 products and non-corrosive antimicrobial products, when recommended in use instructions.
Single paragraph. If refill presentations are in flexible packaging, these must necessarily be of smaller or equal liquid content than the largest capacity presentation in rigid packaging (originals) of the same product, regardless of their versions.
CHAPTER VI
LABELING
Section I
General requirements
Art. 32. Mandatory information, including lot identification, manufacturing date and validity, cannot be written on removable parts for use, such as caps, safety locks and others that become unusable when the container is opened.
Art. 33. Mandatory information must be in the official language of the country where the product is marketed.
Single paragraph. In the case of imported products whose label is in a language different from the official language of the country in which the product is marketed, an adequacy label must be placed in a visible place, containing legibly all mandatory information, according to what is established in this Resolution.
Art. 34. The label must remain mandatorily attached to the primary and secondary packaging of the product under normal use conditions and during its validity period, regardless of its fixation form: glued, directly printed or by any other available system.
Art. 35. Labeling must contain true and sufficient information about uses and essential characteristics of products covered by this Resolution.
Art. 36. Possible incompatibilities with materials and surfaces, if they exist, must be indicated on the label.
Art. 37. All mandatory phrases and pictograms must appear in clear characters, easily visible, indelible under normal use conditions and easily readable by the consumer.
Art. 38. Labeling cannot induce deception and/or error regarding product use and its intended purpose.
Art. 39. The following indications are prohibited on the label:
  1. "maximum efficiency", "with the power of an industrial product", "ultra-powerful", "unique formula", "the best on the market", "reliable", "safe" and similar; and
  2. "non-toxic to humans and domestic animals", "ecological", "contains all natural ingredients", "among the least toxic products known", "free from contamination", "it is less toxic because it does not contain..." and similar.
Art. 40. On the label, it is prohibited to mention, directly or indirectly, that the product:
  1. is recommended by some national, international and/or professional organization, except when the mention is supported by technical bases or experiences accredited by public or private institutions;
  2. can prevent or control diseases or offer health protection, for example "prevents infections", "controls infections" and similar; and
  3. is safe for having a child-proof safety device.
Art. 41. On the label, it is prohibited to include images or symbols that denote that the product is not toxic and/or safe or that contradict what is indicated in the text.
Art. 42. The labeling text must be legible, in colors that do not hinder reading.
Art. 43. Phrases that cannot be included on the primary packaging surface must be contained in an explanatory leaflet or equivalent, which must mandatorily accompany the product.
Section II
Label statements
Art. 44. The main panel of the label must contain the following information:
  1. brand or trade name;
  2. product category, based on its intended use;
  3. the phrase "KEEP OUT OF REACH OF CHILDREN AND DOMESTIC ANIMALS";
  4. the phrase "READ LABEL INSTRUCTIONS BEFORE USE";
  5. the phrase "PRODUCT EXCLUSIVELY FOR PROFESSIONAL USE - DIRECT SALE TO PUBLIC PROHIBITED"; and
  6. the phrase "READ THE LABEL AND PRODUCT SAFETY DATA SHEET CAREFULLY BEFORE USING IT".
§1 The phrases indicated in items III, IV, V and VI of the caput of this article must be in capital letters and bold.
§2 The phrases indicated in items V and VI of the caput of this article apply to products for professional sale.
Art. 45. The main or secondary panel of the label must contain the following information:
  1. AFE number of the company holding the notification or registration;
  2. manufacturer(s) identification;
  3. product identifier number (risk 1) or product registration number (risk 2);
  4. name, address and telephone number of the product holding company;
  5. country of origin of the product;
  6. liquid content;
  7. use instructions;
  8. processing batch identification;
  9. indication of validity period, accompanied by manufacturing date, or expiration date;
  10. composition;
  11. telephone number of at least one Toxicological Information and Assistance Center (Ciat);
  12. product storage instructions;
  13. the phrase "Keep the product in its original packaging";
  14. the phrase "Do not reuse empty packaging for other purposes.";
  15. the phrase "In case of contact with eyes and/or skin, wash immediately with plenty of water.";
  16. the phrase "In case of ingestion, do not induce vomiting and immediately consult the Toxicological Information and Assistance Center (Ciat) or a doctor taking the packaging or product label.";
  17. precautionary phrases for aerosols: "Do not puncture the container.", "Do not spray near flame.", "Do not throw in incinerator.", "Refilling prohibited." and "Do not expose to temperature above 50°C";
  18. precautionary phrases for flammables: "Caution, flammable!", "Keep away from fire and hot surfaces."; and
  19. other mandatory precautionary phrases, indicative phrases and/or pictograms provided for by specific standards.
§1 The liquid content information indicated in item VI of the caput of this article must appear on the main panel and, if not possible, must have differentiated size - larger - of characters, according to Inmetro Ordinance No. 249/2021 and its updates.
§2 The use instructions indicated in item VII of the caput of this article must be clear and simple and, in the case of over-the-counter products, when it is necessary to use a measure, this must be of common use for the consumer or must accompany the product.
§3 In the composition, indicated in item X of the caput of this article, of risk 1 products, the active ingredient(s) and other component(s) of toxicological importance must be informed by internationally accepted technical name(s) and the other formulation components, by their functions.
§4 In the composition, indicated in item X of the caput of this article, of risk 2 products, the active ingredient(s) and other component(s) of toxicological importance must be informed by internationally accepted technical name(s) with their respective concentration(s) and the other formulation components, by their functions.
Art. 46. When the primary packaging surface does not allow inclusion of all information required by this Resolution, the following must be included on the packaging at minimum:
  1. brand or trade name;
  2. category (intended use);
  3. active component(s) and any other component of toxicological importance and their concentrations;
  4. batch;
  5. AFE number of the company holding the notification or registration;
  6. manufacturer(s) identification;
  7. product identifier number (risk 1) or product registration number (risk 2);
  8. expiration date or validity period and manufacturing date;
  9. the phrase "PRODUCT EXCLUSIVELY FOR PROFESSIONAL USE - DIRECT SALE TO PUBLIC PROHIBITED"; and
  10. the phrase "READ THE LABEL AND PRODUCT SAFETY DATA SHEET CAREFULLY BEFORE USING IT";
  11. the warning phrase "READ THE EXPLANATORY LEAFLET INSTRUCTIONS BEFORE USE";
  12. the phrase "KEEP OUT OF REACH OF CHILDREN AND DOMESTIC ANIMALS"; and
  13. liquid content.
§1 The phrases indicated in items IX and X of the caput of this article apply to products for professional sale and must be in capital letters and bold.
§2 The phrases indicated in items XI and XII of the caput of this article must be in capital letters and bold.
CHAPTER VII
FINAL AND TRANSITIONAL PROVISIONS
Art. 47. Petitions for regularization of new sanitizing products must fully comply with the provisions of this Resolution, from the date of its validity.
§1 Petitions for revalidation and declaration of interest in continuing commercialization of sanitizing products must fully comply with the provisions of this Resolution, from the date of its validity.
§2 Petitions that alter already regularized sanitizing products must specifically comply with the Chapters of this Resolution, from the date of its validity, related to the changes they promote.
Art. 48. Non-compliance with the determinations of this Resolution constitutes a health infraction, subjecting the offender to process and penalties provided for in Law No. 6,437, of August 20, 1977, or legal instrument that comes to replace it, without prejudice to applicable criminal and civil responsibilities.
Art. 49. Collegiate Board Resolution - RDC No. 59, of December 17, 2010, published in Official Gazette of the Union No. 244, of December 22, 2010, Section 1, page 80, is hereby revoked.
Art. 50. This Resolution enters into force on the date of its publication.

RÔMISON RODRIGUES MOTA
Substitute Director-President

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