EN ISO 28399:2026
(Main)Dentistry - External tooth bleaching products (ISO 28399:2026)
- Abstract
This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products) or both. It also specifies requirements for their packaging, labelling and manufacturer’s instructions for use.
This document is not applicable to tooth bleaching products:
specified in ISO 11609;
intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;
auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.
This document does not specify biological safety aspects of tooth bleaching products.
NOTE The maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body.
- Status
- Published
- Publication Date
- 13-Oct-2026
- Technical Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 14-Oct-2026
- Completion Date
- 14-Oct-2026
EN ISO 28399:2026 is a CEN standard for external tooth bleaching products used in dentistry. It specifies requirements and test methods for products applied in the oral cavity by dental professionals, by consumers at home under professional or non-professional use, or in both settings. It also covers packaging, labelling and the manufacturer’s instructions for use.
What does EN ISO 28399:2026 specify?
EN ISO 28399:2026 specifies the requirements and test methods for external tooth bleaching products and organizes them into clauses on scope, references, terms, classification, requirements, test methods, and packaging and information supplied by the manufacturer. The document is aimed at products for oral use on the outer surfaces of natural teeth, and it excludes several other whitening or colour-changing approaches.
| Annex | What it covers |
|---|---|
| Annex A | Test procedure for measuring hydrogen peroxide concentration |
| Annex B | Light microscopy method for measuring erosion of enamel and dentine |
| Annex C | Laboratory method for assessing tooth bleaching efficacy |
The scope excludes tooth bleaching products covered by ISO 11609, products that change the appearance of natural teeth by mechanical stain removal or by restorative approaches such as veneers or crowns, and auxiliary materials or devices used with bleaching products such as tray materials or lights. EN ISO 28399:2026 also does not cover biological safety aspects. A note in the scope adds that the maximum bleaching-agent concentration for professional or consumer use is set by each country’s regulatory body.
What are the key requirements of EN ISO 28399:2026?
EN ISO 28399:2026 sets a small number of practical performance limits and test expectations that matter for product safety, product claims and quality control. The main focus is on label claim consistency, tooth surface effects, and how the product is described and supplied.
Product classification and intended use
Clause 4 classifies external tooth bleaching products as either for professional application or for consumer application. Professional application means use only by dental professionals in office, while consumer application includes products intended for home use, either under professional supervision or for direct non-professional use. In practice, the manufacturer has to state who applies the product and in what setting.
Performance requirements
Clause 5 requires the concentration of active bleaching ingredients, expressed as hydrogen peroxide equivalent, in the unexpired product to stay within the stated range around the manufacturer’s original concentration. In practice, this means the product has to remain close to its labelled strength when used according to the instructions.
Clause 5 also limits the reduction in enamel surface microhardness after bleaching. The decrease in Knoop hardness (KHN) or Vickers hardness (VHN) must not exceed the stated limit when tested as described in the document. This matters because it checks whether the bleaching treatment unduly softens the tooth surface.
Clause 5 further requires the tested surface erosion to stay below the level caused by the standard reference solution. This gives manufacturers a way to compare erosion risk against a defined laboratory reference rather than relying on subjective judgement.
Test methods and specimen handling
Clause 6 gives the test set-up for specimen preparation and product application. Enamel and dentine specimens are prepared from human or bovine teeth taken from a consistent location, stored in a neutralized disinfecting solution, ground and polished with specified abrasives, and kept hydrated. In practice, this is what makes laboratory results comparable between products.
Clause 6 also requires bleaching treatments to follow the manufacturer’s instructions for use and to simulate clinical quantity, frequency and duration. Between treatment intervals, and for 24 hours after the last application before testing, specimens are stored at 37 °C in artificial saliva. That helps the test reflect how the product behaves on teeth rather than in an artificial dry condition.
Clause 6.3 sets the microhardness measurement conditions, including the use of a 0.49 N load for 15 s and multiple specimens with repeated indentations. This gives a consistent way to measure whether bleaching changes the tooth surface.
Packaging, marking and instructions
Clause 7 requires packaging that protects the contents and does not harm product quality. It also sets out the information that must appear on the outer package, on containers where relevant, and in the manufacturer’s instructions for use. For single-use containers, the minimum identification includes the manufacturer name, trade name, lot number and expiry date.
What terms does EN ISO 28399:2026 define?
- Bleaching - In this document, bleaching is the removal of intrinsic or acquired discoloration of natural teeth, or changing their colour toward a lighter or whiter shade using chemicals, sometimes with auxiliary means.
- Professional home use - A product used at home after being prescribed by a dental professional and used under repeated supervision by the dentist.
- Erosion - The progressive loss of calcified tooth tissue caused by chemical processes that do not involve bacterial action.
- Professional application - A tooth bleaching product intended by the manufacturer to be applied only by dental professionals in the clinic or office.
- Consumer application - A tooth bleaching product intended by the manufacturer to be applied by the consumer, either for professional home use or for non-professional home use.
- Hydrogen peroxide (H2O2) - The document uses hydrogen peroxide equivalent as the basis for checking active bleaching ingredient concentration.
- Knoop hardness (KHN) and Vickers hardness (VHN) - These are the hardness measures used to check whether bleaching causes too much surface softening.
Who uses EN ISO 28399:2026?
EN ISO 28399:2026 is used by manufacturers of tooth bleaching products, laboratory test providers, dental product quality teams, and regulators or purchasers who need to compare product claims. It is also relevant to dental professionals who prescribe or apply bleaching products and who need to understand what the package label and instructions should tell them.
Typical uses include:
- product design and formulation control
- laboratory verification of bleaching-agent concentration
- erosion and microhardness testing
- preparation of packaging and instructions for use
- checking whether a product is positioned for professional or consumer use
What changed in EN ISO 28399:2026 from the previous edition?
EN ISO 28399:2026 replaces the third edition, ISO 28399:2021. The foreword says the revision is editorial and that the changes are intended to improve clarity throughout the document.
Which standards are used with EN ISO 28399:2026?
EN ISO 28399:2026 refers to several standards and related documents that support its tests and labelling.
- ISO 1942 - Provides dental vocabulary used for the terms and definitions.
- ISO 1042 - Specifies one-mark volumetric flasks used in the erosion test work.
- ISO 3696 - Specifies laboratory water used in sample preparation and test solutions.
- ISO 6344-1 - Supports the abrasive paper grading used when preparing tooth specimens.
- ISO 8601-1 - Gives the date format used for expiry dates on labels.
- ISO 11664-2 - Supports colourimetry and illuminant conditions for visual shade assessment.
- ISO/CIE 11664-1 - Used in Annex C for calibrated visual shade evaluation.
- ANSI/ADA Specification No 41 - Provides the artificial saliva reference used when storing specimens between bleaching intervals.
- ISO 22727 - Is named for additional information and public information symbols in the packaging section.
- ISO 10993-1 and ISO 7405 - Are cited in the introduction and bibliography for biological and toxicological hazard assessment.
What does the EN ISO 28399:2026 document contain?
EN ISO 28399:2026 contains one main classification clause, three technical requirement clauses, a packaging and information clause, and three informative annexes. The annexes are practical laboratory methods rather than general background text.
Annex A gives a modified thiosulfate titration procedure for hydrogen peroxide concentration, including test conditions, sample preparation and a calculation formula. Annex B gives a light microscopy method for erosion measurement, with specimen preparation, standard reference erosion controls, cross-section preparation, digital imaging and software-based measurement steps. Annex C gives a laboratory method for assessing bleaching efficacy using shade guides or electronic colour measurement, including specimen preparation, treatment, colour-change assessment and statistical analysis.
Clause 7 is supported by a table that lists the information for the outer package, the container and the instructions for use. The document also includes figures that show specimen preparation, erosion testing and image analysis set-ups.
Relations
- Effective Date
- 04-Oct-2023
- Effective Date
- 12-Feb-2026
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Frequently Asked Questions
EN ISO 28399:2026 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - External tooth bleaching products (ISO 28399:2026)". This standard covers: This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products) or both. It also specifies requirements for their packaging, labelling and manufacturer’s instructions for use. This document is not applicable to tooth bleaching products: specified in ISO 11609; intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products. This document does not specify biological safety aspects of tooth bleaching products. NOTE The maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body.
This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products) or both. It also specifies requirements for their packaging, labelling and manufacturer’s instructions for use. This document is not applicable to tooth bleaching products: specified in ISO 11609; intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products. This document does not specify biological safety aspects of tooth bleaching products. NOTE The maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body.
EN ISO 28399:2026 is classified under the following ICS (International Classification for Standards) categories: 71.100.70 - Cosmetics. Toiletries; 97.170 - Body care equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 28399:2026 has the following relationships with other standards: It is inter standard links to EN ISO 28399:2021, ISO 28399:2026. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 28399:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2026
Nadomešča:
SIST EN ISO 28399:2021
Zobozdravstvo - Proizvodi za zunanje beljenje zob (ISO 28399:2026)
Dentistry - External tooth bleaching products (ISO 28399:2026)
Zahnheilkunde - Äußere Zahnbleichmittel (ISO 28399:2026)
Médecine bucco-dentaire - Produits d'éclaircissement dentaire par voie externe (ISO
28399:2026)
Ta slovenski standard je istoveten z: EN ISO 28399:2026
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 28399
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2026
EUROPÄISCHE NORM
ICS 71.100.70; 97.170 Supersedes EN ISO 28399:2021
English Version
Dentistry - External tooth bleaching products (ISO
28399:2026)
Médecine bucco-dentaire - Produits d'éclaircissement Zahnheilkunde - Äußere Zahnbleichmittel (ISO
dentaire par voie externe (ISO 28399:2026) 28399:2026)
This European Standard was approved by CEN on 30 August 2026.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 28399:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 28399:2026) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2027, and conflicting national standards shall be
withdrawn at the latest by April 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 28399:2021.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 28399:2026 has been approved by CEN as EN ISO 28399:2026 without any modification.
International
Standard
ISO 28399
Fourth edition
Dentistry — External tooth
2026-10
bleaching products
Médecine bucco-dentaire — Produits d'éclaircissement dentaire
par voie externe
Reference number
ISO 28399:2026(en) © ISO 2026
ISO 28399:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 28399:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 General .2
4.2 Products for professional application .2
4.3 Products for consumer application .2
5 Requirements . 2
5.1 Concentration of active ingredients for bleaching .2
5.2 Surface microhardness .2
5.3 Surface erosion .3
6 Measurements and test methods . 3
6.1 Preparation of tooth specimens .3
6.2 Preparation and application of tooth bleaching product .3
6.3 Surface microhardness .3
7 Packaging, marking and information to be supplied by the manufacturer . 3
7.1 General .3
7.2 Packaging .3
7.3 Marking and instructions for use .3
Annex A (informative) Test procedure for the measurement of hydrogen peroxide
concentration . 5
Annex B (informative) Light microscopy method for measuring erosion of enamel and dentine
caused by external tooth bleaching products . 7
Bibliography . 19
iii
ISO 28399:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 28399:2021), which has been technically
revised.
The changes are as follows:
— editorial changes were made throughout the document to improve clarity;
— Annex C “Test method for laboratory assessment of tooth bleaching efficacy” has been removed.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 28399:2026(en)
Introduction
External tooth bleaching products are used in dentistry for changing the colour of natural teeth towards a
lighter or whiter shade. They are applied in the oral cavity directly on the outer surfaces of teeth.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in
this document. Reference should be made to ISO 10993-1 and ISO 7405 when assessing possible biological or
toxicological hazards.
v
International Standard ISO 28399:2026(en)
Dentistry — External tooth bleaching products
1 Scope
This document specifies the requirements and test methods for external tooth bleaching products. These
products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching
products) or consumer application (professional or non-professional home use of tooth bleaching products)
or both. It also specifies requirements for their packaging, labelling and manufacturer’s instructions for use.
This document is not applicable to tooth bleaching products:
— specified in ISO 11609;
— intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or
using restorative approaches, such as veneers or crowns;
— auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that
are used in conjunction with the bleaching products.
This document does not specify biological safety aspects of tooth bleaching products.
NOTE The maximum concentration of a bleaching agent for professional or non-professional use is subject to each
country’s regulatory body.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 6344-3, Coated abrasives — Determination and designation of grain size distribution — Part 3: Microgrit
sizes P240 to P5000
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 8601-2, Date and time — Representations for information interchange — Part 2: Extensions
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
bleaching
removal of intrinsic or acquired discolorations of natural teeth, through the use of chemicals,
sometimes in combination with the application of external energy
Note 1 to entry: Changing the colour of natural teeth towards a lighter or whiter shade is not limited to changing a
discoloration.
ISO 28399:2026(en)
Note 2 to entry: Auxiliary means for bleaching other than the application of external energy are also conceivable.
[SOURCE: ISO 1942:2020, 3.6.5, modified — Note 1 to entry and Note 2 to entry have been added.]
3.2
professional home use
use prescribed by a professional and for patient or consumer use at home under the supervision
of the dentist
3.3
erosion
progressive loss of calcified dental tissue by chemical processes that do not involve bacterial
action
[SOURCE: ISO 1942:2020, 3.1.3.6, modified — The term “tooth erosion” has been modified to “erosion”, the
admitted term has been deleted and the domain "" has been added.]
4 Classification
4.1 General
External tooth bleaching products can be classified for either:
a) professional application; or
b) consumer application.
NOTE External tooth bleaching products can be used alone or in conjunction with auxiliary means of application.
4.2 Products for professional application
These products are tooth bleaching products that are intended by the manufacturer to be applied only by
dental professionals (in-office tooth bleaching products).
4.3 Products for consumer application
These products are tooth bleaching products that are intended by the manufacturer to be applied by the
consumer (for professional home use or for non-professional home use).
NOTE Such external bleaching products can be prescribed by a dental professional or be made directly available
to consumers.
5 Requirements
5.1 Concentration of active ingredients for bleaching
The concentration of active ingredients for bleaching (equivalent to that of hydrogen peroxide) delivered
by the unexpired product according to the manufacturer's instructions for use shall be within the range
of +10 % and −30 % of the original concentration stated by the manufacturer for the unopened product.
Annex A or any other validated method that supports the use of the thiosulfate approach to H O titrations,
2 2
or any other validated method of similar sensitivity, accuracy and free of biases can be used.
5.2 Surface microhardness
The reduction in the Knoop hardness (KHN) or Vickers hardness (VHN) after bleaching shall not exceed
10 %, when tested in accordance with 6.3.
ISO 28399:2026(en)
5.3 Surface erosion
Surface erosion of the teeth tested shall be less than the level which is caused by the standard reference
solution. The method described in Annex B or other validated methods of similar or better sensitivity,
accuracy and free of biases can be used.
6 Measurements and test methods
6.1 Preparation of tooth specimens
Prepare enamel and dentine specimens taken from a consistent location on extracted human or bovine teeth
that have been stored in a neutralized solution that disinfects but does not alter the physical properties.
Grind the specimen surface under a constant flow of water in accordance with ISO 3696, starting at P400
and sequentially to a minimum of P1200 silicon carbide paper in accordance with ISO 6344-3. Then, polish
the surface using a slurry or paste of 0,3 µm mean particle size aluminium oxide. Ensure a minimum of
1 mm thickness of enamel or dentine tissue for the test specimen. Prevent dehydration of test specimens
during the preparation procedure.
6.2 Preparation and application of tooth bleaching product
The dispensing, processing and application of the tooth bleaching product used in tests (e.g. the test given
in Annex B) shall follow the manufacturer's instructions for use. The method of bleach application shall
simulate the clinical procedure in quantity, frequency and duration of the application. Between bleaching
intervals, and for 24 h after the last bleach application prior to testing, specimens shall be stored at 37 °C
in a solution that is pH 6,8 to 7,2 and saturated with respect to hydroxyapatite with calcium and phosphate
salts (e.g. 4 mmol/l CaCl with 8 mmol/l KH PO titrated to pH 7 with NaOH or HCl).
2 2 4
6.3 Surface microhardness
Evaluate enamel surface microhardness before and after bleaching treatment.
Determine KHN or VHN surface microhardness by applying a load of 0,49 N (equivalent to a 50 g load)
for 15 s. Evaluate a minimum of 10 specimens for each group, with three indentations for each specimen.
Prevent dehydration of test specimens during the specimen preparation procedure.
7 Packaging, marking and information to be supplied by the manufacturer
7.1 General
Additional information may be included at the discretion of the manufacturer.
7.2 Packaging
The components of the material shall be supplied in properly sealed containers which adequately protect
the contents and do not adversely affect the product quality.
7.3 Marking and instructions for use
For each package, the following applies:
a) Information shall be clearly marked on the outermost package or containers appropriate to the product,
as indicated in Table 1.
b) Instructions shall accompany each package of the product and shall include the information appropriate
to the product, as indicated in Table 1.
ISO 28399:2026(en)
Table 1 — Requirements for marking and instructions for use
Manufacturer’s
Outermost
No. Information Container instructions for
package
use
1 Name of the product M M M
2 Identification or name of the manufacturer M M M
3 Address of the manufacturer or the agent responsible for sale M — M
4 Recommended conditions of storage M — M
5 Manufacturer's lot number M M —
Expiry date given in accordance with ISO 8601-1 or —
6 M M
ISO 8601-2
Classification of the external tooth bleaching products
7 M — M
(Clause 4)
Clinical application of the external tooth bleaching products
8 — — M
(Clause 4)
9 Number of containers M — —
10 Net mass of product in each container M M —
11 Chemical name of active ingredient(s) M — M
12 Concentration of active ingredient(s) M — M
13 Concentration equivalent to hydrogen peroxide M — M
14 Instructions for use — — M
15 Recommended auxiliary device(s), exposure times and any special
instructions for use of the equipment
— — M
(for the materials requiring an auxiliary device only)
16 Specific contra-indication(s) or warning(s), such as ”irritation”,
— — M
“avoid contact with eyes”, as necessary
17 Statement equivalent to "It is recommended that you consult with — — M
your dental professional before using this product."
18 Date of issue or latest revision, if applicable — — M
Key
M: mandatory information
—: non-mandatory information
For single use containers, instructions may be labelled on the secondary packaging. The minimum
information on single use containers required are: manufacturer name, trade name, lot number and expiry
date.
ISO 28399:2026(en)
Annex A
(informative)
Test procedure for the measurement of hydrogen peroxide
concentration
A.1 Principle
The content of generated hydrogen peroxide (H O ) in tooth bleaching products is determined using a
2 2
modified thiosulfate titration method.
A.2 Test condition
Perform the test at (23 ± 2) °C.
[7]
A.3 Procedure (modified thiosulfate titration method )
A.3.1 General
Use the following materials:
— analytical grade sulfuric acid;
— potassium iodide;
— ammonium molybdate;
— s
...