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Natural Health Products Online System Standard Terminology Guide
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February 2011 - Version 2.1
Table of Contents
- 1 Introduction
- 2 Ingredients Naming Standard Terminology
- 2.1 NHPID Names
- 2.2 Proper Names
- 2.3 Common Names
- 2.4 Taxonomical Synonyms
- 2.5 Authorized References
- 2.6 The Scope of the Terminology
- 2.7 Types of Ingredients/Organisms
- 2.8 Obtaining the Terminology
- 2.9 Chemical Substances and Herbal Components
- 2.10 Protein Substances
- 2.11 Defined Organism Substances
- 2.12 Homeopathic Substances
- 3 Organism Parts Standard Terminology
- 4 Organism Substance Preparation Terminology
- 5 Organism Types Standard Terminology
- 6 Ingredient Roles
- 7 Ingredient Rules
- 8 International Conference on Harmonization M5 Controlled Vocabularies
- 9 Non-medicinal Ingredient Purposes Standard Terminology
- 10 Test Methods
- 11 Appendices
1 Introduction
The Natural Health Products Directorate (NHPD) and the natural health products industry engage in an intense information exchange during the Natural Health Product (NHP) licensing phase. One of the objectives of the NHP Online System is to capture and validate licence applications and to securely submit them electronically along with appropriate attachments. Applying standards and terminologies to NHP licence applications will provide the ability to exchange product information between the NHPD and industry in a structured and efficient way. Therefore, standards and terminologies are one of the essential elements in this information exchange.
Consistency in naming also assists in the retrieval of information from the NHP Online System and provides the ability of health professionals and the public to compare similar goods.
1.1 Development and Terminologies
Currently, no single internationally agreed upon list or primary reference comprehensively covers all substances or terms used, or likely to be used, with regards to natural health products in Canada. Consequently, the NHPD has been confronted with the challenge of adapting two major standards in order to meet the NHPD requirements for use by the NHP Online System:
- Naming conventions for ingredients have been adapted from the Approved Terminology for Medicines, Australian Therapeutic Goods Administration (TGA). Further refinements and modifications to the terminology are described in this document.
- Terminologies for dosage forms, routes of administration, and units and measurements have been adapted from the International Conference on Harmonization (ICH) controlled lists.
1.2 Using the Terminologies
Currently, tools such as the Natural Health Products Ingredients Database (NHPID) Web application and the electronic product license application (e-PLA) have incorporated this terminology. Wherever applicable, only approved terms should be used. For standalone documents, reports, emails, it is encouraged that the appropriate terms are used accordingly.
1.3 Adding, Deleting, Changing Terms in the Terminologies
For adding new terms, deleting existing terms, or changing any data associated to a term, the requestor should complete a Natural Health Products Ingredients Database Issue Form (NHP Ingredients Database Issue Form Guide.) The change request process is summarized bellow.
- The requestor collects necessary information about the issue and any appropriate references.
- The requester prepares an NHP Ingredients Database Issue Form (NHP Ingredients Database Issue Form Guide) and sends the completed form to ingredient support at ingredient_support@hc-sc.ga.ca by email, or by mail to:
Ingredients Information Management Unit
Bureau of Clinical Trials and Health Sciences
2936 Baseline Road
Ottawa, Ontario
K1A 0K9 - The change request is viewed by a data management officer at the NHPD.
- The original requester is informed of the decision made at the NHPD or is asked for further clarification if required.
The time required for reviewing a request may vary depending on the quality and/or the complexity of the request.
2 Ingredients Naming Standard Terminology
Consistency in naming assists the retrieval of information from the NHP Ingredients Database and will allow for the efficient handling of acceptable ingredient information for non-medicinal ingredients, classified medicinal ingredients and evidence to support safety and efficacy, and quality testing requirements by the NHPD.
NHPID names should be used when submitting applications for product licensing to the NHPD as well as in product information, consumer information and other promotional literature wherever use of the terminology is applicable.
To understand conventions used in assigning approved names to the ingredients, and abbreviations presented in the NHP Ingredients Database, users are encouraged to review the 
Therapeutic Goods Administration - Approved Terminology for Medicines.
2.1 NHPID Names
An NHPID name is a unique identifier of an ingredient. NHPID names should be used as primary ingredient identifiers wherever it is applicable. For homeopathic ingredients, the NHPID name will consist of the pharmacopoeia, an underscore, and the first proper name of the ingredient in the NHPID. Selecting approved names is based on the following rules:
- It must be unique globally;
- It must be the primary name used in the reference cited;
- Avoid long names such as chemical International Union of Pure and Applied Chemistry (IUPAC) names;
- Avoid uncommon synonyms; and
- Trade names, product IDs, registry numbers, and other terminology IDs (such as Flavour & Extract Manufacturers Association (FEMA)) cannot be used as approved names.
2.2 Proper Names
The Natural Health Products Regulations sets out rules for ingredient proper names. In the terminologies, the ingredient proper names are mapped in compliance with the related rules set out in the regulations as follows:
- For chemical substances (except minerals and vitamins) and Protein substances, use any unambiguous chemical name provided by an authoritative reference such as the Merck Index, the United States Pharmacopeia Dictionary, etc., or a name determined using the IUPAC nomenclature system.
- For defined and custom organism substances, use the NHPID names (scientific names) of their parent organisms.
- For vitamins, use Biotin, Folate, Niacin, Pantothenic acid, Vitamin A, Thiamine, Riboflavin, Vitamin B6, Vitamin B12, and Vitamins C, D and E.
- For homeopathic ingredients, the proper names will be as provided in the pharmacopoeia.
2.3 Common Names
The Natural Health Products Regulations set out the definition for common name as "the name by which it is commonly known and is designated in a scientific or technical reference". However, in practice, especially for chemicals, determining an unambiguous common name is not always straightforward. According to the terminology presented here, ingredient common names are mapped based on the following rules:
- For Predefined and Custom organism substances, use any name other than scientific names.
- For Chemicals and Proteins, common names are not separated from other synonyms. Users have the right to select any synonym (including NHPID names) as common names.
- A common name must be supported by at least one authorized reference.
- For homeopathic ingredients, the common names will be as provided in the pharmacopoeia.
2.4 Taxonomical Synonyms
Taxonomical synonyms are scientific names other than the NHPID names for organisms. A taxonomical synonym must be supported by at least one authorized reference. Taxonomical synonyms are part of the common names of an organism.
2.5 Authorized References
Generally, ingredients included in the terminology set must be supported by at least one authorized reference. If an authorized reference cannot be found for any new name, a new authorized reference may be proposed through the NHP Ingredients Database Issue Form.
It is important to note that the citation of an authority or reference for a name in the terminology does NOT imply that the standard specified by that authority is applicable to the substance used in a particular natural health product. Where the reference is not an official standard for the substance, the quality of the substance should comply with the requirements as defined in the Evidence for Quality in Finished Natural Health Product guide.
Where Chemical Abstracts Service (CAS) Registry numbers are given as a reference, the number may identify the composition of the substance only.
Conflicts may occur amongst certain authorized references with regards to the scientific names of organisms. The primary binomial name of a species may vary from one reference to another, or may even be put into different taxonomy nodes. In order to help the NHPD data managers capture taxonomy data and to help users search the NHP Ingredients Database, the NHPD has defined a precedence reference order for adding organism names. Please refer to the Appendix.
2.6 The Scope of the Terminology
The ingredient naming standard terminology captures ingredient names and other NHPD-approved ingredient related information. The terminology captures the following data elements:
- NHPID name. The official name for an ingredient/organism. It should be used as primary identifier for an ingredient/organism.
- Proper name. A proper name is an unambiguous name as defined in the Natural Health Products Regulations.
- Common name. A common name is a secondary identifier for an ingredient/organism.
- Taxon (taxonomical synonym, or other scientific name). Organism taxonomical synonym. It should be used only as one of the organism's scientific names.
- CAS registry number. CAS registry number for a chemical, herbal component or protein. It can be used as a secondary identifier of a chemical or protein ingredient.
- Ingredient role. Medicinal, Non-medicinal role, Non-NHP, and Component.
- Schedule 1 classification. Medicinal ingredient classification defined by Schedule 1 of the Natural Health Products Regulations.
- Ingredient category. See Section 2.7 below.
2.7 Types of Ingredients/Organisms
An ingredient can belong to one of following categories:
- Chemical (ACN). A chemical substance is a purified constituent of a defined molecular structure which can be isolated from a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material or be chemically synthesized.
- Protein (APN). A protein is a macromolecule composed of one or several polypeptides. Each polypeptide consists of a chain of amino acids linked together by covalent (peptide) bonds. An enzyme is a protein that catalyzes a biochemical reaction.
- Herbal name (AHN). An organism of herbal origin (plant or fungus or blue algae).
- Predefined herbal substance (AHS). A substance derived from an herbal organism (AHN).
- Food substance (AFN). A food substance derived from an AHN. AFN are food names and are non-medicinal.
- Biological name (ABN). An organism names from biological origin (non-human animal, bacterium or probiotic).
- Biological substance (ABS). A substance from a non-human animal or bacterium.
- Homeopathic Substance (HMN). A substance as defined in a homeopathic pharmacopoeia.
The terminology also captures herbal components (HCN). An herbal component is a chemical that can be found in an herbal organism or herbal substance as an active/marker constituent.
Aggregated categories are also used for convenience, such as with the ingredient search tools. The categories above are further aggregated as chemical (ACN), protein (APN), organism (AHN and ABN), and organism substance (AHS and AFN, and ABS).
2.8 Obtaining the Terminology
Currently, neither hard copies nor electronic copies of the ingredient naming terminology are available. The terminology can be accessed through the main page of the Natural Health Products Ingredients Database Web application.
The terminology described below is in the context of the presentation of the naming terminology via the Web application. Guidance is also available for using this Web application and can be found in the NHP Ingredients Database Web Application Guide.
2.9 Chemical Substances and Herbal Components
A chemical substance is a purified constituent of a defined molecular structure which can be isolated from a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material; may be chemically synthesized; and may be medicinal, non-medicinal, or non-NHP. Inherently, herbal components are chemicals as well. However, since herbal components are not isolated for medicinal or non-medicinal use they have been assigned an individual category.
The data for chemical substances is organized and displayed by category, synonyms, CAS registry numbers, other registry numbers, reference, etc. The NHPID name together with the reference will define the molecular species in the case of a single substance; the composition of the substance in the case of a mixture; or the characteristics of a variable material. Chemical structures are only available for selected chemical substances.
2.9.1 Guidelines for Chemical Substances Information
Table 1 provides an explanation of how chemical substance information is organized and displayed in the NHP Ingredients Database Web application.
| Chemical Substance Information | Description |
|---|---|
| Name | NHPID names refer to well-characterized chemical substance names. |
| Category | The category that the ingredient name belongs to - in this case, Approved Chemical Name. |
| Structure | Chemical structure of substance. |
| Schedule 1 | Category of substances (for example, plants, non-human animals, vitamins, probiotics, etc.) according to the Natural Health Products Regulations' Schedule I. Provided only for medicinal ingredients. |
| Proper Names | Unambiguous name(s) as per the Natural Health Products Regulations. |
| Common Names | All other names for the chemical substances are displayed. Selecting their hyperlink will display the reference or authority which defines the chemical substance name (e.g. Joint World Health Organization/Food and Agriculture Organization (WHO/FAO) Expert Committee on Food Additives (JECFA), Joint FAO/WHO Expert Committee on Food Additives (CTFA JECFA), Cosmetic, Toiletry, and Fragrance Association (CTFA) Merck Index (MI), United States Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), International Union of Pure and Applied Chemistry (IUPAC)). For flavouring substances, the Flavour & Extract Manufacturers Association (FEMA) number is given. |
| Chemical Abstracts Services (CAS) Registry Number | The CAS Registry Number is assigned by the Chemical Abstracts Service to identify a specific chemical substance. Selecting the CAS number will display its reference. |
| Other Registry Numbers | A chemical name may have more than one registry number. These other registry numbers are associated with other references. |
| Reference | Name reference codes have been included for each chemical substance to indicate the reference or authority which defines the chemical substance name. Only the more commonly used references are displayed. |
2.9.2 Guidelines for Herbal Component Information
Herbal component names (HCN) are chemical compounds or groups of chemical compounds which are components of plant and plant materials. Herbal components themselves are not medicinal or non-medicinal ingredients and their role can only be defined as a Component (see Section 6.0 - Ingredients Roles). An HCN may be used as a marker/active constituent of a standardized herbal ingredient or in claims which concern the strength or concentration of the component in an herbal ingredient.
Since all herbal components are chemicals in nature, naming herbal components follows the convention of naming general chemicals. Furthermore, HCNs may be grouped into the five following chemical classes: carbohydrates and lipids, nitrogen-containing compounds, alkaloids, phenolics, and terpenoids. Each class is further divided into several subclasses.
An herbal component can be contained in various herbal substances and the relative quantities may vary. In order to supply information on the herbal components, the NHP Ingredients Database provides the lower and/or upper amounts of the components in the parts of the source material organisms (see Section 7.6 - Sub-ingredients).
Table 2 provides an explanation of how herbal component information is organized and displayed in the NHP Ingredients Database
| Herbal Component Information | Description |
|---|---|
| Name | NHPID name for a component of a herbal ingredient. |
| Category | The category that the ingredient name belongs to - in this case Herbal Component Name. |
| Proper Names | Unambiguous name(s) as per the Natural Health Products Regulations. |
| Common Names | Other names for the component. |
| Single or Group | Belonging to a single chemical or a group of chemicals. |
| Chemical Class | One of five chemical classes: carbohydrates and lipids, nitrogen-containing compounds, alkaloids, phenolics, and terpenoids. |
| Chemical Subclass | One of the subordinate chemical groups of chemical classes. |
| Chemical Abstracts Service (CAS) Registry Number | The CAS Registry Number is assigned by the Chemical Abstracts Service to identify a specific chemical substance. Selecting the CAS number will display its reference. |
| Other Registry Numbers | A chemical name may have more than one registry number. These other registry numbers are associated with other references. |
| Reference | Name reference codes have been included for each chemical substance to indicate the reference or authority which defines the chemical substance name. Only the more commonly used references are displayed. |
2.10 Protein Substances
Proteins consist of amino acids which are a class of organic molecules that contain amino and carboxyl groups. Proteins can be found in parts of plants, algae, a fungi, bacterium or non-human animal material. Enzymes primarily act as a catalyst increasing the rate at which a specific biochemical reaction occurs. Enzymes are considered to be protein molecules and are mainly of three types: metabolic enzymes, digestive enzymes and food enzymes. An approved protein name (APN) is an NHPD-approved name for the protein supported by an authorized reference.
2.10.1 Guidelines for Protein Substances Information
Table 3 provides an explanation of how protein information is organized and displayed in the NHP Ingredients Database.
| Protein Substance Information | Description |
|---|---|
| Name | NHPID names refer to well-characterized names for protein substances. |
| Category | The category that the ingredient name belongs to - in this case Approved Protein Name. |
| Proper names | Unambiguous name(s) as per the Natural Health Products Regulations. |
| Common names | Other names for the protein. Selecting their hyperlink will display the reference or authority which defines the protein substance (e.g. Merck Index (MI ), United States Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), International Union of Biochemistry and Molecular Biology (IUBMB), Food Chemicals Codex (FCC ). |
| Chemical Abstracts Registry (CAS) Number | The CAS Registry Number is assigned by the Chemical Abstracts Service to identify a specific chemical substance. Selecting the CAS number will display its reference. |
| Other Registry Numbers | A protein name may have more than one registry number. These other registry numbers are associated with other references. |
| Reference | Name reference codes have been included for each protein to indicate the reference or authority which defines the protein substance name. Only the most commonly used references are displayed. |
2.11 Defined Organism Substances
The naming standard for ingredients of natural origin (i.e. a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material, an extract of the preceding or a probiotic) defines three types of organism names for organism substances: approved scientific names for an organism (i.e. Latin binomials), approved names for predefined organism substances, and custom organism substances. Organism substances can belong to either herbal substances (Approved Herbal Name (AHN), Approved Herbal Substance (AHS), Approved Food Name (AFN)) or biological substances (Approved Biological Name (ABN), Approved Biological Substance (ABS)). Herbal substances are preparations of plants, and other organisms that are treated as plants in the International Code of Botanical Nomenclature, such as fungi and blue-green algae. Biological substances are substances of biological origin that are not antibiotics and that are not derived from plants, including bacterium, animal, and non-human animal parts.
2.11.1 Guidelines for Herbal Naming
2.11.1.1 Approved Herbal Name
An Approved Herbal Name (AHN) is an NHPD-approved name for a plant (or fungus or blue alga). It must be a scientific name (binomial Latin name) supported by an NHPD-authorized reference (see the Authorized References section in Appendix).
An AHN consists of a genus name, species descriptor, and any subordinate taxonomical names such as subspecies, variety, and form when applicable. Please note that there may be more than one binomial name (synonyms, spelling variants) for one species. Only those with authorized references are included in the NHP Ingredients Database (approved herbal name and taxonomical synonyms). Some example AHNs are as follows:
- Coffea Arabica
- Lens culinaris subsp. Culinaris
- Coix lacryma-jobi var. ma-yuen
- Cucumis melo subsp. melo var. Reticulats
2.11.1.2 Predefined Herbal Substances
A Predefined Herbal Substance is an herbal substance which is commonly used as a medicinal or non-medicinal ingredient. There are two categories of Predefined Herbal Substances: Approved Herbal Substances Names (AHS) and Approved Food Names (AFN). AHS and AFN are official NHPD-approved ingredient names.
An AHS or AFN must be in English, French, or Latin. If an AHS or AFN originates from another language, it should be translated properly to English or French either by meaning or pronunciation. An AHS or AFN must be supported by at least one authorized reference and there must be at least one parent organism name (AHN) or a parent organism group name. Information for parent organism parts and preparations for AHS and AFN is also included. An organism part is represented by an approved organism part name (see Section 3.0 Organism Parts Standard Terminology) and a preparation is represented by an approved organism preparation name (see Section 4.0 Organism Substance Preparation Terminology).
In general, only six (6) preparations can be used for AFN: dry, fresh, powder, juice dry, juice fresh, and juice concentrated. Other preparations may be used only as a part of an AFN (such as walnut oil). In this case, a preparation name is not required.
AFNs refer only to edible substances fit for human consumption as foods. Even though an inedible substance otherwise complies with the description of a food substance in the AHS List, that inedible substance may not be named as an AFN.
Some examples of AHS and AFN are shown in Table 4.
| Name | AHS/AFN | Parent AHN | Organism Parts | Organism Preparation |
|---|---|---|---|---|
| Ambrette Seed Oil | AHS | Abelmoschus moschatus | Seed | Oil Essential |
| Bayberry Bark Powder | AHS | Morella cerifera | Root bark | Powder |
| Radix Isatidis | AHS | Isatis tinctoria | Root | Dry |
| Beetroot | AFN | Beta vulgaris | Root | Dry |
2.11.1.3 Custom Herbal Substances
Custom Herbal Substances are herbal medicinal which are not commonly used and therefore cannot be readily found in an authorized reference as a Predefined Organism Substance. Naming a Custom Herbal Substance must follow the rules outlined below.
An herbal substance consists of three parts: AHN, the organism part name, and the organism preparation name, where organism part name is an NHPD- approved organism part name (see Section 3.0 Organism Parts Standard Terminology) and organism preparation name is an NHPD-approved organism preparation name (see Section 4.0 Organism Substance Preparation Terminology). The following illustrates the composition of a custom herbal substance:
"Thymus serpyllum" + "herb" + "dry" = "Thymus serpyllum herb dry"
2.11.2 Biological Substances
2.11.2.1 Approved Biological Name
Approved Biological Names (ABN) are the scientific names (binomial or trinomial Latin names) of organisms other than plants (non-human animals mostly). Like an AHN, an ABN consists of three parts: genus name, species descriptor, and any subordinate taxonomical names. Trinomial Latin names are also acceptable. An NHPD-approved biological name must be supported by at least one authorized reference (see the Appendix):
- Bos Taurus
- Gekko gecko
- Bufo bufo
- Clupea harengus harengus
2.11.2.2 Predefined Biological Substances
Predefined Biological Substances are biological substances which are commonly used as medicinal or non-medicinal ingredients, and are defined as Approved Biological Substances (ABS). Like an AHS, an ABS is a substance name in English, French, or Latin that is supported by at least one authorized reference (see Appendix), and has at least one parent ABN. An ABS can be used as an NHPD-approved ingredient name. Some ABS examples are as follows:
- Royal jelly
- Bombyx Batryticatus
- Cornu Cervi Pantotrichum
- Fish oil
2.11.2.3 Custom Biological Substances
Like Custom Herbal Substances, Custom Biological Substances are those biological substances which are not commonly used and are not part of the NHP Ingredients Database. Naming a Custom Biological Substance is similar to naming a Custom Herbal Substance, i.e. approved organism name + organism part name + organism preparation name.
2.11.3 Organism Group
The source materials of some ingredients, especially organism substances, are a group of organisms whose entire members are difficult to define. An approved group name should be created to deal with such situations. An organism group consists of an approved organism group name, an included member list, and a possible excluded member list. The members can be a family name, genus name, species, or any subordinate taxonomical names. Names of all members must be supported by one authorized reference. The following table (Table 5 - Organism group examples) provides an example of an organism group for cottonseed oil.
| Group Name | Included List | Excluded List |
|---|---|---|
|
||
cotton |
Gossypium [genus] | |
2.12 Homeopathic Substances
Homeopathic substances are substances as defined in one of the five pharmacopoeias acceptable to NHPD: the Homeopathic Pharmacopoeia of the United States (HPUS), the Encyclopedia of Homeopathic Pharmacopoeia (EHP), the German Homeopathic Pharmacopoeia (HAB), the French Pharmacopoeia (Pharmacopée française or PhF), and the European Pharmacopoeia (PhEur).
2.12.1 Guidelines for Homeopathic Substance Information
Table 6 provides an explanation of how homeopathic substance information is organized and displayed in the NHP Ingredients Database Web application.
| Homeopathic Substance Information | Description |
|---|---|
| Name | NHPID names consist of the pharmacopoeia, an underscore, and the first proper name of the ingredient. |
| Category | The category that the ingredient name belongs to - in this case Homeopathic Name. |
| Proper names | As provided in the pharmacopoeia. |
| Common names | As provided in the pharmacopoeia. |
| Reference | Pharmacopoeia applicable to the ingredient. |
3 Organism Parts Standard Terminology
Organism parts are used for three purposes:
- as a part of the ingredient name,
- to identify the raw materials of a Custom Organism Substance, and
- to identify the raw materials of substances as a part of source materials.
The first is used for custom organism substances (e.g. Thymus serpyllum herb dry). The second is used for predefined and custom organism substances. Though the detailed requirements for the two substances are different, both require the part(s) of raw materials to be captured. The third is used for isolates and some chemicals.
The organism part standard terminology is developed at the NHPD based on the TGA Terminology for Naming Medicines. The full list of organism parts is searchable through the NHP Ingredients Database Web application. Only the approved names of the list are acceptable wherever the terminology is applicable. If additions of new parts or changes to existing part names are required, a request for change should be sent to the NHPD via the NHP Ingredients Database Issue Form (see above).
Please note that an Approved Organism Part Name may mean either a single organism part (such as a leaf or seed) or a combination of organism parts when they are difficult or impossible to separate, or they can provide the same medicinal activity profiles (such as "root and root nodule" and "whole plant"). Unapproved combination organism part names are not acceptable.
Multiple approved organism part names can be used for purposes 2) and 3) above, as they provide the same medicinal activity profile. However, no multiple approved organism names are allowed for purpose 1) above. They should be named as separate ingredients.
4 Organism Substance Preparation Terminology
The organism substance preparations standard terminology captures preparation names and other related data in preparing or processing Predefined Organism Substances and Custom Organism Substances from raw materials. In all, the following data may be captured:
- Approved organism substance preparation name (method of preparation)
- Potency
- Extraction ratio
- Quantity Raw Equivalent (QRE)
- Solvents
- Preparation steps
4.1 Approved Organism Substance Preparation Name
An approved organism substance preparation name is required for every organism substance preparation. The requirements of other data depend on the preparation names. For example, only standardised preparations require potency. Please refer to Appendix 11.1 for organism preparation dependency rules.
An approved organism substance preparation name consists of one to three parts: basic term, concentrate, and standardised. For example, decoction, decoction concentrate, decoction concentrate standardised. A full list of the acceptable methods of preparation along with their definitions can be found using the NHP Ingredients Database Web application.
4.2 Potency
A potency is required only for standardised preparations. It captures the concentration of an active or marker constituent of an ingredient. It consists of the name of the active or marker constituent and the final amount of the constituent in the ingredient.
4.3 Extraction Ratio
An extraction ratio is required for preparations such as tinctures and extracts. It captures how the preparation is concentrated or diluted in comparison with the raw material used. It is always expressed as 1:X, X:1, or 1:1. The first quantity is the amount of raw materials (in weight) and the second the amount of final preparation (in weight or volume). No units are required. It always means Kg:Kg, or Kg:L, or g:g ,or g:ml, or mg:mg, or mg:microliter.
1:X is used for diluted preparations, X:1 for concentrated ones, and 1:1 for liquid extraction preparations only.
4.4 Solvents
This refers to solvents remaining in final preparations. It is required only when the final preparation contains solvents or water. The solvent term captures a solvent name and its strength (percentage). Only approved solvent names are allowed and these can be found using the NHP Ingredients Database Web application.
5 Organism Types Standard Terminology
Organism types are NHPD-authorized terms for organism group types, such as "Plant", "Fungi", "Algae", and different animal types. Please refer to the Natural Health Products Ingredients Database Web application for all NHPD-authorized organism types.
6 Ingredient Roles
Ingredients approved and named in the terminology by the NHPD under the Natural Health Products Regulations are subsequently assigned a role(s) and any applicable restrictions. Presently, ingredients can be assigned one or more of the following roles: medicinal, non-medicinal, non-NHP, component or homeopathic role.
6.1 Medicinal Ingredients
A medicinal ingredient (MI) is any substance that contributes to the pharmacological activity associated with the recommended use of the product. These substances include plants, plant materials, algae, bacteria, fungi, non-human animal materials, extracts, isolates, vitamins, amino acids, essential fatty acids, synthetic duplicates, minerals and probiotics, as described in Schedule 1 of the Natural Health Product Regulations . A natural health product ingredient must not, under the Food and Drug Regulations, be pursuant to a prescription when it is sold other than in accordance with section C.01.043 of those Regulations (i.e. no Schedule F substances unless it is homeopathic medicine), as per Section 2(2) of the Natural Health Product Regulations.
Homeopathic substances are never given a medicinal role. They are assigned a homeopathic role, meaning they are considered medicinal in homeopathic applications only.
6.2 Non-medicinal Ingredients
A non-medicinal ingredient (NMI) is any substance such as a binder, colouring agent or flavour added to an NHP that is necessary for the formulation of dosage forms. Non-medicinal ingredients should not exhibit any pharmacological effects of their own, and, where applicable, should not exceed the maximum concentration allowed.
As per section 5 of the Natural Health Product Regulations, the proper name and common name of all medicinal ingredients as well as the common name and purpose of all non-medicinal ingredients must be provided on the Product Licence Application form. The NHP Ingredients Database includes non-medicinal ingredients that are generally regarded to be of minimal toxicological concern. Where appropriate, certain limitations regarding quantity, dosage form and route of administration are listed. A full list of acceptable non medicinal purposes can be found using the NHP Ingredients Database Web application.
For any non-medicinal ingredient not contained in the NHP Ingredients Database or used outside of the stated limitations, the NHPD may require a safety assessment as per section 7d of the Natural Health Product Regulations. If there is a particular safety concern with a non-medicinal ingredient, the NHPD may request additional information. The applicant should provide information supporting the non-medicinal use of all proposed non-medicinal ingredients when submitting an application for a product license.
6.3 Components
An ingredient which is assigned a component role is a substance which can be present naturally in plant material and which has neither a medicinal nor a non-medicinal role. Components can be listed on the Product Licence Application form as marker/active constituents in the potency section for standardized extracts.
6.4 Non-Natural Health Product
A non-NHP (non-natural health product) is any substance which cannot be considered to be an MI under some condition of use. It may not belong to one of the items in Schedule 1 of the Natural Health Product Regulations (for example, a synthetic drug does not belong to Schedule 1) or it may be listed in Schedule 2 of the Natural Health Product Regulations (for example, marijuana, being a restricted substance, is not allowed as a natural health product.)
Ingredients may have either a medicinal role or a non-NHP role depending on the condition of use. For example, Vitamin A below 10 000 IU/day is considered medicinal, but above this threshold is treated as a prescription drug, which makes it a non-NHP.
6.5 Homeopathic
An ingredient which is assigned a homeopathic role is a substance defined in a homeopathic pharmacopoeia and which has a medicinal role in applications of type homeopathic. Only homeopathic substances can have a homeopathic role, and they cannot have any other role.
7 Ingredient Rules
One of the objectives of the NHP Ingredients Database is to interface with the NHP Online System in order to be able to automatically and completely validate natural health product licence applications by providing a repository of acceptable medicinal and non-medicinal ingredients and associated validation rules. Applications are validated against a set of rules which derive from legislation, regulations, monographs and other sources, such as approved controlled vocabulary lists. Applications will be matched against rules to determine which rules apply and then be accepted or rejected according to rule results.
There are a number of different rule types necessary for application entry and validation. Some of them are required solely for validation, while others are needed simply to assist the various users or determine screen flow.
The rules described in this section are toxicity restrictions, medicinal rules, non-medicinal rules, non-NHP rules and sub-ingredient rules.
7.1 Toxicity Restrictions
Toxicity restrictions are restrictions which are inherent as part of an ingredient (i.e. safety limits). These restrictions are given in terms of the acceptable daily intake (ADI). ADI is an estimate of the amount of a substance, expressed on a body-weight basis that can be ingested daily without appreciable risk. The safety limit or ADI is listed in units of mg per kg of body weight per day.
7.2 Non-medicinal Restrictions
Some natural health product ingredients have non-medicinal limitations which are listed based on the quantity, route of administration and dosage form. However, an additional factor to take into consideration for non-medicinal restrictions is the fact that, in natural health product licence applications, some ingredients can be both medicinal and non-medicinal. For such ingredients that appear in monographs, it is important to capture both the medicinal and non-medicinal levels for various product types (such as antacids, sunburn protectants, etc). In NHPD and TPD (Therapeutic Products Directorate) Category IV (CAT IV) monographs for various product types, the medicinal ingredients are given an allowable range. For those ingredients that are both medicinal and non-medicinal, the medicinal lower limit translates into an upper non-medicinal restriction. The non-medicinal restriction description is provided in terms of daily acceptable intake, single dose or preparation.
7.3 Non-medicinal Purposes
Acceptable non-medicinal ingredient (NMI) purposes have also been provided. A full list of acceptable non medicinal purposes can be found using the NPH Ingredients Database Web application.
7.4 Medicinal Restrictions
Based on the definition provided in Section 6.1 for medicinal ingredients, some natural health product ingredients could be classified as drugs under Schedule F. These restriction levels, along with some NHPD and TPD monograph limits, are captured for selected medicinal ingredients.
7.5 Non-Natural Health Product Restrictions
Normally, ingredients with a non-NHP role can never be medicinal. However, there are some ingredients that are non-NHPs that can also have a medicinal role below a well-defined threshold. For those ingredients, a non-NHP restriction is provided indicating at which level they become non-NHPs. Below the well-defined threshold, the ingredient is medicinal while above the threshold it is a non-NHP.
7.6 Sub-Ingredients
Sub-ingredient rules are an important part of the NHP Ingredients Database. An ingredient is sometimes equivalent to certain amounts of ingredients or made up of certain components which are known as sub-ingredients in the NHP Ingredients Database. Sub-ingredients are accompanied by the parent compound (chemical substance or an organism). The quantity of the sub-ingredient in the parent compound of a chemical is given in percentage (%).
If a chemical substance has an indicated sub-ingredient, then that chemical substance is considered to be an acceptable source of the indicated sub-ingredient. For example, retinyl acetate has vitamin A as an indicated sub-ingredient, which implies that retinyl acetate is an acceptable source of vitamin A. Similarly, calcium carbonate has calcium as an indicated sub-ingredient, which implies that calcium carbonate is an acceptable source of calcium. The quantity of sub-ingredient in a specific part of a parent organism name is given in microgram/g.
The dataset contains the parent organism name, part name, and lower and upper content limits qualified by an authorized reference from where the information was found. Two primary references used for the dataset are Dr. Duke's Phytochemical and Ethnobotanical Databases and "Phytochemical Dictionary: A Handbook of Bioactive Compounds from Plants." The latter is also used to assign HCN chemical classes and subclasses.
7.7 Source Ingredients and Source Material
The origin of the ingredients can be source ingredients and/or source materials. Source ingredients are other ingredients containing the ingredient while Source materials are parts of organisms containing the ingredient. For example, Bone meal is a source ingredient of Calcium, and the leaf of organism Urtica dioica is a source material for Calcium.
8 International Conference on Harmonization M5 Controlled Vocabularies
Controlled vocabularies in the context of health products are defined as standard core sets of product related data. Due to a lack of a common harmonized approach, the International Conference on Harmonization (ICH) have developed harmonized standards proposed by the ICH M5 Expert Working Group to facilitate the exchange and practical use of medicinal product data by regulators and the pharmaceutical industry (see "ICH; Draft Guideline M5 Data Elements and Standards for Drug Dictionaries"). The ICH M5 defines controlled vocabulary as a standards related to the following terminologies:
- Active ingredients
- Pharmaceutical dosage forms
- Routes of administration
- Units and measurements.
The NHP Online System project has adapted the TGA Terminology for naming medicines (see Section 2.0) since this terminology suits the NHPD requirements for naming substances included in natural health products for market in Canada. NHP Online has recognized the remaining terminologies, namely dosage forms, routes of administration, and units and measurements from ICH M5 and has integrated these controlled vocabularies as part of the overall standard.
8.1 Dosage Form Standard Terminology
Dosage form standard terminology captures all of the dosage forms approved by NHPD. The dosage form controlled vocabulary includes pharmaceutical dosage form terms of standard terminologies in use by the regulators in the ICH regions and observer countries. A dosage form as defined by ICH is a physical manifestation ["entity"] that contains the medicinal and/or non-medicinal ingredients that deliver the dose of the medicinal product. The key defining characteristics of the dosage form can be the state of matter, delivery method, release characteristics, and the administration site or route for which the product is formulated. NHPD has also recognized approved dosage forms which could be considered to be synonymous with terms included in this list. These synonyms have also been identified. All of the approved ICH M5 dosage forms and synonyms can be found by using the NHP Ingredients Database Web application.
8.2 Routes of administration Standard Terminology
Routes of administration standard terminology captures all approved routes of administration by NHPD. The routes of administration controlled vocabulary includes routes of administration terms of standard terminologies in use by regulators in the ICH regions and observer countries and defined in the ICH M5 guideline "Data Elements And Standards For Drug Dictionaries (PDF version - 343 K)". The route of administration indicates the part of the body through or into which, or the way in which, the medicinal product is intended to be introduced. All of the approved ICH M5 routes of administration can be found by using the NHP Ingredients Database Web application.
8.3 Units Standard Terminology
Units standard terminology captures all of the units approved by NHPD. The units and measurements controlled vocabulary includes units and measurements in use by the regulators in the ICH regions and observer countries and defined in the ICH M5 guideline "Data Elements And Standards For Drug Dictionaries (PDF version - 343 K)" All of the approved units can be found by using the NHP Ingredients Database Web application.
9 Non-medicinal Ingredient Purposes Standard Terminology
Non-medicinal ingredient purposes standard terminology captures all of approved non-medicinal ingredient purposes approved by NHPD. A list of these purposes can be found by using the NHP Ingredients Database Web application.
10. Test Methods
As part of the Quality requirements to obtain a license to sell a natural health product, applicants must provide information on the test methods used for identity, microbial testing, chemical contaminant testing, and so on. The Controlled Vocabulary Search section of the NHP Ingredients Database Web Application allows for a search on precleared test method names and type. An NHP Ingredients Database Issue Form should be filled to inform us of any missing test methods
11 Appendices
11.1 Dependency Mapping of Organism Substance Preparation Data and Preparation Names
| Code | Approved Name | Potency | Ratio | Quantity Crude Equivalent | Original Material Used | Solvents | ||
|---|---|---|---|---|---|---|---|---|
| DEC | Decoction | - | Required | 1:X | Required | Required | Required | all |
| DECON | Decoction concentrate | - | Required | X:1 | Required | Required | Required | all |
| DECONST | Decoction concentrate standardised | Required | Required | X:1 | Required | Required | Required | all |
| DECST | Decoction standardised | Required | Required | 1:X | Required | Required | Required | all |
| DIST | Distillate | - | Required | 1:X | Required | Required | Required | WTRPOT;WTRPUR |
| DISTCON | Distillate concentrate | - | Required | X:1 | Required | Required | Required | WTRPOT;WTRPUR |
| DISTCONST | Distillate concentrate standardised | Required | Required | X:1 | Required | Required | Required | WTRPOT;WTRPUR |
| DISTST | Distallation standardised | Required | Required | 1:X | Required | Required | Required | WTRPOT;WTRPUR |
| DRY | Dry | - | - | - | - | - | ||
| DRYDA | Dry damaged | |||||||
| DRYST | Dry standardised | Required | - | - | - | - | ||
| EXDRY | Extract dry | - | Required | X:1 | Required | Required | Required | all |
| EXDRYST | Extract dry standardised | Required | Required | X:1 | Required | Required | Required | all |
| EXLIQ | Extract liquid | - | Required | 1:X | Required | Required | Required | all |
| EXLIQST | Extract liquid standardised | Required | Required | 1:X | Required | Required | Required | all |
| FRESH | Fresh | - | - | - | - | - | ||
| INFCON | Infusion concentrate | - | Required | X:1 | Required | Required | Required | all |
| INFCONST | Infusion concentrate standardised | Required | Required | X:1 | Required | Required | Required | all |
| INFSN | Infusion | - | Required | 1:X | Required | Required | Required | all |
| INFSNST | Infusion standardised | Required | Required | 1:X | Required | Required | Required | all |
| JU | Juice | - | - | - | - | - | ||
| JUCPW | Juice powdered | - | - | - | - | - | ||
| JUCPWST | Juice powdered standardised | Required | - | Required | Required- | - | ||
| JUST | Juice standardised | Required | - | Required | Required | - | ||
| OILFX | Oil fixed | - | - | - | - | - | ||
| OILFXST | Oil fixed standardised | Required | - | - | - | - | ||
| OILIN | Oil infused | - | - | - | - | - | ||
| OILINST | Oil infused standardised | Required | - | - | - | - | ||
| POW | Powdered | - | - | - | - | - | ||
| POWST | Powdered standardised | Required | - | - | - | - | ||
| TINCT | Tincture | - | Required | 1:X | Required | Required | Required | all |
| TINCTST | Tincture standardised | Required | Required | 1:X | Required | Required | Required | all |
| FLEXT | Fluid extract | - | Required | 1:1 | Required | Required | Required | all |
| FLEXTST | Fluid extract standardised | Required | Required | 1:1 | Required | Required | Required | all |
| ATTENTED | Attenuated | - | - | - | - | - | ||
| INACTIVE | Inactivated | - | - | - | - | - | ||
| LIVE | Live | - | - | - | - | - | ||
| TCM | Traditional Chinese Medicine | - | - | - | - | - | ||
| TCM1 | Traditional Chinese Medicine extract 1:X | - | Required | 1:X | Required | Required | Required | all |
| TCMST | Traditional Chinese Medicine standardised | Required | - | - | - | - | ||
| TCMST1 | Traditional Chinese Medicine standardised extract 1:X | Required | Required | 1:X | Required | Required | Required | all |
| TCMSTX | Traditional Chinese Medicine standardised extract X:1 | Required | Required | X:1 | Required | Required | Required | all |
| TCMX | Traditional Chinese Medicine extract X:1 | - | Required | X:1 | Required | Required | Required | all |
| MECH | Pressed (mechanical) extraction | - | Required | X:1 | Required | Required | Required | all |
| MECHST | Pressed (mechanical) extraction standardised | Required | Required | X:1 | Required | Required | Required | all |
| OINT | Ointments and salves | - | - | - | - | - | ||
| PRES | Preservation | - | - | - | - | - | ||
| TRAD | Traditional | - | - | |||||
| TRAD1 | Traditional extract 1:X | - | Required | 1:X | Required | Required | Required | all |
| TRADST | Traditional standardised | Required | - | - | - | - | ||
| TRADST1 | Traditional standardised extract 1:X | Required | Required | 1:X | Required | Required | Required | all |
| TRADSTX | Traditional standardised extract X:1 | Required | Required | X:1 | Required | Required | Required | all |
| TRADX | Traditional extract X:1 | - | Required | X:1 | Required | Required | Required | all |
| FERM | Fermentation | - | - | - | - | - | - | |
| ROGR | Roasted ground | - | - | - | - | - | - | |
| EOEN | Oil, Essential (enfleurage) | - | - | - | - | - | - | |
| EOENST | Oil, Essential (enfleurage) Standardised | Required | - | - | - | - | - | |
| EOEX | Oil, Essential (expression) | - | - | - | - | - | - | |
| EOEXST | Oil, Essential (expression) Standardised | Required | - | - | - | - | - | |
| EOOT | Oil, Essential (other methods of preparation) | - | - | - | - | - | - | |
| EOOTST | Oil, Essential (other methods of preparation) Standardised | Required | - | - | - | - | - | |
| EOWSD | Oil, Essential (water steam distillation) | |||||||
| EOWSDST | Oil, Essential (water steam distillation) Standardised | Required | ||||||
11.2 Authorized References
11.2.1 Organism Scientific Names
| Precedence | Code | Name | Type |
|---|---|---|---|
| 1 | GRIN | Germplasm Resources Information Network |
Web pages |
| 2 | ITIS | Integrated Taxonomic - Information System |
Web pages |
| 3 | COL | Catalogue of Life |
Web pages |
11.2.2 Organism Substances
| Precedence | Code | Name | Type |
|---|---|---|---|
| 1 | TGA | Approved Terminology for Medicines | Electronic documents |
| 2 | CP | Pharmacopoeia of the People's Republic of China | Books |
| 3 | CMM | The Chinese Materia Medica | Books |
| 4 | C | Chinese Herbal Medicine, Materia Medica | Books |
| 5 | API | Ayurvedic Pharmacopoeia of India | Books |
| 6 | BHP | British Herbal Pharmacopoeia | Books |
| 7 | BP | British Pharmacopoeia | Books |
| 8 | FCC | Food Chemicals Codex | Books |
11.2.3 Chemicals
| Precedence | Code | Name | Type |
|---|---|---|---|
| 1 | BP | British Pharmacopoeia |
Books |
| 2 | CAS | Chemical Abstracts Service |
Web page |
| 3 | CHEMID | ChemIDplus |
Web page |
| 4 | EC-FL | Flavouring Substances |
Web page |
| 5 | EP | European Pharmacopoeia | Books |
| 6 | EPA | EPA, Substance Registry System (SRS) |
Web page |
| 7 | FCC | Food Chemicals Codex |
Books |
| 8 | FDA | EAFUS: A Food Additive Database |
Web page |
| 9 | FEMA | FEMA number |
Web page |
| 10 | ICID | International Cosmetic Ingredient Dictionary (CTFA) |
Web pages |
| 11 | INN | International Nonproprietary Names | Books |
| 12 | IUPAC | Principles of Chemical Nomenclature: a Guide to IUPAC Recommendations | Books |
| 13 | JECFA | Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA 1956-2007) (First through Sixty-eighth Meetings) |
Web page |
| 14 | MI | Merck Index 12 | Electronic documents |
| 15 | USP | United States Pharmacopeia 29 | Books |
| 16 | MAR | Martindale: The Complete Drug Reference | Books / Web page |
| 17 | PUBCHEM | Databases of PubChem Substance, Pub Chem Compound and PubChem BioAssay | Web page |
11.2.4 Proteins
| Precedence | Code | Name | Type |
|---|---|---|---|
| 1 | IUBMB | Nomenclature Committee of the International Union of Biochemistry and Molecular Biology (NC-IUBMB) |
Web page |
| 2 | CHEMID | ChemIDplus |
Web page |
| 3 | MI | Merck Index 12 | Books / Web page |
| 4 | USP | United States Pharmacopeia | Books / Web page |
| 5 | MAR | Martindale: The Complete Drug Reference | Books |
11.2.5 Herbal components
| Precedence | Code | Name | Type |
|---|---|---|---|
| 1 | CHEMID | ChemIDplus |
Web page |
| 2 | MI | Merck Index | Books / Web page |
| 3 | USP | United States Pharmacopeia | Books / Web page |
| 4 | PCD | Phytochemical Dictionary | Books |
| 5 | EP | European Pharmacopoeia | Books |
| 6 | DUKE | Handbook of phytochemical constituents of GRAS herbs and other economic plants |
Web page |
