These must be presented on the outer label in a list by common name, excluding the quantity, preceded by the words "non-medicinal ingredients" (see the List of Acceptable Non-medicinal Ingredients in the Evidence for Safety and Efficacy of Finished Natural Health Products Guidance Document for more information on acceptable non-medicinal ingredients and their inclusion in a NHP). The authorized potency of that medicinal ingredient must also be stated, if any. Examples of pressurized containers are aerosol containers and metallic pumps or sprays. Health Canada’s final amendments to the Food and Drug Regulations (FDR) – Nutrition Labelling was published in the Canada Gazette on December 14, 2016. To learn more, see “ Cosmetics Q&A: ‘Personal Care Products’ ” and “ Is It a Cosmetic, a Drug, or Both? NHPs that have been authorized for sale by Health Canada bear a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label. Cosmetic labels in Canada must include: The identity of the product (i.e hand cream) Quantity (i.e. Combination products are products that contain, in addition to the natural health product, a drug, a biologic, or a medical device. Sterile products are free from viable micro-organisms. No person shall sell a natural health product unless it is labelled and packaged in accordance with these Regulations. Natural Health Products Regulations. Boxes with the text of the Regulations appear in relevant locations throughout the text. SOR/2003-196. Any other language can be used on the label in addition to the above language requirements, unless otherwise indicated. when the natural health product is recommended solely for children, it is packaged in a child resistant package. The source material must be associated with its respective medicinal ingredient. If a natural health product has only one label, that label shall show all the statements, information and declarations required by these Regulations to be shown on both the inner and outer labels. Some of the core labelling requirements that are set out by the Canadian Food Inspection Agency include: Common name. If the NHP contains mercury or its salts or derivatives as a non-medicinal ingredient or preservative, a statement that sets out the quantity of mercury contained in the product must be represented on any panel of the outer label. Refer to the explanations in chapter 3.1 for each requirement. Part 5: Labelling and Packaging Pressurized Containers Section 96. Part 5: Labelling and Packaging Language Requirements Section 87. Health Canada introduced this license in order to regulate the sales of supplements, and ensure Canadians are purchasing "safe, effective and high quality" products. The term "food" (definition) is defined in the Food and Drugs Act (FDA). Part 5: Labelling and Packaging Exception to the Labelling Requirements Section 89. This is the name used to distinguish the product. 86 (1)No person shall sell a natural health product unless it is labelled and packaged in accordance with these Regulations. However, if a NHP is labelled as irradiated, it is recommended that one of the following statements be used: "Treated with irradiation," "Treated by irradiation" or "Irradiated". Medicinal ingredients. All NHPs must have a health claim on their label that link the product to a disease or health-related condition (see the Evidence for Safety and Efficacy of Finished Natural Health Products Guidance Document). The proposed label text must be written either in English or French, but preferably in the same language as the majority of the submission. Currently, a combination product may be subject to one or more of the following sets of regulations: Natural Health Products Regulations, Food and Drug Regulations, or Medical Devices Regulations, depending on the ingredients, primary mode of action and health claims of that product. Information such as the product number (natural product number - NPN, or drug identification number - DIN) and lot number (preceded by " Lot number", "Lot No. All labels for products sold in Canada must be clearly printed in English and French. : not to be construed as the final label text copy, Brand Name(s): Echinacea Root/Echinacea Herbals/Corporation's Echinacea Root NPN# XXX 30/60/90 Tablets Outer and Inner Label: Natural Corporation, L4K 6G1 Imported by: Importer Corporation, M3S 5G5 Each tablet contains Echinacea augustifolia (Echinacea) (root), 1000mg Traditionally used to fight off colds, flus and infections Adult: Take 1 tablet 3x/day May be used up to 10-21 days Risk information: Consult a health care practitioner prior to use if you have rheumatoid arthritis Consult a health care practitioner prior to use if you have a progressive systemic disease such as tuberculosis, collagenosis, multiple sclerosis, AIDS, HIV infection Consult a health care practitioner prior to use if you have auto-immune disorders Consult a health care practitioner prior to use if you are taking immunosuppressants Consult a health care practitioner if symptoms persist Do not use if you are pregnant or breastfeeding Do not use if you have an allergy to Asteraceae / Compositae (daisy) family Lot. This section provides resources on regulatory requirements for cosmetic labeling. Sterile products. For products to which labels cannot be attached (e.g. See How do I know if a product has been licensed? Pre-packaged consumer products must comply with labelling requirements, such as generic product descriptions, metric measurement/quantity declarations and manufacturer’s or distributor’s identity and address. When there are multiple brand names used for the product, each should be listed on the proposed label text label. All NHPs are required to meet the labelling and packaging requirements of the Natural Health Products Regulations by the end of the transition period for product licences, December 31, 2009. Inner label may show only item a) from the pressurized container requirements, above, or items a) and b) from the flame projection and flashback container requirements, above. Our designers follow mandatory industry guidelines, so you can rest easy knowing your labels will be Health Canada or FDA approved. Part 5: Labelling and Packaging Reference to Regulations Section 92. Natural Health Products Regulations. Bilingual information may be affixed on a separate panel or sticker. Claims for traditional use must be prefaced with qualifiers such as "traditionally used..." If the claim uses terminology specific to a particular culture or system of medicine, that culture or healing paradigm of medicine must be specified in the claim (e.g. When the quantity of certain medicinal ingredients in a NHP exceeds a specified level, child-resistant packaging is required. Net amount. The purpose of this guidance document is to help product licence applicants interpret the labelling and packaging requirements specified in Section 5 of the Natural Health Products Regulations (the Regulations) when selling a natural health product (NHP) within Canada. Principal Display Panel of Inner Label and Outer Label: One Panel of Either the Inner or Outer Label: The above requirements do not apply, where in relation to a NHP, the design of the container, the materials used in its construction, or the incorporation of a safety device eliminate the potential hazard therein. For example, "Medicinal ingredient: Each tablet contains Echinacea angustifolia (Echinacea) (root), 1000 mg of an extract standardized to 1.2% (v/w) volatile oil". Examples of various common food labelling found in homes . [Natural Health Products Regulations: section 86], The inner and outer labels of a NHP must contain a list of information that helps consumers make more informed choices about products they take. Canadian importers have started to request their suppliers to use food labels that already Products outside the scope of the Canadian Organic Regime, such as pet food, personal care products, natural health products, and aquaculture (nori, spirulina, chlorella, kelp) may not be exported to Canada under this equivalence arrangement. The Consumer Packaging and Labelling Regulations set out specific labelling requirements for prepackaged products wholly manufactured or produced outside Canada (s. 31(2)) and products that are wholly manufactured or produced in a country other than Canada but packaged in Canada at other than the retail level of trade (s. 31(3)). Except as authorized by regulation, no person shall advertise to the general public any contraceptive product or NHP manufactured, sold or represented for use in the prevention of conception. This eBook summarizes these changes. All Canadian manufacturers, packagers, labellers, and importers of natural health products must have site licenses. A … To be legally sold in Canada, all natural health products must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences. For example, if the source material is root, it should be presented as "Medicinal ingredient: Echinacea angustifolia (Echinacea) (root)". Please see the Evidence for Homeopathic Medicines guidance document, chapter 7.4.1, for a definition of this category. Labelling requirements for meat and poultry products. Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) Footnote a of the Food and Drugs Act, hereby makes the annexed Natural Health Products Regulations. Licensed Natural Health Products Unfortunately, the text-based data extract is no longer accessible through the Natural and Non-prescription Health Products (NNHPD) website. Inner Label Requirements. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks. Good Manufacturing Practices for NHPs cover: Good Manufacturing Practices are meant to ensure safe and high quality products while giving manufacturers, packagers, labellers, importers and distributors the flexibility to implement quality systems appropriate for their product lines and businesses. Subsection (3) does not apply if the security feature of a security package is self-evident and is an integral part of the immediate container. HPUS ophthalmic solution specifications include: HPUS nasal solution specifications include: Homeopathic medicine ear drops must be labeled with a statement to the effect of "Consult a health care practitioner if you have a fever, ear pain, changes in hearing and/or discharge from the ear.". The changes require that the ingredient statement be … As a result, improved standardized labelling is required. Natural Product Number. symbols for, alternative spellings of, word sets of and phonetic renderings of these words. Federal responsibility for Canadian food labelling requirements is shared between ... cholesterol-free, high source of fibre, product of Canada, natural, organic, no preservatives added, and so on). (e.g. The following are labelling requirements for flame projection and flashback containers. No reference, direct or indirect, to the Food and Drugs Act, the Food and Drug Regulations or to these Regulations shall be made on any label of or in any advertisement for a natural health product unless the reference is specifically required by law. You can search for licensed natural health products using Health Canada's Licensed Natural Health Products Database. Label must state the recommended use or purpose in specific, current, unambiguous terms. Common abbreviations for months of the year are JA, FE, MR, AL, MA, JN, JL, AU, SE, OC, NO and DE. The three types of health claims allowed on the label are therapeutic claims, risk-reduction claims, and structure-function claims (refer to the Evidence for Safety and Efficacy of Finished Natural Health Products Guidance Document). This is a number assigned to each NHP approved to be marketed under the Regulations as an indication of authorization by the NHPD. The Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products (Health Canada, May 2017) defines dietary fibre as follows: Dietary fibre consists of: carbohydrates with a degree of polymerization of 3 or more that naturally occur in foods of plant origin and that are not digested and absorbed by the small intestine; and All new Canadian manufacturers of disinfectants must use bilingual labelling. Food labelling regulations require that an ingredient statement be shown on the package near the Nutrition Facts table. Organic labeling is voluntary if a NHP is labelled as "organic" or contains organic ingredients. a NHP that has an inner label but no outer label), N.B. [Natural Health Products Regulations: section 96] Child-resistant packaging and pertinent cautionary statements may be required on the label of NHPs that contain ingredients that may be harmful to a child. When the dosage form appears in the brand name of the product, the dosage form does not have to be repeated, for example "Vitamin C Tablets". Part 5: Labelling and Packaging Presentation of Information Section 88, The statements, information and declarations required by these Regulations to be shown on a label of a natural health product shall be. When applicable, recommendations should also be made about the utilization period and storage conditions after opening, dilution, reconstitution of a solution (e.g. These examples are given to increase clarity in the naming of homeopathic ingredients. Registration 2003-06-05. name and address of the product licence holder; name and address of the importer, when applicable; common name of each medicinal ingredient; proper name of each medicinal ingredient, if the proper name is not the chemical name; quantity of each medicinal ingredient per dosage unit; potency of each medicinal ingredient, if any; risk information (cautions, warnings, known adverse reactions and contraindications); description of source material of each medicinal ingredient; the quantity of mercury contained in the product if it contains mercury or its salts or derivatives as a non-medicinal ingredient. Subject to the exceptions listed below, when a NHP is packaged in a pressurized container and has a flame projection of a length set out in column I for items 1 to 3 of Table 1 or a flashback, as set out in column I of item 4 of Table 1, as determined by official method DO-30 (Determination of Flame Projection, dated October 15, 1981), then the requirements for flame projection and flashback containers are as follows: (From Section A.01.062 of the Food and Drug Regulations). This introduction to the requirements … They do not apply to health care practitioners who compound products on an individual basis for their patients, or to retailers of NHPs. All NHPs containing, in solid or semi-solid form, more than 12.5% camphor, must be contained in a child-resistant package. However, an individual can sell a NHP that does not comply with the Regulations, if the sale is restricted to a manufacturer or distributor. SOR/2003-196. Section 9 Act ", "Lot" or "(L)") are included in this list of information. [Natural Health Products Regulations: section 89] If the immediate container of a NHP cannot accommodate an inner label that includes all information required by the Regulations, then small packaging is permitted. You will not receive a reply. Labels will need to specify the product's recommended use or purpose (health claim), dosage information, medicinal and non-medicinal ingredients and any cautions, warnings, contraindications or known adverse reactions associated with the product. The brand name of a NHP must not be misleading to the public (see section 9 of the Food and Dugs Act, below): Product number. Labelling requirements for meat and poultry products. Regulated parties have a five (5) year transition period to meet the new labelling requirements. A child resistant package is a package that. the primary hazard statement set out in column IV of the same item in Table 1 in both official languages. if the security feature is part of the outer package, on the outer label. For expressing extract quantities, it is recommended that the medicinal ingredient, the quantity per dosage unit, the extract ratio and quantity dried equivalent be listed as following: Black Cohosh (6:1 extract)....40 mg (Actaea racemosa) (root) equivalent to 240 mg of Black Cohosh. You will not receive a reply. Hazard symbol must be of a size that can be circumscribed by a circle with a diameter of at least 6 mm. Subject to subsection (4), a statement or illustration that draws attention to the security feature of the security package referred to in subsection (1) shall be shown. 2003-847 2003-06-05. Exp. Using the Canada Organic logo for Imported Products: Imported products carrying the Canada Organic logo on their labels or PLU stickers must indicate ‘product of’ immediately preceding the name of the country of origin, or the statement ‘imported’ in close proximity to the logo. When the proper name is a chemical name, the common name must be listed on the label. The health claim must comply with Section 3 of the Food and Drugs Act as they apply to NHPs: In other words, health claims that refer to diseases or health-related conditions listed in Schedule A are not permitted on the label. Packaging 1. bulk product), the label may be applied, attached or accompany the food. name and address of the importer, if any; proper name (common name) (source), quantity, potency, extract ratio and quantity dried equivalent (as applicable). Refer to Figure 1 for a description of an acceptable proposed label text of a NHP with three brand names and three corresponding net amounts of a NHP that does not have an outer label (i.e. All natural health products (NHPs) are required to be labeled and packaged according to the Natural Health Products Regulations (the Regulations) before sale in Canada. Only the text of the label is required, not advertising information or graphics. Also, these examples only cover the English labelling requirements for homeopathic medicines. This must be specified on the principal display panel of the label. Subject to subsection (2), when required by these Regulations to be shown on the label, the following information respecting a natural health product shall be in both English and French: any of the information referred to in paragraphs (a) to (f) of the definition "recommended conditions of use". In the absence of other risk statements, the label must include a statement to the effect of" "Consult a health care practitioner if symptoms persist or worsen.". Registration 2003-06-05. If the quantity is declared using numbers only, then numbers and metric symbols are considered bilingual. [Natural Health Products Regulations: section 92]. This number lets you know that the product has been reviewed and approved by Health Canada. An inner label means the label on or affixed to an immediate container of a NHP. When multiple net amounts are used for the product, each should be listed on the proposed label text. [Natural Health Products Regulations: section 98], The content and format of the NHPs' labels must comply with requirements outlined in the Regulations. In the U.S., dietary supplements are regulated as a category of foods, but in Canada, dietary supplements—or what Health Canada calls “Natural Health Products” (NHPs)—are treated as non-prescription drugs. On December 14, 2016, amendments to nutrition labelling, list of ingredients and food colour requirements of the Food and Drug Regulations came into force. The Natural Health Products Regulations require product licence holders to monitor all adverse reactions related to their product. However, not all sunscreen products fall under this category. A NHP with a prescribed standard will be exempt from the standard of any NHP contained in any publication in Schedule B to the Act in that such a NHP will differ from that standard with respect to colour, flavour, shape and size, if such a difference does not interfere with any method of assay prescribed in any such publication. Bilingual Labeling Requirements. 100 capsules); or. The risk information represented on the label must be identical to the information approved by the NHPD through the product licence review process. No person shall advertise any NHP to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. that the person advertises to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. a greater variation in potency than the least variation in potency, for that NHP in any publication mentioned in Schedule B to the Act. All NHPs containing, in solid or semi-solid form, more than 25% eucalyptus oil, must be contained in a child-resistant package. More information regarding natural health products … Multiple marks of inspection. When a proposed label text is submitted, the text corresponding to the principal display panel on the inner and/or outer label must be clearly identified. The inspection legend. © Her Majesty the Queen in Right of Canada, represented by the Minister of Health, 2006. The NHPD is requesting that manufacturers of eucalyptus oil and camphor products voluntarily label and package these products in the following manner: All NHPs containing more than 25% eucalyptus oil and/or 2.5% camphor must have a label warning (KEEP OUT OF REACH OF CHILDREN, NOT TO BE TAKEN ORALLY), and directions to contact the Poison Control Centre if accidentally ingested. 2003-847 2003-06-05. intended for topical use, unless it is a liquid preparation containing more than 5% alkyl salicylates; packaged in a non-reclosable package containing not more that two adult standard dosage units per package; repackaged by a pharmacist or practitioner at the time of sale, a lesser degree of purity than the highest degree of purity; or. COVID-19 Disinfectants, sanitizers, cleaners and soaps, Licensed Natural Health Products Database. salicylic acid, a salt thereof or salicylamide; acetylsalicylic acid, or any of its salts or derivatives; more than the equivalent of 250 mg of elemental iron; or, more than the equivalent of 120 mg of fluoride ion, unless the NHP is intended solely for use in dentists' offices. Natural Health Products Regulations. New labelling regulations initiate changes that make the ingredient statement easier to read and understand. Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. Part 5: Labelling and Packaging Product Number Section 91, Every product number required by these Regulations to be shown on a label of a natural health product shall. Despite subsection (1), a person may sell a natural health product that is not labelled and packaged in accordance with these Regulations if the sale is to a manufacturer or distributor. However, it is recommended that the following conditions be met. Également offert en français sous le titre : Natural health products legislation and guidelines, Guidance Documents – Legislation and guidelines – Natural health products, Document de référence concernant l'étiquetage, 1.0 Overview - Labelling and Packaging Requirements, 4.1 Labelling of Nasal, Ophthalmic and Otic Homeopathic Medicines, 5.2 Cautionary Statements and Child-Resistant Packages, 6.0 Presentation of Information on the Label, Total area of such surface, excluding the top and bottom, Any 40% of the total surface area that can be displayed, excluding the top and bottom, Wrapper or confining band too narrow to have a display surface, Total area of one side of a ticket or tag attached to the container. The licensing requirements of the natural health products regulations apply to any person or company that manufactures, packages, labels and/or imports NHPs for commercial sale in Canada. In addition, labels must not have any health claims so as not to be categorized as either a NHP or a drug. Part 5: Labelling and Packaging Security Package Requirements Section 95.