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PROCEDURES FOR REGISTERING NUTRACEUTICAL PRODUCT OR FOOD SUPPLEMENT BY TANZANIA BUREAU OF STANDARD (TBS) IN TANZANIA

PROCEDURES FOR REGISTERING NUTRACEUTICAL PRODUCT OR FOOD SUPPLEMENT BY TANZANIA BUREAU OF STANDARD (TBS) IN TANZANIA

TBS: Is the Tanzania Bureau of Standards established by section 3 of the Act (standard Act,          CAP.130)

NUTRACEUTICAL PRODCT: According to FDA this falls in the group of Food Supplement (Dietary Supplement) since they are not intended to treat, diagnose, prevent or cure diseases. Otherwise, will be categorized as medicine and should be regulated as a Drug and should follow the Drug registration procedure.

FOOD SUPPLEMENT: According to TBS guideline Is a product other than tobacco, cosmetics or drugs intended to supplement the diet, taken orally in the form of tablet, capsule, powder, soft gel, gel cap, pellets, pill, granules or liquid.

APPLICANT: Is an individual, body corporate, partnerships or registered business who intends to import and sell food product in Tanzania market.

Before applying for registration is better to understand if your product is falling within the category of Nutraceutical product/food supplement. This will help to minimize time wasted in application procedures and eventually the application gets rejected.

To be on the safe side let’s look at food categories which are divided according to risk.

Food Product Risk Categories:

High Risk Food for Special Nutritional Purpose: Means high risk food classified as such by the TBS because of its intended use, as food for special nutritional purpose including food supplement or infant formulae, which is for a vulnerable group who due to their physiological conditions are susceptible to adverse health effects when they consume unsafe foods;

High Risk Foods for General Purpose: Means food classified as such by the TBS because of its high possibility of being contaminated or have intrinsic properties which can support growth of pathogenic micro-organisms or contains chemical toxicants;

Low Risk Food: Means food classified as such by the TBS because of its relatively lower possibility of being contaminated with pathogenic micro-organisms of other chemical toxins compared to the high-risk food;

High risk food for special Nutritional purpose  High risk foods for general purposeLow risk foods
Infant formulae and follow-up formulae;Complementary foods for infants and young childrenFoods intended for special medical purposes (eg. Therapeutic foods)Formula foods for use in weight control diets (eg meal replacement)Food supplementVitamins and Minerals;Amino acids (eg. Lysine and L-carnitine);Essential Fatty acids (eg. Omega 3 Fatty acids, Fish Oil);Plant, Plant extracts, and other herbal based supplements (eg. Ginsengs, Ginkgo biloba, Moringa-Mangifera);Enzymes and other metabolites (eg. Coenzyme Q10);Prebiotics (eg. dietary fibres);Probiotics (eg. Bifido bacterium):Animal products and animal extracts (Colostrum, egg york and bee product)Protein concentrates  Milk and Milk productsMeat and Meat products, including poultry and gameFish and Fish products including molluscs, crustaceans and echinodermsEggs and egg productsSpices, Soups, Sauces, Salad and Protein productsProcessed vegetables and vegetable productsReady to eat savouriesComposite foods – foods that could not be categorized in other groupBottle drinking waterHerbal tea/infusion excludingEnergy drinkFats and oils, and fats emulsionEdible ices, including sherbet and sorbetProcessed fruits productConfectionariesCoffee, tea, cocoa and their productCereals and cereals products including products derived from cereal grains, from roots and tubers, pulses and legumesBakery waresSweeteners including honeyNonalcoholic beverages and low alcoholic counterpartsSalt and salt substitutesVinegars

NOTE: The list presented on the table are according to the currently risk evaluation and will be subjected to update from time to time to be align with the contemporary data, therefore the applicant is advised to use the updates list whenever plan for application.

In this article we will focus on the registration procedure of product falls in category of High-Risk Food for Special Nutritional Purpose.

Below is the flow chart for the General application procedure:

NOTE:  

  1. During filling particulars as indicated on the flow chart above, should be filled correctly as appeared on the product label and these details will be featured in the product registration certificate
  2. Information for registration of food product to be submitted shall be in English and Kiswahili
  3. Product label is very critical since it carries the information and directions on which the consumer will relies on, therefore the applicant is advised to make sure allies with the guideline on requirements for labelling of Pre-Packaged Foods which can be accessed in TBS official website.
  4. Requirements for quantity of sample needed by TBS maybe varied therefore the applicant advised to consult the “Guideline for Client Wish to apply for Registration of Pre-Packed food” which can be accessed on TBS official website www.tbs.go.tz 
  5. Under this category there are additional documents during application which are mandatory to be submitted as listed below.
    • Effect payment of GMP inspection fee
    • Valid below mention documents
      • Brief description of the product (typical ingredients, additives and their proportions) and intended user;
      • Health certificate or certificate of free sale;
      • Copy of certificate of GMP or HACCP compliance certificate;
      • Certificate of analysis;
      • Stability study report;
      • Material safety data sheet;
      • Manufacturing site master file;
      • For infant formula, follow-up formula and formula for special medical purposes intended for infants and young children, labelling shall be in Kiswahili and English; and
      • Any other requirement as the Bureau may determine.

POST REGISTRATION PROCEDURES:

The validity of the registered product is five (5) years, after which it’s subject for renewal. For changes related to any registered Product, the Applicant must lodge a variation application.

Authorization of Variations

If for any reason a registrant (Applicant) wishes to alter any matter related to a registered food, shall before marketing the changed product, notify the alteration and obtain approval from the Bureau (TBS).

Application for alteration of any matter of a registered product shall be submitted to TBS accompanied by reasons for the alteration, explanation on the extent of alteration and where applicable submission of both registered and changed product samples for verification.

Notification of minor changes such as change in name and address of registrant (Applicant), name and address of manufacturer (except physical address), food packaging unit, shape, size, color shall not be subject to payment of fees.

The following changes shall require new application: –

  • Change of manufacturing site or processing technology; and
  • Change in type of packaging material, type and proportion of typical ingredients including food additives, form of the product, type and concentration of nutrients in food supplement or any other matter that relates to the product safety and quality.

Renewal of registration

All applications for renewal of registration shall be made as new application by following the pre-mentioned procedure above and shall reach the Bureau at least 60 days (about 2 months) before expiry of the existing registration. The evaluation and issue renewal registration certificate will be done by following the new application procedures.

WITHDRAWAL OF REGISTERED PRODUCT:

  1. Revocation, suspension or cancellation of registration of food or amendment of conditions subject to which the food was registered whenever it is deemed necessary due to new requirements of the law or standard.
  2. The Bureau receives a notice in writing issued by the registrant (Applicant) informing on his intention to withdraw from dealing with the importation of a registered food product.
  3. If new scientific developments reveal that the product or ingredient(s) used are proved to have a significant health effect on the consumer.
  4. The applicant provided false information related to the product that has bearing on the safety or quality of the product.

NOTE: On how to apply and other technical support you can consult www.petalitepharma.com

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