The Standards (Recall, Seizure and Disposal of Product) Regulations, 2021

Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) GOVERNMENT NOTICE No. 682 Published On. 24/9/2021 THE STANDARDS ACT, (CAP. 130) _________ REGULATIONS _________ (Made under section 36(3)(f)) _________ THE STANDARDS (RECALL, SEIZURE AND DISPOSAL OF PRODUCT) REGULATIONS, 2021 ARRANGEMENT OF REGULATIONS Regulation Title PART I PRELIMINARY PROVISIONS 1. Citation. 2. Interpretation. PART II RECALL OF COMMODITY OR PRODUCT 3. Notification of unfit product. 4. Investigation by Bureau and notification to Minister. 5. Responsibility of supplier and manufacturer. 6. Recall procedure. 7. Prohibition to sell product subject to recall. 8. Healthy risk evaluation. SEIZURE, DISPOSAL AND HANDLING OF UNFIT PRODUCTS OR COMMODITIES PART III 9. Seizure of unsafe or substandard products or commodities. 10. Restriction of disposal of unfit product or commodity. 11. Request for voluntary disposal of unsafe or substandard products or 1 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) commodities. 12. Handling of unsafe or substandard products. 13. Transportation and disposal of unsafe or substandard products. PART IV GENERAL PROVISIONS 14. Offence and penalty. 2 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) THE STANDARDS ACT, (CAP. 130) _______ REGULATIONS ________ (Made under section 36(3)(f)) _______ THE STANDARDS (RECALL, SEIZURE AND DISPOSAL OF PRODUCT) REGULATIONS, 2021 PART I PRELIMINARY PROVISIONS Citation 1. These Regulations may be cited as the Standards (Recall, Seizure and Disposal of Products) Regulations, 2021. Interpretation Cap. 130 Cap. 191 of the Act; the context of such that it is harmless; these Regulations, unless 2. In otherwise requires- “Act” means the Standards Act; “Bureau” means the Tanzania Bureau of Standards established by section 3 “disposal” means the process of rendering the unfit products for the duration “environmental inspector” means an inspector appointed or designated under section 82 of the Environmental Management Act; “inspector” means an inspector appointed under section 23 of the Act; “importer” means person or commodities or products; “Minister” means the Minister responsible for industries and trade; “product” means goods and services designed to be released or launched in a “recall” means the removal of specific batch or batches of a commodity or for from reasons relating to deficiencies in the the market quality, institutions importing market; product 3 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) safety or efficacy; “seizure” means the action of capturing suspected or unsafe or unfit product or commodity for further action; “supplier” means a person who releases or launches commodity or product “unfit product” means a commodity or product violating any provision of the Act and these Regulations. in the market; and Notification of unfit product PART II RECALL OF COMMODITY OR PRODUCT 3.-(1) A supplier or manufacturer who suspects on reasonable grounds that a product or commodity is defective or presents a risk of injury to human health or endanger environment or does not meet the requirements of the Act shall, immediately, report the matter to the Bureau and carry out an investigation. (2) Subject to subregulation (1), where the investigation establishes that the product or commodity is defective or presents a risk of injury to human health or endanger environment or does not meet the requirements of the supplier or manufacturer shall immediately notify the Bureau and take action to mitigate the risk. the Act, (3) On or before undertaking an investigation the supplier or the in subregulation (1), the Bureau with referred manufacturer shall provide following: to number, (a) proprietary name and generic name, batch or lot identification information, pack size, the name and address of the manufacturer, manufacturing date and expiry date; unique or (b) the nature of the defectiveness or possible defectiveness, the date on and circumstances under which the defects or possible defects were discovered; 4 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) (c) the total quantity of the defective products or commodity originally in possession of the supplier or manufacturer; (d) the date on which distribution of the product or commodity began; (e) the total quantity of the defective products or commodity that had been distributed up to the time of the reporting the matter to the Bureau; (f) area of distribution of the defective products or commodity; (g) list of customers and their respective contact information and quantity of the product or commodity product or commodity was distributed; and to whom the (h) the quantity of the recalled products or commodity still in his possession. the provisions (4) Notwithstanding of subregulation (1), the supplier or manufacturer may voluntarily initiate a recall of any product or commodity after receiving complaints from users or upon proof after investigation that such product has caused or is about to cause injury to the health or safety of users or endangers environment or defectiveness or substandard or unfit. (5) The supplier or manufacturer who voluntarily initiate a recall under subregulation (4), shall be required to comply with the requirements stipulated under subregulation (1) of this regulation and section 25 of the Act. (6) On or before undertaking a recall referred to in subregulation (1), the supplier or manufacturer of product and commodity shall provide the Bureau with the following: (a) proprietary name and generic name, batch or identification number unique lot or 5 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) information, pack size, the name and address of the manufacturer, manufacturing date and expiry date; (b) the reason for the recall, the nature of the defectiveness or possible defectiveness or substandard or unfit, the date on and circumstances under which the defects or possible defects were discovered; (c) the total quantity of the product being recalled originally in possession of the supplier or manufacturer; (d) the date on which distribution of the product began; (e) the total quantity of the product being recalled that had been distributed up to the time of the recall; (f) area of distribution of the product; (g) list of customers and their respective contact information and quantity of the product or commodity to whom product was distributed; and (h) the quantity of the recalled product or commodity still in possession of the supplier or manufacturer. Investigation by Bureau and notification to Minister shall, upon 4.-(1) The Bureau receiving information or in any way becoming aware that a product or commodity is defective or substandard or unfit or presents a risk of injury to human health or endanger environment or does not meet the requirements of the Act, conduct an investigation into the matter. (2) Subject to subregulation (1), the Bureau shall, upon investigation, notify the Minister for approval to recall the product or commodity as a mitigating measure. (3) Upon issuance of a recall order, the supplier or manufacturer shall, on its own costs- (a) immediately comply with the requirements or 6 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) directives in the order; (b) implement the recall procedure as per these Regulations; and the and (c) prepare and submit to the Bureau a weekly progress report or as may be specified by the Bureau on the implementation of the recall order, the final implementation of the recall order within the period specified these Regulations which shall also include- (i) reconciliation between delivered and recovered quantities of the product or commodity; therein or under report of (ii) detailed causes of the defect; and and (iii) corrective undertaken. preventive actions Responsibility of supplier and manufacturer 5. A supplier or manufacturer shall prepare, keep and maintain documents that set out procedure for receiving, investigating and responding to complaints that are received in relation to its product or commodity. Recall procedure Prohibition to sell products subjected to recall Health risk evaluation 6. A supplier or manufacturer shall prepare, keep and maintain a document that set out a recall procedure that enables the effective recall of a product or commodity, the name of a contact person who is responsible for the procedure and the name of a contact person who is responsible for conducting recalls. 7. A person shall not sell, offer or expose for sale or supply any product or commodity subjected to recall. 8. Where the recall concerns a product or commodity that poses a health risk, the Bureau shall conduct evaluation and take appropriate measures. PART III SEIZURE, DISPOSAL AND HANDLING OF UNFIT PRODUCTS OR COMMODITIES 7 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) Seizure of unsafe or substandard product or commodities 9.-(1) Any product or commodity which is proved or suspected to be unsafe or substandard shall be seized by an inspector in a manner prescribed under these Regulations. (2) An Inspector shall, upon seizure of the product pursuant to subregulation (1), mark it and removes or leave it under the care of the owner or agent, and he shall fill seizure form as prescribed in the First Schedule to these Regulations. (3) A seized product or commodity shall be kept until an order for its disposal or destruction is issued by the Bureau. (4) In effecting the seizure of any product or commodity under this regulation, an inspector may, in writing, notify a nearby police station to provide security during seizure. (5) All accrued costs on seized products or commodities shall be borne by the owner or his agent. (6) The owner of the products or commodity which has been seized may, within fourteen days from the date of service of the notice of seizure, apply in writing to the Director General for reconsideration. (7) Subject to subregulation (6), where the Bureau is satisfied that no applicationhas been made within fourteen days, the products or commodities seized shall be forfeited and disposed off at the cost of the owner or his agent. Restriction of disposal of unfit product or commodity 10. A person shall not dispose off any product or commodity declared by the Bureau to be unsafe or substandard unless he has requested the Bureau and secured a written approval to proceed with disposal under supervision of the Bureau. 8 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) Request for voluntary disposal of unsafe or substandard products or commodities Handling of unsafe or substandard products Transportation and disposal of unsafe or substandard products 11.-(1) Request the products or commodities voluntarily recalled shall be made to the Bureau in writing. to dispose (2) A request shall be accompanied by a list and respective quantity of products or commodities to be disposed. (3) Subject to subregulation (2), the Bureau shall inform the applicant to liaise with relevant authorities responsible for disposal. (4) The applicant shall submit to the Bureau disposal approval from relevant authorities. 12.-(1) A person shall not sell or supply or offer or expose for sale or supply or have in his possession for the purpose of sale or supply unsafe or substandard products. (2) Owner or agent of products or commodities shall adhere to the following requirements: separately unsafe or (a) keep substandard products and commodities; (b) demarcate an area for keeping unsafe or substandard products which shall be labeled conspicuously in red ink with words in English “Unfit for in Kiswahili matumizi “Hazifai yaliyokusudiwa”; and intended use” or kwa (c) maintain safe custody of unsafe or substandard products in registered premises until they are disposed. 13.-(1) Subject to any provisions of these Regulations, an inspector or any other public officer the authorised by transportation of consignment from the premises to the disposal site for destruction. the Bureau supervise shall (2) The destruction shall be supervised by an inspector, or any other public officer authorised by the Bureau and upon completion of the exercise a disposal form set out in the Second Schedule to these Regulations, shall be duly filled in and signed by the supervisor, the 9 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) owner of the consignment or his representative and other authorities who witnessed the destruction. (3) Upon submission of disposal form to the Bureau, the certificate of disposal set out under Third Schedule to these Regulations shall be issued to the owner of the disposed commodities or product. PART IV GENERAL PROVISIONS Offence and penalty 14. Any person who contravenes or fails to comply with any provision of these Regulations commits an offence and upon conviction shall be liable to the penalty provided for in the Act. 10 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) ________ FIRST SCHEDULE ____________ (Made under regulation 9(2)) NOTICE OF SEIZURE To: ………………………………………………… ………………………………………………… ………………………………………………… The following goods stored in ………………………………… situated at ………………………………… are seized as goods proved/suspected to be substandard/unsafe under the provisions of the Standard Act, Cap. 130; that is to say (nature of the goods and problems): SN Description of product(s) Quantity Unit Value REMARKS ………………………………………………………………………………………………….. ………………………………………………………………………………………………………… ………………………………………………………………………………………………………… ………………………………………………………………………………… Any claim against the seizure shall be submitted to the Director General within fourteen days of the seizure. In the event of your failure to file a claim within the time stipulated herein Tanzania Bureau of Standards (TBS) may pose dispose of the above goods as may deem fit under the law. ………………………… ……………… …………… ………….. TBS Inspector (s) Designation Signature Date ………………………… ……………… …………… ………….. The owner/representative of the seized products Designation Signature Date 11 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) __________ SECOND SCHEDULE __________ (Made under regulation 13(2)) DISPOSAL FORM Description of the product(s) ………………………………………………………………………………………………… ………………………………………………………………………………………………… Owned by M/S………………………………………………………………………….……. Quantity………………………………………..Custom/Total value……………………… Fail to comply with requirements for TZS………………………………………………… According to the standards (recall, seizure and disposal of product) regulations, 2020, the named product(s) is not allowed to enter into the Tanzania Market. The destruction exercise was conducted at (location, site)……………………………… on this date …………………………………... by the following methods (state clearly): 1. ………………………………………………………………………………………… 2. ………………………………………………………………………………………… 3. ………………………………………………………………………………………… Name and Signature of the Owner/in charge/representative of the organization: (Name): ………………………………………..... (Signature)……………………………. Names, Title and Signature of TBS Inspector(s)/officer(s), other supervisor(s) and witness of the disposal exercise:- Name Title Organization Signature FOR OFFICIAL USE ONLY Submitted by: Signature:…………………………………………… (Inspector) Date:…………………………………………………. Reviewed by: Signature:……………………………………………. (HPCERT/Assigned Officer) Date………………………………………………….. Approved by: Signature:………………………………...………….. (HCERT/HZone) Date…………………………………………………. 12 Standards (Recall, Seizure and Disposal of Product) GN. NO. 682 (Contd.) _________ THIRD SCHEDULE __________ (Made under regulation 13( 3)) CERTIFICATE OF DISPOSAL This certificate of Disposal is issued to: ………………………………………….. Registered Address: ………………………………………. For the disposal of …………………………………………. at ………………………………………………………………….. facility product was/were under Bill of lading/identification mark ……………………………………. This is to certify that the above product was/were found to be substandard/expired and has/have been destructed by Tanzania Bureau of Standards (TBS) by using ………………………. method. QUANTITY: …………………………………… Date: ………………………………. ……………………………. For: DIRECTOR GENERAL Dodoma, KITILA A. MKUMBO 1st September, 2021 Minister for Industries and Trade 13