BIOSAFETY ACT, 2007: SUBSIDIARY LEGISLATION

INDEX TO SUBSIDIARY LEGISLATION

BIOSAFETY (GENETICALLY MODIFIED ORGANISMS FOR FOOD, FEED AND PROCESSING) REGULATIONS

[Section 46]

[Currency mentioned in this regulation should be re-denominated as stipulated under S 4 of Re-denomination Act, 2012, read with S 29 of Bank of Zambia Act, 1996.]

Arrangement of Regulations

PART I
PRELIMINARY

   Regulation

   1.   Title

   2.   Interpretation

PART II
IMPORTATION OF GENETICALLY MODIFIED ORGANISMS

   3.   Prohibition of importation of genetically modified organism for food, feed or processing

   4.   Application for permit to import genetically modified organism for food, feed or processing

   5.   Consideration of application

   6.   Referral to other agencies

   7.   Public consultation

   8.   Grant of permit

   9.   Rejection of application

   10.   Permit conditions

   11.   Labelling of consignment for importation

   12.   Approval of genetically modified organisms for direct use to be entered in Register

   13.   Notice of arrival of shipment

   14.   Suspension, revocation, or cancellation of permit

PART III
LABELLING AND TRACEABILITY

   15.   Scope of Part

   16.   Traceability

   17.   Labelling

   18.   Exceptions

   19.   Traceability requirements for food and feed produced from genetically modified organisms

   20.   Application to place on market food, feed or product derived from genetically modified organisms

   21.   Unique identifiers

   22.   Withdrawal of certain genetically modified organisms

   23.   Risk management measures

   24.   Inspection and control measures

   25.   Register

   26.   Appeal to Tribunal

   27.   Fees

      FIRST SCHEDULE

      SECOND SCHEDULE

SI 42 of 2010.

PART I
PRELIMINARY

 

1.   Title

These Regulations may be cited as the Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010.

 

2.   Interpretation

In these Regulations, unless the context otherwise requires–

“Authority" has the meaning assigned to it in the Act;

"Feed” means any substance, whether processed semi-processed, or raw, which is intended for animal consumption;

“final consumer” means the ultimate consumer who will not use the product as part of any business operation or activity;

“food” means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drinks, chewing gum and any substance that is used in the manufacture of food, but does not include cosmetic, tobacco or substances used only as drugs;

“genetically modified organism” has the meaning assigned to it in the Act;

“import” has the meaning assigned to it in the Act;

“ingredient” means any substance, including a food or feed additive or component of a compound ingredient, used in the manufacturer or preparation of a foodstuff or feed and present in the final product, whether or not in a modified form;

“label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to, a container of food or feed;

“operator” means a natural or legal person who places a product on the market or who receives a product that has been placed on the market in Zambia, or from another country, at any stage of the production and distribution chain, but does not include the final consumer;

“placing on the market” has the meaning assigned to it in the Act;

“pre-packaged” means packaged or made up in advance in a container, ready for offer to the consumer, or for catering;

“produced from genetically modified organisms” means derived, in whole or in part from genetically modified organisms, but not containing or consisting of genetically modified organisms;

“Register” means the Register established under Regulation 24;

“the first stage of the placing on the market of a product” means the initial transaction in the production and distribution chains, where a product is made available to a third party;

“traceability” means the ability to trace genetically modified organisms and products produced from genetically modified organisms at all stages of their placing on the market through the production and distribution chains;

“Tribunal” has the meaning assigned to it in the Act; and

“unique identifier” means a simple numeric or alphanumeric code which serves to identify a genetically modified organism on the basis of the authorised transformation event from which it was developed and providing the means to retrieve specific information pertinent to that genetically modified organism.

PART II
IMPORTATION OF GENETICALLY MODIFIED ORGANISMS

 

3.   Prohibition of importation of genetically modified organism for food, feed or processing

A person shall not import a genetically modified organism for direct use as food or feed or for processing unless–

   <IN:LF:0.53125,FI:-0.25>   (a)   the importation is duly authorised by the Authority;

   <IN:LF:0.53125,FI:-0.25>   (b)   the genetically modified organism is authorised for commercial distribution as food or feed in the country of origin; and

   <IN:LF:0.53125,FI:-0.25>   (c)   regardless of the intended use, the genetically modified organism poses no significant risks to human or animal health, biological diversity, non-genetically modified crop or the environment.

 

4.   Application for permit to import genetically modified organism for food, feed or processing

An application to import a genetically modified organism for direct use as food or feed or for processing shall be in Form I set out in the First Schedule.

 

5.   Consideration of application

   (1) The Authority shall, within 14 days from the receipt of an application under Regulation 4, examine the application to determine if it meets the requirements of the Ac and these Regulations.

   (2) The Authority shall, where the application meets the requirements of the Act and these Regulations–

      (a)   accept the application and inform the applicant in Form II set out in the First Schedule; and

      (b)   forward a copy of the application to the Scientific Advisory Committee.

   (3)The Scientific Advisory Committee shall evaluate an application referred to it under sub-regulation (2), particularly the risk assessment studies conducted and actions taken by the relevant regulatory authorities in the country of origin, and submit its report to the Authority within 30 days from its receipt of the application.

   (4)The Authority shall, where an application is incomplete or defective, inform the applicant in Form III set out in the First Schedule and give the applicant a period within which to correct the defects in the application.

   (5) Where an applicant to whom a notice is sent under sub-regulation (4) fails to correct the defect within the period specified by the Authority, the Authority shall reject the application.

   (6) An applicant whose application is rejected under sub-regulation (5) may re-submit the application after the defect is corrected.

   (7) The Authority may request an applicant to submit additional information in relation to the application in Form IV set out in the First Schedule.

 

6.   Referral to other agencies

   (1) The Authority shall furnish the following agencies with a copy of an application for their comments–

      (a)   the Plaintiff Quarantine and Phytosanitary Service, if the genetically modified organism is a raw agricultural commodity intended for direct use as food or processing into food; and

      (b)   the authorised veterinary services, if the genetically modified organism is intended for direct use as feed or for processing into feed.

   (2)The agencies referred to under sub-regulation (1) shall submit their comments to the Authority within 30 days of receipt of the application.

 

7.   Public consultation

   (1) An applicant shall, within 15 days from the receipt of the acceptance of the application by the Authority, publish a notice, in at least two daily newspapers of general circulation in Zambia, inviting interested parties to send their comments or objections on the proposed importation for direct use as food or feed, or for processing, to the Authority within a period of 30 days from the date of publication of the notice.

   (2) An applicant shall submit to the Authority proof of the publication within 15 days from the date of publication.

 

8.   Grant of permit

   (1) The Authority shall, within 30 days from the acceptance of an application, approve the application if the use of the genetically modified organism for food or feed, or for processing, does not pose any significant risks to human or animal health, biological diversity, non-genetically modified crops or the environment.

   (2) In calculating the 30 day period referred to under sub-regulation (1), the period of time during which the Authority awaits further information from an applicant or from any relevant regulatory authority in the country of origin of the genetically modified organism in respect of which an application is made shall not be included.

   (3) A permit to import a genetically modified organism for food, feed or processing shall be in Form V set out in the First Schedule.

   (4) A permit may be renewed for a further period of five years where the holder shows that the continued importation of the genetically modified organism as food or feed, or for processing, does not pose any risks to human or animal health, biological diversity, non-genetically modified crop or the environment.

 

9.   Rejection of application

   (1) The Authority shall reject an application–

      (a)   if the genetically modified organism in respect of which the application is made poses risks to human or animal heath, biological diversity, non-genetically modified crop or the environment; or

      (b)   if the application does not meet the requirements of the Act or these Regulations.

   (2) A notification of a rejection of an application shall be in Form VI set out in the First Schedule.

 

10.   Permit conditions

A permit holder shall comply with the following conditions–

      (a)   the genetically modified organism shall be imported solely and exclusively for direct use as food or feed, or for processing into food or feed, and not for field testing or propagation;

      (b)   the genetically modified organism shall be maintained and disposed of in such a manner as to prevent any risks to human or animal health, biological diversity, non-genetically modified crop or the environment;

      (c)   all packing materials, shipping containers and all other materials accompanying the genetically modified organism shall be treated or disposed of in such a manner as to prevent any risks to human or animal health, biological diversity, non-genetically modified crop or the environment;

      (d)   the permit holder shall give an inspector access, during regular business hours, to the facility where the genetically modified organism is located and to any records relating to the importation of the genetically modified organism;

      (e)   the genetically modified organism shall be identified with a label showing the permit number, name of the genetically modified organism and the date of importation;

      (f)   the genetically modified organism shall be subject to the application of measures including final disposal, which the Authority considers necessary to prevent its accidental or unauthorised release;

      (g)   the permit holder shall–

      (i)   in the event of any accidental or unauthorised release of the genetically modified organism, report to the Authority verbally, immediately upon discovery, or in writing, within 24 hours; and

      (ii)   notify the Authority in writing, as soon as possible, but not exceeding three working days, if the genetically modified organism or associated host organism is found to have characteristics substantially different from those listed in the application for a permit, or suffers from any excessive mortality or morbidity, unanticipated effect on non-target organisms or other unusual occurrence;

      (h)   if new information becomes available indicating that the genetically modified organism could pose significant risks to human or animal health, biological diversity, non-genetically modified crop or the environment, the applicant shall report to the Authority who shall immediately take measures to protect human or animal health, biological diversity, non genetically modified crop or the environment;

      (i)   the permit holder shall import the genetically modified organism only at the port of entry designated in the permit;

      (j)   the permit holder shall comply with such other conditions as the Authority may consider necessary or desirable to prevent any risks to human or animal health, biological diversity, non genetically modified crop or the environmental; and

      (k)   the permit holder shall comply with such other conditions specified under the Act.

 

11.   Labelling of consignment for importation

A consignment for importation shall be labelled in accordance with the requirements specified under Part III.

 

12.   Approval of genetically modified organisms for direct use to be entered in Register

The Authority shall record in the Register the genetically modified organism or products of genetically modified organisms that have been approved for importation for direct use as food or feed, or for processing.

 

13.   Notice of arrival of shipment

A holder of a permit for the importation of genetically modified organisms for direct use as food or feed or for processing shall, within 15 days from the date of arrival of every shipment of the genetically modified organism, notify the Authority of such arrival in Form VII set out in the First Schedule.

 

This section of the article is only available for our subscribers. Please click here to subscribe to a subscription plan to view this part of the article.


 
 

Popular Tags