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* Guidelines for Documentation Requirements Main Menu

 

Purpose of the Documentation

GMOs to be Regulated

Requirements

Technical Terms for the Documentation Requirements

Adventitious Threshold

Verifying Compliance

 

Purpose of the Documentation

To ensure safe handling and movement of genetically modified organisms (GMOs) and to provide information to those handling GMOs, the Ordinance requires shipments with GMOs in transboundary movements be accompanied by prescribed documents. The information provided will allow the Administration to produce appropriate and applicable approach to tackle accidental release and reduce any potential adverse effects of the released GMOs on our biodiversity. The adoption of the documentation requirements would also in principle harmonise trading requirements over GMOs in transboundary movements.

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GMOs to be Regulated

All GMOs, except those used as pharmaceutical products by human, when being imported and exported, have to comply with the documentation requirements. Shipments containing GMOs have to be accompanied by prescribed documents. Detailed documentation requirements are set out in the Genetically Modified Organisms (Documentation for Import and Export) Regulation, Cap. 607A (the Regulation).

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Requirements

The Regulation sets out the documentation requirements for GMOs of different intended uses as follows:

  1. intended for release into the environment (e.g. GM seeds to be sown on open land, live recombinant veterinary vaccines to vaccinate animals, GM cut flowers containing viable pollen to be displayed in outdoor environment);
  2. intended for direct consumption as food or feed, or for processing (FFP) (e.g. virus-resistant papaya for direct human consumption, BT maize as pet feed, herbicide-resistant soy beans for soy sauce production); and
  3. intended for contained use (e.g. GM pet fish kept in aquarium tank, GM experimental plants growing in contained greenhouse, GM bacteria for research in confined laboratory condition).

Specified forms for prescribed documents are not mandatory. Any documents, such as commercial invoices or import/export manifests, which contain the required information, could satisfy the documentation requirements under the Regulation. Nevertheless, you may use or make reference to the attached sample forms to provide the required information.

Sample Form for GMOs-FFP

Sample Form for GMOs Intended for Release into Environment

Sample Form for GMOs Intended for Contained Use

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Technical Terms for the Documentation Requirements

International Instruments
They could be those covering handling, packaging and transport of GMOs. At present, specific GMOs may be covered by relevant international rules and standards on the basis of their characteristics rather than because they are GMOs as such. These may include, for example, relevant rules and standards promulgated under the International Plant Protection Convention, or the UN Recommendations on the Transport of Dangerous Goods. Relevant rules and standards may also be developed in the future by the Parties to the Protocol in accordance with Article 18(3) of the Protocol.

Transformation event code
Transformation event code means the code given to the GMO by the person who develops the GMO on the integration of a transgene into the cell of the GMO.

Unique identifier code
Unique identifier code means the unique code that is -

  1. assigned to the GMO in accordance with the Organisation for Economic Co-operation and Development Guidance for the Designation of a Unique Identifier for Transgenic Plants; and,
  2. entered into the Biosafety Clearing-House or other unique identification systems adopted by the Conference of the Parties Serving as the Meeting of the Parties to the Cartagena Protocol on Biosafety.

Commercial name of a GMO-FFP
It should mean the commercial name of the original strain of the GMO (e.g. the GM seed planted) but not the trade name of the products marketed as food or feed, or for processing. For example, if “New Leaf®” potatoes are imported as food into Hong Kong and marketed under a different trade name, the commercial name “New Leaf” should be specified in the prescribed document during its import.

Risk class
According to the "An Explanatory Guide to the Cartagena Protocol on Biosafety", some states define a system of "biosafety levels" (i.e. risk class) according to which some GMOs may be classified according to various factors. Each biosafety level prescribes general levels of risk, and may also prescribe general requirements for handling. For example, a risk assessment classification system for the environmental release of GM micro-organisms (GMMs) has been developed by the Safety in Biotechnology Working Party of the European Federation of Biotechnology to provide a framework for the safe use of GMMs. Under this system, GMMs are assigned to one of the 4 classes according to their risk assessment. Some other countries may also adopt similar risk classification systems.

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Adventitious Threshold

Section 26 of the Ordinance provides that documentation requirements would not be required for shipments containing GMOs, if

  1. the GMOs concerned are imported or exported in a lot together with other living organisms;
  2. the GMO is unintentionally mixed with those other living organisms; and
  3. the percentage of the quantity of the GMOs to the total quantity of living organisms in the lot does not exceed the prescribed percentage.

The prescribed percentage in relation to GMOs-FFP is currently set at 5%, which means that shipments intended for direct consumption as food, feed or for processing, if unintentionally mixed with the GMOs at or below 5% are not required to be accompanied by prescribed documents.

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Verifying Compliance

Agriculture, Fisheries and Conservation Department will conduct random checking for verifying compliance with the documentation requirements on GMO shipments at ports. Non-compliance may be subject to prosecution and liable to a fine of HK$10,000.

Documentation requirements are not applicable for GMOs that have been imported or are produced in Hong Kong, e.g., a box of GM papaya purchased from a local retailer. Random checking for verifying compliance with the documentation requirements will not be conducted on these GMOs.

 

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Last Review Date : 15 September 2017