Ask an Expert: Codex Alimentarius Commission

Dear Mr.Kusukawa,

According to The Annex on “Food Safety Assessment in Situations of Low-level Presence of Recombinant-DNA Plant Material in Food” (Section 3), maintenance of a publicly accessible central database on living modified organisms (including information related to identification and detection) is also within a FAO mandate.
What is your opinion on the current status of implementation of Cartagena Protocol (BCH) and Annex (FAO database) information requirements?
What is your opinion on possible synergies and overlaps between those databases?

Thanking in advance
Aleksej Tarasjev

Starting from the conclusion, the FAO-managed database is not a reproduction of the database in the Biosafety Clearing House (BCH), rather it is an online tool allowing easy access to information relevant to the purposes of Annex 3: Food Safty Assessment in Situations of Low-level Presence of Recombinant-DNA Plant Material in Foods of the “Codex Guidelines for the Conduct of Food Safety Assessment of Foods derived from Recombinant-DNA Plants” (Codex Plant Guideline, CAC/GL 45-2003). Below I will explain some background to the said FAO database and how it is managed.

Annex 3 to the Codex Plant Guideline provides the recommended approach to the food safety assessment when food derived from a recombinant-DNA plant not having been authorized in the importing country is found at a low level in the imported food because it has been authorized for food use in the exporting country. Because the dietary exposure to such unauthorized recombinant-DNA plant material would be very low compared to the case for recombinant-DNA plants authorized for food use and legitimately circulating in the domestic market, the food safety assessment in such situations could be undertaken in an expedited way.

In addition to the guidance for an expedited food safety assessment, the need for an information exchange system was repeatedly stressed throughout the consideration of this annex. It was noted that a database providing information on recombinant-DNA plants authorized for food use, in particular, summary of the risk assessment and contact details for further information, would improve the preparedness of the importing country, bearing in mind that the food safety assessment in situations of low-level presence needs to be completed very quickly in order to avoid prolonged import restriction of the commodity concerned.

As a consequence, the requirement for the FAO-managed database has been to provide the following information on recombinant-DNA plants, authorized for food use in various countries:
- name of product applicant;
- summary of application;
- country of authorization;
- date of authorization;
- scope of authorization;
- unique identifier;
- links to the information on the same product in other databases maintained by relevant international organizations, as appropriate;
- summary of the safety assessment, which should be consistent with the framework of food safety assessment of the Codex Plant Guideline;
- where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained; and
- contact details of the competent authority(s) responsible for the safety assessment and the product applicant.

One would notice that the types of data to be stored in the database are mostly covered by the BCH. In fact, the developer of the FAO database was mindful of the existing resources in the BCH as well as in the OECD Bio Track Product Database and tried not to duplicate work. The FAO database is updated regularly by an automated process, extracting data from several online resources including the BCH and the OECD Bio Track Product Database, picking data for recombinant-DNA plants authorized for food use only. The database currently does not contain the records of authorizations for which no information is available on the risk assessment concerned, because knowing the fact that a certain recombinant-DNA plant is authorized in a country without the rationale for such decision would not be helpful to the users. The database also allows countries to enter relevant data manually, if they have not been captured through the above-mentioned automated process.

For your information, the database can be accessed through: http://www.ipfsaph.org/id/cthttpwwwfaoorgaosipfsaphissuekeywordsbiotechnologyfoodsafetyriskassessment?language=en