Codex Annex

The Codex LLP Annex was adopted by the Codex Alimentarius Commission, the international food-standard setting body, in 2008. This guidance document outlines the international consensus that there is a fundamental difference in food safety requirements for instances of LLP when a product has been approved for human consumption in at least one country, as opposed to adventitious presence of a product that has not yet been approved by a regulatory authority anywhere in the world.

The LLP Annex was developed to enable importing countries to consider an abbreviated, yet internationally recognized, regulatory review process or risk assessment in instances of LLP. The LLP Annex recognizes that those products are considered “safe” and are fully authorized in one or more countries. Codex members believed the guidance would begin to address and mitigate the problematic impacts of LLP experienced to date.

The Codex LLP Annex calls for the establishment of a publicly accessible online platform hosted by the UN Food and Agriculture Organization (FAO) to share information on the safety assessment of foods derived from recombinant-DNA plants approved in accordance with the “Codex Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants.” This database, called the FAO GM Foods Platform, summarizes the information on which authorizing countries base their decisions for full food safety assessments, consistent with the Codex Plant Guideline. Participating governments agree to supply the information to the database as soon as they authorize a biotech event for commercial production for food, feed, or processing. Importing countries can then consider this information in order to take a proactive decision on LLP.

While various reactive precedents have been established in specific instances, robust proactive policies have yet to be enacted. When these policies are not possible, GAABT recommends the proactive use of the Codex LLP Annex by importing countries to conduct LLP risk assessments and assign LLP thresholds for new biotech products. Upon monitoring the FAO database and learning of a new biotech product, importing countries can proactively review the available safety assessment and perform an LLP risk assessment to create a product-specific policy. This could be done before there is any real possibility of the biotech product appearing in import shipments, thereby avoiding potential trade disruption.