Bioproducts (including those of fisheries and aquacultures) for human or veterinary use are subject to validation in an operational environment in order to ensure safety and quality standardization. This is outlined in detail in a series of guidelines; most notably in several relevant Codex Alimentarius documents and EMEA's Note for guidance on specifications: Test procedures and acceptance criteria for biotechnological / biological products (CPMP/ICH/365/96). The procedures apply to the stages of development and processing, the employment of reference standards and validated analytical procedures, all stages of process control (from development to commercialization) and quality characterization (specifications).

Codex Alimentarius (i.e. food code) adopted by the Codex Alimentarius Commission (CAC), which is the core of the Joint FAO/WHO Food Standards Programme, is a collection of internationally adopted food standards, guidelines and codes of practice intended to contribute to the safety, quality and fairness of international food trade by facilitating the harmonization of definitions, requirements and practices, and consequently, international trade. Noteworthy, Codex standards and related texts are not a substitute for, or alternative to national legislation. In addition, Codex standards are subject to revision based on advancements in knowledge (more 3.3.1).

This Unit mainly follows EMEA's guidelines, with additional reference to related Codex Alimentarius texts. More details for foods derived from biotechnology see in Codex Alimentarius guidelines. Some Codex documents relevant to biotechnology products and foods derived from fisheries/aquaculture are listed in Table 3.3.1 . Bioroducts should cause no toxic, allergenic or mutagenic effects. In the case of fish side streams used for human grade food, the quality and safety of the raw materials have to be ensured by handling and controlling side streams in the same manner as the primary product. That is why food safety and quality control systems are applied, including Hazard Analysis and Critical Control Point (HACCP) and Good Manufacturing Practice (GMP). There should be appropriate control on all biological and chemical hazards. To develop appropriate food safety controls, a proper understanding of the association between reduction in hazards associated with food and reduction in risk to consumers is of central importance. To protect the ecosystem and public health, indiscriminate and unregulated use of chemicals and therapeutics in aquaculture should be discouraged (5). The legal framework on food additives in EU is defined in Regulation (EC) N^o 1333/2008.