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the relevant guideline for specific information requirements. In some instances more than one guideline may apply.

     E.1 Data requirements

Note:

The term 'data' in this document refers, among other things, to units of information; facts; observations; or results of an experiment, study or survey.

FSANZ will assess all the available data presented in support of an application.

Wherever the data requirements are mandatory but cannot be met, a reason should be provided.

When a literature search is undertaken, the application must:

    (a) list the databases and journals searched (such as MEDLINE, EMBASE, TOXLINE, FSTA, Science Citation Index, BIOSIS, PsycINFO, CINAHL, Cochrane Library, or the Australian Medical Index etc)

    (b) provide the criteria used to specify the search, such as the key words, the time period of the search, and any other limiting criteria

    (c) list all of the papers. identified in the search

    (d) list and provide in full all of the papers. included as the basis of the evidence in the application. Summaries of study findings and papers. are not adequate.

Note:

Useful guidelines on undertaking literature searches can be found at http://www.nhmrc.gov.au/publications/synopses/cp65syn.htm.

The data underpinning the evidence to support the Application should also:

    (a) identify the source, author(s) and year the data was produced
    (b) be obtained using validated or standardised methods, where these are available. Standardised methods should be validated for accuracy and reproducibility, and declare the sensitivity and specificity of the method where appropriate

    (c) be representative of the Australian and New Zealand populations

    (d) be analysed using appropriate statistical techniques.

     E.1.1 Data related to safety studies

    (a) Studies submitted for safety assessment purposes should be designed and conducted in accordance with the principles and intent of good laboratory practice (GLP). For safety assessments of chemicals, reference should be made to the following:

       (i) OECD Principles on Good Laboratory Practice
       http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm

       (ii) relevant OECD Guidelines for the Testing of Chemicals
       http://www.oecd.org/env/ehs/testing/

       (iii) other recognised test guidelines such as:

       US Food and Drug Administration Redbook 2000 Toxicological Principles for the Safety Assessment of Food Ingredients
       http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2006826.htm.

    (b) All studies conducted for a regulatory purpose should be accompanied by evidence of a quality control/assurance program or evidence of independent auditing of the conduct and reporting of the study.

    (c) Studies should contain full details of the conduct of the study and its results, including raw data where appropriate.

     E.1.2 Data related to surveys on chemicals or other substances in food

    (a) The survey design and method should be clearly enunciated along with the findings and the conclusions. Where surveys are designed to be targeted or selective, the basis for doing so should be clearly stated.

    (b) The survey should use a design that avoids biasing the results. The