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Background The precautionary allergen labelling ( PAL) and Voluntary Incidental Trace Allergen Labelling ( VITAL®) tools were designed by industry to assist consumers with selecting safe foods for consumption. However, a sizeable proportion of food products bear no label, and it is unclear whether these products are free from allergens and therefore safe to consume or have simply not undergone a risk assessment and therefore remain unlabelled for that reason. Objective To assess the prevalence of unlabelled products that have undergone a risk assessment process and to examine the factors influencing industry's uptake of the VITAL® process. Methods A web-based questionnaire was distributed to Australasian food and grocery manufacturers. Results One hundred and thirty-seven Australasian manufacturers were contacted, and 59 questionnaires were returned (response rate: 43%). The respondents represented 454 different manufacturing sites. Manufacturers reported that 23% (95% CI 19-28) of products (n=102/434) that had been through the VITAL® risk assessment process had no PAL statement on the label. 34% (95% CI 30-38), (n=204/600) of products that had undergone another (non- VITAL®) risk assessment process had no PAL statement. In examining the factors that influenced industry's uptake of the VITAL® process, 25 manufacturers reported on factors that influenced the uptake of the VITAL® process, 76% ( CI 95% 55-91) reported that VITAL® was an effective tool because it was based on science; 52% ( CI 95% 31-72) reported that it was too time-consuming and 36% ( CI 95% 18-57) identified a concern with it not being endorsed by the government. Conclusion and Clinical Relevance Currently, we estimate that at least 30% of products may have been through a risk assessment process and yet bear no PAL statement on the label. Permissive labelling could be incorporated onto these products if they have been assessed to be safe for consumption. [ABSTRACT FROM AUTHOR]