Attachment B Draft Explanatory Statement – 1. Authority Section 13 of the (the FSANZ Act) provides Food Standards Australia New Zealand Act 1991 that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New (the Code). Zealand Food Standards Code Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures. FSANZ accepted Application A1124 which seeks to permit the addition of DHA-rich algal oil from Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) as an alternative or replacement oil for other currently permitted DHA-rich algal oils added to infant formula products. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared a draft variation setting out amendments to Schedule 3 and Schedule 25. 2. Purpose The purpose of the draft variation is to permit the voluntary use of oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) as a source of DHA in infant formula products. 3. Documents incorporated by reference The variations to food regulatory measures do not incorporate any documents by reference. 4. Consultation In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1124 will include one round of public consultation following an assessment and the preparation of a draft Standard and associated assessment summary. A Regulation Impact Statement was not required because the proposed variation is likely to have a minor impact on business and individuals, as the permission is for permission for the voluntary addition of a replacement or alternative DHA-rich algal oil. 5. Statement of compatibility with human rights This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 94 of the FSANZ Act. 6. Variation Item [1] Item [1.1] amends Schedule 3 by inserting a reference into the table to subsection S3—2(2) to oil derived from marine micro-algae Schizochytrium sp. (ATCC PTA-9695) and to section S3—35.
Attachment B – Draft Explanatory Statement 1. Authority Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code). Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures. FSANZ accepted Application A1124 which seeks to permit the addition of DHA-rich algal oil from Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) as an alternative or replacement oil for other currently permitted DHA-rich algal oils added to infant formula products. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared a draft variation setting out amendments to Schedule 3 and Schedule 25. 2. Purpose The purpose of the draft variation is to permit the voluntary use of oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) as a source of DHA in infant formula products. 3. Documents incorporated by reference The variations to food regulatory measures do not incorporate any documents by reference. 4. Consultation In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1124 will include one round of public consultation following an assessment and the preparation of a draft Standard and associated assessment summary. A Regulation Impact Statement was not required because the proposed variation is likely to have a minor impact on business and individuals, as the permission is for permission for the voluntary addition of a replacement or alternative DHA-rich algal oil. 5. Statement of compatibility with human rights This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 94 of the FSANZ Act. 6. Variation Item [1] Item [1.1] amends Schedule 3 by inserting a reference into the table to subsection S3—2(2) to oil derived from marine micro-algae Schizochytrium sp. (ATCC PTA-9695) and to section S3—35.