development) Must be referenced to A relationship between the substance and human milk A relationship between the substance and human milk human milk would be expected, and similarly that the proposed level would be expected, and similarly that the proposed level would be modelled after human milk. would be modelled after human milk. Transparency of Part 182 of 21 CFR lists some common substances that are Approved food additives are issues a regulatory number permissions generally recognised as safe. (parts 170-180 of 21 CFR). The on the FDA web site contains GRAS notices received Food Additive Status List is also available on the FDA from companies since 1998, and FDA's response. website at: Post-market monitoring Although a substance may have GRAS status, the FDA may The status of a food additives may be amended or removed at any time prohibit its use or conduct further studies to from regulation if there are safety concerns, in accordance determine its safety if new evidence suggests that a product with 21 CFR 571.130(a). already in use may be unsafe or if consumption levels have changed. Pre-market notification of an infant formula product: Process Prior to marketing a new infant formula in the US, a manufacturer must register with, must notify, and must submit written verification to, FDA (sections 106.110 and 106.120 of 21 CFR). The notification must occur at least 90 days before marketing the product. A infant formula’ includes an infant formula manufactured by a person which has previously manufactured infant ‘new formula and in which there has been a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer. Data & information Section 106.120 of 21 CFR outlines that the notification must include: requirements for inclusion The quantitative formulation of the infant formula; in any notification/ A description of any reformulation of the formula or change in processing of the infant formula; assessment documents Assurances that the infant formula will not be marketed unless it the quality factors and the nutrient requirements of the Act; and
development) Must be referenced to human milk A relationship between the substance and human milk would be expected, and similarly that the proposed level would be modelled after human milk. A relationship between the substance and human milk would be expected, and similarly that the proposed level would be modelled after human milk. Transparency of permissions Part 182 of 21 CFR lists some common substances that are generally recognised as safe. The on the FDA web site contains GRAS notices received from companies since 1998, and FDA's response. Approved food additives are issues a regulatory number (parts 170-180 of 21 CFR). Food Additive Status List is also available on the FDA website at: Post-market monitoring Although a substance may have GRAS status, the FDA may at any time prohibit its use or conduct further studies to determine its safety if new evidence suggests that a product already in use may be unsafe or if consumption levels have changed. The status of a food additives may be amended or removed from regulation if there are safety concerns, in accordance with 21 CFR 571.130(a). Pre-market notification of an infant formula product: Process Prior to marketing a new infant formula in the US, a manufacturer must register with, must notify, and must submit written verification to, FDA (sections 106.110 and 106.120 of 21 CFR). The notification must occur at least 90 days before marketing the product. A ‘new infant formula’ includes an infant formula manufactured by a person which has previously manufactured infant formula and in which there has been a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer. Data & information requirements for inclusion in any notification/ assessment documents Section 106.120 of 21 CFR outlines that the notification must include: The quantitative formulation of the infant formula; A description of any reformulation of the formula or change in processing of the infant formula; Assurances that the infant formula will not be marketed unless it the quality factors and the nutrient requirements of the Act; and
P1028-Consult-SD2-SafetyTechnology.docx