Food and Drug Administration
|RAW MATERIALS |
|REQUIREMENTS |FOR APPROVAL |GROUNDS FOR DENIAL |BASIS |
|1. *Clear and complete loose labels or |-Readable |-No submitted complete picture/artwork/label |Administrative Order 2014-0030 |
|artworks, as applicable, of all packaging |-Reflects all sides of packaging |-Unclear/unreadable information on the picture/artwork/label submitted |Administrative Order 2014-0029 |
|sizes, or equivalents as defined by FDA |-With submitted secondary and/or primary packaging |-Inconsistent product information in data entry and label/artwork/picture |FDA Circular 2016-014 |
|regulations except for bulk raw materials |-Reflects product name/code, lot number |-Not all labels for proposed packaging sizes are submitted | |
| |-Consistent product information in data entry and label/artwork/picture | | |
| |-Complete labels with the proposed packaging sizes | | |
|2. As applicable, documents to substantiate |For Imported and Locally manufactured SALT/Wheat flour/Cooking Oil/Refined |-No submitted Certificate of Analysis (COA) |Administrative Order 2014-0029 |
|claims, but not limited to, such as technical,|Sugar/Rice product: |-Submitted COA does not meet the tolerable level of fortificant used |FDA Circular 2016-014 |
|nutritional or health studies or reports, |-Certificate of Analysis must be signed/verified by QA Analyst/Manager |-Submitted COA contains incomplete information |Republic Act 8976 |
|market-research studies, Certificate of |reflecting the specific content of the fortificant used, specific fortificant| |Republic Act 8172 |
|Analysis to confirm compliance to R.A. 8976, |used, appropriate unit of measurement (ppm, mg/Kg or mcg/g), date of | | |
|R.A. 8172, F.M. 2011-028, quantitative |analysis, product description/name, specifications, method of analysis and | | |
|analysis and computations, scientific report |batch code/ expiry date/ manufacturing date | | |
|or studies published in peer-reviewed | | | |
|scientific journals, certificates or | | | |
|certification to support use of logo/seal on | | | |
|Sangkap Pinoy, Halal, Organic, or Kosher food | | | |
|and in compliance with current labelling | | | |
|regulations. | | | |
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|2. cont. |For Imported and Locally manufactured Soy Sauce product: |-No submitted COA |FDA Memorandum 2011-028 |
| |-Certificate of Analysis must be signed/verified by QA Analyst/Manager |-Submitted COA does not meet the tolerable level of 3-MCPD | |
| |reflecting the specific 3-MCPD content ( ................
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