On the E-copy Submission
1. Why do we need to submit the DVD Copy for notifications and compliance requirements while we already have a pending application?
The submission of DVD copy or E-copy materials is in line with the FDA to computerize/digitize the licensing/registration processes. By requiring clients to start submitting E-copy of all transactions, including letters and compliance materials, will lessen the burden of paper business transaction (filing/recording) as envisioned in the E-Governance Program of the Government. Eventually, after these initial steps to digitizing the licensing/registration procedures the future transaction of the FDA will be paperless.
2. Can we submit several product registration application of same product with varying flavors (variants) of the same brand and manufacturer in one (1) dark blue 3-hole ring binder?
No. The E-copy submission guidelines states that the required format is “per application” thus each product should be submitted as such. Common documents (i.e. affidavit, certification, etc.) may be photocopied provided that the original is submitted in one of the set of applications and the DVD copy should have the scanned image of the original copy.
3. Can we just submit the CD copy and samples for CPR application?
No. The client still needs to submit hard copies of documents in accordance to Memorandum Circular 2013-001-A.
4. What are the qualifying criteria for being categorized as food Category 1 or food Category 2?
The Categories are based on Bureau Order No. 163 series of 1997 for imported products.
On the submission at the Regional Field Offices
1. Can food establishment in the regions (other than NCR) submit LTO and CPR applications at their designated RFOs?
No. CPR applications should be submitted at the CFRR (FDA Alabang). However, LTO applications at the regions should be submitted at their designated RFOs.
2. Can compliance requirements in the regions (other than NCR) including communications relevant to field inspection be submitted in Alabang (FDA)?
No. Compliance and other notifications at the region should be submitted at their designated RFO in accordance with the E-copy guidelines.
3. What is the timeframe for processing of LTO?
As per FDA Citizen’s Charter, the processing time of LTO is 29 working days.
4. What is the timeframe for processing of CPR?
As per FDA Citizen’s Charter, the processing time of CPR is 90 working days.
On the safety of processed food
1. Is this product registered and safe?
Registration is not a guarantee that the product is safe because food safety involves from Farm to Fork, thus, Consumer responsibility after purchase takes effect to continuously assure that product is safe until its consumption.
2. How do we know if the product is registered if FR # is not on the label?
The registration of the product can be verified, searched and viewed through FDA website even by typing the product’s name. FR# to-date, is not yet mandatory to be declared on the label until a new labelling regulation is issued.
3. What is the difference between “Best before date” and “Expiration date”?
“Best before date” is the date which signifies the end of the period, beyond which certain quality of the products will be expected to deteriorate. On the other hand, “Expiration date” is when the estimated shelf-life of the product has ended, beyond which the quality and safety of the product has significantly deteriorated. Thus, foods beyond their expiration date are not marketable and consumable.
On the Certificate of Product Registration
1. CPRs are now required by TV Commercial Agency, as such, how will a bakeshop register its motif cake products? What about the labelling requirements?
The base cakes should be registered not for the motif. Cakes or bakery products for immediate consumption are mostly not pre-packaged, thus, are not covered by the general labelling requirements but only that of Memorandum Circular No. 6 series of 1993 on Open-Date Marking.
2. Will a stability study be required or an actual COA be required for a change in formulation due to change in an ingredient (e.g. cooking oil) at 5% to palm oil at same level?
This is treated as a new formulation thus, new CPR application must be filed and new stability study.
3. If we are to register a Vitamin C product with a dosage of 500mg and 1,000mg, is it still under food supplement category or it is now categorized under Over-the-Counter Drug (OTC)?
This should be registered as an OTC drug per Office Order No. 22 s. 1991 – Guidelines for the classification of Vitamins and Minerals as Drug or Food.
4. We will file initial application for 2 products with different flavour (strawberry and chocolate). Can we submit the stability of Strawberry flavour for the registration of the chocolate flavour because the stability for chocolate is not yet available?
The stability study results of the strawberry flavour can be submitted for the registration of the chocolate flavour as long as both products have the same base.
5. If there is an existing CPR for a certain product but company plans to claim fortification on the label, there will be no changes in formulation, will the company make a letter of request to advise or need an amendment request for the CPR?
Request for change in label together with the justification on the label claim, comply with the Codex CAC/GL 23-2007 Rev. latest - Guidelines on Health and Nutritional Claims.
6. Can we apply for the automatic renewal of the CPR of a product if there has been a slight change in the label? There is no change in the formulation. The only difference is that the old label has pictures while the new label does not.
With the changes, the company can only apply for regular renewal.
7. On importation of Raw materials:
a. Some countries cannot provide Certificate of Free Sale (CFS). Can we submit GMP/health certificates/ Phytosanitary Certificate in lieu of the CFS? Please confirm if this has to be authenticated by the Philippine Consulate as well.
Yes, health certificate can be submitted in lieu of a CFS but with statement that RM is “freely-sold” in the country of source. If certification is issued by a government agency, there is no need for authentication but if it is issued by an industry association, this should be authenticated.
8. With regards to the requirement to submit sample in commercial presentation is this mandatory for RMs?
If product is in bulk packaging, a picture in commercial presentation should be submitted together with the empty labelling material and actual product, packing is small container.
9. What are the basic labelling requirements for imported RMs?
All the basic requirements in the latest general guidelines except the brand name and should have the statement “For Institutional Use.”
10. Is it required to indicate the country of origin on RM label? What if only the source name is indicated, would this be acceptable?
Yes, it is required to indicate the country of origin on the RM label.
11. Is sticker label acceptable for imported RMs?
Yes, as long as traceability and proper markings are in place and material used to label product does not pose any food safety issue (ink used does not contain any chemical contaminant).
12. Is digital photo of the product a requirement for registration? On what premise do we submit a digital photo?
As part of the E-copy requirement – FDA Memorandum Circular 2013-001 and 001-A, a digital picture of the product should be submitted.
13. Can we use the word “consignee” instead of “imported by” on the label since our supplier is using a system generated program for their labels and the default is consignee?
This is acceptable as long as “consignee” is synonymous to “importer” for the specific country.
14. Is “weight gain” an allowed claim? Is a clinical study required for such claim?
Claim for “weight gain” should be scientifically substantiated. This will be classified as Food for Special Dietary Use.