SUBJECT:Guideline on Meat Product Registration

Draft NMIS ADMINISTRATIVE ORDER No. ______as of Oct.14, 2013

Series of 2013

SUBJECT:Guideline on Meat Product Registration

Pursuant to the provisions of Republic Act No. 9296of 2004,as amended by Republic Act No. 10536 of 2013 and their Implementing Rules and Regulations, Department of Agriculture Administrative Orders and all NMIS issuances, the herein guideline is prescribed in the registration of meat products for domestic trade or export.

Section 1

Definition of Terms

Certificate of Product Registration – an official document issued as proof that the product passed the registration requirements and standards for food.

Meat Establishment – premises such as slaughterhouse, poultry dressing plant, meat processing plant, cold storage warehouse, meat cutting plants, and other meat outlets that are approved and registered by the NMIS in which food animals or meat products are slaughtered, prepared, processed, handled, packed or stored.

Meat Product – any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any food animals, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat industry; and which are exempted from the definition as a meat product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat products.

Section 2

Scope

The guideline shall cover the registration of all meat products, from DA and NMIS accredited establishments (Cold Storage Warehouse, Meat Establishment, Meat Importers/Traders and FMEs), local and imported, destined/intended for directconsumption, domestic trade or export.

Product registration is mandatory for all imported meat products, Hazard Analysis and Critical Control Point (HACCP) certified meat products, and local meat products manufactured by NMIS accredited meat establishments.

Section 3

Application for Meat Product Registration

Applications for Meat Product Registration shall be submitted/endorsed to the NMIS Central Office, Product Registration Section of the Accreditation, Regulatory, and Enforcement Division for assessment, payment of fees, evaluation and validation, processing, and endorsement to the Executive Director for approval. The application forms and list of requirements may be secured from the NMIS Office or downloaded from the website(www.nmis.gov.ph).

All documents must be secured and sequentially arranged in a legal size folder according to the checklist requirements. For easy reference, ear tags shall be placed for each documentary requirement. For renewal, a copy of the original CPR must also be submitted. Processing of the application is fifteen (15) working days after submission of complete requirements.

3.1Requirements for Application

3.1.1Locally Manufactured Meat Products

a)Assessment Slip

b)Notarized Letter of Application from manufacturer or distributor addressed to the NMIS Executive Director, Attention ARED –Product Registration Section.

c)Duly accomplished Application Form

d)Copy of Valid Certificate of Accreditation for meat establishment

e)Copy of Good Manufacturing Practices (GMP) Certificate

f)Product Labeling (Mandatory Label Information) and labeling material used in the product.

g)Certificate from flavor supplier that the flavor components are recognized as safe and suitable for human consumption by competent authority.

h)Finished product specification (Physical, Chemical, and Microbiological)

i)One (1) sample of the product in commercial presentation. For initial/new product application, a proposed artwork of the label may be submitted.

j)Certificate of Analysis of the finished product indicating the analytical methods used from DOH-FDA recognized laboratory.

k)Process Flow of Method of Manufacture, packaging, and quality control duly signed by the NMIS plant officer.

l)Packaging certification of suitability for food use.

m)Estimated shelf life data, parameters used and methods of determining shelf life.For initial registration, the shelf life data shall be prepared by a 3rd party service provider. For renewal of registration, company prepared shelf life study will be accepted.

n)Justification of label claims if any.The claim must be verified at the producer’s expense, and the producer must have documentation that the product meets the requirements for the definition.

o)Copy of previouscertificate of product registration (for renewal only).

p)Copy of Official Receipt of Registration Fee payment.

3.1.2 Imported Meat Products

a)Assessment Slip

b)Notarized Letter of Application from importer/distributor.

c)Duly accomplished Application Form

d)Copy of Valid Certificate ofAccreditation as Importer/Exporter.

e)Copy of Foreign Meat Establishment (FME) Accreditation of the product source from the Department of Agriculture

f)Notarized Affidavit of Undertaking

g)Photocopy of the sales invoice from manufacturer

h)One (1) sample of each product in commercial presentation and a copy of the label. A sticker indicating the name and address of the importer must be attached if not printed on the label.

i)Certificate of Free Sale issued by the Government Regulatory Agency in the country of origin stating that the specific products applied for registration are freely sold in the country of origin and fit for human consumption. An International Veterinary Certificate or Certificate of Wholesomeness may be accepted as equivalent to Certificate of Free Sale.

j)Copy of previous certificate of product registration (for renewal only)

k)Copy of Official Receipt of Registration Fee payment.

3.2Amendment and Replacement/Reconstruction of Certificate

Applications for amendments shall be processed fortypographical errors or changes in company, manufacturer, repacker, importer, or distributor name or address.A change in product name shall be treated as an initial application.

Replacement or Reconstruction of lost or damaged certificates shall be requested in writing and supported by an affidavit of loss. A corresponding fee shall be charged for such a replacement based on the schedule of fees for services rendered.

Section 4

Procedures in the Evaluation and Processing of Application

4.1Persons Responsible for the Evaluation, Processing, and Approval of Applications for Product Registration

a)Product Evaluator

b)Product Registration Section Head

c)Division (ARED) Head

d)Executive Director

4.2Process Flow of Application

4.2.1The application for meat product registration shall be received by the Office of the Executive Director (OED) and processed at the NMIS Central Office ARED-Product Registration Section. Applicants shall pay the corresponding registration fee indicated in the assessment slip.

4.2.2Applications are assessed and issued an order of payment. The applicant goes to the Cashier Section for the payment. He then goes back to the Evaluator to submit a copy of the receipt of payment. Applications are processed within fifteen (15) working days upon completion or fulfillment of all the requirements.

4.2.3The Evaluator shall check and verify the application documents submitted based on the checklist of requirements.

4.2.4The Evaluator shall recommend the application for approval or disapproval/denial to the Product Registration Section Head.

4.2.5The Product Registration Section Head shall validate the recommendation of the Evaluator and return it for printing of Certificate of Product Registration (CPR) or issuance of Letter of Disapproval/Denial.

4.2.6The CPR or Letter of Disapproval/Denial shall contain or enumerate the deficiencies to be complied and be submitted to the Division (ARED) Head by the Product Registration Section Head for his initials and endorsement to the Executive Director.

4.2.7The Executive Director shall make/have the final decision and sign the CPR or Letter of Disapproval/Denial.

4.2.8The signed CPR or Letter of Disapproval/Denial is then returned to ARED-Product Registration Section for proper notation in the registry beforeturnover to the Records Section for release.

4.2.9The CPR or Letter of Disapproval/Denial shall be released by the Records Section for personal pick-up or mailing.

4.2.10Process Flow of CPR Application

PRODUCT REGISTRATION

PROCESS FLOW

See Annex A

Section 5

Labeling Requirements

The meat product being applied for registration shall bear a label in compliance to DA Administrative Order No. 24 series of 2010.

5.1Mandatory Label Information

5.1.1Name of the product

5.1.2Net quantity

5.1.3List of ingredients in descending order of proportion

5.1.4Name and address of the manufacturer, packer/distributor/importer, and country of origin if imported

5.1.5Date of preparation or production

5.1.6Lot identification code

5.1.7Safe handling instruction for chilled or frozen meats

5.1.8Information for irradiated foods and use of genetically modified organism (GMO) or biotechnology. Food ingredients that are known to cause hypersensitivity reaction to sensitive population shall also be indicated or declared so that consumers are forewarned.

Section 6

Label Claims, Advertising, and Promotion

6.1Label Claims shall be supported by pertinent documents such as computations, test results, rationale, scientific study, pertinent regulations, or certificates.

6.2Label Claims that may require further deliberation shall be referred to the Committee on Label Claims for approval.

6.3The label shall not bear any advertisements for other products or promotional offers. Advertisements and Promotional Offers may be allowed on product inserts or stick-ons.

6.4Permits relative to advertising and promotion shall be secured from appropriate regulatory unit.

Section 7

Change in formulation, labeling, commercial presentation, and ownership of the product

7.1The NMIS Central Office ARED-Product Registration Section shall be informed in writing of any change in formulation, labeling, and commercial presentation or variant.

7.2If there are changes in product name, ownership,formulation, or variant/commercial presentation, it shall be treated as a new product application.

Section 8

Validity of Registration

8.1The validity of registration is set at a minimum or maximum number of years.

8.2For initial registration, the maximum validity period is two (2) years.

8.3For renewal of registration, the validity period is three (3) years.

8.4A meat product with a CPR that has lapsed for more than a year shall have a validity period similar to an initial registration upon application.

Section 9

Re-application of CPR

9.1Applications that were disapproved or denied may be re-applied after correcting and submitting the deficiencies stated in the letter. Re-application of the product is done within six (6) months after receipt of the Letter of Denial.

9.2The same procedural requirements shall be applied to all re-applications for product registration.

Section 10

Revocation or Cancellation of CPR

10.1The CPR may be revoked/cancelled/terminated anytime if found to be in violation of any pertinent NMIS regulation such as but not limited to false information or claim, misrepresentation, adulteration, non-conformance to registration requirements, etc.

10.2Once a CPR is revoked, the applicant may make an appeal in writing addressed to the Executive Director and NMIS Central Office ARED-Product Registration Section.

10.3The CPR of any product that was Recalled shall be automatically suspended until further notice.

Section 11

Certificate of Product Registration Number

11.1A List of Registered Meat Products shall be kept by NMIS. A unique number shall be assigned to the product registered and shall be retained when applied for renewal.

Section 12

Schedule of Fees

Product RegistrationInitial - Php 400.00 per product

Renewal - Php 600.00 per product

Amendment of CPRPhp 200.00 per CPR

Replacement/ReconstructionPhp 500.00 per CPR

Re-application FeePhp200.00 per product

Section 13

Surcharge

13.1Renewal of CPR can be applied one month prior to the expiration date.

13.2A surcharge of Php100.00 shall be imposed for expired CPR.

Section 14

Repealing Clause

All existing laws, decrees, executive order and rules and regulations or parts thereof which are inconsistent with this Administrative Order, are hereby repealed or modified accordingly.

Section 16

Effectivity

This Order shall take effect fifteen (15) days after its publication in newspaper of national circulation or in the Official Gazette or its filing with the UP Law Center.

Approved:

DR. MINDA S. MANANTAN

Executive Director

Drafted by:

DR. ROSELLER L. MANALO

Senior Meat Control Officer