8.0 Registration Processes

Infant, Follow-up, Young Child Formula
Malaysia

This section provides information on any product notification or registration and manufacturing site registration processes.

8.1 Product Notification

There are no product notification processes specific to “Infant, Follow-up and Young Child Formula”. This category should comply with the requirements in Section 8.1 of 8.0 Registration Processes of the “General Foods” guidebook for Malaysia.

8.2 Product Registration

Refer to Section 8.2 of 8.0 Registration Processes of the “General Foods” guidebook for Malaysia. 

Infant Formula and Follow-up Formula [2]

1. Product registration is not required, but the product label must be approved by the Vetting Committee 
2. The Vetting Committee is part of the National Committee on the Code of Ethics for the Marketing of Infant Foods and Related Products. The chairman is the Deputy Director General of Public Health in Malaysia's MOH, and members include representatives from MOH and health professionals.
3. All information materials and labels of infant formula products must be submitted to the Vetting Committee and comply with the following:
   1. The purpose and target population must be clearly stated in the submission
   2. Every request must be accompanied by one electronic copy of the material for vetting. The number of hard copies shall be determined by the Vetting Committee.
   3. All vetting materials must be "in the final draft" before submission to the Vetting Committee.
   4. All approved materials must be printed exactly in the same format, lettering, design, wording, style, display and proportionate size as approved by the Vetting Committee.
   5. Each vetted material is approved on its own merits and no two or more approved materials can be combined together without the approval of the Vetting Committee.
   6. A copy of the final printed material or label must be sent to the Vetting Committee for record purposes

Approved materials will be valid for a period of:

• 4 years from the date of approval for labels
• 3 years from the date of approval for educational materials for health professionals
• 6 months for can inserts and stickers

A request for extension is obligatory after the expiry period.

Young Child Formula 

“Young Child Formula” should comply with the requirements in Section 8.2 of 8.0 Registration Processes of the “General Foods” guidebook for Malaysia.

8.3 Other Notes or Requirements

Product Notification

Not applicable.

Product Registration

The approval given by the Vetting Committee should be governed by the provision of the Code of Ethics and the issued Approval Code should be reflected on the information material and on the label [1].

8.4 Manufacturing Site Registration

“Infant, Follow-up and Young Child Formula” should comply with the requirements in Section 8.4 of 8.0 Registration Processes of the “General Foods” guidebook for Malaysia. Additionally, the below applies.

Infant, Follow-up and Young Child Formula [3][4][5][6] 

Foreign producers and exporters of dairy products are required to apply for dairy establishment registration and import permits for imported consignments of dairy products. This is issued by Malaysia’s Department of Veterinary Services (DVS) under the Ministry of Agriculture and AgroBased Industry.

• Inspection is based on ‘Cost Recovery’ which covers all expenses including return airfares, accommodation, and in-country transportation during the inspection period will be borne by the exporting establishment. The fee for compliance or review audit is RM5000.00. Regardless of the audit results, the processing fee is not refundable. The Inspection Team will consist of 3 (three) officers from DVS/Department of Islamic Development Malaysia (JAKIM)/Ministry of Health Malaysia.

• The timeline for manufacturing site registration is not mentioned by DVS. 
• There are two pathways for importing dairy facility registration:
  1. For facilities that have a history of exporting to Malaysia, an expedited review of applications received by DVS lasts approximately two weeks. For those facilities with a history of exporting and seeking expedited review, applications will be briefly reviewed for A) verification of the facility’s history of exporting to Malaysia, and B) valid halal certification for the products. Based on this expedited review, DVS issues a decision and either lists the facility in the e-Dagang system, making it eligible to receive import permits, or alternatively notifies the applicant via letter indicating what elements of the application DVS is considered insufficient.
  2. For facilities that do not have a history of exporting to Malaysia, a standard review of applications received by DVS lasts three to six months. For those facilities without a history of exporting to Malaysia undergoing the standard application review process, applications can be submitted at any time, but import permits will not be issued until the facility has been registered by DVS. 
• Once registered, DVS approves the facilities to be listed in an online import permit system called ePermit/Dagang net. The system is relied on by Malaysian Quarantine and Inspection Services (MAQIS) to verify during customs clearance that arriving consignments originate from registered facilities. Without the approved registration, importers will not be given approval to import and issued an import permit, and MAQIS officials will not be able to verify the origin of the consignment. Facilities or exporters may wish to verify their registration status with importers prior to shipping to ensure import permits can be obtained. 
• Usually, the estimated time can be from 1 year or more, because DVS has to organize an onsite audit together with JAKIM and MOH."

8.4.1 Standard/Rules for Manufacturing Site

“Infant, Follow-up and Young Child Formula” should comply with the requirements in Section 8.4.1 of 8.0 Registration Processes of the “General Foods” guidebook for Malaysia. Additionally, the below applies:

Infant, Follow-up and Young Child Formula [6][7]

The application form for dairy establishment can be found here: http://www.dvs.gov.my/dvs/resources/auto%20download%20images/560df048219c3.pdf

• All aspects of the manufacturing establishment including water supply, manpower, food safety program (HACCP), and processing/canning premises must be filled in the form.
• Requirements and inspection procedures are specified in the terms and conditions for the implementation of inspection services at foreign abattoirs and processing plants that request to export meat and products of animal origin to Malaysia. 
• The establishments are assessed primarily on their compliance with Malaysian requirements on sanitary, food safety, and Halal. In this regard, the veterinary inspection focuses on SPS, the effective implementation of GMP (Good Manufacturing Practices), and food safety assurance programs such as HACCP (Hazard Analysis Critical Control Points). Basically, the inspection procedures follow the program on the VHM (Veterinary Health Mark) scheme by DVS and Halal Certification by JAKIM, on local establishments. 

SPS AND VETERINARY REQUIREMENTS

1. Disease Status of the Exporting Countries - Exporting countries have to submit the current disease status based on the DVS format that is available on the DVS web http://www.dvs.gov.my/import_export and to be endorsed by the Competent Authority (CA) of exporting countries.

2. Establishment Profile - Establishments intending to export their products to Malaysia are required to furnish basic information such as; a list of products to be exported to Malaysia, source of raw materials, infrastructure and facilities, product description, manpower, quality assurance program, food safety programs, daily/annual production, capacity, volume of annual export. This information should be provided using the DVS application form completed and declared by the establishment intending to export their products and then endorsed by the CA of the exporting country. The document can be submitted to DVS through the CA of the exporting countries or the embassies of the exporting countries in Malaysia. 

3. Adequacy Audit - The application document will be reviewed by DVS to ensure all the relevant information is complete and adequate for DVS to decide whether to conduct an on-site inspection of the establishments. DVS will communicate through the CA of the exporting countries or the embassies of the exporting countries in Malaysia for any queries with regard to the application by the interested establishments.

4. Compliance Audit - If the application document submitted to DVS is found to be satisfactory, an inspection visit to the establishment in the exporting country will be arranged and the CA will be notified. DVS officials will carry out on-site inspections on the establishments based on criteria as stated in Item 6 below. On completion of the inspection visit, the team will prepare a report of their findings. This report will be submitted to the Technical Committee on Inspection of Foreign Abattoir and Processing Plants for evaluation and recommendations and it then be forwarded to the Committee on Inspection of Foreign Abattoir and Processing Plants for approval. DVS will inform the establishments concerned about the decision through their respective embassies in Kuala Lumpur or through their CA of exporting countries and subsequently will be listed on the DVS website. The approval period for the establishment is valid for a period of one year. Even if the validity period of an approved establishment is valid for 1 (one) year, it may be extended for an additional 2 (two) more years subject to the reports on Annual Performance Evaluation as described in Item 5.1. However, a review audit shall be carried out on the third year of approval before the expiry date.

5. Review Audit - Review audit involves an on-site inspection of the approved establishment to ensure continuous compliance with SPS and veterinary requirements and shall be carried out before the expiry date. The on-site inspection of the establishment will be based on criteria as stated in Item 6 below. On completion of the review audit, the team will submit a report of their findings to the Technical Committee on Inspection of Foreign Abattoir and Processing Plants for evaluation and recommendations. Then it will be forwarded to the Committee on Inspection of Foreign Abattoir and Processing Plants for approval. DVS will inform the establishments concerned about the decision on the review audit on the establishments through their respective embassies in Kuala Lumpur or through their CA of exporting countries. The approval period for the establishment is valid for a period of one year and may be extended for an additional 2 (two) years subject to the reports on the Annual Performance Evaluation. 

• 5.1. The reports on the Annual Performance Evaluation of the exporting countries shall comprise the following:
  • 5.1.1 Based on the review audit on the exporting establishments done by the competent authority of the exporting countries; a copy of the report must be sent to DVS for further evaluation.
  • 5.1.2 The operators of the establishment have to be promptly notified to DVS through the Competent Authority for :
    • 5.1.2.1 Change in management
    • 5.1.2.2 Change in scope of activity/operation
    • 5.1.2.3 Major renovation work to upgrade or increase production
    • 5.1.2.4 Establishment has closed down and/or not in operation
• 5.2 However, the approved establishments may be subjected to a review audit at any time during the validity period to verify compliance with SPS and veterinary requirements.
• 6. Criteria for on-site inspection - DVS officials will conduct an on-site inspection of the establishments for the purpose of a Compliance Audit and Review Audit. The on-site inspection for verification of practices, and examination of documents and records based on the following: 
  • 6.1. Quality and Safety Assurance Manual
  • 6.2. Good Manufacturing Practices (GMP)
    • 6.2.1. Design and Facilities
    • 6.2.2. Control of Operation such as hygiene control system, incoming material requirements, traceability, recall procedures
    • 6.2.3. Maintenance, Cleaning, and Sanitization such as pest control program, waste management, and cleaning program
    • 6.2.4. Personal Hygiene
    • 6.2.5. Transportation and Distribution
    • 6.2.6. Product Information Training
    • 6.2.7. Internal Inspection
    • 6.2.8. Management Review
    • 6.2.9. Records of Implementation
  • 6.3. HACCP Plan
    • 6.3.1. Documentation
    • 6.3.2. Records of Implementation
  • 6.4. Internal Audit Reports
    • 6.4.1 HACCP Plan Audit
    • 6.4.2 GMP Audit
  • 6.5. CA Audit Report

8.4.2 Other Notes or Requirements for Manufacturing Site Registration

Infant, Follow-up, and Young Child Formula [6]

The approval period for the processing plant is valid for a period of one year. Even if the validity period of an approved establishment is valid for 1 (one) year, it may be extended for an additional 2 (two) more years subject to the reports on the Annual Performance Evaluation. A review audit shall be carried out on the third year of approval before the expiry date.

8.5 References

1. Malaysia MOH guideline “What you need to know before importing

http://fsq.moh.gov.my/v6/xs/page.php?s=langkah1

2. Code of ethics for the marketing of Infant foods and related products

https://nutrition.moh.gov.my/wp-content/uploads/penerbitan/buku/TATA%20ETIKA%20PEMASARAN%20MAKANAN%20BAYI%20DA%20PRODUK%20BERKAITAN.pdf

3. Department of Veterinary Services announcement: registration of dairy processing plants from FMD-free countries 

http://www.dagangnet.com/infosite/document/DVS/NOTIS-PEMBERITAHUAN-LIST-UPDATE-UNTIL-Ogos18.pdf

4. Regulations for the importation of milk or milk products into Malaysia   

https://www.dvs.gov.my/dvs/resources/auto%20download%20images/565e5de57eafe.pdf

5. GAIN Report Number MY8001 Registration of Dairy Product Facilities Exporting to Malaysia

https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Registration%20of%20Dairy%20Product%20Facilities%20Exporting%20to%20Malaysia_Kuala%20Lumpur_Malaysia_11-13-2018.pdf

6. Terms and conditions for implementation of inspection services at foreign abattoir and processing plants that request to export meat and products of animal origin to Malaysia 

https://www.dvs.gov.my/dvs/resources/auto%20download%20images/560b9bca7240c.pdf

7. Application template for exporting meat, poultry, milk, and eggs products to Malaysia 

https://www.dvs.gov.my/dvs/resources/auto%20download%20images/560df048219c3.pdf