Circular No. 19/2012/TT-BYT guides the publication of conformity assessment and compliance with food safety regulations.

 CIRCULAR

Guidelines for declaring conformity and compliance with food safety regulations

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Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006 and the Government Decree No. 127/2007/NĐ-CP dated August 1, 2007 detailing the implementation of certain provisions of the Law on Technical Standards and Regulations;

Pursuant to the Law on Product Quality and Goods Quality dated November 21, 2007 and the Government Decree No. 132/2008/NĐ-CP dated December 31, 2008 detailing the implementation of certain provisions of the Law on Product Quality and Goods Quality;

Pursuant to the Food Safety Law dated June 17, 2010 and the Government Decree No. 38/2012/NĐ-CP dated April 25, 2012 detailing the implementation of certain provisions of the Food Safety Law;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Food Safety Administration;

The Ministry of Health issues this Circular guiding the declaration of conformity and compliance with food safety regulations.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the procedures and documentation for declaring conformity and compliance with food safety regulations (hereinafter referred to as product declaration) for processed packaged foods, food additives, food processing aids, food packaging materials, and food contact materials (hereinafter referred to as products); responsibilities of the registration receiving agency for declarations of conformity and compliance with food safety regulations (hereinafter referred to as the registration receiving agency) and organizations and individuals declaring products (hereinafter referred to as organizations and individuals); post-declaration product inspection.

Article 2. Interpretation of Terms

In this Circular, certain terms are understood as follows:

1. Declaration of compliance with food safety regulations: is the act of organizations and individuals self-declaring that their products comply with food safety regulations for products without corresponding technical standards.

2. Main quality criteria: are levels or quantities of substances determining the nutritional value and distinctive characteristics of the product for identification, classification, and differentiation from similar food products.

3. Detailed product information sheet: is a technical specification of a product (with common product name, brand, main quality criteria, physical and chemical standards, microbiological standards) established and declared by organizations and individuals to be consistent with national technical standards (NTS) or consistent with Vietnamese food safety regulations (in cases where there are no NTS) or consistent with Codex Alimentarius Commission regulations in cases where Vietnam has no regulations.

4. Designated testing laboratory: is a testing laboratory designated by the competent authority in Vietnam.

5. Recognized independent testing laboratory: is a testing laboratory recognized by a certification body and independent from the organization or individual producing the product.

6. Recognized testing laboratory: is a testing laboratory of the organization or individual producing the product recognized by a certification body and a testing laboratory designated by the competent authority in another country.

Article 3. Content of evaluation of conformity of declared products with corresponding technical standards and evaluation of conformity of declared products with food safety regulations

1. Evaluation of conformity of declared products with corresponding technical standards (hereinafter referred to as conformity assessment) for products with existing technical standards: The content of conformity assessment applicable to each specific type of product is specified in the corresponding technical standards.

2. Evaluation of conformity of declared products with food safety regulations (hereinafter referred to as food safety regulation compliance assessment) for products without technical standards: The content of food safety regulation compliance assessment applicable to each specific type of product is based on food safety criteria according to food safety laws. In cases where Vietnam does not have regulations, the Codex regulations shall apply.

Chapter II

PROCEDURES AND DOCUMENTATION FOR PRODUCT DECLARATION

Article 4. Procedures and Documents for Announcement of Compliance

1. Procedures for Announcement of Compliance:

a) Step 1: Compliance Assessment

Organizations and individuals shall conduct compliance assessment according to one of the following two methods: self-assessment of compliance in accordance with the content of compliance assessment prescribed in Clause 1, Article 3 of this Circular and conducting product testing at designated laboratories or independent laboratories recognized or accredited; or through a conformity assessment body designated by the Ministry of Health.

b) Step 2: Registration of Compliance Announcement

Organizations and individuals announcing products shall prepare and submit the announcement documents as prescribed in Clause 2 of this Article to the registration authority specified in Article 7 of this Circular.

2. Documents for Announcement of Compliance:

a) Documents and materials prescribed in Articles 5 and 7 of Decree No. 38/2012/ND-CP dated April 25, 2012 of the Government detailing certain provisions of the Food Safety Law (hereinafter referred to as Decree No. 38/2012/ND-CP);

b) Specifically, the product testing results are prescribed as follows: Product testing results within 12 months (original or notarized copy with original for comparison or apostilled), including quality indicators as required by corresponding technical standards, from designated laboratories or independent laboratories recognized or accredited.

Article 5. Procedures and Documents for Announcement of Compliance with Food Safety Regulations

1. Procedures for Announcement of Compliance with Food Safety Regulations:

a) Step 1: Assessment of Compliance with Food Safety Regulations

Organizations and individuals shall conduct product testing at designated laboratories or independent laboratories recognized or accredited; assess compliance with food safety regulations based on testing results and in accordance with the content prescribed in Clause 2, Article 3 of this Circular.

b) Step 2: Registration of Announcement of Compliance with Food Safety Regulations

Organizations and individuals announcing products shall prepare and submit the announcement documents as prescribed in Clause 2 of this Article to the registration authority specified in Article 7 of this Circular.

2. Documents for Announcement of Compliance with Food Safety Regulations:

a) Documents and materials prescribed in Articles 6 and 7 of Decree No. 38/2012/ND-CP;

b) Specifically, the product testing results are prescribed as follows: Product testing results within 12 months (original or notarized copy with original for comparison or apostilled), including major quality indicators, safety indicators, from designated laboratories or independent laboratories recognized or accredited;

c) Testing results on the efficacy of new functional food products with new ingredients or produced using new technology first introduced to the Vietnamese market without proven safety and efficacy.

Article 6. Announcement for Imported Products (excluding functional foods) Intended for Internal Use in Production Facilities, Supermarkets, and Four-Star or Higher Hotels

1. Documents for Announcement of Imported Products Include:

a) Product Declaration Form:

- For imported food raw materials, packaging materials, and equipment directly contacting food intended solely for internal production use by enterprises: the declaration form prescribed in Model No. 2 issued together with this Circular.

- For imported food additives and processing aids intended solely for internal production use by enterprises: the declaration form prescribed in Model No. 3 issued together with this Circular.

- For imported food products intended solely for sale in supermarkets and four-star or higher hotels: the declaration form prescribed in Model No. 4 issued together with this Circular.

b) Business Registration Certificate (Notarized copy with seal of the organization or individual);

c) Product testing results within 12 months from the manufacturer or detailed product information provided by the manufacturer; or product testing results from designated laboratories or independent laboratories recognized or accredited.

2. Organizations and individuals announcing products shall prepare and submit the announcement documents as prescribed in Clause 1 of this Article to the registration authority specified in Article 7 of this Circular.

Article 7. Competence to Accept Registration Applications and Issue Certificates of Receipt for Self-Declaration of Conformity and Certificates of Confirmation of Compliance with Food Safety Regulations

1. The Ministry of Health shall delegate the National Food Safety Agency to accept registration applications; issue Certificates of Receipt for Self-Declaration of Conformity (hereinafter referred to as Certificate of Receipt) and Certificates of Confirmation of Compliance with Food Safety Regulations (hereinafter referred to as Certificate of Confirmation) for: health foods, food additives, food processing aids, imported pre-packaged processed foods, packaging materials, and food contact tools; provide written confirmation for imported products (excluding health foods) solely for internal production purposes within enterprises, supermarket sales, and four-star or higher hotels.

2. The People's Committee of Provinces and Cities shall delegate the Provincial/City Food Safety and Hygiene Control Agency to accept registration applications, issue Certificates of Receipt, and Certificates of Confirmation for: domestically produced pre-packaged processed foods (excluding health foods), packaging materials, and food contact tools of organizations and individuals producing and trading such products within their jurisdiction.

3. Domestic products intended for export shall be registered for product declaration at the National Food Safety Agency or the Provincial/City Food Safety and Hygiene Control Agency where the organization or individual has its main office when required by the importing country.

4. Products of the same quality from the same organization or individual responsible for the product but produced in two or more provinces/cities shall be registered for product declaration at the National Food Safety Agency or at the Provincial/City Food Safety and Hygiene Control Agency where the organization or individual has its main office.

5. The registration acceptance agencies specified in Clause 1 and 2 of this Article shall organize the acceptance and issuance of Certificates of Receipt and Certificates of Confirmation in accordance with Clauses 3, 4, and 5 of Article 4 of Decree No. 38/2012/ND-CP.

Within two months from the date of receipt of the notification letter from the registration acceptance agency explaining the reasons for not issuing the Certificate of Receipt and Certificate of Confirmation, if the organization or individual declaring the product does not supplement or complete the application dossier as requested, the registration acceptance agency will cancel the declaration dossier.

6. The registration acceptance agency is responsible for issuing and managing the serial numbers of Certificates of Receipt and Certificates of Confirmation.

a) For Certificates of Receipt and Certificates of Confirmation issued by the National Food Safety Agency, the corresponding symbols shall be recorded as follows: (serial number)/(year of issuance)/ATTP-TNCB and (serial number)/(year of issuance)/ATTP-XNCB.

b) For Certificates of Receipt and Certificates of Confirmation issued by the Provincial/City Food Safety and Hygiene Control Agency, the corresponding symbols shall be recorded as follows: (serial number)/(year of issuance)/YT+abbreviated name of province/city-TNCB and (serial number)/(year of issuance)/YT+abbreviated name of province/city-XNCB.

Abbreviations for the names of provinces and cities in Certificates of Receipt and Certificates of Confirmation are stipulated in Model No. 5 attached to this Circular.

Article 8. Declaration for Food Additives and Processing Aids

1. For food additives and processing aids listed in the permitted use list issued by the Ministry of Health: Organizations and individuals shall declare products in accordance with Articles 4, 5, 6, and 7 of this Circular.

2. For food additives and processing aids not included in the permitted use list of Vietnam; products containing food additives and processing aids not included in the permitted use list of Vietnam but listed under the Codex Alimentarius regulations or permitted for use in the country of production, the National Food Safety Agency will consider allowing the declaration of such products.

Article 9. Reissuing the Receipt Certificate and Confirmation Certificate

1. The reissuance of the Receipt Certificate and Confirmation Certificate shall be carried out at the competent state agency that initially issued the Receipt Certificate or Confirmation Certificate for the product, in accordance with the provisions of Article 8 of Decree No. 38/2012/NĐ-CP.

2. In cases where organizations or individuals request reissuance but fail to comply fully with the periodic testing regime, the registration receiving authority shall organize inspections of production and business establishments. Based on the results of handling violations and corrective actions, the registration receiving authority will decide whether to reissue or require a new announcement.

Chapter III

RESPONSIBILITIES OF THE REGISTRATION RECEIVING AUTHORITY AND ORGANIZATIONS AND INDIVIDUALS ANNOUNCING PRODUCTS

Article 10. Responsibilities of the Registration Receiving Authority

The Registration Receiving Authority has the following rights and responsibilities:

1. Organizing the receipt of notification files for conformity declaration or food safety compliance declaration from organizations and individuals.

2. Issuing and reissuing the Receipt Certificate and Confirmation Certificate in accordance with the time limits specified in Clause 3, 4, and 5 of Article 4 of Decree No. 38/2012/NĐ-CP.

3. Within seven working days from the date of issuance of the Receipt Certificate or Confirmation Certificate, the Registration Receiving Authority is responsible for publicly announcing the products that have been issued the Receipt Certificate or Confirmation Certificate on its electronic information website.

4. Stamping the Product Detail Information Form and stamping the product label to confirm mandatory labeling contents as prescribed by law. This stamp does not have the value of confirming industrial property rights. The Registration Receiving Authority returns to the organization or individual declaring the product a set of product files and retains the file according to regulations.

5. Organizing the management and use of fees and charges for issuing the Receipt Certificate and Confirmation Certificate in accordance with the guidance of the Ministry of Finance.

Article 11. Responsibilities of Organizations and Individuals Announcing Products

Organizations and individuals announcing products have the following rights and responsibilities:

1. Declaring products and redeclaring products at the registration receiving authority as stipulated in Article 7 of this Circular; paying full fees and charges as prescribed by law.

2. Self-monitoring the quality and food safety of their own products. Implementing the periodic inspection and testing regime as prescribed and being fully responsible for the suitability of the declared products.

3. Clearly declaring the product name, reflecting its true nature (reflecting composition, function, processing technology). If the product name does not reflect its true nature, it must include the product group name and detail all mandatory labeling contents.

4. Submitting the official label within one (01) month from the date of issuance of the Receipt Certificate or Confirmation Certificate, if only a draft design of the label content was submitted when declaring.

5. When discovering products violating laws on product quality and safety, labeling, advertising, and non-transparent declarations, organizations and individuals are responsible for:

a) Promptly notifying the competent state management agency and the registration receiving authority about the unsuitability of the product;

b) Implement measures to correct non-conformities;

c) Temporarily suspending production and shipment and recalling unsuitable products circulating in the market when necessary or upon request of the competent state management agency;

d) Notifying the competent state management agencies and the registration receiving authority about the results of correcting the unsuitability before continuing to produce and sell the products.

6. Retaining product declaration files for the duration required as a basis for inspection, supervision, or to prove the suitability of their products with the contents declared and committed in the file.

7. In cases where only changes are made to the product detail information form regarding label format, packaging specifications, quality index criteria, non-mandatory labeling contents, headquarters address of the organization or individual, or place of production, or the name of the organization or individual (in case of changing the Business Registration Certificate), the organization or individual may submit a supplementary letter requesting confirmation of the changed and supplemented contents by the organization or individual responsible for the product to continue using the previously issued or reissued Receipt Certificate or Confirmation Certificate.

Chapter IV

INSPECTION AFTER PRODUCT DECLARATION

Article 12. Post-publication inspection

The agency receiving registration and the Food Safety Agency where the production and business establishment is located have the authority to organize inspections of the implementation of food safety laws and regular testing regimes for products that have been published.

Article 13. Regular sampling and testing

1. The regular testing regime shall be as follows:

a) One time per year for products from establishments holding one of the advanced quality management system certificates: GMP, HACCP, ISO 22000 or equivalent.

b) Two times per year for products from establishments not holding the aforementioned certificates.

2. Regular sampling and testing shall be carried out by organizations, individuals, or organizations, individuals who proactively invite authorized agencies to conduct such activities.

3. The criteria for regular testing are the main quality indicators published in the Detailed Product Information Sheet or on the label of the product currently in circulation; certain physical and microbiological indicators published in the Detailed Product Information Sheet or as prescribed by law.

4. The testing results of ad hoc inspection teams, regular inspection teams, and national food safety import inspections can be used as regular testing results if they meet the requirements set forth in Clause 3 of this Article.

Chapter V

IMPLEMENTATION PROVISIONS

Article 14. Transitional Provisions

Certificates of product standard compliance issued according to Decision No. 42/2005/QD-BYT dated December 8, 2005, of the Ministry of Health regarding the regulations on publishing food product standards remain valid until their expiration date as stated in the Certificate.

Article 15. Effective Date

1. This Circular takes effect from December 25, 2012.

2. Decision No. 42/2005/QD-BYT of the Ministry of Health dated December 15, 2005, concerning the issuance of regulations on publishing food product standards ceases to be effective from the date this Circular takes effect.

Article 16. Implementation Organization

1. The Ministry of Health assigns the Food Safety Agency to implement and monitor the enforcement of this Circular nationwide.

Every six months, the Food Safety Agency reports to the Minister of Health on the issuance of Acceptance Receipts and Confirmation Certificates.

2. The Department of Health assigns the Food Safety Agency to implement and monitor the enforcement of this Circular within its jurisdictional area.

Monthly, the Food Safety Agency reports to the Department of Health and the Food Safety Agency on the issuance of Acceptance Receipts and Confirmation Certificates./.