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The Decision 42/2005/qd-Byt: Issuance Of "regulation About Standard Announced Food Products"

Original Language Title: Quyết định 42/2005/QĐ-BYT: Về việc ban hành "Quy chế về công bố tiêu chuẩn sản phẩm thực phẩm"

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The DECISION of the MINISTER of Health On issuing "regulation about the announced product standard food" health MINISTER pursuant to Decree No. 49/2003/ND-CP dated 15 May 2003, the Government's regulations on functions, powers and organization of the Ministry of health;
The French base food safety order No. 12/2003/PL-UBTVQH11 on July 26, 2003 and Decree No. 163/2004/ND-CP on September 7, 2004 detailing the Government's implementation of some articles of the Ordinance on food hygiene and safety;
The base quality of goods Ordinance No. 18/1999/PL-UBTVQH10 on December 24, 1999 and Decree No. 179/2004/ND-CP on October 21, 2004 of the Government to manage state on the quality of products, goods;
Proposal of the Director of food safety and hygiene-Health Ministry decision: article 1. Attached to this decision "regulation about the announced food product standard".
Article 2. This decision takes effect 15 days from the date The quote and replace decision No 2318/2001/QD-BYT on 30/5/2001 of the Minister of Health issued a temporary regulation on disclosure quality standard of hygiene and food safety.
Article 3. He (she) Chief, Chief Inspector, Director of Legal Affairs, Ministry of health, Director of Department of safety sinhthực, Director of the provincial health department, central cities, the heads of the relevant unit directly under the Ministry of health, heads of the departments responsible for the implementation of this decision.
 
REGULATION About standard announced food products (attached to decision No 42/2005/QD-BYT on 08/12/2005 of the Minister of health) chapter I GENERAL PROVISIONS article 1. The scope and subjects of application 1. Adjustable range: a) this regulation rules on the profile, the procedure of disclosure, extension announced product standard; examine, inspect; charging mode and the report on the publication of the standard product.
b) to food products announced include:-the product is food, food additive, food processing support, cigarettes, food ingredients are produced locally and imported to the business, consumed in Vietnam.
-Products related to food safety (packing containers in direct contact with food, the main raw material to produce these products) and the product is only intended for export are also encouraged to publicize the product standard as specified in this text.
-Products manufactured in the country, has the purpose of export, announced the product standard in competent State agencies at the request of the importing country.
c) quality products is not stable, packaging products simple to use and the products manufactured according to the weather service, according to the order for short term use under 10 days in normal environmental conditions, are not required to publish standard products according to this regulation.
2. Objects: these rules apply to organizations, individual manufacturing, food business registration business in Vietnam and representatives of foreign companies have put on food products sold on the markets of Vietnam (known collectively as the traders).
Article 2. Explanation of terms In this regulation, a number of terms below are interpreted as follows: 1. The product quality is overall the attributes (these specifications, the specificity) of them, as determined by the parameters can be measured, comparable, consistent with the existing technical conditions , demonstrate the ability to meet the needs of society and of individuals in consumer production conditions determined in accordance with the uses of the product.
2. product quality standards are technical texts regulating the characteristics, technical requirements for the product, test method the characteristics, the technical requirements of the product, the packaging requirements, labeling, transportation, storage of products, the requirements for the quality management system and other issues related to the quality of the product.
3. the overall food quality attributes of a food product can be determined and necessary for the control of the State, including: the sensory criteria quality criteria, primarily, the quality score only standards, standards of hygiene, management, micro-organisms; ingredients and food additives; the duration of use; instructions for use and maintenance; specification packaging and packaging material; labeling content.
4. Hygiene standards are limits or rules allow a maximum of the elements of chemistry, physics and micro-organisms are allowed to have in the product to ensure stable product quality and safety for the user.
5. is the base standard technical requirements for the quality of food products (have the same product name, brand, quality standards, standards) due to traders to build, publish and responsible before the law and consumers. Base standards are usually not Vietnam standards and lower than industry standards.
6. Quality targets mostly quantitative or decide the nutritional value and particular nature of the product to identify, classify and distinguish food products of the same type.
7. quality score only standards are the specifications which can determine the stability of product quality or waste content texture of the product.
8. Certificate of publication the product standard (product standard certificate) is a certificate of competent State agencies give traders have made the announcement of the standard of quality, hygiene, food safety in accordance with the mandatory rules of the law applicable Vietnam. This certificate has a value of three (3) years from the date signed and stamped by the competent health authority level 9. The certification number is recorded on the certificate of publication the product standard of competent State agencies give traders have made the announcement of the standard of quality, hygiene, food safety is valid to be allowed circulation of products on the market, but does not have the certification value each shipment are guaranteed quality as has announced that it is the responsibility of the the trader responsible for the quality of the goods.
10. Special food is a common term on the product group has special properties or for the consumer audience, had using special or have special uses for health. Special food may be the new technology and products in the regulations include the following: a) nutritional products for young children.
b) food nutrition through tubes Emit.
c) genetically modified foods. d) food irradiation.
functional food).
11. Food functions, depending on the use, quality and content of vi manual, also known as the following: a) nutritional supplements (food supplement) is the food was processed from the raw materials active high (nutritional supplements) and/or additional micronutrients (food micronutrient enhancement) with promotional rates use suitable ages, the object used as a rule.
b) food enhance the micro-nutrients are the normal food have enhanced micro-nutrients.
c) medical nutrition food is a special foods through clinical trials, proved to be used as manufacturers have announced and are competent authorities allow circulation, at the same time indicated and usage with the help of physician supervision.

d) health protection food is a common Chinese term, meaning the equivalent of as functional food.
Chapter II PROCEDURES, RECORDS ANNOUNCED the PRODUCT STANDARD of article 3. Announcement 1. For food production and material in direct contact with the food product (packaging containing), records established 2 sets, each set contains: a) A published product standards (according to form 1 attached to this Regulation);
b) A standard basis due to traders issued (stamped), including the content: the sensory criteria (color, taste, status), quality criteria, quality score, only the standard norms of hygiene on the physicochemical, microorganisms, heavy metals; ingredients and food additives; the duration of use; instructions for use and maintenance; packaging material and packaging specification (form 2 attached to this Regulation); production process.
c) business registration certificate of license or Vietnam traders established a representative office of a foreign production company (notarized).
d) Vote results tested include quality criteria, primarily targets the quality score only and sanitary norms of food announced by laboratory accredited or State administration authority. Private natural mineral water must get more votes for the test results of the water source.
DD) samples are labeled and label or draft content matching product labeling laws on the label (stamped by traders).
e) form the basis of certification of eligibility, hygiene and food safety at the State Agency has the authority or certificate has been issued (copies).
g) a copy of the certificate of ownership of a trademark (if available).
h) copies of receipts and records evaluation fees submission fees levels of certification bodies for the certification authority.
I) particularly for food irradiation, genetically modified food, new technology product or part contains material derived genetically modified, irradiated in the published records must have a copy of the certificate of biosafety, radiation safety and production process.
2. With regard to food imports: 2.1. For food imports is not special foods stated at paragraph 10, article 2, the record established 2 sets, each set contains: a) As point a, b paragraph 1 of this Article.
b) business registration certificate of license or Vietnam traders established a representative office of a foreign production company (notarized).
c) standard products (Products Specification) of the manufacturer or test results Votes (about quality criteria, quality score and only targets the relevant hygiene norms) of the manufacturer or of the independent auditing Agency of the country of origin.
d) product label or product label shots and draft content label (stamped by traders); The form labeled (if requested to verify).
certified copies) or in the country of one of the following certificates (if any): certificate of GMP (good manufacturing practice); HACCP (hazard analysis and systems control the tipping point); or an equivalent certificate.
e) copies of receipts and records evaluation fees submission fees levels of certification bodies for the certification authority.
g) copy of the commercial contract (if any).
h) particularly for food irradiation, genetically modified foods or ingredients that contain raw materials derived genetically modified, irradiated in the published records must have a copy of the certificate of the country of export for use with the same purpose on the territory of that country and the manufacturing process.
2.2. food additives, substances that support the processing, records are: a) as defined in paragraph 1 of this Article;
b) free circulation certificate (Certificate of Free Sale) or health certificate (Health Certificate) of the competent State authorities of the country of origin with regard to food additives, substances that support processing.
2.3. for the special food referred to in Article 10, paragraph 2, the record established 2 sets, each set contains: a) as defined in point 2.1, paragraph 2 of this Article;
b) specific requirements for special foods: food is nutritional products for babies: the free circulation of certificates (Certificate of Free Sale) or health certificate (Health Certificate) of the competent State authorities of the country of origin, including product certification content consistent with age or use objects.
-Nutritional food medicine: more clinical research results about that function.
-Nutritional food through pipes, stormed: more clinical research results on the safety in use of the feed through the tube, and efficient bath for the specified object health.
-Functional food: more clinical research results or documentation about the effect and safety of food.
2.4. for food additive use restrictions: a) list food additives allowed use of Vietnam but are allowed to use in the country of origin or in the Codex, the Ministry of health (food safety Bureau) will look in specific cases to allow announced product standard or gets field trips as for total sweetener stated in detail b, point 2.4, paragraph 2 of this Article.
b) for synthetic sweeteners:-If in the form of already mixed, small packaging to use once: traders announced as standard for food additives permitted for use in Vietnam.
-If in the form of packaging to use many times: the trader gets each batch under the mandated import food manufacturer's diet (used for sick people, the obese, don't want FAT) or when the contract with the producer food diet. Imports next, traders must have the invoices or vouchers prove only sells to manufacturers of food diet and other purposes.
7. With respect to the material in direct contact with the food product (packaging containing), imported food additives, only to serve the internal production business and the products to enter business in the hotel, supermarket, business announced by category referred to in Model 7 attached to this regulation.
8. All the records under the provisions of this Article in a foreign language must be translated into Vietnamese, so the trader responsible or is legal translation, if the competent health authority requirements.
Article 4. The procedure of publication 1. Traders standard announced by "A published standard product" according to form 1 accompanied by a standard basis under model 2 attached to this regulation.
2. trade business of bottled natural mineral water, cigarettes, food specials and the trader importing food, raw materials, food additives, materials in contact with food procedures published in the Ministry of health standards (the Bureau of food safety and hygiene). Common products manufactured in the country with the aim of exporting can announce at the Ministry of health (food safety Bureau) if the importing country requires.
3. The traders produce, food business not stated in clause 2 of this standard disclosure filing at the Department of health, the city where the closed production facility on the area or agency is the Department of health authorized.
4. The competent State agencies specified in paragraph 2 and 3 of this Article or the authorized agencies, receiving records, check the computer in accordance with the regulations of the State, within 15 working days of receipt of a valid application, the Agency has the responsibility :

a) certification product standard (form 3a, 3b issued together with this Regulation) or the granting of the extension of the product standard certification (form 4a, 4b attached to this Regulation) if the content of the dossier published in accordance with the current rules of quality, hygiene food safety, the Ministry of health and sent back for traders 1 (there are stamped by the authorities).
b) notice and instructions written for traders to complete the profile if the content of the base standard or product labels not yet consistent with the current rules of the quality, hygiene, food safety.
Article 5. Regulation writing of certified standard publication 1. For the product by the Ministry of health, the following records: rules of the order are granted + slash + in + slash + YT. For example: 234/2003/YT.
2. for products by local health level: same as above only in abbreviations YT (capital) plus the first letter of the name. For example: 123/2004/YTHN means "health Hanoi". The case of the names of the same duplicate duplicate only a word: the first letters of other words, but then add that Word to the adjacent in handwriting.
For example, Vietnam-QNa; Quảng Ngãi-QNg; Quảng Ninh-QNi; Hanoi-HN; Henan-HNa; The symbol name of the city in the form of 5 attached to this regulation.
Article 6. The merchant's responsibility 1. Announced product standards in the competent State agencies are the Ministry of health hierarchy prescribed in article 4 of this regulation; ensure standards apply to meet the mandatory provisions applicable to the product and is responsible for the accuracy, truthfulness of the content was published.
2. Product name of publication must show true nature and causes no myths about the quality for the same products on the market.
3. Ensure full implementation of the requirements of production conditions in accordance with the law and adequate technological equipment with quality has announced.
4. Quality assurance, content labelling and advertising information content of the product in circulation as the content was published.
5. Ensure healthy competition under the provisions of the law.
6. Proactively implemented or proposed periodic test in accordance with the provisions of article 9 of this regulation.
7. Must file charges, testing facility test products periodically to check directly authorized or authorized check and not file charges check, testing in case of unscheduled inspections not notified testing in accordance with the law or not been paid test results.
Chapter III RENEWAL PROCEDURES, RECORDS ANNOUNCED the PRODUCT STANDARD article 7. Profile traders renewed the certification after 3 years from the date signed certification number issued or renewed. Application for renewal, including: a) dispatch please renew product standard certificate (Form 6 attached to this Regulation) with the certificate of the product standard and standard base before (original or certified copy).
b) periodic examination results Slip for domestic products and imported specialty foods (by the free traders send or check the Agency sampled at production facilities, distribution send test agency recognized or specified by Vietnam levels) or the notice of shipment of imported quality for normal food imports of organic concerns about State inspections of food imports.
c) 1 product samples labeled (with extra label for food imports).
d) a copy of the certificate of food facility sanitation qualified (for products manufactured in the country) by the competent State bodies.
DD) copies of receipts and records evaluation fees submission fees levels of certification for State agency certification authority.
-For the food products were granted the vote to receive the profile published standard of quality, food safety and hygiene according to decision No 2318/2001/QD-BYT on 30 May 2001 of the Minister of health, effective 3 years from the date of signing, after the time limit on, traders are made declared back under the provisions of this regulation.
-The case of changing the content was announced, traders have the responsibility to publish again, except only change the form of the label or the packaging specifications filed supplement labels has changed with the writer please add or replace the label are in circulation.
Article 8. Procedure for renewal of trader announced standards where, then please renew announced there.
Chapter IV inspection, inspection CHARGES MODE and Report 9. The regime periodically check the State administration authorities are responsible for the Organization of periodic testing and urging periodic testing of the quality of the product. One of the votes in the results of periodic testing must be done for the product near expired or even just to prove the expiration term of use published is true. Periodic examination modes as follows: a) 1 times/17 years for base products are GMP, GHP certification, HACCP system or equivalent.
b) 1 times/year for products of laboratory facilities, monitoring the quality of the food at the base.
c) 2 times/year for the base's products do not have laboratory monitoring of food quality.
d) 4 times/year for household products business in the family.
DD) 1 times/year and the confirmation of the State Agency for the quality of the imported shipments for common products imported.
e) 1 times/year and the confirmation of the State Agency for the quality of food shipments imported special.
Article 10. Sampling method periodically check The quality control for the food processing industry lines are made for model represented as final products or sell products in the same product group have in common quality criteria mainly, mainly raw material components. The manual processing products are made for testing the final product.
Article 11. Decentralized checks periodically to check periodically in order to sample the product for testing can proceed at the base or by the free traders sent the samples to the testing room but incurred entirely representative of the free samples retrieved as follows: 1. for the production of food products in the country because of the Ministry of health (food safety Bureau) level of management certified health centre, the province is responsible for periodic inspection in the closed production on the order form for the product that need maintenance or sealed samples to traders is responsible for sending it tested.
2. The Department of health assigned test hierarchy, the production base in the country to close on the area for the health unit of the province and the district. The health center is responsible for testing, if exceeding the ability of the sample must be sent to the Institution or the regional function test to test.
Article 12. Check out unscheduled inspections, the State Agency has the authority to conduct unscheduled inspections, checking the base when detected signs of violation, or has a complaint, accusations about violating the rules of the quality, hygiene, food safety according to the direction of the authority.
Article 13. Charging mode and report the competent State organs prescribed in article 4 established the shared track announced product standards and coordinating with market regulators to coordinate management of the same level of quality control of the products circulating on the market.

1. The organization collecting the fees examined, tested and certified product standards announced by the current regulations of the Ministry of finance. Do not charge a fee in the case of welfare, sudden inspection or testing products are circulating on the market.
2. Issued an authoritative text for the competent authorities to check on food hygiene for the basis and periodic testing of the quality, hygiene products, and inform the basis for this credential. Case of violation, the Agency must establish a check and send the competent authority process.
3. Six months/times, the Health Department of the province, central cities are responsible for general situation reports, quality control and food hygiene in the sending of the Ministry of health (food safety Bureau) to track and aggregate./.