The reasons: This procedure has created a big barrier to the business production and has not helped to improve the food safety:
The procedure for issuing a certificate of declaration of conformity has processes and procedures as a sub-license that have made many many difficulties for the business.
+ Costly Time: Decree 38 has stipulated that the response time is 15 working days with normal food; and 30 working days (= 1.5 months) with food supplement micronutrients since filing full dossiers, but in fact after the deadline, and often receive written requests for additional information for many times, each time taking more time for review and be recalculated from the beginning. It may take up to 3-5 months for a license to take over, lost many business opportunities of the business.
+ Be complicated, it is very difficult for the business for self-implementation if not hire through private services: Because there is no clear criteria for review, the investigators arbitrarily inspected businesses to add all kinds of papers that not included in the regulations and adjust the standards from the personal point of view that have made the business does not know the direction to go if not hire private services, except for some large businesses and foreign businesses which have specialized staff for registration.
- How many raw materials, auxiliary materials and packing in each domestic product, businesses have to take those numbers of declared licenses, may be up to dozens of sub licenses.
- Not only taking time for a registration of the circulation, every 3-5 years, businesses have to submit the confirmation of re-declaration, including products have nothing to change and always get good quality.
- This procedure has not got any significant benefits in improving food safety (as in the Confirmation Statement, the licensing agency claims no responsibility for product quality: businesses must be fully responsible for their product quality). For the foodstuffs, businesses have applied advanced quality control measures such as HACCP, GMP, ISO (quality control throughout the process) and imported food (because of the quality control of the state when imported), this procedure was almost completely meaningless.
2.1. To simplify procedures for consideration of issuance of technical regulation certificates in accordance with the Law on Quality and Control & Technical Regulation:
- This is the nature of the notification procedure rather than the registration procedure as the implementation of the past time. (At present, the state agencies which are responsible for decalcification of technical regulation of other sectors. The Ministry of Science and Technology, the Ministry of Construction, ETC... are implementing this form, and do it very simple, fast, not complicated and difficult as Ministry of Health.
- Dossiers must comply with the provisions of the Qqualification & Control & Technical Regulation on items and forms, which must be abolished.
- The recommendation: The time for issuance of notices of declaration is 3 working days.
2.2. To specify: "In case of refusal, it must reply in writing, clearly stating the reasons and the legal basis of that reason" to avoid harassment of officials to businesses when making additional requirements that be unreasonable.
- Specifed measures to deal with officials who deliberately make outlaws (because they are strictly prohibited by Decree 63/2010 / ND-CP).
- The number of additional requests is 1, so that businesses only have to add one time.
2.3. To simplify procedures for import / registration of raw materials, additives, food processing auxiliaries, imported packaging for internal production of businesses, not be sold to the market as follows:
It is not required to announce regulation conformity / technical regulation certification of raw materials, additives, food processing aids, imported packing for internal production of businesses that not be sold on the market. The application for import license only needs:
• Names of raw materials with international code (if any).
• Names and address of the suppliers
• Raw Material Standards (Manufacturers)
• Commitments of businesses are only used internally in production establishments, be responsible for quality and meet the regulations on food safety.
The Reasons: In the practice of production and business, businesses often have to make small changes to the product without affecting the quality such as due dates, packaging materials, or change importers or traders who are responsible for their products (with consents of production units) ... but it must still be re-declared, it is very losing time and costly, causes a huge obstacle for production and business activities and does not help for improvement of the food safety.
- Circular 19/2012-TT / BYT (hereinafter referred to as Circular 19) has allowed minor changes to be allowed to apply, but there are still small changes that have not yet been permitted.
- Clause 5a, Article 8 of the amended draft Decree 38 only allows for changing packing specifications, not for other small changes.
4. The recommendation: To cancel the request to submit samples for periodic testing, and revise as follows:
- Entities shall have to ensure that products, goods, services, processes and environment that comply with the announced technical regulations and standards, and draw up appropriate quality control plans.
- Imported products that have been tested by the manufacturer and the government in Vietnam for imported consignments are allowed to use these results in the quality control plan.
The reasons:
- Regarding Vietnam's legal provisions: This requirement is contrary to the Law on Quality and Control & Technical Regulation. To define the responsibility of examining and inspecting activities in the field of technical regulation; The law enforcement agencies are responsible for handling violations in accordance with the law. Entities shall have to ensure that products, goods, services, processes and environment comply with the declared technical regulations and standards. Entities are not responsible for sending samples for testing, which must belong to state management agencies
- Regarding international practices: This requirement is contrary to international practice because no country requires businesses to send their samples periodically, but it only requires businesses to build their own quality control system. Apply advanced quality management system (GMP, HACCP, ISO 22000).
The Reasons: An unreasonable provision of Decree 38 is food intermediary trade but does not carry out any activities related to the production, preservation, transport or display of foodstuffs. Although not having production and / or business locations, they are not directly engaged in any activities related to food production and trading but must still apply for certificates for eligibility in the food safety.
- Inspection of each batch of imported goods: According to the current regulations, each shipment of imported goods must be inspected, in which, for animal products or containing animal products, two types of inspection are quarantine veterinary (Ministry of Agriculture and Rural Development) and food safety control. This regulation is too complicated, unnecessarily expensive for businesses. While the Law on Food safety and hygiene has not amended, based on the requirements of Resolution 19 on the application of risk management, preferential business regime in the management and inspection of imported goods, it is proposed to add Clause 2 (the following cases shall be exempt from the state inspection of the food safety for imported food.) Article 14 of Decree No. 38 has contents as follows:)
- Clarify Clause 3, Article 14 of Decree No. 38: Imported goods shipments must be inspected only once by a single managing ministry. If there is one product in the whole shipment that is fresh, the whole shipment only bear inspection of the State by the Ministry of Agricultural And Rural Development
- To specify the granting certification of reduction inspection: Within 3 days, the management agency shall have to certify, if not, the reasons and the legal basses of such reason must be clearly stated. If the agency does not reply within 3 days, the customs office shall approve the businesses to be exempt from the inspection.
The reason: According to Decree 38, each batch of food when import must be checked quality. For animal products or animal products are subject to additional quarantine (Ministry of Agriculture and Rural Development under Circular No. 25/2016 / TT-BNNPTNT dated 30 June 2016), unnecessarily expensive although Clause 3, Article 14 of Decree 38 has stipulated that the products are under the jurisdiction of two or more ministries, the Ministry of Health inspects the quality. In particular, if there is fresh food, the Ministry of Agriculture and Rural Development is responsible for checking quality.
- Circular 52/2015 has stipulated the inspection reduced only 2 consecutive batches of quality and will answer after 3 days, but the actual procedure for businesses to check the reduction is not easy, sometimes, it takes months to be confirmed.
8. The recommendation: Add to Article 15 of the regulations on inspection regime at source with the following contents: "Applying the inspection regime at the source, at the root (checking the stages of farming and processing in production countries and import countries). This mode is applicable to businesses that need and pay for inspection.
