상품DB/베트남 살충제용 화학물질 시장동향(2014.8)/살충제ㆍ살서제(쥐약)ㆍ살균제ㆍ제초제ㆍ발아억제제ㆍ식물성장조절제ㆍ소독제와 이와 유사한 물품[소매용 모

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제목	베트남 살충제용 화학물질 시장동향(2014.8)
게시일	2016-03-18	국가	베트남	작성자	김주선(호치민무역관)
품목	살충제ㆍ살서제(쥐약)ㆍ살균제ㆍ제초제ㆍ발아억제제ㆍ식물성장조절제ㆍ소독제와 이와 유사한 물품[소매용 모양이나 포장을 한 것ㆍ조제품으로 한 것ㆍ제품으로 한 것(예: 황으로 처리한 밴드ㆍ심지ㆍ양초ㆍ파리잡이 끈끈이)으로 한정한다]
품목코드	3808 그 외 2건
작성일자: 2014.8.18 작성자: 호치민 무역관 Mr. Hong Suk Kyoon(sukkhong@kotra.or.kr), Ms Nguyen Thi Phuong Thanh(kotra.sgn@gmail.com) 1. RELATED REGULATIONS □ List of chemical ingredients of pesticide and insecticide which are banned or allowed to register for use or import (under the Circular 25/2011/TT-BYT of the Ministry of Health)  ○ We provided the three tables which are issued by the Ministry of Health to regulate the number of chemicals and insecticide which are allowed to register for use, restricted to use and prohibited to use for households and medic purposes. The lists are issued together with the Circular 25/2011/TT-BYT dated June 23, 2011. Table 1. List of chemicals, insecticide which are banned from using in household and medics         Source: Circular 25/2011-TT-BYT Table 2. List of chemicals and insecticide products which are allowed to register but restricted from using in household and medics        Source: Circular 25/2011-TT-BYT Table 3. List of chemicals and insecticide products which are allowed to register for using in household and medics        Source: Circular 25/2011-TT-BYT □ Regulations regarding the management of insecticidal or germicidal chemicals and preparations of insecticidal household and medical use  ○ According to Circular 29/2011/TT-BYT dated June 30, 2011 of the Ministry of Health, insecticidal or germicidal chemicals and preparations of insecticidal household and medical use must be registered to circulate in local market. We’d like to quote some key information (Articles) regarding the registration of the products as follows:  ○ Article 4: Trade names of chemicals and preparations   - 1. Trade names of chemicals and preparations shall be given under the following regulations:    · a/ For each chemical or preparation of a single producer, only one trade name may be registered in Vietnam:    · b/ It is prohibited to use a single trade name for two or more chemicals or preparations of a single producer:    · c/ Trade names of chemicals or preparations must not be identical with those of chemicals or preparations with valid circulation registration numbers;    · d/ It is prohibited to use the names of active ingredients of chemicals or preparations as their trade names:    · e/ It is prohibited to give chemicals or preparations trade names with meanings irrelevant to their effects and safely.   - 2. Trade names may only be changed upon:    · a/ Exportation of home-made chemicals and preparations with valid circulation registration numbers; Dossiers of request for permission to change trade names and the dossier- appraising order comply with the law on certificates of free sale for imported and exported products and goods:    · b/ Issuance of written conclusions by a slate agency in charge of intellectual property or a court on trademark infringements involving chemicals or preparations with valid circulation registration numbers.  ○ Article 5: Circulation registrants   - 1. Units eligible to carry out circulation registration for chemicals and preparations include:    · a/ Vietnam-based organizations and individuals that are owners (producers) of chemicals or preparations. Owners who are not producers of chemicals or preparations must have documents proving their rights to own such chemicals or preparations:    · b/ Vietnam-based organizations and individuals that produce or trade in chemicals or preparations or Vietnam-based permanent representative offices of foreign enterprises which are authorized by chemical or preparation owners to carry out the registration;    · c/ Vietnam-based permanent representative offices of foreign chemical or preparation producers.   - 2. In case chemical or preparation owners permit the unit they authorize to carry out the registration of chemicals or preparations to further grant the authorization to another unit, they shall clearly indicate such permission in the authorization paper.   - 3. In case a chemical or preparation owner authorizes two or more units in Vietnam to carry out registration for a single chemical or preparation, the Ministry of Health (the Health Environment Management Agency) shall only accept and process the complete and valid dossier which is first submitted.  ○ Article 6: Forms of circulation registration   - 1. Official registration applies to:    · a/ Chemicals and preparations which are newly produced in the country;    · b/ Chemicals and preparations which have been permitted for use in foreign countries but are imported for the first time for use in Vietnam;    · c/ Chemicals and preparations which have been granted circulation registration numbers but see changes in the form of product, solvents, additives or contents of active ingredients;    · d/ Chemicals and preparations which have been granted circulation registration certificates but are not re-registered within the time limit specified in Clause 2, Article 9 of this Circular.   - 2. Additional registration applies to chemicals and preparations with valid circulation registration numbers which see:    · a/ Change in packaging specifications;    · b/ Change in the form or contents of specimen labels;    · c/ Change in the address of the producer or registrant:    · d/ Change in the right to own the circulation registration certificate;    · e/ Supplementation of a new production establishment to the officially registered one;    · f/ Domestic bottling or packaging in replacement of overseas bottling or packaging;    · g/ Change in effects, quality criteria or use methods.   - 3. Re-registration applies to chemicals and preparations which have been granted circulation registration certificates with circulation registration numbers to be about to expire under Clause 2, Article 9 of this Circular.  ○ Article 7: Dossiers of official circulation registration   - 1. A dossier of official registration for circulation of a home-made chemical or preparation comprises the following documents:    · a/ A written request for official circulation registration (made according to a set form - not printed herein):    · b/ The registrant's business registration certificate, investment certificate or establishment license, for registrants being representative offices:    · c/ The paper of authorization to carrying out circulation registration, for the case specified at Point b. Clause I. Article 5 of this Circular:    · d/ Results of testing of the composition and contents of active ingredients of the chemical or preparation:    · e/The assay result slip (supplemented under Point b. Clause 3. Article 12 of this Circular);    · f/ The producer's written environmental protection commitment or decision issued by a competent state agency approving the producer's environmental impact assessment report:    · g/ Technical documents of the chemical or preparation requested for registration (covering the details specified in Appendix 2 to this Circular, not primed herein):   - 1. The specimen label and its content registered for circulation in Vietnam.   - 2. A dossier of official registration for circulation of an imported chemical or preparation comprises the following documents:    · a/ A written request for official circulation registration (made according to a set form):    · b/ In addition to the papers specified at Points b. c. d. e. f. g and h. Clause 1 of this Article, a valid certificate of free sale granted by a competent authority of a country permitting the circulation of the chemical or preparation requested for registration is required.  ○ Article 10: Requirements on circulation registration dossiers   - 1. A dossier of official registration, additional registration or re-registration for circulation of a chemical or preparation shall be made in one set.   - 2. For foreign-language documents, their originals must be enclosed with Vietnamese versions. For documents in a foreign language other than English, their Vietnamese versions must be certified by a notary public or a translation service provider.   - 3. Documents included in a dossier must be legibly printed and arranged as required for each form of registration specified in Article 7, 8 or 9 of this Circular A dossier must ha\c covers, an index of documents, and color sheets separating different parts.   - 4. Papers in a circulation registration dossier which must be originals;    · a/ The paper of authorization to carry out circulation registration, for the case specified at Point b. Clause 1, Article 5 of this Circular;    · b/ The assay result slip:    · c/ Results of testing of ingredients and contents.   - 5. Papers in a circulation registration dossier which may be notarized or certified copies:    · a/ The registrant's business registration certificate, investment certificate or establishment license, for registrants being Vietnam-based representative offices;    · b/ The producer's written environmental protection commitment or the decision issued by a competent state agency approving the producer's environmental impact assessment report:    · c/ The certificate of tree sale specified in Clause 2, Article 7 of this Circular. This certificate must be consularly legalized, except cases exempt from consular legalization under law.   - 6. Other papers in a circulation registration dossier must be appended with the registrant's seal.  ○ Article 11: Receipt of circulation registration dossiers   - Registrants shall submit dossiers of registration for circulation of chemicals or preparations directly or by post to the Ministry of Health (the Health Environment Management Agency).  ○ Article 13: Circulation registration numbers and certificates   - 1. Each chemical or preparation may be granted only one circulation registration number.   - 2. The circulation registration number of a chemical or preparation shall be granted in the form of circulation registration certificate, which is valid for 5 (five) years from the date of issue. The circulation registration certificate shall be made according to a set form.  ○ Article 22: Principles of import and export of chemicals and preparations   - 1. The import and export of chemicals and preparations comply with the law on goods import and export.   - 2. In case importing countries require certification of free sale of chemicals or preparations in Vietnam, registrants shall comply with the law on certificates of free sale of imported and exported products and goods.   - 3. Chemicals and preparations with valid circulation registration certificates granted by the Ministry of Health (the Health Environments management agency) may he imported on demand in unlimited volume or value. Import procedures shall be carried out at customs offices without requiring the Ministry of Health's approval. Importers shall take responsibility before law for their operations.   - 4. Chemicals and preparations on the list of those eligible for on-demand import must still have at least 2/3 (two-thirds) of their shelf life, counting from the date of arrival in Vietnam.   - 5. When granting circulation registration numbers for chemicals or preparations produced at home from imported raw materials that have no circulation registration numbers in Vietnam, the Ministry of Health (the Health Environment Management Agency) shall issue a document attesting that such raw materials are permitted for import. This document is as valid as a circulation registration number granted to chemicals or preparations.  ○ Article 23: Import licenses   - 1. Chemicals and preparations requiring import licenses:    · a/ Chemicals and preparations without circulation registration numbers for which assay permits have been granted by the Ministry of Health (the Health Environment Management Agency) and which are imported for assay or testing;    · b/ Chemicals and preparations without circulation registration numbers which are imported for research, donation or other particular purposes (which are gifts or presents or in case similar products or methods are unavailable in the market).   - 2. Dossiers and procedures of application for import licenses for chemicals and preparations without circulation registration numbers to be imported for assay or testing:    · a/ An application for a license to import chemicals or preparations (made according to a set form):    · b/ Within 5 (five) working days after receiving the application, the Ministry of Health (the Health Environment Management Agency) shall issue a document indicating its acceptance or rejection of the import of chemicals or preparations for assay or testing and clearly state the reason.   - 3. Dossiers and procedures of application for import licenses for chemicals and preparations without circulation registration numbers to be imported for research, donation or other particular purposes:    · a/ A dossier of application for a license to import chemicals or preparations:          An application for an import license (made according to a set form):           - A notarized copy of the business registration certificate or other papers proving the legal entity status of the import license applicant, which must be appended with the applicant's seal;           - Technical documents of chemicals or preparations;           - The research outline (for chemicals and preparations imported for research) or written explanations about the use purposes of chemicals or preparations (for those imported for particular purposes);           - A GMP or ISO certificate of the manufacturer and circulation permits of the chemicals or preparations granted by the country of origin or circulation permits granted by other countries in which the chemicals or preparations have been registered and sold, in case of importing chemicals or preparations for donation or other particular purposes in a total weight of 50 (fifty) kilograms upon each importation;           - The assay result slip, for the case specified in Clause 4. Article 19 of this Circular (supplemented to the dossier after the import license applicant receives it from the assaying unit);    · b/ Within 15 (fifteen) working days after receiving a valid and complete dossier, the Ministry of Health (the Health Environment Management Agency) shall issue a reply stating its acceptance or rejection of the import. In case of rejection, the reason must be clearly stated;    · c/ For the cases specified in Clause 4, Article 19 of this Circular:          - Within 5 (five) working days, the Ministry of Health (the Health Environment management agency) shall issue a written request for assay; Within 10 working days after receiving the assay result notice from the import license applicant, the Ministry of Health (the Health Environment management agency) shall issue a document stating its acceptance or rejection of the import. In case of rejection, it shall clearly state the reasons. □ Regulations concerning cosmetic products proclamation (under the Circular 06/2011/TT-BYT regulating the management of cosmetic products manufactured in the country as well as cosmetics imported for circulation in Vietnam)  ○ As cosmetics directly affect human health, their circulation and import are controlled by the Drug Administration of Vietnam (DAV) under the Ministry of Health. In January 25, 2001, the Ministry of Health issued circular 06/2011/TT-BYT regulating the management of cosmetic products manufactured in the country as well as cosmetics imported for circulation in Vietnam.  ○ This regulation stipulates that the promulgation number, or the number issued by the competent authority to certify receipt of a quality notification dossier, simply confirm‎s that the safety of a cosmetic product has been reviewed by the distributing enterprise, not by the medical agency. The distributing enterprise thereby takes full responsibility for the safety, effectiveness and quality of the distributed products.  ○ In order to import the cosmetics and put the products into market circulation, the local company (importer) must get “Proclamation Number” issued by the DAV, Ministry of Health.   1) The cosmetic product proclamation (announcing/notification) regulation   - Organizations which are responsible of putting the cosmetic product on the market just permitted selling cosmetic when being issued the number of cosmetic product proclamation (notification) receiving by the authority agencies as well as responsible for safety, effectiveness, and quality of product. The authority agencies shall carry out after-sales inspection when the product has been being sold in the market.   - Organizations that are responsible for putting the products on the market must have the function of cosmetic business in Vietnam.   - Cosmetic product feature proclamation (the cosmetic usage purpose) must satisfy the ASEAN’s instruction of the cosmetic product feature proclamation. 2) The cosmetic proclamation dossier (document):   - Cosmetic product proclamation report (02 versions) with the proclamation (notification/ announcing) data (soft version of proclamation report);   - Copy of business registration certificate of organizations that are responsible for circulation products into the market (with the enterprise’s signature and seal);   - Original or notarized copy of letter of attorney from the producers or the owners of products authorized for organizations are responsible of putting products on the market in Vietnam (applied to the import or domestic cosmetic of which organizations are responsible of putting products on the market, not the manufacturer). For the import product, the letter of attorney must be a copy notarized sign and consul legalized as provisions of law. The letter of attorney must satisfy requirements as follows:    · The presenting language must be Vietnamese or English or bilingual Vietnamese and English.    · The authorization certificate must have sufficient the following contents:       a/ The producer’s name and address; in case the delegating party is the owner of product, must clearly state name and address of the owner of product, and name and address of the producer as well;       b/ The name and address of authorized organizations, individuals;       c/ The scope of authorization (undersigned on the proclamation and circulation product in Vietnam);       d/ The label or name of authorized product;       e/ The time-limit of authorization;       f/ The commitment of the producer or the owner of product to provide sufficient product information file (PIF) for organizations or individuals who are responsible for putting product on market;       g/ Name, position, and the signature of the delegating party’s representative.    · Certificate of free sale (CFS) is only applied for import cosmetic product proclamation, which satisfies the following requirements:       a/ CFS which is issued by the current territory must have been original or legally notarized and still in the day of validity. In case CFS is not provided of the expiry day, it must be a certificate, which has just been issued within 24 months.       b/ CFS must be consul legalized according to provisions of the law, except consul legalization immunity case according to the international treaties in which Vietnam is a member. 3) Provisions of the authorization certificate:   - The presenting language must be Vietnamese or English or bilingual Vietnamese and English.   - The authorization certificate must have sufficient the following contents:    · The producer’s name and address; in case the delegating party is the owner of product, must clearly state name and address of the owner of product, and name and address of the producer as well;    · The name and address of authorized organizations, individuals;    · The scope of authorization (undersigned on the proclamation and circulation product in Vietnam);    · The label or name of authorized product;    · The time-limit of authorization;    · The commitment of the producer or the owner of product to provide sufficient product information file (PIF) for organizations or individuals who are responsible for putting product on market;    · Name, position, and the signature of the delegating party’s representative. 4) The effect time of the receipt number of cosmetic product proclamation report:   - The receipt number of cosmetic product proclamation report shall be valid for 05 years since issuing day. After 05-year-expiry, if organizations or individuals want to continue selling product in the market, they must make a proclamation again before the expiry of the receipt number of cosmetic product proclamation report and pay a regulated cost fee. □ Insecticide HS Code  ○ So far, we only found the exact HS code for insecticides, rodenticides, fungicides, anti-sprouting products as below. We have not found any specific information regarding HS Code for particular chemical ingredients (Fipronil, Coumatetralyl, Bromadiolone, Brodifacoum, Difethialone, Chlophacione etc.). So we provided the HS Code together with the current impor tax rates imposed on insecticide related products as follows:         Note: MFN: Most favorable nations (applied also for imported goods from Korea)                   AKFTA: Asean – Korea Free Trade Area (applied for imported goods from Korea)                   ACFTA: Asean – China Free Trade Area (Applied for imported goods from China)                   ATIGA: Asean Trade In Goods Agreement (applied for Asean-member nations)          Sources: Circular No. 217/2009/TT-BTC dated November 17, 2009; Vietnam General Export, Import Tax form according to the Decision 216/2009/QD-BTC dated November 12, 2009 of the MOF; Circular 131/2008/TT-BTC of the MOF dated December 26, 2008 on introducing the implementation of value added tax (VAT) according to goods catalog of preferential import tariff.