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Small lecture hall for health food registration filing application (9) plant extracts

Posted on February 7, 2021 by admin

Small lecture hall for health food registration application (9) Plant extracts

TianjianhuachengProducts that use plant extracts and Chinese herbal medicine extracts in health foods Everywhere. Compared with the direct use of plants and medicinal materials as raw materials, after extraction, the content of active ingredients can be increased, the ineffective ingredients can be reduced, and the effect can be improved. Therefore, it is favored by consumers and manufacturers. But because some extraction methods may involve food safety issues, it is even more necessary to strengthen approval and supervision. When registering health food approval documents, the state has special requirements for extracts. Next, a classmate from the Health Food Registration Department of Beijing Tianjian Huacheng International Investment Consulting Co., Ltd. (www.zhuceabc.cn) will tell you:1. General information about plant extracts Requirements1. Formulation, safety and functional requirementsThe production process, material basis, edible method and consumption of raw material extracts should be compatible with safety, health function and quality. The scientific basis of control is consistent. The extract is produced by refining, purifying, hydrolyzing and other processes. Compared with the extract produced by the traditional process, its chemical composition, content and other internal quality have significantly changed, it should be provided according to the requirements of the new raw material Safety assessment materials. 2. Technical requirements(1) Extract quality requirements should select characteristic components related to the product declaration function as the landmark component indicators. (2) Reference should be made to relevant standards such as the Chinese Pharmacopoeia, combined with the specific conditions of the raw material extract production process, etc., to formulate indicators that can accurately quantify and fully reflect the quality characteristics of the extract, and specify the selection of indicators and The basis for determining the index value. (3) The qualit Phenibut Suppliers y requirements for extracts should include the source of raw materials (if there are clear requirements for animal and plant species, the specific species should be clarified, and if necessary, the Latin scientific name of the original plant should be stated), preparation method (including main production Process, key process parameters, etc.), extraction rate (yield), sensory requirements, general quality control indicators (such as moisture, ash, particle size, etc.), pollutant indicators (lead, total arsenic, total mercury, extraction solvent residues, etc.), Pesticide residues, indicator component indicators (specific qualitative identification indicators should be developed if it is difficult to quantitatively determine), microbiological indicators (including total number of colonies, coliforms, molds and yeasts, Staphylococcus aureus, Salmonella), etc. If there are missing items that are difficult to formulate or do not need to be formulated, the reason should be reasonable. (4) The efficacy or iconic component index required by the product technology should include at least one characteristic component index of the extract (if it is difficult to determine quantitatively, a specific qualitative identification index should be established). If it cannot be formulated, the reasons why it cannot be formulated shall be explained in detail. (5) A self-inspection report should be provided for all items of extract quality requirements. 2. Requirements for special extraction methodsFrom the reporting point of view, generally speaking, the relative recognition of traditional water extraction and alcohol extraction processes is relatively high. The extraction process uses organic solvents or other special reagents or equipment in the process review will be more cautious. Therefore, from the perspective of declaration, it is generally not recommended that you use extracts prepared by special extraction methods as raw materials. For example, for separation and extraction by macroporous resin extract Phenibut Suppliers ion, there will be the following requirements when applying. You can feel it: 1. Related information about macroporous resin( 1) Specifications and standards of macroporous adsorption resin. The standard content should include the name, brand (type) number, structure, synthetic raw materials (names and specifications of main raw materials, crosslinking agents, porogens, dispersants, etc.), appearance, polarity and particle size range of the macroporous resin Water volume, wet density, dry density, specific surface area, pore size, porosity, pore volume, etc., and provide standard grades of macroporous adsorption resin. (2) Instructions for use of macroporous adsorption resin. The contents of the instruction manual should include:a. Introduction to the performance of the macroporous adsorption resin, scope of application, types and names of main raw materials and additives;b. Residues (including unpolymerized monomers) Body, crosslinking agent, main additives) and its residual amount detection method and limit standard and basis; c. Use methods and precautions, including the pretreatment method and regeneration treatment method of the new macroporous resin And operation precautions, storage conditions, etc., as well as treatment methods that may occur abnormalities. (3) Production batch number, production time, product inspection report. (4) Relevant supporting documents. Copies of the company name, address, telephone number, business license and relevant production licenses of the macroporous resin production enterprise. 2. Research materials on the preparation process of using macroporous adsorption resin for separation and purification(1) Purpose and basis of using macroporous adsorption resin for separation and purification in the preparation process. Explain in detail the purpose and necessity of using macroporous adsorption resin for separation and purification, and provide relevant research or literature. (2) Pretreatment method and qualification standard of macroporous adsorption resin Phenibut powder wholesale . Pretreatment methods include investigating process parameters and operating procedures such as the type, amount, soaking time, flow rate, temperature, and pH value of the pretreatment solvent. (3) Research materials on production technology. Selection of macroporous adsorption resin model, specific column volume, specific adsorption capacity, specific elution volume, diameter-to-height ratio of the resin column, suitable column temperature, pH and flow rate of the extraction solution, selection of desorption solvent and its conditions , Desorption end point determination method and other research data, and use the above data as part of the production process of the product. (4) Determination of the regeneration method of macroporous adsorption resin. After the macroporous adsorption resin is used, the adsorption capacity will decrease, so it should be regenerated. According to the functional components and the physical and chemical properties of the macroporous adsorption resin, the macroporous adsorption resin regeneration treatment method and its qualification standards shall be formulated. The applicant shall formulate the corresponding standards and operating procedures and include them in the appendix of the enterprise standard. 3. For health foods produced with raw materials manufactured by the separation and purification process of macroporous resins, the application should also provide detailed information of the raw material manufacturer, raw material preparation process and detailed quality standards, including raw materials Standard and test report of medium and large pore adsorption resin residues. The applicant shall provide the inspection report of the raw material macroporous adsorption resin residue issued by the inspection agency determined by the State Food and Drug Administration. 4. Safety evaluation data such as macroporous adsorption resin and its purification process5. In principle, the macroporous adsorption resin purification process should not be mixed with multiple animal and plant materials Production of health food. 6. When necessary, the state may conduct on-site inspections on macroporous adsorption resin manufacturers and companies that use macroporous adsorption resin to produce raw materials for health food.

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