Interpretation of the Announcement on 23 New Varieties of Food-Related Products, Including Poly(12-Hydroxystearic Acid) Stearate

I. Poly(12-hydroxystearic acid) stearate (i) Background. Poly(12-hydroxystearic acid) stearate is produced by polymerization of 12-hydroxystearic acid and stearic acid, and is a solid at room temperature with a melting point of about 50°C. It decomposes above 250°C. The substance is stable to light, heat and water. It is approved by the U.S. Food and Drug Administration and the European Commission for use in food contact materials and products.

(ii) Process necessity. The substance is used in plastics, paints and inks as a dispersant for colorants to enhance color strength and reduce the amount of colorants. In addition, the substance can be used as a nucleating agent for polyolefin plastics, playing a role in reducing the level of product spots and enhancing product brightness.

II. N,N,N-Trimethyl-3-[(1-oxo-2-propen-1-yl)amino]-1-propylammonium chloride polymer hydrochloride with vinylamine (1:1) (a) Background information. N,N,N-Trimethyl-3-[(1-oxo-2-propen-1-yl)amino]-1-propylammonium chloride polymer hydrochloride with vinylamine (1:1), soluble in water. It is approved for use in food contact materials and products by the US Food and Drug Administration. It is not included in the list of banned substances by the Japan Paper Federation.

(ii) Process Necessity. The substance is used as a retention aid, dewatering and contamination control agent prior to the sheet forming step in the paper and paperboard production process, which reduces the amount of other chemicals, improves retention and filtration aids, and improves sheet strength.

III. Polyethylene Glycol 600 Hydroxystearate

(I) Background. Polyethylene Glycol 600 Hydroxystearate has a melting point of 25°C, an initial decomposition temperature of about 310°C, a maximum thermal decomposition temperature of about 410°C, and is insoluble in acetone, ethylene glycol and water. The U.S. Food and Drug Administration and the European Commission have approved its use in food contact materials and products. Japan Hygienic Olefin and Styrene Plastics Association includes it in the production of food utensils, packaging containers with additives. Health Canada approved its use in the production of food contact materials and products.

(ii) Process necessity. The substance is applied to food contact materials and products as a polymer-type additive to improve the stability of plastic food packaging materials under the specified conditions of use.

(iii) Precautions for use. The food contact materials and products produced with this substance are limited to be used for storing food at 25℃ and below, and the materials and products shall not be heat-treated.

IV. Trihydroxypolyalkylene oxide

(I) Background information. Trihydroxy polypropylene oxide is a polymer formed by using propanetriol as the initiator and 1.2-epoxypropane as the monomer, which is a colorless to yellow liquid, with a density of 1.027g/cm3 under the test condition of 25℃ and a boiling point of more than 200℃. The U.S. Food and Drug Administration has approved its use in food contact materials and products, and the European Commission has approved the use of propanetriol and 1.2-epoxypropane in the production of food contact materials and products.

(ii) Process necessity. As one of the necessary components of the polyurethane adhesive, trihydroxypolypropylene oxide reacts with isocyanate prepolymers in the bonding process to generate polyurethane adhesives with molecular weights as high as a few hundred thousand to a few million, which are used to laminate food contact materials and products.

(iii) Precautions for use. 1. The adhesive produced by this substance is only used for dry food packaging, and there should be an effective barrier layer (usually polyethylene or polypropylene film) between it and the food. 2. The average molecular mass of the trihydroxypolypropylene oxide ether should be not less than 250 daltons.

V. Polymer of 1.4-benzenedicarboxylic acid with 2-methyl-1.3-propanediol, sebacic acid, 1.3-benzenedicarboxylic acid and 1.2-ethyleneglycol (i) Background information. 1.4-benzenedicarboxylic acid polymer with 2-methyl-1.3-propanediol, sebacic acid, 1.3-benzenedicarboxylic acid and 1.2-ethyleneglycol is a liquid at room temperature and has a boiling point of 118℃. The U.S. Food and Drug Administration approved the polymer for use in food contact materials and products. The European Commission has approved all monomers of this polymer for use in food contact materials and products.

(ii) Process necessity. The substance, as the main film-forming substance of the coating, is a basic component of the coating system.

VI. Magnesium nitrate (i) Background information. Magnesium nitrate is colorless crystal, soluble in water. The U.S. Food and Drug Administration approved its use in food contact paper and paperboard. The Japan Paper Federation has included the substance in the list of substances allowed to be used in food packaging paper.

(ii) Process necessity. Magnesium nitrate, as one of the fungicide components used in food contact paper, has the effect of stabilizing the fungicide active ingredient.

 VII. Ethoxylated C10-C16 alcohols

(I) Background. Ethoxylated C10-C16 alcohol is a white paste that is soluble in water. It is approved by the US Food and Drug Administration for use in food contact paper and board. The German Federal Institute for Risk Assessment (Bundesanstalt für Risikaufbau) has included the substance in the list of recommended substances for use in food contact materials and products. (ii) Process Necessity. Ethoxylated C10-C16 alcohol as a surfactant added to the pulp in the wet position of the papermaking process, providing a good wetting effect for the polymer flocculant, so that the polymer flocculant better fibers together to provide fiber retention and filtration rate in the forming network of the papermaking machine and the rate of filtration and the dewatering performance of the wet part of the press after the forming network, to ensure that the paper machine is stable and fast operation.

VIII. Ethoxylated C12-C15 alcohols

(i) Background information. Ethoxylated C12-C15 alcohol is a white paste, soluble in water. It is approved by the US Food and Drug Administration for use in food contact paper and board. The German Federal Institute for Risk Assessment (Bundesanstalt für Risikklärung) has included the substance in the list of recommended substances for use in food contact materials and products.

(ii) Process Necessity. Ethoxylated C12-C15 alcohol as a surfactant added to the pulp in the wet position of the papermaking process provides a good wetting effect for the polymer flocculant, so that the polymer flocculant better aggregates the fibers together, provides the retention rate of fibers on the forming net of the papermaking machine and the rate of filtration as well as the dewatering performance of the wet press after the forming net, and ensures the stable and rapid operation of the papermaking machine.

IX. 5-Norbornene-2.3-dicarboxylic anhydride

(A) Background information. 5-Norbornene-2.3-dicarboxylic anhydride, also known as nadic anhydride, is solid at room temperature, melting point of 162 ° C-165 ° C, soluble in benzene, toluene, acetone, chloroform, etc., in contact with water can be hydrolyzed to dicarboxylic acid. The U.S. Food and Drug Administration (FDA) approved the substance for use in food contact materials and products. The European Food Safety Authority (EFSA) has assessed that the substance does not pose a potential safety risk to consumers when used in food contact coatings.

(ii) Process necessity. The polymer produced from the substance as a monomer is the film-forming substance of the coating and the basic component of the coating system.

(iii) Precautions for use. Materials and products produced using the substance should not be used to contact or contain beverages.

X. 1.4-Benzenedicarboxylic acid polymerized with 1.3-benzenedicarboxylic acid, cis-3.6-endomethylene-1.2.3.6-tetrahydrophthalic anhydride, 1.2.4.5-benzenetetracarboxylic anhydride, 1.4-cyclohexanedimethanol, and 2-methyl-1.3-propanediol

(i) Background.The polymer of 1.4-benzenedicarboxylic acid with 1.3-benzenedicarboxylic acid, cis-3.6-endomethylene-1.2.3.6-tetrahydrophthalic anhydride, 1.2.4.5-benzenetetracarboxylic anhydride, 1.4-cyclohexanedimethanol, with 2-methyl-1.3-propanediol is a liquid at room temperature, with a boiling point of 138°C. The polymer has been prepared by the use of the following monomers. All monomers comprising the polymer are listed in GB 9685.The U.S. Food and Drug Administration approved the polymer for use in food contact materials and products. The European Commission has approved all monomers of the polymer for use in food contact materials and products.

(ii)Process necessity. The substance, as the main film-forming substance of the coating, is an essential component of the coating system.

XI. 1.4-Dicyclohexylsulfosuccinic acid sodium salt

(I) Background information. 1.4-Dicyclohexylsulfosuccinic acid sodium salt, molecular formula: C16H25O7SNa, is a common surfactant. It is approved by the U.S. Food and Drug Administration (FDA) as an emulsifier, surfactant for food contact materials. It is approved by the German Federal Institute for Risk Assessment for use in paper and cardboard for food contact.

(ii) Process necessity. The declared substance is used as a surfactant in coatings for paper and cardboard to improve the stability of emulsion polymer dispersions.

XII. Reaction Products of 2-Ethylhexyl Glycidyl Ether and Polyethylene Glycol

(i) Background information: The reaction product of 2-ethylhexyl glycidyl ether with polyethylene glycol is solid at room temperature, dispersible and insoluble in water. The German Federal Institute for Risk Assessment (BGR) has included this substance in the list of recommended substances for food contact materials and products. In addition, the Japan Paper Federation has not included the substance in the list of prohibited substances.

(ii) Process Necessity. The substance is used as a pollution control agent in the wet process of papermaking for removing pollutants such as adhesives introduced in papermaking, preventing the aggregation and accumulation of pollutants, and thus controlling the residue of pollutants in paper.

XIII. Magnesium oxide

(i) Background. Magnesium oxide is a white powder insoluble in water, as a processing aid for the food industry has been included in GB 2760; as food contact materials and products additives have been included in GB 9685 for plastics, coatings, rubber, inks, adhesives, paper, which plastics approved allowable range of PE, PP, PS, AS, ABS, PA, PET, PC. the current application will be the scope of use of magnesium oxide This application extends the use of magnesium oxide to PVDC resin. The U.S. Food and Drug Administration and the European Commission have approved the use of this substance in food contact materials and products. The Japan Polyvinylidene Chloride Hygiene Association has also included it in the list of substances that can be used as food utensils and packaging containers.

(ii) Process necessity. Magnesium oxide is used as heat stabilizer for PVDC resin, which can inhibit the decomposition reaction of PVDC resin and improve its molding and processing performance.

(iii) Precautions for use. The food contact materials and products produced using this substance are allowed to contact all kinds of food, and the contact temperature shall not exceed 130℃, with different contact temperatures and different limits of contact time. If the contact temperature is 121℃～130℃, the contact time should not exceed 1 hour; if the contact temperature is 25℃(excluding 25℃)～120℃, the contact time should not exceed 2 hours; if the contact temperature is 25℃ or lower than 25℃, there is no limitation requirement for the contact time.

XIV. Polyacrylamide

(i) Background. Polyacrylamide is a white, odorless powder. It is stable at room temperature, with a melting point greater than 259°C and a molecular weight of 8 million to 20 million daltons. The substance is soluble in water, with a density of 1.122g/ml (30°C); slightly soluble in glycerol, ethylene glycol, lactic acid, insoluble in methanol, ethanol, ether. The substance has been listed in GB 9685 for food contact paper. This application expands the scope of use to paraformaldehyde resin. The monomer is approved by the European Commission for use in the production of food contact materials and products. Japan Hygienic Olefin and Styrene Plastics Association also included it in the list of resin raw materials that can be used as food utensils, packaging containers for production.

(ii) Process necessity. The use of polyacrylamide as a stabilizer for food contact materials and products improves the thermal stability of the polyformaldehyde resin and reduces its decomposition in heat processing and injection molding.

(iii) Other circumstances that need to be explained. Acrylamide, as a monomer for synthesizing polyacrylamide, can be applied to the production of several food packaging materials. Since the migration of acrylamide monomer in food packaging materials is much lower than the detection limit of the method (DL=0.01mg/kg), the intake of acrylamide into the human body through food contact materials and products is negligible. (iv) Precautions for use. The materials and products produced using this substance are only used for contact with aqueous foods, oily foods, acidic foods and foods with ethanol concentration not exceeding 10% (v/v), and the temperature of use shall not be higher than 121℃.

XV. Dehydrated Sorbitan Monostearate Polyoxyethylene Ether

(I) Background. Dehydrated sorbitan monostearate polyoxyethylene ether is yellow solid, partially soluble in water. The substance is listed in GB 9685. used in plastics, coatings, adhesives. This application expands the use to paper. The U.S. Food and Drug Administration approved the substance for use in food contact paper and paperboard. The German Federal Institute for Risk Assessment (BGR) included it in the list of recommended substances for paper and cardboard for food contact materials.

(ii) Process Necessity. Dehydrated sorbitan monostearate polyoxyethylene ether is added as an emulsifier to the pulp in the wet position of the papermaking process to help the polymer flocculant gather the fibers together more effectively, improve the retention of fibers on the forming web of the paper machine and the rate of filtration of water as well as the dewatering performance of the wet press after the forming web, and to ensure that the paper machine operates in a stable and rapid manner.

Sixteen, phosphoric acid - α - tridecyl - ω - hydroxy - poly (oxy - 1.2 - ethylidene) ester

(I) background information. Phosphoric acid-α-tridecyl-ω-hydroxy-poly(oxy-1.2-ethylidene) ester is colorless to off-white liquid. The substance is listed in GB 9685. The scope of use is plastics (PP, PE, PS, PVC, PA, PC, ABS, AS, PET, PVDC, UP), and this application expands the scope of use to paper. The U.S. Food and Drug Administration approved its use in food contact paper and paperboard. The European Parliament included it in the list of recommended substances for food contact paper and board.

(ii) Process necessity. The substance is added as a dispersant, emulsifier and wetting agent to emulsions coated on the surface of paper to improve dispersion, stability and compatibility of the emulsion.

(iii) Precautions for use. Materials and products produced using the substance are only intended to be used in contact with aqueous food, dry food and fatty food. The substance is only applicable to the production of paper with a weight of 80g/m2 or less.

XVII. C16-18 monoglycerides

(I) Background information. C16-18 monoglycerides is a white to slightly yellow waxy solid powdery substance with a melting point of 270 ℃ and a specific gravity of 0.95 (20 ℃). It is contained in C16-18 (mono- and diglycerides).C16-18 (mono- and diglycerides) as a food additive has been included in GB 2760; as an additive for food-contact materials and products has been included in GB 9685.It is allowed to be used in paper in appropriate amounts according to production needs, and this application expands the scope of use to coatings. The U.S. Food and Drug Administration, Health Canada, Mercosur (the largest economic integration organization in South America) approved its use in food contact materials and products. The European Food Safety Authority (EFSA) has assessed that the substance does not pose a potential safety risk to consumers when used as an oxygen absorber in food contact materials.

(C16-18 monoglyceride, as an emulsifier, plays an important auxiliary role in the film-forming process of coatings, and at the same time reduces the friction of process equipment and acts as a lubricant in the process of coating production. In the process of coating application can also avoid the hoarding of electric charge, play the role of anti-static, very important for safe production.

Eighteen, acrylonitrile and 1.1-dichloroethylene polymer

(I) Background. The polymer of acrylonitrile and 1.1-dichloroethylene is stable in nature, with a decomposition temperature of 200°C and insoluble in water. The U.S. Food and Drug Administration has approved its use in coatings for food contact, and the European Commission has approved individual monomers of the polymer for use in food contact materials and products.

(ii) Process necessity. The crystalline film formed by this resin has high oxygen and water vapor shielding properties, and food contact materials and products produced using this substance as a coating can prevent oxidation of food and keep moisture stable, thereby extending the shelf life of food.

(iii) Precautions for use. The temperature of the materials and products produced by utilizing the substance in contact with food should not exceed 120℃.

XIX. Polymer of 2-methyl-2-propenoic acid methyl ester with 1.1-dichloroethylene

(i) Background information: The polymer of 2-methyl-2-propenoic acid and 1.1-dichloroethylene is stable, has a decomposition temperature of 200°C and is insoluble in water. It is approved by the U.S. Food and Drug Administration for use in coatings for food contact, and the European Commission has approved individual monomers of the polymer for use in food contact materials and products.

(ii) Process necessity. The crystalline film formed by this resin has high oxygen and water vapor shielding properties, and food contact materials and products produced using this substance as a coating can prevent oxidation of food and keep moisture stable, thereby extending the shelf life of food.

(iii) Precautions for use. The temperature of the materials and products produced using the substance in contact with food should not exceed 120℃.

XX. Polymer of methyl 2-methyl-2-acrylate with 1.1-dichloroethene and 2-methyl-2-acrylonitrile

(i) Background information. The polymer of 2-methyl-2-propenoic acid with 1.1-dichloroethene and 2-methyl-2-acrylonitrile is stable, with a decomposition temperature of 200°C and insoluble in water. The U.S. Food and Drug Administration has approved its use in coatings for food contact, and the European Commission has approved the individual monomers of this polymer for use in food contact materials and products.

(ii) Process necessity. The crystalline film formed by this resin has high oxygen and water vapor shielding properties, and food contact materials and products produced using this substance as a coating can prevent oxidation of food and keep moisture stable, thereby extending the shelf life of food.

(iii) Precautions for use. The temperature of the materials and products produced using the substance in contact with food should not exceed 120℃.

XXI. 2-Methyl-2-propenoic acid polymer with styrene

(a) Background information. 2-methyl-2-propenoic acid polymer with styrene is physically stable with a decomposition temperature of 300°C and is insoluble in water. The U.S. Food and Drug Administration has approved its use in coatings for food contact, and the European Commission has approved individual monomers of this polymer for use in food contact materials and products.

(ii) Process necessity. The glass transition temperature (i.e., Tg) of ordinary polystyrene is 100°C, whereas the glass transition temperature of the polymer produced after modification with methacrylic acid is 122°C, thus allowing it to be used in microwave ovens and expanding the range of temperatures at which the material can be used.

(iii) Precautions for use. The contact temperature of the materials and products produced using this substance with food shall not be higher than 121°C.

XXII. Polymer of 1.4-benzenedicarboxylic acid with 5-amino-1.3.3'-trimethylcyclohexanemethylamine and has-lactam

(i) Background information. 1.4-Benzenedicarboxylic acid polymer with 5-amino-1.3.3'-trimethylcyclohexanemethylamine and alpha-lactam is naturally opaque spherical particles with a melting point of 220°C to 230°C, a decomposition temperature of greater than 300°C, and insoluble in cold water. Their monomers and other starting materials have been approved by the EU and MERCOSUR (the largest economic integration organization in the South American region) as food contact materials and products.

(ii) Process necessity. Compared with the traditional nylon (PA6), the resin can slow down the crystallization rate during processing and improve processing performance.

XXIII, isophthalic acid and azacyclotridecan-2-one and 3.3'-dimethyl-4.4'-diaminodicyclohexylmethane polymers

(I) Background. Isophthalic acid polymer with azacyclotridecan-2-one and 3.3'-dimethyl-4.4'-diaminodicyclohexylmethane is a base resin for food contact materials and products. It is insoluble in water, ethanol, toluene or ethylene glycol, and soluble in concentrated sulfuric acid and m-cresol. The polymer is approved by the U.S. Food and Drug Administration for use in food contact materials and products for use in contact with all types of food except those containing more than 8% alcohol. All monomers are approved by the European Commission for use in the manufacture of food contact materials and products. Japan Hygienic Olefin and Styrene Plastics Association confirms that it can be used as a resin raw material for the production of food utensils and packaging containers.

(ii) Process necessity. The application of this polymer as a resin for the production of food contact materials and products allows the materials and products to have higher transparency, lighter density, and better anti-cracking and chemical resistance, and the processing is easier for molding.

(iii) Precautions for use. Food contact materials and products produced using this polymer may be used to contact food with aqueous, acidic, fatty and alcoholic content of not more than 8%, and may not contact food with an alcohol content of more than 8%. (Source: National Health and Family Planning Commission of the People's Republic of China)