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      Restricted Chemical Substances

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      Bisphenol BPA A

      What is BPA/Bisphenol A

      Bisphenol A, scientific name 2,2-bis (4-hydroxyphenyl) propane, also known as diphenylpropane, abbreviated as bisphenol A (BPA), is an English name for bisphenol A. White crystal, flammable, with a slight phenol odor. Boiling point 250-252 (1.773kPa). The melting point of pure products is 155-156 , and the melting point of industrial products is 150-152 . Relative density 1.195 (25 ), flash point 79.4 . Soluble in ethanol, acetone, ether, benzene, and dilute alkali solution, slightly soluble in carbon tetrachloride, almost insoluble in water.

      Bisphenol A is synthesized from phenol and acetone in acidic medium, and is commonly used as the main raw material in products such as epoxy resin, polycarbonate, polysulfone, polyarylester, phenolic resin, unsaturated polyester resin, flame retardant, etc.

      Bisphenol A is basically divided into two grades: polycarbonate grade and epoxy grade, and its quality indicators are shown in Table 1.

      Table 1 Quality Indicators of Bisphenol A Provided by SGS Testing Company

      Indicator

      Polycarbonate   grade

      Epoxy grade

      Appearance

      Powdered, flaky,   granular white crystals

      Crystallization   temperature

      156

      154

      Chromaticity   (platinum cobalt) number

      25 grams of   sample dissolved in 35ml of methanol

      25

      50

      Iron content ppm

      1

      2

      Free phenol   content%

      0.03

      0.1

      Moisture   content%

      0.2

      0.3

      Ash content%

      0.01


      Isomer%

      0.2

      0.5

      The hazards of BPA/Bisphenol A

      According to American experimental researchers, the chemical substance bisphenol A (BPA) commonly found in plastic bottles may cause cancer and other functional disorders. In addition, bisphenol A (BPA) can cause hormonal dysfunction in the human body, posing potential hazards to growth, development, and reproduction. Although this conclusion has not been affirmed by authoritative authorities, it has caused consumer panic among some informed consumers.

       

      Restrictions on BPA/Bisphenol A by Various Countries

      China: GB 13116-91 Hygienic standard for polycarbonate resin used in food containers and packaging materials.

      GB 14942-94 Hygienic standard for polycarbonate molded products used in food containers and packaging materials.

      GB/T 5009.99-2003 Analysis Method for Hygienic Standard of Polycarbonate Resin for Food Containers and Packaging Materials.

      The hygiene standards in our country stipulate that the leaching amount of phenol (distilled water, refluxed for 6 hours) in carbonate resin and molded products shall not exceed 0.05 mg/kg,

      It is a quantitative calculation of free phenols in a solution using titration method.

       

      EU: EU Regulation 2002/72/EC stipulates a migration limit of 3 mg/kg for BPA/bisphenol A in plastic food contact materials.

      The European Union uses liquid chromatography to detect the migration of bisphenol A (with a detection limit of 0.2-0.7 mg/kg).

       

      United States: The Food and Drug Administration (FDA) of the United States stipulates that BPA/bisphenol A can be used as raw materials for food contact materials.

      The EPA (1993) stipulates that the maximum acceptable dose or reference dose is 0.05mg/kg.bw.

      Japan: The Food Hygiene Law stipulates that the dissolution limit of BPA/bisphenol A in polycarbonate food containers is 2.5 mg/kg.

       

      BPA/Bisphenol A detection

      NormalTCI relies on its strong chemical experimental capabilities and professional experimental engineers to provide BPA/bisphenol detection services. For more details, please contact us!

      The European Union has officially banned the use of bisphenol A in food contact materials

      On December 31, 2024, the Official Journal of the European Union officially issued the BPA ban (EU) 2024/3190, which requires further revision of the Plastics Regulation (EU) 10/2011 and the repeal of (EU) 2018/2013. It will officially come into effect on January 20, 2025. The issuance of this ban means the first comprehensive ban on the use of bisphenol A in FCM in the European Union and member states, with a wide range of implications and significant impact. The main content of the ban is as follows:

      1. Prohibition requirements for bisphenol A

      (1) Prohibit the use of bisphenol A and its salts in the manufacture of adhesives, rubber, ion exchange resins, plastics, printing inks, silicone, varnishes, and coatings for food contact materials, and prohibit the placement of food contact materials and products made with bisphenol A on the EU market.

      (2) It is prohibited to use any bisphenol or bisphenol derivatives other than BPA for the manufacture and sale of FCM, unless authorized, and no residual BPA is allowed.

      (3) BPA ban exemption

      Material type

      Particular   application

      Other   restrictions

      Clearcoat and   coating

      Used as a   monomer or starting material for producing liquid epoxy resin, suitable for   self-supporting food contact materials or items with a capacity greater than   1000 liters.

      Can be   transferred to food.

      Items that come   into contact with food should be cleaned and rinsed before their first   contact with food.

      Plastics

      Used as a monomer or starting material   for manufacturing polysulfone filtration membrane components.

      Cannot be   transferred to food.

      Items that come   into contact with food should be cleaned and rinsed before their first   contact with food.

      2. Revision (EU) No 10/2011

      (1) Add the following content to Article 6 "Exemption for substances not included in the EU list":

      As a partial exemption to Article 5, "Bisphenol A" or "BPA" (CAS: 80-05-7) and other harmful bisphenol or harmful bisphenol derivatives defined in the proposal can only be used to manufacture plastic materials and products that comply with the proposed regulations (i.e. Appendix II exemption requirements).

      (2) Delete the entries for substance 151 BPA and substance 154 BPS (CAS: 80-09-1) in Table 1 of Appendix I of (EU) 10/2011.

      3. Provisions for the transition period

      (1) Disposable food contact materials and products

      Disposable FCM products can continue to be sold until July 20, 2026. If it is the following special products, they can continue to be sold until January 20, 2028.

      a. Used for storing vegetables or fruits, excluding products defined in Annex I of Council Directive 2001/112/EC (13);

      b. Or aquatic products as defined in Regulation (EC) No 853/2004 of the European Parliament and of the Council (14);

      c. Only apply varnish or coating made of bisphenol A on the outer surface of the metal.

      (2) Repetitive food contact materials and products

      Repetitive FCM products can be launched on the market for the first time until July 20, 2026.

      But if the reusable food contact items used in professional food production equipment comply with the rules applicable before the effective date of this regulation but do not comply with the rules in this regulation, they can be put on the market for the first time until January 20, 2028.

      In addition, reusable food contact materials and products that are first put on the market in the above two situations can be retained in the market until January 20, 2029 at the latest.

      4. Declaration of conformity

      (1) The identity, address, and contact information of the operator who issued the conformity declaration, including the current phone number or email address;

      (2) The identity, address, and contact information of the operator who manufactures or imports food contact materials and products, including the current telephone number or email address;

      (3) Name information of intermediate materials or final products;

      (4) Declaration date;

      (5) List of Bisphenol or Bisphenol Derivatives Used in the Manufacturing of Food Contact Materials and Products;

      (6) Confirm that the intermediate materials and final products comply with the provisions of this Regulation and Articles 3, 15, and 17 of (EC) No 1935/2004.

       

      Please consult NormalTCI for specific questions

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      Email[email protected]

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