Processing Tips Regulatory Compounding Tips

Regulatory Information  

Chemical Identity

  • CAS Name: 1,3:2,4Bis(3,4-dimethylbenzylidene) sorbitol
  • CAS Number: 135861-56-2

           Millad 3988 MSDS.pdf



Chemical Structure:

International Chemical Substances Approvals

  • United States Toxic Chemical Control Act (TSCA)
  • EEC Directive 67/548/EEC 7th Amendment Notification, Approved December 27, 1993 , EC Number 413-110-2
  • Japanese Existing Chemicals List
  • Australian Inventory of Chemical Substances (AICS), Worksafe Australia , File No.: NA/179
  • Korean Existing Chemicals List (ECL), Serial No. 94-4
  • New Zealand Toxic Substances Database
  • Canadian Domestic Substances List

International Approvals For Use In Plastics For Food Contact Applications

  • United States
Food and Drug Administration (FDA) : Food Additive Regulation 178.3295 Clarifying Agents for Polymers - Conditions A through H, maximum 0.40% by weight of the polymer.
  •   Europe : Food Contact Materials Directive 90/128/EEC (Section A) Product Reference Number 38879.

o        Germany : BGA, April, 994.

o        Italy : Ministero Dello Sanita, February 6,1997.

o        France : Ministere de l'Economie des Finances et du Plan, July 11, 1995.

o        Belgium : Ministère des Affaires Sociales, de la Santé Publique et de l'Environment, July 18, 1995.

  • Canada , Health and Welfare Canada , Health Protection Branch : Food Packaging Materials and Incidental Additives Section, Chemical Evaluation Division, at levels up to 0.4% by weight, in polypropylene homopolymer and high propylene olefin copolymer- Letter of   "No Objection" received, September, 1994.

§     MERCOSUR Food Contact Positives List : Positive List of MERCOSUR for additives in propylene homopolymer and high propylene copolymer articles intended for use in contact with food, annex II, published March, 1996.

 

  •   Japan , JHOSPA : Positive list approval PL No. is G6-46.

 

California Safe Drinking Water and Toxic Enforcement Act (Proposition 65)

  • Although we have not analyzed for every chemical included on the California Safe Drinking Water and Toxic Enforcement Act Proposition 65 list, based upon a review of our process for the manufacture of this product, there should be no Proposition 65 listed chemicals present at regulated quantities in this product.
Product Origin
  • We do not intentionally use any animal products in the manufacturing of our product or in the manufacturing process of this product.
  • With regards to genetically modified organisms, sorbitol, crystalline and solutions are made by hydrogenation of starch hydrolysates from corn. Our Sorbitol supplier’s policy is to procure its raw material corn from internationally approved crop sources. Because of their large scale, non-GM corn and GM corn cannot be segregated from one another. Consequently, their sorbitol, crystalline and solutions, may or may not be produced from GM corn. However, current industry consensus is that any DNA in the raw material stream is denatured, degraded or removed through successive processing steps including physical separation, heating, purification and filtration and most likely cannot be detected in measurable amounts in the sorbitol.
  • As a conclusion, we can state that, based on the above, it is safe to assume that any DNA is being destroyed or removed during the production process of the sorbitol. However, we cannot confirm that for the production of MILLAD ® 3905 and MILLAD ® 3988 , we exclusively use sorbitol originating from corn that has not been genetically modified.

Heavy Metal Content

Chemical

Quantity

Chemical

Quantity

Antimony

< 0.5ppm

Lead

<1.5ppm

Arsenic

<2.5ppm

Mercury

<0.05ppm

Barium

<0.5ppm

Nickel

<1.0ppm

Cadmium

<0.5ppm

Selenium

<0.5ppm

Chromium

<0.5

Zinc

1.3ppm

Copper

<1.5ppm


CONEG
This product is in full compliance with the CONEG (Congress of Northeastern Governors) Model legislation addressing the elimination of heavy metals in packaging and packaging components. Specifically, Milliken Chemical certifies that: A. MILLAD ® 3988 contains no lead, cadmium, mercury or hexavalent chromium which has been intentionally introduced as an element during manufacture or distribution, and B. The sum of the concentration levels of lead, cadmium, mercury and hexavalent chromiumincidentally present in these products shall not exceed 100 parts per million by weight.

Harmonized Tariff Code
  • 2911.00 - Acetals and hemiacetals, whether or not with other oxygen function, and their halogenated, sulfonated, nitrated or nitrosated derivatives
Millad 3988 MSDS.pdf

NOTE: This document is intended solely for Milliken Chemical use in documenting MILLAD ® 3988 regulatory approvals. No warranties as to accuracy or completeness are implied.