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Regulatory and Related Information







Regulatory and Related Information

Regulatory and Related Information
As a DuPont Business, DuPont Soy Polymers follows the strict safety, health and environmental standards benchmarked by our parent company. Our division adheres to the highest standards for the safe operations of facilities and the protection of the environment, our employees, our customers and the people of the communities in which we do business.

Soy protein polymers are used in many food contact applications including food packaging coatings, inks and adhesives for paper and paperboard. Pro-CoteŽ complies with the following regulations and associated requirements.

BfR (Bundesamt fuer Risikobewertung/Federal Risk Institute for Risk Assessment) Compliance (Germany). Pro-CoteŽ soy polymers conform to Recommendation XXXVI of the German BfR.

California Proposition 65. All Pro-CoteŽ soy polymers comply with the requirements in California State Drinking Water and Toxic Enforcement Act of 1986 and contain no substances that require declaration under the provisions of California Proposition 65.

Canadian Domestic Substances List (DSL). Pro-CoteŽ products contains substances that are listed on the Canadian Domestic Substances List, NSN 8832, as published in Canadian Gazette, Part II Volume 136, No. 3.

Council of North Eastern Governors (CONEG). A group of states has implemented regulations mandating phased reductions in heavy metals in packaging components. DuPont Soy Polymers guarantees that Pro-CoteŽ products comply with the most rigorous heavy metal levels of the legislation. See Heavy Metals Content.

Dioxin Content. Dioxins are a class of chlorinated aromatic compounds suspected of extreme toxicity. Two of the most common dioxin or dioxin precursors compounds are 2-4-7-8 TCDF/TCDD (these are usually tested by high-sensitivity GC/MS Techniques). Pro-CoteŽ soy polymers have been found to have no detectable levels of dioxin or dioxin precursors when using a detection limit of 0.5 pg/g (ppt).

FDA Regulatory Compliance (USA). Pro-CoteŽ products comply with United States FDA regulations applicable to paper coating components, including indirect food additives migrating to food from paper and paperboard products, covered in 21 CFR 176.170 (Components of paper and paperboard in contact with aqueous and fatty foods), and 21 CFR 176.180 (Components of paper and paperboard in contact with dry food). There are no Food Type, Use Conditions, or Concentration Limits.

Generally Recognized As Safe (GRAS) (USA). Isolated soy protein, the base ingredient in Pro-CoteŽ polymers, is a substance Generally Recognized As Safe for an intended use for paper and paperboard packaging when used in accordance with good manufacturing practices (see 21 CFR 182.90). It, therefore, is a substance which may be safely used as a component of paper and paperboard food-contact surfaces under Sections 176.170 (a) and 176.180 (b) (1).

Hazardous Air Pollutant (HAPs)/Volatile Organic Compounds (VOCs). The majority of Pro-CoteŽ soy polymers have no VOC content. However certain grades (Pro-CoteŽ 5000 and Pro-CoteŽ 4200) contain an ingredient that is classified as both a Volatile Organic Compound and a Hazardous Air Pollutant. These products contains Propylene Glycol, (1-2 Propanediol, CAS 57556) at a level of approximately 2.0% by weight.

Ozone Depleting Compounds (ODCs). All Pro-CoteŽ soy polymers contain no Class I or Class II ozone-depleting chemicals as identified in EPA’s final rule 40 C.F.R. 82-104, nor are any used in our manufacturing operation.

Resource Conservation and Recovery Act (RCRA). Pro-CoteŽ soy polymers do not exhibit any of the hazardous characteristics listed at 40 CFR 261, Subpart C, nor is it listed in 40 CFR 261.33 paragraphs (e) or (f) - chemical products that are considered hazardous if they become wastes.

Superfund Amendment and Reauthorization Act (SARA) Section 313. Certain grades of Pro-CoteŽ are manufactured as the ammonium salt version of the soy polymer. They contain approximately 1.5% ammonia (expressed as weight of NH3 on the dry weight of product). Ammonia in all forms was added to the SARA 313 list effective 06/26/1995.

Toxic Substance Control Act (TSCA) Compliance (USA). DuPont Soy Polymers guarantees that Pro-CoteŽ soy polymers are mixtures of ingredients, and are certified for inclusion in the Toxic Substance Control Act (TSCA) inventory of chemical substances (40 CFR 710).

Volatile Organic Compounds (VOCs)/Hazardous Air Pollutant (HAPs). The majority of Pro-CoteŽ soy polymers have no VOC content. However certain grades (Pro-CoteŽ 5000 and Pro-CoteŽ 4200) contain an ingredient that is classified as both a Volatile Organic Compound and a Hazardous Air Pollutant. These products contains Propylene Glycol, (1-2 Propanediol, CAS 57556) at a level of approximately 2.0% by weight.