D&R - Compostable Materials Declaration of Compliance
D&R Compostable Products
The raw materials or the subset of raw material used to produce the aforementioned flexible packaging specs have been certified by our raw material suppliers as compostable. This flexible packaging product does not contain any additives or components designed to accelerate the degradation process. In its converted form, this pouch has not been compostable certified as a finished package, and may not fully compost within the target conditions.
FDA Food Contact Status
This is to certify that all raw materials used in production of your flexible packaging comply with the regulations pursuant to section 201(s) of the Federal Food, Drug, and Cosmetic Act, and Parts 182, 184, and 186 of the Food Additive Regulation.
Under good manufacturing practices this product may be safely used as components of articles that directly contact food, in strictest accordance and subject to the limitations as set forth under conditions of use B through H, as described in Table 2 of FDA Food Types & Conditions of Use for Food Contact Substances. However, due to the relatively low softening point we recommend the use of above products only under conditions of E through G. The product group complies with applicable food-contact regulations in the United States (U.S.) when used in contact with all food types, except alcoholic foods, infant formula, and breast milk, as described in Table 1 of FDA Food Types & Conditions of Use for Food Contact Substances.
21 CFR 174.5
21 CFR 175.105
21 CFR 175.300
21 CFR 176.170(c)
21 CFR 177.1520
21 CFR 178.2010
21 CFR 178.3297(e)
21 CFR 178.3860
Components of the subject film are cleared under applicable specific provisions in 21 CFR Parts 175-186, including but not limited to 21 CFR 177.1200.
California Proposition 65
The D&R Spec Product Group does not contain any reproductive toxins or carcinogenic substances, per the state listing of chemicals that would require a warning under the California Safe Drinking Water and Toxic Enforcement Act of 1896 (Proposition 65).
Note: D&R Flexibles does not specifically test for the absence or presence of the chemicals listed in CA
There is no deliberate addition of components which contain cadmium, hexavalent chromium, lead or mercury to the Product Group. The Product Group above are heavy metal free; the raw materials used by D&R in the manufacture of the film contain neither cadmium, nor hexavalent chromium, nor lead, nor mercury.
Note: D&R does not specifically test for the absence or presence of cadmium, hexavalent chromium, lead or mercury.
Animal Derived Components
Based on information received from D&R-Raw Material Suppliers, some materials may contain “Animal Derived Components” further back down the material stream. D&R requests information from its suppliers on a regular basis and will update the film status section to confirm positive exclusion of “Animal Derived Components” when received.
One or more of the raw materials used to manufacture the film(s) D&R uses, may contain one or more
additive(s)/substance(s) synthesized from animal extracts, i.e., hydrolysis, etc. of animal fats (tallow) into fatty acids. The manufacturing process of the fatty acids includes a multi-step chemical treatment involving high temperatures, high pressures and long residence times. These processing conditions greatly exceed the requirements as specified in Section 6.4 of the “Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal product” (EMA/410/01 Rev. 3-July 1, 2011), adopted by the European Commission and published in the Official Journal of the European Union March 5, 2011 (2011/C 73/01). Further, only Category 3 materials or equivalent as defined by Article 6 of European Partiament and Council Regulation (EC) No 177 4/2002 are used as raw materials for the fatty acids.
Thus, the tallow derivatives (irrespective of the geographical origin according to the Note for Guidance) used in the manufacturing of this product are therefore considered compliant with the EMA Note for Guidance referenced above.
Based on information received from D&R-Raw Material Suppliers, materials are formulated and manufactured to exdude the incorporation of ingredients based on most of the FDA’s Big 8 food allergens (eggs, milk, peanuts, fish, crustacean shellfish, wheat gluten).
Food allergens are triggered by the proteins contained within the food. Some raw materials supplied to D&R can contain ingredients derived from tree nuts (resins based on coconut oil as well as free coconut oil) or soy (free soybean oil or resins based on soy). The chemical processing conditions used to refine and purify these substances and the reaction conditions used to manufacture the derived raw materials that may be used in the formulation of some products (high temperatures, saponification, transesterification, etc.) are such that any
protein material will be degraded and eliminated.