Document 6wMaZEyBrnn2vxEdXojvpweaE

IPGoodrich INTER-ORGANIZATION CORRESPONDENCE TO JElaine Mertzel_______ FROM FIELD POINT OR DEPT. 8c BLDG. NO. ALTC FIELD POINT OR DEPT. 8c BLDG. NO. _J*L__CL__Bach tel_________________D/QQ20. Corporate HO SUBJECT DATE YOUR LETTER DATE THIS LETTER 9-16-88 CADMIUM, LEAD PIGMENTS AND/OR STABILIZERS / /i The main concern on the use of cadmium and lead based pigments and/or stabilizers in plastics is related to the potential contamination of water, food, drugs, cosmetics and general consumer products. In the following summary, I will not attempt to address EPA (waste disposal, emissions, etc.) or OSHA regulations since these are generally related to the substance itself. Following is a brief summary based on application in the U.S. Foods: In the U.S. there are no cadmium or lead pigments or stabilizers cleared for use in food contact articles regulated by the FDA. Any use of these heavy metal substances in food contact applications would have to be on a non-migratory basis. Non-migratory in this sense means that neither cadmium or lead would be detected in extractions designed to simulate intended use conditions with an analytical method sensitive to 10 ppb. Although housewares are not regulated under the food additive regulations, FDA has set action levels for leachable lead and cadmium under the general adulteration provisions of the FD&C Act as follows: Ceramic Ware Lead Cadmium flatware small holloware large holloware 7 ppm 5 ppm 2.5 ppm 0.5 ppm 0.5 ppm 0.25 ppm The U.S. Department of Agriculture has jurisdiction over meat and poultry products including such products as meat topped pizzas, canned stews, etc. This agency will not permit the use of heavy metal stabilizers or pigments in equipment or packaging for use in federally inspected meat and poultry processing establishments. Drugs-Devices: There are no specific regulations concerning the use of cadmium or lead substances in drug/device packaging or devices. However, this would be covered by Good Manufacturing Practices which would generally preclude the use of such materials. The United States Pharmacopoeia (USP) has a limit of 1 ppm extractable heavy metals from drug containers. The analytical method used for detection is a sulfite precipitation test. T006ZSTZ BFG-4956-E 11/80 UTHO IN U.S.A. BFG12985 \ Cosmetics: There are no regulations which state what may be used in cosmetic packaging. Cadmium and lead based substances may be acceptable depending on the type and intended use of the cosmetic. For example, what might be acceptable for use to package a shampoo or underarm deodorant may be totally unacceptable for a mouth wash or breath freshener. Water: The EPA has set maximum contaminant levels (MCL) for a variety of substances in potable water. The MCL for lead is to be reduced from 50 ppb to 10 ppb. The MCL for cadmium is 10 ppb. The National Sanitation Foundation certifies materials for use in contact with potable water under NSF Standard 61. Under this standard contribution from any one product may not exceed 10% of an EPA MCL (i.e. 1 ppm for lead or cadmium). Consumer Products (including toys, pacifiers, etc.): With the exception of a ban on the use of lead in paint or similar coatings, ( >0.06%), there are no regulations which prohibit the use of lead or cadmium in consumer products. Product liability would be a controlling factor for these uses. California Proposition 65: Prop 65 prohibits the knowing contamination of drinking water with carcinogens or reproductive toxins. It also requires a clear and reasonable warning be given prior to knowingly exposing individuals to carcinogens or reproductive toxins. Prop 65 lists lead as a reproductive toxin. It lists cadmium as a carcinogen by inhalation with notification at an exposure of over 0.5 vig/day. Europe: Enclosed is a table listing the maximum impurity levels for several metals in four countries including European Economic Proposals. In addition Finland is setting a limit of extractable heavy metals from general utility, consumer goods and food contact applications. The limit for cadmium is <;0.1 mg/dmI2; that for lead is <_0.5 mg/dm2. I hope this will be of help to you; if you have any further questions, please contact me.- jp 80916-2 to H* L0 to tOoo BFG12986 FORMAL REGULATIONS Maximum percentage of allowable impurity in the formal regulations under consideration. N.B. The figures in the three tables refer to the amount of- impurity soluble in N/10 hydrochloric-acid. Where qualified by the letter (T) the figures refer to total impurity. TABLE I: Food Packaging Regulations Impurity Franca* Lead 0.0101 T Arsenic 0.005/ T Mercury 0.005 Cadmium 0.100 Zinc 0.200 Selenium 0.010 Barium 0.010 Chromium Antimony -- Nickel _ Aromatic amine 0.050 Italy* 0.0101 T 0.005/ T 0.005 0.200 0.010 0.010 -- -- 0.050 ESC prepoMla* Belgium4 0.0101 T 0.010/T 0.005 0.200 -- 0.010 0.010 0.100 0.200 -- 0.010 0.005 0.005 0.200 -- 0.010 0.010 0.100 0.200 -- Holland* 0.010 0.010 0.005 0.010 -- 0.010 0.010 0.100 0.050 0.010 0.050 0.050 0.050 The limits above refer to the percentage of impurity in the colorant EOOSZSTZ BFG12987 n