Navigating the Regulatory Environment for Food Contact Applications in the USA. PMA 2014 Annual Meeting

Transcription

1 Navigating the Regulatory Environment for Food Contact Applications in the USA 1

2 Introduction to FDA and Food Contact Any food additive should be deemed unsafe unless it is used in conformity with a regulation or notification issued by the FDA Suppliers and manufacturers are ultimately held responsible for ensuring that the food contact substance and all of its components comply with the FDA s requirements for safe use as indirect food additives 2 9/22/2011

3 Direct vs. Indirect Food Contact FDA regulates food additives, substances which may become components of food by the intended use, either directly or indirectly A Direct food additive is added for a functional purpose, colorant in food An Indirect food additive (called food contact substance) is introduced into food via food contact material and is not intended to have an effect on food colorant in a multi-layer lamination 3 9/22/2011

4 Demonstrating Compliance Listed on the 21 CFR (Code of Federal Regulations) Listing for Food Contact Notification (FCN) Listing for Threshold of Regulation (TOR) Generally Recognized as Safe (GRAS) Prior Sanctions Supplier s Declaration of Compliance 4 9/22/2011

5 Registration Overview Exposure / Tox TOR FCN FCN FAP Reproductive and Chronic toxicity in Rat and Dog Testing Requirements No tox studies required Valid Literature Data Acceptable In vitro mutagenicity testing (2 studies) Subchronic Toxicity in Rat and Dog In vitro mutagenicity testing (2 studies) < 0.5 ppb < 50 ppb * < 1 ppm > 1 ppm * Total Dietary Concentration (DC) of all regulations 5

6 Food Contact Conditions of Use General considerations of use for food contact applications Producing, manufacturing, packaging, processing, preparing, treating, packing, transporting, or holding food Limitations Food Types, per 21 CFR (c) Table I Aqueous, Acidic, Alcoholic, Fatty Temperature Conditions of Use, per 21 CFR (c) Table II A though H, I, and J Concentration (for additives and formulations) 6

7 Food Types and Temp. Conditions of Use 7

8 21 CFR PART INDIRECT FOOD ADDITIVES: POLYMERS Subpart B--Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces Sec Polyurethane resins. The polyurethane resins identified in paragraph (a) of this section may be safely used as the food-contact surface of articles intended for use in contact with bulk quantities of dry food of the type identified in (c) of this chapter, table 1, under Type VIII (a) For the purpose of this section, polyurethane resins are those produced when one or more of the isocyanates listed in paragraph (a)(1) of this section is made to react with one or more of the substances listed in paragraph (a)(2) of this section: (a)(1) Isocyanates (a)(2) List of substances (b) Optional adjuvant substances employed in the production of the polyurethane resins or added thereto to impart desired technical or physical properties may include the following substances 8

9 21 CFR (c)(4)(i) Elastomers PART INDIRECT FOOD ADDITIVES: POLYMERS Subpart C--Substances for Use Only as Components of Articles Intended for Repeated Use Sec Rubber articles intended for repeated use. Polyurethane resins (CAS Reg. Nos or ) derived from the reaction of diphenylmethane diisocyanate with 1,4- butanediol and polytetramethylene ether glycol. Polyurethane resins derived from reactions of diphenylmethane diisocyanate with adipic acid and 1,4-butanediol. 9

10 21 CFR Adhesives PART INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS Subpart B--Substances for Use Only as Components of Adhesives Sec Adhesives. Polyurethane resins produced by: (1) reacting diisocyanates with one or more of the polyols or polyesters named in this paragraph (2) reacting the chloroformate derivatives of one or more of the polyols or polyesters named in this paragraph with one or more of the polyamines named in this paragraph (3) reacting toluene diisocyanate or 4,4' methylenebis(cyclohexylisocyanate) (CAS Reg. No ) with: (i) one or more of the polyols or polyesters named in this paragraph and with eithernmethyldiethanolamine (CAS Reg. No ) and dimethyl sulfate (CAS Reg. No ) or dimethylolpropionic acid (CAS Reg. No ) and triethylamine (CAS Reg. No ) (ii) a fumaric acid-modified polypropylene glycol or fumaric acid-modified tripropylene glycol), triethylamine (CAS Reg. No ), and ethylenediamine (CAS Reg. No ) (4) reactingmeta-tetramethylxylene diisocyanate (CAS Reg. No ) with one or more of the polyols and polyesters listed in this paragraph and with dimethylolpropionic acid (CAS Reg. No ) and triethylamine (CAS Reg. No ),N-methyldiethanolamine (CAS Reg. No ), 2-dimethylaminoethanol (CAS Reg. No ), 2-dimethylamino-2-methyl-1-propanol (CAS Reg. No ), and/or 2-amino-2-methyl-1-propanol (CAS Reg. No ) 10

11 Limitations Recap Polyurethane resins May be safely used as the food-contact surface of articles intended for use in contact with bulk quantities of dry food of the type identified in (c) of this chapter, table 1, under Type VIII Rubber articles intended for repeated use Repeat-Use vs. Single-Use Applications Adhesives The adhesive is either separated from the food by a functional barrier or used subject to additional limitations (as described in the paragraph) In dry foods. The quantity of adhesive that contacts packaged dry food shall not exceed the limits of good manufacturing practice In fatty and aqueous foods The quantity of adhesive that contacts packaged fatty and aqueous foods shall not exceed the trace amount at seams and at the edge exposure between packaging laminates that may occur within the limits of good manufacturing practice Under normal conditions of use the packaging seams or laminates will remain firmly bonded without visible separation 11

12 Food Contact Notifications The Food Contact Notification process is the primary means for the FDA to authorize new uses of food additives that are Food Contact Substances (FCS). A Food Contact Substance is defined as any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food. For a concentration in the daily diet from 0.5 ppb to 1 ppm Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations Effective after 120 days (if FDA does not object) Withdrawal without prejudice Proprietary for manufacturer / notifier and their customers Not published in the 21 CFR, but on the FDA website Limitations For the notified production process only Food types Temperature conditions of use At use concentration maximum in a substrate Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations Preparation of a Notification for a New Use of a Food Contact Substance or FCN Form

13 Guidance for Industry: Dry Foods Dry Foods with Surface Containing No Free Fat or Oil (21 CFR (c), Table 1, Food Type VIII) Dry foods with the surface containing no free fat or oil typically exhibit little to no migration, although some studies have shown migration of certain adjuvants into dry foods (e.g., volatile or low molecular weight adjuvants in contact with porous or powdered foods). If the FCS is intended for use only with dry foods with surface containing no free fat or oil, a migration of 50 ppb may be assumed. This migration level can then be multiplied by the appropriate food-type distribution factor and consumption factor to obtain an estimated dietary concentration. If the intended use for the FCS includes other food types (e.g., acidic, aqueous, or fatty foods), in addition to dry foods with surface containing no free fat or oil, then the migration studies conducted for those food types will subsume any migration for a dry food with surface containing no free fat or oil. If you desire to conduct migration studies for dry foods containing no free fat or oil, consult with FDA for recommended migration protocols. 13

14 Guidance for Industry: Repeat Use Articles Intended for Repeated Use The article should be tested with 10% and 50% ethanol and a food oil (e.g., corn oil) or other fatty-food simulant (e.g., HB307 or Miglyol 812) for 240 hours at the highest intended temperature of use. The test solutions should be analyzed for migration of the FCS after 8, 72, and 240 hours. Sponsors should provide estimates of the weight of food contacting a known area of repeat-use article in a given time period as well as an estimate of the average lifetime of the article. Together with the migration data, this will allow calculation of migration to all the food processed over the service life of the article. In the case of an adjuvant in a repeat-use article, FDA strongly recommends an initial calculation of a "worst-case" level in food by assuming 100% migration of the adjuvant over the service life of the article and dividing that value by the quantity of food processed. If this calculated concentration is sufficiently low, migration studies will be unnecessary. 14

15 Guidance for Industry: Adhesives Adhesives (Room temperature or below) If the adhesive is either separated from food by a functional barrier, or the quantity of adhesive that contacts aqueous and fatty food is limited to the trace amount at seams and edges, then migration levels for the substances generally will be assumed to be no greater than 50 ppb. Applying a CF of 0.14 for adhesives gives a dietary concentration of 7 ppb. If these assumptions cannot be supported, data or calculations should be submitted to model the intended use of any adhesive component. If a sponsor wishes to perform migration testing, multilaminate samples should be fabricated with the maximum anticipated amount of the adhesive component and with the minimum thickness of the food-contact layer. The migration protocol corresponds to condition of use E. Alternatively, migration levels in food can be estimated based on migration modeling (see Section II.D.5.). 15

16 References 21 CFR INDIRECT FOOD ADDITIVES: GENERAL part174 Inventory of Effective Food Contact Substance (FCS) Notifications Notifications/ucm htm Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ ucm htm Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ ucm htm 16

17 Thank you for your attention! Any Questions? Navigating the Regulatory Environment for Food Contact Applications in the USA 17