Migration and Exposure Considerations Jessica Cooper, PhD
|
|
|
- Elmer Boyd
- 6 years ago
- Views:
Transcription
1 Migration and Exposure Considerations Jessica Cooper, PhD Chemistry Reviewer US Food and Drug Administration Office of Food Additive Safety Division of Food Contact Notification
2 FDA Center for Food Safety and Applied Nutrition (CFSAN) Office of Food Additive Safety (OFAS) Division of Petition Review (DPR) Division of Biotechnology and GRAS Notice Review (DBGNR) Division of Food Contact Notifications (DFCN) Direct Additives Color Additives GRAS Substances Biotechnology Food Contact Substances
3 Food Additive All substances the intended use of which results or may reasonably be expected to result, directly or indirectly, in their becoming a component of food or otherwise affecting the characteristics of any food Defined in the Federal Food, Drug and Cosmetic Act (1958), Section 201(s) Require pre-market approval Submission of a Food Additive Petition (FAP) Regulated in Title 21 of the Code of Federal Regulations (21 CFR)
4 Food Contact Substance (FCS) 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 any technical effect in such food. Defined in 1997 Food and Drug Administration Modernization Act (FDAMA) Require pre-market approval - Submission of a Food Contact Notification (FCN) Effective FCNs listed on FDA Website Notifications/ucm htm
5 Food Contact Materials Food Packaging Plastics Metal coatings Paper coatings Paper additives Adhesives Food Processing Filters Lubricants Antimicrobial Agents Conveyor belts Dreamstime.com
6 Food Contact Substances Food Contact Substances are components of food contact materials Review of discrete substances not whole packaging Examples of Food Contact Substances Monomer Catalyst Polymer Polymer modifier Antioxidant Filler Processing aid Antimicrobial agent Oxygen scavenger Stabilizer Epoxy resin Formulation component Colorant Paper additive
7 Food Contact Notification Authorizes new uses of food contact substances Proprietary to the manufacturer / supplier 120-Day statutory review period (from day of acceptance) Must demonstrate that the FCS is safe for the intended use FCN Submission FDA Form 3480 Relevant Information Regulatory Chemistry Toxicology Environmental History Safety Evaluation Impact
8 FDA s Safety Assessment Based on evaluating consumer exposure to a FCS and ensuring that probable dietary exposures are supported by the available toxicological information. Consumer exposure compared to Acceptable Daily Intake Consumer Exposure: EDI < ADI Estimated Daily Intake (EDI) = estimate of the amount of FCS that may be consumed daily by an individual from the intended uses Acceptable Daily Intake (ADI) = estimate of the amount of a FCS that may be consumed daily over a lifetime with reasonable certainty of no harm
9 Toxicology Review Toxicology data needed for establishing a safe level of consumer exposure to an FCS and its constituents Safety Narrative (SN) Describes the scientific basis of the notifier s safety determination Comprehensive Toxicology Profile (CTP) All unpublished and published safety studies and related information relevant to the safety assessment FDA has an exposure-driven tiered approach for safety testing
10 FCN Chemistry Information Chemistry data is reviewed to establish the identity of a FCS and for assessing potential consumer exposure to the FCS. Identity Physical/chemical specification Manufacturing Information Impurities Conditions of Use Technical Effect Stability Migration Levels in Food Exposure Estimates What is the FCS? What has the potential to migrate? How much is migrating? How much are we consuming?
11 Migration Levels in Food An FCS is reasonably expected to become a component of food through migration Migration data is used by FDA to assess potential consumer exposure to a substance (the FCS and its impurities) Migration levels in food may be estimated by: Migration Testing Calculation 100% migration assumption Diffusion theory calculation
12 Typical Migration Testing Accelerated temperature/time conditions intended to simulate thermal processing and extended storage Consistent with the intended conditions of use with respect to use level, food types, and temperatures Use of food simulating solvents rather than real foods
13 Exposure Estimate Focus on the probable exposure that will result from the intended use Exposure Estimates are calculated by combining migration levels with information on uses of food contact articles that contain the FCS Estimate probable consumer exposure in terms of Estimated Daily Intake (EDI, µg/person/day) of the substance
14 Standard Assumptions All calculations are done using highest migration levels 100% Market capture of FCS All food in the diet is in contact with food-contact articles Estimating chronic, average lifetime exposure same exposure, same package, same additive every day, over an entire lifetime Refine exposure calculations for packaging Use of packaging factors
15 Packaging Factors Food-type distribution factor (f T ) distribution of packaging use among food types Example: polymer coated metal f (aq) = 0.16, f (acidic) = 0.35, f (al) = 0.40, f (fatty) = 0.09 Consumption factor (CF) fraction of the daily diet expected to contact specific packaging materials Example: Metal (polymer coated) 0.17 Metal (uncoated) 0.03 Packaging Factors are applied only to food packaging applications
16 Exposure Estimate Total migration of the FCS ( <M> ) <M> = F aq (M aq ) + F acidic (M acidic ) + F alcohol (M alcohol ) + F fatty (M fatty ) Estimated Daily Intake (EDI) EDI = <M> x CF x 3000 g food/person/day = µg FCS/person/day An exposure estimate is calculated for each of the possible migrants (FCS and its impurities)
17 Exposure Estimate: Example FCS is copolymer intended for use as component in can coatings Food types: aqueous, acidic, and fatty foods Maximum temperature of 121 ºC (250 ºF) (High temperature, heat sterilized or retorted) Possible migrants: FCS oligomers (LMWO), monomer A, monomer B, Impurity C
18 Exposure Estimate: Example Migration Testing Test sample: Coating containing FCS Food simulants: 10% ethanol aqueous and acidic foods, miglyol fatty foods Test conditions: High temperature, heat sterilized or retort Test sample heated C and held for 2 hours, then 40 o C for 238 hours for a total of 10 days Tests are conducted in triplicate Samples taken at 2, 24, 96, and 240 hours Test samples analyzed for possible migrants
19 Exposure Estimate: Example Migration Testing Migrant FCS LMWO Migration 10% Ethanol (µg/kg) Monomer A Migration Miglyol (µg/kg) Exposure Calculation For FCS LMWO: <M> = ΣFi (M i ) <M> = F aq (M aq ) + F acidic (M acidic ) + F fatty (M fatty ) <M> = (0.16)(500 µg/kg) + (0.35)(500µg/kg) + (0.09)(600 µg/kg) <M> = 309 µg/kg = 309 ppb Monomer B Impurity C < 5.0 < 5 EDI = CF x <M> x (3kg/p/d) = 0.05 (309 µg/kg ) (3kg/p/d) = 46.4 µg LMWO/p/d
20 Exposure Estimate: Example Chemical Migration 10% Ethanol (µg/kg) Migration Miglyol (µg/kg) <M> (µg/kg) (ppb) EDI (µg/p/d) FCS LMWO Monomer A Monomer B Impurity C < 5.0 < 5 <3 <0.5
21 Application of Packaging Factors Packaging Factors (CF and f T ) are applied for single-use food packaging scenarios Scenarios where Packaging Factors are not applied: Repeat-use scenarios Scenarios where a direct additive calculation might be more appropriate Example: microwave popcorn bag EDI = <M> x g food/p/day (consumption of popcorn) FCS in contact with infant formula and/or human milk
22 FCS in Contact With Infant Formula or Human Milk Examples of food-contact articles: packaged formula, baby bottles, bottle inserts Infant (up to 6 months) Migration Testing Protocols are consistent with general protocols in Chemistry Guidance depending on intended use time and temperatures Exposure estimates account for only one source of food: consumption-to-mass ratio of 140 g/kg bw/d
23 FCN Guidance Documents Administrative IngredientsAdditivesGRASPackaging/ucm htm Chemistry IngredientsAdditivesGRASPackaging/ucm htm Toxicology IngredientsAdditivesGRASPackaging/ucm htm Environmental IngredientsAdditivesGRASPackaging/ucm htm
24
FDA s Food Additives Program
FDA s Food Additives Program LaShonda T. Cureton, PhD Office of Food Additive Safety US Food and Drug Administration Food Additives: A Global Perspective on Safety Evaluation and Use Procedures for Approval
Overview of Regulatory Science of Food Contact Substances
Overview of Regulatory Science of Food Contact Substances Michael A. Adams, PhD Deputy Director, Office of Food Additive Safety FDA, Center for Food Safety and Applied Nutrition 5001 Campus Drive, College
Incorporating Computational Approaches into Safety Assessment
Incorporating Computational Approaches into Safety Assessment Kristi Muldoon Jacobs, Ph.D. Supervisory Toxicologist, DFCN, Office of Food Additive Safety Director (Acting), RIS, Office of Dietary Supplement
Navigating the Regulatory Environment for Food Contact Applications in the USA. PMA 2014 Annual Meeting
Navigating the Regulatory Environment for Food Contact Applications in the USA 1 Introduction to FDA and Food Contact Any food additive should be deemed unsafe unless it is used in conformity with a regulation
The Basics of the FDA s Food Contact Notification Process
The Basics of the FDA s Food Contact Notification Process Seth Goldberg Dr. Mitchell Cheeseman Deborah Attwood November 5, 2015 Copyright 2015 Steptoe & Johnson LLP Moderator: Seth Goldberg Partner in
George Misko is a Partner at Keller and Heckman LLP George joined Keller and Heckman in Mr. Misko's practice focuses on food and drug matters
George Misko is a Partner at Keller and Heckman LLP George joined Keller and Heckman in 1989. Mr. Misko's practice focuses on food and drug matters and environmental concerns, including pesticide regulation,
Food Additives Program
U.S. FDA s Food Additive Program: An Update on Resources and Challenges 18 th Food Packaging Law Seminar October 11, 2017 Arlington, VA 1 Food Additives Program Dennis Keefe, PhD Director, Office of Food
The American Industrial Hygiene Association Stewardship 2015 June 1, 2015
The American Industrial Hygiene Association Stewardship 2015 June 1, 2015 Devon Wm. Hill Partner Keller and Heckman LLP 1001 G Street NW Suite 500 West Washington, DC 20001 +1 202.434.4279 hill@khlaw.com
FDA Food Contact Fundamentals
FDA Food Contact Fundamentals Deborah Attwood 2017 SPE International Polyolefins Conference March 1, 2017 Legal Highlights for Food 1906: Pure Food and Drug Act 1938: Federal Food, Drug and Cosmetic Act
Safety Evaluation for Substances Directly Added to Food
Safety Evaluation for Substances Directly Added to Food Teresa Croce, PhD Office of Food Additive Safety Center for Food Safety and Applied Nutrition US Food and Drug Administration How Does FDA Regulate
SAFETY ASSESSMENT OF FOOD ADDITIVES
SAFETY ASSESSMENT OF FOOD ADDITIVES Department of Health and Human Services U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Acronyms to Know Center for Food Safety and Applied
FOOD CONTACT COATINGS --- A MANUFACTURER S PERSPECTIVE
FOOD CONTACT COATINGS --- A MANUFACTURER S PERSPECTIVE Presented to Mechanical Association Railcar Technical Services Conference September 17, 2009 By Madelyn K. Harding Senior Manager, Corporate Regulatory
The Basics of the U.S. FDA s Regulation of Materials Used in Food Packaging Applications
The Basics of the U.S. FDA s Regulation of Materials Used in Food Packaging Applications RadTech UV & EB Technology Expo & Conference 2012 Presented by David J. Ettinger Partner Keller and Heckman LLP
Comprehensive analysis of the total migrate from can coatings: Solvents vs. simulants vs. foods
Comprehensive analysis of the total migrate from can coatings: Solvents vs. simulants vs. foods What can migrate from FCMs? Known ingredients such as monomers, catalysts, solvents, suspension media, additives,
Harnessing chemical and toxicological data for the evaluation of food ingredients and packaging
Harnessing chemical and toxicological data for the evaluation of food ingredients and packaging Diane M. Schmit, Tammy Page, Kirk B. Arvidson, Patra Volarath, Leighna Holt US Food and Drug Administration
Purpose of this Document
Guidance on the Procedures for Joint Food Safety and Inspection Service (FSIS) and Food and Drug Administration (FDA) Approval of Ingredients and Sources of Radiation Used in the Production of Meat and
SUMMARY: The Food and Drug Administration (FDA or we) is amending the color additive
This document is scheduled to be published in the Federal Register on 08/21/2015 and available online at http://federalregister.gov/a/2015-20676, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
FDA Oversight of Nanotechnology Applications in Foods, Food Packaging, and Nutrient Delivery
FDA Oversight of Nanotechnology Applications in Foods, Food Packaging, and Nutrient Delivery Laura M. Tarantino, Ph.D. Office of Food Additive Safety Center for Food Safety and Applied Nutrition (CFSAN)
Module 34: Legal aspects, ADI and GRAS status of food additives
Paper No.: 13 Paper Title: FOOD ADDITIVES Module 34: Legal aspects, ADI and GRAS status of food additives 34.1 Legal Aspects of Food Additives The data provided by Joint Expert Committee on Food Additives
The Italian approach to the safety assessment of coatings intended for food contact application
The Italian approach to the safety assessment of coatings intended for food contact application Riccardo CREBELLI, Maria Rosaria MILANA Istituto Superiore di Sanità Roma ( ITALY) FIP Network - EFSA ( TC)
Characterization of commercially available nanosilver-polymer composite food packaging
Characterization of commercially available nanosilver-polymer composite food packaging Gregory O. Noonan, Sean Conklin, Laila Ali, Timothy H. Begley Center for Food Safety and Applied Nutrition, US FDA
Using new scientific knowledge to update regulations in the U.S.
Using new scientific knowledge to update regulations in the U.S. Maricel Maffini, Ph.D. Food Packaging Forum 5 October, 2017 US Food Additives Regulatory Program Administered by the Food and Drug Administration
C ONSUMPTION F OOD U SAGE F ACTORS AND PACKAGING. Summary of a Workshop held in July Organised by ILSI Europe Packaging Material Task Force
F OOD C ONSUMPTION AND PACKAGING U SAGE F ACTORS Summary of a Workshop held in July 1996 Organised by ILSI Europe Packaging Material Task Force FOOD CONSUMPTION AND PACKAGING USAGE FACTORS SUMMARY OF
Single use polymeric materials: The science of safety
Engineering Conferences International ECI Digital Archives Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications Proceedings Fall 10-20-2015 Single use polymeric materials: The
Premarket Review. FFDCA Section 201(s) FFDCA Section 201(s) (cont.)
FFDCA Section 201(s) intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food Mitchell
How end-consumer concerns drive raw material innovation in food packaging
How end-consumer concerns drive raw material innovation in food packaging Michaela Hofbauer* 1, Lionel Spack 3 * 1 Eastman Chemical Company, Global Market Leader 3 Nestlé Europe, Senior Packaging Expert
Current state of play on FCMs, including the risk assessment Eric Barthélémy, EFSA FCM team
Current state of play on FCMs, including the risk assessment Eric Barthélémy, EFSA FCM team EFSA safety assessment of FCM Based on guidance for submission of an application (dossier) for safety assessment
NOVEL ADHESIVES AND COATINGS FOR FOOD PACKAGING WITH LOW EXTRACTABLES
NOVEL ADHESIVES AND COATINGS FOR FOOD PACKAGING WITH LOW EXTRACTABLES EARL MELBY, PATRICIA HARMAN, JENNY WEAVER, RICK WILLIAMS >>DYNA-TECH ADHESIVES & COATINGS ABSTRACT Coatings made using monomer free
RISK ASSESSMENT OF PRIMARY PACKAGING MATERIALS FOR FOOD AND BEVERAGES WITH SPECIAL REFERENCE TO PLASTICS
RISK ASSESSMENT OF PRIMARY PACKAGING MATERIALS FOR FOOD AND BEVERAGES WITH SPECIAL REFERENCE TO PLASTICS Dr. S N Sabapathi Defence Food Research Laboratory Mysore 570 011 Food Contact Materials / Substances
GRAS Overview and Industry Perspectives. Janet Balson International Food Additives Council
GRAS Overview and Industry Perspectives Janet Balson International Food Additives Council The International Food Additives Council (IFAC) IFAC is an international association, representing companies who
COMMISSION REGULATION (EU) / of XXX
Ref. Ares(2017)4140854-23/08/2017 EUROPEAN COMMISSION Brussels, XXX SANTE/10578/2017 Rev. 2 CIS (POOL/E2/2017/10578/10578R2-EN CIS.doc) [ ](2017) XXX draft COMMISSION REGULATION (EU) / of XXX on the use
Chemical food safety in the U.S. analysis of FDA s scientific basis for assessing chemical risk. Tom Neltner October 9, 2014
Chemical food safety in the U.S. analysis of FDA s scientific basis for assessing chemical risk Tom Neltner October 9, 2014 Topics 1. Current focus of U.S. public interest community 2. Comparison of U.S.
BISPHENOL A (BPA) RISK MANAGEMENT APPROACH: PERFORMANCE EVALUATION FOR BPA-HEALTH COMPONENT DECEMBER, 2018 HEALTH CANADA.
BISPHENOL A (BPA) RISK MANAGEMENT APPROACH: PERFORMANCE EVALUATION FOR BPA-HEALTH COMPONENT DECEMBER, 2018 HEALTH CANADA Page 1 of 7 Table of Contents BISPHENOL A (BPA) RISK MANAGEMENT APPROACH:... 1 PERFORMANCE
Food Irradiation: FDA s Perspective Teresa Croce, Ph.D.
Food Irradiation: FDA s Perspective Teresa Croce, Ph.D. Office of Food Additive Safety Center for Food Safety and Applied Nutrition US Food and Drug Administration March 25, 2015 Federal Food, Drug, &
COMMISSION REGULATION (EU) / of XXX
Ref. Ares(2017)4140854-23/08/2017 EUROPEAN COMMISSION Brussels, XXX SANTE/10578/2017 Rev. 2 CIS (POOL/E2/2017/10578/10578R2-EN CIS.doc) [ ](2017) XXX draft COMMISSION REGULATION (EU) / of XXX on the use
PACKAGING MIGRATION AND HARMFUL ELEMENT COMPLIANCES. By : Mr. Dilip Singh National Manager SGS India Pvt. Ltd.
PACKAGING MIGRATION AND HARMFUL ELEMENT COMPLIANCES By : Mr. Dilip Singh National Manager SGS India Pvt. Ltd. CONCEPT OF MIGRATION TESTING How do you know if the food packaging you wrap your Food in is
Impact of FCN772 for Future Food Packaging Applications with UV/EB Technology & The Real-Life Converting Practice
Impact of FCN772 for Future Food Packaging Applications with UV/EB Technology & The Real-Life Converting Practice Presented by: Dr. Albert Lin Henkel Corporation Radtech Conference Chicago, May 5, 2008
Recent Progress in the Risk Assessment of FCMs. Laurence Castle
Recent Progress in the Risk Assessment of FCMs Laurence Castle Recent Progress in the Risk Assessment of FCMs TOPICS: 2016 EFSA opinion on FCM 2016 EFSA-WHO Review of the TTC Considerations of Nano Considerations
Food Packaging Forum Workshop 5 October 2017 Zürich, Switzerland
Food Packaging Forum Workshop 5 October 2017 Zürich, Switzerland Packaging Safety Challenges Supply Chain Communication Jim Huang Director, Food Contact Materials Global Scientific & Regulatory Affairs
GRAS Overview and Industry Perspectives. Priscilla Zawislak Ashland, Inc. International Food Additives Council
GRAS Overview and Industry Perspectives Priscilla Zawislak Ashland, Inc. International Food Additives Council IFAC Background The International Food Additives Council (IFAC) is a global association representing
FAQs on bisphenol A in consumer products
FAQs on bisphenol A in consumer products Updated BfR FAQ, 19 February 2015 The substance bisphenol A is contained in polycarbonate products such as food and drink containers and bottles. Bisphenol A is
Inter-Agency Overlap and Jurisdictional Boundaries
Inter-Agency Overlap and Jurisdictional Boundaries FDLI Food Advertising, Labeling, and Litigation Conference September 14, 2017 Jessica P. O Connell Covington & Burling LLP jpoconnell@cov.com 1 FDA Approach/Perspective
IOM3 Afternoon Technical Discussion Meeting. Rubber and Food Contact. 02/07/10. Paul Marchant CSci MIMMM
IOM3 Afternoon Technical Discussion Meeting. Rubber and Food Contact. 02/07/10 Paul Marchant CSci MIMMM 1 Rubber and Food Contact. ARTIS - Polymer R&D laboratory part of Avon Rubber plc. Based in Semington
Opinion. of the Scientific Committee on Food
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Scientific Opinions C2 - Management of scientific committees; scientific co-operation and networks Scientific Committee
KUMHO SAN Overview. November, Kumho Petrochemical Research & Business Development Center
KUMHO Overview November, 2016 Kumho Petrochemical Research & Business Development Center Table of Contents I. General Features of KUMHO Resin II. KUMHO Products III. Food Contact Materials Ⅰ. General Features
FDA Regulation of Claims on Dietary Supplement and Food Products
FDA Regulation of Claims on Dietary Supplement and Food Products Patricia Kaeding August 2004 Topics FDA Overview What are claims Why claims matter Categories of claims Regulatory requirements for types
The Path to U.S. Market for Functional Food Ingredients
The Path to U.S. Market for Functional Food Ingredients American College of Nutrition Symposium Morristown, New Jersey November 18, 2011 DIANE B. McCOLL Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street,
Distillers Grains Opportunities and Challenges
Distillers Grains Opportunities and Challenges RFA National Ethanol Conference February 26, 2008 Linda A. Benjamin, PhD FDA/Center for Veterinary Medicine Center for Veterinary Medicine Approves safe food
memorandum Venable s FDA Practice Group FDA Publishes Draft Guidance on New Dietary Ingredients ( NDIs )
memorandum TO Valued Dietary Supplement Clients DATE July 5, 2011 FROM Venable s FDA Practice Group RE FDA Publishes Draft Guidance on New Dietary Ingredients ( NDIs ) On July 1, 2011, the U.S. Food and
Approaches for the determination of NIAS as a part of Safety-By-Design
Approaches for the determination of NIAS as a part of Safety-By-Design M. Driffield 1, M. Garcia-Lopez 1, E.L. Bradley 1, P.T.K. Oldring 2 1 Fera Science Ltd, 2 Valspar Corp. malcolm.driffield@fera.co.uk
MIGRANTS FROM FOOD CONTACT MATERIALS
MIGRANTS FROM FOOD CONTACT MATERIALS Prof. Sonja Srbinovska Faculty of Agricultural Science and Food, Ss. Cyril and Methodius University in Skopje Eco-sustainable food packaging based on polymer nanomaterials
Indirect Food Additives: Adhesives and Components of Coatings and Paper and Paperboard Components
4 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 175 and 176 [Docket No. 99F-09253 Indirect Food Additives: Adhesives and Components of Coatings and Paper and Paperboard
Taylor C. Wallace, PhD, CFS, FACN, March 22, 2018
Food Ingredients Taylor C. Wallace, PhD, CFS, FACN, March 22, 2018 Disclosures Think Healthy Group, Inc. George Mason University, Department of Nutrition and Food Studies Journal of the American College
The Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j))
The Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j)) January 12, 2011 Cristi Stark, MS Senior Regulatory Health Project Manager Office
Client Alert. FDA Draft Guidance Broadens New Dietary Ingredient Definition and Extends Notification Requirements 1
Contact Attorney Regarding This Matter: Emalee G. Murphy 202.677.4052 - direct 202.677.4053 - fax emalee.murphy@agg.com Attorneys at Law 171 17th Street NW Suite 2100 Atlanta, GA 30363-1031 404.873.8500
Pesticide Inert Ingredient Activities
Pesticide Inert Ingredient Activities CPDA Regulatory Policy Conference Program March 13, 2018 P. V. Shah, Ph.D Chief, Chemistry, Inerts and Toxicology Assessment Branch (CITAB) Registration Division Office
Scientific Challenges in the Risk Assessment of Food Contact Materials 2017 Workshop of the Food Packaging Forum Foundation
Scientific Challenges in the Risk Assessment of Food Contact Materials 2017 Workshop of the Food Packaging Forum Foundation Zürich, October 5, 2017 www.foodpackagingforum.org Welcome FPF s mandate Donations
KEYWAX WX1014 RUBBER WAX CONCENTRATE
PRODUCT DESCRIPTION ADVANTAGES KEYWAX WX1014 RUBBER WAX CONCENTRATE (TYPICAL PROPERTIES) These should not be considered as specifications. KEYWAX WX1014 is a is a blend of 15% polyisobutylene rubber in
Listing of Color Additives Exempt from Certification; Synthetic Iron Oxide
This document is scheduled to be published in the Federal Register on 03/20/2015 and available online at http://federalregister.gov/a/2015-06418, and on FDsys.gov DEPARTMENT OF HEALTH AND HUMAN SERVICES
Epoxy Curing Agents Used in Contact with Food or Potable Water
Epoxy Curing Agents Used in Contact with Food or Potable Water INTRODUCTION In the coatings industry, there are a number of applications where the coating needs to comply with regulations for safe use
Approach for safety assessment of glass fibre-sizing agents in glass fibre-reinforced plastics for food contact
SCIENTIFIC OPINION ADOPTED: 23 June 2015 PUBLISHED: 14 July 2015 doi:10.2903/j.efsa.2015.4168 Approach for safety assessment of glass fibre-sizing agents in glass fibre-reinforced plastics for food contact
Maximum Residue Limits
Maximum Residue Limits a scientific approach to ensure consumer safety ànd (food) animal health Prof Dr Erik De Ridder 1 Residues & safety: ADME Metabolism Distribution Excretion Administration Absorption
Additives for polyolefines: chemistry involved and innovative effects
Additives for polyolefines: chemistry involved and innovative effects Abstract Because many synthetic resins suffer from photo degradation, the investigation of ways to inhibit or at least retard this
Glass Packaging Issues with PET. Key Features Inert and chemically inactive Pure and safe
An ISO 9001:2008 Company Made from nontoxic raw materials - sand, soda ash, limestone, and up to 70 percent recycled glass or cullet - glass is the only packaging material accepted worldwide as generally
Naloxone Expanded Access: OTC status Considerations for a Nonprescription Drug Development Program
Naloxone Expanded Access: OTC status Considerations for a Nonprescription Drug Development Program Andrea Leonard-Segal, M.D., M.S. Director, Division of Nonprescription Clinical Evaluation 1 Contents
Pierre-Marie Baudoin Vandeputte Oleochemicals
Pierre-Marie Baudoin Vandeputte leochemicals Atelier MPR, AG de ValBiom, Gembloux, 25 avril 2012 1 Your linseed oil & vegetable oils derivatives specialist 2 1887: Foundation of the company by the Vandeputte
TOBACCO PRODUCT OR MEDICAL PRODUCT?
TOBACCO PRODUCT OR MEDICAL PRODUCT? Priscilla Callahan-Lyon, MD Deputy Director Division of Individual Health Science Office of Science, CTP Grail Sipes, JD Director Office of Regulatory Policy, CDER Disclaimer:
Q2. What categories of production aids can be used in manufacturing paper pulp?
Q&A of the 4 th Food Contact Material Safety Forum With the publication of new Chinese FCM national safety regulations, the focus of this forum is to discuss the possible impacts on both the surveillance
NEW PACKAGING TECHNOLOGIES- FOOD SAFETY & QUALITY
NEW PACKAGING TECHNOLOGIES- FOOD SAFETY & QUALITY DR TANWEER ALAM JOINT DIRECTOR & REGIONAL HEAD INDIAN INSTITUTE OF PACAKAGING-DELHI Packaging Packaging is a means of ensuring the safe delivery of a product
2014 FDA/JIFSAN Food & Nutrition Webinar
2014 FDA/JIFSAN Food & Nutrition Webinar Medical Foods Shawne Suggs-Anderson, MMSc, _ RD Infant Formula and Medical Foods Staff ONLDS/CFSAN/FDA September 23, 2014 53 Main Objectives History What is a Medical
Fruit Juice and Vegetable Juice as Color Additives in Food: Guidance for Industry
Fruit Juice and Vegetable Juice as Color Additives in Food: Guidance for Industry Draft Guidance This guidance is being distributed for comment purposes only. Although you can comment on any guidance at
NATURAL RESOURCES DEFENSE COUNCIL
NATURAL RESOURCES DEFENSE COUNCIL SENT BY EMAIL AND MAIL October 18, 2013 Dr. Antonia Mattia Office of Food Additive Safety U.S. Food and Drug Administration Mail Stop HFS-255 College Park, MD 20740 Email:
Listing of Color Additives Exempt From Certification; Spirulina Extract
This document is scheduled to be published in the Federal Register on 08/13/2013 and available online at http://federalregister.gov/a/2013-19550, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN
Scientific Opinion on the safety evaluation of the substance, copper hydroxide phosphate, CAS No , for use in food contact materials 1
SCIENTIFIC OPINION Scientific Opinion on the safety evaluation of the substance, copper hydroxide phosphate, CAS No. 12158-74-6, for use in food contact materials 1 EFSA Panel on food contact materials,
Health Canada s Safety Assessment Process for Sugar Substitutes
Health Canada s Safety Assessment Process for Sugar Substitutes Janice Weightman Bureau of Chemical Safety Food Directorate, Health Canada April 24, 2014 Overview Canadians generally have a taste for sweet
Bisphenol A (BPA) in Plastics and Possible Human Health Effects
Order Code RS22869 Updated June 30, 2008 Summary Bisphenol A (BPA) in Plastics and Possible Human Health Effects Linda-Jo Schierow Specialist in Environmental Policy Resources, Science, and Industry Division
FDA REGULATION OF DIETARY SUPPLEMENTS AND FOODS
FDA REGULATION OF DIETARY SUPPLEMENTS AND FOODS Presented by W. Patrick Noonan And Chris Noonan For NUTRITION INDUSTRY ASSOCIATION W. Patrick Noonan, P.C. 21800 Oxnard Street, Suite 840 Woodland Hills,
Packaging Safety FSSAI Perspective by Kumar Anil Advisor (Standards) Food Safety and Standards Authority of India
Packaging Safety FSSAI Perspective by Kumar Anil Advisor (Standards) Food Safety and Standards Authority of India Contents FSSAI and its Structure Overview of Standards Development Procedure Current Scenario
Draft Guidance for Industry and FDA Staff
Draft Guidance for Industry and FDA Staff Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile DRAFT GUIDANCE This guidance document
May 7, Dear Mr. Landa:
Ralph A. Simmons 202 429 6459 rsimmons@steptoe.com 1330 Connecticut Avenue, NW Washington, DC 20036-1795 202 429 3000 main www.steptoe.com May 7, 2013 Michael M. Landa Director, Center for Food Safety
DuPont Neoprene Guide for Safety in Handling and FDA Status of Neoprene Liquid Dispersions
DuPont Neoprene Guide for Safety in Handling and FDA Status of Neoprene Liquid Dispersions Technical Information Rev. 8, July 2010 Introduction The purpose of this bulletin is to present available information
Use of Bridging Justifications to Support the Safety of Excipients in Generic Drug Products
Use of Bridging Justifications to Support the Safety of Excipients in Generic Drug Products Sruthi King, Ph.D. Pharmacology/Toxicology Team Leader Division of Clinical Review, Office of Generic Drugs Center
SAFE AT DIFFERENT APPLICATIONS AND USE PATTERNS. Polycarbonate beverage containers. Typical migration level less than 0,005mg/kg (5ppb)
SAFE AT DIFFERENT APPLICATIONS AND USE PATTERNS There are many different polycarbonate and epoxy products, with different use patterns and exposure situations. This is reflected in different migration
Preventing contamination from food packaging and other food contact materials
Preventing contamination from food packaging and other food contact materials Teagasc Food Packaging seminar for SMEs 29 November 2012 Dr Bernard Hegarty bhegarty@fsai.ie Overview Contamination - How packaging
FDA Activities on Acrylamide, Furan, and Perchlorate
FDA Activities on Acrylamide, Furan, and Perchlorate Lauren Posnick Robin, Sc.D. FDA/CFSAN/OPDF AMI SAC/IC Committee Meeting September 30, 2005 Acrylamide Background on Acrylamide First report, Sweden,
Allergy Inspection Guide (4/01)
Allergy Inspection Guide (4/01) GUIDANCE ON INSPECTIONS OF FIRMS PRODUCING FOOD PRODUCTS SUSCEPTIBLE TO CONTAMINATION WITH ALLERGENIC INGREDIENTS This guidance is reference material for investigators and
Scientific Opinion on the safety assessment of the active substances, palladium metal and hydrogen gas, for use in active food contact materials 1
EFSA Journal 2014;12(2):3558 SCIENTIFIC OPINION Scientific Opinion on the safety assessment of the active substances, palladium metal and hydrogen gas, for use in active food contact materials 1 EFSA Panel
IPAC-RS Conference Rockville, Maryland March 31, 2011
IPAC-RS Conference Rockville, Maryland March 31, 2011 Leachables and Extractables: Evolution of Regulatory Aspects and Perspectives on PQRI Recommendations Guirag Poochikian, Ph.D. Poochikian Pharma Consulting
Draft Scientific Opinion on
DRAFT SCIENTIFIC OPINION ADOPTED: dd mmmm yyyy PUBLISHED: dd mmmm yyyy AMENDED: dd mmmm yyyy doi:10.2903/j.efsa.20yy.nnnn Draft Scientific Opinion on Recent developments in the risk assessment of chemicals
a 1 st list of substances for food contact materials
, 1-9 Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to a 1 st list of substances for
KELLER AND HECKMAN LLP Serving Business through Law and Science
KNiIl KELLER AND HECKMAN LLP Serving Business through Law and Science 1001 G Street, N.W. Suite SOO West Washington, D.C. 20001 tel. 202.434.4100 fax 202.434.4646 Via Electronic and Regular Mail Writer's
The Exposure Matrix Project
The Exposure Matrix Project Assessment of NIAS Based on Exposure Data (Data from Germany only) Dr. Ralf Eisert, BASF SE Matrix Project Team 1 October 2009 Assessment/Evaluation Cascade Monomer(s) listed
Six Classes We can reduce harmful chemicals for a healthier world.
Six Classes We can reduce harmful chemicals for a healthier world. 9 F 17 Cl 35 Br Six classes 1. Highly fluorinated chemicals water and oil repellants, surfactants 2. Antimicrobials triclosan, triclocarban
POLIKAP PVDC COATED FILMS 0Y26, 0X26,0X48
Date: 20/06/2018 REGULATORY COMPLIANCE CERTIFICATE We, Polinas Plastik Sanayii ve Ticareti A.S., hereby declare that the OPP films of the types: comply with the following legislations, POLIKAP PVDC COATED
Global Regulation of Food Additives
Chapter 1 Global Regulation of Food Additives Downloaded via 148.251.232.83 on January 28, 2019 at 18:43:58 (UTC). See https://pubs.acs.org/sharingguidelines for options on how to legitimately share published
Declaration of conformity VEGAPULS 64
Declaration of conformity VEGAPULS 64 Antenna versions PTFE VO (EG) 1935/2004 and VO (EU) 10/2011 as well as acc. to FDA 21 CFR 177.1550 and USP Class VI as well as ADI-free Document ID: 53317 Editing
Update FDA/Center for Food Safety and Applied Nutrition
Update FDA/Center for Food Safety and Applied Nutrition Comments by Susan Mayne, Ph.D. Director Center for Food Safety and Applied Nutrition FDLI Annual Conference May 3, 2018 Food Safety, Nutrition and
Product Declaration FDA Food Contact Specified Products
Ecology & Safety Product Stewardship Product Declaration FDA Food Contact Specified Products Dear Customer, September 16, 2008 is pleased to provide information regarding FDA on the following products:
CFSAN Update Michael M. Landa
CFSAN Update Comments by Michael M. Landa Director, Center for Food Safety and Applied Nutrition JIFSAN Fall Advisory Council Meeting November 14, 2013 1 CFSAN Plan for Program Priorities (2013 2014) Reduce
FOOD SAFETY LEGISLATION INDUSTRY LEAFLET
FOOD SAFETY LEGISLATION INDUSTRY LEAFLET 1 AUTHOR Dr. Sara Limbo University of Milan, Italy EDITORS Dr. Johanna Lahti (WG2 Leader) Tampere University of Technology, Finland Sanne Tiekstra, Msc. (Chair