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Regulatory Reference Page

SIDI™ PROTOCOL REGULATORY REFERNCE GUIDE

•  Part I-Product Information Datasheet

•  Part II-Site Quality Overview

•  National Food/Dietary Supplement Sites

•  International Food/Dietary Supplement Sites


PART I-PRODUCT INFORMATION DATASHEET

Regulatory Information

Compendia/Regulations

USP/NF
Food Chemical Codex
EUROPEAN PHARMACOPOEIA
EDQM Certificate of Suitability
Chinese Pharmacopoeia

American Herbal Pharmacopoeia

Commission E Monographs

American National Standards Institute (ANSI)

Food Chemicals Codex

U.S. Code of Federal Regulations (CFR)

The International Pharmacopoeia
British Pharmacopoeia

Japanese Pharmacopoeia (JP)
JP Supplement I
JP Supplement II

Japanese Standards for Food Additives

United States Department of Agriculture (USDA)-National Organic Program

General Regulatory

Joint FAO/WHO Expert Committee on Food Additives

U.S. Food and Drug Administration (FDA) New Dietary Ingredient

U.S. FDA Proposed cGMP (21 CFR 111)

U.S. FDA Dietary Supplement Labeling Guide

U.S. FDA GRAS Notification

Health Canada-Natural Health Product Clinical Guidance

U.S. Federal Trade Commission (FTC)-Advertising Guide for Dietary Supplements

Substantiation for Dietary Supplement Claims

Bovine Spongiform Encephalopathy (BSE/TSE)

United States
European Union

Japan
China

Allergens

United States

European Union

Japan

Genetically Modified Organisms (GMO)

United States
European Union

Japan
China

Miscellaneous

Residual Solvents (ICH Q3C)
Residual Solvents Tables and List

Kosher
OU Kosher
Star-K

Halal
ifanca-Islamic Food and Nutritional Council of America
National Organic Standards Board

EMEA/ICH

California Proposition 65

Kosher Certification

Muslim Consumer Group

REACH - European Registration/Classification of Chemicals

EPA OPPT Chemical Fact Sheets

CITES List Protected Plant Species

International Chemical Safety Cards (ICSCs): US National Version


PART II-SITE QUALITY OVERVIEW

Good Manufacturing Practices (GMP) Compliance

ISO International Organization for Standardization

Natural Products Association GMPs

NSF International

FPA Food Products Association

USP/NF

Lab Validation

AOAC Dietary Supplement Methods

FDA Guidance for Industry: Validation

NIH/ODS Analytical Methods and Reference Material Program

Miscellaneous Site Information

HAACP

Statistical Process Control/Process Analytical Technology (PAT)

 

Bio-Terrorism Act

Customs - Trade Partnership Against Terrorism (C-TPAT)

Security Information

Hazardous Materials (HM232)
 

Safety And Environmental Information

Environmental Protection Agency (EPA)

ISO 14000
ISO Standards
ACC RESPONSIBLE CARE

 


NATIONAL FOOD/DIETARY SUPPLEMENT WEBSITES

Argentina

National Administration of Drugs, Food and Medical Technology (ANMAT)  

Austria

The Federal Ministry for Health and Women

Australia

Department of Agriculture, Fish and Forestry

Food Standards Australia New Zealand

Therapeutic Goods Administration

Belgium

Ministry of Social Affairs, Public Health and Environment

The Food Agency

Institute for Agricultural and Fisheries Research

Brazil

National Health Surveillance Agency (ANVISA)

Bulgaria

National Drug Institute

Ministry of Health

Canada

Health Canada

Agriculture and Agri-Food Canada Online

Canadian Partnership for Consumer Food Safety Education

Fisheries and Oceans Canada

Canadian Food Inspection Agency

Chile

Institute of Public Health

China (PRC)

State Food and Drug Administration

State Administration of Traditional Chinese Medicine


Czech Republic

Czech Agriculture and Food Inspection Authority  

Czech Republic National Institute of Public Health

Denmark

National Board of Health

Danish Veterinary and Food Administration  

Estonia

Estonia - Ravimiamet State Agency of Medicines

Ministry of Agriculture

Finland

Finish Food Safety Authority

National Public Health Institute

Ministry of Agriculture and Forestry

France

Ministry of Health

Ministry of Agriculture

French Food Safety Agency    

Germany

Federal Ministry of Food, Agriculture and Consumer Protection

Federal Office of Consumer Protection and Food Safety (BVL)

Greece

National Organization of Medicines

Hong Kong

Food and Environmental Hygiene Department

Hungary

Ministry of Health

India  

Ministry of Food Processing Industries

Indonesia

Ministry of Health

Ireland

Food Safety Authority

Department of Health and Children

Department of Agriculture and Food  

Italy

Ministry of Health

Istituto Nazionale di Economia Agraria  

Japan

Ministry of Health, Labor and Welfare

Korea

Korean Food and Drug Administration

Latvia

Food and Veterinary Service

Lithuania

Ministry of Health

Malta

Department of Public Health, Food Safety Commission

Malaysia

National Pharmaceutical Control Board

Mexico

Mexican Ministry of Agriculture (SAGARPA)

Netherlands

Dutch Ministry/Dutch Food Authority

Medicines Evaluation Board

New Zealand

Food Safety Authority

New Zealand Ministry of Health

Norway

Norwegian Medicines Agency    

Philippines

Phillipine Institute of Traditional and Alternative Health Care (PITAHC)

Bureau of Food and Drugs

Poland

Ministry of Agriculture and Rural Development

Portugal

Ministry of Health  

Singapore

Ministry of Health

Slovenia

Ministry of Agriculture, Forestry and Food

Ministry of Health

Slovak Republic    

State Institute for Drug Control

Spain

Spanish Food Safety Agency (AESA)

Sweden

National Food Administration  

Switzerland

Federal Office of Public Health (FOPH)

Taiwan

Department of Health

Thailand

Thailand FDA

Turkey

Ministry of Agriculture and Rural Affairs

United Kingdom (UK)

Department for Environment, Food and Rural Affairs

Food Standards Agency

United States

Food and Drug Administration

U.S. Codex Office

FDA Food and Cosmetic International Activities

U.S. Food Safety System Country Report

State Health Agencies

Institute of Medicine Daily Reference Intake (DRI)-Vitamins

Institute of Medicine Daily Reference Intake (DRI)-Minerals

Department of Commerce Agencies

Department of State

United States Trade Representative

Export Import Bank of the United States

Office of International Trade

Effects of Food-Safety Perceptions on Food Demand and Global Trade

Food Safety and Inspection Service International Affairs

USDA Foreign Agricultural Service

United States International Trade Commission

Organization of American States

Government and International Organizations

American Herbal Products Association (AHPA)

Consumer Healthcare Products Association (CHPA)

Council for Responsible Nutrition (CRN)

Natural Products Association

National Animal Supplement Council

Vietnam

Food Administration


INTERNATIONAL FOOD/DIETARY SUPPLEMENT WEB SITES

European Union

Health and Consumer Protection Directorate-General

Public Health and Food Issues Agency

European Food Safety Authority (EFSA)

Food Safety: WHO Regional Office for Europe

European Medicines Agency (EMEA)

Food and Agriculture Organization

Food and Agricultural Organization Home Page

Codex Alimentarius

Latin America

Pan-American Health Organization

Other International Links

International Alliance of Dietary/Food Supplement Associations (IADSA )

International Conference on Harmonisation (ICH )

International Union of Pure and Applied Chemistry (IUPAC)

Asia-Pacific Economic Cooperation

International Portal on Food Safety, Animal & Plant Health

Ministries of Health, Agriculture, and Fisheries and Related Agencies

Organization for Economic Cooperation and Development

United Nations

United Nations Environment Programme

World Health Organization (WHO)

WHO Food Safety Programme

World Trade Organization