《《中外保健食品管理制度比较-杨悦20160612》》.ppt

FDA已经认可的十二项健康声称Summary of Qualified Health Claims Subject to Enforcement Discretion Qualified Claims About Cardiovascular Disease Risk 有关心血管疾病的健康声称 Nuts Heart Disease 坚果与心脏病 Walnuts Heart Disease 胡桃与心脏病 Omega-3 Fatty Acids Coronary Heart Disease Ω－3脂肪酸 与冠状动脉性心脏病 B Vitamins Vascular Disease B族维生素与血管病 Monounsaturated Fatty Acids From Olive Oil and Coronary Heart Disease 橄榄油中单不饱和脂肪酸与冠状动脉性心脏病 Unsaturated Fatty Acids from Canola Oil Coronary Heart Disease 油菜籽油中单不饱和脂肪酸与冠状动脉性心脏病 Corn Oil Heart Disease 玉米油与心脏病 Functional declaration in China Should be: assisting lowering blood lipids or antioxidation 在中国注册适合的健康声称为：辅助降血脂或或抗氧化 FDA已经认可的十二项健康声称Summary of Qualified Health Claims Subject to Enforcement Discretion Qualified Claims About Cognitive Function 有关认知功能障碍的功能宣称 Phosphatidylserine Cognitive Dysfunction and Dementia 磷脂酰丝氨酸与认知功能障碍和痴呆 Functional declaration in China Should be: assisting Improves memory 在中国注册适合的健康声称为：辅助改善记忆 FDA已经认可的十二项健康声称Summary of Qualified Health Claims Subject to Enforcement Discretion Qualified Claims About Diabetes 与糖尿病有关的健康声称 Chromium Picolinate Diabetes 甲基吡啶铬与糖尿病 Functional declaration in China Should be: assisting lowering blood glucose 在中国注册适合的健康声称为：辅助降血糖 FDA已经认可的十二项健康声称Summary of Qualified Health Claims Subject to Enforcement Discretion Qualified Claims About Hypertension 有关高血压的健康声称 Calcium Hypertension, Pregnancy-Induced Hypertension, and Preeclampsia 钙与高血压，妊娠性高血压以及先兆子痫 Functional declaration in China Should be: assisting regulating blood-pressure 在中国注册适合的健康声称为：辅助降血压 Qualified Claims About Neural Tube Birth Defects 与神经管缺陷有关的健康声称 0.8 mg Folic Acid Neural Tube Birth Defects 0.8毫克与神经管缺陷 Folic Acid is Drug not health food in China 叶酸在中国作为药品注册，不作为保健品注册 欧洲食品安全局对健康声称的审查EFSA evaluate health claims New function” health claims defined under Article 13.5 of the Regulation are based on new scientific evidence and/or for which protection of proprietary data is requested. They require applicants to provide scientific evidence substa