德国特殊医学用途配方食品的法规(欧盟199921EC指令的转换、执行和实施) (1)
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Regulation of Dietary foods for special medical purposes in Germany
德国特殊医学用途配方食品的法规
Transposition, implementation and enforcement of European Directive 1999/21/EC 欧盟1999/21/EC指令的转换、执行和实施
400 350 300 250 200 150 100 50 0
Year
04.11.2014 Folie 11
Notification procedure for FSMP
FSMP通报程序
PROs 优点 → Facilitates an efficient official monitoring of dietary foods for special medical purposes;
German legislation 联邦德国法律
Federal States (“Länder”) 联邦州
Fra Baidu bibliotek
04.11.2014 Folie 4
Ordinance on Dietetic Foodstuffs
膳食食品条例
→ Defines general and specific compositional and information requirements for ‘dietetic foodstuffs’; 定义一般和特殊成分的“膳食食品” 信息的要求 → Requires that foods labeled as dietetic must differ substantially from ‘regular foods’; 要求标签标示为“膳食类”的食品，必须与普通食品有显著区别 → Directive 1999/21/EC was (inter alia) transposed by the Ordinance; 通过此法案将1999/21/EC指令转变为联邦性法规 → No additional specific product related requirements for FSMP beyond Directive 1999/21/EC. 除了1999/21/EC指令,不需要其他特殊的产品相关要求
16 Federal States („Länder“) with 16个联邦州 → their own governments and parliaments; 独立的州政府和议会 → their own state constitutions; 独立的州宪法 → different sizes (400 - 70,000 sqkm); 各州的面积不同，400-7000平方公里 → different numbers of inhabitants (660,000 - 18 million) 常住人口数不同，在66-180万之间
04.11.2014 Folie 7
Notification requirements for FSMP
FSMP通报要求
→ Notification of FSMP is required by Directive 1999/21/EC (Art. 5): 1999/21/EC指令对通报的要求
→ Germany has implemented the obligation to notify FSMP in the Ordinance on Dietetic Foodstuffs (§ 4a) 德国实行在膳食食品条例中要求FSMP必须进行通报 → No pre-marketing authorisation of FSMP in Germany 德国不需要上市前许可
→ For official use only – no public access -> login & pw;
仅官方内部使用，不向公众开放，需要密码登录
→ Technically realised by the powerful and flexible open source web-tool “Alfresco”.
POLAND
04.11.2014 Folie 3
European legislation 欧盟法律
• Regulation (EC) No. 178/2002 “General Food Law” “通用食品法” （EC）No. 178/2002 • Specific Regulations and Directives 专门的法规和指令 • Food and Feed Code (Lebensmittelund Futtermittelgesetzbuch, LFGB) as framework law 以食品和饲料法（LFGB）作为框架法 • Complementary acts 补充法案 • Competent for enforcement of food control and food control legislation 可以实施食品管制及其法规 • Control systems are organised by each Federal State under its own responsibility 各州独立施行控制体系
技术上由高效灵活的开放性企业管理系统Alfresco实现
04.11.2014 Folie 9
Notification system for FSMP
FSMP通报系统
04.11.2014 Folie 10
Number of notifications of Foods for Special Medical Purposes (nutrionally complete and incomplete) 特殊医学用途食品的年通报量（全营养和非全营养配方食品）
04.11.2014 Folie 12
Notification procedure for FSMP
FSMP通报程序
CONs 缺点 → Risk of overwhelming the food inspection authorities due to missing of medical expertise; 由于食品监测机构缺少专业医学人员，存在无法监管的风险 → The application of a standard prior-authorisation procedure would reduce different interpretation and hence ensure better harmonisation across the EU; 采用标准的预授权程序可以减少不同的解释，确保欧盟内协调一致 → Legal difficulties in official sampling at distance selling from outside Germany (EU Member States / Third Countries) 在德国之外销售（欧盟成员国/ 第三国）时官方采样存在法律困难
2司：营养，食品安全，新技术
→ Division 214: Special foods, Food Supplements, Food Additives
214处：特殊食品，食品补充剂，食品添加剂
04.11.2014 Folie 2
The Federal Republic of Germany
联邦德国
04.11.2014 Folie 8
Notification of FSMP
FSMP通报
→ Food business operators (FBO) are required to submit the product's label and a notification form with information about the producer and company details (§ 4a Ordinance on Dietetic Foodstuffs) ;
04.11.2014 Folie 5
Authorization requirement for FSMP production facilities FSMP生产机构要求
→ Producers of FSMP require an official approval (§ 11 of Ordinance on Dietetic Foodstuffs) FSMP生产商需要官方正式许可(§ 11 of Ordinance on Dietetic Foodstuffs) → Issued by the competent control authority of the Federal State (Länder); 由相关联邦州政府的主管部门签发 → Valid for a particular production facility; 只对提出申请的生产机构有效 → Unlimited validity but revocable at any time; 无期限，但可随时撤销 → Demand: Presence of expertise (pharmacist, food chemist or chemist); 需求：有相关专业人员（药剂师，食品化学，化学家） → Demand: Proof of reliability (no repeated violations of the food law); 需求：证据可靠（无违反食品法）
04.11.2014 Folie 6
Authorization requirement for FSMP production facilities FSMP生产机构要求
→ Demand: Presence of appropriate equipment for proper preparation (esp. for precise dosage and homogeneous mixing); 要求：有适合的设备进行生产前的准备工作（尤其是精确的剂量和混合均匀） → Penalties for intentionally violations of § 11: Imprisonment up to one year or a fine; 针对有意触犯 §11: 一年的监禁或是罚款 → Penalties for negligent violations of § 11: fines up to 20,000 Euro 过失性触犯 §11：2万欧元的罚款 → Importers of FSMP need a certificate of conformity with the relevant provisions of the Ordinance on Dietetic Foodstuffs from the competent authority of the country of origin (§ 11a). FSMP进口商需要提供原产国当地主管机构出具符合膳食食品法的证明
www.bmel.de
Federal Ministry of Food and Agriculture
联邦食品与农业部
→ Cabinet-level ministry of the Federal Republic of Germany;
联邦德国内阁级别机构
→ The current Minister for Food and Agriculture is Christian Schmidt ;
食品经销商需提交产品标签和通报单，通报单需包含生产商和公司详情(§ 4a膳食食品条例)
→ The notification system is operated by the Federal Government as a “service” for the Länder;
通报体系由联邦政府负责实施，作为各州的服务
利于有效监控FSMP
→ Puts only a very small administrative burden for businesses;
企业的行政负担非常小
→ The flexibility of the procedure does not hinder innovation.
程序灵活，不阻碍创新
现任食品与农业部部长Christian Schmidt
→ Headquarters are located in Bonn with a second office in Berlin;
总部位于波恩，在柏林设立办事处
→ Department 2: Nutrition, Product Safety, Innovation
德国特殊医学用途配方食品的法规
Transposition, implementation and enforcement of European Directive 1999/21/EC 欧盟1999/21/EC指令的转换、执行和实施
400 350 300 250 200 150 100 50 0
Year
04.11.2014 Folie 11
Notification procedure for FSMP
FSMP通报程序
PROs 优点 → Facilitates an efficient official monitoring of dietary foods for special medical purposes;
German legislation 联邦德国法律
Federal States (“Länder”) 联邦州
Fra Baidu bibliotek
04.11.2014 Folie 4
Ordinance on Dietetic Foodstuffs
膳食食品条例
→ Defines general and specific compositional and information requirements for ‘dietetic foodstuffs’; 定义一般和特殊成分的“膳食食品” 信息的要求 → Requires that foods labeled as dietetic must differ substantially from ‘regular foods’; 要求标签标示为“膳食类”的食品，必须与普通食品有显著区别 → Directive 1999/21/EC was (inter alia) transposed by the Ordinance; 通过此法案将1999/21/EC指令转变为联邦性法规 → No additional specific product related requirements for FSMP beyond Directive 1999/21/EC. 除了1999/21/EC指令,不需要其他特殊的产品相关要求
16 Federal States („Länder“) with 16个联邦州 → their own governments and parliaments; 独立的州政府和议会 → their own state constitutions; 独立的州宪法 → different sizes (400 - 70,000 sqkm); 各州的面积不同，400-7000平方公里 → different numbers of inhabitants (660,000 - 18 million) 常住人口数不同，在66-180万之间
04.11.2014 Folie 7
Notification requirements for FSMP
FSMP通报要求
→ Notification of FSMP is required by Directive 1999/21/EC (Art. 5): 1999/21/EC指令对通报的要求
→ Germany has implemented the obligation to notify FSMP in the Ordinance on Dietetic Foodstuffs (§ 4a) 德国实行在膳食食品条例中要求FSMP必须进行通报 → No pre-marketing authorisation of FSMP in Germany 德国不需要上市前许可
→ For official use only – no public access -> login & pw;
仅官方内部使用，不向公众开放，需要密码登录
→ Technically realised by the powerful and flexible open source web-tool “Alfresco”.
POLAND
04.11.2014 Folie 3
European legislation 欧盟法律
• Regulation (EC) No. 178/2002 “General Food Law” “通用食品法” （EC）No. 178/2002 • Specific Regulations and Directives 专门的法规和指令 • Food and Feed Code (Lebensmittelund Futtermittelgesetzbuch, LFGB) as framework law 以食品和饲料法（LFGB）作为框架法 • Complementary acts 补充法案 • Competent for enforcement of food control and food control legislation 可以实施食品管制及其法规 • Control systems are organised by each Federal State under its own responsibility 各州独立施行控制体系
技术上由高效灵活的开放性企业管理系统Alfresco实现
04.11.2014 Folie 9
Notification system for FSMP
FSMP通报系统
04.11.2014 Folie 10
Number of notifications of Foods for Special Medical Purposes (nutrionally complete and incomplete) 特殊医学用途食品的年通报量（全营养和非全营养配方食品）
04.11.2014 Folie 12
Notification procedure for FSMP
FSMP通报程序
CONs 缺点 → Risk of overwhelming the food inspection authorities due to missing of medical expertise; 由于食品监测机构缺少专业医学人员，存在无法监管的风险 → The application of a standard prior-authorisation procedure would reduce different interpretation and hence ensure better harmonisation across the EU; 采用标准的预授权程序可以减少不同的解释，确保欧盟内协调一致 → Legal difficulties in official sampling at distance selling from outside Germany (EU Member States / Third Countries) 在德国之外销售（欧盟成员国/ 第三国）时官方采样存在法律困难
2司：营养，食品安全，新技术
→ Division 214: Special foods, Food Supplements, Food Additives
214处：特殊食品，食品补充剂，食品添加剂
04.11.2014 Folie 2
The Federal Republic of Germany
联邦德国
04.11.2014 Folie 8
Notification of FSMP
FSMP通报
→ Food business operators (FBO) are required to submit the product's label and a notification form with information about the producer and company details (§ 4a Ordinance on Dietetic Foodstuffs) ;
04.11.2014 Folie 5
Authorization requirement for FSMP production facilities FSMP生产机构要求
→ Producers of FSMP require an official approval (§ 11 of Ordinance on Dietetic Foodstuffs) FSMP生产商需要官方正式许可(§ 11 of Ordinance on Dietetic Foodstuffs) → Issued by the competent control authority of the Federal State (Länder); 由相关联邦州政府的主管部门签发 → Valid for a particular production facility; 只对提出申请的生产机构有效 → Unlimited validity but revocable at any time; 无期限，但可随时撤销 → Demand: Presence of expertise (pharmacist, food chemist or chemist); 需求：有相关专业人员（药剂师，食品化学，化学家） → Demand: Proof of reliability (no repeated violations of the food law); 需求：证据可靠（无违反食品法）
04.11.2014 Folie 6
Authorization requirement for FSMP production facilities FSMP生产机构要求
→ Demand: Presence of appropriate equipment for proper preparation (esp. for precise dosage and homogeneous mixing); 要求：有适合的设备进行生产前的准备工作（尤其是精确的剂量和混合均匀） → Penalties for intentionally violations of § 11: Imprisonment up to one year or a fine; 针对有意触犯 §11: 一年的监禁或是罚款 → Penalties for negligent violations of § 11: fines up to 20,000 Euro 过失性触犯 §11：2万欧元的罚款 → Importers of FSMP need a certificate of conformity with the relevant provisions of the Ordinance on Dietetic Foodstuffs from the competent authority of the country of origin (§ 11a). FSMP进口商需要提供原产国当地主管机构出具符合膳食食品法的证明
www.bmel.de
Federal Ministry of Food and Agriculture
联邦食品与农业部
→ Cabinet-level ministry of the Federal Republic of Germany;
联邦德国内阁级别机构
→ The current Minister for Food and Agriculture is Christian Schmidt ;
食品经销商需提交产品标签和通报单，通报单需包含生产商和公司详情(§ 4a膳食食品条例)
→ The notification system is operated by the Federal Government as a “service” for the Länder;
通报体系由联邦政府负责实施，作为各州的服务
利于有效监控FSMP
→ Puts only a very small administrative burden for businesses;
企业的行政负担非常小
→ The flexibility of the procedure does not hinder innovation.
程序灵活，不阻碍创新
现任食品与农业部部长Christian Schmidt
→ Headquarters are located in Bonn with a second office in Berlin;
总部位于波恩，在柏林设立办事处
→ Department 2: Nutrition, Product Safety, Innovation