国际食品机械设备卫生安全标准与重要法规
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5. Regulation (EC) 2073/2005 on microbiological criteria for foodstuffs
➢ Determining limits for safe food ➢ Food safety criteria for best before date (BBD) ➢ Process hygiene criteria during manufacturing
Annex II (food business operators)
Surfaces (including surfaces of equipment) … will require the use of smooth, washable, corrosion resistant and non-toxic materials, …(Chapter II)
Basic hygiene principles Food & feed business operator: legal
responsibility for ensuring product safety Unsafe foodstuffs may not be placed on
the market Traceability Consideration of long-term, cumulative
HACCP based on principles of Codex Alimentarius
Control and documentation requirement during the whole production process
Registration is mandatory for all food
manufacturing establishments
9
EU
2. Regulation (EC) 852/2004 on the
hygiene of foodstuffs
Risk assessment - HACCP
➢ Conduct hazard analysis ➢ Determine critical control points (CCP’s) ➢ Establish critical limit(s) ➢ Establish system to monitor CCP’s ➢ Establish corrective action ➢ Establish verification procedure ➢ Establish documentation
12
EU
6. Regulation (EC) 1935/2004 on materials and articles intended to come into contact with food
Scope
All materials and articles intended to come (prospectively) into contact with food: ➢ Processing machinery and filling equipment, ➢ Kitchen equipment, container, packaging
➢ 程序控制
➢ 程序控制
➢ 操作安全性
➢ 操作安全性
➢ 衛生設計
僅需符合「功能」 ➢ 設備滅菌
需求！ ➢ 設備易清洗
需符合「食用衛生 安全」需求！
食品級
6
歐美食品與設備衛生重要法規
7
EU 1. Regulation (EC) 178/2002 on the
hygiene of foodstuffs
11
EU 3. Regulation (EC) 853/2004
Specific hygiene rules for food of animal origin (not about equipment)
4. Regulation (EC) 854/2004
Specific rules for the organization of official controls on products of animal origin intended for human consumption (not about equipment)
equipment, components
installation
function
cleanability
process
HACCP, GMP
production, process
product
personal
cleaning
equipment quality risk assessment (machinery)
material.
13
EU Requirement on materials intended
to come into contact with food :
➢ No human health hazards ➢ No indefensible modification of food composition ➢ No detraction from organoleptic food properties ➢ No misdirection of customers ➢ Use “for food contact” or the symbol ➢ Traceability on all manufacturing and distribution
steps
14
EU 7. Regulation (EC) 2023/2006
Good manufacturing practice for materials and articles intended to come into contact with food
8. Regulation (EU) 10/2011
➢ Personnel, premises und equipment of production, ➢ Quality control and labeling, ➢ Contracted manufacturing and (self-) inspection, ➢ Complaints and product recall
for materials and articles intended to come into contact with fof Machinery vs. Hygienic Control of Process
Hygienic Design
machinery
Plastic materials and articles intended to come into contact with food, revokes Directive 2002/72/EC
15
EU
9. GMP-Directive 2003/94/EC
Principles and guidelines of Good Manufacturing Practice in respect of medicinal products for human use and investigational medicinal products for human use.
effects
8
EU
2. Regulation (EC) 852/2004 on the hygiene of foodstuffs
Primary production (Annex I) and further steps (Annex II)
Analysis of potential food safety risks and determination of Critical Control Points (Hazard Analysis and Critical Control Points - HACCP)
- Regulation (EC) 1935/2004 - on materials and articles intended to come into contact with food
- Regulation (EU) 10/2011 Plastic materials in food contact - Regulation (EC) 2023/2006 - on good manufacturing practice
國際食品機械設備衛生安全 標準與重要法規
楊炳輝 南台灣服務中心 財團法人 食品工業發展研究所
2013.06.27
1
簡報大綱
一、食品機械設備與衛生安全之關聯 二、歐美食品與設備衛生重要法規 三、歐美自願性相關標準 四、設備衛生設計相關建議或標準 五、台灣相關設備衛生規範 六、未來展望
2
Codex Alimentarius - Food Hygiene
repair and condition as to minimise any risk of contamination. Be installed in such a manner as to allow adequate cleaning of the
equipment and the surrounding area.
10
EU
2. Regulation (EC) 852/2004 on the
hygiene of foodstuffs
Annex I (primary production)
Articles, fittings and equipment must be able to be cleaned and, where necessary, to be disinfected.
“Food safety”
➢ Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.
➢ Created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the joint FAO/WHO Food Standards Program.
GMP:
“Quality assurance system, which controls and manages manufacturing and quality control of foods, pharmaceutical products and medical devices.”
GMP-Directive affects:
Articles, fitting and equipment must ….(Chapter V)
Be effectively cleaned and, where necessary, disinfected Be so constructed, be of such materials and be kept in such good order,
product quality risk assessment (product)
5
設備規格與衛生等級
工業級與食品級機械設計之差異
工業級
工業級機械設計 食品級機械設計
➢ 設備功能性
➢ 設備功能性
➢ 材料選用
➢ 選用無毒性材料
➢ 質能傳送效率
➢ 質能傳送效率
➢ 機構設計
➢ 機構設計
➢ 機電整合
➢ 機電整合
3
Food Safety
Equipment / Hardware
Hygienic Design Criteria
Process
Hygiene Food Processing Criteria
Machinery directive 2006/42/EC
EU-regulations: RE (EC) 178/2002 RE (EC) 852/2004 RE (EC) 2073/2005
➢ Determining limits for safe food ➢ Food safety criteria for best before date (BBD) ➢ Process hygiene criteria during manufacturing
Annex II (food business operators)
Surfaces (including surfaces of equipment) … will require the use of smooth, washable, corrosion resistant and non-toxic materials, …(Chapter II)
Basic hygiene principles Food & feed business operator: legal
responsibility for ensuring product safety Unsafe foodstuffs may not be placed on
the market Traceability Consideration of long-term, cumulative
HACCP based on principles of Codex Alimentarius
Control and documentation requirement during the whole production process
Registration is mandatory for all food
manufacturing establishments
9
EU
2. Regulation (EC) 852/2004 on the
hygiene of foodstuffs
Risk assessment - HACCP
➢ Conduct hazard analysis ➢ Determine critical control points (CCP’s) ➢ Establish critical limit(s) ➢ Establish system to monitor CCP’s ➢ Establish corrective action ➢ Establish verification procedure ➢ Establish documentation
12
EU
6. Regulation (EC) 1935/2004 on materials and articles intended to come into contact with food
Scope
All materials and articles intended to come (prospectively) into contact with food: ➢ Processing machinery and filling equipment, ➢ Kitchen equipment, container, packaging
➢ 程序控制
➢ 程序控制
➢ 操作安全性
➢ 操作安全性
➢ 衛生設計
僅需符合「功能」 ➢ 設備滅菌
需求！ ➢ 設備易清洗
需符合「食用衛生 安全」需求！
食品級
6
歐美食品與設備衛生重要法規
7
EU 1. Regulation (EC) 178/2002 on the
hygiene of foodstuffs
11
EU 3. Regulation (EC) 853/2004
Specific hygiene rules for food of animal origin (not about equipment)
4. Regulation (EC) 854/2004
Specific rules for the organization of official controls on products of animal origin intended for human consumption (not about equipment)
equipment, components
installation
function
cleanability
process
HACCP, GMP
production, process
product
personal
cleaning
equipment quality risk assessment (machinery)
material.
13
EU Requirement on materials intended
to come into contact with food :
➢ No human health hazards ➢ No indefensible modification of food composition ➢ No detraction from organoleptic food properties ➢ No misdirection of customers ➢ Use “for food contact” or the symbol ➢ Traceability on all manufacturing and distribution
steps
14
EU 7. Regulation (EC) 2023/2006
Good manufacturing practice for materials and articles intended to come into contact with food
8. Regulation (EU) 10/2011
➢ Personnel, premises und equipment of production, ➢ Quality control and labeling, ➢ Contracted manufacturing and (self-) inspection, ➢ Complaints and product recall
for materials and articles intended to come into contact with fof Machinery vs. Hygienic Control of Process
Hygienic Design
machinery
Plastic materials and articles intended to come into contact with food, revokes Directive 2002/72/EC
15
EU
9. GMP-Directive 2003/94/EC
Principles and guidelines of Good Manufacturing Practice in respect of medicinal products for human use and investigational medicinal products for human use.
effects
8
EU
2. Regulation (EC) 852/2004 on the hygiene of foodstuffs
Primary production (Annex I) and further steps (Annex II)
Analysis of potential food safety risks and determination of Critical Control Points (Hazard Analysis and Critical Control Points - HACCP)
- Regulation (EC) 1935/2004 - on materials and articles intended to come into contact with food
- Regulation (EU) 10/2011 Plastic materials in food contact - Regulation (EC) 2023/2006 - on good manufacturing practice
國際食品機械設備衛生安全 標準與重要法規
楊炳輝 南台灣服務中心 財團法人 食品工業發展研究所
2013.06.27
1
簡報大綱
一、食品機械設備與衛生安全之關聯 二、歐美食品與設備衛生重要法規 三、歐美自願性相關標準 四、設備衛生設計相關建議或標準 五、台灣相關設備衛生規範 六、未來展望
2
Codex Alimentarius - Food Hygiene
repair and condition as to minimise any risk of contamination. Be installed in such a manner as to allow adequate cleaning of the
equipment and the surrounding area.
10
EU
2. Regulation (EC) 852/2004 on the
hygiene of foodstuffs
Annex I (primary production)
Articles, fittings and equipment must be able to be cleaned and, where necessary, to be disinfected.
“Food safety”
➢ Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.
➢ Created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the joint FAO/WHO Food Standards Program.
GMP:
“Quality assurance system, which controls and manages manufacturing and quality control of foods, pharmaceutical products and medical devices.”
GMP-Directive affects:
Articles, fitting and equipment must ….(Chapter V)
Be effectively cleaned and, where necessary, disinfected Be so constructed, be of such materials and be kept in such good order,
product quality risk assessment (product)
5
設備規格與衛生等級
工業級與食品級機械設計之差異
工業級
工業級機械設計 食品級機械設計
➢ 設備功能性
➢ 設備功能性
➢ 材料選用
➢ 選用無毒性材料
➢ 質能傳送效率
➢ 質能傳送效率
➢ 機構設計
➢ 機構設計
➢ 機電整合
➢ 機電整合
3
Food Safety
Equipment / Hardware
Hygienic Design Criteria
Process
Hygiene Food Processing Criteria
Machinery directive 2006/42/EC
EU-regulations: RE (EC) 178/2002 RE (EC) 852/2004 RE (EC) 2073/2005