best practice part a compliance management-woody wang
TRANSCRIPT
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Best Practice part A: Compliance management
www.selerant.com
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Brief Introduction to Food Compliance Service Laws & Regulations Management Applications of Compliance Management
• Search of Laws and Regulations • Management of Raw Material Specifications (Internal Control
Standards) • Calculation of Raw Material Compliance • Calculation of Formula Compliance
Outline
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Brief Introduction to Food Compliance Service
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Communication on trans-department Consistency
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Market demand Product positioning
Compliance requirements
Marketing department Sales unit
Sourcing of raw materials Certification of suppliers Project/R&D requirements
R&D staff Purchasing staff
HACCP、GMP Quality assessment Product inspection
Manufacturer/quality management
Compliance management for marketing/sales process
Compliance management for R&D and design process
Compliance management for manufacturing process
Language of communication on cross-department consistency Uniform product/laws & regulations data platform Enhance formula development/compliance check efficiency
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Up-to-date and user-friendly laws & regulations database • covering more than 100 countries and regions • containing over 1,500,000 pieces of structured laws & regulations data • specific limits, original text of laws & regulations and their sources can be
searched
Contents of laws & regulations database • food additives • food contaminants (pesticide residue, veterinary drug residue, heavy metal
pollution, mycotoxin, etc.) • microbiological indicators • scope and dosage of nutrition enhancers • rules and template for labeling • rules for sensitinogen labeling • food contact materials
Global laws & regulations database
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Food additives • GB 2760-2011 National Food Safety Standards Standards for Use of Food Additives
» (No.16 Notice of Ministry of Health of the People’s Republic of China in 2010) Notice on Approval of Extending the Application Scope of 18 Food Additives Like Grape Skin Red
» (No.23 Notice of Ministry of Health of the People’s Republic of China in 2010) Notice on Approval of Use of Lysozyme and Other Substances as Food Additives and Extending the Application Scope of Certain Food Additives and Nutrition Enhancers
» No.1 Notice of Ministry of Health of the People’s Republic of China in 2012) Notice on Approval of Extending the Application Scope and Dosage of Certain Food Additives and Nutrition Enhancer
» (No.6 Notice of Ministry of Health of the People’s Republic of China in 2012) Notice on Approval of Use of 9 Food Additives Like Purple Sweet Potato Pigments
» (No.15 Notice of Ministry of Health of the People’s Republic of China in 2012) Notice on Approval of Use of 5 New Food Additives Like Trisodium Monohydrogen Diphosphate
» (No.2 Notice of Ministry of Health of the People’s Republic of China in 2013) Notice on Approval of Use of 2 New Food Additives Like Chlorophyllin Copper
» (No.9 Notice of Ministry of Health of the People’s Republic of China in 2013) Notice on Approval of Use of 3 New Food Additives Like Calcium Acid Pyrophosphate
» No.2 Notice of National Health and Family Planning Commission of the People’s Republic of China in 2013) Notice on Approval of Use of Potassium Polymetaphosphate as A New Food Additive
List of existing food laws & regulations in China (1/3)
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Nutrition enhancers • GB 14880-2012 Standards for Use of Food Nutrition Enhancers
» (No.6 Notice of Ministry of Health of the People’s Republic of China in 2012) Notice on Approval of Use of 9 Food Additives Like Purple Sweet Potato Pigments
» (No.15 Notice of Ministry of Health of the People’s Republic of China in 2012) Notice on Approval of Use of 5 New Food Additives Like Trisodium Monohydrogen Diphosphate
» (No.2 Notice of Ministry of Health of the People’s Republic of China in 2013) Notice on Approval of Use of 2 New Food Additives Like Chlorophyllin Copper
» (No.9 Notice of Ministry of Health of the People’s Republic of China in 2013) Notice on Approval of Use of 3 New Food Additives Like Calcium Acid Pyrophosphate
» No.2 Notice of National Health and Family Planning Commission of the People’s Republic of China in 2013) Notice on Approval of Use of Potassium Polymetaphosphate as A New Food Additive
List of existing food laws & regulations in China (2/3)
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Contaminants • GB 2761-2011 National Food Safety Standards Limit of Mycotoxin in Foods • GB 2762-2012 Limit of Contaminants in Foods • GB 2763-2012 Maximum Residue Limit for Pesticides in Foods • Maximum Residue Limit for Veterinary Drug in Animal Foods—Annex to
No.235 Notice of Ministry of Agriculture of the People’s Republic of China
Labeling • GB 7718-2011 National Food Safety Standards General Rules for Labeling of
Prepackaged Foods • GB 28050-2011 National Food Safety Standards General Rules for Nutrition
Labeling of Prepackaged Foods
List of existing food laws & regulations in China (3/3)
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Regulatory Database Update
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Database
Database
• Update • Brand New
Selerant Customer
(Push) New substances should be mapped into raw materials for compliance check
Compliance check can be done via raw materials with existing substances and mappings V1 V2
(After approval)
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Visit http://compliancecloud.selerant.com/ to sign up and for free trial。
Selerant Compliance Cloud
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Contents of main regulatory data
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• Maintenance of subscribed regulatory database
• Push of updates
• News on modification of global food laws & regulations
• News Concerning food safety (Alert/Recall)
• Expert support for local laws & regulations
• Support for local language
Data update service
News bulletin service
Support service
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Structured laws & regulation data
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Laws & Regulations Management
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Type of laws & regulations (1/2)
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Code Name Food – Country Food-Country, national laws &
regulations Food – Customer Food-Customer, customer’s
requirements Food – Internal Food-Internal, corporate internal
regulations
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Type of laws & regulations (2/2)
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Name Example Limit GB 2760 Standards for Use of Food Additives
GB 2763 Maximum Residue Limit for Pesticides in Foods
Nutrition labeling
GB 28050 General Rules for Nutrition Labeling of Prepackaged Foods Prepackaged Foods
Ingredient list GB 7718 General Rules for Labeling of Prepackaged Foods
Nutrition claim GB 28050 General Rules for Nutrition Labeling of Prepackaged Foods GB 13432 General Rules for Labeling of Prepackaged Foods for Special Dietary Uses
Product standards
GB 10765 Infant Formula GB 19645 Pasteurized Milk
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Select「Food-Country」for the type of laws & regulations, and enter the name.
General rules for labeling (1/4)
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Set the country or union (e.g. EU) to which it is applicable.
General rules for labeling (2/4)
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Set the rules for ingredient list.
General rules for labeling (3/4)
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Set the rules for nutrition facts.
General rules for labeling (4/4)
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Select「Food-Country」for the type of laws & regulations, and enter the name.
Nutrition claim (1/5)
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Set the country or union (e.g. EU) to which it is applicable.
Nutrition claim (2/5)
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Set the claim information.
Nutrition claim (3/5)
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Edit the claim conditions.
Nutrition claim (4/5)
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Picture of claim editing result.
Nutrition claim (5/5)
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After creating「Food-country」 laws & regulations and setting the country, create a new 「Limit」.
Standards for use of additives (1/6)
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Search the substance specified in the additives laws & regulations.
Standards for use of additives (2/6)
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Set the type of limit.
Standards for use of additives (3/6)
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Set the classification of food applications.
Standards for use of additives (4/6)
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Set the source, upper limit and unit of raw materials.
Standards for use of additives (5/6)
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Picture of the additive input result.
Standards for use of additives (6/6)
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Search of Laws and Regulations
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Take the pesticide residue as an example, search by the name of pesticide.
Search of laws and regulations (1/4)
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Take the pesticide residue as an example, search by the type of food.
Search of laws and regulations (2/4)
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Take the additive as an example, search by the name of additive.
Search of laws and regulations (3/4)
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Take the additive as an example, search by food classification+function.
Search of laws and regulations (4/4)
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After logging in the system, select the country or region on the map.
Search by Selerant compliance cloud (1/6)
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Check the laws & regulations (food additive) and food type (milk and milk product).
Search by Selerant compliance cloud (2/6)
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Enter the keyword of the substance as required and whether to save the search result.
Search by Selerant compliance cloud (3/6)
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One relevant law & regulation found in the search result.
Search by Selerant compliance cloud (4/6)
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One substance and three limits found in the search result.
Search by Selerant compliance cloud (5/6)
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Four files found in the search result.
Search by Selerant compliance cloud (6/6)
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Management of Raw Material Specifications (Internal Control
Standards)
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Work flow for typical raw material specifications
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Q&A Department
Source of new raw material
Admittance of new suppliers
New suppliers
Old supplier
R&D Department Suppliers Department of Supply Chain
Admittance of new suppliers
Admittance of new suppliers
Obtain standard data
Provide the governing standard concerning the raw material by an Excel
template
Provide national or industrial standards concerning the raw
material
New suppliers
Confirm the indicators and
values
Draft the specification sheet
of raw material
Approval by the R&D Department
Old supplier
Approval by the Q&A Department
Provide the spot check period and other information
Submit the approved specifications sheet of raw material to the purchasing system
Obtain the supplier data from the purchasing system
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Logic of raw material specifications
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GB/T18010-1999 Cashew kernel
NY/T486-2002 Cashew
GB/T22165-2008 General Rules for Roasted seeds and
Nuts
GB16326-2006 Hygienic Standard
for Nuts
Total
Indicators Min Max Min Max Min Max Min Max Min Max Water, % 5 8 15 0 5 Peroxide value (by fat), g/100g 0.5 0.08 0 0.08 Acid value (by fat), mg/g 3 4 0 3 Total arsenic (by As), mg/kg 0.5 0 0.5 Pb, mg/kg 0.2 0 0.2 Hg, mg/kg 0.01 0 0.01 Coliforms, MPN/g 0.3 0 0.3 Hexachlorocyclohexane, mg/kg 0 0 0 DDVP, mg/kg 0.2 0 0.2 Dimethoate, mg/kg 1 0 1
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Raw material specifications (1/2)
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Raw material specifications (2/2)
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Calculation of Raw Material Compliance
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Type of limit
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Type Description
ALLOWED Allowed. Timing: it shall be used with appropriate amount as required by the production
BANNED Banned. Timing: banned
LIMITED IN END APPLICATION Limited in end application. Timing: amount of residue
LIMITED IN FORMULA
Limited in formula. Timing: Maximum amount equals to the specified value
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Click「laws & regulations calculation」to check the cadmium content compliance of apple.
Calculation of Raw Material Compliance (1/4)
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Select「Global Food Contaminates」.
Calculation of Raw Material Compliance (2/4)
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Select proper classification of food.
Calculation of Raw Material Compliance (3/4)
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The calculation result indicates that the cadmium content exceeds the limit (200>50).
Calculation of Raw Material Compliance (4/4)
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Calculation of Formula Compliance
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Confirm whether the formula complies with the laws & regulations concerned by 「Calculation of laws & regulations」.
Calculation of Formula Compliance (1/7)
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Check「Global Food Additives Calculation」.
Calculation of Formula Compliance (2/7)
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Set the product classification tree.
Calculation of Formula Compliance (3/7)
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The calculation result indicates that the amount of additive (sucralose) exceeds the specified upper limit.
Calculation of Formula Compliance (4/7)
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Modify the amount in the formula (sucralose).
Calculation of Formula Compliance (5/7)
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The calculation result indicates that the amount of additive (sucralose) meets the specified limit requirement.
Calculation of Formula Compliance (6/7)
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Additional calculation can be carried out to check whether the formula complies with the nutrition claim.
Calculation of Formula Compliance (7/7)
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Q&A
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Thank you!
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