Best practice part a compliance management-Woody Wang

transcript

Best Practice part A: Compliance management

www.selerant.com

Information confidential to and copyright protected by Selerant.

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

Brief Introduction to Food Compliance Service

Communication on trans-department Consistency

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

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

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)

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

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

Regulatory Database Update

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)

Visit http://compliancecloud.selerant.com/ to sign up and for free trial。

Selerant Compliance Cloud

- 10 -

Contents of main regulatory data

- 11 -

• 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

Structured laws & regulation data

- 12 -

Laws & Regulations Management

Type of laws & regulations (1/2)

- 14 -

Code Name Food – Country Food-Country, national laws &

regulations Food – Customer Food-Customer, customer’s

requirements Food – Internal Food-Internal, corporate internal

regulations

Type of laws & regulations (2/2)

- 15 -

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

Select「Food-Country」for the type of laws & regulations, and enter the name.

General rules for labeling (1/4)

- 16 -

Set the country or union (e.g. EU) to which it is applicable.

- 17 -

Set the rules for ingredient list.

- 18 -

Set the rules for nutrition facts.

- 19 -

Select「Food-Country」for the type of laws & regulations, and enter the name.

Nutrition claim (1/5)

- 20 -

Set the country or union (e.g. EU) to which it is applicable.

- 21 -

Set the claim information.

- 22 -

Edit the claim conditions.

- 23 -

Picture of claim editing result.

- 24 -

After creating「Food-country」 laws & regulations and setting the country, create a new 「Limit」.

Standards for use of additives (1/6)

- 25 -

Search the substance specified in the additives laws & regulations.

- 26 -

Set the type of limit.

- 27 -

Set the classification of food applications.

- 28 -

Set the source, upper limit and unit of raw materials.

- 29 -

Picture of the additive input result.

- 30 -

Search of Laws and Regulations

Take the pesticide residue as an example, search by the name of pesticide.

Search of laws and regulations (1/4)

- 32 -

Take the pesticide residue as an example, search by the type of food.

- 33 -

Take the additive as an example, search by the name of additive.

- 34 -

Take the additive as an example, search by food classification+function.

- 35 -

After logging in the system, select the country or region on the map.

Search by Selerant compliance cloud (1/6)

- 36 -

Check the laws & regulations (food additive) and food type (milk and milk product).

- 37 -

Enter the keyword of the substance as required and whether to save the search result.

- 38 -

One relevant law & regulation found in the search result.

- 39 -

One substance and three limits found in the search result.

- 40 -

Four files found in the search result.

- 41 -

Management of Raw Material Specifications (Internal Control

Standards)

Work flow for typical raw material specifications

- 43 -

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

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

Logic of raw material specifications

- 44 -

GB/T18010-1999 Cashew kernel

NY/T486-2002 Cashew

GB/T22165-2008 General Rules for Roasted seeds and

GB16326-2006 Hygienic Standard

for Nuts

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

Raw material specifications (1/2)

- 45 -

Raw material specifications (2/2)

- 46 -

Calculation of Raw Material Compliance

Type of limit

- 48 -

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

Click「laws & regulations calculation」to check the cadmium content compliance of apple.

Calculation of Raw Material Compliance (1/4)

- 49 -

Select「Global Food Contaminates」.

- 50 -

Select proper classification of food.

- 51 -

The calculation result indicates that the cadmium content exceeds the limit (200>50).

- 52 -

Calculation of Formula Compliance

Confirm whether the formula complies with the laws & regulations concerned by 「Calculation of laws & regulations」.

Calculation of Formula Compliance (1/7)

- 54 -

Check「Global Food Additives Calculation」.

- 55 -

Set the product classification tree.

- 56 -

The calculation result indicates that the amount of additive (sucralose) exceeds the specified upper limit.

- 57 -

Modify the amount in the formula (sucralose).

- 58 -

The calculation result indicates that the amount of additive (sucralose) meets the specified limit requirement.

- 59 -

Additional calculation can be carried out to check whether the formula complies with the nutrition claim.

- 60 -

Thank you!

www.selerant.com

Best practice part a compliance management-Woody Wang

Documents