China new food safety law comprehensive compliance guidance part ii

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Laura Wang

REACH24H Consulting Group China

13th August of 2015

China New Food Safety Law: Comprehensive Compliance Guidance

Session II


Content Part II

Impact on infant formula and compliance solutions

Impact on health (functional) food

Impact on special dietary food


Infant

formula

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Regulations and administration of Infant formula

ContentDevelopment of imported infant formula

Challenges of import companies

Changes in new food safety law


Development of imported infant formula in China


Development of infant formula

2008-2015 Annual growth of imported infant formula


Development of infant formula


Regulations and administration of Infant formula


Regulatory authorities

AQSIQ: Import and export of dairy products

CNCA: Dairy manufacturer registration

CFDA: Production, circulation and safety supervision of dairy products in China

NHFPC: Formulation of national food safety standards for dairy products


Regulations for infant formula

Infant formula

Food Safety Law

National food safety standardsGB 13432-2013GB 10765-2010GB 10767-2010

Notifications

CFDA No.133-Reinforce the supervision of imported infant formula-2013AQSIQ No.3-Notification for adjustment of <Administrative measures for inspection, quarantine and supervision of imported and exported dairy products>-2015

MeasuresAQSIQ No.152-Administrative measures for inspection, quarantine and supervision of imported and exported dairy products -2013

AQSIQ-Administrative Provisions on Filing of Importers and Exporters of Imported Foods-2012

Provisions

Advertising Law


National food safety standards

• GB 7718-2011 General standard for the labeling of prepackaged foods

• GB 14880-2011 Standard for uses of nutrition fortification substances in foods

• GB 2760-2010 Standard for uses of food additives

Labeling General requirements

Ingredients

• GB 13432-2013 General standard for the labeling of prepackaged foods for special dietary uses

• GB 10765-2013 Infant formula

• GB 10767-2013 Older infants and young children

• GB 28050-2010 General standard for nutrition labeling of prepackaged foods

General

Ingredient

Labeling


Import procedure of Infant formula


Procedure before export

Registration of foreign manufacturer of imported foods

Importer and exporter filing (

http://ire.eciq.cn/)

Apply certificate of dairy product export

to China with local Government

Chinese label design

NO

YES

http://ire.eciq.cn/


Overseas Manufacturer registrationThe manufacturer submits the

application form and other registration materials to their

local dairy authority

The local dairy authority will then submit the registration

materials to CNCA

Expert review of the registration materials

submitted

Site visit of the manufacturer

v

CNCA entrusted by China AQSIQ is responsible for the registration affairs

Manufacturer registration is an inter-governmental issue other than an exclusive enterprise behavior

Site visit for the manufacturer will be carried out whenever necessary

Relevant documents for dairy manufacturer registration can be found at CNCA’s website: http://www.cnca.gov.cn/bmzz/zcglb/xgxz/jkspjwscqyzcxgxz/jkrpjwscqyzcxgwj/

http://www.cnca.gov.cn/bmzz/zcglb/xgxz/jkspjwscqyzcxgxz/jkrpjwscqyzcxgwj/

http://www.cnca.gov.cn/bmzz/zcglb/xgxz/jkspjwscqyzcxgxz/jkrpjwscqyzcxgwj/


Issuance of the CNCA-Approved overseas dairy manufacturers

http://www.cnca.gov.cn/ywzl/gjgnhz/jkzl/




Procedure of products arrived target port

Label Filing

CIQ Inspection

Customs Declaration

Required Documents:1. Application form of inspection2. Certificate for country of origin3. Sanitary certificate of original country4. Full testing report5. Business license6. Original packaging label7. Label Chinese translation8. Chinese label

Required Documents:1. Original packaging label and Chinese translation2. Chinese label 3. Exporter business licenses4. Reference documents of Nutrition or other

claims 5. Other required documents

Required Documents:1. Result form of inspection2. Bill of lading, Trade contract, Invoice, Packing list,

Letter of entrustment


CIQ Inspection


Key Point of CIQ inspection

Label requirements at each local CIQ vary a little bit

Label filing is part of the content of CIQ inspection and will only be done when the products arrive at the port

According to AQSIQ announcement No.133-2013 on Enhancing the Imported Baby Formula Management, starting from April 1st of 2014, imported baby formula products must have already have been on the minimum sales packaging before entering into China, and labeling within China has been forbidden.

Products with unqualified labels will be rejected or destroyed


Workflow of inspection &quarantine for imported food

Declaration

Documents Verification

Site Physical Inspection & Sampling

Lab Test

Quarantine Disposal

Import


Accept Application

Verify inspection & quarantine permission (PARTLY),check

certificate of origin Sanitary certificate

of original waybill packing list contract invoice, etc.


Onsite Inspection & Quarantine

Container No. and seal No. in accordance with applied documents

Any food spoilage or abnormal

Container or package is in good condition

Sensory and food label checking

Sampling according to intelligent sampling system and sent to the laboratory for testing.


Test Items

• Microbes

• Physicals & Chemicals

• Mycotoxin

• Pesticide &Drug Residues

• Environmental pollutants

• Quality

• GMO

Lab Testing


Sign to Let Pass or Notify Treatment

Signed inspection & quarantine certificates if qualified, which can be processed, sold or used.


FAQ for import infant formula


Q: What qualification needed for distributor?

A: 1. Importer filing through the system and paper materials submission2. Registration form for foreign trade dealers3. Food circulation license4. Registration certificate of consignor and consignee of import and export goods5. China E-port enterprise IC card6. Membership for China Chamber of Commerce of Foodstuffs7. Filing for enterprises importing bulk agricultural products subject to import report8. Automatic import license

QUESTION 1


Question 2

Q: What tax and testing fees shall the exporter need to pay?

A: Added-value tax:17%Tariff: 5%(most favoured nation )- 40%Testing fee is around 6% of total value of import.


1 2

3 4

0-6monthGB 10765-2010 Infant formula

6-12monthGB 10767-2010 Older infants and

young children formula

12-36monthGB 10767-2010

Older infants and young children

formula

36+monthGB 19644-2010

Milk powder

Question 3Q: How to divide stages of Infant formula?

A:


Changes in Food Safety Law


Article 74 The State executes strict regulations over special foods including

healthfoods, foods for special medical

purposes, and infant formula foods.

• Health Foods

• Foods for Special Medical Purposes

• Infant Formula Foods

Food Safety Law-Infant formula

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Article 81 Infant formula food producers shall implement the whole process quality control from raw material purchase to exit of finished products; each batch of infant formula products exit the factory shall be inspected to guarantee food safety.

The food materials (such as raw milk, supplementary substances) and food additives used for infant formula production shall comply with laws, regulations and provisions, as well as national food safety standards; they shall guarantee sufficient nutritional content for infant growth and development.

Infant formula food producers shall report the raw materials, food additives, product formula and labels to provincial food and drug regulatory department for recording.

Product formula of infant formula foods shall be registered with CFDA by providing the R&D report of the formula as well as other materials proving the science and safety of the formula.

Infant formula foods are not allowed to be produced in the means of sub-packaging; the same company is not allowed to produce infant formula powder of different brands by using the same formula.



Article 82 The person who applies for the registration or filing of health foods, foods for special medical purposes and infant formula foods shall take responsibility of the trueness of the materials submitted.The provincial and above level food and drug regulatory department shallpublicize the catalogue of health foods, foods for special medical purposes and infant formula foods that have been registered or filed, and keep the commercial information obtained from registration or filing confidential.Manufacturers of health foods, foods for special medical purposes and infant formula foods shall organize the production in accordance with the registered or filed product formula and production techniques.



Article 83 Producers of health foods, foods for special medical purposes, infant formula foods, and staple/supplementary food dedicated to other specific populations shall comply with the good manufacturing practice, establish the quality management system that match its produced products. Producers shall conduct self-inspection of the production quality management on a regular basis to guarantee its effective operation; the self-inspection report shall be submitted to the food and drug regulatory department at the county-level government.


Challenges for import companies


Registered formula

• Make sure do not use the same formula for one product in different brands.


Be aware of the local policies

ExamplesShanghai: Whey protein/protein

Nanjing: Whey 63% Casein 37%

Yantai:


Be familiar with China regulations

Case sharingH company exported infant formula to China, at the port, it was inspected that some of the key nutrition does not achieve the level on the label. Total amount of 30k bottles are rejected.

Mistakes:• Too confident in their own testing report, didn’t take pre-GB

testing• Not familiar with Chinese regulation, the way to communicate

with the authority• Bad choice of importer who are less experienced


Thank you for your attention!

Laura Wang

Tel: +86 571 8710 3829Email: [email protected]

www.reach24h.com

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