China new food safety law comprehensive compliance guidance part ii

© REACH24H CONSULTING GROUP CHINA WWW.REACH24H.COM© REACH24H CONSULTING GROUP CHINA WWW.REACH24H.COM
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

1
2
34
Regulations and
administration
of Infant
formula
Content
Development 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 13432-2013
GB 10765-2010
GB 10767-2010
Notifications
CFDA No.133-Reinforce the
supervision of imported infant
formula-2013
AQSIQ 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

Overseas Manufacturer registration
The 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/jks
pjwscqyzcxgxz/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 inspection
2.Certificate for country of origin
3.Sanitary certificate of original country
4.Full testing report
5.Business license
6.Original packaging label
7.Label Chinese translation
8.Chinese label
Required Documents:
1. Original packaging label and Chinese translation
2. Chinese label
3. Exporter business licenses
4. Reference documents of Nutrition or other
claims
5. Other required documents
Required Documents:
1. Result form of inspection
2. 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 submission
2. Registration form for foreign trade dealers
3. Food circulation license
4. Registration certificate of consignor and consignee of import and export
goods
5. China E-port enterprise IC card
6. Membership for China Chamber of Commerce of Foodstuffs
7. Filing for enterprises importing bulk agricultural products subject to
import report
8. 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
 0-6month
GB 10765-2010
Infant formula
 6-12month
GB 10767-2010
Older infants and young
children formula
 12-36month
GB 10767-2010
Older infants and
young children formula
 36+month
GB 19644-2010
Milk powder
Question 3
Q: How to divide stages of Infant formula?
A:

Changes in Food Safety Law

Article 74 The State executes strict
regulations over special foods including
health
foods, foods for special medical
purposes, and infant formula foods.
• Health Foods
• Foods for Special Medical Purposes
• Infant Formula Foods
Food Safety Law-Infant formula

© REACH24H CONSULTING GROUP CHINA WWW.REACH24H.COM© REACH24H CONSULTING GROUP CHINA WWW.REACH24H.COM 29
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 shall
publicize 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
Examples
Shanghai: Whey protein/protein
Nanjing: Whey 63%
Casein 37%
Yantai:

Be familiar with China regulations
Case sharing
H 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 3829
Email: wangningjie@reach24h.cn
www.reach24h.com
36

China new food safety law comprehensive compliance guidance part ii

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