The China Food and Drug Administration (CFDA) issues a draft version of revised regulations for infant formula.

1. Draft Rules for Infant Formula Processors Launched
Summary: The China Food and Drug Administration (CFDA) issues a draft version of revised
regulations for infant formula.
Tags: infant formula, CFDA, professor, food safety, raw materials, R & D, information
management, storage, distribution
According to Dairy Products China News 1309 issued by CCM, on 2 August, the China Food
and Drug Administration (CFDA) issued the draft revised version of the proposed Detailed
Rules for Infant Formula Processor Approval for 2013 to solicit opinions from the dairy industry
and the public (the previous version was issued by the General Administration of Quality
Supervision, Inspection and Quarantine and took effect from 1 November 2010). The period for
receiving comment on the revised draft lasted for 13 days and closed on 15 August. Compared
with the old version, the new draft is more specific and includes some new regulations, aiming
to increase the requirements for infant formula processors in production and management
aspects. Some new regulations are notable:
• Food safety management. Processors are required to implement Hazard Analysis Critical
Control Point (HACCP) and Good Manufacturing Practice (GMP) systems. Companies are
required to set up a quality and safety management department, with full-time managers
responsible for the establishment, implementation and improvement of the company’s food
safety and quality system
• Raw materials. Processors using raw milk are required to build their own dairy farms, while
those using milk powder are required to have a clear, defined and controlled milk source
(whether through building their own farms, cooperating with other companies or having firm
contractual relationships in place with producers); water supply for processing and cleaning
should be purified to meet the quality standards in the Pharmacopoeia of China; processors
must make a safety and quality assessment of their raw material suppliers and sign a quality
assurance agreement with them, in which both sides must take on responsibility for quality
• R&D capability. Processors should establish an R&D department capable of developing new
infant formula products, determining the products’ shelf life, researching potential risk factors in
the production process and taking corresponding measures. The department should have no
less than 5 researchers, including at least 2 senior engineers or holders of a master’s degree
• Information management. A searchable system should be established to provide information
on labelling, packaging, quality standards and factory inspection report for consumers;
processors must record data on their operations from raw material procurement through to
product sales in order to establish a complete product traceability system
• Storage and distribution. The storage area should have enough space to house all goods in an
orderly fashion, including raw materials, finished products, packing materials etc; the

2. warehouse should be able to protect the goods from the effects of the climate; the company
should complete data records on materials circulation
In addition to the above aspects, some other regulations are more specific and stricter
compared with the old version. For example, in terms of production facilities, the requirements
include cleanliness of the production environment, required production equipment and
detection equipment, etc. More pieces of equipment are required than before: 13 dry blenders
are required instead of 6, for instance, with stricter requirements for these items. This implies
processors will need to buy more equipment, so impacting their production costs.
The core objective of the new document is to strengthen management in the infant formula
sector and ensure the quality and safety of products, signifying the Chinese government’s
determination to promote the development of the local infant formula industry. In line with the
requirement for sector consolidation, it will prove much easier for large-scale processors to
meet the new requirements in areas such as GMP and R&D than for some small scale
processors, which may even lack a technician. Processors are expecting the authorities to
provide more details; there is a general expectation that about half of the small scale
processors may be eliminated from the dairy market, and more strict regulations will follow.
On the same day (2 August), CFDA issued a list of 128 domestic companies that are qualified
for producing infant formula. The list will assist the public to readily identify the producers as a
basis for assessing their qualifications and credentials. CFDA said that it will launch a campaign
to examine and record information on the infant formula processors as part of its efforts to clean
up the industry and standardise product information, and detailed information on the infant
formula producers and their products will be published after this campaign. It indicated that
some small players are expected to be eliminated in this manner.
Table of Contents of Dairy Products China News 1309:
Dairy Industry Progress in Q2
BCA Releases Infant Formula Quality Comparison Report
Infant Formula Sales to Roll Out at Pharmacies
Infant Formula Processors Show Growth in H1
Bacteria Crisis Shakes Chinese Customers’ Confidence
Draft Rules for Infant Formula Processors Launched
Government Promotes Dairy Industry Development
Beijing Sanyuan Continues Integration
Xiyuchun Dairy to Enter Infant Formula Market
Rapid Development of Raw Milk Supply in Heilongjiang
Raw Milk Price Rises
Aohua Food Launches Almond Protein Milk
Dairy Products China News, a monthly publication issued by CCM on 15
th
, offers you the
latest information on new market dynamics, company development, new products, technology,
packaging and raw material supply, etc. It also focuses on the government’s direction and

3. polices, helping you get the whole picture of the industry.
About CCM
CCM is dedicated to market research in China, Asia-Pacific Rim and global market. With a staff
of more than 150 dedicated highly-educated professionals, CCM offers Market Data, Analysis,
Reports, Newsletters, Buyer-Trader Information, Import/Export Analysis, and Consultancy
Service.
For more information, please visit http://www.cnchemicals.com.
Guangzhou CCM Information Science & Technology Co., Ltd.
17th Floor, Huihua Commercial & Trade Mansion, No.80 Xianlie Zhong Road, Guangzhou
510070, China
Tel: 86-20-37616606
Email: econtact@cnchemicals.com