Monday, September 23, 2013

Draft Rules for Infant Formula Processors Launched

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 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

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