The Chinese State Council recently announced the draft amendment
of the Food Safety Law ("Draft Amendment") for public
comments through November 29, 2013. A high priority initiative
on the Chinese government's agenda to contain food safety
risks, the Draft Amendment presents the following major
To clarify the segregation of duties amongst competent
The China Food and Drug Administration ("CFDA") will
oversee food manufacturing and distribution through the issuance of
manufacturing and distribution licenses. The National Commission of
Health and Birth Planning ("NCHBP") will be responsible
for the evaluation of food safety risks and development of food
safety standards. The General Administration of Quality
Supervision, Inspection and Quarantine ("AQSIQ") will
oversee the production of food-related products and the
import/export of foods.
To impose more regulatory obligations on food manufacturers and
Food manufacturers and distributors will be expected to comply
with the Good Manufacturing and Sales Practices to be issued by the
CFDA, assign dedicated personnel to food safety management,
establish a management process and build the necessary IT
infrastructure to ensure food traceability, purchase mandatory food
safety liability insurance, regularly conduct self-inspections, and
take necessary measures to withdraw high risk food products from
To enhance controls over health foods, infant formula and
New health food varieties launched or imported for the first
time into China or which contain new ingredients will need to be
approved in advance by the CFDA. Contract manufacturing, OEM
manufacturing or re-packaging of infant formula will be
prohibited. Food importers will be expected to seek prior
approvals from the NCHBP on food safety standards applicable to
imported foods new to China, establish an audit system on the
offshore food manufacturers and distributors to ensure their
compliance with the Chinese food regulations, be held liable for
inaccurate or misleading labels or instructions for use, and cease
importation/recall on imported food products which do not meet the
Chinese food safety standards or are imbued with risks to human
health and safety.
To increase penalties for non-compliance.
In addition to significantly increasing the amount of fines
by three criminal liabilities are expected to be imposed on
individuals who are directly responsible for severe breaches of the
Food Safety Law. Any individual sentenced for imprisonment
will not be allowed to engage in food manufacturing or distribution
in his/her lifetime.
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