Heavier fines and stricter criteria: China proposes five changes to infant formula registration process
State Administration of Market Regulation (SAMR) announced that it was seeking public consultation on five changes proposed to the “Administrative Measures for the Registration of Product Formulas of Infant Formula Milk Powder” – a set of regulations first implemented in 2016.
“Since its implementation in Oct 2016, the measures have garnered attention within and outside of the country. There is a need to improve the means to a stricter registration process and clearly state the impermissible conditions,” the proposal said.
The following are the five changes proposed:
1. Stricter registration criteria
If passed, applicants would need to “possess the entire production process (of infant formula milk powder)”.
The proposal also stated the seven conditions under which an application will be rejected.
These include instances whereby applicants do not possess R&D, manufacturing, or inspection capability for the formula registered; or if the raw materials listed in the registration forms do not support or lack evidence to support the science and safety behind the product.
More details on the restrictions regarding product labelling and product manuals will be released at a later date.
2. Heavier penalties for offenders
The submission of any applicant that has been blacklisted as an “enterprise with a serious breach of trust” would not be considered for product registration.
There would also be heavier penalties if changes are made to the product registration certificate, or if the certificate is resold, rented out, or lent to others.
3. Streamlining workflow
The proposed changes would also affect government administration bodies, with the aim to further simplify registration procedures, decentralise power, enhance supervision, and provide better public services.
For example, the amount of time allowed for the administrative parties to inspect infant formula products as part of the product registration process would be reduced from 30 working days to 20 working days under the revised regulations.
In addition, repetitive rounds of inspections will be eliminated to simplify the workflow, and digital certificates will be granted greater legal recognition.
4. Clearer job scope and timeline
As for product inspection units, the proposed state that clearer job scopes, responsibilities and timelines will be outlined accordingly.
These would include adjustments to on-site inspection processes as well as the amount of time that is catered for this.
5. Change of department title
In addition, the name of the department in charge of product registration will be changed from the China Food Drug Administration to the State Administration of Market Regulation.
Accelerating the process
The above changes were proposed in response to a set of food safety working plan released by the central committee of the communist party and the state council about two months ago.
In the working plan, the Chinese authorities also expressed eagerness to revive the country’s infant formula industry, which was hard hit by the 2008 melamine scandal, within the next three years.
Besides releasing a working plan, the Chinese authorities have also introduced initiatives to boost the domestic infant formula industry at a faster rate in recent months.
Earlier this month, the Ministry of Industry and Information Technology (MIIT) launched the country’s first WeChat mini programme that allows consumers to trace the supply chain of infant formula products.
