There are concerns that exports to China might be halted if factory registrations are not completed by the deadline. There are also feedback on a lack of clarity and instructions required for completing the registration.
The General Administration of Customs PRC (GACC) announced in April that overseas factories manufacturing all imported food, including health foods/nutraceuticals, will need to be registered with the GACC. The registration certificates will be valid for five years.
At the moment, only overseas manufacturers producing four types of imported food are required to be registered with the GACC. They are meat, aquatic products, dairy – including infant formula, and edible bird’s nest.
With the announcement, the list has been expanded to 18 food categories, including health foods and special dietary products such as Foods for Special Medical Purpose (FSMPs) and complementary foods for toddlers.
In addition, overseas manufacturers of health foods and special dietary foods will need to show proof of recommendation from their country’s competent authority in order to register their factories with the GACC.
Regulatory experts whom NutraIngredients-Asia spoke with said that to date, the GACC had only passed down a general announcement without further details on how the registration would take place.
As such, they believe that GACC’s intention is to allow companies to start registering their factories from January 1 next year, instead of requiring them to complete registrations by then.
“Some of the companies that we worked with are worried that they will no longer be able to export their products to China from January 1 next year since they have not completed registration with the GACC.
“Our understanding is that it is the imperative of GACC to publish further details of the new rules, and as long as the details are not out by then, I believe that the companies will not be penalised and exports will still continue,” Cathy Yu, GM of the food business division at consultancy firm CIRS told NutraIngredients-Asia.
Regulatory manager at US-China Health Products Association (US-China HPA) Charles Diao also expressed similar views.
“We have been monitoring this and communicating with the GACC on this. Since the operational details are not out yet, I believe that the plan is for the GACC to open registrations from January 1 next year,” Diao said.
Both experts believe that there would be a transition period before the new rules are fully implemented.
“The new rules are going to have a big impact since it affects many imported foods and so I believe that there will be a transition period. I don’t expect China to stop incoming exports that are not yet registered with the GACC out of a sudden from January 1 next year,” Diao said.
Yu added that the new rules were not passed down out of the blue. She said that the GACC has been planning to implement custom registrations for overseas manufacturers producing all food products since a few years ago.
“From what I understand, at the moment, although only meat, aquatic products, dairy, and edible bird’s nest need to be registered with the GACC, the GACC has been requesting companies producing other types of food products to register their factories with them in the recent years.
“Some of these are rice, some are ice cream, in other words, the GACC has been implementing the new rules gradually even before announcing its plan of requiring all imported food to be registered,” she said, adding that the reason for the new rule was to ensure safety of imported foods.
Which local authority?
Although the GACC has stated the materials required for registration, it is unclear as to which local authority will be the one overseeing the registration recommendation – which is one of the key problems at this stage.
Logically speaking, GACC will need to issue memos to the overseas authorities to inform that they require registration recommendations from them – at least to the major food exporting countries such as US, Europe, and Australia, said Diao.
Diao believes that in the case of the US, it will be the FDA that is in charge.
The Complementary Medicines Australia (CMA) said in its China Regulatory Update newsletter that it was seeking clarification on which local authority – between the Therapeutic Goods Administration and The Department of Agriculture, Water, and the Environment (DAWE) will be handling the assessment and recommendation.
On the other hand, Diao also foresees that there might be some challenges on how overseas authorities could work with the GACC.
“Some overseas regulators might not readily agree to whatever requirements China is proposing, so they probably will need some time to adjust to one another.
“Also, so compared to general foods, I believe health foods registered with the GACC will be subjected to more complicated regulations, since China is known for having strict regulations for health foods.”
Are CBEC products affected?
On the other hand, both experts differed in their views on whether the new rules would apply to factories manufacturing cross-border e-commerce (CBEC) food products.
Diao believes that CBEC products are unlikely to be affected. He explained that this was because the CBEC trade was regulated by the state council, which has been paying a lot of attention to CBEC.
“Unlike normal trade, CBEC is a B2C model instead of a B2B model. It means that the entire workflow for CBEC exports is different from normal trade,” he said, adding that the state council has been trying to boost the country’s CBEC trade.
In contrast, Yu believes that CBEC products will affected by the new rules.
She explained that this was because pet food sold via CBEC were already required to be registered with the GACC. Thus, it is likely that overseas manufacturers making CBEC food products for human consumption will need to be registered as well.
“All manufacturers making pet food and pet food additives are required to go through the Registration of Overseas Manufacturers of Imported Foods [published by the GACC].
“At first, the registration is not required for manufacturers making pet food for sale via CBEC. But in the recent one to two years, some customs in China have required manufacturers producing pet foods for sale via CBEC to be registered with the customs.
“Since it has already come to this stage for pet food, I believe this would eventually be applied to the food manufacturers as well," Yu said.
What can firms do now?
At the moment, Diao believes that companies can start to contact and notify local regulatory authorities on GACC’s registration rules.
“The best thing to do now is to work with the USFDA first to let them know [about the arrangements and requirements for food exports by the Chinese government]. As for the other matters, we will need to wait for the Chinese government to publish the details.”
He added that the US-China HPA would also contact its members after the GACC has released more details.
Yu, on the other hand, said that there was no real direction for companies to go about working on the GACC registration.
“Right now, there is no clear direction for companies to start preparing for the registration as the GACC has not published the details, we [as a consultancy firm] are also following up closely with the GACC for details.
“We haven’t heard much complaints from our customers, though they did say that the rules are getting stricter,” said Yu.