New strict regulations for infant formula - Mark Schaub

Mark Schaub

China has released new rules for infant formula milk powder, one of the most-discussed products after massive domestic scandals and waves of foreign imports, both legally and illegally. Shanghai-based lawyer Mark Schaub discusses at Lexology the impact, as domestic and foreign formulas are now treated equally, and it is going to be more complicated.

Mark Schaub:

The registration procedures for infant formula outlined by the Registration Measures were based upon the PRC drug management system and accordingly the registration procedures for infant formula are complicated and time-consuming. The registration procedure for infant formula has several stages, namely acceptance, review and evaluation, on-site verification, sampling inspection, determination and issuance of decision. 

In addition it should be noted that each stage has a time limit and these time limits can be complicated to determine. At most the procedure will take 170 working days to finish registration commencing from acceptance until issuance. This period does not include collection of supplementary documents required by the CFDA. 

However, it should be noted that the Registration Measures do not provide clear guidance as to how to proceed with on-site verification and sampling inspections for imported formula products and verification periods. 

The Registration Measures provide detailed provisions aimed at avoiding false advertising and causing confusion amongst consumers in respect of  the products including:

• Prohibited to use ambiguous terms such as “imported milk source”, “ecologic pasture”, “imported raw materials”. The applicant is required to clearly identify the source of the product;
• Prohibited from  explicitly or implicitly expressing that there is a health care function;
• Prohibited from including functional expressions, implicitly or explicitly, that the products may increase intelligence, build up resistance, increase immunity or protect the intestine;
• Prohibited from using misleading or negative expression(s) (i.e. “no additives”);

As the Registration Measures would become effective on October 1, 2016, as such, unless the laws stipulated otherwise, the infant formula milk powder manufactured in and imported to China via the trade in goods would subject to this Registration Measures sooner. 

It is important to note the complexity and time limits in respect of registration it is recommended that both domestic or foreign manufacturing enterprises engaging in production of infant formula milk powder to start preparing for and initiating registration procedures as quickly as possible. 

Time is ticking – it should be noted that PRC Ministry of Finance regulations[2] require that registration requirements for infant formula will come into force on January 1, 2018. Accordingly, although there is still time for companies to register but the clock is ticking.  

Brands relying strongly upon the cross-border ecommerce channel should start registration preparations immediately. It is likely that supervisory requirements and procedures for formula products which have not been imported to China via general trade will become more complex and subject to more scrutiny.

More at Lexology.

Mark Schaub is a speaker at the China Speakers Bureau. Do you need him at your meeting or conference? Do get in touch or fill in our speakers' request form.

Are you looking for more strategic experts at the China Speakers Bureau? Do check out this list.  

Tough rules for instant formula - Mark Schaub

Mark Schaub

A range of food scandals with milk powder for babies has caused a wild-west market for mainly foreign instant formula, doing good business in China. Lawyer Mark Schaub warns that regulators are catching up, and new tough registration rules face a deadline for October 1, hard to manage for import products, he writes in Lexology.

Mark Schaub:

New PRC regulations have just been issued that will have a substantive impact on infant formula manufacturers – both international and domestic. 

The Administration Measures for the Registration of Formulas of Infant Formula Milk Powder (“Registration Measures”) was officially published on June 6, 2016 by China Food and Drug Administration (“CFDA”) some eight months after the CFDA released its draft for public comment (“Draft”). The Registration Measures will become effective on October 1, 2016 and their genesis can be found in the PRC Food Safety Law of 2015. 

According to Registration Measures and new Food Safety Law effective since last year, the formulas for all infant formula products manufactured and/or sold in China must be registered with CFDA, otherwise such products may not manufactured or sold. Formula registration is a new approach of PRC government aiming to improve the safety of infant formula products. The Registration Measures have specified the application scope, process, and other related issues. It will have substantial impact on various domestic and foreign diary companies, regardless of their reliance on traditional trade model or cross-border e-commerce. ... 

As the Registration Measures would become effective on October 1, 2016, as such, unless the laws stipulated otherwise, the infant formula milk powder manufactured in and imported to China via the trade in goods would subject to this Registration Measures sooner. It is important to note the complexity and time limits in respect of registration it is recommended that both domestic or foreign manufacturing enterprises engaging in production of infant formula milk powder to start preparing for and initiating registration procedures as quickly as possible. 

Time is ticking – it should be noted that PRC Ministry of Finance regulations[2] require that registration requirements for infant formula will come into force on January 1, 2018. Accordingly, although there is still time for companies to register but the clock is ticking. Brands relying strongly upon the cross-border ecommerce channel should start registration preparations immediately. It is likely that supervisory requirements and procedures for formula products which have not been imported to China via general trade will become more complex and subject to more scrutiny.

More in Lexology. 

Mark Schaub is a speaker at the China Speakers Bureau. Do you need him at your meeting or conference? Do get in touch or fill in our speakers´request form.

Are you looking for more experts who can help you to manage your China risk as the China Speakers Bureau? Do check out this list.