Special foods registration in China

We have attended the Meeting on China’s Special Foods Registration Regulatory Policies held in Beijing on 20 July, 2017.

This meeting was an extremely important moment for sharing data and information about special foods regulatory due to the high profile of the speakers – high officers from CFDA’s special food registration department and international cooperation department, as well as representatives of EU delegation to China and US Embassy

BACKGROUND FOR SPECIAL FOODS

Since 2015 revision of PRC Food Safety Law, Special Food category designates basically (i) health food products, (ii) infant and elder infant formula and (iii) food for special medical purposes (i.e. food products specifically intended for certain demographic groups with certain medical conditions or diseases).

These products – still belonging to the food category rather than pharmaceuticals – are yet subject to specific market entry requirements which differ from so-called ordinary food products. Generally speaking, Special Foods can me imported or anyway marketed in China only if they have prior registered with CFDA. The only exception to registration is for those health-food products which use ingredients listed on a specific catalogue – not yet fully published – and for minerals and vitamins supplements: in this case a simple record/notification is enough to market the products.

Since 2016 until May 2017 several implementing regulations have been approved to regulate the registration and record procedures for these three subcategories of Special Foods, labeling, recipe, claims and advertising. We count not less than 7 fundamental pieces of legislation in this regard, which add up to the many other general standards, laws and provisions applicable to food products.

More importantly, a deadline has been set at 1 January 2018 for what is probably the most premium Special food, i.e. infant formula. This means that by that date, only infant formula already registered with CFDA can be marketed in China.

Additionally, the reform allows each manufacturer to register no more than 3 series with 3 products each (therefore no more than 9 SKUs). Each series include infant milk powder formula (0-6 months, stage 1), older infant milk powder formula (6-12 months, stage 2) and young children milk powder formula (12-36 months, stage 3). (therefore, no more than 9 SKUs registered for each manufacturer).

Finally, a same manufacturer can apply for registration of more than 2 product recipes for same age group only if there are evident difference (明显差异) among recipes, which shall be confirmed with scientific evidence.

GOALS OF THE REFORM

With more than domestic 108 manufacturers marketing more than 2000 infant formula products (!) the goal of the 2015 Special Food reform is clear: the clear the market from excessive number of products, aiming at improving their safety while reduce risks for consumers to be misled and confused by aggressive yet vague/illegitimate advertising and marketing behaviors.

CFDA confirms that the inspiring principles are: safety, consumer protection, science-based approach.

REGULATORY HIGHLIGHTS

Without any aiming to discuss hereby in detail the very complex regulatory framework for infant formula registration, we report hereby some of the most interesting elements highlighted during the Meeting:

• Infant formula is regulated by two national standards; moreover, 68 testing methods apply to this product;
• Infant formula’s product compliance pivots on 30 required nutrients, 17 optional nutrients, 6 edible cultures, 7 monomeric acids;
• Older infant formula compliance pivots on 27 required nutrients and 20 optional ones;
• Registration procedure on principle has a duration between 110 working days and 260 working days – depending on whether document integrations or additional analysis are required by CFDA;
• Only manufacturers – domestic and foreign – are eligible for application;
• Groups having already one subsidiary successfully registered can exploit such registration also to market infant formula from other subsidiaries. In this case therefore a new registration is not required, but the new subsidiary shall prove to have qualified;
• In the application materials, in case foreign standards applicable to raw materials are inconsistent with PRC standards, applicant shall provide evidence of equivalence with PRC standards;
• Stability dossier might not be required for the registration purpose, however applicants are recommended to keep such dossier which will be useful when inspection will be carried out on products at a later stage – for instance, when products are on the shelves and not far from end of shelf life;
• R&D reports and in particular production technology report shall provide clear evidence of how the manufacturer controls that certain forbidden substances are not present into the final product;
• On-site inspection of the manufacturer premises is aimed mainly at verifying that the plant and the manufacturing process is consistent with the information filed with CFDA;
• Each infant formula product to be registered shall have an official name comprised by the product category and also by the specific name identifying that product. Such specific name can include the trademark name only if it meets specific requirements set by the implementing regulations, failing which the trademark can still be used but not in the official denomination and not in the front pack. “Organic” cannot be part of the specific name – even when the product is legally qualified for such claim.

WHERE ARE WE TODAY

According to figures shared by CFDA officers at the Meeting, as of June 30, 2017 already 74 manufacturers applied for registration (of which 57 domestic and 17 foreign), accounting for a total of 427 infant formulas (of which 93 from foreign manufacturers).

Application packages are huge and formalisms requirements are very strict.

General comments by several applicants so far stress that CFDA in practice demands a deep know-how disclosure, which – combined with the officially-declared intention by PRC government to build “Chinese local champions” in the infant formula industry – sounds a little worrying. Again, continuous innovation will be the key to keep an hedge on competition, in a very, very rewarding market such as the Chinese one, and foreign companies seem ready and confident to face challanges.