As an early Christmas’ gift, the draft Implementing Regulations of PRC Food Safety Law (anxiously awaited for indeed) were released for public comments on December 9, 2015. Comments could be submitted until January 9, 2016, therefore this phase has just concluded and we need to wait for CFDA to issue the final version of the regulation (no timeline is available).
Even though the current draft is not final and can still be modified, it might not be too different from the final version. There is a lot of interesting content, among which would like to focus on the following highlights:
Chinese labels directly printed on the package
For import food, the provisions likely to have the major impact concerns labeling: under art. 114 of the draft, all import food must have Chinese labels directly printed on the package. This means that Chinese labels cannot be stuck anymore upon the original package. Before, this was only required for import infant formula (although de facto this applied also to import milk).
All food exporters shall significantly increase their level of attention on Chinese labels, as mistakes will be very expensive: basically in case of wrong label the whole stock shall be destroyed and reprinted or – only when possible for minor mistakes –“rectified”(which can be extremely time consuming).
Mandatory Chinese labels include – amongst other - ingredient list, nutritional label, expiry date, and there are specific and strict provisions on food denomination, ingredients and additives indication, fonts, position of the items on the packaging, rounding intervals, order of nutrients, label lay-out etc... Important to remember: such provisions are significantly different from those applicable in Hong Kong.
Recall for non compliant label
Non-compliant labels which do not pose threat for food safety do expose anymore the food operator to pay 10-fold punitive damages to the consumer; however they trigger obligation to a Grade-III recall (within 72 hours). This is the case for mistakes of typos, spaces between words, size of fonts, use of traditional Chinese rather than simplified, rounding intervals (for nutrition label) etc..
The new draft has some provisions also for misleading labels (art. 78): expression such as “Specially Supply to”, “Exclusive Supply to” or “Produced with the supervision of” are expressly forbidden, as well as claims “without added”, or “not containing” referred to substances which – according to food safety standards – shall not be contained in food (such as – for instance – non approved GMO).
In case of a plurality of pre-packaged food products packaged together and sold within one external packaging, the draft requires that the manufacture date and best before date on the labels (supposedly: of the external package, although not clearly stated) shall be those of the earliest manufacture date and of the earlies best before date out of all the individual food products (art. 75).
This provision slightly conflicts with the specific article 126.96.36.199 of GB 7718-2011, which allows as date of manufacture declared on the external package also the date on which such external package is formed for sale.
Health food cannot be sold as normal food
Until now, in order to avoid long and costly CFDA registration procedure, many companies exported or sold health-food in China as normal food, waiving any function claims versus a faster entry into the market.
Now this will be completely forbidden. The new draft provides a clearer definition of health food, which implies that all food matching such definition cannot be sold as normal food anymore and must be registered or filed with CFDA as health-food. In particular this applies to:
- food which contains ingredients included in the specific Catalogue of Health-Food Ingredients (art. 81);
- import food which contains ingredients included in the specific Catalogue of Health-Food Ingredients (art. 115);
- food produced in special dosage formulation (pills, capsules, tablet, granules, oral dissolving) having health claims on the labels or even just on the description. Sale as normal food instead of health-food in this case exposes the failing which the guilty operator (producer, importer or trader) shall be subject to CFDA investigation (art. 191).
Let’s remember that under the new 2015 Food Safety Law, registration (time consuming and costly) is required for health food using ingredients not included in the catalogue or imported for the first time, while any other product need a simpler record filing procedure with CFDA. When record filing applies, the application for import of such health food as well as custom clearance shall be done within 3 months (i.e. health-food should arrive at China’s entry port within 3 months).
Finally, ingredients to be used for health-food but not included in the Catalogue cannot be cleared through novel food approval in order to avoid CFDA registration.
Import infant formula must be registered
The draft clarifies that import infant formula shall be subject to CFDA registration (art. 90). This is very important, as prior to issuance of the new Food Safety Law general opinion was that import formula would not need registration.
Milk used for producing infant formula can only be from milk or cow (art. 92). The draft stresses the obligation whereby different formulas for same age infants from one same producer must have significant differences in their formula: in principle, no more than 9 formulas for three series of products can be registered by one company (art. 92).
Infant formula cannot be tailored for specific clients and its distribution cannot be restricted to specific regions. It is not clear which impact such provision has on exclusivity clauses in specific areas with distributors.
Special food to be clearly distinguished from normal food
To give a more physical separation between normal food and special food (i.e. health food, food for special medical purposes and infant formula), art. 89 provides that special food must be sold in specific counters or areas within the shop, clearly marked as “special area/counter for health foods”, “special area/counter for foods for special medical purposes” and “special area/counter for infant formula food”.
At the same time, special food must be kept physically and visually separated also from medicines.
The health-foods area or counter shall clearly mark “these products cannot replace medicine”.
Even stronger separation for specific whole-nutrient formula foods (i.e. food that can be used as single nutrition source for people affected by specific diseases or medical condition): those shall be sold only in hospitals or medicine retailers.
ONLINE AND CROSS BORDER ECOMMERCE
This import channel has become so important to deserve specific mention under the draft Implementing Regulations. All food imported through cross-border ecommerce shall comply with the Food Safety law as well as the regulations to be implemented by AQSIQ. This is an implicit reference to the Detailed Rules for Supervision and Administration on Food Imported by Bonded Mode of Cross-Border E-commerce whose draft has been issued in October 2015 and now is pending final revision by AQSIQ. Based on the draft, we can expect that food to be imported through cross-border ecommerce shall be subject to same requirements as food imported through traditional channels (labels in Chinese, producers to be duly registered with CNCA, etc…).
Third-party platforms shall publish in outstanding space on their webpage the food safety infringements by traders and producers selling through such platform (art. 60).
CONTRACTS ARE MANDATORY
In an attempt to improve their legal compliance, the draft Implementing Regulations specifically requires by food operators to have food safety manager with good knowledge of food safety regulations (art. 41) and to enter into contracts clearly setting the parties’ obligations in several cases:
- outsourcing production of food or additives (art. 34);
- food storage and transportation services (art. 52);
- outsourcing cafeteria services (for schools, hospitals, constructions sites, nurseries) (art. 56);
- outsourcing catering management services (for catering companies) (art. 58);
- outsourcing cleaning and sterilization services (for catering companies) (art. 54).
While these obligations obviously cannot be enforced, having a solid contract can help food operators to disclaim themselves in case of food accidents.
USE OF ADDITIVES IN CATERING
Catering companies, when using additives into self-made food, shall disclose name and amount of such additives (art. 53). The draft does not specify how such disclosure shall be done (in the menu?), nor whether such obligation exists also when additives are already contained into raw material purchased and used to prepare food.