Authors：CHEN Bing 陈兵, DAI Enchao 戴恩潮
Corporate & Commercial Group, King & Wood Mallesons
Generally speaking, transgenic technologies refer to use of DNA recombination, transformation and other technologies to transfer specific exogenous target genes to the recipient organism, so as to achieve predictable and directional genetic changes. At present, transgenic technologies have been widely used in many fields such as industrial, agricultural, fishery, animal husbandry, medical, environmental protection, etc.
Transgenic technologies can speed up growth of related varieties, increase yield, and enhance disease resistance and adaptability to the environment. However, the possible impact of transgenic technologies on humans and the ecology is not yet clear, so like most countries and regions in the world, China holds a quite cautious attitude toward the application and supervision of transgenic technologies. Because China’s regulations on genetically modified organisms (“GMOs”) mainly focused on agricultural GMOs (“Agricultural GMOs”), this article will mainly discuss regulatory rules, policies and practice on Agricultural GMOs with regard to research and experiment, production and processing, import and export, labeling and other aspects, and address issues that enterprises may face frequently during operation.
II. Basic legal framework and competent authorities of GMO administration in China
The legal concept of “transgene” can be traced back to the year 2000 when the Seed Law was promulgated (where “genetically modified plant varieties” were introduced) and the Fishery Law was amended (where “genetically modified aquatic seedlings” was introduced). Since then, the Agriculture Law (issued in 2002, which puts forward the commonly used concept of “agricultural GMO” which is commonly used at present) and the Animal Husbandry Law (issued in 2005, which puts forward “genetically modified livestock and poultry varieties”) have been issued in succession. At that time, these laws only require “safety evaluation” and take “safety control measures” for the relevant genetically modified varieties in the process of breeding and testing in a general way. In the aspect of labeling, they only require genetically modified seeds “to be labeled with obvious words”.
It is obvious that the above-mentioned regulations are far from being sophisticated to the increasingly common seen transgenic technologies and products. Since 2001, a series of laws and regulations with general binding force or guidance in this field have been promulgated. State Council promulgated Administrative Regulation for the Safety of Agricultural GMOs (“Regulation”) to regulate the research, experiment, production, processing, operation, import and export activities of Agricultural GMOs in China. Ministry of Agriculture (current as Ministry of Agriculture and Rural Affairs) issued three supporting rules in 2002, namely Administrative Measures for the Safety Evaluation of Agricultural GMOs (“Measures for Safety Evaluation“), Administrative Measures for Safety Control of Importation of Agricultural GMOs and Administrative Measures for the Labeling of Agricultural GMOs (“Measures for Labeling“), marking the overall establishment of China’s legal regime of Agricultural GMOs. The Regulation and the three supporting measures have been amended for several times. Up to now, they are still the key regulations and rules in the field of Agricultural GMOs in China. Together with laws with higher effect and other applicable regulations, these regulations and rules established the current supervision framework of GMOs in China.
Ministry of Agriculture and Rural Affairs (“MOA”) and its local counterparts (“Agricultural Department”) are responsible for supervision and management of the safety of Agricultural GMOs throughout the country. The MOA, as the competent authority of Agricultural GMOs industry, is also responsible for reviewing and issuance of Agricultural GMOs Safety Certificate (“Safety Certificate”) which is a critical license for the operation of the relevant industries of agricultural genetically modified crops.
In addition, since the industry of genetically modified crops involve such various aspects as market entry, domestic sales and distribution, import and export, labeling management, and management of various organisms (such as forest trees), therefore, other government authorities such as Forestry Departments, Science and Technology Departments, Development and Reform Commissions, Commerce Departments, Customs, and Market Regulation Departments also play their respective roles in different areas as concerned.
III. Clarification of relevant legal definitions
3.1 Agricultural GMOs
China’s laws and regulations related to genetically modified organisms mainly focus on Agricultural GMOs. The first thing to understand how the GMOs work under PRC law is to have a crystal understanding of the definition of Agricultural GMOs, because it involves whether and how specific regulatory requirements shall be applied, and it is also related to a series of other related definitions (discussed below).
According to the Regulations, Agricultural GMOs refer to “the animals, plants, microorganisms and their products for the use in agricultural production or processing, whose genomic structures have been modified by genetic engineering technologies. They mainly include:
(a) genetically modified animals, plants (including plant seeds, breeding livestock and poultry, aquatic fry and seeds) and microorganisms;
(b) products of genetically modified animals, plants and microorganisms;
(c) products directly processed from genetically modified agricultural products;
(d) plant seeds, breeding livestock and poultry, aquatic fry and seeds, pesticides, veterinary drugs, fertilizers, additives and other products containing ingredients of genetically modified animals, plants and microorganisms or their products.”
From the above definition, it can be seen that an Agricultural GMO is actually a very broad but general concept. The Regulation also provides a few examples in order to provide an easy way to understand what exactly GMOs refer to.
The definition’s item (a) lists “genetically modified animals, plants (including plant seeds, breeding livestock and poultry, aquatic fry and seeds)”, which are generally considered as genetically modified animals, plants and microorganisms, such as “herbicide resistant rape“, “insect resistant soybean”, etc.
What is the specific scope of “genetically modified animals and plants, microorganisms products” in the item (b)? Since relevant legislation or background information does not provide examples for item (b), it is hard to ascertain its exact scope and its relationship with item (a) simply by relying on the literal meaning of item (b), for example, whether the genetically modified animals, plants and microorganisms also fall within the scope of the genetically modified animals, plants and microorganisms products? From the perspective of legislation, since item (a) and item (b) are juxtaposed, logically at least they should not be the same, in other words, there are differences between “genetically modified animals and plants, microorganism’s products” and “genetically modified animals and plants, and microorganisms”. It is worth noting that Measures of Examination and Approval for Processing of Agricultural GMOs (“Processing Approval Measures”) clearly defines “agricultural GMOs processing” as “an activity of producing Agricultural GMOs products by using active Agricultural GMOs as raw materials”. Processing Approval Measures further clarifies that “Agricultural GMOs products” refer to those listed in the above items (b) and (c) in the definition of Agricultural GMOs. To sum up, we tend to believe that item (a) listed by the Regulations refers to active genetically modified animals, plants and microorganisms, such as alive genetically modified “herbicide resistant rape”, alive “insect resistant soybean” or its seeds and seedlings, while item (b) refers to the Agricultural GMOs that no longer alive after initial processing, such as the “herbicide resistant oil” and “insect resistant soybeans” after harvesting and cleaning, etc.
The definition’s item (c) also puts forward the concepts of “genetically modified agricultural products” and “directly processed products”. Although we have not located the formal legal definition of “genetically modified agricultural products”, in a reply to a proposal of People’s Political Consultative Conference in 2015, the MOA once mentioned that “genetically modified agricultural products in domestic market” includes 17 agricultural products under 5 categories, namely, soybean, rape, corn, cotton and tomato, which are the first batch of agricultural products subject to the Labeling Management Catalogue of Agricultural GMOs, as well as subsequently approved cotton, papaya and sugar beet for specific purposes (domestic planting or imported as processing materials). It can be seen that although the commonly understood “genetically modified agricultural products” may include various products made from genetically modified crops, the management of “genetically modified agricultural products” by the Agricultural Department may only be limited to the genetically modified crops themselves, such as the genetically modified crops listed in Labeling Management Catalogue and several genetically modified crops approved subsequently.
As for what is “directly processed products”, the Legislative Affairs Office of the State Council once explained: “directly processed products refer to products directly processed from genetically modified agricultural products“. Although this explanation still does not clearly define “direct processing”, Legislative Affairs Office of State Council listed a number of directly processed products, including soybean meal, soybean oil, bean pulp, corn meal, corn oil, rapeseed oil, rapeseed meal, tomato sauce etc. Even so, the way of enumerative definition is obviously difficult to solve identification issue for all “directly processed products”. In addition, the definition of “directly processed products” also affects scope and definition of genetically modified food. See Section 3.2 below for details.
The scope of products covered by item (d) is relatively broad, and it appears that the category of deeply-processed “food products” (excluding agricultural products and directly processed products explicitly included in the above definition) is not explicitly included in Agricultural GMOs. We are of the opinion that it is reasonable to exclude the “food” category (including prepackaged food sold in the market and food additives under Food Safety Law) from the scope of Agricultural GMOs. In addition to the essential feature of using genetic engineering technologies to change genome composition, Agricultural GMOs should be limited in scope to uses for agricultural production or agricultural products processing according to the Regulations. After further processing, the prepackaged food and other food products that directly enter into consuming market are directly edible, and they are no longer used for agricultural production or processing of agricultural products, so they should no longer belong to the category of Agricultural GMOs. On the other hand, from the perspective of responsibilities of the government authorities, generally food and agricultural products have historically and still are respectively regulated by two different regulatory bodies, i.e., agricultural products, including genetically modified agricultural products, being mainly supervised by Agricultural Department, and food being mainly supervised by market regulation departments at all levels (previously Health Departments, Food and Drug Supervision Departments).
3.2 Genetically modified food
Although Food Safety Law and other relevant laws and regulations require that genetically modified food be labeled conspicuously, and stipulate the legal liabilities for failure to do so, unfortunately, current effective laws and regulations in China do not clearly define the genetically modified food and its scope.
We can only find some clues through several rules that had already been repealed. According to Hygiene Administration Measures for Genetically Modified Food issued by the former Ministry of Health in 2002, “genetically modified food refers to food and food additives that are made from animals, plants and microorganisms whose genome structures have been modified through genetic engineering technologies. These include:
(a) genetically modified animals, plants, or microorganism products;
(b) products directly processed from genetically modified animals, plants, or microorganisms;
(c) food and food additives made from raw materials of genetically modified animals, plants, or microorganisms or their directly processed products.”
Similar to Agricultural GMOs, we believe that item (a) of the definition refers to non-active genetically modified animals, plants and microorganisms that lose their activity after primary processing. This type of products, if classified as food, shall be subject to the rules applied to genetically modified food, or, if used for agricultural production and processing purposes, subject to the rules applied to Agricultural GMOs. The identification of item (b) and (c) are also affected by interpretation of “directly processed products”. For instance, based on our analysis of “directly processed products” in Section 3.1, if the sugar extracted from genetically modified beet is a directly processed product, then a product (such as candy or chocolate) produced with such sugar as an ingredient is certainly a genetically modified food, which shall subject to administration of the genetically modified food, otherwise, it will be free from requirements applied to genetically modified food. In the industrial era of global purchasing, it is very difficult for enterprises to completely eliminate GMOs from all raw materials, clear identification will help enterprises to implement the rules of genetically modified food labeling more effectively, and protect consumers’ right to be informed in a better way.
The Hygiene Administration Measures for Genetically Modified Food issued in 2002 was repealed by Measures for the Administration of New Resource Food in 2007, and the latter was again repealed by Administrative Measures for the Safety Review of New Food Raw Materials in 2013. Neither Measures for the Administration of New Resource Food nor Administrative Measures for the Safety Review of New Food Raw Materials defines the genetically modified food again after the old rule is abolished.
It is worth noting that the former State Administration for Quality Supervision and Inspection and Quarantine issued Inspection Procedures for Labels of Imported and Exported Food and Cosmetics (Trial) in 2006 (“Inspection Procedures”), in which the definition of genetically modified food is basically the same as that under Hygiene Administration Measures for Genetically Modified Food in 2002, except for not including food additives. Regretfully, it was also repealed by an announcement that includes no provision on definition of genetically modified food.
Therefore, the definition of “genetically modified food” in Administration Measures for Genetically Modified Food Hygiene and Inspection Procedures can only be used as a reference. The current laws remain silent on this definition, leaving confusions and inconsistency in implementation of relevant rules.
3.3 Genetically modified products
In the import and export process, there is also a concept of “genetically modified products”, and the Chinese Customs also implements the corresponding regulatory measures based on whether the imported products belong to “genetically modified products”.
According to the amended Measures for the Administration on the Inspection and Quarantine of the Genetically Modified Products Entering and Exiting the Territory (“Inspection and Quarantine Measures“), the “genetically modified products” referred to in Inspection and Quarantine Measures include not only all Agricultural GMOs specified in the Regulations, but also GMOs and products specified in other laws and regulations. Therefore, it is generally understood as long as a product contains GMO (animals, plants, microorganisms) component (whether as raw materials, auxiliary materials or additives), it will be deemed as “genetically modified product”, and the import and export of which shall be subject to Inspection and Quarantine Measures and other customs supervision policies. See section 4.8 for details.
IV. Management system of Agricultural GMOs
4.1 Safety Certificate system during entire industry chain全过程的安全证书制度
All links of Agricultural GMOs (including research and experiment, production, processing, operation, import and export) involve Safety Certificates. Review and issuance of Safety Certificates, one of the most important licenses in GMO sector, is an effective means for the Agricultural Department to regulate this business sector. Like most of the other licenses in China, Safety Certificates can be revoked by the agricultural departments if the concerned Agricultural GMOs cause significant risk to a human beings, animals, plants and the ecological environment and the relevant GMOs would be destroyed accordingly.
Regarding the specific materials for application of the Safety Certificate, Measures for Safety Evaluation have made detailed provisions, which will not be addressed here.
4.2 Research and experiment
Before widespread planting, Agricultural GMOs need to go through the research and experiment stage. The bio-safety committee of Agricultural GMOs is responsible for the safety evaluation and management of research and experiment of Agricultural GMOs.
(a) What are the conditions and procedures for obtaining the Safety Certificate to engage in the research and experiment of Agricultural GMOs?
First of all, it is a must to have safety facilities and measures appropriate to the safety class – this is the condition that all institutions engaged in the research and experiment of Agricultural GMOs need to meet; relevant institutions should also establish an Agricultural GMOs safety team to be responsible for the safety of research and experiment.
According to the degree of risk to human beings, animals and plants, microorganisms and ecological environment, China divides Agricultural GMOs into four classes, I, II, III and IV. The bigger the number of classes, the higher the degree of risk, and the stricter the supervision. For research GMOs of Class III and Class IV, report shall be made to MOA in advance.
The procedures are shown below:
After obtaining the Safety Certificate, the experiment institution can apply for variety approval, registration and other procedures, and then the relevant genetically modified varieties can be promoted and sold in the market.
4.3 Production administration
A market player producing genetically modified plant seeds, breeding livestock and poultry, aquatic fry and seeds shall obtain the production license issued by the MOA. Taking the production of genetically modified crop seeds as an example, the market player shall obtain the Safety Certificate for the relevant varieties and pass the variety approval or registration before planting, or use the seeds that have already obtained the Safety Certificates and the variety approvals or registrations. In addition, the applicant shall also satisfy other planting conditions and have corresponding safety management measures in place before the application for Seed Production License with MOA.
A market player producing genetically modified plant seeds, breeding livestock and poultry, aquatic fry and seeds shall keep production files in accordance with regulations to clearly record the places of production, genes and their sources, methods for genetic modification, as well as the whereabouts of plant seeds, breeding livestock and poultry, aquatic fry and seeds, etc.
After obtaining the approval of the MOA or the provincial Agricultural Department, the business operators engaged in the production or processing of Agricultural GMOs shall organize the production and processing in accordance with the approved varieties, scopes, safety administration requirements and appropriate technical standards, and shall regularly report to the local competent agricultural department of the people’s government at the county level.
4.4 Processing administration
As mentioned above, Agricultural GMO processing refers to producing the Agricultural GMO products (i.e. genetically modified animals and plants, microorganisms products and directly processed products of genetically modified agricultural products) by making use of active Agricultural GMOs as raw materials.
According to Processing Approval Measures, an entity or individual that engages in the processing of Agricultural GMOs within the territory of China shall obtain the Agricultural GMOs Processing License issued by the provincial Agricultural Department at the location of processing (“Processing License”). An entity or individual that engages in the processing of Agricultural GMOs shall not only meet the requirements for establishment as prescribed by applicable laws and regulations but also meet the following requirements:
(a) having the relevant special production line and closed warehousing facilities match the processing of Agricultural GMOs;
(b) having the relevant equipment and facilities for processing wastes and disposing of inactivation;
(c) adopting control measures for pollution disposal in the processing of and conversion between Agricultural GMOs and non-GMOs raw materials;
(d) sound management system for the security of Agricultural GMOs processing.
4.5 Administration on sales and promotion
Currently in China the way of administration and requirements on Agricultural GMOs may differentiate depending on the exact type of GMOs (plant seeds, breeding livestock and poultry, aquatic fry and seeds, and other Agricultural GMOs) as operated by the companies.
Any entity or individual running the business of genetically modified plant seeds, breeding livestock and poultry, aquatic fry and seeds shall obtain an operation license from the MOA. Taking operation of genetically modified plant seeds as an example, market players shall meet the corresponding operational conditions and have corresponding safety management system before applying to the MOA for Seed Operation License.
Any entity or individual operating genetically modified plant seeds shall establish operational files to clearly record the sources, storage, transportation and whereabouts of the seeds etc. Domestic sales of Agricultural GMOs listed in the catalogue of Agricultural GMOs shall comply with applicable provisions on the labeling of Agricultural GMOs. For details, please see the following labeling management section.
In addition, as an important way of marketing, advertising is also restricted by the Chinese law: advertisements for Agricultural GMOs may only be published, broadcasted, and posted only after they have been examined and approved by the MOA.
4.6 Labeling management
In China, except for genetically modified plant seeds, breeding livestock and poultry, aquatic fry and seeds, management of Agricultural GMOs operation are mainly conducted through the labeling system.
Various laws and regulations, such as Food Safety Law and its implementing regulation, Law on Quality and Safety of Agricultural Products, Measures for Labeling and Measures for administration of Packaging and Operation of Agricultural Products, require appropriate labeling of Agricultural GMOs, especially genetically modified food.
(a) What are the specific categories of Agricultural GMOs applicable to labeling management?
Measures for Labeling is a key rule setting out the labelling requirements on GMOs. It also prescribed the mechanism of catalogue that can be amended by MOA from time to time. Any GMOs listed in the catalogue shall follow the labelling requirements. The First Batch of Agricultural GMOs Catalogue (“Labeling Management Catalogue”) lists 17 kinds of Agricultural GMOs under 5 categories (soybean, corn, rape, cotton and tomato) .
However, the Agricultural GMOs that need to be labeled are not limited to the above 5 categories and 17 varieties. Measures for Labeling were issued in 2002. Since then, the MOA has issued Safety Certificates for several other varieties of Agricultural GMOs. Under current system, if these varieties are used for sales after approval, registration and other procedures, the labeling requirement of Agricultural GMOs should also apply. According to our review of the Safety Certificates issued by the MOA, these additionally approved genetically modified plants varieties include rice, beet, rape and papaya.
(b) Is it required to label agricultural genetically modified crops outside Labelling Management Catalogue?
Measures for Labeling stipulates that all Agricultural GMOs listed in Labeling Management Catalogue for sales shall be labeled accordingly, otherwise such products cannot be imported or sold. There is no doubt about those Agricultural GMOs listed in the catalogue. However, does it mean that Agricultural GMOs not listed in the catalogue are not subject to labelling?
For those not listed in the Label Management Catalogue (including the varieties not listed in the subsequently approved lists of Safety Certificates), we tend to hold the opinion that based upon current regulatory principles, they are neither allowed to be imported nor allowed to be used and circulated commercially, so there is no basis for application of the labelling rules. Such interpretation is also consistent with the basic regulatory system established by GMOs’ legislations (reporting and approval system been implemented from research and experiment phase in the beginning, and issuance of Safety Certificate after safety evaluation is passed, and approval and registration of varieties). In addition, the current law requires that products made from Agricultural GMOs or made from products containing Agricultural GMOs components should be labeled even if the genetically modified ingredients are no longer contained or cannot be detected in the final products been sold. Given the final products cannot be detected with genetically modified ingredients are still required to be labeled, it would be hard to come to a conclusion that genetically modified products not listed in the Label Management Catalog do not need to be labeled. According to our communication with relevant officials, Agricultural Department and the Customs also adopt the same position in practice.
(c) What are the specific requirements for the label management of Agricultural GMOs?
First of all, labeling is a mandatory requirement. GMOs shall be labeled by the entity or individual producing or subpacking the products. Unlabeled products shall not be sold.
Secondly, different types of products should meet different labeling requirements:
- Genetically modified plants and animals (including plant seeds, breeding livestock and poultry, aquatic fry and seeds) and microorganisms, genetically modified animal, plant and microorganism products, products such as planting seeds, breeding livestock and poultry, aquatic fry and seeds, pesticides, veterinary medicines, fertilizers and additives that contain genetically modified plant, animal or microorganism ingredients shall be directly labeled as “genetically modified ××“. For example, “genetically modified soybeans”.
- Products directly processed from genetically modified agricultural products shall be labeled as “products (finished products) processed from genetically modified × ×” or “with genetically modified × × as raw materials”. For example, “soybean oil (genetically modified soybean as processing materials)” and “genetically modified rapeseeds as processing materials”.
- Products processed from Agricultural GMOs or from materials containing Agricultural GMO ingredients and for which the genetically modified ingredients are no longer contained or cannot be detected in the final products for sales shall be labelled as “this product is made from genetically modified × ×, but it no longer contains genetically modified ingredients” or labelled as “this product uses genetically modified × × as raw materials, but it no longer contains genetically modified ingredients”.
(d) What such labeling requirements mean?
Special attention shall be paid to “products processed from Agricultural GMOs or from materials containing Agricultural GMO ingredients” in Item (iii) above. In practice it is controversial as to whether all products containing genetically modified ingredients shall be labeled. In fact, the former two labeling requirements (i) and (ii) have completely covered the scope listed in the definition of Agricultural GMOs, while item (iii) is beyond the scope of s definition. We tend to hold the opinion that this provision itself is indeed broad, but from the perspective of legislative logic, labeling examples and multiple other laws and regulations, it should be limited to the scope listed in the definition of “Agricultural GMOs”, rather than including any “genetically modified food”.
The labels of Agricultural GMOs shall be outstanding and shall be designed and printed together with product packaging and product labels, with the exception of attaching the label to the products. The business operators or individuals disassembling the original packaging for sales shall re-label the said products. For the Agricultural GMOs with special requirements on sale scopes, the sale scope shall also be clearly indicated, for example, “only for xx sales (production, processing or use)”, and the GMOs shall be sold within the designated scope.
In addition, other requirements on the position, labeling method, text specifications and color of Agricultural GMOs shall also conform to the national standard of Labeling of Agricultural GMOs (Announcement no.869-1-2007 of the MOA). If it is food, it shall also conform to the relevant regulatory provisions on food labeling.
4.7 Foreign investment management system
(a) Can foreign investors invest in Agricultural GMOs in China?
Like other industries, Special Administrative Measures (Negative List) for Admission of Foreign Investment (“Negative List of Foreign Investment”) shall apply to foreign investment GMO related industries. According to Negative List of Foreign Investment (2019), foreign investment in the breeding of genetically modified varieties of crops, livestock and poultry, and aquatic seedlings and the production of genetically modified seeds (seedlings) are expressly prohibited. Special Administrative Measures (Negative List) for Foreign Investment Access in Pilot Free Trade Zones (2019) has the same rules, which indicates the free trading zones does not offer any exception.
Business activities except for those listed in the Negative List shall be regulated in the same way with domestic investment with respect to market access. Based on the published laws, these business activities (such as R&D， processing and production of GMO products) are permitted for foreign investment.
(b) In addition to market access, what are the regulatory measures that are specifically applicable to foreign investors during their operation?
For example, Regulations clearly stipulate that research and experiment of Agricultural GMOs within China conducted by Sino-foreign cooperation, joint venture or entirely foreign-owned capital shall be approved by the competent agricultural administrative department of the State Council. In contrast, domestic investors shall report to the competent agricultural administrative departments of the State Council prior to the commencement of the research only when the research of Agricultural GMOs is classified as Classes III (with moderate risk) or IV (with high risk).
4.8 Import and export management system
Under current legal supervision regime, China has basically formed such a supervision regime for genetically modified products: for Agricultural GMOs products produced in China, China implements strict catalogue management, and products not in the catalog can neither obtain Safety Certificates nor sell in China. For products imported from abroad, even if they are produced and processed abroad legally, they may not be able to meet the requirements of Agricultural GMOs or genetically modified food in China. Therefore, supervision of such products is conducted in a way of self-declaration during import and random inspection of GMO ingredient in the products. Considering it is impossible to trace the sources of genetically modified food produced abroad, it is reasonable and feasible to regulate imported food by ingredients in the import and export practice.
In April 2018, China allocated the entry-exit inspection and quarantine supervision responsibility from former State Administration for Quality Supervision and Inspection and Quarantine to General Administration of Customs, so competent department of import and export inspection and quarantine (including the inspection and quarantine of genetically modified products) also changed from the former national quality supervision, inspection and quarantine departments to the Customs.
According to Inspection and Quarantine Measures revised by General Administration of Customs, inspection and quarantine measures are applicable to entry and exit of genetically modified products by various means (including trading, processing customer’s materials, mailing, carrying, production, reproduction for others, scientific research, exchange, exhibition, aid, and donation, and other ways). In addition, in view of the broad definition of “genetically modified products” in Inspection and Quarantine Measures, Customs has carried out extensive supervision on relevant products in the process of law enforcement.
The declaration requirement applies to imported genetically modified products. Where a consignor or its agent is handling formalities for entry inspection declaration, it shall indicate in the Bill of Inspection Declaration on Entry Goods whether the goods are genetically modified products. If the goods are declared as genetically modified products, Safety Certificates and the relevant approval documents (for example, the Safety Certificate of genetically modified products imported for research purpose are yet to be obtained) for the concerned goods shall be provided. In addition, according to Administrative Measures for Quarantine of Articles Carried by Entry-Exit Personnel, personnel carrying Agricultural GMOs into China shall provide quarantine certificates issued by the official authorities of the export countries or regions to go through relevant procedures, in addition to Safety Certificates.
GMO Testing: for genetically modified products listed in the catalogue of the Agricultural GMOs, the Customs will decide the way of carrying out GMO testing based whether these products are declared as genetically modified products. If they are declared as genetically modified nature, the Customs shall conduct genetically conformity testing. If the products are declared as non-genetically modified products (no matter on the catalogue of the Agricultural GMOs or not), the Customs will take random inspection to check any genetically modified ingredient is contained. If the products fail to pass the GMO test (including situation in which the products are declared as the genetically modified products, but the genetically modified ingredients do not correspond with the Safety Certificates upon testing; or the products are declared as non-genetically modified products, but there are genetically modified ingredients in them upon testing), Customs shall notify the consignor or his agent to return the goods or destroy them.
(a) Can foods with genetically modified ingredients be imported?
It is common for foreign enterprises to use the substances extracted from genetically modified crops as raw materials or auxiliary ingredient to produce food, for example, to use the sugar extracted from genetically modified beets to produce biscuits, candy, chocolate and other products. Can these biscuits, candy and chocolate products be exported to China for sales?
Technically the Chinese law is not clear for this situation. Although relevant laws and regulations make it clear that overseas companies can export relevant products to China after obtaining Safety Certificates issued by the agricultural departments, through our review of the Agricultural GMOs approved with Safety Certificates, we found that the current crop products with valid Safety Certificates are all agriculture products themselves (such as soybean, corn, rape, cotton and beet, etc.), without any further processed products produced from these using these crops, and the import purpose of these crop products is also limited to “raw materials for processing”. This indicates that that foreign enterprises or domestic import enterprises can only import these certified crops as processing raw materials to produce finished products in China.
According to our observations, the Customs’ supervision attitude towards the above-mentioned prepackaged food is consistent with our analysis, that is, as long as the products contain genetically modified ingredients, they are regarded as genetically modified products by Customs, and they are not allowed to enter China without Safety Certificates, and as a matter of fact, the MOA has not issued any Safety Certificates for such genetically modified products, so import is not allowed. It is worth mentioning that at present, the genetically testing technologies conducted by the Customs are quite mature. In addition, the genetically testing standards in China are based on qualitative basis rather than quantitative one. This means, if the prepackaged food containing any genetically modified ingredient, the related company may be ordered to ship back the products or destroy them in addition to facing potential risk of other penalties.
Export management system: There are not many regulations on the export control for genetically modified products. In addition to the export management system applicable to general trading, basically it mainly focuses on carrying out genetically modification testing and issuance of certificate of non-genetically modification product by the Customs based on the application of consignors or agents. After accepting the application, the competent Customs shall issue relevant quarantine for genetic modified products if the products conform to the standards of import countries or regions, or issue a certificate of non-genetically modified product if the testing result is consistent.
 According to Article 3.5 of the Inspection Procedures, “Genetically modified food in this regulations refers to food that are made from animals, plants and microorganisms whose genome structures have been modified through genetic engineering technology. These include:
(a)genetically modified animals, plants, or microorganism products;
(b)products directly processed from genetically modified animals, plants, or microorganisms;
(c) food made from raw materials of genetically modified animals, plants, or microorganisms or their directly processed products.”
 They are: 1. Soybean seed, soybean, soybean powder, soybean oil and soybean meal; 2. Corn seed, corn, corn oil and corn meal (including corn meal with tax codes of 11022000, 11031300 and 11042300); 3. Rapeseed, rapeseed, rapeseed oil and rapeseed meal; 4. Cotton seed; 5. Tomato seed, fresh tomato and tomato sauce.