OCI Interpretation: Identification of Substantial Equivalence in Noval food Declaration
According to the relevant laws and regulations on the declaration of noval food ingredient in China, the National Health Commission shall receive the safety assessment materials for new food ingredients within 60 working days. The expert review committee is organized internally to conduct the review. The expert review committee makes 4 types of technical review conclusions on new food ingredients through the review: deferred re-review, recommended approval, terminated review and recommended approval conclusions, and made the "termination review" technical review conclusions :
(1)The technical evaluation conclusion that has been verified as ordinary food or is substantially equivalent to that of ordinary food
(2)technical review conclusions that are substantially equivalent to the announced noval food ingredients
(3)Other circumstances of termination of review (for example, food materials that have national standards, or products with traditional eating habits, etc.).
It is worth noting that the "termination of review" ,technical review conclusions contain
"substantial equivalence". What is substantive equivalence, and how is it stipulated in Chinese laws and regulations?
- The concept of substantial equivalence
According to Noval Food Ingredients Safety Examination Management Measures provisions: Substantial equivalence, it is to point to a noval food ingredients and food to declare or has released noval food ingredients in species, source, biological characteristics, main components, edible parts, usage, scope and application of the crowd, the same used by technology and quality requirements, can be regarded as they are equally safe, has the substantive equality.
Traditional eating habits refer to the production and operation history of a certain type of food within the jurisdiction of the province for more than 30 years as a type or non-type of packaged food, which is not included in the Pharmacopoeia of the People's Republic of China.
- Noval food ingredient that have been listed in the catalogue of substantial equivalents
So far, 14 of the 61 substances have been suspended for substantive equivalence.
|
Name of raw material |
Review Comment |
|
L-arabinose |
This product is made from corn cob, corn husk as raw material, through dilute acid hydrolysis, Saccharomyces ceravis fermentation, separation and purification, crystallization, drying and other processes, and has been approved the announcement of L-arabic sugar (the former Ministry of Health in 2008, 12 announcements) has the essence of the same. When used as food raw materials, it shall be carried out in accordance with the relevant content of L-arabinose that has been announced, and the health and safety indicators shall be implemented in accordance with the relevant standards of China. |
|
γ-aminobutyric acid(GABA) |
This product is made of sodium L-glutamate as raw material through Lactobacillus brevis fermentation, purification, filtration, concentration, crystallization, separation, spray drying and other processes. It is combined with the approved γ-aminobutyric acid ( The original Ministry of Health Announcement No. 12, 2009) is substantially equivalent. Except for the production process, other requirements shall be implemented in accordance with the relevant content of γ-aminobutyric acid that has been announced, and the health and safety indicators shall be implemented in accordance with the GB relevant standards. |
|
γ-aminobutyric acid(GABA) |
This product is made of L-glutamate sodium as raw material, through the Lactobacillus gardii fermentation, heating sterilization, cooling, activated carbon treatment, filtration, crystallization, drying and other processes of Lactobacillus, and has the same substance with the approved announcement of γ-aminobutyric acid (the former Ministry of Health in 2009 No. 12). In addition to the production process, other requirements are in accordance with the announced content of γ-aminobutyric acid. |
|
Medium and long carbon chain triglycerides |
This product is substantially equivalent to the approved and announced medium and long-chain fatty acid edible oil (formerly Ministry of Health Announcement No. 16 in 2012); the quality indicators are implemented in accordance with the enterprise's product quality specifications, and the health and safety indicators are implemented in accordance with relevant Chinese standards. |
|
Medium and long chain fatty acid structure oil (also renamed medium and long chain fatty acid edible oil) |
This product is made from edible vegetable oil and medium-carbon chain fatty acid caprylic acid or caprylic acid (from palm kernel oil and coconut oil) as raw materials, through immobilized lipase catalyzed acidolysis reaction, molecular distillation purification, deodorization and other processes. , It is substantially equivalent to the approved and announced medium and long-chain fatty acid edible oil (formerly Ministry of Health 2012 Announcement No. 16); the quality indicators are implemented in accordance with the company’s product quality specifications, and the health and safety indicators are implemented in accordance with relevant Chinese standards. |
|
Milk mineral salts |
This product is substantially equivalent to the milk mineral salt that has been approved and announced (Announcement No. 18, 2009 of the Ministry of Health); the quality indicators are implemented in accordance with the product quality specifications, and the health and safety indicators are implemented in accordance with relevant Chinese standards. |
|
Chitosan Oligosaccharide |
This product is made from chitosan as raw material through enzymatic hydrolysis, filtration and spray drying. The production process is roughly the same as the approved and announced chito-oligosaccharides (Announment No. 6 of National Health and Family Planning Commission in 2014). The product has the same molecular formula and molecular weight, the same purity range, the same quality requirements, and the same substance isomeness. The relevant requirements shall be implemented in accordance with the relevant contents of chito-oligosaccharides announced. |
|
Mulberry Leaf Extract |
This product is made of mulberry leaf as raw material through water extraction, microfiltration, ultrafiltration, concentration, spray drying and other processes. This process is a traditional process, and it is both food and mulberry leaf (Weifa Jianfa [2002] No. 51). The list of medicines) has substantial equivalence, and its health and safety indicators are implemented in accordance with relevant food safety standards inChina. |
|
Phosphatidylserine |
This product uses soybean lecithin and L-serine as raw materials, and is purified and dried after phospholipase conversion reaction. It is substantially equivalent to the phosphatidylserine in the 2010 Announcement No. 15 of the former Ministry of Health. It is hygienic. Safety indicators are implemented in accordance with relevant food safety standards in China. |
|
Krill oil |
This product is made of krill as raw material, processed into powder by water washing, chopping, enzymatic dehulling, drying and other processes, and then made by ethanol extraction, filtration, concentration and other processes. It is combined with the approved krill oil ( The National Health and Family Planning Commission Announcement No. 16 of 2013) is substantially equivalent. Except for the addition of the enzymatic hydrolysis process in the production process compared with the original announcement, other requirements shall be implemented in accordance with the relevant announcement content of the announced krill oil, and the health and safety indicators shall be implemented in accordance with the relevant food safety standards in China. |
|
DHA algae oil from Schizochytrium |
This product is made of Schizochytrium, glucose, yeast powder, etc. as raw materials. The bacteria are obtained through fermentation and culture. The bacteria are made through processes such as filtration, drying, extraction, and purification. It is combined with the approved DHA algae oil (hygiene Ministry of Announcement No. 3 of 2010) is substantially equivalent. Except for the production process and raw materials, other requirements shall be implemented in accordance with the announced contents of DHA algae oil, and the health and safety indicators shall be implemented in accordance with my country's relevant standards. |
|
fish oil |
This product is substantially equivalent to the fish oil and extracts that have been approved and announced (Announcement No. 18 of the Ministry of Health, 2009). The composition ratio of fish oil shall be implemented in accordance with the product quality specifications, and other requirements shall be implemented in accordance with the announced contents of fish oil and extracts. The health and safety indicators are implemented in accordance with the relevant standards in China. |
|
fish oil |
This product is made of edible marine fish through distillation, esterification, reductive esterification, refining, deodorization and other processes, and is substantially equivalent to the fish oil and extracts that have been approved and announced (Announcement No. 18, 2009 of the Ministry of Health) . In addition to the production process, other requirements shall be implemented in accordance with the announced fish oil and extract related content, and the health and safety indicators shall be implemented in accordance with the relevant standards in China. |
|
fish oil |
This product is made of edible marine fish through purification, distillation, esterification, inclusion, reductive esterification and other processes. It has substance with the fish oil and extracts that have been approved and announced (formerly the Ministry of Health, 2009 Announcement No. 18). In addition to the production process, other requirements shall be implemented in accordance with the announced fish oil and extract related content, and the health and safety indicators shall be implemented in accordance with the relevant standards in China. |
URL query：https://slps.jdzx.net.cn/xwfb/gzcx/PassFileQuery.jsp
- Identification of "substantial equivalent" access link
Judging from the historical evolution of the identification of “substantial equivalence”, the identification system of “substantial equivalence” was first established in the “New Resource Food Management Measures”. The characteristics, ingredients, edible parts, suitable crowd, etc. are roughly the same, and the production process and quality requirements are basically the same, so the enterprise does not need to apply again, and the "substantial equivalent" can be determined by the enterprise itself. However, the new regulations implemented in 2013 only provided a clearer and stricter definition of the concept of "substantial equivalence", and did not specify the specific implementation content and subject of implementation. There are still ambiguities in the subject of "substantial equivalence" determination.
Substantive equivalence identification requires very professional technical knowledge and complete and formal testing results. Some companies may not be recognized by local regulatory agencies after self-certification. They often need to repeat testing or entrust additional testing by institutions trusted by regulatory agencies, resulting in a lot of complicated and unnecessary links, only the British New Resource Food and Technology Advisory Committee has given clear guidance abroad. The guidelines require that new resource food and traditional counterparts shall be substantially equivalent in terms of composition, nutritional value, metabolism, use, and content. The level of undesirable substances and other five aspects are compared, and the European Commission needs to make a final recommendation that is substantially equivalent. In view of the inspection of the substantial equivalent of nonal food ingredient at home and abroad, our company recommends that enterprises strictly follow the declaration and approval of noval food ingredient Procedures, report to the local regulatory agency or the National Health Commission, the agency organizes experts to conduct ingredient review and necessary on-site verification to determine whether it is "substantial equivalent." For raw materials that have been identified as substantially equivalent, the time to solicit opinions from the public can be saved, and the time for declaration of raw materials can be greatly shortened. The applicant enterprise can directly carry out raw material-related production, import, or other matters that do not contradict the review conclusion.
Beijing OCI was founded in 2006. It is a product compliance service company headquartered in Beijing. Our company currently declares and registers national standardized products in different fields. Our company is in health The Planning Commission has a wealth of experience in the declaration of food and food-related products. In the recent approval announcements, our food department has received a number of announcements, including noval food,new varieties of food additives, expanded application scope of food additives, and new varieties of food contact materials. In the consultation and application work for many years, we have already possessed applicants with outstanding technical background, accumulated and formed a systematic database of food policies and regulations, and an expert advisory group with talents in various fields. It has provided professional consulting services for government departments, well-known food companies at home and abroad, and has won unanimous praise from customers. We are a food declaration service provider for international companies such as DSM China, Johnson & Johnson Asia Pacific, BAYER China, Master Kong, ABBOTT, BASF and other companies.
