What is DHA Algae oil?
DHA algae oil is a type of oil extracted from marine microalgae that is rich in DHA.
DHA algae oil is directly derived from algae and bypasses the food chain, resulting in lower levels of mercury or other heavy metal contaminants; thus, algae oil products are more suitable for vegetarians and individuals allergic to fish products. Also, algae oil typically has a milder odor and lower levels of EPA (another Omega-3 fatty acid) compared to fish oil, making it better suited to the needs of infants and toddlers. Therefore, for those seeking a healthy, safe, and environmentally friendly source of DHA, DHA algae oil products are an ideal choice.
Market Size of DHA Algae Oil
According to data from Straits Research, the global market size of algae-derived omega-3 ingredients was $975.14 million in 2022. It is projected to reach $2.9669 billion by 2031, with a compound annual growth rate of 13.16% during the forecast period (2023-2031).
According to specific statistics, the market size of China's DHA algae oil industry was 129.8 billion yuan in 2018. By 2023, it had reached 186.07 billion yuan, with a year-on-year growth of 6.46%. It is projected that from 2024 to 2030, the growth rate of China's algae oil DHA industry market size will remain between 5% and 7%. By 2030, the market size is expected to reach 283.548 billion yuan.
Chart: The market size of China's DHA algae oil industry from 2018 to 2023
Source: Zhiyanzhan
On Chinese e-commerce platforms, sales of DHA algae oil products are astounding. Some popular items have exceeded 200,000 units sold. Major brands include BioIsland, Wyeth, Nature's Bay, Child's Life, Elevit, and Autili. The target demographic for these DHA algae oil products on e-commerce platforms is primarily children and pregnant women.
Best-selling DHA algae oil products on Taobao, sourced from Taobao official website
Regulatory Requirements for DHA Algae Oil Products in China
Following the Food Safety Law of the People's Republic of China and the Administrative Measure on Health Food Registration and Filing, China imposes strict supervision and management of health food and other special foods. Only health food that has obtained a registration or filing certificate can be marketed and sold in the Chinese market.
In China, health food is subject to a dual-track registration and filing system. According to the Catalogue of Health Functions Permitted to be Claimed by Health Food Non-Nutrient Supplements (2023 Edition) (hereinafter referred to as the Catalogue), which came into effect on October 1, 2023, DHA algae oil, as one of the health food ingredients, can be used for filing-class health food.
Names for DHA Algae Oil Product Filing
When filing DHA algae oil products, the ingredient is named "DHA 藻油"（DHA Algae Oil）.
When DHA algae oil is used as a single ingredient for product filing if the ingredient is in an oily form, the product is named "商标名+DHA +属性名" or "商标名+DHA 藻油+属性名"（which means **Brand DHA +Attribute / **Brand DHA Algae Oil +Attribute）， such as " **牌DHA软胶囊" or " **牌DHA藻油软胶囊"（which means "**Brand DHA Softgel Capsules" / "**Brand DHA Algae Oil Softgel Capsules"）; if the ingredient is in powder form, the attribute name should be "片"(which means tablets).
When DHA is combined with other nutritional supplements, the product name should still comply with the current rules for naming health foods. The order of nutrients should be adjusted for product names that may create ambiguity when combined. For example, when combined with Vitamin A, the product should be named "**牌DHA维生素A片"（which means "**Brand DHA Vitamin A Tablets") rather than "**牌维生素A DHA"(which means "**Brand Vitamin A DHA Tablets")
Claims for Health Functions during the Filing of DHA Algae Oil Products
When filing products containing DHA Algae Oil, the allowed claim for health functions is "补充n-3多不饱和脂肪酸"（which means supplementing n-3 polyunsaturated fatty acids）. When DHA is combined with other nutrient supplements, health functions should be claimed according to the sequence of nutrient effects in the Catalogue.
Formulation Compatibility of DHA Algae Oil Products
It is recommended that products containing DHA algae oil be filed as single-component materials. In cases where it is necessary to combine with other materials listed in the Catalogue, the filer should provide scientific literature, information on product formulation compatibility, dosage form, and reasonable production processes. The filer should also commit to the product's safety, efficacy, and quality control.
Commercialization and Use of DHA Algae Oil
Under necessary manufacturing processes, commercialized DHA ingredients that require the addition of antioxidants, such as Vitamin C or Vitamin E, must specify the amounts of antioxidants added in the product manufacturing documentation. Simultaneously, it is required to test and establish the indicator values of Vitamin C or Vitamin E, which will serve as the physicochemical standards for product specifications. For filed products, it is essential to clearly state in the precautions that "本品含有维生素C和/或维生素E" (which means this product contains Vitamin E or Vitamin C).
Vitamin C, E, etc., added as necessary additives in manufacturing, shall not claim health function. Suppose vitamins C and E are added as excipients reach the recommended daily intake of the corresponding population of nutrients; the dosage basis for their use should also be provided, as well as research data to ensure product safety. For field products with DHA combined with vitamins C and E, the filer should provide product development information to prove the safety and efficacy of the products.
How do you set the technical requirements range for filing products with DHA algae oil as an ingredient?
For filing products adding DHA, a nutrient supplement ingredient, the efficacy component range should be between 80% to 120% of the indicated amount while also complying with the daily consumption amount for adults.
Filing documents
| NO. | Documents |
|
(1) |
Application Form for Filing Overseas Health Food Products and Undertaking of Legal Responsibility for Authenticity of Application Materials by the Applicant |
|
(2) |
Copy of the Registration Certificate of the Filer |
|
(3) |
Product Formula Materials |
|
(4) |
Product Production Process Materials |
|
(5) |
Safety and Health Function Test Evaluation Materials |
|
(6) |
Types, Names, and Standards of Packaging Materials Directly in Contact with Health Food |
|
(7) |
Sample of Product Labels and Instructions |
|
(8) |
Product Technical Requirements Materials |
|
(9) |
Full Testing Report Meeting Product Technical Requirements Issued by a Qualified Inspection Agency with Legal Qualifications |
|
(10) |
Materials Related to the Retrieval of Product Names |
|
(11) |
Other Materials Demonstrating Product Safety and Health Functions |
|
(12) |
Qualification Certificate Issued by the Competent Authority of the Production Country (Region) or Legal Service Agency Proving that the Filer is an Overseas Manufacturer of Listed Health Food Products |
|
(13) |
Proof of Health Food Sales for Over One Year Issued by the Government Authority or Legal Service Agency of the Production Country (Region) or Safety Report on Overseas Sales and Consumption Situations of the Product |
|
(14) |
Original Technical Regulations or Standards related to Health Food from the production country (region) or international organizations |
|
(15) |
Actual Samples of Packaging, Labels, and Instructions used in the production country (region) |
|
(16) |
For foreign applicants handling registration affairs through a permanent representative office in China, submit the Registration Certificate of Foreign Enterprise Permanent Representative Office in China and its copy; for foreign applicants entrusting domestic agencies to handle registration matters, submit the original notarized power of attorney and a copy of the business license of the entrusted agency. |
Filing process
Overseas applicants should be overseas health food manufacturers whose products are already on the market. Overseas manufacturers refer to legal entities or other organizations whose products meet the listing requirements of the country or region where they are located; that is to say, non-manufacturing enterprises, as applicants, can entrust other overseas enterprises to produce productions.
