Correct point of view.Today, let's take a look at the filing of imported health foods in 2023.The filing system is the main direction of health food management reform, which is good for enterprises to get closer to the market, and the disadvantage is to intensify the homogeneous competition of products.
|In 2023, health food will be imported for the record
As of December 20, 2023, Shuzheng Kangxun has counted a total of 206 imported health foods from 13 countries and regions announced by the State Administration of Market and the Food Evaluation Center. The U.S. has the largest number of filings with 106, followed by Canada (33) and Australia (23).
In 2023, a total of 36 new imported products will be recorded, which has increased significantly compared with last year, and there are also many bright spots.
|Taiwan's first backup was successful
The products that have been successfully filed in 2023 come from 6 countries and regions. Among them, the first successful new product in Taiwan is the Weatherson brand multi-mineral granules (Food Health Preparation J202300000035) from Shengzhan Biotechnology Co., Ltd.
|Come prepared for a large proportion of "newcomers".
36 imported registered products from 11 companies. It is worth mentioning that the number of "newcomers" who filed for the first time reached 7.
There are many large-scale enterprises in the first filing, such as the United States Kanglong Group won 10 products in one go, Brunel in the United Kingdom revenue 5 products, and Australia Aolinda also "won 3 in one fell swoop", which shows that the preliminary preparations are very sufficient.
|Highlights of the filing in 2024
DHA algal oil has been included as a nutrient supplement in the "Health Food Raw Material Catalogue Nutrient Supplements (2023 Edition)", which will be officially implemented on October 1, 2023, and the claimed health function is "supplementing N-3 polyunsaturated fatty acids".
Health Food Raw Material Catalogue Nutrient Supplements (2023 Edition).
Compared with fish oil, which is only allowed to be filed domestically, this year's DHA algal oil included in the nutrient supplement catalogue supports the filing of importers. At the same time, DHA algae oil can be compounded, which is a great benefit for overseas brands, and it is believed that it will set off a small upsurge in import filing.
|Attached: 2023 Imported Health Food Filing List
How to do the health food import filing?
For enterprises, the following three steps are required:
Step 1 Confirm the ICP filing of the product
For the filing of imported health foods. First, you need to find out whether your company can become a product filing person. The ICP filing person can be the overseas manufacturer or brand holder of the product, and it will appear on the final product ICP filing certificate.
Step 2 Obtain the login account of the ICP filing system
For enterprises that apply for ICP filing for the first time, they need to obtain the login account of the ICP filing system first. The filing person may apply to the State Administration for Market Regulation to log in to the account.
When applying for an account login, imported health food manufacturers should submit a letter of authorization from the contact person in addition to the qualification documents of the overseas manufacturer. The content of the letter of authorization of the contact person shall be that the overseas manufacturer entrusts the contact person to only handle the authorization of the login account of the health food filing management system, and in accordance with 68 requests for relevant information.
The certification documents and power of attorney (agreement) issued by the overseas institution shall be original, and shall be in the official language of the country (region) where the product is produced, with the seal of the record-filing person or the signature of the legal representative (or its authorized person), and shall be notarized by the notary public of the country (region) where it is located and confirmed by the Chinese embassy or consulate in the country where it is located. If the validity period is indicated in the supporting documents, power of attorney (agreement), etc., it shall be used within the validity period. ”
Step 3 Apply for an ICP filing
After obtaining the account, you can apply for product filing according to the operation process, and the list of materials is as follows:
TIPS: List of Filing Materials for Imported Health Foods
1.The registration form for the filing of imported health food and the legal responsibility commitment of the filing person to be responsible for the authenticity of the submitted materials.
2.A copy of the registration certificate of the filing person.
3.Product Formula Materials: Product Formula Table (the original registrant with a change in the formula is required to submit an explanation of the adjusted formula and the change in the formula).
4.Product production process materials, including production process diagram and description.
5.Safety and health function evaluation materials.
5.1. Three batches of product efficacy ingredients or iconic ingredients, hygiene, and stability inspection reports produced by large-scale processes above the pilot scale (this is not required if the product formula of the original registrant has not changed).
5.2. Instructions for the reasonable use of raw materials and auxiliary materials, as well as labels, instructions, and product technical requirements, and instructions for formulating instructions that comply with relevant laws and regulations.
6.The type, name, and relevant standards of packaging materials that are in direct contact with health food.
7.Sample product label instructions.
8.Product technical requirements materials.
9.The inspection report of the whole project issued by the inspection agency with legal qualifications that meets the technical requirements of the product.
9.1. Qualification certificate of food inspection agency.
9.2. Three batches of full-project inspection reports that meet the technical requirements of the product.
10.Search materials related to the product name.
11.Other materials that indicate the safety and health function of the product.
12.The qualification certificate issued by the competent authority of the country (region) or legal service institution of the product manufacturer is an overseas manufacturer of listed health food.
13.A certificate issued by the competent authority of the country (region) where the product is produced or a legal service agency that similar products of health food have been on the market for more than one year, or a safety report on the overseas sales of the product and the consumption of the population.
14.The original text of the technical regulations or standards related to health food in the country (region) or international organization where the product is produced.
15.Packaging, labels, actual samples of instructions, Chinese translations and notarial certificates listed in the country (region) of the product.
16.If the filing affairs are handled by the resident representative office of the overseas filing person in China, the Registration Certificate of the Permanent Representative Office of Foreign Enterprises in China and its copy shall be submitted. If the overseas filing person entrusts a domestic ** institution to handle the filing matters, it shall submit the original notarized power of attorney and a copy of the business license of the entrusted ** institution.
After the materials are successfully submitted, the receiving department will review the materials and issue a filing certificate.
Sample ICP filing certificate).
How long does it take for imported health food to be recorded?
We have produced a work cycle reference
Of course, you'll definitely have some questions, such as:
What should be done if the filing applicant belongs to overseas commissioned processing?What should I do if the raw and auxiliary materials are not in the filing catalog?Item 11 of the list of materials, other materials that indicate the safety and health function of the product, what is it?How to fill in the product ingredients for embedding and microencapsulation in the filing system?Do you need to fill in all the ingredients for the premix?......
The access consulting team has rich practical application experience, rigorous work attitude and professional technical force, and the goal is to provide enterprises with "zero risk, zero delay" access solutions. If you have any questions about health food registration, filing and group standards, you are also welcome to discuss with us.