What certification is required for exporting cosmetics to the United States?
FDA is one of the executive agencies of the U.S. government within the Department of Health and Human Services (DHHS) and the Department of Public **** Health (PHS). As a scientific regulatory agency, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biologicals, medical devices, and radiological products manufactured in or imported into the United States. It was one of the first federal agencies whose primary function was to protect consumers. The agency is relevant to the lives of every U.S. citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries seek and receive help from the FDA to promote and monitor the safety of their own products. The Food and Drug Administration (FDA) is in charge of the supervision and inspection of: food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, and electronic products; it also includes cosmetics, products that emit radiation, combination products, and other electronic and medical products related to personal health and safety. Products in the use or consumption process of ionic, non-ionic radiation affecting human health and safety project testing, inspection and certification. According to the regulations, the above products must be tested by the FDA to prove safety before they can be sold in the market. the FDA has the right to inspect manufacturers, the right to prosecute offenders. Cosmetics FDA certified cosmetics Voluntary Registration Program (VCRP) FDA Office of Cosmetics and Pigmentation at the request of the cosmetics industry to develop a voluntary registration program for cosmetics. The program consists of two parts: voluntary registration of cosmetic manufacturers and cosmetic ingredient declarations. Benefits of participating in the VCRP Manufacturers voluntary registration and access to the registration number does not mean that the FDA approval of the manufacturer or its products, the FDA also does not allow manufacturers to use participation in the VCRP or access to the registration number or listing number of commercial publicity; however, the manufacturer can participate in the VCRP through the direct access to the following benefits: access to important information on cosmetic ingredients. the FDA will get from the VCRP all the information entered into the computer FDA enters all information received from the VCRP into a computerized database. If a currently used cosmetic ingredient is deemed hazardous enough to be banned, FDA will notify the manufacturer or seller of the product through the directory in the VCRP database. If your product is not in the registry database, the FDA will not be able to notify you. Avoid having your product recalled or detained upon importation due to ingredient issues. If a cosmetic manufacturer files its product formulations with the VCRP, the FDA will alert the manufacturer whenever it discovers that the manufacturer has used unapproved color additives or other banned ingredients in its formulations. This allows the manufacturer to modify the product formulation before the product is imported or sold, thereby eliminating the risk of product recall or detention due to improper ingredient use. Help retailers identify safety-conscious manufacturers. Retailers (e.g., department stores) sometimes ask FDA whether a particular cosmetic company is registered with FDA. While registration does not indicate FDA approval, it shows that your product has been reviewed by the FDA and entered into the government's database. The FDA will notify you if you submit a product with an incomplete formulation or one that contains a banned ingredient or unapproved color additive. The decision to collect a sample is based on the nature of the product; the FDA's priority concerns; and the product's past history.The FDA obtains a physical sample and sends it to an FDA Regional Laboratory for analysis If the FDA finds that the sample complies with the requirements, it sends a Notice of Release to the U.S. Customs Service and to the importer, respectively. If the FDA determines that the sample is in violation of the FDCA and other relevant laws, it sends a Notice of Seizure and Hearing to U.S. Customs and the importer, respectively. The notices detail the violation and nature of the violation and give the case and importer 10 business days to provide evidence that the shipment is admissible. Imported goods that have been seized must be reconditioned, repatriated, or destroyed under the supervision of the FDA or U.S. Customs. The hearing is the importer's only opportunity to defend the imported goods or to provide evidence that the goods are reconditioned and fit for entry. If the case and the underwriter, owner, importer, or a designated representative do not respond to the notice, FDA sends a Notice of Denial of Entry to U.S. Customs and the case and the importer. The product in question is then returned or destroyed. If the case and underwriter, owner, importer, or a designated representative responds to the Notice of Seizure and Hearing, FDA holds a hearing on the seized product when the importer provides evidence that the product complies with the requirements or submits a petition to repair the product. If the firm provides evidence that the product complies with the requirements, FDA will take follow-up samples. The decision is made after analysis, and the product is either released or denied entry. FDA reviews the importer's proposed amendment program and approves or disapproves it as appropriate. Once approved, FDA conducts a follow-up inspection/sample collection to determine compliance. If the sample passes, a Notice of Release is sent to U.S. Customs and the importer. If the sample fails, a Notice of Rejection is issued. Section 8(C) of the FDCA requires the applicant to pay all costs, including travel, per diem, and wages of FDA officers or employees, in addition to the costs of updating labels or other measures to bring the seized merchandise into compliance with the terms of the application (Form FDA-766). By submitting Form FDA-766, the applicant agrees to pay the full regulatory costs in accordance with current regulations. In order to ensure that FDA is aware of all products required to be admitted to the United States, the importer or his/her representative must establish an entry notification file and obtain the appropriate documentation to enable him/her to pick up the shipment from the U.S. Customs Service. Customs notifies FDA of the entry, and FDA determines whether the merchandise is admissible into the United States. If FDA is unwilling to inspect the imported goods, the product is allowed into the United States. Generally, if FDA samples the imported goods, FDA will send an agent to take a sample from the shipment and analyze it in an FDA laboratory. If the results of the analysis show that the product complies with the requirements, the entire shipment can be released and entered into the U.S. market. If it does not, the product is denied entry. Importers need to take several steps to make the product comply with the requirements of the relevant regulations. Please contact your local FDA District Office to find out what procedures are required for non-compliant products. Regulations issued by the FDA are an important part of the implementation of the Federal Food, Drug, and Cosmetic Act, and some of these regulations are particularly important, such as: the current Good Manufacturing Practices regulations, which impose many requirements for sanitation, inspection of raw materials, inspection of finished products, and other quality controls; the FDA Food Standards, which impose specific requirements on many foods. These regulations help both consumers and factories by telling them what they can do to ensure that their products are acceptable. all FDA regulations are republished annually with the most recent changes. Importation Overview: Importers can expedite the entry of food products into the U.S. market. Ensure that imported goods are legal before shipment. Samples of the food to be imported are examined in a private laboratory and a certificate is issued for the results of the analysis. Although such certificates are not final, such analyses can at least indicate that the processor of the product is capable of producing a competent, legal product. Familiarize yourself with the FDA's legal requirements before signing a shipment contract. Request assistance from the FDA district office responsible for your imported product. Understand the food import procedures described in FDA Import Procedures (1-14B). The regulatory requirements imposed by the FDA were published in the first edition of the Requirements of the United States Food, Drug, and Cosmetic Act (officially known as FDA Publication No. 2) when it was published in 1947, and it was subtitled Notice to Foreign Manufacturers and Shippers. Prior to the publication of this Act, entire shipments were held in U.S. ports to prevent damage or contamination. In an effort to bring foreign producers (manufacturers) up to speed on U.S. policy at the time, FDA's Publication No. 2 (No. 1 was the Federal Food, Drug, and Cosmetic Act) had an immediate and favorable effect in this regard. The European and South African Chambers of Commerce released translations in French, Spanish and German.