The U.S. has very strict regulations for colorants, requiring a process of batch certification or approval. At present, there are 65 kinds of colorants for cosmetics included in Title 21 of the Code of Federal Regulations, "Food and Drugs", which can be divided into two categories:
Exemption from certification: 21 CFR Part 73 Part C includes 29 colorants, typically plant, animal, or mineral. The regulations, such as the characteristics, specifications, scope of use, labeling, etc., of the raw materials are specified.
Certification required: 21 CFR Part 74 Part C includes 36 colorants, which are usually organically synthetic. The regulations also stipulate the characteristics, specifications, scope of use, labeling and other requirements of raw materials. The use of these ingredients requires U.S. FDA batch certification to ensure that each batch meets the requirements for composition and purity. Repackaging batch certification is also required for those that have already been batch certified but repackaged.
The colorant batch certification application needs to go through a series of work, including confirming whether the product is within the scope of FDA certification, applying for batch certification account, ** certification application, sending samples for FDA inspection, etc. For raw material suppliers outside the United States, it is also necessary to designate a U.S. ** person.
Any individual who applies for certification services on a regular basis may make an advance deposit in advance of the request as an advance payment for the fees specified in this section. However, fees are non-refundable regardless of whether the colorant batch passes the certification test or not.
Send a letter of request for opening an account signed by the person in charge of the company to [email protected]。Write the request letter on company letterhead, including the name of the company, all addresses (production, business, and warehouse), the contact information of the person in charge of the company (email address, **number), and for foreign companies, the name of the person in the United States
Fill in the appropriate information form according to the type of colorant to be certified (e.g., solid colorant, lake, colorant mixture, and colorant that has been certified but repackaged), which mainly includes: colorant name, manufacturer's batch number, batch quantity, applicant's name and postal address, and any label or label to be used. Solid colorant certification application information
The name of the solid color colorant shall be the name listed in Part 21 CFR. The information required for the certification of this type of colorant is shown in the figure below:
Lake certification application information
The lake name shall be the name derived from the manner described in 21 CFR Part 82. The information required for the certification of this type of colorant is shown in the figure below:
Mixed colorant certification application information
A mixed colorant is a mixture of two or more solid colorants, or a mixture made from one or more solid colorants and a diluent. Batch certification is required if the colorant blend contains a colorant listed in 21 CFR Clause 74. However, if the solid colorants contained in the colorant mix are exempt from certification or have all been batch certified and the properties of the solid colorant have not changed after mixing, then the mixture does not need to be batch certified. The colorant mixture name should be the name of the mixture given by the person requesting certification. The information required for the certification of this type of colorant is shown in the figure below:
Colorant certification request information for colorants that have been certified but repackaged
The name of the repackage shall be the name applicable in subparagraphs (h)(1), (2) or (3) of Part 80 of 21 CFR. The information required for the certification of this type of colorant is shown in the figure below:
Once the FDA receives the sample, the specialist will analyze and evaluate the sample (usually no more than 5 business days). After the necessary investigations, if it is determined that the submitted request does not contain a false statement of material facts and meets the specifications and conditions set out in the regulations, the Commissioner will issue a certificate to the applicant. The contents of the certificate include: colorant name, certification purpose, FDA batch number, batch weight, manufacturer's name and address, etc. If the lot does not meet the requirements, FDA will reject the certification and explain the reason to the applicant.
All colorants must be labelled with sufficient information to ensure their safe use and to allow for the determination of compliance with any restrictions imposed by the regulations. The colorant label should state:
1) The name of the pure color or each ingredient that makes up the colorant, in the case of a mixture.
2) A general restriction statement indicating the use of colorants, e.g. "for food use only";"For food, drug and cosmetic use";"For use in pharmaceutical products for external applications only". (3) If the regulations impose quantitative restrictions on the general or specific use of pure colors, pure colors are measured in units of volumetric weight or as a percentage by weight.
4) If there is a stability data requirement, include the expiration date. Colorants with limited or other restrictions should be indicated on the label. For example, "Do not use in products for eye use" and "Do not use for coloring injectable drugs".
Colorants that require certification should also include the batch certification number obtained on their labels, except in the following cases: household products contain no more than 15% solid colorants and no more than 3 ounces of net packaging. And the manufacturer explains in writing to the FDA that the relevant ** number is associated with the batch certification number. Then the ** number can be used on the label instead of the batch certification number.
The raw materials of the sample batch to be certified should be stored in a container that prevents changes in composition and managed by the applicant. Before a certificate can be obtained, it must be clearly marked and prohibited by labeling or other means.
Once the colorant has been certified as a batch, the applicant should associate it with the certified lot number by labeling and store it in a way that prevents changes in composition until it is packaged and labeled as specified.
Once a colorant has been batch-certified, a complete usage record is required. When regulatory officials request records, they must give records that are at least two years old and allow them to check the inventory list to check for accuracy. These records shall include the quantity, date, kind, quantity and date of each shipment or delivery of the lot, and the name and address of the recipient, and must be kept separate from other records.
Certificates obtained through fraud or misrepresentation are invalid;If the composition of the colorant changes, the relevant certificate will be invalid on the changed colorant, and the expired colorant will be considered uncertified unless it meets certain conditions;If the packaging label does not comply with the regulations, the seal is not in accordance with the regulations, the colorant does not meet the purpose, the specifications are revoked or amended, the corresponding certificate will also be invalid.
The following will be provisionally certified: certificates obtained through fraud or misrepresentation;falsifying records that are required to be kept;Failure to retain, provide, or verify required records;Deny inspection of facilities, processes, and formulations for the production of colorants and their derivatives by persons authorized by the Food and Drug Administration. U.S. FDA Cosmetic Factory Registration and Product List RegistrationU.S. FDA Colorant Batch Certification, U.S. Cosmetic and OTC Drug Notification, U.S. FDA Cosmetic Label Webpage AuditMakeup compliance