Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Guidance for Industry 
Cosmetic Good Manufacturing Practices 
Draft Guidance  
Additional copies are available from: 
Office of Cosmetics and Colors, HFS-100 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-1130 
http://www.fda.gov/CosmeticGuidances  
You may submit written comments regarding this guidance at any time.  Submit written 
comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be 
identified with the title of the guidance document.  
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
February 12, 1997; revised April 24, 2008 and June 2013  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Table of Contents  
 
 
I.  Introduction 
 
II.  Background 
 
III.  Discussion  
  A.  Overview 
B.  Definitions 
C.  Specific Guidance for Cosmetics 
-    Documentation 
-    Records 
-    Buildings and Facilities 
  -    Equipment 
-    Personnel 
-    Raw Materials 
  Water 
  Color Additives 
Prohibited and Restricted Cosmetic Ingredients 
-    Production 
-    Laboratory Controls 
-    Internal Audit 
-    Complaints, Adverse Events, and Recalls 
 
 
 
 
  2 Contains Nonbinding Recommendations 
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Guidance for Industry1
 
Cosmetic Good Manufacturing Practices 
This guidance represents the Food and Drug Administration's (FDAs) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance.  
I.  Introduction
This document provides guidance to industry and other stakeholders (e.g., consumer interest 
groups, academia, other regulatory groups) on FDAs current thinking concerning what 
constitutes Good Manufacturing Practices (GMPs) for cosmetics.  It is intended to assist industry 
and other stakeholders in identifying the standards and issues that can affect the quality of 
cosmetic products.   
This guidance revises the Cosmetic Good Manufacturing (GMP) Guidelines/Inspection 
Checklist by updating it to set forth current practice, and clarify certain topic areas based on 
recent experience.  In addition, as part of an international harmonization effort with the 
International Cooperation on Cosmetic Regulations (ICCR), FDA (or we) agreed to consider the 
current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 
22716:2007) when revising this guidance.  We reviewed ISO 22716 and decided to incorporate, 
modify, or exclude specific aspects of it into this guidance based on our experience.      
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required. 
II. Background
The predecessor to this guidance, FDAs Cosmetic Good Manufacturing Guidelines/Inspection 
Checklist, was based on documents and information dating before the early 1990s.  Much of 
the material in the predecessor document has become outdated.  In addition, there has been a 
great deal of progress in developing international consensus standards for cosmetics, specifically 
1 This guidance has been prepared by the Office of Cosmetics and Colors in the Center for Food Safety and Applied 
Nutrition at the U.S. Food and Drug Administration.   
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ISO 22716 (Cosmetics  Good Manufacturing Practices (GMP)  Guidelines on Good 
Manufacturing Practices.  ISO 22716:2007.  Geneva, Switzerland:ISO.).   
 
ISO is a non-governmental organization that develops and publishes international consensus 
standards.  In September 2007, the International Cooperation on Cosmetic Regulation (ICCR), 
the quadrilateral international harmonization group, met in Belgium.  During that meeting, the 
regulators from the United States, Canada, the European Union, and Japan agreed that it would 
be useful for the cosmetic industry to have a standardized scheme for GMPs that could apply to 
their jurisdictions.  As a result, the regulators from these four jurisdictions agreed to take ISO 
standards for cosmetic GMPs into consideration when developing or updating guidelines or other 
measures addressing GMPs (See International Cooperation on Cosmetic Regulation: Outcome of 
Meeting, September 26-28, 2007).  In developing this guidance, FDA has incorporated elements 
of ISO 22716, as appropriate, and consistent with FDA regulations. 
 
III.  Discussion 
 
A. Overview 
 
The Federal Food, Drug and Cosmetic Act (the FD&C Act) prohibits the introduction, or 
delivery for introduction, into interstate commerce of cosmetics that are adulterated or 
misbranded (Section 301 of the FD&C Act). 
 
If you manufacture cosmetics, you can reduce the risk of adulterating or misbranding cosmetics 
by following the GMP recommendations in this guidance.  By following these recommendations, 
you can effectively conduct a self-inspection to rate your operations.     
 
Tampering and other malicious, criminal, or terrorist activity present additional risks that can 
also have a direct impact on your products quality.  To help minimize these risks to cosmetics 
under your control, we recommend that you consult a separate FDA guidance document entitled 
Guidance for Industry:  Cosmetic Processors and Transporters of Cosmetics Security Preventive 
Measures Guidance.   
 
B. Definitions 
 
We recommend that you refer to the FD&C Act and Title 21 of the Code of Federal Regulations 
(21 CFR) for definitions of the terms cosmetic (Section 201(i) of the FD&C Act) and tamper-
resistant packaging (21 CFR 700.25). In addition, the following terms apply to this guidance:  
 
Documentation: 1) The supplying of documents or supporting references; use of documentary 
evidence; 2) the documents or references thus supplied; 3) the collecting, abstracting, and coding 
of printed or written information for future reference. (documentation, Websters New World 
Dictionary Third College Edition, 1988 ed.).   
 
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Good manufacturing practice (GMP): That part of quality assurance aimed at ensuring that 
products are consistently manufactured to a quality appropriate to their intended use.  It is thus 
concerned with both manufacturing and quality control procedures.  (Sharp, John, Good 
Manufacturing Practice, Philosophy and Applications, Buffalo Grove, IL: Interpharm Press, 
1991, pg. 47.).   
 
Internal Audit:  Systematic and independent examination made by competent personnel inside 
the company, the aim of which is to determine whether activities covered by these guidelines and 
related results comply with planned arrangements and whether these arrangements are 
implemented effectively and are suitable for achieving objectives. (Cosmetics  Good 
Manufacturing Practices (GMP)  Guidelines on Good Manufacturing Practices, ISO 
22716:2007, Geneva, Switzerland: ISO.).   
  
Standard operating procedure (SOP):  Instructions on how to perform tasks and descriptions 
of the approved or required procedures for accomplishing specific quality assurance objectives. 
(Garfield. F.M., Klesta, E., and Hirsch, J., eds., Quality Assurance Principles for Analytical 
Laboratories, 3rd Ed., Gaithersburg, MD: AOAC International, 2000, pg. 26). 
 
C. Specific Guidance for Cosmetics2 
 
Documentation 
 
Documentation creates a mechanism that shows how products are manufactured and tested.  
Documentation should define your organizations processes and capture every aspect of your 
manufacturing process.  Documentation prevents errors of interpretation or loss of information 
that may result from reliance on verbal communication.  Documentation also allows you to trace 
where any problems may have occurred and to take appropriate corrective action. 
 
Records 
 
Records should be retained in either paper or electronic format.  Records should capture in detail 
the operations, procedures, deviations from procedures, justifications, instructions (including 
training), specifications, protocols, reports, methods, precautions, corrections and other measures, 
and other appropriate information related to GMPs. 
 
You should review raw material records to determine if raw material is adequately controlled.  
These records may include origin, receipt, examination, testing, disposition, and use records. 
 
You should determine whether disposition of rejected materials or returned goods is documented.  
(For example, reworking operations, returns to suppliers, and disposals). 
 
You should evaluate batch production control records, which should include: 
                                            
2 There are no GMP regulations for cosmetics.    
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  Documentation of all ingredients (name, code, lot number, quantity, etc.) added to the       
batch 
  Documentation of all production steps (for example, processing, handling, transferring, 
holding, and filling) 
  In-process sampling, controlling, and adjusting steps 
  Batch and finished product lot or control numbers  
  The finished products control status  accepted or rejected 
 
You should evaluate laboratory control records for raw materials, in-process materials, and 
finished products.  These records should include documentation of sampling procedures, test 
results, and interpretation of the test results (accepts or reject). 
 
You should determine if records are adequate to conduct an effective recall.  Initial distribution 
records identifying the consignee, the product, and the lot or control number should be retained. 
 
You should determine if records are developed in a timely manner after an event occurs. 
 
Buildings and Facilities 
 
You should determine whether the buildings and facilities used for manufacturing are of suitable 
size, design, and construction, and maintained in a clean and orderly manner.  Buildings should 
provide: 
  Space of sufficient size and adequate organization to prevent selection errors (i.e., mix-
ups) or cross contamination between consumables, raw materials, intermediate 
formulations (i.e., in-process materials), and finished products  (This applies to 
containers, closures, labels and labeling materials as well.) 
  Adequate filth and pest controls  (Examples of filth may include any objectionable 
matter, contributed by animal contamination such as rodent, insect, or bird matter; or any 
other objectionable matter contributed by insanitary conditions.) 
  Floors, walls, and ceilings constructed of smooth, easily cleanable surfaces 
  Adequate lighting and ventilation, and, if necessary for control purposes, screening, 
filtering, dust, humidity, temperature, and bacteriological controls 
  Adequate washing, cleaning, plumbing, toilet, and locker facilities to allow for sanitary 
operation; cleaning of facilities, equipment, and utensils; and personal cleanliness; and  
  Fixtures, ducts, pipes, and drainages installed to prevent condensate or drip 
contamination 
 
Equipment 
 
You should determine whether equipment and utensils used in processing, holding, transferring 
and packaging are of appropriate design, size, material and workmanship for the intended purpose 
to prevent corrosion, accumulation of static material and/or adulteration with lubricants, coolants, 
dirt, and sanitizing agents.  The equipment (for example, utensils, pipework, cosmetic contact 
surfaces, and balances) should be: 
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  Maintained in a clean and orderly condition, sanitized at appropriate times, and stored in a 
manner that protects against splash, dust, and other contaminants 
  Constructed to facilitate adjustment, cleaning, and maintenance 
  Of suitable size and accuracy for measuring, mixing, and weighing operations 
  Calibrated regularly or checked according to an SOP with results documented, where 
appropriate 
  Removed from use if it is defective, does not meet recommended tolerances, or cannot be 
repaired and calibrated immediately 
 
Personnel 
 
You should determine whether personnel supervising or performing cosmetics manufacturing or 
control have the education, training, and/or experience to perform their assigned functions.  In 
addition: 
  Personnel coming in direct contact with cosmetic raw materials, in-process materials, 
finished products, or contact surfaces should wear clean clothing appropriate for the duties 
they perform and necessary protective apparel (for example, uniforms, gloves, safety 
glasses, and hair restraints).   
  Personnel should also maintain adequate personnel cleanliness, and be free from abnormal 
sources of microbiological contamination (for example, sores and infected wounds) 
  Eating food, drinking beverages, or using tobacco should be restricted to appropriate 
designated areas away from storage and processing areas 
  All personnel and visitors should be properly supervised while in the manufacturing 
facility; and 
  Only authorized personnel should be allowed access into production, storage, and product 
control areas 
 
Raw Materials 
 
You should determine whether raw materials are identified, stored, examined, tested, inventoried, 
handled, and controlled to ensure they conform to appropriate standards and specifications.  In 
particular, raw materials should be: 
  Stored and handled to prevent mistakes (i.e., mix-ups or selection errors), contamination 
with microorganisms or other chemicals, and degradation from exposure to excessive 
environmental conditions (e.g., heat, cold, sunlight, moisture, etc.) 
  Held in closed containers and stored off the floor   
  Maintained in containers that are labeled with the identity, lot number, and control status 
(release or quarantine) 
  Sampled and tested for conformance with specifications and to ensure the absence of filth, 
microorganisms, and other adulterants prior to processing or usage  (Animal and vegetable 
origin materials and those produced by cold processing methods should be reviewed for 
filth and/or microorganism contamination.); and 
  Properly identified and controlled to prevent the use of materials that fail to meet 
acceptance specifications 
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Water  
 
  You should determine whether: 
  The water used as a cosmetic ingredient is used as-is (i.e., directly from the tap) or if it has 
been treated before being used (i.e., has it been treated by such means as deionization, 
distillation, or reverse osmosis) 
  There are established procedures for ensuring that the water used as a cosmetic ingredient 
  Is of a defined quality 
  Is not affected by materials used in the water treatment equipment 
  Is being tested or monitored regularly to verify that it meets applicable chemical, 
physical, and microbiological specifications for quality; and 
  The entire system for supplying water used as a cosmetic ingredient is set up to 
avoid stagnation and risks of contamination  (This system should be routinely 
cleaned and sanitized according to an appropriate SOP that ensures no biofilm 
build-up.) 
   
Color Additives 
 
You should determine whether color additives are approved for use in your specific cosmetic 
products (21 CFR parts 73, 74, and 82).  Should an unlisted color additive be an ingredient of the 
cosmetic, approval of a petition for a new color additive is required pursuant to 21 CFR parts 70 
and 71. A summary chart for color additives can be found on FDAs website.  Color additives 
subject to certification must be labeled with the lot number assigned by the Color Certification 
Branch3 (21 CFR 70.25(d)) (see exception below4). 
 
Prohibited and Restricted Cosmetic Ingredients 
   
Certain ingredients are prohibited from use in cosmetic products marketed in the United States; 
others have restrictions on their use.  Ingredients whose use is prohibited or restricted are listed in 
the tables below. 
 
In addition to the prohibited and restricted ingredients listed in the following tables, you should 
check the CFR, specifically 21 CFR part 700, Subpart B, for any additional requirements regarding 
specific cosmetic products or their ingredients that may have been added to FDAs regulations. 
 
 
                                            
3 The Color Certification Branch is located in the Office of Cosmetics and Colors in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration. 
4 Color additives must be labeled with the lot number assigned by the Color Certification Branch, except in the case 
of any mixture for household use which contains not more than 15 percent of pure color and which is in packages 
containing not more than 3 ounces there appears on the label, a code number which the manufacturer has identified 
with the lot number by giving to the FDA written notice that such code number will be used in lieu of the lot number 
(21 CFR 70.25(d)).     
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Prohibited Cosmetic Ingredients  CFR Citation 
Bithional  21 CFR 700.11 
Vinyl chloride  21 CFR 700.14 
Certain halogenated salicylanilides  21 CFR 700.15 
Zirconium in aerosol products  21 CFR 700.16 
Chloroform  21 CFR 700.18 
Methylene chloride  21 CFR 700.19 
Chlorofluorocarbon propellants  21 CFR 700.23 
Prohibited cattle material  21 CFR 700.27 
 
Restricted Cosmetic Ingredients  CFR Citation 
Mercury compounds  21 CFR 700.13 
Hexachlorophene  21 CFR 250.250 
 
Production 
 
You should determine whether written manufacturing and control SOPs have been established (for 
example, formulations, processing instructions, in-process control methods, packaging instructions, 
instructions for operating equipment).   Procedures should include provisions to ensure that: 
  The selection, weighing, and measuring of raw materials and the determination of 
finished yield are reviewed by a second individual 
  Major equipment, transfer lines, containers and tanks used for processing, holding, or 
filling are identified to indicate contents, batch identification/designation, stage of 
processing and control status 
  There are appropriate measures to prevent contamination with microorganisms, 
chemicals, filth, or other extraneous material 
  There are in-process controls to ensure product uniformity, integrity (for example, in-
process batch weights), accurate fill of mixing containers, and adequacy of mixing. 
   The theoretical yield for a production batch is compared with the actual yield   
  The tamper-resistant packaging and labeling for liquid oral hygiene products and 
vaginal products meet the requirements of 21 CFR 700.25 
  The storage and handling of packaging materials that are intended to come into direct 
contact with the product prevent selection errors and microbiological or chemical 
contamination; and 
  Finished product packages bear permanent meaningful, unique lot or control numbers 
and you have a coding system that corresponds to these numbers 
 
Laboratory Controls 
 
You should evaluate laboratory controls including sample collection techniques, specifications, test 
methods, laboratory equipment, and technician qualifications.  Laboratory controls should include 
provisions to ensure that: 
   Raw materials (including water), in-process and finished product samples are tested or      
examined for identity and compliance with applicable specifications (for example, 
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physical and chemical properties), microbial contamination, and hazards or other 
chemical contamination 
    Samples are representative of the lot 
    Current finished product samples as well as retained product samples are tested for                         
adequacy of preservation against microbial contamination under reasonable conditions 
of storage and use 
    Samples of approved lots of raw materials and finished products are retained for an  
adequate time period 
    Retained samples are stored under conditions which protect their integrity (for example, 
to avoid contamination and deterioration), and are retested at appropriate intervals to 
assure continued compliance with established specifications; and 
    Returned cosmetics are examined for deterioration, contamination, and compliance  
with acceptance specifications 
   
Internal Audit 
 
You should determine whether effective procedures for internal audits are followed.  At a 
minimum, internal audit procedures should provide that: 
  Internal audits occur regularly or on demand 
  Internal audits are conducted by individuals who do not have direct responsibility for 
the matters being audited 
  All observations made during the internal audit are evaluated and shared with 
appropriate management, production, quality control, and/or lab personnel; and 
  Internal audit follow-up confirms the satisfactory completion or implementation of 
corrective actions 
 
Complaints, Adverse Events, and Recalls 
 
You should review product complaints, consumer adverse event reports, and product recall files 
and determine the following: 
  For complaints: 
   Whether there are SOPs for reporting, recording, filing, evaluating, and following up on 
both written and oral complaints 
  For complaints alleging adverse events involving bodily injury: 
  The kind and severity of each reported injury 
  The body part involved 
  Product and code numbers 
  Whether medical treatment was sought, and, if so, the nature of the medical 
treatment and the name of the attending physician or other healthcare 
professional 
  Whether resolution of the event occurred, with or without long-term or 
persistent effects (If long-term or persistent effects occurred, the nature of those 
effects) 
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  The name(s) and location(s) of any poison control center, government agency, 
physicians group, etc., to whom formula information and/or toxicity data has 
been provided; and 
  Whether you are voluntarily reporting adverse events to FDA through the 
MedWatch program 
  For voluntary product recalls, the guidelines in 21 CFR part 7, Subpart C, should be 
considered, including:  
  Whether there is a proposed strategy for conducting a recall 
  Whether recall notifications are capable of being initiated promptly 
  Whether the appropriate FDA district office has been notified of recalls 
  Whether recalled products have been identified and stored separately in a secure 
area until the firm has made a decision about the proper disposition or 
correction consistent with the degree of risk of the recalled product; and 
  Whether FDAs guidance as outlined in 21 CFR 7.59 has been considered 
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