To protect the public health, safety, and welfare by setting forth requirements that cosmetic manufacturers must follow to ensure the safety of the products.

Notice of Proposed Rule

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.010Guidelines for Manufacturing Cosmetics

PURPOSE AND EFFECT: To protect the public health, safety, and welfare by setting forth requirements that cosmetic manufacturers must follow to ensure the safety of the products.

SUMMARY: The proposed rule development addresses good manufacturing practices that must be followed by persons that manufacture or are seeking licensure to manufacture cosmetics in Florida, including but not limited to: building and facility, equipment, personnel, raw material, product, internal audit, and complaint and recall requirements.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The economic review conducted by the agency.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 499.05 FS.

LAW IMPLEMENTED: 499.002, 499.008, 499.009 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dinah Greene, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 N. Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047, [e-mail], [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.010 Guidelines for Manufacturing Cosmetics.

(1) All persons who manufacture or relabel label cosmetics in Florida must follow the minimum guidelines requirements for manufacturing contained in this section to help assure product safety and quality. If a person does not engage in all phases of cosmetic manufacturing, that person need only comply with paragraphs applicable to those operations in which the person is engaged. Recordkeeping to document compliance with these guidelines is not mandatory however; observation by an inspector of a deviation from these guidelines may constitute non-compliance with current good manufacturing practices.

(2) Manufacturers must assure that personnel do not contribute to contamination or adulteration of the product.

(3) Any facility used for the manufacture, processing, packaging, or labeling of a cosmetic shall be of suitable size and construction to produce a product that is not adulterated or misbranded.

(4) Any facility and equipment used in the manufacture, processing, packaging, or labeling of a cosmetic shall be maintained in a clean and sanitary condition.

(a) Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than contained laboratory animals). No domestic animals may be in the manufacturing areas.

(b) Sewage, trash, and other refuse or waste matter in and from the building and immediate premises shall be disposed of in a safe and sanitary manner.

(5) Components, containers, and closures shall not be reactive, additive, or absorptive so as to alter the safety or purity of the cosmetic.

(6) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the cosmetic product.

(7) An appropriate identification or tracking system should be in place to facilitate a rapid and effective recall or market withdrawal.

(a) As used in this section, “good manufacturing practice” means 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.

(b) As used in this subparagraph, “internal audit” means a systematic and independent examination made by competent personnel inside the company, the aim of which is to determine whether activities covered by these rules and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives.

(c) As used in this section, “standard operating procedure” means instructions on how to perform tasks and descriptions of the approved or required procedures for accomplishing specific quality assurance objectives.

(2) Buildings and facilities requirements.

Buildings and facilities used for manufacture, processing, packaging, or relabeling of cosmetics must:

(a) Be of suitable size, design, and construction, and maintained in a clean and orderly manner 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.);

(b) Be free of filth and infestation by rodents, birds, insects, and other vermin;

(c) Have a designated quarantine area for the storage of products that are suspected of being contaminated, adulterated, or otherwise potentially injurious to users;

(d) Have floors, walls, and ceilings constructed of smooth, easily cleanable surfaces;

(e) Have adequate lighting and ventilation, and, if necessary for control purposes, screening, filtering, dust, humidity, temperature, and bacteriological controls;

(f) Have adequate washing, cleaning, plumbing, toilet, and locker facilities to allow for:

1. Sanitary operation;

2. Cleaning of facilities, equipment and utensils; and

3. Personal cleanliness; and

(g) Have fixtures, ducts, pipes, and drainages installed to prevent condensate or drip contamination.

(3) Equipment requirements.

Equipment, machinery and utensils used in manufacturing, processing, packaging, or relabeling of cosmetics must be of appropriate design, size, material and workmanship for the intended purpose to prevent corrosion, accumulation of static material, and adulteration with lubricants, coolants, dirt, and sanitizing agents. The equipment must be:

(a) Maintained in a clean and orderly condition, sanitized at appropriate times, and stored in a manner that protects against splash, dust, and other contaminants;

(b) Constructed to facilitate adjustment, cleaning, and maintenance;

(c) Of suitable size and accuracy for measuring, mixing, and weighing operations;

(d) Calibrated regularly or checked according to a standard operating procedure with results documented, where appropriate; and

(e) Removed from use if it is defective, does not meet recommended tolerances, or cannot be repaired and calibrated immediately.

(4) Personnel requirements.

(a) Personnel supervising or performing cosmetics manufacturing must have the education, training, experience, or combination thereof, to perform their assigned functions.

(b) Personnel coming in direct contact with cosmetic raw materials, in-process materials, finished products, or contact surfaces must wear clean clothing appropriate for the duties they perform and necessary protective apparel (for example, uniforms, gloves, safety glasses, and hair restraints).

(c) Personnel must maintain adequate personal cleanliness, and be free from abnormal sources of microbiological contamination (for example, sores and infected wounds).

(d) Eating food, drinking beverages, or using tobacco must be restricted to appropriate designated areas away from storage and processing areas.

(e) All personnel and visitors must be properly supervised while in the manufacturing facility.

(f) Only authorized personnel shall be allowed access into production, storage, and product control areas.

(5) Raw materials requirements.

Raw materials must be identified, stored, examined, tested, inventoried, handled, and controlled to ensure they conform to appropriate standards and specifications. In particular, raw materials must be:

(a) 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.);

(b) Held in closed containers and stored off the floor;

(c) Maintained in containers that are labeled with the identity, lot number, and control status (release or quarantine);

(d) Sampled and tested for conformance with specifications and to ensure the absence of filth, microorganisms, and other adulterants prior to processing or usage; and

(e) Properly identified and controlled to prevent the use of materials that fail to meet acceptance specifications.

(6) Water requirements.

(a) There must be established procedures for ensuring that the water used as a cosmetic ingredient is being tested or monitored regularly to verify that it meets applicable chemical, physical, and microbiological specifications for quality.

(b) The entire system for supplying water used as a cosmetic ingredient must be set up to avoid stagnation and risks of contamination (This system should be routinely cleaned and sanitized according to an appropriate standard operation procedure that ensures no biofilm build-up.).

(7) Product requirements.

Cosmetic manufacturers shall develop and maintain written manufacturing and control standard operating procedures addressing formulations, processing instructions, in-process control methods, packaging instructions, and instructions for operating equipment); the procedures must include provisions to ensure that:

(a) The selection, weighing, and measuring of raw materials and the determination of finished yield are verified;

(b) Major equipment, transfer lines, containers and tanks used for processing, holding, or filling are identified to indicate contents, batch identification or designation, stage of processing and control status;

(c) There are appropriate measures to prevent contamination with microorganisms, chemicals, filth, or other extraneous material;

(d) 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;

(e) The tamper-resistant packaging and labeling for liquid oral hygiene products and vaginal products meet the requirements of 21 CFR 700.25;

(f) 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

(g) Finished product packages bear permanent meaningful, unique lot or control numbers and there is a coding system that corresponds to these numbers.

(8) Laboratory controls.

Cosmetic manufacturers shall develop and maintain laboratory controls addressing sample collection techniques, specifications, test methods, laboratory equipment, and technician qualifications; the laboratory controls should include provisions to ensure that:

(a) Raw materials (including water), in-process and finished product samples are tested or examined for identity and compliance with applicable specifications (for example, physical and chemical properties), microbial contamination, and hazards or other chemical contamination; and

(b) Returned cosmetics are examined for deterioration, contamination, and compliance with acceptance specifications.

(9) Internal audit requirements.

Cosmetic manufacturers must have internal audit procedures that ensure:

(a) Internal audits occur regularly or on demand;

(b) Internal audits are conducted by individuals who do not have direct responsibility for the matters being audited;

(c) All observations made during the internal audit are evaluated and shared with appropriate management, production, quality control, and lab personnel; and

(d) Internal audit follow-up confirms the satisfactory completion or implementation of corrective actions.

(10) Complaints, adverse events and recall requirements.

Cosmetic manufacturers must have standard operating procedures sufficient to:

(a) Facilitate the receipt, processing, evaluation and follow up on written and oral complaints;

(b) Facilitate the identification and retrieval of reported adverse incidents involving allegations of bodily injury or harm;

(c) Facilitate the effective and efficient identification and recall of products, including market withdrawal; and

(d) Ensure timely notification of adverse incidents and product recalls to the appropriate state and federal regulatory agencies.

Rulemaking Authority 499.013, 499.05 FS. Law Implemented 499.013, 499.002 499.008, 499.009, FS. History–New 7-1-96, Formerly 10D-45.0505, Formerly 64F-12.010, Amended ____________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Reginald Dixon, Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ken Lawson, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 25, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 16, 2015