Guidelines for Manufacturing Cosmetics  



    Drugs, Devices and Cosmetics


    61N-1.010Guidelines for Manufacturing Cosmetics


    Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 41 No. 85, May 1, 2015 issue of the Florida Administrative Register.

    61N-1.010 Requirements Guidelines for Manufacturing Cosmetics.

    (1) No change.

    (2) Buildings and facilities requirements.

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

    (a) Be constructed 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) through (e) No change.

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

    1. through 3. No change

    (g) No change.

    (3) Equipment requirements.

    Equipment, machinery and utensils used in manufacturing, processing, packaging, or relabeling of cosmetics must be specifically designed and constructed 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) through (b) No change.

    (c) Constructed to ensure accurate 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) No change.

    (4) Personnel requirements.

    (a) through (c) No change.

    (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) No change.

    (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) through (d) No change.

    (e) Specifically Properly identified and controlled to prevent the use of materials that would be injurious to users if such material were incorporated into a cosmetic product and such product were used under the conditions of use prescribed in the labeling or advertisement of the product or under such conditions as are customary or usual 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 shall should be routinely cleaned and sanitized according to a 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) through (b) No change.

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

    (d) through (f) No change.

    (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, product development specifications, test methods, laboratory equipment, and technician qualifications; the laboratory controls shall should include provisions to ensure that:

    (a) No change.

    (b) Returned cosmetics are examined for deterioration, contamination, and compliance with the manufacturer’s product development acceptance specifications.

    (9) Internal audit requirements.

    Cosmetic manufacturers must have internal audit procedures that ensure:

    (a) Internal audits are conducted randomly and occur regularly or on demand for a specific reason;

    (b) No change.

    (c) All observations made during the internal audit are evaluated and shared with appropriate management, production, quality control, and lab personnel who are responsible for developing and implementing corrective measures; 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) through (c) No change.

    (d) Ensure timely notification of adverse incidents and product recalls to the appropriate state and federal regulatory agencies; such notification shall be no later than 30 calendar days of receipt of the adverse incident and no later than 10 calendar days where the manufacturer has declared a product recall.

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