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Regulations, Safety & Manufacturing
Author: Debbie May
Friday, May 30, 2014

When making melt and pour soaps, some guidelines must be followed to ensure the finished product falls under the appropriate rules and regulations.

Regulatory Agencies

In the United States, if the content of a bar of MP Soap is predominately comprised of alkali salts of fatty acids, and its primary purpose is to cleanse the body, it does not need to follow cosmetic labeling rules as defined by the FDA. If the soap contains detergents and/or claims to have special properties, such as moisturizing or exfoliating, then it falls into the FDA cosmetic category and must be labeled following cosmetic rules.
 
Soap, when not defined as a cosmetic, is regulated by the US Consumer Product Safety Commission (CPSC). The US Consumer Product Safety Commission is an independent federal regulatory agency that is charged with protecting the public against unreasonable risks of injuries and deaths associated with consumer products. It is highly recommended that you use cosmetic grade materials for manufacturing soap. Although, a cosmetic label may not be required, you can still be held liable for manufacturing a product that has not been approved as safe for skin contact. The US Consumer Product Safety Commission states that you are responsible for creating a safe personal care product. 

Good Manufacturing Practice Guidelines

These are industry guidelines that should be followed when making MP Soap.  They include, but are not limited to: 
 
  1. Space is sanitary with proper cleaning and has orderly storage.
  2. Equipment and utensils are free of corrosion, buildup of material, dirt or sanitizing agent.
  3. Cleaned and sanitized utensils are stored in a manner that protects them from dust or contamination.
  4. The personnel performing the manufacturing have the training to perform the assigned functions.
  5. Persons coming into direct contact with products must maintain their personal cleanliness and wear appropriate outer garments, gloves, goggles and hair restraints.
  6. Food, drink, and use of tobacco are not permitted in manufacturing areas.
  7. Raw materials and primary packaging materials are stored and handled in a manner which prevents their mix-up, contamination, or decomposition from exposure to excessive heat, cold, sunlight or moisture.
  8. Containers of materials are closed.  Bagged or boxed materials are stored off the floor.
  9. Containers of materials are labeled with identity and lot number.
  10. Records on raw materials are maintained indicating lot numbers, date received, quantity, testing data, certificate of analysis, and material safety data sheets.
  11. Records on manufacturing of batches should document the following steps:
    1. Identity, lot numbers and quantities of materials used.
    2. Processing, handling, transferring, holding and filling.
    3. Sampling, controlling, adjusting and reworking.
    4. Code marks of batches and finished products.

Material Safety Data Sheet (MSDS)

In the United States, this is a document containing data regarding the properties, such as flash point, of a particular substance. It is intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner. The document includes information such as physical data, toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill handling procedures.  Outside of the United States, this document may be called Safety Data Sheet (SDS).

The exact format and content of an MSDS or SDS can vary from source to source. In the U.S., the Occupational Safety and Health Administration (OSHA) requires that MSDS be available to employees for potentially harmful substances handled in the workplace under the Hazard Communication regulation. The MSDS is also required to be made available to local fire departments and local and state emergency planning officials under Section 311 of the Emergency Planning and Community Right-to-Know Act.

Washing & Sanitizing Equipment

Washing removes visible soil and contamination. Sanitizing kills and reduces the number of harmful bacteria that you cannot see. You should both wash and sanitize all work areas and utensils.

When sanitizing equipment, FDA guidelines specify a concentration between 50 and 100 parts per million of bleach. The only sure way to properly measure the concentration is with a chlorine paper test strip. The white paper test strips will change to a medium blue if the chlorine bleach is at the correct concentration. 1-2 teaspoons of bleach added to one gallon of water is generally a safe solution.

Occupational Safety & Health Administration (OSHA)

OSHA falls under the US Department of Labor. OSHA's purpose is to save lives, prevent workplace injuries and illnesses, and protect the health of all America's workers. This includes efforts to protect group of workers who are small and unorganized but who are particularly vulnerable or who face special hazards. Employer must be committed and offer meaningful employee participation and involvement in safety and health is a key ingredient in effective programs. All safety and health services, resources, rules, and information must be readily accessible and understandable to employees, employers, and OSHA's staff. 

Environmental Protection Agency (EPA)

The mission of EPA is to protect human health and the environment. Their purpose is to ensure that all Americans are protected from significant risks to human health and the environment where they live, learn and work. Their national efforts to reduce environmental risk are based on the best available scientific information. They have federal laws protecting human health and the environment which are enforced fairly and effectively. It is important to note that their environmental protection contributes to making our communities and ecosystems diverse, sustainable and economically productive and the United States plays a leadership role in working with other nations to protect the global environment. 

Local Agencies






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