Post-pandemic, the demand for Soap has increased drastically. People have moved away from traditional bar of soap and evolved into body wash, liquid soap, soap with scrubbers, bath bombs, and other products.
Manufacturers are launching innovative soaps with enhanced fragrances, ingredients and innovation, giving their consumers a wide variety to choose from. However, these developments have challenged the success ratios as several customers have reported allergic reactions and discomfort after using these products. Additionally, some ingredients were a threat to the environment.
Considering the safety of public health and the protection of the environment, governments have decided to implement some safety and compliance measures, which are highlighted in this blog. Before we continue, let us first understand:
What is Soap?
Soap is a cleansing agent made by reacting fats or oils with a strong alkaline solution, such as sodium hydroxide (lye) or potassium hydroxide. This chemical reaction, known as saponification, produces soap molecules with a hydrophilic (water-attracting) end and a hydrophobic (water-repelling) end. When combined with water, these properties allow Soap to effectively remove dirt, oil, and bacteria from the skin. Soap comes in various forms, including solid bars and liquid formulations, and it may contain additional ingredients such as fragrances, moisturisers, or exfoliants.
Some of the different uses of body soap include:
Bathing: Body soap is primarily used for bathing to cleanse the skin, remove dirt, oil, and sweat, and leave the body feeling fresh and rejuvenated.
Personal Hygiene: It helps maintain personal hygiene by washing away germs, bacteria, and impurities, reducing the risk of infections and body odour.
Antibacterial: Some body soaps contain antibacterial ingredients, such as triclosan or tea tree oil, which can help kill bacteria on the skin and prevent infections.
Treating Skin Conditions: Certain types of body soap are formulated to address specific skin conditions, such as acne, eczema, or dry skin. They may contain ingredients like salicylic acid, sulfur, or moisturisers to soothe and heal the skin.
Handwashing: Body soap can be used for thorough handwashing to remove dirt, germs, and contaminants, promoting good hand hygiene and reducing the spread of illness.
Our specialists support manufacturers to ensure that their product meets the correct set of regulations. Sometimes, a soap can be a cosmetic product or a drug!
Let’s check this out!
The Soap Dilemma:
When it comes to cosmetics, the term encompasses a wide range of products designed for personal care and beautification.
Cosmetics refer to products that are applied to the body for cleansing, beautifying, promoting attractiveness, or altering appearance. They include items like makeup, skincare products, fragrances, hair care products, and more.
A drug is any chemical substance that affects the functioning of living organisms, including bacteria, fungi, viruses, and humans. Here are some key points about drugs:
A drug, also known as a pharmaceutical, is a substance used to prevent or cure a disease or ailment or alleviate symptoms associated with a condition.
Soap falls into a unique category that is neither purely a cosmetic nor a drug. Let’s break it down:
Cosmetics:
Cosmetics are products used for personal care, beautification, or enhancing appearance.
Examples include makeup, moisturisers, perfumes, and hair products.
Cosmetics are primarily intended for external use and do not alter the body’s structure or function.
Soap can be considered a cosmetic if it meets specific criteria (as mentioned earlier).
Drugs:
Drugs are substances used to diagnose, treat, cure, or prevent diseases or medical conditions.
They have specific therapeutic effects on the body.
Soap is not typically used as a drug, although some speciality soaps (such as medicated or antibacterial soaps) may have additional properties that classify them as drugs.
Soap:
Soap is primarily used for cleansing and maintaining hygiene.
It doesn’t alter bodily functions or treat medical conditions directly.
Traditional Soap (made from fats/oils and alkali) is regulated as a cosmetic if it meets specific criteria (composition, cleaning action, and intended use).
Soap may be regulated as a drug if it makes additional claims (e.g., treating skin conditions).
In summary, soap straddles the line between cosmetics and drugs, depending on its formulation and intended use.
How is soap regulated in the USA?
In the United States, the regulation of soap depends on its intended use and composition. Let’s explore the relevant guidelines:
Cosmetic Definition:
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering appearance”.
Cosmetics include a wide range of products such as skin moisturisers, perfumes, lipsticks, makeup, shampoos, hair colours, and deodorants.
Drug Definition:
The FD&C Act defines drugs, in part, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Drugs have therapeutic effects and can alter bodily functions.
Dual Function Products:
Some products serve both cosmetic and drug purposes.
For example:
A shampoo is a cosmetic (intended for hair cleansing).
An antidandruff treatment is a drug (intended to treat dandruff).
An antidandruff shampoo is both a cosmetic and a drug.
Other examples include toothpaste with fluoride, deodorants with antiperspirant properties, and makeup with sun-protection claims.
FDA and CPSC Jurisdiction:
Cleansing products, including those marketed as “soap,” may fall under different regulations:
Cosmetics: If they meet cosmetic criteria.
Drugs: For example, “antibacterial” soaps.
Consumer Products: Regulated by the Consumer Product Safety Commission (CPSC).
The CPSC regulates true soaps (meeting the regulatory definition), while the FDA regulates cosmetics.
Specific Soap Regulations:
If a cleanser does not meet all the criteria for true soap (such as containing detergents), it is either a cosmetic or a drug.
Soaps would be subject to the Federal Hazardous Substances Act (FHSA) and the Consumer Product Safety Act (CPSA).
How is soap regulated in the EU and UK?
In both the European Union (EU) and the United Kingdom (UK), the regulation of soap falls under specific guidelines. Let’s explore how soap is regulated in each region:
EU (European Union):
Soap must comply with the Cosmetics Regulation (EC 1223/2009).
This regulation ensures the safety of cosmetic products on the European market by regulating the use of chemicals in these products.
Notably, it bans the use of animal testing for cosmetic purposes.
UK (United Kingdom):
Post-Brexit, the EU’s Cosmetics Regulation has been carried over into UK law - Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019
Key requirements include:
Cosmetic Product Safety Report (CPSR): Sellers must hold a valid CPSR for all products sold, signed by a suitably qualified safety assessor.
Responsible Person: All cosmetic products available to consumers must have a “Responsible Person”. The Responsible Person ensures safety measures and legal obligations are followed.
A Responsible Person can be the manufacturer, importer, distributor, or an appointed company/person.
They hold and maintain a Product Information File (PIF), including the Cosmetic Product Safety Report (CPSR) and notify the relevant authorities before making the product available to consumers.
We understand your challenges and are here to eliminate the regulatory risk! Reach out to our specialists by sending us an email at creme@creme.uk.com or submitting an online form - https://www.creme.uk.com/contact-us