Want to Develop Cosmetic Products? Read this First
Welcome to the first article in the Regulatory and Scientific series.
In the ever-evolving world of cosmetics, understanding “Regulatory and Scientific Affairs” is essential if you wish to develop cosmetic products and sell in any market.
Defining “Regulatory” can be challenging as it encompasses a broad range of activities. Some view it as restrictive, especially with innovation. However, Regulatory and Scientific Affairs are integral to the success of any cosmetic company, ensuring compliance with legislation, managing risks, and maintaining product quality and safety.
Why is Regulatory and Scientific Affairs Important to Develop Cosmetic Products?
R&D, Formulations and Ingredients
Ingredients are the foundation of any cosmetic product and Regulatory are deeply connected with R&D, especially in formulations. Ingredient selection is key when developing a formula as any unsafe and non-compliant choice will greatly reduce your chances of placing your product on any market, let alone keeping it there. Additionally, if any health issues occur as a result of a consumer/s using your product/s, your reputation will deteriorate and you could face heavy fines and/or prison.
Furthermore, Companies must decide whether to go above-and-beyond existing legislation and adopt a proactive stance on ingredient compliance by creating internal blacklists and anticipating future regulations.
Manufacturing
Aside from ingredient compliance, Regulatory intersects with Quality Control and Good Manufacturing Practices (GMP). Adhering to standards like ISO22716 is vital to producing high-quality products that meet market expectations.
Claims
In order to place products on global markets, product claims need to be worded in a manner acceptable for that market to avoid barriers to trade and market entry. Equally, it is necessary to prove any claims on your products through testing which comes with a cost consideration.
Documentation
The Product Information File (PIF) is a crucial legal document required by the European Cosmetics Regulation 1223/2009. This document is needed to launch in the EU among other international markets, although additional documentation* may be needed depending on the market
Finished Products
Labelling
Regulatory ensures that packaging labelling meet the required standards depending on the launch market. Again, without these verifications, market entry and keeping your product on the market would be jeopardised.
Packaging
Regulations on packaging are continually evolving which needs to be followed to ensure the right packaging is chosen during the development phase and relevant documentation is at hand*. Further, compatibility studies ensure formulations do not interact negatively with packaging materials and Scientific Affairs, R&D oversee these studies to ensure product safety which is needed for the PIF.
Lobbying & Influencing
Setting standards, defining the legislation and policy making is partially under Scientific Affairs which deals with the technical aspects and working within trade industry associations** to agree common industry positions. Having a seat at the table is key for large Companies as more products are implicated by any legislation changes.
Stakeholder Interactions
Internal Stakeholders
Regulatory Teams interact with marketing, sales, logistics, supply chain, production, quality control, legal departments, etc. These interactions are crucial throughout the product development process and it is simply not possible to develop compliant products without Regulatory Teams.
External Stakeholders
Externally, Regulatory and Scientific Affairs could interact with customs officials, government authorities, distributors, and trade industry associations**, depending on the company set-up. These interactions are essential to resolving trade barrier issues and getting products to market.
What is a Cosmetic vs a Drug?
Knowing and being able to convince authorities your product is a cosmetic is key, as you will be ensuring compliance to cosmetic regulations during the entire development process. Should the status of your product change due to falling out of scope of the definition of a cosmetic product, you will be subject to a different legislation which is very difficult to conform to, the further down the line you are in the development process.
What is a Cosmetic?
According to the European Cosmetics Regulation 1223/2009, a cosmetic is defined by its target site of application and intended main function. Cosmetics are applied to external parts of the body, teeth, or mucous membranes, with functions such as cleaning, perfuming, changing appearance, correcting body odors, and protecting or keeping the skin in good condition.
In the US, the definition is similar but includes fewer functions. Products like SPF, antiperspirants, and anti-acne treatments are considered over the counter (OTC) drugs in the US but cosmetics in the EU.
What is a Drug?
Drugs are defined by their target site of application and intended medicinal function. According to the European Medicines Agency (EMA), drugs are applied to internal parts of the body and have functions such as treating, preventing, diagnosing, alleviating symptoms, modifying physiological functions, or restoring health.
In the US, the definition of a drug is similar but includes fewer functions.
Cosmetic vs. Drug
In the EU, a product is either a cosmetic or a drug, NOT both BUT in the US, a product can be both a cosmetic and a drug, such as an anti-dandruff shampoo, i.e. an OTC product.
Develop Cosmetic Products
In summary, the goal to develop cosmetic products is to ensure they remain compliant by staying within the cosmetic definition and avoiding claims or presentations that would classify them as drugs.
If you liked this article, and would like to know more, then why not check out one of our bite-sized Regulatory & Scientific Training Courses or the full size course on Perry Romanowski’s website.
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