Functionality and efficacy claims

The choice of a raw material generally begins with its desired functionality in the product formulation which includes properties like emulsification, moisturization, cleansing, thickening, coloring, fragrance or preservation.  The nature of product form and packaging (cream, gel, hot pour, spray, stick, etc.) impacts how the product is dispensed, applied and feels to the consumer representing additional concerns when selecting ingredients. 

Compatibility and stability of ingredients within a formulation and with packaging are also important considerations. A good technical data sheet or other literature from a supplier will indicate known incompatibilities and stability issues like pH limitations, potential for oxidation, hot/cold tolerance, and lightfastness (which is of specific importance to colorants) so that these conditions can be avoided. The limited stability of Vitamin C in water-based formulation is a good and well-known example of ingredient instability but the current changing landscape of preservatives has left the formulator with limits on pH that can further restrict the choice of other ingredients and packaging. For example, potassium sorbate is becoming more widely used but must be converted to sorbic acid by lowering formula pH below 4.5 to be effective but being that it is an unsaturated fatty acid it is subject to oxidation and can also turn a solution yellow. 

A sometimes more subjective consideration are the claims associated with a raw material.  All ingredient efficacy claims should be substantiated with appropriate test methods and supporting data. These claims will, of course, need to also be evaluated in your unique application. If the claims seem too good to be true, they may just be and it is important to remember that cosmetic ingredients should not be marketed as drugs that allege to prevent, treat or cure disease. It’s worth it to be skeptical and cautious.

Safety substantiation and regulatory compliance

Using any raw material today requires a full dossier of technical information that fulfills regulatory and safety requirements along with evidence to support ever-evolving non-governmental organization (NGO) and retailer certifications.  While NGO certifications regarding naturalness or sustainability are important, safety information and compliance with regulations are mandatory and may prohibit use of even the most interesting ingredients.  

Cosmetic ingredient suppliers often have safety data on their products and additional safety data may be found in published in scientific journals or historical literature as many ingredients have a long history of safe use. Cosmetic Ingredient Reviews (CIR) are, by far, one of the best resources for information about the safety of individual ingredients. They provide a comprehensive, critical review of relevant studies and are conducted by an expert panel of scientists including toxicologists and medical professionals. The CIR process was established by the Personal Care Products Council with the support of the US Food and Drug Administration (USFDA) and follows the methodology of the USFDA’s over-the-counter drug review. Complete CIRs are published in the peer-reviewed literature (the International Journal of Toxicology) and fully available to the public. Consulting CIRs should be one of the first steps in evaluating the use of a cosmetic ingredient.

A good example of stringent regulatory compliance is the category of colorants. Countries around the world require colorants used in cosmetics and personal care products to come from an approved list that has been vetted for safety and that those colorants conform to certain specifications for identity, source and impurities.  In particular, the USFDA mandates that synthetic organic pigments (often designated with FD&C or D&C, a color name, and a number like FD&C Blue 1) used in any cosmetics and personal care products pass testing against their specifications and this requirement applies to products sold in the United States even if not manufactured there. This testing is performed by the FDA and referred to as batch certification. Each lot of color is issued a unique batch certification number once testing requirements have been satisfied. If a colorant is later repackaged for sale after this initial round of testing, for example if it is being portioned into smaller containers, it must be recertified by the FDA because of the potential for contamination or adulteration. If you are manufacturing in the US or selling products with synthetic organic pigments in the US, you should confirm with the supplier that these ingredients have been properly certified by requesting the batch certification number if it was not included on the certificate of analysis. This number also needs to be recorded for each batch of finished product that the colorant is mixed into.

Availability

Incorporating rare ingredients or cutting-edge technologies can provide a substantial competitive advantage in an extremely crowded marketplace but when inventory of that material depends on a single supplier or manufacturing location the impacts of supply chain disruption can be severe.  Exotic extracts and oils that are sourced only from specific geographic locations can also leave you vulnerable to supply chain interruptions and may not make the most sense in terms of sustainability due to the carbon footprint of transportation.  The COVID pandemic has exposed supply chain vulnerabilities for even some of the most commonplace raw materials and lead to increasing costs due to transportation bottlenecks and labor shortages.  

Minimum Order Quantities (MOQ)

Minimum order quantities represent the smallest amount of raw material a supplier is willing to sell per order and that may not always align with your manufacturing or inventory plans. While they may be frustrating, MOQs are put in place for good reason. Suppliers need to cover the cost of business without compromising on quality and service. Utilizing a distributor for raw materials may help. Distributors carry multiple product lines and are set up to more effectively serve small businesses by offering more flexibility in MOQs or a total minimum purchase amount. They may be able to provide more attentive technical service to smaller customers as well. But a distributor has their own warehouses and employs their own sales and customer service staff so you will likely pay a higher price for raw materials because they have to build in their own margins to keep the business running. 

Specifications and quality

Familiarize yourself with the parameters of specifications for each raw material and gauge the impact of the ranges provided on the finished product, especially when working with new ingredients. Specification ranges are an indication of quality and can also be indicative of the limits of the supplier’s manufacturing capabilities. Consider if the reported variance is acceptable and whether or not it can be improved.  These characteristics not only contribute to your formula’s performance, they can be used to verify that the material has not degraded or become contaminated. When possible, it is a good idea to evaluate multiple suppliers for a desired ingredient by comparing specification tolerances and performance in formulation.

A sign of supplier commitment to quality is certification according to International Organization for Standardization (abbreviated as ISO) 9001. ISO 9001 standard sets out criteria for a Quality Management System (QMS) and mandates a process of continuous improvement which reduces errors, increases efficiencies and ensures consistent delivery of goods that meet customer requirements. ISO 9001 requires documentation of processes and procedures along with calibration of measuring and testing equipment, also referred to as measurement traceability. 

Green certifications and retailer requirements

Today’s consumer desires products that are more than just efficacious, they want to use their money wisely and align purchases with their values. Green, sustainable, cruelty-free, ethically-sourced represent some of these claims. The number and types of certifications for these claims is growing. Much like the debate around the definition of natural cosmetics in the aughts, eventually a few of these new certifications will shake out as the most meaningful to the consumer. And some claims can be in conflict, not all natural ingredients can be sustainably sourced. Essential oils can require tens of thousands of pounds of source material which also makes them expensive to produce and therefore often at risk of being diluted or adulterated. 

The concept of clean beauty, whether scientifically accurate or not, is here to stay. Retailer clean beauty lists are becoming more complex and require that you cross-reference ingredients with a list of prohibited materials to ensure you can be compliant before even starting the product development process. Unfortunately, these lists may vary significantly from retailer to retailer making the task more challenging. Many ingredient suppliers are beginning to include this information in technical literature and there are some databases that help you search for these restricted ingredients for multiple retailers at once. 

Choosing the right ingredient may be complex and the factors mentioned here are certainly not exhaustive, but a defined evaluation process will be critical to the success of the final product in terms of marketability, quality, and safety. To minimize risk, you need to choose each ingredient and source(s) wisely, ensure it is safe to use and test each raw material to verify that it meets expectations.

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