Why Raw Material Quality Matters in Skin-Contact Products

Before a finished skin-contact product can be mixed, filled, packaged, tested, or shipped, something much more fundamental has to happen:

The manufacturer needs the right raw materials.

Every finished formulation begins with individual ingredients. Those materials may arrive as liquids, powders, polymers, resins, solvents, oils, preservatives, colorants, fragrances, or other substances depending upon the product being manufactured.

And although two containers may carry the same ingredient name, that does not necessarily mean their contents are identical in every meaningful respect.

Raw materials can differ in:

identity;
concentration;
purity;
grade;
impurity profile;
physical characteristics;
microbiological quality;
storage history;
manufacturing source;
and lot-to-lot consistency.

That is why responsible manufacturing doesn't begin at the mixing tank.

Quality begins with understanding and controlling what goes into it.

What Exactly Is a Raw Material?

A raw material is an ingredient or material used in manufacturing a finished product.

For a skin-contact formulation, raw materials might include:

polymers;
solvents;
water;
oils;
emulsifiers;
surfactants;
preservatives;
antioxidants;
fragrances;
pigments or colorants;
thickeners;
plasticizers;
or other functional ingredients.

Different products require very different materials.

A liquid skin adhesive, cleanser, shampoo, conditioner, cosmetic cream, and adhesive-removal product may have little in common chemically even though all are intended to be used on or near the body.

For that reason, raw-material controls need to make sense for the particular formulation and material.

Isn't an Ingredient Name Enough?

Not necessarily.

Consider something as familiar as water.

“Water” describes a substance chemically, but water used in manufacturing can vary considerably in its:

mineral content;
dissolved substances;
microorganisms;
treatment history;
and overall quality.

FDA's cosmetic GMP guidance specifically calls for water used as a cosmetic ingredient to be of defined quality and recommends regular monitoring for chemical and microbiological quality. (fda.gov)

The same basic principle applies to other ingredients.

Knowing the name is important.

Knowing the quality and characteristics of the particular material being used is better.

Identity Comes First

One of the most fundamental questions about an incoming material is:

Is this actually the material we ordered?

That sounds almost too obvious to mention.

But manufacturing environments may handle numerous drums, pails, bags, bottles, and containers, sometimes containing materials with similar appearances.

FDA's cosmetic GMP guidance addresses identification of raw materials, lot identification, control status, examination or testing, and procedures intended to prevent mix-ups. (fda.gov)

Using the wrong ingredient can affect much more than appearance.

It may alter:

product performance;
viscosity;
stability;
compatibility;
preservation;
drying behavior;
or other important characteristics.

So the first requirement of good raw-material control is wonderfully uncomplicated:

Know what you have.

What Does “Purity” Mean?

Purity describes how much of a material consists of the intended substance relative to other substances that may be present.

But “pure” should not automatically be interpreted as meaning 100.000% of one molecule and absolutely nothing else.

Commercial raw materials may contain:

residual materials from manufacturing;
trace impurities;
water;
stabilizers;
naturally occurring constituents;
or other components associated with their production.

What matters is whether the material meets the appropriate specification for its intended use.

That distinction helps us avoid another common misconception:

An ingredient does not become appropriate merely because someone describes it as “pure.”

The relevant questions are how pure, with respect to what specification, and appropriate for what use?

What Is a Raw-Material Specification?

A specification defines characteristics a material is expected to meet before it is considered acceptable for use.

Depending upon the ingredient, a specification might address:

identity;
appearance;
concentration or assay;
viscosity;
pH;
moisture;
density;
purity;
microbial limits;
particular impurities;
or other relevant properties.

Not every characteristic is meaningful for every material.

The objective isn't to create the longest specification sheet possible.

It is to identify characteristics that matter to the identity, quality, consistency, performance, or safety of the material.

FDA's cosmetic GMP guidance specifically discusses specifications and examination or testing of raw materials for compliance with established requirements. (fda.gov)

Why Do Impurities Matter?

An impurity is something present in a raw material other than the intended principal substance or components.

Not every impurity automatically represents a meaningful hazard.

Its importance depends upon factors such as:

what it is + how much is present + how much material enters the formulation + how the finished product is used + the resulting exposure

This is why toxicology and manufacturing quality require more nuance than simply declaring:

“Chemical detected!”

Detection alone does not establish risk.

FDA notes that cosmetic contamination can arise from raw materials, manufacturing conditions, water, packaging, storage, or other sources. It also maintains specific information concerning potential contaminants such as heavy metals and microorganisms. (fda.gov)

The meaningful question is whether contaminants or impurities are present at levels relevant to product quality and safety.

Why Does the Supplier Matter?

A manufacturer doesn't manufacture every raw material it uses.

It relies upon suppliers.

That makes the supply chain part of the quality system.

An appropriate supplier program may consider information such as:

supplier history;
material specifications;
manufacturing consistency;
documentation;
test results;
change notifications;
complaint history;
regulatory status;
and previous performance.

ISO 22716 includes purchasing and raw-material controls within its framework for cosmetic GMP. (iso.org)

A long relationship with a supplier can provide useful experience.

But longevity alone doesn't prove that every future shipment will automatically meet requirements.

Supplier confidence and incoming-material control complement one another.

What Is a Certificate of Analysis?

A Certificate of Analysis, commonly abbreviated CoA, is a document associated with a particular material or batch that reports information about specified characteristics or tests.

A CoA may include:

material name;
supplier;
lot or batch number;
manufacturing or test date;
specifications;
analytical tests;
acceptance limits;
actual results;
and disposition.

A useful CoA therefore answers more than:

“Did it pass?”

It may help show what was evaluated and against what criteria.

But a CoA should not be treated as a magic piece of paper.

Does a CoA Guarantee the Material?

No.

A CoA is part of a quality system.

It is not the entire quality system.

Manufacturers need procedures appropriate to their operations for determining how supplier documentation is reviewed, qualified, verified, and relied upon.

FDA's GMP materials contemplate examination or testing of incoming materials and the maintenance of records associated with their acceptance or rejection. (fda.gov)

The important principle is:

Documentation provides evidence. The quality system determines how that evidence is used.

Why Does Lot Traceability Matter?

Raw materials usually arrive with lot or batch identifiers.

Those identifiers allow a manufacturer to distinguish one production lot of an ingredient from another.

Imagine that six months after manufacturing, a supplier discovers a problem affecting one particular raw-material lot.

A traceable manufacturing system may allow the manufacturer to determine:

Which material lot was affected?

↓

Which finished batches used it?

↓

Where did those finished batches go?

That is enormously more useful than knowing only:

“Yes, we sometimes buy that ingredient.”

FDA's cosmetic GMP guidance emphasizes raw-material lot identification and manufacturing records connecting materials and quantities with finished production. (fda.gov)

Traceability turns a general problem into an investigable one.

Storage Matters Before Manufacturing Too

A perfectly acceptable material can deteriorate if it is stored improperly.

Depending upon the material, storage considerations might include:

temperature;
humidity;
light exposure;
container closure;
contamination;
shelf life;
and separation from incompatible materials.

FDA's cosmetic GMP guidance addresses storing raw materials in closed containers under conditions intended to prevent contamination, deterioration, and mix-ups. (fda.gov)

This means incoming inspection isn't the end of raw-material control.

A material has to remain suitable until it is actually used.

Why Does Lot-to-Lot Consistency Matter?

Even when successive shipments contain the correct ingredient, small differences may occur.

Depending upon the material, variation might influence:

color;
odor;
viscosity;
concentration;
moisture;
processing behavior;
or finished-product characteristics.

Specifications help establish acceptable boundaries for that variation.

This is especially important when a raw material contributes directly to the functional performance of a finished formulation.

If incoming materials vary significantly, maintaining consistent finished-product performance becomes more difficult.

Consistency downstream depends partly upon consistency upstream.

Does “Natural” Mean Higher-Quality Raw Material?

No.

A material's origin does not establish its quality.

Natural materials can contain:

contaminants;
allergens;
variable constituent concentrations;
microorganisms;
pesticides;
naturally occurring toxic substances;
or substantial lot-to-lot variation.

Synthetic materials can also contain impurities or fail specifications.

Neither category receives an automatic quality award.

FDA explicitly states that selecting ingredients described as “natural” or “organic” does not ensure cosmetic safety. (fda.gov)

A better question is:

Is this particular material appropriately characterized, controlled, and suitable for its intended use?

Does a Familiar Ingredient Name Mean It's Appropriate for Skin?

Not automatically.

The safety of an ingredient depends upon more than its name.

Important considerations can include:

concentration;
purity;
route of exposure;
duration and frequency of exposure;
formulation;
impurities;
interactions with other ingredients;
and intended use.

FDA explains that manufacturers are responsible for ensuring the safety of cosmetic products and ingredients under labeled or customary conditions of use, and that safety substantiation may draw upon available scientific information and additional testing where appropriate. (fda.gov)

This is another reason raw-material selection involves both quality and toxicological relevance.

What About Ingredients a Manufacturer Chooses to Avoid?

Companies sometimes formulate products without particular ingredients.

There can be legitimate reasons for doing so.

An ingredient might be:

restricted by regulation;
unsuitable for the intended application;
incompatible with other ingredients;
associated with unwanted performance characteristics;
difficult to source consistently;
unnecessary to the formulation;
or deliberately excluded under a company formulation policy.

But care is needed when explaining these decisions.

“We don't use Ingredient X”

does not automatically mean:

“Ingredient X is dangerous in every product.”

That leap can turn useful formulation information into misleading fear-based marketing.

Ingredient safety depends upon identity, concentration, exposure, formulation, and use.

Our job as consumers—or manufacturers—is to understand those distinctions.

What Happens If a Raw Material Doesn't Meet Specification?

It shouldn't simply disappear into production because throwing it away would be inconvenient.

Appropriate controls should identify the material's status and prevent unintended use while its disposition is determined.

Depending upon the circumstances, the material might be:

rejected;
returned;
further investigated;
appropriately re-evaluated;
or otherwise handled according to established procedures.

FDA's cosmetic GMP guidance specifically addresses identifying rejected materials and controlling them to prevent their use. (fda.gov)

This is one of those manufacturing decisions customers never see.

But it matters.

The Finished Product Cannot Erase Its Ingredients' History

Once raw materials are mixed together, their history doesn't cease to matter.

The finished product contains the consequences of:

how those materials were manufactured;
how they were characterized;
how they were transported;
how they were stored;
whether they met specifications;
and whether the correct lots entered production.

Finished-product testing provides important information.

But it cannot always reconstruct everything that happened upstream.

That's why good manufacturing practice doesn't rely exclusively upon testing the final bottle.

It establishes controls before, during, and after manufacturing.

What Should Consumers Take Away?

Consumers don't need to request a Certificate of Analysis for every ingredient in every product they purchase.

Nor does a longer ingredient list necessarily mean poorer quality.

A shorter ingredient list doesn't necessarily mean better quality either.

What matters is the system behind the formulation.

Responsible raw-material management asks:

Do we know what this material is?

Do we know where it came from?

Does it meet appropriate specifications?

Can we trace its lot?

Has it been stored appropriately?

Is it suitable for the intended formulation and use?

Those aren't glamorous questions.

They don't fit particularly well into advertising slogans.

But they are among the questions that matter most before manufacturing ever begins.

A finished product can only be controlled as well as the materials, information, and processes used to make it.

Quality doesn't begin when the bottle is filled.

It begins at the loading dock.

What Does Good Manufacturing Practice Mean for Products Used on Skin?

Why Quality Control Matters for Products Used on Skin

What Happens Before a Skin-Contact Product Is Released for Sale?

How Manufacturers Help Control Contamination

What Do Certifications Really Tell You About a Product?

Why Do Manufacturers Avoid or Restrict Certain Ingredients?

Sources

U.S. Food and Drug Administration. Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics. Addresses raw-material identity, lot identification, control status, specifications, examination or testing, storage, water quality, rejected materials, records, and manufacturing traceability. (fda.gov)
U.S. Food and Drug Administration. Potential Contaminants in Cosmetics. FDA information concerning contaminants that can enter cosmetic products through ingredients, manufacturing, or other sources, including microorganisms and certain chemical contaminants. (fda.gov)
U.S. Food and Drug Administration. Product Testing of Cosmetics. Discusses manufacturers' responsibility for cosmetic safety and the use of existing scientific information and additional testing where appropriate to substantiate product and ingredient safety. (fda.gov)
U.S. Food and Drug Administration. Small Businesses & Homemade Cosmetics: Fact Sheet. Explains manufacturer responsibility for product and ingredient safety and cautions that “natural” or “organic” ingredients are not automatically safe. (fda.gov)
International Organization for Standardization. ISO 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. International guidance addressing production, control, storage, and shipment of cosmetic products, including raw-material management within the manufacturing system. (iso.org)
U.S. Food and Drug Administration. Microbiological Safety and Cosmetics. Discusses microbial contamination from raw materials, water, manufacturing conditions, preservation, packaging, shipping, storage, and consumer use. (fda.gov)