This is a guest post by UK cosmetic chemist Colin Sanders. You can read more from Colin on his excellent blog at Colins Beauty Pages.

The latest iteration of the EU cosmetic regulations come into force in July 2013, and they are a pretty major upgrade with lots of new provisions and innovations that will affect everyone in the business of supplying cosmetics and personal care into the European market. If you are doing so, you really should know all about them by now, but here is a quick whistle stop tour if you are just starting or if you don’t operate in Europe but are curious.

EU cosmetic regulations

There are 6 main new areas.

Claims – it is now necessary to have data on file to support any claims you make for the product. This has been an implied requirement for some time via other bits of consumer legislation but it has now been codified into the actual cosmetic regulations. One eye catching provision is that it is now illegal to make claims that denigrate safe and legal ingredients. This sounds a bit like somebody somewhere is working out their pet peeve. In theory this outlaws claims like ‘paraben free’, though I dare say ways will be found round this one soon enough.

Nanoparticles – nanoparticles as defined by the EU will now need to be specified as such on the label. The format will distinguish a nano particle with the suffix ‘nano’, so Titanium Dioxide becomes Titanium Dioxide nano.

Cosmetic GMP – cosmetics will now have to be produced under controlled conditions, i.e., pretty much how they already are but it is now mandatory.

Notification – all products and their individual raw materials will have to be disclosed on a database covering the whole EU. This is to provide information for poison centres for them to use in the event of dealing with an adverse event where the ingredients of the cosmetics the victim is using might be relevant. (If any toxicologists reading this can give an example of how this might be useful I would love to hear it.)

Safety Assessments – currently the safety of cosmetic products have to be assessed prior to release by a ‘suitably qualified’ person. The new regulations specify that the qualifications should be in toxicology and that the assessment should follow a particular protocol.

Adverse Event Reporting – all adverse reactions now need to be reported directly to the authorities in the country in which the reaction occurs. The intention is that the data thus generated will be made public.

Regulation implications

Overall these changes represent a significant tightening of the regulations governing the manufacture, promotion and sale of cosmetics. I am planning to allocate an hour a day to the work needed to get ready for it, and I imagine that it will create about 2 hours a month extra work per formulation to keep compliant once it is in force. This isn’t too much of a burden for a large company or even for a medium sized one, but I think it might be onerous for smaller ones and start ups.

There are some clear advantages to the user. The adverse event reporting is long overdue and will give us all a better idea of what is causing problems and issues. The notification system is going to be expensive both for companies providing the data and for the general public who will pick up the tab for maintaining the database. Whether it is worth it or not is a matter of opinion. It seems to me a huge investment of resources for very little return, but I am open to being corrected on that if it turns out that lives are saved by the rapid availability of detailed cosmetic formulation information.

The requirement for cosmetic GMP is probably neutral. There are poorly produced and controlled cosmetics around. But whether the companies who make them will take any notice of this regulation is a good question. The companies that will comply with the new regulations are probably doing it already. I am particularly unimpressed by the tightening of the rules about safety assessments. It is good news if you are a toxicologist in want of employment, but it doesn’t seem to me that by being more prescriptive it makes things any safer. The phrase suitably qualified seemed to me to a good description, because it allowed for different levels of assessment for different products. I would say that just about anyone is suitably qualified to assess the safety of a bar of soap for example. On the other hand, a really advanced skin innovation using a lot of materials that don’t have a track history of use really ought to be assessed by somebody who understands that specific technology. Getting in a toxicologist off the street and following a set format doesn’t sound like the way to determine whether it should be released to me.

But however I feel about it, it is coming. It is such a large and widely ranging piece of legislation that I dare say most people will be able to find bits they like and bits they hate.

Don’t miss the podcast episode that featured a discussion with Colin Sanders!

When developing products we often walk a fine line in terms of formulating for efficacy and marketing claims. It is important to understand the regulatory and legal implications of the decisions we make.

Cosmetic or Drug?

In the United States, the Federal Food, Drug and Cosmetic Act defines cosmetics as “article intended to be rubbed, pour, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Examples include blush, lipstick, nail polish, shampoo, and toothpaste.

But once the product claims venture into diagnosis, treatment, or prevention of disease and alleges to affect the structure or any function of the body, the product is a drug. Drugs are subject to stringent regulations, labeling (actives are called out from other ingredients) and testing requirements, which result in the investment of both time and money.

Products can be both cosmetic and drug if the intended use meets both definitions. Moisturizers with sunscreens, moisturizing hand sanitizers, and anti-dandruff shampoos all fall into this category. These cosmetic/drug combinations are subject to the regulations for both drugs and cosmetics. They are considered OTC or Over the Counter drugs.

Soaps

True soaps represent an additional category and are regulated by the Consumer Products Safety Commission, not the FDA. True soaps are made purely of fat and alkali. Soaps made with any other ingredient or claim any other benefit like moisturization or deodorizing are cosmetics.

Cosmeceuticals

One other classification of products is cosmeceuticals. The oft-controversial but significant contributor to our field, dermatologist Dr. Albert Kligman, coined the term cosmeceutical almost 30 years ago. He defined cosmeceuticals as topically applied products that do have a physiological effect on the skin. The industry was quick to respond because the potential regulation of cosmetics as drugs could cripple innovation due to time and cost. Kligman, however, intended to draw attention to the potential biological effects of all cosmetics that did not just merely camouflage or add color. In fact he said it was “scientifically silly to pretend that cosmetics did not do anything” and that cosmetics might actually be doing a lot of good.

The term cosmeceutical is not recognized as part of the Federal Food, Drug, and Cosmetic Act. But whether you agree or disagree, this term has become part of our consumer’s vernacular. The controversy and conversation the term has created remains, in my mind, one of Kligman’s great contributions to cosmetic science.

Further information can be found on the FDA’s website.

My first experience with cosmetic labeling came in college when I turned over the bottle of a shampoo and looked at the ingredient list. It was right around the time when I was learning how to name chemicals and I was confused why I couldn’t recognize almost any of the ingredients. It turns out that the cosmetic industry doesn’t follow the IUPAC system which is what they teach you in college. It follows the system set up by the Personal Care Products Council (PCPC) as described in the INCI Dictionary. See our previous post on cosmetic labeling and the naming conventions in it.

But the ingredients names in your formula are only part of the labeling process. You also have to follow the labeling rules laid out by the FDA that affect ingredient order, placement on the label, text size, language and more. Here are the relevant facts.

Cosmetic ingredient list

In the United States, it is a requirement that all cosmetics be labeled with their ingredients. The LOI (list of ingredients) is supposed to be printed on the container and needs to follow some rules when listing ingredients.

1. Ingredients above 1% need to be listed in order of concentration
2. Ingredients 1% or below can be listed in any order
3. Exception: Color ingredients are listed at the end

The names of the ingredients must be those found in the INCI (International Nomenclature of Cosmetic Ingredients) Dictionary.

Where does the list go?

Once you have the list, you’ll have to put it on the package in the proper position. The FDA requires that it be put on the principle display panel which in most cases just means somewhere on the primary package where people can read it. See this for details.

What kind of font?

To ensure that the ingredient list is readable, the FDA requires that the font size be no smaller than 1/16th of an inch unless your packaging is really small in which case you can make the font 1/32nd of an inch.

What language?

Products sold in the United States must be written in English.

What else do you include?

Other information you need to list includes

1. Name of the product (e.g shampoo, lipstick, eyeshadow)
2. Name of manufacturer or distributor
3. Address of manufacturer including city and zip code
4. Net contents in container
5. Warning statements if required

For more details about what and how you specifically need to list information on your labels in the United States, see this section on the FDA website.