REGULATION

Many consumers have a morning routine, do you? Most mornings, after walking my dog, a 2 kg chihuahua named Lenny, I have a light breakfast of rye toast, grapefruit juice, and a double-espresso latte. Breakfast is followed by a shower and shave. Similar routines are followed all around the world. Most people give little thought to the ingredients that are used in their everyday personal care products, but I do because I’m responsible for managing fragrance regulations, so I think about ingredients and regulations often. Whether it’s soap, deodorant, hairspray, or lipstick, consumer products are meant to come in contact with our skin, hair, teeth, or nails for the purpose of cleaning, perfuming, or changing appearance and are regulated to help ensure safety.

In the EU, Cosmetics are managed under regulation (EC) No 1223/2009, but this 150+ page regulation can be intimidating. Fortunately, the regulation can be broken down to a few simple elements. The central mantra of the EU regulatory approach is any cosmetic product brought to market must be safe when used under typical conditions. This safety is supported by proper labeling including clear labeling for the use and disposal of the cosmetic.  

Manufacturing and quality controls are meant to ensure that unexpected hazards are not introduced during production, but the cosmetic must be safe to begin with. Cosmetics must be made under proper conditions, called good manufacturing practices, meant to ensure a reproducible product that meets expected, predetermined conditions.  

Safety of the cosmetic is established through a product safety report. This report reviews the raw materials including product specification, microbiological risks, and the presence and concentration of known or reasonably expected impurities. Safety data including toxicological data, if not already known, must also be presented. The proposed labeling for the cosmetic product must also be included in the product safety report. 

LUKE GROCHOLL      

Merck KGaA | United States

FASCICOLO SPONSORIZZATO DA

Fortunately, a full toxicity report is often not necessary since many ingredients with known safety levels are listed in the regulation. In fact, much of the regulation’s 150+ pages are dedicated to known ingredients and their acceptable use in cosmetics or to prohibited ingredients. The EU identifies >1300 ingredients considered prohibited due to safety concerns. Prohibited ingredients cannot intentionally be added to cosmetics and should not be present in any amount. In addition to the list of prohibited ingredients in the cosmetic regulation, materials identified as CMR substances (carcinogenic, mutagenic, or toxic for reproduction) are also restricted. Many of these products are prohibited, but some may be allowed under certain conditions where the Scientific Committee for Consumer Safety (SCCS) determines the conditions for safe use.  

Preservatives are used in many cosmetics to extend shelf life and maintain the safety and efficacy of the cosmetic. Preservatives could introduce their own health risks, however. Fortunately, the regulation lists ~60 preservatives approved for use in cosmetics and the conditions under which they can be used. Similarly, safe color and UV filter ingredients are listed, as well as the allowed conditions for which they can be used. For other applications, >250 materials are identified with “restricted” use, that is, can be used under the conditions listed.  

Cosmetic must disclose all ingredient on their labels. Fragrances in cosmetics or household products are typically complex mixtures of small quantities of many different aromatic ingredients intended to impart a single olfactory sensation. Because of the small quantities and complexities of these mixtures, the regulation allows for the fragrance to be simply listed as “parfum” or “aroma” rather than listing every individual component of the fragrance. There are 26 fragrance ingredients identified in the cosmetic regulations “restricted” use list that may cause negative skin reactions (e.g. itchiness, redness, or even blistering) when used by some individuals. Because of the sensitivity of some individuals to these 26 “fragrance allergens” these ingredients must be listed separately on cosmetic labels rather than under the blanket ingredient parfum or aroma. There is considerable consideration on expanding the list of restricted fragrance allergens. The SCCS published an extensive study in 2011 on hundreds of fragrance compounds identifying over 50 known skin allergens (including the 26 compounds identified in the cosmetic regulation) and many suspected allergens with either known or likely allergenic effects. The comment period on this report ended in early 2019 and we have yet to see an expansion of identified allergens in the regulations, although it is recommended by the SCCS to expand the list of fragrance allergens identified in regulation (EC) No 1223/2009. 

Even where approved ingredients are used, special care should also be taken for any ingredient of nano-dimensions. Safety profiles must be submitted for evaluation for nanomaterials used in cosmetics. The European Commission reviews all submitted safety data for nanomaterials to approve their use. Care should also be taken in the safety data submitted, as most animal testing of cosmetics or cosmetic ingredients is prohibited in the EU whether for nanomaterial safety or other safety studies.

All this complexity may be difficult to navigate. This is why the EU requires a qualified individual who is responsible for the safety of the product, labeling, product claims, testing, and other elements needed to ensure the safety of the cosmetic product. The qualified individual is thus responsible to ensure the proper safety, approval, and labeling requirements are met. 

There are many tools and sources available for cosmetic products. IFRA, the International Fragrance Association, maintains an extensive list of ingredients safe to use in cosmetics. Although IFRA standards do not align with all elements of the EU regulation, they are an excellent resource for safety data on hundreds of fragrance ingredients. IFRA’s extensive review of fragrance products provides clear recommendations on not only which materials should be avoided in cosmetics, but also the safe conditions and material specifications for those they determine are safe for use.  

IFRA also provides other guidance and support for the use of fragrances in cosmetics and other products such as a labelling manual. Cosmetics must be labelled in accordance with the regulation with clear disclosure of any fragrance allergens. Any efficacy or benefit claims must be supported by evidence. Some ingredient claims may not be straight-forward, however, if they are not addressed in the regulations. Unlike flavour regulations, for example, there is no regulatory definition for a “natural” fragrance ingredient. Global standards exist to help with claims, however. Many organizations rely on ISO standards and ISO standard 9235 provides guidance on natural ingredient claims. In addition to providing a definition of natural raw materials, this standard also defines many other types of ingredients used in cosmetics. 

The EU regulations on cosmetics may seem daunting at first. But once each element can be broken down to understand and utilizing the extensive lists and guides available, to help guide cosmetic manufactures to produce safe cosmetic products. So, as I sit now in the warm sun, Lenny on lap, sipping my second latte of the day and thinking about cosmetic ingredients, I am confident the products I use are safe and effective. I may think about these ingredients often, but thanks to the regulations and programs in place, I do not worry about them.