Our Intertek Assuris experts, Joshua Ochola and Mathis Ralaivao will discuss how the distinction between product classes can be unclear or ambiguous, sometimes requiring interpretation and input from competent authorities. Wrong product classification can negatively impact a business and can have serious safety ramifications for the end user if the intended product use or function is confused or misunderstood.
Tune in to learn more.
00 :16 à 01 :06
Hello everyone, welcome to Assurance in Action podcast. I am Mathis Ralaivao, R&D engineer and here with me is Joshua Ochola, Toxicologist from Assuris. Today’s podcast is dedicated to borderline cosmetics.
The distinction between product classes can be unclear or ambiguous, sometimes requiring interpretation and input from competent authorities.
A mouthwash with antibacterial or antiseptic claims can be categorised as a cosmetics product, a biocidal product, or as a medicinal product.
When products straddle between two or more regulatory definitions, the European Commission defines these products as "borderline."
But first Joshua can you tell us what is a cosmetic product?
01 :07 à 01 :58
Thank you, Mathis. Hello everyone.
We all know a cosmetic product in the borderline context can be very complicated. In understanding borderlines as it relates to cosmetics, it is important we define what a cosmetic product is.
As defined by the EU Cosmetic Regulation, a cosmetic product is any substance or mixture intended to be placed in contact with the various external parts of the human body or with the teeth and mucous membranes of the oral cavity for the purposes of cleaning them, perfuming them, changing their appearance, correcting body odours, and/or protecting them or keeping them in good condition.
01 :58 à 02 :09
That is clearer now, with this definition we can better understand cosmetic product classification. Are there any other key notions linked to the cosmetic products?
02 :09 à 03 :40
To classify a cosmetic product under the EU Cosmetic Regulation, the purpose/function, formulation, and site of application has to be clearly defined.
The primary functions include altering of appearance, cleaning, beautifying, perfuming, protecting or correcting odours.
A cosmetic product can also have a secondary function, for instance biocidal/antimicrobial activity or functions or hygiene products or deodorants where the primary purpose is of a cosmetic nature.
In the evaluation of a cosmetic product function, the following considerations are important, these include, the manufacturer’s intention, presentation, labelling, advertising, claims, mode of action, composition, and consumer perception of the product.
The indications for not allocating a clearly defined primary or main function to a cosmetic product, it stands the risk of being defined into a different product category or miscategorised.
03 :40 à 03 :50
What about the formulation of the cosmetic product? How does it help in classifying a product as cosmetic?
03 :50 à 05 :24
There is a strong association between the composition of a cosmetic product and its function. Claims are made on the strength of specific ingredients used in the formulation of a cosmetic product. A cosmetic product formulation should comply with EU Cosmetics Regulation, meaning:
- It should not not contain prohibited ingredients listed in Annex II
- It should comply with the guidelines on restricted substances in Annex III
- and need to conform to the requirements relating to colorants, preservatives, and ultraviolet (UV) filters found in Annexes IV to VI of the EU cosmetic regulation.
The last key element in defining a cosmetic is the site of application:
Cosmetic products are intended for application on external parts of the human body such as the epidermis, hair system, nails, lips and external genital organs, or the teeth and mucous organs of the oral cavity.
I hope all these elements help in identifying what cosmetic products are. The definition separates cosmetics from other product classes especially closely related products, i.e., “borderline” products such as biocides, medicine, and medical devices.
05 :25 à 05 :40
Practically what does this mean? We have a clear understanding of a cosmetic, how can this be confused with other product categories? e.g., biocides. Can you provide practical examples?
05 :41 à 06 :51
The definition and primary function of the product serves as a guide to its classification. There are instances where the intersection between the primary functions of 2 products are so close, that inputs from competent authorities are required to simplify and agree to a product class. For instance, what is a biocidal product?
A biocidal product is a product with an active substance that is intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on harmful or undesired organisms. A product's primary function, as determined by claims, is a major determinant in making a distinction between a cosmetic and a biocidal product. For example, bath soaps with antibacterial or antiseptic properties are classified as biocidal products, and sunscreens, with their UV repelling properties, are also considered biocidal products.
06 :51 à 07 :04
How about other product categories? Does this principle also apply, and have you got any practical examples to share as well?
07 :04 à 09 :02
Absolutely so, same principles apply. Let’s look at medicinal product.
What is a medicinal product?
According to Directive 2001/83/EC of the European Parliament, a medicinal product is any substance or mixture that has therapeutic or prophylactic properties in human beings. This includes substances administered with the aim of restoring, correcting, or modifying a physiological function by exerting a pharmacological, immunological, or metabolic action, or making a medical diagnosis. For example, shampoo is considered a cosmetic product since its intended use is to cleanse the hair; however, an anti-dandruff treatment is categorised as a drug because its intended use is to treat dandruff through a pharmacological action. Consequently, an antidandruff shampoo is both a cosmetic and a drug. For instance, if you have, an anti-dandruff shampoo that does not have an active biocidal ingredient- if the action is strictly anticeborial that will be a cosmetic product. Whereas, when you have an anti-dandruff shampoo that has an antifungal principal like ketoconazole, that will be a drug and hence you can see where there is always difference from the formulation and the definition how both of them come together to help us define and present a particular product in the appropriate class or category.
09 :02 à 09 :20
It is very clear now. Medical devices are quite a unique category, given the regulatory definition of medical devices; how does this apply? What are the salient points and please share relevant practical examples.
09 :20 à 10 :59
Thank you, Mathis. Again, let’s look at what the definition of a medical device is.
According to European Union Regulation (EU) 2017/745, a medical device refers to any instrument, apparatus, equipment, software, implant, reagent, material, or other article, used alone or in combination. In short, a medical device is intended for use in human beings in relation to a disease, injury or disability, an anatomical structure or function, a physiological or pathological process, as well as other special medical cases.
In addition, this regulation includes certain products for aesthetic purposes, such as tinted contact lenses, equipment emitting high intensity electromagnetic radiation such as lasers and intense pulsed light equipment used for skin resurfacing, tattoo removal, hair removal or other skin treatments.
Many medical devices are applied to superficial parts of the human body. The distinctive feature of a medical device is that the product is claimed to be used for a medical purpose or to belong to one of the aesthetic categories, which differentiates it from cosmetic products.
For example, a foot cream used to treat dry skin is a cosmetic product but will be classified as a medical device if it is associated with a claim to heal skin damaged by cracks or fissures.
10 :59 à 11 :15
Having discussed cosmetics robustly and the critical considerations in defining a product classification with important practical examples; Can you summarise importance and impact of wrong product classification.
11 :15 à 13 :12
Wrong product classification can negatively impact a business and can have serious safety ramifications for the end user if the intended product use or function is confused or misunderstood. Other direct consequences can include potential product recalls, redesign of product labels, re-application or re‑notification to the appropriate competent authorities, reformulation of the product, and/or application for variation in some product class within the same regulatory framework. There is also the burden of associated costs, loss of brand reputation, loss of time, etc.
It is imperative that manufacturers, suppliers, and distributors correctly classify their products from the onset; this will subject the product to the appropriate regulatory framework and meet relevant compliance requirements. In the case of uncertainty, the competent national authorities in the EU and UK Member States will decide on a case-by-case basis. Do you have questions about this topic, your obligations under the relevant regulatory framework, or a related topic? Contact our experts at Intertek Assuris—we're here to help!
For more information about our service offerings for the consumer healthcare, cosmetics, and toiletries industries, visit: https://www.intertek.com/assuris/cosmetics/.