A new frontier for cosmetics - products in ampoules

Concept borderline cosmetics is increasingly coming up in discussions about the boundaries of product classification. At issue are formulations and forms of administration that balance the boundary between cosmetic and medicinal product, medical device or supplement. Examples of such products are cosmetics in ampoules - an increasingly popular solution inspired by the pharmaceutical segment.

The form of the ampoule can affect how the product is received - not only by the consumer, but also by inspection authorities. This means that proper classification and documentation become even more important.

What are borderline cosmetics?

Borderline cosmetics are products that are difficult to classify unambiguously due to their composition, claimed action or method of application. Their legal status can be questionable - especially when the active ingredients have a strong physiological effect or the form is more like a medicine than a cosmetic.

In the context of EU regulations, the declared purpose of use - if the product is intended to affect the functioning of the body - is crucial, may be considered a medicinal product. Manufacturers should therefore take great care when designing such formulations.

Cosmetics in ampoules - characteristics of form and use

Cosmetics in ampoules are distinguished by their single-use, precisely dosed application form. This type of packaging reduces the need for preservatives, which is important for people with sensitive skin. At the same time, this form is associated with professional products and increases consumer confidence.

The high concentration of active ingredients, the tightness of the packaging and limited contact with air increase the durability of the formula. Ampoules are most often used in anti-wrinkle, regenerating or soothing treatments, where fast and noticeable action is important.

Can a cosmetic in an ampoule be considered a medicine or a medical device?

The form of application may affect the classification of the product. Cosmetic in an ampoule, which contains ingredients with a strong physiological effect and is advertised as a therapeutic agent, could be challenged by regulatory authorities. In such a case, it would need to go through the notification process as a medicinal product or medical device.

It is therefore important to:

• avoiding the declaration of therapeutic effect,
• precise documentation of composition and operation,
• compliance with the definition of a cosmetic in Regulation (EC) No 1223/2009.

Regulatory challenges - documentation and safety assessment

Introduction a cosmetic in an ampoule to market requires not only an effective formulation, but above all meticulously prepared documentation. Although the form may seem inconspicuous, it is precisely this - due to its association with pharmaceutical preparations - that is likely to attract particular attention from supervisory authorities.

This is based on the development of Cosmetic Product Safety Report (CPSR)which should be drawn up by a qualified Safety Assessor. The document considers:

• cosmetic composition,
• the physico-chemical properties and microbiological purity of the finished product and raw materials,
• contamination from raw materials and the risk of migration of substances from the packaging,
• packaging analysis - including compatibility of the mass with the packaging,
• toxicological evaluation of ingredients,
• exposure to cosmetics,
• results of tests on the finished product (tests in use, dermatological tests)
• analysis of adverse effects,
• the expert's final assessment.

Every cosmetic must be notified to the CPNP (Cosmetic Products Notification Portal)before being placed on the market. The CPNP enables control authorities (e.g. sanitary authorities, European Commission) Each cosmetic must be notified to the CPNP portal before being placed on the market. CPNP enables control authorities (e.g. sanitary authorities, the European Commission) for access to information about the cosmetic and for medical services to have quick access to the composition of the cosmetic in case of adverse effects (e.g. poisoning, allergy). The notification form requires, inter alia, the INCI composition, the data of the responsible entity, the product label and the country in which the product will be marketed.

• microbiological purity and sterility testing of the packaging,
• instructions on how to open and use it safely,
• testing for skin irritation and allergies - particularly important if the product is intensely concentrated.

Careful preparation of this documentation reduces the risk of the product being challenged by inspection bodies and avoids costly modifications after the cosmetic has been placed on the market.

The MPR LABS laboratory supports manufacturers at the documentation and testing stage. Every product - including cosmetic in an ampoule - must pass physico-chemical tests, microbiological tests and stability tests and packaging compatibility.

DD Additionally, it is worth carrying out:

• application studies - assessing the user experience,
• instrument studies - using specialised equipment to objectively measure the effectiveness of the cosmetic. 
• dermatological examinations - confirm that the cosmetic does not cause irritation or allergic reactions.

It is only with a full package of tests that a cosmetic can be safely placed on the market and potential legal consequences due to misclassification can be avoided.

Marketing profit or regulatory risk?

Ampoules attract consumer attention - they are seen as more 'concentrated', professional and effective formulas. This is an undoubted marketing advantage. On the other hand, the line between a cosmetic and a product with a pharmacological effect is becoming ever thinner.

It is worth remembering that efficacy proven by research results is much more valuable and inspires consumer confidence. This is why manufacturers are increasingly willing to invest in application studies or instrumental testing of cosmeticswhich provide objective data and support product positioning.

What does the future hold for borderline cosmetics?

The 'on the border' product segment will grow. Customers expect intensive action and the forms familiar from pharmacies build a sense of efficacy. With the growing popularity of ampoules, greater interest from regulatory institutions and potential legal changes can be expected.

Manufacturers planning to introduce a cosmetic in ampoules should take care in advance to ensure compliance with current regulations and comprehensive documentation.

If you want to develop an effective and safe ampoule cosmetic, contact us - see how we can help you at MPRlabs.com.