For all your Regulatory Affairs challenges

Borderline Substances

We can help you with:

  • Advice on the classification of your product
  • Preparing briefing documents for pre-registration discussions with the relevant regulatory body, to clarify product qualification
  • Identifying the regulatory status and suitable regulatory pathway for your product.
  • Reviewing your label claims
  • Gap Analysis of data requirements taking into account anticipated regulatory route and label claims
  • Assistance with any clinical trials needed to support claims

What is a borderline substance?

A healthcare product which does not distinctly fall into a particular area is referred to as a ‘borderline product’. This term is used when a product is not clearly identifiable as a medicine and may be, for example, a cosmetic or food supplement. There are 3 main borderlines:

  • Medicinal Product/Medical Device
  • Medicinal Product/Food
  • Medicinal Product/Cosmetic

For such products it is important to define their primary function to determine which side of the borderline they fall and which set of regulations must be followed before placing them on the market.

Where does my product fit?

Not sure then give us a call on 01480 465755

Medicines/Medicinal claims

If a borderline product contains a pharmacologically active substance or makes a medicinal claim then it would fall within the definition of a medicinal product and would be subject to medicines control, requiring approval through ECMarketing Authorisation procedures. A product which does not meet these criteria may still subject to other EU regulations such as the medical devices directive or the food safety and food labeling legislation rather than medicines control see below. 

Medicine/Medical Device

The term medical device covers an extremely wide range of products including, for example: first aid bandages, tongue depressors, hip prostheses, X-ray equipment, ECG, heart valves, spectacles and dental materials. In general, if a product acts pharmacologically, immunologically or metabolically it is unlikely to be considered to be a medical device. In order to determine whether a product is a device or a medicine, the definitions of both need to be considered, along with the claims for the product, the mode of action on the human body and intended purpose of the product.

If your product falls within the Medical devices regulations CambReg can guide you through classification and route to conformance. We can help with QA compliance, technical file preparation and completion of the CE-marking process as necessary.


There are many food products on the market that are termed neutraceuticals. The dictionary definition of a nutraceutical is, “any food or food ingredient which is considered to have a beneficial effect on health”. The description nutraceutical is broadly used and can refer to anything from a vitamin supplement to an energy enhancing drink.

The name implies that nutraceuticals have medicinal properties, although they are in fact food types. Claims regarding the beneficial effects of nutraceuticals can only be “health claims” and not “medicinal claims”. For instance the claims must not state that by eating/taking the nutraceutical a disease will be prevented or cured but only that it may help to improve health, possibly assisting in the avoidance of the onset of illness.

If a claim is made that implied medicinal benefit regarding a nutraceutical product, the product would then be required to comply with the regulatory requirements for medicines control

Nutraceuticals are required to comply with food law; The Food Safety Act 1990 and legislation covering their labeling and advertising.


A cosmetic is defined as (refer to Article 1 93/35/EEC) “any substance or preparation intended to be placed in contactwith the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainlyto cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.”. The definition is based on two aspects, the target site of application and the principal function.

The main objective of the cosmetics directive is to ensure safety, therefore each product has to subjected to a safety assessment before placing them on the market

If your product can be shown to be cosmetic and not medicinal then it will be subject to the regulations set down in the cosmetics directive.

We can help you with your borderline products

Our team at CambReg has experience of working with a variety of borderline products and has the in house expertise to help you negotiate the best route for your product.