Since the outbreak of COVID-19, we have received numerous enquiries about the registration procedures for hand sanitiser/cleanser products. For many companies this is a new product category. We have experienced that there is a lack of knowledge among companies about the regulatory requirements and implications.
Some of the frequently asked questions that we receive:
· How do I get to the market fast?
· How long is the registration procedure and what does it take?
· How much does it cost?
· What can I say about the product efficacy?
· Which claims are allowed and which not?
· Are these products cosmetics or biocides?
From an EU regulatory point of view a hand sanitiser/cleanser can either be a cosmetic or a biocide product. Which of the two applies depends on whether the product in its totality (composition, naming, presentation, claims, etc.) fits within the legal definition of a cosmetic product or that of a biocide product.
A hand cleanser is regarded as a cosmetic product when the product name, functions, claims and description are primarily related to cleaning/cleansing.
Denominating a product a “hand sanitiser” is disqualifying it as a cosmetic product. According to EU guidance on borderline products, the name “sanitiser” itself is regarded as a biocidal claim. A more appropriate denomination would be “hand cleanser”, “hand gel” or comparable.
For this type of products the primary cosmetic function is cleaning/cleansing for personal hygiene. Additional secondary anti-bacterial or other claims are optional, e.g. specific skin benefits like hydration, protection and improvement of personal hygiene.
In addition, it is also important that the product description, the use instruction and any efficacy claims do not classify it as a biocidal product. “Disinfects”, “kills microorganisms (bacteria, virus, etc.)”, “proven effective against viruses” and comparable claims and statements disqualify the product from being a cosmetic.
Regarding the product composition, alcohol based products are common in cosmetics (e.g. after-shaves, colognes, etc.). Therefore alcohol based formulations may be regarded as cosmetics within some limitations.
A hand sanitiser is regarded as a biocide product when it is presented to consumers as having a primary biocidal function. In this case meaning sanitation and/or disinfection of the hands with the primary goal to kill/neutralise/render harmless the microorganisms on the hands.
Biocide products for human hygiene are often used in professional settings, e.g. by healthcare professionals for hand disinfection. This makes the efficacy of these products highly relevant. Therefore biocide products must have proven efficacy according to standardised ISO test methods. Applications for authorisation of biocide products for human hygiene are evaluated and authorised by competent authorities. These biocide product authorisation procedures are demanding, complex, lengthy and expensive.
The choice of product category highly impacts the short term marketability and potential success of your product on the EU market. It is important to take a well-informed strategic choice.
We have summarised the key items to consider. We have listed the pro’s and con’s for both the cosmetic and the biocide product category
A product intended for hand sanitation (e.g. alcohol based hand gel) can either be a cosmetic or a biocide product for human hygiene (PT1). Different regulatory frameworks apply for both product categories.
It is a strategic decision to market a product as a cosmetic or as a biocide. For cosmetic products compliance and market access can be achieved short term and at limited costs. However, these cannot have a primary biocidal claim and additional requirements apply. Once notified, cosmetic products can be marketed on the entire EU market, while ethanol-based biocides have to be authorised in each EU member state.
The TRC team can help you to make the right strategic choice that best fits your company and marketing strategy. Cosmetic or Biocide? In each case we can offer you the appropriate support to ensure your products are compliant and make it to the market in the most efficient way.
Feel free to contact me to discuss your strategic decisions and product details.