The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) applies to products that are used to protect humans, animals, materials or articles against harmful (micro)organisms like bacteria, moulds or insects, based on the action/effect of the active substances contained in the biocidal product.
All biocidal products must get an authorisation before they can be sold on the EU market. Depending on their product and the number of countries where the products will be sold, different processes can be followed to acquire the mandatory authorisations.
Some examples of biocidal products that may be mistaken or confused with cosmetic products are:
• Hand disinfection gel (e.g. alcohol gel claiming disinfection and/or efficacy against bacteria and/or viruses)
• Products effective against odour causing microorganisms, e.g. gloves or shoe refreshers with active biocidal substances
• Mosquito repellents
Some cosmetic products may have a secondary biocidal claim (e.g. hand soap with anti-bacterial claim). However, products with a primary biocidal function, either by presentation or by mode of action, will fall under the biocidal products regulation.
We can help you with the appropriate product classification and, in case your product requires authorization under the BPR and we can support you with the preparation of your biocide dossier and the application for product authorization. Please contact us for further information on BPR support.
Some products intended for consumer use may not be regulated by specific product category legislation. That does not mean that those products are not regulated at all. In those cases, the products are regarded as “general consumer goods” and the requirements of the EU General Product Safety Directive (GPSD, Directive 2001/95/EC) apply.
The GPSD defines that businesses should only sell products on the EU market which are safe and that businesses have to inform consumers of any risks associated with the products they supply. Businesses must also ensure that any (potentially) dangerous products present on the market are traceable and if needed can be removed from the market to prevent any risks to consumers.
The requirements of product specific legislation such as cosmetics or biocides, which are more specific and/or strict, will apply in addition to those basic safety requirements defined by GPSD.
Please contact us in case you are unsure about which EU legislation applies to your products or in case you need further support in bringing your products on the EU market.
The Detergent Regulation EC 648/2004 applies to products containing detergents (soap and/or other surfactants) intended for washing and cleaning processes and marketed for household, institutional or industrial purposes.
Products for rinsing or bleaching clothes and household linen, fabric-softeners, all purposes cleaners, surface and/or material/machinery cleansers etc. fall within the scope of the detergent regulation.
This Regulation sets rules for product labelling including fragrance allergens, information on websites, biodegradability of surfactants used, standards for test methods and laboratories and information that manufacturers must hold at the disposal of the Member States competent authorities and medical personnel.
In addition to the Detergents Regulation, other legislation may also apply, such as:
· Classification Labeling and Packaging (CLP) Regulation in relation to safety data sheets, product notification and safety warnings on product label
· Biocide Regulation
Please do contact us in case you need further support in order to bring your product to the EU market.
A Traditional Herbal Medicinal Product is defined by EU Directive 2004/24/EC as any medicinal product, exclusively containing as active ingredients one or more herbal substances and/or herbal preparations.
Due to the strict regulationsthat apply to making health claims for food supplements many companies have decide to position their products as THMP which makes it possible to make more relevant health claims and additional medical claims for your products based on traditional experience.
To be eligible for a simplified THMP registration procedure, at least the following conditions must be met:
• The product should be intended for indications for which no doctor’s prescription is required
• Its botanicals are known for medical traditional use (at least 30 years of which at least 15 years in the EU)
• The product should be safe in the specified conditions of use and the efficacy of the product is plausible on the basis of long-standing use and experience
• The quality should be according the requirements of EU Directive 2001/83/EC on medicinal products for human use
We can inform and support you on the steps and the information requirements to register your product as THMP.
FSMPs are developed for consumers who, because of a particular disease, disorder or medical condition, have nutritional needs that cannot be met by consuming standard foodstuffs. FSMPs should be used under medical supervision, possibly with the assistance of other competent health professionals.
Regulation 609/2013 defines general rules on the composition, information labelling and presentation requirements for FSMPs, which come in addition to the food information requirement for regular food. Contrary to other food categories, nutrition and health claims are not allowed on FSMPs.
Before placing FSMPs on the market, companies should notify the competent authority of each Member State where the product concerned is marketed. Each competent authority may reasonably request information to establish compliance with the Regulation.
We can further inform you about the steps you should take in order to bring FSMPs to the EU market.
Medical devices are products intended to be used by humans for specific medical purposes, but which are not pharmaceutical (drug) products. Contrary to drugs, medical devices achieve their main purpose by physical rather than pharmacological, metabolic or immunological mode of action.
Examples of common consumer products which can be on the borderline between cosmetics and medical devices are certain types of tooth care products (toothpaste preventing sensitivity) and cooling/warming products for pre/post workout muscle or joints treatments (cooling/warming massage gels and oils).
To discuss your strategic decisions on product positioning between cosmetics and medical devices that will best fit your company profile and your EU market strategy in more detail, please contact one of our experts. We will help you understand the regulatory requirements of these different product categories and assist you in the next steps towards market access.