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In the EU products are classified based on the key product ingredients and the key product claims/effects. This classification determines which EU and/or member state regulations apply, and impacts the product label, claims, PIF requirements, notification procedures, timelines and costs.
TRC can advise you on these very strategic and impactful decisions.
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 cosmetic products on 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 for cosmetics.
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
- REACH
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:
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 support you with the appropriate product classification.
