Cosmetics
Cosmetics include a wide group of products with various purposes, from everyday hygiene products such as soap, shampoo, deodorant, creams, balsams or toothpaste to luxury beauty items including perfumes, makeup and other decorative products. Following with Regulation (EC) 1223/2009, referring to cosmetics regulation at the European level, these products are defined as any substance or mixture:
- intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs), or the teeth and the mucous membranes of the oral cavity
- with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
The European Union is a world leader in the cosmetics industry and the biggest cosmetics exporter. The sector is highly innovative, growing fast and provides significant employment in Europe.
Cosmetic products are not as strictly regulated as pharmaceutical products, but when placing them on the market, it is necessary to comply with the relevant legal and regulatory requirements, both at the national and EU levels. The main aim of all the regulations is to ensure consumer safety. The regulatory activities may refer to the notification of the cosmetic product to the responsible agency through CPNP (Cosmetic Products Notification Portal), registration of the manufacturer/importer to the responsible agency (if necessary), adjustment of labeling to the legal requirements and other specific activities.
It should be underlined that sometimes it may be unclear whether a particular product is a cosmetic product under cosmetics legislation or whether it falls under other sectorial legislation, e.g., medicinal products or medical device. In the case of these ‘borderline products’, the decision on a product’s classification must be taken on a case-by-case basis.
SciencePharma may help you customize the product and meet the legal requirements for your cosmetic product.
Research and development
We offer consulting services in the field of assessing the potential of various projects development of medicinal products, devices or dietary supplements.
Preclinical and clinical development
SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies.
Audits
Having broad experience in auditing of API manufacturers as well as of contract medicinal products facilities we offer independent GMP auditing services.
Regulatory Affairs
We offer multidisciplinary services in the field of Regulatory Affairs including support for pre-registration, registration and post-registration.
Pharmacovigilance
Pharmacovigilance is the process of monitoring the safety of medicines. Marketing Authorization Holders have a legal obligation to set up and maintain a Pharmacovigilance system.