Safely register your cosmetics for the European market.
The European market doesn’t only have legal requirements for pharmaceuticals, there are also specific regulations you have to follow for cosmetic products.
To guarantee human health and safety in the manufacturing and use of cosmetics, Regulation (EC) No 1223/2009 specifies the requirements for placing a cosmetic product on the European market. To ensure you comply with this regulation properly, we support you in different areas along the way.
There are a number of processes and safety assessments you have to conduct first in order to register your cosmetic for the European market. We take care of:
- creating and maintenance of the required Product Information File (PIF) with all relevant information on your cosmetic product, such as product description, methods of manufacture and Cosmetic Product Safety Report (CPSR). The latter is based on a Safety Assessment of the ingredients and final cosmetic product that includes processes like safety and efficacy trials, toxicity evaluation, allergens analysis, and the development of the safety profile.
- submitting the product notification with all required information via the EU Cosmetic Products Notification Portal (CPNP) before your product gets placed on the market
- drafting the Safety Data Sheet (SDS) using the collected information. This document communicating the hazard information associated with your product is required from any manufacturer, distributor or importer.
To ensure your compliance with the EU cosmetics regulation, we also support you with
- implementing a quality system in accordance with ISO 22716 as well as Good Manufacturing and Laboratory Practices (GMP and GLP) for cosmetics and cosmetic ingredients
- implementing Good Manufacturing Practices for fragrances in accordance with the International Fragrance Association (IFRA)
- providing the required EU-based Responsible Person who will undertake regulatory obligations such as submitting product notifications, keeping a product information file (PIF), and creating product safety assessments
- designing plans for facilities that are processing essential oils, fragrances, and cosmetics. We also check for compatibility and perform a risk analysis in multi-product plants.
- authorization or renewal of manufacturers, importers, and control laboratories
- internal and third-party audits
- staff training in GMP requirements.
Occupational Exposure Limits
Employees handling cosmetic ingredients are exposed to their potential risks. It is therefore necessary to determine the toxicity and concentration of any cosmetic ingredient in the workplace air to ensure the health and safety of staff. Especially the Occupational Exposure Limit (OEL) can be used to implement the proper containment strategies accordingly.
Our team of certified toxicology experts determines the OEL following international and widely accepted guidelines. Learn more about our OEL services here.
Consumers increasingly demand cosmetic products of natural origin and with a manufacturing process committed to the environment and human health, both because of ethical reasons and a lack of faith in chemical products. This group of consumers is also less price-sensitive than consumers of non-environmentally friendly products, so it makes sense to label your product accordingly.
The COSMOS-standard (COSMetic Organic and Natural Standard) defines the criteria your product has to meet to be labeled as a genuinely organic or natural cosmetic. We support you in getting the according COSMOS-standard signature to confirm the credibility of your product.