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This quantity-based regulation can lead to supply chain disruption and fines for lack of registration. Laws also allow for criminal penalties and “dissuasive” levels of penalties.
International Cosmetics provides the following EU Regulatory Compliance Services to US companies seeking to expand their cosmetic-product business in Europe.
This requirement must be considered by all companies marketing products in the EU. CLP regulations impact finished cosmetic product labeling as well as the technical documents used for the EU Product Information Files. The Safety Dat Sheets are required to meet the CLP requirements as of 2010 .
Only Representatives (OR) for REACH chemical compliance must be a legal entity in Europe. International Cosmetics has satisfied this requirement in all aspects since 2007. Any non-EU company marketing goods, including cosmetics, may be subject to the requirements of REACH. REACH regulates ingredients even if contained in a finished, cosmetic product. Retailers in Europe often require non-EU companies to have an Only Representative to qualify the products under REACH. International Cosmetics Chemical Services has been providing this service since 2007.
The REACH regulation for applicable products may result in mandatory registration. In some cases, simple "late" pre-registrations can be made. REACH requires an Only Representative that must fulfill legal EU residence status. International Cosmetics had the first cosmetic chemical registration for Butylene Glycol for a missed opportunity to cover the chemical use under pre-registration.
Good Manufacturing Practices (GMP) has now been address by the International Standards Organization (ISO) for cosmetics. Since the issue of ISO GMP 227L6 Europe and many other countries have adopted this standard as a requirement for products offered for sale. International Cosmetics participated in the creation and finalizing of ISO 227L6 and continue to be involved with updates and the ISO meetings Internationally. These GMP requirements can be used worldwide.
The United States have had Good Manufacturing Practices (GMP) requirements for products since the early 1970' s. Primarily the focus of these audit requirements were for prescription and devices with some guidance's for cosmetics. 21 Code of Federal Regulations part 211 is used by FDA for Over The Counter Drugs as well as prescriptions and some veterinary items. International Cosmetics has been providing this service since 1996 as a 3rd party auditor for compliance.