EU - eu labeling regulations - contact Cosmetic Regulatory EU - eu labeling regulations - contact Cosmetic Regulatory

901-683-3564

Whittington@Cosmetic-Regulations.com
EU - eu labeling regulations - contact Cosmetic Regulatory

 
  Services  
EU, Canada, Int'l Product
Registration
 
Claims, Global Labels,
Translation Service
 
USA/FDA, California/States,
Organic Cosmetics
 
  Our Approach
 
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Canada - Canadian labeling regulations - contact Cosmetic Regulatory

EU, Canada, Int'l Product
Registration

An Approach to the European Union (EU)

With 27 countries and a population of over 500 million all under one regulatory scheme, it is not a surprise that USA companies of all sizes are flocking to Europe.

For this reason, a good deal of Whittington's time in the last several years has been focused on assisting companies enter -or- increase their presence in Europe.

There is a range of compliance issues facing companies, but there is no reason why these cannot be simplified and streamlined to make entry an inexpensive and easily completed task.

EU Labeling Regulations / New Safety Report/ EU Responsible Person / Notifications

Europe is transitioning from the old European Cosmetic Directive to a new Pan European Regulation [1223/2009] which comes into effect in phases over the next several months and years.

We can assist you in developing a compliance strategy tailored to your specific plans and activities.

Greater emphasis is being placed on the RESPONSIBLE PERSON - the EU entity placing the products on the market and the EU address required on the product label.

This address is the physical location for access to the Product Information File [PIF] by the competent authorities.

  eu labeling regulations - contact Cosmetic Regulatory
   
   
The newly designed SAFETY REPORT remains the central element of the PIF and must be done according to the new guidelines to avoid a redo at a later date.

The new central portal for NOTIFICATIONS of the products to the member states and to the Poison Control Centers is ready for implementation.




 Let our team of native speaker translators with cosmetic experience assist you.

 CRS, LLC works with an EU based Assessor who can do this work very efficiently.




Canada > Cosmetics

  Canadian labeling regulations - contact Cosmetic Regulatory
   
   
Canada's personal care regulations for cosmetics, overseen by Health Canada in Ottawa, is similar to the USA scheme and represents an easy target for USA based marketers.

Label: The Canadian label should be basically bilingual and we can provide the French from our Quebec-based native speaker expert in cosmetics.

Approvals: There are no premarketing approvals and one can ship across the border to individual retail accounts.

Formulas: All formulas must be checked against the Canadian list of restricted ingredients (the "Hot List") and Health Canada does require that Cosmetic Notifications be submitted at the time of entry to the market.

Canada > Over-the-Counter (OTC) Drugs

Canadian regulations for OTC drugs are similar to those of the USA as to which products are drugs and which products are cosmetics. Therefore, sunscreens, acne products, antimicrobials and such are regulated as drugs.

Approvals: Unlike the USA, there is premarketing approval and these reviews are handled by the Drug Division or by the Natural Health Products Directorate if the actives are natural. In either case, a number (DIN or NHPN) is issued which must appear on the product label after the application has been approved.

Shipping: The challenge for shipping OTC's into Canada is the GMP regulation that requires the products to be brought into the country, warehoused, evaluated and released by a Canadian based Quality Assurance unit.

CRS, LLC is experienced in navigating this hurdle and can expedite this process. Call or email us today to get started.

International Product Registration

  international product registration - Cosmetic Regulatory
   
   
Virtually all countries outside the EU require premarketing approval, and this process continues to increase in complexity.

This trend is seen in Latin America, Russia, the Middle East and also in Asia.

CRS, LLC is experienced in taking a hands-on approach to securing the registration of products on behalf of clients in an expedited and cost effective manner.

Often this process is facilitated by a local distributor or representative, especially if there are language barriers.
In many of these countries, the data and information presented has to be defended to the authorities. Demands for data can exceed what actually is required by the legislation. Experience is important.

CRS, LLC is experienced in many of these markets and can expedite entry.

For information on cosmetic regulations for California, The States, and organic personal care regulations, click here

Personal care regulations l EU labeling regulations