We are excited to announce that ADSL is now able to offer a U.S. MoCRA Responsible Person Representative.
The details of this service are based on the number of products/SKUs and include:
- U.S. MoCRA Responsible Person Representative.
- A retainer billed annually and in advance.
- The agreement to include an appendix with a list of products to be covered.
Frequently Asked Questions
What happens if we want to add additional products to the Agreement?
There is added flexibility in the agreement for products you introduce during the year. Any added products will be prorated based on the subsequent price bracket.
Are there Exemptions under MoCRA?
Under the new regulations, there are “Exemptions” that you should consider to ensure your business complies with MoCRA. MoCRA provides exemptions for certain small businesses, excusing them from the GMP, registration, and product listing requirements.
How do we know if our business is considered a small business by MoCRA?
U.S. business owners and operators of facilities, may be considered a small business if their average gross annual sales of cosmetic products in the U.S. for the past three years is less than $1 million (adjusted for inflation). However, to qualify, they must not participate in the manufacturing or processing of certain cosmetic products (as listed below)
- Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
- Products that are injected.
- Products that are intended for internal use.
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer are not part of such conditions of use.
USA Product registration
The FDA are currently trialling this process with 8 companies who applied for the trial. ADSL was not selected for the trial; however, we will advise on this service as soon as we have further information.
We also offer a U.S. MoCRA Agent Service which covers the registration of your facility in the U.S. If you are interested, please provide information about your products via email to [email protected] and we will provide you with a quote.
Take the next steps
Let ADSL support you with current and upcoming US compliance updates. Please speak to our compliance team today. Please call +44 (0) 1803 520 048 or book a free video consultation with us using the Get Started link.