Regulation - Global

A project from a UK brand to check and implement changes required for them to be BREXIT ready.
As the UK was separating from the European Union, compliances needed to be reviewed, changed, re-do and duplicate for all products in their portfolio.
My role comprised of
- suggesting action plan for setting up RP in the EU
- Proofing all artwork for EU and UK compliance
- Reviewing CPSR for both markets
- Re-registering products on UK portal.
- Making changes on the EU portal
- Train marketing and sales teams on what to expect before and after BREXIT.

This project is from a client who is manufacturing Ayurveda based cosmetics in India and selling globally.
After their packaging was flagged by their retailers as non-compliant they approached me to deduce the Ayurvedic ingredient list in the EU and USA acceptable formats.

To ensure all ingredients in the base formulation and the botanical extracts was captured correctly, I ran a thorough regulatory check on each ingredient for these markets.

The products contained botanicals and essential oils of high value and hence getting their allergens and toxicological data was necessary too.

Main tasks of this project were
- Deducing ingredient nomenclature for botanical ingredients which are not generally recorded in global databases
- forming ingredient list for packaging considering INCI breakdowns of the ingredients.
- Compilation of allergen % in the formulations
- Obtaining statements and documents from suppliers
- Proofreading artwork prints after new Ingredient list is put on them.

A multi-market labels unification requirement demanded that minimum mandatory requirements were suggested for a product developed to be marketed globally.
The client wanted to unify the labelling as much as possible across all their markets.

The product was classified as a cosmetic.
It was composed of a box (outer/secondary packaging) containing 10 single use vials with 2 mL each.
It has a very small printable area app. 45 x 20 mm, therefore the information needed to be reduced to minimum.
The shelf-life is 36 months, application is single use.

A detailed report on minimum requirements in common and optional market specific requirements was suggested. I also adviced on translations required and use of certain symbols in place of a write-up.

The client based in the EU was a new brand and wanted to launch 6 products into the market in year 1.
The project was to compile all the necessary documents and enable EU product notifications so that the client can launch all 6 products across e-commerce platforms and retail spaces in the EU.
The project was to guide their product development team to prepare documents for the PIF.
The documents for all products included
- Stability testing reports
- Microbial and Challenge test reports
- Labels and packaging artworks
- Full formulation
- Ingredient list
- Allergen declarations
- Raw material documentation
- Packing material specifications
- Compatibility testing data
- Shelf life data
- CPSR
- Efficacy testing data
- Claims and Marketing content
- Certifications
- Manufacturing protocol

Training for Notification of cosmetic on CPNP portal was also provided.

The brand launches 3-4 SKUs every year and PIF documentation review is performed with attention to detail.

This service was exclusively provided for a clean beauty brand to facilitate preparing and submitting all documentation to the e-commerce platform regulatory team. The brand launched over 11 products on this platform globally. The documentation was aligned for the USA and EU regulations.
The service also included liaising with the e-commerce platform teams in order to comply with all their requirements.
Some of the documents were
- USA/EU compliant Ingredient lists
- Various "free-from" statements obtained from suppliers.
- Claim substantiation documents
- Stability and Challenge test results
-COA's and MSDS in GHS/CLP formats
- Marketing content for the product - ensuring language is suitable to enter global markets.
- Filling and submitting all the documents, forms and tables received from the e-commerce teams.