How long would registration take?
This depends on your paperwork. If you have all the data complete, the procedure can be done within two weeks up to one month, including the CSA and the Notification at CPNP.
What does Lafirgo need to perform a CSA?
To perform a CSA we need your documentation. Here’s a shopping list of what you will need:
1. Commercial name – catalogue number – factory of origin- contact information-description – classifications.
2. The qualitative and quantitative composition of the cosmetic product (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible and their intended function), including colorants CI number.
3. Material Safety Data Sheets (ISO) and Certificates of Analysis for all raw materials used with physicochemical and microbiological specifications.
4. Data on the presence of fragrance allergens. Specifically in case of essential oils and fragrances this is relevant. Allergens above 0,01 % for rinse off products and 0,001 % for leave on products have to be listed at the label.
5. Test results of the finished product (including the results of the stability test) and the purity and microbiological control criteria. Depending on the packaging material: results of compatibility test.
6. A description or flow chart of the method of manufacturing
7. A certificate or a statement on compliance with good manufacturing practice (ISO standards) of the production facility.
8. Existing data on serious undesirable effects on human health resulting from use of the cosmetic product and the corrective measures. Hopefully NONE.
9. Proof of the effect claimed for the cosmetic product (on package and in advertising!), where justified by the nature or the effect of the cosmetic product. In case of organic products: proof from your certifying organisation that you are organic.
10. The final Label and translated artwork for both product container and outer-packaging and the original labelling, and, where reasonably legible, a photograph of the corresponding packaging.
11. Data on animal testing performed by the distributor, importer, manufacturer, his agents or suppliers. A declaration none was done.
What does Lafirgo need to make a notification at the CPNP?
1. Safety assessment. Which is provided by Lafirgo.
2. The by Lafirgo approved final version of the product label
3. A picture of (the dummy of) the product.
Do I need an RP?
Yes! You need a company or person within the EU whom is able to make sure your products are compliant. You need a written mandate that states you make someone your RP. The RP should sign this paper to show he accepts the assignment. Nothing fancy needed! A normal paper will do.