CPNP vs FDA: what each registration actually asks for
The EU's CPNP notification (Article 13) and the FDA's facility registration and product listing (FD&C Act §607/§608) are different filings, made by different parties, at different times. One does not substitute for the other.
Short answer: the CPNP notification is an EU filing the responsible person makes to the Commission before placing a product on the market (Regulation 1223/2009, Article 13). The FDA registration and listing are two US filings under FD&C Act §607 (facilities) and §608 (products). They share a goal — regulators know what is on the market — and almost nothing else.
The numbers
| Question | EU (CPNP, Article 13) | US (FD&C Act §607 / §608) |
|---|---|---|
| Who files | The responsible person (established in the EU) | Facility: the manufacturer/packer. Listing: the responsible person named on the label |
| When | Before placing the product on the market | Facility registration and product listing per the FDA schedule in force |
| What it contains | Product category and name; responsible person's details; product information file location; contact person for emergencies; ingredient information incl. nanomaterial identification and substance names (CAS/INCI); fragrance and allergen information | Registration: facility details, product categories. Listing: product name, category, ingredients, label as used |
| Filing fee | Free | Free |
| Scope | One notification per product | Registration per facility; listing per product |
What each filing does not do
CPNP is not an approval — no EU authority pre-approves the cosmetic; it is a notification that triggers poison-center and market-surveillance functions. FDA registration and listing are not approvals either. Neither filing checks your ingredient limits: the EU checks happen against the Annexes (via the safety assessment and the responsible person), the US ones against the prohibited list and drug rules.
Common mistakes
- Assuming CPNP covers the US or FDA filings cover the EU. They are parallel, not interchangeable.
- Letting the contract manufacturer be the EU responsible person by default. CPNP files must match the designated responsible person under Article 4.
- Treating facility registration as product listing in the US. Two filings, two sections.
- Filing CPNP after the first sale. The deadline is "prior to placing on the market".
Do this now
Make a two-column sheet for every SKU: "CPNP done (date, RP name)" and "FDA registration/listing done (date)". Any row missing a column is a market you cannot lawfully sell into yet.
FAQ
What is the CPNP?
The EU notification under Article 13 of Regulation 1223/2009: the responsible person submits product and safety information electronically before placing the product on the market.
What are the US filings?
Facility registration under FD&C Act §607 and product listing under §608.
Does one filing cover the other market?
No. CPNP and the FDA filings are parallel and not interchangeable.
Sources
- Regulation (EC) No 1223/2009, Article 13 (notification) — consolidated text 18.05.2026
- FD&C Act §607 (facility registration) and §608 (product listing), added by MoCRA — fda.gov MoCRA overview
- Regulation (EC) No 1223/2009, Article 4 (responsible person) — consolidated text 18.05.2026
Last verified: 2026-11-10. FDA filing deadlines are stated on the FDA pages and change through rulemaking; confirm them there.
Not legal advice, and not a guarantee of compliance or of acceptance by any authority.
Want this checked against your own formula? Run the free label check. It produces the ingredient and label content both filings need, and flags the limits first. It returns an issue list, not a print-ready label.
Related: MoCRA product listing · The EU responsible person for US brands