COMPLIANCE

Compliance built into development, not bolted on after

Every formula we develop is checked against FDA and EU requirements from the first draft — so the product you approve is the product you can legally sell.

How compliance works across a project

We support compliance throughout the product development process in two key stages.
During formulation, ingredients are reviewed against applicable regulatory requirements and restricted-substance lists for your target market before samples are developed.
During production, we provide the technical documentation required for market compliance and maintain documented quality control procedures. our production and quality control systems are covered in detail on the Process page.

Market registration and notification are normally completed by the brand owner or responsible person, as required by local regulations. We support this process by providing the necessary technical information and compliance documentation.

United States — FDA & MoCRA

General cosmetics

  • Formulas are reviewed against applicable FDA requirements, including ingredient restrictions and labeling requirements, before sampling begins.
  • Since MoCRA (2022), cosmetic companies placing products on the US market must comply with requirements such as facility registration, product listing, and adverse event reporting.
  • These regulatory submissions are completed by the responsible company under MoCRA requirements. Enrich supports the process by providing ingredient documentation and safety substantiation support.

OTC products (e.g. sun care)

  • Sun care and other OTC products are regulated under the FDA OTC Monograph framework (for example, sunscreen under 21 CFR Part 352).
  • OTC products require additional regulatory review, testing, and documentation beyond standard cosmetics. We identify these requirements during the formulation stage to help avoid unexpected compliance issues later.

European Union — Regulation (EC) 1223/2009

  • Every cosmetic product placed on the EU market requires an EU-based Responsible Person — a legal role assigned by the brand owner or another responsible economic operator.
  • We support PIF preparation and CPSR assessment by providing formula composition, raw material documentation, and safety data.
  • As a working example, our standard wash and cream reference formulas have CPSR (Cosmetic Product Safety Report) assessments independently prepared by Intertek (ITS) — illustrating the assessment process and documentation quality. Your finished product will still require its own product-specific CPSR.
  • Formulas are reviewed against the applicable Annex II–VI restricted and permitted-substance lists before sampling.
  • CPNP notification — the EU's online portal filing — is completed by the Responsible Person using the technical documentation provided by us.
AT A GLANCE

What Enrich Lab handles at each compliance step

The same development-stage groundwork applies whether you're targeting the US, the EU, or both — registration is the one step where the two markets diverge.

Compliance Step
Who's Responsible
Formula & ingredient compliance review
Enrich —review formulation against target market requirements before sampling
Product safety & technical documentation
Enrich — compiles safety documentation as the formula develops — INCI, SDS, CoA and test reports are finalized once the formula is locked.
Quality system & production support
Enrich — operates under GMP (ISO 22716) with ISO 9001:2015 quality systems — the manufacturing standard your safety documentation assumes.
Market notification & registration
US: Brand — FDA Facility Registration & Product Listing (no separate pre-market filing required).
EU: Brand — appoints an EU Responsible Person, who files the CPNP submission.
Label & claim compliance review
Enrich review potential compliance issues before Brand signs off
Post-market support
Enrich — troubleshooting support, reformulation review & regulatory-update compliance checks (Brand handles reporting)
COMMON PITFALLS

What happens when compliance is treated as an afterthought

Restricted-ingredient conflicts found after sampling

Reformulating after a sample has shipped adds weeks to a timeline and can force a batch to be scrapped. We screen every formula against target-market restricted-substance lists before the first sample is made.

Documentation missing when filing comes due

Brands often discover they're short a batch record or safety data point only when their Responsible Person asks for it. We prepare that documentation alongside development, not after it's requested.

Unclear ownership of the filing itself

In a cross-border partnership, it's easy for both sides to assume the other has filed the registration. We set out who's responsible for what before a project starts, in writing.

What you receive — and what stays with you

We provide

  • Full INCI ingredient list
  • Stability testing report
  • Microbial testing report
  • Safety Data Sheet (SDS)
  • Certificate of Analysis (CoA)
  • CPSR / PIF support documentation — for EU-market projects
  • Packaging material information — to support your own PPWR compliance work (not a formal compliance certificate)
  • Toxicological Risk Assessment (TRA) — for US-market projects

You are responsible for

  • FDA Facility Registration & Product Listing (US)
  • EU Responsible Person appointment
  • CPNP notification filing (EU)
  • Adverse event monitoring & reporting
  • Trademark registration in target markets
  • Final retail label compliance review
FAQ

Compliance questions we hear most

Can you help if I already have my own formula?

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Yes. We can start with your existing formula rather than reformulating from scratch. Before sampling, we review the ingredient list and usage levels against the requirements of your target market and flag restricted ingredients, concentration limits, or other obvious compliance concerns.

If changes are needed, we discuss them with you before making the first sample, with the aim of keeping the original product concept, performance, and cost as close as possible.

What compliance documents will you provide for my product?

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The document package depends on the product and where it will be sold. Typical documentation may include the INCI list, product specification, SDS where applicable, COA, raw-material compliance information, stability and microbiological test reports, and other supporting documents required for safety assessment or market filing.

We confirm the required document list at the beginning of the project rather than applying the same package to every product.

Do you provide CPSR and PIF documents for EU products?

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We provide the formula, raw-material information, test reports, manufacturing information and other technical data needed to support the CPSR and PIF.

The CPSR itself must be completed and signed by a qualified safety assessor, while the PIF is maintained by the EU Responsible Person. We can work with your appointed RP or safety assessor and respond to technical questions or additional document requests during the assessment.

What testing does my product need before it can be sold?

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There is no single test package for every cosmetic product. Requirements depend on the formula, product type, packaging, claims and target market.

For a typical cosmetic, this may include stability and compatibility testing, microbiological testing and, where applicable, preservative challenge testing. Products with specific claims or regulatory classifications — such as sunscreen or certain children's products — may require additional testing.

We identify the expected testing program during development so that it can be built into the project timeline and cost before production.

Do you support compliance for markets outside the US and EU?

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Yes, but we first define the exact destination market because requirements are not interchangeable between countries.

For markets such as the UK, Canada, Australia and others, we review the formula and documentation requirements against the applicable local framework and identify any additional testing, labeling or documentation needed. Where a local Responsible Person, importer, notification or third-party assessment is required, we clarify that responsibility before production.

Can you help make sure my product label meets local requirements?

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Yes. Once the destination market is confirmed, we can review your artwork for required product information and flag missing or potentially non-compliant items before printing.

Depending on the market and product, this can include the ingredient list, net contents, warnings, directions, age recommendations, Responsible Person or importer details, country of origin, batch information and required local-language text. We can also flag claims that may change the product's regulatory classification.

Final artwork approval remains with the brand and, where applicable, its Responsible Person or local regulatory representative.

See it in practice

We've helped indie brands take products from formulation through compliant market launch — including a fungal-acne-safe line cleared across 12+ SKUs. See how we help brands launch products →

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