REGULATORY & MARKET READINESS · US + EUROPE

Ready for market.
Built on compliance.

Practical cosmetic regulatory support from product development through launch, with US market guidance and EU Responsible Person services through our German office.

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A PRACTICAL APPROACH

Regulatory considerations belong in product development.

Cosmetic compliance is not a final packaging checklist. Ingredient restrictions, product claims, safety documentation, labeling and market-specific obligations can influence decisions from the earliest stages of formulation.

Innova brings together cosmetic formulation, manufacturing experience and regulatory support to help brands prepare products for sale in the United States and the European Union.

We define the scope for each market and coordinate specialist documentation or external assessments where required.

Illustrative quality and documentation review
UNITED STATES

US cosmetic regulatory support.

Support for cosmetics entering or operating in the US market, including requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

01 / MOCRA

Registration & Listing

Guidance on applicable cosmetic facility registration and product listing requirements, including preparation and review of supporting information.

02 / LABEL REVIEW

Cosmetic Label Review

Detailed review of cosmetic labels and packaging copy, including INCI ingredient declarations, mandatory particulars, warnings, net contents, business identification and market-specific requirements.

03 / CLAIMS REVIEW

Cosmetic Claims Review

Assessment of proposed product, ingredient and marketing claims against applicable cosmetic requirements, including claim wording, supporting substantiation and potential drug-claim or misleading-advertising risks.

04 / DOCUMENTATION

Safety & Documentation

Assistance organizing product safety substantiation, manufacturing and quality documentation, and other records relevant to regulatory readiness.

Regulatory responsibilities vary. Applicable obligations depend on the business, product and market role; some entities and products qualify for statutory exemptions. We evaluate project-specific requirements rather than assuming every rule applies universally.
EUROPEAN UNION

European market access, supported from Germany.

Innova supports EU cosmetic compliance through its German office, including Responsible Person services and the preparation or coordination of essential product documentation under Regulation (EC) No 1223/2009.

For brands expanding from the United States into Europe, we help identify differences in ingredients, labeling, safety assessment and notification requirements before market entry.

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Illustrative documentation and market readiness image
EU COMPLIANCE SERVICES

The documentation behind a compliant launch.

01 / EU RESPONSIBLE PERSON

Responsible Person Services

EU Responsible Person support through our German office, with defined responsibilities for product compliance and market oversight.

02 / SAFETY

Cosmetic Product Safety Report

Coordination of CPSR preparation by appropriately qualified safety assessors, informed by formula, ingredient and testing documentation.

03 / PRODUCT RECORDS

Product Information File

Support compiling and maintaining the PIF, including the required product description, safety documentation, manufacturing information and relevant substantiation.

04 / NOTIFICATION

CPNP Notification

Assistance with required notification through the EU Cosmetic Products Notification Portal before products are placed on the EU market.

05 / PACKAGING

EU Label & Claims Review

Review of EU ingredient declarations, mandatory labeling particulars, warnings and product claims, including alignment with applicable EU cosmetic claims criteria and supporting evidence.

06 / FORMULATION

Ingredient Compliance Review

Assessment of formula composition against applicable restrictions, including prohibited or restricted substances and relevant annex requirements.

OUR PROCESS

From regulatory review to market readiness.

STEP 01

Scope

Confirm target markets, product categories, business roles and existing documentation.

STEP 02

Review

Assess formulation, packaging, claims, testing and documentation gaps.

STEP 03

Prepare

Compile records and coordinate external safety assessment or specialist work as needed.

STEP 04

Support

Assist with applicable notifications, listings and launch-readiness follow-through.

Clear scope, clear responsibilities. Regulatory services are tailored to the project. Independent safety assessments, specialist testing, official fees and legal advice are identified separately where applicable.
LET'S PREPARE YOUR LAUNCH

Bringing a cosmetic product to the US or EU market?

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