Obelis Group

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Brussels, 1200, Belgium

Tel: +32 (0)2 732 59 54

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Medical devices

Cosmetics

Food Supplements 

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Frequently Asked Questions

Is MoCRA enough to sell cosmetics in California?

No. California has separate requirements such as Prop 65 and CSCA that go beyond MoCRA. 

What ingredients trigger California reporting?

Ingredients linked to cancer, reproductive toxicity or other health concerns may trigger reporting under Prop 65 or CSCA. 

Does New York have separate cosmetic regulations?

New York is increasing oversight on cosmetic ingredients and safety, making proactive compliance important.

Do foreign manufacturers need a U.S. Agent?

Yes. Under MoCRA, foreign facilities must appoint a U.S. Agent for FDA registration and communication. 

Why Our Clients Choose Us

Since 1988: Decades of proven expertise in the cosmetic regulatory industry across global markets.

Client-centric approach: Tailored regulatory strategies designed around your business needs and timelines.

Proven track record: Thousands of successful cosmetic product launches delivered compliantly to market.

Fast processes: Efficient execution without compromising regulatory accuracy with high-quality guidance.

Cross-border regulatory specialists: Seamless coordination between U.S and other international markets to ensure compliance requirements.

In-country representation: Our local offices in the USA provide you with a trusted local presence to act on your behalf and communicate with authorities.

Enter the U.S Market with Confidence

Selling Cosmetics in California?

MoCRA Compliance May Not Be Enough

California imposes some of the most demanding cosmetic regulations in the United States. 

In addition to FDA MoCRA requirements, brands may need to comply with: 

California Proposition 65 (Prop 65)

California Safe Cosmetics Act (CSCA) 

Ingredient disclousure requirements

Fragrance and flavour reporting 

Restricted substance compliance 

Product reformulation obligations

Obelis California Compliance Services

Prop 65 ingredient assessments

CSCA reporting support

Warning label evaluations

Ingredient compliance reviews

Reformulation guidance 

Regulatory monitoring 

Failure to comply may result in warnings, penalties, product recalls or restricted market access. 

Prop 65

Requires warning labels when products expose consumers to certain chemicals associated with cancer or reproductive harm.

CSCA Reporting

Manufacturers must report products containing certain ingredients identified by California authorities. 

Ingredient Transparency

California continues expanding oversight of cosmetic ingredients and disclosures. 

Ongoing Regulatory Changes

Requirements evolve frequently, making continuous  monitoring essential. 

Selling Cosmetics in New York?

New York is increasing its focus on cosmetic ingredient transparency, product safety and environmental compliance. 

Obelis Group helps brands assess New York-specific obligations and prepare for evolving regulations.

Ingredient transparency reviews

Product safety assessments

Label claims verification 

Regulatory monitoring 

Regardless of the State, FDA MoCRA Compliance Remains Mandatory

Whether you sell in California, New York, Texas, Florida or any other U.S state, cosmetic products must comply with FDA MoCRA requiremenst

Obelis Supports You With

U.S Agent Representation

Facility Registration 

Product Listing 

Safety Substantation

Serious Adverse Event Reporting

Label Review

GMP Readiness

Laboratory & Patch Testing

California + State Requirements

FDA MoCRA Requirements

Complete U.S. Compliance

From California Prop 65 compliance and CSCA reporting to New York market readiness and full FDA MoCRA support, Obelis helps cosmetic brands stay compliant and launch faster.