Custom Manufacture :The Modernization of Cosmetics Regulation Act (MoCRA) has brought a significant transformation to the cosmetics industry in the United States. With a strong focus on product safety, accountability, and transparent documentation, MoCRA has made it mandatory for cosmetics companies to substantiate the safety of every product they sell in the US market.
Among all new MoCRA guidelines, the most critical one is Safety Substantiation, which requires cosmetic manufacturers and responsible persons to maintain scientific evidence that proves a cosmetic product is safe for repeated consumer use. This requirement has immediately increased scrutiny for brands, contract manufacturers, and private-label cosmetics businesses planning to market products in the United States.
In this detailed guide, we will break down the MoCRA safety substantiation requirements, explain what is expected from cosmetic manufacturers, and share how HCP Wellness, a global cosmetics and personal care manufacturer, helps brands achieve complete MoCRA readiness.
What Are the Key MoCRA Requirements?
MoCRA has modernized US FDA cosmetics regulations after decades. The act ensures stronger safety practices, increased consumer protection, and improved reporting standards.
To market cosmetics in the US, businesses must comply with a range of updated MoCRA compliance requirements, which include:
● Cosmetic product listing
● Facility registration with FDA
● Good Manufacturing Practices (cGMP for cosmetics)
● Safety substantiation (mandatory)
● Updated cosmetics product labelling guidelines
● Fragrance allergen disclosure
● Serious adverse event reporting
● Record-keeping requirements
MoCRA has placed accountability on the manufacturer or responsible person, making it essential for every cosmetic brand to update its documentation, testing standards, and regulatory submissions.
Understanding MoCRA Safety Substantiation Requirements
MoCRA clearly states that every cosmetics product must be supported by adequate safety evidence, and the responsible person must maintain scientific documentation to prove that the product is safe under its recommended conditions of use.
This means:
● Every ingredient and finished formulation should be evaluated for safety
● Scientific data must support product claims and safety
● Documentation must be maintained and ready for FDA inspection
● Products without safety substantiation may be treated as misbranded or adulterated
● Non-compliance may lead to product recalls, penalties, or regulatory actions.
MoCRA does not dictate which exact tests must be conducted. Instead, it requires that safety must be demonstrated using tests, studies, analyses, toxicological data, historical data, or expert evaluations that are considered scientifically valid.
What Defines Cosmetic Product Safety Under MoCRA?
Under MoCRA, a cosmetic product is considered safe when it:
● Does not cause harm when used as directed
● Contains ingredients assessed for purity, composition, specification, and impurities
● Has supporting scientific evidence at the raw material and finished product level
Cosmetic safety must be substantiated at two essential levels:
1. Raw Material Level
Safety at the raw material level includes:
● Ingredient specifications
● Source and purity data
● Impurities profile
● Allergen declarations
● Safety data sheets
● CIR (Cosmetic Ingredient Review) reports
● Toxicology data (if available)
The percentage of each ingredient used in the formulation and the presence of impurities can directly impact product safety and stability.
2. Finished Product Level
Evaluation of the final product typically includes:
● Physicochemical tests
● Microbiological testing
● Stability studies
● Packaging compatibility tests
● Clinical evaluation (patch test, HRIPT, repeat-use testing when required)
● Clear directions of use and precautions on labels
The responsible person must maintain well-organized documentation proving safety at both levels.
How to Comply With MoCRA Safety Substantiation Requirements?
To comply with MoCRA’s safety substantiation guidelines, cosmetic manufacturers must ensure:
● Each product has a Safety Assessment Report prepared by a qualified expert
● Adequate toxicological data is available for each ingredient
● Supporting data is scientifically robust and defensible
● Documentation is maintained properly for FDA review
● Reports are updated whenever formulation, ingredients, or suppliers change
FDA also clarifies that:
● Animal testing is not required for MoCRA compliance
● Alternative non-animal test methods are recommended
● Manufacturers must justify why specific data was considered sufficient
A strong safety substantiation file typically includes:
● Ingredient safety summaries
● Toxicology profiles
● Raw material specifications
● Microbiological test results
● Stability and compatibility data
● Safety assessment signed by a qualified expert
HCP Wellness – Your MoCRA-Ready Cosmetics Manufacturing Partner
As MoCRA reshapes the US cosmetics market, brands need manufacturers who are not just compliant—but also experienced in handling US FDA requirements, GMP manufacturing, safety documentation, and regulatory support.
HCP Wellness, based in Ahmedabad, India, is one of the leading cosmetic, skincare, oral care, and personal care manufacturers serving global brands through:
● FDA-compliant manufacturing practices
● End-to-end private label and contract manufacturing
● Complete documentation support for MoCRA compliance
● In-house R&D, formulation development, and safety assessment assistance
● Export-ready manufacturing and MoCRA-ready product documentatio
How HCP Wellness Supports MoCRA Safety Substantiation
Ingredient-Level Safety Documentation
HCP sources ingredients from verified suppliers and maintains specifications, MSDS, CoA, allergen statements, and impurity data aligned with MoCRA expectations.
Finished Product Safety Testing
We conduct stability testing, microbial analysis, dermatological safety tests, and compatibility assessments required for US compliance.
Customised Product Safety Substantiation Files
HCP Wellness prepares detailed safety documentation packages that support your MoCRA compliance needs.
Regulatory Assistance for US FDA & MoCRA
Whether you’re a startup or an established global brand, our regulatory team helps with labelling, product registration, documentation, and export requirements.
GMP Certified Manufacturing Facility
With an ultramodern production setup and in-house quality control, we ensure that every batch meets stringent global standards.
Brands working with HCP Wellness get a fully compliant and export-ready product that meets MoCRA guidelines, US FDA labelling requirements, and international safety standards.
MoCRA has introduced a new era of responsibility for the cosmetics industry. The emphasis on safety substantiation, documentation, and scientifically robust evidence makes it essential for brands to partner with experienced, compliant, and globally recognized manufacturers.
With strong R&D capability, FDA-aligned manufacturing systems, and full support for MoCRA compliance, HCP Wellness ensures your cosmetic products are safe, compliant, and ready for the US market.
If you’re planning to launch or export cosmetics into the USA, HCP Wellness provides end-to-end private label manufacturing and MoCRA documentation support to help you stay fully compliant and market-ready.
