What compliance documents should be prepared for exporting cosmetics? MoCRA,CPNP,SCPN and CNF What are the differences

1. First, distinguish six types of documents that are often called qualifications.

The same project may require both factory documentation and product documentation. Asking "Are there any FDA"Too general. Be clear about what you need to prove."

• Production license: whether the factory can legally produce the corresponding category
• Quality system: how production, control, storage and shipping are managed
• Facility Registration: Submission of manufacturing site information to regulatory agencies
• Product listing or notification: Submit specific product information to the target market
• Product safety information: formulation, safety assessment, testing and PIF
• Labeling and import information: responsible parties, warnings, language and customs clearance information

2. US market: MoCRA is not FDA Approval certificate

The U.S. Cosmetics Regulatory Modernization Act (MoCRA) establishes applicable facility registration and cosmetic product listing requirements.FDA Officially, facilities generally need to be registered using FEI information, and the responsible person needs to submit a listing for the product and associate the manufacturing or processing facility. Exemptions exist for some small businesses, but exemptions do not apply to specific products.

Completing registration or listing does not mean FDA approved the cosmetic product.FDA It is also made clear that using a registration or registration number to create the impression of official approval can be misleading. Brands remain responsible for safety certification, labeling, serious adverse event reporting and other applicable obligations.

• Confirm whether the product is a cosmetic, a drug, or both
• Confirm responsible person, U.S. contact, and facility FEI information
• Complete applicable facility registration and product listing
• Check ingredients, labels, warnings and adverse event procedures
• Don't write it in the promotion FDA certification or FDA approve

3. EU Market: Responsible Person, CPSR, PIF and CPNP indispensable

Under the EU cosmetics regulations, products require EU responsible persons. Before going on the market, a cosmetics safety report (CPSR) is usually completed, and the formula, manufacturing, testing, labeling and safety information are compiled into the product information file PIF and approved by the responsible person.CPNP Submit a product notification.

European Commission notes that product is complete CPNP After notification, there is no need to repeat national-level notifications in each EU member state. But this does not mean that a CPNP Records may cover different formulas, brands or responsible persons and do not represent CPNP Issue a general certification to the factory.

• EU Responsible Person and Label Address
• Complete INCI and quantitative safety information
• CPSR and PIF
• Evidence of compliance with requirements for labeling and claims
• CPNP Notification and change maintenance

4. British market:SCPN cannot be CPNP direct replacement

The British market usually requires a UK responsible person and approval before the product is launched on the market.SCPN Submit notification to OPSS. The information listed by the UK government includes product category and name, responsible person, PIF storage location, emergency contact person, nanomaterials, specific substances, ingredient summary, label diagram and packaging photos.

The UK responsible person will also ensure that the product completes a qualified safety assessment, saves the PIF, checks the label and can prove the marketing claims. The applicable paths in Northern Ireland are different from those in Great Britain, and specific projects should be confirmed according to the latest official guidance.

5. Canadian market: Submit within 10 days after the first sale CNF

Official Health Canada guidance requires manufacturers and importers to submit a Cosmetic Notification Form within 10 days of the first sale of a cosmetic product, i.e.CNF. When the brand name, contact person or formula changes, changes will also need to be submitted as required.

CNF It's a notification, not a product approval certificate. The formula must also comply with Canadian Cosmetic Ingredient Hotlist and other requirements, and the label and importer information should be checked before listing.

6. Chinese market: ordinary filing and special registration

China's "Regulations on the Supervision and Administration of Cosmetics" divides cosmetics into ordinary cosmetics and special cosmetics. General cosmetics are subject to filing management, and special cosmetics are subject to registration management. The registrant and filing person are responsible for product quality, safety and efficacy claims.

Product launch also involves information such as formula, implementation standards, label samples, inspection and safety assessment. Labels and efficacy claims should comply with the relevant measures and evaluation standards of the State Food and Drug Administration, and overseas notification records cannot be used to replace Chinese filing or registration.

7.ISO 22716,GMPC What does it prove separately from ISO 9001?

ISO 22716 is a guide to good manufacturing practices for cosmetics, covering quality aspects of the production, control, storage and shipment of cosmetics.GMPC It is usually an industry title or audit expression for the cosmetics good manufacturing practice system. The specific certificate must look at the issuing agency, scope, address and validity period.

ISO 9001 is a universal quality management system standard applicable to different organizations and industries. It can illustrate that the company has established a quality management system, but it cannot replace the registration, notification, safety assessment and labeling obligations of products in the United States, the European Union, the United Kingdom or China.

8. What is the clearest division of labor between the brand and the factory?

Factories can usually provide INCI, formula information, manufacturing processes, product specifications, raw material and finished product inspection, batch number traceability and quality system documents. The brand owner, responsible person or importer is responsible for determining the country of listing, compliance path, responsible entity, label language, notification submission and market supervision.

A compliance responsibility matrix should be created at the start of the project to indicate who prepares, reviews, submits and updates each document. Don’t wait for the product to be completed before you find the person responsible or change the label.