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Regulatory Compliance Glossary

Your reference for compliance, identity verification, and regulatory terminology. Clear definitions of key terms.

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Serious Undesirable Effects (SUE) Reporting

Serious Undesirable Effects (SUE) reporting refers to the obligation to notify authorities when a cosmetic product causes serious adverse health effects. Responsible Persons must report such cases without delay and cooperate with authorities to assess and mitigate risks.

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Prohibited Substances (Annex II)

Annex II of the EU Cosmetics Regulation contains substances that are strictly prohibited in cosmetic products sold in the EU. Use of any listed ingredient makes a product non-compliant and subject to enforcement action.

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Restricted Substances (Annex III)

Annex III of the EU Cosmetics Regulation lists substances that may only be used under specific conditions, such as concentration limits or product-type restrictions. Manufacturers must ensure these ingredients comply fully with the stated limitations before market placement.

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INCI

INCI (International Nomenclature of Cosmetic Ingredients) is the standardised naming system used to list cosmetic ingredients on product labels. It ensures consistent terminology across the EU and internationally, allowing consumers and regulators to clearly identify ingredients.

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Good Manufacturing Practice (ISO 22716)

ISO 22716 is the recognised Good Manufacturing Practice (GMP) standard for cosmetic production. It sets guidelines for consistent manufacturing, quality control, hygiene, and documentation to ensure product safety and reliability. Compliance with GMP is mandatory under EU cosmetics legislation.

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Product Information File (PIF)

The Product Information File (PIF) is a required compliance file for cosmetic products sold in the EU or UK. It includes the product formula, CPSR, manufacturing details, labelling information, and supporting safety evidence. The Responsible Person must keep the PIF readily accessible for inspection by authorities.

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Cosmetic Product Safety Report (CPSR)

A Cosmetic Product Safety Report (CPSR) is a mandatory safety assessment required before placing a cosmetic product on the EU or UK market. It evaluates ingredients, exposure levels, toxicological data, and overall safety for human use. The CPSR must be prepared by a qualified safety assessor and forms part of the Product Information File.

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Responsible Person

The Responsible Person for cosmetics is the EU- or UK-based entity legally accountable for ensuring a cosmetic product complies with applicable regulations. This includes maintaining the Product Information File (PIF), ensuring the Cosmetic Product Safety Report (CPSR) is completed, and submitting required notifications. Each cosmetic product placed on the market must have a designated Responsible Person.

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EU Cosmetics Regulation

Regulation (EC) 1223/2009 is the main EU framework governing the safety and market placement of cosmetic products. It sets requirements for ingredient restrictions, product safety assessments, labelling, notification, and responsible persons. Before a cosmetic product can be sold in the EU, it must comply with this regulation and meet all documentation and safety obligations.

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