Kallik minimizes the impact of staying compliant with current and forthcoming cosmetics regulations
What are the requirements?
EU Regulation (EC) No 1223/2009 on cosmetic products makes it an offence to supply an incorrectly labeled cosmetic product. The labeling requirements include the name and address of the manufacturer / importer, the ingredients, durability marking, function and precautions. The FDA requires all cosmetics products to comply with the Food, Drug & Cosmetic Act, including sections 602 and 21CFR 1.21 as applied to labeling.
How does Kallik help with Cosmetics Regulations?
Kallik’s cloud-based solution simplifies labelling and artwork management for the cosmetics industry to meet regulatory-driven requirements and achieve global compliance.
- Simplify compliance with EU Cosmetics Regulation (1223/2009)
- Ensure alignment across labelling content and Product Information Files (PIF) with Complete transparency from ingredients and processes to finished products
- Deliver consistent marketing and regulatory imagery and statements across all packing and promotional materials and ensure brand and color consistency
Timeline of Cosmetic Requirements
1938: US Food, Drug and Cosmetic Act Passed
The Food, Drug and Cosmetic Act is passed as federal law in 1938. The law established quality standards for food, drugs, medical devices, and cosmetics manufactured and sold in the United States. The law also provided for federal oversight and enforcement of these standards and has gone through several major amendments since being passed. 21 CFR Part 701 Subpart A - (Sections 701.1 Through 701.9) apply to cosmetic labeling.
1973: INCI System Established
INCI (International Nomenclature of Cosmetic Ingredients) system established by the CTFA to harmonize ingredient labeling. INCI standards for International Nomenclature of Cosmetic Ingredients. INCI names are used in the United States, the European Union, China, Japan, and many
other countries, for listing ingredients on cosmetic product labels. With few exceptions, the INCI labeling names in all countries are the same.
November 2009: Regulation (EC) No 1223/2009 Enters Into Force
The regulation states that the person or company who places the cosmetic product on the market is responsible for that product (so called ‘Responsible Person’). It is the responsibility of that person or company to ensure that the product is safe and meets all the requirements of the Cosmetics Regulation.
July 2013: Cosmetics Directive (76/768/EEC) Replaced by Regulation 1223/2009
This new regulation has included harmonized notifications, clearer provisions for the content and format of product safety assessments and product information files (PIF) and strengthened coordinated efforts of market surveillance activities among competent authorities of member states.
How To Be Compliant
Establish a global source of labeling truth backed up by digital signatures and comprehensive audit trails that all market-facing product information and materials flow from to deliver process transparency and simplify proof of compliance.
Eliminate multiple siloed systems by moving to a centralized cloud-based solution will improve visibility, control and co-ordination making it easier to identify and updated impacted labels whilst demonstrating compliance
Unite dispersed teams and eliminate disjointed processes resulting from use of spreadsheets, documents, emails and localized desktop solutions that otherwise make identification of all impacted labels an almost impossible task.
Identify opportunities to maximize operational gains across multiple contract manufacturing and supply chain partners by standardizing content and layout for multiple packaging processes and graphic elements across global supply chain partners.
Data integrity plays a key role in all areas of GMP compliance including labeling and FDA expects data to be meaningful, taking into consideration the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.
Ensure the quality, format and positioning of linear and 2D serialization barcodes contained within multiple types of print and packaging labeling are detectable to the range of optical and scanning devices used throughout the supply chain.