ISO 22716:2007 provides guidance for documenting and regulating the production, control, storage, and shipping of cosmetic products. The standard’s guidelines provide practical methods for managing the numerous factors that can affect product quality.
What is ISO and what is it for?
ISO is a non-governmental organization that develops and publishes international consensus standards. In September 2007, the International Cooperation on Cosmetic Regulation (ICCR), the international quadrilateral harmonization group, met in Belgium. During that meeting, regulators from the United States, Canada, the European Union, and Japan agreed that it would be useful for the cosmetics industry to have a standardized Good Manufacturing Practices (GMP) framework that could be applied to their jurisdictions.
As a result, regulators from these four jurisdictions agreed to take ISO standards for cosmetic GMPs into consideration when developing or updating guidelines or other measures addressing GMPs.
What do good manufacturing practices for cosmetic products indicate?
Good manufacturing practices (GMP) are part of quality assurance designed to ensure that products are consistently manufactured with a quality suitable for their intended use. It is therefore related to manufacturing and quality control procedures.
GMPs are critical for organizations seeking to reduce the risk and liability of their products. An organization can demonstrate GMP compliance by implementing ISO 22716. The benefits of ISO 22716 certification for your organization:
- Improves quality management systems.
- Demonstrates commitment to cosmetic product safety.
- Ensures compliance with international guidelines
On the other hand, Good Manufacturing Practices are based on sound scientific principles and criteria, grounded in risk assessments, to produce products that meet the expected characteristics. The requirements also affect the production, control, storage, and shipping of cosmetic products, as well as the quality and safety aspects of the product.
What does the scope of ISO 22716:2007 indicate?
The purpose of ISO 22716 is to provide a specific tool for quality management in the manufacturing, packaging, testing, storage, and transportation of cosmetic products. This approach to quality based on common ISO standards and schemes ensures seamless integration with other quality systems such as ISO 9001 and even other schemes dedicated to consumer products such as the BRC (British Retail Consortium).
ISO 22716 combines the benefits of Good Manufacturing Practices with the implementation of a management system as a tool to drive continuous process improvement. The introduction of ISO 22716 represents a significant step forward in the safety of cosmetic products worldwide. This final ISO 22716 standard is an auditable standard that specifies:
- Requirements for cosmetic products
- Safety management systems incorporating GMP (Good Manufacturing Practices) elements
- Risk assessment combined with overall quality.
- ISO 22716 certification is compatible with the company’s ISO certification, adding further value to the system.
What can be certified with ISO?
The types of cosmetic products covered by this regulation would include: creams, emulsions, lotions, gels, and skin oils. Also included are facial masks, tinted foundations (liquid, paste, powder), makeup powder, after-bath powder, and hygiene powders. These include perfumes, deodorants, and hair care products, among others.
What are the objectives of ISO 22716:2007?
Its main objective is to address the legal uncertainty caused by different directives and remedy inconsistencies by establishing a set of definitions and implementing measures. This also increases the safety of cosmetic products, as previous cosmetics directives did not provide clear requirements for safety assessment.
Unnecessary procedures are reduced, minimum safety requirements are clarified, notification requirements are simplified, cross-border trade is facilitated with more uniform application across the EU, etc.; all of which will result in cost reductions for the sector and, therefore, benefits for consumers and product safety.
Scope of application and general principles
The definition of cosmetic products is maintained, and new definitions were proposed, such as manufacturer, importer, marketing, undesirable effect, serious undesirable effect, etc.
It also introduced the concept of a responsible person established in the Community and the principles of good manufacturing practices, sampling and analysis, and claims related to cosmetic products.
A pictogram referring to the date of minimum durability and minimum requirements for safety assessment was included on cosmetic product labels. Furthermore, the product information file must be included.
Regarding product safety, the differentiated regime based on risk assessment for carcinogenic, mutagenic, or toxic for reproduction (CMR) substances allows, under strict conditions, the use of CMR 1 and 2 substances if their use in cosmetics is proven to be safe. A simplified, centralized, and electronic notification system was also proposed. Administrative collaboration between competent authorities and the implementation of good administrative practices are strengthened.
Unwanted effects and animal testing
An approach was adopted for managing adverse effects and serious adverse effects. These data will be incorporated into the cosmetic product safety report and communicated to the public. Competent authorities must be actively informed about serious adverse effects.
The global strategy for banning animal testing for finished products and the timeline for banning the marketing of cosmetic products containing ingredients or combinations of ingredients that have been tested on animals are maintained.
The scope of ISO 22716:2007
ISO 22716:2007 addresses all aspects of the cosmetic product supply chain, from the advance delivery of raw materials and components to the shipment of the final product to the consumer. The requirements also affect the management of human resources, technical and administrative departments that affect product quality.
This standard is primarily of interest to cosmetic manufacturers, cosmetic ingredient suppliers, retailers, brand owners, and wholesalers of cosmetic products.
Finally, it specifies the general requirements for Quality Management Systems, with the additional incorporation of risk assessment based on the identification of critical elements that ensure the high quality of products obtained from production lines.
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