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January 23, 2025

ISO 22716

Written by:
Agnieszka Zwiewka
Manager of Technology Department

In today’s rapidly growing cosmetics market, one of the key aspects determining the success of products is their quality and safety. In response to increasing consumer expectations and legal regulations, ISO 22716 was established to precisely define Good Manufacturing Practices (GMP) in the cosmetics industry.

ISO 22716 is a set of guidelines aimed at supporting cosmetics manufacturers in ensuring the highest quality production processes and protecting user health. In this article, we will takea closer look at the importance of this standard, its key requirements, and the benefits it offers companies in the cosmetics sector. Understanding and implementing ISO 22716 has become not only a part of building a competitive advantage but also an essential tool in achieving compliance with international quality standards.

The objective of ISO 22716 is to ensure compliance with the EU Cosmetics Regulation, directly contributing to a higher level of product safety for consumers. The foundation for this is the so-called “Good Manufacturing Practice.” The standard emphasizes not only the quality and safety of cosmetic production but also the “journey” the product must take—from raw material procurement to the delivery of the finished productto the customer. This includes qualified raw material suppliers, proper storage, and distribution practices.

ISO 22716 provides a comprehensive approach to managing cosmetics production by defining detailed guidelines for Good Manufacturing Practices (GMP). It consists of several key elements fundamental to ensuring high quality and safety in cosmetic products:

  • Personnel Management: One of the essential components of the standard is the responsibility for staff trainingand competence. ISO 22716 emphasizes that all employees should have the necessary knowledge and skills required to perform their tasks, which directly impacts the quality of the final product.
  • Infrastructure Control: The standard requires that manufacturing facilities are appropriately designed, equipped, and maintained to minimize the risk of contamination and ensure hygienic production conditions. This applies not only to production areas but also to storage and auxiliary spaces.
  • Control of Raw Materials and Products: ISO 22716 defines detailed rules for receiving, storing, and testing raw materials and packaging materials. Regular quality checks are intended to identify and exclude materials that may pose a risk to product safety.
  • Management of Documentation and Records: Documentation plays a crucial role in ensuring compliance with the standard. ISO 22716 requires maintaining accurate and complete records of all aspects of production, enabling traceability of every batch and ensuring transparency in operations.
  • Handling Complaints and Product Recalls: The standard requires the implementation of procedures for effective complaint management and, if necessary, the safe and rapid withdrawal of products from the market. This is crucial for maintaining consumer trust and protecting the brand.
  • Control of Finished Products: This includes detailed procedures for testing and evaluating finished products before they are released to the market. This process is essential to ensure that all products meet the required quality standards and are safe for consumers.

The ISO certification process involves several key steps. The first step is selecting a certification body with the appropriate credentials and then submitting an application to initiate certification. This is followed by setting the conditions and date of the audit in accordance with the guidelines of the selected certification body. If no significant issues a rise concerning the organization’s activities, the certification audit can proceed. Upon successful completion, the organization receives a certificate confirming the implementation of the ISO 22716 system.

Companies that obtain certification are subject to annual surveillance audits. During these audits, the functioning of the system within the company is assessed, with attention to the implementation of quality policies and objectives, internal audits, corrective and preventive actions, and the consistency of management reviews.

Implementing ISO 22716 provides cosmetics companies with numerous benefits that go beyond mere regulatory compliance. These include:

  • Improved Product Quality: ISO 22716 ensures a systematic approach to managing production processes. Rigorous quality controls and production parameter monitoring enable companies to manufacture products of consistent and high quality.
  • Enhanced Consumer Safety: Adopting Good Manufacturing Practices reduces the risk of product defects, leading to a higher level of safety for cosmetics users. Consumers can trust that products meet the required safety standards.
  • Increased Customer Trust and Brand Reputation: ISO 22716 certification serves as proof that a company takes quality and safety seriously. This strengthens trust among customers and business partners and can be a significant competitive advantage in the market.
  • Facilitated Access to International Markets: For companies seeking to expand into new international markets, ISO 22716 certification can be a valuable asset. Many countries recognize the standard as proof of compliance with local regulations, simplifying the introduction of products into new markets.
  • Operational Process Optimization: Implementing the standard often leads to identifying and eliminating inefficiencies in production processes. This can result in greater operational efficiency, cost savings, and increased profitability.
  • Reduced Risk and Fewer Complaints: Establishing and adhering to clearly defined processes under ISO 22716 minimizes the likelihood of production errors and complaints. This not only protects the brand from potential financial losses but also reduces the risk of reputational damage.
  • Support in Meeting Legal Requirements: ISO 22716 helps companies comply with legal regulations regarding cosmetics production. Aligning with the standard can help avoid legal sanctions and issues with regulatory authorities.

In conclusion, ISO 22716 serves as a foundation for cosmetics companies striving to ensure the highest quality and safety of their products. By focusing on key aspects such as personnel management, raw material and infrastructure control, and documentation, the standard helps companies effectively manage production processes. Implementing ISO 22716 offers benefits not only in terms of building customer trust and brand growth but also operational savings and compliance with international regulations. The comprehensive approach to quality and safety promoted by the standard not only meets the expectations of modern consumers but also prepares companies for dynamic changes in the global cosmetics market. For companies seeking certification, ISO 22716 provides a strategic advantage that can transform how they operate and compete on the global stage.