ISO 22716:2007

ISO 22716:2007

"New European Union Regulations" have been published for cosmetic products. According to new legal regulations, all cosmetic products must be produced in accordance with GMP as defined in the ISO 22716 standard. Regardless of whether the manufacturer is located within the borders of the European Union, all raw material producers, final product producers, distribution companies, importer and exporter companies that sell products to the European Union and are included in the cosmetics chain are obliged to comply with the "New European Union Regulations". While ISO 22716 offers an integrated approach to cosmetics production, it also brings a set of rules and recommendations in the fields of testing, packaging, storage and transportation. ISO 22716 also allows establishing an integrated system with ISO 9001 and BRC.

SAFETY IN COSMETIC PRODUCTS

Consumer concerns about the cosmetic products they use have increased over the years. Allergies and skin inflammations caused by products that are out of date or contain toxic ingredients introduced to the market in the past years have caused fear and distrust in consumers. Essences and preservatives that form the basis of the product we choose can trigger allergic reactions. Using these essences and preservatives in appropriate doses is of primary importance in protecting against skin irritations.

Overdosing of preservatives is a frequently encountered example. One of these examples is the excessive use of mercury in beauty creams, which causes consumer poisoning. The fact that such reports frequently come before legislative committees has led to increased measures regarding consumer safety.

The rapid increase in the number of trademarks, product range and trade volume in recent years has made it impossible to control individual products, necessitating the necessity of a regulation and standard covering manufacturers, testing institutions, packaging facilities, importers, exporters, storage and distribution companies.< br />
As a result of the studies carried out between 2002 and 2006, the ISO 22716 guide was published in 2007. In 2008, the USA, Food & Drug Administration (FDA), EU, European Committee for Standardization (CEN), Japan, Japan Chemical Industry Association (JCIA) and many other countries revised their existing standards and accepted ISO 22716.

FUNDAMENTALS OF ISO 22716 STANDARD

The standard consists of five basic elements, these are;
• Cosmetic quality management system and organization.
• Devices and campuses.
• Production realization and material management.
• Mechanism for deviations, complaints and recall of faulty product.
• It is continuous improvement.

COSMETIC QUALITY MANAGEMENT SYSTEM and ORGANIZATION

ISO 22716, like other ISO standards, requires a functional document management system. In addition, one of the most important factors in cosmetic GMP is the fact that safe products can only be produced by personnel and senior management whose job descriptions are clearly defined, responsibilities are defined, well-trained, and have proven their competence in their field. For example, who will make the decisions about quarantine, release, rejection, error control, inspection, change control, and internal audit within the enterprise must be determined and documented and announced to all employees. Another important issue is that the communication channels of the personnel within the business and with second and third parties are determined for each level.

DEVICES and FACILITIES

The design of production, storage and quality control areas is key to the standard and is defined in detail. Areas must be designed in accordance with their purposes, and entry and exit points must be constructed taking into account product hygiene, production flow, risks of mixing products with each other and cross contamination. Maintenance, cleaning, calibration and monitoring of the campus and devices should be carried out systematically and in accordance with predetermined parameters. Additionally, a personnel access policy should be determined for production areas. Special access controls should be used for access to sensitive sections such as the initial packaging area, clean room, raw material area.

MATERIAL MANAGEMENT AND PRODUCTION ACTIVITY

Businesses operating in accordance with the ISO 22716 Standard must establish precise quality parameters for different stages of production. These quality parameters must be constantly observed and recorded in a strict manner. In the procurement of raw materials, the business must create an entry quality plan in line with international and self-determined criteria, and prove that it will not purchase raw materials that do not comply with this quality plan for financial reasons.

DEVIATIONS, COMPLAINTS AND DEFECTIVE PRODUCT RECALL MECHANISM

Every business should document what to do when there is a deviation (nonconformity) in the production chain. It must have established a mechanism to recall faulty products that have been put on the market and must be able to ensure traceability in all its products. If the business has decided to reprocess in the future, it should determine which materials can be reprocessed, establish strict rules for their control and release, and conduct a risk analysis considering the entire production chain.

CONTINUOUS IMPROVEMENT

Organizations should constantly follow the good manufacturing practices implemented in their sectors and aim for continuous quality improvement in all their operations. The most effective way for this purpose is internal audits, all businesses should operate an active internal audit process, record the errors found and solve them in time to prevent possible problems in the future.

BENEFITS OF APPLYING ISO 22716:2007 GOOD MANUFACTURING PRACTICES STANDARD FOR COSMETIC PRODUCTS

• It proves that your production system is suitable and meets legal requirements.
• Prepares your business for ministry of health inspections.
• It shows your customers that the product they buy is reliable.
• It allows you to obtain export permits to many countries, especially the European Union countries.
• Ensures you remain in a competitive position thanks to internal audits and continuous improvement.