ISO 22716 and European Regulations : Cosmetics GMP

ISO 22716 and European Regulations: ISO 22716 GMP is one of the foundations of the new European Union regulations for Cosmetics. This sets strict requirements for ensuring consumer safety. The ISO 22716 Good Manufacturing Practices (GMP) for cosmetics or simply Cosmetics GMP guide was designed to give guidelines for the production, control, storage, packaging, labeling, shipment, and distribution of cosmetic products. 

In a nutshell, all cosmetics products in the European market will have to be produced following Cosmetics GMP in compliance with ISO 22716.

Moreover, Cosmetics GMP is a set of operational rules and organizational guidelines focused on administrative, managerial, human, and technical factors that impact the quality of cosmetic products.

It has been developed in collaboration with cosmetics industry professionals. By promoting best-in-class methods, the Cosmetics GMP determines the activities that make the product conform to the expected specifications and demands.

Likewise, it is arranged to complement current management systems in place, like the ISO 9001. The standard highlights the quality of cosmetic products to customers, as well as the accountability and traceability in the production and distribution phases of products.

Finally, ISO 22716 GMP covers all aspects of the supply chain of cosmetics. It focuses on the safety and quality of the product. Yet, the standard also concentrates on the impact of products on consumers, manufacturers, retailers, suppliers, and brand holders.

Is ISO 22716 Certification Important to Cosmetics Companies?

Absolutely. The European Union Cosmetics Directive states that a cosmetic is any substance, mixture, or preparation intended to be placed in contact with:

• external parts of the human body, such as the hair system, lips, epidermis, nails, and external genital organs
• the teeth and the mucous membranes of the oral cavity

Under the standard, the products are viewed exclusively to cleaning, changing the appearance, perfuming, protecting, correcting odors, or keeping the said body parts in good condition.

Hence, ISO 22716 guides cosmetics businesses in committing to the production of safe, excellent, and quality cosmetic products.

Note that the manufacturing system of a cosmetic company will be inspected and audited on the following areas under the ISO 22716 guide:

• Personnel or employees
• Contracting/subcontracting
• Material management
• Laboratory quality controls
• Control of hygiene
• Production and in-process controls
• Facilities, buildings, premises
• Packaging and labeling
• Storage
• Distribution
• Internal audits
• Complaint and recalls
• Documentation

EC Cosmetics Regulation 1123/2009

After reviewing its cosmetics regulation, the EU published the revised edition in December 2009 in the Official Journal of the European Union.

The whole regulation came into effect in July 2013, with the European Community presenting a coordinated regulatory framework.

The laws of each of the respective nations must be following the regulation. This includes any relevant standards or guidance affecting the cosmetics industry.

This requirement applies to any cosmetics manufacturers outside the European Union that want to import products into countries within the region.

Besides, the regulation aims to utilize a uniform terminology, as well as common procedures, across the EU.

How Do ISO 22716 and European Regulation Work Together?

The framework outlines stronger in-market controls. It aims to guarantee a higher level of protection of human health. Within the framework, all cosmetic products circulating in the European market should be produced under ISO 22716 GMP. Also, the framework emphasizes:

• simplification
• reduced red tape
• better administration

More than that, the framework covers a new approach covering uniform standards across the European Union, including the Good Manufacturing Practice. Under both ISO 22716 and the European Regulation, cosmetic products must be safe when applied in normal or reasonably foreseeable conditions of use. Therefore, the framework encompasses general standards for sampling and analytical methods.

All common standards, including the ISO 22716, target putting procedures in place that enable manufacturers to attain this safety goal. Aside from that, ISO 22716 defines the responsibilities of the participants in the cosmetics manufacturing chain:

• ingredient manufacturers
• end-product companies
• distributors
• importers
• exporters

The importance of ISO 22716 for those organizations that need to follow GMP has been stressed by EU publication 2011/C 123/04 from April 2011. The European Regulations explain the differences between the manufacturer, distributor, and importer. Note that there is an emphasis on a ‘responsible person’ who guarantees compliance with all safety and labeling requirements, including notification obligations and corrective measures.

The ‘responsible person’ can be the manufacturer, distributor, or importer as long as that party has a registered office within the EU. The cosmetic product’s packaging must show this detail. Each responsible person must have a full Product Information File available to public authorities. In effect, there’s greater responsibility on the manufacturer concerning the ingredients and make-up of each cosmetics product.

Furthermore, the European Regulation states that sampling and analysis of cosmetics products during the manufacturing process must be performed in a standardized and reproducible manner. This aims to ensure the control of all restricted substances as detailed within the Product Information File. This applies both within the market and within companies. Cosmetic companies must know that a Europe-wide notification process for all cosmetics products is a prerequisite before market entry.

Consequently, this replaces any current notification arrangements within the individual countries of the region. Moreover, compulsory notifications and a more comprehensive product file are necessary for introducing product labeling to the European Commission. For the European Regulation and ISO 22716, safety is dominant to every implementation of global standards.

Requirements of the European Union’s Cosmetics Good Manufacturing Practices

Cosmetics GMP:

The EU Cosmetics Regulation includes the EU Cosmetics GMP requirements. The regulation developed the requirements to guarantee safety to clients and those involved in the cosmetics sector, whether European or non-European.

The legal requirements specify that all cosmetic products circulating in the European Union must be produced as per the ISO 22716 Good Manufacturing Practices. Cosmetic companies can prove compliance through an ISO 22716 certification. They can also show that the products are created according to ISO 22716 requirements.

ISO 22716 has arranged the following specific requirements and principles:

• Personnel
• Staff should have suitable training to manufacture, control, and store products that comply with quality standards.
• Organizational chart.
• The number of employees.
• Key responsibilities of the management and staff.
• Training and workshop.
• Personal hygiene and health of staff, visitors, and untrained personnel.

• Equipment

Equipment should be relevant and useful for the intended purpose. All pieces of equipment must be cleaned, sanitized, and maintained. ISO 22716 requires a cosmetics company’s equipment to be designed, installed, calibrated, and have adequate back-up systems.

• Raw materials and packaging

Purchased materials, both raw and for packaging materials, must meet defined acceptance criteria significant to the quality of end products. It covers physical, microbiological, and chemical aspects. Set up proper criteria and measures for purchasing, receipt, status, release, storage, and re-evaluation of raw materials.

• Premises and Locations

            Premises should be designed, built, located, and optimized to assure protection of the product, as well as efficient cleaning, sanitation, and maintenance. This will minimize the risk of a mix-up of raw materials, packaging units, and products.

• Production

ISO 22716 obliges cosmetic companies to take measures in every stage of manufacturing processes and packaging operations to manufacture an end product that fulfills the identified characteristics. Cosmetic companies should ensure the availability of relevant documents, perform start-up checks, assigned batch numbers, and re-stock raw materials. They must identify in-process operations, in-process controls, and product storage during the manufacturing and packaging stages.

• Subcontracting

Subcontracting obtains a product or service that adheres to the defined contract giver’s requirements. The contractor and subcontractor must set, confirm, and control a written contract.

• Finished products

ISO 22716 compels cosmetic companies to guarantee that the end products fulfill the defined acceptance criteria before distribution. Finished products must be controlled in compliance with the set test methods.

• Quality control laboratory

Quality control laboratory should apply ISO 22716 principles for personnel, equipment, premises, subcontracting, and documentation. It must conduct sampling, testing, and analysis to ensure relevant and necessary controls.

• Deviations

Use sufficient data and corrective measures to determine deviations. Cosmetic companies must identify the treatment of product that is out of specification.

 

• Waste Management

            ISO 22716 requires cosmetic companies to dispose of wastes in a sanitary, orderly, and timely manner.

• Conducting and Controlling Changes

            Authorized personnel should approve and make changes that could impact the finished product’s quality based on adequate data.

• Handling complaints and recalls

            According to ISO 22716, companies must manage, investigate, review, and follow up all complaints. Take appropriate corrective actions if there’s a recall.

• Performing an internal audit

            Cosmetic companies must check the implementation and status of the ISO 22716 Good Manufacturing Practices. They must plan and recommend corrective actions.

• Proper and complete documentation

            ISO 22716 states that documentation is a crucial part of Good Manufacturing Practices. Documentation aims to define GMP activities, secure evidence of processes, and prevent confusion and loss of information.

In Conclusion

The European Regulation EC 1223/2009 legally requires any cosmetics manufacturer to follow a set of Good Manufacturing Practices before circulating products onto the European market. Guidelines from ISO 22716 includes guidance for regulating and documenting production, control, storage, and shipment of cosmetic products. Both cosmetics companies and stakeholders must meet and comply with the new ISO 22715 requirements and European Regulation. GMPs relates to quality assurance through the description of the activities using risk assessments and scientific judgment. Once your company complies with ISO 22716 guidelines, Cosmetics GMP, and European Regulation, you can ensure:

• • • • • • • Overall cosmetics product quality and safety.
            • Improved Quality Management Systems.
            • Continuous improvement and enhanced operating efficiency.
            • Confidence of the public, business partners, and regulatory bodies.
            • Minimized risk while optimizing the supply chain.
            • Compliances to local and national guidelines.
            • Access to the European market.

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