What do I need to know about ISO 22716 Cosmetic GMP?

ISO 22716 focuses on enhancing the safety of consumer cosmetics across every section of the supply chain. With this standard, you can ensure the production and specification of cosmetics result in products that are safe to use.

ISO 22716 creates a set of comprehensive guidelines for Good Manufacturing Practices (GMP) of cosmetics and personal care. In-fact, in 2007, the International Cooperation on Cosmetic Regulations (formed by the United States, Canada, European Union, and Japan) determined that this standard would be used when recommending or publishing cosmetic GMP guidelines for each country.

How does ISO 22716 relate to cosmetics?

ISO 22716 is a quality management system for anyone involved in the cosmetic process, not only limited to production but also the control, storage, and transportation of products, including the purchase of raw materials, components and packaging material.

Cosmetics are goods or materials intended to enhance, cleanse, or alter a consumer’s face or body through makeup, creams, deodorants, hair products, and fragrances. Cosmetics are created from a mixture of chemical compounds, from either natural sources or synthetically produced ones.

In America, the Food and Drug Administration (FDA) is responsible for regulating cosmetics. The FDA defines cosmetics as products “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions”.

Does ISO 22716 comply with GMP requirements?

Regulation No (EC) 1223/2009 is a necessary set of regulations companies must comply with to sell their cosmetic products within the European Union (EU) market.

A new feature of the European cosmetics regulation is proving compliance with GMP. One of the significant aims of GMP is to ensure the quality and safety of cosmetic products in circulation within the European Union. Beyond the regulatory aspect and supporting with compliance, ISO 22716 helps you improve your brand image, facilitates your exports, and prepares you for inspections by the relevant authorities.

The UK and EU Cosmetics Regulations apply regardless of how much you are selling or how you sell your products, including those used in the professional setting and free samples.

Failure to comply with the UK and EU Cosmetics Regulations requirements can lead to enforcement action and sanctions, which may include a fine and/or imprisonment. The UK Cosmetic Products Enforcement Regulations 2013 outlines possible penalties. Each EU Member States have their penalties set out in local legislation.

ISO 22716 and Good Manufacturing Practices in the supply chain 

It is becoming more common for larger companies in the supply chain to require their suppliers to have GMP/ISO 22716 to comply with their regulations. As seen in recent news, Amazon has made it mandatory for their suppliers to comply with the UK and EU regulations.

Below is an abstract taken from the amazon supplier website.

“If you also sell cosmetics products on Amazon EU website(s), then you must also comply with EU Cosmetics Regulation and with other national requirements in the countries in which you sell these products.” 

What are the benefits of ISO 22716?  

ISO 22716 integrates the criteria for products and processes from the goods manufacturing requirements. It can also bring a variety of benefits, including:

• Enabling your organization to manage the quality and safety requirements of the supply chain
• Controlling hazards/risks associated with cosmetic products, ensuring continuous improvement
• Implementing easily within all business sizes and levels of complexity
• Supporting the organization in meeting legal compliances

What are the next steps?  

Talk to your local ISO experts today to see how we can support you and your business.