ISO Show

#119 What are the key regulatory drivers for ISO 22716?


ISO 22716 sets out the framework for a quality management system for anyone involved in the manufacture of cosmetics and other healthcare related products. While this Standard’s focus is on the manufacture of cosmetics specifically, many of the requirements can apply to any manufacturing process, especially those that involve a risk of contamination.

On the surface, ISO 22716 may be considered a niche Standard, so why it is still so widely adopted?

Today, Mel is joined by Derek Hall, a Senior Consultant here at Blackmores, to discuss the key drivers behind ISO 22716, including legal EU requirements and other related regulations.

You’ll learn

  • Why is ISO 22716 used as an industry Standard?
  • What is ISO 22716’s relation to the Cosmetic Regulation (EC) No. 1223/2009?
  • Who are these regulations applicable to?
  • Other regulations and Standards applicable to cosmetics manaufacturing


In this episode, we talk about:

[00:42] A brief summary of ISO 22716 – watch the last episode for a full summary

[01:25] Do you still need to comply with EU directives? Short answer – Yes, especially if you sub-contract parts of your manufacturing process / packaging or export product within the EU.

[02:00] Why was the Cosmetic Regulation (EC) No 1223 created? To streamline and modernize current legislation across Europe for Cosmetics (though this can also include hygiene products i.e. soaps, toothpaste, deodorants ect)

[03:30] What is the Cosmetic Regulation (EC) No 1223? This regulation establishes rules to be complied with by any cosmetic product made available on the market – to ensure a high-level of protection of human health

[04:21] ISO 22716 is the central pillar of the Cosmetic Regulation (EC) No 1223

[05:02] A bit of background to the EU adoption of ISO 22716 – On April 21st 2011 – ISO 22716 officially became the Good Manufacturing Practices Standard for cosmetic product across Europe. This created a harmonised approach that ensured cosmetic products are safely manufactured, stored and shipped.   

[05:58] The whole regulation came into effect in July 2013. The laws for each nation had to follow this regulation – which included any relevant Standards or guidance affecting the cosmetic industry. This requirement also applies to any cosmetic manufacturers outside the EU that want to import into the EU.  

[07:36] Who are the regulations applicable to? Anyone involved in the cosmetic products chain (European and non-European). This includes raw materials producers, product assembly, distributors, exporters ect

[08:05] ISO 22716 provides guidance for most parts involved in cosmetic production i.e. production, control, storage and shipment. However, it does not cover: safety for personnel (this may fall more under ISO 45001), protection for the environment, is not appliable to research & development and not appliable to the distribution of finished product

[09:55] ISO 22716 is almost 20 years old – so environmental considerations weren’t as much at the forefront of product manufacturing as they are today. Any manufacturers should be doing what they can about their impact regardless of current regulations (new versions may add guidance around this, so keep up-to-date with regulatory changes)

[11:45] Other applicable standards include: The two part ISO 16128 Standard:

ISO 16128-1: Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products

ISO 16128-2: Describes approaches to calculate natural, natural origin, organic and organic origin indexes that apply to the ingredient categories 

[13:58] COSMOS (standard Cosmetics Organic and Natural Standard) was created by many different International parties including BDIH (Germany), COSMEBIO & ECOCERT (France), ICEA (Italy), AISBL (Belgium) and Soil Association (UK). Its purpose is to define common requirements and definitions for organic and / or natural cosmetics.

[15:25] Standards are created collaboratively by technical committees made up of global experts of their respective fields – they take years to develop to establish best practice

[16:09] ISO 22716 has been approved by many regulatory bodies around the world, including the ICCR (The International Cooperation on Cosmetic Regulation), FDA (Food and Drug Administration), JCIA (The Japan Chemical Industry Association) and ASEAN Consultative Committee for Standards

[17:10] Through current regulations, there is increased responsibility in regards to: Ingredients toxicity, product labelling, more comprehensive product file and compulsory notification of new products introduced to the EU

[21:00] The current regulations have specific requirements for ingredient toxicity and product labelling

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