ISO 22716 – Cosmetic GMP. What is it and why do cosmetics manufacturers need to be familiar with it?

Cosmetics manufacturers operating in the EU market work within a highly regulated environment. One of the key obligations under EU cosmetics legislation is to manufacture products in accordance with the principles of Good Manufacturing Practice – GMP for short. ISO 22716 is a standard that clarifies these principles and translates them into specific system requirements – and its implementation is now not only good practice but a practical necessity for cosmetics manufacturers.

The origins of the standard and its place in cosmetics law

ISO 22716 (full title: ‘Cosmetics – Good Manufacturing Practice – Guidelines on Good Manufacturing Practice’) was published by the International Organisation for Standardisation in 2007 and adopted in Poland as standard PN-EN ISO 22716:2009. Its development was a direct response to the need to harmonise GMP requirements within the cosmetics industry at a global level.

Regulation No 1223/2009/EC introduced elements of the EU’s New Approach into the cosmetics industry, on the basis that a product complying with the requirements of the relevant harmonised European standards automatically complies with legal provisions. For the cosmetics industry, this harmonised standard is ISO 22716. In accordance with EU Regulation No 1223/2009 and the Polish Cosmetics Act, cosmetics manufacturers are obliged to apply GMP principles and to provide the relevant supervisory authorities with appropriate documentation certifying compliance with these principles.

In practice, this means that holding an ISO 22716 certificate exempts the manufacturer from the need to demonstrate compliance with the GMP requirements set out in Regulation (EC) No 1223/2009 separately – the certificate automatically confirms this to regulatory authorities and trading partners.

Who is ISO 22716 intended for?

The standard is intended for all organisations involved in the production and distribution chain for cosmetics. It can be applied by all organisations operating within the cosmetics supply chain – regardless of their size or organisational structure.

In practice, ISO 22716 certification applies to:

• Cosmetics manufacturers producing products under their own brand or on a contract basis (private label / contract manufacturing)
• Distributors and importers placing cosmetics on the EU market from outside the EU – importers and distributors of cosmetics for the EU market are obliged to ensure that every cosmetic product they place on the market has been manufactured in accordance with GMP and meets the requirements of harmonised standards, such as ISO 22716
• Subcontractors and component suppliers – companies producing semi-finished products, cosmetic raw materials or packaging for final manufacturers
• Companies outsourcing production to external manufacturers – responsibility for the product’s compliance with GMP rests with the entity placing it on the market, regardless of who physically manufactured it

Scope of the standard – what does ISO 22716 cover?

The ISO 22716 standard sets out guidelines for the manufacture, infrastructure, quality control, storage and transport of cosmetics. Its scope extends beyond mere manufacturing – it covers the entire product life cycle, from the receipt of raw materials to the delivery of the finished product to the customer.

Key areas of the standard include personnel management and training, requirements for production premises and equipment, control of raw materials and packaging materials, supervision of the production process, quality control of the finished product, management of documentation and records, handling of non-conforming products, and the handling of complaints and product recall systems.

ISO 22716 does not impose specific technologies or solutions – it defines requirements for outcomes and processes, whilst leaving the organisation free to choose the methods by which to meet them. This makes the standard scalable and suitable for implementation in both large manufacturing plants and small cosmetics companies.