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Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products is the primary piece of legislation governing the cosmetics industry in the European Union. It imposes a number of obligations on manufacturers, importers and distributors – including one of the most important: the manufacture of cosmetics in accordance with the principles of Good Manufacturing Practice. ISO 22716 is the standard that specifies these principles and translates them into a concrete management system. However, the relationship between the standard and the Regulation goes beyond the issue of GMP alone – and it is worth understanding it thoroughly.
Article 8 of Regulation 1223/2009/EC imposes an obligation on manufacturers to produce cosmetic products in accordance with Good Manufacturing Practice. However, it does not define in detail what this practice entails in the day-to-day operations of a facility – instead, it refers in this regard to harmonised European standards. The standard for the cosmetics industry is ISO 22716.
Regulation No 1223/2009/EC introduced elements of the EU’s New Approach into the cosmetics industry, which assumes that a product complying with the requirements of the relevant harmonised European standards automatically complies with legal provisions. This means that a manufacturer holding ISO 22716 certification is automatically regarded by the supervisory authorities as complying with the GMP requirements set out in the Regulation. The absence of certification does not constitute a formal breach of the law – but in the event of an inspection or a quality incident, the manufacturer must prove on its own that it applies GMP principles, which is considerably more difficult without a certified system.
The ISO 22716 standard sets out requirements for good manufacturing practices in the cosmetics industry in accordance with the applicable legal requirements of Regulation No 1223/2009. Its aim is to ensure that the finished cosmetic product placed on the market is safe by maintaining appropriate conditions during its manufacture, storage and transport.
Product Information File (PIF) – what does the standard contribute? Regulation (EC) No 1223/2009 requires that a Product Information File (PIF) be maintained for every cosmetic product placed on the EU market and made available to supervisory authorities upon request. One of the mandatory elements of the PIF is a description of the manufacturing method and a declaration of compliance with GMP. A well-functioning ISO 22716 system provides ready-made process documentation – formulations, manufacturing instructions, batch records – which forms a natural part of the PIF and can be incorporated directly into it.
Traceability and product notification to the CPNP – how does the standard support these requirements? The Regulation requires manufacturers and importers to notify cosmetic products to the European CPNP (Cosmetic Products Notification Portal) database before placing them on the market. ISO 22716 requires a traceability system – the ability to trace each product batch from raw material to the end user – which is an essential element of managing potential product recalls and handling adverse events, which must be reported to national authorities in accordance with the Regulation.
Serious Undesirable Effects (SUEs) – procedures required by both documents. Regulation (EC) No 1223/2009 imposes an obligation to report serious undesirable effects (SUEs) to the competent national authorities within 10 working days of their detection. ISO 22716 requires documented procedures for handling complaints and adverse events, including mechanisms for identifying events that qualify as SUE. A company with an ISO 22716 system in place has the necessary process infrastructure to fulfil this obligation – a complaints register, escalation procedures and a notification pathway.
Product recall – a common requirement. Both the Regulation and the standard require effective procedures for recalling dangerous products from the market. ISO 22716 goes a step further – it requires these procedures to be regularly tested through simulations, which ensures that, in the event of a real incident, the facility is able to carry out the recall efficiently.
ISO 22716 is a powerful tool to support compliance with Regulation (EC) No 1223/2009, but it is not a substitute for it. Several key requirements of the Regulation go beyond the scope of the standard and must be met independently.
The Regulation requires a product safety assessment to be carried out by a qualified specialist (Safety Assessor) and documented in a Product Safety Report (Part B of the PIF). ISO 22716 does not contain any requirements regarding product safety assessment – this is a purely regulatory requirement.
The obligation to notify the product to the CPNP database prior to placing it on the market is a requirement arising directly from the Regulation and is not addressed by the standard. Similarly, the obligation to include the information required by law on the packaging – ensuring that labelling complies with legal requirements – is a regulatory obligation, although ISO 22716 requires that the management system ensures labels comply with approved specifications.
The optimal approach is to treat ISO 22716 and Regulation (EC) No 1223/2009 as complementary tools: the standard establishes a quality management and GMP system, which serves as the infrastructure for meeting regulatory requirements, whilst the Regulation defines the legal obligations, the fulfilment of which is managed and documented by that system.
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DJB DORADZTWO
Marcin Chorąży
