Achieve compliance following the EU Cosmetics Regulation

Achieve compliance following the EU Cosmetics Regulation

In the three years since the EU Cosmetics Regulation amendments were legalised in Europe, we recap the changes we’ve seen surrounding EU Cosmetics Regulation.

The regulations were brought in to simplify the regulatory requirements across each member state with unified intentions of improving product safety, reducing business costs and minimising legal uncertainties. Below we detail the key revisions related to safety assessments, GMP, marking and labelling requirements, product information file requirements and the role of the responsible person.

The cosmetic product safety assessment sought to clarify ambiguous, previous assessment prerequisites. The changes permitted safety assessors to detect any potential problems with a cosmetic formulation taking into account the foreseeable use. Additionally, assessments must be delivered alongside a cosmetic safety report prior to sign off. This should detail the results of microbiological specifications and preservative challenge testing, purity specification of the raw materials and packaging and packaging material compatibility.

Good Manufacturing Practice or GMP, has always been a mandatory requirement, and remains so under the most recent revisions. The main difference is the reference to the harmonised standard, EN ISO 22716:2007 and its presumption of conformity to the Regulation’s GMP requirements offered by compliance.

The Regulation (EC) No 1223/2009 introduced changes to the existing Product Information File (PIF) but the majority of the content remains the same. Structurally, the PIF is now defined by the following components: a description of the cosmetic product, description of the method of manufacture and compliance with GMP, proof of effect and data on any animal tests completed after September 2004 and the aforementioned cosmetic product safety report.

There were no big changes to marking & labelling requirements. However, a new egg timer symbol has been included for use alongside the best before date.

By default, the manufacturer or importer assumes the identity of the “responsible person”. The distributor within the EEA could also be the responsible person, if they were to place a cosmetic product on the market under their own name or trademark or if they were to modify a product already placed on the market in a way which could alter its compliance.

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