Safety assessment and the EU Cosmetic Regulation: 5 years on

The Cosmetic Regulation substantially increased the robustness of the safety assessment process, but there are several areas that still need refinement and careful consideration

July 2018 marked five years since the replacement of the EU Cosmetics Directive (76/768/EEC) with the EU Cosmetic Regulation (1223/2009), and while many things stayed the same, one area that saw a major overhaul was that of safety assessment.

Although assessments had been necessary since the enforcement of the 6th Amendment (93/35/EEC) in June 1995, the content of such documentation was entirely unregulated.

It was not uncommon to find safety assessments that consisted of just a simple statement like: "I, the undersigned, have reviewed this product for safety and consider it suitable for the intended use".

The Regulation, however, brought with it a proscriptive requirement for minimum levels of information to be included within a cosmetic product safety report (CPSR).

It is not surprising, therefore, that the Regulation has led to a significant shift in the way assessments are conducted. Five years on, we consider the ongoing challenges faced by industry, safety assessors, regulators and enforcement agencies alike.


The margin of safety

The day-to-day practices involved in safety assessment were among those most significantly impacted by the introduction of the EU Cosmetic Regulation in 2013.

Having previously had almost no regulatory restrictions on the content of their reviews, safety assessors were now faced with legislation that detailed minimum requirements to consider across 14 headings.

While some of these dealt with information on the product, such as physical-chemical properties and intended usage, significant among them was a need to provide and review detailed toxicological data for all individual ingredients.

Moreover, the regulation states clearly that . . .

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