In this article Dr. Cardoso assesses the reasoning behind the regulation and explains how best to achieve compliance, together with pointing out the consequences for failing to comply.
Regulation (EC) No 1223/2009
The new regulation ((EC) No 1223/2009) is intended to ensure consumers’ health is protected by providing easy traceability of individual products and their ingredients; the processes involved in making them and getting them to market; the way they are presented to customers; and the quality, consistency and depth of information that is provided to the consumers who buy and use the products. The Regulation also provides for the assessment of product safety and the prohibition of animal testing.
Any European cosmetic business should be aware of the new regulation but I doubt whether any have yet achieved compliance. It is an involved and massive undertaking, changing the way companies capture and manage data right across the product lifecycle, for current products and any launched in future.
One major change for cosmetics companies is that they must now have one single EU-based member of staff with sole responsibility to ensure the compliance of each product with the rules set out in the new regulation.
This covers manufacturing, testing on animals, consumer safety and customer communications. With product safety, the role takes on the on-going monitoring and recording (or post-marketing surveillance) of all undesirable effects in a health context that could be due to the use of cosmetic products.
The single responsible person must maintain a ‘product information file’ which is readily accessible to the public authorities. They must identify the distributors of each product – information which must be kept for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor.
There are also requirements to meet around the issues of safety and animal testing. Cosmetics firms must be vigilant and transparent about the ingredients used in their products, and be able to show that they have abided by restrictions around certain substances. Animal testing in the EU for ingredients or combinations of ingredients as well as for finished products is strictly prohibited.
If these requirements are not met, the relevant national authorities could take corrective measures. In the case of a potential safety risk, products could be withdrawn or recalled.
Addressing the demands
Although these demands are both onerous and expensive to manage, greater transparency will benefit cosmetics firms, allowing them to trace processes and products quickly and efficiently. Over time the US and Asian markets will likely bring in their own regulation around cosmetics transparency, so EU businesses can save time and resource by doing so earlier.
Achieving this is no small undertaking but external service providers can assist with getting operations in order. IT systems will play a big role in meeting the regulation, helping to organise and automate the way data is collected and managed. Cosmetics firms should decide how much of this they want to manage themselves, and then bring in an external partner to fill in any gaps.
But action must start now. Penalties for non-compliance are yet to be decided but they are likely to be severe. If a product is recalled, a brand is damaged and that can have a serious impact on the bottom line.