GLOBAL REGULATIONS
Capturing regulatory chaos in a bottle
Sebastian Clifton-Welker – Selerant
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In August 2020, lilial, a common fragrance used in cosmetics, was banned in the EU and Northern Ireland. Deemed a carcinogenic, mutagenic or reprotoxic substance, companies had two years to remove the floral scent from products in these markets. This meant engaging with stakeholders
across several brands, several product lines and digging into numerous ingredients lists to rapidly reformulate, then reregister mixtures with various authorities to verify compliance. The industry had gone through a similar
process a few years prior, when Lyral (butylphenyl methylpropional), another common fragrance allergen, was added to the list of prohibited substances. As with lilial, Lyral would no longer be permitted in Europe after August 2019, with existing product lines permitted to stick around until August 2021. Only two years apart, the new regulations
proved to be a complex and confusing minefield, but this is the new normal for companies doing business across global markets. Regulations will continue to evolve, new guidelines will be introduced and companies will have to react if they wish to continue doing business in those countries. Navigating the response effort has
widespread implications for the industry. The
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process is often fraught with anxiety, with plans and teams often derailed by the disruption. Opaque and disparate business structures make it difficult to track progress and verify compliance measures. This lack of traceability and visibility often results in loose ends, which can spell serious disaster for regulatory adherence and customer safety.
Not everyone is on the same page Even with a long runway to implement change, new regulations can sneak up on companies. This is especially true for a large organisation, where operationalising a company-wide effort can be difficult. It is common for bigger enterprises to be
made up of several brands, each of various size, likely split into several divisions focused on specific goals. There can be additional segmentation, like a separation between fragrance or skincare lines, which are further broken down into product groups, all tasked with different responsibilities. This degree of fragmentation means
information can be incomplete, inaccurate or even get lost in all the confusion. The problem of silos creates several inefficiencies for an organisation, but it can introduce a major obstacle for compliance.
Regulatory affairs inform stakeholders
of the impact of new legislation, but unless there is one person looking at all functions across brands and product lines, it is easy for directives, including those from regulatory, to get muddled or sent adrift. Some teams might not even know about the
change or which products are affected until late in the game. Why? It is not always immediately clear which line items contain the prohibited ingredient. Without clear recordkeeping and a strong database of ingredients and formulas, there is no easy way to evaluate product lines. The more stock keeping unit (SKUs) in a product line, the harder this investigation becomes. Unless the enterprise has consolidated
its product information, there is no easy way to automate formula analysis or perform a catalogue-wide search. Instead, every step in the process must be validated manually, across every division, group, product, and team. Variant products, like the division between saleable, samples, and testers—including different sizing options—only increase the complexity of this task. And the climate is always changing. New
regulations or frequent revisions to existing legal definitions and requirements create an
July 2022 PERSONAL CARE
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