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Product Lifecycle Management
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Blogs
Posted By:
Angelica Guoli
What you need to know to gain a global grasp of regulatory product lifecycle management
Every cosmetics business needs a good way to manage formula compliance while developing, launching, maintaining and retiring products. Technological enablement has revolutionized this process. Moreover, ineffective product lifecycle management (PLM) can impact the ability to compete in the marketplace and sustain customer trust.
There are a lot of myths floating around about product lifecycle management and its role in helping to lock down regulatory requirements worldwide. It’s time to take a snapshot of the regulatory environment for cosmetics scientists, formulators and business managers to dispel myths about mastering regulation compliance within PLM processes.
Myth #1 PLM is an R&D and manufacturing problem—I don’t have to worry about it at all if I don’t work in these areas, and I sure don’t have to worry about upcoming regulatory changes.
There are a lot of myths floating around about the limits of PLM and how it differs from enterprise resource planning (ERP) and other centralized systems within the cosmetics business. If you know all about the crucial role that gold-standard PLM plays in a company’s ability to innovate and respond quickly to consumer trends, you probably also know that solid PLM practices encompass sustainability and environmental responsibility. The product lifecycle, from idea to shelf or online cart, also includes manufacturing and maintaining and retiring products. Go ahead and skip to the next myth if you know all of this, but if you’d like a mini refresh, read on.
PLM in a nutshell
PLM demands a single source of truth because managing the data within your product lifecycle will determine how well you can expedite products to market and build customer loyalty.
Other enterprise systems, like your ERP (which normally handles finance, human resources, manufacturing, supply chain, services and procurement), manufacturing execution system (MES) and customer relationship management (CRM) systems connect with your PLM system to protect the value of all of your product data.
Formula-based product developers must be able to integrate PLM tools to show up for consumers with a powerful selection of products. Within the product lifecycle—from idea to production and launch into maintenance and through retirement and disposal phases, how well you reduce the effort of managing each product often determines how well you can navigate your markets. A PLM software platform helps cosmetics manufacturers manage suppliers and vendors gain efficiencies by managing formulation development, standardizing formulas and timelines, and automating regulatory and labeling needs.
As Lionel Grealou writes on his virtual+digital blog, “Broadly speaking, PLM knows ‘what’ (technical requirements), ERP knows why (strategic requirements), while CRM knows “who” (customer requirements).”[i] This is a bit of a simplification, and small to medium businesses sometimes do not have integrated systems with PLM, or they stick with legacy systems that don’t support more than a few countries. They may not even have their own strategy for oversight over cosmetics product development. That’s normal. However, once a cosmetics business meets a certain level of maturity, no matter the size of its market or P&L, it’s going to need a strong PLM process to uncover all the value in its product portfolio and within future product launches.
So, to return to the first myth—many people who work in personal care and cosmetics organizations touch some aspect of PLM every day. And quality, regulatory and compliance PLM protects company viability in the long run. It’s not a stretch to claim it protects everyone’s jobs, no matter where they sit.
Myth #2 One system can never manage regulatory PLM needs.
There are certainly improvements even the most advanced PLM platform is in the process of making, within roadmaps based on emerging customer needs. However, most companies absolutely can manage most (if not all) of their chemical and/or cosmetic product needs with a solid PLM system.
Technologies that automate regulatory requirements are obviously preferred over those that don’t. A great technological tool also connects to legacy systems all along the product pipeline and connects to regulatory bodies’ systems. A facet of the system should manage regulations during packaging and labeling, along with any document repositories required by the U.S., EU, and other global regulatory bodies. Finally, those companies that require both raw materials and cosmetics regulatory control should only have a single system to manage compliance for both.
Labeling, hazard mitigation, unique formula identifier (UFI) codes and Poison Centre Notifications (PCNs) —a lot of companies have broad compliance needs to fulfill. They need to be able to use one platform for them all.
Myth #3 There’s no such thing as up-to-date monitoring of regulatory changes in a PLM tool.
Thanks to cloud-based PLM, that’s no longer the case. PLM managers can run expert-checked queries powered by artificial intelligence (AI) that will ensure they’re taking the most current regulations into account for every material sourced. The same systems can pre-authorize suppliers based on templated questionnaires that cover global regulations and compare fields for these against competing suppliers during requests for X (RFX).
Myth #4 If I know what the EU requires, I’m probably covered for the rest of the world.
The EU often sets new precedents in the global regulatory landscape. Since the EU’s guidance for chemical and cosmetics manufacturers has been clear for a few years now, and many markets have followed suit, manufacturers and suppliers may assume they’ve got it covered. However, PLMs without transparency for global markets may be at risk. Moreover, even though Asia-Pacific and Chinese markets release regulatory updates a few months or years after the EU or the FDA, these markets are expected to continue to grow exponentially in the years to come. Analysis from Data Bridge Market Research shows that the Asia-Pacific market alone is growing with a CAGR of 6.5% in the forecast period of 2022 to 2029 and is expected to reach USD 167,702.63 million by 2029.[i]
It's certainly complicated to track these markets’ regulatory changes. However, PLM developer teams with dedicated, language-specific resources have a clear advantage. The Inventory of Existing Cosmetic Ingredients in China (IECIC) and the Safety and Technical Standards for Cosmetics (STSC) need to be reflected in automated workflows across PLM processes. Both the source and the compliance calculations in these jurisdictions must be up to date. Look for embedded technology teams that can contact the authorities for clarification as they update platforms. Chemical and cosmetic manufacturers access the correct library data because these PLM technology teams have done the footwork. True experts lend market expertise in managing the ever-changing Chinese regulatory landscape.
Myth #5 New regulations for allergen-labeling for “parfum” will remain an EU issue.
The EU released new requirements for listing fragrance ingredients which cause allergies instead of simply printing “parfum” or “aroma” on the label.[ii]
This will be difficult for many cosmetics companies to manage. If the known composition of parfum isn’t 100% clear, companies will have to do a lot of digging to surface missing ingredients and list them when required. Future labeling regulations must be supported by a robust PLM to support real-time libraries, accurate reporting, instant updates, and supplier management.
Myth #6 Consumers aren’t very educated about what’s in their cosmetics.
The explosion of clean, organic, vegan and other “natural beauty” cosmetics brands arose to meet consumer demand. More and more, shoppers have been searching online by ingredient, and they are not only seeking allergen-free products. They now look at labels for ecologically sound and socially sustainable practices, as well. Ensuring product labeling and online ingredients satisfy this trend may ensure viability in the cosmetics marketplace now and in the future.
PLMs need to automate labeling to include these new consumer preferences as well as regulatory needs. Consumers are much savvier about gluten and other sensitivities, too. Even if they’re not technically allergic, they still expect to be able to check the label of personal care items for these ingredients. The EU’s recent new rules require companies to submit “green claims” for approval before using them on packaging. These and other packaging regulations need to be part of your digital thread of product lifecycle management, ensuring each formulation exists digitally with all of its attributes, from idea to label and launch.
Myth #7 I don’t need to worry about microplastics yet. I’m not commercialized in the EU, nor do I serve its cosmetics customers.
Microplastics, or synthetic polymer microparticles, will continue to be highly regulated or even banned, worldwide. It seems certain that everyone will be subject to some form of microplastics regulation by 2050, when some experts say there will be more plastics than fish in the ocean[iii].
The European Regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) published new measures to reduce microplastics pollution in October. Microplastics are banned on their own or in mixtures if intentionally added in concentrations greater than or equal to 0.01%. The European Chemicals Agency (ECHA) has been working on guidance for exfoliating microbeads in facial or body scrubs and toothpastes for years. Products like these, including glitter in many cosmetics, will be banned, while others will require more detailed safety data sheets (SDS) and/or additional labeling compliance.
On February 1, 2024, Environmental Science & Technology published a paper calling for an international ban on the sale of products with intentionally added microplastics and products that release microplastics over time.[iv] PLM managers and cosmetics leadership should be prepared with PLM processes and technologies that support this growing area of concern.
At minimum, each product in your pipeline and portfolio should be managed for microplastics to:
- Track the percentage of microplastics present in the ingredients
- Calculate the total amount of microplastics in the product
- Integrate product labels and/or SDS with additional information as required
Myth #8 Real-time, system-to-system coordination between my PLM system and regulatory agencies is still many years away.
How can a PLM system communicate with a governmental system, without the IT department hacking through miles of red tape? Turns out that the best PLM systems have found a way to do it. For example, managing PCNs, which is required for all mixtures classified as hazardous based on their health or physical effects, is much easier when your PLM system is integrated with ECHA PCN portal online. Cosmetics companies and raw materials suppliers should also look for network connectivity into real-time libraries, including a history of global lab trial versions and outcomes, within their PLM. These are pure gold when running ROI on new or expanded formulations. An automated process for prioritizing projects in your PLM through product analysis helps you respond to OEM requests faster, too.
Shiseido, one of the oldest and largest multinational cosmetics companies in the world, enhanced product traceability and visibility using a PLM system that allowed teams, including R&D and regulatory teams, to work better together when managing worldwide changes to product launch compliance requirements.
Myth #9 Migrating to a PLM system will be a nightmare
Due diligence when choosing a platform and a team for your journey should include more than a few conversations about how implementation will look. Most excellent PLM software companies will guide you through design workshops and help you configure your system and plan for rollout. Each team training and each step toward validation and testing should be independently checked, one-on-one, with a current user of the PLM software. They’ll be able to tell you if minimum downtime and change management support promises were kept. Make sure your new PLM team supports customers in your regions and that they have people who can help in your most challenging emerging markets.
Cut through the noise
Chemical and cosmetics companies battle a lot of noise in their industry when it comes to new regulations and how to handle them. Technology has advanced to the point where you can quiet the noise once and for all with cross-vertical chemical and cosmetics PLM workflows. Consistency is crucial to successful compliance. PLM systems help ensure consistency above all—a compliant PLM process central to every single move you make, with every single product, every single launch.
[1] Gealou, Lionel, "PLM+ERP+MES+CRM: The Four Cornerstones of Manufacturing," v+d blog, 2017
[1] FMCG, "Asia-Pacific Cosmetics Market - Industry Trends and Forecast to 2029," Nov 2022
[1] Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products (Text with EEA relevance) (OJ L 188 27.07.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1545/oj)
[1] [1] Liberal Party of Canada, The New Plastics Economy: Rethinking the future of plastics by the Ellen MacArthur Foundation; Stemming the Tide: Land-based strategies for a plastic-free ocean by the Ocean Conservancy; Plastic waste inputs from land into the ocean, Science, 2015, Volume 347, Number 6223; Plastics — the Facts 2018, Plastics Europe; Production, use, and fate of all plastics ever made, Science Advances, 2017, Vol. 3, no. 7, e1700782; How many fish are in the sea? The Atlantic; Catch reconstructions reveal that global marine fisheries catches are higher than reported and declining, Nature Communications, 2016, volume 7, Number 10244; Thoughts & Sayings, Prof. John Shepherd
[1] Environ. Sci. Technol. 2024, 58, 6, 2591–2594
Publication Date: February 1, 2024