How to navigate the complex world of regulatory and compliance in the beauty industry

Whether you’re a big or small beauty brand, regulatory and compliance topics are critical topics that can be complicated to navigate but are critical to ensuring a smooth product launch plan. Overlooking one step or doing something incorrectly could send you on a re-formulation loop that results in lost time and extra costs.

Even if most brands delegate this work to an in-house regulatory team, contract manufacturers, or an external agency, it’s important for anyone working within the beauty industry across all professions to understand the important points within the regulatory and compliance space. That’s because regulatory and compliance touches upon all aspects of beauty product development, from R&D topics like testing and ingredient selection to marketing topics like packaging artwork and claims.

On our second episode of Covalo’s podcast The Beauty Beat, we met with Sarah Smiley, Senior Regulatory Officer at regulatory and compliance consulting company Personal Care Regulatory Ltd., to get her take on the common regulatory and compliance topics that beauty companies overlook and what aspects to address and plan for when developing a new product.

  • "It is critical that you engage with a regulatory expert from the very beginning of the beauty product development process when you are creating your project brief."


Here are a few takeaways from our discussion. Although the lists are not exhaustive, it gives you an idea of the important topics to keep in mind:

What are some regulatory and compliance topics that beauty brands often overlook? (at 02:38 in the podcast episode)

  1. Regulatory as a whole function can often be overlooked because brands are so focused on the making of their product and promoting it (this applies to both small and large brands). In fact, the regulatory function can be seen as a bottleneck to your well thought out product, claims, and marketing strategy but it’s so important to clarify and double check your claims and formulations as early as possible to avoid further costs and delays down the line.
  2. Engage early with a regulatory expert: Many brands don’t know when to engage with a regulatory expert and what documentation to have ready at each step of the product development process. It’s a headache for everyone involved when brands engage with a regulatory expert only in the final new product development (NPD) process stages right before the production and printing of packaging/artwork. Have conversations with regulatory support right from the start to understand more about the required documents and what documents to collate at each stage. 
  3. Prepare different artwork for each launch market: Although the same artwork/product label might be usable for a few different markets, careful consideration is needed to meet all markets’ requirements. You often have different packaging waste, advertising/artwork, and consumer protection requirements in each market.
  4. Carefully select the person/organization who will be doing your safety assessment: Brands pick a safety assessor based on cost and turnaround time but the quality of the safety report is often overlooked since many aren’t aware of what makes a good Cosmetic Product Safety Report (CPSR). Key things to look out for in a report: Are there any caveats due to unavailable data e.g. are stability and microbiology data provided in report to support a conclusion? The quality and qualification of the safety assessor is also important and the required scientific background can differ between countries.

What are the concrete steps a brand should make when launching a new beauty product and in what order? (at 09:34 in the podcast episode)

  1. Discuss product brief with a regulatory expert before you start any development work to ensure what you’re briefing is actually a compliant cosmetic product and understand the key points of when to engage with a regulatory expert throughout the NPD process.
  2. Define who is going to be your Responsible Person (RP) for your different launch markets and products. The RP is the person who is responsible for ensuring the compliance of the cosmetic product(s) in a specific market and has to be physically based in the respective launch market. An RP could be the manufacturer, distributor, importer or regulatory consultant, etc. This RP must hold this Product Information File (PIF) for a period of 10 years after the last batch of this cosmetic product was placed on the market. More on the PIF below.
  3. Start planning all the documents you need for your Product Information File (PIF) early. Description of your product, manufacturing method and compliance with GMP, proof of effect/claims for product, data on animal testing, safety report, etc. 
  4. Make sure the classification of your product is correct. Is it classifiable as a cosmetic? What are its primary and secondary functions? It is sometimes not so straightforward and some products that you assume would be cosmetics might be classified as medicinal, a biocide, a medical device, etc. One example is a sunscreen with an insect repellent in it. Due to the insect repellent it could be classified as a biocide product.
  5. Define and substantiate the claims you will make in association with your product. What will you say about your product on pack, website, social media and other advertising channels? The specific wording really does matter in terms of developing a relevant formulation and feasibility of gathering evidence to support the claim. For claim substantiation will you be conducting finished product efficacy tests or using raw material literature or both? Is this claim accepted in the market you want to sell in?
  6. A formulation should be checked for compliance in each of the markets in which you plan to sell. This should be done as soon as you have a good sample and base formulation before you go any further in terms of production to ensure that all ingredients can be used in your target markets. This will prevent re-formulation work.
  7. Get artwork reviewed for compliance early. Here are a few things to ensure you have on your artwork: Does it have your RP’s name and address per market? It also needs to have the country of origin, nominal weight, PAO or date of minimum durability, legally required warnings (safety assessor could define this), ingredient list, compliant claims, and logos linked to packaging waste or certifications, among other things.
  8. Gather documents early for your Cosmetic Product Safety Report (CPSR). The CPSR assesses the safety of the finished product and a few documents need to be collated for this. Documents needed: Final formulation broken down in detail including trade name and source of raw material, raw material documents, physical chemical characteristics of your product, impurity data, stability and microbiology tests including packaging compatibility, directions for foreseeable use of finished product, undesirable effects, and toxological profiles, among others. 
  9. Submit information on your product to the intended launch markets. There are various portals through which you can upload this information. Only the authorities and poison control centers can view this information, not the public.
  10. Ensure post launch and post market cosmetovigilance to ensure your product remains compliant going forward.

Do you have any tips for identifying the right regulatory partner and Responsible Person (RP)? (at 22:25 in the podcast episode)

  1. Small brands can’t afford regulatory personnel so it can be appealing to leave everything to the manufacturer, but it’s worth getting advice from experts within the field so you and your partner can make sure that your PIF is in a good place. 
  2. Even big brands might outsource the regulatory and compliance topic to a regulatory partner based in some markets where they are not.
  3. A good regulatory partner should be able to complete PIF reviews and safety assessments working directly with contract manufacturers if needed.
  4. The RP has to physically be in the markets you are selling in. Having one consulting company with a presence in many of your target markets could simplify things.
  5. The RP should be able to explain how they are setting up their cosmetovigilance process and surveillance.
  6. It’s helpful to have internal toxicologists and specialists within your regulatory agency who can update your CPSR when needed.
  7. Cost and lead time are important when identifying a good regulatory partner, but quality of the output of relevant reports and documents are very important and should not be overlooked. If you run into issues at inspection this could create more headaches down the line.
  8. The RP should be pro-active in updating you of changing regulations and should be a trustworthy company.

What are some regulatory topics that should be on beauty companies’ radars right now? (at 27:12 in the podcast episode)

  1. BREXIT (for brands selling in the EU/UK): The UK regulation for beauty products is currently a mirror of the EU version, but this might change going forward. Brands have a two year transition period to amend artwork and packaging for the UK market.
  2. Ingredient bans and restrictions on the horizon: Fragrance allergens Lyral and Lilial will be banned soon. Products containing Lyral must be off shelf by 23rd August 2021, Lilial 1st March 2022.
  3. Sustainability claims: Be specific about the whole supply chain in terms of sustainability and define exactly what is sustainable about your product to avoid using greenwashing/buzzwords in your marketing material.
  4. Influencer marketing: Influencers can only mention the same marketing claims that the brand uses on other websites. Make sure they are promoting your products in a compliant way.
  5. Safety is a topic that should always be on everyone’s radars. Consumers are more aware now of ingredients in beauty products. The impurities of the exact raw material sources you are using is a very important part of raw material assessment e.g. making sure your source of talc is free from asbestos. Have your RP to review your CPSR whenever you change your raw material sources. 


Meet our guest Sarah Smiley

Sarah Smiley is a Senior Regulatory Officer at Personal Care Regulatory Ltd., a company that offers consulting,end to end compliance and safety assessment services for cosmetic products. Prior to this she was a New Product Development Technologist at Superdrug, one of the leading health and beauty retailers in the UK, where she oversaw the product development process for Superdrug’s own brand products, and later joined retailer Boots as a Regulatory Officer. She studied Cosmetic Science at the London College of Fashion.


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