Cosmetics and the Product Information File (PIF): avoid the pitfalls of not planning early for the safety assessment

What are some of the common issues you find when companies haven’t undertaken the safety assessment before placing their product on the market?

At TSG, we sometimes get companies coming to us for assistance with the PIF/safety assessment and product notification after they’ve finalized product development. Some already have their product on the production line, and some may even have the product on the market even though the Cosmetics Regulation states that the safety assessment must be done prior to it being placed on the market. As we’re working on the product, we find issues such as:

• The product contains ingredients which are either banned in cosmetics or which are present above the maximum permitted levels
• Cosmetic companies are using third party manufacturers that do not adhere to Good Manufacturing Practices as required by the EU Cosmetics Regulation (Regulation (EC) No 1223/2009
• Manufacturers are using raw material suppliers that do not comply with the REACH Regulation’s requirements
• Very often, product labels are not compliant. They may be missing mandatory items such as the country of origin; the stated ingredient list may not be correct, for example allergens may not be listed; or they may be using non-compliant claims

What are the consequences of not considering a regulatory review at the product development stage?

Most of the issues I’ve mentioned are not readily solved and bringing the product into compliance could incur a huge cost, which is not always affordable. In many cases it could end up with a considerable amount of product being wasted, warehoused and unsellable. In the worst-case scenario, if products are already on the market this might involve withdrawing them from sale.

What are the key things a company should consider to ensure their cosmetic products are compliant from the outset?

I can’t emphasise enough the importance of planning the entire product development process. This includes:

• Formula development. Once the product formula has been drafted, an initial regulatory check should be done, in order to make sure that none of the ingredients present are banned or above maximum permitted levels
• For some of our clients we have sometimes performed a toxicological pre-review, when novel (or not very common) ingredients are used. This is because, even if an ingredient is not banned, if it is not (toxicologically) safe at the levels of use then it is not allowed in a product
• Once the product formula is decided, product claims should be reviewed for various reasons: claims should be compliant with the relevant regulation and related to this, they should be properly supported with appropriate evidence. Knowing the claims in advance allows the adequate design of a testing strategy. If the performed tests fail to support a given claim, then there is still time to amend the claims used
• Alternatively, product testing may reveal product properties which were not initially accounted for and that could also be claimed
• Label designs should be reviewed before printing them. Cosmetic product labels must include certain mandatory items. If these are not present, an amendment may imply throwing away any already available labels, amending them with stickers, and so on, which could incur a huge cost

Case study

A client requested assistance with cosmetic products in the EU. We identified that one of the ingredients in their product was being evaluated by the EU scientific committee, so there was a risk that their product might no longer be compliant in the mid-term. The client postponed their decision to go ahead with the product marketing until we could gather additional information on the ingredient. Once it was clear that there would be no issues with the ingredient in the formula, all of the compliance work could be completed, and the product was placed on the market without further risks. Although the product’s launch was delayed by several months, potential risks and extra costs, such as reformulation and withdrawal of the product from the market, were avoided.

Get in touch

Helena Eixarch is a Cosmetics & Toxicology Consultant, providing clients with support on all aspects of regulatory compliance. She holds a Diploma on Cosmetic Products Safety Assessment and is a European Registered Toxicologist. If you’d like to chat with Helena about planning for or undertaking a safety assessment for your cosmetic product, please get in touch at [email protected]