Blacklists in Cosmetics development

The Cosmetics Regulation EC No. 1223/2009, effective since July 11, 2013, in European Economic Area countries, sets strict standards for cosmetic product safety. This regulation lists over 1,700 banned and restricted substances, regularly updated by the European Commission to reflect new scientific discoveries and safety concerns.

Brands must not only comply with this evolving legislation but also meet customer expectations. Consequently, they create their own ingredient "blacklists" to exclude specific substances from their formulations.

How are these blacklists compiled, and how are banned substances managed during product development?

Blacklists in cosmetics tailored to each brand

Substances most commonly blacklisted due to potential health and environmental risks

Parabens: Used as preservatives, parabens are suspected of being endocrine disruptors by mimicking the properties of certain hormones, allergens and carcinogens. In Europe, five parabens are banned (isopropyl paraben, isobutyl paraben, phenyl paraben, benzyl paraben and pentyl paraben) and several others are subject to restrictions on use (Regulations EC No. 1223/2009, No. 358/2014, No. 1004/2014). Parabens are a very diverse family of molecules and as a precautionary measure, many brands exclude all parabens from their products.
Phthalates: Phthalates are commonly used in cosmetic products such as perfumes, deodorants, hairsprays, gels, nail polishes, aftershave lotions and lubricants, where their primary function is as a fixing agent. Due to their potential endocrine disrupting effects, their toxicity and their bioaccumulation in the environment, the use of certain phthalates has been banned in the European Union: DBP, DEHP, BBP, DMEP, and mixtures of C5 and C7-C11 phthalates (Regulation EC No. 2021/2045). Many brands go further by extending the ban to the entire family of related chemicals.
Artificial colorants and fragrances: Some artificial colorants and fragrances may pose a risk to human health, including allergic reactions, long-term toxic effects, and endocrine disruption. The approved colorants, 153 in total, are listed in Annex IV of the Cosmetics Regulation. And, some of these colorants are subject to restrictions of use (Regulation EC No. 2016/1120, No. 2017/1413). Colorants not listed in this annex or not used according to the established conditions are therefore prohibited. Due to their synthetic origin and health risks, artificial colorants and fragrances are under increasing pressure from consumers. In response to this, many brands have chosen to eliminate these substances from their formulations altogether.
Ethoxylated compounds: PEG, Sodium Laureth Sulfate...: Ethoxylated compounds are not dangerous in themselves. However, their manufacturing process poses significant environmental problems. They are made using ethylene oxide, a highly reactive, extremely toxic, carcinogenic and mutagenic gas that reacts with a phenol or alcohol under high pressure and at very high temperatures. In addition, these compounds are not biodegradable. Consumers have expressed a preference for more natural and environmentally friendly products, prompting many manufacturers to blacklist all ethoxylated surfactants.
Nanomaterials: Nanomaterials, defined as substances with at least one dimension smaller than 100 nanometers, are subject to strict controls. Their ability to penetrate the skin and interact at the cellular level requires a rigorous assessment of potential health risks. Based on scientific data and opinions from the Scientific Committee on Consumer Safety (SCCS), certain nanomaterials have been progressively banned. Recently, 12 new nanomaterials have been banned in cosmetics and the use of hydroxyapatite has been specifically restricted by Regulation (EC) No. 2024/858 of March 14, 2024. Nanoparticles are found in many cosmetic products, including mineral-filtered sunscreens, toothpaste, makeup and hair care products. The use of these controversial molecules in cosmetics is a growing and legitimate consumer concern, which is why nanomaterials are sometimes included in brand blacklists.
Microplastics: Although microplastics in cosmetics are not specifically regulated by cosmetics legislation, they are subject to restrictions in several European countries, including France. Since January 2018, France has imposed restrictions on the use of microplastics in cosmetic products for environmental and public health reasons. The banned microplastics are those intentionally added to cosmetic products for their exfoliating or texturizing properties. The recent Regulation EC No. 2023/2055 outlines the criteria for banning synthetic polymer microparticles. These include particle size, biodegradability and potential for accumulation in the environment. It should be noted that not all microplastics are banned or restricted for use in personal care products. However, a number of brands have already eliminated the use of all plastic microbeads from their cosmetic formulations.

Blacklists that reinforce brand identity

"Free-from" cosmetic products play a central role in brand strategy by reinforcing brand image and identity. By adopting formulations that exclude certain ingredients, brands can meet the expectations of consumers in terms of safety, ethics and sustainability, while also standing out in the marketplace.

Brands with free-from policies often prudently exclude entire families of compounds, including some that are restricted or banned by European regulations.
Some brands opt for vegan-only formulations. This eliminates all animal-derived ingredients. This approach appeals to consumers concerned about animal rights and the environmental impact of animal exploitation.
Other brands focus on environmentally friendly and sustainable formulations. They eliminate controversial ingredients such as silicones, microplastics and triclosan to minimize their impact on ecosystems.
Many brands now prioritize 100 % natural ingredients and avoid chemically synthesized compounds. As a result, they exclude artificial fragrances, chemical dyes and synthetic preservatives from their products.

As you can see: These blacklists are individual and specific to each company or brand.
They are not exhaustive. They evolve based on customer specifications and expectations meaning that products made yesterday may not be relevant tomorrow. In this evolving landscape, how can companies easily integrate blacklists into development strategies and respond quickly to formulation needs?

How to successfully develop or reformulate the cosmetic formulations without banned ingredients?

The development, adaptation or reformulation of a recipe to exclude all blacklisted and regulated ingredients is a major challenge for cosmetic manufacturers. Brands need a strategic approach without compromising the popularity or compliance of their products. The solution is product lifecycle management (PLM) software.

Here are four of the benefits of implementing a PLM system:

Compliance with original specifications: Ensures that all original specifications are met. Even if the recipe is changed, ingredients are substituted, or proportions are changed.
Enables rapid innovation: Facilitates rapid innovation, allowing companies to respond quickly to changing markets, consumer expectations, and regulatory requirements.
Claims Management for Packaging and Marketing: Manages all data changes as a result of recipe reformulation (label updates, product claim validation, etc.).
Reduce Costs: Ensures that changes or developments remain economically viable by providing detailed cost analysis.

Choosing Coptis PLM software helps ensure compliance, safety and commercial appeal when effectively managing recipe reformulation or the development of new products without prohibited ingredients.