The cosmetics sector in Europe is facing a significant period of adjustments due to the update of various regulations aimed at ensuring consumer safety, enhancing product transparency, and promoting more sustainable practices. These regulations will impact product formulation, labeling, and distribution.
Update on Allergen Listing in Cosmetics: Implications for the Industry
Regulation (EU) 2023/1545, published in July 2023, introduces one of the most extensive changes in cosmetic product labeling by expanding the list of declarable allergens from 24 to 81 ingredients. This change responds to increasing evidence of allergic sensitization among the European population, with the goal of providing consumers with more comprehensive information about potential allergens in the products they use.
Among the newly included allergens are compounds frequently used in cosmetics, such as benzaldehyde, menthol, vanillin, and essential oils derived from plants like Cananga odorata and Juniperus virginiana. These substances, commonly found in perfumery and personal care products, must now be declared if they exceed certain concentration thresholds. For rinse-off products, declaration is mandatory when the allergen is present at concentrations equal to or greater than 0.01%, while for leave-on products, the limit is set at 0.001%.
Although the concentration rules remain unchanged from previous regulations, the increased number of allergens requires manufacturers to modify their labels to comply with these new requirements. This presents logistical challenges, especially for products with small packaging where space is limited. To address this, the industry is considering technological alternatives such as fold-out labels or QR codes that allow consumers to access complete information via electronic devices.
The regulation includes a transition period to facilitate its implementation. Manufacturers must redesign labels and adjust formulations for new products by August 2026. Products already on the market have a longer timeline, with compliance required by August 2028.
Restriction of Hazardous Substances: Impact of the OMNIBUS VI Regulation
Another significant change for the cosmetic industry is the implementation of Regulation (EU) 2023/1490, known as OMNIBUS VI. This regulation, aligned with the REACH Regulation, introduces additional restrictions on the use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). It came into force in December 2023 and aims to phase out ingredients that pose potential risks to human health or the environment.
Restricted substances include benzophenone, identified as an endocrine disruptor; Azadirachta indica extract, known as margosa; trimethylolpropane triacrylate, used in specific products; and pentetic acid along with its pentasodium salt form. These compounds, now prohibited in cosmetic products, must be removed from current formulations, and products containing them can no longer be sold in the European Union.
OMNIBUS VI is part of a series of regulations that have updated cosmetic legislation in recent years to address the risks associated with CMR substances. Since 2019, six versions of this regulation have been adopted.
Microplastics and Sustainability in Cosmetics: A Long-Term Focus
The regulation on microplastics, introduced as an amendment to Annex XVII of the REACH Regulation in September 2023, imposes new restrictions aimed at reducing the release of these particles into the environment. While initial restrictions focused on microplastics used in facial and body scrubs, the new regulation broadens its scope to include synthetic polymers that degrade into microscopic plastic particles. This affects ingredients such as polyvinylpyrrolidone and certain acrylic thickeners, widely used in cosmetic products.
Although the implementation dates for this regulation are relatively extended, with deadlines extending into 2027 and 2028, manufacturers must begin assessing current formulations and seeking viable alternatives. This change not only affects the cosmetics industry but also other sectors, such as textiles, where microplastics can be generated during garment washing. For cosmetics, the challenge lies in reformulating products without compromising their functionality or key characteristics.
Review of Silicones D4, D5, and D6 in Cosmetics: Future Regulations
Silicones D4, D5 and D6, valued for their properties in hair and skincare products, are under review due to their persistence in the environment. The new Regulation 2024/1328 tightens restrictions. D4 has been added to Annex II as a prohibited substance (entry 1388). While D5 and D6 are not fully banned, specific limitations have been imposed on their use, particularly in rinse-off products that could contribute to water pollution. This could significantly impact the industry, which must explore substitutes offering similar properties without the same environmental impact.
Scientific Opinions and Upcoming Updates
The Scientific Committee on Consumer Safety (SCCS) continues to evaluate key ingredients used in cosmetics, anticipating future regulatory updates. Among the ingredients under review are retinol, parabens, and certain nanomaterials.
For retinol, restrictions have been considered to limit its concentration in cosmetic products and minimize associated risks such as irritation and photosensitivity. The evaluation concluded that concentrations up to 0.05% of retinol equivalents (RE) in body lotions and 0.3% in prolonged or rinse-off products are safe. However, the SCCS warns that while cosmetics alone do not pose a significant risk of exceeding tolerable vitamin A levels, they may contribute to total exposure, which could be problematic for consumers already exposed to high levels through diet and supplements. Parabens, such as methyl and butyl variants, have been reevaluated, with minor proposed changes. Additionally, nano-hydroxyapatite, used in dental products, and other nanomaterials are being thoroughly examined to determine their safety.
Preparing the Industry for New Regulatory Challenges
To comply with these regulations, cosmetic companies must review and adjust their formulation, labeling, and marketing processes. Staying informed about deadlines and specific requirements will be essential to ensure compliance and avoid penalties. Proactive collaboration with regulatory experts can ease the transition to this new regulatory framework.
Why Choose SHAPYPRO?
SHAPYPRO offers a comprehensive approach to helping companies comply with evolving cosmetic regulations. From product reformulation to designing labels that meet the latest standards, our technical team is prepared to provide tailored solutions. Contact us to learn how we can facilitate your adaptation to new regulations and optimize your product’s success in the market.