ECHA’s Enforcement Findings and What They Mean for Cosmetics
On October 30, 2024, The European Chemicals Agency (ECHA) recently conducted a pilot enforcement project revealing that certain cosmetics on the market still contain hazardous chemicals. These substances, classified as persistent organic pollutants (POPs) or persistent, bioaccumulative, and toxic (PBT/vPvB), pose significant environmental and health risks. The findings underscore the need for the cosmetics industry to understand regulatory gaps and ensure compliance across both REACH and the EU Cosmetic Products Regulation (CPR).
ECHA’s project involved inspecting approximately 4,686 cosmetic products across 13 European Economic Area (EEA) countries. The focus was to identify banned hazardous substances, including:
- Perfluorononyl Dimethicone
- Perfluorooctylethyl Triethoxysilane
- Perfluorononylethyl Carboxydecyl PEG-10 Dimethicone
- Cyclic Siloxanes, including D4 (cyclotetrasiloxane) and D5 (cyclopentasiloxane)
Historically, cyclic siloxanes were widely used for their emollient functions. However, these substances present clear risks. Their persistence and bioaccumulative properties mean they remain in the environment and accumulate in living organisms, posing health risks such as reproductive toxicity and carcinogenicity.
Some of these chemical substances are classified under REACH as POPs or PBT/vPvB. While some are fully or partially restricted under REACH, others are not included in the Cosmetic Products Regulation (CPR) Annex II, which lists banned ingredients specifically for cosmetics. ECHA’s report reveals that 6.4% of inspected cosmetics were non-compliant with REACH or POP regulations—a finding we will explore further in this article.
Understanding the Regulatory Discrepancies and Risks
The findings spotlight significant regulatory gaps between REACH and CPR, particularly for perfluorinated compounds and cyclic siloxanes:
Perfluorononyl Dimethicone and other PFOA-Related Compounds
Perfluorononyl dimethicone, commonly used in eyeliners and lip liners, is restricted under REACH due to its environmental persistence and its degradation into perfluorooctanoic acid (PFOA), a compound known for its high toxicity and suspected carcinogenic properties. PFOA’s widespread presence, found in 98% of Americans, reflects its persistence and accumulation in both the environment and human bodies.
PFOA and its related compounds have been restricted under REACH since July 4, 2020, as per Annex XVII, Entry 68, which limits their concentrations to 25 ppb in products, including cosmetics. This restriction extends to compounds that degrade into PFOA, covering a broad range of perfluorinated chemicals like perfluorononyl dimethicone and other related substances not explicitly listed in CPR’s Annex II. Although a three-year grace period allowed companies to phase out these substances, the regulatory gap in CPR continues to create ambiguity around their permissibility in cosmetic products.
These substances, apart from PFOA, are absent from Annex II of the CPR, meaning they are not explicitly banned for use in cosmetics under CPR standards. This regulatory gap around perfluorinated compounds creates discrepancies that may lead the cosmetics industry to mistakenly believe these substances are safe and permissible in cosmetic formulations.
Cyclic Siloxanes (D4 and D5)
Cyclic siloxanes, including D4 and D5, are restricted under both REACH and POPs due to their persistence, bioaccumulation potential, and reproductive toxicity. They have been detected in remote regions such as the Arctic, illustrating their ability to persist in ecosystems and travel long distances.
Cyclotetrasiloxane (D4) is fully prohibited in cosmetics under regulation EC 1223/2009, while Cyclopentasiloxane (D5) is restricted to a maximum concentration of 0.1% in wash-off products as of January 31, 2020, and Cyclohexasiloxane(D6) to 0.1% in wash-off products from June 6, 2027 with this limit extending to all cosmetic products, including leave-on formulations for both D5 and D6, by June 6, 2027.
However, without listing D5 in CPR’s prohibited substances, D5 continues to appear in products like hair conditioners, despite its environmental impact.
What the Cosmetics Industry Should Prioritize
To ensure consumer safety and regulatory compliance, cosmetics companies and industry stakeholders should focus on these priorities:
Align Ingredient Safety Beyond CPR Standards
REACH’s PBT/vPvB classifications restrict many persistent, toxic chemicals. Aligning with these standards enables companies to proactively avoid high-risk substances like perfluorinated compounds and cyclic siloxanes, fostering greater safety and brand trust.
Anticipate and Act on Future Regulatory Changes
With increased scrutiny on PFAS and cyclic siloxanes, further restrictions are likely. Proactively finding alternatives and adjusting formulations now helps prevent disruptions and ensures compliance with emerging regulations, demonstrating commitment to consumer and environmental health.
Leverage the Precautionary Principle in Ingredient Selection
By phasing out known hazardous chemicals, companies can reduce compliance risks and position themselves as leaders in environmental responsibility. Over 50% of EU consumers prefer brands committed to sustainability and transparency.
Enhance Transparency and Consumer Communication
Transparency in sourcing and ingredient safety is key. Clear communication on ingredient changes driven by regulation can foster customer loyalty, with research indicating that 70% of consumers are willing to pay more for products that prioritize safety and sustainability.
Moving Toward Safer, Compliant Cosmetics
ECHA’s findings highlight the importance of aligning with REACH and CPR to meet EU safety and environmental standards. Proactive ingredient choices and transparent practices help cosmetics companies maintain compliance and meet rising consumer demand for sustainable, safe products, strengthening regulatory adherence and consumer loyalty.
How EcoMundo Can Help
With a dedicated team specializing in regulatory compliance, EcoMundo provides tailored support, including expert analysis on high-risk substances like perfluorinated compounds and cyclic siloxanes, compliance audits to keep brands aligned with REACH and CPR requirements. Our proactive regulatory monitoring and safe ingredient recommendations empower brands to meet evolving standards, remove hazardous chemicals, and transparently communicate these changes to eco-conscious consumers.
For more information, contact EcoMundo's experts.
ECHA’s Enforcement Findings and What They Mean for Cosmetics
On October 30, 2024, The European Chemicals Agency (ECHA) recently conducted a pilot enforcement project revealing that certain cosmetics on the market still contain hazardous chemicals. These substances, classified as persistent organic pollutants (POPs) or persistent, bioaccumulative, and toxic (PBT/vPvB), pose significant environmental and health risks. The findings underscore the need for the cosmetics industry to understand regulatory gaps and ensure compliance across both REACH and the EU Cosmetic Products Regulation (CPR).
ECHA’s project involved inspecting approximately 4,686 cosmetic products across 13 European Economic Area (EEA) countries. The focus was to identify banned hazardous substances, including:
- Perfluorononyl Dimethicone
- Perfluorooctylethyl Triethoxysilane
- Perfluorononylethyl Carboxydecyl PEG-10 Dimethicone
- Cyclic Siloxanes, including D4 (cyclotetrasiloxane) and D5 (cyclopentasiloxane)
Historically, cyclic siloxanes were widely used for their emollient functions. However, these substances present clear risks. Their persistence and bioaccumulative properties mean they remain in the environment and accumulate in living organisms, posing health risks such as reproductive toxicity and carcinogenicity.
Some of these chemical substances are classified under REACH as POPs or PBT/vPvB. While some are fully or partially restricted under REACH, others are not included in the Cosmetic Products Regulation (CPR) Annex II, which lists banned ingredients specifically for cosmetics. ECHA’s report reveals that 6.4% of inspected cosmetics were non-compliant with REACH or POP regulations—a finding we will explore further in this article.
Understanding the Regulatory Discrepancies and Risks
The findings spotlight significant regulatory gaps between REACH and CPR, particularly for perfluorinated compounds and cyclic siloxanes:
Perfluorononyl Dimethicone and other PFOA-Related Compounds
Perfluorononyl dimethicone, commonly used in eyeliners and lip liners, is restricted under REACH due to its environmental persistence and its degradation into perfluorooctanoic acid (PFOA), a compound known for its high toxicity and suspected carcinogenic properties. PFOA’s widespread presence, found in 98% of Americans, reflects its persistence and accumulation in both the environment and human bodies.
PFOA and its related compounds have been restricted under REACH since July 4, 2020, as per Annex XVII, Entry 68, which limits their concentrations to 25 ppb in products, including cosmetics. This restriction extends to compounds that degrade into PFOA, covering a broad range of perfluorinated chemicals like perfluorononyl dimethicone and other related substances not explicitly listed in CPR’s Annex II. Although a three-year grace period allowed companies to phase out these substances, the regulatory gap in CPR continues to create ambiguity around their permissibility in cosmetic products.
These substances, apart from PFOA, are absent from Annex II of the CPR, meaning they are not explicitly banned for use in cosmetics under CPR standards. This regulatory gap around perfluorinated compounds creates discrepancies that may lead the cosmetics industry to mistakenly believe these substances are safe and permissible in cosmetic formulations.
Cyclic Siloxanes (D4 and D5)
Cyclic siloxanes, including D4 and D5, are restricted under both REACH and POPs due to their persistence, bioaccumulation potential, and reproductive toxicity. They have been detected in remote regions such as the Arctic, illustrating their ability to persist in ecosystems and travel long distances.
Cyclotetrasiloxane (D4) is fully prohibited in cosmetics under regulation EC 1223/2009, while Cyclopentasiloxane (D5) is restricted to a maximum concentration of 0.1% in wash-off products as of January 31, 2020, and Cyclohexasiloxane(D6) to 0.1% in wash-off products from June 6, 2027 with this limit extending to all cosmetic products, including leave-on formulations for both D5 and D6, by June 6, 2027.
However, without listing D5 in CPR’s prohibited substances, D5 continues to appear in products like hair conditioners, despite its environmental impact.
What the Cosmetics Industry Should Prioritize
To ensure consumer safety and regulatory compliance, cosmetics companies and industry stakeholders should focus on these priorities:
Align Ingredient Safety Beyond CPR Standards
REACH’s PBT/vPvB classifications restrict many persistent, toxic chemicals. Aligning with these standards enables companies to proactively avoid high-risk substances like perfluorinated compounds and cyclic siloxanes, fostering greater safety and brand trust.
Anticipate and Act on Future Regulatory Changes
With increased scrutiny on PFAS and cyclic siloxanes, further restrictions are likely. Proactively finding alternatives and adjusting formulations now helps prevent disruptions and ensures compliance with emerging regulations, demonstrating commitment to consumer and environmental health.
Leverage the Precautionary Principle in Ingredient Selection
By phasing out known hazardous chemicals, companies can reduce compliance risks and position themselves as leaders in environmental responsibility. Over 50% of EU consumers prefer brands committed to sustainability and transparency.
Enhance Transparency and Consumer Communication
Transparency in sourcing and ingredient safety is key. Clear communication on ingredient changes driven by regulation can foster customer loyalty, with research indicating that 70% of consumers are willing to pay more for products that prioritize safety and sustainability.
Moving Toward Safer, Compliant Cosmetics
ECHA’s findings highlight the importance of aligning with REACH and CPR to meet EU safety and environmental standards. Proactive ingredient choices and transparent practices help cosmetics companies maintain compliance and meet rising consumer demand for sustainable, safe products, strengthening regulatory adherence and consumer loyalty.
How EcoMundo Can Help
With a dedicated team specializing in regulatory compliance, EcoMundo provides tailored support, including expert analysis on high-risk substances like perfluorinated compounds and cyclic siloxanes, compliance audits to keep brands aligned with REACH and CPR requirements. Our proactive regulatory monitoring and safe ingredient recommendations empower brands to meet evolving standards, remove hazardous chemicals, and transparently communicate these changes to eco-conscious consumers.
For more information, contact EcoMundo's experts.
