New Restriction of D5 and D6 in cosmetics
D4, D5, and D6 are cyclic volatile methylsiloxanes (cVMS) commonly used in cosmetics for their ability to enhance smoothness and form protective films on the skin and hair. Despite their benefits in personal care products, these substances have been identified by the European Chemicals Agency (ECHA) as Substances of Very High Concern (SVHC) due to their persistent, bioaccumulative, and toxic (PBT) properties also classified as very persistent and very bioaccumulative (vPvB). The EU has taken a progressive approach to regulate these compounds, beginning with the restriction of D4 and D5 in wash-off cosmetics in 2020.
Under Regulation 2024/1328, the use of D5 and D6 is further restricted across all cosmetic products:
- According to Regulation 1223/2009, D4 has been entirely banned in cosmetic products since 2019 (published in 2018).
- D5 has been restricted to a maximum concentration of 0.1% in wash-off cosmetics since 2020.
- From June 6, 2027, both D5 and D6 will be banned in concentrations exceeding 0.1% in all cosmetic products, including leave-on products*.
*Note: compared to the original draft, the intention to phase out D6 progressively depending on the nature of the product (wash-off vs leave-on) has been reviewed, in a sense that all cosmetic products except for the one already restricted will comply by the same deadline.
D4, D5 and D6: Substances of Very High Concern
Environmental Concerns
The environmental impact of D4, D5, and D6 is significant due to their persistence and bioaccumulative nature. These substances do not break down easily, leading to long-term presence in ecosystems. They have been detected in remote areas, such as the Arctic and Antarctica, highlighting their capacity for long-range environmental transport. Key environmental concerns include:
- Aquatic Toxicity: These silicones are toxic to aquatic organisms, disrupting aquatic ecosystems. Their persistence means they accumulate in water bodies, affecting the food chain.
- Terrestrial Toxicity: D5, in particular, has been identified as toxic to terrestrial organisms, including plants. This can lead to broader ecological imbalances.
- Bioaccumulation: The substances accumulate in living organisms over time, leading to higher concentrations higher up the food chain. This can affect wildlife health and biodiversity.
Health Concerns
Human health risks associated with D4, D5, and D6 stem from their bioaccumulation and potential toxicity. These substances have been detected in human tissues, raising several health concerns:
- Tissue Accumulation: D4, D5, and D6 have been found in human plasma, abdominal fat, and breast milk, indicating widespread exposure and bioaccumulation.
- Endocrine Disruption: There is potential for these compounds to act as endocrine disruptors, interfering with hormone systems and potentially leading to reproductive and developmental issues.
- Long-Term Exposure Risks: Prolonged exposure to these substances, even at low levels, may pose chronic health risks, including impacts on liver function and potential carcinogenicity.
Concerns and Challenges for the Cosmetic Industry
The new restrictions on D4, D5, and D6 pose several significant challenges for the cosmetic industry, which must now navigate a complex landscape of compliance, reformulation, and market adaptation.
1. Reformulation Challenges:
- Technical Difficulties: Replacing D5 and D6 in cosmetic formulations is technically challenging. These substances provide unique properties, such as a silky texture and quick drying effects, which are difficult to replicate with alternative ingredients. For example, it is used in makeup formulas to enhance the texture and add a soft touch, which is difficult to replicate as naturally derived alternatives are less stable and reproducible on a scale-up compared to the conventional synthetic ingredients such as D5 and D6.
- R&D Investment: Companies will need to invest heavily in research and development to find suitable substitutes that maintain product performance and consumer satisfaction. This process is both time-consuming and costly.
2. Regulatory Compliance:
- Compliance Costs: Adhering to the new regulations will incur significant costs. Companies must update their product formulations, revalidate safety and efficacy, and ensure that all products meet the new legal standards by the specified deadlines.
- Supply Chain Adjustments: The entire supply chain must adapt to these changes, from raw material suppliers to manufacturers and retailers. Ensuring that all stages of production comply with the new restrictions adds another layer of complexity.
3. Market Impact:
- Product Availability: The transition period may lead to temporary shortages of certain products as companies reformulate and re-release compliant versions. This could impact brand loyalty and market dynamics.
- Competitive Disadvantages: Smaller companies may struggle to meet the new requirements due to limited resources, leading to a consolidation of market share among larger, more resource-rich firms.
4. Consumer Perception:
- Communication Strategies: the cosmetic industry will have to effectively communicate these changes to consumers, explaining why their favorite products might feel or perform differently. Transparency about the mandatory safety and environmental obligations for all cosmetics sold in the EU will help raise consumer awareness about the importance of these measures, ensuring they understand that these changes are regulatory requirements and not promotional tactics.
- Brand Image: Successfully navigating these changes presents an opportunity for brands to enhance their reputation by emphasizing their commitment to sustainability and regulatory compliance.
The amendments to the REACH regulation signify the EU's commitment to minimizing the environmental and health impacts of hazardous chemicals. The phased restrictions on D4, D5, and D6 in cosmetics are designed to ensure a high level of protection while allowing time for industry adaptation. These measures, alongside ongoing efforts under the Stockholm Convention (global treaty aimed at protecting human health and the environment from persistent organic pollutant), aim to mitigate the widespread environmental dissemination and bioaccumulation of these substances, safeguarding both human health and the ecosystem.
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New Restriction of D5 and D6 in cosmetics
D4, D5, and D6 are cyclic volatile methylsiloxanes (cVMS) commonly used in cosmetics for their ability to enhance smoothness and form protective films on the skin and hair. Despite their benefits in personal care products, these substances have been identified by the European Chemicals Agency (ECHA) as Substances of Very High Concern (SVHC) due to their persistent, bioaccumulative, and toxic (PBT) properties also classified as very persistent and very bioaccumulative (vPvB). The EU has taken a progressive approach to regulate these compounds, beginning with the restriction of D4 and D5 in wash-off cosmetics in 2020.
Under Regulation 2024/1328, the use of D5 and D6 is further restricted across all cosmetic products:
- According to Regulation 1223/2009, D4 has been entirely banned in cosmetic products since 2019 (published in 2018).
- D5 has been restricted to a maximum concentration of 0.1% in wash-off cosmetics since 2020.
- From June 6, 2027, both D5 and D6 will be banned in concentrations exceeding 0.1% in all cosmetic products, including leave-on products*.
*Note: compared to the original draft, the intention to phase out D6 progressively depending on the nature of the product (wash-off vs leave-on) has been reviewed, in a sense that all cosmetic products except for the one already restricted will comply by the same deadline.
D4, D5 and D6: Substances of Very High Concern
Environmental Concerns
The environmental impact of D4, D5, and D6 is significant due to their persistence and bioaccumulative nature. These substances do not break down easily, leading to long-term presence in ecosystems. They have been detected in remote areas, such as the Arctic and Antarctica, highlighting their capacity for long-range environmental transport. Key environmental concerns include:
- Aquatic Toxicity: These silicones are toxic to aquatic organisms, disrupting aquatic ecosystems. Their persistence means they accumulate in water bodies, affecting the food chain.
- Terrestrial Toxicity: D5, in particular, has been identified as toxic to terrestrial organisms, including plants. This can lead to broader ecological imbalances.
- Bioaccumulation: The substances accumulate in living organisms over time, leading to higher concentrations higher up the food chain. This can affect wildlife health and biodiversity.
Health Concerns
Human health risks associated with D4, D5, and D6 stem from their bioaccumulation and potential toxicity. These substances have been detected in human tissues, raising several health concerns:
- Tissue Accumulation: D4, D5, and D6 have been found in human plasma, abdominal fat, and breast milk, indicating widespread exposure and bioaccumulation.
- Endocrine Disruption: There is potential for these compounds to act as endocrine disruptors, interfering with hormone systems and potentially leading to reproductive and developmental issues.
- Long-Term Exposure Risks: Prolonged exposure to these substances, even at low levels, may pose chronic health risks, including impacts on liver function and potential carcinogenicity.
Concerns and Challenges for the Cosmetic Industry
The new restrictions on D4, D5, and D6 pose several significant challenges for the cosmetic industry, which must now navigate a complex landscape of compliance, reformulation, and market adaptation.
1. Reformulation Challenges:
- Technical Difficulties: Replacing D5 and D6 in cosmetic formulations is technically challenging. These substances provide unique properties, such as a silky texture and quick drying effects, which are difficult to replicate with alternative ingredients. For example, it is used in makeup formulas to enhance the texture and add a soft touch, which is difficult to replicate as naturally derived alternatives are less stable and reproducible on a scale-up compared to the conventional synthetic ingredients such as D5 and D6.
- R&D Investment: Companies will need to invest heavily in research and development to find suitable substitutes that maintain product performance and consumer satisfaction. This process is both time-consuming and costly.
2. Regulatory Compliance:
- Compliance Costs: Adhering to the new regulations will incur significant costs. Companies must update their product formulations, revalidate safety and efficacy, and ensure that all products meet the new legal standards by the specified deadlines.
- Supply Chain Adjustments: The entire supply chain must adapt to these changes, from raw material suppliers to manufacturers and retailers. Ensuring that all stages of production comply with the new restrictions adds another layer of complexity.
3. Market Impact:
- Product Availability: The transition period may lead to temporary shortages of certain products as companies reformulate and re-release compliant versions. This could impact brand loyalty and market dynamics.
- Competitive Disadvantages: Smaller companies may struggle to meet the new requirements due to limited resources, leading to a consolidation of market share among larger, more resource-rich firms.
4. Consumer Perception:
- Communication Strategies: the cosmetic industry will have to effectively communicate these changes to consumers, explaining why their favorite products might feel or perform differently. Transparency about the mandatory safety and environmental obligations for all cosmetics sold in the EU will help raise consumer awareness about the importance of these measures, ensuring they understand that these changes are regulatory requirements and not promotional tactics.
- Brand Image: Successfully navigating these changes presents an opportunity for brands to enhance their reputation by emphasizing their commitment to sustainability and regulatory compliance.
The amendments to the REACH regulation signify the EU's commitment to minimizing the environmental and health impacts of hazardous chemicals. The phased restrictions on D4, D5, and D6 in cosmetics are designed to ensure a high level of protection while allowing time for industry adaptation. These measures, alongside ongoing efforts under the Stockholm Convention (global treaty aimed at protecting human health and the environment from persistent organic pollutant), aim to mitigate the widespread environmental dissemination and bioaccumulation of these substances, safeguarding both human health and the ecosystem.
Need help?
Contact our experts now, they'll be happy to help you!
