Case study: SVHC, Biocides and PPP; project to transfer more than 100 substances to Annex VI of the CLP regulation
The European Commission and ECHA are considering transferring more than 100 substances already identified under other regulatory frameworks (the REACH Candidate List of SVHCs, the Biocidal Products Regulation, and the Plant Protection Products Regulation) to Annex VI of the CLP Regulation, in order to assign them a mandatory harmonized classification across the EU.
A new approach of the harmonized classification linked to a more integrated classification system
The European regulatory landscape for chemicals is evolving towards an increasingly integrated and cross-cutting approach.
Until now, harmonizing the classification of a substance under the CLP Regulation primarily involved a dedicated CLH procedure, comprising a scientific assessment by ECHA and a decision by the European Commission prior to the substance’s inclusion in Annex VI.
However, many substances are already being assessed under other European regulations, such as REACH, the Biocidal Products Regulation, or the Plant Protection Products Regulation. These procedures generate significant data on the hazardous properties of substances and can already lead to their identification as substances of concern or trigger specific regulatory measures.
Consequently, the European Commission and ECHA plan to make better use of these existing assessments by transferring over 100 substances, already identified within these various regulatory frameworks, to Annex VI of the CLP Regulation.
This development would mark a significant shift: rather than viewing each regulatory process in isolation, the European Union aims to leverage scientific assessments already conducted to accelerate the establishment of harmonized classifications.
For industry, the stakes are tangible: including a substance in Annex VI can make its classification mandatory across the entire EU and have direct repercussions for mixtures containing it. Anticipating these developments is therefore essential for identifying the products affected and assessing, well in advance, the potential impacts on their classification and regulatory compliance.
Objective of the regulation draft for the transfer to CLP Annex VI
The aim is to ensure better consistency between European regulations and improve hazard communication by imposing harmonized classifications for substances already recognized as being of concern.
Main Substances Concerned (SVHC, Biocides and PPP)
The proposal includes, among others:
- Siloxanes: D4, D5 and D6.
- Polycyclic aromatic hydrocarbons (PAHs): anthracene, pyrene, etc.
- Flame retardants: decaBDE, HBCDD.
- Several UV stabilizers: UV-328, UV-327.
- Certain PFAS, including PFHxS and related substances.
- Endocrine disruptors, including bisphenol B and several phenolic derivatives.
New Classifications Highlighted by the regulation draft
Many substances would receive classifications for:
- PBT (Persistent, Bioaccumulative and Toxic).
- vPvB (very Persistent and very Bioaccumulative).
- Endocrine disruption for human health or the environment.
The new CLP hazard classes introduced in recent years would therefore be widely applied through this transfer, including:
- EUH380: Endocrine disruptor for human health.
- EUH430: Endocrine disruptor for the environment.
- EUH440: Substance that accumulates in the environment and living organisms.
- EUH441: Very persistent and very bioaccumulative substance.
Impact of the regulation draft on Companies
Affected companies will need to:
- Review their CLP classifications.
- Update labels and Safety Data Sheets (SDSs).
- Reassess the classification of mixtures.
- Verify the concentrations of the relevant substances in formulations.
- Consider substitution or reformulation where necessary.
For industry, this is likely to be one of the most significant CLP developments since the introduction of the new hazard classes (endocrine disruptors, PBT/vPvB, PMT/vPvM). If adopted, this transfer would mean that many substances currently identified only as SVHCs or regulated under sector-specific legislation would become subject to mandatory harmonized classifications, with direct consequences for labels, SDSs, PCN notifications, mixture classifications, and potentially substitution strategies.
Anticipate the regulatory impacts on your products portfolio.
With EcoMundo, identify products likely to be affected by regulatory changes early on and anticipate the necessary actions.
Through a tailored impact assessment, our experts analyze your product portfolio to identify affected mixtures and evaluate potential classification changes.
For instance, we can identify all mixtures containing pyrene and determine which products might be subject to a vPvB classification.
This analysis enables you to:
- Quickly identify high-risk products within your portfolio;
- Anticipate classification changes and their consequences;
- Prioritize necessary actions;
- Ensure regulatory compliance;
- Effectively plan adjustments to your products and portfolio.
With EcoMundo, turn regulatory changes into a concrete, well-managed action plan.
👉 Anticipate the impact on your product portfolio today, by contacting us.
Case study: SVHC, Biocides and PPP; project to transfer more than 100 substances to Annex VI of the CLP regulation
The European Commission and ECHA are considering transferring more than 100 substances already identified under other regulatory frameworks (the REACH Candidate List of SVHCs, the Biocidal Products Regulation, and the Plant Protection Products Regulation) to Annex VI of the CLP Regulation, in order to assign them a mandatory harmonized classification across the EU.
A new approach of the harmonized classification linked to a more integrated classification system
The European regulatory landscape for chemicals is evolving towards an increasingly integrated and cross-cutting approach.
Until now, harmonizing the classification of a substance under the CLP Regulation primarily involved a dedicated CLH procedure, comprising a scientific assessment by ECHA and a decision by the European Commission prior to the substance’s inclusion in Annex VI.
However, many substances are already being assessed under other European regulations, such as REACH, the Biocidal Products Regulation, or the Plant Protection Products Regulation. These procedures generate significant data on the hazardous properties of substances and can already lead to their identification as substances of concern or trigger specific regulatory measures.
Consequently, the European Commission and ECHA plan to make better use of these existing assessments by transferring over 100 substances, already identified within these various regulatory frameworks, to Annex VI of the CLP Regulation.
This development would mark a significant shift: rather than viewing each regulatory process in isolation, the European Union aims to leverage scientific assessments already conducted to accelerate the establishment of harmonized classifications.
For industry, the stakes are tangible: including a substance in Annex VI can make its classification mandatory across the entire EU and have direct repercussions for mixtures containing it. Anticipating these developments is therefore essential for identifying the products affected and assessing, well in advance, the potential impacts on their classification and regulatory compliance.
Objective of the regulation draft for the transfer to CLP Annex VI
The aim is to ensure better consistency between European regulations and improve hazard communication by imposing harmonized classifications for substances already recognized as being of concern.
Main Substances Concerned (SVHC, Biocides and PPP)
The proposal includes, among others:
- Siloxanes: D4, D5 and D6.
- Polycyclic aromatic hydrocarbons (PAHs): anthracene, pyrene, etc.
- Flame retardants: decaBDE, HBCDD.
- Several UV stabilizers: UV-328, UV-327.
- Certain PFAS, including PFHxS and related substances.
- Endocrine disruptors, including bisphenol B and several phenolic derivatives.
New Classifications Highlighted by the regulation draft
Many substances would receive classifications for:
- PBT (Persistent, Bioaccumulative and Toxic).
- vPvB (very Persistent and very Bioaccumulative).
- Endocrine disruption for human health or the environment.
The new CLP hazard classes introduced in recent years would therefore be widely applied through this transfer, including:
- EUH380: Endocrine disruptor for human health.
- EUH430: Endocrine disruptor for the environment.
- EUH440: Substance that accumulates in the environment and living organisms.
- EUH441: Very persistent and very bioaccumulative substance.
Impact of the regulation draft on Companies
Affected companies will need to:
- Review their CLP classifications.
- Update labels and Safety Data Sheets (SDSs).
- Reassess the classification of mixtures.
- Verify the concentrations of the relevant substances in formulations.
- Consider substitution or reformulation where necessary.
For industry, this is likely to be one of the most significant CLP developments since the introduction of the new hazard classes (endocrine disruptors, PBT/vPvB, PMT/vPvM). If adopted, this transfer would mean that many substances currently identified only as SVHCs or regulated under sector-specific legislation would become subject to mandatory harmonized classifications, with direct consequences for labels, SDSs, PCN notifications, mixture classifications, and potentially substitution strategies.
Anticipate the regulatory impacts on your products portfolio.
With EcoMundo, identify products likely to be affected by regulatory changes early on and anticipate the necessary actions.
Through a tailored impact assessment, our experts analyze your product portfolio to identify affected mixtures and evaluate potential classification changes.
For instance, we can identify all mixtures containing pyrene and determine which products might be subject to a vPvB classification.
This analysis enables you to:
- Quickly identify high-risk products within your portfolio;
- Anticipate classification changes and their consequences;
- Prioritize necessary actions;
- Ensure regulatory compliance;
- Effectively plan adjustments to your products and portfolio.
With EcoMundo, turn regulatory changes into a concrete, well-managed action plan.
👉 Anticipate the impact on your product portfolio today, by contacting us.
