Europe Regulatory News

On 21 January 2025, the European Chemicals Agency (ECHA) updated the Candidate List of Substances of Very High Concern (SVHC) to a total of 247 substances. The latest update includes five newly identi...

On 21 January 2025, the European Chemicals Agency (ECHA) updated the Candidate List of Substances of Very High Concern (SVHC) to a total of 247 substances. The latest update includes five newly identified chemicals with potential risks to human health and the environment and a revision of one existing entry.

New Additions to the Candidate List

ECHA has identified the following substances on the basis of their hazardous properties:

• 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (EC: 701-118-1, CAS: 2156592-54-8)

  • Classified as toxic for reproduction under Article 57(c) of REACH.

  • Used in lubricants, greases, release products, and metalworking fluids.

• O,O,O-triphenyl phosphorothioate (EC: 209-909-9, CAS: 597-82-0)

  • Classified as persistent, bioaccumulative, and toxic (PBT) under Article 57(d) of REACH.

  • Used in lubricants and greases.

• Octamethyltrisiloxane (EC: 203-497-4, CAS: 107-51-7)

  • Classified as very persistent and very bioaccumulative (vPvB) under Article 57(e) of REACH.

  • Found in cosmetics, personal/health care products, pharmaceuticals, washing and cleaning products, and sealants.

• Perfluamine (EC: 206-420-2, CAS: 338-83-0)

  • Identified as vPvB under Article 57(e) of REACH

  • Used in the manufacture of electrical, electronic, and optical equipment.

• Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives (EC: 421-820-9, CAS: 192268-65-8)

  • Classified as PBT under Article 57(d) of REACH.

  • No active registrations under REACH.

Updated Entry

• Tris(4-nonylphenyl, branched and linear) phosphite

  • Now recognized for endocrine disrupting properties impacting the environment.

  • Used in polymers, adhesives, sealants, and coatings.

Implications for Companies

The inclusion of these substances give rise to a number of obligations under REACH, including:

• Information Requirements: Suppliers must provide safety information to customers and consumers if a substance is present in an article above 0.1% w/w.

• Notification Obligations: Importers and manufacturers of articles containing these substances must notify ECHA within six months of the listing date (by 21 July 2025).

• Safety Data Sheet Updates: EU and EEA suppliers must revise safety data sheets to reflect the inclusion.

• Waste Framework Directive Compliance: Companies must report the presence of SVHCs to ECHA’s SCIP database.

• EU Ecolabel Restrictions: Products containing SVHCs are not eligible for Ecolabel certification.

Next Steps

Substances on the Candidate List may be considered for inclusion in the Authorisation List, requiring companies to seek approval for continued use.

For more details, visit the Candidate List of SVHCs here.

On 18 December 2024, the European Chemicals Agency (ECHA) published its report on Aromatic Brominated Flame Retardants (ABFRs), identifying significant environmental risks associated with certain non-...

On 18 December 2024, the European Chemicals Agency (ECHA) published its report on Aromatic Brominated Flame Retardants (ABFRs), identifying significant environmental risks associated with certain non-polymeric additives. These substances, which are characterized by persistence, bioaccumulation and toxicity, are released into the environment throughout their life cycle, with waste management being a critical stage of concern.

Background on ABFRs

ABFRs are a broad category of flame retardants in which bromine atoms are covalently bonded to an aromatic ring. They are additives used to enhance the fire resistance of polymeric materials. They are classified as:

• Additive ABFRs: Mixed into polymers without forming bonds. Non-polymeric additives leach out more easily than their polymeric counterparts.

• Reactive ABFRs: Chemically bound to polymers, making them less susceptible to environmental release.

Key Findings on ABFRs

ECHA's report, commissioned by the European Commission, investigated 60 ABFRs potentially present on the EU market. Key findings include:

• Environmental Impact: Non-polymeric ABFR additives pose the greatest risks due to their tendency to leach. Five substances were identified as persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB), while 37 are likely to be PBT, including 17 non-polymeric additives.

• Uses and Releases: ABFRs are widely used in electronics, construction, and textiles. Waste stages, especially shredding or landfilling, are the main contributors to environmental releases.

• Alternatives: Viable alternatives include organophosphate flame retardants and polymeric ABFRs. However, some alternatives, such as organophosphates, may have similar hazardous properties.

• Waste Management: Inefficient recycling systems exacerbate the release of ABFRs. ECHA recommends eliminating problematic additives early in the value chain.

• Group Approach for Regulation: Some non-polymeric ABFRs detected in high environmental concentrations remain unregistered under REACH. ECHA proposes a group approach for regulatory action to address these gaps.

Implications for Future Regulation

ECHA's findings will assist the European Commission in deciding whether to request a restriction proposal for ABFRs and may influence future regulatory action under the EU's Chemicals Strategy for Sustainability. A restriction on flame retardants is already included in the Commission's Restrictions Roadmap.

Next Steps

The report highlights the need for sustainable waste management and early intervention to reduce the environmental impact of flame retardants. Stakeholders are encouraged to review the report to understand its implications for the industry.

For more details, the full ECHA investigation report is available here.

On 6 January 2025, the European Union notified three proposed amendments to Directive 2011/65/EU (RoHS 2 Directive) to the World Trade Organization (WTO). These amendments seek to temporarily exempt s...

On 6 January 2025, the European Union notified three proposed amendments to Directive 2011/65/EU (RoHS 2 Directive) to the World Trade Organization (WTO). These amendments seek to temporarily exempt specific uses of lead in electrical and electronic equipment. The proposals, detailed in notifications G/TBT/N/EU/1102, G/TBT/N/EU/1103 and G/TBT/N/EU/1104, concern exemptions for lead in high melting temperature solders, glass or ceramic components, and as an alloying element in steel, aluminium, and copper.

The Restriction of Hazardous Substances (RoHS) Directive restricts the use of certain hazardous substances, including lead, in electrical and electronic equipment to protect human health and the environment while promoting sustainable innovation.

Key Details of the Notifications

1. High Melting Temperature Solders (Notification G/TBT/N/EU/1102)

   • Scope: Proposes a temporary exemption for lead used in high melting temperature solders under Annex III of the RoHS Directive.

   • Objective: To adapt Annex III of the RoHS Directive to scientific and technical progress while maintaining the objectives of Directive 2011/65/EU, including the protection of human health and the environment.

   • Proposed Adoption Date: March 2025, with entry into force 20 days after publication in the Official Journal of the EU.

   • Further Details: The full text of the draft delegated directive is available here.

2. Glass or Ceramic Components (Notification G/TBT/N/EU/1103)

   • Scope: Proposes a temporary exemption for lead used in glass or ceramic components under Annex III of the RoHS Directive.

   • Objective: To adapt Annex III of the RoHS Directive to support technological development without compromising health and environmental protection.

   • Proposed Timetable: Same as above.

   • Further Details: The full text of the draft delegated directive can be found here.

3. Alloying Element in Metals (Notification G/TBT/N/EU/1104)

   • Scope: Proposes a temporary exemption for lead as an alloying element in steel, aluminium, and copper under Annex III of the RoHS Directive.

   • Objective: To adapt Annex III of the RoHS Directive to address technical challenges while ensuring compliance with environmental objectives.

   • Proposed Timetable: Same as for the other notifications.

   • Further Details: The full text of the draft delegated directive can be found here.

Objectives and Justification

The aim of these amendments is to adapt Annex III of the RoHS Directive to reflect scientific and technical progress. The exemptions will allow industry to continue to innovate while protecting human health and the environment. Each proposal is supported by comprehensive scientific studies available on the official website of the European Commission.

Public Consultation and Next Steps

The European Commission is inviting comments on these drafts within 60 days of their notification.

Conclusion

The proposed exemptions underline the EU's commitment to balancing technological progress with its health and environmental goals. Stakeholders are encouraged to provide feedback to help shape the final adoption of these amendments.

The European Commission has adopted an amendment to the EU’s Prior Informed Consent (PIC) Regulation, adding 40 hazardous chemicals to Annex I. The amendment was published in the Official Journal of...

The European Commission has adopted an amendment to the EU’s Prior Informed Consent (PIC) Regulation, adding 40 hazardous chemicals to Annex I. The amendment was published in the Official Journal of the European Union on 31 December 2024 and will enter into force on 20 January 2025. From 1 March 2025, exporters will have to notify the European Chemicals Agency (ECHA) before shipping these substances outside the EU. The update strengthens the EU’s control over hazardous chemicals, with the aim of protecting human health and the environment worldwide.

Highlights of the New Amendments

• Addition of 40 Chemicals to Annex I:

  • Includes 35 pesticides such as abamectin, difenacoum, fenpropimorph and triadimenol.

  • Includes 5 industrial chemicals such as dihexyl phthalate and sodium perborate).

• Export Notification and Explicit Consent:

  • Most of the newly listed substances (38) require both export notification and explicit consent from the importing country.

  • Two pesticides already listed in Annex I, cyanamide and warfarin, will also need explicit consent for export from 1 March 2025.

• Export Ban for the PFHxS Group:

  • Perfluorohexane sulfonic acid (PFHxS), its salts and related compounds will be added to Annex V, prohibiting their export. This reflects their classification as persistent organic pollutants (POPs) under the Stockholm Convention.

What Exporters Need to Know

• ePIC System Updated: ECHA’s IT tool, ePIC, is ready to handle export notifications for the updated list of chemicals. Exporters are encouraged to start submitting notifications to ensure compliance.

• Extended Annex I: With this update, the PIC Regulation now covers 321 chemical entries.

• Explicit Consent Requirement: For chemicals listed in Part 2 of Annex I, explicit approval from the importing country must be obtained prior to export.

Background on the PIC Regulation

The PIC Regulation regulates the trade of hazardous chemicals that are banned or severely restricted within the EU. Its main aim is to provide importing countries with information on the risks of these chemicals and to ensure their prior informed consent for import.

Action for Exporters

EU exporters should familiarize themselves with the new requirements and plan ahead to avoid disruption to their supply chains. Notifications through the ePIC system should be submitted well in advance of the enforcement date of 1 March 2025.

The full list of substances can be found in the Commission Delegated Regulation (EU) 2024/3199 here.

On 5 December 2024, ECHA's Risk Assessment Committee (RAC) published its meeting highlights and adopted changes to the list of chemicals. The discussion decided that two groups of essential oil fr...

On 5 December 2024, ECHA's Risk Assessment Committee (RAC) published its meeting highlights and adopted changes to the list of chemicals. The discussion decided that two groups of essential oil fragrances should be classified as category 1B reproductive toxicants under the EU’s Classification, Labelling, and Packaging (CLP) Regulation.

Burgeonal and Cyclamal Groups Classified as Reprotoxic 1B Under CLP Regulation

The RAC opinions are based on two proposals for fragrance substances: one for Burgeonal compounds and the other for Cyclamal compounds. Both are widely used as fragrances in personal care, cleaning, and consumer products. The classification reflects concerns about their potential to impair fertility or harm the unborn child.

Industry Concerns over RAC’s Classification of Essential Oil Compounds

The European Federation of Essential Oils warned that the classification could potentially lead to some essential oils being classified as Reprotoxic 1B, potentially stopping their use in cosmetics and consumer products. The industry also argued that reproductive toxicity observed in laboratory animals does not apply to humans, as seen in a similar classification proposed for tea tree oil.

Details of RAC's Decisions on Burgeonal and Cyclamal Groups

ECHA’s Risk Assessment Committee has accepted the proposed changes to the essential oil classification that specify the potential reproductive toxicity under the CLP Regulation. The list of accepted changes is listed below:

For further details, refer to the RAC Meeting highlights in the Annex

The General Product Safety Regulation (EU) 2023/988 (GPSR) applies from 13 December 2024, replacing the General Product Safety Directive (2001/95/EC) and Council Directive 87/357/EEC. This modernized ...

The General Product Safety Regulation (EU) 2023/988 (GPSR) applies from 13 December 2024, replacing the General Product Safety Directive (2001/95/EC) and Council Directive 87/357/EEC. This modernized regulation ensures consumer protection in the EU by addressing new challenges posed by digitalization, global supply chains and technological advances. It acts as the default safety framework for non-food consumer products not covered by harmonized product-specific legislation, such as cosmetics and food.

Key Updates under the General Product Safety Regulation

The GPSR introduces significant updates to the safety of consumer products:

• Extended Scope to Cover Online Sales:

  • Online marketplaces must take greater responsibility for removing unsafe products and protecting consumers in digital transactions.

• Accident Reporting Through the Product Safety Gateway:

  • Economic operators are now required to report all individual accidents involving products to the authorities, not just those that pose a "risk."

• Improved Product Recall Mechanisms:

  • Mandatory templates for recall notices and direct communication with consumers improve the efficiency of recalls. Consumers are also entitled to a remedy (e.g., repair, replacement, or refund) for recalled products.

• New Rules on the Responsible Person in the Supply Chain:

  • A designated "Responsible Person" must be based in the EU and ensure compliance with technical documentation, labelling, and safety requirements.

  • The Responsible Person must liaise with market surveillance authorities and verify ongoing product compliance.

• Labelling and Contact Information Requirements:

  • Products must now include an "electronic address" in addition to the name and postal address of the manufacturer or importer.

• Importer Responsibilities:

  • If no other relevant EU-based party can be identified, the importer is considered the Responsible Person and must ensure that all regulatory obligations are met. Importers must work with non-EU suppliers to obtain the necessary documentation.

Harmonized Market Surveillance for Safer Products

The GPSR strengthens the enforcement powers of national authorities to ensure compliance across the EU. Improved cooperation between Member States will enable rapid responses to safety issues, including the recall of unsafe products.

With 31% of product safety alerts stemming from online sales, the GPSR addresses risks in the digital marketplace and ensures that all products sold in the EU meet stringent safety standards.

A Major Step in EU Consumer Protection

Adopted on 10 May 2023, the GPSR is part of the EU's New Consumer Agenda and replaces outdated rules to adapt to a rapidly changing market. By strengthening oversight, enhancing safety measures, and addressing the complexities of digital and globalized supply chains, the GPSR reaffirms the EU’s position as a global leader in consumer product safety.

The official text of the GPSR can be found here.

On 10 December 2024, the European Commission officially decided not to proceed with the inclusion of medium-chain chlorinated paraffins (MCCPs – CAS No 85535-85-9) and tetrabromobisphenol A (TBBP-A ...

On 10 December 2024, the European Commission officially decided not to proceed with the inclusion of medium-chain chlorinated paraffins (MCCPs – CAS No 85535-85-9) and tetrabromobisphenol A (TBBP-A – CAS No 79-94-7) under the Restriction of Hazardous Substances (RoHS) Directive. The substances, widely used as flame retardants and plasticizers in electrical and electronic equipment (EEE), had been under consideration due to concerns about their persistence in the environment and potential health risks.

Timeline of the Proposal

The decision marks the end of a multi-year process:

• 2019: MCCPs and TBBP-A were identified as candidates for restriction under RoHS due to their classification as Persistent Organic Pollutants (POPs) and bioaccumulative properties.

• 2021: The European Commission initiated a formal assessment to determine the need to restrict these substances under RoHS.

• 2022-2023: Public consultations and technical evaluations took place. Industry stakeholders raised concerns about regulatory overlap with existing measures under the REACH Regulation.

• 10 December 2024: Following these evaluations, the Commission concluded that the risks posed by MCCPs and TBBP-A are adequately addressed under REACH and that making additional restrictions under RoHS are not necessary.

Reason for the Decision

The Commission found that:

• The REACH Regulation already provides sufficient control of MCCPs and TBBP-A, including their risks and uses.

• Adding these substances to the RoHS Directive would lead to regulatory redundancy without significant additional environmental or health benefits.

Conclusion

While the proposal to restrict MCCPs and TBBP-A under the RoHS Directive has been abandoned, the substances remain regulated under REACH. The decision reflects the Commission’s efforts to balance regulatory efficiency with environmental and health protection.