Europe Regulatory News

On 10 January 2025, the EU Scientific Committee on Consumer Safety (SCCS) adopted its preliminary opinion on the safety of using butylparaben as a preservative in cosmetic products for children. The d...

On 10 January 2025, the EU Scientific Committee on Consumer Safety (SCCS) adopted its preliminary opinion on the safety of using butylparaben as a preservative in cosmetic products for children. The deadline for comments is 10 March 2025.

Background on butylparaben as a preservative

Butylparaben (CAS No 94-26-89), a preservative in cosmetic products, has been subject to several safety evaluations by the SCCS and its predecessor, the Scientific Committee on Consumer Products (SCCP). In 2023, the SCCS re-assessed the safety of butylparaben due to potential endocrine-disrupting effects. The Scientific Committee confirmed its safety at concentrations up to 0.14%. However, the experts noted that potential safety concerns could not be excluded due to the lack of exposure data specific to children. In March 2024, the Commission received additional information from industry to defend the use of butylparaben in children's cosmetic products.

SCCS Committee opinion

The SCCS reached the following conclusion after a human risk study:

• Safety Assessment for Children: The SCCS has determined that the use of butylparaben as a preservative in cosmetic products at a maximum concentration of 0.14% is not safe for children aged 0.5-1 years, 1-3 years, 3-6 years, and 6-10 years when used in combination. However, it is safe in single dermal and oral product categories when used only in the respective product category, except for body lotion.

• Recommended Concentration: The SCCS recommends limiting the concentration of butylparaben in final products to 0.028% for children. However, the need for a reduction could be reconsidered after a thorough dermal absorption study and better exposure studies specifically tailored to EU children.

• Environmental Safety: The opinion does not cover the environmental safety of butylparaben as environmental aspects are not covered by the SCCS mandates.

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.

The European Union has taken an important step to improve the safety and transparency of plant protection products by updating Regulation (EU) No 547/2011. The proposed updates aim to harmonise labell...

The European Union has taken an important step to improve the safety and transparency of plant protection products by updating Regulation (EU) No 547/2011. The proposed updates aim to harmonise labelling standards, improve risk communication to end-users, and strengthen safety measures while supporting sustainability goals. This updated legislation seeks to make information clearer and more accessible to farmers and other users, while also aligning with the EU's Farm to Fork strategy. It is important that all users of plant protection products understand these significant improvements.

Key Changes in the Updated Regulation

• Standardised Risk Mitigation Phrases: Clear and concise language will be provided. These phrases will be grouped according to evaluations of the risks to the environment and human health.

• Enhanced Bee Safety: Agrochemicals, that may endanger bees will be prominently marked with a particular phrase and symbol.

• Micro-organism Sensitization Warnings: Precautionary statements will be included to warn and alert consumers to the possible sensitisation effects of micro-organisms used in plant protection products.

• Combating Illegal Trade: Plant protection products covered by ‘a parallel trade permit’ will be required to carry a special label that includes the batch number, date of manufacture date, permit number, and details about the permission holder.

• Improved Research Labelling: Plant protection products used in research and development must have clearer labelling instructions that highlight their experimental nature and the need for utmost caution.

• Improved Disposal Guidance: To reduce packaging waste, standardised language will be used to instruct consumers on how to properly dispose of plant protection product containers.

• Colour-coded Labelling: To quicky communicate the hazard status of active ingredients, the presence of micro-organisms, and whether the product is approved as low-risk, a colour-coded scheme shall be used on labels.

• Accessibility of Digital Labelling: Digital labels will be made available to users through links or machine-readable forms, including features such as voice assistance, auto-search, larger fonts, and multilingual support.

Feedback Period

Public consultation: Open from January 6, 2025, to February 3, 2025.

Expected Entry into Force:  January 1, 2026.’

The revised regulation supports the Farm to Fork strategy, which seeks to reduce dependency on chemical plant protection products. By improving labelling clarity and risk communication, the EU seeks to help consumers make informed choices while minimising risks to the environment, animal health, and human health.

*Source

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