Europe Regulatory News

On 21 January 2025, the European Chemicals Agency (ECHA) published a new infographic to help companies manage their Unique Formula Identifiers (UFIs) effectively. The infographic provides guidance on ...

On 21 January 2025, the European Chemicals Agency (ECHA) published a new infographic to help companies manage their Unique Formula Identifiers (UFIs) effectively. The infographic provides guidance on how to ensure that UFIs included in Poison Centre Notifications (PCNs) are accurate and comply with the 'one UFI – one composition' principle.

Understanding the 'One UFI – One Composition' Principle

The 'one UFI – one composition' principle requires that each UFI corresponds to a single, specific mixture composition. Recent reports from Member States have identified cases where the same UFI was assigned to different mixture compositions, a practice that is prohibited. Such mismanagement can prevent poison centre operators from providing accurate information in emergencies and can lead to regulatory non-compliance and enforcement actions.

Guidelines for Proper UFI Management

To avoid problems related to UFI mismanagement, ECHA recommends that companies:

• Establish Clear Internal Processes: Implement structured procedures within the organisation to systematically manage UFIs.

• Maintain Good Practices with Third Parties: Ensure effective communication and collaboration with suppliers, distributors, and other stakeholders in the supply chain.

• Use Available Tools and Support: Use the resources provided by ECHA, such as the UFI Generator tool and guidance documents, to facilitate the correct assignment and management of UFIs.

Upcoming Enforcement Actions

Starting in January 2025, EU inspectors have launched a six-month pilot project to verify notifications for hazardous mixtures. The inspections will include checks of mixture labels and, where necessary, Safety Data Sheets, to ensure compliance with UFI regulations.

Access the UFI Management Infographic

For a visual guide and more detailed advice on proper UFI management, companies can access ECHA’s newly published infographic here.

By following these guidelines and using the resources available, companies can ensure compliance with UFI regulations, thereby facilitating accurate and efficient emergency responses by poison centres.

The European Council has formally adopted the Packaging and Packaging Waste Regulation (PPWR)  which focuses on reducing packaging waste and promoting sustainability. The rules introduce binding targ...

The European Council has formally adopted the Packaging and Packaging Waste Regulation (PPWR)  which focuses on reducing packaging waste and promoting sustainability. The rules introduce binding targets for re-use, restrict certain single-use packaging items, and require businesses to minimize packaging material. The regulation also encourages re-use by requiring take-away businesses to allow customers to use their own containers, marking a significant step towards a circular economy in the EU.  

Implementation 

The new regulations adopted by the EU will promote safe, sustainable, and recyclable packaging. These include setting ambitious targets for recycled content, such as 65% for single-use plastic bottles by 2040, and reducing packaging waste by minimizing its weight, volume, and harmful substances such as PFAS. The rules also introduce restrictions on single-use plastics for items such as pre-packed produce, food and drinks consumed in restaurants, small cosmetic products, and lightweight plastic bags. Furthermore, businesses will be required to allow customers to use their own containers for take-away food and drinks, with binding re-use targets set for 2030 and 2040. These changes aim to significantly reduce packaging waste and promote a circular economy across the EU. 

Key measures  

• Targets for recycled content in packaging for 2030 and 2040. 

• Limits on harmful substances such as PFAS.  

• New labelling requirements to help consumers with recycling and waste sorting. 

Entry into force 

The Regulation was published in the Official Journal of the EU on 22 January 2025 and will enter into force 20 days later. Its provisions will apply from 12 February 2026 (except for Article 67(5) which will apply from 12 February 2029. 

The full text of the Regulation can be accessed here. 

On January 13, 2025, the EU Scientific Committee on Consumer Safety (SCCS) released its preliminary opinion on the safety of salicylic acid as a cosmetic preservative concerning children's exposur...

On January 13, 2025, the EU Scientific Committee on Consumer Safety (SCCS) released its preliminary opinion on the safety of salicylic acid as a cosmetic preservative concerning children's exposure. The draft opinion is open for comments until March 10, 2025.

Background on Salicylic Acid

Salicylic acid (CAS No. 69-72-7), also known as benzoic acid, 2-hydroxy, is a chemical widely used in cosmetic products as a denaturant, hair and skin conditioning agent, exfoliant, anti-sebum agent, anti-dandruff/anti-seborrheic agent, and product preservative. It is currently regulated under Annex III and Annex V of the EU Cosmetics Regulation (EC) No 1223/2009, with specific concentration limits and conditions of use.

SCCS Scientific Opinion on Salicylic Acid

Based on its safety assessment, the SCCS concluded that:

• Salicylic acid is not safe when used as a preservative in cosmetic products at a concentration of 0.5%, despite the current restrictions. However, it is safe in single dermal and oral product categories, except body lotion. This opinion does not apply to sprayable products that may expose the lungs of the end-user by inhalation.

• The use of salicylic acid as a restricted ingredient for reasons other than to prevent the development of micro-organisms is not safe at the following doses when aggregate exposure is considered: Except for body lotion, it is safe when used in a single dermal and oral product category.

• The opinion does not consider the use of salicylic acid in products intended for children under 3 years of age due to the Cosmetic Regulation's prohibition. The conclusions only apply to salicylic acid as a cosmetic ingredient and do not cover other salicylates or salicylic acid salts. The SCCS mandates do not address environmental safety.

• The use of dermal products and toothpaste can be made safer by reducing the concentration of certain substances, such as 0.1%.

Comments Deadline

The preliminary opinion is open for comments till March 10, 2025.

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.

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.