Europe Regulatory News

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.

The updated EU Classification, Labelling, and Packaging (CLP) Regulation (Regulation (EU) 2024/2865) officially entered into force on 10 December 2024. The updated CLP Regulation was adopted by the Co...

The updated EU Classification, Labelling, and Packaging (CLP) Regulation (Regulation (EU) 2024/2865) officially entered into force on 10 December 2024. The updated CLP Regulation was adopted by the Council of the European Union on 14 October 2024 and published in the Official Journal of the European Union on 20 November 2024. This update aims to improve the identification and communication of chemical hazards, while ensuring greater protection for consumers and the environment.

Key Changes Under the Updated CLP Regulation

The updated CLP Regulation introduces several improvements to better protect public health and the environment. Notable updates include

• Improved Classification Rules: Clarification on how to classify mixtures and substances with multiple constituents.

• New Hazard Classes: Endocrine disruptors (ED), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), and very persistent and very mobile (vPvM) substances are now considered to be hazards of very high concern.

• Focus on Grouping and Harmonization: Enhanced emphasis on grouping substances for harmonised classifications.

• Clearer Labelling Requirements: Introducing of rules for clearer labelling for hazardous chemicals.

• Online Hazard Communication: Mandatory inclusion of chemical hazard information in online sales and advertisements to effectively inform consumers.

• Flexible Labelling Options: Introduces fold-out and digital labelling options to improve legibility and accessibility for users.

• Distributor Responsibilities: Distributors now play an important role in poison centre notifications. They are required to submit information for certain chemicals to ensure appropriate emergency response.

• Regulations for Refill Stations: New rules regulate the sale of chemicals at refill stations to enhance consumer safety.

• ECHA and EFSA Proposals: The European Commission may request harmonized classification proposals from the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA).

• User-Friendly Substance Inventory: Development of an inventory system that improves access to information for SMEs and increases transparency for all stakeholders.

The Role of Distributors under the Updated CLP Regulation

One of the key changes introduced by the updated CLP Regulation is the clarification of the responsibility of distributors in poison centre notifications. Distributors are now required to notify poison centres of certain hazardous mixtures they place on the market, ensuring that emergency responders have accurate information in the event of an incident. This change underscores the growing importance of transparency and preparedness in chemical safety management.

Different Application Dates for Specific Measures

While the regulation entered into force on 10 December 2024, the applicability of certain provisions varies, giving industry time to adapt:

• General Obligations: Most of the new rules will apply from 1 July 2026, giving companies time to align their operations with the updated requirements.

• Label Formatting Rules: The new label formatting requirements, including fold-out and digital labels, will apply from 1 January 2027.

• Exemptions for Existing Products: Substances and mixtures already placed on the market before 1 January 2027 will not need to be re-labelled or re-packaged under the updated rules.

  • Substances: These can remain in the supply chain until 1 July 2028 without having to update to their labels or packaging.

  • Mixtures: These can remain in the supply chain until 1 January 2029 without having to comply with the new labelling and packaging rules.

These staggered deadlines provide industry with flexibility to ensure compliance while minimizing disruption to existing supply chains.

Compliance Guidance and Resources

To assist companies with these new requirements, ECHA has published resources, including

• Detailed guidance on the new hazard classes, such as ED and PBT substances.

• Guidance on the implementation of mixture classification using bridging principles.

Upcoming resources in 2025 will provide additional guidance on labelling, Annex VIII (poison centres), and practical methods for grouping and read-across approaches.

Industry Action Required

ECHA urges companies to review their chemical portfolios and update classifications to comply with the revised regulation. This includes revising REACH registration dossiers and CLP notifications.

The full text of the updated CLP Regulation is available here.

From 29 November 2024, the European Union enforces a strict ban on lead in polyvinyl chloride (PVC) products, targeting concentrations of 0.1% or more by weight. This measure aims to further reduce ex...

From 29 November 2024, the European Union enforces a strict ban on lead in polyvinyl chloride (PVC) products, targeting concentrations of 0.1% or more by weight. This measure aims to further reduce exposure to the toxic substance, thereby protecting both human health and the environment.

Key Provisions of the Restriction

• Scope: The regulation applies to all PVC products, including imported goods and recycled materials.

• Transition Periods for Recovered PVC Applications

Recognising the challenges in eliminating lead from recycled materials, the EU has introduced transition periods for certain applications:

• PVC Articles Containing Recovered PVC: A 15-year derogation is granted, allowing higher lead content limits - up to 2% by weight for rigid PVC and 1% for flexible PVC. This period allows for the gradual reduction of lead in recycled PVC and supports recycling initiatives.

• Review Timeline: The derogation will be reassessed within 7.5 years of the entry into force of the restriction to evaluate progress in reducing lead content in recycled PVC.

Health and Environmental Concerns

Lead is known to cause serious damage to the nervous system, particularly in children, and is associated with chronic kidney disease and high blood pressure. It is also highly toxic to aquatic life, underlining the importance of minimising its use.

EU's Industry Initiative and Regulatory Impact

The PVC industry in the European Union has already voluntarily phased out the use of lead stabilisers. This regulation goes further by addressing imported products and materials containing recycled PVC, ensuring comprehensive protection.

Detailed information can be found in the official EU regulation here.

The revised Classification, Labelling and Packaging (CLP) Regulation, which came into force on 10 December 2024, introduces important updates for poison centre notifications. Under the new rules, dist...

The revised Classification, Labelling and Packaging (CLP) Regulation, which came into force on 10 December 2024, introduces important updates for poison centre notifications. Under the new rules, distributors (i.e. companies that relabel, rebrand, or retail hazardous mixtures) are now classified as Duty Holders, which clarifies their responsibilities for ensuring compliance.

What Distributors Need to Know

Distributors must ensure that all hazardous mixtures placed on the market have accurate poison centre notifications. If no notification exists, or if product identifiers are updated, distributors must

• Provide the necessary information to the original notifier or supplier for inclusion, or

• Submit their own notification directly to the relevant poison centre.

Keeping Information Up to Date

In addition to initial notifications, Duty Holders must keep poison centres informed on changes in

• Packaging type

• Product category

• Contact information that could affect emergency response.

Guidance and Deadlines

To assist companies, the European Chemicals Agency (ECHA) is updating its guidance on poison centre notifications, expected by summer 2025. Companies should prepare now to meet the revised requirements.

For more details, visit ECHA’s poison centre notifications page here.