Brief

On 23/10/2024, the European Chemicals Agency (ECHA) issued an update regarding ECHA's Integrated Regulatory Strategy achieves its goal – high production volume chemicals screened. The report highlights that the strategy has successfully identified and prioritized substances for regulatory risk management, with over 6,000 substances assessed since 2019, and around 1,900 potentially requiring further action due to potential hazards.

ECHA’s Integrated Regulatory Strategy achieves its goal – high production volume chemicals screened
ECHA/NR/24/27
Helsinki, 23 October 2024 – The Integrated Regulatory Strategy (IRS) has increased our knowledge on chemicals and sped up identification of substances for which regulatory risk management actions are required. Refocussed IRS 2024-2028 will continue moving substances to risk management.

ECHA’s sixth and final report of its Integrated Regulatory Strategy 2019-2023 shows that it achieved its goal of screening high production volume chemicals, manufactured or imported above 100 tonnes per year, that were on the European markets in 2018.
Since 2019, ECHA has grouped and screened 6 000 substances, and addressed almost all of the 4 100 high production volume chemicals. Around 1 900 of substances screened in ECHA’s assessments of regulatory needs may potentially require regulatory risk management, mostly harmonised classification and labelling (CLH) or restriction under REACH. For more than two thirds of those, further data is needed first to confirm the relevant hazards. Around 60 % of all substances screened did not require further action.
Several substance groups, identified as requiring regulatory risk management, have been included in the EU’s Restrictions Roadmap, for example bisphenols, ortho-phthalates, flame retardants, hydrocarbyl siloxanes and hydrocarbylphenols.
Ofelia Bercaru, ECHA’s Director of Prioritisation and Integration, said:
“The strategy has significantly contributed to the EU ambition towards reaching the United Nations’ 2030 Sustainable Development Goals concerning chemicals. Over the next four years, we will continue the coordinated approach towards prioritising substances for risk management, whilst maintaining our good knowledge on ECHA’s chemical database, enhancing transparency with authorities and stakeholders, and exploring synergies with ECHA’s new tasks.
”This will allow us to continue to protect health and the environment through our work for chemical safety.”
Next steps

The reviewed IRS for 2024-2028 will continue to improve the protection of human health and the environment from risks posed by hazardous chemicals. ECHA, the European Commission and Member States’ authorities will focus on agreeing more swiftly the necessary risk management measures for the identified substances of concern.
The future prioritisation of authorities’ activities will focus, for example, on the one substance one assessment principle. ECHA will integrate its new tasks to this approach in coming years.
Background

ECHA’s Integrated Regulatory Strategy aimed to speed up data generation, identification of groups of substances of concern, and regulatory action. It did so by integrating different regulatory processes into one approach to manage chemical risks effectively and efficiently. The strategy also encouraged collaboration between ECHA, Member States authorities and the European Commission.
The original goal of the IRS was achieved: to clarify which REACH registered substances are a high priority for regulatory risk management or data generation, and which are currently a low priority for further regulatory action.

Further information

Integrated Regulatory Strategy – Past successes and future outlook [PDF][EN]
Addressing substances of concern – integrated regulatory strategy
Working with groups
Assessment of regulatory needs

Press contact: Mikko Väänänen, press@echa.europa.eu, +358 40 520 3513

Highlights content goes here...

Purpose:

The European Chemicals Agency’s (ECHA) Integrated Regulatory Strategy (IRS) has successfully achieved its goal of screening high production volume chemicals, manufactured or imported above 100 tonnes per year, that were on the European markets in 2018. The strategy aimed to speed up data generation, identify groups of substances of concern, and regulatory action by integrating different regulatory processes into one approach to manage chemical risks effectively and efficiently.

The IRS has increased knowledge on chemicals and sped up identification of substances for which regulatory risk management actions are required. The strategy has also encouraged collaboration between ECHA, Member States authorities, and the European Commission. The sixth and final report of the IRS 2019-2023 shows that it achieved its goal, screening 6,000 substances and addressing almost all of the 4,100 high production volume chemicals.

Effects on Industry:

The IRS has significant implications for industries that manufacture or import high production volume chemicals. The strategy’s focus on risk management and data generation has led to a more comprehensive understanding of chemical risks. Industries will need to comply with regulatory actions taken by ECHA and Member States authorities, such as harmonised classification and labelling (CLH) or restriction under REACH.

The IRS has also encouraged collaboration between industries, stakeholders, and regulatory bodies, promoting a more coordinated approach to managing chemical risks. This collaborative approach will continue in the next phase of the strategy, with ECHA working closely with Member States authorities and the European Commission to agree on risk management measures for identified substances of concern.

Relevant Stakeholders:

The IRS affects various stakeholders, including:

  • Industries that manufacture or import high production volume chemicals
  • Consumers who are exposed to these chemicals through their products
  • Regulators at ECHA, Member States authorities, and the European Commission
  • Other stakeholders, such as NGOs and consumer organizations

These stakeholders will be impacted by the IRS’s focus on risk management and data generation. Industries will need to comply with regulatory actions, while consumers will benefit from a more comprehensive understanding of chemical risks.

Next Steps:

The reviewed IRS for 2024-2028 will continue to improve the protection of human health and the environment from risks posed by hazardous chemicals. ECHA, the European Commission, and Member States authorities will focus on agreeing more swiftly on necessary risk management measures for identified substances of concern.

Key next steps include:

  • Integrating new tasks into the approach
  • Focusing on one substance, one assessment principle
  • Enhancing transparency with authorities and stakeholders

These actions will ensure that industries comply with regulatory requirements and stakeholders are informed about chemical risks.

Any Other Relevant Information:

The IRS has achieved significant successes since its inception in 2019. Some key outcomes include:

  • Screening of 6,000 substances
  • Addressing almost all of the 4,100 high production volume chemicals
  • Identification of several substance groups that require regulatory risk management

These successes demonstrate the effectiveness of the IRS approach and highlight the importance of continued collaboration between stakeholders to manage chemical risks.

European Chemicals Agency (ECHA)

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