European Commission Proposes Changes to Prior Informed Consent Regulation

The European Commission has initiated a public consultation period for a new draft regulation aimed at updating the list of hazardous chemicals subject to international trade rules. This effort, part of the European Union's rigorous regulatory framework, aims to bolster global safety by preventing the unwarranted import of hazardous chemicals into non-EU countries and ensuring detailed information on the hazards, risks, and safe handling of these substances when exported.

Public Feedback and Engagement

The draft regulation is open for public feedback from 19 July 2024 to 16 August 2024. During this period, EU citizens, industry stakeholders, and civil society organisations are encouraged to share their opinions and comments. The feedback gathered will be instrumental in shaping the final regulation, ensuring it addresses a wide array of perspectives and concerns.

Aims of the Regulatory Update

The key objective of this update is to assist non-EU countries in better managing hazardous chemicals. By revising the list of regulated chemicals, the Commission aims to stay aligned with the latest developments in Union law and international conventions, such as the Rotterdam and Stockholm Conventions. The initiative underscores the necessity of international collaboration in reducing the risks posed by hazardous chemicals.

Substances in Scope

The draft regulation proposes the inclusion of several new chemicals to the list of controlled substances, reflecting recent scientific findings and regulatory decisions. Notable additions include:

Dihexyl Phthalate (CAS No. 84-75-3): A plasticizer used in the production of flexible plastics, identified for its potential reproductive toxicity.
Benfluralin (CAS No. 1861-40-1): A herbicide used to control annual grasses and certain broadleaf weeds, which has been restricted due to concerns over its environmental impact.
Metiram (CAS No. 9006-42-2): A fungicide used in agriculture, recognised for its potential to cause adverse health effects in humans and its persistence in the environment.
Dimethomorph (CAS No. 110488-70-5): A fungicide used to control downy mildew, noted for its potential environmental hazards.
Fenpropimorph (CAS No. 67564-91-4): A fungicide used in cereal crops, banned due to its potential risks to human health and the environment.
Abamectin (CAS No. 71751-41-2): An insecticide and miticide, which raises concerns for its potential effects on non-target species and human health.
Acrolein (CAS No. 107-02-8): A biocide used in water treatment, identified for its acute toxicity and environmental hazards.
Warfarin (CAS No. 81-81-2): An anticoagulant used as a rodenticide, noted for its high toxicity and risk to non-target organisms.

These substances have been classified as hazardous due to their potential risks to human health and the environment. The regulation requires that these chemicals can only be exported under certain conditions, ensuring importing countries are fully informed about the risks involved.

Recent and Ongoing Regulatory Measures

This update is part of a series of regulatory measures the Commission has undertaken over the past year. Several chemicals, including dimethomorph, oxamyl, and fenpropimorph, have been removed from the approval process or banned under various EU regulations. These actions demonstrate the Commission's dedication to upholding high safety standards and safeguarding public health and the environment.

Legal and Procedural Framework

The draft delegated regulation amends Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals. It is based on Article 23(4) of the regulation, which requires regular reviews of the chemical list based on new scientific and regulatory advancements. An expert group, including representatives from member states, the European Chemicals Agency, the chemicals industry, and civil society, has already reviewed and provided feedback on the draft.

Invitation to Contribute

The European Commission invites all interested parties to engage in the consultation process by submitting their feedback online. This inclusive approach aims to ensure that the final regulation is comprehensive, balanced, and considers the insights and concerns of all stakeholders.