Europe Regulatory News

After a long wait, the European Union (EU) is set to adopt a new regulation governing the approval of safeners and synergists (crucial ingredients in many pesticides) used in plant protection products...

After a long wait, the European Union (EU) is set to adopt a new regulation governing the approval of safeners and synergists (crucial ingredients in many pesticides) used in plant protection products. This long-awaited regulation is expected to be released in the ‘first quarter of 2024’.

Safeners and synergists are often combined with pesticides to:

• Protect crops from the harmful effects of the main pesticide ingredient (safener)

• Increase the effectiveness of the main pesticide ingredient (synergist)

Why New Regulations?

Safeners and synergists have previously flown under the radar, raising concerns about potential risks to public health and the environment. Current regulation hasn't adequately addressed these concerns and lacks specific data requirements for the authorisation of these substances.

Background

The initiative established data requirements for the authorisation of safeners and synergists, which were comparable to those for active substances under Regulation (EC) No 1107/2009. It also required the development of a work plan for the systematic, phased review of safeners and synergists already on the market when the Regulation went into effect. The European Commission published a draft Regulation on 22 November 2023. The European Commission was expected and received feedback from stakeholders, NGOs, and various associations & societies throughout Europe. The feedback period was 22 November 2023 to 20 December 2023.

Key changes in the draft Regulation! These include:

• Inclusion of recent scientific data.

• Establishes a work program to gradually review existing safeners and synergists used in plant protection products.

• Defines data requirements for approval, similar to those for active substances.

• Creates a list of all authorized safeners and synergists currently used in the EU.

• Allows interested parties to submit applications for approval of these substances under the new guidelines.

This new Regulation is expected to:

• Improve the safety assessments for safeners and synergists.

• Create a public list of authorized substances to improve transparency.

• Remove certain safeners and synergists from the market if they do not meet the safety criteria.

Overall, the new EU regulation represents a significant step towards ensuring the safety of pesticide ingredients and promoting environmentally responsible agricultural practices.

Source*

Disclaimer: ''The information presented in this article is based on public data and reports collected from various authorities. We do not claim direct involvement in the events described."

On 9 April 2024 the European Chemicals Agency (ECHA) announced that the new hazard classes in the Classification, Labelling, and Packaging (CLP) Regulation will be included in the IUCLID software. Fr...

On 9 April 2024 the European Chemicals Agency (ECHA) announced that the new hazard classes in the Classification, Labelling, and Packaging (CLP) Regulation will be included in the IUCLID software. From 29 April 2024, companies will be able to include information on these updated hazard classes in their IUCLID dossiers.

New CLP Hazard Classes

Following the adoption of a Delegated Act by the European Commission amending the CLP Regulation on 20 April 2023, Annex I of the CLP Regulation has been amended. In particular, the hazard class for endocrine disruptors (ED) was divided into two categories:

• Category 1: Known or presumed endocrine disruptors for human health.

• Category 2: Suspected endocrine disruptors for human health.

In addition, hazard classes were introduced for the following properties:

• Persistent, Bioaccumulative, and Toxic (PBT)

• Very Persistent and very Bioaccumulative (vPvB)

• Persistent, Mobile, and Toxic (PMT)

• Very Persistent, very Mobile (vPvM)

Labelling of substances under the amended Regulation will be mandatory from 1 May 2025. However, substances placed on the market before this date will not require compliant labelling until 1 November 2026. For mixtures, the corresponding dates are 1 May 2026 and 1 May 2028.

Updated IUCLID Software

This update of the IUCLID software will allow companies to incorporate data related to these hazards when preparing and submitting dossiers to ECHA under the CLP, REACH, and Biocidal Products Regulations.

Different transition periods have been given for substances and mixtures as described above. At the end of these periods, companies are required to indicate the classification of their substances or mixtures according to the new hazard classes when submitting information to ECHA.

While no changes have been made to the completeness check of REACH registrations in relation to the new hazard classes, the IUCLID Validation Assistant will prompt companies to enter this data where available. Additionally, ECHA is updating the dossier preparation manuals to provide guidance on the new IUCLID fields.

Expansion of the ECHA CHEM Database

ECHA's recently launched chemicals database, ECHA CHEM, will be extended in autumn 2024. This extension will include the revised Classification and Labelling Inventory, including the newly introduced hazard classes.

On 13 March 2024, the European Union took a significant step towards improving environmental transparency by advancing a proposal for a new regulation on environmental data collection. Entitled "Propo...

On 13 March 2024, the European Union took a significant step towards improving environmental transparency by advancing a proposal for a new regulation on environmental data collection. Entitled "Proposal for a regulation of the European Parliament and of the Council on reporting of environmental data from industrial installations and establishing and Industrial Emissions Portal" it sets out rules for the collection and sharing of environmental data from industrial installations.

Key to this legislation is the creation of an Industrial Emissions Portal, a publicly accessible online database. In line with the United Nations Economic Commission for Europe (UNECE) Protocol on Pollutant Release and Transfer Registers, the Regulation aims to increase public participation in environmental decision-making and to combat industrial pollution through improved monitoring.

The Industrial Emissions Portal

In line with the Commission's aim to improve environmental reporting, a new Industrial Emissions Portal has been developed to replace the European Pollutant Release and Transfer Register. This initiative, supported by the European Environment Agency, aims to provide the public with free online access to a comprehensive dataset on the environmental impact of industrial installations.

The Portal will provide integrated data, allowing easy comparison and informed decision-making on environmental issues. It will encourage better performance, track trends, and demonstrate progress in reducing pollution. Users will be able to access both aggregated and non-aggregated data, allowing for targeted searches and easy extraction for analysis.

Reporting Requirements

Under the proposed Industrial Emissions Portal, reporting will be required at the installation level to align with the reporting standards under the Industrial Emissions Directive (IED). Operators of industrial installations will be required to submit annual data not only on releases and transfers, but also on resource use (water, energy and raw materials).

This comprehensive reporting will make it possible to track progress in resource efficiency. Additionally, operators will have to provide contextual information such as annual production volume, number of employees, operating hours, and details of accidents resulting in releases. They must also indicate whether the facility is covered by other relevant EU legislation, such as the IED, the Urban Wastewater Treatment Directive, the Seveso III Directive and the Emission Trading System (ETS) Directive. These measures ensure robust and transparent reporting, promoting accountability and informed decision-making in environmental management.

On 25 March 2024, the European Chemicals Agency (ECHA) announced that enforcement authorities will check poison centre notifications (PCNs) of hazardous chemical mixtures in order to improve emergency...

On 25 March 2024, the European Chemicals Agency (ECHA) announced that enforcement authorities will check poison centre notifications (PCNs) of hazardous chemical mixtures in order to improve emergency preparedness. This initiative, agreed at the March meeting of ECHA’s Enforcement Forum, aims to ensure that suppliers are complying with the regulations requiring the notification of such substances.

Aim of the Checks

The main objective of these inspections is to protect human health by enforcing the obligation of chemical suppliers to inform national authorities about hazardous mixtures. This information is essential for poison centres to provide accurate advice in emergencies and to enable informed decisions by citizens and medical professionals.

Inspectors will verify the submission of notifications and examine mixture labels, along with Safety Data Sheets where necessary. The full scope of these inspections will be defined in the coming months.

Project Timeline

The inspections, scheduled to begin in January 2025 and run for six months, are designed to ensure that poison centres have accurate information for effective emergency response. A detailed report of the project's findings will be published by the end of 2025.

Background on the Enforcement Forum

The Enforcement Forum including its Biocides subgroup (BPRS), is a network of enforcement authorities from the European Union (EU) and the European Economic Area (EEA). They are responsible for coordinating the enforcement of the REACH, CLP, PIC, POPs and the Biocidal Product Regulations. The overall aim of these initiatives is to protect human health and the environment while ensuring a level playing field for companies across the EU market.

On 19 March 2024, the European Chemicals Agency (ECHA) published the Community Rolling Action Plan (CoRAP) for 2024-2026, which aims to identify substances suspected of posing a risk to human health a...

On 19 March 2024, the European Chemicals Agency (ECHA) published the Community Rolling Action Plan (CoRAP) for 2024-2026, which aims to identify substances suspected of posing a risk to human health and the environment. Substance evaluation is the process under REACH Regulation (EC) No 1907/2006 (Articles 44 to 48) that allows such potential risks to be identified. The 2024-2026 plan lists 28 substances to be evaluated by 11 Member State Competent Authorities.

ECHA has published a guidance document for registrants who need to update their dossiers with new relevant information such as hazards, tonnage, use and exposure.

Substances to be evaluated

The CoRAP includes 28 substances, 11 of which are newly allocated substances and 17 of which were already included in the previous CoRAP 2023-2025. For 11 of the previously included substances, the evaluation year has been postponed, mainly to await the submission of new information requested as part of the dossier evaluation.

Evaluation of 10 substances is scheduled for 2024 (including evaluation of 4 substances as a group), 13 in 2025 and 5 in 2026. It is important to note that the schedule for 2025 and 2026 may be adjusted in subsequent CoRAP updates.

One substance previously listed in CoRAP 2023-2025, tris[2-chloro-1-(chloromethyl)ethyl] phosphate (CAS No 13674-87-8), has been withdrawn from CoRAP  due to the current low priority of the substance evaluation. A compliance check is required for this substance before evaluation can proceed.

The full list of substances included in CoRAP 2024-2026 can be found here.

More about CoRAP and the Substance Evaluation Process

A description of the Community Rolling Action Plans and the substance evaluation process can be found on ECHA’s website. ECHA encourages interaction between registrants and Member State Competent Authorities to address any concerns related to the substances under evaluation. This applies in particular to the substance to be evaluated in 2024. The contact details of the Member State Competent Authority are provided for each substance in the CoRAP.

On 13 March 2024, the European Parliament adopted proposals to better prevent and reduce food and textile waste across the EU.  Objectives:  The proposed amendments to the Waste Framework Dire...

On 13 March 2024, the European Parliament adopted proposals to better prevent and reduce food and textile waste across the EU. 

Objectives: 

The proposed amendments to the Waste Framework Directive (WFD) focus on two resource-intensive sectors: textiles and food. The main objectives are to reduce the environmental and climate impacts associated with waste management and to prevent food waste, thereby contributing to improved public health and food security. 

Background: 

The EU generates a significant amount of waste each year, including 60 million tonnes of food waste and 12.6 million tonnes of textile waste. Clothing and footwear alone contribute 5.2 million tonnes of waste annually, highlighting the urgent need for action. Despite these alarming figures, less than 1% of the world’s textiles are recycled into new products. 

Key Proposals: 

Tougher Food Waste Reduction Targets: The Parliament proposes higher binding waste reduction targets to be achieved by 2030, including at least a 20% reduction in food processing and manufacturing and a 40% per capita reduction in retail, restaurants, food services, and households. It also calls on the Commission to evaluate the feasibility of even higher targets for 2035. 

Extended Producer Responsibility (EPR) for Textiles: Producers selling textiles in the EU would be required to cover the costs of separate collection, sorting, and recycling. This extension of producer responsibility schemes aims to incentivize more sustainable practices within the textile industry. 

Conclusion: 

These measures represent a significant step forward in promoting circular economy principles and addressing waste management challenges in the EU. By adopting tougher targets and extending producer responsibility, the Parliament is demonstrating its commitment to achieving a more sustainable and environmentally friendly future. 

On 27 February 2024, the European Parliament approved revised EU procedures and control measures for waste shipments. The agreed regulation implements stricter measures to protect human health and the...

On 27 February 2024, the European Parliament approved revised EU procedures and control measures for waste shipments. The agreed regulation implements stricter measures to protect human health and the environment, while contributing to the EU’s climate neutrality, circular economy and zero pollution goals.  

Some background  

The rationale behind the adoption of this regulation stems from the significant increase in global waste trade, which reached 182 million tonnes in 2018, valued at approximately EUR 80.5 billion. This trade has witnessed substantial growth over the last decades, peaking at nearly 250 million tonnes in 2011. Within the EU, there has been a notable increase in waste exports to non-EU countries, totalling around 32.7 million tonnes in 2020, an increase of 75% since 2004 and a value of EUR 13 billion. The majority of exported waste consists of ferrous and non-ferrous metal scrap, paper waste, plastic waste, textile waste, and glass waste. Additionally, the EU imported approximately 16 million tonnes of waste worth EUR 13.5 billion. Moreover, intra-EU shipments of waste amount to around 67 million tonnes per year.  

While cross-border shipments of waste offer economic benefits as secondary raw materials that support the transition to a circular economy, they also pose risks to human health and the environment if not adequately regulated. Thus, the updated regulations aim to address these challenges while harnessing the economic potential of waste materials in a sustainable manner. 

Key Highlights 

Stricter Controls: The endorsed deal with the Council aims to improve the protection of the environment and human health while contributing to the EU's circular economy and zero- pollution goals. 

Export Restrictions: Exports of plastic waste to non-OECD countries will be prohibited within two and a half years after the regulation's entry into force, with stricter conditions for exports to OECD countries. 

Digitalisation of Information Exchange: The exchange of information and data on waste shipments within the EU will be digitalized through a central electronic hub, enhancing reporting and transparency. 

Enforcement Group: An enforcement group will be established to facilitate cooperation between EU countries and improve efforts to prevent and detect illegal waste shipments. 

The proposed revisions set out procedures and control measures based on various factors such as waste origin, destination, transport route, and treatment type. The adoption of this revision aligns with citizens' expectations that the EU will raise environmental standards for waste shipments and enforce stricter controls and sanctions to combat illegal exports. 

Next Steps: 

Following the final vote in plenary, formal endorsement by the Council is required before the text is published in the EU Official Journal. 

This significant development underlines the EU's commitment to promoting sustainability and environmental protection.