Europe Regulatory News

On 25 September 2024, the European Union notified the World Trade Organization (WTO) about a Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 on classification, labelling, a...

On 25 September 2024, the European Union notified the World Trade Organization (WTO) about a Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 on classification, labelling, and packaging (CLP) of hazardous substances and mixtures. The Regulation updates Table 3 of Part 3 of Annex VI to the CLP Regulation by introducing and revising the harmonised classification and labelling (CLH) of 32 substances or groups of substances.

Updated Substances

These updates are based on scientific opinions from the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC), which reviewed data on several chemicals. The substances are listed in the table below.

The list of updates with details about hazard classes can be found here. The substances were flagged for potential hazards, such as carcinogenicity, environmental toxicity, or serious health risks, which require stricter regulation in the EU.

Consultation Process 

The proposed changes were informed by public consultations managed by ECHA, where Member States and stakeholders provided feedback. Comments were taken into account in the final RAC opinions. Additionally, expert input was sought through the CARACAL group, which brings together Member States competent authorities responsible for REACH and CLP, as well as industry and regulatory stakeholders.

Main Objectives and Rationale 

The main objectives of the amendments are:

• To ensure the protection of human health and safety.

• Strengthen the protection of the environment by tightening regulations on hazardous substances.

• To facilitate the free movement of substances and mixtures in the EU by harmonising classifications at EU level.

Timeline for Adoption and Application 

The Regulation is expected to be adopted in the fourth quarter of 2024. It will enter into force 20 days after its publication in the Official Journal of the EU, probably in early 2025. A transition period of 18 months is included to allow companies time to adapt their labelling and packaging to the new requirements. However, suppliers will be able to voluntarily apply the new classifications once the regulation enters into force.

Next Steps and Stakeholder Involvement 

Stakeholders are invited to submit comments on the draft Regulation within 60 days of its notification. The final regulation will be shaped by the feedback received during this consultation period to ensure that the amendments address industry concerns while maintaining high safety standards.

Further Resources 

The full text of the Draft Commission Delegated Regulation is available here and the full list of substances is available here.

In a recent plenary session on 18 September 2024, the European Parliament blocked two European Commission decisions that would have allowed residues of pesticides currently banned in the EU in importe...

In a recent plenary session on 18 September 2024, the European Parliament blocked two European Commission decisions that would have allowed residues of pesticides currently banned in the EU in imported food products.

Details of the Blocked Decisions

The decisions concerned maximum residue levels (MRLs) for pesticides such as cyproconazole and spirodiclofen in cereals, seeds and meat products, as well as benomyl, carbendazim and thiophanate-methyl in citrus fruits and okra. These pesticides are highly toxic and are banned in the EU due to their serious health and environmental risks. Carbendazim, thiophanate-methyl and cyproconazole are classified as mutagenic, reprotoxic and endocrine disruptors, with the potential to harm human health and aquatic life. MEPs argued that allowing residues of these pesticides in imports would endanger public health and create unfair competition for EU farmers.

MEPs Call for Equal Standards

The resolutions stressed that products imported from non-EU countries should meet the same safety standards as those produced in the EU, to ensure a level playing field. The objection to the Commission’s decision on cyproconazole and spirodiclofen was supported by 522 MEPs, while 516 MEPs voted against the use of benomyl, carbendazim and thiophanate-methyl.

Next steps

The Commission must now withdraw its proposals and come forward with new draft that lower the MRLs to the limit of detection or set a default value of 0.01 mg/kg.

The European Commission has launched a call for evidence on its initiative to phase out animal testing in chemical safety assessments. The consultation is open from 17 September to 15 October 2024 and...

The European Commission has launched a call for evidence on its initiative to phase out animal testing in chemical safety assessments. The consultation is open from 17 September to 15 October 2024 and invites stakeholders to provide input on the transition to non-animal methods. Feedback can be given here.

European Commission Roadmap

This initiative follows the European Citizens’ Initiative (ECI) ‘Save Cruelty-Free Cosmetics’, which gathered over 1.2 million signatures. In response, the Commission published Communication C(2023) 5041, outlining its commitment to develop a roadmap detailing the actions and milestones needed to move towards an animal-free regulatory system.

The ECI, submitted on 25 January 2023, calls for legislative reforms to eliminate animal testing for regulatory and scientific purposes in the EU. The Commission aims to finalise the Roadmap by Q4 2025/Q1 2026 and thereby address the necessary steps to replace animal testing under various chemicals legislation, including REACH.

Challenges to be Addressed

Currently, animals are used to assess the safety of chemicals where there are no viable alternatives. Despite progress in developing alternative methods, challenges remain in assessing complex toxicities without animal testing. The Roadmap will seek to overcome these obstacles while ensuring the safety of human health and the environment.

Objectives of the Roadmap

The Roadmap will:

• Outline specific legislative and non-legislative actions to reduce and ultimately eliminate animal testing.

• Analyse the feasibility of establishing an expert scientific committee to support the transition.

• Promote the validation and international acceptance of non-animal test methods.

• Increase the visibility of EU agencies in global discussions on chemical safety.

Expected Impacts

Transitioning to animal-free methods is anticipated to accelerate chemical safety assessments and lower costs for both the industry and regulatory bodies. The initiative aims to improve clarity and certainty for stakeholders regarding the use of non-animal testing methods in regulatory contexts.

Conclusion

This initiative underscores the EU's commitment to animal welfare while ensuring a high level of safety for humans and the environment. By developing and implementing a roadmap to phase out animal testing, the Commission aims to foster innovation and maintain competitiveness in the chemicals market.

The S.T.O.P. Carcinogens at Work campaign is a European initiative to address the growing problem of workplace-related cancer, which is responsible for over 100,000 deaths in the EU each year. In part...

The S.T.O.P. Carcinogens at Work campaign is a European initiative to address the growing problem of workplace-related cancer, which is responsible for over 100,000 deaths in the EU each year. In partnership with among others the European Chemicals Agency (ECHA), this initiative provides companies and workers with practical tools to identify and reduce exposure to carcinogens in their working environments.

Workplace Cancer

In Europe, cancer is the leading cause of work-related death, accounting for more than half of all occupational deaths. Common workplace carcinogens include asbestos, benzene, formaldehyde and certain heavy metals. Exposure to these substances occurs in a wide range of industries, from manufacturing to construction and even healthcare. The campaign emphasises that many of these cancers are preventable if the proper precautions are taken.

Focus on Prevention

The S.T.O.P. initiative emphasises the importance of prevention. The website offers comprehensive guidelines, downloadable tools and awareness campaigns aimed at employers, health and safety professionals and workers. These resources help organisations identify hazardous materials, assess risks and implement control measures such as proper ventilation, use of protective equipment and substitution of harmful substances with safer alternatives.

Tools and Resources

The website provides free access to a range of tools to help reduce exposure to carcinogens. These include:

• Risk assessment checklists.

• Educational materials to raise awareness among workers.

• Best practice guidelines for the safe handling of hazardous substances.

In addition, the site offers case studies of successful reduction efforts in different sectors. Companies can use these examples as a model for their own safety strategies.

Legal and Regulatory Framework

The S.T.O.P. initiative is aligned with existing European legislation, particularly the EU’s Carcinogens and Mutagens Directive, which sets binding limits on the use of certain carcinogens. The website encourages employers to stay updated on regulatory changes and to ensure compliance by carrying out regular workplace assessments and employee training.

The campaign underlines that reducing occupational cancer risks is a shared responsibility between employers, workers and policy-makers. Working together is essential to create safer working environments and reduce the health burden caused by exposure to carcinogens.

For more information, visit: https://stopcarcinogensatwork.eu/

Today, 19 September 2024, the European Commission adopted new measures under the REACH Regulation to restrict the use of undecafluorohexanoic acid (PFHxA) and PFHxA-related substances, which are a par...

Today, 19 September 2024, the European Commission adopted new measures under the REACH Regulation to restrict the use of undecafluorohexanoic acid (PFHxA) and PFHxA-related substances, which are a part of the wider group of entire group of per- and polyfluoroalkyl substances (PFAS). These chemicals are highly persistent in water and pose risks to human health and the environment.

Targeted Product Bans Under the PFHxA Restriction

The restriction targets products where risks are not adequately controlled, and bans the sale and use of PFHxA in:

• Consumer textiles such as raincoats

• Food packaging such as pizza boxes

• Consumer compounds such as waterproofing sprays

• Cosmetics such as skin care products

• Firefighting foam applications for training and testing

Other applications such as semiconductors, batteries and green hydrogen fuel cells are not affected by the restriction.

Background on PFAS Chemicals

Per- and polyfluoroalkyl substances (PFAS), often referred to as "forever chemicals", are a large group of synthetic chemicals known for their extreme resistance to degradation in the environment. Due to their unique water- and grease-resistant properties, PFAS have been widely used in various industrial processes and consumer products, including non-stick cookware, waterproof textiles, food packaging and firefighting foams.

However, their persistence means that they accumulate over time in the environment and in living organisms, contributing to widespread contamination of soil and water, including drinking water supplies. This has raised significant concerns about the long-term effects of PFAS on human health, including links to cancer, endocrine disruption and immune system effects.

Key Objectives

The move is part of the EU’s wider effort to reduce PFAS emissions, as PFHxA often replaces the previously banned perfluorooctanoic acid (PFOA). The measure is based on scientific evaluations by the European Chemicals Agency (ECHA) and has been approved by the European Parliament and the Council.

Implementation Timeline

The restriction will enter into force 20 days after its publication in the Official Journal, with transition periods ranging from 18 months to 5 years, depending on the specific use, to allow industry to switch to safer alternatives.

Future Steps

While the current restriction specifically targets PFHxA and related substances, it is separate from the broader EU initiative to address the risks posed by the entire group of per- and polyfluoroalkyl substances (PFAS). The broader PFAS ban is currently being evaluated by the ECHA. This potential ban stems from a 2023 proposal by five European governments - Germany, Denmark, the Netherlands, Sweden and Norway - calling for significant restrictions on all PFAS chemicals due to their persistent environmental and health risks.

In April 2023, the European Commission introduced three new hazard classes under the Classification, Labelling and Packaging (CLP) Regulation. These new classifications aim to better protect human hea...

In April 2023, the European Commission introduced three new hazard classes under the Classification, Labelling and Packaging (CLP) Regulation. These new classifications aim to better protect human health and the environment by addressing specific hazards that were not fully covered under the existing Regulation.

New Hazard Classes Defined

The new hazard classes are: 

- Endocrine Disrupting Properties: Affects hormones and can cause reproductive, developmental and neurodevelopmental problems in humans and wildlife.

- Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) Properties: These substances persist in the environment, accumulate in organisms and are not easily broken down.

- Persistent, Mobile, and Toxic (PMT) or very Persistent and very Mobile (vPvM) Properties: These chemicals are highly mobile and persistent in the environment, with long-term effects that are still difficult to predict.

These hazards were introduced into the CLP Regulation because they were not adequatly covered by existing classifications. However, they are not entirely new to the Regulation. Endocrine disrupting and persistent, bioaccumulative and toxic properties have already been assessed under other regulatory frameworks, such as the Substance of Very High Concern (SVHC) process of the REACH Regulation, as well as the Biocides Products Regulation (BPR) and the legislation on plant protection products regulations. However, mobility is a relatively new considerationin European legislation.

New Obligations for Companies

With the addition of these new hazard classes, companies must assess their substances and mixtures to determine if they meet the new classification criteria. If they do, the following actions are required:

- Inform the European Chemicals Agency (ECHA): Update REACH registration dossiers with the new classification information.

- Notify Classifications: If a substance or mixture was not previously classified but now meets the new criteria, companies must notify the Classification and Labelling Inventory on the ECHA website.

- Poison Centre Notifications: Companies must also submit new poison centre notifications for mixtures that meet the criteria of the new hazard classes.

- Revise Safety Data Sheets: Safety data sheets must be updated to reflect the new classification, ensuring that accurate safety information is passed along the supply chain.

The IUCLID software was updated to include the new hazard classes on 29 April 2024. Since then, companies have been able to submit dossiers to ECHA containing information related to these new classifications.

Compliance Deadlines

To help companies adapt, the ECHA has set transition periods for the application of the new classifications as follows: 

- New substances: Compliance required by 1 May 2025. 

- Existing substances: Compliance required by 1 November 2026. 

- New mixtures: Compliance required by 1 May 2026. 

- Existing mixtures: Compliance required by 1 May 2028.

Support and Guidance

ECHA is currently updating its guidance to incorporate the new hazard classes, which is expected to be published in autumn 2024. In the meantime. companies can refer to existing guidance, such as the EFSA-ECHA guidance for endocrine disruptors and the REACH guidelines for PBT/vPvB assessments. The ECHA website also provides detailed support material, including main obligations, to help companies prepare or update their notifications.

Ongoing CLP Revisions 

An update of the CLP Regulation is also underway to further clarify classification rules and improve hazard communication. These changes will improve poison centre notifications, harmonised classification proposals, and online sales rules.

The Federal Office for Food Safety has issued an important reminder regarding the amended Fertilizer Act 2021 (DMG 2021), which has been in effect since October 1, 2021. This amendment includes an imp...

The Federal Office for Food Safety has issued an important reminder regarding the amended Fertilizer Act 2021 (DMG 2021), which has been in effect since October 1, 2021. This amendment includes an important regulation on the time limit for the approval of fertilizers, soil improvers, growing media and plant additives. This Act specifically regulates the approval and marketing of fertilizers, soil improvers, growing media and plant additives within Austria.

Products approved for an unlimited period according to Section 9a of the Fertilizer Act 1994 must be re-approved or removed from the market by January 1, 2025.

Action Required: To continue marketing these products after the deadline, a new application for approval must be submitted.

Application Process: Applications for “Re-approval of previously approved fertilizer products according to Section 9a of the DMG 1994” should be submitted via the BAES homepage. Make sure to upload the previous admission letter under the “Other” category for procedural efficiency.

Fertilizer Approvals: Austria 2025 Regulation aims to ensure that all fertilizers, soil improvers, growing media, and plant additives meet current safety and quality standards. Stakeholders are urged to take prompt action to comply with the new requirements and avoid disruptions in the availability of their product.

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