Europe Regulatory News

On 22 April 2024, the European Commission adopted criteria outlining what constitutes ‘essential uses’ of the most harmful chemicals (‘Guiding Criteria and Principles for the Essential Use Conce...

On 22 April 2024, the European Commission adopted criteria outlining what constitutes ‘essential uses’ of the most harmful chemicals (‘Guiding Criteria and Principles for the Essential Use Concept in EU Legislation Dealing with Chemicals’). This move aims to improve health and environmental protection by accelerating the phase-out of non-essential uses while allowing time for substitution in essential cases.

What is an essential use

In the Communication published on 22 April, the Commission defines that a use of a most harmful substance is essential only if both of the following two criteria are met:

1. Its use is necessary for health or safety or is critical for the functioning of society.

2. There are no acceptable alternatives.

The concept of essential use will only have legal effect if it is included in specific legislation which is currently not the case in the EU.

Most harmful chemicals

A most harmful substance has one or more of the following hazard properties:

• Carcinogenicity Category 1A and 1B.

• Germ cell mutagenicity Category 1A and 1B.

• Reproductive/developmental toxicity Category 1A and 1B.

• Endocrine disruption Category 1 (human health).

• Endocrine disruption Category 1 (environment).

• Respiratory sensitisation Category 1.

• Specific target organ toxicity – repeated exposure (STOT-RE) Category 1, including immunotoxicity and neurotoxicity.

• Persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB).

• Persistent, mobile and toxic/very persistent and mobile (PMT/vPvM).

• Hazardous to the ozone layer Category 1.

Use necessary for health and safety

The use of a most harmful substance is necessary for health or safety if the use and the technical function of the substance in that use are necessary in order to:

• Prevent, monitor or treat disease and similar health conditions.

• Maintain essential conditions for human or animal life and health.

• Manage health crises and emergencies.

• Ensure personal safety.

• Ensure public safety.

These elements are described in the Annex to the Communication (Table 2).

Uses critical for the functioning of society

The use of a most harmful substance is critical for the functioning of society if the use and the technical function of the substance in that use are critical in order to:

• Provide resources or services that need to be maintained for society to function (e.g. ensure the supply of energy and critical raw materials or resilience to supply disruptions).

• Manage societal risks and impacts of natural crises and disasters.

• Protect and restore the natural environment.

• Undertake scientific research and development.

• Protect cultural heritage.

These elements are described in the Annex to the Communication (Table 3).

Definition of ‘use’

In the context of the essential use concept, 'use' applies to substances in various forms, including mixtures, articles, products or processes. It covers activities such as processing, formulation, consumption, storage, treatment and production. The assessment of essentiality takes into account both the technical function of the substance and the context of its use. A substance may be essential for one product, but not for another.

Integrating essential use into legislation

The Communication outlines the guiding principles and criteria for the concept of essential use, with the aim of incorporating it into EU legislation in a harmonised way. The legal effect of the concept will only be achieved through its inclusion in legislation, a process which depends on impact assessments.

At present, the essential use concept is not part of the REACH regulation and therefore does not influence initiatives such as the restriction of PFAS. Nevertheless, the Communication reaffirms the Commission's commitment to phasing out harmful substances while recognising their essential societal role, particularly in the green and digital transition.

The European Commission is in the process of amending the regulatory frameworks governing plastic materials and articles intended for food contact. A feedback period on a draft regulation ended recent...

The European Commission is in the process of amending the regulatory frameworks governing plastic materials and articles intended for food contact. A feedback period on a draft regulation ended recently and the amendments are planned to be adopted in the fourth quarter of 2024.

Aimed at improving food safety and environmental standards, these amendments will update Regulation (EU) No 10/2011 and Regulation (EC) No 2023/2006 and include provisions for the use of recycled plastics and refinement of quality control measures across the EU.

Key highlights of the draft regulations include:

- Clarification on Plastic Materials: The new regulations will address ambiguities in the current legislation by redefining "plastic layers" to ensure broader coverage of all plastic materials and articles, thereby strengthening safety measures.

- Use of Recycled Plastics: To promote sustainability, the updated rules will specify the conditions under which recycled plastics can be used in food contact materials, ensuring that they meet stringent safety standards to prevent chemical migration into food.

- Purity and Safety: The amendments emphasize the high level of purity required for materials used in food contact articles. This includes detailed purity specifications for natural and synthetic substances to protect consumer health from potential chemical contamination.

- Biocidal Products: The new framework will align with Regulation (EU) No 528/2012 which outlines the use of biocidal products in the manufacture of food contact materials, ensuring that all substances used are authorized and safe for food contact.

- Increased Transparency: Manufacturers will be required to provide detailed documentation of compliance to enforcement authorities, improving traceability and accountability in the manufacturing process.

- Consumer Information: The regulations will also enforce clearer labelling requirements to inform consumers on the safe use of plastic food contact materials, especially those intended for repeated use, to avoid deterioration and potential health risks.

Impact on Manufacturers and Consumers

Manufacturers will need to adapt to these stricter controls which may increase production costs due to higher purity standards and more rigorous testing requirements. However, these changes are expected to benefit consumers by providing greater assurance of the safety and quality of food contact materials in the EU.

Regulatory Transition and Implementation

The amendments will provide a transitional period for manufacturers and businesses to comply with the new standards, allowing products that comply with the previous regulations to be marketed until stocks are exhausted. This phased approach aims to minimize disruption to the supply chain while maintaining a high level of  public health and food safety protection.

Conclusion

This regulatory update underscores the EU's commitment to public health, environmental sustainability and the highest safety standards for food contact materials. By incorporating modernized procedures and stringent controls, the EU continues to lead in comprehensive consumer safety and environmental protection initiatives.

On 23 April 2024, the European Parliament approved new EU rules to initiate a more sustainable era of product design and consumption.  Key Highlights:  Ecodesign Directive: The European Parlia...

On 23 April 2024, the European Parliament approved new EU rules to initiate a more sustainable era of product design and consumption. 

Key Highlights: 

Ecodesign Directive: The European Parliament has adopted new regulations aimed at embedding sustainability into product design and manufacturing processes. These rules will revolutionize the way products are made and used, promoting a more circular economy and reducing environmental impact. 

Ambitious Targets: The new regulations set ambitious targets for products across a range of sectors, including electronics, textiles and construction. These targets will encourage manufacturers to prioritize sustainability and longevity in their designs, leading to products that are more energy -efficient, durable, and recyclable. 

Consumer Benefits: Consumers can expect a number of benefits from these new rules. From reduced energy bills to longer-lasting products and increased access to repair services, the changes are designed to empower consumers and encourage more sustainable consumption habits. 

Global Impact: The EU's commitment to sustainable product design not only benefits European citizens, but also sets a precedent for global environmental action. By leading the way in eco-friendly product regulation, the EU is encouraging other countries to follow suit and prioritize sustainability in their own industries. 

What's Next: 

With these new rules in place, the EU is poised to make significant strides towards a more sustainable future. By embracing eco-friendly product design and manufacturing practices, we can create a world where sustainable products are the norm rather than the exception. 

On 23 April 2024, the European Parliament endorsed the "Right to Repair" initiative. This initiative aims to make repairs more accessible and appealing to consumers across the EU.  Background:  ...

On 23 April 2024, the European Parliament endorsed the "Right to Repair" initiative. This initiative aims to make repairs more accessible and appealing to consumers across the EU. 

Background: 

With the proliferation of electronic devices and appliances, the issue of electronic waste has become increasingly pressing. The "Right to Repair" initiative addresses this challenge by encouraging manufacturers to design products that are easier to repair and maintain. By extending the life of products, this initiative aims to reduce electronic waste and promote a circular economy. 

Key Points: 

Access to Spare Parts: The new rules proposed by the EU Parliament would require manufacturers to provide access to spare parts and repair information for their products. This would enable consumers to repair their devices rather than throw it away when it breaks down. 

Improved Reparability: Manufacturers would be required to design products with repairability in mind, ensuring that components are easily accessible and replaceable. This would not only benefit consumers but also encourage innovation in product design and engineering. 

Consumer Rights: The "Right to Repair" initiative emphasizes consumer rights and gives individuals more control over the products they purchase. By empowering consumers to repair their devices, this initiative promotes sustainability and reduces reliance on disposable products. 

Environmental Impact: By reducing electronic waste and encouraging sustainable consumption habits, the "Right to Repair" initiative contributes to environmental protection efforts. It is in line with the EU's wider objectives of combating climate change and promoting a greener economy. 

Next Steps: 

The proposed rules for the "Right to Repair" initiative will now be subject to further deliberation and negotiation within the EU legislative process. If adopted, these rules have the potential to transform the way products are designed, manufactured, and consumed across the European Union. 

Conclusion: 

The "Right to Repair" initiative is an important step towards creating a more sustainable and consumer-friendly economy. By promoting repairability and empowering consumers, the EU Parliament is paving the way for a future where products are built to last, and electronic waste is minimized.

In a plenary session on 23 April 2024, the European Parliament adopted a provisional political agreement with the EU countries to update the Classification, Labelling and Packaging (CLP) regulation. T...

In a plenary session on 23 April 2024, the European Parliament adopted a provisional political agreement with the EU countries to update the Classification, Labelling and Packaging (CLP) regulation. This revision aligns with the EU's broader Chemicals Strategy for Sustainability, aiming to strengthen and simplify the legal framework for chemicals and promote a sustainable and competitive environment.

As part of the revision a delegated regulation implementing new hazard classes for chemicals and criteria for classification, labelling and packaging of substances and mixtures entered into force on 20 April 2023.

Key highlights of the updated CLP regulation include:

• Mandatory uniform and adequate classification of all hazardous chemicals in the EU.

• Implementation of more accessible and understandable labels, including for products sold online.

• Improved identification and classification of hazardous chemicals to better communicate chemical hazards and address legal gaps and non-compliance issues.

The full text of the update can be found here.

Next Steps

The law is now set for adoption by the Council, followed by publication in the EU Official Journal. It will enter into force 20 days after publication, marking a significant increase in the level of consumer and the environment protection.

In a report published on 17 April 2024, the European Environment Agency (EEA) and the European Chemicals Agency (ECHA) have presented their joint assessment of chemical pollution across Europe. The re...

In a report published on 17 April 2024, the European Environment Agency (EEA) and the European Chemicals Agency (ECHA) have presented their joint assessment of chemical pollution across Europe. The report (EU indicator framework for chemicals) shows a mixed picture: while progress has been made in some areas, there is still much to be done to ensure the safety and sustainability of chemicals.

In the face of increased scrutiny, authorities have stepped up their evaluation of industrial chemicals under EU legislation. This increased oversight has led to a better understanding of the hazardous properties of various substances, and to proactive measures to mitigate risks.

Despite these efforts, the use of the most harmful chemicals, particularly those with carcinogenic, mutagenic and reprotoxic properties, continues to grow, albeit at a slower rate than the overall chemicals market. Pressure is mounting to phase out substances of very high concern and to adopt the principles of the Safe and Sustainable by Design (SSbD) framework.

Urgent Calls for Stronger Safety Measures

The report highlights the need to protect consumers from hazardous substances, including endocrine disrupters and persistent, bioaccumulative and toxic chemicals. However, gaps remain in the data and information needed to fully understand human and environmental exposure to these harmful compounds.

Leena Ylä-Mononen, Executive Director of the European Environment Agency, said: “While chemicals have a positive role to play in our lives, further action is urgently needed to address the risks posed by the use of unsafe and unsustainable substances. The knowledge generated in this assessment will help us shift to safe and sustainable chemicals in the future.”

Sharon McGuinness, Executive Director of the European Chemicals Agency, added: “We need to accelerate the transition towards safe and sustainable chemicals. Actions by authorities and industry has helped to minimise and control the risks from hazardous chemicals. But we need to further increase our knowledge on chemicals and support risk management of groups of chemicals to protect people and the environment.”

Key Findings and Way Forward

The key findings of the assessment show both progress and continuing challenges. While action has been taken to minimise risks from hazardous chemicals, there is little evidence of progress in eliminating substances of concern from waste and secondary materials.

Efforts to reduce emissions of harmful chemicals to water and air have had some success, but further action is needed to ensure that concentrations do not pose a threat to human health or the environment.

Human biomonitoring is emerging as an important tool for understanding chemical exposures and assessing associated health risks, underscoring the importance of continued vigilance in chemicals management.

Indicator Framework for Chemicals

The EU's Chemicals Strategy for Sustainability (CSS) aims to address the challenges posed by the production and use chemicals through innovation, strengthened regulations, and knowledge-building initiatives. The EEA, ECHA and the European Commission have developed a set of key indicators presented in this report, to support the objectives of the strategy.

Chemicals Indicator Dashboard

Together with the report, the EEA has launched a tool developed with ECHA, the European Commission and several other European agencies: the Chemicals Indicator Dashboard.

The Chemicals Indicator Dashboard consists of 25 quantitative indicators that provide insights into the drivers and impacts of chemical pollution in the EU. These indicators are supported by 22 signals, which provide additional insights, including qualitative and/or quantitative data, and may highlight emerging trends or phenomena that merit further investigation, even if data coverage is incomplete.

Together, the indicators and signals provide a robust framework to help decision-makers make informed choices and drive policy towards the goal of a toxic-free environment, ensuring the safety and well-being of both people and ecosystems.

The full text of the report is available here and more information on the indicator dashboard can be found here.

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."