Europe Regulatory News

Companies that downgrade the tonnage band in their registrations after ECHA’s draft decision will need to prove the volume of their substance.     ECHA has updated the rules on tonnage bands ...

Companies that downgrade the tonnage band in their registrations after ECHA’s draft decision will need to prove the volume of their substance.    

ECHA has updated the rules on tonnage bands for dossier evaluation. If a downgrade in the tonnage band draft decision on the company’s dossier provided by ECHA a company downgrades its tonnage band, it will now have to show the proof for the new tonnage band.  

On the 27th of July ECHA announced that they will take into consideration any changes for tonnage bands made by companies in their dossiers. This means that after ECHA’s draft decision on a company’s dossier, it will now be required to communicate to ECHA the changes made to the dossier regarding tonnage bands and update their dossiers. In case of a downgrade in tonnage bands, it is furthermore required to provide proof showing the volume of the imported or manufactured substance for the previous year. 

When the adopted dossier evaluation decision is communicated to companies no further changes are allowed and the companies are expected to fulfil all information requirements as per the decision.  

On 26 July, 2022, the European Commission presented its monitoring framework for the EU’s eighth Environment Action Programme (EAP), which will apply up to December 2030. EU environment action progr...

On 26 July, 2022, the European Commission presented its monitoring framework for the EU’s eighth Environment Action Programme (EAP), which will apply up to December 2030. EU environment action programmes set out – in broad terms – the environmental priorities of the European Union as well as the actions to achieve them. The European Green Deal is a common part of the eighth programme, which was agreed by the Council of the EU and the European Parliament in April 6, 2022.  

One of the novelties of the 2020-2030 EAP relative to its predecessor is the establishment of a set of indicators to track progress on the objectives agreed upon. The European Commission will report yearly on the indicators. Annual reports will serve as a basis for EU institutions to consider whether developments on the ground align to the environmental ambitions of the Union.

The 6 objectives on which progress will be assessed are:

• Climate change mitigation
• Climate change adaptation
• A regenerative circular economy
• Zero pollution and a toxic free environment
• Biodiversity and ecosystems
• Environmental and climate pressures related to EU production and consumption

Progress on each objective will be assessed by between 2 and 5 indicators. Additional indicators will be included for the type of actions taken for advances towards the EAP’s overall vision of a society living within planetary boundaries by 2050.

Chemical management is an integral part of the EU’s environmental vision. While no specific indicators on the use of chemicals are yet included in the year-to-year set of indicators, existing data will be part of more in-depth evaluations to be carried out in 2024 and 2029. New indicators on chemicals (for instance, on the sustainable use of chemicals) will be developed, and may be considered for inclusion at a later stage.

Additionally, the European Chemicals Agency (ECHA) is developing a stand-alone monitoring framework dedicated to chemicals.

On 22 June 2022, the European Commission adopted a proposal to revise Directive 2009/128/EC on the sustainable use of pesticides. Adopted in 2009, the Sustainable Use of Pesticides Directive sought to...

On 22 June 2022, the European Commission adopted a proposal to revise Directive 2009/128/EC on the sustainable use of pesticides. Adopted in 2009, the Sustainable Use of Pesticides Directive sought to reduce the risks to human health and the environment arising from the use of pesticides in agriculture. To achieve these objectives, the Directive promotes the use of integrated pest management – a general approach to agriculture considering all available plant protection methods and techniques – and non-chemical alternatives to pesticides.

However, the implementation of the Directive in the EU Member States has been found to be insufficient to achieve its objectives. To address these shortcomings together with the consideration of the EU’s ambition in this area in line with the European Green Deal, the European Commission proposes to replace the Sustainable Use of Pesticides Directive with an enhanced regulation (which would therefore be directly applied across the European Union).

The new rules would build on the existing system by establishing binding reduction targets for the use of chemical plant protection products. These would be set at the Member State level within an overarching target of a 50% reduction by 2030 at the European level. Public authorities in the Member States would then be responsible to take measures to reduce pesticide use. An equivalent target is set for the reduction of the use of “more hazardous plant protection products” (namely, products containing active substances that have been designated as candidates for substitution under the Union’s plant protection product legislation).

In addition to the overall reduction targets, the use of all types of pesticides would be prohibited in what the regulation calls “sensitive areas” (such as public parks, gardens and paths, protected areas, or human settlements). Persons wishing to use pesticides within or near these areas would need to procure an authorisation, which may only be given where there is a “proven, serious and exceptional” risk of pests spreading and no other technically feasible alternatives are available.

Additionally, the regulation proposal contains several procedural provisions. These relate to the calculation of national targets, the drafting and implementation of national plans, the training and certification of operators involved in pesticide use, and the inspection of equipment for pesticide application.

The proposal adopted by the European Commission will now be scrutinized and debated by the European Parliament and the Council of the European Union, both of which must agree on a version that will then become law.

On July 6, 2022, at the meeting of CARACAL (the EU’s expert group bringing together the Competent Authorities for the REACH and CLP Regulations), the European Commission presented some of the option...

On July 6, 2022, at the meeting of CARACAL (the EU’s expert group bringing together the Competent Authorities for the REACH and CLP Regulations), the European Commission presented some of the options it is currently considering for the reform of the Registration and Authorisation regimes under REACH.

The revision of the REACH Regulation is one of the key ongoing processes in what comes to chemicals legislation. It is expected to address current shortcomings with the regulation’s implementation. It also seeks to bring it in line with the EU’s ambition for a pollution-free environment under the European Green Deal and the EU Chemicals Strategy for Sustainability, especially the operationalization of an “essential use” approach governing the acceptable uses of chemical substances.

Reform of the Authorisation and Restriction Regimes

Some of the key shortcomings that the review seeks to address are the slow pace, inflexibility, and overall complexity of both the authorisation and restriction procedures under REACH – which are its two main tools in what comes to phasing-out hazardous chemicals. Under Authorisation, Substances of Very High Concern (SVHCs) can generally only be used once an individual authorisation is obtained. Only the applicants for an authorisation benefit from it. Under Registration, on the other hand, general requirements for the use of specific substances are set (which all economic operators must respect).  

The Commission working paper discussed at the CARACAL meeting presented three options in relation to the Restriction and Authorisation regimes.  A first option would see the current system maintained, where substances can either be subject to Authorisation or Restriction and can be used in line with authorisations or restriction derogations.

A second option would merge authorisation and restrictions into one single system. While the procedures to identify SVHCs would remain the same, the outcome of this designation would be similar to that of restrictions (for instance, SVHCs would be included in the same Annex as restricted substances). In relation to this second option, the Commission is also deciding how the remaining possibilities for use would be established. In addition to the existing approaches (general pre-established rules and individual applications), a new possibility for authorisations benefitting all actors beyond the applicants is being considered. The new rules would apply to both SVHCs and restricted substances, which would essentially become the same group of substances.

A third and final option is to abandon the authorisation regime altogether and rely instead on restrictions as the main tool to enforce chemical legislation at the European level (complemented by national legislation).

Implementing “essential use” into EU Chemicals legislation

As regards the implementation of the “essential use” concept, the Commission restates that this implies that chemicals can only be used where they are necessary for health, safety, or the functioning of society, and where there are no acceptable alternatives. While this standard might not apply to all chemicals – the paper speaks about “the most harmful chemicals” – it clearly signals a push for more stringent chemicals regulation.

The idea of essential use would therefore be relevant when assessing applications for authorisation or when setting the general rules under restrictions. The Commission is considering several options to bring this concept into European law, ranging from the adoption of non-binding guidance to the introduction of legal changes replacing socio-economic analysis with essential use considerations.

The Commission is also considering two different procedures for this essentiality assessment. Under a first proposal, in cases where the availability of alternatives is hard to establish in a preliminary analysis by the ECHA secretariat, a committee composed of the Member States would decide on the essentiality of the use in parallel with the assessments in ECHA’s Socio-Economic Analysis and Risk Assessment Committees.  In the second option, the essentiality assessment by the Member States will be placed at the beginning of the process, and only unclear cases would be studied by ECHA’s Committee. 

While the fact that the Commission is still considering several options makes it hard for businesses to anticipate upcoming compliance implications, the options under consideration signal a commitment to advance toward the vision set out in the European Green Deal. Comprehensive chemical management and the phase-out of substances of concern is an essential part of the said vision and many of the ongoing changes point in that direction.

On 29 June 2022, the European Commission published its draft agenda for the second half of 2022. The agenda contains the meetings to take place between July and December 2022. Approval of a text at a ...

On 29 June 2022, the European Commission published its draft agenda for the second half of 2022. The agenda contains the meetings to take place between July and December 2022. Approval of a text at a joint meeting of all Commissioners is the last step for the Commission to formally adopt it as a proposal. Therefore, the topics to be discussed in meetings are an indication of what files the EU executive is expecting to advance on.

In relation to chemicals legislation, two key proposals are mentioned in the draft agenda. First, the revision of Regulation (EC) 1272/2008, on the classification, labelling and packaging of substances and mixtures (the CLP Regulation) will be discussed in late October according to the schedule. Second, new rules on intentionally added microplastics will be discussed in late November.

If progress on both initiatives aligns with these timelines, negotiations between the Parliament and the Council on these two key initiatives would be an important part of the legislative agenda in 2023.

Another key piece of legislation when it comes to chemicals – the revision of Regulation (EC) 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) – is not mentioned in the agenda. This could signal that it will be delayed and presented in 2023.

This would be consistent with the fact that, while all three initiatives have seen delays relative to their initial expected timelines, the CLP review and the microplastics proposal are more overdue than the REACH revision.

At the Green Economy Business Summit on June 8, 2022, it was highlighted that the successful implementation of the Chemicals Strategy for Sustainability (CSS) is "preconditioned" so that the European ...

At the Green Economy Business Summit on June 8, 2022, it was highlighted that the successful implementation of the Chemicals Strategy for Sustainability (CSS) is "preconditioned" so that the European chemical industry is able to keep its competitiveness.

Another underlined emphasis is their stand that for the timeline of REACH revision, there will be no compromising for the CSS as long as it is steered in the right way. The main concern discussed was the fear of decreasing the competitiveness of the bloc’s industry on the global market upon imposing the stricter regulation of chemicals in the EU.

The Commission is now working on a transition pathway to earn more time for the industry to adapt to any upcoming regulatory changes, intending to continue the new innovation and competitiveness the regulatory system has brought to the EU market and industries. Although several external factors such as the war in Ukraine has however hampered the measures under the CSS to be implemented holistically, the Commission expects no postponement, in general, to fulfil the EU’s toxic-free future.

According to two studies done by trade body, Cefic, regarding the potential impact of changes to REACH in 2021, it plans to increase hazard classes to the CLP Regulation and extension of the Generic Risk Approach (GRA) could possibly lead to a loss of 12% of the EU chemical portfolio by 2040. Plus, the introduction of a Mixture Assessment Factor (MAF) of ten could as well impose high costs for the industry, along with significant turnover losses and job losses.

Despite the conducted studies, it is believed that the transition pathway planned as a collaborative exercise with relevant stakeholders shall provide the industry with a clearer idea to manage and put things together by the end of 2022 ideally.

The Helsinki Chemicals Forum held from June 8 to 9, 2022 was a great success, from which key highlights of the industry were discussed brilliantly. This is a hybrid event, a first of its kind and ther...

The Helsinki Chemicals Forum held from June 8 to 9, 2022 was a great success, from which key highlights of the industry were discussed brilliantly. This is a hybrid event, a first of its kind and there were more than 200 international policymakers, industry representatives, NGOs and academicians who attended the event.

Some of the discussions centred around the need to accelerate chemical regulations, to define sustainable by design chemicals, to merge chemical risk management with circularity and climate policy objectives, to speed up the replacement of animal testing, and the role of a global science-policy interface panel.

The session on the integration of chemical risk management with circularity and climate policy objectives was moderated by Steve Van de Broeck, the director of REACH and Chemicals Policy, Cefic. This is called the 3Cs and it is aimed at helping the EU meet the EU Green Deal goals. This integration is possible but would not be a smooth one due to conflicting and competing interests such as short and long-term benefits and differences in environmental aims.

Following the panel discussion on replacing animal testing, there is a consensus that there is a need to replace animal testing and most regulations are now tilting towards its replacement. Animal testing is time consuming, expensive, and sometimes not accurate to speculate the chemical effects on humans. Although new approach methods (NAMs) are coming up, their implementation is slow and most regulatory bodies need assurance that these NAMs are as effective as the use of animals for testing.

Also, NAMs are more readily available for endpoints such as aquatic toxicity and genotoxicity which is not the same for the more challenging endpoints such as carcinogenicity, immunotoxicity, and endocrine disruption.

A key update regarding animal testing is the project set up by the European Partnership for Alternative Approaches to Animal Testing (EPAA). The project ‘Use of NAMs for regulatory decisions on chemical safety’ has workstreams that are studying the application of NAMs within the industry.

The full report can be accessed here.