Europe Regulatory News

The European Commission is extending an ongoing consultation by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the presence of cobalt in toys until September 8, 2022....

The European Commission is extending an ongoing consultation by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the presence of cobalt in toys until September 8, 2022. 

The consultation is part of an evaluation on the permissibility of the use of cobalt in toys under the provisions of Directive 2009/48/EC (the Toy Safety Directive). Under the Directive, CMR substances can not be used in toys unless: 

• Their concentration is below under the thresholds for classification, or
• There are inaccessible in any form when used as intended or in a foreseeable way, bearing in mind the behaviour of children, or
• A decision to authorize them for specific uses has been made under the Directive

The ongoing consultation refers to the third option. To take a decision to authorize the use of a CMR substance, three conditions are needed. 

• The substance must be found to be safe by a Scientific Committee (SCHEER in this case)
• There must be no suitable alternatives, and  
• The substances must not be prohibited for use in consumer articles under REACH 

Therefore, the analysis of SCHEER concerns the safety of the use of cobalt in toys, as well as the availability of alternatives. Interested stakeholders can submit their comments on SCHEER’s preliminary report, which finds that information available is insufficient, and recommends limits on the use of cobalt in products liable to inhalation. 

A similar consultation on a SCHEER opinion on the use of titanium dioxide in toys concluded on July 4, 2022. 

The push for safer toys and children’s products is part of the Chemicals Strategy for Sustainability. Consultations on the review of the Toy Safety Directive concluded on May 25, 2022, and adoption of the Commission’s proposal is expected before the end of the year. Additionally, consultations are ongoing for safety requirements in standards for children products under Directive 2001/95/EC (the General Product Safety Directive). 
 

Under the Chemical Strategy for Sustainability (CSS) plan (2020) the EU outlined a renewal of the UN Globally Harmonized System (GHS)chemical hazard classes for endocrine disruption and persistence.�...

Under the Chemical Strategy for Sustainability (CSS) plan (2020) the EU outlined a renewal of the UN Globally Harmonized System (GHS)chemical hazard classes for endocrine disruption and persistence.  

In the CSS strategy, the EU plans for the creation of new hazard classes for both GHS and the EU CLP Regulation. The EU has already started its work on the CLP proposal and it will be announced on the 26th of October. While the GHS formal proposal will come after – in December. There are several issues with this approach, however: 

1. The CLP system is based on GHS, therefore the more logical approach implies starting with a renewal of the GHS system rather than the CLP. 

2. The fact that the EU is working on a GHS proposal ahead of the UN, which is responsible for the GHS, creates confusion and threatens to disarray the international system. 

3. There is some scepticism on whether the new classes are needed since the current ones function well and how new hazard classes will regulate the animal-testing requirements in that case. 

All in all, it seems like the EU has taken the lead on the renewal of GHS for endocrine disruption and persistence classes, but we are yet to see how this will be applied in practice.  

The European Commission opened, on 5 August 2022, a consultation on the safety requirements to be met by standards applying to several categories of children products.  The draft Commission Deci...

The European Commission opened, on 5 August 2022, a consultation on the safety requirements to be met by standards applying to several categories of children products. 

The draft Commission Decision is adopted under the framework set up in Directive 2001/95/EC, known as the General Product Safety Directive. Under the Directive, the Commission can establish safety requirements to be met by product standards, which then must be incorporated into the standards adopted by European standardization bodies. 

The Commission proposal would establish safety requirements for standards concerning: 

• Products intended to be worn by children
• Products intended to facilitate seating, sleeping, bathing, body care, relaxation, transportation, and early learning 
• Products intended to facilitate feeding, drinking, or sucking 
• Products related to children’s products (accessories to the covered categories above, or products to be mounted or installed by adults which are accessible or offer protective functions to a child)

The safety standards address a broad range of hazards, such as chemical hazards, flammability hazards or hazards associated with the project’s parts. 

Despite the broad scope of the new standards, some product categories will not be covered by them. This is especially the case of toys, which are governed by their own piece of legislation (Directive 2009/48/EC, the Toy Safety Directive). The provisions of the General Product Safety Directive only apply to products to the extent that they are not covered by product-specific legislation. 

The Commission is also working on a revision of the Toy Safety Directive, for which public consultations concluded in May 2022.

Both the proposed standards for children’s products and the revision of the Toy Safety Directive are actions taken under the EU’s Chemicals Strategy for Sustainability, which applies the vision of the European Green Deal to the chemicals sector. You can learn more about the Chemicals Strategy for Sustainability by re-watching our recent webinar on the topic. 
 

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.