Europe Regulatory News

Under Annex VIII to the CLP Regulation, importers and downstream users placing hazardous mixtures on the EU market are to provide specific information on their mixtures to appointed bodies. The platfo...

Under Annex VIII to the CLP Regulation, importers and downstream users placing hazardous mixtures on the EU market are to provide specific information on their mixtures to appointed bodies. The platform for submission is called “Poison Center Notifications” (PCN), and companies dealing with certain hazardous chemicals and mixtures are obligated to report and provide information to it. On 31 August 2022 it was announced that Iceland has joined ECHA’s submission portal and from now on would accept PCN submissions through ECHA’s submission portal. It is expected that Bulgaria and Slovakia would join the ECHA’s submission portal. Currently, both countries remain unconnected to ECHA’s submission system. However, it is reported that both counties are in process of working through the onboarding procedure. 

The Original information regarding Iceland joining ECHA could be found on the following link: 

https://echa.europa.eu/view-article/-/journal_content/title/9109026-208 

More information regarding PCN and ECHA could be found on the following link: 

https://poisoncentres.echa.europa.eu/about-us 

The United Nation’s Environment Programme (UNEP) intersessional process on the Strategic Approach to International Chemicals Management (SAICM) and the sound management of chemicals and waste beyond...

The United Nation’s Environment Programme (UNEP) intersessional process on the Strategic Approach to International Chemicals Management (SAICM) and the sound management of chemicals and waste beyond 2020 held its fourth meeting between August 29 and September 2. 

SAICM is a global policy framework aimed at promoting the sound management of chemicals through all of their life-cycle. It brings together governmental, industrial and public-interest stakeholders to address effective chemicals management. The work of SAICM includes aspects relative both to specific approaches and measures to be taken and to their practical implementation (such as financing and capacity-building). The initial implementation of SAICM foresaw a 2020 completion date, but lagging uptake in many jurisdictions around the world means that continued work towards effective chemical management will be needed. 

To this end, the International Conference on Chemicals Management (ICCM) will discuss a post-2020 framework in its upcoming 5th Session. Work on the specifics of the post-2020 framework is being carried out in what’s known as the “intersessional process”. Kickstarted after the ICCM’s 4th session – which was held in late 2015 – the process brings together involved stakeholders to discuss the following points relative to the post-2020 global framework: 

• Targets, indicators and milestones 
• Governance and mechanisms to support implementation 
• Issues of concern 
• Financial considerations 

While work on these topics had been moved online due to the Covid pandemic, the 4th intersessional process meeting will be held in person in Bucarest, Romania. Discussions there will be followed by the 5th Session of the ICCM. This is the last ICCM Session planned under SAICM, and it was initially planned for 2020. It is currently scheduled to be held in person in Bonn, Germany, in 2023. 
 

In its recently held 60th session, the United Nations (UN) Sub-Committee of Experts on the Transport of Dangerous Goods adopted proposed amendments to the UN Model Regulations on the Transport of Dang...

In its recently held 60th session, the United Nations (UN) Sub-Committee of Experts on the Transport of Dangerous Goods adopted proposed amendments to the UN Model Regulations on the Transport of Dangerous Goods that would clarify the scope of test data sharing in the value chain. 

The Model Regulations are an effort by the UN to develop common approaches to the management of dangerous goods in transport. While not directly applicable, they seek to inform the development of national regulation. Under the Model Regulations, manufacturers and subsequent distributors have a duty to “make available” test summaries for lithium batteries or equipment containing them. 

The amendment proposal adopted by the Sub-Committee would add a note to the provision clarifying that the purpose of this requirement is to enable other actors in the supply chain to assess the compliance of the batteries. 

The Sub-Committee is a subsidiary body of the Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Chemicals. If the amendments are adopted, they would be incorporated into upcoming revisions of the Model Regulations. After that, it would fall upon national governments to incorporate changes in their legislation. 
 

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.