Europe Regulatory News

A proposal to restrict per- and polyfluoroalkyl substances (PFASs) under the European Union's chemicals regulation, REACH, has been submitted to the European Chemicals Agency (ECHA) by the nationa...

A proposal to restrict per- and polyfluoroalkyl substances (PFASs) under the European Union's chemicals regulation, REACH, has been submitted to the European Chemicals Agency (ECHA) by the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden . 

The detailed proposal will be published by ECHA on February 7th, 2023. This proposal comes after the five authorities identified risks in the manufacture, placement on the market, and use of PFASs that need to be addressed throughout the EU and European Economic Area. ECHA will run the necessary administrative checks before the proposal and supporting documents are made available. 

The next steps include a scientific evaluation by ECHA's scientific committees for Risk Assessment and Socio-Economic Analysis in March 2023, followed by a six-month consultation starting on March 22nd, 2023. The final opinions will be sent to the European Commission and EU Member States for a decision on a potential restriction.  

On 17 January 2023, the European Chemicals Agency (ECHA) announced that 9 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) because of their hazardous propertie...

On 17 January 2023, the European Chemicals Agency (ECHA) announced that 9 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) because of their hazardous properties. This means that the Candidate List now contains 233 entries.

SVHCs are substances that can have serious and often irreversible effects on human health and the environment. A substance that is identified as an SVHC will be added to the Candidate List for eventual addition to the Authorisation list. Some of the entries in the Candidate list are groups of chemicals, so the overall number of impacted chemicals is higher. The Authorisation list has 59 entries. If a substance is on the Authorisation list, its use is prohibited unless the European Commission grants authorisation for continued use.

Under REACH there are legal obligations when it comes to substances in the Candidate List. Suppliers must give their customers and consumers information if their articles contain more than 0.1 % (weight by weight) of a Candidate List substance. Consumers have the right to ask suppliers whether their products contain SVHCs. Suppliers of substances on the Candidate List, either on their own or in mixtures, have to provide a Safety Data Sheet to their customers.

Importers and producers of articles that contain a substance from the Candidate List must notify ECHA within six months from the date the substance has been added to the List.

The uses of the nine new entries to the Candidate List are for example in flame retardants, paints and coatings, inks and toners, coating products, plasticisers, and in the manufacture of pulp and paper. The substances are for example very persistent and very bioaccumulative (vPvB), carcinogenic, toxic for reproduction,  or have endocrine disrupting properties. The new entries included on 17 January 2023 are listed below.

On 13 December 2022 the European Chemicals Agency (ECHA) released a draft of their annual update for the Community Rolling Action plan (CoRAP). Registrants are encouraged to check the draft list of su...

On 13 December 2022 the European Chemicals Agency (ECHA) released a draft of their annual update for the Community Rolling Action plan (CoRAP). Registrants are encouraged to check the draft list of substances planned for evaluation in 2023 and update their dossiers to include all relevant information before March 2023.

The draft CoRAP covers the next three years i.e. 2023-2025. The draft plan was submitted to the Member State Competent Authorities and the ECHA Member State Committee on 30 November 2022. The Committee is expected to give its opinion in February 2023 and ECHA aims to adopt and publish the CoRAP update on 21 March 2023.

The Community Rolling Action Plan contains substances that are suspected to pose a risk to human health and the environment. Substance evaluation is the process under REACH Regulation (EC) No 1907/2006 (Articles 44 to 48) that makes it possible to clarify such potential risks.

The draft CoRAP contains 24 substances of which 6 substances are new compared to the current CoRAP 2022-2024. Evaluation of 5 substances is planned for 2023 and the remaining 19 will be divided for evaluation in 2024 and 2025.

The following information is included in the draft CoRAP:

• Non-confidential substance names
• The EC/List numbers and CAS RN
• The initial grounds for concern
• Contact details for the Member State that intends to conduct the substance evaluation

The complete list of substances included in the CoRAP 2023-2025 can be found here.

The Safe and Sustainable by Design (SSbD) is a design, development, production, and use strategy for chemicals and materials that emphasises delivering the desired function (or service) while avoiding...

The Safe and Sustainable by Design (SSbD) is a design, development, production, and use strategy for chemicals and materials that emphasises delivering the desired function (or service) while avoiding or minimising detrimental effects on human health and the environment.  

The SSbD idea incorporates elements for the domain of chemical and material safety, circularity, and functionality, with sustainability consideration throughout their existence, minimising their environmental impact. 

The concept "Safe and Sustainable-by-Design" covers four areas: 

1. Going climate neutral 

2. Driving the circular economy 

3. Enhancing the quality of life 

4. Scaling up digital and tech 

In accordance with the SSbD concept, chemicals are produced/used in a way that maximises their benefits to society while avoiding harm to the planet and people. The production and use of safe and sustainable chemicals in Europe has become a benchmark worldwide. Chemical markets as well as chemical innovation are expected to be shaped in the future by the concept of SSbD. The concept should advance the creation of chemicals that are safe for people and the environment, provide a smaller environmental impact, and provide the expected performance and value to stakeholders along the entire value chain. It should be based on the most recent cutting-edge scientific research. 

On the 8th of December 2022, the European Commission published a “Recommendation” and an “Annex” that together constitute the long-awaited SSbD framework. The SSbD framework contains methods for assessing safety and sustainability features of chemicals.   The European Commission encourages all market stakeholders to use the “Recommendation” in their research and innovation activities. The “Recommendation” is launched at a testing phase with voluntary reporting. 

 The development is guided by the principles outlined in the Annex, which are to be used by industry and other stakeholders. For example, to prevent unfortunate substitutes, a hierarchy that prioritises safety is established. In addition, 'cut-off' criteria for the design of chemicals and materials must be established in order to encourage sustainable research and development. This would be based on the information cited in the chemical regulations of the EU as well as information that is not covered by those requirements, making the best possible use of the information on negative effects. Likewise, to assess the expected likelihood of having a negative impact on human health or the environment, every new chemical or material should be thoroughly compared to existing compounds that are structurally or functionally similar. Additionally, the supply chain should be informed of the SSbD actions taken, and all pertinent and non-confidential data should be made available in a high-quality findable, accessible, interoperable and reusable (FAIR) format for greater transparency and accountability. 

The outcomes from the current framework will direct efforts to build grading systems and standards as well as criteria for "Safe and Sustainable by Design." The Commission will begin the process of developing the criteria during the review stage of the input evaluation. The official criteria will most likely be published in 2025. 

On 1 December 2022, the Swedish Chemicals Agency (KEMI) published an announcement asking the government for more funding to ensure that Sweden can fulfil the demands of EU’s Market Surveillance Regu...

On 1 December 2022, the Swedish Chemicals Agency (KEMI) published an announcement asking the government for more funding to ensure that Sweden can fulfil the demands of EU’s Market Surveillance Regulation. This regulation that came into force in July 2021, establishes new processes and frameworks for market surveillance, customs, and regulatory enforcement authorities from each member state to work together to take non-compliant articles off the EU market.

In the future KEMI wants to strengthen and expand market control in the chemical sector to better protect human health and the environment and create fairer competition for companies on the Swedish market

KEMI is planning to implement the following measures to make it easier for the companies to act in accordance with the regulations:

• Increase the quantity of inspections and analyses of chemicals and biocides
• Systematic follow-up of companies that have previously failed during inspections
• Increase the development of methods for controlling markets
• Develop and adapt guidance rules for the municipalities that perform parts of the market controls
• Collaborate with Swedish customs to identify companies that have not previously been inspected.

The request for extra funding is a result of the budget for 2023-2025 that was recently unveiled by Sweden’s new right-wing government. The budget allocated to KEMI was lower than expected. The budget decisions follow the government’s decision to close the Ministry of the Environment as a separate ministry.

KEMI is one of five European authorities (together with Germany, Denmark, the Netherlands, and Norway) that are preparing a restriction proposal covering all per- and polyfluoroalkyl substances (PFASs) which is expected in January 2023.

Tetrabromobisphenol A (TBBPA) is a potent flame retardant used in numerous appliances and is a major pollutant in households and ecosystems. It is the most widely used Bromophenolic flame retardant (B...

Tetrabromobisphenol A (TBBPA) is a potent flame retardant used in numerous appliances and is a major pollutant in households and ecosystems. It is the most widely used Bromophenolic flame retardant (BFR). TBBPA was thought to account for over 60% of all BFR production globally in 2004, with the yearly production in the United States, Japan, and Israel reaching about 170,000 tonnes. 

TBBPA is produced in large quantities, and as a result, it has been found in both terrestrial and aquatic environments as well as in air and inhaled dust. It has been demonstrated to have an impact on thyroid signaling, neurodevelopment, and the hypothalamic-pituitary-gonadal axis in vertebrates. Particularly at the level of transcriptome reprogramming, the molecular phenotype brought on by TBBPA exposure is only sketchily defined. 

TBBPA influences a significant number of genes, according to research from the National Museum of Natural History in Paris that applied a systems biology method to analyse experimental data on rodent stem cells. Surprisingly, they also discovered the following "hotspots of action": 

1. at the level of immune system operations  

2. at the level of neural development indicators  

The most well-known effects are related to its neurotoxicity and its impact on reproduction and the hypothalamo-pituitary-gonadal axis. Three weeks old mice exposed through maternal milk of mothers fed with high doses of TBBPA resulted in neurological and behavioral alterations. TBBPA also affects the nervous system. A high throughput toxicity test of a bank of 84 compounds identified TBBPA as a selective toxicant targeting dopaminergic neurons of midbrain-like tissues grown as organoids. 

TBBPA has the ability to impair not just the homeostatic balance of multiple endocrine pathways and neural development, but also the primary system defending body integrity from aggressors and the potential to cause cancer, hence Norway has asked Echa to designate it as a substance of very high concern (SVHC). In accordance with the Community Rolling Action Plan (Corap) of the EU, Denmark is also testing the drug for endocrine-disrupting characteristics. 

Electronic and electrical products contain several hazardous substances, including lead, mercury and other metals, flame retardants, and certain phthalates. During material extraction and manufacturin...

Electronic and electrical products contain several hazardous substances, including lead, mercury and other metals, flame retardants, and certain phthalates. During material extraction and manufacturing, workers and their surrounding communities may come into direct contact with hazardous chemicals. Further downstream, hazardous chemicals can be released from e-waste during disposal and recycling, directly affecting workers and entering ecosystems. 

The UN Environment Programme (UNEP) has produced guidance on how to incorporate chemical management in public procurement rules for electronics. The advice is primarily intended for decision-makers and project commissioners who establish technical specifications for the purchase of electronic items and services. The report suggests that public sector organizations clearly state how they plan to control chemicals and reduce negative effects. 

Moreover, the Strategic Approach to International Chemicals Management (SAICM), has released a new policy brief urging electronic product producers to adopt a progressive approach to chemicals of concern in e-products. According to SAICM's brief, there is currently a lack of transparency regarding the effects of chemicals on the environment, society, and human health. Hazardous chemicals in electronics and electrical products have been a priority sector within the work on chemicals in products by SAICM. The International Conference on Chemicals Management (ICCM) endorsed the addition to the Global Plan of Action of new activities related to hazardous substances within the life cycle of electrical and electronic products.