Europe Regulatory News

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.

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. 

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. 

Background  The European Parliament has long believed that heavy metal pollution must not be made worse by recycling polyvinyl chloride (PVC). Due to the voluntary commitment of the PVC industry i...

Background 

The European Parliament has long believed that heavy metal pollution must not be made worse by recycling polyvinyl chloride (PVC). Due to the voluntary commitment of the PVC industry in the EU, lead in PVC has been phased out in the EU since 2015; nonetheless, lead in PVC continues to enter the EU through imported products. 

In 2020, the adoption of a resolution by the Environment Committee objected to the European Commission's plan to change the laws governing lead concentration, in particular lead in PVC. Members of Parliament believe that the proposed changes fall short of adequately protecting the environment and human health, which is the main goal of the REACH regulation. The proposed regulation by the Commission would prohibit the use and presence of lead and its compounds in items made of PVC, a common synthetic plastic. It would set a lead content level of 0.1% by weight of the PVC material as the maximum. Additionally, it adds two exemptions. 

Revised draft 

The European Union (EU) has announced its intention to broaden the restrictions on lead and its compounds under entry 63 to Annex XVII of Regulation (EC) 1907/2006, "Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)" in a draft regulation that was made public by the World Trade Organization (WTO) on June 8, 2022. 

The revised version requires the label to reflect "Warning: Contains Lead" and decreases the transition time after the proposed regulation's date of entry into effect from 24 months to 18 months. On October 26, 2022 the REACH Committee met to discuss the idea. 

Various regulatory changes are listed in the proposed draft. The tables below represent the draft rule on lead in PVC. 

Based on the WTO report and the proposed regulations projected adoption date for the draft regulation is the fourth quarter of 2022 and it will come into effect two years after the date of entry into force.

On 11th November 2022, the EU parliament adopted the Corporate Sustainability Reporting Directive (CSRD) act. This act will require businesses to regularly publish information on their societal and en...

On 11th November 2022, the EU parliament adopted the Corporate Sustainability Reporting Directive (CSRD) act. This act will require businesses to regularly publish information on their societal and environmental impact, which in return will make the businesses located in the EU region to be more publicly accountable. Thus, the EU's social market economy could be strengthened, and it could in the future lay the groundwork for sustainability reporting standards at the global level.   

The CSRD addresses the shortcomings found in the legislation on the disclosure of non-financial information (NFRD), which is believed to be insufficient and unreliable. The CSRD sets new standards and rules for better and more detailed reporting requirements on companies which would be in line with the EU climate goals.  

The CSRD has set requirements to ensure that companies are providing reliable information. These requirements include independent auditing and certification. Moreover, this directive will make digital access to sustainability information available. Furthermore, financial and sustainability reports will have equal conditions and investors will have comparable and reliable data. This directive will affect all large companies, whether listed on stock markets or not. Furthermore, companies which are not based in the EU will be affected if their turnover is more than €150 million euro in the EU. 

Timeline: 

It is expected that the European Council will adopt the proposal on 28 November 2022. After the approval of the proposal, it would be signed and published in the EU Official Journal. The directive will enter into force 20 days after publication. The following rules will apply to companies starting from 2024 to 2028: 

• From 1 January 2024, large public-interest companies with more than 500 employees will be subjected to the non-financial reporting directive. Moreover, companies need to submit their reports by 2025. 

• From 1 January 2025, large companies with more than 250 employees, or more than €40 million in turnover and/or €20 million in total assets will be affected by this act. Furthermore, these companies should not be presently subject to the non-financial reporting directive. If a company is categorized within this specification, their reports should be submitted by 2026. 

• From 1 January 2026, companies which are listed Small and Medium-sized Enterprises (SMEs) and other undertakings will be affected. If a company is categorized within this specification, their reports should be submitted by 2027. However, SMEs can wait to submit their report until 2028. 

 
The current rules cover 11 700 companies, compared to this the CSRD would include approximately 50 000 companies in the EU. 

Background  Graphene is chemically defined as a single-atom-thick layer of monocrystalline graphite, a two-dimensional sheet of sp2-bonded carbon atoms arranged in a hexagonal pattern.   Foll...

Background 

Graphene is chemically defined as a single-atom-thick layer of monocrystalline graphite, a two-dimensional sheet of sp2-bonded carbon atoms arranged in a hexagonal pattern.  

Following the first isolation and characterization of graphene,  

• research and production of “graphene-related” nanomaterials (one external dimension in the nanoscale) have expanded exponentially. 

• The total forecasted global market for graphene-based materials is tens of billions and hundreds of billions of dollars for large-area graphene and bulk or flake graphene, respectively. Applications are led by the field of electronics for large-area graphene and use in filtration by both the petroleum and gas industry and the water/wastewater treatment industry for bulk/flake graphene.  

• The global market is predicted to grow considerably in the next 10 years. The current and potential applications of graphene nanomaterials are numerous including, but not limited to, use in electronics, energy storage, lighting, filtration, aerospace engineering, sensors, structural engineering composites, and health. 

Study 

In a 2020 study for the EU's Graphene Flagship project, a team from the National Graphene Institute of the University of Manchester in the UK demonstrated that a single exposure to micrometer-sized graphene oxide caused a negative reaction in rodent lungs, with inflammation lasting in some places for as long as 90 days. Animals exposed to nanometer-sized sheets, on the other hand, were totally recovered 28 days after exposure. 

The' potential for inhalation toxicity of graphene oxide sheets is significantly influenced by their width, according to a mouse study from the Manchester team. The team proposes that when building safer two-dimensional materials for commercial uses, the results, which reveal DNA damage with repeated high-dose exposure, should be taken into consideration. 

Numerous commercial products comprising composites, dispersions, or spray coatings have already been developed as a result of graphene oxide's low cost of manufacture. Other prospective uses for graphene oxide include the deposition of films on substrates in flexible electronics, solar cells, and chemical sensors. In their research paper, the experts note that there are still issues with the substance's safety profile. Although several studies have examined the genotoxic potential of graphene oxide on lung cells in vitro, there aren't many in vivo lung investigations, and the main characteristics that might contribute to toxicity are still up for debate.    

Chronic exposure  

The Manchester researchers assessed whether chronic exposure to graphene oxide could result in genotoxicity in their most recent study, which was also partially sponsored by the Graphene Flagship project:  

Animals were given high doses of graphene oxide sheets once for a maximum of 28 days or several times for a maximum of 84 days. For both exposure sets, graphene oxide sheets of equivalent thickness and physicochemical properties were employed in the micrometer- and nanometer-sized (LGO) and USGO, respectively. A low dose of 3 micrograms reflects a realistic working exposure, whereas a high dose of 30 micrograms includes the adverse circumstance. 

In contrast to an earlier study's investigation of the entire lung, the more recent study used immunostaining to pinpoint specific areas of DNA damage. Although total tissue analysis is typically the standard method, the researchers assert that it tends to produce a distorted image and underestimate local detrimental effects since nanomaterials cluster together to accumulate in various lung sections. 

Overall, the results indicate that: - 

• while LGO sheets may have long-term genotoxic effects, rodent lungs can quickly recover from exposure to USGO sheets.  

• A single high dose of LGO sheets left the rats quickly recovering, but repeated exposure led to long-term DNA double strand breakage.  

• The researcher's hypothesis that two pathways contributing to the long-term DNA damage are oxidative stress and inflammation.   

According to the researchers, the study lays some foundations for a deeper comprehension of the major elements that reduce lung injury following exposure to graphene oxide sheets. They write in the journal Particle and Fibre Toxicology that the study also “emphasises the importance of their lateral dimensions, which will be a crucial consideration for the risk classification of these materials and towards designing safer two-dimensional materials for future commercial applications."   

Research on graphene and graphene oxide is being done for the European Union Observatory for Nanomaterials (Euon). The work package on environment and health for the Graphene Flagship will be completed in 2023.