Europe Regulatory News

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.

The EU’s Green Deal Farm to Fork Strategy is moving us towards a sustainable food system.   The European Union has announced, amended, and adopted the regulations regarding biopesticides on (...

The EU’s Green Deal Farm to Fork Strategy is moving us towards a sustainable food system.

The European Union has announced, amended, and adopted the regulations regarding biopesticides on (EU) Nos. 546/2011 and 1107/2009 (Annex II). They lay out standardized principles and criteria for assessing and authorizing plant protection products and microorganism active substances. Regulation (EU) No. 283/2013 gives the information to be submitted for active substances and the specific data requirements for micro-organisms.  Regulation (EU) No 284/2013 gives the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organism origin.

The draft was proposed on 26 October 2021. From 26 October to 23rd November 2021 was the feedback period. Now, it has been adopted on 31August 2022.

Major points were segregated in those amendments.

The term microbial active substance has been replaced by ‘Microbial Pest Control Agent (MPCA)’.

The number of requirement of studies has been reduced. In this case mostly ‘the weight of evidence’-approach with justification shall be followed.

The amended version focuses on identifying, taxonomizing, and phylogeny of the microorganism, as well as its origin, occurrence, and history of use.

It also gives clarity about dossier submission which shall be done in accordance with Part A if the active substance is a chemical substance (including both semiochemicals and extracts from biological material), or a metabolite produced by a micro-organism.

To provide information on development of resistance, in case of provision of data is required, such data may be generated in experimental studies (either in laboratories or under field conditions) or retrieved from available scientific literature. Otherwise, information already submitted for the active substance under point 3.4 of Part B of the Annex to Regulation (EU) No 283/2013 are sufficient to permit an assessment to be performed.

The goal is to reflect the specificities and use of biological substances as compared to chemical substances.

The European Food Safety Authority (EFSA) is currently evaluating its 2013 document on the risk assessment of plant protection products and bees (Apis mellifera, Bombus spp., and solitary bees).  ...

The European Food Safety Authority (EFSA) is currently evaluating its 2013 document on the risk assessment of plant protection products and bees (Apis mellifera, Bombus spp., and solitary bees).

What is the content of the guidance document published in 2013?

The objective of this Guidance Document (GD) is to outline a process by which plant protection products (PPPs) can be evaluated for their potential risk in causing unacceptable harm to groups of non-target organisms (bees). The guidance document has taken care of the potential risk in causing unacceptable harm to a group of non-target organisms (bees), maximum exposure level given by the specific protection goals (SPGs), the use of a tiered risk assessment scheme with a simple and cost-effective first tier to more complex higher tier studies under semi-field and field conditions.

Updates

In a meeting held on 17 February 2022, the Commission initiated discussions with Member States on setting specific protection goals for bumblebees and solitary bees.

The EFSA has prepared a revised draft guidance document based on the mandate, which has been submitted for public comment along with the respective data, analysis, and background data.

The EFSA launched a public consultation on 18 July 2022 on its draft guidance document on risk assessment of plant protection products and bees, covering honeybees, bumble bees, and solitary bees.

The consultation was open for 12 weeks and closed on 3 October 2022.

In addition, the Commission has asked the EFSA to ensure that all opinions and viewpoints are taken into consideration in the process.

Following the completion of the workshop with stakeholders and member states, the EFSA can finalize the revision of the guidance document.

New regulations will be established for the EU for some persistent organic pollutants, according to a news release from the European Parliament on October 4, 2022. (POPs). The new regulations will mak...

New regulations will be established for the EU for some persistent organic pollutants, according to a news release from the European Parliament on October 4, 2022. (POPs). The new regulations will make sure that EU laws support the circular economy and EU Green Deal. 

According to the European Parliament, there will be reduced limitations for: 

• POPs in waste 

• The chemical perfluorohexane sulfonic acid is a recent addition (PFHxS) 

 Companies looking to obtain and employ recycled materials for their products must consider the decision's ramifications. Waste having too high amounts of POPs must be destroyed or incinerated and cannot be recycled in order to maintain the cyclic lifespan of items. 

 With 534 votes to 25, and 66 abstentions, MEPs approved the new rule. The new regulations will go into effect six months after they are published in the EU Official Journal after being formally adopted by the council. 

 After the European Commission proposed new restrictions under the EU's POPs Regulation in 2021, Members of Parliament (MEPs) and member states temporarily agreed to modify the standards. The Council had requested higher restrictions and later application dates, although the European Parliament had initially advocated for lower limits than those put forth by the EU executive. 

The new threshold levels are:   

•  For polybrominated diphenyl ethers, 200 mg/kg (PBDEs). Five years after the law's enforcement, the new restriction will take effect. The cap is now set at 500 mg/kg, and after three years it will be reduced to 350 mg/kg. presently, it is set at 1,000 mg/kg; 

• 1 mg/kg for perfluorooctanoic acid (PFOA) and its salts, and 40 mg/kg for PFOA-related compounds  

•  Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs) have a toxic equivalency quotient (TEQ) of 5 micrograms (g) per kilogramme (TEQ/kg), which will take effect one year after the regulation's effective date and have a transitional value of 10 g in the interim. PCDD/Fs are now restricted to 15 g/kg. 

• 40 mg/kg for PFHxS-related compounds and 1 mg/kg for PFHxS and its salts. Five years after they become effective, these values will be evaluated. This chemical was included during the trialogue process after being listed in the Stockholm Convention on June 9; it was earlier excluded from the Commission's recommendation. 

•  Hexabromocyclododecane (HBCDD) have a limit of 500 mg/kg, which will be reduced to 200 mg/kg five years after the regulation goes into effect; 

• 500 mg/kg for polybrominated diphenyl ethers (PBDEs), which will thereafter be reduced to 350 mg/kg three years after the regulation enters into force and again to 200 mg/kg after five years; and 

•  Short-chain chlorinated paraffins (SCCPs) are subject to a 1,500 mg/kg limit with a five-year review period. 

The vote demonstrates the European Parliament's "commitment to the implementation of the Stockholm Convention, which is clear: the only way to deal with POPs which are one of the most dangerous chemicals we know - is to work toward eliminating them," according to report author Martin Hojsk, a Renew Europe MEP.   

Products that contain Substances of Very High Concern (SVHC) fall under notification obligation to the ECHA. This means that all products imported or produced on the EU market containing SVHCs have to...

Products that contain Substances of Very High Concern (SVHC) fall under notification obligation to the ECHA. This means that all products imported or produced on the EU market containing SVHCs have to be notified to ECHA’s database of Substances of Concern in Products (SCIP).  

The SCIP database was developed under the Waste Framework Directive and the notification obligation for all EU countries started to apply in January 2021. The EEA countries (Iceland, Liechtenstein, and Norway) were not able to notify to the database until now since the Waste Framework Directive did not constitute a part of the EEA Agreement. However, starting from 7 November 2022 the notification for EEA countries will also become possible.  

The SCIP database is developed to enable consumers to make more informed choices and to help waste operators to reuse and recycle articles and materials. The database contains 8.7 million articles from over 8 600 EU companies. Only EU-based companies are allowed to notify to the database. In the case of exporters from non-EU countries – the importing company in the EU should do the notification. 

As presented in the “Eu Strategy on Sustainable Chemicals” in 2020, the EU REACH regulation was about to be revised and updated by end of 2022 to better correspond to the sustainability plans of t...

As presented in the “Eu Strategy on Sustainable Chemicals” in 2020, the EU REACH regulation was about to be revised and updated by end of 2022 to better correspond to the sustainability plans of the EU.  

However, in the last quarter of 2022, no revision has yet been done and the announcement about its postponement keeps on coming. The reform might now be delayed to 2024. The delay is particularly concerning due to the upcoming EU Parliamentary elections that might further delay the revision. 

The delay is seen as a setback to the sustainability ambitions of the Union. Furthermore, the decision was heavily criticized by NGOs. Certain opinions see the delay as being a result of lobbying from the chemical industry. 

The delay of the revision is seen as a “life and death” matter by the members of the parliament and NGOs. After all, the revision aims to enforce the protection of human health and the environment. If not adopted before 2024, the new laws from the revision cannot come into force till 2028 which is far too late to be able to have an impact on the environmental crisis. 

The European Parliament has actively monitored the implementation of the legal framework of Directive 2009/128/EC which specifically regulates the Sustainable Use of Pesticides (SUDP). Timelines ...

The European Parliament has actively monitored the implementation of the legal framework of Directive 2009/128/EC which specifically regulates the Sustainable Use of Pesticides (SUDP).

Timelines

On 22 June 2022, the European Commission submitted a proposal to revise the SUDP. This submission was initially scheduled for 23 March 2022, has been delayed, reportedly, due to Russia's war on Ukraine.

This proposal is part of a package of legislation on nature conservation that also includes a proposal for legally binding nature restoration rules. As part of the European Green Deal, both proposals are related to farm to fork, biodiversity, and zero pollution.

Updates: Member states shall take necessary actions on-

• Pesticide reduction has never been an official policy objective of the SUD.

• Encourage the development and introduction of Integrated Pest Management (IPM) and of alternative approaches or techniques to reduce dependency on the use of pesticides.

• To ensure that the use of pesticides is reduced or banned in specific areas such as playgrounds, public parks, sports fields, or close to healthcare facilities.

• Ban the spraying of pesticides by air.

• Specifically, safeguard drinking water from the effects of pesticides in water.

• Develop programmes to raise public awareness of the potential dangers associated with the usage of pesticides.

European Court of Auditors Recommendations

To ensure compliance with the SUDP requirements, the European Commission conducts audits in the Member States (MSs).

1. The Commission should make sure the MSs have converted the general principles of IPM into practical and measurable criteria, (verified on farms by 2022), and incorporate these measurable IPM criteria into the 'conditionality' of the post-2020 common agricultural policy (CAP). 

2. By 2023, the Commission must address the following to improve statistics and environmental monitoring: First, the restrictive aggregation requirements for Plant Protection Product (PPP) statistics should be removed so that more useful statistics can be published (such as low-risk PPPs and active substances with specific properties), and second, the EU statistics on agricultural use of PPPs should be clarified, improved and harmonised to make them more useful, comparable and accessible. 

3. The Commission should develop new (harmonised risk indicators) HRIs, or improve the existing ones, by 2023.