Europe Regulatory News

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The EFSA has prepared a revised draft guidance document based on the mandate, which has been submitted for public comment along with the respective data, analysis, and background data.

The EFSA launched a public consultation on 18 July 2022 on its draft guidance document on risk assessment of plant protection products and bees, covering honeybees, bumble bees, and solitary bees.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

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.

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.

On 3 October 2022, as a step into the Endocrine Disrupting Chemicals (EDC) blueprint that was received in June, the Belgian Federal Ministry of Economy and the Ministry of Public Health sent a survey ...

On 3 October 2022, as a step into the Endocrine Disrupting Chemicals (EDC) blueprint that was received in June, the Belgian Federal Ministry of Economy and the Ministry of Public Health sent a survey to stakeholders requesting to derive information on Substances of Very High Concern (SVHCs). 

Belgium is exploring industry views to identify SVHCs, their uses and alternatives under its recently approved action plan on Endocrine Disrupting Chemicals. EDCs, also known as hormone disruptors, are synthetic chemicals that block, mimic, or interfere with the natural hormones in our bodies.   

The scientific project on substitution of SVHCs began in April. The aim of this project is to accelerate the elimination and replacement of SVHCs as well as advancing Belgium's economic competitiveness and status into the transition to safer and more sustainable products. 

 The objectives of the project are to develop: 

• Methodological analysis to recognize the fundamental uses and manufacturing processes of SVHCs in Belgium and to identify priority substances.  

• A brief list of policy measures to be proposed to support the replacement of SVHCs and for inclusion in the national replacement plan. 

• Estimate the socio-economic impacts affiliated with the shortlisted policy  options by identifying both positive and negative aspects, along with figuring out the  potential (unwanted) consequences of each option. 

Estimating social-economic impacts will help Belgian authorities design their policies in a way that minimizes negative aspects, such as the risk of regrettable replacement, while at the same time helping to reduce the use of SVHCs and develop the market for safer substances.  

The Belgian Plan for Chemical Alternatives is part of the country's Federal action plan for a circular economy and Belgium Builds back Circular – a part of the EU's Recovery and Resiliency Plan.  

Belgium’s national action plan on EDCs 

Belgium’s action plan aims to establish a general and coherent framework to reduce exposure to EDCs in Belgium and will run for the period June 2022 to December 2026. 

The action plan is focused on: 

1. Awareness-raising and prevention strategies, targeting the public and relevant professionals 

2. Legislative action at national and EU levels aimed to serve EDC exposure reduction 

3. Research and work on identification of EDCs, including biomonitoring. 

Other countries that have already taken similar initiatives including France, Denmark, and Sweden. France worked on a number of priority areas, including creating a list with the harmful substances, along with raising awareness of the associated risks.