Europe Regulatory News

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.  

The proposal to the European legislation on Food Contact Materials (FCMs) has now been opened for public consultation. The FCM legislation has been in place since 2004 and has been criticized for not ...

The proposal to the European legislation on Food Contact Materials (FCMs) has now been opened for public consultation. The FCM legislation has been in place since 2004 and has been criticized for not being efficient, foremost by NGOs.  

In the summer of 2022, the European Commission made a review of the current regulation, and their conclusion supported the argument as the FCM legislation was called only “partially effective”. For example, the current regulation has regulatory specificity mostly for plastics but lacks it for other materials. 

An update of the regulation has been underway since 2020 but has been slow due to the complexity of the FCM legislation. The main objectives of the FCM regulation are to secure and protect human health and to ensure the functioning of the internal market.  

The proposed updated legislation is expected to be adopted in 2023. If adopted, the initiative aims to modernize the rules, to: 

• ensure food safety & a high level of public health protection 

• reduce the presence and use of hazardous chemicals 

• take account of the latest science & technology  

• support innovation & sustainability by promoting safe reusable and recyclable solutions and help reduce the sector’s environmental impact. 

The public consultation is open from 5 October 2022 to 11 January 2023. The feedback can be submitted on the website of the European Commission: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12497-Revision-of-EU-rules-on-food-contact-materials_en.  

In August the European battery industry was joined by Argentina, Australia, and the US in warning against classification of Lithium compounds under the EU’s CLP. Their statements were sent to the Co...

In August the European battery industry was joined by Argentina, Australia, and the US in warning against classification of Lithium compounds under the EU’s CLP. Their statements were sent to the Competent Authorities for REACH and CLP to examine the socio-economic and supply concerns. 

In July 2021, the European Commission was requested to cover the potential impact of classification of three lithium compounds. Later in September 2021 the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) accepted a French proposal on classification of lithium salts into Category 1A (Reproductive toxicity).  

Three Lithium salts were categorized with no existing entry in Annex VI of the Classification, Labelling and Packaging regulation (CLP): 

1.  Lithium chloride - used widely in battery production 

2. Lithium hydroxide - used widely in battery production 

3. Lithium carbonate - used to produce lithium salt and to manufacture aluminum 

• Australia is the largest producer of lithium concentrate. According to a CARACAL (Competent Authorities for REACH and CLP Comment from the Australian Mission to the EU, Australia is willing to work with the European Commission to clarify that the classification of lithium salts as 1A reproductive toxicant "does not inadvertently impede our shared interest to support the development and expansion of clean energy supply chains". 

• Argentina warned that the 1A classification could affect in many ways such as increasing regulatory uncertainty, deterring new investments, increasing the administrative burden, and increasing the costs for the whole battery supply chain. In a letter it said that "1A classification could negatively impact Argentina and the European Union’s strategic objectives regarding lithium salts and lithium batteries and their role in achieving our shared climate goals". 

• The US department of Commerce asked the EU commission to pay attention to their concerns on "uncertainties in risk management measures, which could have adverse effects on global lithium supply chains". 

The EU listed lithium as a critical material in 2020. It is one of the most prominent minerals for clean energy transitions, according to a 2022 report on world energy investment by the International Energy Authority (IEA). IEA data suggests that demand could increase by over 40 times by 2040. 

A seven-year extension, valid until 30 June 2027, to the exemption for the use of lead in medical equipment under the EU Directive on the Restriction of Hazardous Substances (RoHS) has been approved b...

A seven-year extension, valid until 30 June 2027, to the exemption for the use of lead in medical equipment under the EU Directive on the Restriction of Hazardous Substances (RoHS) has been approved by the European Commission.

On 12 December 2018, the European Commission received an application for renewal of the exemption for the use of lead in medical devices. In 2020 an application submitted by the European Coordination Committee of Radiological, Electromedical and Healthcare IT Industry demanded the extension of the exemption till 30 June 2027.

The exemption covers the use of lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors that are used in certain medical ‘Magnetic Resonance Imaging (MRI) equipment. 

The result of technical and scientific studies, and public consultation show that older-design MRI devices are limited in quantity and highly dependent upon lead containing components compared to new lead-free versions. Although non-integrated lead-free MRI models are available, concerns are that it will require additional time to develop a lead-free integrated MRI solution. The lack of redesigned models can create a supply gap, which could affect healthcare for patients.

The exemption entry 27 in Annex IV is proposed to be approved for renewal in order to provide MRI equipment for medical services in a compatible manner and to permit the time to be taken for development of lead-free devices. Two points are added in the exemption proposal as follows -

• MRI non-integrated coils, for which the Declaration of Conformity of this model is issued for the first time before [the date of publication in the Official Journal of the Delegated Directive + 1 day]
• MRI devices including integrated coils, which are used in magnetic fields within the sphere of 1m radius around the isocenter of the magnetic in medical magnetic resonance imaging equipment, for which the Declaration of Conformity issued for the first time before 30 June 30 2024.

Superconductor 

Due to the lack of lead-free alternative devices on the market with properties such as ductility and electrical resistivity at low temperature, the Commission has also renewed an exemption for the use of lead in Bismuth Strontium Calcium Copper Oxide (BSCCO) superconductors for use in cables and wires, and lead in related electrical connections for other Electrical and Electronic Equipment (EEE) components. 

Lead-doped BSCCO is used to:

• create superconducting magnetic circuits for medical devices and monitoring and control instruments
• achieve higher resolution images for medical diagnosis or research and stable operation mode of the relevant applications

According to the EU RoHS Directive, the EU member states must adopt and publish the necessary legislation by 28 February 2023. 

The renewed exemption expires on 30 June 2027. 

Under the EU Directive on the Restriction of Hazardous Substances (RoHS) in Electrical and Electronic Equipment (EEE), Germany’s Öko-Institut has initiated an evaluation on exemption requests for c...

Under the EU Directive on the Restriction of Hazardous Substances (RoHS) in Electrical and Electronic Equipment (EEE), Germany’s Öko-Institut has initiated an evaluation on exemption requests for cadmium quantum dots in lighting and display applications.

On 17 October 2022 the study will be completed. Due to the short duration, stakeholders with information are invited to contact the institute directly and stakeholder consultation will not be held. This was stated in note on 7 September 2022.

Technical and scientific support to the European Commission will be provided by the study. The study is based on an assessment of exemptions published in January 2021.

Exemption Overview-

According to the German assessment body, the  decision  for these exemption requests is still pending and a review on the current state of the scientific and technical progress will be given by the Öko-Institute.

Because of carcinogenic, and suspected mutagenic and reprotoxic properties, cadmium is on the REACH candidate list of Substances of Very High Concern (SVHC). An exemption on cadmium is opposed by the NGO Chemical Secretariat (ChemSec). Cadmium-free technologies are widely available and major manufacturers such as Samsung, LG, Apple, and Sony have already adopted a no-cadmium policy says ChemSec’s policy adviser.

The deadline for updating EU Safety Data Sheets (SDSs) authored before January 2021 is approaching. All SDSs compiled under EU 2015/830 must be replaced by 31 December 2022 with a new SDS authored ...

The deadline for updating EU Safety Data Sheets (SDSs) authored before January 2021 is approaching. All SDSs compiled under EU 2015/830 must be replaced by 31 December 2022 with a new SDS authored under the Regulation EU 2020/878.

Background:

On 1 January 2021, Annex II to Regulation (EU) 2015/830 was replaced by the updated Regulation (EU) 2020/878. The regulation aligned REACH Annex II with the 6th and 7th revisions of GHS and brought in several modifications to Saftety Data Sheets.

Due to this all the (M)SDS/eSDS prepared before 2021 need to be updated as per the new EU 2020/878 regulation. This implies that all new Safety Data Sheets, authored after 1 January 2021 must consider the new requirements. SDSs complying with the 2015 regulation are no longer acceptable.

However, all existing SDSs, authored before January 2021, are valid only until the grace period ends on 31 December 2022 (except for bulk mixtures requiring a UFI).  After this date, all Safety Data Sheets will need to be updated to the new requirements (EU 2020/878).

GPC can help you to update your EU Safety Data Sheets compiled before January 2021 according to the new EU Regulation 2020/878 requirements. For more information on the procedure please contact us: compliance@gpcregulatory.com