Europe Regulatory News

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.

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. 

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 

On 7 September 2022, the European Chemicals Agency (ECHA) published a call for comments on nine proposals to identify new Substances of Very High Concern (SVHC). SVHCs are substances that can have ser...

On 7 September 2022, the European Chemicals Agency (ECHA) published a call for comments on nine proposals to identify new Substances of Very High Concern (SVHC). 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. As of 10 June 2022, the Candidate list has 224 entries, some 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. 

The identification of SVHCs is based on the hazard properties of a substance. All interested parties are invited to submit comments during the consultation which lasts until 17 October 2022. Comments are particularly welcome on: 

• The identity of the substance (i.e. on the substance name/EC number/CAS number/molecular structure etc.) 

• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) properties and on other properties that give rise to equivalent levels of concern. 

The nine proposals that the ECHA is looking for comments on are: 

• 4,4'-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). Used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals. 

• Perfluoroheptanoic acid and its salts (EC -, CAS -). The substances are not registered under REACH. 

• Melamine (EC 203-615-4, CAS 108-78-1). Used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals. 

• Isobutyl 4-hydroxybenzoate (EC 224-208-8, CAS 4247-02-3). Used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners. 

• Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (EC -, CAS -). Used as a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives. 

• Barium diboron tetraoxide (EC 237-222-4, CAS 13701-59-2). Used in paints and coatings. 

• Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine (FC-770) (EC 473-390-7, CAS -). Used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing. 

• 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol (tetrabromobisphenol-A; TBBPA) (EC 201-236-9, CAS 79-94-7). Used as a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles. 

• 1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] (EC 253-692-3, CAS 37853-59-1). The substance is not registered under REACH. 

On 20 September 2022 the European Commission published a Draft delegated regulation introducing new hazard classes to the system established in Regulation (EC) 1272/2008, on the classification, labell...

On 20 September 2022 the European Commission published a Draft delegated regulation introducing new hazard classes to the system established in Regulation (EC) 1272/2008, on the classification, labelling and packaging of substances and mixtures (the CLP Regulation). 

The CLP Regulation implements the UN Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) in the European Union. It is a key piece of legislation, given that general chemicals legislation and product-specific legislation often refer to it when establishing compliance obligations. 

Now, the Commission is proposing the introduction of new hazard categories that would go beyond the most recent revision of the UN GHS (Revision 9, adopted in 2021). The introduction of new hazard categories had been signaled by the Commission in recent years. For instance, the European Green Deal (2019) suggests to take into account scientific evidence on endocrine disruptors and persistent chemicals. Furthermore, the EU Chemicals Strategy for Sustainability, adopted in 2020, also calls new hazard classes and criteria addressing environmental toxicity, persistency, mobility and bioaccumulation. 

The Draft regulation would introduce the following new hazard classes and categories: 

• Endocrine disruptors for human health, category 1 (known or presumed) and category 2 (suspected) 
• Endocrine disruptors for the environment, category 1 (known or presumed) and category2 (suspected) 
• Persistent, bioaccumulative and toxic (PBT) or Very Persistent, Very Bioaccumulative (vPvB) substances 
• Persistent, Mobile and Toxic (PMT) or Very Persistent, Very Mobile (vPvM) substances 

The regulation includes the classification criteria for substances and mixtures, as well as the relevant labelling elements, including new hazard statements.  For PBT/vPvB substances, common criteria are established for persistence and bioaccumulation. However, given their difference in toxicity, they remain different categories. The same situation applies to PMT/vPvM substances. 

The new classification and labelling requirements would apply to substances 18 months after the regulation’s entry into force. In the case of mixtures, the transitional period would be 36 months. However, the draft establishes grace periods for substances and mixtures labelled before the entry into force and placed on the market before the end of the transitional period. The old classifications may continue to apply for 42 months for substances and 60 months for mixtures. 

While still a draft, the introduction of new hazard classes and categories in the CLP Regulation is a key development in chemicals management worldwide. As many countries around the world seek to adopt both the GHS and REACH-like regulations, this development opens space for divergence between the global and EU frameworks. Additionally, it is related to the upcoming revision of EU Regulation 1907/2006 (the REACH Regulation), as the Chemicals Strategy for Sustainability pointed to the categorization of endocrine disruptors, PMT and vPvM substances as substances of very high concern (SVHC) under REACH. 

In addition to these developments through delegated regulations, further changes to chemicals management in Europe are expected in the coming months, when the European Commission proposes amendments to the REACH and CLP Regulations themselves. 

Once adopted by the Commission, delegated acts enter into force automatically unless the European Parliament or the Council of the EU explicitly oppose them. The current draft is open for public comments until October 18, 2022. 

The Chemicals and Biotechnology Committee of the Organisation for Economic Co-operation and Development (OECD) adopted on September 2, 2022, a working document on the application of the “Safe and Su...

The Chemicals and Biotechnology Committee of the Organisation for Economic Co-operation and Development (OECD) adopted on September 2, 2022, a working document on the application of the “Safe and Sustainable by Design” (SSbD) concept to nanomaterials. These working descriptions – as the document is called – will be used in the further work of the OECD Working Party on Manufactured Nanomaterials, a body of the Chemicals Committee. Most notably, the work of the Working Party on nanomaterials includes: 

• Supporting innovation to ensure that nanomaterials and advanced materials are developed in a safe and sustainable way supported by a circular economy.
• Supporting a process for identifying and prioritizing the elements to be considered for safety and sustainability.

The document outlines working definitions for the key concepts of sustainability and SSbD. For the OECD Chemicals Committee, environmental sustainability entails remaining within the planetary boundaries and using green and sustainable chemistry principles to minimize the environmental footprint of chemical products. Socio-economically, the beneficial social impact and contribution to growth and innovation of products has to be ensured.

As for SSbD, its application to nanotechnology can be summarized in three pillars: 

• Safe and sustainable products, which can be achieved by minimizing hazards and potential environmental issues at the design stage 
• Safe and sustainable production, which relates to occupational and process safety and environmental preservation aspects (for instance, resource consumption and occupational health and safety).
• Safe and sustainable use and end of life, which must be aligned with the circular economy and the waste hierarchy.

Discussions on a SSbD concept to guide policy discussions have been ongoing in several organizations after the European Commission included the concept in its Chemicals Strategy for Sustainability, published in October 2020. As a result of the Strategy, the Commission has been undertaking a far-reaching reform of its chemicals legislation and policy framework, including a development of the SSbD framework for research purposes. You can learn more about the SSbD concept and the Chemicals Strategy for Sustainability through our webinar on the topic. 
 

On September 8, 2022, the European Commission adopted a delegated act under Regulation (EU) 2019/1021, on persistent organic pollutants (the POP Regulation), clarifying the acceptable limits for the u...

On September 8, 2022, the European Commission adopted a delegated act under Regulation (EU) 2019/1021, on persistent organic pollutants (the POP Regulation), clarifying the acceptable limits for the unintentional presence of hexachlorobenzene. 

Hexachlorobenzene is a Persistent Organic Pollutant banned under the 2001 Stockholm Convention on Persistent Organic Pollutants. In the European Union, the ban is implemented through Regulation (EU) 2019/1021, on persistent organic pollutants (the POP Regulation). The POP Regulation consolidated the older Regulation (EC) 850/2004 and its amendments into one single Regulation. It Annex I contains prohibited POPs, and includes – but is not limited to – POPs listed under the Stockholm Convention. Substances included in Annex I can not be placed in the market or used except under the conditions specified in the same Annex. 

The prohibition of placing Annex I POPs in the market does not apply to POPs that can be found in substances, mixtures or articles as unintended trace contaminants. Typically, Annex I includes a specific limit value for what constitutes an acceptable unintended trace contaminant. However, some listed POPs do not have this specification, creating uncertainty over the acceptable amount of contamination. 

Under the POP Regulation the European Commission is empowered to adopt delegated acts to align the system to the evolution of the Stockholm Convention and to account for scientific and technological progress. Now, it is adopting a Delegated Regulation amending the Annex I entry for hexachlorobenzene to establish a specific unintentional trace contaminant limit of 0.001% by weight (10 mg/kg). 

Similar delegated regulations have been adopted to establish or modify trace contaminant limits for PFOA, its salts and related compounds, and pentachlorophenol and its salts and esters. 

Under the POP Regulation, delegated acts become law 2 months after their adoption by the Commission unless the European Parliament or the Council of the EU explicitly oppose them. Said two-month period will be fulfilled on November 8, 2022.