Europe Regulatory News

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. 

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. 

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. 
 

The European Union’s Committee for the REACH Regulation will discuss a restriction proposal on microplastics by the European Commission in its upcoming meeting on September 23, 2022. The releas...

The European Union’s Committee for the REACH Regulation will discuss a restriction proposal on microplastics by the European Commission in its upcoming meeting on September 23, 2022.

The release of microplastics – “synthetic polymer microparticles” in the restriction proposal – is a key environmental concern due to their pervasiveness and their lack of biodegradability. Microplastics may end up in the environment through the use of bigger plastic products (a phenomenon known as unintentional release of microplastics) or might be intentionally added to a range of products. 

The current REACH restriction proposal by the European Commission is one of the deliverables under the EU’s Circular Economy Action Plan adopted in 2020. It focuses on tackling intentionally added microplastics by forbidding their placement in the market (be it on their own or as an intentional addition in mixtures).

Natural, degradable and soluble polymers are excluded from the restriction, which includes references to the relevant tests with which biodegradability can be demonstrated. Beyond these exemptions, the use of microplastics will still be allowed for use at industrial sites and for several product categories (such as for instance medicinal products for humans and animals, fertilizing products, or food additives). The proposal includes labelling and reporting provisions for many of the exempted products. 

For some of the product groups within the scope of the restriction proposal, the Commission is proposing phase-in deadlines for the prohibition of placement in the market. For those groups, said prohibition of placing intentionally added microplastics in the market would apply as detailed in the table below. 

REACH restrictions are adopted through a procedure known as “regulatory procedure with scrutiny”. In it, the European Commission needs to secure the favorable opinion of the REACH Committee. Furthermore, for the three months after the Committee’s opinion, both the European Parliament and the European Commission can object to the proposed measure. If no such objection is raised, the Commission proposal is incorporated into Annex XVII of the REACH Regulation and becomes law.

Expert committees for the Rotterdam and Stockholm conventions will hold meetings in the upcoming weeks. At the meetings, aspects relative to trade requirements for hazardous pesticides and chemicals, ...

Expert committees for the Rotterdam and Stockholm conventions will hold meetings in the upcoming weeks. At the meetings, aspects relative to trade requirements for hazardous pesticides and chemicals, and regulatory action on persistent organic pollutants (POPs) will be discussed. 

The 18th session of the Rotterdam Convention’s Chemical Review Committee will be held in Rome from 19 to 23 September. The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade focuses on information exchange on the restrictive measures taken by parties to the convention. Its Committee discusses whether substances in which parties are taking action should be added to the Convention’s Annex III, which requires that other parties express whether they would like to ban, permit or attach conditions to the import of such substance. 

At its 18th meeting, the Chemical Review Committee  will discuss guidance documents (the basis for  for the following two chemicals: 

• iprodione
• terbufos 

Additionally, it will review the regulatory action notified by several parties on the following chemicals: 

• amitrole
• carbaryl
• carbon tetrachloride
• chlorfenvinphos
• methidathion
• methyl bromide
• methyl parathion
• mirex
• paraquat 
• thiodicarb

The Stockholm Convention POPs Review Committee will also hold its meeting between 26 and 30 September in Rome. The Stockholm Convention on Persistent Organic Pollutants (POPs) seeks to mitigate the impacts of said chemicals on human health and the environment. It does so by listing specific POPs in its different Annexes for Prohibition, Restrictions, or measures to reduce their impact. 

The POPs review Committee evaluates proposals by parties to classify substances as POPs and take regulatory action on them. It develops risks profiles for the substances to determine whether global action is needed, evaluates risk management measures, and proposes specific action to be taken under the Convention. 

In its 18th meeting, the POPs Review Committee will consider risk management for the chemicals Dechlorane Plus and UV-328. It will also consider risk profiles for chlorpyrifos, chlorinated paraffins with carbon chain lengths in the range C14-17 and chlorination levels at or exceeding 45 per cent chlorine by weight, and long-chain perfluorocarboxylic acids (LC-PFCAs), their salts and related compounds. 

The Committee will also consider proposals for exemptions for decabromodiphenyl ether and short-chain chlorinated paraffins, and alternatives to perfluorooctane sulfonic acid, its salts, and perfluorooctane sulfonyl.

While not directly applicable, the decisions taken under the Rotterdam and Stockholm conventions are incorporated into national law (in the EU, through Regulations (EU) 649/2012, concerning the export and import of hazardous chemicals, and (EU) 2019/1021, on persistent organic pollutants). 

Under Annex VIII to the CLP Regulation, importers and downstream users placing hazardous mixtures on the EU market are to provide specific information on their mixtures to appointed bodies. The platfo...

Under Annex VIII to the CLP Regulation, importers and downstream users placing hazardous mixtures on the EU market are to provide specific information on their mixtures to appointed bodies. The platform for submission is called “Poison Center Notifications” (PCN), and companies dealing with certain hazardous chemicals and mixtures are obligated to report and provide information to it. On 31 August 2022 it was announced that Iceland has joined ECHA’s submission portal and from now on would accept PCN submissions through ECHA’s submission portal. It is expected that Bulgaria and Slovakia would join the ECHA’s submission portal. Currently, both countries remain unconnected to ECHA’s submission system. However, it is reported that both counties are in process of working through the onboarding procedure. 

The Original information regarding Iceland joining ECHA could be found on the following link: 

https://echa.europa.eu/view-article/-/journal_content/title/9109026-208 

More information regarding PCN and ECHA could be found on the following link: 

https://poisoncentres.echa.europa.eu/about-us