Europe Regulatory News

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 

The United Nation’s Environment Programme (UNEP) intersessional process on the Strategic Approach to International Chemicals Management (SAICM) and the sound management of chemicals and waste beyond...

The United Nation’s Environment Programme (UNEP) intersessional process on the Strategic Approach to International Chemicals Management (SAICM) and the sound management of chemicals and waste beyond 2020 held its fourth meeting between August 29 and September 2. 

SAICM is a global policy framework aimed at promoting the sound management of chemicals through all of their life-cycle. It brings together governmental, industrial and public-interest stakeholders to address effective chemicals management. The work of SAICM includes aspects relative both to specific approaches and measures to be taken and to their practical implementation (such as financing and capacity-building). The initial implementation of SAICM foresaw a 2020 completion date, but lagging uptake in many jurisdictions around the world means that continued work towards effective chemical management will be needed. 

To this end, the International Conference on Chemicals Management (ICCM) will discuss a post-2020 framework in its upcoming 5th Session. Work on the specifics of the post-2020 framework is being carried out in what’s known as the “intersessional process”. Kickstarted after the ICCM’s 4th session – which was held in late 2015 – the process brings together involved stakeholders to discuss the following points relative to the post-2020 global framework: 

• Targets, indicators and milestones 
• Governance and mechanisms to support implementation 
• Issues of concern 
• Financial considerations 

While work on these topics had been moved online due to the Covid pandemic, the 4th intersessional process meeting will be held in person in Bucarest, Romania. Discussions there will be followed by the 5th Session of the ICCM. This is the last ICCM Session planned under SAICM, and it was initially planned for 2020. It is currently scheduled to be held in person in Bonn, Germany, in 2023. 
 

In its recently held 60th session, the United Nations (UN) Sub-Committee of Experts on the Transport of Dangerous Goods adopted proposed amendments to the UN Model Regulations on the Transport of Dang...

In its recently held 60th session, the United Nations (UN) Sub-Committee of Experts on the Transport of Dangerous Goods adopted proposed amendments to the UN Model Regulations on the Transport of Dangerous Goods that would clarify the scope of test data sharing in the value chain. 

The Model Regulations are an effort by the UN to develop common approaches to the management of dangerous goods in transport. While not directly applicable, they seek to inform the development of national regulation. Under the Model Regulations, manufacturers and subsequent distributors have a duty to “make available” test summaries for lithium batteries or equipment containing them. 

The amendment proposal adopted by the Sub-Committee would add a note to the provision clarifying that the purpose of this requirement is to enable other actors in the supply chain to assess the compliance of the batteries. 

The Sub-Committee is a subsidiary body of the Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Chemicals. If the amendments are adopted, they would be incorporated into upcoming revisions of the Model Regulations. After that, it would fall upon national governments to incorporate changes in their legislation.