On 7 November 2024, the European Chemicals Agency (ECHA) added triphenyl phosphate to the Candidate List of Substances of Very High Concern (SVHC), bringing the total number of entries on this list to 242. This list includes chemicals that pose significant risks to human health or the environment, and companies must manage these risks by providing customers and consumers with information on safe usage.
Details on Triphenyl Phosphate
Triphenyl phosphate, with EC number 204-112-2 and CAS number 115-86-6, has been added to the list due to its endocrine-disrupting properties that may impact the environment. This chemical is commonly used as a flame retardant and plasticiser in polymer formulations, adhesives, and sealants. Initially planned for discussion in June, its inclusion was delayed to October due to the emergence of substantial new information about its hazardous properties.
Legal Obligations and Consequences for Companies
The addition of triphenyl phosphate to the Candidate List imposes new legal obligations on companies under the REACH regulation:
Information Requirements: If an article contains any SVHC from the Candidate List at a concentration above 0.1% (weight by weight), suppliers must inform customers and consumers on safe use practices. Consumers have the right to inquire about the presence of SVHCs in products.
Notification to ECHA: Importers and producers of articles must notify ECHA if their products contain any SVHC within six months of its inclusion on the list.
Safety Data Sheet (SDS) Updates: EU and EEA suppliers must update the SDS for any product that contains substances from the Candidate List, whether in pure form or in mixtures.
Additionally, under the Waste Framework Directive, companies must notify ECHA if their articles contain SVHCs at concentrations above 0.1%. This information is then added to ECHA’s SCIP database (Substances of Concern In Products), ensuring traceability.
Moreover, products containing SVHCs are ineligible for the EU Ecolabel, which promotes products with reduced environmental impact.
Ukraine is in the process of integrating national legislation with European standards in the field of chemicals regulation. In 2024, three new regulations are planned to be implemented, covering rules on biocides, classification, labeling and packaging of chemical products (CLP) and registration, evaluation and restriction of chemicals (REACH). These laws are aimed at improving chemical safety, protecting public health and the environment.
Biocides Act
The Law of Ukraine “On Biocidal Products”, which is due to enter into force in 2024, introduces strict control over the production, import and use of biocides. It establishes the requirements for the registration of biocidal products before entering the market and complies with the European Regulation EU No. 528/2012. The law obliges enterprises using biocidal products to ensure their safety, as well as to obtain permission to sell. It provides for a mandatory assessment of the impact on the environment and human health.
CLP Technical Regulations
On May 10, 2024, the Cabinet of Ministers of Ukraine approved a new Technical Regulation on the Classification, Labeling and Packaging of Chemical Products (UA-CLP), which will enter into force six months after its publication. This regulation complies with the European CLP Regulation and is based on the United Nations Globally Harmonized System for the Classification of Chemicals. UA-CLP obliges manufacturers and importers to collect information about the hazardous properties of chemicals, label and package products in accordance with the requirements.
REACH Act
The draft Law “UA-REACH” developed by the Ministry of Environmental Protection is awaiting government approval and will enter into force at the end of 2024. The law will establish rules for the registration, evaluation and authorization of chemicals used on the Ukrainian market to prevent potentially hazardous chemicals. Similar to the European REACH Regulation, it obliges enterprises to carry out a full analysis of the effects of chemicals, assess safety and ensure compliance with European standards.
These regulations will provide Ukraine with a new level of chemical safety, integrating its market with the European one.
On October 30, 2024, the European Chemicals Agency (ECHA) released results from a pilot enforcement project, revealing that 6% of inspected cosmetic products contained hazardous chemicals banned under the POPs and REACH regulations.
The project involved inspections by authorities in 13 countries of the European Economic Area (EEA), who examined approximately 4,500 cosmetic products. The main focus was on identifying perfluorooctanoic acid (PFOA), long-chain perfluorocarboxylic acids (PFCAs), and cyclic siloxanes D4 and D5 in ingredient lists. Out of these, 285 products were found to contain banned hazardous substances, including:
Cyclopentasiloxane (D5), cyclomethicone (a blend of D4, D5, D6), cyclotetrasiloxane (D4)
These chemicals are banned in cosmetics as they are identified as persistent organic pollutants (POPs) or (very) persistent, (very) bioaccumulative, and toxic (PBT/vPvB), with adverse effects on human health and the environment. For example, perfluorononyl dimethicone degrades into PFOA and other persistent acids, while D4 and D5 accumulate in the environment and are toxic to reproduction.
Enforcement authorities have taken action to remove non-compliant products from the market, with ongoing investigations in half of the cases.
The European Commission has taken a major step towards implementing the EU Deforestation Regulation (EUDR), aimed at preventing deforestation globally by regulating products entering or exported from the EU market.
Extended Timeline for EUDR Requirements
Recognizing the global scope of this legislation and the challenges it poses to businesses, the European Commission has proposed extending the compliance deadlines. Large and medium-sized enterprises have until 30 December 2025, to fully implement the EUDR requirements, while small and micro-enterprises have until 30 June 2026. The additional 12 months will serve as a transitional period. If the proposal is accepted, businesses will have the time to implement due diligence systems, ensuring that their supply chains are deforestation-free.
New Guidelines and Dedicated Information System
In tandem with the extended timeline, the European Commission has issued updated guidelines and an extensive framework for international cooperation. These guidelines clarify key definitions within the regulation, such as concepts of operators, due diligence and market placement, as well as legal requirements and timeframes. Moreover, SMEs can benefit from simplified rules and reduced obligations.
As previously announced, a fully operational IT system will be made available in December of this year, allowing businesses to submit their due diligence declarations. Registration and submission of documents will therefore be possible even before the Regulation officially comes into force.
Strategic International Cooperation Framework
The Commission’s strategy emphasizes international collaboration, recognizing that deforestation is a global issue requiring coordinated responses. Accordingly, most countries worldwide will be classified as “low risk”. This aims to focus efforts on cooperating with high-risk countries to help them meet EUDR standards. These goals will be achieved through actions such as:
Promoting sustainable agricultural practices and deforestation-free supply chains worldwide, and
Integrating human rights principles, particularly the rights of indigenous communities affected by deforestation.
Importance of EUDR
The EU Deforestation Regulation is a crucial tool in combating climate change, aimed at reducing the EU’s contribution to global deforestation and forest degradation. Forests are essential in absorbing carbon dioxide, and their destruction accelerates global warming and biodiversity loss. The success of this regulation hinges on cooperation between the EU, businesses, and international partners, particularly in regions most affected by deforestation. The additional time granted to companies to comply with the EUDR is expected to facilitate a smooth and effective transition towards deforestation-free supply chains, ensuring that environmental sustainability and global trade go hand in hand.
At the end of September, the European Commission updated Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (POPs). The update cover two substances included in Annex I:
a) Methoxychlor – concentration equal to or below 0.01 mg/kg if methoxychlor is present in substances, mixtures or articles.
b) Hexabromocyclododecane – concentration equal to or below than 75 mg/kg if it is present in substances, mixtures or articles, or is part of flame retardant articles; and concentration equal to or less than 100 mg/kg in the case of using recycled polystyrene in the production of EPS and XPS materials.
The aim of introducing the restriction is to protect human health and the environment by eliminating, limiting the production, use of substances and introducing persistent organic pollutants into circulation as soon as possible, because they accumulate in living organisms and remain permanently in the environment.
Chemical substances considered persistent organic pollutants may be contained in pesticides, industrial chemicals, as well as in by-products of production processes, degradation and combustion.
Let us recall that the regulation prohibits the production, placing on the market and use of substances listed in Annex I on their own, in mixtures or articles, with the specific exemption on intermediate use, listed in the annexes.
Commission Delegated Regulation (EU) 2024/2570 of 22 July 2024 amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards methoxychlor
Commission Delegated Regulation (EU) 2024/2555 of 21 March 2024 amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards hexabromocyclododecane
The end of the transition period for poison centre notifications is approaching. This means that all notifications for hazardous mixtures placed on the EU market must be in the harmonised format according to Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation from 1 January 2025.
The transition period has allowed companies to continue placing their hazardous mixtures on the market according to non-harmonised national requirements. From 1 January 2025, these submissions will no longer comply with the CLP Regulation.
If companies intend to keep placing these mixtures on the market after this date, they will have to submit a new notification as required by Annex VIII and include the unique formula identifier (UFI) on the label. ECHA recommends notifiers to use the ECHA Submission portal to prepare and submit their information in the harmonised format.
For help, visit the support page on the poison centre website, or reach out to your national or ECHA Helpdesk.
Ensuring the prevention of chemicalaccidents at hazardous facilities is a key component of chemicals management.
This document is based on a 2023 OECD seminar series on the Management of Hazardous Substances at Port Areas. The first seminar covered examples from countries on the functioning of their ports with regard to the management of hazardous substances. The second focused on elements of chemical accidents management at port areas. The results of these discussions are combined here along with the main challenges to managing chemical accidents risks and safety at port areas and possible means for improvement.
The European Commission has introduced new restrictions under the REACH Regulation to limit the use of undecafluorohexanoic acid (PFHxA) and related substances. These are part of the per- and polyfluoroalkyl substances (PFAS) group, known as “forever chemicals” for their persistence in the environment and resistance to degradation. The new regulations aim to reduce the health and environmental risks associated with PFHxA, commonly used in various consumer products.
Scope of the Restrictions
The PFHxA restriction focuses on areas where the risks are not adequately controlled, and alternatives are available. The restriction will impact products such as:
Textiles
Food Packaging
Consumer Mixtures
Cosmetics
Firefighting Foams
These restrictions are designed to protect human health and the environment while limiting the socio-economic impact. Certain sectors, such as semiconductors, batteries, and fuel cells for green hydrogen, are exempt where no safe alternatives exist.
Timeline for Implementation
The new restrictions will officially come into force 20 days after publication in the Official Journal of the EU. A phased transition period of 18 months to 5 years, depending on the product type, will allow manufacturers time to adapt and replace PFHxA with safer alternatives.
EU’s Commitment to Reducing PFAS Pollution
This restriction is part of the EU’s larger effort to reduce PFAS pollution, aligned with the Chemicals Strategy for Sustainability. PFAS have been used in industrial processes and consumer products for decades, leading to widespread contamination of soil and water, including drinking water. By limiting PFHxA, the EU continues its work to reduce public health risks while balancing industrial needs for a greener economy.
This measure builds on existing bans and restrictions of other harmful PFAS, like PFOA, contributing to a safer, more sustainable future.
From 1 April 2026, a new requirement in Europe is to assess the impact of water treatment processes on active substances and their metabolites. This initiative, which is jointly led by the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), covers new registrations and renewal of registrations of active substances in plant protection products and biocidal products.
A guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water was published at the end of 2023. Discussions are ongoing between chemical, agrochemical companies and contract research organizations to define and validate clear testing strategies and analytical support to meet the new requirements.
Drinking water is obtained from sources, including surface and/or groundwater. The guidance provides different approaches to measure the impact of water treatment processes on both active substances and their metabolites in drinking water production. The guideline applies to processes used mainly in the European Union, including filtration, chlorination, pre-oxidation, ozonation and UV disinfection. This will help address public health concerns related to exposure to harmful compounds in drinking water.
What is included in testing?
Within a multi-level framework, it avoids, where possible, studies in operation and incorporates, where appropriate, the use of weighting of evidence methodologies and a new approach.
The exact number of active substances already in use that will need to be assessed is not yet known, but it is estimated that there will be around 100 to 500, each of which has multiple potential metabolites. This leads to concerns for manufacturers who would be forced to complete testing to ensure the ongoing compliance of their products.
How can the company Ecotox Center help?
The company Ecotoxicological Centre Bratislava, s.r.o. offers expert advice on the registration of active substances in line with the new requirements of ECHA and EFSA. We help with testing strategies, analytical support, and meeting legislative requirements for product compliance. Our goal is to ensure the safety of drinking water and compliance with all regulations.
If your company is classified as micro, small, or medium-sized (SME), it’s essential to ensure that you’ve accurately stated your company size in REACH-IT during your substance registration. Incorrect declarations can lead to administrative charges.
Helsinki, 10 September 2024 – The European Chemicals Agency (ECHA) is actively verifying the size of companies that have claimed SME status during their REACH registrations.
If you realize that you mistakenly declared a smaller company size, it’s crucial to contact ECHA’s Helpdesk promptly. Failing to do so could result in an administrative charge of up to EUR 19,900, in addition to the fee difference based on your correct size.
However, if you proactively inform ECHA of the error before they initiate verification, you will only be required to pay the registration fee difference, avoiding the administrative charge.
Guidelines on determining your company size are available on ECHA’s website. Make sure to upload supporting documents for your SME status in REACH-IT, regularly monitor your REACH-IT account for updates, and ensure that your registrations and contact details are always up to date.
When you use our website, we may collect information to operate and improve your experience through cookies. By closing or accepting, you agree this use of cookies.Accept cookiesDeclinePrivacy policy
