EU Chemical Legislation and Sustainability Developments 2024: Updates and Impacts - Madeni Yağ Dünyası

Dr. Eyüp Şimşek – Chemvisor General Manager

2024, especially for the European Union (EU), has been a year in which fundamental legislative changes in the fields of chemicals, product safety and sustainability have been brought to the agenda, while preparations have been made for the important changes planned for the following years. Significant updates to regulations such as the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the Classification, Labelling and Packaging (CLP) Regulation, and the Digital Product Passport (DPP) reflect the EU’s commitment to protecting human health and the environment in line with the European Green Deal and the Chemicals Sustainability Strategy (CSS). This article will provide a detailed overview of the most important chemical legislation changes that will come into force throughout 2024, their impacts and the steps that businesses need to take to comply.

1. EU REACH Legislation: Restrictions are Extended, Inspections are Strengthened

Regarding the REACH revision envisaged within the scope of the European Green Deal and the Chemicals Sustainability Strategy (CSS) on October 14, 2020; the revision was not brought to the EU Commission agenda in the 2019-2024 period. However, Ursula von der Leyen announced in her political guidelines for the 2024-2029 Commission that the Commission will present a new package for the chemicals industry aimed at ‘simplifying REACH’ and ‘providing clarity on perfluoroalkyl and polyfluoroalkyl substances (PFAS)’. Accordingly, a targeted revision of REACH is planned in the Commission’s 2025 work programme under the heading of ‘simplification’ in the last quarter of the year [1]. However, new regulations have already been introduced within the existing REACH legislation that could affect certain sectors and product groups in 2024.

Substances of Very High Concern (SVHC): New Substances Added

The European Chemicals Agency (ECHA) continues to increase regulatory pressure on substances of very high concern (SVHC). As of January 2024, some UV absorbers such as UV-327, UV-350 and UV-320 have been added to the SVHC list. These substances are considered risky due to their persistent, bioaccumulative and toxic (PBT) properties. During 2024, a total of 8 new substances were added to the SVHC list, bringing the number of substances listed as SVHCs to 242 by the end of 2024. [2]

PFAS Restrictions: Expanding Scope

The per- and polyfluoroalkyl substances (PFAS) restriction proposal submitted by ECHA under the REACH Restrictions (Annex 17) was prepared with contributions from five European countries (Germany, the Netherlands, Denmark, Sweden and Norway) and is considered one of the most comprehensive chemical regulations ever proposed in Europe.

The key elements of the proposal include a regulation covering more than 10,000 PFAS derivatives, broad restrictions on the marketing and use of all products containing PFAS, and provision of transition periods for specific sectors.

The proposal sees a general ban or phase-out processes for all PFAS use with only very limited exceptions and conditional exceptions for specific sectors as an alternative approach.

As is known, a comprehensive PFAS restriction proposal was published in February 2023 and as of November 2024 (2024/EC 2462), this proposal was updated in response to more than 5,600 public feedback. A final decision is expected by mid-2026 [3].

The main sectors that are expected to be affected by the PFAS restriction are; Electronics and Batteries (lithium-ion batteries and semiconductors), Healthcare and Medical Devices (implants), Automotive and Aviation (high-performance lubricants, hydraulic fluids and seals), Textiles (waterproof clothing) and Consumer Products (kitchenware, fire retardant coatings). There may be exceptions during the transition period for some relevant sector uses. The views of the relevant committees (Risk Assessment Committee-RAC and Socio-Economic Analyses Committee-SEAC) on the subject will be followed.

In 2025, the RAC opinion and the SEAC draft opinion will be prepared in more detail, and a targeted consultation on the SEAC draft opinion is expected to be carried out afterward, to gather socio-economic information from stakeholders.

ECHA’s 2025 Work Plan, published in November 2024, states that imported chemicals will be subject to stricter monitoring. In addition, implementations such as regulating chemicals sold via e-commerce and pilot projects to monitor importers’ compliance with registration obligations will be put in place.

Microplastics: Restrictions in Force

The European Union has defined “Microplastics” in Article 78 of Annex XVII of REACH as all plastics with a length/diameter ratio greater than 3, with dimensions below 5 mm or below 15 mm.

Microplastics typically come from microbeads in facial cleansing products, abrasive particles in sandblasting, synthetic fibers, plastic pellets, plastic particle drug vectors and degradation under weather conditions, exposure to sunlight and mechanical impact.

The European Union REACH regulation on microplastics was published in the EU Official Journal on 27 September 2023 and entered into force on 17 October 2023. The regulation regulates the prohibition of microplastics in products placed on the European Union/European Economic Area (EU/EEA) market.[4]

2. CLP Legislation: New Classification Label Rules and PCN Notifications

New Classification and Labelling Rules: Change

The amendment to the EU Classification, Labelling and Packaging (CLP) Regulation (EU 2024/2865) was published in the Official Journal of the European Union on 20 November 2024 and entered into force as of 10 December 2024. The new regulation includes the following [5]:

New hazard classes for endocrine disruptors (ED), persistent, bioaccumulative and toxic (PBT) and persistent, mobile and toxic (PMT) substances.
Digital labelling requirements will allow online information sharing in addition to physical labels.
Accelerated processes for label updates will require label changes for products with new hazard classes to be completed within 6 months.

When considering the impacts on industry and trade sectors,

Safety Data Sheets (SDS) and labels must be updated by July 2026.
Digital labeling systems must be developed to ensure compliance.
Companies must comply with these processes as new obligations for Poison Center Notifications (PCN) will come into force in January 2025.

On December 3, 2024, the European Chemicals Agency (ECHA) published a comprehensive inspection report covering 28 countries in the EU-European Economic Area and examining more than 2,500 Safety Data Sheets (SDS) for chemicals. The report found that despite a significant improvement in the compliance of SDSs provided by suppliers, approximately 35% of them still did not meet regulatory requirements. In addition, inspectors found that in 96% of cases, suppliers provided SDSs to buyers when needed, indicating that the SDS process in the supply chain was functioning well [6].

In this context, it is recommended that attention be paid to SDS compliance based on the new requirements in exports to the EU region. In particular, the requirement for digital labels can be considered an important step in terms of traceability requirements foreseen in the following years.

PCN Notifications: Inspections Start in 2025

As of January 1, 2024, the transition period for Poison Center Notifications (PCN) for mixtures used in professional, consumer or industrial contexts has ended. Existing national notifications remain valid until January 1, 2025, but changes to product composition or identifiers require a new PCN in a harmonized format. With the start of targeted PCN compliance inspections, the focus will be on the consistency of products and PCN notifications, labels and SDSs. Businesses should ensure that Unique Formula Identifiers (UFIs) are correctly included in the SDS and labels to avoid non-compliance issues.

According to ECHA’s latest announcement, the Implementation Forum will start inspections on EU Poison Center Notifications (PCN) in January 2025. These inspections will last for six months and the final report is expected to be published by the end of 2025. Inspectors will not only monitor the submission of PCN notifications but also the accuracy of labels and Safety Data Sheets (SDS) for mixtures [7]. This inspection process aims to enforce the duty holders’ obligation to notify national authorities about hazardous mixtures, with the ultimate aim of protecting human health. In emergencies, poison centres can use this information to advise citizens or healthcare personnel. It is therefore vital that poison centres have accurate information about hazardous mixtures in order to respond appropriately in emergencies.

According to Article 45 of the CLP Regulation, importers and downstream users placing hazardous mixtures (creating a physical or health hazard) on the market within the EU must provide detailed information on 100% of the composition of the mixture and other necessary details to poison centres. Suppliers outside the EU who wish to protect their trade secrets may designate a legal entity within the EU (e.g. the Only Representative appointed under REACH legislation) to submit a voluntary notification. In such cases, it is possible to protect the confidentiality of the components of the mixture by simply providing the Unique Formula Identifier (UFI).

3. CBAM: The Transition Period Continues

The EU’s Carbon Border Adjustment Mechanism (CBAM) is a tool to set a fair price for the carbon emitted during the production of carbon-intensive goods entering the EU and to encourage cleaner industrial production in countries outside the EU. By confirming that a price is paid for the tangible carbon emissions generated in the production of certain goods imported into the EU, the CBAM will ensure that the carbon price of imports is equal to the carbon price of domestic production and that the EU’s climate goals are not undermined. Initially, it covers specific sectors: iron and steel, aluminium, cement, fertilisers, electricity and hydrogen. However, the EU Commission is discussing the inclusion of organic chemicals, plastics and other carbon-intensive sectors in the scope of CBAM in the coming years [8].

Under CBAM, the definitive period, during which free allowances will be gradually reduced, will be implemented from 2026, while the current transitional period, during which free allowances are provided, will last from 2023 to 2025. It is planned to completely eliminate free allowances from 2034.

The transition phase for CBAM harmonization (1 October 2023 – 31 December 2025) is currently ongoing

The first reporting process under CBAM was completed as of 1 January 2024. Companies exporting to the EU submitted their emission data for the last quarter of 2023 to the EU Commission. However, in order to ensure data security for operators outside the EU, it is planned to open the CBAM Portal to non-EU operators. In this way, the data collected by the operators can be presented collectively to EU resident declarants. One of the biggest challenges in the reporting process is observed to be accurate emission calculations and timely collection of necessary data.

Importers must fulfill their quarterly reporting obligations throughout 2024. There is no financial obligation in this process; however, companies must declare the carbon emissions of imported products. For example, the reports that must be completed in 2024 were submitted in January, April, July and October.

As part of the reporting; direct and indirect emissions arising in the production processes of imported products must be determined. The EU requires companies to make carbon emission calculations specific to their production facilities. Organizations must collect carbon emission data in accordance with the methodologies determined by the EU and upload them to the CBAM Digital Portal. Within the scope of Preparation for Carbon Certificates Before 2026; The transition period will be completed at the end of 2025, and importers will have to purchase CBAM certificates as of 2026.

It is recommended that organizations exporting to the EU region in relevant sectors prepare for the 2026 final implementation process by taking into account the relevant obligations.

4. EU General Product Safety Regulation: Requirements Expand for Non-EU Products

The European Union has enacted the EU General Product Safety Regulation (Regulation (EU) 2023/988, GPSR) to better protect consumers and modernize product safety rules. This regulation replaces the existing General Product Safety Directive 2001/95/EC (GPSD) and expands it to cover new risks in e-commerce, digital services and the supply chain. The GPSR will come into effect as of December 13, 2024. The GPSR covers all consumer products imported into the EU and imposes additional obligations, particularly on companies selling online [9, 10].

The prominent changes under the GPSR can be listed as follows:

New Security Rules for Digital and Online Marketplaces: Online marketplaces are required to quickly detect and remove dangerous products. Digital service providers will need to take greater responsibility for product safety.
Product Safety Assessment and Traceability: Manufacturers must conduct risk assessments and create technical dossiers proving that their products are safe. Traceability requirements for all products have been increased. Manufacturers and importers must assess potential risks in their products in advance and take preventive measures.
Mandatory Product Recall Processes: More effective recall notifications will be made to consumers in the EU market. Companies must communicate directly with consumers during recall processes and facilitate product returns.
New Obligations for Companies Exporting to the EU: Manufacturers, importers and distributors supplying products to the EU market must comply with the new rules. It has been made mandatory to appoint a “responsible person” resident in the EU. This person will communicate directly with EU authorities regarding product safety and provide the necessary documents. In addition to products bearing the CE marking, products that do not require the CE marking will also be subject to the GPSR.
E-Commerce and Platform Obligations: E-commerce platforms must implement a “single point warning system” to quickly remove products that do not comply with EU legislation. Consumers must be provided with clear and understandable information about the product, and rapid intervention mechanisms must be developed for unsafe products.

Possible risks for Turkish exporters can be listed as follows:

Companies that fail to comply with the additional obligations imposed by GPSR may have difficulty entering the EU market.
Companies exporting to the EU will need to strengthen their safe product certification and reporting processes.
The obligation to have a representative resident in the EU may create additional costs, especially for SMEs.

The following steps can be suggested for the management of relevant risks:

The product category must be determined and the necessary product safety assessments and technical files must be prepared completely.
Supply chain traceability must be increased.
E-commerce companies must comply with the new obligations imposed by GPSR for online platforms.
Recall procedures must be established and effective communication mechanisms with consumers must be developed.
The process of compliance with GPSR should be accelerated by appointing a “responsible person” in the EU.

5. Ecodesign Regulation for Sustainable Products: Updates and Scope of Application

The European Union (EU) has put into effect the Ecodesign Regulation (EC 2024/1781) on July 18, 2024, replacing the existing Ecodesign Directive (EC 2009/125) in order to reduce the environmental impact of products and promote sustainable production and consumption models within the framework of the 2020 Circular Economy Action Plan [9,10]. The Ecodesign Directive determines the minimum requirements for improving the environmental performance of energy-related products and in this direction regulates manufacturers to take ecological criteria into account in their product design processes, and while it is only applied to energy-related products, the ESPR expands this scope to cover almost all physical products.

In this context, by increasing resource efficiency, products are encouraged to have a longer life by using less raw materials, and design criteria are determined to minimize energy and water consumption in production, use and disposal processes. In addition, it has been made mandatory to increase the durability of products, to make them easy to repair, to provide spare parts and to establish technical support mechanisms. In order to ensure recyclability, products must have recyclable components at the waste stage, and the use of hazardous chemicals has been limited within the scope of regulations regarding chemical contents. In addition, it is aimed to provide digital traceability for all products with the Digital Product Passport (DPP) application and to provide comprehensive information on the environmental footprint.

Prioritized Product Groups

In the first work plan to be adopted by April 19, 2025, the Commission is expected to prioritize the following product groups: iron and steel; aluminum; textiles, especially clothing and footwear; furniture, including mattresses; plastics; detergents; paints; lubricants; chemicals; energy-related products for which eco-design requirements will be set for the first time or for which existing measures adopted pursuant to Directive 2009/125/EC will be reviewed in accordance with this Regulation; and information and communication technology products and other electronic products.

Digital Product Passport (DPP) Obligation

Under the ESPR, the concept of a Digital Product Passport (DPP) will be implemented, a digital identity card for products, components and materials that will store relevant information to support the sustainability of products, promote circularity and strengthen legal compliance. The information under the DPP will be accessible electronically and will facilitate better informed decisions by consumers, producers and authorities on sustainability, circularity and regulatory compliance. It will also allow customs authorities to carry out automated checks on the existence and authenticity of DPPs for imported products.

The information to be included in the DPP will be determined by the Commission in close consultation with all relevant stakeholders and will depend on the specific product in question. This information may include the technical performance of the product, materials and their origin, repair activities, recycling capabilities, and life cycle environmental impacts. The scope of application of the DPP will be gradually expanded until 2026.

The new regulation has introduced additional requirements for manufacturers to make their products more durable, modular and recyclable: Repairability scores have been determined to ensure that products have a longer lifespan. The modular design requirement will ensure that products can be easily disassembled and parts can be replaced. Certain percentage rates have been introduced for manufacturers regarding the use of recycled materials in order to reduce the amount of waste [9,10].

New Criteria for Supply Chain and Production Processes

The Ecodesign Regulation regulates not only final products but also a wide range from raw material supply to production processes. As of 2024:

Emission reduction targets have been set for companies with carbon-intensive production processes.
Manufacturers have been made obliged to comply with sustainability standards in their supply chains.
Manufacturers have been made obliged to declare their environmental impacts during the raw material supply, production, transportation and usage stages.

The ESPR is a type of framework legislation and forms the basis for the subsequent adoption of concrete rules, either on a product-by-product basis or horizontally – on the basis of product groups with similar characteristics.

The process will start with a prioritization exercise and the Commission will adopt a first ESPR work plan in the first half of 2025, which will determine which products will be prioritized in the coming years. The development of product rules will then begin, based on comprehensive planning, detailed impact assessments and regular stakeholder consultation within a dedicated Ecodesign Forum.

In particular, it is recommended that early adaptation to the requirements under the DPP be prepared on the basis of relevant product groups, in order to ensure a smooth management of the adaptation process for companies exporting to the EU. It is recommended that the process be closely monitored, as existing products may need to be improved or new products may need to be developed, in order to meet the relevant requirements.

Conclusion

2024 has been a critical period in which comprehensive changes to the chemical legislation of the European Union have been implemented and paved the way for future regulations. Updates to regulations such as the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the Classification, Labelling and Packaging (CLP) Regulation, the Carbon Border Adjustment Mechanism (CBAM), the General Product Safety Regulation (GPSR), and the Ecodesign Regulation for Sustainable Products (ESPR) strengthen the EU’s goals of protecting human health and the environment in line with the Green Deal and Chemical Sustainability Strategy (CSS). In particular, PFAS and microplastic restrictions, new hazard classes, carbon border regulations and the digital product passport requirement have introduced new compliance requirements for manufacturers and exporters. In this context, it has become a critical necessity for companies operating in the EU market or exporting to this market to switch to more sustainable production models, align their supply chain processes with environmental requirements and fully comply with the new legislation.

In particular, ESPR and GPSR bring new responsibilities in terms of product design, production processes and consumer safety, and increase the importance of adaptation to digital labeling and traceability systems. Likewise, the gradual expansion of CBAM applications requires companies operating in carbon-intensive sectors to invest in production processes with a lower carbon footprint.

Considering all these developments, in order to maintain competitive advantage in the EU market and ensure legal compliance, businesses need to closely follow legislative changes, develop their technical and operational capacities for new regulations, and adopt a sustainability-focused transformation strategy. As the scope of legislation is expected to expand and control mechanisms to become even tighter in the coming years, adopting a proactive approach will ensure the long-term success of organizations.

References:

#REACH #CBAM #CLP #EyupSimsek #Chemvisor

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