Ecodesign has become an important tool for ensuring sustainable development aimed at reducing the negative impact of products on the environment throughout their life cycle.
According to the new approaches, the regulation of sustainable products requires manufacturers to implement eco-design principles at all stages of the production process. This applies to both the individual components and the final products entering the market. Manufacturers must consider the environmental impact of their products from the moment the raw materials are extracted to the disposal of waste after use. Ecodesign not only reduces harmful effects on ecosystems, but also helps to reduce production costs by optimizing the use of resources.
One of the key requirements of ecodesign is to ensure the energy efficiency of products. This means that when developing new products, you need to take into account their energy consumption and look for ways to reduce it. Another important aspect is the possibility of reusing materials and recycling them at the end of the product life cycle.
European Union legislation on sustainable product ecodesign defines the framework within which manufacturers are obliged to act to ensure that their products comply with environmental standards.
Energy Efficiency of Products
Resource Utilization Optimization
Recycling and reuse
Durability and maintainability
Reducing environmental impact
Innovation & Sustainability
These points emphasize the importance of ecodesign as a tool for creating products that meet modern requirements for sustainable development and environmental protection.
The Ecodesign for Sustainable Products Regulation (ESPR) entered into force on 18 July 2024. The ESPR aims to significantly improve the circularity, energy performance and other environmental sustainability aspects of products placed on the EU market.
The Technical Regulation on Cosmetic Products is based on Regulation (EC) No 1223/2009 on Cosmetic Products, adopted on 30 November 2009. This regulation defines the requirements for the safety, quality and labeling of cosmetics entering the Ukrainian market, and in accordance with the Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021, it enters into force on August 3, 2024. Placing cosmetic products on the market, which was put into circulation before August 3, 2026, cannot be prohibited or restricted due to the non-compliance of such cosmetic products with the requirements of the TR approved by this resolution.
The purpose of the technical regulation is to ensure a high level of consumer protection by establishing clear and unambiguous requirements for cosmetic products. It covers all aspects related to the manufacture, labeling, testing, and sale of beauty products.
The main provisions of the regulation include:
Product safety: Requirements for the composition of cosmetics to prevent possible harmful effects on the health of consumers. Products must undergo toxicological and other types of testing to confirm their safety.
Labeling and packaging: Clear and understandable labeling, which includes all the necessary information about the composition, instructions for use, date of manufacture and expiration date.
Declaration of Conformity: Manufacturers and importers must provide documents confirming the compliance of their products with all established standards and requirements.
Quality Control: Rules are established to carry out quality control at all stages of the production and supply of cosmetics.
Requirements for advertising materials: False or misleading statements about the properties of products that may mislead consumers are prohibited.
According to the new regulations, every cosmetic product must be thoroughly tested and certified to ensure that it meets high safety and quality standards. This regulation will help consumers better navigate the choice of cosmetic products and provide greater transparency in the market.
Ukraine has officially adopted the REACH regulation, marking a significant step in aligning its chemical safety standards with those of the European Union. This move requires companies operating in Ukraine to register their chemical substances, ensuring comprehensive information on the safety and use of these substances is available.
Important Registration Deadlines:
October 1, 2026:
Substances at ≥1,000 t/a
CMR substances (Category 1A and 1B) at ≥1 t/a
Substances very toxic to aquatic organisms (acute or chronic) at ≥100 t/a
June 1, 2028:
Substances at 100 – 1,000 t/a
March 1, 2030:
Substances at 1 – 100 t/a
REACH Regulation: REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. It is a comprehensive EU regulation aimed at protecting human health and the environment from the risks posed by chemicals.
Registration Timeline: Companies in Ukraine must begin their registration process, with all necessary registrations due by 2026. This timeline provides businesses with a clear framework for compliance.
Scope and Impact: The regulation applies to all chemical substances manufactured, imported, or used in Ukraine. This includes chemicals used in industrial processes as well as those found in everyday products like cleaning agents, paints, and articles such as clothes and furniture.
Benefits: By adopting REACH, Ukraine aims to improve public health and environmental protection. The regulation promotes safer handling of chemicals, reduces the number of hazardous substances, and encourages the use of safer alternatives.
What This Means for Businesses:
Compliance Requirements: Companies must identify and manage the risks linked to the substances they manufacture and market in Ukraine.
Data Sharing: Businesses will need to share data on the properties and uses of their substances, along with guidance on safe handling.
Regulatory Support: Enterprises can seek assistance and detailed guidance from Ukrainian regulatory bodies to ensure they meet REACH requirements.
This adoption signifies Ukraine’s commitment to enhancing chemical safety standards and integrating with European norms, ultimately fostering a safer environment for its citizens and ecosystems.
Helsinki, 23 July 2024 – In accordance with new provisions confirmed by the European Commission, the European Chemicals Agency (ECHA) will now issue only one administrative charge for joint authorisation applications that include applicants with incorrectly declared company sizes. This policy applies even if multiple applicants falsely claim to be micro, small, or medium-sized enterprises (SMEs).
The administrative charge will be based on the size of the largest applicant within the joint application group. This aligns with the fee structure outlined in the Commission’s Implementing Regulation on fees and charges payable to ECHA. The lead applicant will receive the invoice. If all applicants have accurately declared their company sizes, no administrative charge will be imposed.
Additionally, the definition of ‘financial gain’ has been amended to include ex-ante verification, which occurs before the invoice is issued. Since SMEs benefit from lower fees, ‘financial gain’ refers to the amount of fees avoided due to false or incomplete information.
The levels of the administrative charge and other provisions remain unchanged. The revised and consolidated decision by ECHA’s Management Board, as confirmed by the Commission, is effective as of 22 July 2024.
Pool definition: Pool 0 contains substances that are already included in the Registry of Intention (RoI) for restrictions1 or where the Commission has requested ECHA to prepare a restriction dossier. Restriction dossiers that have already been submitted are not included in pool 0 but are listed in Appendix 1.
Pool 0 – ECHA Article 69.2;
Pool 0 – Member States;
Pool 1 -Anticipated Commission request to ECHA;
Pool 1 -ECHA Article 69.2;
Pool 1 -Member States.
Annex II – Groups of substances under assessment with a restriction as a potential regulatory management option
Annex II lists substances that are under assessment with restrictions as a potential regulatory management option. For the time being, no decision has yet been taken on whether a restriction will be prepared, nor on who submits the dossier (a Member State, or ECHA on behalf of the Commission). Annex II also serves as a list for authorities to develop their priorities for future restriction dossiers. Similar as for pool 1, for some (groups of) substances classification under the CLP Regulation or SVHC-identification under REACH might be the next regulatory action, which is then potentially followed by a restriction.
Substances are listed in Annex II due to different reasons. It includes (groups of) substances for which:
– ECHA’s Assessment of Regulatory Needs suggests a restriction as a potential regulatory management option;
– ECHA, in accordance with Art. 69(2), identified a restriction as a regulatory follow-up action;
– Preliminary assessments of Member States, the Commission or working groups involving Member States, the Commission and ECHA suggest that a restriction could potentially be an adequate regulatory management option;
– Review reports or previous assessments indicate that revising a restriction could be necessary (e.g. lead in consumer articles; nickel in articles intended to come into direct and prolonged contact with the skin).
The Candidate List of substances of very high concern (SVHC) now contains 241 entries for chemicals that can harm people or the environment. Companies are responsible for managing the risks of these chemicals and giving customers and consumers information on their safe use.
Helsinki, 27 June 2024 – The newly added chemical, bis(α,α-dimethylbenzyl) peroxide, is toxic for reproduction and is used as a processing aid, e.g. as a flame retardant.
Entries added to the Candidate List on 27 June 2024:
ECHA’s Member State Committee (MSC) has confirmed the addition of this substance to the Candidate List. The list now contains 241 entries – some are groups of chemicals so the overall number of impacted chemicals is higher.
This substance may be placed on the Authorisation List in the future. If a substance is on this list. Companies cannot use it unless they apply for authorisation and the European Commission authorises its continued use.
Other substances
The MSC agreement seeking process to identify triphenyl phosphate (TPhP; EC no. 204-112-2) as an SVHC was foreseen for the committee’s June meeting. However, having consulted the committee members and the dossier submitter, ECHA decided to suspend the agreement seeking process for this substance because substantial new information became available in the days preceeding the meeting.
This suspension ensures that the newly provided data will be properly evaluated and considered in the SVHC identification process. This is an exceptional arrangement and applies only in the conditions specific to this case.
ECHA’s Enforcement Forum agreed to a new EU-wide project to check that hazardous mixtures present in products, such as air fresheners or electronic cigarettes, are classified, labelled and packaged correctly to protect consumers and children from chemical hazards.
Helsinki, 17 June 2024 – The objective of the checks in the new REF-14 project is to protect human health by enforcing the requirement to classify and label hazardous mixtures. The checks will include consumer products which are widely available on the market and known to contain hazardous mixtures – such as nicotine products with acutely toxic substances or air fresheners containing sensitising or irritant substances.
Enforcement authorities noted that these products are sometimes not classified and labelled to inform consumers about the hazards and how to use them safely. They are also sometimes found without child resistant fastening, which may result in children being exposed.
Inspectors will check if the suppliers of these products fulfil their duties under the CLP regulation, including classification and labelling, as well as requirements for packaging and child resistant fastening. They will also check the notifications to the poison centres and the safety data sheets of the mixtures. The REF-14 project will be prepared in 2025 and inspections are expected in 2026.
We encourage you to read the current issue of EkotoxInfo news. In the summary of resent developments in the area of chemicals legislation and management you will find the following topics:
Nanomaterials in cosmetic products
Extension of EU’s review of biocidal active substances
Revision of the EU Packaging and Packaging Waste Directive
The essential use concept in EU legislation dealing with chemicals
Restriction on the manufacture, placing on the market and use of Per- and polyfluoroalkyl substances (PFAS)
Restriction proposal on chromium (VI) to cover more substances
Octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) substances restricted under EU Comission Regulation
Submitting downstream user notification of authorised uses
REACH Conference 2024 will be held in Bratislava on October 15-16, 2024
1. Nanomaterials in cosmetic products
COMMISSION REGULATION (EU) 2024/858 (March 14, 2024) of European Parliament and Council Regulation 1223/2009/EC on styrene/acrylate copolymer, sodium styrene/acrylate copolymer, copper, copper colloid, hydroxyapatite, on the modification of gold, gold colloid, gold thioethylaminohyaluronic acid, acetyl heptapeptide-9 gold colloid, platinum, platinum colloid, acetyl tetrapeptide-17 platinum colloid and silver colloid nanomaterials in cosmetic products.
3. Revision of the EU Packaging and Packaging Waste Directive
The proposed regulation would set out provisionson sustainability (e.g. on substances of concern, recyclability, and mandatory recycled content and packaging minimisation); labelling, marking and information (e.g. on the material composition of packaging); obligationsfor economic operators (e.g. prohibition of certain packaging formats and setting reuse and refill targets); management of packaging and packaging waste (e.g. targets for packaging waste reduction and on deposit and return systems for single-use plastic beverage bottles and metal beverage containers); and green public procurement.
4. The essential use concept in EU legislation dealing with chemicals
The essential use concept in EU legislation addressing chemicals is a framework designed to determine when the use of certain substances is necessary for societal needs. It aims to balance health, safety, and environmental concerns with societal demands. This concept entails identifying uses that are critical for health, safety, or societal functioning, while also assessing the availability of alternatives. Through structured assessments, non-essential uses can be filtered out, simplifying regulatory processes and promoting the transition to safer alternatives. The implementation of this concept requires careful consideration of specific criteria and procedures within individual legislative frameworks to ensure its effectiveness and applicability across various sectors.
5. Restriction on the manufacture, placing on the market and use of Per- and polyfluoroalkyl substances (PFAS)
PFASs are, or ultimately transform into, persistent substances, leading to irreversible environmental exposure and accumulation. Due to their water solubility and mobility, contamination of surface, ground- and drinking water and soil has occurred in the EU.
One of the major societal concerns is the irreversibility of contamination, together with endocrine disrupting effects, carcinogenicity, toxicity to reproduction, effects on immune system and on lipid metabolism for a broad range of PFASs.
Universal PFAS restriction proposal is under legislative proces
7. Octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) substances restricted under EU Comission Regulation
COMMISSION REGULATION (EU) 2024/1328 of 16 May 2024
8. Submitting downstream user notification of authorised uses
Downstream users of a substance listed on the Authorisation List (Annex XIV) using it under an authorisation granted to a supplier further up your supply chain, must notify ECHA of the use.
REACH Conference 2024 will be held in Bratislava on October 15-16, 2024
Conference REACH 2024 is organized for the fourteenth time combining lecturers and participants from different sectors of industry, authorities, academia and other stakeholders.
Now EU chemicals legislation reached the important milestone defined by new policies of Chemicals Strategy for Sustainability in frame of European Industrial Deal to complement the Green Deal. To manage all new requirements will be a challenge for all involved.
EKOTOX CENTERS – consultancy and advisory group focused primarily on legal requirements on EU market in case of products (articles), mixtures and chemical substances, hazard and risk assessment. We cover wide range of regulatory areas to help our customers to comply with specific requirements for their products on EU market.
EKOTOX CENTERS:
Ekotox Hungary Kft., HUNGARY
CENTRUL EKOTOX S.R.L. ROMANIA
Centrum Ekotoksykologiczne Sp. z o.o., POLAND
Ekotoxikologické centrum CZ s.r.o., CZECH REPUBLIC
Ekotoxikologické centrum Bratislava s.r.o., SLOVAKIA
ЕКОТОКС ЦЕНТР УКРАЇНА, Ekotox Center Ukraine LLC., UKRAINE
PFASs are, or ultimately transform into, persistent substances, leading to irreversible environmental exposure and accumulation. Due to their water solubility and mobility, contamination of surface, ground- and drinking water and soil has occurred in the EU.
One of the major societal concerns is the irreversibility of contamination, together with endocrine disrupting effects, carcinogenicity, toxicity to reproduction, effects on immune system and on lipid metabolism for a broad range of PFASs.
Universal PFAS restriction proposal is under legislative process:
ECHA Committees for Risk Assessment and for Socio-Economic Analysis meet in June to discuss:
* Metal plating and manufacture of metal products; and
COMMISSION DELEGATED REGULATION (EU) 2024/1398 of 14 March 2024
Ensures the continuation of the work program for the systematic review of all existing active substances used in biocidal products, initiated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and Council.
The work program to be implemented is planned for 31 December of 2024, however, its implementation is significantly delayed due to member state resources, emerging technical issues and the development of guidelines, and the introduction of new scientific criteria created to determine endocrine-disrupting properties.
Given that the work program will not be implemented until 31 December 2024, it is necessary to extend its duration for 2030, which the Commission considers appropriate.
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