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.
If you are a downstream user of a substance listed on the Authorisation List (Annex XIV) and are using it under an authorisation granted to a supplier further up your supply chain, you must notify ECHA of your use. Additionally, when using the substance, you must adhere to the conditions of the authorisation, which your supplier is required to outline in the safety data sheet.
To verify whether your use of an Annex XIV substance is authorized, follow these steps:
Check the Safety Data Sheet (SDS): The authorisation number is provided in the SDS that your supplier gives you.
Examine the Label: The authorisation number is also displayed on the substance or mixture label. It follows the format “REACH/x/x/x”.
Contact your Supplier: If you cannot find the authorisation number in either place, reach out to your supplier for confirmation.
You must notify ECHA within three months of the first delivery of the substance. This obligation starts after the authorisation decision is published in the Official Journal.
You need to submit the following information:
Your company’s identity
The authorization number
Contact information
You may also provide details about the typical annual volume and the number of staff using the substance. Additionally, you can include a brief description of your use and any involvement in potential substitution activities.
If the authorisation decision requires specific data, such as exposure information, you must attach a file to your notification by the deadline set in the decision.
Create Your Notification Dossier in IUCLID
Create an IUCLID dossier to notify your use to ECHA. You can do this on your local computer or use IUCLID on ECHA Cloud Services. IUCLID 6 on our Cloud Services is free and always up to date.
Submit Your Notification
You need an active REACH-IT account to submit your notification. Links to REACH-IT are on the right-hand side of this page.
Sign up in REACH-IT (skip this step if your company already has an account). Log into REACH-IT. From the Menu, select “Upload a IUCLID dossier” under “Downstream user notification of authorised uses.” Follow the submission wizard.
COMMISSION REGULATION (EU) 2024/1328 of 16 May 2024
Entry 70 of Annex XVII to Regulation (EC) No 1907/2006 is replaced by the following:
The substances shall not be placed on the market as a substance on its own, as a component of other substances, or in mixtures, if its concentration is equal to or greater than 0.1% by weight after June 6, 2026 (paragraph 1).
Additionally, the substance shall not be used as a solvent for the dry cleaning of textiles, leather, and fur after June 6, 2026 (paragraph 2).
By way of derogation (among others):
– For D4 and D5 in wash-off cosmetic products if it is in mixtures, it shall apply after January 31, 2020.
– For all cosmetic products other than those mentioned above, paragraph 1 shall apply after June 6, 2027.
– Paragraph 1 will take effect after June 6, 2031, for medical devices and their accessories.
– For medicinal products and for veterinary medicinal products, paragraph 1 shall apply after June 6, 2031.
– Regarding the use of D5 as a solvent in dry cleaning textiles, leather, and fur, paragraphs 1 and 2 will take effect after June 6, 2034.
European Parliament adopted new measures to make packaging more sustainable and reduce packaging waste in the EU.
The rules, which have been provisionally agreed on with the Council, include packaging reduction targets (5% by 2030, 10% by 2035 and 15% by 2040) and require EU countries to reduce, in particular, the amount of plastic packaging waste. To reduce unnecessary packaging, a maximum empty space ratio of 50% is set for grouped, transport and e-commerce packaging; manufacturers and importers will also have to ensure that the weight and volume of packaging are minimised.
Certain single use plastic packaging types will be banned from 1 January 2030. These include packaging for unprocessed fresh fruit and vegetables, packaging for foods and beverages filled and consumed in cafés and restaurants, individual portions (for e.g. condiments, sauces, creamer, sugar), accommodation miniature packaging for toiletry products and very lightweight plastic carrier bags (below 15 microns).
To prevent adverse health effects, the text includes a ban on the use of so called “forever chemicals” (per- and polyfluorinated alkyl substances or PFASs) above certain thresholds in food contact packaging.
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.
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