#ECHA Tag

07 Nov

Posted at 10:55h in Blog, Regulatory Updates

Recent Regulatory Developments in Biocidal Active Substances:

The European Union has recently published a series of regulatory updates concerning the approval and non-approval of certain active substances for use in biocidal products.

 

Approvals Granted

Two implementing regulations have been published, approving a complex reaction mass of various ammonium propionate compounds for use in biocidal products:

  • Implementing Regulation (EU) 2023/2088 approves the substance for use in product-type 8 biocides, effective from October 19, 2023. This active substance was previously approved under a different name, which has now been updated to reflect its correct chemical identity.
  • Implementing Regulation (EU) 2023/2089 extends the approval to include product-types 2 and 4 biocides, also effective from October 19, 2023.

 

Non-Approvals Announced

Conversely, two decisions have been made to not approve certain active substances:

  • Implementing Decision (EU) 2023/2052 does not approve silver sodium hydrogen zirconium phosphate for use in product-type 4 biocides, with the decision taking effect on October 16, 2023.
  • Implementing Decision (EU) 2023/2377 does not approve silver and copper zeolite for use in product-type 4 biocides, effective from October 23, 2023.

 

Extensions on Approval Expiry Dates

The European Commission has also published decisions to extend the approval expiry dates for several active substances pending renewal decisions:

  • Implementing Decision (EU) 2023/2100 extends the approval of copper (II) oxide for product-type 8 biocides until October 19, 2023.
  • Implementing Decision (EU) 2023/2378 extends the approval of alfa-chloralose for product-type 14 biocides until October 23, 2023.
  • Implementing Decision (EU) 2023/2380 extends the approval of basic copper carbonate for product-type 8 biocides until October 22, 2023.
  • Implementing Decision (EU) 2023/2386 extends the approval of copper hydroxide for product-type 8 biocides until October 22, 2023.

These extensions have been granted as applications for renewal were submitted in a timely manner, and the decisions on renewal are pending.

 

REACH:

  • The European Chemicals Agency (ECHA) is preparing to propose restrictions on certain high-concern chromium (VI) substances, currently listed for authorization under REACH. This action, requested by the European Commission, is to manage the heavy workload from numerous authorization applications and to prevent potential resource strain on ECHA’s risk assessment committees. The proposal, due by October 2024, could lead to the removal of these substances from the REACH Authorisation List for the first time. The substances are known carcinogens and have other serious health risks, commonly used in electroplating. Companies affected by these potential restrictions can consult a Q&A document published by the Commission for guidance.
  • Switzerland is set to update its chemical regulations to exempt specific uses of five substances listed under the EU’s REACH Annex XIV. The Swiss Federal Office for the Environment (FOEN) aims to align more closely with EU regulations by amending the Chemical Risk Reduction Ordinance (ORRChem). This change, which was reported to the WTO at the end of October, involves adding these substances to a Swiss annex that mirrors the EU’s authorization requirements for Substances of Very High Concern (SVHCs).
  • The substances in question include three that are toxic to reproduction: tetraethyllead (used in fuels), DOTE (used in polymers), and a reaction mass of DOTE and MOTE.
  • The other two are a carcinogen used in inks and toners, known as:4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol (with traces of Michler’s ketone or Michler’s base), and an endocrine disruptor for the environment, which is a reaction product of certain chemicals (with a specific percentage of 4-heptylphenol).
  • The updated regulation is expected to be officially adopted on the first day of the new year and will come into effect on January 1, 2027. This follows a previous amendment in April where Switzerland granted exemptions for the use of SVHCs in the pharmaceutical and aircraft industries.

 

EU Parliament Votes for Stricter Asbestos Exposure Limits:

  • The European Parliament has taken a significant step towards enhancing worker safety by voting to reduce the occupational exposure limit (OEL) for asbestos by ten times. The new directive, which garnered overwhelming support with 614 votes in favor, aims to lower the OEL from 0.1 to 0.01 fibers per cubic centimeter. This move is part of the EU’s broader strategy to combat the risks posed by asbestos, a known carcinogen.
  • The directive mandates stringent measures, including the use of protective gear, specialized respiratory equipment, and comprehensive training for workers dealing with asbestos. Additionally, within six years, EU member states are required to provide workers with advanced electron microscopes capable of detecting asbestos fibers at the new lower concentration levels.
  • Despite this progress, some organizations, like the European Trade Union Confederation (ETUC), argue that the new OEL still falls short of the more stringent 0.001 fibers per cm³ level recommended by the International Commission on Occupational Health (ICOH).

 

EU Commission Revokes Sodium Dichromate Authorization:

  • In another regulatory development, the European Commission has withdrawn an authorization for Gruppo Colle to use sodium dichromate in wool dyeing. This decision follows a review that identified available alternatives to the substance, which is classified as a Substance of Very High Concern (SVHC) due to its carcinogenic nature.
  • The Commission’s action aligns with the European Chemicals Agency’s (ECHA) socio-economic assessment committee’s (SEAC) findings, which highlighted deficiencies in Gruppo Colle’s substitution plan. The authorization’s withdrawal is part of the EU’s ongoing scrutiny of SVHCs, particularly chromium VI compounds, and follows a trend of moving from authorization to restriction to minimize the use of hazardous substances.

 

Cosmetic Safety Limits for Methyl Salicylate in Children’s Products:

  • Lastly, the European Commission’s Scientific Committee on Consumer Safety (SCCS) has confirmed concentration limits for methyl salicylate in cosmetics for children. The final opinion sets specific maximum concentrations for various products, such as shower gels, shampoos, and creams, for children aged six months to three years. Methyl salicylate, commonly used for fragrance and flavoring, is restricted due to its classification as reprotoxic.
  • These regulatory updates reflect the EU’s commitment to safeguarding public health and the environment by tightening controls on hazardous substances and ensuring safer working conditions across the Union.

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

03 Oct

Posted at 10:15h in Blog, Regulatory Updates

Regolamentazione EU sulle PFAS:

  • La proposta dell’UE di restringere l’uso delle PFAS ha sollevato dubbi riguardo l’esclusione di prodotti biocidi e farmaceutici. Il comitato ECHA per l’analisi socioeconomica (SEAC) ha dichiarato che tale decisione “non è adeguatamente giustificata”. Nonostante l’ECHA abbia precedentemente escluso questi prodotti citando misure esistenti, il SEAC sostiene che l’argomentazione attuale non è pienamente giustificata.
  • Il dossier ha riconosciuto che queste applicazioni portano a significative emissioni, paragonabili ad altri usi delle PFAS. Inoltre, la persistenza di queste sostanze non è adeguatamente considerata nelle normative attuali. L’industria farmaceutica e veterinaria ha già chiesto un’esenzione, sottolineando la mancanza di sostituti pronti per queste sostanze chimiche.
  • Il documento trapelato è ancora in fase preliminare e sarà rivisto. Una volta finalizzato, l’opinione del SEAC sarà inviata alla Commissione Europea per la stesura del testo legale. Se l’opinione rimanesse invariata, le industrie farmaceutiche e biocide potrebbero affrontare incertezze legali sul futuro uso di queste sostanze.
  • In conclusione, il SEAC concorda con la proposta che le deroghe dovrebbero essere concesse solo in assenza di alternative. Tuttavia, ha sottolineato che l’assenza di alternative non dovrebbe essere l’unico criterio per giustificare una deroga.
  • La recente proposta di restrizione mira a un divieto totale dei fluoropolimeri più comuni, tra cui il politetrafluoroetilene (PTFE), il più diffuso nel gruppo con un’ampia gamma di applicazioni.
  • In risposta, centinaia di aziende hanno sollecitato un’esenzione per i fluoropolimeri, sostenendo che la maggior parte dei composti chimici che producono o utilizzano dovrebbe essere considerata come polimeri a basso rischio. Inoltre, affermano che le emissioni di PFAS possono essere gestite in modo adeguato attraverso misure volontarie.

 

FCM:

  • È stato pubblicato il Regolamento (UE) 2023/1627 che modifica l’allegato I del Regolamento (UE) n. 10/2011 per quanto riguarda l’autorizzazione della sostanza bis(2-etilesile)cicloesano-1,4- dicarbossilato (MCA n. 1079).

 

REACH:

  • ECHA ha informato che avvierà le verifiche sulla dimensione delle aziende che hanno dichiarato di essere una PMI al momento della registrazione REACH.
  • Le autorità tedesche hanno ritirato la proposta di restrizione sui bisfenoli dal processo di formazione del parere da parte dei comitati scientifici dell’ECHA.
  • È stato pubblicato il Decreto del Ministero della Salute del 31 marzo 2023, che introduce le tariffe per l’integrale copertura dei costi sostenuti dal Ministero della Salute per l’espletamento dell’attività di notifica di esportazione e di richiesta di consenso ai sensi del Regolamento (UE) 649/2012 (cd. PIC). È stata pubblicata la rettifica della Direttiva Delegata (UE) 2023/1526, che modificava la Direttiva 2011/65/UE per quanto riguarda un’esenzione relativa al piombo come stabilizzatore termico del cloruro di polivinile impiegato come materiale di base nei sensori utilizzati nei dispositivi medico-diagnostici in vitro.
  • È stato pubblicato il Regolamento Delegato (UE) 2023/1608, che modifica l’Allegato I del Regolamento (UE) 2019/1021 (cd. Regolamento POP) per quanto riguarda l’inclusione dell’acido perfluoroesansolfonico (PFHxS), dei suoi sali e dei composti a esso correlati.
  • Sul sito di ECHA sono state pubblicate le proposte di classificazione ed etichettatura armonizzata per le seguenti sostanze:
  • 3,4-dimethyl-1H-pyrazol-1-ium dihydrogen phosphate (CAS 202842-98-6) – La proposta prevede la classificazione come Repr. 1B (H360FD), Acute Tox. 4 (H302) con oral: ATE = 500 mg/kg bw e STOT RE 2, H373 (nasal cavity). La sostanza è impiegata nei fertilizzanti; attualmente la sostanza non è presente in Allegato VI del CLP;
  • 3,4-dimethyl-1H-pyrazole (CAS 2820-37-3) – La proposta prevede la classificazione come Carc. 2 (H351), Repr. 2 (H361f), Acute Tox. 4 (H332) con inhalation: ATE = 2.1 mg/L, Acute Tox. 4 (H312) con dermal: ATE = 1100mg/kg bw, Acute Tox. 4 (H302) con oral: ATE = 500 mg/kg bw, STOT RE 2, H373 (nasal cavity), Eye Dam. 1 (H318) e Aquatic Chronic 3 (H412); Attualmente la sostanza è presente in Allegato VI del CLP con classificazione Acute Tox. 4* (H302), Eye Dam. 1 (H318) e Aquatic Chronic 3 (H412);
  • 3,5-dimethylpyrazole (CAS 67-51-6) – La proposta prevede la classificazione come Repr. 1B (H360FD), Acute Tox. 4 (H302) con oral: ATE = 1700mg/kg bw e STOT RE 2, H373 (liver, blood). Attualmente la sostanza non è presente in Allegato VI del CLP;
  • Minerali di boro, in particolare ulexite (CaNaH12(BO3)5.2H2O) (CAS 1319-33-1) e ulexite (CaNaH12(BO3)5.2H2O), calcined (CAS 92908-33-3); colemanite (CaH(BO2)3.2H2O) (CAS 1318-33-8), boron calcium oxide (B6Ca2O11), hydrate (1:5) (CAS 854267-07-5) e colemanite, calcined (CAS 92908-12-8); tincalconite (B4Na2O7.5H2O) (CAS 12045-88-4). La proposta prevede la classificazione come Repr. 1B (H360FD) con la nota 11 per ogni singola voce. Attualmente le sostanze non sono presenti in Allegato VI del CLP;
  • rape oil; rape seed oil (CAS 8002-13-9). La proposta prevede la classificazione come Aquatic Chronic 4 (H413). La sostanza attualmente non è presente in Allegato VI del CLP.

È possibile rispondere alla consultazione per le sostanze entro il 13 ottobre 2023.

 

Varie:

  • 3 ottobre 2023 – ECHA organizza il webinar “Towards faster regulatory action: ECHA’s approach to assessing chemicals in groups”, durante il quale saranno illustrati l’approccio di ECHA nella valutazione delle esigenze normative, i futuri miglioramenti relativi al modo in cui l’Agenzia informa i dichiaranti sulle valutazioni pubblicate e le modalità per reagire nel caso in cui la sostanza di interesse venga coinvolta in una valutazione di gruppo.

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

19 Sep

Posted at 09:31h in Chemical

La formaldeide e i suoi molteplici usi:

La formaldeide è una sostanza chimica che, a temperatura ambiente, si presenta come gas incolore, infiammabile e dall’odore pungente.

La formaldeide è anche prodotta in piccole quantità dal corpo umano, così come da piante e animali.

A livello industriale il 98 % della formaldeide fabbricata o importata nell’Unione Europea viene utilizzata nella produzione di resine a base di formaldeide, materiali termoplastici ed altre sostanze chimiche.

Le resine a base di formaldeide sono poi utilizzate principalmente nella fabbricazione di pannelli a base di legno, in quanto fungono da legante per le particelle di legno, e nella produzione di altri prodotti a base di legno (come mobili e pavimenti) nonché per carta da parati, schiume, parti di veicoli stradali e aeromobili, prodotti tessili e in pelle.

 

Restrizione ai sensi del Regolamento REACH:

Nel 2017 la Commissione europea ha chiesto ad ECHA (l’Agenzia europea per le sostanze chimiche) di valutare il rischio per la salute umana derivante dall’utilizzo della formaldeide e dalle sostanze che rilasciano formaldeide da parte dei consumatori.

Il processo di valutazione si è recentemente concluso con l’introduzione di una nuova restrizione (voce n. 77 dell’Allegato XVII del REACH) relativa alla formaldeide e alle sostanze che rilasciano formaldeide.

Nello specifico, secondo la nuova restrizione, non è ammessa l’immissione sul mercato di queste sostanze dopo il 6 agosto 2026 in articoli se la concentrazione di formaldeide rilasciata da tali articoli è superiore a:

  1. a) 0,062 mg/m3 per i mobili e gli articoli a base di legno;
  2. b) 0,080 mg/m3 per gli articoli diversi dai mobili e dagli articoli a base di legno.

La restrizione prevede però anche diverse esenzioni. In particolare, sono esentati dall’applicazione della restrizione i seguenti prodotti:

  • gli articoli in cui la formaldeide o le sostanze che rilasciano formaldeide sono esclusivamente presenti in natura nei materiali con cui sono prodotti gli articoli;
  • gli articoli destinati esclusivamente all’uso all’aperto in condizioni prevedibili;
  • gli articoli da costruzione utilizzati esclusivamente al di fuori dell’involucro edilizio e della barriera al vapore e che non emettono formaldeide nell’aria degli ambienti chiusi;
  • gli articoli destinati esclusivamente all’uso industriale o professionale, a meno che la formaldeide da essi rilasciata non comporti l’esposizione del pubblico in condizioni d’uso prevedibili;
  • gli articoli per i quali si applica la restrizione di cui alla voce 72;
  • i biocidi;
  • i dispositivi medici;
  • i dispositivi di protezione individuale;
  • gli articoli destinati a venire a contatto, direttamente o indirettamente, con i prodotti alimentari;
  • gli articoli usati (in quanto dovrebbero essere già degassati).

 

I veicoli stradali e la nuova restrizione:

La restrizione sulla formaldeide e sui rilasciatori di formaldeide prevede, inoltre, delle disposizioni specifiche per alcune tipologie di veicoli stradali.

 

Infatti, non è ammessa l’immissione sul mercato dopo il 6 agosto 2027 in veicoli stradali se la concentrazione di formaldeide all’interno dei veicoli stradali è superiore a 0,062 mg/m3.

 

La restrizione prevede però una esenzione per i veicoli usati e per i veicoli stradali destinati esclusivamente all’uso industriale o professionale, a meno che la concentrazione di formaldeide all’interno di tali veicoli non comporti l’esposizione del pubblico in condizioni d’uso prevedibili e i veicoli usati.

 

Indicazioni sulla misurazione di formaldeide – appendice 14:

La restrizione ha inoltre aggiunto, all’allegato XVII del REACH, l’appendice 14 che fornisce indicazioni sulla misurazione della formaldeide rilasciata dagli articoli nell’aria degli ambienti chiusi e sulla misurazione della concentrazione di formaldeide all’interno dei veicoli.

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

05 Sep

Posted at 09:55h in Blog, Regulatory Updates

ECHA:

  • Updates on Battery Regulations: ECHA Takes on New Responsibilities for Safer Batteries

The European Chemicals Agency (ECHA) is stepping up to play a pivotal role in enhancing battery safety across the European Economic Area (EEA). The agency has been tasked with supporting the European Commission in identifying hazardous substances present in batteries or involved in their production process. This initiative aims to make batteries more sustainable throughout their entire lifecycle.

 

A New Chapter in EU Battery Regulations

As of August 17, 2023, the European Union has updated its regulatory framework concerning batteries. ECHA has been given new responsibilities to assist the European Commission in this endeavor. Specifically, the agency will contribute to a comprehensive report that will investigate substances in batteries that pose risks to human health, environmental safety, or the recycling process for obtaining high-quality raw materials.

 

Upcoming Milestones

This crucial report is slated for completion by December 31, 2027. Work on this report is expected to commence in 2024. The report will not only identify these hazardous substances but will also explore potential follow-up actions, including the possibility of imposing restrictions across the EU.

Additional Responsibilities

Beyond the report, the European Commission may also call upon ECHA to draft proposals for restricting harmful substances in both new and waste batteries. ECHA will evaluate these proposals through its specialized committees for Risk Assessment and Socio-Economic Analysis. These committees will assess the effectiveness of the proposed restrictions in mitigating risks and their broader societal impact.

 

Regulatory Background

The updated regulations come under the new EU law, Regulation (EU) 2023/1542, which was enacted by the European Parliament and the Council on July 12, 2023. This law amends previous directives and regulations, including Directive 2008/98/EC and Regulation (EU) 2019/1020, and rep

 

  • A Shift in Germany’s Stance on Bisphenols

In a surprising turn of events, Germany has withdrawn its initial proposal to limit the use of bisphenols throughout the European Union. This reversal follows a six-month public consultation, marking an unprecedented move by the proposal’s originator.

 

The German Federal Institute for Occupational Safety and Health (BAuA) decided to pull back the proposal even before the European Chemicals Agency (ECHA) could weigh in. BAuA is now revising the proposal based on the public feedback received and plans to reintroduce it soon.

 

Key Points of the Original Proposal:

  • The original proposal differentiated between ‘free’ and ‘chemically-bound’ bisphenol molecules, with the latter facing fewer restrictions.
  • The proposal aimed to limit five specific bisphenols—BPA, BPB, BPS, BPF, and BPAF—due to their potential environmental impact.

 

Why the Reversal?

  • Stakeholder feedback led to a reevaluation of the environmental risks associated with both types of bisphenols.
  • Industry players, particularly in plastics and textiles, opposed the proposal, citing impractical testing requirements and high costs.
  • Environmental groups argued that the proposal’s scope was too narrow and called for more comprehensive restrictions.

 

What’s Next?

Once revised, the proposal will undergo another round of public consultation and will be reviewed by ECHA’s specialized committees. The European Commission, under the REACH regulation, retains the right to make changes to the proposal, provided a detailed rationale is given.

This development highlights the complexities involved in regulating chemicals like bisphenols, which are widely used in various industries but pose potential risks to the environment.

 

  • EU’s Chips Act Faces Challenges Due to PFAS Restrictions

The European Union’s ambitious Chips Act, aimed at doubling the EU’s global market share in semiconductor production to 20% by 2030, is facing significant hurdles. Industry leaders warn that the proposed restrictions on per- and polyfluoroalkyl substances (PFASs) could derail these plans.

 

The Dilemma

The EU plans to invest €47 billion to boost its semiconductor manufacturing capabilities, especially in the wake of global chip shortages. However, companies in the semiconductor and chemical sectors argue that achieving these goals would be nearly impossible without the continued use of PFASs. These substances are crucial for various manufacturing processes and currently have no viable alternatives.

 

Industry Concerns

Major players like Infineon Technologies and Dupont have expressed that a blanket ban on PFASs would severely compromise the EU’s competitive edge in semiconductor manufacturing. The SEMI association also stated that such restrictions would be counterproductive to the EU’s objectives. Japanese firms like Nippon Pillar Packaging and Nikki Fron echoed these concerns, suggesting that the EU could even lose its current 10% market share.

 

Time Constraints

The EU has proposed a 12-year derogation period with an 18-month transition for the semiconductor industry to adapt. However, industry experts argue that even this timeframe is insufficient for finding alternatives that meet the technical requirements and safety standards.

Global Implications

Similar concerns have been raised in the United States, where trade associations are cautioning that new PFAS regulations could also hamper semiconductor production.

 

What’s Next?

The EU’s PFAS restrictions are expected to be finalized by 2025 and implemented in 2026-27. With the consultation period ending on September 25, it remains to be seen how these regulations will evolve to balance environmental concerns with industrial ambitions.

 

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

11 Jul

Posted at 09:23h in Food

On the 6th of July, the EFSA released the very long-awaited conclusion on the safety of glyphosate in the context of the renewal of its use as herbicide (pesticide). They conclude <<The assessment of the impact of glyphosate on the health of humans, animals and the environment did not identify critical areas of concern>>. Uncertainties have been underlined (data gaps) which leads to impossibility of carrying out a risk assessment. The latter are related to the assessment of one of the impurities in glyphosate, the consumer dietary risk assessment, and the assessment of risks to aquatic plants.

The entire opinion has been sent to the European Commission but not published, yet. EFSA is legally required to ensure all content complies with rules on personal data protection and confidentiality before publishing. As soon as this process is complete, EFSA will publish its conclusions (expected by late July) and all background documents (expected by late October) related to the peer review and risk assessment in full on its website.

In the late 2022 the ECHA shared its opinion on the issue, concluding that no concerns were to be raised by Glyphosate within its intended use in the Europen Union.

With the EFSA favourable opinion, the European Commission will have to amend the renewal of glyphosate as active substance for PPP (Plant Protection Product).

 

The timeline of Glyphosate

In 2019, the Glyphosate Renewal Group (GRG) formally applied to renew the approval of glyphosate for use after the current approval expires at the end of 2022.

Four EU Member States – France, Hungary, the Netherlands and Sweden – formed the Assessment Group on Glyphosate (AGG). They assessed the application and submitted their reports to ECHA and the European Food Safety Authority (EFSA).

In parallel with EFSA’s assessment, ECHA’s Committee for Risk Assessment, (RAC), reviewed the classification of glyphosate. RAC is mandated to review only the hazardous properties of the substance, and not the likelihood of exposure to glyphosate.

RAC’s assessment started in 2021. A consultation on the classification proposal was launched in September 2021. RAC’s final opinion was published in July 2022 and it will feed into EFSA’s risk assessment.

EFSA has released a FactSheet on Glyphosate available here chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.efsa.europa.eu/sites/default/files/2023-07/glyphosate_factsheet.pdf

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

04 Jul

Posted at 09:54h in Blog, Regulatory Updates

ECHA:

EU-wide PFAS ban in firefighting foams warranted

  • The Committee for Socio-Economic Analysis (SEAC) of the European Chemicals Agency (ECHA) has given its approval to a phased ban on per- and polyfluoroalkyl substances (PFAS) in firefighting foams. This ban has the potential to reduce PFAS emissions into the environment by approximately 13,200 tonnes over a span of 30 years.

 

  • SEAC has determined that the proposed restriction on the marketing, use, and formulation of PFAS in firefighting foams is the most effective measure to address the identified risks across the European Union. This decision takes into account the available alternatives and the balance between the benefits and societal costs associated with the restriction. These conclusions are based on an assessment of the risks conducted by ECHA’s Committee for Risk Assessment (RAC) in March 2023.

 

  • In order to ensure safety in areas where fires could have serious consequences for the environment and human health, SEAC advises conducting a thorough evaluation of fluorine-free alternatives for facilities involved in the production, treatment, or storage of hazardous substances (as outlined in the Seveso Directive) as well as neighboring sites. This evaluation should be completed before the end of the 10-year transition period.

 

  • Additionally, SEAC suggests extending the transition period from five to 10 years for offshore installations in the oil and gas industry, and conducting a similar review of fluorine-free alternatives for these sites. SEAC considers these reviews to be essential for maintaining safety standards.

 

REACH:

New EU chemicals enforcement project to focus on products sold online

  • The European Chemicals Agency (ECHA) has recently released an article announcing the initiation of a new project called REACH-EN-FORCE (REF)-13. This project, led by ECHA’s Enforcement Forum, aims to guarantee that products available for purchase online adhere to the restrictions outlined by REACH and the requirements of the Classification, Labelling and Packaging (CLP) Regulation. The project will specifically target items such as toys, common household goods, and chemicals that are sold online. Inspections under this project are scheduled to occur in the year 2025.

 

  • In the context of non-compliance, the online sale of chemicals has emerged as a significant concern. Specifically, in a previous Forum project (REF-8), inspectors frequently encountered instances where mixtures and articles sold online contained hazardous substances that are restricted due to their potential to cause cancer. The project revealed a staggering statistic, indicating that 78% of controlled mixtures or articles failed to meet the conditions outlined in the REACH restrictions.

 

  • How will the implementation of the Digital Services Act and General Product Safety Regulation impact the upcoming project in terms of strengthening enforcement measures for inspectors in online sales?

 

  • The Biocidal Products Regulation (BPRS) subgroup of the Forum has reached a consensus that the upcoming major enforcement project on biocides (BEF-3) will primarily concentrate on ensuring the accuracy of product labels for biocidal products. During inspections, inspectors will verify if the information provided on the labels of biocides aligns with the authorized information included in the Summary of Product Characteristics. Additionally, inspectors may also assess the presence and accuracy of information in the Safety Data Sheets, specifically for biocidal products where it is mandatory.

 

  • In order to obtain a thorough and accurate response, please provide detailed information regarding the preparations, inspections, and publication timelines for both the REF-13 and BEF-3 projects. Specifically, please include the specific activities planned for 2024, the proposed schedule for inspections in 2025, and the expected timeline for publishing reports in 2026.

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

16 May

Posted at 10:48h in Chemical

Cosa sono i PFAS?

I PFAS (sostanze perfluoroalchiliche) sono una grande famiglia di migliaia di sostanze chimiche sintetiche costituite da catene di atomi di carbonio a lunghezza variabile legate ad atomi di fluoro e ad altri gruppi funzionali.

La presenza del legame carbonio-fluoro (uno dei legami chimici più forti nella chimica organica) fa sì che tali sostanze siano altamente persistenti e che possano continuare ad accumularsi nell’ambiente, senza degradarsi, per decenni o secoli.

I PFAS, inoltre, hanno la capacità di essere estremamente “mobili”, ossia possono essere facilmente trasportati nell’ambiente e raggiungere aree remote e incontaminate. Molti PFAS possono poi avere effetti (eco)tossicologi e risultare quindi dannosi per la salute umana.

 

Cosa sta facendo l’Europa?

Alcuni gruppi di sostanze PFAS sono già normati a livello europeo (la loro produzione e utilizzo è vietata o soggetta a specifiche restrizioni).

Tuttavia, viste le caratteristiche di tali sostanze, l’Europa (nello specifico, ECHA, l’Agenzia europea per le sostanze chimiche) sta attualmente valutando una restrizione decisamente più ampia di quelle già in vigore.

 

Cosa prevede la restrizione in discussione?

Rientrano nello scopo della proposta di restrizione(1):

Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I atom attached to it).

Sono esclusi dalla definizione di PFAS esclusivamente alcuni specifici sottogruppi di PFAS in quanto completamente biodegradabili in condizioni ambientali normali.

Per i PFAS oggetto della restrizione è previsto il divieto di produzione, utilizzo e immissione sul mercato; tale divieto è valido sia per le sostanze in quanto tali sia per i PFAS presenti in una miscela, in un articolo o come costituenti di un’altra sostanza (quando presenti al di sopra di determinate concentrazioni).

La proposta di restrizione prende in considerazione due opzioni di restrizione. La prima è un divieto totale senza esenzioni e con un periodo di transizione di 18 mesi, mentre la seconda è un divieto totale con deroghe per usi specifici limitate nel tempo (18 mesi di periodo di transizione ai quali si sommano 5 o 12 anni di periodo di deroga).

Al momento la seconda opzione risulta essere quella maggiormente sostenuta in quanto più bilanciata.

 

Quali settori e prodotti sono coinvolti?

I PFAS vengono utilizzati per rendere resistenti ai grassi e all’acqua materiali quali tessuti e tappeti, servono per fissare il rivestimento delle pentole antiaderenti, per le schiume antincendio, come rivestimento antipolvere per la microelettronica e sono usati nella produzione di cosmetici e di alcuni farmaci e per moltissime altre applicazioni.

La restrizione su cui sta lavorando ECHA riguarda più di 10.000 sostanze e prende in considerazione ben 14 settori di utilizzo diversi (e 78 sotto-usi!).

Tra i principali settori industriali coinvolti dalla proposta di restrizione sui PFAS vi sono: aerospaziale e difesa, automobilistico, aviazione, materiali a contatto con gli alimenti, tessile, cuoio e abbigliamento, prodotti per l’edilizia e per la casa, elettronica, antincendio, trasformazione alimentare e articoli medici.

Il divieto proposto nella restrizione si applica anche per quegli usi che non sono esplicitamente menzionati nella restrizione.

 

Quali sono i prossimi step?

Il 22 marzo u.s. ECHA ha avviato una consultazione pubblica(2) che terminerà il 25 settembre p.v.. L’obiettivo della consultazione è di dare l’opportunità a chiunque abbia informazioni su PFAS di fornire il proprio parere. Di particolare interesse sono le informazioni relative ai rischi, agli aspetti socio-economici e alle alternative ai PFAS.

I comitati scientifici di ECHA per la valutazione dei rischi (RAC) e per l’analisi socioeconomica (SEAC) utilizzeranno poi il contributo della consultazione per valutare la restrizione proposta e formulare un parere in merito.

I due pareri dei comitati di ECHA verranno utilizzati dalla Commissione europea per prendere una decisione in merito; la Commissione valuterà in modo equilibrato sia i rischi identificati sia i costi e i benefici della restrizione.

I nostri esperti in Chemsafe sono sempre informati sugli sviluppi di questi temi, per approfondire qualsiasi tematica non esitate a contattarci a chemsafe@chemsafe-consulting.com.

 

 

Note:

(1)https://echa.europa.eu/it/registry-of-restriction-intentions/-/dislist/details/0b0236e18663449b

(2)https://echa.europa.eu/it/restrictions-under-consideration/-/substance-rev/72301/term

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

03 May

Posted at 10:20h in Regulatory Updates

ECHA:

ECHA recommended eight substances for REACH authorisation

–    Ethylenediamine;

–    2-(4-tertbutylbenzyl)propionaldehyde and its individual stereoisomers;

–    Lead;

–    Glutaral;

–    2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one;

–    2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone;

–    Diisohexyl phthalate; and

–    Orthoboric acid, sodium salt.

 

Biocides:

List of notifications to Review Programme updated

An updated list of substance and product-type combinations notified to Review Programme is now available. It contains the names of the notifying companies to help you collaborate when submitting an application for active substance approval. This can help you avoid unnecessary testing on animals.

 

Member States’ plans to submit assessment reports

It has been published a table with an overview of dates when evaluating competent authorities are planning to submit assessment reports for biocidal active substance approvals or renewals. The Biocidal Products Committee assesses these reports in their opinion-forming. The table will be updated regularly.

 

Commission decisions on Union authorisations

The European Commission has granted Union authorisations for:

  • Biocidal product family C(M)IT/MIT formulations
  • Single biocidal product Arche Chlorine

 

REACH:

EU member states approve microplastics restriction proposal

EU member states have approved the European Commission’s proposal to restrict intentionally added microplastics in products.

The Commission can now send the proposal to the European Parliament and the Council, which have three-month to analyze the text. If they do not raise objections within that time period, the proposal will enter into force.

The EU executive set out the scope of the restriction in a draft published last September, after nearly six years in the making. The proposal is regarded as being one of the most complex chemical bans prepared in the EU.

The Commission’s latest draft made some amendments to ECHA’s prior proposal,which include allowing an increase in the size of particles covered, more generous transition periods of up to 12 years and exemptions for uses at industrial sites and medicinal products.

Industry has welcomed the more realistic deadlines set out in the proposal to allow for the development of alternatives, and the exclusion of soluble or biodegradable polymers. But it continues to regard the scope as being too broad and difficult to enforce, with methods to detect microplastics in products yet to be agreed.

 

European Commission considers future polymer registration plans

The European Commission keep on discussing information requirements and timelines for polymer notification and registration under REACH while stakeholders anxiously wait for the publication of the delayed revision proposal for the Regulation.

The REACH revision proposal, due by the end of the year, will contain the basic provisions for polymers. However, the exact details of what information registrants should submit in the registration phase is not likely to be part of the proposal this year.

Meanwhile, the Commission has come up with several options. One of these, concerning registration, is that after the amended Regulation enters into force, companies would have at least eight years to register low molecular weight (MW) polymers (type 1), and at least 12 years for medium and high MW polymers (types 2 and 3). Collectively they are known as polymers requiring registration (PRRs) and would be those manufactured or imported in quantities above one tonne a year.

There are between 70,000 and 400,000 polymers on the EU market with a figure of 200,000 used as a “working average”. With the scope of helping industry and ECHA process registrations for this vast number, the Commission will ask for polymers to be registered in groups. For these, the idea would be that the group and total tonnage determines the tonnage threshold.

A mandatory notification phase will precede the registration stage. The Commission’s current thinking is that after the Regulation’s entry into force, notifications must be made immediately for new polymers, whereas companies with those substances already on the market will have three years to notify.

While the exact type of information companies must deliver is to be determined, it could include:

  • Basic identification (names and identifiers);
  • Chemical composition of polymeric and non-polymeric parts;
  • Structural information;
  • Information allowing Echa to define grouping criteria; and
  • Optional information, such as physico-chemical, (eco)toxicological, environmental fate, and bioavailability properties.

 

Notification and registration overview

Step 1: notification (PRR/non-PRR identification and information required for grouping) for all manufactured or imported polymers above one tonne

Step 2: Echa defines grouping criteria

Step 3: grouping by industry

Step 4: registration for type 1 PRRs

Step 5: registration for PPR types 2 and 3

 

Derogations possible for fluoropolymers in EU PFAS restriction proposal

The relevant authorities could consider derogations for fluoropolymers in the EU’s universal PFAS restriction proposal if it can be proven that they degrade at the end of their lifecycle.

the EU proposal aims for a full ban, including polytetrafluoroethylene (PTFE), the most prominent one in the group with a wide range of applications, including non-stick coating on pots and pans, wire insulation for aircraft parts and lubrication products for musical instruments.

The EU proposal derogates applications such as medical devices that are manufactured from PTFE due to a lack of alternatives.

The fluoropolymers industry has objected to the inclusion of the chemicals in the scope of the restriction proposal.

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

18 Apr

Posted at 08:30h in Chemical

the new guidance helps companies analyse alternatives under the Biocidal Products Regulation for potentially dangerous active biocidal substances

Currently, there are 59 biocidal active substances identified as “candidates for substitution” (CfS) under the BPR (Art.10), and 441 active substances under assessment.

Article 5 of the BPR ensures that, during the evaluation of an application for active substance approval, active substances will be assessed against exclusion criteria which have been set to phase out substances which raise particular concerns. Active substances meeting one of such criteria shall not be approved unless at least one of the conditions set out in Art. 5(2) of the BPR is met. Art.5(2) specifies that the availability of suitable and sufficient alternative substances or technologies shall be a key consideration when deciding on the approval of substances meeting the exclusion criteria. In this sense, the submission of an analysis of alternatives by the applicant is required.

When substances meet at least one of the criteria for substitution, but do not meet any of the exclusion criteria, a comparative assessment at biocide product level is performed by the relevant competent authority. The placing on the market of the biocidal products containing an active substance which is CfS shall be prohibited/restricted in case the comparative assessment demonstrates that suitable alternatives are available. The submission of an analysis of alternatives by applicants for approval/renewal of such active substances is not legally required but strongly recommended to support the comparative assessment at product authorisation stage.

The ECHA guidance “Analysis of alternatives to biocidal active substances for applicants and authorities: a recommended framework guidance”, released on last January, is primarily aimed at:

  • The applicants to support their application for approval/renewal of a biocidal active substance meeting the exclusion/substitution criteria, and
  • The competent authorities willing to perform an analysis of alternatives for such active substances.

An alternative to a biocidal active substance is a means able to replace the function that the active substance performs, and it must fulfil the following criteria:

  • Safer, i.e. it reduces the risk to human health, animal health and the environment, and
  • Technically and economically feasible for the users in the EU (including efficacy), and
  • Available, from the perspective of production capacities, or of feasibility of the alternative technology.

The alternatives can be chemical substances or non-chemical alternatives (non-chemical means of control and prevention methods). Non-chemical alternatives can be e.g. physical means of achieving the same function of the biocidal active substance, or organisational procedures, preventive measures, devices, changes in a product manufacturing process, changes in the end-product, changes in the material of the end-product (e.g. steel pole instead of wooden pole), etc.

Overall, the analysis of alternatives should comprise:

  • A brief description of the steps taken to identify potential alternatives.
  • The main conclusions of the analysis regarding the identification of potential alternatives and the suitability and availability of these alternatives for the identified uses
  • If there are no or insufficient suitable alternatives, a summary of the actions needed to make potential alternatives suitable and available and the timescale for these actions.

For further details, you can download the guidance here: https://echa.europa.eu/documents/10162/1276600/guidance_analysis_alternatives_biocides_en.pdf/10646cd2-8ec9-36a8-2f00-201fcc49c43e?t=1675846602684

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?

04 Apr

Posted at 10:19h in Regulatory Updates

ECHA:

ECHA’s Committee for Risk Assessment (RAC) supports the proposed restriction on per- and polyfluoroalkyl substances (PFAS) in firefighting foams. The draft opinion of the Committee for Socio-Economic Analysis (SEAC) is open for consultation until 15 May.

RAC has adopted its opinion on the proposal to restrict the marketing authorisation, use and formulation of all PFAS in firefighting foams, after sector-specific transition periods.

With 470 tonnes of PFAS released into the environment every year, the committee came to a close that there is an EU-wide risk for people and the environment from their use in firefighting foams. The proposed restriction would effectively decrease emissions and the associated risks caused by these persistent substances. The committee’s concerns are based on the ‘very persistent’ property combined with others, such as ‘mobility’.

 

Cosmetics:

ECHA’s Enforcement Forum agreed to run a pilot project to check for the presence of restricted perfluorocarboxylic acids (PFCAs) and related substances in consumer products such as cosmetics.

Inspections in this pilot project starts in 2023 and continue throughout 12 participating countries during 2024. The goal is to protect consumers from being exposed to PFCAs and related substances, as well as perfluorooctanoic acid (PFOA), which have been highlighted as substances of very high concern due to their hazardous properties.

The project will also bring awareness about the restrictions under the REACH and Persistent Organic Pollutants (POPs) regulations among companies that sell cosmetics and other consumer products. It was triggered by cases of PFOA, the use of which is restricted under the POPs Regulation, found in cosmetics sold on the EU market.

Inspectors can enforce restrictions under the REACH or POPs Regulation, as applicable. Where breaches are detected, inspectors will take enforcement measures to guarantee compliance with the applicable legislation. The project report should be published at the end of 2024.

PFOA and related substances are outlawed in the EU market under the POPs Regulation. Cosmetics are not excluded from this prohibition. REACH also restricts the use of PFCAs as substances on their own as well as in mixtures and articles. Furthermore, REACH specifically outlaws the use of certain substances that are toxic to aquatic life in wash off cosmetics.

 

CLP:

On March 31, It was published in the Official Journal on “Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards the criteria and hazard classes for the classification, labelling and packaging of substances and mixtures”.

The Regulation, which amends Annexes I, II, III and VI of the CLP, introduces the following new hazard classes, with relevant H and P phrases and classification criteria for substances and mixtures:

– Endocrine interference for human health

– Interference with the endocrine system for the environment

– Persistent, bioaccumulative and toxic or very persistent and very bioaccumulative properties

– Persistent, mobile and toxic or very persistent and very mobile properties

For all hazard classes, the Regulation provides the following dates of application:

– Substances: are classified by 1 May 2025 at the latest; however, substances placed on the market before 1 May 2025 shall not be classified until 1 November 2026.

– Mixtures: they are classified by 1 May 2026 at the latest; however, mixtures placed on the market before 1 May 2026 are not subject to classification until 1 May 2028.

Latest posts

Back to all posts

Have questions on what Chemsafe can do for you?