Regulatory Updates

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.

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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.

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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.

 

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02 Aug

Posted at 09:43h in Blog, Regulatory Updates

REACH:

Formaldeide e Rilasciatori di formaldeide.

  • È stato pubblicato il Regolamento 2023/1464 che modifica l’Allegato XVII del Regolamento REACH (restrizioni). L’aggiornamento introduce una nuova restrizione che riguarda la formaldeide e i prodotti che rilasciano formaldeide.
  • Il Regolamento 2023/1464 entrerà in vigore il 6 agosto 2023.

 

CLP:

  • Sono stati pubblicati il Regolamento 2023/1434 (19°ATP) e il Regolamento 2023/1435 (20°ATP) che apportano delle modifiche all’Allegato VI del Regolamento CLP.
  • Il 19° ATP introduce alcune note all’allegato VI parte 1 del Regolamento CLP che riguardano dei composti del boro e l’acido 2-etilesanoico e i suoi Sali.
  • I due Regolamenti entreranno in vigore il 31 luglio 2023 mentre le disposizioni del 20° ATP si applicheranno dal 1° febbraio 2025.

 

Biocidi:

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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.

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06 Jun

Posted at 10:35h in Regulatory Updates

  • Food:

EU adhesives and sealants body submitted guidance on MOH migration in FCMs.

The Association of the European Adhesive and Sealant Industry (FEICA) has published a guidance document on how to evaluate the potential migration of adhesives containing mineral oil hydrocarbons (MOHs) from food contact materials (FCMs).

The goal is to aid adhesive producers and users in the compliance with the rules on MOH release into food under article 3 of the EU FCM regulation.

EU authorities and experts have recognised printing inks used on graphic or newsprint paper as a major contributor to the presence of the substances in recycled paper, which can leech into packaged food, causing concerns over consumer safety.

This is further complicated, FEICA said, by the difficulties of MOH analysis in adhesive raw materials such as waxes, resins and oligomers.

The guidance appears ahead of the European Commission’s long-delayed proposal to redraft the FCM regulation which will not be ready until at least 2025.

 

  • Cosmetics:

European Commission presented regulatory action on more nanomaterials used in cosmetics.

The European Commission has changed its draft regulation concerning measures for certain nanomaterials in cosmetics products by adding a proposal to ban colloidal silver (nano) and to restrict hydroxyapatite (nano).

The move alters a February 2022 draft text that initiated a ban on five nanomaterials, or groups of them, which resurfaced almost seven years after the EU executive first launched a call for data on some of the substances.

The draft, which amends the cosmetics products regulation, now includes the following substances in Annex II – the list of those forbidden for use:

– styrene/acrylates copolymer (nano) and sodium styrene/acrylates copolymer (nano);

– copper (nano) and colloidal copper (nano);

– colloidal silver (nano);

– gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano) and acetyl heptapeptide-9 colloidal gold (nano); and

– platinum (nano), colloidal platinum (nano) and acetyl tetrapeptide-17 colloidal platinum (nano).

The Commission has proposed introduction of hydroxyapatite (nano)  given that potential risk to human health arises from the use of the chemical when the concentration surpass certain levels or when it is used in sprayable products that might lead to exposure of the consumer’s lungs to nanoparticles by inhalation.

The EU executive is therefore planning to restrict it to a maximum concentration of 10% in toothpaste and of 0.465% in mouthwash.

For all these substances, the EU executive is suggesting a transition period of nine months after the regulation’s entry into force for industry to stop placing cosmetics products that contain them on the market.

There have been many developments on substances of concern in cosmetics products recently: in February, trade association Cosmetics Europe released a free online database where consumers can find information about 30,000 cosmetics ingredients.

 

The European Commission’s Scientific Committee on Consumer Safety has submitted a draft about concentration limits for the use of methyl salicylate in cosmetics for use by children.

Methyl salicylate is frequently used in fragrances, as a flavouring agent and as a soothing agent in oral hygiene products.

The substance is classified as reprotoxic (category 2) under CLP, triggering regulatory measures under the cosmetics regulation.

In its draft opinion, published on 16 May, the committee expands on its 2021 opinion, concluding that methyl salicylate is safe in certain cosmetics for children of six months to three years, used in concentrations of up to 0.02%. The conclusion explicitly covers shower gel, hand soap, shampoo, body lotion, face cream, hand cream and lip products.

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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.

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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.

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07 Mar

Posted at 10:01h in Regulatory Updates

Pharma:

  • È disponibile un file contenente i Valori Limite di Esposizione Professionale definiti dall’American Conference of Governmental Industrial Hygienists (ACGIH®) per le normative nazionali ed europee, aggiornato all’edizione 2023 dei valori limite di esposizione professionale. Questo file rappresenta uno strumento di lavoro utile per le imprese

 

Packaging:

  • CONAI ha predisposto un documento di supporto alle imprese per veicolare le informazioni relative all’etichettatura ambientale degli imballaggi tramite canali digitali.
  • CONAI ha predisposto un documento di supporto alle imprese contenente una mappatura internazionale sull’etichettatura dell’imballaggio ai fini della raccolta differenziata
  • CONAI ha reso disponibile il nuovo strumento “Codice Imballaggio”, che attraverso un questionario aiuta l’utente ad individuare, per le più diffuse tipologie di imballaggio, la voce e il codice di dichiarazione nonché il corrispondente valore unitario del Contributo ambientale CONAI e l’eventuale fascia contributiva in vigore dal 2018 in poi.

Rifiuti:

  • Il Comitato Nazionale dell’Albo gestori ambientali ha emanato la delibera n. 1 del 13 febbraio 2023, che introduce la possibilità (dal 15 giugno 2023) per le imprese di dimostrare la propria iscrizione all’Albo non solo attraverso l’esibizione agli enti di controllo del documento cartaceo, ma anche con un QR code generato nell’area riservata del sito web dell’Albo nazionale gestori ambientali. Il QR code contiene i dati identificativi dell’impresa iscritta, il numero di iscrizione, le categorie di iscrizione con i veicoli iscritti ed il dettaglio dei codici CER autorizzati. Gli enti di controllo potranno quindi verificare l’iscrizione utilizzando un’apposita applicazione per dispositivi mobili, che inquadrerà il QR code esibito dall’impresa in formato digitale o cartaceo.
  • Il Comitato nazionale dell’Albo nazionale gestori ambientali ha approvato il calendario delle verifiche per Responsabili Tecnici (art. 13 c. 1 DM 120/2014) per l’anno 2023.

 

CLP:

  • È stata avviata la prima fase di consultazione delle parti sociali sugli aggiornamenti programmati per la Direttiva Cancerogeni, Mutageni e Reprotossici (Direttiva 2004/37/CE); in particolare è in discussione: − l’inserimento di valori limite di esposizione professionale per il cobalto e i suoi composti inorganici, gli idrocarburi policiclici aromatici (IPA), l’isoprene e l’1,4-diossano; − l’inclusione dei fumi di saldatura nell’Allegato I della Direttiva, che riporta un elenco di sostanze, miscele e procedimenti definiti cancerogeni. In questo contesto, è stato affidato ad un consorzio di società (RPA, COWI etc) il compito di svolgere degli studi sugli impatti che queste introduzioni avrebbero per le imprese europee; per raccogliere le informazioni utili allo studio d’impatto, sono stati definiti alcuni questionari. Dal momento che i risultati di questi studi d’impatto, unitamente alle opinioni del RAC sulle sostanze, saranno la base per i prossimi step dell’iter normativo, si invitano le imprese interessate a rispondere ai relativi questionari entro venerdì 10 marzo 2023.

 

Trasporto Merci Pericolose:

  • È stata presentata la Monografia ADR 2023 e il Ministero delle Infrastrutture e dei Trasporti ha confermato importanti informazioni riguardo le esenzioni dalla nomina del consulente ADR.
  • Bruxelles, 2 febbraio – Si è riunito il Network fo Expert Transport & Safety del Cefic per definire la posizione dell’industria chimica sui diversi documenti di modifica ai Regolamenti per il trasporto interno di merci pericolose in discussione

 

Biocidi:

  • ECHA ha pubblicato la versione aggiornata del work program del Comitato sui prodotti biocidi (BPC) che tuttavia comprende solo la programmazione del 2023.
  • Nell’ambito del Regolamento Biocidi, sul sito di ECHA è stata aperta una consultazione pubblica sul 2,2-dibromo-2- cyanoacetamide (DBNPA) per il PT 6 come potenziale candidato alla sostituzione. La consultazione, il cui scopo è di raccogliere informazioni sulla disponibilità di sostituti o alternative alla sostanza attiva in questione è aperta fino al 25 marzo 2023.
  • È stato pubblicato in Gazzetta Ufficiale il Comunicato del Ministero della Salute relativo all’Elenco dei presidi medico chirurgici che sono stati registrati o di cui sia stata autorizzata la variazione dell’autorizzazione all’immissione in commercio dal 1° gennaio 2022 al 31 dicembre 2022.

 

REACH:

  • Il 7 febbraio sul sito di ECHA è stato pubblicato il dossier di allegato XV contenente la proposta di restrizione sui PFAS, a cui seguirà una consultazione pubblica di 6 mesi che si aprirà il 22 marzo. Il dossier si compone di un documento centrale, 7 allegati e 3 appendici: la proposta prevede un divieto totale con deroghe limitate nel tempo per uso specifico (periodo di transizione di 18 mesi più un periodo di deroga di cinque o 12 anni).
  • È stata aperta la terza call for evidence dell’ECHA sul PVC e i suoi additivi. In particolare, in questa fase l’Agenzia chiede informazioni sulle alternative al PVC e a un sottoinsieme di additivi del PVC utilizzati come stabilizzanti termici, plastificanti e ritardanti di fiamma (“additivi nel focus”). La consultazione si chiuderà il 31 marzo 2023.
  • L’8 febbraio 2023 l’Agenzia delle Accise, Dogane e Monopoli ha pubblicato una circolare contenente disposizioni per gli operatori economici che importano prodotti da extra-UE in relazione alle sostanze soggette all’allegato XVII del REACH (restrizioni). Tali disposizioni sono entrate in vigore il 10 febbraio 2023.
  • Il 15 febbraio ECHA ha aperto una “call for evidence” per le sostanze classificate come CMR di categoria 1A o 1B nell’allegato VI, parte 3, del CLP negli articoli di puericoltura. L’obiettivo è di raccogliere dati utili a chiarire la necessità di una restrizione. La consultazione è aperta fino al 31 marzo 2023.
  • Il 17 febbraio è stata aperta una consultazione pubblica relativa all’identificazione come SVHC del bis(4-chlorophenyl) sulphone e del Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide. Entro il 3 aprile 2023 è possibile presentare commenti, che riguardino in particolare l’identità della sostanza e le sue proprietà.
  • La guida di ECHA su monomeri e polimeri è stata rivista per allinearsi a una decisione della commissione di ricorso (Board of appeal) di giugno del 2021 (Case number: A-001-2020); la revisione ha comportato modifiche alla descrizione degli obblighi di registrazione per coloro che importano e fabbricano polimeri e monomeri.
  • Sul sito di ECHA è stata pubblicata la versione aggiornata delle raccomandazioni per le imprese per conformarsi ai requisiti del Regolamento REACH e garantire l’uso sicuro delle sostanze chimiche. In particolare, tali raccomandazioni si concentrano sull’evitare la sperimentazione sugli animali, fornendo in particolare consigli sul read-across.

 

Sostanze e Miscele Pericolose:

  • Sul sito di ECHA è stata pubblicata la proposta di classificazione ed etichettatura armonizzata per: − fosthiazate (ISO); S-sec-butyl O-ethyl (2-oxo-1,3-thiazolidin3-yl)phosphonothioate (CAS 98886-44-3). La proposta prevede la classificazione come Repr. 2 (H361fd), Lact. (H362), Acute Tox. 3 (H331) con Inhalation: ATE = 0.53 mg/L (dusts or mists), Acute Tox. 3 (H311) con Dermal: ATE = 861 mg/kg bw, Acute Tox. 3 (H301) con Oral: ATE = 57 mg/kg bw, STOT SE 1 (H370 – nervous system), STOT RE 2 (H373 – adrenals), Eye Irrit. 2 (H319), Skin Sens. 1 (H317), Aquatic Acute 1 (H400) con M = 1 e Aquatic Chronic 1 (H410) e M = 1. Attualmente la sostanza è in Allegato VI del CLP con la classificazione come Acute Tox. 3* (H301), Acute Tox. 4* (H312), Acute Tox. 3* (H331), Skin Sens. 1 (H317), Aquatic Acute 1 (H400) e Aquatic Chronic 1 (H410). La sostanza è utilizzata come principio attivo fitosanitario.
  • Sul sito di ECHA è stato pubblicato il parere del RAC sulla classificazione armonizzata dell’Argento metallico e suoi composti.

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07 Feb

Posted at 10:46h in Blog, Regulatory Updates

Chemical:

New IUCLID pharmaceutical datasets support alternatives to animal testing

ECHA has published IUCLID structured datasets for 348 approved pharmaceuticals, with results from non-clinical animal studies and human information.

Helsinki, 24 January 2023 – The new datasets provides robust pharmaceutical information for industry and research in a structured format. They support toxicity assessment of structurally similar chemicals in order to decrease the dependency on animal testing.

They can also be utilized to develop predictive models and to analyse correlations based on animal and human data. Users can assess the relevance of animal models to humans by comparing results of animal tests with effects in humans.

Ofelia Bercaru, ECHA’s Director of Prioritisation and Integration claimed:

“We welcome the datasets as one further step to combine and assess available data on chemicals. The data will be useful for developing read-across or weight of evidence approaches and supports our reinforced priority to reduce the need for animal testing.”

The datasets relied on extracting animal and human data from files offered by the United States’ Food and Drug Administration. These included studies related to carcinogenicity as well as repeat-dose, developmental and reproductive toxicity. They also have information on the effects medicines have on humans, extracted from standard product labels of approved drugs.

Later in 2023, a total of 530 datasets for pharmaceuticals will be available. A scientific paper will also be released later this year to give details on their development and architecture.

 

REACH:

Changes to completeness checks of REACH registrations.

The European Commission revised some of the information prerequisites for registering chemicals under REACH in 2021 and 2022. As of 1 May 2023, ECHA will start checking both new registrations and updates to existing ones against the changed requirements.

Helsinki, 23 January 2023 – ECHA carries out a completeness check on each incoming registration as set out in Article 20(2) of the REACH Regulation.

The new and amended checks will take effect as of 1 May 2023 and will apply to both new registrations and updates of existing ones. Registrants should, therefore, prepare for the changes as registrations presented before may no longer pass the completeness check.

The new and amended checks concern:

  1. Substance identity: guaranteeing correct and consistent identification of a substance’s boundary composition and its constituents and additives determined by clarifications made to Annex VI.
  2. Standard information requirements based on Annexes VII-XI: supporting registrants in reporting information for endpoints regarding mutagenicity, degradation and aquatic toxicity based on Annex VII-XI information requirements. Registrants adding a new weight-of-evidence adaptation will be prompted to give arguments for the approach in a more structured format.

Alongside, limited revisions have been made to the completeness check in other areas, such as use information.

The IUCLID validation assistant will also be updated with the amended completeness check rules when the new version of IUCLID is released at the end of April 2023. Registrants are prompted to utilize the validation assistant to check their registrations before presenting them to ECHA.

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