Regulatory Updates

02 Nov

Posted at 10:23h in Regulatory Updates

Rifiuti:

  • Il 27 settembre 2022 il Governo ha notificato a Bruxelles il testo, esaminato dal Consiglio dei ministri il 16 settembre 2022, del correttivo al d.lgs. n. 116 del 2020, che ha recepito le direttive in materia di rifiuti e imballaggi del 2018. Sul testo non è stata aperta alcuna consultazione pubblica a livello nazionale con gli stakeholder. Lo schema sarà sottoposto ai pareri delle nuove commissioni parlamentari di Camera e Senato non appena saranno costituite. Le principali modifiche apportate dal decreto riguardano: − art. 184 (Classificazione dei rifiuti); − art. 188-bis (Sistema di tracciabilità dei rifiuti); − art. 219-bis (Sistema di riutilizzo di specifiche tipologie di imballaggi). Confindustria ha segnalato le criticità relative alle modifiche degli articoli 184 e 219-bis e continuerà a lavorare per modificare entrambe le disposizioni.
  • Il 29 settembre 2022 la CE ha ricevuto lo schema di regolamento sulla disciplina del sistema di tracciabilità dei rifiuti e del registro elettronico nazionale per la tracciabilità dei rifiuti (cd. “Rentri”). A partire dal 29 settembre decorrono, quindi, i 90 giorni del periodo sospensivo (che terminerà il 30 dicembre 2022) entro i quali la CE o altri Stati membri possono esprimere un parere circostanziato sullo schema di decreto legislativo italiano. In questi tre mesi, lo Stato italiano non può dar seguito al decreto; decorso tale termine, se la CE non chiederà maggiori approfondimenti, verrà dato il nulla osta a procedere. Tale schema di regolamento, previsto dall’articolo 188-bis del Dlgs 152/2006, disciplina il sistema di tracciabilità dei rifiuti che si compone delle procedure e degli adempimenti di cui agli articoli 189, 190 e 193 del Dlgs 152/2006 (Catasto rifiuti, registro carico/scarico, formulario di trasporto) integrati nel Registro elettronico nazionale per la tracciabilità dei rifiuti. Nel dettaglio, lo schema di regolamento disciplina: − modelli e formati del registro cronologico dei rifiuti e del formulario di identificazione con l’indicazione altresì delle modalità di compilazione, vidimazione e tenuta degli stessi; − le modalità di iscrizione al Rentri e relativi adempimenti, da parte dei soggetti obbligati o di chi volontariamente vi aderisce; − il funzionamento del Rentri comprese le modalità di trasmissione dei dati; le modalità di condivisione dei dati del Rentri con l’Istituto superiore per la ricerca ambientale (Ispra) al fine del loro inserimento nel Catasto rifiuti nonché le modalità di coordinamento tra il Mud e gli adempimenti trasmessi al Rentri.

 

Chemical:

  • Bruxelles, 8 settembre – In una riunione congiunta tra CEFIC e Plastics Europe è stato analizzato l’esito del Sottocomitato PPR9 dell’International Maritime Organization (IMO) circa la classificazione e la gestione sicura del trasporto marittimo dei granuli di plastica. Il Correspondance Group dedicato ha predisposto un documento da utilizzare come base e al quale i componenti del Gruppo possono contribuire, indicando le misure ritenute maggiormente rilevanti per ridurre il rischio di inquinamento associato al trasporto di plastic pellets in mare.

 

Biocidi:

  • Sulla GUUE L 233 dell’8 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1484 della Commissione del 7 settembre 2022, che posticipa la data di scadenza dell’approvazione del carbonato di didecildimetilammonio ai fini del suo uso nei biocidi del tipo di prodotto 8, in conformità del Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.
  • Sulla GUUE L 233 dell’8 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1485 della Commissione del 7 settembre 2022, che posticipa la data di scadenza dell’approvazione dell’IPBC ai fini del suo uso nei biocidi del tipo di prodotto 8, in conformità al Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.
  • Sulla GUUE L 233 dell’8 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1486 della Commissione del 7 settembre 2022, che posticipa la data di scadenza dell’approvazione dell’acroleina ai fini del suo uso nei biocidi del tipo di prodotto 12, conformemente al Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.
  • Sulla GUUE L 233 dell’8 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1487 della Commissione del 7 settembre 2022, che posticipa la data di scadenza dell’approvazione dell’etofenprox ai fini del suo uso nei biocidi del tipo di prodotto 8, conformemente al Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.
  • Sulla GUUE L 233 dell’8 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1488 della Commissione del 7 settembre 2022, che posticipa la data di scadenza dell’approvazione del K-HDO, ai fini del suo uso nei biocidi del tipo di prodotto 8 in conformità al Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.
  • Sulla GUUE L 233 dell’8 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1489 della Commissione del 7 settembre 2022, che posticipa la data di scadenza dell’approvazione dello spinosad ai fini del suo uso nei biocidi del tipo di prodotto 18, conformemente al Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.
  • Sulla GUUE L 234 del 9 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1495 della Commissione dell’8 settembre 2022, che posticipa la data di scadenza dell’approvazione della medetomidina ai fini del suo uso nei biocidi del tipo di prodotto 21, in conformità al Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.
  • Sulla GUUE L 234 del 9 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1496 della Commissione dell’8 settembre 2022, che posticipa la data di scadenza dell’approvazione del tebuconazolo ai fini del suo uso nei biocidi del tipo di prodotto 8, conformemente al Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.
  • Sulla GUUE L 234 del 9 settembre 2022 è stata pubblicata la Decisione di esecuzione (UE) 2022/1497 della Commissione dell’8 settembre 2022, che stabilisce se un prodotto contenente “estratto di oleoresina di Capsicum pressato” sia un biocida a norma dell’articolo 3, paragrafo 3, del Regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio.

 

Food:

  • Sulla GUUE L 243 del 20 settembre 2022 è stato pubblicato il Regolamento (UE) 2022/1616 della Commissione del 15 settembre 2022 relativo ai materiali e agli oggetti di materia plastica riciclata destinati a venire a contatto con i prodotti alimentari. Il Regolamento 2022/1616 abroga il Regolamento (CE) n. 282/2008.
  • Sulla GUUE L 244 del 20 settembre 2022 è stata pubblicata la Rettifica del Regolamento (UE) 2022/1616 della Commissione, del 15 settembre 2022.

 

REACH:

  • La Commissione europea ha reso disponibile la bozza di Regolamento di modifica dell’allegato XVII del REACH per quanto riguarda le microplastiche.
  • È stata aperta una consultazione pubblica relativa all’identificazione come SVHC di 9 sostanze; per ognuna di esse è possibile presentare informazioni che riguardano in particolare l’identità della sostanza (così come descritta nel background document) e le sue proprietà e, se disponibili, anche su usi, alternative, esposizione come SVHC. È possibile partecipare fino al 17 ottobre 2022.

 

CLP:

  • È stata pubblicata la bozza di Atto Delegato del CLP che andrà a modificare il Regolamento CLP per quanto riguarda l’inclusione di nuove classi di pericolo. È possibile trasmettere le proprie osservazioni entro il 18 ottobre 2022. Federchimica sta lavorando, insieme a Cefic, alla predisposizione dei commenti da inviare alla Commissione.
  • Sul sito di ECHA sono state pubblicate le proposte di classificazione ed etichettatura armonizzata per: − barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene4-sulphonate]; C.I. Pigment Red 53:1 (CAS 5160-02-1 ). La proposta prevede la classificazione come Carc. 2 (H351). Attualmente la sostanza non è in Allegato VI del CLP ed è utilizzata nel settore tessile e della pelle, negli inchiostri, vernici, adesivi, rivestimenti e prodotti di rimozione, giocattoli, carta, prodotti in plastica e gomma, nelle calzature, nei colori per tatuaggio e per il trucco permanente, prodotti per la pulizia e la manutenzione dei veicoli, nei macchinari, apparecchiature meccaniche, articoli elettrici/elettronici, articoli in metallo, articoli in legno; − fluoroethylene (CAS 75-02-5). La proposta prevede la classificazione come Muta. 2 (H341) e Carc. 1° (H350). Attualmente la sostanza non è in Allegato VI del CLP. La sostanza è utilizzata principalmente nella produzione di polivinilfluoruro (PVF) e altri fluoropolimeri. È possibile rispondere alle consultazioni entro il 18 novembre 2022.
  • Sulla GUUE L245 del 22 settembre 2022 è stata pubblicata la Direttiva delegata (UE) 2022/1631 che modifica, adeguandolo al progresso scientifico e tecnico, l’allegato IV della Direttiva 2011/65/UE del Parlamento europeo e del Consiglio, per quanto riguarda l’esenzione dell’uso del piombo sia nei cavi e nei fili superconduttori di ossido di bismuto stronzio calcio e rame, sia nelle pertinenti connessioni elettriche.
  • Sulla GUUE L245 del 22 settembre 2022 è stata pubblicata la Direttiva delegata (UE) 2022/1632 che modifica, adeguandolo al progresso scientifico e tecnico, l’allegato IV della Direttiva 2011/65/UE del Parlamento europeo e del Consiglio per quanto riguarda l’esenzione relativa all’uso di piombo in determinati dispositivi diagnostici per la risonanza magnetica per immagini.

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05 Oct

Posted at 14:58h in Regulatory Updates

Cosmetics:

EU to set labelling requirement for 56 additional fragrances in cosmetic products.

The European Commission is planning an amendment to the cosmetics Regulation that will set a labelling requirement for an additional 56 fragrance allergens.

The changes, set out in a European Commission draft amendment, mean cosmetic products in the EU must list on their labels 81 allergenic chemicals found in fragrances or essential oils if they are present at levels greater than 0.001% for leave-on products or 0.01% for rinse-off products.

The new substances, derived from synthetic fragrances, include;

  • menthol;
  • terpineol;
  • linalyl acetate;
  • camphor;
  • vanillin; and
  • geraniol derivatives (geranial and geranyl acetate).

The newly added substances also include some natural essential oils/extracts such as ylang ylang oil (cananga odorata flower oil), cinnamon oil (cinnamomum zeylanicum bark oil) and lavender oil (lavandula officinalis flower oil).

The amendment offers companies a transition period of three years from when the amendment takes effect to reformulate their products and comply. However, it also gives five years for the withdrawal of non-compliant products.

Currently, 25 cosmetic fragrance ingredients, listed in Annex III of the cosmetics Regulation, must be included in the list of product ingredients on cosmetics packaging, while all other fragrances can be listed as “parfum” or “aroma”.

The draft amendment follows a 2012 Opinion by the Scientific Committee on Consumer Safety (SCCS) that identified the additional 56 allergens, which have caused allergies in humans and have currently no requirement of individual labelling.

The Commission is expected to open the amendment for feedback soon, after which it is expected to be adopted in the first half of 2023, according to a WTO notification.

 

ECHA

Commission bans 14 CMRs under EU cosmetic products Regulation.

New concentration limits for uses of methyl salicylate

The European Commission has banned 14 carcinogenic, mutagenic or toxic for reproduction (CMR) chemicals from being used in cosmetic products.

A Commission amending Regulation, dated 15 September, has added the chemicals to the prohibited substances list under Annex II of the cosmetic products Regulation.

The banned CMRs include:

  • tetrafluoroethylene;
  • 3-methylpyrazole;
  • 4-methylpentan-2-one oxime;
  • 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol; and
  • methyl isobutyl ketone.

The ban will come into force on 17 December and cover all cosmetic products on the EU market, imported and EU-made. It marks the fifth annual update to the Commission Regulation restricting and/or prohibiting the use of CMR substances in cosmetic products.

Methyl salicylate

The amending Regulation also introduces new restrictions on the use of methyl salicylate, an ingredient in many fragrance mixtures and oral hygiene products.

The European Commission’s Scientific Committee on Consumer Safety (SCCS) concluded in October that the substance is safe when used in cosmetic products up to set maximum concentrations.

However, the SCCS pointed out that methyl salicylate is also used in other consumer products, such as household cleaning items, so combined exposure could exceed safe levels.

Therefore, the use of methyl salicylate will be restricted as follows:

  • up to 0.06% in leave-on skin products (except face make-up, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products);
  • up to 0.05% in face make-up (except lip products, eye make-up and make-up remover);
  • up to 0.002% in eye make-up and make-up remover;
  • up to 0.009% in leave-on hair products spray/aerosol;
  • up to 0.003% in deodorant spray/aerosol;
  • up to 0.4% in body lotion spray/aerosol;
  • up to 0.06% in rinse-off skin products (except hand wash) and rinse-off hair products;
  • up to 0.6% in hand wash, hydroalcoholic-based fragrances, and mouthwash intended for children above 10 years of age and adults;
  • up to 0.03% in lip products;
  • up to 2.52% in toothpaste;
  • up to 0.1% in mouthwash intended for children aged 6-10 years; and
  • up to 0.65% in mouth spray.

Methyl salicyclate is banned from use in cosmetic products for children under six. The only exception is toothpaste.

 

REACH

European Commission adopts authorisation decision for use of 4-tert-OPnEO

EU executive permits application of the endocrine disruptor in pharmaceuticals

The European Commission has adopted a REACH authorisation decision granting a specific use of the SVHC 4-tert-OPnEO.

In an EU Official Journal entry on 13 September, the EU executive announced it has permitted Pfizer Manufacturing Belgium use of the chemical – also known as 4-(1,1,3,3-tetra methylbutyl)phenol, ethoxylated – as a surfactant within a lubricant used in the manufacture of pharmaceutical drug products.

The review period runs until 4 January 2030. The Commission said it granted permission for this use because it believes the socio-economic benefits outweigh the risk to human health and the environment from the uses of the substance, and that suitable alternative substances or technologies do not exist.

The substance is listed on the REACH Annex XIV authorisation list for its endocrine disrupting properties affecting the environment. The latest application date for 4-tert-OPnEO was 4 July 2019, and it had a sunset date of 4 January 2021.

In March, in its parallel UK REACH legislation, the Department for Environment, Food and Rural Affairs (Defra) approved an application for a use of the substance.

At the EU level, the Commission has been working on plans to reform the authorisation process under REACH as part of its wide-ranging chemicals strategy for sustainability.

Pharma

QSAR Toolbox extension broadens possibilities for animal-free chemicals assessment

The new add-on helps users to predict chemical properties, including endocrine activity, while avoiding testing on animals.

The OPERA extension contains models for predicting properties that are important for assessing chemical hazards. The extension can be used to screen chemical databases to identify substances that may cause endocrine disruption. It also helps users to estimate acute oral toxicity and other regulatory relevant properties.

Developed by the US National Institute of Environmental Health Sciences (NIEHS), OPERA can predict properties related to the absorption, distribution and metabolism of substances that can strengthen read-across justifications and facilitate the regulatory use of in vitro test results.

The extension can be downloaded for free from the QSAR Toolbox Repository.

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13 Sep

Posted at 10:45h in Regulatory Updates

REACH:

Assessment of substance group published

A new report is now available for Acyl glycinates and sarcosinates.

ECHA submitted a proposal to restrict per- and polyfluoroalkyl substances (PFAS) in firefighting foams in early 2022.

 

CLP:

New proposals and intentions to harmonise classification and labelling.

New intentions have been received for:

  • eugenol; 4-allyl-2-methoxyphenol (EC 202-589-1, CAS 97-53-0);
  • 2,3-epoxypropyl o-tolyl ether(EC 218-645-3, CAS 2210-79-9); and
  • Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene; Reaction products of diphenylamine with nonene, branched (EC -, CAS -).

Two proposals have been submitted for:

 

Hazardous substances:

Updates on toys regulation.

Two decrees transposing two Commission directives amending Directive 2009/48/EC on the safety of toys have been published in the Italian Official Journal. The amendments concern the ban on the use and labelling of allergenic fragrances in toys.

In particular, the decree transposing Directive 2020/2088/EU replaces the entry on citronellol and adds 61 new allergenic fragrances. In detail, the names of the allergenic fragrances shall be indicated on the toy, on the label, on the packaging and in the instructions attached to the toy, if present and added as such in the toy in concentrations greater than 100 mg/kg of the toy or its components.

 

ECHA:

Nine proposals to identify new substances of very high concern.

The substances and examples of their uses are:

  • 4,4′-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). The substance is used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals.
  • Perfluoroheptanoic acid and its salts (EC -, CAS -). The substances are not registered under REACH.
  • Melamine (EC 203-615-4, CAS 108-78-1). The substance is used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
  • Isobutyl 4-hydroxybenzoate (EC 224-208-8, CAS 4247-02-3). The substance is used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners.
  • Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (EC -, CAS -). The substance is used as a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.
  • Barium diboron tetraoxide (EC 237-222-4, CAS 13701-59-2). The substance is used in paints and coatings.
  • Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine (FC-770) (EC 473-390-7, CAS -). The substance is used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.
  • 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol (tetrabromobisphenol-A; TBBPA) (EC 201-236-9, CAS 79-94-7). The substance is used as a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles.
  • 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] (EC 253-692-3, CAS 37853-59-1). The substance is not registered under REACH.

 

REACH:

Modified recommendations to registrants on how to cover mutagenicity information requirements.

ECHA’s Member State Committee (MSC) agreed to modify the approach for investigating chromosomal aberration under REACH dossier evaluation during its June meeting.

The main changes include:

To fulfil REACH Annex VIII 8.4.2 requirements, an in vitro micronucleus study (OECD Test Guideline 487) is the default test as it allows the mode of action (clastogenicity and/or aneugenicity) to be identified.

If a concern for chromosomal aberration is identified in vitro, a follow-up study combining an in vivo comet assay (OECD Test Guideline 489) and an in vivo micronucleus test (OECD Test Guideline 474) will be needed in most cases.

Recommendations to registrants have been modified to reflect these changes, which have applied since 1 September 2022.

The European Commission has granted an authorisation for the use of sodium chromate (EC 231-889-5, CAS 7775-11-3) to Ariston Thermo SpA with a review period expiry date on 26 August 2033.

 

Biocides:

Have your say: EFSA and ECHA guidance on the impact of water treatment processes on active substance residues in drinking water.

ECHA has collaborated with the European Food Safety Authority (EFSA) to launch a consultation on a draft guidance on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water.

The deadline for comments is 27 October 2022.

New report on European arthropods and their role in pollination 

A report has been published describing the biodiversity and the ecology of four insect orders: Diptera, Lepidoptera, Coleoptera and Hymenoptera, covering the majority of flower visiting insects. The report focuses on the sensitivity of these organisms to biocidal products.

 

SDS:

Publication of the updated version of the Guideline “SAFETY DATA SHEETS” – Part 4.

How to evaluate the (e)SDS and decide the subsequent actions” and the “Tool to verify compliance with exhibition scenarios” in the light of the changes that REACH has made in recent years to the format and content of the Safety Data Sheets and following the changes introduced by the latest revision of the ECHA Guidelines on descriptors.

 

Source: https://echa.europa.eu/it/information-on-chemicals

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07 Jun

Posted at 09:30h in Regulatory Updates

Agrochemical:

  • Glyphosate: no change proposed to hazard classification

ECHA’s Committee for Risk Assessment (RAC) agrees to keep glyphosate’s current classification as causing serious eye damage and being toxic to aquatic life. Based on a wide-ranging review of scientific evidence, the committee again concludes that classifying glyphosate as a carcinogen is not justified.

https://echa.europa.eu/it/-/glyphosate-no-change-proposed-to-hazard-classification

REACH:

  • Assessments of two substance groups published.

Assessments of regulatory needs are now available for:

Methylene diphenyl ureas; and Aralkylamines

https://echa.europa.eu/it/assessment-regulatory-needs?utm_source=echa-weekly&utm_medium=email&utm_campaign=weekly&utm_content=20220601&_cldee=tg0Kup3vx6_GlvuqZTICneBIo83xMR9d74aNqTQv0mfoJZqqRQF5iZbcKxRm4IXcOJFnsT_NfrOK-z3YfvJ_-g&recipientid=lead-67c0fcd4c0e0e71180fa005056952b31-948887e921a44a9db97c5ca582fa4681&esid=3f5e0192-84e1-ec11-813c-005056b9310e

  • Consolidated texts for UK REACH and CLP laws published

https://chemicalwatch.com/484152/consolidated-texts-for-uk-reach-and-clp-laws-published

Nanomaterials:

  • Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices

https://euon.echa.europa.eu/nanopinion/-/blogs/urinary-microrna-based-early-cancer-detection-using-nanowire-based-devices?_cldee=tg0Kup3vx6_GlvuqZTICneBIo83xMR9d74aNqTQv0mfoJZqqRQF5iZbcKxRm4IXcOJFnsT_NfrOK-z3YfvJ_-g&recipientid=lead-67c0fcd4c0e0e71180fa005056952b31-948887e921a44a9db97c5ca582fa4681&esid=3f5e0192-84e1-ec11-813c-005056b9310e

Cosmetics:

  • Danish Consumer Council exposes ‘undesirable’ substances in sunscreen products

https://chemicalwatch.com/493607/danish-consumer-council-exposes-undesirable-substances-in-sunscreen-products

Food:

  • Efsa issues final list of plasticisers in FCMs prioritised for risk assessment

https://chemicalwatch.com/486442/efsa-issues-final-list-of-plasticisers-in-fcms-prioritised-for-risk-assessment

 

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05 May

Posted at 09:53h in Regulatory Updates

Biocidi:

  • DECISIONE DI ESECUZIONE (UE) 2022/323 DELLA COMMISSIONE del 22 febbraio 2022 relativa alle obiezioni irrisolte riguardanti le condizioni per il rilascio dell’autorizzazione del biocida Sojet conformemente al regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio

https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2022&codLeg=86917&parte=1%20&serie=S2

 

REACH:

  • Upcoming changes to REACH information requirements:

The European Commission has revised certain information requirements for registering chemicals under REACH. Companies should start to prepare as the changes will begin to apply in October 2022. ECHA will publish further advice later this year.

https://echa.europa.eu/it/-/upcoming-changes-to-reach-information-requirements-1

  • Group assessment of bisphenols identifies need for restriction:

ECHA and the Member States have assessed a group of 148 bisphenols and recommended that more than 30 bisphenols need to be restricted due to their potential hormonal or reprotoxic effects.

https://echa.europa.eu/it/-/group-assessment-of-bisphenols-identifies-need-for-restriction

  •     Five substances added to REACH Authorisation List

Companies that want to continue using these substances after the agreed sunset dates will need to apply for authorisation. The Authorisation List now contains 59 entries.

The five substances are:

  • Tetraethyllead (TEL) (EC 201-075-4, CAS 78-00-2);
  • 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol [with ≥ 0.1% w/w of Michler’s ketone (EC 202-027-5) or Michler’s base (EC 202-959-2)] (EC 209-218-2, CAS 561-41-1);
  • Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥ 0,1% w/w 4-heptylphenol, branched and linear (4-HPbl)] (EC -, CAS -);
  • 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (EC 239-622-4, CAS 15571-58-1); and
  • Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) (EC -, CAS -).

https://echa.europa.eu/it/-/five-substances-added-to-reach-authorisation-list

 

Food:

  • Salmonella e Campylobacter continuano a presentare elevati livelli di resistenza agli antibiotici

La resistenza agli antibiotici nei batteri Salmonella e Campylobacter è ancora elevata, si afferma in un rapporto pubblicato oggi dal Centro europeo per la prevenzione e il controllo delle malattie (ECDC) e dall’Autorità europea per la sicurezza alimentare (EFSA).

https://www.efsa.europa.eu/it/news/salmonella-and-campylobacter-continue-show-high-levels-antibiotic-resistance

  • L’EFSA e l’ECDC indagano su un focolaio epidemico plurinazionale di Salmonella legato ad alcuni prodotti a base di cioccolato.

Si sta evolvendo rapidamente in sette Paesi UE/SEE e nel Regno Unito (UK) un focolaio epidemico di Salmonella Typhimurium, variante monofasica. A partire dal 5 aprile 2022 sono stati segnalati 134 casi, soprattutto tra bambini di età inferiore a 10 anni. Il primo caso è stato individuato nel Regno Unito il 7 gennaio 2022. Dal 17 febbraio 2022 in poi sono stati individuati casi anche in altri luoghi d’Europa.

https://www.efsa.europa.eu/it/news/efsa-and-ecdc-investigate-multi-country-salmonella-outbreak-linked-chocolate-products

 

Chemical:

  • EU adopts ‘great detox’ roadmap to ban thousands of chemicals

https://chemicalwatch.com/469632/eu-adopts-great-detox-roadmap-to-ban-thousands-of-chemicals

 

CLP:

Pubblicazione del 18° Adeguamento al Progresso Tecnico e Scientifico (ATP) del CLP

E’ stato pubblicato il Regolamento Delegato (UE) 2022/692 che modifica l’Allegato VI del Regolamento CLP, comprendente una lista di sostanze con classificazione ed etichettatura armonizzata. Il 18° ATP si applica alle sostanze e alle miscele a decorrere dal 23 novembre 2023, anche se è possibile anticiparne volontariamente l’adozione.

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05 Apr

Posted at 11:39h in Regulatory Updates

CLP:

Ad hoc consultation on harmonised classification and labelling of glyphosate

The proposal for the harmonised classification and labelling of glyphosate (EC 213-997-4, CAS 1071-83-6) was proposed by Sweden and subject to a consultation, which ended on 22 November 2021.

Meanwhile, new articles potentially relevant to the classification of the substance have been published. They concern to the following hazard classes:

  • respiratory sensitisation,
  • specific target organ toxicity – single exposure (respiratory irritation),
  • germ cell mutagenicity,
  • carcinogenicity,
  • reproductive toxicity, and
  • hazardous to the aquatic environment.

ECHA is looking for comments related to these.

The deadline for comments is 12 April 2022.

 

Biocides:

Guidance on human health information requirements updated

We have published an update to the guidance document for the Biocidal Products Regulation (BPR) Volume III – Human Health – Information Requirements (Part A). The update aligns the guidance with the new information requirements of the BPR (Annexes II and III) amended by Regulation (EU) 2021/525, which will enter into force on 15 April 2022.

 

QSAR:

QSAR Toolbox updated

The web client of the QSAR Toolbox has been updated, simplifying its use. The new functionalities contain the possibility to run QSAR models or access the details of study results.

The OECD QSAR Toolbox is a freely available software for animal-free evaluation of chemical substances. It has over 25 000 users worldwide from regulatory authorities, industry, academia, and non-governmental entities. The Toolbox is co-developed by ECHA and the OECD.

 

EU PFAS restriction will have ‘very limited’ derogations, says dossier submitter:

An EU restriction dossier for a universal ban on per- and polyfluoroalkyl substances (PFASs) will have “very limited” derogations even without essential use criteria contained in it, the project lead at the Dutch National Institute for Public Health and the Environment (RIVM) has said.

The comments from one of five European competent authorities jointly preparing the dossier come after a European Commission official established last week that the restriction would not incorporate essential use because criteria would not be ready in time, even though the Montreal Protocol concept was first pictured, in the context of chemicals, for a ban on PFASs

 

Cosmetics:

European Commission begins consulting on cosmetics Regulation revision

The European Commission has begun public consultation on the targeted revision of the EU cosmetic products Regulation, which is set to introduce significant changes to the law.

It opened on 29 March and will regard five measures under consideration. They are:

·         the generic risk assessment (GRA) approach, which would automatically ban the most hazardous chemicals and only allow their use if they are found to be essential to society;

·         a new measure to account for combination effects from exposure to chemicals from different sources;

·         a review of the definition of nanomaterials;

·         improving the labelling information on cosmetic products; and

·         streamlining the scientific assessment of cosmetic products by integrating the Scientific Committee on Consumer Safety (SCCS) into Echa.

The consultation is based off of a questionnaire and is for all relevant stakeholders, ranging from EU citizens to professional users of cosmetics, industry associations, civil society organisations, and member state authorities, including those involved in customs and market surveillance.

REACH:

Resorcinol to be added to REACH candidate list after long battle

The European Commission has won its battle over the identification of resorcinol as an SVHC based on endocrine disrupting properties for human health, after its controversial draft Decision narrowly won the backing of EU member states.

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01 Mar

Posted at 10:36h in Regulatory Updates

WHAT HAPPENED THIS MONTH?

 

REACH:

  • The European Chemicals Agency submits a proposal for an EU-wide restriction on all per-and polyfluoroalkyl substances (PFASs) in firefighting foams. The proposal’s goal is to prevent further groundwater and soil contamination and health risks for people and the environment. 
  • ECHA has updated its recommendations to help companies improve their registration dossiers and has added more advice on using read-across and weight of evidence. Statistics are available on the progress made in evaluating registered substances in 2021.

 

Hazardous substances:

  • European Commission to end exemptions for use of mercury in certain lamps +e European Commission has published 12 delegated Acts that will end exemptions for uses of mercury in general purpose compact (CFL) and linear fluorescent (LFL) lamps, while renewing several others.

 

CLP:

  • Ad hoc consultation on the harmonized classification and labelling of S-metolachlor (ISO)

 

The proposal for the harmonized classification and labelling (CLH) of S-metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide; (RaSa)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl]acetamide [contains 80-100% 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide and 0-20% 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2R)-1-methoxypropan-2-yl]acetamide] (EC -, CAS 87392-12-9) was brought forward by Germany and subject to a consultation, which ended on 3 September 2021.

As, in the meanwhile, additional data on carcinogenicity has been released, we are looking for comments on this new information.

The deadline is 7 March 2022.

  • New proposals to harmonize the classification and labelling

 

Three proposals have been introduced for:

  • (RS)-S-sec-butyl-O-ethyl-2-oxo-1,3-thiazolidin-3-ylphosphonothioate; fosthiazate (ISO) (EC 619-377-3, CAS 98886-44-3);
  • 2,3-epoxypropyl isopropyl ether (EC 223-672-9, CAS 4016-14-2); and
  • 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one; proquinazid (ISO) (EC 606-168-7, CAS 189278-12-4).

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