#REACH Tag

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.

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

Ancora 6 mesi di tempo per aggiornare le SDS al nuovo formato

 

Per tutte le aziende che gestiscono e forniscono SDS questo è un momento impegnativo, in quanto stiamo andando incontro a 2 scadenze importanti che le riguardano.

Mancano infatti 6 mesi alla fine del periodo transitorio che permette di redigere le schede con l’ormai vecchio formato secondo il Regolamento 2015/830; dal 1° gennaio 2023, infatti, tutte le SDS dovranno essere aggiornate e fornite in conformità al nuovo Regolamento 2020/878.

Nel 2020 è stato pubblicato il Regolamento 2020/878, che va a sostituire l’Allegato II del Regolamento (CE) n. 1907/2006 (REACH) e tutti i successivi aggiornamenti. Tale regolamento si applica dal 1° gennaio 2021 e prevede un periodo transitorio di 2 anni, nei quali è possibile continuare a fornire le schede in conformità al Regolamento 2015/830. Chi, quindi, non ha ancora provveduto ad aggiornare le proprie SDS, ha ancora circa 6 mesi a disposizione per renderle conformi alle nuove disposizioni.

Ma quali sono le principali modifiche apportate col nuovo formato? Quali le sezioni interessate? Vediamole insieme:

  • UFI: se una miscela è legata, in conformità all’Allegato VIII del CLP, ad un UFI (identificatore unico di formula), e se l’UFI è riportato in SDS, l’UFI va riportato in sezione 1.1

 

  • Interferenti endocrini: in caso di sostanze considerate interferenti endocrini conformemente ai criteri stabiliti nel Regolamento Delegato (UE) 2017/2100 o nel Regolamento (UE) 2018/605, devono essere fornite informazioni. L’identità delle sostanze con proprietà di interferenza endocrina che sono contenute in miscele va inserita nella sezione 3.2 della sds quando presenti in concentrazione  ≥ 0,1 %. Inoltre, informazioni sugli interferenti endocrini vanno riportate in sezione 2.3, 11.2 e 12.6.

 

  • Nanoforme: vanno riportate informazioni per le sostanze con dimensioni nanometriche. Per le schede di sostanze, la sezione che subisce un impatto maggiore è la 9, in cui devono essere riportate le caratteristiche delle particelle; inoltre, in sezione 1 della scheda si riporta la dicitura “nanoforma”.

 

  • Sezioni 3: sia nelle sds di sostanze sia in quelle di miscele, è necessario riportare in questa sezione, se disponibili, le seguenti informazioni:
  • Stima di tossicità acuta
  • Fattori M
  • Limiti di concentrazione specifici

Per quanto riguarda la sezione 3.2, vengono abbassati alcuni limiti di concentrazione per         l’inserimento in scheda delle sostanze contenute in miscela e viene introdotto il limite ≥0,1% per gli interferenti endocrini.

 

Per quanto riguarda le schede di sicurezza destinate all’Italia, un’altra data va tenuta da conto: il 1 ottobre 2022. Il Decreto del 28 dicembre 2020, riguardante le nuove procedure di notifica delle miscele pericolose prima dell’immissione sul mercato, stabilisce che, da tale data, in sezione 1.4 vengano riportati gratuitamente i numeri di telefono dei 10 CAV (centri antiveleni):

CAV Numero di emergenza
Centro Antiveleni di Bergamo

Azienda Ospedaliera Papa Giovanni XXII

800 88 33 00
Centro Antiveleni di Milano

Ospedale Niguarda Ca’ Granda

+39 02 6610 1029
Centro Antiveleni di Roma

CAV Policlinico “A. Gemelli”, Dipartimento di Tossicologia Clinica
Universita Cattolica del Sacro Cuore

+39 06 305 4343
Centro Antiveleni di Roma

CAV Policlinico “Umberto I”, Università di Roma

+39 06 4997 8000
Centro Antiveleni di Firenze

Az. Osp. “Careggi” U.O. Tossicologia Medica, S.O.D. di Tossicologia Clinicaicologia Clinica

+39 055 794 7819
Centro Antiveleni di Pavia

CAV Centro Nazionale di Informazione Tossicologica, IRCCS Fondazione Maugeri

+39 03 822 4444
Centro Antiveleni di Roma

CAV “Osp. Pediatrico Bambino Gesù” Dip. Emergenza e Accettazione DEA

+39 06 6859 3726
Centro Antiveleni di Foggia

Az. Osp. Univ. Foggia

+39 800 183 459
Centro Antiveleni di Napoli

Az. Osp. “A. Cardarelli”

+39 081 54 53 333
Centro Antiveleni di Verona

Azienda Ospedaliera Integrata Verona

+39 800 011 858

 

 

Per ulteriori dettagli, potete consultare il Regolamento 2020/878 e la guida ECHA sulle schede di sicurezza.

 

Fonti:

Regolamento (UE) 2020/878 della Commissione del 18 giugno 2020

DECRETO 28 dicembre 2020. Modifica dell’allegato XI del decreto legislativo 14 marzo 2003, n. 65. Nuove procedure di notifica delle miscele pericolose prima dell’immissione sul mercato.

https://echa.europa.eu/documents/10162/2324906/sds_it.pdf/4c34f76f-89a8-4d01-a08f-d09a555cbc16

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

 

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.

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.

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).

Quali sono i comitati istituiti in ECHA e di che cosa si occupano

 

Molti di noi quotidianamente consultano il sito dell’ECHA (Agenzia Europea per la Chimica) per cercare informazioni relative a tematiche REACH, CLP, BPR, CAD e CMD, POP, acqua potabile, direttiva quadro sui rifiuti e sul regolamento sull’assenso preliminare.

Quasi tutti ci soffermiamo sul sito alla ricerca delle informazioni tecniche di cui necessitiamo ma, probabilmente, non ci è mai capitato di approfondire come sia strutturata l’agenzia europea per la chimica.

Soffermiamoci per un momento per capire quale sia la mission di ECHA: operare per rendere sicuro l’uso delle sostanze chimiche, attraverso la costruzione di un centro di conoscenza per la gestione sostenibile delle sostanze chimiche.

ECHA ha una struttura gerarchica con un management Board a cui fanno capo quattro comitati che si occupano di specifiche tematiche e che possono essere di supporto sia alle attività della Commissione, Forum ed una Commissione di ricorso.

Vediamo in dettaglio di cosa si occupano i diversi comitati:

Comitato degli Stati membri (MSC) è composto da un rappresentante per Stato membro, il mandato del comitato è di tre anni ed è rinnovabile.

Il comitato si occupa principalmente di tematiche REACH legate alla valutazione e all’autorizzazione delle sostanze. Il compito principale del comitato è quello di riuscire ad appianare le divergenze di opinioni tra gli Stati membri per arrivare ad ottenere l’accordo unanime da parte degli Stati membri. In particolare, il comitato si occupa delle proposte finalizzate all’identificazione delle sostanze SVCH, fornisce pareri relativi al progetto di raccomandazione dell’ECHA per quanto riguarda l’elenco delle sostanze da inserire in allegato XIV e al CORAP per la procedura di valutazione della sostanza.

Comitato per la valutazione dei rischi (RAC) Si occupa di elaborare pareri relativi ai rischi per la salute umana e per l’ambiente che comporta l’utilizzo delle sostanze chimiche. I temi affrontati dal RAC sono legati alle procedure REACH e CLP. Il RAC valuta proposte di classificazione armonizzata, le restrizioni e le autorizzazioni. Gli stati membri nominano dei candidati, ma la nomina dei membri del RAC spetta al consiglio di amministrazione dell’ECHA. Anche in questo caso il mandato è triennale e rinnovabile.

Comitato per l’analisi socioeconomica SEAC si occupa di preparare I pareri relativi all’impatto socioeconomico che risulterebbe dall’applicazione di provvedimenti normativi riguardanti le sostanze chimiche. Come nel caso del RAC, i membri del SEAC vengono nominati dal consiglio di amministrazione dell’ECHA tra i candidati scelti dagli Stati membri. Il mandato è triennale e rinnovabile.

Il comitato sui biocidi (BPC) Si occupa di preparare i pareri legate a diversi processi previsti dal BPR. In particolare, si occupa della redazione di pareri sia relativi alle sostanze attive si appalesi relative alle domande di autorizzazione dell’unione e domande di mutuo riconoscimento. Ogni Stato membro ha il diritto di nominare un membro del BPC, in questo caso esiste la possibilità di nominare anche un supplente. Il mandato è triennale e rinnovabile. Dal momento che il BPC si occupa di tematiche molto ampie in ambito BPR, sono stati istituiti dei gruppi di lavoro dedicati alle specifiche tematiche biocide.

I comitati si riuniscono circa 4 volte all’anno le date dei meeting e le agende sono consultabili sul sito dell’ECHA.

Nel mese di Marzo 2022 si riuniranno il RAC, il comitato per l’analisi socioeconomica e il BPC.

Tra le tematiche che verranno trattate dal RAC ci saranno lo sviluppo delle opinioni relative ai limiti di esposizione per 1,4-diossano e isopropene e la proposta di classificazione armonizzata per il glifosato. Il BPC si occuperà delle opinioni preparate per l’approvazione di due sostanze attive e dell’opinione preparata per il rinnovo del propiconazolo (PT8) e di molte opinioni preparate per le richieste di autorizzazione dell’Unione.

The planned REACH revision is one of the actions announced in the Chemicals Strategy for Sustainability

 

We have already spoken about the new discussion about polymers’ registration. Of course, this is “THE” massive change in the REACH, however it is not the only one.

As some of you have noticed, the European Commission has launched a public consultation on the revision of the REACH, with the deadline scheduled for 15th April 2022.

As part of the EU’s zero pollution ambition, which is a key commitment of the European Green Deal, the European Commission published the “Chemicals Strategy for Sustainability” the preceding on 14 October 2020.

 

  1. Increased information on critical hazards

To better protect human health and the environment, the Chemical Strategy for Sustainability has committed to increase the information requirements under REACH for all chemicals, especially for so-called critical hazards such as carcinogenicity, mutagenicity and reproductive toxicity, endocrine disruption. This may imply the need for companies (registrants of substances, i.e. manufacturers and importers of substances) to test more chemicals for more hazardous properties.

  1. Information on substances marketed at the lowest tonnage level

The REACH regulation seeks to address information deficits on chemicals by requiring manufacturers and importers to provide toxicological and ecotoxicological information on substances placed on the market in quantities of more than 1 tonne per year.

Article 138 of REACH requires the Commission to undertake reviews of the requirements for 1-10 tonnes substances and the Chemicals Strategy for Sustainability notes that information required for substances in the low and medium tonnages under REACH does not fully allow substances with critical hazard properties to be identified and their risks managed.

  1. Information requirements to provide information on endocrine disruption

As part of the impact assessment on the revision of the REACH Regulation, the Commission is assessing options for introducing standard information requirements at each tonnage level that will allow EDs to be identified.

  1. Information on environmental footprint

The Chemicals Strategy for Sustainability concludes that the EU is still lacking a comprehensive information base on all substances placed on the market and on their overall environmental footprint, including their impact on climate, and that this hinders the proper management of chemicals and products and does not allow for a full sustainability assessment. Therefore, to improve the availability of chemical data, the Chemicals Strategy for Sustainability asks for an assessment of how to best introduce information requirements under REACH on the overall environmental footprint of chemicals, including on emissions of greenhouse gases.

  1. Information requirements on use and exposure

Information on uses and exposures is one of the key building blocks of REACH, allowing registrants to implement and/or recommend operational conditions and risk management measures to downstream users (end users) that ensure the safe use of chemicals.

However, shortcomings in the currently available use and exposure data have been identified which impact regulatory management of chemical risk including the above-mentioned processes under REACH. The European Commission is therefore considering a potential revision of the registration requirements and downstream user obligations as regards the provision of information on uses and exposures.

  1. Introduction of a Mixture Assessment Factor

Various studies have shown that ‘unintentional’ co-exposure to substances can lead to adverse effects on people and the environment. Exposures at concentrations that are regarded as safe for individual substances (i.e., where no effects are expected) can still result in adverse (eco)toxicological effects when humans or other organisms are exposed to several substances together or subsequently.

Under REACH, registrants are required to document the safety of their substances, but they are not required to take into account the possibility of co-exposure to other substances. Indeed, they are seldom in a position to do so, as they usually do not have information on how other substances are used.

Assessment factors are already widely used in REACH to account for uncertainties in data: a mixture assessment factor (MAF) is a pragmatic approach to manage the unknown unintentional co-exposures.

When applying a MAF, exposure levels that are considered sufficiently safe for single chemicals are reduced by a certain factor (i.e., by MAF) to safeguard against risk from combined exposure to multiple chemicals.

The maximum risk ratio (RCR) demonstrating “safe use” for the substance is then equal to 1/MAF to account for unintentional co-exposures of substances.

  1. Changes to the provisions on the evaluation process

Companies must ensure that the information contained in their registration dossiers is correct at the time of registration and that any changes to this information are reported without delay. The REACH evaluation provisions give ECHA the responsibility to check whether registrations are in compliance.

However, update of registration dossiers by companies is still a weak point: most dossier owners do not routinely review their REACH data and most dossier updates only take place after prompting by the authorities.

The REACH review from 2018 identified specific weaknesses and opportunities to further increase the effectiveness of some of the evaluation provisions. Moreover, in relation to the announced zero tolerance approach to non-compliance, EU-wide measures are being considered to address persisting non-compliance established during an evaluation process.

  1. Including the concept of essential use in authorisations and restrictions

The Commission’s Chemicals Strategy for Sustainability outlines a number of commitments to tackle chemical pollution.

One of the commitments is to “define criteria for essential uses to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health”.

At present, there is no common definition of “essential use of a chemical substance”.

Defining the criteria will be the first step. This will allow the adoption of criteria to be used in policy, ultimately to prevent the non-essential use of the most harmful chemicals, speeding up the authorization and restriction processes.

  1. Generic risk management approach

The Chemicals Strategy for Sustainability announced extending the generic risk management approach to further hazard classes and uses. This generic approach means that the existing mandate to the Commission to prohibit substances that may cause cancer (carcinogenic), gene mutations (mutagenic) or affect the reproductive system (reprotoxic), based on their hazard and on generic exposure considerations (e.g. used by consumers, used by children), will be extended to additional very harmful chemical substances and to professional uses (e.g. use by construction, equipment maintenance or cleaning workers), while allowing limited exemptions for essential uses.

This differs from a specific approach to risk management requiring proof of an unacceptable risk for each use before introducing a restriction.

 

(not exhaustive) Summary of “Chemicals Strategy for Sustainability”

Promoting safe and sustainable-by-design chemicals

The strategy promotes the transition to safe and sustainable by design chemicals and materials, which is a societal urgency as well as an economic opportunity. As a first step, the Commission is developing a framework defining the concept of ‘safe and sustainable by design’ and a set of criteria.

Achieving safe products and non-toxic material cycles

In a clean circular economy, it is essential to boost the production and uptake of secondary raw materials and ensure that both primary and secondary materials and products are always safe. the creation of a well-functioning market for secondary raw materials and the transition to safer materials and products is being slowed down by a number of issues, in particular the lack of adequate information on the chemical content of products.

To move towards toxic-free material cycles and clean recycling it is necessary to ensure that substances of concern in products and recycled materials are minimized.

As a principle, the same limit value for hazardous substances should apply for virgin and recycled material. However, there may be exceptional circumstances where a derogation to this principle may be necessary. This would be under the condition that the use of the recycled material is limited to clearly defined applications where there is no negative impact on consumer health and the environment, and where the use of recycled material compared to virgin material is justified on the basis of a case by case analysis.

Protect consumers, vulnerable groups and workers from the most harmful chemicals

One of the biggest health benefits of the EU chemicals legislation in the past decades has been the reduction in the exposure of citizens to carcinogenic substances. This has been possible in particular thanks to a preventive approach across legislation which has led to generally ban of carcinogenic substances from most consumer products.

Ample evidence and citizens’ worries justify that for the most harmful chemicals the generic approach to risk management becomes the default option.

·         Tier I: extend the generic approach to risk management to ensure that consumer products do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative

·         Tier II: extend to further harmful chemicals, including those affecting the immune, neurological or respiratory systems and chemicals toxic to a specific organ

·         Tier III: extend to professional users under REACH the level of protection granted to consumers.

A zero-tolerance approach to non-compliance

Enforcement and compliance of EU chemicals legislation must be stepped up. These are priorities to ensure the highest level of protection of health and the environment from hazardous chemicals as well as to ensure a level playing field. The Strategy announces a set of actions for all relevant players to work together – to step up enforcement of EU rules on chemicals nationally and at the EU borders, and to promote compliance.

News sul nuovo regolamento UE n. 979/2021 della Commissione Europea

 

A decorrere dall’8 gennaio 2022 si applica il nuovo regolamento UE n. 979/2021 della Commissione che modifica gli allegati da VII a XI del regolamento (CE) n. 1907/2006 del Parlamento europeo e del Consiglio concernente la registrazione, la valutazione, l’autorizzazione e la restrizione delle sostanze chimiche (REACH).

Tale regolamento è stato pubblicato in Gazzetta Ufficiale il 16 giugno 2021.

L’Agenzia e la Commissione, all’interno del piano d’azione comune per la valutazione REACH del giugno 2019, hanno fatto chiarezza sugli obblighi dei dichiaranti e sul ruolo e le responsabilità dell’Agenzia., introducendo prescrizioni supplementari relativamente agli studi sperimentali.

Gli allegati da VII a X del regolamento fissano le prescrizioni in materia di informazioni standard per le sostanze fabbricate o importate in quantitativi pari o superiori, rispettivamente, a una tonnellata, 10 tonnellate, 100 tonnellate o 1 000 tonnellate. L’allegato XI definisce invece le norme generali per l’adattamento del regime di sperimentazione standard di cui agli allegati da VII a X.

 

Per quanto riguarda l’allegato VII (prescrizioni in materia di informazione per le sostanze nel range di tonnellaggio 1-10 ton/anno), vengono chiarite alcune disposizioni relative:

  • alle proprietà fisico-chimiche – tensione superficiale e idrosolubilità di metalli e composti metallici scarsamente solubili;
  • alle informazioni tossicologiche – studi in vitro di irritazione oculare

Per l’allegato VIII (prescrizioni in materia di informazione per le sostanze nel range di tonnellaggio 10-100 ton/anno), vengono chiarite alcune disposizioni relative:

  • agli studi in vivo di irritazione cutanea od oculare e allo studio di tossicità a dose ripetuta (28 giorni). Si predilige sempre la scelta di uno studio in vitro, quando possibile;
  • allo studio di screening di assorbimento /desorbimento. Tale studio, poteva essere omesso sulla base del basso coefficiente di ripartizione ottanolo/acqua o in base alla rapida degradazione. La precisazione del nuovo regolamento impone di considerare un contesto più ampio, valutando anche altre proprietà della sostanza, come la liposolubilità, l’attività superficiale e la ionizzazione.

Per l’allegato IX (prescrizioni in materia di informazione per le sostanze nel range di tonnellaggio 100-1000 ton/anno):

  • vengono introdotte precisazioni in riferimento alla costante di dissociazione e alla viscosità, allo studio di tossicità subcronica e alla tossicità per la riproduzione;
  • vengono effettuate precisazioni sulla necessità di svolgere studi sul destino e sul comportamento della sostanza nell’ambiente, analoghe a quelle dell’allegato VIII.

Tali modifiche vengono assorbite dalla versione consolidata del REACH del 18 gennaio 2022 e sono da considerare in un eventuale aggiornamento del dossier di registrazione.

E’ già disponibile una versione draft del testo del REACH datata 1 marzo 2022 che assorbe anche la normativa più recente, il  Regolamento (UE) 2021/2204 della Commissione del 13 dicembre 2021 che modifica l’allegato XVII del REACH, per quanto riguarda le sostanze cancerogene, mutagene o tossiche per la riproduzione (CMR) .