#news Tag


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.



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



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.


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’.



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.



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.


  • 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



  • 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.


  • 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.



  • 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



  • 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.



  • 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.


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.



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.


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.



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.



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.


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.


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.



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.



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.



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.



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.



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


  • 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.



  • Assessments of two substance groups published.

Assessments of regulatory needs are now available for:

Methylene diphenyl ureas; and Aralkylamines


  • Consolidated texts for UK REACH and CLP laws published



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



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



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




  • 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




  • 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.


  • 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.


  •     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 -).




  • 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).


  • 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.




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




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.


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.



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 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



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.


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.

Riorganizzazione degli Uffici

La Direzione Generale dei Dispositivi Medici e del servizio Farmaceutico (DGDMF) sta andando incontro ad una riorganizzazione degli Uffici e ad una revisione del proprio protocollo che comporterà l’invio di ogni comunicazione inerente i PMC e i biocidi all’Ufficio 8 (Biocidi e cosmetici) e non più all’Ufficio 1 (Affari generali e prodotti di interesse sanitario diversi dai dispositivi medici).


Nuove modalità di redazione e trasmissione dei provvedimenti

A partire dall’ 8 marzo 2022 i provvedimenti inerenti i PMC e i biocidi, come quelli di autorizzazione all’immissione in commercio di biocidi e PMC o di autorizzazione alla produzione di PMC e le relative modifiche, rilasciati dall’Ufficio 8 secondo il Regolamento (UE) 528/2012 ed il D.P.R. 6 ottobre 392/1998, sono firmati digitalmente. I documenti così formati, costituenti i provvedimenti autorizzativi o di modifica di autorizzazione, verranno trasmessi via posta elettronica certificata o per via telematica, consentendo tempi di notifica più celeri e benefici, nel medio periodo, in termini di tempi di trattazione del procedimento.


Aggiornamento delle tariffe dei servizi erogati dal Ministero su richiesta

Dal 27 novembre 2021 è entrato in vigore il nuovo aggiornamento delle tariffe dovute per i servizi erogati su richiesta dalla Direzione Generale dei Dispositivi Medici e del servizio Farmaceutico (DGDMF). Questo aggiornamento è stato disposto dal Decreto Ministeriale del 6 agosto 2021, pubblicato in Gazzetta Ufficiale il 12 novembre 2021, n. 270.

Per le richieste pervenute al Ministero della salute a partire dal 27 novembre 2021, anche spedite anteriormente, per le quali sia stata pagata la precedente tariffa, occorre integrare l’importo del versamento dovuto.

Gli aggiornamenti riguardano, in particolare, i servizi relativi a:

  • biocidi (CLV)
  • cosmetici
  • dispositivi medici
  • dispositivi medico-diagnostici in vitro
  • indagini cliniche
  • PMC
  • pubblicità sanitaria
  • sostanze stupefacenti

Qui sotto il nuovo prezzario relativo a PMC e biocidi:

Accertamenti conseguenti alla domanda diretta ad ottenere l’autorizzazione a produrre presidi medico chirurgici Euro 3.827,60
Accertamenti conseguenti alla domanda diretta ad ottenere una modifica dell’autorizzazione a produrre presidi medico chirurgici attinente l’officina di produzione Euro 1.913,80
Accertamenti conseguenti alla domanda diretta ad ottenere una modifica dell’autorizzazione a produrre presidi medico chirurgici, non concernente l’officina di produzione e non attinente esclusivamente alla sede legale Euro 382,80
Accertamenti conseguenti alla domanda diretta ad ottenere una modifica dell’autorizzazione a produrre presidi medico chirurgici, attinente esclusivamente alla sede legale Euro 0
Accertamenti conseguenti alla domanda diretta ad ottenere l’autorizzazione a mettere in commercio un presidio medico chirurgico Euro 1.531,00
Accertamenti conseguenti alla domanda diretta ad ottenere un’integrazione o modifica dell’autorizzazione a mettere in commercio un presidio medico chirurgico, con riferimento ad ogni integrazione o modifica non imposta dal Ministero della salute attinente alla composizione o alle caratteristiche tecniche sostanziali o alla denominazione del presidio o all’officina in cui esso e’ prodotto Euro 382,80 per presidio medico chirurgico
Accertamenti conseguenti alla domanda diretta ad ottenere un’integrazione o modifica dell’autorizzazione a mettere in commercio un presidio medico chirurgico, con riferimento ad ogni modifica concernente la ragione, la denominazione sociale, la partita iva, il codice fiscale o l’indirizzo della societa’ titolare dell’autorizzazione all’immissione in commercio, anche a seguito di trasferimento della proprietà del/dei presidio/presidi medico chirurgico/i Euro 382,80 per il complesso dei presidi medico chirurgici interessati
Accertamenti conseguenti alla domanda diretta ad ottenere un’integrazione o modifica dell’autorizzazione a mettere in commercio un presidio medico chirurgico, con riferimento ad ogni modifica concernente la ragione sociale o la denominazione sociale della società che rappresenta in Italia la società estera titolare dell’autorizzazione all’immissione in commercio Euro 382,80 per il complesso dei presidi medico chirurgici interessati
Rilascio certificato di “libera vendita” Euro 95,00


Riferimenti: https://www.trovanorme.salute.gov.it/norme/dettaglioAtto?id=83873