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07 Jun

Posted at 09:30h in Regulatory Updates

Agrochemical:

  • Glyphosate: no change proposed to hazard classification

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

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

REACH:

  • Assessments of two substance groups published.

Assessments of regulatory needs are now available for:

Methylene diphenyl ureas; and Aralkylamines

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

  • Consolidated texts for UK REACH and CLP laws published

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

Nanomaterials:

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

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

Cosmetics:

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

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

Food:

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

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

 

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31 May

Posted at 09:00h in Food

#

Negli ultimi anni i composti che vanno sotto il nome di ftalati entrati a far parte delle sostanze di maggior attenzione sia per i consumatori che per le autorità, attenzione principalmente smossa dalla presenza di questi composti negli alimenti.

Qui di seguito una piccola panoramica dei punti salienti.

Gli ftalati sono una classe di composti chimici organici, derivanti dal petrolio, utilizzati come agenti plastificanti, ossia impiegati per consentire al materiale plastico (nella maggioranza dei casi PVC) di essere flessibile e elastico. Industrialmente, gli ftalati sono i plastificanti maggiormente impiegati. Dal punto di vista fisico questi si trovano in forma liquida e hanno l’aspetto di un olio; sono incolori ed inodori.

La struttura chimica che li accomuna è quella di un anello aromatico e due esteri. Il nome ftalati deriva dalla struttura dell’acido ftalico, portante due gruppi carbossilici legati all’anello aromatico dalla quale derivano tutti gli altri.

La lunghezza delle catene laterali si traduce industrialmente in un impiego differente così come anche la tossicità di questi composti sembra essere correlata alla lunghezza delle catene; per semplificare catene lunghe sono associate ad un ridotto grado di tossicità rispetto alle catene corte.

Tra gli ftalati più conosciuti abbiamo il DINP (Di-isononilftalato) , il DIDP (Di-isodecilftalato) e il DPHP (Bis(2-etilesil)ftalato) che occupano la fetta più larga degli ftalati impiegai in Europa.

 

Ma dove li troviamo quindi nella nostra quotidianità?

Li troviamo in tutti i materiali plastici che necessitano una certa flessibilità come tubi, cavi, pellicole, teloni, rivestimenti di vario tipo ma anche in prodotti dove vengono impiegati come lubrificanti senza grasso, agenti antischiuma, solventi, come smalti, spray per i capelli ed altri cosmetici e profumi e anche in formulazioni per l’agricoltura, come i pesticidi. Nel campo farmaceutico anche alcuni dispositivi medici, sacche o flebo possono contenere ftalati, sempre per lo stesso motivo tecnologico.

Si può quindi comprendere immediatamente l’onnipresenza di questi composti nella nostra vita quotidiana e la quantità di ftalati a cui il consumatore può essere esposto. Le vie di esposizione agli ftalati si possono riassumere in: per ingestione (alimenti), inalazione (aria degli spazi interni; rivestimenti di mobilio), dermico (per contatto diretto con la pelle nell’utilizzo di materiale contente ftalati).

 

Come finiscono negli alimenti?

Nella produzione delle plastiche, molte di queste hanno fini alimentari come imballaggi, o packaging, ma anche come banali utensili da cucina o rivestimenti di macchinari che processano gli alimenti, senza considerare ovviamente a tutte le tubature del trasporto dell’acqua potabile. Dal punto di vista regolatorio questi materiali cadono sotto la denominazione di Food Contact Materials (o FCM) o Materiali ed Oggetti a Contatto con gli Alimenti (o MOCA)*. Quando gli ftalati vengono impiegati nelle plastiche rimangono all’interno del materiale e sono in un secondo momento facilmente estraibili da agenti grassi o liquidi o per semplice erosione meccanica del materiale, finendo inevitabilmente nel cibo e quindi ingeriti dal consumatore. L’esposizione di questi composti attraverso gli alimenti pare essere la via di assorbimento principale: i cibi processati e ultra-imballati sono maggiormente responsabili di questa esposizione rispetto a quelli non processati o sciolti.  Il fenomeno di passaggio degli ftalati verso gli alimenti viene definito migrazione. 

 

Il profilo tossicologico

La tossicità, per quanto riguarda gli ftalati, è legata agli effetti a lungo termine che questi sembrano avere sull’apparato riproduttore umano e non relativi ad una tossicità di tipo acuto.

Alcuni di questi sono stati già classificati “tossici per la riproduzione”: da studi su animali è stato riscontrato come l’esposizione ad essi abbia una correlazione con effetti sulla fertilità maschile (sterilità) e che siano responsabili di una produzione ridotta di spermatozoi. Non ci sono tuttavia studi sull’uomo che confermino questa stretta correlazione causa-effetto, anche per la difficoltà di perimetrare e relazionare questo effetto unicamente agli ftalati. Resta però l’allerta che queste sostanze siano degli “interferenti endocrini” -ossia che hanno una qualche interazione con il sistema ormonale umano- e pertanto da trattare con molta attenzione.

Come anticipato, alcuni ftalati sono di maggior preoccupazione di altri, principalmente vengono considerati più dannosi quelli a catena corta (il DEHP è quello di maggior allarme e il più presente negli alimenti) i quali stanno venendo sostituiti a livello industriale da quelli a catena più lunga (es. DiNP e DiDP).

Nel campo alimentare, l’EFSA, l’Agenzia della Sicurezza Alimentare, ha valutato 5 ftalati presenti negli alimenti e di maggiore preoccupazione: Di-butilftalato (DBP) – FCM n. 157, Butil-benzil-ftalato (BBP) – FCM n. 159, Bis(2-etilesil) ftalato (DEHP) – FCM n. 283, Di-isononilftalato (DINP) – FCM n. 728, Di-isodecilftalato (DIDP) – FCM n. 72; il parere rilasciato conclude che i quantitativi a cui ad oggi il consumatore è esposto sono al di sotto della soglia considerata di rischio.

Data l’allerta di questi composti, in Europa alcuni di questi sono vietati nei prodotti destinati ai bambini, dai giocattoli ai materiali a contatto con gli alimenti. In diversi paesi dell’Unione e no, alcune categorie di prodotti vedono restrizioni per particolari ftalati (es. cosmetici in Svizzera).

Sebbene nel nostro continente la problematica abbia portato a restrizioni e limitazioni per l’impiego di queste sostanze nei prodotti destinati al contatto con il cibo, la Food and Drug Administration (FDA), negli Stati Uniti, non ha ancora investigato la sicurezza degli alimenti in termini di ftalati e soprattutto non ha posto soglie legali entro le quali gli ftalati devono trovarsi all’interno dei materiali a contatto con gli alimenti. Alcuni studi (1, 2) condotti dalle università sul territorio statunitense hanno evidenziato risultati preoccupanti di accumulo di ftalati, soprattutto nei consumatori che frequentano fast foods in quantità maggiore.

 

* per completezza, gli impianti per il trasporto dell’acqua potabile non vengono considerate MOCA secondo Reg. 1935/2004.

Reference:

– https://www.efsa.europa.eu/it/news/faq-phthalates-plastic-food-contact-materials

– https://www.bag.admin.ch/dam/bag/it/dokumente/chem/themen-a-z/factsheet-phthalate.pdf.download.pdf/factsheet-phthalate_it.pdf

– https://www.nature.com/articles/s41370-021-00392-8

– https://ehp.niehs.nih.gov/doi/10.1289/ehp.1510803

 

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24 May

Posted at 09:25h in Medical

Introduction:

In May the MDCG Guideline 2022 – 5 “Guidance on Borderline between medical devices and medicinal products under MDR 2017/745” was published, at the conclusion of a long comparison within the Community.

Borderline products are those products that by their nature are not immediately traceable to a particular sector, for which it is therefore difficult to define what is the reference legislation to be applied.

The demarcation between Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and Directive 2001/83/EC on medicinal products (MPD) for human use on the other is crucial for the implementation of these legislative acts and for their correct interpretation and application.

 

General aspects:

As a general rule, a product is regulated either by the MDR or by the MPD but not both. The conformity assessment procedure or the marketing authorisation procedure to be followed prior to placing a given product on the market will therefore be governed either by the MDR or by the MPD.  The procedures of both regulatory regimes do not apply cumulatively. However, for products that have properties of both medicinal products and medical devices (e.g. medical devices incorporating as an integral part, a substance which, if used separately, would be considered to be a medicinal product), some cross-references are made within one regime to specific provisions of the other regime.

The wording of Article 2(2) of the MPD shows that it only applies if, after a case-by-case assessment, taking in consideration all the characteristics of a product, the product in question may fall within the definition of both, medical device and medicinal product. In such a case, the provisions of the MPD applies5. The MDR and the MPD may not be applied cumulatively.

The aim of this guideline is to support the uniform application of the Regulation throughout the European Union.

The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.

According to Article 1(6)(b) of the MDR, in deciding whether a product falls under the MDR or the MPD particular account shall be taken of the principal mode of action of the product. The nature of the principal mode of action i.e. whether it is pharmacological, immunological or metabolic or other is generally the same irrespective of the quantity.

According to Article 2(1) MDR a medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but may be assisted in its function by such means. The concept that a medical device may be assisted in achieving its principal intended action by pharmacological, immunological or metabolic means should be understood as covering those cases when the medical device incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product, and that has an action ancillary to that of the device.

Typically, the medical device’s principal intended action is achieved by physical means (including mechanical action, physical barrier such as a film, lubrication, heat transfer, radiation, ultrasound, replacement of or support to organs or body functions). Furthermore, hydration or dehydration and pH modification may also be means by which a medical device achieves its principal intended action.

The determination of the nature of the substance, i.e. whether it is “considered to be a medicinal product” is independent of the intention of the manufacturer, of the quantity of the substance in the device and of the method or route of administration.

 

Conclusion:

The document may be revised in the light of the update of technical-scientific knowledge and in the light of the results of discussions within the Borderline and Classification medical devices expert group (B&C) of the Medical Device Coordination Group.

 

For more information: https://ec.europa.eu/health/latest-updates/mdcg-2022-5-guidance-borderline-between-medical-devices-and-medicinal-products-under-regulation-eu-2022-04-26_en

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17 May

Posted at 09:30h in Chemical

Disposizioni particolari del packaging dei prodotti per il consumatore:

Vi siete mai chiesti come mai alcuni prodotti di uso comune hanno un’apertura o un applicatore complicati? Avete notato un piccolo triangolo in rilievo sul packaging ma non sapete a cosa serva? Niente paura, ve lo spieghiamo noi!

Questi componenti del packaging, con cui tutti siamo abituati ad avere a che fare (pensiamo, ad esempio, alla classica bottiglia di alcool denaturato) ma di cui spesso non conosciamo lo scopo, sono la chiusura di sicurezza per i bambini e le indicazioni di pericolo riconoscibili al tatto.

Essi sono strettamente legati ai pericoli del prodotto, riportati sull’etichetta CLP, o al contenuto di determinate sostanze; sono previsti per i prodotti per il consumatore dall’Articolo 35 del Regolamento (CE) n. 1272/2008 (CLP) e apposti secondo le disposizioni al punto 3 dell’Allegato II (in dettaglio, punto 3.1.1 per la chiusura di sicurezza per i bambini, e punto 3.2.1 per l’indicazione di pericolo riconoscibile al tatto). Tali requisiti non sono applicabili ai packaging dei prodotti destinati unicamente all’uso professionale.

Queste due disposizioni di sicurezza, che interessano il packaging, e le rispettive caratteristiche tecniche sono regolate da specifiche norme, indicate dal regolamento CLP:

– Avvertenze riconoscibili al tatto: norma EN ISO 11683;

– Chiusura di sicurezza per bambini: norma EN ISO 8317 (per gli imballaggi richiudibili), norma CEN EN 862 (per gli imballaggi non richiudibili).

 

Ma andiamo più nel dettaglio. In cosa consistono questi due elementi? Quali scopi hanno? In quali casi devono essere presenti?

 

Chiusura di sicurezza per bambini:

Gli imballaggi, sia richiudibili che non richiudibili, che devono rispettare questa disposizione, sono composti da un contenitore e una chiusura che ha lo scopo di rendere difficile ai bambini l’apertura o di entrare in contatto con il prodotto contenuto, e di conseguenza di salvaguardarne la sicurezza; tale chiusura risulta invece agevole da utilizzare per gli adulti.

Un imballaggio, indipendentemente dalla propria capienza, deve avere la chiusura di sicurezza per bambini se contiene sostanze o miscele:

– classificate per:

Classe di pericolo Categoria
Tossicità acuta (tutte le vie d’esposizione) Categorie da 1 a 3
STOT – esposizione singola Categoria 1
STOT – esposizione ripetuta Categoria 1
Corrosione della pelle Categoria 1; sottocategorie 1A, 1B, 1C
Pericolo in caso d’aspirazione Categoria 1

Sono esenti sostanze e miscele fornite al consumatore sotto forma di aerosol o in un contenitore dotato di un dispositivo di nebulizzazione sigillato, se non classificate per altri pericoli che prevedano la chiusura

 

– che contengano almeno una delle due seguenti sostanze in concentrazione uguale o superiore al limite di concentrazione indicato nella sottostante tabella:

Identificazione della sostanza Limite di concentrazione
CAS Nome EC No.
67-56-1 metanolo 200-659-6 ≥3%
75-09-2 diclorometano 200-838-9 ≥1%

 

Avvertenze riconoscibili al tatto:

L’avvertenza riconoscibile al tatto, un triangolo in rilievo, ha la finalità di indicare alle persone con disabilità visiva la presenza di sostanze o miscele pericolose all’interno di un contenitore.

L’avvertenza è normalmente un triangolo equilatero, simbolo previsto dallo standard ISO; tuttavia, in casi eccezionali, possiamo trovare al suo posto tre puntini.

Il simbolo deve rimanere riconoscibile al tatto per tutta la normale durata di utilizzo del collo, deve essere collocato sul packaging in modo che non venga confuso con altri elementi in rilievo e posizionato in modo tale da essere sentito prima dell’apertura del prodotto.

Un imballaggio, a prescindere dalla propria capienza, deve avere l’avvertenza riconoscibile al tatto se contiene sostanze o miscele:

– classificate per:

Classe di pericolo Categoria
Tossicità acuta (tutte le vie d’esposizione) Categorie da 1 a 4
STOT – esposizione singola Categoria 1 e 2
STOT – esposizione ripetuta Categoria 1 e 2
Corrosione della pelle Categoria 1; sottocategorie 1A, 1B, 1C
Sensibilizzazione delle vie respiratorie Categoria 1; sottocategorie 1A, 1B
Mutagenicità per le cellule germinali Categoria 2
Cancerogenicità Categoria 2
Tossicità per la riproduzione Categoria 2
Pericolo in caso d’aspirazione Categoria 1

Sono esenti sostanze e miscele fornite al consumatore sotto forma di aerosol o in un contenitore dotato di un dispositivo di nebulizzazione sigillato, se non classificate per altri pericoli che prevedano la chiusura
Gas infiammabili Categoria 1 e 2
Liquidi infiammabili Categoria 1 e 2
Solidi infiammabili Categoria 1 e 2

 

– che contengano, analogamente a quanto riportato per la chiusura di sicurezza per bambini, metanolo e/o diclorometano in percentuale uguale o superiore a quanto riportato nella tabella sopra riportata.

 

Se volete saperne di più, potete trovare ulteriori approfondimenti nel Regolamento CLP e nella Guida ECHA su etichettatura e imballaggio.

 

Fonti:

Regolamento (CE) n. 1272/2008 (CLP)

https://echa.europa.eu/documents/10162/2324906/clp_labelling_en.pdf/89628d94-573a-4024-86cc-0b4052a74d65

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10 May

Posted at 09:47h in Food

#

In 1979, on the proposal of the European Council, “The rapid alert system for food and feed” (RASFF) was conceived and launched. It was officially established with Regulation (EC) no. 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in food safety matters. In 2016, the RASFF brought together the food safety authorities of the member states of the European Union, Norway, Liechtenstein, Iceland and Switzerland (EFTA), and the European Commission, EFSA.

It is defined as an alert system in the form of a network, for the notification of a direct or indirect risk to human health from food or feed, according to Article 50 of Regulation (EC) no. 178/2002. Over the years, it has been extended to the risks associated with materials and objects intended to come into contact with food – FCM (respectively with Regulation (EC) No. 1935/2004) and feed for pets – pet food (Regulation (EC) No. 183/2005).

The system collects and publishes notifications and alarms within Europe relating to health risks in a short time, specifying the notifying country, the type and reasons for the notice, and the country of origin of the product. Trademarks and company names are not disclosed, seeking a balance between public information and the protection of commercial interests. The data is communicated and shared among the members of the network in real-time through the i-RASFF online platform implemented by the IMSOC system.

The IMSOC system complements the existing IT systems managed by the Commission and it is used for official controls as well. It is used to exchange data, information rapidly, and documents concerning the risks to human health, animal health and welfare and plant health.

Following the ascertainment, and sometimes even the suspicion, of a non-compliance at the border of the Union or within the Union, the competent authorities activate the RASFF notification system.

When non-conformities are associated with risk (serious, not serious or undecided) to human, animal or environmental health, the alert system’s notifications are:

  • alert (A notification of a risk that requires rapid action. The product subject to an alert must be withdrawn or recalled from the market)
  • information for follow-up
  • information for attention
  • border rejection (A notification about a product that was refused entry into the market for reasons relating to a serious risk to human health. Food can also be subject to information for attention or information for follow-up. These are both notifications that do not require rapid action either because the risk is not considered serious, or the product is not on the market at the moment of the notification.)
  • news

Alert and border rejection are the notifications that have a strong impact on public health.

The RASFF portal provides various information on products such as *The classification of the notifications, * The date of the case, * The notifying country, * The subject, * The product category, * The product type, * The risk decision.

If other details are needed, it is possible to extract information on: * The action taken, * The distribution status, * The hazard, * The category, * The analytical result, * The sampling date.

The benefits of the information provided through RASFF are especially relevant for:

*Importers: RASFF allows them to take advantage of the information about global imports/exports and thus prevent future detentions; and

*Consumers: RASFF ensures consumers the security of traceability and provides them information about the most frequent risks.

If the product subject to notification is still available on the market, it is necessary to activate the withdrawal and recall measures as required by Regulation (EC) 178/2002.

 

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05 May

Posted at 09:53h in Regulatory Updates

Biocidi:

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

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

 

REACH:

  • Upcoming changes to REACH information requirements:

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

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

  • Group assessment of bisphenols identifies need for restriction:

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

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

  •     Five substances added to REACH Authorisation List

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

The five substances are:

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

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

 

Food:

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

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

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

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

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

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

 

Chemical:

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

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

 

CLP:

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

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

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03 May

Posted at 10:00h in Medical

One of the most significant changes introduced by the Scientific Committee on Consumer Safety (SCCS) in the Notes of Guidance with the eleventh revision of March 2021 is the use of two mathematical models for the calculation of inhalation exposure.

Cosmetic products, by definition, are designed to be applied to the external surfaces of the human body, teeth and mucous membranes of the mouth. However, sometimes these products, or some of the ingredients that compose them, can be inhaled in the form of vapours, powders and aerosols.

The first model applies to products that can generate vapours (for example liquid products that contain volatile solvents). For these products, the inhalation Systemic Exposure Dose (SEDinh) of the ingredients is calculated by multiplying the daily exposure to the product by the concentration and evaporation fraction (a value between 0 and 1).

The second model applies to powder and spray products. Spray products fall into two categories: propellant sprays (which produce a finer aerosol) and pump sprays (which produce a less fine and more difficult to inhale aerosol).

For the assessment of inhalation exposure to these types of products, the SCCS proposed the use of a 1- or 2-Box model.

In a classical 1-Box model it is assumed that the entire spray amount is instantaneously released into the air and distributed in a box of a specific size, which e.g. simulates the breathing zone. The resulting air concentration is then multiplied by the breathing rate and the time spent in the box to calculate the exposure. A 2-Box model takes into account the dilution of the substance over time. As in the 1-Box model, the assumption is that the spray is instantly released and distributed in a box around the head. There the aerosol is present for exposure over a defined time, after which the full amount of aerosol in the first box is transferred to a larger second box (representing a room where the product is used), where it is available for inhalation for a second defined time period. For a conservative approach, the air exchange (fresh air getting in, exhaust air getting out) can be assumed as zero.

In addition to the size of the two boxes and the time that the product remains in suspension, the size of the aerosol generated by the product must also be taken into account for the calculation of the SEDinh, which vary according to the type of spray used. A finer aerosol is more easily breathable and consequently the substances contained within will be more systemically available.

The application of these mathematical models allows a better characterization of exposure to the ingredients contained within cosmetic products and is a further step towards a greater guarantee of safety for the final consumer.

For more details see:

https://ec.europa.eu/health/system/files/2021-04/sccs_o_250_0.pdf

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12 Apr

Posted at 09:37h in Food

The Maximum Residue Levels compliance

 

Every year, according to the rules established by Regulation (EC) No 396/2005, the EFSA releases a report on the pesticides residues in foodstuff over Europe. This report is based on data from the official national control activities carried out by EU Member States, Iceland and Norway. The report shows the results of extensive analyses of more than 800,000 samples from all over Europe to ensure and check the compliance of products on the market.

On the 30th of March 2022, the report for 2020 was released. The summary states

Analysis of the results shows that 94.9% of samples fell within legally permitted levels. For the subset of 12,077 samples analysed as part of the EU-coordinated control programme (EU MACP), 98.2% were within legal limits.

The entire report can be found here: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7215

Let’s see a bit more about how things work over pesticides and how some definitions would help understand the regulations at best.

The term “pesticide” is commonly misused with the intended meaning of Plant Protection Product (PPP). Pesticides are not only substances used for killing plants’ pests (as the PPPs) but also include substances for non-plant uses. To this extent, biocides are pesticides. EFSA oversees assessing PPT but not biocides.

Plant Protection Products are pesticides made of at least one active substance to keep crops healthy and prevent them from being destroyed by disease and infestation. PPP include herbicides, fungicides, insecticides, acaricides, plant growth regulators and repellents.

Plant protection products cannot be placed on the market or used without prior authorization. As it happens for other substances intended for the food sector (new additives, novel foods), EFSA evaluates active substances used in PPP while the Member States (MSs) authorize the products at the European level. The EFSA role is a scientific role of assessment while the EU Commission and the Member States take risk management decisions on regulatory issues, including approval of active substances. The EFSA scientific role is to evaluate the safety profile of the substance(s) and their potential harmfulness for humans. Based on their opinions, MSs can decide what to do.

The Regulation mentioned above, (EC) No 396/2005, set and harmonized the legal limits for pesticide residues (called Maximum Residue Levels or MRLs) in food and feed and gave the provisions for official controls. These legal limits also apply to imported food, set as “import tolerances” to meet international trade needs. These limits are defined because PPPs may pose a risk to public health if not controlled. Limits are established based on the hazard profile of each substance during the safety risk assessment carried out by EFSA panels. According to Regulation (EC) No 396/2005, maximum residue levels (MRLs) are the upper levels of pesticide residues that are legally permissible in or on food or animal feed, based on good agricultural practice (GAP) and the lowest exposure necessary to protect vulnerable consumers.

The yearly report released by the EFSA on pesticides residues checks the compliance of the pesticides (or better PPPs) residues. That is done also to understand if agricultural practices are done properly and are efficient in guaranteeing human health and whether consumers are protected.

Source: EFSA website available from: https://www.efsa.europa.eu/en/topics/topic/pesticides

 

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05 Apr

Posted at 11:39h in Regulatory Updates

CLP:

Ad hoc consultation on harmonised classification and labelling of glyphosate

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

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

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

ECHA is looking for comments related to these.

The deadline for comments is 12 April 2022.

 

Biocides:

Guidance on human health information requirements updated

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

 

QSAR:

QSAR Toolbox updated

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

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

 

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

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

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

 

Cosmetics:

European Commission begins consulting on cosmetics Regulation revision

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

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

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

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

·         a review of the definition of nanomaterials;

·         improving the labelling information on cosmetic products; and

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

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

REACH:

Resorcinol to be added to REACH candidate list after long battle

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

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29 Mar

Posted at 10:34h in Medical

Introduction:

The end of the state of emergency will be the end of the derogation regime which, in view of the exceptional situation resulting from the SARS-cov-2 pandemic, has introduced into our legislation the possibility of placing on the market surgical masks authorised by derogation. From 1 April 2022, manufacturers who want to continue to market surgical masks in Italy will have to comply with the ordinary legislation on medical devices.

For authorised masks already placed on the market, the Circular of 4 March 2022 (https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2022&codLeg=86093&parte=1%20&serie=null ) indicates that they may be made available only until 31 May 2022 and that only masks that are part of existing stocks available to personnel participating in efforts to contain the virus and prevent its further spread may be made available until such stocks are exhausted and at the latest by 31 July 2022.

The circular of 4 March 2022 clarified certain aspects of the procedures for placing surgical masks on the market in view of the imminent expiry of the state of emergency.

The circular recalls that from 26 May 2021 it is no longer possible to place on the market surgical masks marked CE pursuant to Directive 93/42/EEC, implemented in Italy with the d.lgs. 46/97, and it is stressed that manufacturers who intend to place on the market surgical masks, must ensure compliance with the requirements of Regulation (EU) 2017/745.

 

Technical Documentation:

According to MDR 2017/745 before placing a device on the market, the manufacturer is obliged to prepare the technical documentation that must enable it to assess its compliance with the general performance and safety requirements(GSPR) set out in Annex I to the Regulation.

This documentation shall be presented in a clear, organised, unambiguous and easily searchable format and shall include methods and test results to support compliance with the specifications. For surgical masks, these are mainly tests of bacterial filtration (BFE) efficiency, respirability (Pa/cm2), microbial contamination (cfu/g), splash resistance (kPa) (only in the cases provided, type IIR masks) and biocompatibility.

The manufacturing, design and performance requirements and test methods for surgical masks are set out in UNI EN 14683:2019 “Medical face masks – Requirements and test methods”, which, although not yet harmonised in accordance with the Regulation (cf. Circular of 12 November 2021) is the main tool for the manufacturer to demonstrate the conformity of the device.

 

Quality Management System (QMS):

To ensure that series production continues to comply with the requirements of the Regulation, the manufacturer establishes, documents, applies, maintains, updates and constantly improves a quality management system, in accordance with the obligations laid down in art. 10, paragraph 9 of the Regulation.

 

Post Market Surveillance:

The manufacturer shall establish and update a post-market surveillance system throughout the life cycle of the device.

 

In conclusion, the manufacturers of surgical masks already CE marked, in accordance with Directive 93/42/EEC, and persons who have obtained derogation authorisations for the production and marketing of surgical masks having an interest in continuing to regularly place on the EU market its own masks such as medical devices, must follow all the indications contained in the Circular and in the reference standards indicated.

 

For more information:

https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5834

 

 

 

 

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