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22 Mar

Posted at 10:11h in Chemical

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:

PRESIDI MEDICO CHIRURGICI
TIPOLOGIA DI PROCEDIMENTO IMPORTO DOVUTO
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

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15 Mar

Posted at 10:04h in Food

Le informazioni in etichetta

 

Il packaging più attraente, il prezzo, la comodità nel quale il prodotto viene dispensato, i messaggi accattivanti, il contenuto di calorie, l’assenza di zuccheri, i valori nutrizionali; sono questi i parametri attraverso i quali il consumatore fa delle scelte al supermercato mentre fa la spesa.

Oggi faremo una breve panoramica di quello che in etichetta è consentito (e no) sui prodotti alimentari e come fare ad ottenere una nuova dicitura (un nuovo claim) per un alimento o ingrediente.

La prima distinzione da fare nella lettura di un’etichetta è quella tra le informazioni obbligatorie e quelle facoltative. Il Regolamento No 1169/2011, relativo alla fornitura di informazioni sugli alimenti ai consumatori, stabilisce quelle che sono le informazioni che il produttore (o venditore ultimo) deve apporre sulla confezione per informare in maniera trasparente il consumatore su quello che sta comprando e che, in un secondo tempo, andrà a mangiare.

Tra queste informazioni troviamo, citate all’Art. 9 del Regolamento, la denominazione dell’alimento, l’elenco ingredienti, la presenza di allergeni, la percentuale di alcuni ingredienti, le quantità della confezione, la scadenza, le modalità di conservazione (per citarne alcuni).

Tra le facoltative invece, troviamo facilmente quelle definite come indicazioni nutrizionali o nutritional claim, come ad esempio “ricco di fibre”, “senza zuccheri”, “light”, che però non sono da confondere con le indicazioni sulla salute, o health claims, i quali sottolineano invece un effetto benefico sulla salute, come ad esempio “contribuisce a rafforzare le difese naturali dell’organismo”.

La Commissione Europea, nel 2006, ha adottato il Regolamento No 1924/2006 (o Regolamento Claims) per far fronte alla necessità di armonizzare queste diciture, con scopo primo quello di garantire un’informazione chiara al consumatore e soprattutto definire dei requisiti (scientifici) sui quali si basano queste diciture.

Per quanto riguarda le indicazioni nutrizionali, il regolamento Claims all’allegato I, riporta le “Indicazioni nutrizionali e relative condizioni di applicazione” come ad esempio <<FONTE DI FIBRE: L’indicazione che un alimento è fonte di fibre e ogni altra indicazione che può avere lo stesso significato per il consumatore sono consentite solo se il prodotto contiene almeno 3 g di fibre per 100 g o almeno 1,5 g di fibre per 100 kcal>>. In questa sezione sono infatti stati standardizzate queste espressioni e rese comuni a tutti gli stati Membri.

 

Discorso diverso invece per le indicazioni sulla salute. L’introduzione di tale regolamento ha sancito per esse una vera a propria pre-validazione da parte dell’Autorità della Sicurezza Alimentare (EFSA) e della Commissione prima dell’utilizzo sulle etichette alimentari.

In questo senso, l’EFSA ha il compito di valutare, tramite il suo parere scientifico, la veridicità dell’associazione alimento-effetto benefico, secondo una correlazione causa-effetto e approvare quindi, in seconda battuta, il relativo claim. La validazione da parte delle autorità permette l’utilizzo del claim salutistico.

Il Regolamento Claims descrive come sottomettere una richiesta di autorizzazione, la quale è accompagnato da una guida, rilasciata da un Panel di EFSA, dove vengono riportate le istruzioni su come fornire il materiale necessario alla valutazione.

Tra i compiti dell’EFSA rientra quello di fornire consulenza scientifica su*:

*(per ogni punto il link in riferimento del sito EFSA)

Negli anni è diventato evidente quando l’approvazione di un health claim sia un processo difficile: molte sono state le proposte non approvate. Le evidenze scientifiche a supporto, solitamente, non sono tali da confermare la relazione causa-effetto e quindi vengono bocciate dai Panel di EFSA.

Una panoramica sulla situazione dei claims la si può trovare al link: https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=search

Dal punto di vista del consumatore, la difficoltà nell’ottenere un health claim, potrebbe essere interpretata con un aumentata fiducia per quelli che invece sono stati approvati. Se non altro, una nota positiva.

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08 Mar

Posted at 09:44h in Medical

What is IFRA?

The International Fragrance Association (IFRA), founded in 1973, represents the interests and is the voice of the fragrance industry worldwide. It promotes the safety and benefits of the fragrance industry’s products through stakeholder dialogue on a global basis.

When warranted by concerns regarding the safe use of a specific ingredient identified by the Research institute for Fragrance Materials (RIFM) safety assessment program, IFRA will issue an IFRA Standard as part of an IFRA Amendment.

IFRA Standards

To ensure the safety of fragrances, IFRA has established rules (known as IFRA Standards) recognized by government authorities and commercial entities around the world.

IFRA Standards can either prohibit, restrict or set purity requirements for specific ingredients. The safety of ingredients, whether the subject of an IFRA Standard or not, remains the responsibility of IFRA members. Compliance with IFRA Standards is therefore necessary for compliance with the IFRA Code of Practice but may not be sufficient to ensure regulatory compliance and the safety of fragrance mixtures or ingredients.

The IFRA Standards and related documents are subject to regular changes as new information relevant to the safety of fragrance ingredients become available. All these changes are part of an IFRA Amendment, which is designed pursuant to an inclusive procedure and is subject to a broad consultation of all relevant stakeholders before its Notification. Last one is the 50th Amendment, an ‘off-cycle’ amendment for one ingredient, Mintlactone, published on 30 June 2021.

The Expert Panel for Fragrance Safety is an independent panel of experts that reviews the activities of the Research Institute for Fragrance Materials (RIFM). They determine safety of use for fragrance ingredients through consideration of available information and active generation of additional data. If the Expert Panel for Fragrance Safety determine that a restriction of use is necessary for consumer and environmental protection, an IFRA Standard will be published.

All fragranced consumer products are in the scope of the IFRA Standards except for products clearly not covered in the RIFM Safety Assessments, such as:

– medical devices;

– prescriptive drugs;

– aromatherapy applications;

– consumer products used in occupational settings (e.g. shampoos applied in hair salons, hand sanitizers applied in hospitals, etc.).

A detailed list of the products covered under the scope of the IFRA Standards is provided in “Guidance for the Use of IFRA Standards”. In case a final product application is not included therein, it remains the responsibility of the final consumer product manufacturing company to adequately categorize this final product application in order to comply with the requirements of the IFRA Standards.

For practical reasons, IFRA Standards are set per product category, each covering a range of product types which can be grouped together based on risk assessment considerations.

With IFRA 49th Amendment, issued at the beginning of 2020, the number of categories in the IFRA Standard has changed from 11 categories for dermal sensitization Standards and 4 for systemic toxicity-based Standards to 12.

Product categorization is achieved by grouping consumer product types based on functional type, and major factors in habits and practices of consumers such as area of use (head, face, axillae, etc.) and whether they are rinse-off or leave-on applications.

Certificate of conformity

The Certificate of Conformity to the IFRA Standards is a document established by companies creating fragrance mixtures, which declares compliance with the requirements expressed in the IFRA Standards and confirms that a specific fragrance mixture up to a certain concentration can be used in a specified consumer product in compliance with up to and including a specific Amendment (the number and the Notification date of the Amendment should be stated in the Certificate).

The Certificate is only applicable for fragrance mixtures intended to be directly included in a finished consumer product. By using a Certificate, a fragrance supplier assures its customer that the product they supply is in compliance with the requirements set by the IFRA Standards for an intended use.

It is important to note that IFRA is not involved in its preparation and that the Certificate of Conformity declares compliance with the requirements expressed in the IFRA Standards but does not replace a safety assessment.

 

Source: https://ifrafragrance.org

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01 Mar

Posted at 10:36h in Regulatory Updates

WHAT HAPPENED THIS MONTH?

 

REACH:

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

 

Hazardous substances:

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

 

CLP:

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

 

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

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

The deadline is 7 March 2022.

  • New proposals to harmonize the classification and labelling

 

Three proposals have been introduced for:

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

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23 Feb

Posted at 10:01h in Chemical

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.

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15 Feb

Posted at 10:25h in Food

New Regulation sets out the requirements for the manufacture and marketing of  articles intended to come into contact with food

 

As we all know, food comes into contact with many materials and articles during its production, processing, storage, preparation and serving, before its eventual consumption. Such materials and articles are called Food Contact Materials (FCMs).

FCMs are either intended to be brought into contact with food, are already in contact with food, or can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use; it includes direct or indirect contact (ex. Containers for transporting food, machinery to process food, packaging materials, kitchenware and tableware).

Regulation (EC) 10/2011 (the “Plastics Regulation“) sets out the requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food. These requirements supplement the general rules laid down in Regulation (EC) No 1935/2004 (the “Framework Regulation”) on materials and articles intended to come into contact with food.

Article 16 of the EU food contact material Framework Regulation (EC) 1935/2004 requests the Declaration of Compliance (DoC); more details are set out in Annex IV of the Plastics Regulation (EU) 10/2011.

The DoC is a document delivered by the supplier to his customer at marketing stages up to but excluding the retailer. It has two main aims:

  • It confirms to the customer the compliance of the product with the relevant requirements of the Plastics Regulation and the Framework Regulation.
  • It provides the consumer with relevant information necessary to establish or check the compliance of the product with relevant legislation.

The purpose of the DoC is to demonstrate that the product is fully compliant with certain regulations and specify the testing methods applied to prove this. Ultimately it comes down to demonstrating that the food contact product is safe and doesn’t contain or transfer restricted chemicals or heavy metals.

It means that all European manufacturers of plastic material that comes into contact with food (including recycled plastics), active and intelligent materials, ceramics and regenerated cellulose film are obliged to issue a DoC for the articles and products they provide. For other types of food contact materials (i.e, paper, inks), DOC is not mandatory at the moment.

The DoC requirement extends all the way from the chemical supplier to any intermediate plastic supplier (suppliers of things like plastic granules and masterbatch) to the supplier of the finished plastic article, to the distributor and finally to the end-user.

According to Annex IV of the “Plastic Regulation”, there are 9 important items that have to be on a DoC:

  1. The identity and address of the business operator issuing the declaration of compliance. A DoC needs to contain information to ensure that the product is traceable if needed.

 

  1. The identity and address of the business operator that manufacturers or imports the plastic material or article. The official name and address of the manufacturing company. If the same company is issuing the DoC and manufacturing/importing the product, points 1 and 2 can be combined into one. This information, together with that contained in point one above will help

determine responsibility and traceability of the FCM if necessary

 

  1. The identity of the plastic material or article. Including the trade name, manufacturer’s code, catalogue reference number or any other code identifier that will allow the downstream user to adequately identify and trace the material. You need to know which product/products are covered in the DoC. The products should be specifically identifiable via something like an item number. With regard to the materials used, it is important to declare the type of polymer used in the material. Other materials – such as adhesives, coatings or inks – should also be listed.

 

  1. The date of the declaration. This date indicates that the product was compliant with the legislation in place at that time. Given that the legislation is ever evolving, it is possible that it can become more restrictive and compliant products can subsequently become non-compliant due to legislative amendments.

 

  1. Confirmation that the plastic material or article complies with all applicable regulations. This confirms that the plastic article is manufactured using only monomers, other substances and additives that are listed and authorised under (EU) 10/2011. The DoC should also mention that the article complies with the overall migration limit (OML). Details about the test conditions, such as any food simulants used and the OM test number according to Annex V to (EU) 10/2011, can be included.

Part of complying with (EU) 10/2011 is that a company’s manufacturing processes must comply with good manufacturing practices (GMP) as set out in Regulation (EC) 2023/2006. This regulation should therefore also be mentioned, if appropriate.

  1. Information on substances with restrictions in Annex I or II of (EU) 10/2011. This provides the identity of any substances with specific migration limits (SML) in Annex I and II of (EU) 10/2011, or information about the presence of any such substances. There should also be confirmation that the substances featuring SMLs do not migrate above the migration limit, if used under the specified conditions.

 

  1. Dual use additives. Dual-use additives are substances that can be used by food business to perform a technological function in food as well as having a function as additives in the manufacture of certain FCMs. Information on the use of dual-use additives should be provided to guarantee they are compliant with the legislation applying to Food Additives/ Flavourings and Food Contact Materials.
  2. Specifications on the use of the FCM, that includes:

(i) type or types of food with which it is intended to be put in contact; It is important to know which kind (aqueous, acidic, alcoholic, fatty and/or dry) of food the plastic product is intended for use with. Only products that have been tested in the food simulants 10% ethanol, 3% acetic acid and olive oil are suitable for use in contact with all food types. You should be aware of any restrictions in food types.

(ii) time and temperature of treatment and storage in contact with the food; How long can you use the product in contact with food and at which temperatures? This information is crucial for the safety of your food products.

(iii) ratio of food contact surface area to volume used to establish the compliance of the material or article; This is technical information from the test laboratory about the ratio of food contact surface area to volume that has been used to determine the compliance of the product. This figure is often given in dm2/ml.

  1. Functional barrier. When a functional barrier is used in multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of the Plastics Regulation (EU) 10/2011. This point is only relevant for multi-layer articles that feature a functional barrier. This point confirms that the non-authorised additives behind the functional barrier are not mutagenic, carcinogenic or toxic for human reproduction, and are not in nano-form. It also confirms that the non-authorised substances comply with the detection limit of 0.01 mg/kg.

 

With this, you should be updated about all the requirements featured in DoC and what to look for the next time you receive one.

In order to allow the exchange of relevant information, the information to be included in the DoC is set out in standard format in Annex IV of the Plastics Regulation.

It is recommended that the DoC and the Adequate Information are issued in one or more EU languages that are easily understood both by the supplier and by the customer. The information given has to be clear and distinct. Information should relate to the actual composition of the material. Several materials with different composition leading to significant differences in reportable substances cannot be covered by one DoC.

One DoC can cover a number of variations of a material or article which differ in their size, shape, thickness or colour or in the source of supply of one or a few of the components, leading to a limited number of variations in the reportable substances, provided that all reportable substances are listed.

The EU Rules on food contact materials can be of general scope, i.e. apply to all FCMs or apply to specific materials only. EU law may be complemented with Member States national legislation if specific EU rules do not exist.

The safety of FCM is evaluated by the European Food Safety Authority (EFSA).

The safety of Food Contact Materials is tested by the business operators placing them on the market, and by the competent authorities of the Member States during official controls. Scientific knowledge and technical competence on testing methods is being maintained by the European Reference Laboratory for Food Contact Materials (EURL-FCM).

Union legislation on food contact materials at EU level aims to:

  • Protect consumers’ health
  • Ensure the effective functioning of the internal market

An EU declaration of conformity (DoC) is a mandatory document that a manufacturer or his European authorised representative (if the manufacturer is based outside the EU) needs to sign to declare that their products comply with the EU requirements.

By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product by Reg. No 10/2011 on plastic materials and articles intended to come into contact with food (the “Plastics Regulation”).

The EU Declaration of Conformity

 

 

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01 Feb

Posted at 11:07h in Medical

THE MEDICAL DEVICE COORDINATION GROUP RELEASED A NEW GUIDANCE DOCUMENT REGARDING general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) (mdcg 2022-2)

 

Scope:

This document outlines the general principles of clinical evidence and provides guidance on the continuous process of performance evaluation for in vitro diagnostic medical devices (hereafter referred to as IVDs), as set out in Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR).

In this guidance is described the approach by which collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing on the market or putting into service. As the performance evaluation will be updated throughout the life cycle of an IVD.

Definition of IVD according to Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR).

Article 2(2)

IVD: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

  1. a) concerning a physiological or pathological process or state;
  2. b) concerning congenital physical or mental impairments;
  3. c) concerning the predisposition to a medical condition or a disease;
  4. d) to determine the safety and compatibility with potential recipients;
  5. e) to predict treatment response or reactions;
  6. f) to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.

As accessories for an IVD fall under the scope of the IVDR, this document also provides guidance on these devices.

 

Introduction:

Prior to placing an IVD on the market or putting it into service, the manufacturer must demonstrate compliance with all applicable requirements of the IVDR, in accordance with the appropriate conformity assessment procedure(s). Therefore, the manufacturer must demonstrate that the IVD achieves its intended purpose in accordance with the claimed performance over the lifetime of the device.

The IVDR outlines that evidence for an IVD’s conformity is established by demonstrating and substantiating the scientific validity, analytical performance and clinical performance.  Furthermore, the IVDR underlines that the necessary clinical evidence should be based on a sufficient amount and quality of data in order to allow a qualified assessment of whether the IVD is safe, performant and achieves the intended clinical benefit(s), when used as intended.

General principles of Clinical Evidence:

Clinical evidence for IVDs is established through the collection of data as a result of a performance evaluation. Performance evaluation covers the assessment and analysis of data to establish and verify the scientific validity, analytical performance and, where applicable, clinical performance of an IVD. Each indication and claimed clinical benefit specified in the intended purpose should be assessed and have the appropriate supporting clinical evidence.

Performance Evaluation:

Performance Evaluation is a structured, transparent, iterative and continuous process which is part of the quality management system and is conducted throughout the life cycle of an IVD. The general performance evaluation principles are laid down in Article 56 and Annex XIII, Part A, 1 of the IVDR and can be summarised as follows:

  • Planning (Performance Evaluation Plan, PEP);
  • Data establishment;
  • Analysis, conclusions and documentation (Performance Evaluation Report, PER);
  • Continuous monitoring and updates (Periodic <safety Update Report, PSUR; Post Market Performance Follow-up, PMPF).

The performance evaluation of an IVD must consider the benefit-risk ratio in light of the state-of-the-art. The three essential pillars of performance evaluation can be summarised as:

  • Scientific validity: the extent to which the analyte, or marker to be determined by the IVD is associated with the targeted physiological state or clinical condition.
  • Analytical performance: demonstration of the IVD’s ability to correctly detect or measure a particular analyte.
  • Clinical performance: demonstration of an IVD’s ability to yield results that are correlated with a particular clinical condition or a physiological/pathological process or state in accordance with the target population and intended user.

The risk management system should be carefully aligned with and reflected in the performance evaluation process of the IVD, considering the clinical risks to be addressed as part of the performance evaluation, performance studies, and post-market performance follow-up(s).  Due to their nature, in the majority of cases, deficiencies of IVDs do not directly lead to physical injury or damage to the health of people. If any, these devices may lead to indirect harm, rather than direct harm.

For more information: https://ec.europa.eu/health/latest-updates/mdcg-2022-2-guidance-general-principles-clinical-evidence-vitro-diagnostic-medical-devices-ivds-2022-01-27_en

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27 Jan

Posted at 15:30h in Chemical

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.

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25 Jan

Posted at 12:15h in Chemical

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) .

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18 Jan

Posted at 10:47h in Food

Le tappe del Bisfenolo A

 

Il bisfenolo A (BPA), è un composto organico di sintesi con due gruppi fenolici geminali. È impiegato nella produzione delle plastiche in policarbonato (molto diffuse per le proprietà di trasparenza, resistenza termica e meccanica) utilizzate nei recipienti per uso alimentare e nelle resine epossidiche usate in pellicole e nel rivestimento protettivo interno, presente nella maggior parte delle lattine per alimenti e bevande.

L’uso del BPA nei MOCA (materiali a contatto con gli alimenti) è autorizzato nell’Unione Europea ai sensi del regolamento 10/2011/UE, che riguarda i materiali e gli oggetti di materia plastica destinati a venire a contatto con i prodotti alimentari.

Il BPA è autorizzato per l’impiego a contatto con i prodotti alimentari anche in altri Paesi (es. gli Stati Uniti, il Giappone).

Nel 2006 l’EFSA ha concluso la sua prima valutazione completa dei rischi da BPA. Ad oggi, il BPA è considerato un interferente endocrino, cioè una sostanza in grado di danneggiare la salute alterando l’equilibrio endocrino, soprattutto nella fase dello sviluppo all’interno dell’utero e nella prima infanzia. Pertanto, può alterare lo sviluppo dei sistemi riproduttivo, nervoso ed immunitario. Ma vediamo come negli anni il BPA è stato considerato.

Dal 2009 il BPA è inserito nell’elenco delle sostanze vietate nei prodotti cosmetici (Regolamento (CE) 1223/2009).

Dal 2011 il suo uso è vietato per la fabbricazione di biberon di policarbonato per lattanti (Regolamento (UE) 321/2011).

L’EFSA ha esaminato le nuove informazioni scientifiche apparse sul BPA nel 2008, 2009, 2010 e 2016.

Nel gennaio 2015, l’EFSA pubblica gli esiti del proprio riesame integrale della tossicità e dell’esposizione al BPA, e riduce la dose giornaliera tollerabile (DGT) da 50 a 4 µg/kg di peso corporeo.

Numerosi studi continuano a essere portati avanti per comprendere l’effetto a basse dosi. Essendo un interferente endocrino, cioè una sostanza in grado di danneggiare la salute alterando l’equilibrio endocrino, soprattutto nella fase dello sviluppo all’interno dell’utero e nella prima infanzia, il BPA potrebbe avere effetti sulla salute che non seguono funzioni matematiche lineari ed essere tossico a dosi più basse di quelle prese in considerazione per le normali valutazioni normative. Pertanto, può alterare lo sviluppo dei sistemi riproduttivo, nervoso ed immunitario.

Nel 2017 viene aggiunto alla Candidate List of Substances of Very High Concern dall’European Chemical Agency (ECHA).

Nel dicembre del 2021 è uscita la bozza di valutazione ex novo del BPA dove il gruppo CEP (esperti dell’EFSA sui materiali a contatto con gli alimenti, gli enzimi e i coadiuvanti tecnologici) ha stabilito una DGT di 0.04 nanogrammi/kg di peso corporeo al giorno. L’abbassamento di 100 mila volte del valore è il risultato della valutazione di studi apparsi nella letteratura dal 2013 al 2018, in particolare quelli che evidenziano effetti avversi del Bisfenolo A sul sistema immunitario.

Confrontando i nuovi limiti con le stime dell’esposizione dei consumatori al BPA tramite l’alimentazione, l’EFSA conclude che sia l’esposizione media che quella elevata superano la nuova dose giornaliera in tutte le fasce di età, dando così adito a preoccupazioni di termini di salute. Il presidente del gruppo CEP, Claude Lambré ha dichiarato:” Questa bozza aggiornata è il risultato di un’accurata valutazione durata diversi anni. Abbiamo applicato un approccio sistematico per selezionare e valutare le evidenze disponibili. I nuovi studi scientifici apparsi nella letteratura ci hanno aiutato ad affrontare importanti elementi di incertezze circa la tossicità del Bisfenolo A”.

Per questa nuova valutazione è stato effettuato un approfondito lavoro preparatorio da parte degli esperti dell’EFSA, tra cui la pubblicazione e poi sperimentazione di un protocollo di valutazione in termini di pericolo nel 2017 e nel 2019.

Tutte le parti interessate sono invitate a presentare osservazioni sulla bozza di parere tramite l’apposita pagina della consultazione pubblica entro l’8 febbraio 2022. Gli esperti del gruppo CEP e del gruppo di lavoro sulla nuova valutazione del BPA presenteranno gli elementi scientifici su cui poggia la bozza di parere in una riunione tecnica riservata agli stakeholders di interesse il 24 gennaio 2022.

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