Slide background
Slide background




Rapporto ECHA: Impatti socioeconomici delle autorizzazioni REACH

ID 4634 | | Visite: 1980 | Documenti Chemicals ECHAPermalink: https://www.certifico.com/id/4634

Report: ECHA’s scrutiny has a profound impact on authorisation decisions

Helsinki, 18 September 2017

According to ECHA’s report the requirements for authorisation have introduced stricter controls of use and have therefore reduced risks from harmful chemicals to workers and the population at large. They have often led to early substitution to safer alternatives. Where applicants made a convincing case that substitution was not possible the recommended authorisations permit them to continue using substances of very high concern and to avoid substantial costs to society.

The authorisation system has entailed costs to applicants and regulatory authorities, but the benefits outweigh the remaining risks, based on ECHA’s analysis of the first 100 applications for authorisation submitted and evaluated by the end of 2016.

The authorisation requirements as well as the reputational issues of continued use of substances of very high concern (SVHCs) have driven companies to substitute hazardous substances with safer alternatives as witnessed by the non-receipt of applications for seven substances on the Authorisation list.

Substitution of substances on the REACH Authorisation List is taking place. No applications were received for seven substances and several applications contained planned substitution activities.   

Three findings stand out:

- Whilst the remaining risks associated with the continued use of SVHCs are important, the risk reductions brought about by the authorisation system have reduced the exposure to harmful chemicals of workers and the population at large. Thereby, the authorisation system has helped to lower the burden of occupational and other diseases in the EU.

- The aggregate benefit of authorisations (i.e. the costs that applicants, their clients and society as a whole would have to bear if the authorisations had not been granted) were estimated to outweigh the remaining monetised risks to human health and the environment by on average a factor of 15 to 1. This ratio varied a lot from one application to another.

- While ECHA’s scientific committees recommended to the European Commission that all the authorisations be granted, they suggested additional conditions and/or monitoring requirements in two-thirds of the uses. Furthermore, they recommended that the review periods be – on average – 2.5 years shorter than proposed by the applicants. Thus, the scientific scrutiny of the applications manifests itself in the opinion-making process.

The authorisation title of the REACH Regulation is a new way of approaching the management of hazardous chemicals, which incentivises firms in the European Union (EU) to substitute away from SVHCs where this is feasible.

In particular, SVHCs listed under Annex XIV to REACH must not be used after a specified sunset date unless a user or their supplier (e.g. the manufacturer or importer of the substance) hold an authorisation.

For substances for which a threshold in accordance with Annex I to REACH was established authorisations must be granted if the risk to human health or the environment from the use applied for is adequately controlled. Authorisations for substances for which it is not possible to determine a threshold may be granted if suitable alternatives to the specific use of the substance are not available and the applicant can credibly show that the socio-economic benefits of continuing its SVHC use beyond the sunset date outweigh the associated risk to human health and the environment.

The REACH authorisation title provides a flexible policy tool to manage the risks associated with the use of SVHCs. Together with EU Member States, the European Commission adds substances to Annex XIV to REACH. This ‘authorisation list’ includes substances which:

(i) are carcinogenic, mutagenic or toxic to reproduction (CMR);
(ii) are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB); or
(iii) give rise to an equivalent level of concern (e.g. endocrine disrupters).

Firms, in turn, decide whether they wish to use a specific substance after the sunset date — and thus apply for authorisation on their own or under the umbrella of an upstream application — or discontinue the use of the substance.

ECHA and its scientific committees then examine the claims made by the applicants in their applications and forward an opinion on each application to the European Commission, which then decides together with the Member States whether and for how long an authorisation will be granted.

As of May 2017, ECHA had received 115 applications for authorisation for 199 of some 20 different SVHCs. Each of these applications includes a specification of the substance and the use for which authorisation was applied for, supported by a chemical safety report (CSR), an analysis of alternatives (AoA) and a socio-economic analysis (SEA).

ECHA’s Committee for Risk Assessment (RAC) assesses the risks to human health and the environment arising from the specific use of the substance as well as the appropriateness and effectiveness of the risk management measures as described in the CSR. ECHA’s Committee for Socio-economic Analysis (SEAC) examines the applicant’s report on the availability and suitability of alternatives for the use applied for and assesses the socio-economic consequences of the authorisation decision. RAC and SEAC then provide a joint opinion to the European Commission for supporting regulatory decisions.

Fonte: ECHA

Correlati:

Candidate list ECHA: Sostanze estremamente preoccupanti SVHC

ebook Regolamento REACH

Pin It


Tags: Chemicals Abbonati Chemicals Candidate list Guida ECHA

Articoli correlati

Ultimi archiviati Chemicals

Study on workability 1272 2008
Gen 23, 2020 63

Relazione UE: CLP Informazioni armonizzate risposta emergenza sanitaria

Relazione UE: CLP Informazioni armonizzate risposta emergenza sanitaria EU, 23.01.2020 Questa è la relazione finale (EN) per uno studio su questioni di lavorabilità relative all'attuazione dell'allegato VIII del regolamento (CE) n. 1272/2008 relativo alle informazioni armonizzate relative alla… Leggi tutto
EIGA 177 20
Gen 21, 2020 53

Medical Gas Cylinders Colour Coding

Medical Gas Cylinders Colour Coding EIGA Doc. 177/20 Medical Gas Cylinders Colour Coding Questo documento tratta la codifica a colori delle bombole utilizzati per l'uso di gas medicinali e medici in Europa, dove vengono applicati gli standard europei (EN). Può essere utilizzato anche in altri paesi… Leggi tutto
livelli massimi di tetraidrocannabinolo
Gen 15, 2020 188

Decreto Ministero della Salute 4 novembre 2019

Decreto Ministero della Salute 4 novembre 2019 Definizione di livelli massimi di tetraidrocannabinolo (THC) negli alimenti. (GU Serie Generale n.11 del 15-01-2020) Art. 1. Campo di applicazione 1. Il presente decreto fissa i valori delle concentrazioni massime (limiti massimi) di THC totale… Leggi tutto
Regolamento delegato UE 2020 11
Gen 10, 2020 395

Regolamento delegato (UE) 2020/11

Regolamento delegato (UE) 2020/11 Regolamento delegato (UE) 2020/11 della Commissione del 29 ottobre 2019 che modifica il regolamento (CE) n. 1272/2008 del Parlamento europeo e del Consiglio relativo alla classificazione, all’etichettatura e all’imballaggio delle sostanze e delle miscele per quanto… Leggi tutto
Gen 08, 2020 96

Nichel: Quadro Chemicals

Nichel: Chemicals, Health e Safety Il Nichel e suoi composti sono naturalmente presenti nella crosta terrestre e sono emessi in atmosfera attraverso fonti naturali (come la polvere portata dal vento, le eruzioni vulcaniche, i fumi prodotti da incendi boschivi e la polvere meteorica), nonché da… Leggi tutto
Piano nazionale OGM 2015 2018
Gen 06, 2020 111

Piano nazionale OGM 2015-2018

Piano nazionale OGM 2015-2018 Piano nazionale di controllo ufficiale sulla presenza di organismi geneticamente modificati negli alimenti 2015-2018 Il Piano nazionale di controllo ufficiale sulla presenza di organismi geneticamente modificati (OGM) negli alimenti rappresenta la realizzazione di una… Leggi tutto
Relazione Piano nazionale OGM   risultati del 2018
Gen 06, 2020 111

Relazione Piano nazionale OGM | risultati del 2018

Relazione Piano nazionale OGM | Risultati del 2018 Piano nazionale di controllo ufficiale sulla presenza di organismi geneticamente modificati negli alimenti risultati anno 2018 Il 2018 è il quarto anno della programmazione del Piano Nazionale OGM 2015-2018. Introduzione Con il 2018 si conclude il… Leggi tutto

Più letti Chemicals

Regolamento  CE  852 2004
Mar 06, 2019 23301

Regolamento (CE) N. 852/2004

Regolamento (CE) N. 852/2004 Regolamento (CE) N. 852/2004 del Parlamento europeo e del Consiglio del 29 aprile 2004 sull'igiene dei prodotti alimentari GU L 139/1 del 30.4.2004 Testo consolidato 2009Modificato da: Regolamento (CE) n. 1019/2008 della Commissione del 17 ottobre 2008 (GU L 277 7… Leggi tutto
Mar 02, 2019 22031

Regolamento (CE) n. 2023/2006 (Regolamento GMP)

Regolamento (CE) n. 2023/2006 Regolamento (CE) N. 2023/2006 della Commissione del 22 dicembre 2006 sulle buone pratiche di fabbricazione dei materiali e degli oggetti destinati a venire a contatto con prodotti alimentari (Regolamento GMP - Good Manufacturing Practices) ... Il presente regolamento… Leggi tutto
Regolamento  CE  n  178 2002
Set 04, 2019 21919

Regolamento (CE) N. 178/2002

Regolamento (CE) n. 178/2002 Regolamento (CE) n. 178/2002 del Parlamento europeo e del Consiglio del 28 gennaio 2002 che stabilisce i principi e i requisiti generali della legislazione alimentare, istituisce l'Autorità europea per la sicurezza alimentare e fissa procedure nel campo della sicurezza… Leggi tutto