Slide background
Slide background




Guidance on the Application of the CLP Criteria 07.2017 - EN

ID 4321 | | Visite: 3989 | Documenti Chemicals EntiPermalink: https://www.certifico.com/id/4321

Guidance on the Application of the CLP Criteria  07.2017 - EN

Versione 5.0

Questa guida è un documento tecnico e scientifico completo sull'applicazione del regolamento (CE) n. 1272/2008 relativo alla classificazione, all'etichettatura e all'imballaggio delle sostanze e delle miscele (CLP). L'obiettivo di questo documento è quello di fornire indicazioni dettagliate sull'applicazione dei criteri CLP per i rischi fisici, sanitari e ambientali.

...

Version 5.0 Partial revision of the Guidance to update the content mainly following the 8 th Adaptation to Technical Progress to the CLP Regulation (Commission Regulation (EU) No 286/2011).

Revision of few specific additional topics.

The update includes the following:

(i) Throughout the document:
- Revision of legal references and legal text quotations.
- Renumbering of some sections.
- Deletion of sections regarding the reclassification of substances and mixtures previously classified in accordance with the DSD or DPD.

(ii) Revision of Part 1:
- Deletion of reference to pre-CLP legislation and transitional period.
- Addition of reference to read-across and grouping in the context of bioavailability.
- Removal of quotation of Article 31(3) of REACH.
- Clarification about applicability of additivity principle.
- Clarification about the application of mixture rules to substances with CMR constituents.
- Reduction of section 1.2.3.1 on physical hazards to avoid redundancy with section 2.0.4.
- Revision of section 1.7 and removal of unnecessary information. Table on additional information using transport classification moved to a new Annex VII.

(iii) Revision of the following sections of Part 2:
- 2.1 (Explosives): replacement of new figure 2.1.3; update of label elements; addition new note 2 to table 2.1.2 on requirement for SDSs.
- 2.3 (Aerosols): update of text on classification criteria; update of decision logic 2.3.1-a; update of section 2.3.6 on the relation to transport classification.
- 2.14 (Oxidising solids): addition of criteria using test 0.3; update of labelling elements.

(iv) Minor changes to the following sections in Part 2:
-  2.8 (Self-reactive): update of label elements.
-  2.12 (Emitting flammable gases): update of label elements.
-  2.15 (Organic peroxides): update of decision logic.2.15.1; update of label elements.

(v) Revision of following sections in Part 3:
-  3.1 (Acute toxicity): Reference to new in-vitro test. Indication that harmonised ATE values will be included in Annex VI to CLP. Deletion of reference to the concept of relating the conditions of an acute inhalation test to real life. Indication that not-classified components may influence ATE and, in general, clarification about components to be considered for mixture classification according to the case. Indication to avoid under classification for oral toxicity. Additon of a new example (13) on the application of additivity methods for mixtures with components in different physical forms.
-  3.2 (Skin corrosion): Subsection on non-testing methods updated and clarified the need to assess the relevance. Update of classification criteria. Inclusion of new figure illustrating the tiered evaluation approach.
Inclusion of a new figure illustrating the relative weight of different available pieces of information to be considered when weight of Evidence (WoE) is applied.
Replacement of the decision logic chart with separate decision logics for substances and mixtures, based on the chart from GHS. Clarification about classification of mixture as Category 1 without subcategory.
-  3.3 (Serious eye damage/irritation): Clarification of the need for further data when considerations about alkaline/acid reserve suggest no risk added.
Interpretation of non-testing methods results enhanced. Mentioned the use of LVET data. Inclusion of new figure illustrating the tiered evaluation approach. Inclusion of reference to new figure on hierarchy of information added in section 3.2. Replacement of the decision logic chart with separate decision logics for substances and mixtures, based on the chart from GHS.
-  3.4 (Respiratory or skin sensitisation): Deletion of the relationship between skin and respiratory sensitisation potential. Identification of non-human data brought in line with REACH guidance. Introduction of available nontesting systems. Clarification of the test sample to be used in human diagnostic patch testing.
-  3.5 (Germ cell mutagenicity): Reference to OECD TG 488 added. New section on classification of substances containing CMR constituents, additives or impurities included.

(iv) Minor changes to the following sections in Part 3:
- 3.6 (Carcinogenicity): Removal of reference to supporting evidence for classification under DSD.
Update of label elements. New section included on classification of substances containing CMR constituents, additives or impurities.
- 3.7 (Reproductive toxicity): New section included on classification of substances containing CMR constituents, additives or impurities.
- 3.8 (STOT-SE): Editorial corrections to the examples.

(vi) Minor changes to Part 4 to update the terminology when referring to short-term (acute) and long-term (chronic) studies.

Edizione EN
Ed. 5.0 Luglio 2017
Fonte: ECHA

Riferimenti normativi:

Regolamento (CE) n. 1272/2008 CLP

DescrizioneLinguaDimensioneDownloads
Scarica questo file (Guidance on the Application of the CLP Criteria.pdf)Guidance on the Application of the CLP Criteria Ed 5.0
Regolamento CLP
EN13658 kB1193

Tags: Chemicals Regolamento CLP

Articoli correlati

Ultimi archiviati Chemicals

Decreto 20 giugno 2022
Lug 04, 2022 29

Decreto 20 giugno 2022 | Suppl. 10.8 Farmacopea europea 10ª ed.

Decreto 20 giugno 2022 | Suppl. 10.8 Farmacopea europea 10ª ed. Entrata in vigore dei testi, nelle lingue inglese e francese, pubblicati nel supplemento 10.8 della Farmacopea europea 10ª edizione. (GU n.154 del 04.07.2022) Art. 1. 1. I testi nelle lingue inglese e francese dei capitoli generali e… Leggi tutto
Recast Drinking Water Directive
Lug 01, 2022 81

Recast Drinking Water Directive, state of play

Recast Drinking Water Directive, state of play EU JRC - June 2022 Guidance note for the analysis of microbiological parameters The quality of drinking water in the European Union is verified by measuring parameters established in the recast of the Drinking Water Directive (DWD) 2020/2184. Compared… Leggi tutto
Giu 24, 2022 67

Regolamento (UE) 2021/2142

Regolamento (UE) 2021/2142 Regolamento (UE) 2021/2142 della Commissione del 3 dicembre 2021 che modifica il regolamento (CE) n. 1881/2006 per quanto riguarda i tenori massimi di alcaloidi oppiacei in alcuni prodotti alimentari. (GU L 433 del 6.12.2021) Collegati[box-note]Regolamento (CE) n.… Leggi tutto
Faster action on groups of harmful chemicals
Giu 17, 2022 101

ECHA - Integrated Regulatory Strategy (IRS) Annual Report 2021

ECHA - Integrated Regulatory Strategy (IRS) Annual Report 2021 Faster action on groups of harmful chemicals - Integrated Regulatory Strategy Annual Report June 2022 Helsinki, 17 giugno 2022 È stato pubblicato il quarto rapporto dell'ECHA nell'ambito della sua strategia di regolamentazione… Leggi tutto
Mag 31, 2022 119

Decreto 11 ottobre 2001

Decreto 11 ottobre 2001 Condizioni per l'utilizzo dei trasformatori contenenti PCB in attesa della decontaminazione o dello smaltimento. (GU n.255 del 02.11.2001) Collegati
D.P.R. 24 maggio 1988, n. 216Decreto Legislativo 22 maggio 1999 n. 209
Leggi tutto
Mag 31, 2022 139

D.P.R. 24 maggio 1988, n. 216

D.P.R. 24 maggio 1988, n. 216 Attuazione della direttiva CEE n. 85/467 recante sesta modifica (PCB/PCT) della direttiva CEE n. 76/769 concernente il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative degli Stati membri relative alle restrizioni in materia di immissione… Leggi tutto

Più letti Chemicals

Regolamento  CE  n  178 2002
Mar 17, 2022 65217

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