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 220.127.116.11 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.
Ed. 5.0 Luglio 2017