Embed Size (px)
Citation preview
THE CLP REGULATION and its relation with the Seveso IIIDirectiveIndustrial Safety
Regulation 1272/2008 of 16 December 2008 on classification, labelling andpackaging of substances and mixtures, hereinafter products, sets out toensure a high level of protection of human health and the environment.This Classification, Labelling and Packaging Regulation, usually shortened toCLP, lays down the properties and rules for classification of products ashazardous, to ensure they can then be properly identified by users.
One of the knock‐on effects of its implementation has been adaptation ofSeveso legislation to the Regulation’s provisions. The end result has beenthe replacement of Directive 96/82/EC of 9 December 1996 (Seveso II) byDirective 2012/18/EU of 4 July 2012 (Seveso III), which adopts productsspecifically denominated by the CLP Regulation as well as some of itsclassifications of major‐accident hazards involving dangerous substances.This article, the first of a series on the Seveso III legislation, looks at themost important aspects of the CLP Regulation and its relation to the aforesaid Seveso legislation.
By E. GONZÁLEFERRADAS. Doctor in Chemistry. Professor of Murcia University. Department of Chemical Engineering. School ofChemistry. Campus de Espinardo. Universidad de Murcia ([email protected])). E. GONZÁLEDUPERÓN. Doctor in Chemistry. Professor ofMurcia University. MARÍA ISABEL RECHE MOTOS. Chemical engineer. Research fellow. J. RUIGIMENO. Chemist. Professor of MurciaUniversity.
Background
The environmental‐ protection issues addressed by the UN Conference on the Environment and Development held in Río deJaneiro (Brazil) from 3 to 14 June 1992 included in particular the protection of human beings from the potential harmfulimpacts of chemical products, on the following principles:
Many chemical products (substances, mixtures or articles containing them) are hazardous to human health and theenvironment.
These products are very frequently used by the public at large on a widespread basis, thereby exposing them to theirhazards.
National legislation is bound to ensure the safest possible use, transport and disposal of these products. It has beenfound, however, that the available information on their hazardousness is patchy and even wrong in many countries.
The Conference therefore recognised the need to take a harmonised worldwide approach to the problem, includingprevention, the giving of proper information and management of the risks deriving from these hazardous products. Itproposed a six‐point programme. The second dealt with the Globally Harmonized System of Classification and Labelling ofChemicals, shortened to the acronym GHS. To drive and develop the GHS a committee of experts was set up comprisingmembers of the International Labour Organisation (ILO), The Organisation for Economic Cooperation and Development(OECD) and the UN Sub‐Committee of Experts on the Transport of Dangerous Goods (UNSCETDG). The programme wascompleted by the end of 2002 and the first edition of the GHS was brought out in early 2003.
European organisations responsible for these matters worked directly and closely with the abovementioned UN work group,though not on an official basis. In this group worked many of the experts involved in implementation of the Europeandirectives 67/548/EEC of 27 June (1), 91/155/EEC of 5 March (2) and 1999/45/EEC, of 31 May (3), the whole set of whichushered Europe into the tasks of classification, labelling and packaging of hazardous substances and mixtures. Thisspadework then served as the basis for drawing up the GHS programme.
Year 35 nº137 First Quarter 2015
The CLP Regulation, which hasadapted the Seveso legislation,came into force on 20 January
2009 and its definitiveenforcement in EU countries will
occur on 1 June 2015
After publication of the first GHS version in 2003 the European Commission conducted a study to assess the impact of saidproposal on the whole set of European legislation likely to be affected, given the ongoing, across‐the‐board concern sincethe publication of this draft to integrate it into Community legislation.
So it was that, in 2006, two years before the passing of the CLP Regulation (4), it was agreed to set up a Technical WorkingGroup to assess the likely impact of this Regulation in the context of Seveso legislation (5). The first official meeting of theGroup, comprising two subgroups of specialists, one studying physical hazards and the other focusing on health hazards,established as a basic principle the harmonisation of the Regulation’s provisions with the upcoming Seveso Directive III (6),on the following criteria:
1. Not to reduce the level of protection afforded by Seveso Directive II (7), avoiding as far as possible any significantchanges in the thresholds of relevant substances already included in the scope thereof.
2. Try as far as possible, within the global context of the new Directive (Seveso III), to avoid any unnecessary andsignificant extension of the scope of Seveso II Directive as a consequence of the CLP alignment, in order to avoidincreasing the burden on industry and administration, unless it would otherwise significantly increase the hazard.
To this end, said meeting set itself the following remit:
Collect information and provide specific and detailed guidance for competent authorities on the impact of the newCLP on the classification system of Seveso Directive II.
Identify appropriate CLP categories considering the hazardousness of dangerous substances and mixtures correspondingto the 10 categories in Annex I Part 2 of Seveso II. For those categories not fully matching the categories in Annex IPart 2:
Develop options considering the hazardousness of substances and bearing in mind the aim of a clear, simplesystem, keeping the CLP categories as far as possible intact.
Estimate the likely impact of these options (substances concerned, number of establishments possibly covered).
After several meetings the Group published on 27 June 2007 a Draft Regulation on the classification, labelling andpackaging of substances and mixtures and finally, on 31 December 2008 published in the Official Journal of the EuropeanUnion L353 the definitive CLP Regulation, which then came into force on 20 January 2009. Its technical content tallies veryclosely with the GHS project, although administrative aspects were brought into line with current European legislation onthis matter.
One of the first steps was to determine which properties of substances and mixtures should lead to a classification ashazardous, following the same criteria as the GHS, breaking down the hazards into three groups: physical hazards, hazardsto human health and hazards to the environment, then tagging on a fourth category of «hazards to the ozone layer».
It should be pointed out here that this Regulation does not apply to products governed by their own regulations, such ascosmetics, medicinal products, health products and veterinary products, foodstuffs and food additives, mainly.
Responsibility for the identification of hazards of substances and mixtures andfor deciding on their classification falls on manufacturers, importers anddownstream users of those substances or mixtures. These responsible parties arebound to ensure that they themselves and the chain of users are all in possessionof the proper information on the hazards of the products they make, market oruse. The safety data sheets, therefore, drawn up initially under Regulation1907/2006 of 18 December 2006 (the so‐called REACH Regulation) (8), contain themost comprehensive information possible and serve as one of the starting points
for drawing up safety studies under Seveso legislation.
Like the GHS project, the CLP Regulation is an open document that calls for frequent updating. Amendments to date areshown in Table 1, but the growing number of products being synthesised and used, together with the diversity ofclassification and categorisation tests thereon (some of which tests are very time‐consuming) mean that the productscurrently recorded in the European Chemical Agency (ECHA), serving as the bedrock Regulation data, represent only a verysmall percentage of total known products. For example persistent, bioaccumulative, and toxic (PBT) substances andmixtures, as well as the very persistent and very bioaccumulative products (vPvB), and even some of those specificallydenominated in Seveso III legislation are not yet recorded in this Regulation, such as ammonium nitrates or potassiumnitrates, sulphur trioxide, polydibenzofurans and polybenzoxazines, among others.
Table 1. CLP Regulation amendments up to August 2014.
OJEU Regulation Amended articles and annexes of the CLP Regulation
L‐2009‐81638 790/2009, of 10 August (9) Annex VI
L‐2011‐80561 286/2011, of 10 March (10) Articles 25 and 26, Annexes I to VII
L‐2012‐81245 618/2012, of 10 July (11) Annex VI
L‐2013‐81105 487/2013, of 8 May (12) Articles 14 and 23, Annexes I to VII
L‐2013‐81639 758/2013, of 7 August (13) Annex VI
L‐2013‐82005 944/2013, of 2 October (14) Annexes IV and VI
L‐2014‐81235 605/2014, of 5 June (15) Annexes III, IV and VI
Definitive implementation of the CLP Regulation in EU member countries will take place on 1 June 2015, overriding by thatdate the aforementioned Directives 67/548/EEC of 27 June (on the classification, packaging and labelling of substances and1999/45/EC of 31 May (on mixtures). During the transition period up to that date, substances and mixtures can be classifiedeither by the criteria of the former directives or with the new CLP Regulation.
Technical Aspects of the CLP Regulation
The Regulation is a very wide‐ranging document. We therefore summarise below the various component parts, stressingthose that bear the most direct relationship with the Seveso III legislation.
The preamble sets out 79 prior considerations vouching for the need of passing this Regulation, summing up andcommenting on its most important contents.
There follow 62 Articles grouped under six titles, setting out to classify and categorise hazardous substances andmixtures, the information to be given on the labels and the basic packaging conditions. It also lays down the bindingduty for member states to designate the competent authorities to manage these matters and ensure compliancetherewith.
It contains seven annexes:
Annex I lays down the classification and labelling requirements for hazardous substances and mixtures; this is the part ofgreatest interest for our purposes here. It has five parts. Part 1 sets out the general principles for classification andlabelling of hazardous substances. Parts 2, 3 and 4 describe, respectively, the various physical hazards, hazards to humanhealth and hazards to the environment. Part 5 includes an additional ozone layer hazard class; this is exclusive to thisRegulation. This annex is described later in greater detail.
Annex II sets out special EU rules for labelling and packaging of certain substances and mixtures; it is divided into fiveparts. Part 1 defines new EUH phrases for physical hazards and hazards to human health. Part 2 defines EUH phrasesapplicable to mixtures containing certain products (paints and varnishes containing lead, adhesives based on cyanoacrylate,cement containing chromium VI, isocyanates, mixtures containing epoxy constituents, compounds containing activechlorine, brazing or soldering electrodes containing cadmium, mixtures containing at least one substance classified assensitising, halogenated hydrocarbons, mixtures not intended for the general public and aerosols). Part 3 lays down specialrules on packaging for child‐resistant and safety fastenings and tactile warnings to be fitted on the containers of sometypes of especially toxic substances. Part 4 deals with special rules for labelling of plant protection products (defining aEUH phrase for these products). Part 5 is an open list of hazardous substances and mixtures to which Regulation article29(3) applies, currently including only «Ready mixed cement and concrete in the wet state». The EUH phrases are includedin Table 2.
Table 2. Supplementary information on EU hazards
Physical properties
EUH001 Explosive when dry
EUH006 Explosive with or without contact with air
EUH014 Reacts violently with water
EUH018 In use, may form flammable/explosive vapour‐air mixture
EUH019 May form explosive peroxides
EUH044 Risk of explosion if heated under confinement
Health properties
EUH029 Contact with water liberates toxic gas
EUH031 Contact with acids liberates toxic gas
EUH032 Contact with acids liberates very toxic gas
EUH066 Repeated exposure may cause skin dryness or cracking
EUH070 Toxic by eye contact
EUH071 Corrosive to the respiratory tract
Environmental properties
EUH059 Hazardous to the ozone layer
Special Rules for Supplemental Label Elements for Certain Mixtures
EUH201/201A
Contains lead. Should not be used on surfaces liable to be chewed or sucked by childrenWarning! Contains lead
EUH 202 Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children
EUH 203 Contains chromium (VI). May produce an allergic reaction (in cement)
EUH 204 Contains isocyanates. May produce an allergic reaction
EUH 205 Contains epoxy constituents. May produce an allergic reaction
EUH 206 Warning! Do not use together with other products. May release dangerous gases (chlorine)
EUH 207 Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by themanufacturer. Comply with the safety instructions (alloys used in brazing and soldering)
EUH 208 Contains (name of sensitising substance). May produce an allergic reaction
EUH209/209A
Can become highly flammable in useCan become flammable in use
EUH 210 Safety data sheet available on request
EUH 401 To avoid risks to human health and the environment, comply with the instructions for use
Annex III contains the hazard indications together with supplementary elements that have to feature on labels and Annex Vthe hazard pictograms.
Tables 3, 4 and 5, below, show the following information for physical hazards, hazards to health and hazards to theenvironment:
The denomination of the hazard statement and their definition.
The hazard classes and categories.
The associated pictograms.
Table 3. Indications of physical hazards and pictograms of the CLP Regulation. The classes and categories considered inSeveso III are in capital letters.
HAZARDSTATEMENT
DEFINITION OF THE STATEMENT HAZARD CLASS AND CATEGORY PICTOGRAM
H200 UNSTABLE EXPLOSIVE EXPLOSIVES. UNSTABLE EXPLOSIVE
GHS 01 H201 EXPLOSIVE; MASS EXPLOSION HAZARD EXPLOSIVES. DIVISION 1.1
H202 EXPLOSIVE, SEVERE PROJECTION HAZARD EXPLOSIVES. DIVISION 1.2
H203 EXPLOSIVE; FIRE, BLAST OR PROJECTIONHAZARD
EXPLOSIVES. DIVISION 1.3
H204 FIRE OR PROJECTION HAZARD EXPLOSIVES. DIVISION 1.4
MAY MASS EXPLODE IN FIRE EXPLOSIVES. DIVISION 1.5 WITHOUTPICTOGRAM
NO HAZARD STATEMENT EXPLOSIVES. DIVISION 1.6 WITHOUTPICTOGRAM
H220 EXTREMELY FLAMMABLE GAS. FLAMMABLE GAS. CATEGORY 1 GHS 02
H221 FLAMMABLE GAS. FLAMMABLE GAS. CATEGORY 2 WITHOUTPICTOGRAM
H222 EXTREMELY FLAMMABLE AEROSOL FLAMMABLE AEROSOL. CATEGORY 1
GHS 02
H223 FLAMMABLE AEROSOL. FLAMMABLE AEROSOL. CATEGORY 2
H224 EXTREMELY FLAMMABLE LIQUID AND VAPOUR FLAMMABLE LIQUID. CATEGORY 1
H225 HIGHLY FLAMMABLE LIQUID AND VAPOUR FLAMMABLE LIQUID. CATEGORY 2
H226 FLAMMABLE LIQUID AND VAPOUR FLAMMABLE LIQUID. CATEGORY 3
H228 Flammable solid Flammable solid. Categories 1 &2
H240 HEATING MAY CAUSE AN EXPLOSION SELF‐REACTIVE SUBSTANCES OR MIXTURES. TYPEA
GHS 01
ORGANIC PEROXIDES. TYPE A
H241 HEATING MAY CAUSE A FIRE OR EXPLOSION SELF‐REACTIVE SUBSTANCES OR MIXTURES. TYPEB
GHS 01
GHS 02
ORGANIC PEROXIDES. TYPE B
H242 HEATING MAY CAUSE A FIRE. SELF‐REACTIVE SUBSTANCES OR MIXTURES.TYPES C&D TYPES E&F
GHS 02
ORGANIC PEROXIDES. TYPES C&D AND TYPES E&F
Self‐reactive substances or mixtures. Type G WITHOUTPICTOGRAM
Organic peroxides. Type G WITHOUTPICTOGRAM
H250 CATCHES FIRE SPONTANEOUSLY IF EXPOSEDTO AIR.
PYROPHORIC LIQUIDS, CATEGORY 1
GHS 02 PYROPHORIC LIQUIDS, CATEGORY 2
H251 Self‐heating: may catch fire. Self‐heating mixtures and substances. Category1
H252 Self‐heating in large quantities; may catchfire
Self‐heating mixtures and substances. Category2
H260 IN CONTACT WITH WATER RELEASESFLAMMABLE GASES WHICH MAY IGNITESPONTANEOUSLY
SUBSTANCES OR MIXTURES THAT RELEASEFLAMMABLE GASES IN CONTACT WITH WATER.CATEGORY 1
GHS 02
H261 In contact with water releases flammablegases
Substances or mixtures that release flammablegases in contact with water. Category 1
H270 MAY CAUSE OR INTENSIFY FIRE; OXIDISER OXIDISING GASES. CATEGORY 1
GHS 03 H271 MAY CAUSE FIRE OR EXPLOSION; STRONG
OXIDISEROXIDISING LIQUIDS. CATEGORY 1
OXIDISING SOLIDS. CATEGORY 1
H272 MAY INTENSIFY FIRE; OXIDISER OXIDISING LIQUIDS. CATEGORY 2&3
OXIDISING SOLIDS. CATEGORY 2&3
H280 Contains gas under pressure; may explode ifheated
Gases under pressure, compressed gas, liquidgas or dissolved gas GHS 04
H281 Contains refrigerated gas; may causecryogenic burns or injury
Gases under pressure, refrigerated liquid gas
H290 May be corrosive to metals Corrosive to metals GHS 05
Table 4. Indications of hazards to human health and pictograms of the CLP Regulation. The classes and categoriesconsidered in Seveso III are in capital letters.
HAZARDSTATEMENT
DEFINITION OF THE STATEMENT HAZARD CLASS AND CATEGORY PICTOGRAM
H300 FATAL IF SWALLOWED ACUTE TOXICITY. CATEGORIES 1&2 GHS 06
H301 Toxic if swallowed Acute toxicity. Category 3
H302 Harmful if swallowed Acute toxicity. Category 4 GHS 07
H304 May cause genetic defects Aspiration hazard. Category 1 GHS 08
H310 FATAL IN CONTACT WITH SKIN ACUTE TOXICITY. CATEGORIES 1&2 GHS 06
H311 Toxic in contact with skin Acute toxicity. Category 3
H312 Harmful in contact with skin Acute toxicity. Category 4 GHS 07
H314 Causes severe skin burns and eye damage Skin irritation or corrosion. Categories 1A, 1B,1C
GHS 05
H315 Causes skin irritation Skin irritation or corrosion. Categories 2A, 2B,2C
GHS 07
H317 May cause an allergic skin reaction Respiratory or skin sensitisation. Category 1
H318 Causes serious eye damage Serious eye damage or irritation. Category 1 GHS 05
H319 Causes serious eye irritation Serious eye damage or irritation. Category 2 GHS 07
H330 FATAL IF INHALED ACUTE TOXICITY. CATEGORIES 1&2 GHS 06
H331 TOXIC IF INHALED ACUTE TOXICITY. CATEGORY 3
H332 Harmful if inhaled Acute toxicity. Category 4 GHS 07
H334 May cause allergy or asthma symptoms orbreathing difficulties if inhaled
Respiratory or skin sensitisation. Category 1 GHS 08
H335 May cause respiratory irritation Specific target organ toxicity after singleexposure. Category 3 GHS 07
H336 May cause drowsiness or dizziness Specific target organ toxicity after singleexposure. Category 3
H340 May cause genetic defects (1) Germ cell mutagenicity. Categories 1A & 1B GHS 08
H341 Suspected of causing genetic defects (1) Germ cell mutagenicity. Category 2
H350 May cause cancer Carcinogenicity. Categories 1A or 1BGHS 08
H350i May cause cancer by inhalation Carcinogenicity. Category 1B
H351 Suspected of causing cancer (1) Carcinogenicity. Category 2
H360 May damage fertility or the unborn child (1) Reproductive toxicity. Categories 1A or 1B
GHS 08 H360F May damage fertility Reproductive toxicity. Categories 1A or 1B
H360D May damage the unborn child Reproductive toxicity. Categories 1A or 1B
H360FD May damage fertility. May damage the unbornchild.
Reproductive toxicity. Categories 1A or 1B
H360Fd May damage fertility. Suspected of damagingthe unborn child.
Reproductive toxicity. Categories 1A or 1B
GHS 08
H360Df May damage the unborn child. Suspected ofdamaging fertility
Reproductive toxicity. Categories 1A or 1B
H361 Suspected of damaging fertility or the unbornchild (1) (2)
Reproductive toxicity. Category 2
H361f Suspected of damaging fertility Reproductive toxicity. Category 2
H361d Suspected of damaging the unborn child Reproductive toxicity. Category 2
H361fd Suspected of damaging fertility. Suspected of Reproductive toxicity. Category 2
(1) State route of exposure if it is conclusively proven that no other routes of exposure cause the hazard. (2) State specificeffect if known. (3) State all organs affected, if known.
damaging the unborn child
H362 May cause harm to breast‐fed children Reproductive toxicity. Lact. NOPICTOGRAM
H370 CAUSES DAMAGE TO ORGANS (1) (3) SPECIFIC TARGET ORGAN TOXICITY AFTERSINGLE EXPOSURE. CATEGORY 1
GHS 08 H371 Causes damage to organs (1) (3) Specific target organ toxicity after single
exposure. Category 2
H372 Causes damage to organs (3) throughprolonged or repeated exposure (1)
Specific target organ toxicity after singleexposure. Category 2
H373 May cause damage to organs (3) throughprolonged or repeated exposure(1)
Specific target organ toxicity after singleexposure. Category 2
Table 5.Indications of hazards to the environment in the CLP Regulation. The classes and categories considered inSeveso III are in capital letters.
HAZARDSTATEMENT
DEFINITION OF THE STATEMENT HAZARD CLASS AND CATEGORY PICTOGRAM
H400 VERY TOXIC TO AQUATIC LIFE VERY TOXIC TO AQUATIC LIFE. ACUTECATEGORY 1
GHS 09 H410 VERY TOXIC TO AQUATIC LIFE WITH LONG
LASTING EFFECTSVERY TOXIC TO AQUATIC LIFE. CHRONICCATEGORY 1
H411 TOXIC TO AQUATIC LIFE WITH LONG LASTINGEFFECTS
VERY TOXIC TO AQUATIC LIFE. CHRONICCATEGORY 2
H412 Harmful to aquatic life with long lastingeffects
Very toxic to aquatic life. chroniccategory 3
NOPICTOGRAM
H413 May cause long lasting harmful effects toaquatic life
Very toxic to aquatic life. chroniccategory 4
NOPICTOGRAM
Annex IV , divided in two parts, sets out the list of precautionary statements. Part 1 has five tables, corresponding to the P(Precautionary) statements of the following types of advice: 1) general precautionary statements; 2) preventionprecautionary statements (recommending what should and should not be done when handling the hazardous product); 3)response precautionary statements (the recommended measures if anyone should come to any harm or actions to take inthe event of any accidents caused by the product); 4) storage precautionary statements (appropriate storage sites,conditions of temperature, humidity, solar radiation, ventilation…), and (5) disposal precautionary statements. Part 2defines the P statements in all the official EU languages; it therefore inputs no additional information.
Annex VI sets out the harmonised classification and labelling for certain hazardous substances and mixtures. It is brokendown into three parts and is the longest section of all, containing as it does the list of the hazardous products of theRegulation.
Part 1 of this annex defines the various headings of the tables 3.1 and 3.2 of Part 3 of this annex. For table 3.1, whichcontains the products selected in this Regulation, it defines mainly the following concepts:
The index numbers, i.e. the EC numbers and CAS numbers.
The International Chemical Identification, using the IUPAC of each substance wherever possible.
For classification purposes: the category codes, hazard classes and hazard statements (H statements).
For labelling purposes: the hazard pictogram codes, signal words and hazard statements (H statements) and thesupplemental statements (EUH statements).
The specific concentration limits and M‐factors for the mixtures.
The clarifying notes assigned to an entry.
For table 3.2 (containing the substances listed in Directive 67/548/EEC), it defines:
The classification codes (R statements) and labelling codes according to said Directive.
The Specific Concentration Limits
There follow two tables (6 and 7) to help explain all the above.
Table 6. Example of the classification and labelling of a substance included in table 3.1 of Annex VI of the CLP Regulation. Theaim of this table is to show the presentation and information of each product in said table.
IndexNumber
InternationalChemical
Identification
ECNumber
CASNumber
Classification Labelling Specificconcentrationlimits and M‐
factors
Categorycodes,hazardclasses
Hazardstatements
Hazardpictogram
codes,signalwords
Hazardstatements
Supplementalstatements
603‐057‐00‐
5
benzylalcohol
202‐859‐9
100‐51‐6
AcuteTox. 4
H332 GHS07 H332
AcuteTox. 4
H302 Wng H302
Table 7. Example of the classification and labelling of a substance included in table 3.2 of Annex VI of the CLPRegulation. The aim of this table is to show the presentation and information of each product in said table.
IndexNumber
International ChemicalIdentification
ECNumber
CASNumber
Classification Labelling Concentrationlimits
Notes
C: Some organic substances might be marketed in a specific isomeric form or as a mixture of several isomers. In this casethe provider has to indicate on the label whether the substance is a single isomer or a mixture.
607‐031‐00‐4
butyl butyrate 203‐656‐8 109‐21‐7 R10 R: 10 S: (2‐)
C
Part 2 of Annex VI deals with the dossiers for harmonised classification and labelling. As mentioned beforehand, theresponsibility for classifying hazardous products falls on manufacturers and importers and they have to be registered by theEuropean Chemicals Agency (ECHA). Each registration application has to be accompanied by a dossier vouching for saidclassification; this must be drawn up in due accordance with the instructions given in Annex I of Regulation 1907/2006 of 18December 2006 (REACH Regulation).
Part 3 includes the aforementioned tables 3.1 and 3.2.
Finally, Annex VII contains the translation tables showing the correspondence between classification under Directive67/548/EEC and under the CLP Regulation. Specifically, table 1.1 interrelates the Directive’s hazard classes and Rstatements with the Regulation’s hazard class‐and‐category and H statements, while table 1.2 interrelates the Directive’srisk phrases with the Regulation’s EUH statements (supplementary labelling requirements).
Annex I of the CLP Regulation: classification and labelling requirements for hazardous substances andmixturesWe restrict our comments on this annex to those aspects bearing a relation to Seveso Directive III. No consideration istherefore given here to the packaging and labelling factors.
This annex has five parts. Part 1 lays down the general principles (testing and information) used for determining thecategories and hazard classes of the substances, while the four remaining parts describe said classes and categories,subdivided into physical hazards (Part 2), health hazards (Part 3), environmental hazards (Part 4) and hazardous to theozone layer (Part 5).
PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND LABELLING
This has six sections. The first contains the definitions of the states of the matter (gases, liquids and solids) in terms ofvapour pressure or melting point.
The second describes the principles used for classifying product hazardousness. It calls for cooperation betweenmanufacturers and suppliers of the same hazardous product to facilitate compliance with classification requirements. Italso puts forward the possibility of using expert judgment to determine the weight of evidence, which must come fromtrustworthy tests or sources.
To classify hazardous mixtures this section lays down specific concentration limits, M‐factors and generic cut‐off values.These factors, which may pose some practical difficulties, are crucial for deciding on the hazards of said mixtures andthereby the types and seriousness of the accidents they may cause; this is fundamental for the risk analyses that have to becarried out in chemical plants.
The four last sections deal with labelling and packaging issues, which fall beyond our remit here, bearing no relationship tothe Seveso legislation.
The CLP Regulation is a verywide‐ranging document
comprising 79 priorconsiderations, 62 Articles
grouped under six titles andseven annexes
PARTS 2 TO 5: CLASSIFICATION OF THE VARIOUS HAZARDS OF SUBSTANCES ANDMIXTURES
Tables 8 to 10 show the categories of physical hazards, health hazards andenvironmental hazards of the CLP Regulation. It is worthwhile commentingbeforehand on the following common aspects:
The first columns shows the hazard classes considered: 16 for physical hazards (Part 2), 10 for health hazards (Part 3)and 2 for environmental hazards (Part 4).
Some category definitions (column 3) describe the substances’ behaviour in certain tests; these descriptions are oftenlong‐winded and at times complex so they have been left out of the tables, but a reference is given to the sections ofthe original document where they are defined. In some cases the original definitions have been simplified for inclusionin the tables herein.
The fourth column gives the hazard statements (H). Each one of them might be associated with several classes orcategories. A rough idea is given (in brackets) of the number of substances or mixtures associated with the hazardstatement in question on the basis of CLP Regulation data. This information comes in useful for finding out the numberof CLP Regulation database substances posing the hazard in question, especially for subsequent analysis thereof in thecontext of Seveso III.
The last column shows some representative substances for the classes and categories considered in the CLP Regulation,selecting the most widely used ones. Some Regulation database classes or categories have no assigned substance, orthey are not quoted herein because they are not in habitual use or because they have very complex chemicalstructures, inputting no important information vis‐à‐vis Seveso Directive III.
Some comments by the authors of this article, trying to clear up or debate issues of interest, are added in red (C).
Part 2: PHYSICAL HAZARDS
Table 8. Classes and categories of physical hazards of substances and mixtures of the CLP Regulation.
Class and Definition Category Definition of the category Hazardstatement
Representativesubstances
2.1 EXPLOSIVESA solid or liquid substance or mixtureof substances which is in itselfcapable by chemical reaction ofproducing gas at such a temperatureand pressure at such a speed as tocause damage to the surroundings
Unstable Substance or mixture which isthermally unstable or toosensitive for normal handling,transport and use.
H200 (12) Ethyl nitrate. Mercury(II)Fulminate. Lead diazide.Dichloroacetylene.Hydroxylamine.
Division 1.1 Substances, mixtures andarticles posing a massexplosion hazard C. Theseare the most characteristicexplosives
H201 (28) Ammonium perchlorate.Glyceryl Trinitrate.Cellulose Nitrate.Trinitrotoluene.Trinitrophenol.
Division 1.2 Substances, mixtures andarticles posing a projectionhazard without a massexplosion hazard
H202 (0) Without substances.
Division 1.3 Substances, mixtures andarticles posing a fire, blast orprojection hazard
H203 (2) Complex substances nothabitually used
Division 1.4 Substances, mixtures andarticles which present only asmall hazard in the event ofignition or initiation
H204 (0) Without substances.
Division 1.5 Very insensitive substances ormixtures which have a massexplosion hazard
H205 (0) Without substances.
Division 1.6 Extremely insensitive articleswhich do not have a massexplosion hazard
No hazardstatement
(0)
Without substances.
2.2 FLAMMABLE GASESGases that are flammable at 20oCand a standard pressure of 101.3kPa:
1 (a) are ignitable when in amixture of 13 % or less byvolume in air; or (b) have aflammable range with air ofat least 12 percentage points
H220(178)
Hydrogen. Methane.Ethane. Propane.Butane. Ethylene.Acetylene.Chloromethane.
regardless of the lowerflammable limit.
Dimethyl ether. Ethyleneoxide. Ethylamine
2 Gases, other than those ofCategory 1, which have aflammable range while mixedin air.
H221 (1) Ammonia.
2.3. FLAMMABLE AEROSOLSReceptacles containing a gascompressed, liquefied or dissolvedunder pressure, with or without aliquid, paste or powder, and fittedwith a release device allowing thecontents to be ejected as solid orliquid particles in suspension in agas, as a foam, paste or powder or ina liquid state or in a gaseous state
1 Classification depends on itscomponents, its chemicalheat of combustion and theresults of certain tests (Seesection 2.3.2.2 and figures2.3.1 a, b and c of Annex I ofthe CLP Regulation)
H222 (0) Sin sustancias.
2 H223 (0) Without substances.
2.4 OXIDISING GASESDefined in category
1 Any gas or gas mixture whichmay, generally by providingoxygen, cause or contributeto the combustion of othermaterial more than air doesC. It would be best for thedefinition to indicate theoxidising character in eachcase, regardless of therelease and presence ofoxygen
H270 (5) Chlorine dioxide.Fluoride. Chloride.
2.5 GASES UNDER PRESSURE Gases which are contained in areceptacle at a pressure of 200 kPa(gauge) or more, or which areliquefied or liquefied andrefrigerated
Compressedgas
With a critical temperature <‐ 50 oC.
H280 (0) Without substances.
Liquified gas (i) high pressure liquefied gas:a gas with a criticaltemperature between ‐ 50 oCand + 65 oC; and (ii) lowpressure liquefied gas: a gaswith a critical temperatureabove + 65 oC.
H280 (0) Sin sustancias.
Refrigeratedliquefied
gas
Normally needs to be kept atlower than room temperature
H281 (0) Sin sustancias.
Dissolved Dissolved in a liquid phasesolvent.
H280 (0) Sin sustancias.
2.6 FLAMMABLE LIQUIDS A liquid with a flash point of notmore than 60 oC.
Initial boiling point
1 Flash point < 23 oC and initialboiling point ≤ 35 oC
H224 (13) Isoprene. Isopentane.Acetaldehyde.Methylamine. Propyleneoxide.
2 Flash point < 23 oC and initialboiling point > 35 oC
H225(125)
Pentane. Hexane.Cyclohexane. Benzene.Dichloroethane.Dichloroethylene.Methanol. Ethanol.Acetone.
3 Flash point ≥ 23 oC and ≤ 60oC
H226(115)
Includes fuel oils andlight oils. Xylenes.Cumene. Styrene.Chlorobenzene. Butanol.Acetic anhydride.
2.7 FLAMMABLE SOLIDS 1 Categorised on the basis of H228 (16) Powder of: Magnesium,
A solid that is readily combustible, ormay cause or exacerbate a firethrough friction
tests. A distinction is madebetween metals and nonmetals. (See section 2.7.2.3.for Annex I of the CLP)
Aluminium, RedPhosphorus,Pentachlorobenzene
2 H228 (6) Trioxymethylene.Hexamethylenetetramine
2.8 SELF‐REACTIVE SUBSTANCESAND MIXTURES Thermally unstable liquid or solidsubstances or mixtures liable toundergo a strongly exothermicdecomposition even withoutparticipation of oxygen (air). Thisdefinition excludes substances andmixtures classified as explosives,organic peroxides or as oxidising.
Type A My detonate or deflagraterapidly as packaged
H240 (2) Hydrazine‐Trinitromethane
Type B Does not detonate ordeflagrate rapidly aspackaged unless heated
H241 (1) Azidosulfonyl BenzoicAcid.
Type C Has properties of explosivesbut does not behave as typesA and B
H242 (8) 2,3‐Epoxy‐1‐Propanol
Type D Defined according to test (seesection 2.8.2.3 of Annex I ofthe CLP Regulation).
H242 (1) Complex mixture not incommon use
Type E Defined according to test (seesection 2.8.2.3 of Annex I ofthe CLP Regulation).
H242 (0) Without substances.
Type F Defined according to test (seesection 2.8.2.3 of Annex I ofthe CLP Regulation).
H242 (0) Without substances.
Type G Defined according to test (seesection 2.8.2.3 of Annex ofthe CLP Regulation)).
Withoutstatement
(0)
Without substances.
2.9 PYROPHORIC LIQUIDS Defined in category
1 Ignites within 5 min whenadded to an inert carrier andexposed to air, or it ignites orchars a filter paper oncontact with air within 5 min.C. Another category shouldbe defined for ignition timesof over 5 minutes.
H250 (8) Liquid trialkylborane.Alkyls of magnesium oraluminium.Trichlorosilane.
2.10 PYROPHORIC SOLIDS Defined in category
1 Liable to ignite within fiveminutes after coming intocontact with air. C. Anothercategory should be definedfor ignition times of over 5minutes.
H250 (9) Solid Trialkylborane.Powder of Magnesium,Aluminium, WhitePhosphorous, Zinc orZirconium
2.11 SELF‐HEATING SUBSTANCESAND MIXTURES Solid substance or mixture, otherthan a pyrophoric liquid or solid,which, by reaction with air is liableto self‐heat when present in in largeamounts (kg) and after long periodsof time
1 Defined according to test (seesection 2.11.2.2 of Annex I ofthe CLP Regulation).
H251 (4) Sodium Hydrosulphite,Sodium Potassium orLithium Ethanolate orMethanolate
2 Defined according to test (seesection 2.11.2.2 of Annex I ofthe CLP Regulation).)
H252 (2) Magnesium powder.
Defined according to test (seesection 2.11.2.2 of Annex I)
H252 (2) Magnesium powder.
2.12 SUBSTANCES AND MIXTURESWHICH IN CONTACT WITH WATEREMIT FLAMMABLE GASES
The category depends on therate of evolution of theflammable gas emitted duringa reference time period
1 If the rate of evolution offlammable gas is equal to orgreater than 10 litres perkilogram of substance overany one minute.
H260 (23) Sodium, Potassium,Sodium, Aluminium,Lithium and CalciumHydrides. CalciumCarbide, MagnesiumPowder, Zinc
The annexes include
2 If the rate of evolution offlammable gas is equal to orgreater than 20 litres perkilogram of substance perhour
H261 (4) Calcium, MagnesiumPowder, Aluminium
3 Maximum rate of evolution offlammable gas is equal to orgreater than 1 litre perkilogram of substance perhour
H261 (0) Without substances.
2.13 OXIDISING LIQUIDS A liquid substance or mixture which,while in itself not necessarilycombustible, may, generally byyielding oxygen, cause, or contributeto, the combustion of other material
1 Defined according to test (seesection 2.13.2.1 of Annex I ofthe CLP Regulation).)
H271 (4) Hydrogen peroxide.Perchloric acid.
2 Defined according to test (seesection 2.13.2.1 of Annex I ofthe CLP Regulation).
H272 (0) Without substances.
3 Defined according to test (seesection 2.13.2.1 of Annex I ofthe CLP Regulation).
H272 (1) Nitric acid.
2.14 OXIDISING SOLIDS A solid substance or mixture which,while in itself is not necessarilycombustible, may, generally byyielding oxygen, cause, or contributeto, the combustion of other material
1 Defined according to test (seesection 2.14.2.1 of Annex I ofthe CLP Regulation).)
H271 (12) Sodium peroxide andBarium, Potassium,Sodium and AmmoniumChlorate andPerchlorate.
2 Defined according to test (seesection 2.14.2.1 of Annex I ofthe CLP Regulation).
H272 (12) Potassium nitrite.Calcium hypochlorite.Sodium, Potassium andAmmonium dichromate.
3 Defined according to test (seesection 2.14.2.1 of Annex I ofthe CLP Regulation).
H272 (3) Sodium, persulphate andAmmonium nitrite.
2.15 ORGANIC PEROXIDES Liquid or solid organic substanceswhich contain the bivalent ‐O‐O‐structure and may be consideredderivatives of hydrogen peroxide,where one or both of the hydrogenatoms have been replaced by organicradicals. Organic peroxides arethermally unstable substances ormixtures that are liable to: (a) Explode;(b) Burn rapidly;(c) React with other substances
Type A Liable to detonate ordeflagrate rapidly aspackaged
H240 (1) Complex mixture not incommon use.
Type B Liable to undergo a thermalexplosion as packaged
H241 (2) Benzoyl peroxide.
Type C Has explosive properties butdoes not behave like types Aor B
H242 (5) Cyclohexanone peroxide.
Type D Defined according to test (seesection 2.15.2.2 of Annex I).
H242 (9) Dilauroyl peroxide.Peracetic acid.
Type E Defined according to test (seesection 2.15.2.2 of Annex I).
H242 (3) Di‐tert‐butyl peroxide.
Type F Defined according to test (seesection 2.15.2.2 of Annex I).
H242 (1) Very infrequentsubstance
Type G Defined according to test (seesection 2.15.2.2 of Annex I).
Withoutstatement
(0)
Without substances.
2.16 CORROSIVE TO METALS A substance or a mixture that bychemical action will materiallydamage, or even destroy, metals
1 Corrosion rate on either steelor aluminium surfacesexceeding 6.25 mm per yearat a test temperature of 55oC when tested on bothmaterials
H290 (2) Hydroxylamine.Hydroxylamine chloride
Part 3: HEALTH HAZARDS
classification and labellingrequirements, community rulesfor the packaging of hazardous
substances, hazard warnings andprecautionary advice, among
other matters
Table 9. Health hazard classes and categories of the substances and mixtures of the CLP Regulation.Class and Definition Category Definition of the category
statement
3.1. ACUTE TOXICITY Substances or mixtureswhose effects becomeevident following oral ordermal administrationof a single dose of asubstance or a mixture,or multiple doses givenwithin 24 hours, or aninhalation exposure of 4hours
1 Oral mg/kg
(1)
Dermalmg/kg(1)
Inhalation (conc. inair)
Derm: H310
Gas ppm
VapourMg/l
DustsandMists
(mg/l)
ATE <5
ATE ≤ 50 ATE≤
100
ATE ≤0.5
ATE ≤0.05
2 5 <ATE ≤ 50
50 < ATE≤ 200
100<
ATE≤
500
0.5 <ATE ≤2.0
0.05 <ATE≤ 0.5
ATE: Acute ToxicityEstimate The preferred testspecies for evaluation ofacute toxicity by theoral and inhalationroutes is the rat. Therat or rabbit ispreferred for evaluationof acute dermaltoxicity. Whenexperimental data foracute toxicity isavailable in severalanimal species,scientific judgementshall be sought.
3 50 <ATE ≤ 300
200 <ATE
≤ 1000
500<
ATE≤
2500
2 <ATE ≤ 10
0.5 <ATE ≤
1 Derm: H311
H331 (193)
4 300 <ATE
≤2000
1000<ATE ≤ 2000
2500<
ATE≤
20,000
10 <ATE ≤ 20
1 <ATE ≤ 5 Derm: H312
H332 (245)
(1) mg of substance/kg of animal weight Acutetoxicity values are expressed as LD50s or 4‐hourLC50s. For more information see Annex I.3.1. of theCLP.
The above representativesubstances have been selectedwith hazard statements H330, 331and 332, given that inhalation isthe likeliest intake vector inindustrial accidents.
3.2. SKINCORROSION/IRRITATIONIrreversible damage tothe skin; namely, visiblenecrosis through theepidermis and into thedermis, following theapplication of a testsubstance for up to 4hours
1.Subdividedinto threecategories:1A, 1B &
1C
Causes skin corrosion.Definitions are made on the basis ofanimal tests taking into account theskin exposure time of the substance
and the observation period to observepossible effects. See table 3.2.1. of
Annex I of the CLP.
H314 (335)
2 Causes skin irritation. See table 3.2.2.of Annex I of the CLP.
H315 (413)
3.3. SERIOUS EYEDAMAGE/EYEIRRITATION Tissue damage in theeye, or serious physicaldecay of vision,following application ofa test substance to theanterior surface of theeye, which is not fullyreversible within 21
1 Causes eye damage. Defined by testing.See table 3.3.1 of Annex I of the CLP
Regulation.
H318 (327)
2 Causes eye irritation.Defined by testing.
See table 3.3.2 of Annex I of the CLPRegulation.
H319 (379)
days of application
3.4. RESPIRATORY ORSKIN SENSITISATION Substances or mixturesthat will lead tohypersensitivity of theairways or skin, wherebythe tissues produce anantibody‐mediatedallergic responsecausing asthma, rhinitisor allergic contactdermatitis
1 Causes respiratory sensitisation Seetable 3.4.1 of Annex I of the CLP
Regulation
1 Causes skin sensitisation See table3.4.2 of Annex I of the CLP Regulation
H317 (706)
3.5. GERM CELLMUTAGENICITY Mutation means apermanent change inthe amount or structureof the genetic materialin a cell. Mutagenicsubstances or mixturesincrease the risk ofmutation
Substances or mixtures of category 1 induce heritable mutations in the germ cells ofhumans and mammals. They are subdivided into 1A and 1B
1A Substances and mixtures that induceheritable mutations in the germ cells of
humans
H340 (178)
1B Substances and mixtures that induce invivo heritable germ cell mutagenicitytests in mammals; or positive results
from tests showing mutagenic effects inthe germ cells of humans, withoutdemonstration of transmission to
progeny. (See table 3.5.1 of Annex I ofthe CLP Regulation)
2 Substances and mixtures that inducemutagenic effects in the germ cells ofhumans. (See table 3.5.1 of Annex I of
the CLP Regulation)
3.6. CARCINOGENICITY A substance or amixture of substanceswhich induces cancer orincreases its incidence
1A Known to have carcinogenic potentialfor humans
H350 (849)
1B Presumed to have carcinogenicpotential for humans, classification is
largely based on animal evidence inhalation
Associated with the letter “I” afterH350: can cause cancer by inhalation
2 Suspected human carcinogens butevidence is not sufficiently convincingto place the substance in Category 1A
or 1B
H351 (138)
3.7 REPRODUCTIVETOXICITY Substances or mixturesthat produce adverseeffects on sexualfunction and fertility inadult males andfemales, as well asdevelopmental toxicityin the offspring
1A Known human reproductive toxicant
1B Presumed human reproductive toxicant
2 Suspected human reproductive toxicant
The letters following the hazard statement stand for the following: D and d: “Maycause” (D) or “suspected of causing” (d) damage to the unborn child: F and f: “May
cause” (F) and “suspected of causing” (f) damage to fertility.
3.8 SPECIFIC TARGETORGAN TOXICITY —SINGLE EXPOSURE Substances or mixturesthat produce a specific,non lethal target organtoxicity arising from asingle exposure. Allsignificant healtheffects that can impairfunction, bothreversible andirreversible, immediateor delayed
1 Substances that have producedsignificant toxicity in humans or that,
on the basis of evidence from studies inexperimental animals, can be presumed
to have the potential to producesignificant toxicity in humans following
single exposure
2 Substances that, on the basis ofevidence from studies in experimentalanimals can be presumed to have the
potential to be harmful to humanhealth following single exposure.
3Transient target organ effects. This
category only includes narcotic effectsand respiratory tract irritation
H335 (252)(respiratory
irritation)
drowsiness
3.9 SPECIFIC TARGETORGAN TOXICITY —REPEATED EXPOSURE Substances or mixturesthat produce a specific,non lethal target organtoxicity arising fromrepeated exposure. Allsignificant healtheffects that can impairfunction, bothreversible andirreversible, immediateor delayed
1 Substances that have producedsignificant toxicity in humans or that,
on the basis of evidence from studies inexperimental animals, can be presumed
to have the potential to producesignificant toxicity in humans following
repeated exposure
2 Substances that, on the basis ofevidence from studies in experimentalanimals can be presumed to have the
potential to be harmful to humanhealth following repeated exposure
H373 (245)
3.10 Aspiration hazard ‘Aspiration’ means theentry of a liquid or solidsubstance or mixturedirectly through the oralor nasal cavity,producing chemicalpneumonia, varyingdegrees of pulmonaryinjury or death
1 A substance is classified in Category 1based on reliable and good quality
human evidence or if it is ahydrocarbon on the basis of its
kinematic viscosity
H304 (187)
Part 4: ENVIRONMENTAL HAZARDS
Table 10. Environmental hazard classes and categories of substances and mixtures of the CLP Regulation
Class and Definition Category Definition of the category Hazardstatement
Representativesubstances
Notas: N1: LC50 x h: Concentration of the substance or mixture that is lethal for 50% of the species studied during the indicatedtime X. N2: EC50 x h: Concentration of the substance or mixture producing appreciable harmful (non‐ lethal) effects on the speciesstudied during the indicated time X.N3: ErC x h: Concentration of the substance or mixture producing effects on the growth of the algae or plants studied
during the indicated time X.
ACUTE AQUATIC TOXICITY Acute aquatic toxicity means theintrinsic property of a substanceto be injurious to an organism ina short‐term exposure to thatsubstance
1 For fish:96 hr
LC50 ≤ 1mg/l(N1)
Forcrustacea:
48 hrEC50 ≤ 1mg/l (N2)
Foralgae:72 hr
ErC50 ≤1 mg/l.
(N3)
For otheraquatic
plants: 96hr ErC50 ()≤ 1 mg/l.
(N3)
H400(482)
Hydrogen cyanide.Carbofuran.Chlorine dioxide.Ammonia.Hydrazine and itssalts. Sodiumnitrate. Whitephosphorous.Silver nitrate.
CHRONIC AQUATIC TOXICITY Chronic aquatic toxicity meansthe intrinsic property of asubstance to be injurious to anorganism during exposuresdetermined by the lifecycle ofthat organism
1 For fish:(N1) 96hr LC50≤ 1 mg/l
Forcrustacea:(N2) 48 hrEC50 ≤ 1
mg/l
Foralgae:(N3) 72hr ErC50
≤ 1mg/l.
For otheraquatic
plants: (N3)96 hr ErC50≤ 1 mg/l.
H410(746)
Carbofuran.Hydrazine and itssalts. Zincphosphorous. FTriphenylphosphite. Methylmercaptan. Ethylmercaptan.Calcium cyanide.Lead nitrate.
And the substance is not rapidly degradableor the experimentally determined BCF ≥ 500
(or, if absent, the log Kow ≥ 4).
2 For fish:96 hrLC50(N1)
Between1 and 10
mg/l
Forcrustacea:
48 hrEC50 (N2)Between 1
and 10mg/l
Foralgae:72 hrErC50(N3)
Between1 and 10
mg/l
For otheraquatic
plants: 96hr ErC50
(N3)Between 1
and 10mg/l
H411(445)
Vanadiumpentoxide.Manganesesulphate.Antimonytrichloride andpentachloride.Compounds ofuranium. Pentane,Methylcyclohexane
And the substance is not rapidly degradableor the experimentally determined BCF ≥ 500(or, if absent, the log Kow ≥ 4), unless the
chronic toxicity NOECs are > 1 mg/l.
3 For fish:96 hrLC50(N1)
Between10 and
100mg/l
Forcrustacea:
48 hrEC50 (N2)Between10 and
100 mg/l
Foralgae:72 hrErC50(N3)
Between10 and
100mg/l
For otheraquatic
plants: 96hr ErC50
(N3)Between 10
and 100mg/l
H412(271)
Cyclopentane.Dibromomethane.Carbontetrachloride.Chloroethane.Furan. O‐,m‐andp‐nitroaniline.
And the substance is not rapidly degradableor the experimentally determined BCF ≥ 500(or, if absent, the log Kow ≥ 4), unless the
chronic toxicity NOECs are > 1 mg/l.
4 Cases when data do not allow classificationunder the above criteria but there are
nevertheless some grounds for concern.(See table 4.10 of the CLP Regulation)
H413(136)
Cobalt, Nickel andcompounds.Complex organiccompoundmixtures not incommon use.
during the indicated time X. N4: BCF: Bioconcentration Factor. This is the quotient of the concentration of the substance in the aquatic organismstudied during a certain time and the concentration of the same substance during the same period.N5: Octanol‐Water Partition Coefficient (Kow). This is the ratio of the compound's concentration in a known volume ofoctanol (Co) to its concentration in a known volume of water (Cw) after the octanol and water have reached equilibrium:Kow=Co/Cw.N6: NOEC: This is the “No Observed Effect Concentration” of the species in the environment (water in this case). Thisfactor is currently questioned on the ground of its statistical uncertainty.
Part 5 considers an additional hazard class for the ozone layer, applicable within the European union. We only touch on thisbriefly since this hazard class is not taken into account in Seveso Directive III.
Substances harmful to the ozone layer are understood to be those that, according to available tests on their properties andthe observed or predicted environmental behaviour, are likely to pose a hazard to the structure or the workings of thestratospheric ozone layer. The hazard warning statement of these substances is EUH059. The CLP Regulation states onlyfour substances with said hazard statement: bromomethane, carbon tetrachloride, methyl chloroform and 1,1‐Dichloro‐1‐fluoroethane, since they also pose other types of hazards (physical, health and environmental).
Acknowledgements
This study has been financed under a FUNDACION MAPFRE grant.
References
1. Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisionsrelating to the classification, packaging and labelling of dangerous substances (OJEC 196, of 16 de agosto).
2. Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the systemof specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC(OJEC L 76, of 22 March 1991).
3. Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation ofthe laws, regulations and administrative provisions of the Member States relating to the classification, packaging andlabelling of dangerous preparations (OJEC L 200, of 30 July 1999).
4. REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 onclassification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJEU 353 of 31 December 2008).
5. Gyenes, Z. (2011). Application of GHS Substances Classification Criteria for the Identification of Seveso Establishments.Joint Research Centre. Institute for the Protection and Security of the Citizen. European Commission.
6. Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major‐accidenthazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJEU 197of 24 July).
7. Council Directive 96/82/EC of 9 December 1996 on the control of major‐accident hazards involving dangeroussubstances (OJEU 10 of 14 January 1997).
8. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning theRegistration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European ChemicalsAgency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation(EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,93/105/EC and 2000/21/EC (OJEU 396, of 30 December).
9. Commission Regulation (EC) No 790/2009 of 10 August 2009 amending, for the purposes of its adaptation to technicaland scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification,labelling and packaging of substances and mixtures OJEU 235, of 5 September).
10. Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technicaland scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification,labelling and packaging of substances and mixtures (OJEU 83, of 30 March).
11. Commission Regulation (EU) No 618/2012 of 10 July 2012 amending, for the purposes of its adaptation to technical andscientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification,labelling and packaging of substances and mixtures (OJEU 179, of 11 July).
12. Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of its adaptation to technical andscientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification,labelling and packaging of substances and mixtures (OJEU 149 of 1 June).
13. Commission Regulation (EU) No 758/2013 of 7 August 2013 correcting Annex VI to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJEU216, of 10 August).
14. Commission Regulation (EU) No 944/2013 of 2 October 2013 amending, for the purposes of its adaptation to technicaland scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification,labelling and packaging of substances and mixtures (OJEU 261, of 3 October).
15. Commission Regulation (EU) No 605/2014 of 5 June 2014 amending, for the purposes of introducing hazard andprecautionary statements in the Croatian language and its adaptation to technical and scientific progress, Regulation(EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging ofsubstances and mixtures Text with EEA relevance(OJEU 167 of 6 June).
