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Environmental Hazard Environmental Hazard Classification: moving to the Classification: moving to the
Globally Harmonized System (GHS)Globally Harmonized System (GHS)
Maristella RubbianiMaristella RubbianiNational Center National Center forfor ChemicalsChemicals
ISSISS
22
The European Union Globally Harmonised The European Union Globally Harmonised System for the Classification & Labelling of System for the Classification & Labelling of
ChemicalsChemicals
is a draft of European Union Regulationadopted by the European Commission on 2007/06/27 which proposes to align the EU system of classification, labelling and packaging substances and mixtures to the United Nations Globally Harmonized System (GHS).
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ScopeScope• It is expected to facilitate global trade and
harmonised communication of hazard information of chemicals and to promote regulatory efficiency.
• It will complement the Registration, Evaluation, Authorisation and Restriction of Chemicals(REACH) Regulation and replace the current system contained in Directive 67/548/EEC and Directive 1999/45/EC.
• It will cover all substances and mixtures placed on the market (regardless of volume)
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ObjectiveObjective• The proposal incorporates the classification criteria and
labelling rules agreed at UN level, the so called Globally Harmonized System of classification and labelling of chemicals (GHS).
• It will introduce new classification criteria, hazard symbols (pictograms) and labelling phrases, while taking account of elements which are part of the current EU legislation.
• The aim of the proposed Regulation is to enable a judgement on a substance or mixture (preparation) withrespect to its hazardous properties and to provide a hazardous chemical with pertinent hazard labelling and information on safety measures.
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The The proposedproposed new new regulationregulation::
• Applies the general principles of the UN GHS, • Uses the “building block approach” of the UN GHS and a few other options to adapt
the system to the EU’s needs, • Keeps the scope as close as possible to the existing EU system, • Maintains the current level of protection by including EU “left-overs” that are not yet
covered by the GHS, e.g. ozone depletion, • Ensures consistency with transport, • Takes over the current Annex I of Council Directive 67/548/EEC, • Takes over Title XI (Classification & Labelling Inventory) from the REACH
Regulation, • Defines a transitional period during which both the current legislation and the new
Regulation will be in place, • Stays as close as possible to the UN GHS format and terminology, e.g. “mixture”
instead of “preparation”, or “hazardous” instead of “dangerous”, but maintains the concept of “dangerous”, to avoid changing the scope of REACH and other Community legislation
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Moreover:Moreover:
Substitutes:• Directive 67/548/EEC on classification and labelling
of dangerous substances and Directive 1999/45/EC on classification and labelling of preparations (mixtures)
Establishes:• A list of substances with harmonised
classifications and labelings at Community level (Annex VI)
• A classification and labelling inventory of substances placed on the market
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TimingTiming• As with the current legislation, the proposed
Regulation is intended to be primarily a self-classification system for enterprises.
• After entry into force, the deadline forsubstance reclassification is 30 November 2010 and for mixtures 31 May 2015.
• The current Directives on classification, labelling and packaging, i.e. Council Directive67/48/EEC and Directive 1999/45/EC, will berepealed on 1 June 2015
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C&L Criteria for Environment by Hazard class
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DefinitionsDefinitions• Classification of dangerous substances and
mixtures for environmental hazards requires the identification of the hazards they present to the aquatic environment.
• The aquatic environment is considered in terms of the aquatic organisms that live in the water, and the aquatic ecosystem of which they are part.
• The basis, therefore, of the identification of hazard is the aquatic toxicity of the substance or mixture, although this shall be modified by taking account of further information on the degradation and bioaccumulation behaviour, if appropriate.
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Main data elementsMain data elements• water solubility, • octanol/water partition coefficient (log Kow), • bioaccumulation, • bioconcentration factor in fish or mussels
(BCF), • acute aquatic toxicity (L(E)C50s), • chronic aquatic toxicity (NOECs), • degradation (evidence of rapid degradability,
hydrolysis, photolysis in water).C&L Criteria for Environmentby Hazard class
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The Weight of EvidenceThe Weight of Evidence
• The Weight of Evidence process is described as “a decision making activity aiming at concluding on toxicity of a substance based on integration of information from different sources and various aspects of uncertainty. It will often require expert judgement”
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The Weight of EvidenceThe Weight of Evidence• The current approach for classification and labelling uses
the lowest available toxicity value from all of the available experimental studies, i.e. the most sensitive species that has been tested.
• There is reference to two scenarios where the Weight of Evidence approach may need to be employed:
Data-rich substances where more than one piece of information is available for a given endpoint relevant to a classification and labelling decision.
Data-poor substances, where there are no, or limited experimental end-point data available.
C&L Criteria for Environmentby Hazard class
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Step 1 – Characterisation of the substance- Structure and physico-chemical properties of the substance- Information about reactivity and degradation of the substance. - Identification of possible relevant metabolites
Step 2 - Analysis of Mode of Action-Characterisation of the mode of action according to appropriate schemes- Identification of structural alerts
Step 3- Identification & evaluation of possible analogues-Collection of possible analogues-Identification of existing or new chemical categories
-Evaluation of available information for these analogues
Step 4- Evaluation of existing in vivo testing data-Evaluation of available standard information
- Evaluation of available non-standard information
Step 4a-Evalation of QSARS results-Are reliable QSAR predictionsavailable?- Can QSAR results provideadditional information?
Step 4b- Evaluation of in vitro test data Are reliable in vitro results available?Can in vitro results provide additionalinformation?
Step 5 Weight of evidence assessment-Summary of reliable results and preliminary conclusions on the toxicity of the substance-using all information from standard, non-standard, and non-testing methodsIdentification of data gaps according to Annexes VII-X
-Summary of additional information that might be helpful for the assessment (e.g. for modificationof assessment factors) -Summary of remaining uncertainty (e.g. consistency of data)
Step 6 Evaluation of factors relevant for waiving-Mitigating factors (intrinsic properties indicating that aquatic toxicity is unlikely to occur
- Possibility for test modification e.g. fish threshold approach
C&L Criteria for Environmentby Hazard class
General aspects of Weight of EvidenceGeneral aspects of Weight of Evidence
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Chronic (long-term) aquatic hazardChronic Category 1 (Note 1)96 hr LC50 (for fish) ≤ 1 mg/l and/or48 hr EC50 (for crustacea) ≤ 1 mg/l and/or72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l (Note 2)and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4).
Acute (short-term) aquatic hazardAcute Category 1 (Note 1)96 hr LC50 (for fish) ≤ 1 mg/l and/or48 hr EC50 (for crustacea) ≤ 1 mg/l and/or72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l. (Note 2)
Classification categories for hazardous to the aquatic environmeClassification categories for hazardous to the aquatic environmentnt
“Safety net” classificationChronic Category 4Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for
example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 3), and which are not rapidly degradable and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or evidence of rapid degradation in the environment.
Chronic Category 396 hr LC50 (for fish) >10 to ≤ 100 mg/l and/or48 hr EC50 (for crustacea) >10 to ≤ 100 mg/l and/or72 or 96 hr ErC50 (for algae or other aquatic plants) >10 to ≤ 100 mg/l (Note 2)and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4) unless the chronic
toxicity NOECs are > 1 mg/l.
Chronic Category 296 hr LC50 (for fish) >1 to ≤ 10 mg/l and/or48 hr EC50 (for crustacea) >1 to ≤ 10 mg/l and/or72 or 96 hr ErC50 (for algae or other aquatic plants) >1 to ≤ 10 mg/l (Note 2)and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4), unless the chronic
toxicity NOECs are > 1 mg/l.
C&L Criteria for Environment
by Hazard class
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Setting MSetting M--factor for highly toxic factor for highly toxic substancessubstances
• Substances with acute toxicities well below 1 mg/l contribute as components of a mixture to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach.
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Multiplying factors for highly Multiplying factors for highly toxic components of mixtures toxic components of mixtures
L(E)C50L(E)C50C&L Criteria for Environmentby Hazard class
L(E)C50 value Multiplying factor (M)
0.1 < L(E)C50 = 1 10.01 < L(E)C50 =< 0.1 100.001 < L(E)C50 =< 0.01 1000.0001 < L(E)C50 =< 0.001 10000.00001 < L(E)C50 =< 0.0001 10000(continue in factor 10 intervals)
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Tiered approach to classification of Tiered approach to classification of mixturesmixtures
for acute and chronic (long term) for acute and chronic (long term) aquatic environmental hazardsaquatic environmental hazards
A q u a ti c to x i c i ty te st d a ta a v a i l a b l e o n th e m i x tu re a s a w h o l e
S u ffic ie n t d a t a a va i la b le o n s im ila r m ix t u re s t o e s t im a t e h a z a rd s
Y e sN o
Y e s A p p ly b rid g in g p rin c ip le s(s e e 4 . 1 . 3 . 4 . )
C L A S S I F Yfo r a c u t e / c h ro n ic a q u a t ic h a z a rd (s e e 4 . 1 . 3 . 3 )
C L A S S I F Yfo r a c u t e / c h ro n ic a q u a t ic h a z a rd
N o
E it h e r a q u a t ic t o x ic i t y o r c la s s i fic a t io n d a t a a va i la b le fo r a l l re le va n t c o m p o n e n t s
Y e s A p p ly s u m m a t io n M e t h o d (s e e 4 . 1 . 3 . 5 . 5 ) u s in g :• P e rc e n t a g e o f a l l c o m p o n e n t s c la s s i fie d a s " C h ro n ic "• P e rc e n t a g e o f c o m p o n e n t s c la s s i fie d a s " A c u t e "• P e rc e n t a g e o f c o m p o n e n t s w it h a c u t e t o x ic i t y d a t a : a p p ly A d d i t i t ivi t y F o rm u la (s e e 4 . 1 . 3 . 5 . 2 ) a n d c o n ve rt t h e d e r ive d L (E )C 5 0 t o t h e a p p ro p r ia t e " A c u t e " C a t e g o ry
C L A S S I F Yfo r a c u t e / c h ro n ic a q u a t ic h a z a rd
U s e a va i la b le h a z a rd d a t a o f k n o w n c o m p o n e n t s .
N o
A p p ly S u m m a t io n M e t h o d a n d / o r A d d i t ivi t y F o rm u la (s e e 4 . 1 . 3 . 5 ) a n d a p p ly 4 . 1 . 3 . 6
C L A S S I F Yfo r a c u t e / c h ro n ic a q u a t ic h a z a rd
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Classification criteria for Classification criteria for MixturesMixtures
• The classification system for mixtures covers all classification categories which are used for substances, i.e. Acute Category 1 and Chronic Categories 1 to 4.
• The “relevant components” of a mixture are those which are classified “Acute Category 1”or “Chronic Category 1” and present in a concentration of 0.1% (w/w) or greater, and those which are classified “Chronic Category 2”, “Chronic Category 3” or “Chronic Category 4” and present in a concentration of 1% (w/w) or greater,unless
• there is a presumption (e.g in the case of highly toxic components ) that a component present in a lower concentration can still be relevant for classifying the mixture for aquatic environmental hazards.
• Generally, for substances classified as “Acute Category 1” or "Chronic Category 1" the concentration to be taken into account is (0.1/M)%. 2. C&L Criteria
for Environmentby Hazard class
C&L Criteria for Environment
by Hazard class
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HAZARDOUS TO AQUATIC ENVIRONMENT
C&L Criteria for Environmentby Hazard class : guidance
Guidance already existing in Annex IX and X to the GHSAdditional issues that might need further guidance:
How to use of weight of evidence in case of several data points for the same species or for different species
Additional guidance could be useful for certain issues concerning classification of metals, for example: additional guidance on transformation dissolution testing based on the experience from the OECD ring test, normalisation of bio availability, the use of Species Sensitivity Distribution (SSD), rapid partitioning from the water column and possible use of the critical surface area.
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HAZARDOUS FOR THE OZONE LAYER
C&L Criteria for Environmentby Hazard class: guidance
This hazard class is already applied within the EU and no further guidance is necessary.
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HAZARDS TO ENVIRONMENT
TOXICITY TO AQUATIC ENVIRONMENT
DANGEROUS FOR THE OZONE
LAYER
VERY TOXIC
VERY TOXIC& LONG-TERM
ADVERSE EFFECT
TOXIC& LONG-TERM
ADVERSE EFFECT
HARMFUL& LONG-TERM
ADVERSE EFFECT
LONG-TERM ADVERSE EFFECT
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HAZARDS TO ENVIRONMENT HAZARDOUS TO
THE AQUATIC ENVIRONMENT
HAZARDOUSTO THE OZONE
LAYER AQUATIC ACUTE
AQUATIC CHRONICCATEGORY 1
CATEGORY 1
CATEGORY 2CATEGORY 3
CATEGORY 4ADDITIONAL EU HAZARD CLASS
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HOW DOES IT LOOK LIKE?
LABELLING ELEMENTS:
1. SYMBOLS2. RISK PHRASES3. SAFETY PHRASES
Very toxic to aquatic organisms
This material and its container must be disposed as hazardous waste
N
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WHAT WILL IT LOOK LIKE?
LABELLING ELEMENTS:
1. PICTOGRAMS2. SIGNAL WORDS3. HAZARD STATEMENTS4. PRECAUTIONARY
STATEMENTS
Very toxic to aquatic life
Avoid release to the environment. Collect spillage. Dispose of contents/container to…WARNING
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Hazard statementsHazard statementsThe label shall include the relevant hazard statements in accordance with the classification of the hazardous substance or mixture and shall be worded in accordance with Annex III to Regulation.
The hazard statements (and the Hazard statement Codes) relevant for the hazard class Hazardous to the Aquatic Environment are:- Very toxic to aquatic life (H400)- Very toxic to aquatic life with long lasting effects(H410)- Toxic to aquatic life with long lasting effects (H411)- Harmful to aquatic life with long lasting effects(H412)- May cause long lasting harmful effects to aquatic life (H413)
The hazard statement H400 is required only for substances or mixtures classified as:-Acute hazard category 1
The hazard statements H410 to H413 are respectively required for substances or mixtures classified as:- Chronic hazard category 1, 2, 3 or 4
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PHYSICAL CHEMICAL HAZARDS
HAZARDS TO HUMAN HEALTH
HAZARDS TO ENVIRONMENT
SYMBOLS
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PHYSICAL HAZARDS
HAZARDS TO HUMAN HEALTH
HAZARDS TO ENVIRONMENT
SYMBOLS
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PHYSICAL HAZARDS
HAZARDS TO HUMAN HEALTH
HAZARDS TO ENVIRONMENT
SYMBOLS – TRANSPORT SYMBOLS ON SINGLE PACKAGES
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SUBSTANCES:SOME SUBSTANCES HAVE A COMPLETELY HARMONISED AND LEGALLY BINDING CLASSIFICATION THROUGH ANNEX I TO DIRECTIVE 67/548SUBSTANCES NOT LISTED IN ANNEX I ARE SUBJECT TO ‘SELF-CLASSIFICATION’ IN ACCORDANCE TO THE SAME CRITERIA
HARMONISED CLASSIFICATION &
LABELLING vsSELF- CLASSIFICATION &
LABELLING SUBSTANCES:SOME SUBSTANCES HAVE A COMPLETETLY OR PARTIALLYHARMONISED AND LEGALLY BINDING CLASSIFICATION THROUGH ANNEX VI TO THE NEW REGULATIONSUBSTANCES NOT LISTED IN ANNEX VI ARE SUBJECT TO ‘SELF-CLASSIFICATION’IN ACCORDANCE TO THE SAME CRITERIA AND THESE CLASSIFICATIONS MUST BE REGISTERED IN THE C&L INVENTORY
PREPARATIONS:ALL PREPARATIONS ARE SUBJECT TO ‘SELF-CLASSIFICATION’ IN ACCORDANCE TO THE CRITERIA IN DIRECTIVE 67/548 AND ADDITIONAL PROVISIONS FOR PREPARATIONS IN DIRECTIVE 1999/45
MIXTURES:ALL MIXTURES ARE SUBJECT TO ‘SELF-CLASSIFICATION’ IN ACCORDANCE TO THE CRITERIA IN THE NEW REGULATION
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THE ONE PLACING THE SUBSTANCE OR MIXTURE ON THE MARKET MUST CLASSIFY AND LABEL IN ACCORDANCE WITH DIRECTIVE 67/548
‘PLACING ON THE MARKET’MEANS MAKING AVAILABLE TO THIRD PARTIES. IMPORTATION INTO THE COMMUNITY CUSTOMS TERRITORY SHALL BE DEEMED TO BE PLACING ON THE MARKET FOR THE PURPOSES OF THIS DIRECTIVE.
WHO IS RESPONSIBLE IN THE SUPPLY CHAIN
THE MANUFACTURER, IMPORTER OR DOWNSTREAM USER PLACING THE SUBSTANCE OR MIXTURE ON THE MARKET MUST CLASSIFY AND LABEL IN ACCORDANCE WITH THE NEW REGULATIONTHE DISTRIBUTOR MUST ENSURE THAT THE LABEL IS CORRECT AND UNCHANGED ON THE FINAL PACKAGE
THE DEFINITIONS OF MANUFACTURER, IMPORTER, DOWNSTREAM USER AND DISTRIBUTOR ARE THE SAME AS IN REACH
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PREPARATIONS (1999/45/EC)
RESTRICTIONS ON MARKETING AND USE
(76/769/EEC)
WORKPLACE PROTECTION
(98/24/EC)
SEVESO –MAJOR ACCIDENT
HAZARDS (96/82/EC)
COSMETICS (2003/15/EC)
HAZARDOUS WASTE
(91/689/EC)
EXPORT-IMPORT (304/2003)
PLANT PROTECTION
PRODUCTS(91/414/EEC)
BIOCIDES(98/8/EC)
… and others
DOWNSTREAM LEGISLATION
ALL PROVISONS
UNDER THIS DIRECTIVE ARE INCLUDED UNDER THE NEW REGULATION
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LinksLinks• The Regulation proposed by the Commission, the
executive summary of the Commission’s impact assessment and the full Commission impact assessment are available via the following website:
• http://ec.europa.eu/enterprise/reach/ghs_more_on_com_proposal_en.htm
• All 23 language versions of the Regulation proposed by the Commission and the executive summary of the Commission’s impact assessment are available in Eur-Lex:
• http://europa.eu.int/eur-lex/lex/RECH_naturel.do