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  • Chemical residues in food and water; challenges for a future sustainable agriculture

    MGPR 2008 - Piacenza (Italy), 13 e 14 November 1

    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).

  • Chemical residues in food and water; challenges for a future sustainable agriculture

    MGPR 2008 - Piacenza (Italy), 13 e 14 November 2

    33

    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)

    44

    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.

  • Chemical residues in food and water; challenges for a future sustainable agriculture

    MGPR 2008 - Piacenza (Italy), 13 e 14 November 3

    55

    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 EUs 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

    66

    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

  • Chemical residues in food and water; challenges for a future sustainable agriculture

    MGPR 2008 - Piacenza (Italy), 13 e 14 November 4

    77

    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

    88

    C&L Criteria for Environment by Hazard class

  • Chemical residues in food and water; challenges for a future sustainable agriculture

    MGPR 2008 - Piacenza (Italy), 13 e 14 November 5

    99

    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.

    1010

    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

  • Chemical residues in food and water; challenges for a future sustainable agriculture

    MGPR 2008 - Piacenza (Italy), 13 e 14 November 6

    1111

    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

    C&L Criteria for Environmentby Hazard class

    1212

    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

  • Chemical residues in food and water; challenges for a future sustainable agriculture

    MGPR 2008 - Piacenza (Italy), 13 e 14 November 7

    1313

    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

    1414

    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), i

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