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					BASTA Product Qualification Workflow
Process            Work steps                                                                 Considerations                                             BASTA Template              Helpful tools

1. Specification   a) Specify the different parts/materials in the product                                                                               BASTA Assessment Record -   Product specification,
                                                                                                                                                         Material specification      environmental declaration,
                   b) Specify concentration of materials (% of total weight)                                                                                                         Saftey Data Sheet etc.

2. Qualification   Choose one of the following alternatives:
                   Alternative 1: Full knowledge of content
                      a) Specify chemical content of material (CAS-numbers)                   No information is accuired for naturally occuring raw      BASTA Assessment Record -   CLP/GHS Database
                                                                                              material lacking relevance for registration.               Material specification

                      b) Specify concentration of chemical substances (% of total weight)                                                                BASTA Assessment Record -   Product specification from
                                                                                                                                                         Material specification      supplier

                      c) Specify classification of chemical substances                        Collect environmental propery data for constituent         BASTA Assessment Record -   CLP/GHS Database
                                                                                              substances lacking classification (use BASTA Criteria      Material specification
                                                                                              Checklist).
                                                                                                                                                         BASTA Criteria Checklist

                      d) Specify data about the proterties of the substances related to the   Investigate the presence of Hg, Pb and Cd in the material. BASTA Assessment Record -
                         BASTA criteria C5-C11                                                                                                           Basis of assessment

                                                                                                                                                         BASTA Criteria Checklist

                                                                                              Investigate the presence of substances included in the     BASTA Assessment Record -   EU's Endocrine Distupters
                                                                                              priority group 1 according to the EU priority list of      Basis of assessment         Website
                                                                                              substances that may cause endocrine disruptions.
                                                                                                                                                         BASTA Criteria Checklist

                                                                                              Specify data on half-life, Bio Concentration Factor (and   BASTA Assessment Record -   Useful databases
                                                                                              cronic NOEC if approriate) for organic substances.         Basis of assessment

                                                                                                                                                         BASTA Criteria Checklist

                   Alternative 2: Lacking knowledge of content - chemical product
                      a) Acquire a Safety Data Sheet from the supplier                                                                                   BASTA Assessment Record -   Saftey Data Sheet from
                                                                                                                                                         Basis of assessment         supplier

                      b) Get a "Amendment of Safety Data Sheet" signed by the supplier                                                                   Amendment of Safety Data
                                                                                                                                                         Sheet
                   Alternative 3: Lacking knowledge of content - article
                   a) Get a "Sub-supplier declaration" signed by the supplier                                                         BASTA Assessment Record -
                                                                                                                                      Basis of assessment

                                                                                                                                      Sub-supplier declaration

3. Assessment   a) Compliance with BASTA criteria                               Check the compliance of the substance data with the   BASTA Criteria Checklist
                                                                                BASTA criteria in the BASTA Criteria Checklist and
                                                                                acquired documentation from the suppliers.
BASTA Assessment Record
Product name:
Material specification                                                                                                       Basis of                                                                                                                                                                    Annex
                                                                                                                             assessment
                                                                                                                             Alt. 1 Own assessment - Investigate compliance with indicated criteria                                                                Alt. 2 SDS              Alt. 3 SSD
Material    Concentration of      Supplier   Chemical        CAS No Propotional     Concentration of      Assessment         Is the substance   Yes   Endocrine       Half-life        BCF            Chronic     Pb (C9)   Hg (C10)   Cd (C11) No   Check all     SDS      Amendment of   Subsupplier
            materials                        specification          concentration   product               (meet the          classified?              disruption (C5) (C6-C7)          (C6-C7)        NOEC (C7)                                      criteria in            SDS            declaration
            (% of total weight)                                     (%)             (% of total weight)   criteria or not)                                                                                                                           "Criteria
                                                                                                                                                                                                                                                     checklist"
BASTA Criteria Checklist
Product name:                                           Chemical specification:
                                                                                                                                                                                                            Concentration   Compliance
   BASTA Criteria               Definition                                            Details (more information in KIFS 2005:7)                                    Concentration     Results   References     in whole      with BASTA
                                                                                                                                                                 limit (by weight)                             product        criteria


1. Carcinogenic     Substances with properties          Category 1                                                                                                    < 0,1%
                    according to hazard class of        Substances that are carcinogenic in humans. There is sufficient evidence to establish a causal
                    carcinogenic in category 1 or 2     relationship between exposure to the substance and development of human cancers.
                    (R45, R49)
                                                        Category 2
                                                        Topics to be considered as carcinogenic to humans. There is sufficient evidence to suspect that cancer
                                                        can occur in people exposed to the substance. The assessment is generally based on relevant long-
                                                        term studies in animals.

                    Substances with properties          Category 3                                                                                                     < 1%
                    according to hazard class           Substances which are carcinogenic to humans. The available information is not enough to make a
                    of carcinogenic in category 3       meaningful assessment. There is some evidence from appropriate animal studies, but they are
                    (R40)                               insufficient to place the substance in Category 2.
2. Mutagenic        Substances with properties          Category 1                                                                                                    < 0,1%
                    according to hazard class           Substances which are mutagenic to man. There is sufficient evidence to establish a causal relationship
                    of mutagenic in category 1 or 2     between exposure to the substance and heritable genetic damage in humans.
                    (R46)
                                                     Category 2
                                                     Topics to be treated as if they are mutagenic to man. There are enough strong reasons to believe that
                                                     inherited genetic damage can occur in people exposed to the substance. The assessment is generally
                                                     based on
                                                      - appropriate animal studies
                                                      - other relevant information.
                    Substances with properties       Category 3                                                                                                        < 1%
                    according to hazard class        Substances which are mutagenic to man. There is evidence from appropriate mutagenicity studies,
                    of mutagenic in category 3 (R68) but they are insufficient to place the substance in Category 2.


3. Toxic to         Substances with properties          Category 1                                                                                                    < 0,5%
reproduction        according to hazard class           Substances that impair fertility in humans. There is sufficient evidence to establish a causal
                    of toxic to reproduction in         relationship between exposure to the substance and impaired fertility in humans. Substances that
                    category 1 (R60)                    cause toxic effects on embryo / fetus in humans. There is sufficient evidence to establish a causal
                                                        relationship between exposure to the substance prior to birth and toxic effects on embryo / fetus in
                                                        humans.

                    Substances with properties          Category 2                                                                                                    < 0,5%
                    according to hazard class           Topics to be treated as if they impair fertility in humans. There are enough strong reasons to believe
                    of toxic to reproduction in         that exposure to the substance may lead to impaired fertility in humans based on a) the clear results
                    category 2 (R61)                    from relevant animal studies, or b) other relevant information. Topics to be considered if they cause
                                                        toxic effects on embryo / fetus in humans. There are enough strong reasons to believe that exposure
                                                        to the substance may cause toxic effects on embryo / fetus in humans, usually based on a) the clear
                                                        results from relevant animal studies, or b) other relevant information.
                     Substances with properties          Category 3                                                                                                 < 5%
                     according to hazard class           Substances which cause concern for human fertility. The assessment is generally based on a) results
                     of toxic to reproduction in         from appropriate animal studies, or b) other relevant information. Substances which can cause toxic
                     category 3 (R62 and/or              effects on embryo / fetus in humans. The assessment is generally based on a) results from
                                                         appropriate animal studies, or b) other relevant information.
                     R63)

4. Effect during     Substances with properties          R64 May cause harm to breastfed babies                                                                     < 0,1%
lactation            according to hazard class            - Substances that are absorbed into the body and may affect breastfeeding or present in breast milk
                     of: may cause harm to breastfed     (including metabolites) in quantities sufficient to cause the infant. Normally be assigned to R64
                     babies (R64)                        because of
                                                          - toxicokinetic studies that indicate that the substance is likely to be-come the levels in breast milk
                                                         that can be toxic, or
                                                          - results from such one-or two-generation studies in animals suggest that feeding affected (eg,
                                                         reduced quantities of milk or reduced quality of milk) or to transfer in the milk has caused adverse
                                                         effects on the offspring, or
                                                          - evidence in humans indicating a risk of harm to breastfed babies.
5. Endocrine         While awaiting criterias there      European Commission DG Environment (2000).Towards the establishment of a priory list of                    < 0,1%
disruption           may be no use of                    substances for further evaluation of their role in endocrine disruption.
                     substances included in priority     Final report, http://ec.europa.eu/environment/docum/pdf/bkh_main.pdf
                     group 1 according                   Annex 1. Candidate list of 553 substances,
                                                         http://ec.europa.eu/environment/docum/pdf/bkh_annex_01.pdf
                     to EU “candidate list of 553
                     substances” European
                     Commission DG Environment
                     (2000), Annex 1
6. Very persistent   Substances with                                                                                                                                < 0,1%
and very             1) a half-life
bio accumulative     > 60 days in seawater or
organic              freshwater or
compound             > 180 days in seawater or
                     freshwater sediment or
                     > 180 days in soil and
                     2) BCF (Bio Concentration Factor)
                     >5000
7. Persistent, bio   Substances with                                                                                                                                < 0,1%
accumulative and     1) a half-life
toxic                > 60 days in seawater or
organic compound     >40 days in freshwater or
                     > 180 days in seawater sediment
                     or
                     >120 days in freshwater
                     sediment and

                     2) BCF (Bio Concentration Factor)
                     >2000 and
                   3) Chronic NOEC
                   < 0.01mg/l or
                   < 30 mg/kg food or
                   CMR or classified T; R48 or XN;
                   R48 or R64
8. Potentially     There is for the time being no
persistent,        generally confirmed definition
bio accumulative   for a potentially persistent,
and toxic          biaccumulative and toxic organic
organic compound   compound. The criteria
                   document will be amended
                   when such definition is at hand.

9. Lead (Pb)       Pure substances or compounds                                                                                                                       < 0,1%
                   of lead                                                                                                                                       Check Properies
                                                                                                                                                                 Criteria for BETA
10. Mercury (Hg)   Pure substances or compounds                                                                                                                      Total ban
                   of mercury                                                                                                                                    Check Properies
                                                                                                                                                                 Criteria for BETA
11. Cadmium (Cd)   Pure substances or compounds                                                                                                                       < 0,01%
                   of cadmium
12. Dangerous to   Ozon Depletion Potential             R59 Dangerous for the ozone layer                                                                             < 0,1%
the ozone          (ODP) > 0 (R59)                      Substances that could endanger the structure or function of the stratospheric ozone layer. The
layer                                                   assessment will be based on evidence concerning their properties and anticipated or observed
                                                        behavior and fate. This includes substances that are listed in Annex I to Council Regulation (EC) No
                                                        2037/2000 on substances that deplete the ozone layer.
13. Sensitising    Substances with properties           R42 May cause sensitization by inhalation                                                                      < 1%
                   according to hazard class of          - If there is evidence that the substance or preparation can induce specific respiratory
                   causing sensitisation by             hypersensitivity.
                   inhalation and/or on skin contact     - If the substance or positive results from relevant animal studies.
                                                         - If the substance is an isocyanate unless there is evidence that the substance does not cause
                   (R42, R43)
                                                        respiratory hypersensitivity.
                                                        R43 May cause sensitization by skin contact
                                                         - If experience shows the substance or preparation capable of inducing sensitization by skin contact
                                                        in a significant number of people.
                                                         - If the substance or positive results from relevant animal studies.
14. Very toxic     Substances with properties        R26 Very toxic by inhalation                                                                                      < 1%
                   according to hazard class of very - LC50 inhalation, rat, aerosols and particulate matter: ≤ 0.25 mg / L, 4 hours.
                   toxic on inhalation, on skin      - LC50 inhalation, rat, for gases
                   contact and/or if swallowed
                   (R26, R27, R28)
                                                        R27 Very toxic by skin contact
                                                        - LD50 dermal, rat or rabbit: ≤ 50 mg / kg.
                                                        R28 Very toxic if swallowed
                                                        - LD50 oral, rat ≤ 25 mg / kg;
                                                        - less than 100% survival at 5 mg / kg (oral, rats) by a method for fixed dose, or
                                                        - high mortality at doses ≤ 25 mg / kg (oral, rats) by a method for determining the acute toxic class.
                  Substances with properties           39 Danger of very serious irreversible                                                                  < 1%
                  according to hazard class of very     - Strong evidence that irreversible damage can occur, generally in the above-mentioned dose range
                  toxic: danger of serious             after single, brief exposure by an appropriate route. Not carcinogenic, mutagenic and reproductive
                  irreversible damage to health by     toxic effects.
                  inhalation, on skin contact or if
                                                       R26-R28 above
                  swallowed (R39 in combination
                  with R26, R27 and/or R28)

15. Toxic         Substances with properties         R23 Toxic by inhalation                                                                                   < 25%
                  according to hazard class of toxic - LC50 inhalation, rat, aerosols and particulates: 0.25 <LC50 ≤ 1 mg / L, 4 hours.
                  on inhalation, on skin contact     - LC50 inhalation, rat, for gases and vapors: 0.5 <LC 50 ≤ 2 mg / L, 4 hours.
                  and/or if swallowed (R23,
                  R24, R25)

                                                       R24 Toxic by skin contact
                                                       - LD50 dermal, rat or rabbit: 50 <LD50 ≤ 400 mg / kg.
                                                   R25 Toxic if swallowed
                                                    - LD50 oral, rat: 25 <LD50 ≤ 200 mg / kg
                                                    - discriminating dose, oral, rat, 5 mg / kg: 100% survival but evident toxicity, or
                                                    - high mortality in the dose range> 25 to ≤ 200 mg / kg (oral, rats) by a method for determining the
                                                   acute toxic class.
                  Substances with properties       39 Danger of very serious irreversible                                                                      < 10%
                  according to hazard class of     Strong evidence that irreversible damage can occur, generally in the above-mentioned dose range
                  toxic: danger of serious         after single, brief exposure by an appropriate route. Not carcinogenic, mutagenic and reproductive
                  irreversible damage to health by toxic effects.
                  inhalation, on skin contact or if
                                                       R23-R25 above
                  swallowed 3) (R39 in
                  combination with R23, R24
                  and/or R25)
16. High cronic   Substances with properties           R48 Risk of serious damage to health by prolonged exposure                                              < 10%
toxicity          according to hazard class of         Repeated or prolonged exposure by an appropriate route is likely to cause serious damage. With
                  toxic: danger of serious             serious injuries clear functional disturbance or morphological changes of toxicological significance.
                  irreversible damage to health in     Refer to 2005:7.
                  prolonged exposure by
                                                       R23-R25 above
                  inhalation, on skin contact or if
                  swallowed (R48 in combination
                  with R23, R24 and/or R25).
17. Volatile organic   Initial boiling point <250 oC      R20 Harmful by inhalation                                                                                   < 10%
compounds              measuerd at a standard pressure - LC50 inhalation, rat, aerosols and particles: 1 <LC50 ≤ 5 mg / L, 4 hours.
                       of 101,3 kPa and has properties - LC50 inhalation, rat, for gases and vapors: 2 <LC50 ≤ 20 mg / L, 4 hours.
                       according to the criteria for risk
                       phrase R20 (harmful by
                       inhalation) or R23(toxic by
                       inhalation) R65 (harmful: May
                       cause lung damage if swallowed)
                       or R67 (vapours may cause
                       drowsiness and dizziness) or R48
                       together with R20 (harmful:
                       danger of seroius damage to
                       health by prolongedexposure
                       through inhalation).



                                                            R23 Toxic by inhalation
                                                            - LC50 inhalation, rat, aerosols and particulates: 0.25 <LC50 ≤ 1 mg / L, 4 hours.
                                                            - LC50 inhalation, rat, for gases and vapors: 0.5 <LC 50 ≤ 2 mg / L, 4 hours.
                                                            R48 Risk of serious damage to health by prolonged exposure
                                                            Repeated or prolonged exposure by an appropriate route is likely to cause serious damage. With
                                                            serious injuries clear functional disturbance or morphological changes of toxicological significance.
                                                            Refer to 2005:7.
                                                            R65 Harmful: may cause lung damage if swallowed
                                                            Liquid substances and preparations which, because of its low viscosity is a danger to human
                                                            aspiration.
                                                             a) For substances and preparations containing aliphatic, alicyclic or aromatic hydrocarbons in a total
                                                            concentration of 10% or more
                                                             and
                                                             - have a flow less than 30 seconds, measured with a 3 mm flow cup according to Swedish standard SS-
                                                            EN ISO 2431, edition October 11, 1996
                                                             or
                                                             - has a kinematic viscosity of less than 7 x 10-6 m2 / s at 40 ° C, measured by a calibrated glass
                                                            capillary in accordance with Swedish standards ISO 3104, edition March 3, 1995 and ISO 3105, edition
                                                            of the October 27, 1995
                                                             or
                                                             - has a kinematic viscosity of less than 7 x 10-6 m2 / s at 40 ° C, from measurements of rotational in
                                                            accordance with Swedish standards ISO 3219, releases on 24 February 1995.
                                                             Substances and preparations need not be classified in the hazard class of harmful with risk phrase
                                                            R65 if they have an average surface tension higher than 33 mN / m at 25 ° C, as determined by You
                                                            Nouy tensiometer or by tests carried out by the methods described in Annex V to Directive
                                                            67/548/EEC.
                                                             b) For substances and preparations which may cause lung damage if aspiration, based on experience
                                                            in humans.
                                                       In the allocation of R67, the following data used:
                                                        a) data from animal studies showing clear signs of functional impairment in the central nervous
                                                       system, such as narcotic effects, lethargy, lack of coordination (including the absence of up-
                                                       rätningsreflex) and ataxia, either
                                                        - at a ratio between concentration and exposure time does not exceed 20 mg / l / 4 hours, or
                                                        - the ratio of the concentration that gives rise to effects during the exposure time ≤ 4 hours and
                                                       saturation vapor concentration at 20 º C ≤ 1 / 10.
                                                        b) experience in humans (eg narcosis, drowsiness, reduced alertness, loss of reflexes, lack of coordi-
                                                       your production, vertigo) from well documented reports under exposure conditions that are
                                                       comparable to those listed above for animals.

18. Dangerous for   Substances with properties       R50 Very toxic to aquatic organisms                                                                             Less than the
the environment     according to hazard class of     Acute toxicity:                                                                                             concentration limit
                    dangerous: very toxic to aquatic - 96-hour LC50 (for fish) ≤ 1 mg / l, or                                                                      specified in the
                    organisms (R50)                  - 48-hour EC50 (for Daphnia) ≤ 1 mg / l, or                                                                 CLP/GHS Database
                                                        - 72 hours IC50 (for algae) ≤ 1 mg / l                                                                        (Annex VI to
                                                                                                                                                                 Regulation (EC) No
                                                                                                                                                                 1272/2008). If the
                                                                                                                                                                   substance not is
                                                                                                                                                                   specified in the
                                                                                                                                                                 CLP/GHS Database,
                                                                                                                                                                  the concentration
                                                                                                                                                                    limits is < 25%.



                    Substances with properties       R50 Very toxic to aquatic organisms, and                                                                        Less than the
                    according to hazard class of     R53 May cause sensitization by skin                                                                         concentration limit
                    dangerous: very toxic to aquatic Acute toxicity:                                                                                               specified in the
                    organisms, may cause longterm - 96-hour LC50 (for fish) ≤ 1 mg / l, or                                                                       CLP/GHS Database
                                                     - 48-hour EC50 (for Daphnia) ≤ 1 mg / l, or                                                                     (Annex VI to
                    adverse effects in the aquatic
                                                     - 72 hours IC50 (for algae) ≤ 1 mg / l                                                                      Regulation (EC) No
                    environment (R 50/53)
                                                        and                                                                                                      1272/2008). If the
                                                        - the substance is not nedbrytbart20                                                                       substance not is
                                                        - the log Pow (log octanol / water) - ≥ 3.0 (unless the experimentally determined BCF ≤ 100).              specified in the
                                                                                                                                                                 CLP/GHS Database,
                                                                                                                                                                  the concentration
                                                                                                                                                                   limits is < 2.5%.



                    Substances with properties         R53 May cause sensitization by skin                                                                             < 25%
                    according to hazard class of        Subjects not meeting any of the criteria for environmental hazard as previously stated, but which
                    dangerous: may cause long-term     nevertheless are expected to bring long-term or delayed danger to the aquatic ecosystem structure or
                    adverse effects in the aquatic     function. The assessment is based on data on persistence and bioaccumulation, and the substances
                                                       expected or observed behavior and fate. Substances that are insoluble in water, ie. substances with a
                    environment (R53)
                                                       solubility of less than 1 mg / l under this criterion if
                                                        - the substance is not readily biodegradable, and
                                                        - the log Pow ≥ 3.0 (unless the experimentally determined BCF ≤ 100).
Substances with properties       R51 Toxic to aquatic organisms, and                                                           < 25%
according to hazard class of     R53 May cause sensitization by skin
dangerous: toxic to aquatic      Acute toxicity:
organisms, may cause long-term   - 96-hour LC50 (for fish) 1 mg / l <LC50 ≤ 10 mg / l, or
                                 - 48-hour EC50 (for Daphnia) 1 mg / l <EC50 ≤ 10 mg / l ≤ 1 mg / l
adverse effects in the aquatic
                                 or
environment (R 51/53)
                                 - 72 hours IC50 (for algae) 1 mg / l <IC50 ≤ 10 mg / l
                                 and
                                 - the substance is not readily biodegradable 16, or
                                 - the log Pow (log octanol / water) ≥ 3.0 (unless the experimentally determined BCF ≤ 100).

				
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