Day 039 - 20 Oct 94 - Page 04

     
     1        are aware of it.  What was the fourth category you just
     2        added?  I have got intolerances and allergies,
     3        carcinogenicity, hyperactivity?
     4        A.  Well, I think I characterised the other broad group of
     5        effects as other long-term adverse effects.  So, they
     6        include, for instance, ulceration in respect of carrageenan
     7        and possible birth defects in respect of another compound
     8        and, rather than generate a lengthy list of some
     9        categories, I would be happy to organise it under those
    10        headings.
    11
    12   MR. JUSTICE BELL:  I will start, as it were, with Sunset
    13        Yellow.  I will merely say that the parts I have
    14        underlined, because we dealt with this yesterday, are on
    15        page 9 of your new statement:  "Certain azo-dyes including
    16        Sunset Yellow FCF have been shown to be associated with
    17        hypersensitive reactions in man", reference 1.
    18
    19        Over the page:  "There is some direct evidence that it",
    20        that is Sunset Yellow, "can provoke unpleasant acute
         symptoms in humans", reference 8.  "It was reported as
    22        recently as 1989 that a physician in the USA had been found
    23        to be suffering with allergic gastroenteritis in reaction
    24        to Sunset Yellow, and this causal link was confirmed by
    25        double-blind challenge".
    26
    27        Reference 1 records that "efforts should be made to define
    28        the extent of these phenomena. In the meantime", it says,
    29         "the use of Sunset Yellow FCF", you remember we looked at
    30        this yesterday, "as a colouring in food is acceptable.
    31        (Reading to the words) in support of the statement has been
    32        shown to be associated with hypersensitive reactions in
    33        man, a reference to document 8", which is the reference for
    34        the second part I read out.  In document 8, I have to say,
    35        "Sunset Yellow was administered in doses 1, 2, 5 and 10
    36        milligrams to seven patients".  It is not clear to me just
    37        what doses were administered to the individual patients,
    38        but bear in mind that the ADI is 2.5 milligrams per
    39        kilogram of body weight.  So if you had, for instance, a 60
    40        kilo woman, one milligram would be about 20 times the ADI
         and 10 milligrams would be about 200 times the ADI.
    42
    43        "Of the seven patients there was no reaction or no reaction
    44        to Sunset Yellow mentioned in five.  There was a doubtful
    45        reaction in one and a positive reaction in another.  The
    46        reactions were the allergic (reading to the words)
    47        into tissue".  We looked at the physician yesterday.
    48
    49        I merely mention that in case you want to follow it up.
    50        I have not looked at other matters in such detail, or in 
    51        case you want to ask Dr. Millstone if he has got any 
    52        further comment on that. 
    53
    54   MR. MORRIS:  Do you want to start on that, Dr. Millstone?
    55
    56   MS. STEEL:   Can I say something else?  You said you picked out
    57        the bits relating to people.
    58
    59   MR. JUSTICE BELL:  Yes.
    60