Day 038 - 19 Oct 94 - Page 57


     
     1        term, what do they include so far as Sunset Yellow is
     2        concerned?
     3        A.  I am not aware of specific reports of other specific
     4        reactions in respect of Sunset Yellow.
     5
     6   MR. JUSTICE BELL:  Apart from the?
     7        A.  Apart from skin rashes, the gastroenteritis and the
     8        hyperactivity.  I think it might be useful if I were to
     9        point out that Sunset Yellow was not very widely used in
    10        the UK prior to the mid-80s.  The far more popular compound
    11        of that hue was tartrazine, also known as E102.  There was
    12        a great deal of criticism voiced of tartrazine in the mid
    13        and late 80s, and many manufacturers consequently withdrew
    14        tartrazine and replaced with it with Sunset Yellow.  There
    15        has been a relatively brief period of time of widespread
    16        use and, therefore, even though Sunset Yellow has been on
    17        the market for many years since the late 19th Century, its
    18        use was relatively rare until about 10 years ago.
    19        Therefore, the occasion for adverse reaction reports in the
    20        interim has been relatively slight.
    21
    22   MR. MORRIS:  When Professor Walker was examined by Mr. Rampton
    23        he was asked about the allergy risk on page 24 of the
    24        transcript.  "It is said to cause skin rashes, swelling,
    25        blood vessels, gastric ulcer and vomiting.  How did he
    26        characterise that?"  He categorised it as a number 1 which
    27        was "Without gloss, comparatively rare allergies and not
    28        very serious". He said: "Is it rare?"  "It is relatively
    29        rare. It is not serious. It is reversible".  These are
    30        allergies separate from hyperactivity.  He said:  "Stomach
    31        upset was only in extreme cases, nettle rash, hives". "What
    32        is 'hives'?" "Nettle rash type".  "I thought that ..."
    33        A.  I think Professor Walker and I would not disagree about
    34        the kinds of symptoms which may be ascribed to Sunset
    35        Yellow, though we might have a difference of opinion about
    36        the frequency.  Quite what numbers correspond to terms like
    37        "rare" and "very rare" is also a matter we could dispute,
    38        but I am not -- I might say, I might agree with him that
    39        they are rare, but by "rare" I mean perhaps not more than
    40        five per cent of the time; whereas by "rare" he might mean
    41        less frequently than one person in a 1,000.
    42
    43   MR. JUSTICE BELL:  I think there must be some difference,
    44        because I have to say that five per cent of the population
    45        (which is one in 20 people) reacting adversely to some
    46        degree to Sunset Yellow would seem quite high to me?
    47        A.  I would consider it high, but I have been in meetings
    48        with professional toxicologists who have characterised
    49        frequency of five per cent as rare, as if they treat --
    50        sorry, let me rephrase that.  It is almost as if they think 
    51        something is only a real effect if it occurs at a much 
    52        higher frequency than that; one that can be properly 
    53        ascribed to the compound rather than to the person who
    54        reacts.
    55
    56   MR. JUSTICE BELL:  Did you want to ask any more about that or do
    57        you want to go on to amaranth?
    58
    59   MR. MORRIS:  I think we can move on.  Before we leave Sunset
    60        Yellow, you said about the regulatory status in Norway.  It

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