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
