CELEX: 51988PC0132
Language: en
Date: 1988-04-06
Title: Amended Proposal for a COUNCIL DIRECTIVE amending for the eighth time the Directive of 23 October 1962 of the approximation of the rules of the Member States concerning the colouring matters that are authorized for use in foodstuffs intended for human consumption (COM(85) 474 final) (submitted to the Council by the Commission pursuant to the third paragraph of Article 149 of the EEC Treaty)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 132
Vol. 1988/0040
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                         COM(88 ) 132 final - SYN 43
                                         Brussels , 6 April 1988
                          Amended Proposal for a
                             COUNCIL DIRECTIVE
   amending for the eighth time the Directive of 23 October 1962 of
     the approximation of the rules of the Member States concerning
     the colouring matters that are authorized for use in foodstuffs
           intended for human consumption ( COM(85 ) 474 final )
   ( submitted to the Council by the Commission pursuant to the third
               paragraph of Article 149 of the EEC Treaty )
 ---pagebreak---                                  EXPLANATORY NOTE
In September 198 5 the Commission proposed that the Directive
concerning colouring matters in food should be updated in three ways
to reflect the situation in the enlarged Community . These were as
follows :
       1 . modifying the list of permitted substances
       2 . updating the purity criteria for the permitted substances
       3 . consequential éditorial modifications
The Council has still not been able to agree on a common position for
submission to the Parliament for its second reading , despite the clear
statement in the initial proposal that the modifications should be
quickly adopted ( see paragraphs 3.3 to 3,5 of the explanatory note to
the initial proposal ) .
In the intervening period new data have become available on the safety
of a number of colouring matters which , in the opinion of the
Commission , require it to modify its initial proposed amendment .
The purpose of the present proposal is to address the new situation
and is without prejudice to other action which the Commission believes
should be taken in the context of       its aims to   introduce an internal
market by 1992 , in particular in the fixing of limits for the
conditions of use for colouring matters in general .          This is
especially important where the safety margin between the level of
consumption accepted by the Scientific Committee for Food as without
effect ( i.e based on the Acceptable Daily Intake set by the committee
on the basis of the safety data on the substance ) and the actual
intake based on information on current usage patterns in food of the
colouring matter concerned is small .
The Commission regrets that its proposals f or simplifying the
procedure by which technical changes to Directives on food additives
( including colouring matters ) may be adopted has still not been agreed
by the Council   ( COM ( 86 ) 8 ? final and COM ( 87 ) 243 final ) .
As soon as the new simplified procedure is agreed , the Commission
intends to make further proposals for introducing Commun i ty rules on
conditions of use for other colouring matters not covered by the
present proposal . In the meantime the Commission believes it should
exceptionally use the more cumbersome procedure in Article 100A to
modify the Directive in respect of canthaxanthin , erythrosine and
caustic sulphite caramel , given the implications to public health of
the recently agreed opinion of the Scientific Committee for Food .
The latest report of the Scientific Committee for Food , which was
agreed on 10 December 1987 , includes the following recommendations on
the three above-mentioned colouring matters :
Canthaxanthin
The committee noted reports that the use of the substance as an
orally - administered skin pigment ing agent had led to crystalline
deposits in the human retina , with possible other related effects on
vision , The committee has requested additional data to clarify the
situation , and assess the implications of the food use of the
substance , These data have been requested for 1989 .
 ---pagebreak--- The Committee concluded that in the meantime , on the basis of current
knowledge , the Acceptable Daily Intake ( ADI ) should be substantially
reduced to a temporary value of 0-0,05 mg / kg bw ,
Severe limitations on use must   hr introduced to ensure that the ADI     is
not exceeded ,    It has been put to the Commission by industry that
canthaxanth i n has a limited use in a wide range of foods , but that the
overall average consumption based on sales is well within the ADI set
by the committee ,    The limited information available to the
Commission on the actual food consumption of individual consumers made
it impossible to confirm that consumers with diets which might not be
equivalent to the average are also protected ,      Therefore the
Commission has proposed restrictions on use which err on the side of
caution to ensure that the consumer has a high level of protection ,
bearing in mind that canthaxanthin is already permitted in animal
feedingstuf fs for certain uses by other Community rules .
Clearly , when more detailed information on actual eating habits , or on
the safety of the substance is provided , the Commission will re-assess
the situation and make appropriate proposals ,
Erythrosine
Erythrosine has now been shown to cause adverse effects on
experimental animals in particular to the thyroid of rats fed at
higher doses than would be expected to occur from its food use . Other
effects suggesting that the substance may be carcinogenic to animals
were also noted .
Clinical  studies hâve shown that the substance has minimal     effect in
humans at a dose of 2Ü0mg daily over 14 days , while a dose of 60mg
daily is without effect .
The Scientific Committee   for Food concluded that the ADI   for
erythrosine could be fixed at 0-0.1mg / kg bw .
The Commission has been informed by industry that in many cases other
colouring matters , e.g. Allura Red , can be used .    However , for some
purposes , erythrosine is said to be irreplaceable ,     Similar problems
to those described for canthaxanthin were encountered when the
Commission was drawing up the restricted list of uses it is now
proposing .    The Commpission has made its decision on the principle
that the consumer requires a high level of protection .      Uses , ranging
from sugar confectionery to cured meats , are currently common , but the
Commission believes that the short list of uses it is proposing is a
more appropriate choice given the ADI for the substance and the nature
of the effects found in the animals tested .
Caustic sulphite caramels
The Scientific Committee for Food wishes to see further information
confirming its assumptions that materials on the market are reasonably
homogeneous and are chemically similar to other classes of caramels .
In the meantime the committee has accepted the temporary use of the
material in alcoholic beverages ,    The Commission believes that it
would be appropr iate to introduce this restriction on use as part of
the present proposal .
 ---pagebreak--- The present proposal to allow the substance in alcoholic beverages is
without prejudice to Community rules which prohibit the use of
colouring matters in certain categories of alcoholic beverages .
                       M      A     X    X
The Commission has also been asked to reintroduce the substance
lycopene into the Community list . The Commission is making no proposal
at this time as it has been informed that no lycopene obtained from
foods ( notably tomatoes ) is available on the market and that the
alternative , synthetically manufactured material cannot be
economically produced . The Scientific Committee for Food has advised
that while it would see no objection to the continued use of a
material prepared from foods ( it has made specific suggestions on the
procedure to be followed in such cases ), if a synthetic substance were
to become available the committee would expect to evaluate it in terms
of a modern toxicological data base appropriate to the substance and
its intended use .   The Commission would take this opinion into account
in formulating any new proposals .
                                    -4-
 ---pagebreak--- The following new amendments are made to ftnnex 1 ..:
 1 .   The references to E127 , E'150b and E161g are deleted from Part 1 ,
2.     The following references are added to Part 3 :
Column 1                     Column 2                    Column 3
El 27          Erythrosine                        454-30  ( Food Red 14 )
               - cocktail cherries  -
                 cherries           350 mg / kg
               - glac£ cherries -
                 cherries           150 mg / kg
               - canned mixed
                 fruit -
                 cherries           150 mg / kg
                 canned cherries  -
                 cherries           150 mg /' kg
El 50b         Caustic sulphite caramel           Caramel prepared by the
               - alcoholic beverages only         controlled heat    treat ¬
                                                  ment of carbohydrates
                                                  with sulphite
                                                  containing compounds
El 60g         Canthaxanthin                      40850 ( Food Orange 8 )
               - Strasbourg sausages 30 m g / k g
               - cake decorations     60 mg / kg
               - candied fruit      150 mg / kg
               - chewing gum        100 mg / kg
               - sugar-coated
                 dragees               50 mg / kg
   «
                                       -5-
 ---pagebreak---                       COMPETITIVES ' AUO r^PLOYMENT I.1- -, ACT STATEMENT
  1.        What is the main reason for introducing the .. easure ?
            Evidence of adverse effects on animals ( indue '9 man ) from
            the use of these materials .
  III ,     Features on the businesses in question .         In particular :
            (a)  Are there many SMEs ?        Yes , food manufacturer .
           (b)   Are they concentrated in régions which are :.
                 Ci )   eligible for régional aid in the Member States ?        No .
                 ( ii ) eligible under the ERDF7        No .
           Please note that the colour manufacturers concerned are net SMEs .
 III .    What direct obligations does this measure impose on businesses ?
           They may only use the colours in a restricted list of foods specifies
           at Community level .      Without the proposal all Member States would acr
           similarly but not necessarily identically . Therefore the impact          tbe
           proposal will not add appreciably to these national measures .
 IV .     What indirect obligations are local authorities likely to impose
          on businesses ?
          None .
V.       Are there are special measures in respect of SMEs ?             Please
         specify . .
          No .
VI .     What is t'ne likely effect on :
         Ca5    the competi ti ve.ness of business ?      None
         (b)    employment ?                              None
VII .    Hâve both sides of industry been consulted ?              Tes .
        Please indicate their opinions .
         Generally favourable to restrictions on use of these colourings .
         Some differences of opinion on the actual list of food to be
         specified .