CELEX: 51986PC0087
Language: en
Date: 1986-04-14
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING FOOD ADDITIVES AUTHORIZED FOR USE IN FOODSTUFFS INTENDED FOR HUMAN CONSUMPTION

No C 116/2                                 Official Journal of the European Communities                                  16. 5. 86
                                                                  II
                                                          (Preparatory Acts)
                                                    COMMISSION
               Proposal for a Council Directive on the approximation of the laws of the Member States
                 concerning food additives authorized for use in foodstuffs intended for human consumption
                                                         COM(86) 8 7 final
                                  (Submitted by the Commission to the Council on 17 April 1986)
                                                           (86/C 116/02)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                              such food additives, the elaboration of methods of
                                                                      analysis and sampling and the fixing of conditions of use
Having regard to the Treaty establishing the European                 are also technical matters to be entrusted to the
Economic Community, and in particular Article 100                     Commission;
thereof,
Having regard to the proposal from the Commission,                    Whereas existing Community provisions on colouring
                                                                      matters, preservatives, antioxidants and emulsifiers, stabi-
                                                                      lizers, thickeners and gelling agents will require
Having regard       to    the   opinion    of   the   European        amendment in the light of this Directive;
Parliament,
Having regard to the opinion of the Economic and                      Whereas in all cases where the Council empowers the
Social Committee,                                                     Commission to implement rules relating to foodstuffs,
                                                                      provision should be made for a procedure instituting
Whereas differences between national laws relating to                 close cooperation between Member States and the
food additives and their conditions of use hinder the free            Commission within the Standing Committee for
movement of foodstuffs and may create conditions of                   Foodstuffs, set up by Council Decision 69/414/EEC (2),
unfair competition, thereby directly affecting the
establishment or functioning of the common market;
                                                                      HAS ADOPTED THIS DIRECTIVE:
Whereas the approximation of these laws is necessary for
the free movement of foodstuffs;
                                                                                                Article 1
Whereas the drawing up of lists of the categories of food
additives to be covered by a Directive is a matter to be               1.   This Directive shall apply to food additives used or
decided by the Council under the procedures described                 intended to be used as ingredients during the manu-
by Article 100 of the Treaty;                                         facture or preparation of a foodstuff and still present in
                                                                      the final product, even if in altered form, hereinafter
Whereas the use of food additives belonging to such                   called 'food additives', the various categories of which
categories should be authorized only on the basis of                  are given in Annex I.
agreed scientific and technological criteria laid down by
the Council;
                                                                      2.     For the purposes of this Directive 'food additive'
                                                                      means any substance not normally consumed as a food
Whereas, in the context of specific Directives, the
                                                                      by itself and not normally used as a typical ingredient of
Scientific Committee for Food, set up by Commission
                                                                      food whether or not it has nutritive value, the intentional
Decision 74/234/EEC ('), should be consulted before
                                                                      addition of which to food for a technological (including
the adoption of provisions likely to have an incidence in
                                                                      organoleptic) purpose in the manufacture, processing,
respect of public health;
                                                                      preparation, treatment, packaging, transport or holding
                                                                      of such food results, or may be reasonably expected to
Whereas the inclusion of individual substances in a                   result (directly or indirectly), in it or its by-products
category or categories of food additives is thereafter a              becoming a component of such foods.
technical matter to be entrusted to the Commission;
whereas the determination of the criteria of purity for
(') O J N o L 136,20. 5. 1974, p. 1.                                  O OJ No L 291, 29. 11. 1969, p. 9.
 ---pagebreak--- 16. 5. 86                                Official Journal of the European Communities                               No C 116/3
The term does not include substances added to food as               (e) where necessary, the procedure for taking samples
nutrients.                                                               and the methods for the qualitative and quantitative
                                                                         analysis of food additives in and on foodstuffs;
3.     This Directive shall not apply to:
                                                                    (f) other rules necessary to ensure compliance with the
(a) processing aids;                                                     provisions of Article 2.
(b) substances used in the protection of plants and plant
     products and covered by Community rules relating               Provisions which are likely to have an incidence on
     to plant health;                                               public health shall be adopted after consultation of the
                                                                    Scientific Committee for Food.
(c) flavourings for use in foodstuffs; falling within
     the scope of Council Directive . . / . . ./EEC
     (flavourings).                                                                            Article 4
                                                                    1.    Where a Member State, as a result of new infor-
                           Article 2                                mation or of a reassessment of existing information made
                                                                    since this Directive, or any Directive drawn up under
1.     No food additive shall be used in the manufacture            Article 3, was adopted has detailed grounds for
or preparation of a foodstuff for any technological                 establishing that the addition to food of one of the sub-
function described and defined in Annex I other than the            stances listed in one of the categories in Annex I or the
substances included in lists and where applicable only              maximum level which may be present or the level of one
under the conditions of use specified therein.                      or more of the components defined in the criteria of
                                                                    purity referred to in Article 3, although it complies with
2.     Food additives shall be included in one of the cat-          the provisions of this Directive, or any Directive drawn
egories in Annex I according to the principal function              up under Article 3, endangers human health, that
normally associated with the food additive in question.             Member State may temporarily suspend or restrict
However, the allocation of the additive to a particular             application of the provisions in question in its territory. It
class does not exclude the possibility that the substance           shall immediately inform the other Member States and
might be capable of several functions.                              the Commission thereof and give reasons for its decision.
3.     Food additives may only be included in a list on the         2.     The Commission shall examine as soon       as possible
basis of the criteria on safety and technological need              the grounds given by the Member State            within the
described in Annex II.                                              Standing Committee for Foodstuffs, and            shall then
                                                                    deliver its opinion forthwith and take the       appropriate
                                                                    measures.
                           Article 3
1.     Particular provisions relating to categories of food
additives listed in Annex I shall be laid down by way of            3.     If the Commission considers the amendments to
specific Directives.                                                this Directive are necessary in order to resolve the
                                                                    difficulties mentioned in paragraph 1 and to ensure the
                                                                    protection of human health, it shall initiate the procedure
2.     The specific Directives, including amendments to             laid down in Article 9, with a view to adopting those
existing specific Directives on particular categories of            amendments; the Member State which has adopted
additives shall be adopted according to the procedure               safeguard measures may in that event retain them until
laid down in Article 9.                                             the amendments have been adopted.
3.     The specific Directives shall include:
                                                                                               Article 5
(a) the list of substances, the use of which is authorized
     to the exclusion of all others;                                 1.    Food additives not intended for sale to the ultimate
                                                                    consumer may be marketed only if their packaging or
(b) the criteria of purity for the substances in question;          containers bear the following information, which must be
                                                                    conspicuous, clearly legible and indelible:
(c) where necessary, the foodstuffs to which these sub-
     stances may be added and the conditions under                  (a) for food additives sold singly or mixed with each
     which they may be added;                                            other, for each component, the name laid down by
                                                                         any Community provisions applying to the product
(d) where necessary, the methods of analysis needed to                   in question and its EEC number or in the absence of
    verify that the criteria of purity referred to in                    such provisions, a description of the product that is
     paragraph 2 are satisfied;                                          sufficiently precise to enable it to be distinguished
 ---pagebreak--- No C I 16/4                               Official Journal of the European Communities                                         16.5.86
    from products with which it could be confused, in                containers bear the following information which must be
    descending order of the proportion by weight which               conspicuous, clearly legible and indelible:
    each component bears to the total;
    other substances or materials or food ingredients                 (a) the name under which the product is sold. This name
    may be incorporated in quantities strictly necessary                  shall be that laid down by any Community provisions
    to facilitate storage, sale, standardization, dilution or             applying to the product in question and its EEC
    dissolution of a food additive or food additives; their               number, or in the absence of such provisions a
    presence shall not affect the name of the product,                    description of the product that is sufficiently precise
    but they shall also be declared in the mixtures in                    to enable it to be distinguished from products with
    descending order of proportion by weight which                        which it could be confused;
    each component bears to the total;
                                                                     (b) the information required by Article 5(1) (a), (b), (c),
(b) either the statement 'for use in food' or a more                      (d), (e), ( f ) a n d ( h ) ;
    specific reference to its intended food use;
                                                                     (c) the date of minimum durability within the meaning
                                                                          of Article 9 of Council Directive 79/112/EEC (x);
(c) if necessary, any special        storage   conditions   or
    conditions of use;
                                                                     (d) any other information provided for in the specific
                                                                          Directives referred to in Article 3.
(d) instructions for use when it would be impossible to
    make appropriate use of the product in the absence
    of such instructions;                                                                               Article 7
                                                                     The provisions of Articles 5 and 6 are without prejudice
(e) an identifying batch or lot number;                              to more detailed or more extensive laws, regulations or
                                                                     administrative        provisions          regarding weights   and
(f) the name or business name and address of the manu-               measures, or applying to the classification, packaging
    facturer or packager, or of a seller established within          and labelling of dangerous substances and preparations
    the Community;                                                   or the transport of such substances.
(g) an indication of the percentage of any component                                                    Article 8
    which is subject to a quantitative limitation in a food
    or adequate compositional information to enable the              Member States shall refrain from laying down
    purchaser to comply with any                   Community         requirements more detailed than those already contained
    provisions, or in their absence national provisions,             in Articles 5 and 6 concerning the manner in which the
    applying to the food. Where the same quantitative                particulars provided for therein are to be shown.
    limitation applies to a group of components used
    singly or in combination, the combined percentage
                                                                     The particulars provided for in Articles 5 and 6 shall
    may be given as a single figure. Where Community
                                                                     appear in a language easily understood by purchasers
    provisions provide for the addition of materials for
                                                                     unless other measures have been taken to ensure that the
    the purposes of standardization, the quantity of
                                                                     purchaser is informed. This provision shall not prevent
    additive may be taken to include the permitted
                                                                     such particulars from being indicated in various
    standardizing agents;
                                                                     languages.
(h) the nominal net quantity expressed in units of mass
    or volume.                                                                                          Article 9
                                                                     Where the procedure laid down in this Article is
2.    By way of derogation from paragraph 1 the infor-               invoked, the Commission shall decide after consulting
mation required by paragraph 1 (d), (g) and (h) may                  the Standing Committee on Foodstuffs set up under
appear on the relevant trade documents relating to the               Decision 69/414/EEC, hereinafter referred to as 'the
consignment to be furnished on or before delivery,                   Committee'. The Committee shall discuss matters on
provided that the statement 'for food manufacturing                  which the Commission has requested an opinion. When
purposes, not for retail sale' appears in a prominent                seeking the opinion of the Committee, the Commission
position on the packagings or container of the product in            may set a time limit within which such opinion shall be
question.                                                            given. No vote shall be taken. However, any member of
                                                                     the Committee may demand that his views be set down
                                                                     in the minutes.
                           Article 6
Food additives intended to be sold to the ultimate
consumer may be marketed only if their packagings or                 (') O J N o L 33, 8. 2. 1979, p. 1.
 ---pagebreak---  16.5.86                                  Official Journal of the European Communities                              No C 116/5
                         Article 10                                  grounds for prohibiting, restricting or hampering the
                                                                     marketing and use of food additives if they comply with
1.    Member States shall take all measures necessary to             the requirements of this Directive or the specific
ensure that food additives belonging to the categories               Directives.
defined in Annex I may be marketed only if they
conform to the definitions and rules laid down in this                                        Article 13
Directive and the Annexes thereto.
                                                                     Member States shall amend their laws, regulations and
2.    Member States may not prohibit, restrict or                    administrative provisions in such a way as to:
obstruct the marketing of food additives, food or food
ingredients on grounds relating to food additives, if these          — permit by (18 months after notification) at the latest
comply with the provisions of this Directive and the                    the trade and use of food additives complying with
specific Directives.                                                    this Directive, without prejudice to the application of
                                                                        national provisions which, in the absence of specific
                         Article 11                                     Directives, apply to certain groups of food additives,
                                                                     — prohibit from (three years after notification) trade in
Measures to bring existing Community Directives into                    and use of food additives not complying with this
line with this Directive shall be adopted according to the              Directive.
procedure laid down in Article 9.
                                                                     They shall forthwith inform the Commission thereof.
                         Article 12
                                                                                              Article 14
Member States may not invoke the composition,
labelling or behaviour in foods of food additives as                 This Directive is addressed to the Member States.
                                                             ANNEX I
                                              CATEGORIES OF FOOD ADDITIVES
                                  Colour
                                  Preservative
                                  Antioxidant
                                  Emulsifier
                                  Thickener
                                  Gelling agent
                                  Stabilizer
                                  Flavour enhancer
                                  Acid
                                  Acidity regulator
                                  Anticaking agent
                                  Modified starch
                                  Sweetener
                                  Raising agent
                                  Antifoaming agent
                                  Glazing agent
                                  Flour treatment agent
                                  Firming agent
                                  Humectant
                                  Sequestrant
                                  Yeast nutrient
                                  Foam stabilizer
                                  Enzyme
 ---pagebreak--- N o C 116/6                                Official J o u r n a l of the E u r o p e a n Communities                         16.5.86
                                                                    ANNEX       II
                                  GENERAL CRITERIA FOR T H E USE OF FOOD ADDITIVES
            1. All food additives must be subjected to appropriate toxicological testing and evaluation. This evaluation
               should take into account, among other things, any cumulative, synergistic or potentiating effects of their
               use.
               Before an additive is accepted for use in food, it must have been subjected to an adequate toxicological
               evaluation. Implicit in this evaluation is the assumption that the proposed level of use does not exceed
               the lowest level which is necessary to ensure that the desired results in food manufacturing pratice are
               achieved. Additionally, there should be evidence that the proposed use of the additive would have
               technological advantages and confer benefit on the consumer, in other words it is necessary to establish
               the case for what is commonly referred to as 'need'. A 'need' for a food additive may be claimed if the
               use of the additive gives demonstrable technological, economic or other advantages of benefit to the
               consumer.
               The existence of the comparatively infrequent phenomenon of human intolerance to substances foreign
               to the body cannot be ignored, whether this intolerance takes the clinical form of hypersensitivity or
               allergy.
            2. Only those food additives must be endorsed which, so far as can be judged on the evidence presently
               available, present no hazard to the health of the consumer at the levels of use proposed.
            3. All food additives must be kept under continuous observation and must be re-evaluated whenever
               necessary in the light of changing conditions of use and new scientific information.
            4. Food additives must at all times conform with approved criteria of purity.
            5. The use of food additives is justified only where they serve one or more of the purposes set out from (a)
               to (d) and only where these purposes cannot be achieved by other means which are economically and
               technologically practicable and do not present a hazard to the health of the consumer:
               (a) to preserve the nutritional quality of the food; an intentional reduction in the nutritional quality of a
                    food would only be justified where the food does not constitute a significant item in a normal diet,
                    or where the additive is necessary for the production of foods for groups of consumers having
                    special dietary needs;
               (b) to provide necessary ingredients or constituents for foods manufactured for groups of consumers
                    having special dietary needs;
               (c) to enhance the keeping quality or stability of a food or to improve its organoleptic properties,
                    provided that this does not so change the nature, substance or quality of the food as to deceive the
                    consumer;
               (d) to provide aids in manufacture, processing, preparation, treatment, packing, transport or storage of
                    food; provided that the additive is not used to disguise the effects of the use of faulty raw materials
                    or of undesirable (including unhygienic) practices or techniques during the course of any of these
                    activities.
            6. Approval for food additives must:
               (a) as far as possible be limited to specific foods for specific purposes and under specific conditions;
               (b) be at the lowest level of use necessary to achieve the desired effect;
               (c) as far as possible take into account any acceptable daily intake, or equivalent assessment, established
                    for the food additives and the probable daily intake of it from all sources. Where the food additive
                    is to be used in foods eaten by special groups of consumers, account should be taken of the
                   probable daily intake of the food additive by consumers in those groups.