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, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas differences between national laws relating to 
food additives and their conditions of use hinder the free 
movement of foodstuffs and may create conditions of 
unfair competition, thereby directly affecting the 
establishment or functioning of the common market; 
Whereas the approximation of these laws is necessary for 
the free movement of foodstuffs; 
Whereas the drawing up of lists of the categories of food 
additives to be covered by a Directive is a matter to be 
decided by the Council under the procedures described 
by Article 100 of the Treaty; 
Whereas the use of food additives belonging to such 
categories should be authorized only on the basis of 
agreed scientific and technological criteria laid down by 
the Council; 
Whereas, in the context of specific Directives, the 
Scientific Committee for Food, set up by Commission 
Decision 74/234/EEC ('), should be consulted before 
the adoption of provisions likely to have an incidence in 
respect of public health; 
Whereas the inclusion of individual substances in a 
category or categories of food additives is thereafter a 
technical matter to be entrusted to the Commission; 
whereas the determination of the criteria of purity for such food additives, the elaboration of methods of 
analysis and sampling and the fixing of conditions of use 
are also technical matters to be entrusted to the 
Commission; 
Whereas existing Community provisions on colouring 
matters, preservatives, antioxidants and emulsifiers, stabi­
lizers, thickeners and gelling agents will require 
amendment in the light of this Directive; 
Whereas in all cases where the Council empowers the 
Commission to implement rules relating to foodstuffs, 
provision should be made for a procedure instituting 
close cooperation between Member States and the 
Commission within the Standing Committee for 
Foodstuffs, set up by Council Decision 69/414/EEC (2), 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive shall apply to food additives used or 
intended to be used as ingredients during the manu­
facture or preparation of a foodstuff and still present in 
the final product, even if in altered form, hereinafter 
called 'food additives', the various categories of which 
are given in Annex I. 
2. For the purposes of this Directive 'food additive' 
means any substance not normally consumed as a food 
by itself and not normally used as a typical ingredient of 
food whether or not it has nutritive value, the intentional 
addition of which to food for a technological (including 
organoleptic) purpose in the manufacture, processing, 
preparation, treatment, packaging, transport or holding 
of such food results, or may be reasonably expected to 
result (directly or indirectly), in it or its by-products 
becoming a component of such foods. 
(') OJNoL 136,20. 5. 1974, p. 1. O OJ No L 291, 29. 11. 1969, p. 9. 
16. 5. 86 Official Journal of the European Communities No C 116/3 
The term does not include substances added to food as 
nutrients. 
3. This Directive shall not apply to: 
(a) processing aids; 
(b) substances used in the protection of plants and plant 
products and covered by Community rules relating 
to plant health; 
(c) flavourings for use in foodstuffs; falling within 
the scope of Council Directive . . /. . ./EEC 
(flavourings). 
Article 2 
1. No food additive shall be used in the manufacture 
or preparation of a foodstuff for any technological 
function described and defined in Annex I other than the 
substances included in lists and where applicable only 
under the conditions of use specified therein. 
2. Food additives shall be included in one of the cat­
egories in Annex I according to the principal function 
normally associated with the food additive in question. 
However, the allocation of the additive to a particular 
class does not exclude the possibility that the substance 
might be capable of several functions. 
3. Food additives may only be included in a list on the 
basis of the criteria on safety and technological need 
described in Annex II. 
Article 3 
1. Particular provisions relating to categories of food 
additives listed in Annex I shall be laid down by way of 
specific Directives. 
2. The specific Directives, including amendments to 
existing specific Directives on particular categories of 
additives shall be adopted according to the procedure 
laid down in Article 9. 
3. The specific Directives shall include: 
(a) the list of substances, the use of which is authorized 
to the exclusion of all others; 
(b) the criteria of purity for the substances in question; 
(c) where necessary, the foodstuffs to which these sub­
stances may be added and the conditions under 
which they may be added; 
(d) where necessary, the methods of analysis needed to 
verify that the criteria of purity referred to in 
paragraph 2 are satisfied; (e) where necessary, the procedure for taking samples 
and the methods for the qualitative and quantitative 
analysis of food additives in and on foodstuffs; 
(f) other rules necessary to ensure compliance with the 
provisions of Article 2. 
Provisions which are likely to have an incidence on 
public health shall be adopted after consultation of the 
Scientific Committee for Food. 
Article 4 
1. Where a Member State, as a result of new infor­
mation or of a reassessment of existing information made 
since this Directive, or any Directive drawn up under 
Article 3, was adopted has detailed grounds for 
establishing that the addition to food of one of the sub­
stances listed in one of the categories in Annex I or the 
maximum level which may be present or the level of one 
or more of the components defined in the criteria of 
purity referred to in Article 3, although it complies with 
the provisions of this Directive, or any Directive drawn 
up under Article 3, endangers human health, that 
Member State may temporarily suspend or restrict 
application of the provisions in question in its territory. It 
shall immediately inform the other Member States and 
the Commission thereof and give reasons for its decision. 
2. The Commission shall examine as soon as possible 
the grounds given by the Member State within the 
Standing Committee for Foodstuffs, and shall then 
deliver its opinion forthwith and take the appropriate 
measures. 
3. If the Commission considers the amendments to 
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 
laid down in Article 9, with a view to adopting those 
amendments; the Member State which has adopted 
safeguard measures may in that event retain them until 
the amendments have been adopted. 
Article 5 
1. Food additives not intended for sale to the ultimate 
consumer may be marketed only if their packaging or 
containers bear the following information, which must be 
conspicuous, clearly legible and indelible: 
(a) for food additives sold singly or mixed with each 
other, for each component, the name laid down by 
any Community provisions applying to the product 
in question and its EEC number or in the absence of 
such provisions, a description of the product that is 
sufficiently precise to enable it to be distinguished 
No CI 16/4 Official Journal of the European Communities 16.5.86 
from products with which it could be confused, in 
descending order of the proportion by weight which 
each component bears to the total; 
other substances or materials or food ingredients 
may be incorporated in quantities strictly necessary 
to facilitate storage, sale, standardization, dilution or 
dissolution of a food additive or food additives; their 
presence shall not affect the name of the product, 
but they shall also be declared in the mixtures in 
descending order of proportion by weight which 
each component bears to the total; 
(b) either the statement 'for use in food' or a more 
specific reference to its intended food use; 
(c) if necessary, any special storage conditions or 
conditions of use; 
(d) instructions for use when it would be impossible to 
make appropriate use of the product in the absence 
of such instructions; 
(e) an identifying batch or lot number; 
(f) the name or business name and address of the manu­
facturer or packager, or of a seller established within 
the Community; 
(g) an indication of the percentage of any component 
which is subject to a quantitative limitation in a food 
or adequate compositional information to enable the 
purchaser to comply with any Community 
provisions, or in their absence national provisions, 
applying to the food. Where the same quantitative 
limitation applies to a group of components used 
singly or in combination, the combined percentage 
may be given as a single figure. Where Community 
provisions provide for the addition of materials for 
the purposes of standardization, the quantity of 
additive may be taken to include the permitted 
standardizing agents; 
(h) the nominal net quantity expressed in units of mass 
or volume. 
2. By way of derogation from paragraph 1 the infor­
mation required by paragraph 1 (d), (g) and (h) may 
appear on the relevant trade documents relating to the 
consignment to be furnished on or before delivery, 
provided that the statement 'for food manufacturing 
purposes, not for retail sale' appears in a prominent 
position on the packagings or container of the product in 
question. 
Article 6 containers bear the following information which must be 
conspicuous, clearly legible and indelible: 
(a) the name under which the product is sold. This name 
shall be that laid down by any Community provisions 
applying to the product in question and its EEC 
number, or in the absence of such provisions a 
description of the product that is sufficiently precise 
to enable it to be distinguished from products with 
which it could be confused; 
(b) the information required by Article 5(1) (a), (b), (c), 
(d), (e), (f)and(h); 
(c) the date of minimum durability within the meaning 
of Article 9 of Council Directive 79/112/EEC (x); 
(d) any other information provided for in the specific 
Directives referred to in Article 3. 
Article 7 
The provisions of Articles 5 and 6 are without prejudice 
to more detailed or more extensive laws, regulations or 
administrative provisions regarding weights and 
measures, or applying to the classification, packaging 
and labelling of dangerous substances and preparations 
or the transport of such substances. 
Article 8 
Member States shall refrain from laying down 
requirements more detailed than those already contained 
in Articles 5 and 6 concerning the manner in which the 
particulars provided for therein are to be shown. 
The particulars provided for in Articles 5 and 6 shall 
appear in a language easily understood by purchasers 
unless other measures have been taken to ensure that the 
purchaser is informed. This provision shall not prevent 
such particulars from being indicated in various 
languages. 
Article 9 
Where the procedure laid down in this Article is 
invoked, the Commission shall decide after consulting 
the Standing Committee on Foodstuffs set up under 
Decision 69/414/EEC, hereinafter referred to as 'the 
Committee'. The Committee shall discuss matters on 
which the Commission has requested an opinion. When 
seeking the opinion of the Committee, the Commission 
may set a time limit within which such opinion shall be 
given. No vote shall be taken. However, any member of 
the Committee may demand that his views be set down 
in the minutes. 
Food additives intended to be sold to the ultimate 
consumer may be marketed only if their packagings or (') OJNoL 33, 8. 2. 1979, p. 1. 
16.5.86 Official Journal of the European Communities No C 116/5 
Article 10 
1. Member States shall take all measures necessary to 
ensure that food additives belonging to the categories 
defined in Annex I may be marketed only if they 
conform to the definitions and rules laid down in this 
Directive and the Annexes thereto. 
2. Member States may not prohibit, restrict or 
obstruct the marketing of food additives, food or food 
ingredients on grounds relating to food additives, if these 
comply with the provisions of this Directive and the 
specific Directives. 
Article 11 
Measures to bring existing Community Directives into 
line with this Directive shall be adopted according to the 
procedure laid down in Article 9. 
Article 12 
Member States may not invoke the composition, 
labelling or behaviour in foods of food additives as grounds for prohibiting, restricting or hampering the 
marketing and use of food additives if they comply with 
the requirements of this Directive or the specific 
Directives. 
Article 13 
Member States shall amend their laws, regulations and 
administrative provisions in such a way as to: 
— permit by (18 months after notification) at the latest 
the trade and use of food additives complying with 
this Directive, without prejudice to the application of 
national provisions which, in the absence of specific 
Directives, apply to certain groups of food additives, 
— prohibit from (three years after notification) trade in 
and use of food additives not complying with this 
Directive. 
They shall forthwith inform the Commission thereof. 
Article 14 
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 
No C 116/6 Official Journal of the European Communities 16.5.86 
ANNEX II 
GENERAL CRITERIA FOR THE 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.