No C 31/6 Official Journal of the European Communities 1.2.85 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of the laws of the Member States 
relating to modified starches intended for human consumption 
COM(84) 726 final 
(Submitted by the Commission to the Council on 3 January 1985) 
(85/C 31/09) 
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 any laws concerning modified starches 
which may be used in foodstuffs intended for human 
consumption must take account firstly of the need to 
protect human health, secondly of the need to protect 
the consumer from adulterated products and thirdly 
of the economic and technological necessities within 
the limits imposed by health protection 
considerations; 
Whereas differences between national laws relating to 
these substances, in so far as they impede the free 
movement of foodstuffs intended for human 
consumption, can lead to unequal conditions of 
competition and thus directly affect the establishment 
or proper functioning of the common market; 
Whereas the approximation of these laws is necessary 
to ensure the free movement of foodstuffs intended 
for human consumption; 
Whereas for this purpose it is appropriate to draw up 
a single list of relevant substances, use of which in 
foodstuffs intended for human consumption does not, 
according to the present state of scientific knowledge, 
pose a threat to human health; whereas this list 
should be supplemented by the definition of purity 
criteria which these substances must satisfy; 
Whereas, in the event of a subsequent threat to public 
health, the Member States should be able to take protective measures without delay; whereas, however, 
such action should be followed by a Community 
Decision; 
Whereas it is necessary to define labelling 
requirements in respect of modified starches in order 
to facilitate trade and to enable the manufacturers of 
such products to provide a more precise indication of 
their intended use, by adopting the designations listed 
in Annex 1; 
Whereas, however, since foodstuffs intended 
specifically for infants and young children constitute 
the principal source of infant nutrition in many cases, 
the use of certain starches should be limited to 5 % 
and the use of propylene oxide-modified starches 
should be prohibited; 
Whereas the list of authorized modified starches 
should be adapted in line with scientific and technical 
developments; whereas, however, it is advisable in 
such cases to entrust the Member States with the task 
of contributing, through the adoption of temporary 
national measures, to the search for a Community 
solution; 
Whereas any changes, based on advances in scientific 
and technical knowledge, to the conditions of use and 
the upper residue limits set out in Annex 1 as well as 
the definition of sampling and analysis methods for 
the purpose of checking the listed substances and 
their purity constitute technical implementing 
measures; whereas, for the purpose of simplifying and 
accelerating their adoption and facilitating their 
implementation, steps should be taken to ensure close 
cooperation between the Member States and the 
Commission within the framework of the Standing 
Committee on Foodstuffs set up pursuant to Council 
Decision 69/414/EEC (*), 
0) OJ No L 291, 19. 11. 1969, p. 9. 
1.2.85 Official Journal of the European Communities No C 31/7 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
For the purposes of this Directive, the term 'modified 
starches' means the products obtained by one or more 
chemical treatments of edible starches, which may 
have previously undergone a physical or enzymatic 
treatment. 
Article 2 
1. Subject to the provisions of Article 3, and 
notwithstanding Community or national requirements 
governing the composition of certain foodstuffs which 
are justified on grounds of the prevention of fraud, 
Member States shall authorize the marketing and use 
as foodstuffs ingredients of the modified starches 
listed in Annex 1 under the conditions laid down 
therein. 
2. The Member States shall prohibit the marketing 
and use of all other modified starches. 
Article 3 
Without prejudice to Community provisions relating 
to infant formulae and follow-up milk, use as an 
ingredient of foodstuffs intended specifically for 
infants and young children: 
(a) shall be prohibited in the case of the modified 
starches listed in Annex 1 under the letters K 
and R; 
(b) shall be limited to 5 % m/m in the case of the 
modified starches listed in Annex 1 under jhe 
letters D, F, G, H, I, J and N. 
Article 4 
Modified starches shall satisfy the general purity 
criteria set out in Annex 2. 
Article 5 
1. In order to take account of scientific or 
technical developments which have occurred since the 
adoption of this Directive, a Member State may 
authorize the marketing and use within its territory of 
a modified starch not listed in Annex 1, provided that 
the following conditions are satisfied: 
(a) the authorization shall be limited to a maximum 
period of three years; 
(b) the Member States must ensure that foodstuffs 
containing any modified starch it has authorized 
are officially monitored; (c) all foodstuffs manufactured therewith shall bear a 
special indication to be laid down in the author­
ization. 
2. The Member States shall communicate to the 
other Member States and to the Commission the text 
of any authorization decision adopted pursuant to the 
provisions of paragraph 1, within two months after 
the date on which the decision takes effect. 
3. Before the three-year period stipulated in 
paragraph 1 has expired the Member State may 
request the Commission to include in Annex 1 the 
modified starch which had been the subject of 
national authorization pursuant to the provisions of 
paragraph 1. At the same time, the Member State 
shall provide the evidence which, in its view, supports 
such inclusion and shall indicate how the modified 
starch is to be used. 
Within 18 months from the date of submission of the 
request, a decision shall be taken, on the basis of data 
relating to public health and after consulting the 
Scientific Committee for Food in accordance with the 
procedure laid down in Article 9, as to whether the 
modified starch in question can be included in Annex 
1 or whether the authorization given by the Member 
State should be revoked. If provisions additional to 
those set out in Annex 2 are found to be necessary, 
they shall be adopted using the same procedure. By 
way of derogation from paragraph 1 (a), an author­
ization granted by a Member State shall remain in 
force until a decision has been taken on the request 
for inclusion. 
If, in accordance with the provisions of the second 
subparagraph, it is decided that the authorization 
granted by a Member State must be revoked, this 
decision shall apply simultaneously to any author­
ization of the same modified starch granted by any 
other Member State. 
Article 6 
1. If, as a result either of the submission of a 
detailed assessment based on new data or the re-
evaluation of existing data since the adoption of this 
Directive, a Member State ascertains that the use as a 
foodstuffs ingredient of one of the modified starches 
listed in Annex 1 or its content in one or more of the 
substances referred to in Annexes 1 and 2 constitutes 
a hazard for public health, notwithstanding its 
compliance with the provisions of this Directive, that 
Member State may provisionally suspend or restrict 
the application of the relevant provisions within its 
territory. It shall immediately inform the other 
Member States and the Commission of such action 
and of the reasons therefor. 
2. As soon as possible thereafter, the Commission 
shall examine the reasons cited by the Member State 
concerned and shall consult the Member States within 
the framework of the Standing Committee on 
Foodstuffs. It shall then deliver its opinion without 
delay and proceed to the adoption of the appropriate 
measures. 
No C 31/8 Official Journal of the European Communities 1.2.85 
3. If the Commission is of the opinion that 
amendments to the Directive are necessary to mitigate 
the difficulties referred to in paragraph 1 and to 
ensure the protection of public health, it shall initiate 
the procedure laid down in Article 9 with a view to 
the adoption of those amendments; in that case, the 
Member State which originally adopted the protective 
measure shall be permitted to maintain them until 
those amendments enter into force. 
Article 7 
1. The labelling of modified starches shall consist 
solely of the following mandatory wording: 
(a) the denomination under which the product is 
sold, consisting 
— either of the term 'modified starch' followed 
by the reference letter of the product 
indicated in Annex 1, 
— or of the name of the modified starch as given 
in Annex 1, 
the constituents of a mixture being designated 
individually; 
(b) the words 'for human consumption' or an 
indication of the specific intended use of the 
modified starch; 
(c) the net quantity, except in the case of products 
put up in bulk; 
(d) the date of manufacture, or identification of the 
production batch; 
(e) the name or business name and address of the 
manufacturer or packer, or of a vendor 
established within the Community. 
2. The information referred to in paragraph 1 (a) 
and (d) shall appear on the package or on a label 
attached thereto. 
The information referred to in paragraph 1 (b) and 
(c) shall appear: 
— either on the package or on a label attached 
thereto; 
— or on the commercial documents relating to the 
modified starch in question. 
3. The provisions of this Article shall be without 
prejudice to more specific or more comprehensive 
Community provisions relating to metrology. 
Article 8 
The rules relating to sampling and the methods of 
analysis necessary for checking the composition and manufacturing characteristics of the modified starches 
shall be adopted in accordance with the procedure 
laid down in Article 9. 
Article 9 
1. If the procedure laid down in this Article is 
invoked, the matter shall be referred to the Standing 
Committee on Foodstuffs, hereinafter referred to as 
the 'Committee', by its chairman, acting either on his 
own initiative or at the request of a representative of 
a Member State. 
2. The Commission representative shall submit to 
the Committee a draft of the measures to be taken. 
The Committee shall deliver its opinion on the draft 
within a time limit to be set by the chairman in the 
light of the urgency of the matter. Opinions shall be 
delivered by a qualified majority, the votes of the 
Member States being weighted as provided for in 
Article 148 (2) of the Treaty. The chairman shall not 
vote. 
3. (a) The Commission shall adopt the measures in 
question if they accord with the opinion of the 
Committee. 
(b) If the measures do not accord with the opinion 
of the Committee or if it is not able to deliver 
an opinion, the Commission shall immediately 
submit to the Council a proposal relating to 
the measures to be taken. The Council shall 
act by a qualified majority. 
(c) If the Council does not act within three 
months following the date on which the 
proposal is submitted, the proposed measures 
shall be adopted by the Commission. 
Article 10 
Member States shall take the measures necessary to 
comply with this Directive. They shall forthwith 
inform the Commission thereof. 
Those measures shall be applied in such a way as to: 
— permit products complying with this Directive to 
be marketed as from 1 July 1986 at the latest ('); 
— prohibit products not complying with this 
Directive from being marketed with effect from 
1 November 1987 (2). 
Article 11 
This Directive is addressed to the Member States. 
(') 18 months after notification. 
(2) Three years after notification. 
1.2. 85 Official Journal of the European Communities NoC 31/9 
ANNEX 1 
LIST OF MODIFIED STARCHES 
Notes 
1. The raw materials used may be dry, moist or in an aqueous suspension. 
2. The percentages given relate to the dry material (m/m). 
Reference 
letter 
A 
B 
C 
D 
E 
F 
G 
H 
I Denomination 
White or yellow dextrin, 
roasted or dextrinated 
starch 
Starch modified by acid 
treatment 
Starch modified by alkali 
treatment 
Oxidized starch 
Bleached starch 
Monostarch phosphate 
Acetylated starch 
Acetylated distarch 
adipate 
Distarch phosphate Treatment 
Dry heat treatment in the presence of 
not more than 0,15 % hydrochloric 
acid or not more than 0,17 % ortho-
phosphoric acid (E 338) 
Treatment with not more than 7 % 
hydrochloric acid or not more than 
2 % sulphuric acid or not more than 
7 % orthophosphoric acid (E 338) 
Treatment with not more than 1 % 
sodium hydroxide or potassium 
hydroxide 
Treatment with not more than 5,5 % 
sodium hypochlorite, expressed as 
chlorine 
Treatment with peracetic acid and/or 
hydrogen peroxide containing not 
more than 0,45 % active oxygen, "or 
with sodium hypochlorite containing 
not more than 0,82 % available 
chlorine, or with 0,5 % sodium 
chlorite; or with sulphur dioxide 
(E 220) or other permitted forms of 
sulphites (E221-E227) 
With not more than 0,2 % potassium 
permanganate, or with not more than 
0,075 % ammonium persulphate 
Esterification with orthophosphoric 
acid (E 338), sodium (E 339) or potas­
sium (E 340) orthophosphate or 
sodium tripolyphosphate (E 450b) 
Esterification with not more than 10 % 
acetic anhydride 
Esterification with not more than 
7,5 % vinyl acetate 
Esterification with not more than 
0,10 % acetic anhydrides and not more 
than 0,12 % adipic anhydrides 
Esterification with sodium trimeta-
phosphate 
Esterification with not more than 
0,1 % phosphorus oxychloride Specification of the finished product 
Final pH of 2,5 to 7,0 
Final pH of 4,8 to 7,0 
Final pH of 5,0 to 7,5 
Not more than 1 % of carboxyl groups 
and not more than 0,5 % of sodium 
chloride 
Not more than 0,1 % of added carboxyl 
groups 
No reagent residues 
Not more than 50 mg/kg of residual 
manganese 
Not more than 0,5 % residual 
phosphate, calculated as phosphorus in 
the case of potato starch or wheat 
starch, or not more than 0,4 % in the 
case of other starches 
Not more than 2,5 % acetyl groups 
Not more than 2,5 % acetyl groups 
Not more than 2,5 % acetyl groups 
Not more than 0,14 % residual 
phosphate, calculated as phosphorus in 
the case of potato starch and wheat 
starch, or not more than 0,04 % in the 
case of other starches 
Not more than 0,14 % residual 
phosphate, calculated as phosphorus in 
the case of potato starch and wheat 
starch, or not more than 0,04 % in the 
case of other starches 
No C 31/10 Official Journal of the European Communities 1. 2. 85 
Reference 
letter 
J 
K 
N 
R Denomination 
Distarch phosphate 
Hydroxypropyl starch 
Phosphated distarch 
phosphate 
Hydroxypropyl distarch 
phosphate Treatment 
Esterification with not more than 
0,1 % sodium trimetaphosphate or 
phosphorus oxychloride combined with 
esterification with not more than 10 % 
acetic anhydride or not more than 
7,5 % vinyl acetate 
Esterification with not more than 10 % 
propylene oxide 
Combination of the treatment under F 
and I 
Esterification with sodium trimeta­
phosphate or phosphorus oxychloride, 
combined with etherification with not 
more than 10 % propylene oxide Specification of the finished product 
Not more than 2,5 % acetyl groups and 
not more than 0,14 % residual 
phosphate, calculated as phosphorus in 
the case of potato starch and wheat 
starch, or not more than 0,04 % in the 
case of other starches 
Not more than 0,1 mg/kg (0,1 ppm) 
propylene chlorhydrins 
Not more than 0,5 % residual 
phosphate, calculated as phosphorus in 
the case of potato and wheat starch, or 
not more than 0,4 % in the case of other 
starches 
Not more than 0,1 mg/kg (0,1 ppm) 
propylene chlorhydrin, and not more 
than 0,14 % residual phosphate, calcu­
lated as phosphorus in the case of potato 
starch and wheat starch, or not more 
than 0,04 % in the case of other starches 
ANNEX 2 
GENERAL PURITY CRITERIA APPLICABLE TO MODIFIED STARCHES 
1. Modified starches shall not: 
— contain any substances in quantities that are liable to endanger public health; 
— contain moulds, insects, remains of insects or other impurities of an animal nature or origin; 
— have an abnormal flavour or odour. 
2. The maximum contents set out below shall not be exceeded: 
NB: Where the amounts refer to one or more vegetable species, these amounts only refer to the 
products derived from a single species. In the case of mixtures, it is necessary to calculate 
the permissible amounts proportionately to the percentages of the various constituents. 
Substance 
— Arsenic 
— Lead 
— Cadmium 
— Mercury 
— Sulphur dioxide 
Moisture 
— Modified starches made from cereals 
— Modified starches made from potatoes 
— Modified starches of other origins 
Proteins 
— Starches in general 
— Amylase-rich starches Maximum content 
1 mg/kg 
1 mg/kg 
0,1 mg/kg 
0,05 mg/kg 
50 mg/kg 
15 % m/m 
21 % m/m 
18 % m/m 
0,5 % 
1,0%