Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending for the third time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients
Date: 1996-07-22
Institutions: European Commission
Subjects: approximation of laws, consumer protection, foodstuff, marketing, solvent

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

Brussels,  22.07.1996 
COM(96)375 final 

96/0195 (COD) 

Proposal  for a 

EUROPEAN PARLIAMENT  AND COUNCIL DIRECTIVE 

amending for the third time Directive 88/344/EEC 
on the approximation of the laws of the Member States 
on extraction solvents used in the production of foodstuffs 
and food ingredients 

(presented by the Commission) 

EXPLANATORY MEMORANDUM 

In  1981 the Scientific  Committee for  Food (SCF) delivered an opinion on 48  extraction 
solvents1 and issued provisional ADIs for a large number of them. 

Directive  88/344/EEC,2 which authorized  some of these substances  in foodstuffs,  called 
upon  the  Commission  to  review the provisions  relating  to the  solvents  two  years  after 
adoption and to make amendments as necessary. 

In May  1990 the SCF reviewed all the solvents once more with a view to establishing a 
definitive  evaluation.  The information the Commission had at that time was not enough 
for the Committee to complete this task, and thus additional information was requested. 

Since  the  information  received  concerned  certain  specific  substances  only,  a  new 
deadline was set for April  1991. 

Acting on the generally insufficient  information  provided, the SCF decided to confirm  its 
agreement  on  a  number  of  solvents  already  approved  in  the  past  and  to  withdraw 
provisional  agreement for  others for  lack of the information  requested.  Furthermore, its 
decision : 

to maintain its provisional agreement for butyl acetate and hexane, and 
not to oppose continued use of methyl-propanol-1, which had not been evaluated 
up to that point, 

was  accompanied  by  a  request  to  receive  all  the  information  needed  to  establish 
permanent agreement within two years. 

In June 1993 the  SCF  issued  definitive  agreement  for  hexane  only.  For  the  two  other 
substances  it  repeated  its  request  for  the  information  needed  to  make  a  complete 
evaluation within two years. 

The  industry  has  never  supplied  the  information  requested  and  one  of  the  sectors 
contacted (European Flavour and Fragrance Association) replied that it had no interest in 
these two substances. 

The  Commission  has,  however,  received  a  request  for  the  use  of  a^new  substance, 
1,1,1,2-tetrafluoroethane,  as  an  extraction  solvent  in  the  preparation  of  flavours.  The 
Scientific Committee gave its agreement in December 1995. 

This proposal takes account of all these developments. 

1 
2 

SCF reports -  11th edition,  1981. 
OJL  157, 24.6.1988. 

Proposal  for  a 

EUROPEAN PARLIAMENT  AND COUNCIL  DIRECTIVE 

amending for the third time Directive 88/344/EEC 
on the approximation of the laws of the Member States 
on extraction solvents used in the production of foodstuffs 
and food ingredients 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN 
UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 100a thereof, 

Having regard to the proposal from the Commission,3 

Having regard to the opinion of the Economic and Social Committee,4 

Acting in accordance with the procedure set out in Article 189b of the Treaty,5 

Whereas  the  Scientific  Committee  for  Food  has  reexamined  all  the  extraction  solvents 
listed  in the Directive with a view to replacing  the provisional  acceptable  daily  intakes 
(ADIs)  set  in  1981  by  definitive  figures;  whereas  this  has  not  always  been  possible 
because  the  information  needed,  although  requested  from  the  industry,  has  not  been 
communicated;  whereas,  with  the  information  received,  the  Scientific  Committee  for 
Food has been able to confirm its agreement for the majority  of the solvents;  whereas the 
maximum residues of the solvents in certain foodstuffs  can be reduced; 

Whereas some solvents are no longer used and should thus be taken off the list; 

Whereas  scientific  progress  has  made  for  other  substances  which  can  be  added  to  the 
Directive; 

Whereas  a  new  solvent  which  has  received  a  favourable  opinion  from  the  Scientific 
Committee should be authorized; 

Whereas, in view of technical and scientific progress, the amendments needed amount to 
measures  of  a  technical  nature;  whereas  to  simplify  and  accelerate  the  procedure 
adoption of these measures should be entrusted to the Commission; 

OJNoC... 
OJ No C... 
OJNoC... 

Whereas a procedure of this kind makes for quicker placing on the market of innovations, 
which is to the benefit of both the industry and the consumer, 

HAVE ADOPTED THIS DIRECTIVE: 

Artickl 

Directive 88/344/EEC is hereby amended as follows: 

1. 

The following new paragraph (a) is added to Article 4: 

"(a) 

In  view  of  the  scientific  and  technical  progress  in  the  field  of  solvents, 
their  conditions  of  use  and  maximum  residue  limits  the  requisite 
amendments to the Annex; 

The  old  paragraphs  (a),  (b)  and  (c)  become  paragraphs  (b),  (c)  and  (d) 
respectively." 

2. 

The Annex to the Directive is amended as follows: 

(a) 

(b) 

Part I 
The substance butyl acetate is deleted. 

Part II 
The entry for hexane is amended as follows: 

— —- 

I 

' 

i  i i 

i 

- i

l

l .» 

Name (1)  Conditions of use 

(Summary description of extraction) 

"Hexane 

Production or fractionation  of fats and 
oils and production of cocoa butter 

II 

- ^ ^ —. 

in 

i, 

• 

i 

i 

^ — —— 

Maximum residue limits in the 
extracted foodstuff  or food 
ingredient 
1  mg/kg in the fat or oil or 
cocoa butter 

Preparation of defatted protein products  10 mg/kg in the food containing 
and defatted 

flours 

the defatted protein products 
and the defatted flours 

Preparation of defatted cereal germs 

The two footnotes remain unchanged. 

30 mg/kg in the defatted  soya 
proudcts as sold to the  final 
consumer 

5 mg/kg in the defatted cereal 
germs". 

(c) 

Part III 

The substance methyl-propanol-1 is deleted 
The following substance is added: 

|  Name 

1,1,1,2-tetrafluoroethane 

Maximum residue limits in the  foodstuff 
due to the use of extraction solvents in the 
preparation of flavourings from natural 
flavouring materials 
0.02 mg/kg 

I 

Artkkl 

1. 

The  Member  States  shall  amend  their  laws,  regulations  and  administrative 
provisions so as to: 

authorize trade  in products  complying  with this  Directive  by  1 July  1997 
at the latest;  and 

ban  trade  in  products  not  complying  with  this  Directive  as  from 
1 January  1998. 

They shall forthwith inform the Commission  thereof. 

2. 

Where  the  Member  States  adopt  these  provisions  the  latter  shall  contain  a 
reference  to  this  Directive  or  be  accompanied  by  such  a  reference  on  official 
publication.  How  this  reference  is  made  shall  be  determined  by  the  Member 
States. 

Artkki 

This  Directive  shall  enter into  force  on the  twenty-first  day  following  its  oublication  in 
the Official  Journal of the European Communities. 

This Directive is addressed to the Member States. 

Article 4 

Done at Brussels, 

For the Parliament 
The President 

For the Council 

The President 

ISSN 0254-1475 

COM(96) 375 final 

DOCUMENTS 

EN 

06  15 

Catalogue number  :  CB-CO-96-376-EN-C 

ISBN  92-78-07303-2 

Office for Official  Publications of the European Communities 

L-2985 Luxembourg 

6