Proposal for a Directive of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Recast)
Date: 2008-03-27
Institutions: European Commission
Subjects: approximation of laws, codification of EU law, food chemistry, foodstuff, foodstuffs legislation, solvent

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 27.3.2008 
COM(2008) 154 final 

2008/0060 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the approximation of the laws of the Member States on extraction solvents used in 
the production of foodstuffs and food ingredients 

(Recast) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

On 1 April 1987 the Commission decided1 to instruct its staff that all legislative acts 
should  be  codified  after  no  more  than  ten  amendments,  stressing  that  this  is  a 
minimum  requirement  and  that  departments  should  endeavour  to  codify  at  even 
shorter  intervals  the  texts  for  which  they  are  responsible,  to  ensure  that  the 
Community rules are clear and readily understandable. 

The  codification  of  Council  Directive  88/344/EEC  of  13  June  1988  on  the 
approximation  of  the  laws  of  the  Member  States  on  extraction  solvents  used  in  the 
production of foodstuffs and food ingredients2 has been initiated by the Commission, 
and  a  relevant  proposal  has  been  submitted  to  the  legislative  authority3.  The  new 
Directive was to have superseded the various acts incorporated in it4. 

In  the  meantime  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures  for the exercise of implementing powers conferred on the Commission5 
has  been  amended  by  Decision  2006/512/EC,  which  introduced  a  regulatory 
procedure  with  scrutiny  for  measures  of  general  scope  designed  to  amend  non-
essential  elements  of  a  basic  instrument  adopted  in  accordance  with  the  procedure 
referred to in Article 251 of the Treaty, including by deleting some of those elements 
or by supplementing the instrument by the addition of new non-essential elements. 

In accordance with the joint statement of the European Parliament, the Council and 
the Commission6 on Decision 2006/512/EC, for this new procedure to be applicable 
to instruments adopted in accordance with the procedure laid down in Article 251 of 
the  Treaty  which  are  already  in  force,  those  instruments  must  be  adjusted  in 
accordance with the applicable procedures. 

It is therefore appropriate to transform the codification of Directive 88/344/EEC into 
a recast in order to incorporate the amendments necessary for the adjustment to the 
regulatory procedure with scrutiny. 

COM(87) 868 PV. 
Carried  out  pursuant  to  the  Communication  for  the  Commission  to  the  European  Parliament  and  the 
Council – Codification of the Acquis communautaire, COM (2001) 645 final. 
COM(2003) 467 final. 
See Annex II, Part A of this proposal. 
OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 
OJ C 255, 21.10.2006, p. 1. 

1. 

2. 

3. 

4. 

5. 

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(cid:208) 88/344/EEC (adapted) 

2008/0060 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

of […] 

on the approximation of the laws of the Member States on extraction solvents used in 
the production of foodstuffs and food ingredients 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article ⌦ 95 ⌫ thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 

Whereas: 

(1) 

Council  Directive 88/344/EEC of 13  June 1988 on the approximation of the laws of 
the  Member  States  on  extraction  solvents  used  in  the  production  of  foodstuffs  and 
food  ingredients4  has  been  substantially  amended  several  times5.  Since  further 
amendments are to be made, it should be recast in the interests of clarity. 

(cid:216) new 

1 
2 
3 
4 

5 

OJ […], […], p. […]. 
OJ […], […], p. […]. 
OJ […], […], p. […]. 
OJ  L  157,  24.6.1988,  p.  28.  Directive  as  last  amended  by  Regulation  (EC)  No  1882/2003  of  the 
European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
See Annex II, Part A. 

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(2) 

Differences  between  national  laws  relating  to  extraction  solvents  hinder  the  free 
movement  of  foodstuffs  and  may  create  conditions  of  unequal  competition  thereby 
directly affecting the functioning of the ⌦ internal ⌫ market. 

(cid:208) 88/344/EEC Recital 1 (adapted) 

(3) 

The  approximation  of  those  laws  is  therefore  necessary  if  the  free  movement  of 
foodstuffs is to be achieved. 

(cid:208) 88/344/EEC Recital 2 

(4) 

Laws relating to extraction solvents for use in foodstuffs should take account primarily 
of human health requirements but also, within the limits required for the protection of 
health, of economic and technical needs. 

(cid:208) 88/344/EEC Recital 3 

(5) 

Such  approximation  ⌦ should ⌫  involve  the  establishment  of  a  single  list  of 
extraction solvents for the preparation of foodstuffs or food ingredients. General purity 
criteria should also be specified. 

(cid:208) 88/344/EEC Recital 4 (adapted) 

(6) 

The  use  of  an  extraction  solvent  under  conditions  of  good  manufacturing  practice 
should result in the removal of all or the major part of the solvent residues from the 
foodstuff or food ingredient. 

(cid:208) 88/344/EEC Recital 5 

(7) 

Under such conditions, the presence of residues or derivatives in the final foodstuff or 
food ingredient may be unintentional but technically unavoidable. 

(cid:208) 88/344/EEC Recital 6 

(8) 

Although  in  general  a  specific  limitation  is  useful,  it  need  not  be  laid  down  for 
substances listed in Part I of Annex ⌦ I ⌫ which have been found acceptable from 
the  point  of  view  of  safety  to  the  consumer  when  used  under  conditions  of  good 
manufacturing practice. 

(cid:208) 88/344/EEC Recital 7 (adapted) 

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(9) 

To take account of protection of public health, the conditions of use of other extraction 
solvents listed in Parts II and III of Annex ⌦ I ⌫ and residues permitted in food and 
food ingredients ⌦ should ⌫ be established. 

(cid:208) 88/344/EEC Recital 8 (adapted) 

(10)  Specific purity criteria for extraction solvents and methods of analysis and sampling of 

extraction solvents in and on foodstuffs should be established. 

(cid:208) 88/344/EEC Recital 11 

(11)  Should  the  use  of  an  extraction  solvent  provided  for  in  this  Directive  appear  to 
constitute a health risk as a result of new information, Member States should be able to 
suspend  or  limit  such  use,  or  to  reduce  existing  limits,  pending  a  decision  at 
Community level. 

(cid:208) 88/344/EEC Recital 12 

(cid:208) 88/344/EEC Recital 13 
(adapted) 

(12)  ⌦ The  measures  necessary  for  the  implementation  of  this  Directive  should  be 
adopted  in  accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying 
down  the  procedures  for  the  exercise  of  implementing  powers  conferred  on  the 
Commission 6.⌫ 

(cid:216) new 

(13)  Power  should  be  conferred  on  the  Commission  in  particular  to  amend  the  list  of 
extraction solvents which may be used during the processing of the raw materials, of 
foodstuffs, of food components or of food ingredients, and their conditions of use and 
maximum residue limits, and to establish specific purity criteria for extraction solvents 
and  the  methods  of  analysis  necessary  to  verify  compliance  with  the  general  and 
specific  purity  criteria  as  well  as  methods  of  analysis  and  sampling  of  extraction 
solvents  in  and  on  foodstuffs.  Since  those  measures  are  of  general  scope  and  are 
designed  to  amend  non-essential  elements  of  this  Directive  and  to  supplement  this 
Directive  by  the  addition  of  new  non-essential  elements,  they  must  be  adopted  in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of 
Decision 1999/468/EC. 

(14)  On  grounds  of  efficiency,  the  normal  time-limits  for  the  regulatory  procedure  with 
scrutiny  should  be  curtailed  for  the  adoption  of  amendments  of the  list  of  extraction 

6 

OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 

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solvents which may be used during the processing of the raw materials, of foodstuffs, 
of food components or of food ingredients, and their conditions of use and maximum 
residue  limits,  and  for  the  establishment  of  specific  purity  criteria  for  extraction 
solvents. 

(15)  When, on imperative grounds of urgency, in particular where a risk to human health 
exists,  the  normal  time-limits  for  the  regulatory  procedure  with  scrutiny  cannot  be 
complied with, the Commission should be able to use the urgency procedure provided 
for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments of the 
list  of  extraction  solvents  which  may  be  used  during  the  processing  of  the  raw 
materials,  of  foodstuffs,  of  food  components  or  of  food  ingredients,  and  their 
conditions  of  use  and  maximum  residue  limits,  and  for  the  establishment  of  specific 
purity criteria for extraction solvents, as well as for the adoption of amendments to this 
Directive  when  it  is  established  that  the  use  in  foodstuffs  of  any  substance  listed  in 
Annex  I  or  the  level  of  one  or  more  of  the  components  referred  to  in  Article  3 
contained in such substances might endanger human health although it complies with 
the conditions laid down in this Directive. 

(16)  The  new  elements  introduced  into  this  Directive  only  concern  the  committee 
procedures. They therefore do not need to be transposed by the Member States. 

(17)  This  Directive  should  be  without  prejudice  to  the  obligations  of  the  Member  States 
relating to the time-limits for transposition into national law of the Directives set out in 
Annex II, Part B, 

(cid:208)  

HAVE ADOPTED THIS DIRECTIVE: 

(cid:208) 88/344/EEC 

1. This Directive applies to extraction solvents used or intended for use in the production of 
foodstuffs or food ingredients. 

Article 1 

This Directive shall not apply to extraction solvents used in the production of food additives, 
vitamins  and  other  nutritional  additives,  unless  such  food  additives,  vitamins  or  nutritional 
additives are listed in Annex ⌦ I ⌫. 

(cid:208) 88/344/EEC (adapted) 

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However, the Member States shall ensure that the use of food additives, vitamins and other 
nutritional additives does not result in foodstuffs containing extraction solvent residue levels 
dangerous to human health. 

(cid:208) 88/344/EEC 

This  Directive  shall  apply  without  prejudice  to  the  provisions  adopted  under  more  specific 
Community rules. 

(cid:208) 92/115/EEC Art. 1 pt. 1 

⌦ 2. ⌫ For the purposes of this Directive: 

(cid:208) 88/344/EEC (adapted) 

(cid:208) 88/344/EEC 

(a) 

(b) 

‘solvent’ means any substance for dissolving a foodstuff or any component thereof, 
including any contaminant present in or on that foodstuff; 

‘extraction solvent’ means a solvent which is used in an extraction procedure during 
the  processing  of  raw  materials,  of  foodstuffs,  or  of  components  or  ingredients  of 
these products and which is removed but which may result in the unintentional, but 
technically unavoidable, presence of residues or derivatives in the foodstuff or food 
ingredient. 

Article 2 

1.  Member  States  shall  authorise  the  use  as  extraction  solvents  in  the  manufacture  of 
foodstuffs  or  food  ingredients  of  those  substances  and  materials  listed  in  Annex  ⌦ I ⌫, 
under  the  conditions  of  use  and  where  appropriate  within  the  maximum  residue  limits 
specified ⌦ therein ⌫. 

(cid:208) 88/344/EEC (adapted) 

Member  States  may  not  prohibit,  restrict  or  obstruct  the  marketing  of  foodstuffs  or  food 
ingredients  on  grounds  relating  to  the  extraction  solvents  used  or  their  residues  if  these 
comply with the provisions of this Directive. 

(cid:208) 88/344/EEC 

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2. Member States shall not authorise the use of other substances and materials as extraction 
solvents,  nor  extend  the  conditions  ⌦ of ⌫  use  or  permitted  residues  of  the  extraction 
solvents listed in Annex ⌦ I ⌫ beyond those specified therein. 

(cid:208) 88/344/EEC (adapted) 

3. Water to which substances regulating acidity or alkalinity may have been added and other 
food substances which possess solvent properties are authorised as extraction solvents in the 
manufacture of foodstuffs or food ingredients. 

(cid:208) Corrigendum 88/344/EEC 
OJ L 32, 5.2.2004, p. 34 

(cid:208) 88/344/EEC (adapted) 

Article 3 

Member  States  shall  take  all  measures  to  ensure  that  the  substances  and  materials  listed  as 
extraction solvents in Annex ⌦ I ⌫ satisfy the following purity criteria: 

(cid:208) 88/344/EEC 

(a) 

(b) 

they  shall  not  contain  a  toxicologically  dangerous  amount  of  any  element  or 
substance; 

subject to any exceptions deriving from the specific purity criteria referred to in (c), 
they shall not contain more than 1 mg/kg of arsenic or more than 1 mg/kg of lead; 

(c) 

they  shall  satisfy  the  specific  purity  criteria  determined  in  accordance  with 
Article 4 ⌦ (d) ⌫. 

(cid:208) 88/344/EEC (adapted) 

Article 4 

(cid:208) 88/344/EEC (adapted) 
(cid:214) new 

The  (cid:214) Commission  shall  adopt  the   following  shall  be  in  accordance  with  the  procedure 
referred to in Article 6(2): 

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(a) 

the necessary amendments to Annex ⌦ I ⌫ in the light of scientific and technical 
progress  in  the  field  of  the  use  of  solvents,  their  conditions  of  use  and  maximum 
residue limits; 

(cid:208) 97/60/EC Art. 1 pt. 1 (adapted) 

(cid:206)1 (b)  

the  methods  of  analysis  necessary  to  verify  compliance  with  the  general  and 

specific purity criteria referred to in Article 3; 

(cid:208) 88/344/EEC 
(cid:206)1 97/60/EC Art. 1 pt. 1 

(cid:208) 88/344/EEC (adapted) 
(cid:206)1 97/60/EC Art. 1 pt. 1 

(cid:206)1 (c)  

the  procedure  for  taking  samples  and  the  methods  for  qualitative  and 
quantitative  analysis  of  the  extraction  solvents  cited  in  Annex  ⌦ I ⌫  used  in 
foodstuffs or food ingredients; 

(cid:206)1 (d)  

if  necessary,  the  specific  purity  criteria  for  the  extraction  solvents  listed  in 
Annex  ⌦ I ⌫,  and  in  particular  maximum  permitted  limits  of  mercury  and 
cadmium  in  the  extraction  solvents[;  these  criteria  are  to  be  adopted  within  three 
years from the date of adoption of this Directive]. 

(cid:216) new 

The measures referred to in points (b) and (c), designed to amend non-essential elements of 
this  Directive,  inter  alia,  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 6(2). 

The measures referred to in points (a) and (d), designed to amend non-essential elements of 
this  Directive,  inter  alia,  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 6(3). 

Where necessary, the measures referred to in points (a) and (d) shall be adopted in accordance 
with the regulatory procedure with scrutiny referred to in Article 6(4). 

(cid:208) 88/344/EEC (adapted) 
(cid:214) new 

Article 5 

1.  Where  a  Member  State,  as  a  result  of  new  information  or  of  a  reassessment  of  existing 
information  made  since  ⌦ this ⌫  Directive  was  adopted,  has  detailed  grounds  for 
establishing that the use in foodstuffs of any substance listed in Annex ⌦ I ⌫ or the level of 

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one  or  more  of  the  components  referred  to  in  Article  3  contained  in  such  substances  might 
endanger human health although it complies with the conditions laid down in this Directive, 
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  evidence  given  by  the  Member 
State concerned and consult the Committee ⌦ referred to in Article 6(1) ⌫, and shall then 
deliver  its  opinion  forthwith  and  take  the  appropriate  measures,  which  may  replace  the 
measures referred to in paragraph 1. 

3.  If  the  Commission  considers  that  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 ⌦ adopt ⌫ these amendments. 

(cid:214) Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive  shall  be 
the ⌫  (cid:214) regulatory   ⌦ procedure ⌫  (cid:214) with 
adopted   ⌦ in  accordance  with 
scrutiny  ⌦ referred to in Article 6 ⌫ (cid:214) (4) . 

Any Member State which has adopted safeguard measures may in that event retain them until 
the amendments enter into force in its territory. 

(cid:208) 1882/2003 Annex III pt. 9 
(adapted) 

Article 6 

1.  The  Commission  shall  be  assisted  by  the  Standing  Committee  on  the  Food  Chain  and 
Animal  Health,  set  up  by  Article  58  of  Regulation  (EC)  No  178/2002  of  the  European 
Parliament and of the Council7, hereinafter referred to as “the Committee”. 

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall 
apply, having regard to the provisions of Article 8 thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 

(cid:216) new 

2.  Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4),  and  Article  7  of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

3. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The time-limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall 
be set at two months, one month and two months respectively. 

7 

OJ L 31, 1.2.2002, p. 1. 

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4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

3. The Committee shall adopt its rules of procedure. 

(cid:208) 1882/2003 Annex III pt. 9 
(adapted) 

(cid:208) 88/344/EEC (adapted) 

Article 7 

1. Member States shall take all the necessary measures to ensure that the substances listed in 
Annex ⌦ I ⌫ and intended for use as extraction solvents in foodstuffs may not be marketed 
unless their packaging, containers or labels carry the following information in such a way as 
to be easily visible, clearly legible and indelible: 

(a) 

the commercial name as given in Annex ⌦ I ⌫; 

(cid:208) 88/344/EEC 

a clear indication that the material is of a quality suitable for use for the extraction of 
food or food ingredients; 

a reference by which the batch or lot may be identified; 

the name or business name and address of the manufacturer or packer or of a seller 
established within the Community; 

the net quantity given as units of volume; 

if necessary, the special storage conditions or conditions of use. 

(b) 

(c) 

(d) 

(e) 

(f) 

2. By way of derogation from paragraph 1, the information specified in points (c), (d), (e) and 
(f)  of  that  paragraph  may  appear  merely  on  the trade  documents relating to  the batch  or lot 
which are to be supplied with or prior to the delivery. 

3.  This  Article  ⌦ shall  be ⌫  without  prejudice  to  more  precise  or  more  extensive 
Community  provisions  regarding  weights  and  measures  or  provisions  applying  to  the 
classification, packaging and labelling ⌦ of ⌫ dangerous substances and preparations. 

(cid:208) 88/344/EEC (adapted) 

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(cid:208) 88/344/EEC 

4.  Member  States  shall  refrain  from  laying  down  requirements  more  detailed  than  those 
already contained in this Article concerning the manner in which the particulars provided are 
to be shown. 

Member  States  shall,  however,  ensure  that  the  sale  of  extraction  solvents  within  their  own 
territories  is  prohibited  if  the  particulars  provided  for  in  this  Article  do  not  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 8 

1. This Directive shall ⌦ also ⌫ apply to extraction solvents used or intended for use in the 
production of foodstuffs or ingredients imported into the Community. 

(cid:208) 88/344/EEC (adapted) 

2.  This  Directive  shall  not  apply  to  extraction  solvents  or  foodstuffs  intended  for  export 
outside the Community. 

(cid:208) 88/344/EEC 

(cid:208)  

Article 9 

Directive 88/344/EEC as amended by the acts listed in Annex II, Part A is repealed, without 
prejudice to the obligations of the Member States relating to the time-limits for transposition 
into national law of the Directives set out in Annex II, Part B. 

References  to  the  repealed  Directive  shall  be  construed  as  references  to  this  Directive  and 
shall be read in accordance with the correlation table set out in Annex III. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 10 

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(cid:208) 88/344/EEC 

Article 11 

This Directive is addressed to the Member States. 

Done at Brussels, […] 

For the European Parliament 
The President 

For the Council 
The President 

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(cid:208) 88/344/EEC (adapted) 
(cid:206)1 92/115/EEC Art. 1 pt. 3 
(cid:206)2 97/60/EC Art. 1 pt. 2 
(cid:206)3 94/52/EC Art. 1 

ANNEX I 

EXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING 
OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF 
FOOD INGREDIENTS 

Extraction  solvents  to  be  used  in  compliance  with  good  manufacturing  practice  for  all 
uses1 

PART I 

Name: 

Propane 

Butane 

Ethyl acetate 

Ethanol 

Carbon dioxide 

Acetone(cid:206)1 2  

Nitrous oxide 

1 

2 

An extraction solvent is considered as being used in compliance with good manufacturing practice if its 
use  results  only  in  the  presence  of  residues  or  derivatives  in  technically  unavoidable  quantities 
presenting no danger to human health. 
The use of Acetone in the refining of olive-pomace oil is forbidden. 

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Extraction solvents for which conditions of use are specified 

PART II 

Name 

Conditions of use 
(summary description of 
extraction) 

Maximum residue limits in the 
extracted foodstuff or food 
ingredient 

(cid:206)2 Hexane3  

(cid:206)2 Production or fractionation 
of fats and oils and production 
of cocoa butter  

(cid:206)2 1 mg/kg in the fat or oil or 
cocoa butter  

(cid:206)2 Preparation of defatted 
protein products and defatted 
flours  

(cid:206)2 10 mg/kg in the food 
containing the defatted protein 
products and the defatted 
flours  

(cid:206)2 30 mg/kg in the defatted 
soya products as sold to the 
final consumer  

(cid:206)2 Preparation of defatted 
cereal germs  

(cid:206)2 5 mg/kg in the defatted 
cereal germs  

Decaffeination of, or removal 
of irritants and bitterings from 
coffee and tea 

20 mg/kg in the coffee or tea 

Production of sugar from 
molasses 

1 mg/kg in the sugar 

Methyl acetate 

Ethylmethylketone(cid:206)1 4  

Fractionation of fats and oils 

5 mg/kg in the fat or oil 

Dichloromethane 

Decaffeination of, or removal 
of irritants and bitterings from 
coffee and tea 

Decaffeination of, or removal 
of irritants and bitterings from 
coffee and tea 

20 mg/kg in the coffee or tea 

(cid:206)1 2 mg/kg  in the roasted 
coffee and 5 mg/kg in the tea 

(cid:206)1 Methanol  

(cid:206)1 For all uses  

(cid:206)1 10 mg/kg  

(cid:206)1 Propan-2-ol  

(cid:206)1 For all uses  

(cid:206)1 10 mg/kg  

3 

4 

Hexane means a commercial product consisting essentially of acylic saturated hydrocarbons containing 
six  carbon  atoms  and  distilling  between  64 °C  and  70 °C.  (cid:206)1 The  combined  use  of  Hexane  and 
Ethylmethylketone is forbidden.  
(cid:206)1 The ⌦ level ⌫  of  n-Hexane  in  this  solvent  should  not  exceed  50  mg/kg.  The  combined  use  of 
Hexane and Ethylmethylketone is forbidden.  

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Extraction solvents for which conditions of use are specified 

PART III 

Name 

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

Diethyl ether 

Hexane(cid:206)1 5  

2 mg/kg 

1 mg/kg 

(cid:206)3 Cyclohexane  

(cid:206)3 1 mg/kg  

Methyl acetate 

Butan-1-ol 

Butan-2-ol 

Ethylmethylketone(cid:206)1 5  

1 mg/kg 

1 mg/kg 

1 mg/kg 

1 mg/kg 

Dichloromethane 

(cid:206)1 0,02 mg/kg  

(cid:206)1 Propan-1-ol  

(cid:206)1 1 mg/kg  

(cid:206)2 1,1,1,2-tetrafluoroethane  

(cid:206)2 0,02 mg/kg  

__________ 

5 

(cid:206)1 The combined use of ⌦ Hexane and Ethylmethylketone ⌫ is forbidden.  

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(cid:207) 

ANNEX II 

Part A 

Repealed Directive with list of its successive amendments 
(referred to in Article 9) 

Council Directive 88/344/EEC 
(OJ L 157, 24.6.1988, p. 28) 

Council Directive 92/115/EEC 
(OJ L 409, 31.12.1992, p. 31) 

Directive 94/52/EC of the European 
Parliament and of the Council 
(OJ L 331, 21.12.1994, p. 10) 

Directive 97/60/EC of the European 
Parliament and of the Council 
(OJ L 331, 3.12.1997, p. 7) 

Regulation (EC) No 1882/2003 of the 
European Parliament and of the Council 
(OJ L 284, 31.10.2003, p. 1) 

Point 9 of Annex III only 

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Part B 

List of time limits for transposition into national law 
(referred to in Article 9) 

Directive 

Time-limit for transposition 

88/344/EEC 

92/115/EEC 

94/52/EC 

97/60/EC 

13 June 1991 

a. 1 July 1993 

b. 1 January 19941 

7 December 1995 

a. 27 October 1998 

b. 27 April 19992 

__________ 

1 

2 

In accordance with Article 2 of Directive 92/115/EEC: 
“1. Member States shall amend their laws, regulations and administrative provisions in such a way as 
to: 
-  permit  trade  in  products  not  complying  with  this  Directive  at  the  latest  by  1  July  1993, 
- prohibit trade in products not complying with this Directive with effect from 1 January 1994.” 
In accordance with Article 2 of Directive 97/60/EC: 
“1.  Member  States  shall  amend  their  laws,  regulations  and  administrative  provisions  so  as  to: 
-  authorise  trade  in products  complying  with  Directive 88/344/EEC,  as  amended  by  this  Directive  by 
27 October 1998 at the latest; 
-  ban  trade  in  products  not  complying  with  Directive  88/344/EEC,  as  amended  by  this  Directive,  as 
from  27  April  1999.  However,  products  placed  on  the  market  or  labelled  before  that  date  and  not 
complying with Directive 88/344/EEC, as amended by this Directive, may be marketed until stocks are 
used up.” 

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ANNEX III 

CORRELATION TABLE 

Directive 88/344/EEC 

This Directive 

Article 1(1) 

Article 1(3) 

Article 2(1) 

Article 2(2) 

Article 2(3) 

Article 2(4) 

Article 3 

Article 4 

Article 5 

Article 6(1) 

Article 6(2) 

Article 6(3) 

— 

— 

— 

Article 7 

Article 8 

Article 9 

— 

— 

Article 10 

Article 1(1) 

Article 1(2) 

Article 2(1) 

Article 2(2) 

— 

Article 2(3) 

Article 3 

Article 4 

Article 5 

Article 6(1) 

— 

— 

Article 6(2) 

Article 6(3) 

Article 6(4) 

Article 7 

Article 8 

— 

Article 9 

Article 10 

Article 11 

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Annex 

— 

— 

Annex I 

Annex II 

Annex III 

_________ 

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