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 (Codified version)
Date: 2003-07-30
Institutions: European Commission
Subjects: approximation of laws, codification of EU law, food chemistry, foodstuff, foodstuffs legislation, solvent

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 30.7.2003
COM(2003) 467 final

2003/0181 (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

(Codified version)

(presented by the Commission)

1.

2.

3.

4.

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3

4

EXPLANATORY MEMORANDUM

In  the  context  of  a  people’s  Europe,  the  Commission  attaches  great  importance  to
simplifying  and  clarifying  Community  law  so  as  to  make  it  clearer  and  more
accessible to the ordinary citizen, thus giving them new opportunities and the chance
to make use of the specific rights it gives him.

This aim cannot be achieved so long as numerous provisions that have been amended
several times, often quite substantially, remain scattered, so that they must be sought
partly  in  the  original  instrument  and  partly  in  later  amending  ones.  Considerable
research work, comparing many different instruments, is thus needed to identify the
current rules.

For  this  reason  a  codification  of  rules  that  have  frequently  been  amended  is  also
essential if Community law is to be clear and transparent.

On  1  April  1987  the  Commission  therefore  decided1  to  instruct  its  staff  that  all
legislative measures should be codified after no more than ten amendments, stressing
that  this  was  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 were clear and readily understandable.

The  Conclusions  of 
the  Edinburgh  European  Council
(December 1992) confirmed this2, stressing the importance of codification as it offers
certainty as to the law applicable to a given matter at a given time.

the  Presidency  of 

Codification  must  be  undertaken  in  full  compliance  with  the  normal  Community
legislative procedure.

Given  that  no  changes  of  substance  may  be  made  to  the  instruments  affected  by
codification, the European Parliament, the Council and the Commission have agreed,
by  an  interinstitutional  agreement  dated  20  December  1994,  that  an  accelerated
procedure may be used for the fast track adoption of codification instruments.

is 

this  proposal 

to  undertake  a  codification  of  Council
The  purpose  of 
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
ingredients3. The new Directive will supersede the various Directives incorporated in
it4;  their  content  is  fully  preserved,  and  they  are  brought  together  with  only  such
formal amendments as are required by the codification exercise itself.

COM(87) 868 PV.
See Annex 3 to Part A of such Conclusions.
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.
Annex II, Part A of this proposal.

2

                                                
5.

The codification proposal was drawn up on the basis of a preliminary consolidation,
in all official languages, of Directive 88/344/EEC and the instruments amending it,
carried out by the Office for Official Publications of the European Communities, by
means  of  a  data-processing  system.  Insofar  as  the  Articles  have  been  given  new
numbers, the correlation  between the old and the new  numbers  is  shown  in  a  table
contained in Annex III to the codified Directive.

3

2003/0181 (COD)

Proposal for a

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

DIRECTIVE …/…/EC (cid:1) OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL (cid:2)

of […]

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

(cid:1) (Text with EEA relevance) (cid:2)

THE  (cid:2) EUROPEAN  PARLIAMENT  AND  THE  COUNCIL  OF  THE  EUROPEAN
UNION, (cid:3)

Having  regard  to  the  Treaty  establishing  the  European  Community  and  in  particular
Article (cid:2) 95 (cid:3) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee1,

(cid:2) Acting in accordance with the procedure laid down in Article 251 of the Treaty2, (cid:3)

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  ingredients3  has  been  substantially  amended  several  times4.  In  the  interests  of
clarity and rationality the said Directive should be codified.

(cid:1) 

1

2

3

4

[…]
(cid:1) […] (cid:2)
OJ  L  157,  24.6.1988,  p.  28.  Directive  as  last  amended  by  Directive  97/60/EC  of  the  European
Parliament and of the Council (OJ L 331, 3.12.1997, p. 7).
See Annex II, Part A.

4

                                                
(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 common market.

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

(3) 

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

(cid:1) 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:1) 88/344/EEC Recital 3

(5) 

(cid:1) 88/344/EEC Recital 4 (adapted)
Such  approximation  (cid:2) should (cid:3)  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.

(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:1) 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:1) 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 (cid:2) I (cid:3) which have been found acceptable from
the  point  of  view  of  safety  to  the  consumer  when  used  under  conditions  of  good
manufacturing practice.

(cid:1) 88/344/EEC Recital 7 (adapted)

5

(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 (cid:2) I (cid:3) and residues permitted in food and
food ingredients (cid:2) should (cid:3) be established.

(cid:1) 88/344/EEC Recital 8 (adapted)

(cid:1) 88/344/EEC Recital 9 (adapted)
(10)  Pending  the  adoption  of  Community  rules  on  (cid:2) substances  used  for  diluting  and
dissolving (cid:3) flavourings, Member  States should not  be prevented from  authorising,
as  extraction  solvents  for  certain  flavourings,  substances  used  for  diluting  and
dissolving such materials.

(11)  The  provisions  on  certain  extraction  solvents  should  be  reviewed  within  a  period  of
time on the basis of the ongoing scientific and technical research on the acceptability
of such solvents and the conditions for their use.

(cid:1) 88/344/EEC Recital 10

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

extraction solvents in and on foodstuffs should be established.

(cid:1) 88/344/EEC Recital 11

(13)  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:1) 88/344/EEC Recital 12

(cid:1) 88/344/EEC Recital 13
(adapted)

(14)  (cid:2) 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
Commission5. (cid:3)

5

(cid:1) OJ L 184, 17.7.1999, p. 23. (cid:2)

6

                                                
(cid:1) 

(15)

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,

HAVE ADOPTED THIS DIRECTIVE:

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

Article 1

1.

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

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 (cid:2) I (cid:3).

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.

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

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

(cid:2) 2. (cid:3) For the purposes of this Directive:

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

(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 (cid:2) I (cid:3)  ,  under  the  conditions  of  use  and  where  appropriate  within  the
maximum residue limits specified (cid:2) therein. (cid:3)

7

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.

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 (cid:2) I (cid:3) beyond those specified therein.

(cid:1) 88/344/EEC

Until  the  adoption  of  Community  provisions  on  substances  used  for  diluting  and
dissolving  flavourings  Member  States  may,  on  their  territory,  allow  the  use,  as
solvents  for  the  extraction  of  flavourings  from  natural  flavouring  materials,  of
substances used for diluting or dissolving flavourings.

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

2.

3.

4.

(cid:1) 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 (cid:2) I (cid:3) satisfy the following purity criteria:

(a)

(b)

(c)

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;

they  shall  satisfy  the  specific  purity  criteria  determined  in  accordance  with
Article 4 (cid:2) (d) (cid:3) .

The  following  shall  be  determined  in  accordance  with  the  procedure  (cid:2) referred  to (cid:3)  in
Article 6 (cid:2) (2) (cid:3) :

Article 4

(a)

The necessary amendments to Annex (cid:2) I (cid:3) 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:1) 97/60/EC Art.1 pt.1 (adapted)

8

(cid:1) 88/344/EEC (adapted)
(cid:4)1 97/60/EC Art.1 pt. 1

(cid:4)1 (b) (cid:5) the  methods  of  analysis  necessary  to  verify  compliance  with  the  general  and

specific purity criteria referred to in Article 3;

(cid:4)1 (c) (cid:5) the  procedure  for  taking  samples  and  the  methods  for  qualitative  and
quantitative  analysis  of  the  extraction  solvents  cited  in  Annex  (cid:2) I (cid:3)  used  in
foodstuffs or food ingredients;

(cid:4)1 (d) (cid:5) if  necessary,  the  specific  purity  criteria  for  the  extraction  solvents  listed  in
Annex  (cid:2) I (cid:3)  ,  and  in  particular  maximum  permitted  limits  of  mercury  and
cadmium in the extraction solvents.

1.

2.

3.

1.

Article 5

Where  a  Member  State,  as  a  result  of  new  information  or  of  a  reassessment  of
existing  information  made  since  (cid:2) this (cid:3)  Directive  was  adopted,  has  detailed
grounds  for  establishing  that  the  use  in  foodstuffs  of  any  substance  listed  in
Annex (cid:2) I (cid:3) 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,  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.

The  Commission  shall  examine  as  soon  as  possible  the  evidence  given  by  the
Member  State  concerned  and  consult 
in
Article 6(1) (cid:3) , and shall then deliver its opinion forthwith and take the appropriate
measures, which may replace the measures referred to in paragraph 1.

the  Committee  (cid:2) referred 

to 

If the Commission considers that amendments to (cid:2) this (cid:3) Directive are necessary
in  order  to  resolve  the  difficulties  mentioned  in  paragraph  1  and  to  ensure  the
protection  of  human  health,  it  shall  (cid:2) adopt (cid:3)  these  amendments  (cid:2) in
accordance  with  the  procedure  referred  to  in  Article  6(2) (cid:3)  .  Any  Member  State
which  has  adopted  safeguard  measures  may  in  that  event  retain  them  until  the
amendments enter into force in its territory.

Article 6

(cid:2) The Commission shall be assisted by the Standing Committee on the Food Chain
and  Animal Health, instituted by  Article 58(1) of Regulation  (EC)  No  178/2002  of
the  European  Parliament  and  of  the  Council6,  hereinafter  referred  to  as  “the
Committee”. (cid:3)

6

(cid:1) OJ L 31, 1.2.2002, p. 1. (cid:2)

9

                                                
2.

3.

1.

2.

3.

4.

reference 

(cid:2) Where 
this  paragraph,  Articles  5  and  7  of
Decision 1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8
thereof. (cid:3)

is  made 

to 

(cid:2) The  period  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be  three
months. (cid:3)

(cid:2) The Committee shall adopt its rules of procedure. (cid:3)

Article 7

Member  States  shall  take  all  the  necessary  measures  to  ensure  that  the  substances
listed  in  Annex  (cid:2) I (cid:3)  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)

(b)

the commercial name as given in Annex (cid:2) I (cid:3) ;

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

(c)

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

(d)

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

(e)

the net quantity given as units of volume;

(f)

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

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.

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

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.

1.

This Directive shall (cid:2) also (cid:3) apply to extraction solvents used or intended for use
in the production of foodstuffs or ingredients imported into the Community.

Article 8

10

2.

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

(cid:1) 

Article 9

Directive 88/344/EEC, as amended by the Directives 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 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

(cid:1) 88/344/EEC Art. 10

Article 11 

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President
[…]

For the Council
The President
[…]

11

(cid:1) 88/344/EEC Annex

ANNEX I

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

PART I

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

Name:

Propane

Butane

Ethyl acetate

Ethanol

Carbon dioxide

Acetone(cid:4)1 2 (cid:5)

Nitrous oxide

(cid:1) 88/344/EEC (adapted)
(cid:4)1 92/115/EEC Art.1 pt.3
(cid:4)2 97/60/EC Art.1 pt.2
(cid:4)3 94/52/EC Art.1

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.

12

                                                
PART II

Extraction solvents for which conditions of use are specified

Name

Conditions of use

(summary description of
extraction)

Maximum residue limits in the
extracted foodstuff or food
ingredient

(cid:4)2 Hexane 1 (cid:5)

(cid:4)2 Production or fractionation of
fats and oils and production of
cocoa butter (cid:5)

(cid:4)2 1 mg/kg in the fat or oil or
cocoa butter (cid:5)

(cid:4)2 Preparation of defatted
protein products and defatted
flours (cid:5)

(cid:4)2 10 mg/kg in the food
containing the defatted protein
products and the defatted
flours (cid:5)

(cid:4)2 30 mg/kg in the defatted soya
products as sold to the final
consumer (cid:5)

(cid:4)2 Preparation of defatted cereal
germs (cid:5)

(cid:4)2 5 mg/kg in the defatted cereal
germs (cid:5)

Methyl acetate

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

20 mg/kg in the coffee or tea

Ethylmethylketone
(cid:4)1 2 (cid:5)

Production of sugar from
molasses

1 mg/kg in the sugar

Fractionation of fats and oils

5 mg/kg in the fat or oil

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

20 mg/kg in the coffee or tea

1

2

Hexane  means  a  commercial  product  consisting  essentially  of  (cid:1) acyclic (cid:2) 
saturated
hydrocarbonscontaining  six  carbon  atoms  and  distilling  between  64 °C  and  70 °C.  (cid:3)1 The  combined
use of Hexane and Ethylmethylketone is forbidden. (cid:4)
(cid:3)1 The presence of n-Hexane in this solvent should not exceed 50 mg/kg. This solvent may not be used
in combination with Hexane. (cid:4)

13

                                                
Dichloromethane

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

(cid:4)1 2 mg/kg (cid:5) in the roasted
coffee and 5 mg/kg in the tea

(cid:4)1 Methanol (cid:5)

(cid:4)1 For all uses (cid:5)

(cid:4)1 Propan-2-ol (cid:5) (cid:4)1 For all uses (cid:5)

(cid:4)1 10 mg/kg (cid:5)

(cid:4)1 10 mg/kg (cid:5)

14

PART III

Extraction solvents for which conditions of use are specified

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:4)1 1 (cid:5)

2 mg/kg

1 mg/kg

(cid:4)3 Cyclohexane (cid:5)

(cid:4)3 1 mg/kg (cid:5)

Methyl acetate

Butan-1-ol

Butan-2-ol

Ethylmethylketone(cid:4)1
1 (cid:5)

1 mg/kg

1 mg/kg

1 mg/kg

1 mg/kg

Dichloromethane

(cid:4)1 0,02 mg/kg (cid:5)

(cid:4)1 Propan-1-ol (cid:5)

(cid:4)1 1 mg/kg (cid:5)

(cid:4)2 1,1,1,2-
tetrafluoroethane (cid:5)

(cid:4)2 0,02 mg/kg (cid:5)

_____________

1

(cid:3)1 The combined use of these two solvents is forbidden. (cid:4)

15

                                                
(cid:6)

ANNEX II

Part A

Repealed Directive with 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)

______________

16

Part B

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

Directive

Time-limit for transposition

Directive 88/344/EEC

13 June 1991

Directive 92/115/EEC

a. 1 July 1993

b. 1 January 19941

Directive 94/52/EC

7 December 1995

Directive 97/60/EC

a. 27 October 1998

b. 27 April 19992

_____________

1

2

permit trade in products 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(1) of Directive 92/115/EEC:
“1. Member States shall amend their laws, regulations and administrative provisions in such a way as
to:
-
-
They shall forthwith inform the Commission thereof.”
In accordance with Article 2(1) 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 by 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.

-

They shall forthwith inform the Commission thereof.”

17

                                                
ANNEX III

Correlation Table

Directive 88/344/EEC

This Directive

Article 1(1)

Article 1(3)

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

-

-

Article 10

Annex

-

-

Article 1(1)

Article 1(2)

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

-

Article 9

Article 10

Article 11

Annex I

Annex II

Annex III

_____________

18