CELEX: 51976PC0680
Language: en
Date: 1976-12-20
Title: Proposal for a COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to materials and articles containing vinyl chloride monomer and intended to come into contact with foodstuffs (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (76) 680
Vol. 1976/0205
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                          COM(76 ) 680 final
                                          Brussels , 20 December 1976
                             Proposal for a
                            COUNCIL DIRECTIVE
                  on the approximation of the laws of the
                  Member States relating to materials and
                  articles containing vinyl chloride monomer
                  and intended to come into contact with
                               foodstuffs
                ( submitted to the Council by the Commission )
 C0M(76 ) 680 final
 ---pagebreak---                                            *° iL~~
                              EXPLANATORY MEMORANDUM
I.     General
V? ,yi chloride monomer (VC ) \ a colourless gas which is used as a basic
sv. . stance in "the production c..f; ■ olyvlnyl chloride (PVC ) , at present one of
the plastics most commonly used » ox- th packaging of food products . Until
 196O , VC was regarded as a harmle - gas ,'ith a narcotic effect .         In the
early sixties some scientists demoi * tratt . that VC had harmful effects on
health and caused acrosteolysis , sclt coder.. 0., and liver diseases . In 1970 ,
 it was first suspected that VC could , when - haled , he r sponsible for
 oncogenous effects . In 1973 and 1974 » the si-v-iltaneous dJv covery of
tumours of the same type ( angiosarcoma in the „.'ver) in ratt exposed to
high doses of VC and in men who had worked for iv-ng periods              the PVC
 industry confirmed the validity of the early suspicions .
 While experiments were being carried out on inhalation of VC , research was
 started in 1974 "to determine the effects on rats of the administration of
 VG per os .    After about a year of this research the discovery of tumours in
 some rats immediately prompted the Commission departments concerned to
 question the Scientific Committee for Foodstuffs* , which on 27 June 1975 had
 delivered an opinion which included the following passages "The aim should
 therefore be to take all possible steps tc reduce all forms of exposure to VC
  ...    The levels of VC in PVC and related polymers should be reduced as far
 as possible ... VC should not be detectable in food or potable water by an
 agreed method             At a subsequent meeting held on 13-14 November 1975 ,
 the Scientific Committee recognized the limits of sensitivity of the methods
 and suggested , as a temporary measure , the adoption of "a method of analysis
 which would be applicable generally to most foods by most control laboratories
 with a unit of detection of 0.050 mg/kg".
 In order to study ways of applying the opinion of the Scientific Committee
 and of defining the method of analysis for VC , the Commission organized
 several meetings with representatives of the Member States * Governments
 and of the PVC industry , and asked for the opinion of the Advisory Committee
 on Foodstuffs , in which the various economio and social groups are
 represented .
 Until the various series of experiments currently in hand in many countries
 have been completed and the results of the research allow an exact
 assessment to be made of the risk inherent in the use of VC in materials
 and articles intended to come into oontact with foodstuffs , the Commission
wishes , as a precautionary step , to present the appended proposal for a
directive .              "                                               .
 1
   OJ No L 136 of 20 May 1974 .
 2
   OJ No L 182 of 12 August 1975
 ---pagebreak---                                            - 2 -
   II . Comments on the proposal for the directive
   The appended draft represents a directive implementing the
  Directive 76/.../EEC of 22 November 1976 concerning
  materials and articles intended to come into contact with foodstuffs
   (Article 1 ). It proposes fixing limits for the VC content in materials
  and articles prepared with VC and in foodstuffs which come into contact
  with such materials and articles (Article 2 and Annex i ).
  The fixing of limits for the VC content of materials and articles as well
  as for the presence of VC in foodstuffs is proposed with a view to reducing
  to a minimum the probability of VC migration into foodstuffs , and thus
  offering an additional guarantee to the consumer . Furthermore , the fixing
  of such limits obliges industry to monitor the production of PVC materials
 and articles continuously and allows the State to intervene , if necessary ,
 before the marketing of the materials and articles , or the foodstuffs with
 which such materials and articles are in contact . Monitoring of the VC
  level in foodstuffs , although essential (according to the opinion of the
 Scientific Committee ; "there is no good correlation between the free vinyl
 chloride monomer concentration in PVC end the related polymers and the
 amount of VC migrating into food in contact with these polymers"), does not
 permit preventive monitoring of production and does not reduce the presence
 of VC in foodstuffs to an absolute minimum, since this minimum depends on the
 sensitivity and accuracy .of the analytical methods . Finally, the fixing of a
 limit cnVC in materials and articles is an effective and simple way' of reducing
 to a minimum the arigrjfclon of VC from materials and articles ( e.g. tubes , plastic
 sheets , parts of apparatus used for food processing) in cases where the
 fixing of a VC limit in the foodstuff would be totally inadequate to protect
 consumer health , since such materials and articles are not marketed together
with the food but are intended to come into contact only incidentally when
 official government inspection cannot be carried out .
The maximum value of 0.050mg/kg for VC in foodstuffs is the minimum amount
which can at present be determined with sufficient accuracy in the
majority of foodstuffs by the majority of laboratories . This value is also
the one currently envisaged in the laws or proposed laws already existing
in the countries of the European Community.          The maximum values for VC in
the various types of PVC materials and articles , however , represent the
minimum quanities which can now be obtained by applying the most advanced
technologies . With these limits and on the basis of currently available
scientific documentation, it is highly probable that the maximum quantity
of VC present in foodstuffs under the most stringent conditions of
preservation is well below 0«050mg/kg.
Since further developments in the manufacturing techniques used for PVC
materials and articles , in the methods of determining VC in foodstuffs and
in the assessment of the hazards presented by VC are to be expected , a rapid
procedure for adapting the Directive to technical progress is also provided
for (Article 4).
 ---pagebreak---                                     -3-
Anxx6X XI sets ou*t "tho method of* analysis "bo be us©d for verifying VC
levels in foodstuffs and PVC materials or articles .
m* Consultation of the European Parliament and th* Economic and
      Social Committee                                      ~~–    ––-
      The text now proposed will constitute a " specific Direct ive "
      within the meaning of Article 3 of the Directive 76/..../EEC and
      therefore must be adopted under the procedure provided for in
      Article 100 of the Treaty – By virtue of the second paragraph of
      this latter Article , consultation with the European Parliament
      and the Economic and Social Committee is required.
      Implementation of the provisions of the Directive will involve
      amendments to the legal provisions in all the Member States.
 ---pagebreak---                                     - 4-
Proposal for a Counoil Direct ive on the approximation of the laws of the
Member States relating to materials and articles containing vinyl chloride
monomer arri intended to come into oontaot with foodstuffs
C .3 COUNCIL TO THE EUROPEAN COMMUNITIES ,
n zing regard to the Treaty establishing the European Economic Community ,
Having regard to Directive 76/.«../EEC of 22 November 1976 on the approxi­
mation of the laws of the Member States relating to materials and artioles
intended to come into contact with foodstuffs , erd in particular Article 3 thereof ,
Having regard to the proposal from the Commission ,
Having regard to theepinion of the European Parliament ,
Having regard to the opinion of the Economio and Social Committee ,
Whereas       Article 2 of     Directive 76/..../EEC provides that materials
and articles must not transfer to foodstuffs at^y constituents in quantities
liable to endanger publio health ;
Whereas Article 3 of the same Directive provides that the Council under the
procedure provided for in Article 100 of the Treaty shall adopt by
Directive special provisions applicable to certain groups of materials and
articles ('fepecific Direotives") ; whereas these provisions may include specific
limits on the migration of certain constituents into or onto foodstuffs as
well as other rules to ensure compliance with Article 2 of the said Direotive ;
Where as the administration of large doses of vinyl chloride monomer to expe­
rimental animals has been shown to produce harmful        effects and whereas
such effeots could also occur in man;
Whereas the Scientific Committee for Foodstuffs has given the opinion that
"the levels of vinyl chloride monomer in polyvinyl chloride and related
polymers should be reduced as far as possible " and at the same time recom­
mended that " no trace of vinyl ohloride should be deteotable in food or potable
water by a method which can be generally applied to the majority of foodstuffs
by most laboratories ";
                                                                        ■/.
( 1 ) J.O. n° L
 ---pagebreak---                                  -2-
Whereas further research is at present in progress on vinyl ohloride monomer ,
"but as a precaution the absorption of vinyl chloride monomer should be res­
tricted until these results are known ;
Whereas the adaptation of the Directive to technical progress is an imple­
menting measure and whereas , in order to simplify and accelerate the procedure ,
 this should be the responsibility of the Commission ;
Whereas, in all cases in which the Council oonfers on the Commission autho­
rity to implement rules relating to materials and articles intended to
 come into contact with foodstuffs , a procedure should be laid down esta­
blishing close cooperation between the Member States and the Commission
within the Standing Committee on Foodstuffs set up under the Council
Decision of 13 November 1969 »
HAS ADOPTED THIS DIRECTIVE s
 ---pagebreak---                                          Art iole 1
pursuant to Article 3          of the Directive 76/... /EEC of 22 November 1976
this "Directive coneerne materials and articles prepared with vinyl
c*v oriac polymers or copolymers vfliich in their finished state are
xr,   udsd +.o come into contact with         foodstuffs , or whioh are in
co - act w. 'h foodstuffs and are intended for that purpose.             They axe
hereinafter'      called "materials and articles ".
                                         Article 2
                                              Materials   and articles shall not
 contain vinyl chlo.-. &e monomer in quantities exceeding the limits laid
 down in Annex I.
                           Foi. v* stuffs having come into contact with materials
  and articles shall not contain ^iny! chloride monomer in quantities
  exceeding the limit      laid down in Annex I.
                                         Artide 3
  Compliance with the limits laid down in Annex I shall be checked "by the
  method described in Annex II .
                                          Article 4
  Amendments "to adapt "the Annexes to "this Directive in accordance with developments in
  scientific and technical knowledge shall be adopted in accordance with
  the procedure laid down in Article 10 of the Direotive 76/... /EEC of
    22 November 1976 .
                                         Article 5
  This Direotive shall not affect national provisions relating to other
  possible standards provided for in Article 3               of the Directive 76/. ../EEC
    of 2.2 November 1976 .
                                         Article 6
   1 . To comply with the provisions of this Directive, the Member States
   shall , where necessary, amend their respective laws by 1 January 1978
  and inform the Commission forthwith.
   2.    The laws as thus amended shall be applied with effect from 1 July 1978
    both to materials and articles , and to foodstuffs with which such materials
    and articles have come into contact .
                                         Article 7
   This Direotive is adrassed to the Member States .
 ---pagebreak---                                  ANNEX I
Limits of vinyl ohloride monomer in materials , articles and foodstuffs
Materials and articles :     1 mg/ kg in the final product .  However,
                             in the case of materials and artioles
                             prepared with vinyl chloride copolymers
                             and not intended for use in packaging or
                             containing liquids for human consumption,
                             the limit shall "be 5 mg/kg .
Poodsturfsî                  0.050 mg/kg.
 ---pagebreak---                                                5 «
                                          AfflîOC II
 T.-e-t smln.'-xt ion ef v^rryl cMoride ( VCÌ moaomer in materials . articl<>s anA
  i oods c uf 13
          Principle
 The presence of VC in foodstuffs , materials or articles is determined by meana
 of gas–liquid chromatography using the "head space" method after solution
 or suspension           of       the sample in dimethylaoetamida ( DMA).
 2.       Reagent s
 2.1        VC , of purity greater than 93.5%.
 2.2        K-IT DMA, not containing any volatile impurity, with the same
 chromatography retention time as VC .
 2.3
 in DMA .
            Any appropriate internal standard solution, such as diethyl ether
3»        Apparat us
M. An instrument or piece of apparatus is mentioned only if it is
special or made to particular specifications; usual laboratory
apparatus is assumed to be available.
3.1 Gas chromatograph fitted with an automatic head-space sampler and
A-vsme ionization detectors. Alternatively, a gas chromatograph fitted
        manual sample injection and equipped with a flame ionization
detector may be used.            It has also been found that it is satisfactory
to use a specific detector in the gas chromatograph instead of a flame
ionization detector, e.g. , a micro–electrolytic conductivity detector
of tiie kind described in the Journal of Chromatographic Soience.
Vol . 12 ( March 1974 ), p. 152.
3« 2       À c,otentiometer «
3-3
sept .MB .
           Sample phials or flasks fitted with a silicone or butyl rubber
 ---pagebreak--- When using the manual technique, the taking of a sample in the head
space by means of a syringe may cause the formation of & partial vaouum
inside the phial or flask.      Hence, for manual techniques where the phials
are not pressurized before the sample is taken, the use of large phials
iB recommended.
3.4     Micro-syringes .
3.5     Gaslight syringeB for manual head–space sampling.
4.     Proo adore
4.1     Preparation of standard VC solution
NB .    VC must be handled in a ventilated fume cupboard.
Weigh a suitable glass vessel accurately and plaoe in it a quantity
( e.g. , 30 ml ) of DM.    Reweigh.    Add to the DMA a quantity of VC
( e.g. , 0.1 mg) in liquid or gas form, in the latter case by bubbling in
or injecting .     After again reweighing, calculate from the difference the
quantity of VC in solution and hence the concentration of the solution
obtained ( standard solution).      This standard solution will keep for a
long time if stored in a refrigerator.
Prepare a dilute VC solution by taking an aliquot of standard solution
and adding it to a predetermined quantity of DMA oontained in an already
tared glass phial, at the same time reducing the volume of air (head
spaoe ) as much as possible . Reweigh and calculate the VC oonoentration
by difference .
4.2     Preparation of sample
NB .    Take all the necessary precautions to ensure that no VC is lost
through volatilization.
Take samples of foodstuffs, materials or articles in such a way that they
are representative of the product under investigation.       For this purpose,
in the oase of non-liquid foodstuffs, homogenize the samples under
investigation accurately before taking an aliquot .
 ---pagebreak--- 4.2.1    Foodstuff sample
Weigh accurately into each of a Bet of three phials a suitable quantity
of foodstuff under investigation .    If considered necessary, add an
appropriate quantity of DMA ( this sometimes promotes the attainment
of a state of equilibrium) and/or        of the internal standard. Seal
Immediately and homogenize .
4. 2. 2  Calibration curve for the determination of VG in foodstuffs
Weigh into each of a set of not less than five phials a proportionate
quantity of the same foodstuff which has never been in contact with
materials or articles containing VC .    If some DMA and/or some of the
internal standard has been added to the foodstuff sample under section 4*2 .}., add
proportionate quantities to each reference sample .
Finally, add diluted standard VC solution in quantities such as give
VC concentrations equal to 0.000, 0.050, 0. 075 » 0.100, 0.1 50, etc .,
mg/kg.    Seal immediately and homogenize .
4.2.3    Sample of material and article
Weigh accurately into each of a set 01 three phials about 200 mg
of the material or artiole , sampled from the product under investigation
and reduced to small size .    Insert a magnetic stirrer and about
2 ml of DMA containing, if considered neoessary, an appropriate
quantity of internal standard solution .     Seal the phial , suspend it in
a waterbath held at 60-70 C and dissolve the sample by stirring the
solution vigorously.
4.2.4    Calibration  curve for the determination of VC in materials or
articles
 Place about 200 mg of  a   material or artiole of the same type as
described in section 4*2.3 , not containing any detectable amount of VC ,
 in each of a set of not less than five phials .    Insert   a magnetic
 stirrer and add about 2 ml of DMA containing a suitable quantity of
 internal standard, if this has been used under section 4*2.3 *
 ---pagebreak---  Dissolve the material or article by stirring .     Add diluted Btandard
 VC solution in quantities such aa give a range of o one ent rat ions
 comprising the concentration of the VC in the sample under investigation.
 Seal immediately and homogenize .
 4.3     Gaa-chromat ography determination
 4.3.1     Bring the sample to a state of equilibrium
 Allow the samples contained in the sealed phials a sufficient time to
 attain a state of equilibrium "before beginning the head–space sampling
 operation.      A period of two hours at 50°C is usually sufficient for
 this purpose .
 4»3 » 2   Determination
 Choose a gas-chromat ography column and operating conditions such
that the produot under investigation does not interfere with the
VC or, if applicable , with the internal standard.      Periodically
flush the column so as to eliminate DMA peaks from the chromatogram.
Measi-re the area ( or height ) of the peaks representing the VC or
the internal standard, if used, and deduce the VC concentration of
the saraplo of foodstuff, material or article under investigation
from the constructed calibration curves .
4.4      Interference peaks on the chromatogras?s
Certain foodstuffs give rise to interference peaks .      In that event ,
confirm that ¥0 is actually present in the foodstuff sample, either
by using a micro-elect rolytio conductivity detector as mentioned
in section 3.1 or by means of mass spectrometry.      In this event ,
the fact that molecular ions with parent masses ( a/e ) of 62 and 64
are present in the ratio      of   3*1 is regarded as confirming that
VC is present .      If such interference is confirmed, use a different
column .