CELEX: 51991PC0007
Language: en
Date: 1991-01-28
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 76/769/EEC ON THE APPROXIMATION OF THE LAWS, REGULATIONS AND ADMINISTRATIVE PROVISIONS OF THE MEMBER STATES RELATING TO RESTRICTIONS ON THE MARKETING AND USE OF CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS

COMMISSION OF THE EUROPEAN COMMUNITIES
                                           C0M(91) 7 f i n a l - SYN 325
                                           Brussels, 28 January 1991
                           Proposal for a
                         COUNCIL DIRECTIVE
    amending Directive 76/769/EEC on the approximation of the
      laws, regulations and administrative provisions of the
          Member States relating to restrictions on the
              marketing and use of certain dangerous
                    substances and preparations
                   (presented by the Commission)
 ---pagebreak---                                            -   1 -
                               EXPLANATORY        MEMORANDUM
1.     INTRODUCTION
In May 1989 the German authorities communicated to the Commission
their concern about dangers posed to human health and the
environment by a family of chemicals known as poIybromobIphenyI
ethers (PBBE'S)           which are used as flame retardants In certain
p l a s t i c s . They further Invited the Commission to take the
Initiative at Community level and propose a way to solve the
problems posed by PBBE'S. The Commission studied the rationale
provided by the German authorities and subsequently announced Its
Intention to propose Community measures covering the PBBE family.
The Commission,          having taken Into account the available
Information, Is          now proposing to Introduce Community measures
restricting the          marketing and use of PBBE'S by -sans of a
modification to          Directive 7 6 / 7 6 9 / E E C .
The Commission considers that this proposal Is consistent with
the high level of protection required under the Treaty.                        The
rationale underlying the Commission's proposal Is given below.
2. HISTORICAL          BACKGROUND
The ever Increasing use of plastic materials presents a special
challenge to the control of fire.                    This challenge has been met
effectively by Incorporating flame retardant formulations In
plastics likely to be so exposed (about 1 % of all p l a s t i c s ) :
Various types of flame retardants can be used In p l a s t i c s .
Brominatea organic compounds are however m o muo.. »idciy used ?.t
present and within this group the PoIybromobIphényI Ethers
(PBBE'S) have In recent years recorded rapid growth In most
c o u n t r i e s . The PBBE'S are used as f I a m e r e t a r d a n t s In plastics
finding application In a range of product components (e.g.
housings, electrical c o n n e c t o r s ) and final products (e.g.
televisions, computers, a u t o m o b i l e s ) .
The widespread application of PBBE'S has occured because of their
special p r o p e r t i e s .  The fire retardancy action of PBBE
formulations Is particularly effective as it Is available at the
optimum           temperature for effective fire c o n t r o l . In addition
PBBE's need be present only In small amounts and thus Impair to a
minimum extent the original properties of the p l a s t i c .
 ---pagebreak---                                          - 2 -
Production of PBBE's           In Western Europe amounted to several
thousand tonnes In 1989, having fallen slightly from 1936 levels.
By contrast      Imports of PBBE's Into the Community have risen
significantly since 1986 and now exceed EC production by a
considerable margin. An unknown, but certainly very large amount
of PBBE reaches the Community through imports of plastics and of
goods containing plastics e.g. TV's, cars, a Ircraft .etc.
The recent fall In Community production Is the result of concerns
about the dangers to health posed by PBBE's. Most worrying Is the
release     Into     the   atmosphere       of      toxic     chemicals   known   as
poIybromodIbenzofurans            (furans        for      short)    when   plastics
containing     PBBE'S      are     exposed       to   heat     (e.g.   In   plastics
processing, accidental fires, municipal Incineration).
3. INFORMATION ON THE SUBSTANCES COVERED BY THIS PROPOSAL
    3.1. Genera I.
The PBBE family Includes the following homologue s
 I.e.             DecabromobIphenyI Ether CAS 1163- 19-5)
                  Nona «        «     «                " 63936-56-1)
                                                       M
                  Octa M       "     M      M
                                                            32536 -52-0)
                  Septa-                               " 689 2 8-80-3)
                  Hexa M                               " 36483-60-0)
                  Penta"                                    32534 -81-9)
                                                        M
                  Tetra"                                    40088 -47-9)
                  T . I  H      II     H      II
                                                        " 49690-94-0)
                  Q I    H      N      H      II
                                                        " 2050-47-7)
                        BromobIphenyI Ether             "    101-55-3)
Of these, only the penta, octa and deca varieties are used
 commercI a I 1 y.
 However, while no commercial use Is known of the seven other
 homologues there Is at present no legal Impediment to their
marketIng and use .
Within the Community several companies have already ceased                      PBBE
production      though     three     producers        remain.     The  PBBE'S   find
application In some sixteen distinct types of resin and
polymer :
 ---pagebreak---                                                           - 3 -
Res 1n/substrate :                                             Use of
                                           Deca-BBE           Octa-BBE   Penta-BBE.        Other homo I.
 1.   ABS*                                                        X
 2.   Epoxy Resins                                  x
 3.   Pa Ints/Iacquers                              X                         X
 4.   PhenoI Ic Res Ins                             X                         X
 5.   PolyacryIon I tr I le                         X
 6.   Polyamide                                     X               X
 7.   PBT**                                         X               X
 8.   Polyethylene                                  X
 9.   PET***                                        X
  10. Polypropylene                                 X
  11. PoIystyrene                                   X               X
  12. PVC                                           X                         X
  13. Polyurethane                                                            X
  14. Rubber                                        X                         X
  15. Text I les                                    X
  16. Polyesters                                    X                         X
*      Acrylonltrlle-Butadlene-Styrene
**    P o l y b u t y l e n e T e r e p h t h a I ate
***   P o l y e t h y l e n e TerephthaI ate
          The deca h o m o l o g u e Is produced             In the largest v o l u m e s and finds
          most w i d e s p r e a d a p p l i c a t i o n .
          3.2. P r o p e r t i e s of the s u b s t a n c e s .
          ToxIcIty.
          The deca h o m o l o g u e a p p e a r s to have no u n d e s i r a b l e t o x l c o l o g l c a
          effects.
          Acute toxicity tests have shown that octa too Is n o n - t o x i c .
          However a n i m a l s subjected to long term e x p o s u r e to very high
          doses of octa have suffered c o m p o u n d - r e l a t e d liver and thyroid
          effects.
 ---pagebreak---                                                    - 4 -
P e n t a Is a s l i g h t e y e I r r i t a n t and h a s s i m i l a r liver and t h y r o i d
e f f e c t s to o c t a .
It Is c o n c l u d e d that t h e c o m m e r c i a l l y I m p o r t a n t P B B E ' S p r e s e n t a
small h a z a r d In t e r m s of t o x i c i t y . W h a t risk that e x i s t s Is
l a r g e l y c o n f i n e d to t h e w o r k p l a c e w h e r e P B B E ' S a r e p r o d u c e d and
c o m p o u n d e d . T h e r e Is, a p p a r e n t l y , no d a n g e r to t h e p u b l i c In
handling plastics containing PBBE'S.
EnvIronment.
Deca       h a s no u n d e s i r a b l e   environmental           effects.
Minimal          bioconcentration            has been         recorded      In t h e c a s e  of o c t a .
T r a c e s of p e n t a h a v e b e e n I d e n t i f i e d       In c e r t a i n river    sediments
and In s o m e m u s s e l and cod s a m p l e s .
W h i l e t h e U n i t e d S t a t e s E P A h a s r e c o m m e n d e d f u r t h e r t e s t s o n the
c h e m i c a l f a t e and e n v i r o n m e n t a l e f f e c t s     of t h e t h r e e c o m m e r c i a l
P B B E h o m o l o g u e s , t h e r e Is l i t t l e e v i d e n c e at p r e s e n t of d a n g e r s
to t h e e n v i r o n m e n t t h r o u g h a c c u m u l a t i o n of P B B E ' S .
Exposure           to the h e a t .
V e r y h i g h q u a n t i t i e s of d l o x l n s and f u r a n s h a v e b e e n d e t e c t e d
d u r i n g p y r o l y s e In t h e l a b o r a t o r y of t h e p u r e f l a m e r e t a r d a n t s ,
especially those containing penta.
 S m a l l e r q u a n t i t i e s of f u r a n s I n c l u d i n g m i n u t e t r a c e s of the very
 toxic 2,3,7,8 tgtràbrûiïiûuluoiù^iUi an *<«.« L » _ :. _" _':?*•-• ^ !n the
p r o d u c t s of c o m b u s t i o n w h e n p l a s t i c s c o n t a i n i n g P B B E art» b u r n a d .
H o w e v e r t h e s e c o m b u s t i o n p r o d u c t s g a v e no c l i n i c a l slrjnt- of
 tox I c I ty In an I m a I s .
M e a s u r m e n t s at the w o r k p l a c e h a v e , h o w e v e r , s h o w n that f u r a n
e m i s s i o n s p o s e a c e r t a i n r i s k . E x p o s u r e s t u d i e s In p l a s t i c
 processing plants have confirmed furan c o n c e n t r a t i o n s when
 p l a s t i c s a r e w o r k e d at h i g h t e m p e r a t u r e (at t h e e x t r u d e r h e a d ) .
T h e e x i s t e n c e of risk Is c o n f i r m e d by t h e I n t e r i m r e s u l t s of o n e
 s e r i e s of e p i d e m i o l o g i c a l s t u d i e s .
 ---pagebreak---                                                      - 5 -
R i s k s a s s o c i a t e d w i t h n o n - p r o f e s s i o n a l e x p o s u r e w o u l d s e e m to be
s l i g h t . T e s t s h a v e I n d i c a t e d that t h e r e Is n o r i s k to the TV
v i e w i n g p u b l i c a r i s i n g f r o m f u r a n e m i s s i o n s and it h a s yet to be
e s t a b l i s h e d w h e t h e r any r i s k is p o s e d by the p r o d u c t s of
a c c i d e n t a l f i r e s . A s far as w a s t e d i s p o s a l by I n c i n e r a t i o n Is
c o n c e r n e d , hazard a s s e s s m e n t c a l c u l a t i o n s have shown a b!g
p o t e n t i a l for f u r a n r e l e a s e t h o u g h t h i s h a s not b e e n c o n f i r m e d by
actual e m i s s i o n m e a s u r e m e n t s .
 It s t i l l r e m a i n s to be s h o w n w h e t h e r b r o m o d I b e n z o f u r a n s or
b r o m o d l o x l n s a r e p r e s e n t In the e n v i r o n m e n t .
 It d o e s s e e m f r o m the a v a i l a b l e e v i d e n c e that p l a s t i c s c o n t a i n i n g
P B B E ' S d o , w h e n s u b j e c t e d to h e a t , p o s e a t h r e a t to h u m a n h e a l t h .
3.3.       Existence         of    alternatives.
S u b s t i t u t e s for P B B E ' s m u s t be J u d g e d In t e r m s of v a r i o u s
c r i t e r i a . F i r s t and f o r e m o s t t h e y m u s t a l l o w c u r r e n t f i r e
s t a n d a r d s to be r e s p e c t e d . T h e y m u s t a l s o be s a f e r t h a n P B B E ' s In
t e r m s of p r o t e c t i o n of h e a l t h and the e n v i r o n m e n t . In a d d i t i o n
t h e r e a r e m a n y p r a c t i c a l c o n s t r a i n t s ; for e x a m p l e , t h e y m u s t not
 impair the m a n u f a c t u r e and p e r f o r m a n c e of p l a s t i c g o o d s nor
s h o u l d t h e y be e x c e s s i v e l y e x p e n s i v e .
W h i l e s o m e c a n d i d a t e s u b s t i t u t e s h a v e a l r e a d y b e e n I den t I led  f    It
h a s not yet b e e n s h o w n c o n c l u s i v e l y that t h e y are p r e f e r a b le to
P B B E ' s . For e x a m p l e T e t r a b r o m o b I s p h e n o I A , w h i c h Is a l r e a d y u s e d
e x t e n s i v e l y In G e r m a n y and J a p a n , m a y a l s o lead to r e l e a s e of
f u r a n s a s d e s c r i b e d for P B B E ' s , t h o u g h p r o b a b l y in s m a l l e r
a m o u n t s . S u b s t i t u t e s of the I n o r g a n i c t y p e m a y not h a v e
s u f f i c i e n t f l a m e r e t a r d a n c y In p l a s t i c s to a l l o w e x i s t i n g f I re
s t a n d a r d s to be m e t . C l e a r l y d e t a i l e d h a z a r d a n a l y s e s m u s t be
c o m p l e t e d for the v a r i o u s p o s s i b l e s u b s t i t u t e s b e f o r e any ban I s
 I m p o s e d o n t h e P B B E ' s c u r r e n t l y In u s e .
3.4. C o n e I us I on.
 It Is c o n c l u d e d that P B B E ' s p o s e a t h r e a t to h u m a n h e a l t h and the
e n v i r o n m e n t w h i c h Is u n a c c e p t a b l e In the long t e r m . T h i s d a n g e r
a r i s e s m a i n l y f r o m the r e l e a s e of f u r a n s to the a t m o s p h e r e !n
 t h e r m a l e x p o s u r e of p l a s t i c s c o n t a i n i n g P B B E ' S . P B B E ' S s h o u l d
t h e r e f o r e be p h a s e d out o n c e s a f e r s u b s t i t u t e s c a n be f o u n d .
 ---pagebreak---                                - 6 -
The best strategy to adopt towards this end Is a stepwise
withdrawal of PBBE'S from the market. This would take the form of
an Immediate ban on the seven PBBE homologues not presently In
commercial use and on preparations and products potentially
containing them and of an eventual ban five years later on the
three commercially Important homologues and their preparations
and p r o d u c t s .
4. CONFORMITY WITH THE TREATY.
As Is clear from section 3 above, this proposal Is Intended to
afford a high level of protection for both persons and the envi-
ronment and is therefore In conformity with Article 100A(3) of
the Treaty.
The proposal does not call for any special  provisions of the kind
referred to In Article 8c of the Treaty.
5. CONSULTATION OF THE EUROPEAN PARLIAMENT  AND THE ECONOMIC AND
SOCIAL COMMITTEE.
 In compliance with Article 100A of the Treaty, the cooperation
procedure with the European Parliament is a p p l i c a b l e . The
Economic and Social Committee has to be consulted.
 ---pagebreak---                               - 7 -
                         Proposal for a
                       COUNCIL DIRECTIVE
  amending Directive 76/769/EEC on the approximation of the
    laws, regulations and administrative provisions of the
        Member States relating to restrictions on the
            marketing and use of certain dangerous
                  substances and preparations
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100 A thereof,
Having regard to the proposal from the Commission,1
In cooperation with the European Parliament,2
Having regard   to the opinion of     the Economic and Social
Commlttee,3
Whereas measures should be adopted for the progressive
establishment of the internal market by 31 December 1992;
whereas the internal market is an area without internal
frontiers in which the free circulation of goods, persons,
services and capital is guaranteed;
1 0J No
2 0J No
3 OJ No
 ---pagebreak---                                           - 8    -
Whereas    poIybromobipheny I ether                 used   as   fire    retardant     in
certain    plastic      polymers         and     in   certain    plastic      products
may,   under     the    uncontrolled            condition     of   a   fire,     during
plastics    manufacture,        during        plastics     processing      and   during
waste    disposal      by    incineration            lead    to   the    emission     of
poIyhalogenated        dibenzo       furans       and   poIyhalogenated         dibenzo
dioxins which      are dangerous           to man and      to the     environment;
Whereas     the   restrictions           on     the   use   of   poIybromobipheny I
ethers    laid    down    by   this       Directive       take   into    account     the
current    state     of   knowledge          and    techniques     regarding       safer
subst i tutes ;
Whereas    restrictions       planned         by certain Member        States on     use
and marketing      of po I ybromobiphenyI              ethers or     preparations      or
products     containing      them      would      have   a direct     effect     on  the
establishment        and     functioning            of    the    internal       market;
whereas    it   is therefore        necessary        to approximate       the   laws of
the Member     States     in this       field     and   thus   to amend    Annex    I to
                                            4
Council    Directive      76/769/EEC ,           as   last   amended    by   Directive
/       /EEC5;
Whereas      present       Community             legislation       concerning        the
possible      adoption       by      Member        States     of    more     stringent
restrictions      on    the   use     of    the    substances     and    preparations
 in   question      at     the      workplace          is   unaffected        by    this
D i rect i ve ,
HAS ADOPTED      THIS    DIRECTIVE
4 OJ No L 2 6 2 , 2 7 . 9 . 1 9 7 6 , p. 2 0 1 .
5 OJ No L
 ---pagebreak---                                     - 9 -
                                  Article 1
Annex  I to Directive       76/769/EEC     is hereby     amended   as set   out
in the Annex     hereto.
                                  Article 2
      Member     States      shall    bring      into     force    the   laws,
      regulations      and   administrative      provisions      necessary   to
      comply    with     this   Directive     no   later     than   18  months
      after    the   date    of   its   adoption     and    shall    forthwith
      inform   the Commission       thereof.
      When  Member     States    adopt   these   provisions,      these  shall
      contain     a   reference     to   this    Directive      or   shall   be
      accompanied       by  such    reference     at    the   time   of  their
      official    publication.       The procedure       for  such   reference
      shall  be adopted       by Member    States.
      Member    States     shall   communicate      to   the   Commission    no
      later  than    18 months     afer   the   date   of   its adoption    the
      text  of   the basic provisions of national              law which   they
      adopt   in the field      covered    by  this   Directive.
                                  Article 3
This Directive      is addressed     to the Member       States
Done at  Brussels,                                 For   the Counc i I
                                                    The Près i dent
 ---pagebreak---                                10
                                                          ANNEX
The following point   is hereby added to Annex   1 of Directive
76/769/EEC
  28. PoIybromobIphenyI   Ethers
        28.1   The placing on the market of
               NonabromobiphenyI Ether   (CAS  63936-56-1)
               HeptabromobiphenyI Ether  (CAS  68928-80-3)
               HexabromobiphenyI Ether   (CAS  36483-60-0)
               TetrabromobiphenyI Ether  (CAS  40088-47-9)
               TribromobiphenyI Ether    (CAS  49690-94-0)
               DibromobiphenyI Ether     (CAS  2050-47-7)
               BromobIphenyI   Ether     (CAS  101-55-3)
         in concentrations by mass equal to or greater than
         .1% is prohibited in substances, preparations and
        products
        28.2   The placing on the market of
               DecabromobIphenyI Ether   (CAS 1163-19-5)
               OctabromobiphenyI Ether   (CAS 32536-52-0)
               PentabromobIphenyI Ether (CAS 32534-81-9)
         in concentrations by mass equal to or greater than
         . 1% shall    be prohibited   from   ../../....   (five
        years    from   adoption    of  this    Directive)    in
        substances, preparations and products."
 ---pagebreak---                                         -11 -
   Draft proposal for a Council Directive modifying for a
        twelvth time Council Directive 7 6 / 7 6 9 / E E C on the
              approximation of the laws, regulations and
          administrative provisions of the Member States
     relating to restrictions on the marketing and use of
           certain dangerous substances and p r e p a r a t i o n s
        COMPETITIVENESS         AND EMPLOYMENT      IMPACT   ASSESSMENT
I.    The       current      proposal     concerns    restrictions        on    the
      m a r k e t i n g and use of a family of chemicals known as
      poIybromob I phenyI ethers ( P B B E ' s ) .
      Only three of the 10 PBBE's are commercially produced
      namely,           pentabromobIphenyI,         octabromobIphenyI           and
      decabromobIphenyI and these find applications In flame
      retardant formulations mainly for use In p l a s t i c s .
       It has been concluded               that   the PBBE's constitute a
      potential risk to man and the environment and that they
      should be prohibited once safer substitutes have been
      proven.
       it has been decided, therefore, that the PBBE's should
      be      banned      In stages, starting         with     the seven       non-
      commercial          products which are prohibited as from the
      date of Implementation of the D i r e c t i v e .
  II. Features of          the Business     in question.
       The       commercially       important     PBBE s    are      produced     In
       F r a n c e , Netherlands and the U.K. The three- companies
       concerned produce about one third of E.C. requirements
       and        the    balance      Is     Imported    from       outside     the
       CommmunIt y.
       PBBE's are also contained In a wide range of plastic
       goods imported Into the Community.
 III. What         Direct    Obligations     does   the   measure       Impose    on
       Industry.
       The       marketing      and    use    of   penta,    octa      and   deca-
       bromob I pheny I ethers           lr prohlb't**       fr.-.-t s years of
       Implementation           of    the     Directive.     The      prohibition
       applies not only to the three PBBE's as such but to
       plastic goods or any other goods containing them.
       The industry concerned will have to adopt                      alternative
       systems or Introduce substitute p r o d u c t s .
 ---pagebreak---                               - 12-
IV. What Indirect Obligations are     local Authorities    likely
    to Impose on business 7
    None
V.  Are there any special measures     In respect of PME's 7
    No.
VI. What Is the likely effect on :
          (a)    competitiveness of Industry ;
          (b)    employment.
    (a)   The PBBE's are the cheapest and most effective
          flame    retardants    for    most   plastics.    Their
          prohibition will add slightly to user Industry
          costs. The effect of this harmonised measure will
          be to equalise the conditions of competition
          within the Community       though   It may adversely
          affect   In a small way the competitiveness of
          companies exporting from the Community.
     (b)   It  Is unlikely     that   the measure     will   have
          significant Impact on employment as the producers
          and users of PBBE's will move to substitutes
          products once these are available.
 ---pagebreak---  ---pagebreak---                                               -13-
                                                                              ÏSSN 0254-1475
                                                                     COM(91)7final
EN                                                                                         06
                                Catalogue number : CB-CO-91-Û24-EN-C
                                                              ISBN 92-77-68927-7
PRICE                        1-30 pages: 3.50 ECU        per additional 10 pages: 1.25 ECU
Office for Officiai Publications of the European Communities
L-2985 Luxembourg