CELEX: 51993PC0134
Language: en
Date: 1993-04-02
Title: Proposal for a COUNCIL DIRECTIVE amending for the fourteenth time 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

ISS ION OF THE EUROPEAN COMMUNITIES
                                                          C0MC93) 134 def. - SYN 456
   am
                                                          Brussels, 2  Apr!I 1993
                                         Proposal for a
'^mamm:                                 COUNCIL DIRECTIVE
                 amending for the fourteenth time 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
                 préparât ions.
                                  (presented by the Commission)
   <;
 •« :sa#l
          I~«!fl
  s i^rît
 ^^.ssja
 ---pagebreak---                        EXPLANATORY   MEMORANDUM
I .    Introduct ion
On 27th June 1989 Denmark adopted a law providing for a ban
of the use of nickel in a wide range of Jewellery and other
personal items where the rate of nickel release may exceed a
certain threshold value. The purpose of the law was to
protect     the    health    of   consumers   from   the    possible
sensitizing effects of nickel items coming into contact with
the skin.
On 21st March 1991 Germany notified the Commission and other
Member States of       its intention to regulate       in the same
field.   However, unlike in the Danish case, the approach
proposed was to ban the use of nickel           in posts for ear-
piercing and to require labelling of all nickel containing
Jewellery coming into contact with the skin.
The Commission having examined these divergent           legislative
initiatives, having received a letter expressing the concern
of the Italian authorities and having consulted experts from
all Member States gave notice of its intention to propose to
the Council an amendment to Annex I of Council Directive
76/769    to    provide    for   harmonized   limitations    on   the
marketing and use of certain nickel containing items which
contact the skin.
The Commission considers that this proposal           is consistent
with the Principle of Subsidiarity and with the requirement
under the Treaty to take as of base in its harmonization
proposals a high        level of protection concerning        health,
safety, environmental protection and consumer protection.
I I.   Background
Nickel    is widely      used   in costume   Jewellery    and   other
personal items coming into contact with the skin.           Not only
is it cheap but it is especially resistant to corrosion that
may result from human perspiration.
Unfortunately, however, up to 10% of certain              population
groups are sensitized to nickel and may suffer              allergic
reactions in the form of skin irritation and eczema when
they come into intimate and prolonged contact with nickel
containing personal items. There is evidence of increase in
the numbers of sensitized persons and that the phenomenon is
 ---pagebreak--- particularly prevalent among teenagers.
Consumers become sensitized after exposure to a particularly
high concentration of nickel. This usually occurs when
parts of the body such as ears and noses are pierced and a
nickel containing post is inserted into the cavity during
healing of the piercing wound.
Sensitised persons subsequently coming into intimate and
prolonged contact with nickel containing           items such as
costume    Jewellery    may   suffer    an   allergic     reaction.
Irritation may not be limited to the point of contact; there
may be secondary spread to flexural areas, hands and
eyelids. Such      allergic    reactions,     known    as    nickel
dermatitis can usually be treated successfully with a skin
cream (topical corticosteroids) but may recur on further
contact with a nickel containing item.
Essentially there are two families of nickel containing
personal goods which when used in a prolonged contact with
the skin can provoke nickel           dermatitis    in sensitized
persons. The      first    family    uses   homogeneous      alloys
containing nickel and the second family contains nickel but
coated with a non-nickel coating. Both families include the
same types of products; examples are earrings, necklaces,
bracelets, wrist watch cases and straps, spectacle frames,
zippers but there are many others. Typically such products
are cheap fantasies and have a short life.
Given the hazards of nickel and that consumers are likely to
be exposed to these hazards in every day situations it is
desirable that the use of nickel be limited especially in
the posts for piercing wounds but also in the case of
Jewellery and other personal items coming into intimate and
prolonged contact with the skin.
III. Def init ion of Nickel
Nickel is a silvery metal placed in Group VIII of the
Periodic Table together with cobalt            and   iron. It is
identified by the following:
     CAS N*: 9440-02-0
     EINECS N': 2311114
IV.  Properties of Nickel
Initial sensitization to nickel as mentioned above usually
occurs when parts of the body are pierced and a nickel post
is inserted in the piercing wound. Sensitization takes the
 ---pagebreak--- form of an irreversible  reaction of the immune system which
spreads from the wound   and becomes generalised throughout
the body.
Nickel dermatitis may occur subsequently when sensitised
persons come into intimate and prolonged contact with nickel
containing items such as custom Jewellery. The probability
of an allergic reaction has been shown to depend upon the
rate of nickel release where skin contact takes place.
Danish research has shown that no reaction is likely where
the rate of release is less than 0.5/xg/cm2/week.
 ---pagebreak--- V.    Existence of     substitutes
Substitutes     for nickel are available        in  all   the    nickel
applications restricted by this proposal.
In the case of posts for pierced body parts the preferred
substitute is titanium though silver might also be used. The
higher cost of these metals is hardly significant in view of
the limited number of posts used and their small size.
The most suitable substitutes for nickel in uncoated nickel
items contacting the skin are stainless steel and white
gold.
The solution in the case of coated items is not to remove
the nickel but rather to increase the thickness of noble
metal coating on the surface (typically silver, gold or
rhodium).
VI.   Cone lus ion
It is concluded that the use of nickel in personal                items
coming into intimate and prolonged contact with the skin may
under certain circumstances pose a danger to the health of
consumers. The         strategy    proposed    therefore      is    the
foI low!ng:
      The use of nickel in posts for pierced          ears  and   other
      pierced body parts should be banned.
      The rate of nickel release       from those parts of nickel
      containing personal       items   in intimate and prolonged
      contact      with    the   skin    should    be    limited      to
      0.5/*g/cm2/week.
      The rate of nickel release form the items in (b) which
      have in addition a non-nickel coating should be limited
      to 0.5/ug/cm2/week for at least three years of normal
      use.
VII. Conformity with the Treaty
 It  is clear      from   the foregoing    that   this proposal       is
 intended to afford a high level of protection for consumers
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.
 ---pagebreak---                                                               è
VIII 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
applicable. The Economic and Social Committee has to be
consul ted.
 ---pagebreak---                         Proposal for a
                      COUNCIL DIRECTIVE
amending for the fourteenth time 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 100a 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
Committee,3
Whereas article 8A of the Treaty establishes an area without
internal barriers in which the free circulation of goods, of
persons, of services and capital is assured;
Whereas work on the internal market should gradually improve
the quality of life, health protection and consumer safety;
whereas the measures proposed by this Directive are in line
with the Council resolution of 9 November 1989 on future
priorities for relaunching consumer protection policy;4
1    0J No
2    0J No
3    0J No
4    0J No C 294 of 23.11.1989 p. 1
 ---pagebreak---                                                               £>
Whereas the presence of nickel in certain objects coming
 into direct and prolonged contact with the skin may cause
sensitisation of man to nickel and may lead to allergic
reactions; whereas for these reasons the use of nickel in
such objects should be limited;
Whereas one Member State has already introduced a set of
control measures on its territory to counteract nickel
sens itisation and nickel allergy, a second Member State
plans to introduce on its territory a different set of
control measures and that there exists therefore a risk of
barriers to trade; whereas it is therefore necessary to
approximate the laws of the Member States in this field and
consequently amend Annex I to Directive 76/769/EECC5) as
 last amended by Directive 91/339/EEC(6);
Whereas the test methods needed to check conformity with the
essential requirements detailed in the annex hereto will be
the subject of a European standard to be incorporated in an
annex to this Directive; whereas recourse shall be made to
the test methods detailed in this annex;
Whereas limitations already adopted or planned by certain
Member States on the use of nickel directly affect the
completion and functioning of the internal market; whereas
 it is therefore necessary to approximate the laws of the
Member States in this field and consequently amend Annex I
to Directive 76/769/EEC, 5 as last amended by Directive
91/339/EEC; 6
HAS ADOPTED THIS DIRECTIVE:
                           Article 1
Annex I to Directive 76/769/EEC is hereby amended as set out
 in the Annex hereto.
                           Article 2
1.    Member States shall adopt and publish the laws,
      regulations and administrative provisions necessary to
      comply with this Directive no later than 1 year after
      the date of its adoption and shall forthwith inform the
      Commission thereof. They shall apply these provisions
      from (3 months after the date stated above).
5     OJ No L 262, 27.9.1976, p.201.
6     OJ No L 186 Of 12.7.1991 p. 64
 ---pagebreak--- 2.   When Member States adopt the abovementioned 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 the Member States.
                          Article 3
This Directive is addressed to the Member States.
Done at Brussels,                     For the Council
 ---pagebreak---                                                        AD
                  ANNEX
xx. Nickel           May not be used:
CAS N*7440-02-0      1. in post assemblies which
EINECS N'2311114     are inserted into pierced
and its compounds    ears and other pierced parts
                     of the human body during
                     ephithe Iisation of the wound
                     caused by piercing, whether
                     subsequently removed or not,
                     unless such post assemblies
                     are homogenous and the
                     concentration of Nickel -
                     expressed as mass of nickel to
                     total mass - is less than
                     0.05%
                     2. in products such as the
                     foI Iow i ng:
                     - earr ings
                     - necklaces, bracelets and
                     chains, anklets, finger rings,
                      hair ci ips and si ides
                     - wrist watch cases, watch
                      straps and tighteners
                     - spectacle frames
                     - buttons, tighteners, rivets,
                      zippers and metal marks, when
                      these are used in garments
                      if the rate of nickel release
                      from the parts of these
                      products coming into direct
                      and prolonged contact with the
                      skin is greater than 0.5
                     /Ltg/cm2/week
                      3. In products such as those
                       Iisted in paragraph 2 above
                      where these have a non-nickel
                      coating unless such coating
                       is sufficient to ensure that
                      the rate of nickel release
                      from those parts of such
                      products coming into direct
                      and prolonged contact with the
                      skin will not exceed 0.5
                      /Ltg/cm2/week for a period of at
                       least 3 years of normal use of
 ---pagebreak---                               />
the product.
Furthermore, products which
are the subject of paragraphs
1, 2 and 3 above, may not be
placed on the market unless
they conform to the
requirements of these
paragraphs
 ---pagebreak---                                                                  A\-
                      FINANCIAL STATEMENT
              SECTION 1:    FINANCIAL IMPLICATIONS
1.  Title of operation
    Proposal    for  a    fourteenth  amendment    to  Directive
    76/769/EEC
2.  Budget heading    involved
    Article B5-300:     completing the internal market
3.  Legal basis
       Article 100a of the Treaty
       Council Resolution of 7 May 1985 on a new approach
       to technical harmonization and standardization
4.  Description of operation
4.1 Specific objective of operation
    The proposed operation involves:
    - restricting the marketing and use of nickel in
       personal goods coming into intimate and prolonged
       contact with the skin
4.2 Durât ion
    This is a "one-off" operation                    ~
4.3 Target population
    Industrialists and consumers
5.  Classification of expenditure
       Differentiated appropriation
       Non-compulsory
 ---pagebreak--- 6.  Type of expenditure
    The expenditure would consist of financial support
    granted    by    the "Commission    to   standardization
    organizations. As in the case of other "New Approach"
    directives, the Commission intends to entrust the CEN
    with the task of drafting harmonized standards. The
    necessary mandate for this task comes under the
    framework contract signed on 10 October 1985, which
    provides for Just such financial support from the
    Commiss ion.
7.  Financial impact on appropriations for operations
7.1 Method of calculating the cost
    The calculation method relating to Article B5-300
    applies here. According to calculations performed by
    the European Committee for Standardization (CEN) on the
    basis of their experience of existing mandates, the
    average cost to the Commission of each new standard is
    ECU 50.000.
    As two standards are to be introduced, the impact
    should be about ECU 100.000.
7.2 Proportion of the mini-budget
    N/A
7.3 Schedule    of   commitment    (CE)  and  payment   (CP)
    approorlat ions
    (Article 5B-300)
               £1                ÇP
    1993      100.000            50.000
    1994                         50.000
    TOTAL     100.000           100.000
8.  What anti-fraud measures are planned?
    Expenditure under the CEN contract is subject to the
    anti-fraud measures laid down in that contract and to
    any audits carried out by CEN.
 ---pagebreak---                                                                              AM
              SECTION 2:     ADMINISTRATIVE     EXPENDITURE
No new administrative expenditure is foreseen.                Any meetings
to be held would take place pursuant to Directive 76/769/EEC
in the framework of which the "Technical Progress Committee:
Dangerous Substances and Préparations" would be convoked,
and would be covered by the budget for that Directive.                   The
estimated annual budget for this Committee is made up of
174.000 ECU for meetings of experts (01/03/U/080) and 12.000
ECU for meetings of the Committee                itself    (01/03/T/080).
However, no extra meetings are foreseen at this time.
     SECTION 3:     ELEMENTS OF COST-EFFECTIVENESS ANANLYSIS
1.     Objective and coherence with financial            programming
1.     The aim of the proposed operation                is to harmonize
       restrictions on       the marketing        and   use of       certain
       personal    goods    containing      nickel    so    as   to    avoid
       creating obstacles to trade and, at the same time, to
       provide a high level of protection for consumers.
       The   proposal    lays down       essential     requirements      for
       control of nickel. These will provide a solid basis
       for standardization in Europe. The amount of work to
       be done on standards           should   thus be reduced          and,
       consequently     the     impact    on   the    Community       budget
       lessened.
2.     The operation Is incorporated           in DG Ill's financial
       programming    and    is    included    in the      appropriations
       allocated      to       technical        standardization          and
       harmoni zat ion.
3.     The general     objective      is   to  complete      the   internal
       market.
II.    Grounds for the operation
Harmonization serves to prevent obstacles to trade and, at
the same time, to provide a high level of protection for
consumers. Standardization           is necessary       in the case of
personal     goods containing       nickel; otherwise         the    various
tests and conditions considered necessary before marketing
the product might act as obstacles to trade.
III. Monitoring and evaluation of the operation
The Committee set up under Directive 76/769/EEC will be
responsible      for    monitoring       the   application        of    this
D i rect i ve .
 ---pagebreak--- Evaluation will be c a r r i e d out annually via the p r o g r e s s
reports on the a d o p t i o n of the standard drafted by the CEN
 ---pagebreak---                                                                            •LC
     COMPETITIVENESS AND EMPLOYMENT          IMPACT ASSESSMENT
i.  Nature and Rationale of the Measure
    The   current     proposal     concerns     restrictions       on  the
    marketing     and    use    of    nickel    and      its    compounds.
    Specifically it limits the use of nickel                   in certain
    goods of a personal nature which come into intimate and
    prolonged contact with the skin.
    The objective of the measure is to protect consumers
    from    sensitization        to     nickel     and      from    nickel
    dermatitis.      Sensitization usually occurs following ear
    piercing and is attributed to the nickel content of
    posts inserted in the pierced hole during the period
    when    the    wound     is    healing.    Once       so    sensitized
    consumers may suffer from nickel dermatitis each time
    nickel    containing      objects     come     into     intimate   and
    prolonged contact with their skin.
    The proposal would ban the use of nickel in piercing
    posts and stipulate          that    nickel    release should       be
    limited from all nickel containing objects coming into
    intimate and prolonged contact with the skin.
    The proposal takes the form of an amendment (the 14th
    amendment)      to   Directive      76/769/EEC,       the    framework
    directive to limit the marketing and use of dangerous
    substances       and    preparations.      It     is     not   à   new
    legislative       departure,      so   that     the      question   of
    subsidiarity       does     not     arise. As        with     previous
    amendments      Community      intervention      is    essential    to
    protect the Internal Market this being impossible to
    achieve by Member States acting alone.
II. Features of the Business         in Question
    The main businesses to be affected by the measure are
    custom      jewellery       and     clothing.      Thus      companies
    producing piercing posts must stop using nickel and
    producing cheap earrings, necklaces, bracelets, watches
    and other fantasy type jewellery products must limit
    their use of nickel. So too must companies making
    garments e.g. Jeans, brassiers etc. limit the use of
    nickel   in buttons, rivets, zippers etc. where these
    come into intimate and prolonged contact with the skin.
    There  are   at   least   two companies      in the Community      (F,
 ---pagebreak---      UK) making piercing                  posts.
     Much of the c h e a p Jewellery c o n c e r n e d and many of the
     g a r m e n t s are imported                 into the C o m m u n i t y from third
     c o u n t r i e s e.g. from South East A s i a , United S t a t e s and
     Canada.           Only 5 0 % of these i n d u s t r i e s are thought to be
     Community based.
III. What direct                obligations          does        the    measure          impose      on
     Industry?
     The     Jewellery           industry       must:
     (a)         replace         nickel by a n o t h e r metal             e.g.       titanium       or
                 silver,         in p i e r c i n g p o s t s .
     (b)         reduce the use of nickel                           in h o m o g e n e o u s nickel
                 alloy p a r t s coming into intimate and p r o l o n g e d
                 contact with the skin e.g. by increasing the use
                 of s t a i n l e s s steel or w h i t e g o l d .
     (c)          increase the t h i c k n e s s of p r e c i o u s metal c o a t i n g s
                 on coated nickel                  c o n t a i n i n g p a r t s coming          into
                  intimate and p r o l o n g e d contact with the s k i n .
     The o b l i g a t i o n s of       the c l o t h i n g       industry will           be m a i n l y
     of the type ( b ) .
     The         industry          have         expressed             concern          about       the
     i m p l e m e n t a t i o n of the type (b) and (c) o b l i g a t i o n s as
     s u i t a b l e test m e t h o d s are not p r e s e n t l y a v a i l a b l e -              For
     this reason the C o m m i s s i o n will m a n d a t e CEN to develop
     s u i t a b l e m e t h o d s in the p e r i o d p r e c e d i n g implementation
     ( P r e l i m i n a r y work has been u n d e r w a y since February 1992
     in CEN Technical C o m m i t t e e N o . 2 8 3 , W o r k i n g Group No.
     4) .
IV.  What indirect o b l i g a t i o n s              are      local    authorities          likely
     to impose on b u s i n e s s ?
     None.
V.   Are there any special                    measures          in respect        of     SME's?
     No.       The D i r e c t i v e e s t a b l i s h e s e s s e n t i a l         requirements
     for nickel control that must be met by all c o m p a n i e s ,
     large and small so that                           the p r o t e c t i o n of consumer
     health can be a s s u r e d .
VI.  What        is    the likely effect on                       (a)   competitiveness              of
     industry          and (b) e m p l o y m e n t ?
 ---pagebreak---                                                                                                          A*
        (a)        X o m p et 11Iv en e s s of           industry
                    C o m p a n i e s m a k i n g p i e r c i n g p o s t s will h a v e to use
                    m o r e e x p e n s i v e m a t e r i a l s ; all will be s i m i l a r l y
                    affected,                  however,             so            that        relative
                    c o m p e t i t i v e n e s s s h o u l d not c h a n g e .
                     If      anything            the     competitiveness                of    European
                    j e w e l l e r y and c l o t h i n g         i n d u s t r i e s will      benefit
                    from the m e a s u r e s p r o p o s e d .               European       companies
                    will h a v e to c o m p e t e             less w i t h           imports of      low
                    qua I i ty g o o d s .
                    N e i t h e r the cost of the m e a s u r e s nor the                         timing
                    are of p a r t i c u l a r c o n c e r n to the i n d u s t r y .
        (b)         EmpIoyment
                    T h e e f f e c t s on e m p l o y m e n t are           likely to be s l i g h t
                    and to be felt m a i n l y o u t s i d e                the C o m m u n i t y .
V I I . C o n s u I tat i on
        T h e f o l l o w i n g industry and c o n s u m e r a s s o c i a t i o n s w e r e
        consulted               on        preparation            of        the        proposal       and
        p a r t i c i p a t e d in m e e t i n g s of the M e m b e r S t a t e e x p e r t s :
               Interest          Group                  Representative               Association
        Indust ry          (Meta Is)                    European Association                of
                                                        Meta I s (BrusseI s)
        Consumers                                       BEUC
        B o t h are           in b r o a d a g r e e m e n t .       However,           the   European
        A s s o c i a t i o n of M e t a l s m a i n t a i n a r e s e r v e until such a
        t i m e as a d e q u a t e test m e t h o d s a r e d e v e l o p e d .
        The        European             Standards           organisation              CEN    will     be
        mandated            to d e v e l o p       the test          methods           that   will    be
        n e e d e d to c h e c k that the n i c k e l                      containing         personal
        g o o d s c o v e r e d by the D i r e c t i v e a r e in c o n f o r m i t y w i t h
        the e s s e n t i a l          requirements which                   the D i r e c t i v e   sets
        down.         D e v e l o p m e n t of such test m e t h o d s will be f u n d e d
        in part by the C o m m i s s i o n and in part by CEN and it is
        i n t e n d e d that the E u r o p e a n S t a n d a r d s i n c o r p o r a t i n g the
        test m e t h o d s will be a v a i l a b l e b e f o r e the                        Directive
        e n t e r s i nto f o r c e .
 ---pagebreak---                                                                                     A9>
        a                                                            ISSN 0254-1475
                                                              COM(93) 134 final
                                                     DOCUMENTS
   .^.*
   -•*'
ES                                                                             06
                                Catalogue number : CB-CO-93-159-EN-C
                                                             ISBN 92-77-54348-5
Office for Official Publications of the European Communities
L-2985 Luxembourg