ISS ION OF THE EUROPEAN COMMUNITIES 
am C0MC93) 134 def. - SYN 456 
Brussels, 2 Apr!I 1993 
'^mamm: 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 
préparât ions. 
(presented by the Commission) 
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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 
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 
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. 
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. 
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. 
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 
£> 
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 
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 
ANNEX AD 
xx. Nickel 
CAS N*7440-02-0 
EINECS N'2311114 
and its compounds May not be used: 
1. in post assemblies which 
are inserted into pierced 
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 
/> 
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 
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 
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. 
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 . 
Evaluation will be carried out annually via the progress 
reports on the adoption of the standard drafted by the CEN 
•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, 
UK) making piercing posts. 
Much of the cheap Jewellery concerned and many of the 
garments are imported into the Community from third 
countries e.g. from South East Asia, United States and 
Canada. Only 50% of these industries are thought to be 
Community based. 
III. What direct obligations does the measure impose on 
Industry? 
The Jewellery industry must: 
(a) replace nickel by another metal e.g. titanium or 
silver, in piercing posts. 
(b) reduce the use of nickel in homogeneous nickel 
alloy parts coming into intimate and prolonged 
contact with the skin e.g. by increasing the use 
of stainless steel or white gold. 
(c) increase the thickness of precious metal coatings 
on coated nickel containing parts coming into 
intimate and prolonged contact with the skin. 
The obligations of the clothing industry will be mainly 
of the type (b). 
The industry have expressed concern about the 
implementation of the type (b) and (c) obligations as 
suitable test methods are not presently available- For 
this reason the Commission will mandate CEN to develop 
suitable methods in the period preceding implementation 
(Preliminary work has been underway since February 1992 
in CEN Technical Committee No. 283, Working Group No. 
4 ) . 
IV. What indirect obligations are local authorities likely 
to impose on business? 
None. 
V. Are there any special measures in respect of SME's? 
No. The Directive establishes essential requirements 
for nickel control that must be met by all companies, 
large and small so that the protection of consumer 
health can be assured. 
VI. What is the likely effect on (a) competitiveness of 
industry and (b) employment? 
(a) Xom p et 11Iv en ess of industry 
Companies making piercing posts will have to use 
more expensive materials; all will be similarly 
affected, however, so that relative 
competitiveness should not change. 
If anything the competitiveness of European 
jewellery and clothing industries will benefit 
from the measures proposed. European companies 
will have to compete less with imports of low 
qua I i ty goods. 
Neither the cost of the measures nor the timing 
are of particular concern to the industry. A* 
(b) EmpIoyment 
The effects on employment are likely to be slight 
and to be felt mainly outside the Community. 
VII. ConsuI tat i on 
The following industry and consumer associations were 
consulted on preparation of the proposal and 
participated in meetings of the Member State experts: 
Interest Group Representative Association 
Indust ry (Meta Is) European Association of 
Meta I s (BrusseI s) 
Consumers BEUC 
Both are in broad agreement. However, the European 
Association of Metals maintain a reserve until such a 
time as adequate test methods are developed. 
The European Standards organisation CEN will be 
mandated to develop the test methods that will be 
needed to check that the nickel containing personal 
goods covered by the Directive are in conformity with 
the essential requirements which the Directive sets 
down. Development of such test methods will be funded 
in part by the Commission and in part by CEN and it is 
intended that the European Standards incorporating the 
test methods will be available before the Directive 
enters i nto force. 
a ISSN 0254-1475 
COM(93) 134 final 
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