WRITTEN QUESTION E-0004/00 by Bart Staes (Verts/ALE) to the Commission. Cobalt and nickel used in dentistry.
Date: 2000-01-19
Institutions: European Parliament, Provisional data
Subjects: EU research policy, dangerous substance, dental medicine, infringement of EU law, medical device

3.10.2000

EN

Official Journal of the European Communities

C 280 E/153

This transparency is intended to avoid subsidies, but it also reflects a definite feature of the single market.
In ten or so Member States postal rates differ depending on whether the mail
is to be delivered
domestically or elsewhere in the Community.

The differing rates for domestic and intra-Community mail may be based on different types of service. If
these are justified, they would not infringe Community rules on competition. Compliance with the cost
accounting principles laid down in the postal services directive will allow such justifications to be
examined, if need be.

(1) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the
development of the internal market of Community postal services and the improvement of quality of service,
OJ L 15, 21.1.1998, p. 12.

(2000/C 280 E/174)

WRITTEN QUESTION E-0004/00

by Bart Staes (Verts/ALE) to the Commission

(19 January 2000)

Subject: Cobalt and nickel used in dentistry

Scientific research shows that more and more people are sensitive to heavy metals such as cobalt and
nickel. Cars, industry and modern farming are some of the causes of the increasing number of heavy
metals in food. Recent research in France has shown a link between heavy metals (nickel, copper, cobalt
and aluminium, along with sulphate) in drinking water and Alzheimer(cid:146)s disease. Since the human body
needs only a small amount of these metals, the remainder is stored and this results in allergies.

Cobalt and nickel are frequently used in dentistry. Hypersensitive patients suffer as a result. From the
public health point of view, it would be better to use (cid:145)healthier(cid:146) alternatives such as covering dentures with
a complete non-corroding, wear-resistant coating. All too many dentists and laboratories argue that a
coating is not necessary because there is no obligation. Nevertheless, directive 92/59/EEC (1) bans the use
of products which are (cid:145)dangerous to the health and safety of consumers(cid:146).

1.
Has the Commission had any scientific research carried out into the increasing sensitivity to cobalt
and nickel, in particular when they are used in dentistry? If so, what are the findings of this research? If
not, is the Commission prepared to have such research carried out in view of the adverse effects on public
health?

Is the Commission prepared to make use of cobalt and nickel

2.
in dentistry dependent on the
obligatory covering of dentures with a complete non-corroding, wear-resistant coating, in view of the
adverse effects on public health and the European ban on products which are (cid:145)dangerous to the health and
safety of consumers(cid:146) (directive 92/59/EEC)? If not, what is the Commission(cid:146)s justification for the continued
use of cobalt and nickel in dentistry without covering dentures with a complete non-corroding, wear-
resistant coating?

(1) OJ L 228, 11.8.1992, p. 24.

Answer given by Mr Liikanen on behalf of the Commission

(16 March 2000)

1.
The Commission ordered in December 1994 a study on dental amalgam and alternatives, products
covered by the medical devices Directive 93/42/EEC (1), and which was performed by an ad hoc working
group. Members included experts representing Member States(cid:146) ministries of health, scientists from different
European universities, industry representatives, medical professionals, dentists(cid:146) professional associations and
two experts from the United States department of Health and Human Services.

C 280 E/154

Official Journal of the European Communities

EN

3.10.2000

The study, aimed at assessing the potential risks that might put into jeopardy a high level of health
protection for patients and consumers, focused on dental amalgam, composite resins, coating and on the
biocompatibility and toxicological aspects of a number of alloys used in dentistry, in particular those based
on nickel, palladium, silver, gold, cobalt.

The main conclusions of the report indicate that all dental restorative materials, including dental amalgam
as well as its alternatives, i.e. alloys or resins, have the potential to cause some adverse reactions. The
casting alloys have the potential to cause allergy. It is believed that dental casting alloys, whilst eliciting
reactions in sensitised individuals, do not generally induce sensitisation. Allergic reactions to metal alloys,
however, are rarely reported. Problems are usually resolved following the removal of the material. The
prevalence of adverse effects related to dental restorative materials and patients is generally low. Available
data is sparse; literature overviews and research articles indicate this to be less than 0,1 % of the general
population. The risk-benefit ratio corresponds to the currently acknowledged and accepted state of the art.

The standards that support Directive 93/42/EEC represent the current state of the art. The Commission
therefore considers that this Directive provides an appropriate legal framework for dental restorative
materials, and that no modification of this legislation is needed at this stage. Nevertheless, the Commission
will closely follow the development of scientific knowledge in this area and draw appropriate conclusions
as concerns Directive 93/42/EEC.

Directive 92/59/EEC, on general product safety, defines in its article 2 a) (cid:145)safe product(cid:146) as (cid:145)any
2.
product which (cid:133) does not present any risk or only the minimum risks compatible with the product(cid:146)s use,
considered as acceptable and consistent with a high level of protection for the safety and health(cid:146). At this
stage the scientific data available do not permit the conclusion that the use in dentistry of cobalt and nickel
is incompatible with the definition of safe product of the Directive, taking also into account the benefits of
such use. Therefore, the Commission does not plan action at this stage concerning the use of cobalt or
nickel alloys without coating. However, the Commission will carefully follow the development of the
scientific knowledge in this area.

(1) OJ L 169, 12.7.1993.

(2000/C 280 E/175)

WRITTEN QUESTION E-0007/00

by Roberta Angelilli (UEN) to the Commission

(19 January 2000)

Subject: Measures to combat drugs in the Region of Lazio

In its Decision No 5057 of 5 October 1999 the Region of Lazio laid down the criteria for allocating
funding to combat drugs. The decision sets strict conditions for policies in the sector, especially at local
authority level, obliging such authorities to comply with the provisions established by the regional
government. Instead of laying down the criteria and terms for the submission of applications for funding,
leaving scope for public and private projects (as intended in Law No 45/99), the decision specifies in detail
both the content and form of measures, all of which are aimed at (cid:145)damage limitation(cid:146). All of this happens
without in any way involving the local authorities (as specified by the law), which are by their very nature
closer to the territory involved. This has prompted some of them, for example the local authority of
Latina, to lodge an appeal with the Administrative Court of Lazio. The Decision inhibits prevention
measures, since according to its terms only projects targeting individuals at risk are eligible for funding,
whereas there should be more scope for prevention, as envisaged in the law and in many Community
decisions. The decision does not make provision for curing addicts. Since funding is envisaged for
returning addicts to work and the concept of rehabilitation is replaced by damage limitation,
the
implication is that in the Region of Lazio the people who are to be found jobs are those who still use
drugs, rather than those who have been cured, which is tantamount to legalising drugs.