WRITTEN QUESTION P-1236/00 by Giuseppe Nisticò (PPE-DE) to the Council. Medicinal herbs and plants.
Date: 2000-04-10
Institutions: European Parliament, Provisional data
Subjects: European social policy, market approval, medical plant, toxic substance

C 26 E/160

Official Journal of the European Communities

EN

26.1.2001

What steps will the Commission take to ensure that Directive 92/104/EEC is properly transposed in Spain
and, specifically, to make the Spanish authorities repeal Article 2(4) of Royal Decree 1389/1997 of
5 September 1997?

(1) OJ L 245, 26.8.1992, p. 6.
(2) OJ L 404, 31.12.1992, p. 10.

Answer given by Mrs Diamantopoulou on behalf of the Commission

(26 May 2000)

The Commission has examined the Spanish measures for implementing Council Directive 92/57/EEC of
24 June 1992 on the implementation of minimum safety and health requirements at temporary or mobile
construction sites (eighth individual Directive within the meaning of Article 16(1) of Directive 89/391/
EEC) and Council Directive 92/104/EEC of 3 December 1992 on the minimum requirements for
improving the safety and health protection of workers in surface and underground mineral-extracting
industries (twelfth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and
has concluded that they have been correctly transposed into Spanish law.

This conclusion remains unaffected by the fact that under Real Decreto 1389/1997, which transposes
Directive 92/104/EEC on surface and underground mineral-extracting industries into Spanish law, tunnel-
ling activities of all kinds are subject to the minimum requirements applicable to the mining sector. Indeed,
Real Decreto 1389/1997 states that this provision is without prejudice to the rules applicable to the
construction sector,
i.e. provisions transposing Council Directive 92/57/EEC on temporary or mobile
construction sites.

Insofar as Directive 92/57/CEE was adopted on the basis of Article 137 of the EC Treaty (ex Article 118A),
it lays down (cid:145)minimum requirements(cid:146) in the field of health and safety to be implemented on temporary or
mobile construction sites. The expression (cid:145)minimum requirements(cid:146) indicates that the Member States are at
liberty to maintain or introduce measures more stringent that those which form the subject of the
Directive, in accordance with Article 137(5) of the EC Treaty. This means that a Member State may extend
the scope of application of the minimum requirements laid down for the mining sector to include
activities in the construction sector provided that the minimum requirements established for this sector by
Directive 92/57/EEC are not compromised.

An examination of Spanish legislation has shown that the application of the minimum requirements for
the mining sector to some construction activities such as tunnelling has increased the level of protection
for workers as laid down by Directive 92/57/EEC.

It is the responsibility of the Member States to ensure proper checks and monitoring of the national
provisions transposing directives. In this connection, the appointment of the competent authorities is
entirely a matter for the Member States.

(2001/C 26 E/199)

WRITTEN QUESTION P-1236/00

by Giuseppe Nistic(cid:242) (PPE-DE) to the Council

(10 April 2000)

Subject: Medicinal herbs and plants

Because of the widespread distribution and abuse of medicinal herbs, without proper controls over either
the marketing or prescribing of these products, this highly sensitive sector needs to be regulated as a
matter of urgency, bearing in mind the possible effects on human health.

International scientific literature on the subject has revealed, as widely reported in the media recently in
both the United States and Europe, that some of these medicinal herbs, when used without medical
supervision, are responsible for thousands of cases of fatal poisoning, as well as causing a series of
unwanted or toxic side-effects in the form of allergies or affecting the cardiovascular system, the kidneys,
the central nervous system and other systems or organs.

26.1.2001

EN

Official Journal of the European Communities

C 26 E/161

Unfortunately, as a result of subtle and deceitful propaganda by the industries and operators concerned,
the belief has taken root that herbs, being natural products, are useful and harmless and produce no toxic
effects.

The uncontrolled use of medicinal herbs is dangerous for the following reasons:

(cid:129) the concentrations and/or doses of the active principles present in herbs freely sold by herbalists are
not properly standardised, with the result that it is never possible to be sure what dose has been taken;

(cid:129) it is not known whether pollutants such as herbicides, pesticides or heavy metals may be present;

(cid:129) little is yet known about interactions between herbs and other drugs or foodstuffs or caused by the
administering of several herbs at the same time, with the result that the taking of some medicinal
herbs may produce unforeseeable toxic effects;

(cid:129) there is a danger that the use of medicinal herbs thought to be effective and innocuous by uninformed
patients may lead to their abandoning conventional treatments such as antineoplastic drugs with
serious consequences for their health.

Consumer protection is needed in the following areas:

(cid:129) consumers must be informed of the active principles and possible pollutants present in the medicinal

herbs they are taking;

(cid:129) consumers must be aware of the exact dose they are taking;

(cid:129) consumers must be informed of interactions between herbs and other drugs or foodstuffs;

(cid:129) consumers must be informed of risks deriving from the toxicity of the active principles and possible

pollutants.

In the light of the above considerations, what steps does the Council plan to take to protect public health?
Will
it review the rules governing the marketing of medicinal herbs in the light of the documented
scientific findings? Will it ask the EMEA to assess the information available on individual plants and herbs
and provide the guidelines needed for the proper dispensing of these products, which are currently
administered with hardly any controls?

Reply

(26 June 2000)

The Council shares the concerns expressed by the Honourable Member about the uncontrolled use of
medicinal plants and herbs and the advisability of protecting the consumer against the risks of abusing
these products.

It was with this in mind that the Council, on 20 December 1995, adopted a resolution on medicinal plant
preparations in which it invited the Commission to study, in close collaboration with the Member States,
the problems posed in this context (1). The Commission has yet to respond to this invitation.

(1) OJ C 350, 30.12.1995, p. 6.

(2001/C 26 E/200)

WRITTEN QUESTION E-1254/00

by Armando Cossutta (GUE/NGL) to the Council

Subject: Murder of the Irish lawyer, Rosemary Nelson

(27 April 2000)

On 15 March last year the solicitor, Rosemary Nelson, died of injuries sustained in a car bomb attack.