The New Directive 2001/18/EC on the Deliberate Release of Genetically Modified Organisms into the Environment: Changes and Perspectives

• DOI: http://doi.org/10.1111/1467-9388.00290
• Author: Silvia Francescon
• Published date: 01 November 2001
• Date: 01 November 2001

RECIEL 10 (3) 2001. ISSN 0962 8797

The New Directive 2001/18/EC on the

Deliberate Release of Genetically Modified

Organisms into the Environment: Changes

and Perspectives

Silvia Francescon

INTRODUCTION

The development of modern biotechnology has acceler-

ated over the last 20 years. Nevertheless, uncertainties

remain regarding its socio-economic benef‌its and

adverse effects on the environment and human health.

1

While the use of genetically modif‌ied (GM) crops is

expanding in the American continent,

2

public concern

about potential risks linked to genetically modif‌ied

organisms (GMOs) is growing in other areas of the

world. In the European Union (EU) in particular,

environmental and consumer non-government organi-

zations (NGOs) have been demanding, for some time

now, a strictly regulated use of biotechnology.

In order to restore public conf‌idence, particularly in the

wake of the bovine spongiform encephalopathy (‘mad

cow disease’), epizootic afta (‘foot and mouth disease’)

and poultry dioxin crises, and to maintain a high level

of protection for human health and the environment,

the EU has recently reviewed its horizontal (i.e.

technology-oriented) regulatory framework on GMOs,

3

1

On the potential risks and benef‌its associated with genetically modi-

f‌ied organisms, see Food and Agriculture Organization (FAO), Geneti-

cally Modif‌i ed Organisms, Co nsumers, Food Saf ety and the Environ ment

(2001), available at rFen.htm> (last visited

on 8 May 2001).

2

The United States accounts for 70% of the world-wide sowing of GM

crops, Argentina for 14% and Canada for 9%. The sowing of crops

is not allowed in Brazil. However, in this country illegal sowings of

GM soybeans are estimated to account for 10% of the area under

soybeans. See European Commission, DG Agriculture, Genetically

Modif‌ied Crops: Economic Issues on the Agri-food Sector, available

at Fen.pdf>;

for a synthesis of the document, see the website available at

(both last

visited on 28 March 2001).

3

Horizontal legislation in force consists of Council Directive

90/220/EEC of 23 April 1990 on the Deliberate Release of Genetically

Modif‌ied Organisms into the Environment, [1990] OJ L117/15, as last

amended by Council Directive 97/35/EC of 18 June 1997, [1997] OJ

L169/72; and Council Directive 90/219/EEC of 23 April 1990 on the

Contained Use of Genetically Modif‌ied Micro-organisms, [1990] OJ

L117/1, as amended by Directive 98/81/EC of 26 October 1998,

[1998] OJ L330/13.

Blackwell Publishers Ltd. 2001, 108 Cowley Road, Oxford OX4 1JF, UK and 350 Main Street, Malden, MA 02148, USA.

309

and is reviewing its vertical (i.e. sectoral or product-

oriented) legislation.

4

In February 2001, the European Parliament endorsed

a text

5

repealing horizontal Directive 90/220/EEC on

the Deliberate Release of Genetically Modif‌ied Organ-

isms into the Environment (hereinafter the Deliberate

Release Directive)

6

by 338 votes to 52, with 85 absten-

tions. The text was subsequently voted upon in the

Council of Environment Ministers, where Italy and

France abstained.

7

The joint text,

8

adopted as Directive

4

Sectoral legislation includes, inter alia, Regulation 258/97/EC of 27

January 1997 concerning Novel Foods and Novel Food Ingredients

(hereinafter the Novel Foods Regulation), [1997] OJ L43/1; Regulation

1139/98 of 26 May 1998 on the Labelling Requirements of Foods

and Food Ingredients Produced from GM Soya and Maize, [1998] OJ

L159/4, as amended by Regulation 49/2000/EC of 10 January 2000,

[2000] OJ L006/13; Regulation 50/2000/EC of 10 January 2000 on

the Labelling of GMO Additives and Flavourings, [2000] OJ L006/15;

Directive 98/95/EC of 14 December 1998 on the Labelling of GM

seeds, [1999] OJ L025/1; Regulation 2309/93/EEC of 22 July 1993

on Authorization of Medicinal Products for Human and Veterinary Use

(including those derived from GMOs), [1993] OJ L214/1. Although

eight GMOs are authorized in accordance with the Deliberate Release

Directive for the purpose of use in feed, for the moment there is no

specif‌ic Community legislation on GM-derived feed. The Commission

published a proposal for a Regulation of the European Parliament and

of the Council on GM food and feed on 25 July 2001: COM (2001)425

f‌inal. Finally, several pieces of legislation regulate the transport of

GMOs.

5

European Parliament Decision of 14 February 2001.

6

Directive 90/220/EEC, n. 3 above.

7

Council of Ministers Decision of 15 February 2001.

8

The Revised Directive (as well as the Deliberate Release Directive)

has been adopted under Article 95 of the Treaty Establishing the Eur-

opean Community (hereinafter the EC Treaty), [1992] OJ C224/76.

Its objective, alongside the protection of the environment and human

health, is the approximation of national legislation (Revised Directive,

Article 1) and the establishment of the internal market. According to

Articles 251 and 254 of the EC Treaty, measures under Article 95 are

adopted by way of co-decision,i.e. jointly by the European Parliament

and the Council. See L. Kramer, EC Environmental Law (Sweet &

Maxwell, 2000), at 99.