European Information Network - Ethics in Medicine and Biotechnology

Genetically modified Food

--- Overview Germany ----

- Ethical discussion -

There is no country specific discussion.

- Legislation -

(Author: DRZE staff, Germany)

The regulations stipulating the use of genetic engineering in food production can be divided into four main areas: 1. Licensing procedures, 2. Labelling regulations, 3. Liability and 4. Patent protection.

Apart from the relevant provisions laid down in German legislation - such as the Genetic Engineering Act (GenTG) and the Food and Essential Commodities Act (Lebensmittel- und Bedarfsgegenständegesetz - LMBG) - European Community law has regulating power in all four areas. A clear distinction between national law and European legislation is not always possible. When, for example, the Genetic Engineering Act was passed, this resulted not only in the widening of the existing installation-oriented provisions (of the Federal Immissions Control Act (BImSchG)) it also implemented EC Directives 90/219/EEC (Systems Directive) and 90/220/EEC (Deliberate Release Directive). Other relevant legislation includes the "Regulation of the European Parliament and of the Council of 27 January 1997 on novel foods and novel food ingredients" (or Novel Foods Regulation for short) which entered into force on 15 May 1997.

LICENSING PROCEDURES

In the context of licensing procedures in genetically modified food production several different levels have to be distinguished. First, licences are required for the installations themselves and working procedures involved in GM food production. Moreover, there are the regulations governing the release of organisms created in the laboratory (such as seeds for GM crops). And, lastly, there are rules for the placing on the market of products, which consist of or contain genetically modified organisms.

On the production side, a distinction has to be made between installation and operating licences. In German law, such licensing procedures come under §§ 1 and 2 of the Genetic Engineering Act (GenTG). A point to note here is that, in implementing European legislation and in line with previous national regulations, the legislators have opted largely for a licensing model: what is required is not a mere mandatory reporting, but the government licence has to be applied for prior to working with genetically modified organisms. This is intended to counter the risks such work might present to large parts of the population.

Under § 2 no. 1 GenTG, the law applies to plants and installations in which genetic engineering takes place. As defined in § 3 no. 4 GenTG, such an installation is a facility in which genetic engineering is conducted in a contained system, in particular making use of physical barriers. The reporting and licensing procedures apply to both constructing and operating genetic engineering installations. On this point, the Genetic Engineering Act refers to the existing standards of the Federal Immissions Control Act (BImSchG).

Under § 2 no. 2 GenTG, the law also applies to genetic engineering work itself. This covers any kind of work with genetically modified organisms other than merely transporting them between installations and existing biotechnology processes which have been recognised as non-hazardous. The working provisions of the Genetic Engineering Act are based on Directive 90/219/EEC (Systems Directive).

Paragraph 2 no. 3 GenTG governs the release of genetically modified organisms to the environment. Paragraph 3 no. 7 GenTG defines this as the intentional release of a GMO to the environment, in so far as a licence for marketing (i.e. selling seed for sowing) has not yet been granted. If GMOs escape accidentally, this does not count as releasing them under the regulations of this provision. The Deliberate Release Directive has since been modified. As well as tightening up the regulations for a safety assessment, the revised Directive now limits consent to marketing to ten years. Moreover, the use of antibiotic resistance markers is to be limited step by step.

Finally, placing products on the market containing GMOs or consisting of GMOs comes under § 2 no. 4 GenTG. In contrast to § 2 no. 3 GenTG, this is not about releasing products into the environment, but marketing them to people. This act is always subsidiary to other acts, where licences are required and where those licences are subject to a risk assessment of the potential impact on people and the environment. For example, the Pharmaceuticals Act takes precedence over the Genetic Engineering Act, if a GM product can also be classified as a pharmaceutical product. The main criterion in deciding whether to allow novel foods to be placed on the market is their equivalence to conventional foods.

Under § 6 GenTG, anyone involved in any of the activities described in § 2 nos. 1 to 4 is required to make a comprehensive assessment of the risks involved to people and the environment, take steps to avert those risks in line with the state of the art in science and technology and keep records of the work they do. In the interest of flexibility, the actual precautions to be taken are laid down, not by the law itself, but by statutory regulations.

LABELLING REGULATIONS

Before the Novel Foods Regulation entered into force, the problems involved in labelling GM foods and those foods produced using genetic engineering were largely ungoverned by German law, although a debate was already taking place as to whether and, if so, to what extent a requirement for such products to be labelled should be enshrined in law. One position held that formulating an obligation to label products was not only within the legislators' discretionary powers, but was even a constitutional requirement.

The debate as to whether labelling requirements were admissible or necessary in Germany was settled by the passage of the Novel Foods Regulation (EC Regulation 258/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients). The Regulation aims to harmonise the handling of novel foods throughout Europe in order to prevent impediments to the free movement of goods within the Community: so it is aimed not merely at health policy or consumer protection, but also at trade policy. As an EC Regulation, the NFR applies directly as law in Germany, and does not have to be ratified by the national legislators.

Art. 1 para. 2 NFR states that it covers food and food ingredients containing or consisting of GMOs, foods and food ingredients produced from but not containing GMOs and foods and food ingredients with a new or intentionally modified primary molecular structure. The Regulation does not, however apply to food additives, flavourings for use in foodstuffs or extraction solvents, provided that the safety levels of the relevant specific Directives correspond to the safety level of the NFR.

Products which fall within the scope of the NFR are subject to licensing procedures under Art. 3 para. 2 in conjunction with Arts. 4, 6 and 7. In this respect, the NFR follows the principle of prohibition with the reservation of permission enshrined in the Genetic Engineering Act. This is remarkable, in that it marks a departure from the principle of punishing abuses which prevails in food law otherwise. In the first instance, safety assessment is conducted in accordance with the criteria laid down in Art. 3 para. 1 by the competent national authority (in Germany, the Federal Institute for Health Protection of Consumers and Veterinary Medicine, in conjunction with the Robert Koch Institute). The Commission may be involved in a second stage (advised by the Standing Committee for Foodstuffs), depending on the outcome of the assessment. Exceptions are made in the case of certain groups of novel foods, which have to be notified to the Commission under Art. 5 in conjunction with Art. 3 para. 4 NFR.

The general labelling requirements come under Art. 8 NFR. First, Art. 8 para. 1 a) states that any characteristic or food property which renders a novel food or food ingredient no longer equivalent to an existing food is to be labelled in such a way that the modifications together with the method by which they were obtained are indicated. Art. 8 para. 1 b) NFR imposes an obligation to label material which is not present in existing equivalent foods and which might affect the health of certain population groups. This applies particularly to people with allergies, who need more protection. Art. 8 para. 1 c) also states that substances which are not found in existing equivalent foods and which are subject to ethical concerns must also be stated. Under Art. 8 para. 1 d), these labelling requirements also apply to existing GMOs which have been modified by the methods listed in Annex I A Part 1 of Directive 90/220/EEC (this list is not exhaustive). Finally, Art. 8 para. 2 NFR governs cases where there are no existing products equivalent to the novel food or ingredient. In this case, appropriate provisions must be adopted, where necessary, to ensure that consumers are adequately informed about the product. The NFR makes express provision for negative labelling as "Does not contain GM ingredients".

LIABILITY

Liability for damages arising as a result of the characteristics of an organism based on genetic engineering is governed by §§ 32 seq. of the Genetic Engineering Act (GenTG).

Diverging from the general provisions of civil law, under which liability is fault-based, the legislators here have opted for a liability regardless of fault. This covers injury to life, body and health of persons and damage to property. This departure from the conventional principles of liability can be explained by the particular propensity to create hazards involved in genetic engineering. By applying genetic engineering techniques hazards are created which are difficult to assess in terms of the threat to people and property. At the current state of scientific knowledge, neither the behaviour of GMOs nor their possible impacts on natural genetic material can be predicted with absolute certainty. This also applies in relation to a decision as to what level of safety precautions is sufficient to prevent the hazards from becoming reality, which is why limiting liability to the actual fault on the part of the operators fails to meet the particular circumstances (seen always from an ex post perspective). Instead, the operator is also liable, if he cannot be held to be at fault directly. In particular, licences for genetic engineering installations or work granted under public law do not therefore exempt from liability for damages.

At the same time, however, the liability for damages in respect of any one claim (i.e. per event, not per victim) is limited to about EUR 82 million under § 33 GenTG. This limit merely relates to the liability regardless of fault according to §§ 32 seq. GenTG; under § 37 III GenTG, however, claims brought forth on other grounds are left untouched by this limitation. A victim may claim further damages or even damages for pain and suffering under the general principles of civil law, over and above the EUR 82 million. Such claims, however, are once again subject to the principle of fault-based liability.

PATENT PROTECTION

When applying for an invention to be patented, the first distinction which has to be made is that between international patents (under the international Patent Co-operation Treaty), European patents (under the Convention on the Grant of European Patents - European Patent Convention) and national patent applications. The following only covers German and European patenting procedures. Applications for German patents are made under the Patent Act (PatG), while European patents are applied for under the Convention on the Grant of European Patents (EPC). The German Patent Act has largely been harmonised with the provisions of the EPC.

Para. 1 no. 1 PatG and § 52 no. 1 EPC agree in stating that patents can be granted in respect of inventions which are new, are based on inventive activity and which are commercially usable. In relation to genetic engineering in food processing, there are a number of exceptions to patentability which are of reference. Under § 2 no. 2 PatG (§ 53 b EPC), patents cannot be granted for plant varieties, animal species or essentially biological procedures for breeding plants and animals. This exception though does not apply to microbiological methods and the products obtained using those methods. It is notable that neither German nor European patent law prohibits plants or animals being patented. It is only plant varieties and animal species which cannot be patented (on this distinction see the decisions of the European Patent Office Board of Appeal ). Notwithstanding these provisions, however, plant varieties can be protected under the Plant Variety Protection Act (SortenG).

Another reason why genetic engineering inventions may not be patented lies in § 2 no. 1 PatG (§ 53 a EPC), which states that inventions cannot be patented, if they violate public order or morals. This is a legal term in need of interpretation, and of being defined in the legal systems concerned. It covers those methods stated in Directive 98/44/EC (Biotechnology Patents Directive) Art. 6 no. 2d. These are "processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes". While the EU Directive does not apply directly to the EPC, it has been included as part of the implementation regulation.

Links

(Collected by: DRZE staff, Germany)

Ethics
There are no ethical links.

Legislation

• Genetic Engineering Act (only available in German)
• Patent Act (PatG) (only available in German)
• BImSchG - Bundes-Immissionsschutzgesetz (only available in German)
• Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
• Proposal for a Regulation of the European Parliament and of the Council on genetically modified foods and feed of 25 July 2001
• COUNCIL DIRECTIVE of 23 April 1990 on the contained use of genetically modified micro-organisms (90/219/EEC)
• COMMISSION DIRECTIVE 94/51/EC of 7 November 1994 adapting to technical progress Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms
• Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
• DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, in: Official Journal of the European Communities. 17.4.2001, L 106 p. 1-38
• Commission Declaration, in: Official Journal of the European Communities. 17.4.2001, L 106 p. 39
• CONVENTION ON THE GRANT OF EUROPEAN PATENTS (EUROPEAN PATENT CONVENTION) of 5 October 1973
• DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998 on the legal protection of biotechnological inventions, in: Official Journal of the European Communities, 30.7.98, L 213 p. 13-21

Further
There are no further links.