Biotechnology Law at Slovakia
Slovakia's biotechnology law is primarily governed by Act No. 140/2021 on the Use of Genetic Technologies and Genetically Modified Organisms (GMOs). This legislation outlines the rights and responsibilities of users of genetic technologies and GMOs, emphasizing the protection of biological diversity and the precautionary principle.
Key Provisions of Act No. 140/2021
Environmental Protection: The Act mandates that the use of genetic technologies must not harm the biological diversity of wild species or disrupt natural ecological balances. It also prohibits the implementation of genes that confer resistance to antibiotics used in human and veterinary medicine.
Risk Assessment and Emergency Planning: It requires comprehensive environmental impact assessments for GMOs, considering both immediate and long-term effects on humans and the environment. Additionally, users must develop emergency response plans to address potential accidental releases.
Regulatory Oversight: The Act establishes a Commission for Biological Safety to oversee the implementation of biosafety measures and ensure compliance with the law.
Market Authorization and Labeling: Procedures for placing GMOs on the market are outlined, including requirements for labeling food products containing GMOs to inform consumers.
Supporting Regulations
To implement the provisions of Act No. 140/2021, Slovakia has enacted several decrees:
Decree Implementing the Act on Biotechnologies and GMOs (2019): This decree provides detailed rules concerning the environmental risk assessment of GMOs, classification of genetic technologies into risk classes, and the content of emergency plans. It also specifies the documentation required for the use of GMOs and the procedures for evaluating their effects.
Amendments to the Decree (2008): These amendments establish criteria for the safety of GMOs that do not apply to indoor usage, including provisions for their registration and safety documentation.
European Union Context
As an EU member state, Slovakia aligns its biotechnology regulations with EU directives, notably Directive 2001/18/EC on the deliberate release into the environment of GMOs. This directive harmonizes national legislation on GMOs, ensuring that environmental and human health risks are assessed before GMOs are released or placed on the market.
Public and Government Stance
Slovakia has maintained a cautious approach toward GMOs, reflecting public concerns about their safety. The government has opposed EU proposals to loosen GMO regulations, emphasizing the need for stringent risk assessments and clear labeling to protect biodiversity, animal health, and consumer choice.
Accessing Legal Documents
The full text of Act No. 140/2021 and related decrees can be accessed through the UNEP Law and Environment Assistance Platform:
These documents provide comprehensive information on Slovakia's biotechnology regulations and their alignment with EU standards.
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