On the proposal for a regulation of the European Parliament and of the Council establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
ENVI-AD-788881
Committee on the Environment, Climate and Food Safety · Rapporteur: Nicolás González Casares
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The Committee on the Environment, Climate and Food Safety gives its opinion on the proposed European Biotech Act, which amends several laws including the General Food Law and the mandate of the European Food Safety Authority (EFSA).¶ It proposes amendments to anchor the regulation in the One Health approach, the precautionary principle and fair benefit-sharing under the Nagoya Protocol, and to keep high standards of consumer, environmental and scientific protection.¶¶ It sets rules on EFSA pre-submission advice and panel chairs, gives EFSA 28 full-time posts, and strengthens its role on New Approach Methodologies (NAMs) to phase out animal testing.¶¶ It allows novel foods in regulatory sandboxes under conditions, keeps a limited exemption from environmental risk assessment for certain gene-modified advanced therapies, and makes tacit approval for strategic projects optional.¶¶¶ It opposes extending supplementary protection certificates to veterinary medicines for zoonotic diseases and instead proposes a One Health Priority Product designation with priority advice, accelerated authorisation, reduced fees and HERA consideration.¶¶¶ The amendments also add environmental, social and ethical conditions to funding and strategic projects, and require compliance with Union law as a precondition for support.¶¶¶
Committee position. The committee proposes amendments to the Commission proposal: anchor it in the One Health approach and precautionary principle, strengthen EFSA's independence and resources, allow novel foods in sandboxes under safeguards, limit the GMO exemption, make tacit approval optional, and replace the supplementary protection extension with a One Health Priority Product designation.¶¶¶
Key points
- The regulation should uphold protection under Union law on the environment, GMOs, chemicals, waste, animal welfare, food and feed safety, medicinal products and biosecurity; compliance is a precondition for authorisation, funding and support.¶
- Implementation should follow the One Health approach, the precautionary principle and science- and risk-based rules, and promote fair and equitable benefit-sharing under the Nagoya Protocol.¶¶¶
- EFSA staff giving pre-submission advice should not assess the same application; where unavoidable they must file a declaration of interests and may not chair the panel or adopt the opinion.¶¶
- EFSA panel chairs should be non-voting staff, functionally independent from pre-submission advice, while opinions remain the collective responsibility of independent experts.¶¶
- EFSA should receive additional resources equivalent to 28 full-time posts; any fees should be proportionate, cost-related and not burden small firms, with stable public funding where fees fall short.¶
- EFSA should promote New Approach Methodologies, including a dedicated panel, to phase out animal testing without lowering safety standards.¶¶
- The blanket exclusion of novel foods from regulatory sandboxes is removed; sandboxes may only generate evidence and support regulatory learning without replacing the authorisation procedure, and need the Member State's prior consent.¶¶¶
- The Commission may establish Union-level sandboxes on EFSA's recommendation; all sandboxes need justification, consumer consent, labelling, traceability, stakeholder engagement and public reporting.¶¶
- The exemption from environmental risk assessment for advanced therapies containing GMOs is kept but limited to products with no or negligible risk, with a reasoned justification verified by the Committee for Medicinal Products for Human Use.¶¶¶
- For veterinary medicines containing GMOs, Union GMO legislation does not apply only if an environmental risk assessment has been carried out, without prejudice to food and feed rules.¶¶
- Health biotechnology strategic projects may, rather than shall, benefit from tacit approval in environmental assessments; publicly funded projects must comply with ethical, environmental and social law, and the public must be informed and consulted.¶¶¶
- The opinion rejects extending supplementary protection certificates to veterinary medicines for zoonotic diseases, and proposes a One Health Priority Product designation with priority advice, accelerated authorisation, reduced fees and HERA consideration, conferring no exclusive rights.¶¶¶
Who is affected
- The European Food Safety Authority: gains tasks on pre-submission advice, NAMs and sandbox guidance, with 28 full-time posts requested and new independence safeguards.¶¶¶
- Applicants and notifiers, especially small and medium-sized enterprises and first-time applicants: receive pre-submission advice on rules, study design and testing strategies.¶
- Developers of novel foods and innovative food technologies: may test products in regulatory sandboxes under conditions, including consumer consent and labelling.¶¶¶
- Sponsors of clinical trials with advanced therapies containing GMOs: may claim an exemption from environmental risk assessment if they submit a reasoned justification.¶¶
- Developers of veterinary medicines for zoonotic diseases: may apply for One Health Priority Product designation for priority advice, accelerated authorisation, reduced fees and HERA consideration.¶¶