The EU legal framework applying to the alternative protein sector, including the novel food regulation, can be made more supportive and efficient, thus removing burdens hindering decision-making within the sectors while protecting consumer interests and the environment.

 

1. Include environmental impacts in risk assessments informing authorisation processes for alternative proteins

The policy would require regulatory change to add environmental criteria to the current policy regime for authorising the production and commercialisation of alternative proteins, where such criteria are not foreseen or very detailed (e.g., novel food regulation).

 

In so doing, the policy would reflect market trends observed in the EU and elsewhere in recent years where most innovations in the field of alternative proteins are driven by environmental sustainability considerations rather than by other factors such as food safety or nutrition.

 

This policy would entail a significant change in the current approach followed by the EU regarding risk assessment as the latter is largely focused on safety aspects. Overall, environmental impacts are considered only in part and merely from a risk standpoint, thus not taking into account potential benefits in terms of sustainability.

 

This regulatory change would require extensive public consultations with stakeholders (e.g., EU Member States, industry associations, consumer and environmental NGOs, academia etc.) to:

• identify the appropriate environmental criteria that EFSA should consider when risk-assessing alternative proteins; and
• determine the relative weight that should be allocated to the environmental impacts identified (e.g., vis-à-vis food safety aspects).

 

Such consultations should also help establish whether this policy should be limited to alternative proteins or could be usefully extended to other food innovations requiring pre-market authorisation in the EU. In this context, consideration should also be given as to whether it would be fair to subject to such environmental impact assessments alternative proteins (and other food innovations) but not food products already on the market.    

 

This policy is likely to involve a complex legislative process, requiring the introduction of changes to well-established EU regulations (notably, the General Food Law, novel food framework etc.) and possibly to other legal acts under preparation (e.g., the Sustainable Food System Framework). 

 

Advantages

• Highly relevant to microbial fermentation, cultured meat, insects, and microalgae, considering some of the environmental impacts of certain production systems; less so to seaweed   
• Ensures EU risk assessment follows a more holistic value-chain approach
• Promotes research on environmental impacts in support of EU authorisations
• Contributes to reducing the environmental impact of the EU food system
• Strengthens the role of the EU as a global leader in the sustainability of food systems

 

Disadvantages

• Requires a complex consultation and legislative process
• Requires strengthening EU (EFSA) assessment capabilities, particularly with regard to Life Cycle Assessment methods
• Environmental criteria are likely to be generic for all food innovations rather than specific to alternative proteins
• Implementation might be challenging as the assessment of environmental impacts depends upon several different elements and details
• Likely to result in additional costs for applicants
• Likely to slow down regulatory approval processes

 

Outcomes

It fosters the production of alternative proteins that are safe and sustainable, thus contributing to reducing their negative externalisties on the environment.

 

Beneficiaries

It provides for a scenario that, by supporting sustainable food innovatons, ultimately benefits the environment as well as the public at large.

 

 

2. Improve implementation of the EU framework for alternative proteins (novel foods, GMOs, etc.)

The current EU framework applicable to alternative proteins includes various legal acts governing regulated food products such as novel foods, GMOs, and food improvement agents. Such a framework would be made more efficient by developing tailor-made guidance alongside the provision of additional resources in the EU budget for the submission of EU-level applications for regulated products. Sector-specific guidance would address the specific characteristics and needs of the alternative protein sector.

 

Besides EU legislation on novel foods, alternative proteins may be subject to other regulatory regimes requiring prior approval (e.g., GMOs in the case of certain products resulting from microbial fermentation; food improvement agents in the case of algae as well as products obtained through precision fermentation). Therefore, providing practical guidance (e.g., in the form of a decision-tree) would enable future applicants to identify the correct approval pathway and regulatory requirements from the start, securing faster access to the EU market. The guidance may also identify the type of scientific studies and primary data that applicants must present when submitting an application and secondary sources and data that can be used to that effect. It might also explain the main requirements and bottlenecks of the authorisation procedures, including:

• the need to notify EFSA in advance of scientific studies supporting an application to make sure that the latter is deemed valid;
• how to handle requests for additional information from EFSA throughout the procedure; and
• how to guarantee legal protection of confidentiality and proprietary data covered by an application.

 

As the development of technical guidance is quite common in the area of regulated products at EU level, this policy does not present any major feasibility issues. It would be coherent with the existing policy framework.

 

Advantages

• Highly relevant to cultured meat (because of the current lack of EU authorisations), microbial fermentation and algae (in both cases, because of the complexity of the EU legal framework that applies to them); less so to insects (because their legal framework is clear and first approvals have been obtained)
• Greater legal certainty / awareness for potential applicants, particularly SMEs
• Could lead to a higher number of applications covering alternative proteins
• Reduces the costs associated with applications, notably for SMEs

 

Disadvantages

• Producing and maintaining updated guidance imposes an additional administrative burden on public authorities

 

Outcomes

It aims to resolve knowledge obstacles faced by alternative protein companies to complying with EU regulatory requirements.

 

Beneficiaries

It supports alternative protein companies, particularly SMEs, to understand their obligations under the EU regulatory framework and secure faster market access.