The following, non-exclusive legislation is deemed most relevant for this opinion.

Plant protection products legislation

Plant protection products (PPPs) are used to protect plants against pests or diseases. PPPs and their residues are regulated respectively in the EU by Regulation (EC) No 1107/2009 as regards their placing on the market, by Directive 2009/128/EC as regards their sustainable use and by Regulation (EC) No 396/2005 as regards their residues in food and feed. The Commission approves active substances, i.e. the agent used to achieve the protective effect, for the use in PPPs, which are authorised by the Member States. In order to protect consumers, the Commission also sets maximum residue levels (MRLs) for pesticides, i.e., the highest levels of pesticide residues that are legally tolerated in or on food or feed, including imported products.

Regulation 2015/2283 on novel foods

Regulation 2015/2283 on novel foods applies since January 2018 and replaces older rules in such a way as to simplify and centralise the authorisation procedure, which ensures conditions so that the authorization process has become more streamlined and made free of charge, which makes it less burdensome to put novel foods on the EU market while maintaining a high level of food safety for European consumer. It expanded the categories of novel foods, describing the various situations of foods originating from plants, animals, microorganisms, cell cultures, minerals, etc., specific categories of foods (e.g., insects, vitamins, minerals, food supplements, etc.), foods resulting from production processes and practices, and state of the art. It also established a Union list of authorised novel foods, which included all authorisations of novel foods under the previous novel food regulation, making them generic and improving conditions for safety evaluations.

Regulation 1924/2006 on nutrition and health claims made on food

Regulation 1924/2006 (Claims Regulation) is the legal framework used by food business operators when they want to highlight the particular beneficial effects of their products, in relation to health and nutrition, on the product label or in its advertising. The objective of this Regulation is to ensure the effective functioning of the internal market whilst providing a high level of consumer protection. The rules of the regulation apply to nutrition claims (such as "low fat", "high fibre") – which are listed in the annex of the regulation - and to health claims (such as "Vitamin D is needed for the normal growth and development of bone in children"), which have to be authorised on a case-by-case basis. It applies to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer, including foods which are placed on the market unpacked or supplied in bulk. It also applies to foods intended for supply to restaurants, hospitals, schools, canteens and similar mass caterers. The objective of those rules is to ensure that any claim made on a food's labelling, presentation or advertising in the European Union is clear, accurate and based on scientific evidence.

Further legislation:

Legislation on Plant Protection Products

Sustainable use of Pesticides

Evaluation of the EU legislation on plant protection products and pesticides residues

Novel Food legislative framework webpage

EU nutrition and health claims legislative framework website

Probiotics - European legal framework

Fit for Future Platform

The Platform suggested to:

1: Modify the current regulatory framework to speed up the authorisations of microbiological and low-risk products within Regulation (EC) 1107/2009

2: Further develop legally binding data requirements for other biological control categories than microbial products, namely semiochemicals, natural substances within Regulation (EU) 283/2013 and Regulation (EU) 284/2013 setting the data requirements under Regulation (EC) 1107/2009

3: Adopt fast-track approval procedures for innovative, low-risk biological and sustainability-enabling pesticides

4: Allow extension of the use on one crop to all other crops without the addition of upfront efficacy data for biological control product under Regulation (EC) 1107/2009

5: Further develop the regulatory framework for biological control products

6: Analyse opportunities and challenges when revising existing relevant legislation to focus on the potential risk pertaining to the product itself rather than the production process employed

7: Support adoption of novel food products while ensuring food safety

8: Improve the harmonization of the use of the term ‘probiotics’ in the context of the health claims across the EU Member States to provide clarity for industry and consumers

9: Develop industry guideline for food cultures as food ingredients

10: Update EU NACE codes

Follow up by the Commission

The Platform raised several issues pointing out to a need to update the framework to reflect the state of the scientific knowledge on the micro-organisms. The Commission recently adopted four implementing acts that simplify the process of approval and authorisation of biological plant protection products containing micro-organisms as active substances to streamline the framework.

• Commission Regulation (EU) 2022/1438, amending Annex II to Regulation (EC) No 1107/2009 as regards specific criteria for the approval of active substances that are micro-organisms, 31 August 2022

• Commission Regulation (EU) 2022/1439, amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms, 31 August 2022

• Commission Regulation (EU) 2022/1440, amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms, 31 August 2022

• Commission Regulation (EU) 2022/1441, amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms, 31 August 2022

These acts reflect the latest scientific developments and are based on the specific biological properties of micro-organisms. So far, the requirements for micro-organisms have been based on principles very similar to those relating to chemical active substances. The new acts follow a different approach, which is based on the biology and ecology of each micro-organism and takes into account the most recent scientific knowledge. In this way, the regulatory requirements for micro-organisms are made more "fit-for-purpose" and flexible. In addition, only focusing on relevant data also means less animal testing, because fewer experiments on animals will be required.

The biological properties of the micro-organisms play a central role in these new-style risk assessments and much of the data required in the new implementing acts is conditional to the biology and ecology of the particular micro-organism. In any case, a micro-organism can only be approved for use if it is proven that it does not cause disease in humans or animals. More "fit for purpose" and flexible requirements also imply streamlined application dossiers, more straight forward risk assessment, and shorter timelines to get access to the EU market. These new Regulations make the EU one of the most advanced regulators on the global stage for these products.

Follow-up actions have been initiated to ensure proper implementation of those acts such as the Better Training for Safer Food scheme and a call for proposals for EU financial grants to help Member States increase their competence in micro-organisms and speed up evaluations of this kind of active substances. In December 2022 the Commission completed and published a “Study on the Union’s situation and options regarding invertebrate biological control agents for the use in plant health and plant protection”. These products are currently not covered by the European regulations for placing into the market of the plant protection products. The study concluded that there were insufficient quantitative data on the potential market and use of the invertebrate biological control agents in the Member States to allow a proper analysis of the possible added value of EU intervention, making it impossible for the Commission to formulate, at this stage, any appropriate proposal. However, the study also identified a number of improvements that can be pursued through action at national or regional level, without the need for additional EU intervention.

In January 2023, the Commission launched a call for proposals for financial grants (managed by HADEA) under the Single Market Programme, inviting proposals contributing to more sustainable and circular food production systems by boosting Member States’ capacities to evaluate and remove from the market unsafe pesticides and biocides. Among other objectives, the grants intend to support competent authorities to build expertise/ scientific capacity in new areas such as risk assessment for micro-organisms used for plant protection.

The Commission will continue to work with the Member States to fully exploit all existing possibilities in Regulation (EC) 1107/2009 to accelerate the processes for the evaluation of biocontrol products. Suggestions with regard to better defining biocontrol products, shortening the processing timelines for dossiers concerning biocontrol products, allowing provisional authorisations for biocontrol products and not limiting the approval of biocontrol active substances in time may be considered by the Council and European Parliament in the current inter-institutional negotiations of the Commission proposed Regulation on the sustainable use of plant protection products. Concerning the suggestion to focus the safety evaluation of genetically modified organisms on the potential risk pertaining to the product itself rather than the production process employed, in July 2023 the Commission tabled a proposal for a regulation on plants produced by certain new genomic techniques and their food and feed, amending Regulation (EU) 2017/625. To lay the foundation to consider the appropriateness of a potentially similar approach in the risk assessment of genetically modified micro-organisms obtained by new genomic techniques the Commission has already mandated the European Food Safety Authority to collect additional scientific knowledge on micro-organisms.

To support the authorisation process for novel food products, which ensure their safety, there are clear Commission implementing rules and EFSA guidance. The EFSA administrative guidance for the preparation of applications on novel foods was updated in November 2022. Food business operators may also benefit from a pre-submission advice from EFSA to help them prepare their application dossiers.

The term “probiotics” is considered a health claim according to the Guidance document on the implementation of Regulation (EC) No 1924/2006 (Claims Regulation), which states that a claim is a health claim if in the naming of the substance or category of substances, there is a description or indication of a functionality or an implied effect on health, examples: ‘contains antioxidants’ (the function is an antioxidant effect); ’contains probiotics/prebiotics’ (the reference to probiotic/prebiotic implies a health benefit). The Claims Regulation provides that health claims may only be made on foods if they are authorised, following a scientific assessment by the European Food Safety Authority (EFSA). It is therefore prohibited, for the time being, to use health claims on probiotics in the EU market, when no authorisation of a health claim exists. The Commission would welcome a dialogue with Member States on the current situation regarding the use of the term “probiotics” across the EU.

The Platform also called to reflect on the way of classifying biocontrol products under the NACE statistical codes. The Commission could consider how to improve such statistical data, based for example on an index of relevant NACE codes for such economic activities and continue to ensure that NACE evolves according to the new technological realities. The Commission stresses nevertheless that NACE codes are based on economic activities of enterprises and not economic products. Additionally, the use of biotechnology – understood as the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services – is not an economic activity and a classification of units based on the use of biotechnology would completely contradict the methodological principles of NACE. There is a number of categories under which the production of biotech products are mentioned already (some also recognised in the opinion) but their searchability could be facilitated. The NACE classification is revised in a complex inclusive process in which the Commission works closely with its partners in the European Statistical System and business associations. The recent revision of NACE - NACE Rev. 2.1 – included several (new) activities that integrate biotechnology into the production processes, but the technology used for their production is not a NACE classification criterion.