Food, feed, and consumer products safety

In the EU, food improvement agents include food additives, food enzymes, and food flavourings.

• Food additives, among others, preserve, colour and stabilise food during its production, packaging or storage
• Food enzymes have specific biochemical actions which serve technological purposes at any stage of the food chain
• Food flavourings give or change the odour or taste to food.

Authorisation process

In order for the product to be legally placed on the market, it must undergo a common authorisation procedure for the assessment and authorisation of food additives, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs. The European Food Safety Authority (EFSA) conducts risk assessments as part of this process.

Find more on the general framework for food improvement agents. 

See also

EU regulation on food additives

EU regulation on flavourings

EU regulation on enzymes

If your company produces feed additives, knowing EU rules is essential for bringing your products to the market. Here’s a summary of the standard procedure:

• Submit your application to the European Commission: you must demonstrate that your additive is safe (for humans, animals, and the environment) and efficacious for its intended purpose.
• Scientific evaluation by EFSA: the European Food Safety Authority (EFSA) evaluates the safety and efficacy of feed additives and issues an opinion.
• EU Commission decision: based on EFSA’s evaluation, the Commission grants or denies the authorisation.

For detailed information, see the EU Feed Additives Authorisation Guide.

Special procedures for feed additives containing, consisting of, or produced from GMOs

If your feed additive contains, consists or is produced from GMOs:

• You need two authorisations: one under the GMO rules and one under the feed additives rules.
• The GMO authorisation must be granted first.

Please note: for additives produced with GMOs (but not containing, consisting of, or produced from GMOs) the standard procedure applies.

See also

Rules on the preparation and presentation of applications, assessment and authorisation of feed additives

EU regulation on feed additives

EU directive on deliberate release of GMOs

EU regulation on GMOs in food and feed

'Novel food’ means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997 and that falls under at least one of the categories listed in the EU regulation on novel foods.

Authorisation process

Only novel foods authorised and included in the “Union list of novel foods” may be placed on the market. The novel food authorisation procedure ensures that only safe novel foods reach the EU market. In this procedure, risk assessment is carried out by European Food Safety Authority (EFSA).

The Novel Food status Catalogue may be used to check if a food needs a pre-market authorisation.

See also

Novel foods overview

Novel foods legislation

EFSA guidance on novel foods

If your products involve the use of genetically modified organisms (GMOs), understanding EU rules is critical for market access and compliance.

Genetically modified food and feed

If your food or feed product contains, consists of or is produced from GMOs, it must be authorised for sale or for cultivation in the EU.

• Application preparation: you must submit a scientific dossier demonstrating product safety and provide a detection method. The European Food Safety Authority (EFSA) tools and guidance can help applicants including SMEs in this process.
• Submission and assessment: the application must be submitted to the national competent authority. EFSA evaluates your application as regards safety aspects. Approved products receive EU-wide authorisation and are listed in the GMO register.

Deliberate release of GMOs into the environment

• Market release: products other than food and feed containing or consisting of GMOs that are intended for the European market or for cultivation require EU authorisation. An application must be submitted to the national competent authority. This authorisation is valid in all EU countries and is listed in the GMO register.
• Release for non-marketing purpose (e.g. field trials): the deliberate release of GMOs into the environment for non-marketing purposes also requires approval. You must notify your national competent authority if you wish to conduct a release for research or other non-marketing purposes. Public registers of such notifications ensure transparency.

Contained use of GM micro-organisms (GMMs)

For laboratory or facility use:

• Notification: depending on the risk of the contained use, notify or get approval from your national competent authority before starting.
• Scope: EU rules apply to GMMs but not GM plants or animals (some EU countries may have separate national rules to cover the latter).

See also

EU GMO legislation

EU directive on deliberate release of GMOs

EU regulation on GMOs in food and feed

EU directive on contained use of GMMs

If you are developing alternatives to synthetic pesticides, like micro-organisms, semiochemicals, peptides, or iRNA, here’s what you need to know:

• Micro-organisms as active substances in pesticides: these are a key sustainable option and can also be used in organic farming. EU rules streamline authorisation for products containing them.
• Other emerging alternatives: substances like semiochemicals (e.g. pheromones), plant extracts, and peptides are gaining traction. EU guidance explains and simplifies authorisation for these innovations.
• EU pesticide guidance database: a dedicated database of test methods and guidance documents can help SMEs prepare applications.

Before a plant protection product can be authorised in an EU country, all the active substances it contains need to be approved at EU level. A scientific evaluation on the dossier with safety and efficacy data ensures your product is safe for health and the environment.

See also

EU pesticides overview

The European Food Safety Authority (EFSA) provides tools and guidance that can help applicants. Examples of guidance include:

• GMO applications: regulations and guidance
• Feed additive applications
• Guidance on the characterisation of microorganisms used as feed additives or as production organisms
• Pesticide evaluations: regulations and guidance
• Novel and traditional food applications and notifications: regulations and guidance
• EFSA pesticide webpage
• EFSA also has special services for SMEs, such as fast processing of web form queries.