EU Regulations for Food & Beverage Manufacturers

1. General Food Law - Regulation (EC) No 178/2002

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 lays down the general principles and requirements of food law, establishes the European Food Safety Authority and lays down procedures in matters of food safety.^[2]

This Regulation provides the basis for the assurance of a high level of protection of human health and consumers' interest in relation to food, taking into account in particular the diversity in the supply of food including traditional products, whilst ensuring the effective functioning of the internal market. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food and feed safety.^[2]

Core Food Safety Principles

The general principles of food and feed law are outlined in Articles 5 to 10. Article 14(2) requires that food is not placed on the market if it is injurious to health or is unfit for human consumption. The regulation forms the foundation of food and feed law, setting out an overarching and coherent framework for the development of food and feed legislation both at Union and national levels.^[2]

Risk Analysis and Transparency

Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, which applies as of March 27, 2021, amends mainly Regulation (EC) No 178/2002. This amendment enhances transparency in risk assessment processes and strengthens consumer confidence in the EU food safety system.^[1]

2. Food Information to Consumers - Regulation (EU) No 1169/2011

Regulation (EU) No 1169/2011 establishes the general principles, requirements and responsibilities governing food information, and in particular food labelling. The regulation entered into application on 13 December 2014, with the obligation to provide nutrition information applying since 13 December 2016. EU Regulation 1169/2011 brings together in a single legislative text the set of rules on food labelling, presentation and advertising.^[3]

Mandatory Labelling Information

For prepacked foods, the Regulation requires mandatory particulars including:^[4]

• The name of the food
• List of ingredients
• Allergen information (with emphasis by font, style or background colour)
• Quantity of certain ingredients or categories of ingredients
• Net quantity of the food
• Date of minimum durability or 'use by' date
• Storage conditions and/or conditions of use
• Name and address of the food business operator
• Country of origin or place of provenance (where required)
• Instructions for use (where appropriate)
• Nutrition declaration

Allergen Labelling Requirements

The Regulation provides clearer and harmonised presentation of allergens (e.g. soy, nuts, gluten, and lactose) for prepacked foods (emphasis by font, style or background colour) in the list of ingredients and mandatory allergen information for non-prepacked foods, including in restaurants and cafes.^[3]

Nutrition Declaration

The mandatory nutrition declaration must include energy value, amounts of fat, saturates, carbohydrates, sugars, protein and salt. This information must be presented in a standardized table format to ensure consistency and clarity for consumers across the EU.

3. Food Hygiene Regulations - 852/2004 and 853/2004

Regulation (EC) 852/2004 was established on 29 April 2004 on the hygiene of foodstuffs, while Regulation (EC) 853/2004 lays down specific hygiene rules for food of animal origin. These regulations have been in force since 1 January 2006.^[5]

HACCP Requirements

Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles. However, this requirement applies only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations.^[6]

Key Hygiene Principles

The hygiene rules are based on several principles including:^[5]

• Primary responsibility for food safety borne by the food business operator
• Food safety ensured throughout the food chain starting with primary production
• General implementation of procedures based on HACCP principles
• Application of basic common hygiene requirements
• Maintenance of the cold chain for foods requiring temperature control

National Guides to Good Practice

Member States shall encourage the development of national guides to good practice for hygiene and for the application of HACCP principles, though food business operators may use these guides on a voluntary basis.^[5]

4. Traceability Requirements - Article 18 of Regulation 178/2002

The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution. Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed.^[7]

One-Step-Back, One-Step-Forward Approach

The requirement relies on the 'one-step back'-'one-step forward' approach which implies that food business operators have in place a system enabling them to identify their immediate supplier(s) and their immediate customer(s), except when they are final consumers. Although traceability is not a new notion in the food chain, it is the first time that the obligation for all food business operators to identify the suppliers and direct recipients of their food/feed is stipulated explicitly in a horizontal Community legal text.^[7]

Rationale for Traceability

Past food incidents have demonstrated that being able to trace food and feed throughout the food chain is of prime importance for the protection of public health and consumers' interests. However, traceability does not itself make food safe.^[7]

5. Novel Foods - Regulation (EU) 2015/2283

Only novel foods authorised and included in the Union list may be placed on the market within the Union as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified therein.^[8]

Definition of Novel Food

The term novel food refers to food that was not used for human consumption to a significant degree within the European Union (EU) prior to 15 May 1997 and that can be categorised as falling under at least one of the food categories listed in the Novel Food Regulation (EU) 2015/2283.^[9]

Authorization Process

The authorization process consists of the following steps: Submission of the application to the European Commission, administrative and technical validation by EFSA, scientific evaluation (typically lasting between 12 and 18 months), and final decision and inclusion in the EU Union List of Novel Foods.^[10]

Application Requirements

The application dossier typically includes: Administrative part (identity of the Novel Food, applicant details, confidentiality requests, conditions of use, and regulatory status outside the EU), public summary (non-confidential product description and safety evidence), and technical dossier (production process, compositional data, stability, toxicology, allergenicity, dietary exposure, and safety conclusions).^[10]

6. Food Additives - Regulation (EC) No 1333/2008

Regulation (EC) No 1333/2008 lays down general requirements for the safe use of food additives and contains the EU list of authorised food additives and their conditions of use. Since 2008, this regulation sets out the criteria by which additives are assessed and approved for use, harmonizing the European legislation of all food additives, including sweeteners and colours which were previously covered by separate pieces of legislation.^[11]

Approved Substances and E Numbers

E-numbers are codes for substances approved as food additives within the EU and are essential in maintaining food quality, appearance, and shelf life. More than 300 substances are authorised for use as food additives in the EU. The European Food Safety Authority (EFSA) has evaluated the safety of the majority of these, while the remainder were assessed by the European Commission's Scientific Committee on Food before EFSA was established.^[12]

Labeling Requirements

Food and drink labels must identify both the function of the additive in the finished food and the specific substance used, either by referring to the appropriate E number or its name (e.g. E 415 or Xanthan gum).^[12]

7. Nutrition and Health Claims - Regulation (EC) No 1924/2006

Regulation (EC) No 1924/2006 was established to ensure that any claim made on a food's labeling, presentation or advertising in the European Union is clear, accurate and based on scientific evidence. The regulation started to apply on 1 July 2007 and covers nutrition claims (such as "low fat", "high fibre") and health claims (such as "Vitamin D is needed for the normal growth and development of bone in children").^[13]

General Requirements

The use of nutrition and health claims will only be allowed if the presence, absence or reduced content in a food of a substance has been shown to have a beneficial effect, as established by accepted scientific data. Nutrition and health claims are required to be based on scientific evidence and may only be used in commercial communications if they have been authorized following scientific assessment of substantiating evidence.^[14]

Authorization Process

Health claim applications are forwarded to the European Food Safety Authority (EFSA) and the Commission then takes a decision on the use of the claim based on the EFSA's scientific opinion. When a health claim is made, nutrition information must be provided.^[13]

8. Organic Production - Regulation (EU) 2018/848

Regulation (EU) 2018/848 establishes the principles of organic production and lays down the rules concerning organic production, related certification and the use of indications referring to organic production in labelling and advertising, as well as rules on controls. The new organic regulation has been in force within the EU since January 1, 2022.^[15]

Certification Requirements

Every company that produces, processes or markets organic products must be certified according to the requirements of the current EU Organic Regulation. Products must be certified by a certification body approved by the competent authorities to attest their compliance to the EU organic regulation.^[16]

Inspection Frequency

Operators and groups of operators (with some exceptions) must be subject to an audit, including a physical on-the-spot inspection at least once a year. Audits may be less frequent (up to a maximum of 24 months) if the operator or group has been assessed as low risk of non-compliance, and previous inspections have revealed no non-compliances in the past 3 consecutive years.^[17]

Group Certification

A system of group certification has been introduced to reduce costs for small farmers. Certification of farmer groups is no longer restricted to low-income countries, but can take place in any third country or within the EU. Maximum size of a group will be 2,000 members.^[17]

9. Food Contact Materials - Regulations 1935/2004 and 10/2011

Regulation (EC) No 1935/2004 provides a harmonised legal EU framework and sets out the general principles of safety and inertness for all Food Contact Materials (FCMs). The regulation requires that FCMs not transfer their constituents to food in quantities that could (a) endanger human health, (b) bring about an unacceptable change in the composition of food, or (c) bring about a deterioration in the organoleptic characteristics thereof.^[18]

Plastics Regulation (EU) 10/2011

The most comprehensive specific EU measure is Commission Regulation (EU) No 10/2011 on plastic materials and articles, which sets out rules on the composition of plastic FCMs and establishes a Union List of substances that are permitted for use in the manufacture of plastic FCMs.^[19]

Key Requirements

• Compositional Requirements: Only the substances included in the Union list of authorised substances set out in Annex I may be intentionally used in the manufacture of plastic layers
• Declaration of Compliance: A written declaration must be available for plastic materials and articles at marketing stages other than at the retail stage
• Migration Limits: A limit on the total amount of material that can be transferred to food from plastic packaging (overall migration limit)

10. Recent Developments and 2026 Updates

New rules to streamline EU chemical assessments entered into force on January 1, 2026, with EFSA working with other EU agencies to create a common data platform on chemicals. The European Commission has published its Health and Food Audits and Analysis work programme for 2026, aimed at keeping the highest standards of food and feed safety across the EU.^[20]

Emerging Restrictions

• New restrictions begin in July 2026 for BPA (Bisphenol A)
• PFAS (per- and polyfluoroalkyl substances) are facing strict new EU controls, preventing them from being used in food packaging if they exceed certain concentrations

How Launch™ Simplifies EU Compliance

EU compliance involves navigating multiple interconnected regulations covering labelling, hygiene, traceability, novel foods, additives, health claims, organic certification, and food contact materials. For food and beverage manufacturers, these requirements create significant regulatory complexity and can delay market entry into the EU.

Launch™ turns EU compliance into executable workflows by:

• Centralizing product data and EU regulatory requirements into a single execution-ready workspace
• Validating labels against Regulation 1169/2011 requirements including mandatory information and allergen highlighting
• Checking ingredients against approved additives lists (Regulation 1333/2008)
• Verifying nutrition and health claims against authorized lists (Regulation 1924/2006)
• Generating nutrition declarations in the required EU format
• Maintaining traceability records aligned with Article 18 requirements
• Organizing HACCP documentation and hygiene compliance records
• Preparing novel food applications with required scientific evidence
• Compiling submission-ready product dossiers with full traceability for EU inspections
• Capturing regulatory decisions in a Compliance Context Graph that preserves the "why" behind every approval

Every execution is reviewable and adjustable by your team. Launch™ keeps humans firmly in control while automating the heavy lifting - ensuring compliance is accurate, auditable, and aligned with EU expectations.