Regulation (EC) No 178/2002 — General Food Law: Principles,

If a contamination incident hits our supply chain tomorrow, can we actually trace every ingredient back to its source — and what happens if we cannot?

Every food and feed business operator in the EU must be able to identify suppliers and recipients of all products at all times — failure to maintain traceability triggers immediate withdrawal obligations and Member State penalties that are required to be effective, proportionate and dissuasive [Art. 18, Art. 17(2)].

Short Answer

Regulation (EC) No 178/2002 is the foundational framework for EU food safety law. It establishes the general principles of risk analysis, the precautionary principle, and transparency that underpin all sector-specific food legislation [Art. 5–10]. It created the European Food Safety Authority (EFSA) as the independent scientific risk assessor [Art. 22] and mandates the Rapid Alert System for Food and Feed (RASFF) for cross-border incident notification [Art. 50]. Crucially, it places primary legal responsibility on food and feed business operators to ensure their products satisfy food law requirements and to verify compliance at every stage of production, processing and distribution [Art. 17(1)].

Who is affected

All food and feed business operators at any stage of production, processing and distribution — whether for profit or not, public or private — including importers, retailers, distributors, catering operations, supermarkets and wholesale outlets [Art. 3(2), Art. 3(3)]. The only exclusion is primary production for private domestic use and domestic preparation for private consumption [Art. 1(3)]. Third-country operators exporting to the EU must also comply [Art. 11].

Deadline

Fully applicable since 1 January 2005 (traceability and safety obligations under Art. 11–20); general principles applicable since 1 January 2007 at the latest [Art. 4(3)]. These are permanent, ongoing obligations. The next evaluation of EFSA performance is due by 28 March 2026 [Art. 61(2)].

Risk

The Regulation does not set EU-wide fine amounts but requires each Member State to lay down penalties that are 'effective, proportionate and dissuasive' [Art. 17(2)]. Placing unsafe food on the market is prohibited outright [Art. 14(1)]. The Commission may adopt emergency measures including suspension of market placement, forced withdrawal or import bans [Art. 53]. In practice, national enforcement actions range from administrative fines and product seizures to criminal prosecution for serious food fraud. RASFF notifications can trigger EU-wide border rejections and reputational damage across all Member States.

Proof

Legal status

• In force
• as of 2026-04-19
• Consolidated version of 01.01.2026 (012.001), incorporating amendments up to Regulation (EU) 2025/2457

Primary sources

• EUR-Lex — Full text
• EFSA — European Food Safety Authority

What to do now

Legal / DPO

•Verify that supplier and customer traceability records cover all food, feed and ingredients at every supply chain stage, with systems to make this information available to competent authorities on demand [Art. 18(2), Art. 18(3)].
•Establish a documented withdrawal and recall procedure that includes immediate notification to competent authorities when any product placed on the market may be injurious to human health [Art. 19(1), Art. 19(3)].
•Review import contracts to confirm that all food and feed entering the EU complies with EU food law requirements or equivalent conditions recognised by the EU [Art. 11].

Compliance

•Implement an internal verification system ensuring that food law requirements are met at all stages of production, processing and distribution under the operator's control [Art. 17(1)].
•Maintain a crisis communication protocol aligned with the RASFF notification obligations so that any serious direct or indirect risk to human health can be reported immediately [Art. 50(2), Art. 50(3)].
•Audit labelling, advertising and presentation of all products to confirm they do not mislead consumers regarding the nature, composition, properties or effects of the food [Art. 16].

IT / Security

•Ensure traceability IT systems can identify suppliers and recipients for every batch within the timeframes demanded by competent authorities, including data integrity safeguards against tampering [Art. 18(2), Art. 18(3)].
•Implement access controls and audit logging for RASFF-related data exchanges and internal food safety incident records to meet the confidentiality and professional secrecy requirements [Art. 52].
•Integrate product identification and batch/lot tracking across ERP and warehouse management systems so that recall scope can be determined rapidly — the Regulation presumes an entire batch is unsafe unless a detailed assessment proves otherwise [Art. 14(6)].

Product / Engineering

•Conduct a safety assessment for each product line against Article 14 criteria: a food is unsafe if it is injurious to health or unfit for human consumption, considering normal conditions of use and consumer information [Art. 14(2)–(5)].
•Ensure that labelling provides accurate information enabling traceability and does not create misleading consumer expectations about the food's properties or composition [Art. 16, Art. 18(4)].
•For products containing ingredients from third countries, verify that the supply chain meets equivalent food safety requirements and that RASFF border rejection history for the source country has been reviewed [Art. 11, Art. 50(3)(c)].

Key Terms

Food business operator: The natural or legal person responsible for ensuring that the requirements of food law are met within the food business under their control [Art. 3(3)].
Traceability: The ability to trace and follow a food, feed, food-producing animal or substance intended for incorporation into food or feed through all stages of production, processing and distribution [Art. 3(15)].
Risk analysis: A process consisting of three interconnected components: risk assessment (scientific evaluation), risk management (policy decisions) and risk communication (information exchange) [Art. 3(10)].
Hazard: A biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect [Art. 3(14)].
Placing on the market: The holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves [Art. 3(8)].
RASFF (Rapid Alert System for Food and Feed): An EU-wide network for notifying direct or indirect risks to human health from food or feed, involving all Member States, the Commission and EFSA [Art. 50(1)].
Precautionary principle: Allows provisional risk management measures when scientific assessment identifies possible harmful health effects but uncertainty persists; measures must be proportionate and reviewed [Art. 7].

Frequently Asked Questions

What exactly does 'traceability' require under this Regulation?

Food and feed business operators must be able to identify any person from whom they received a food, feed, food-producing animal, or any substance incorporated into food/feed, and identify the businesses to which their products were supplied. Systems must allow this information to be provided to competent authorities on demand [Art. 18(2), Art. 18(3)].

When can the precautionary principle be invoked?

When an assessment of available information identifies the possibility of harmful health effects but scientific uncertainty persists, provisional risk management measures may be adopted. These measures must be proportionate, no more trade-restrictive than necessary, and reviewed within a reasonable period [Art. 7(1), Art. 7(2)].

What is the RASFF and how does it work?

The Rapid Alert System for Food and Feed (RASFF) is a network involving all Member States, the Commission and EFSA. When a network member has information on a serious direct or indirect risk to human health from food or feed, it must immediately notify the Commission, which transmits the alert to all members. Member States must also notify any market restriction, withdrawal, recall or border rejection taken for health protection reasons [Art. 50].

What happens if a food is deemed unsafe?

It must not be placed on the market [Art. 14(1)]. If already on the market, the operator must immediately initiate withdrawal and inform the competent authorities. If the product may have reached consumers, the operator must recall it and accurately inform consumers of the reason [Art. 19(1)]. If unsafe food is part of a batch, the entire batch is presumed unsafe unless a detailed assessment proves otherwise [Art. 14(6)].

Does the Regulation apply to food exports from the EU?

Yes. Food and feed exported from the EU must comply with EU food law requirements, unless the importing country's authorities request otherwise or the importing country's own legislation applies. Food that is injurious to health or feed that is unsafe may never be exported [Art. 12(1)].

What role does EFSA play?

The European Food Safety Authority (EFSA) provides independent scientific advice and risk assessments to the Commission and Member States on all matters with a direct or indirect impact on food and feed safety [Art. 22(2)]. It also collects and analyses risk data, identifies emerging risks, and communicates on risks to the public [Art. 22(4), Art. 23].

Who enforces the Regulation in practice?

Member States are responsible for enforcement. They must maintain official control systems, monitor compliance at all stages, and lay down rules on penalties that are effective, proportionate and dissuasive [Art. 17(2)]. The Commission may adopt emergency measures (import suspension, market withdrawal) where risks cannot be contained by individual Member States [Art. 53].

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