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The EU rules on food withdrawal and recall sit in Regulation (EC) No 178/2002, the General Food Law Regulation. Its Articles 18 and 19 require every food business operator to be able to trace one step back and one step forward, and an operator that has reason to believe its food does not meet food safety requirements to start procedures to withdraw it. MAAK Advocaten N.V. in Amsterdam advises non-EU exporters and their Dutch importers on these duties.
See also our overviews of product compliance in the Netherlands and EU product law.
Who must trace and recall under the EU food recall regulation?
The duties fall on the food business operator, the person responsible for compliance with food law in the business under their control (Article 3(3)). The stages covered include import (Article 3(16)), so the company that imports your food is covered.
Article 19(1) names the operator that imported, produced, processed, manufactured or distributed the food. Imported food must meet the relevant requirements of food law, conditions recognised as at least equivalent, or those of a specific agreement with the exporting country (Article 11); see also selling products in the EU.
Articles 14 to 20 of the Regulation have applied since 1 January 2005 (Article 65).
What exporters outside the EU often get wrong is the assumption that the importer takes care of it. The law places the duties on the party that imports and on every operator in the chain; what the importer needs from you is set out in your contract. My advice: before the first shipment, agree which data you supply, within what period, and who bears the costs if a batch has to come back.
What does Article 18 require: one step back, one step forward?
Article 18(2) and (3) require an operator to identify who supplied it and which other businesses it supplied, and to have systems and procedures that make this information available to the competent authorities on demand.
Article 18(3) looks at the other businesses supplied, not at the final consumer. Article 18(4) adds that food on the market is adequately labelled or identified to facilitate traceability. For label content, see food product labelling.
The Regulation sets no retention period, no form and no deadline for handing over the data. In practice you want the records to be quickly retrievable, but that is advice, not a rule. Sector-specific rules under Article 18(5) may exist; they are not covered here. What your Dutch importer needs from you, and how fast, is for your supply contract.
When is a withdrawal enough, and when must you recall?
Under Article 19(1), an operator that has reason to believe its food does not comply with food safety requirements immediately initiates procedures to withdraw it from the market once it has left its immediate control, and informs the authorities. It recalls from consumers only if necessary, when other measures are not sufficient.
| Step | When | Who | Article |
|---|---|---|---|
| Procedures to withdraw from the market, started immediately | The operator has reason to believe the food does not comply with food safety requirements and it has left its immediate control; authorities informed | Operator that imported, produced, processed, manufactured or distributed the food | 19(1) |
| Information to consumers | The product may have reached the consumer | Same operator | 19(1) |
| Recall from consumers | If necessary, when other measures are not sufficient | Same operator | 19(1) |
| Notification of the authorities | Food the operator placed on the market may be injurious to human health; it also reports the action taken | Any operator | 19(3) |
| Withdrawal and cooperation in retail or distribution | Activities that do not affect packaging, labelling, safety or integrity | Retail or distribution operator | 19(2) |
If an unsafe food (injurious to health or unfit for human consumption, Article 14(2)) is part of a batch of food of the same class or description, the whole batch is presumed unsafe, unless a thorough assessment finds no evidence that the rest is unsafe (Article 14(6)).
The procedure to withdraw and the information to the authorities must start immediately; the Regulation sets no number of hours or days. The rapid alert system of Article 50 is a network of Member States, the Commission and EFSA, not of operators: an operator informs the competent authority itself (Article 19(1) and (3)).
Withdrawal is the first step: you remove the batch from your customers and inform the authority. Recall from consumers follows if necessary, when the batch may have reached the consumer and other measures are not sufficient to achieve a high level of health protection (Article 19(1)). You assess that with your quality manager and with the facts on the table; I make sure the decision and its reasoning are recorded, for your customers and for the authority.
For NVWA enforcement and the general recall regime, see NVWA enforcement and administrative fines and recall under Dutch law; products that are not food follow their own regime, covered in our article on the GPSR.
What does Article 19(2) ask of distributors and retailers in the chain?
A retailer or distributor whose activities do not affect packaging, labelling, safety or integrity of the food starts procedures to withdraw non-compliant products within its own activities, passes on the information needed to trace the food and cooperates with producers and authorities (Article 19(2)).
Article 19(2) covers only retail or distribution activities that do not affect packaging, labelling, safety or integrity. Whether your Dutch partner stays within that line depends on what it does with your product.
Who bears the cost when your importer withdraws a batch?
The Regulation does not say. Article 21 only provides that Chapter II (general food law) is without prejudice to Directive 85/374/EEC on liability for defective products; costs and recourse between businesses follow national law and the contracts.
The Dutch Warenwet (Commodities Act) does not say who in the chain bears the costs of a recall or who can recover them from whom. Whether you can recover costs from your own supplier depends on the contracts and national law.
How does the Regulation work in the Netherlands?
The Regulation applies directly in the Netherlands, and Member States enforce it with measures and sanctions that are effective, proportionate and dissuasive (Article 17(2)). Articles 14 to 20 have applied since 1 January 2005 (Article 65).
The Dutch Warenwet follows the Regulation’s definition of food (Article 1). In general it provides for an order subject to administrative coercion (Article 32) and an administrative fine (Article 32a).
The Warenwet duty to notify the Minister (Article 21b) and its power to order products to be taken back (Article 21(2)) cover goods other than food and drink. For food, the duty to notify comes from Article 19(3) of the Regulation. Whether and on what basis a breach of Article 18 or 19 can lead to a measure in the Netherlands is something we assess per case.
What do you do when a Dutch authority asks for traceability data?
Read what exactly is asked, by whom and about which batch, then collect supplier and customer data and batch numbers. Article 18(2) and (3) require that this information can be given to the competent authorities on demand.
I respond for the company with the documents that exist, and I say what we are still investigating. A late, incomplete response often costs more than an honest response with a clear plan. Report what you must report without delay, and record when and why you took each decision. If a measure is announced, we prepare the written view (zienswijze) together.
What can you arrange yourself, and what needs legal advice?
Your quality team can set up the traceability system, record batch numbers and organise a recall team: Article 18(2) and (3) ask for systems and procedures, not for legal work. A lawyer is needed for roles in the chain, costs and contact with the authority.
I suggest three things, in this order. First: can you say from whom you received a batch and to whom you supplied it? The law asks that of you (Article 18). Next: who in your business decides on withdrawal and notification, and who records it. Third: what your contracts say about information and costs if a batch has to come back, because that is where the money is. Set up the system first, because without working data you cannot demonstrate or recover anything; the contract follows directly after.
Setting up a traceability system, recording batches and organising a recall team is work for your quality department. You need a lawyer once it is about the allocation of roles in the chain, costs or the authority: a customer wants to put recall costs on you, an inspector asks for data, or you must decide what to write to a customer or the authority. Do not wait until a letter arrives.
When do you need a Dutch lawyer for food traceability and recall?
You need a Dutch lawyer when it is about your role in the chain, the contract or a Dutch authority. Articles 18 and 19 set the duties; the Regulation sets no deadline or form for data sharing and does not regulate recall costs (Articles 18, 19 and 21).
| Your situation | What is at stake | Why a lawyer, not only a quality manager | What we do in the first days |
|---|---|---|---|
| Your Dutch importer asks for traceability data and a recall protocol | Art. 18(2) and (3) apply to every operator, including the one that imports; the Regulation sets no deadline, form or retention period | The Regulation sets no deadline or form for data sharing between you and your importer; the supply contract is where you agree it | Review the supply agreement and propose how data sharing and cooperation are arranged |
| A batch is withdrawn or recalled | Art. 19(1); the Regulation does not allocate the costs (Art. 21 only leaves Directive 85/374/EEC untouched) | Who pays depends on the contract and on national law | Assess recourse against your own supplier and your contract position |
| The importer asks for an unlimited indemnity | The Regulation does not allocate the costs (Art. 21 only leaves Directive 85/374/EEC untouched) | An open indemnity moves the whole recall cost to you | Negotiate a clear cost split with a limit |
The agreement that makes the most difference is who supplies which traceability data, within what period, and who bears the costs if a batch has to leave the market, including retrieval and destruction. The Regulation does not regulate those costs; the contract and national law do. I advise a clear split of data, period and costs with a limit, over a blanket indemnity: a clear split keeps the relationship intact.
Example: a non-EU producer and its Dutch importer
A producer outside the EU sells packaged food to an importer in Rotterdam, which supplies Dutch retail chains. The producer’s supplier reports a problem with an ingredient in a batch already shipped.
The importer has reason to believe the batch does not comply with food safety requirements. Under Article 19(1) it immediately initiates procedures to withdraw the batch and informs the competent authorities. It then asks the producer to bear the costs. The Regulation does not answer that question (Article 21 only leaves Directive 85/374/EEC untouched); the supply contract and national law do, and here the contract has no clause on traceability data or costs.
This is a hypothetical example for illustration, not a description of an actual case.
How does MAAK Advocaten work on food traceability and recall matters?
MAAK Advocaten acts for food exporters outside the EU and their Dutch importers and distributors: supply contracts, recall costs and recourse, contact with authorities, objection and appeal. In the first days we read the contract and the traceability documents and set out your position under Articles 18 and 19 and the contract. The traceability system and recall logistics stay with your quality team.
Is your Dutch importer asking for traceability data or a recall indemnity? We can set out your role under Articles 18 and 19 and the contract position before the next shipment: contact our product law partner in the Netherlands.
Frequently asked questions about the EU food recall regulation
What does Article 18 of Regulation 178/2002 require?
Every food business operator must be able to identify who supplied it with food and which other businesses it supplied, and must have systems and procedures to give this information to the competent authorities on demand (Article 18(2) and (3)). The Regulation names no form or retention period.
What is the difference between withdrawal and recall under Article 19?
An operator that has reason to believe its food does not meet food safety requirements immediately initiates procedures to withdraw it from the market once it has left its immediate control, and informs the authorities. Recall means retrieving the food from consumers; it follows only if necessary, when the product may have reached consumers and other measures are not sufficient (Article 19(1)).
Does the EU food recall regulation set a deadline in hours or days?
Not in Regulation 178/2002. Article 19(1) and (3) require the operator to act immediately, and Article 18 sets no deadline, retention period or form for traceability data. Terms for data sharing between you and your importer are for your supply contract; sector-specific rules (Article 18(5)) are not covered here.
Who pays for a food recall?
Regulation 178/2002 does not allocate recall costs; Article 21 leaves Directive 85/374/EEC on defective products untouched. The Warenwet does not say who in the chain bears the costs of a recall or who can recover them from whom, so costs and recourse follow the contracts and national law.
When should an exporter outside the EU call a Dutch lawyer about food traceability and recall?
When a Dutch importer asks for traceability data or an indemnity for recall costs, when a batch is withdrawn, or when a Dutch authority asks for data. MAAK Advocaten reviews your role and the contract before you share data or sign.
Since when do Articles 18 and 19 apply in the Netherlands?
The Regulation applies directly in the Netherlands. Articles 11 and 12 and Articles 14 to 20 have applied since 1 January 2005 (Article 65); Member States enforce the Regulation with effective, proportionate and dissuasive measures and sanctions (Article 17(2)).
Primary sources
- Regulation (EC) No 178/2002 (General Food Law Regulation): Articles 3, 11, 14, 17, 18, 19, 21, 50 and 65
- Warenwet (Dutch Commodities Act): Articles 1, 21, 21b, 32 and 32a
Do you export food to the EU and is it unclear what your importer may ask of you? Put your situation to our product law partner in the Netherlands.
