Guidelines on withdrawal of products

Guidelines to food business operators* on withdrawal of products and on notification to authorities and to consumers

If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection (178/2002/EC, Article 19 Item 1).

Article 19 of the Regulation of the European Parliament and of the Council No. 178/2002 (so-called general food law) lays down the requirements that apply to all food business operators in a withdrawal situation (http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32002R0178&qid=1450092673237&from=FI).  The European Commission has published a guidance document concerning the withdrawal of a product from the market. The document is available in e.g. English at http://ec.europa.eu/food/food/foodlaw/guidance/guidance_rev_8_en.pdf (cf. Appendices).

Operator's responsibilities

Pursuant to the Regulation, when a product is not in compliance with the food safety requirements*** and the product has already reached consumers, the operator is responsible for:

a) removing the food from the market (withdrawal),

b) informing the authorities about the withdrawal (municipality/official veterinarians (at meat establishments that operate in conjunction with slaughterhouses) and Finnish Food Safety Authority Evira)

c) informing consumers about the defect and the cause of withdrawal and providing advice about how the product can be returned (e.g. returned to the point of sale).

The company's in-house control plan shall include a withdrawal plan that specifies these activities.

a) Withdrawal

The operator shall at his own initiative assess the risk associated with the ingestion of the non-safe food. The assessment should be based on the precautionary principle with the risk assessed according to the worst-case scenario. The authorities are responsible for assessing the risk assessment procedure and for cooperating with the operators as necessary.

Reasons that normally result in the product being withdrawn from the market include e.g. failure of sealing or heat treatment, microbiological contamination and an allergen that is not indicated in the labelling.  High levels of contaminants, violations of regulations concerning additives, errors in the dosage of added nutrients and serious errors in composition are also reasons that may make the withdrawal of the product necessary. Evira has issued detailed instructions for withdrawal a.o. due to an allergen labelling error (cf. Appendices).

b) Informing authorities

The operator shall without delay inform the control authorities of the municipality in which the operator's business is located of the withdrawal in compliance with the procedure described in the in-house control plan. Meat establishments operating in conjunction with slaughterhouses shall inform the official veterinarian of Evira about the withdrawal instead of the municipal authorities. In addition, a notice shall also be immediately filed to Evira by filling in the Withdrawal Form on the Internet site of the Authority and by sending it to takaisinvedot at-merkki.gif : 1Kb evira.fi (cf. Appendices) or, when needed, by sending documents not available in electronic form (e.g. analysis certificates) to the Authority by fax (+ 358 20 7724 350). "Withdrawal" shall be indicated as the subject in E-mail messages and fax cover notes. If the operator also wishes to contact the Authority by telephone, in addition to the e-mail message, the Director of the Food Hygiene Unit can be contacted about microbiological defects and the Director of the Product Safety Unit about other defects (Authority’s exchange number: +358 20 772 003). However, the Withdrawal Form shall always be filled in and submitted as quickly as possible.

If the product to be withdrawn has only been offered for sale or for any other form of transfer within one municipality, the responsible authority is the municipality. Evira need not be informed in this case.

The Withdrawal Form describes the product, in which the defect has been detected, the nature of the defect and the action the operator has taken/is about to take, and gives the name and contact information of the person who handles the matter. This information, at least, shall be immediately submitted to the authorities. The municipal authorities can take action on the basis of this information and Evira can issue a notice to municipal authorities and answer any inquiries from the media or the consumers. The operator shall supplement the information provided in the form as soon as the information becomes available to the operator. However, all the required information shall be acquired as soon as possible, within a few days.

Action taken by Evira when notice of withdrawal is received

If required, Evira gives its opinion on the adequacy of the planned withdrawal process. The Authority sends the municipal control authorities a notice of the withdrawal for information and the municipal authorities shall verify that the withdrawal has been implemented successfully (cf. Appendices). A copy of the notice is sent to the operator for information. If the defect in the opinion of the Authority calls for immediate action to be taken by authorities, the subject line of the notice will read "Urgent withdrawal, requires immediate action". The Authority   also draws up a brief press release of the withdrawal and posts it on the Authority's Internet site under "Product withdrawals" (cf. Appendices). Evira also decides whether other EU member countries need to be informed through the RASFF system.

c) Informing consumers

In order to prevent consumers from being exposed to any risks, the operator shall run a paid announcement in the press and send a press release to the Finnish News Agency STT (toimitus at-merkki.gif : 1Kb stt.fi). The press release and the announcement shall identify the affected product clearly and explain why the withdrawal procedure has been activated, i.e. what the defect is (cf. Appendices). The size of the announcement shall be at least 90 mm x 100 mm to make it discernible from other text. Evira recommends that the word "Withdrawal" be used in the announcement.

Depending on the nature of the defect and the circulation of the product, the announcement shall be published in different newspapers and other media. For a product delivered to the whole country, the announcement shall primarily be published in all the main Finnish newspapers, both in Finnish and in Swedish. For products only marketed in a certain area, the announcement is published in local newspapers of the area. When the product is only of interest to a restricted group of consumers (e.g. offered for sale in an ethnic store), the announcement can be posted in the store in question.

The operator shall describe a plan for effective and appropriate communication to consumers in the withdrawal notice submitted to the authorities.

d) Withdrawal from market, recalling and destroying products

Food business operators are responsible for recalling, rectifying or destroying food withdrawn from the market. Depending on the product, it can be brought to comply with regulations (e.g. indicate an allergen in the labelling), used for a purpose other than as food or destroyed.

Summary of operator's responsibilities concerning withdrawal, (picture, GIF)

Appendices

  • Withdrawal Form: Notification to Evira and municipal control authorities/official veterinarian (at meat establishments that operate in conjunction with slaughterhouse)  about withdrawal of food
  • Example of announcement to consumers published at operator's cost
  • Example of Evira’s notice to food control authorities about a defect in food (withdrawal).
  • Example of a press release about withdrawal on Internet site of the Finnish Food Safety Authority Evira
  • Guidance document published by the EU Commission on the implementation of Articles 11, 12, 16, 17, 18, 19, 20 of Regulation (EC) No. 178/2002 (cf. Article 19)
  • Instructions for withdrawal due to allergen labelling error.
  • Instructions on withdrawal of novel foods from the market
  • Instructions on withdrawal of foods due to irradiation

Feedback about these Guidelines can be sent to takaisinvedot at-merkki.gif : 1Kb evira.fi

* Applies to all food business operators, from farm to fork. Definitions of e.g. food business operators are provided in the general food law (178/2002/EC).

** Food is not considered safe if it is harmful to health or unfit for human consumption (cf.178/2002/EC Article 14).

*** The Guidelines do not apply to withdrawal initiated by the operator for reasons other than product safety (e.g. defective colour).

 

Appendices for withdrawal