EUROPEAN COMMISSION

HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate D - Food Safety: production and distribution chain

D3 - Chemicals, Contaminants and Pesticides

standing committee on the food chain and animal health

Working document

Modus operandi for management of new food safety incidents with a potential for extension involving a chemical substance

1. Scope

This document covers the management of new food safety incidents with a potential for extension, involving a chemical substance and presenting a potential risk for public health. The incident could result from an accident, a lack of precaution or a fraud.

2. Procedure

The way to ensure that concerted action is taken from the outset is to implement the following:

2.1. RASFF

· Member States should notify the RASFF immediately and in any event before making information public at national level.

2.2. Science

· The RASFF notification of any newly identified problem should be accompanied or followed as soon as possible by any information available, such as toxicological data, possible extent of the problem, etc. This should not delay the RASFF notification.

· The RASFF notification concerning such a problem which requires testing should contain the analytical method and sampling strategy applied, for use by the other Member States.

· Agree with Member States that they do not develop their own (possibly divergent) method but collaborate with the Member State having sent the initial notification. The original method should be applied pending further refinements to be developed normally under the leadership of the notifying country.

2.3. Determination of the conditions for choice of the most appropriate risk management tool

· Type and level of risk;

· Determination if the incident is linked to a fraud or an unintentional event;

· Degree of proactivity/ co-operation of the operators;

· Anticipated duration for phasing out of the problem;

· Consumer information;

· Actions taken by Member States against fraudulent practices.

2.4. Action on the market

· In SCOFCAH, agreement in writing on a harmonised approach:

o No action;

o Withdrawal;

o Recall;

o Consumer information.

2.5. Binding EU measures

· If necessary, adoption of emergency measures under article 53 of the Food Law :

o Special marketing conditions;

o Special import conditions;

o Suspension of the import of the product.

2.6. Follow-up

· Collation of Member States monitoring data;

· If necessary, Commission control missions to verify that the relevant measures are taken by the Member States and/or the country of origin (e.g. import controls, implementation of HACCP, etc).

PROCEDURAL FLOW-CHART

TOOLBOX

Elements for a "toolbox" intended to characterise and manage a new food safety incident or a food safety incident with a potential for extension involving a chemical substance and to propose subsequent actions.

The use of the available tools will be possible after establishment of the nature of the incident.

1. Characterisation of the incident

1.1. The problem

Severity of the problem	Acute incident with high level of severity
	Repetition of incidents

Nature of the problem	Accident
	Lack of precaution
	Fraud

1.2. Type of the chemical substance causing the problem

Analytical test	Existence of a test	If necessary, improvement for routine use
Analytical test	Absence of a test	Need for developing rapidly a test

Legal status of the substance	No status
	Not authorised (not listed on a positive list)
	Prohibited

Limit for the substance causing the problem	Absence of legal limit for this substance	Possible use of the limit of detection of the analytical test
		Possible establishment of an action limit (for management)
	Possible existence of a legal limit in another area	Action limit (MRPL)
		Safety limit (MRL for VMP)

2. Tools for managing the incident

These tools should be used by the COM, MS and/ or food business operators:

· according to the risk;

· in consistency with previous actions taken on comparable problems.

The incident will be managed by using a combination of the options below.

2.1. Type of measures

Status of the measures	Own measures by food business operators
	Written agreement between the MS/ COM in SCOFCAH
	Formal Commission Decision

2.2. Actions on the market

2.2.1. Controls

Controls performed in MS	Own checks carried out by food business operators
	Random check on the market and/ or at the import
	Systematic checks on the market and/ or at the import

2.2.2. Actions

The tables describe the actions which can be carried out by the competent authorities. These actions range by increasing level of stringency from "no action" to recall, according to the level of risk.

2.2.2.1. No action

No action is taken by the competent authorities.

2.2.2.2. Withdrawal of relevant batch(es)

The withdrawal is voluntary or mandatory.

		Food production and distribution chain
Withdrawal based on the results of analytical tests	Raw material	Analytical test ® if presence of the chemical = withdrawal
Withdrawal based on the results of analytical tests	Processed product	Analytical test ® if presence of the chemical = withdrawal
Withdrawal based on analytical tests on raw material and traceability for processed products	Raw material	Analytical test ® if presence of the chemical = withdrawal
	Processed products	1. Traceability strictly implemented all along the food chain = withdrawal
		2. Traceability on the basis of a management limit and the % of incorporation of the ingredient in the food product = withdrawal
		3. Traceability after 1 transformation = withdrawal

2.2.2.3. Recall of relevant batch(es)

Extension of the scheme under 2.3.2.2 up to the consumer. The recall is voluntary or mandatory.

2.2.2.4. Consumer information

Consumer should be informed in particular of the withdrawal or the recall in accordance with Article 19 of Regulation 178/2002.

2.2.3. Food containing the chemical substance

Action carried out on food containing the chemical substance	Destruction
	Re-processing
	Cleaning of the supply chain + Food kept on the market

2.3. Binding measures on EU markets and/ or imports

Commission Decision	Special marketing conditions	Compulsory controls on the market
	Special import conditions	Analytical report attesting the absence of undue substance (exporters responsible)
		Official certificate with the analytical report
		Requirement of additional guarantees (sampling and analysis by the competent authorities before export)
		Import controls in the MS
	Restrictions and listing	Establishment of a list of obligatory point of entry in the EU
		Listing of the exporters authorised to export on a positive list
		Listing of the third countries authorised to export on a positive list
	Suspension	Prohibition of the import of the product coming from certain countries.
	Suspension	Suspension on the placing on the market.