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Rapid Alert System for Food and Feed

Unit 1 - Reminde on the European Union and the EU food law

In the first Unit, we will provide you basic information about the EU, its composition and functions.

Then, we will look at the food law and its requirements concerning hygiene, safety and controls to perform.

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The European Union plays an important role in the control and alert system for the quality of food and feed.

In this topic the focus is the European Union and the different authorities.

We will see how the food and feed safety are monitored for compliance towards the food laws.

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The European Parliament

Elected by EU voters every 5 years, members of the European Parliament represent the people. Parliament is

one of the EU’s main law-making institution.

The European Parliament has three main roles:

Debate and pass laws, with the Council

Scrutinise the EU institutions to ensure democracy

The Council of the European Union

In the Council of the European Union, the national ministers vote EU laws, coordinate the broad economic

policies, sign agreements with other countries, adopt the multi annual budget, approve the annual EU budget,

develop the EU's foreign and security policy and coordinate the cooperation between courts and police forces

of member countries.

The European Commission

The European Commission upholds the interests of the EU, it drafts proposals for new laws and manages

business and budgets for EU policies. The EU President assigns to each Commissioner a specific policy area. The

appointment of Commissioners and President is subject to the approval of the European Parliament.

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With the aim to ensure the safety of the food, the EU established specific laws to which all Members States

have to comply.

This topic is focused on:

the food law

the hygiene requirements

the food safety legal framework

the control and inspection criteria

who monitors the market of foods, against the requirements of the food laws.

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<Risk Analysis>

The Regulation establishes the principles of risk analysis in relation to food and establishes the structures

and mechanisms for the scientific and technical evaluations which are undertaken by the European Food

Safety Authority (EFSA).

Depending on the nature, food law - and in particular measures relating to food safety - must be

underpinned by strong science. The EU has been at the forefront of the development of the risk analysis

principles and their subsequent international acceptance.

Regulation (EC) No 178/2002 establishes in EU law that the three inter-related components of risk analysis

(risk assessment, risk management and risk communication) provide the basis for food law as appropriate

to the measure under consideration. Clearly not all food law has a scientific basis, e.g. food law relating to

consumer information doesn’t need a scientific foundation.

<Risk management process>

Scientific assessment of risk must be undertaken in an independent, objective and transparent manner

based on the best available science.

Risk management process assesses the policy alternatives in the light of results of a risk assessment and

selecting the appropriate actions necessary to prevent, reduce or eliminate the risk to ensure the high level

of health protection determined as appropriate in the EU.

In the risk management phase, the decision makers need to consider a range of information in addition to

the scientific risk assessment. For example, the feasibility of controlling a risk, the most effective risk

reduction actions depending on the part of the food supply chain where the problem occurs, the socio-

economic effects and the environmental impact. According to Regulation (EC) No 178/2002, risk

management actions aren’t just based on a scientific assessment of risk but takes also into consideration a

wide range of other legitimate factors.

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<Transparency>

Food safety and the protection of consumer interests are of increasing concern to the general public, non-

governmental organizations, professional associations, international trading partners and trade

organisations. The Regulation establishes the mechanisms necessary to increase consumer confidence in

food law. This consumer confidence is an essential outcome of a successful food policy and is therefore a

primary goal of EU action related to food.

Transparency of legislation and effective public consultation are essential elements of building this greater

confidence. Better communication about food safety and the evaluation and explanation of potential risks,

including full transparency of scientific opinions, are of key importance.

<Transparency>

The Regulation sets out the general requirements of food law which include food safety requirements,

responsibilities of both food and feed business operators and Member States. The Regulation establishes

the principle that the primary responsibility for ensuring compliance with food law, rests with the food

business operator.

“Food business” is defined in the Regulation as meaning any undertaking, whether for profit or not and

whether public or private, carrying out any of the activities related to any stage of production, processing

and distribution of food.

“Food business operator”means the natural or legal persons responsible for ensuring that the requirements

of food law are met within the food business under their control.

More Info <Food safety requirements>

Τhe Key Obligations of Food and Feed Business Operators are:

Safety: Operators shall not place on the market unsafe food or feed

Responsibility: Operators are responsible for the safety of the food and feed which they produce, transport,

store or sell

Traceability: Operators shall be able to rapidly identify any supplier or consignee

Transparency: Operators shall immediately inform the Competent Authorities if they have a reason to

believe that their food or feed is not safe

Emergency: Operators shall immediately withdraw food or feed from the market if they have a reason to

believe that it is not safe

Prevention: Operators shall identify and regularly review the critical points in their processes and ensure

that controls are applied at these points

Co-operation: Operators shall co-operate with the Competent Authorities in actions taken to reduce risks

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<General criteria>

All food businesses are required to be registered with the Competent Authority, according to the business type.

Some food business operators have to be approved (e.g: food business processing products of animal origin, see

Reg (EC) No 853/2004)

Food Business Operators except primary production (for instance farmers and growers) are also required to put

in place, implement and maintain a permanent procedure, or procedures, based on Hazard Analysis Critical

Control Points (HACCP) principles

The legislation is structured to ensure that the appropriate level of public health protection is in place without

unnecessary burdens on businesses. Food businesses can apply the legislation flexibly and proportionately

according to the nature of the business.

<Duty of Food Business Operators>

Food Business Operators must:

provide the Competent Authority with evidence of their compliance with the requirement to have procedures

based on the HACCP principles in the manner that the Competent Authority requires, taking into account the

nature and size of the food business;

ensure that any documents describing the procedures developed in accordance with this are up-to-date at all

times;

retain any other documents and records for an appropriate period.

<HACCP>

Hazard Analysis and Critical Control Point (HACCP)

However, the Regulation (EC) No 852/2004 recognises that in businesses undertaking low risk activities the

prerequisite hygiene requirements (i.e. the general and specific hygiene requirements outlined in Article 4 and

Annex II of Reg. (EC) No 852/2004) are sufficient to control food safety without the need to develop a HACCP

based system.

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Additionally, it allows businesses to follow guides to good practice where typical hazards and controls have been

identified.

The European Commission has published a “Guidance Document on the implementation of procedures based

on the HACCP principles, and facilitation of the implementation of the HACCP principles in certain food

businesses”

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<Identity checks>

At most EU entry points, a computer program randomly select the consignments of food products subjected

to identity checks. Identity checks are carried out to verify that the consignment indeed contains the food

products described on the documentation. The procedure for an identity check includes:

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Verification for container number and seal number (where appropriate)

Verification that seals are intact (where appropriate).

For wrapped or packaged products: a check on specific labeling present on these products.

<Physical checks>

Physical checks include inspection of the product itself and of the packaging.

Checks can consist of measuring of temperature (e.g. in the case of quick-frozen food), organoleptic testing

and laboratory testing (for hazards and fitness). Products that do not comply with the requirements

applicable to the type of food concerned will not be allowed to enter the EU. Physical checks are (randomly)

carried out based on estimated risks at the point of entry in the EU. Fruits and vegetables that are

accompanied by a phytosanitary certificate are always subject to physical checks. Furthermore, in practice

most consignments of products of animal origin (e.g. fishery products and honey) undergo physical checks.

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<Entrance through Designated points of entry>

All products can only enter the EU through designated points of entry. Each EU Member State has one or more

designated points of entry. Products that are offered at other posts, for instance at ports to which

manufactured goods are shipped, will be rejected from EU entry. The designated points of entry of each EU

Member State can be verified with the competent food authority of that country or with any EU buyer. All costs

associated with inspections carried out under Regulation (EC) 669/2009 are imposed on the Feed and food

business operators responsible for the consignment.

<Official laboratories (Accredited Labs)>

According to (EC) Regulation 882/2004 each Competent Authority shall designate laboratories that may carry

out the analysis of samples taken during official controls. However, Competent Authorities may only designate

laboratories that operate and are assessed and accredited in accordance with the following European

standards:

EN ISO/IEC 17025 on «General requirements for the competence of testing and calibration laboratories»;

EN 45002 on «General criteria for the assessment of testing laboratories»;

EN 45003 on «Calibration and testing laboratory accreditation system - General requirements for operation and

recognition», taking into account criteria for different testing methods laid down in Union feed and food law.

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Correct! The food and veterinary office is part of DG Health and Consumers (DG SANCO). It fulfils its

objectives by the mean of missions inside and outside the EU and issues reports in relation with all these

aspects.

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