EU Food Law Institutional structure and basic principles

Historical Timeline

mid. 1990sBSE Crisis

(Mad Cow Disease Outbreak)

2000White Paper on Food

Safety

2002General Food Law

(GFL)

1979

“Cassis de

Dijon” case

1997

Green Paper

(general

principles)

Stages of EU Food Law Development

I. Market oriented development

Main goal is to develop common internal market byeliminating all trade barriers caused by different foodsafety standards

II. Post “Casis de Dijon” case development

Introduction of “principle of mutual recognition”.Realization that there is no need to make all standardsidentical for creation of common market. Attention shiftedto the need to alleviate the consequences of the internalmarket

III. Post BSE crisis development

Understanding that previous food safety system need tobe reformed and more attention must be paid to thequality of food safety standards

Institutional structure

1979 – The Rapid Alert System for Food and Feed (RASF) – database that allows Commission,EEU countries (EU Members, Iceland, Liechtenstein, Norway) and Switzerland to exchange urgentnotifications, when food safety breach occurs

1997 - Directorate General for Health and Consumer Affairs (DG SANCO) – one of thedepartments of the European Commission *In 2015 its name was changed to DG Sante (Frenchword for health) - responsible for the implementation of EU laws on the safety of food and otherproducts, on consumers’ rights and on the protection of people’s health

1997 - Food and Veterinary Office (FVO) – part of DG Sante, responsible for conducting audits inEU Member States

2002 - European Food Safety Authority (EFSA) – independent agency, that provides scientificadvise on risks associated with food chain to European Commission and Member States

2004 – Trade Control and Expert System (TRACES) –European-scale computer networkdedicated to food safety and animal health, linking together veterinary authorities of member statesand non-EU countries it provides electronic sanitary certificates mandatory for tracking goods andlive animals.

Institutional structure

There are several supra-national bodies and agencies that actively

participate in shaping, implementing and supervising policies in the food

safety area:

European Food Safety Agency (EFSA)

European Union Commission and its Directorate General SANTE

The Food and Veterinary Office (FVO)

In addition, there is a competent authority in each member state that is

responsible for food safety control

Food Control System in EU

Food safety control

Approval by product vs. by producer

Positive list systems

General Food Law (Regulation 178/2002 dated 28 January 2002)

Established the European Food Safety Authority (EFSA)

Listed general principles of the EU Food law

Established common definition of food

Legal instruments

There are three main types of legal acts used in the European Union:

Regulations - legal acts that are directly applicable in member states, have thepower of laws and supersede national laws; they incorporate implementationmechanisms

Directives establish objectives that are compulsory to member states, but requiretransposition into national law as they do not include implementation mechanisms

Decisions can be addressed to both member states and specific entities; they aredirectly applicable but usually cover a narrow topic or issue

In recent years, the European Union has moved to the control of food safety throughregulations (earlier – mostly directives)

That way, all the most important aspects of food control are regulated throughregulations thus creating a high level of harmonization and uniformity in the memberstates.

Definition of Food (Article 2 GFL)

‘Food’ (or ‘foodstuff’) means any substance or product, whether processed,

partially processed or unprocessed, intended to be, or reasonably expected

to be ingested by humans. ‘Food’ includes drink, chewing gum and any

substance, including water, intentionally incorporated into the food during its

manufacture, preparation or treatment. (…) ‘Food’ shall not include: (a) feed;

(b) live animals unless they are prepared for placing on the market for human

consumption33; (c) plants prior to harvesting; (d) medicinal products (…) (e)

cosmetics (…) (f) tobacco and tobacco products (…) (g) narcotic or

psychotropic substances within the meaning of the United Nations Single

Convention on Narcotic Drugs, 1961, and the United Nations Convention on

Psychotropic Substances, 1971; (h) residues and contaminants.

In contrast to the US legislation EU’s definition of food does not include

animal feed

Main principles (Art.5-7 GFL)

Science-based risk assessment

Precautionary principle

Conformation with international standards

Transparency

Precautionary principle

Implementation on the International level

1992 - Rio Declaration on Environment and Development; the United nations Convention on Climate Change

1994 – World Trade Organization Agreement on Sanitary and phytosanitary Measures (SPS)

2000 – Biosafety Protocol

Implementation In Europe

1970s – reflected in West German Environmental law

1992 - Maastricht Treaty amends Treaty of European Community: “Community policy on theenvironment … shall be based on the precautionary principle …” – precautionary principle notdefined

1998 – ECJ Judgment in BSE case - “When there is uncertainty as to the existence or extent ofrisks to human health, the institutions may take protective measures without having to wait until thereality and seriousness of those risks becomes fully apparent” - First time PP spread to the FoodLaw area (C-180/96 United Kingdom v. Commission )

Precautionary principle

Community law definition: Article 7(1) of GFL: “In specified circumstances where,

following an assessment of available information, the possibility of harmful effects on

health is identified but scientific uncertainty persists, provisional risk management

measures necessary to ensure the high level of health protection chosen in the

Community may be adopted, pending further scientific information for a more

comprehensive risk assessment”

Key Elements:

Scientific uncertainty

Recent scientific evidence suggests that there is may be a potential risk (+ riskassessment)

Measures based on PP must be temporary

Proportionate

Precautionary principle

“if there is a suspected risk to public human health or the environment

globally due to the absence of scientific proof about its safety, preventive

actions should be taken”

Council Directive prohibited use of beef hormones

Imports of the U.S. Beef (produced with Growth Hormones)

got banned

WTO dispute (DSB ruled in favor of the

US)

Debates around food safety in the EU

GMO (mandatory labeling)

Chlorinated Poultry Products

Food Dyes

Since 2008 in the UK specific food colors banned for import. In the rest of the

EU special labeling warning is required regarding “ potential adverse effects

of the dyes on children’s attention and behavior”

Implementation of risk-based approach

In the European Union it is required by law that Member States develop

national annual and multi-annual control plans that are submitted to

the Commission.

Rapid Alert System for Food and Feed (RASFF)

The Food and Veterinary Office (FVO) conduct audits of Member States’

competent authorities to determine the capability and capacity to

implement the European Union regulatory requirements.

FARM-TO-FORK approach

Traceability

Farm-to-Fork

Concept

HACCP

System

Recent developments

March 2014 Regulation 665/2014

use of quality term “mountain product”

March 2015Directive 2015/412 power of Member

States to restrict or allow cultivation of

GMO’s

November 2015Regulation 2015/2283

on Novel Foods