What is Dioxin?

1. Major food safety scares * BSE crisis (1996 - present) * dioxine crisis (1999 - 2000) * FMD crisis (2001) • consumers lost confidence  political repercussions • effect on food law • EU law changed after these crises

2. What is Dioxin? • A group of chlorinated organic compounds including dioxins, furans, and some PCBs. • Produced when materials containing chlorine are burned. • Occur naturally and from combustion of fuels & waste, paper making, and other chemical and industrial processes.

3. Major Past Sources of Dioxins (20th Century Problem) • Chloralkali facilities • Chlorinated herbicide and biocide production • Leaded gasoline • Municipal, medical, and hazardous waste incineration • Chlorine bleaching of paper and pulp products

4. Recently Identified Sources • Open burning of household waste • Uncontrolled combustion • forest fires and volcanos • Metal refining

5. Human Cancer • Dioxin is a human carcinogen • Exposure to TCDD increases the risk of cancer at multiple sites • Overall increased risk in occupational/accident studies is 40-100%

6. Human Non-cancer Effects • good evidence • chloracne acute or chronic • liver enzyme changes • reproductive hormone changes • decreased testosterone • decreased libido Chloracne in herbicide worker Libido = sexual urge or desire

7. Agent Orange (toxic defoliant used in Vietnam) contains Dioxin. Dioxin acts like a hormone. It gets to the receptors in the cells of a developing foetus before the normal hormones and directs the cells to do crazy things. The end result has been tens of thousands of deformed children and an even greater number of miscarriages and stillbirths.

8. Soil ingestion Vegetable fat Soil dermal contact Other meats Poultry Freshwaterfish and shellfish 6% Pork 5% 19% Marine fish and shellfish Beef 7% 14% 1% Inhalation 4% 16% Eggs 21% Milk Dairy U.S. Adult Average Daily Intake of CDDs/CDFs/ Dioxin - Like PCBs

9. Public concern about the quality of animal food in general became a hot issue in the media. • This forced the commission to ban certain recycling streams (like frying oil) from entering the food chain, in order to prevent future contamination. • Later studies indicated that there was never a serious danger for human health because the contaminated material was largely diluted during the production of the animal feed. • Seven million chickens and fifty thousand pigs were slaughtered and discarded. Agent orange deformities Viktor Yushchenko before (L) and after dioxin poisoning

10. Many farms were closed down for months, and animal food products were banned from the market. • During the investigation, questions were raised if the costs for destroying the food and feedstock were necessary, as it seemed obvious that the contaminated food had already passed through the food market during the period January - May. • To protect the farmers, the Belgian government promised to compensate the losses. • The crisis also damaged the export of Belgian animal products. • Many Belgians went shopping for meat and dairy products in foreign countries. • The total costs of the food crisis are estimated at 625 million Euros.

11. Introduction to EU law

12. Structure: EU Institutions • Council of EU (ministers, topic) • European Council (heads of state) • European Parliament (732 members directly elected) • European Commission (1 per state) • Now 27 commissions • European Court of Justice (1 per state) • Court of Auditors

13. European Institutions Institutional Triangle: Decision Makers European Council (heads of the states) European Commission Council of the EU European Parliament European Court of Justice Advisory Committees Economic & Social Committee Committee of the Regions European Court of Auditors Institutional triangle – make the decisions about EU law 13

14. The Role of the Commission • Initiate & negotiate draft legislation • Ensure implementation of EU policies • Apply EU laws • Represent the EU on the world stage The Berlaymont, Commission headquarters 14

15. Primary law • The primary law is made up of the set of founding Treaties as amended and adapted by a variety of other treaties and instruments. • It consists mainly of: • the Treaties establishing the Communities and the European Union; • the major Treaties amending provisions governing the various Communities and the Union; • the protocols annexed to those treaties, such as Protocol No 2 annexed to the Treaty of Amsterdam, integrating the Schengen rules into the Community; • additional treaties making changes to specific sections of the founding Treaties; • the Treaties of accession of new Member States to the European Communities and the European Union. It’s a static law !!

16. Primary law • The Treaties establishing the Communities and the Union are: • the Treaty of Paris (18 April 1951); • the Treaties of Rome (Euratom Treaty and the Treaty establishing the European Economic Community) (25 March 1957); • the Maastricht Treaty on European Union (7 February 1992). The amending Treaties are: • the Single European Act (17 and 28 February 1986); • the Treaty of Amsterdam (2 October 1997); • the Treaty of Nice (26 February 2001); • the Treaty of Lisbon (13 December 2007) being ratified.

17. Sources of secondary law • Secondary law comprises unilateral acts and agreements. • Unilateral acts can be divided into two categories: • (1)those listed in Article 249 of the Treaty establishing the European Community: • regulations, • directives, • decisions, • opinions and • recommendations; • (2)Those not listed in Article 249 of the Treaty establishing the European Community, i.e. "atypical" acts such as • communications and recommendations, and • white and green papers.

18. A regulation is a legislative act of the European Union[that becomes immediately enforceable as law in all member states simultaneously. When a new country joins the EU they have to translate & apply These regulations • Regulations are the most direct form of EU law - as soon as they are passed. National governments do not have to take action themselves to implement EU regulations.They are different from: • Directives - addressed to national authorities, who must then take action to make them part of national law • Decisions - apply in specific cases only, involving particular authorities or individuals.Regulations are passed either jointly by the EU Council and European Parliament, and by the Commission alone.

19. EU directives lay down certain end results that must be achieved in every Member State. National authorities have to adapt their laws to meet these goals, but are free to decide how to do so. Directives may concern one or more Member States, or all of them.Each directive specifies the date by which the national laws must be adapted - giving national authorities the room for manoeuvre within the deadlines necessary to take account of differing national situations.Directives are used to bring different national laws into line with each other, and are particularly common in matters affecting the operation of the single market (e.g. product safety standards).

20. Decisions are EU laws relating to specific cases. They can come from the EU Council (sometimes jointly with the European Parliament) or the Commission.They can require authorities and individuals in Member States either do something or stop doing something, and can also confer rights on them.EU decisions are:• addressed to specific parties (unlike regulations),• fully binding.

21. EU food law • EU food and feed laws cover: • How farmers produce feed and food • How plants are grown, and how pesticides are used • How ALL animals are fed, looked after, and transported • How feed and food is processed, packaged, and sold • How feed and food is labelled for consumers “A World Class Food Safety System from the Farm to the Fork” 21

22. Development European Food Law • (harmonisation of food law of the member states) • 1st phase – vertical directives • Community food law was initiated by Council Directive 62/2645 of 23rd October 1962. • Over the next twenty years the European Commission dealt with the development of common standards (relevant standards, technical specifications) for food products. • The progress of harmonization of law in this way was very slow due to the difficult negotiations of technical details.

23. Development European Food Law 2nd phase – horizontal directives Due to many difficulties in the process of law harmonization the Commission issued the 1985 "White Paper" which was a program of common internal market. The new laws have been created on the basis of legislation in a "horizontal" system and depart from the applicable standards of food composition, both nationally and internationally.

24. 1st phase – vertical directives work on specific products 2nd phase – horizontal directives in order to make EU 1 big producer, directives are common for every facility (same regulations)

25. Development European Food Law • 3rd phase – towards food safety law • A series of food scares during last years (BSE, Dioxin, FMD) • Food safety crises have shown loopholes in E.U. food safety legislation • Commission issued the 2000 "White Paper on Food Safety”

26. A radical new approach • To ensure EU highest standards of food safety • Food safety “from farm to fork” • To restore and maintain public confidence in our: • food supply • food science • food legislation • food control • To involve all interested parties • To promote better enforcement • To provide greater transparency to consumers

27. Proposals for structural changes • creation European Food Safety Authority • re-inforce the scientific basis of risk assessment • separate risk assessment from risk management • develop a new capacity for risk communication • strengthen co-operation with and between Member States • re-organization of Commission Services

28. A document of fundamental importance for European Food Law in the future is: Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety 178/2002 – most imp regulations on food law !!!