REFERENCES OF THE EUROPEAN AND NATIONAL LEGISLATIONS

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate D - Food Safety: production and distribution chain D3 - Chemical and physical risks; surveillance File: INT/REF_LEG(04/2003) REFERENCES OF THE EUROPEAN AND NATIONAL LEGISLATIONS (Version updated to 15 April 2003) Introduction The references of the EC Directives and, in future, of the national legislation are mentioned hereinafter. As regards the EC Directives, you can find, in general, the references and the texts on two data bases contained in the EU internet website ( The first data base ( EUR-LEX ) gives the references of all EC directives and the second one ( CELEX ) gives the texts. In this website you can find also information on where and how you can buy the Official Journals of the European Union. EUROPEAN DIRECTIVES [1] 76/893/EEC Council Directive of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs. O.J. n L340, of (Old framework directive, repealed by Directive 89/109/EEC [11]) [2] 78/142/EEC Council Directive of 30 January 1978 on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs. O.J. n L44, of , p.15 (Plastics: limits on vinyl chloride monomer (VCM)) [3] 80/590/EEC Commission Directive of 9 June 1980 determining the symbol that may accompany materials and articles intended to come into contact with foodstuffs. O.J. n L151, of , p.21 (Symbol for materials and articles)

2 [4] 80/766/EEC Commission Directive of 8 July 1980 laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs. O.J. n L213, of , p.42 (Plastics: Determination of VCM in finished products) [5] 81/432/EEC Commission Directive of 29 April 1981 laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs. O.J. n L167, of , p.6 (Plastics: Determination of VCM in foods) [6] 82/711/EEC Council Directive of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs. O.J. n L297, of , p.26 (Plastics: Basic rules for testing migration) [7] 83/229/EEC Council Directive of 25 April 1983 on the approximation of the laws of the Member States relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs. O.J. n L123, of , p.31 (Cellulose regenerated) [8] 84/500/EEC Council Directive of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs. O.J. n L277, of , p.12 (Ceramics) [9] 85/572/EEC Council Directive of 19 December 1985 laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs. O.J. n L372, of , p.14 (Plastics: list of simulants for testing migration) 2

3 [10] 86/388/EEC Commission Directive, of 23 July 1986, amending Council Directive 83/229/EEC on the approximation of the laws of the Member States relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs. O.J. n L228, of , p.32 (Cellulose regenerated: 1st Amendment - Limits on MEG and DEG) [11] 89/109/EEC Council Directive of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs. O.J. n L40, of , p.38 (New framework directive) Corrigendum O.J. n L347 of , p.37 [12] 90/128/EEC Commission Directive of 23 February 1990 relating to plastics materials and articles intended to come into contact with foodstuffs. O.J. n L75, of , p.19 (Plastics: general rules) Corrigendum O.J. n L349 of , p.26 [13] 92/15/EEC Commission Directive of 11 March 1992, amending Council Directive 83/229/EEC on the approximation of the laws of the Member States relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs. O.J. n L102, of , p.44 (Cellulose regenerated: 2nd Amendment) [14] 92/39/EEC Commission Directive of 14 May 1992, amending Directive 90/128/EEC concerning plastics materials and articles intended to come into contact with foodstuffs. O.J. n L168, of , p.21 (Plastics, Ist amendment) [15] 93/9/EEC Commission Directive of 15 March 1993 amending for the second time Directive 90/128/EEC relating to plastics materials and articles intended to come in contact with foodstuffs O.J. n L90, of , p.26 (Plastics, 2nd Amendment) [16] 93/11/EEC Commission Directive of 15 March 1993 concerning the release of the N-nitrosamines and N- nitrosatable substances from rubber teats and soothers O.J. n L93, of , p.37 (Rubber: Limits for nitrosamines) 3

4 [17] 93/8/EEC Commission Directive of 15 March 1993 amending Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastics materials and articles intended to come into contact with foodstuffs O.J. n L90, of , p.22 (Plastics: Basic rules for testing migration - 1st amendment) [18] 93/10/EEC Commission Directive of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs O.J. n L93, of , p.27 (Cellulose regenerated: Codification of 83/229/EEC) [19] 93/111/EEC Commission Directive of 10 December 1993, amending Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs. O.J. n L310 of , p.41 (Cellulose regenerated: Amendment) [20] 95/3/EC Commission Directive of 14 February 1995, amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs. O.J. n L41 of 23 February 1995, p.44 (Plastics: 3 rd amendment) [21] 96/11/EC Commission Directive of 5 March 1996, amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs. O.J. n L61 of 12 March 1996, p.26 (Plastics: 4th amendment) [22] 97/48/EC Commission Directive of 29 July 1997 amending for second time Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastics materials and articles intended to come into contact with foodstuffs O.J. n L222, of , p 10 (Plastics: Basic rules for testing migration - 2nd amendment) [23] 1999/91/EC Commission Directive of 23 November 1999, amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs. O.J. n L310 of 4 December 1999, p.41 (Plastics: 5th amendment) 4

5 [24] 2001/61/EC Commission Directive of 8 August 2001 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs. O.J. n L215 of 9 August 2001, p.26 (Badge/Bfdge/Noge) [25] 2001/62/EC Commission Directive of 9 August 2001 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs. O.J. n L221 of 17 August 2001, p.18 (Plastics: 6th amendment) [26] 2002/16/EC Commission Directive of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs. O.J. n L51 of , p.27 (Badge/Bfdge/Noge) [27] 2002/17/EC Commission Directive of 21 February 2002 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs. O.J. n L58 of , p.19 (Plastics : 7th amendment) [28] 2002/72/EC Commission Directive of 6 August 2002 relating to plastics materials and articles intended to come into contact with foodstuffs. O.J. n L220 of , p.18 (Plastics : Codification of 90/128/EEC + 7 amendments) [29] Corrigendum to 2002/72/EC Corrigendum to Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs. O.J. n L39 of , p.1 (Plastics : Codification of 90/128/EEC + 7 amendments) 5

6 OTHER EU DIRECTIVES RELATED TO FOOD CONTACT MATERIALS [1] 85/591/EEC Council Directive of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption O.J. n L372 of , p 50 (Foodstuffs and Food Contact Materials: Control) [2] 89/397/EEC Council Directive of 14 June 1989 on the official control of foodstuffs O.J. n L186, of , p 23 (Foodstuffs and Food Contact Materials: Control) [3] 93/99/EEC Council Directive of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs O.J. n L290 of , p 14 (Foodstuffs and Food Contact Materials: Control) REFERENCES OF NATIONAL LEGISLATIONS See the document below. For further information on national legislation, you can contact National Authorities (see addresses in the document EU and National Authorities ) 6

7 EUROPEAN COMMISSION COMPENDIUM OF NATIONAL REGULATIONS ON FOOD CONTACT MATERIALS AND ARTICLES 15 April 2003 This document will be regularly updated by the European Commission Updated to 15 April

8 AUSTRIA SUMMARY All EC Directives implemented. Additional national provisions. Legislation published in the Bundesgesetzblatt für die Republik Österreich (BGBl.) Legislation is made under powers of the Lebensmittelgesetz [Food Act] 1975, BGBl. Nr. 86/1975, the Bundesgesetz gegen den unlauteren Wettbewerb 1984, BGBl. Nr. 448/2984, Chemikaliengesetz, BGBl. Nr. 53/1997 Teil I, and the Abfallwirtschaftsgesetz, BGBl. Nr. 325/1990. Sales Agents : Print Media Austria AG, Verlag Österreich Postfach G 7 (Tenschertstraße 7) A 1239 Wien Tel. (+43 1) DW 294 Fax (+43 1) DW 442 [email protected] Buchhandlung Verlag Österreich Wollzeile 16 A 1010 Wien Tel. (+43 1) Manz sche Verlagsu. Universitätsbuchhandlung Kohlmarkt 16 A 1010 Wien Tel. (+43 1) IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Lebensmittelgesetz 86/1975 i.d.f. BGBl. Nr. 63/1998 Teil I ausgegeben am 30/04/1998 Verordnung des Bundesministers für wirtschaftliche Angelegenheiten über die Kennzeichung von Gebrauchsgegenständen, die für die Verwendung bei Lebensmitteln bestimmt sind BGBl. Nr. 217/1995, ausgegeben am 28/03/ /590/EEC (symbol) Verordnung des Bundesministers für wirtschaftliche Angelegenheiten über die Kennzeichung von Gebrauchsgegenständen, die für die Verwendung bei Lebensmitteln bestimmt sind BGBl. Nr. 217/1995, ausgegeben am 28/03/1995 PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) Lebensmittelgesetz 86/1975 i.d.f. BGBl. Nr. 63/1998 Teil I ausgegeben am 30/04/1998 Kunststoff Verordnung (KVO) Full title - Verordnung des Bundesministers für Gesundheit, Sport und Konsumentenschutz über Gebrauchsgegenstände aus Kunststoff, die für die Verwendung bei Lebensmittels und Verzehrprodukten bestimmt sind BGBl. Nr. 775/1994, ausgegeben am 23/09/ /39/EEC (1st amend. 90/128/EEC) 93/9/EEC (2nd amend. 90/128/EEC) 95/3/EC (3rd amend. 90/128/EEC) 96/11/EC (4th amend. 90/128/EEC) 99/91/EC (5th amend. 90/128/EEC) Änderung der KVO BGBl. Nr. 69/1995, ausgegeben am 20/01/1995 Änderung der KVO BGBl. Nr. 898/1995, ausgegeben am 29/12/1995 Änderung der KVO BGBl. Nr. 528/1996, ausgegeben am 04/10/1996 Änderung der KVO BGBl. Nr. 262/1997, ausgegeben am 16/09/1997 Änderung der KVO BGBl. Nr. II 93/2001, ausgegeben am 22/02/2001 8

9 PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2nd. amend. 82/711/EEC) KVO BGBl. Nr. 775/1994, ausgegeben am 23/09/1994 Änderung der KVO BGBl. Nr. 554/1995, ausgegeben am 18/08/1995 Änderung der KVO BGBl. Nr. 236/1998 II ausgegeben am 23/07/1998 PLASTICS Vinyl chloride monomer 78/142/EEC 80/766/EEC 81/432/EEC KVO BGBl. Nr. 775/1994, ausgegeben am 23/09/1994 REGENERATED CELLULOSE FILM 93/10/EEC Verordnung des Bundesministers für wirtschaftliche Angelegenheiten über die 93/111/EEC (1st amend. 93/10/EEC) Kennzeichung von Gebrauchsgegenständen, die für die Verwendung bei Lebensmitteln bestimmt sind BGBl. Nr. 217/1995, ausgegeben am 28/03/1995 Zellglasfolien-Verordnung Full title - Verordnung des Bundesministers für Gesundheit, Sport und Konsumentenschutz über Gebrauchgegenstände aus Zellglasfolie BGBl. Nr. 128/1994, ausgegeben am 22/02/1994 CERAMICS 84/500/EEC BADGE, BFDGE, NOGE 2002/16/EC Keramik-Verordnung Full title - Verordnung des Bundesministers für Gesundheit, Sport und Konsumentenschutz über Gebrauchsgegenstände aus Keramik und Gebrauchsgegenstände mit einem Überzug aus BGBl. Nr. 893/1993 ausgegeben am 23/12/1993 Epoxyderivate-Verordnung Full title - Verordnung des Bundesministers für soziale Sicherheit und Generationen über die Verwendung bestimmter Epoxyderivate in Gebrauchsgegenständen, die dazu bestimmt sind, mit Lebensmitteln und Verzehrprodukten in Berührung zu kommen BGBl.II Nr. 161/2003 ausgegeben am 21/02/2003 ADDITIONAL (NON-EC) NATIONAL PROVISIONS Geschirrverordnung BGBl. 258/1960 ausgegeben am 23/11/1960 Verordnung über den Verkehr mit Essigsäure zu Genußzwecken BGBl. 148/1959 ausgegeben am 29/06/1959 Verordnung über die Kennzeichnung von Verpackungen aus Kunststoffen BGBl. 137/1992 ausgegeben am 13/03/1992 Cadmiumverordnung BGBl. 855/1993 ausgegeben am

10 BELGIUM SUMMARY All EC Directives implemented. Additional national provisions. Belgian legislation on materials and articles which come into contact with foodstuff is published in the belgian Official newspaper, "Le Moniteur Belge", and on the internet. The web site address is : IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (Framework) Arrêté royal du 11 mai 1992 concernant les matériaux et objets destinés à entrer en contact avec les denrées alimentaires 80/590/EEC (Symbol) Arrêté royal du 11 mai 1992 concernant les matériaux et objets destinés à entrer en contact avec les denrées alimentaires Arrêté ministériel du 30 juin 1981 déterminant les règles d'application pour le marquage des objets et matières destinées à être mis en contact avec les denrées alimentaires. PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) Arrêté royal du 11 mai 1992 concernant les matériaux et objets destinés à entrer en contact avec les denrées alimentaires. 92/39/EEC (1 st amend. 90/128/EEC) Arrêté royal du 9 juillet 1993 modifiant l'arrêté royal du 11 mai /9/EEC (2 nd amend. 90/128/EEC) Arrêté royal du 9 juillet 1993 modifiant l'arrêté royal du 11 mai /3/EEC (3 rd amend. 90/128/EEC) Arrêté royal du 24 novembre 1997 modifiant l'arrêté royal du 11 mai /11/EEC (4 th amend. 90/128/EEC) Arrêté royal du 24 novembre 1997 modifiant l'arrêté royal du 11 mai /91/EC (5 th amend. 90/128/EEC) Arrêté royal du 31 janvier 2001 modifiant l'arrêté royal du 11 mai /62/EC (6 th amend. 90/128/EEC) Arrêté royal du 10 décembre 2002 modifiant l'arrêté royal du 11 mai 1992 (published in the Moniteur Belge of 20/2/ st edition) 2002/17/EC (7 th amend. 90/128/EEC) Arrêté royal du 10 décembre 2002 modifiant l'arrêté royal du 11 mai 1992 (published in the Moniteur Belge of 20/2/ st edition) 2002/72/EC (Consolidation) Arrêté royal du 10 décembre 2002 modifiant l'arrêté royal du 11 mai 1992 (published in the Moniteur Belge of 20/2/ st edition) PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) Arrêté royal du 11 mai 1992 concernant les matériaux et objets destinés à entrer en contact avec les denrées alimentaires Arrêté royal du 11 mai 1992 concernant les matériaux et objets destinés à entrer en contact avec les denrées alimentaires 93/8/EEC (1 st amend. 82/711/EEC) Arrêté royal du 9 juillet 1993 modifiant l'arrêté royal du 11 mai /48/EEC (2 nd amend 82/711/EEC) Arrêté royal du 20 octobre 1998 modifiant l'arrêté royal du 11 mai 1992 PLASTIC Vinyl chloride monomer 78/142/EEC Arrêté royal du 11 mai 1992 concernant les matériaux et objets destinés à entrer en contact avec les denrées alimentaires 80/766/EEC Arrêté royal du 11 mars 1983 fixant les méthodes d'analyses pour la détermination du chlorure de vinyle dans les matériaux et objets destinés à entrer en contact avec les denrées alimentaires et du chlorure de vinyle cédé par les matéraiux et objets aux denrées alimentaires.

11 81/432/EEC Arrêté royal du 11 mars 1983 fixant les méthodes d'analyses pour la détermination du chlorure de vinyle dans les matériaux et objets destinés à entrer en contact avec les denrées alimentaires et du chlorure de vinyle cédé par les matéraiux et objets aux denrées alimentaires. REGENERATED CELLULOSE FILM 93/10/EEC Arrêté royal du 9 juillet 1993 modifiant l'arrêté royal du 11 mai /111/EC - CERAMIC 84/500/EEC Arrêté royal du 11 mai 1992 concernant les matériaux et objets destinés à entrer en contact avec les denrées alimentaires. SPECIFIC RULES 2002/16/EC (Badge, Bfdge, Noge) Arrêté royal du 20 septembre 2002 concernant l utilisation de certains dérivés époxydiques dans des matériaux et des objets destinés à entrer en contact avec des denrées alimentaires;. ADDITIONAL (NON-EC) NATIONAL REGULATIONS AND RECOMMENDATIONS Résolution AP (97) 1 du Conseil de l'europe concernant les résines échangeuses d'ions destinées à entrer en contact avec des denrées alimentaires Résolution AP (96) 5 du Conseil de l'europe concernant les vernis destinés à entrer en contact avec des denrées alimentaires Résolution AP (99) 3 du Conseil de l'europe concernant les silicones destinés à entrer en contact avec des denrées alimentaires Ces dispositions sont en cours d'adaptation au niveau belge 11

12 DENMARK SUMMARY All EC Directives implemented. Denmark has national provisions regarding the mouthrim on ceramics etc. All legislation consolidated in one document: Bekendtgørelse nr. 111 af 20. februar 2003 om materialer og genstande i kontakt med fødevarer (Order no. 111 of 20 February 2003 on materials and articles intended to come into contact with foodstuffs. Made under powers of the General Food Act. Sales Agent: Schultz Information Herstedvang 12 - Postbox Albertslund Tel Fax: [email protected] Website: Homepage : (all Danish legislation) IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS, INCLUDING SPECIFIC MATERIALS All EC directives on food contact Fødevaredirektoratets Bekendtgørelse nr. 111 af 20/02/2003 om materialer og genstande i materials kontakt med fødevarer. Fødevareministeriet Fødevaredirektoratets cirkulære nr af 25. november 2002 om kontrol med materialer og genstande bestemt til kontakt med fødevarer.

13 FINLAND SUMMARY All EC Directives implemented. Additional national provisions for heavy metals and paper and board. Legislation implemented in various Decisions of the Ministry of Trade and Industry (Kauppa- ja teollisuusministeriön). Published in the Finnish Statutes in Finnish (Suomen säädöskokoelma) and Swedish (Finlands författningssamling). Made under powers of Elintarvikelaki [Food law] (361/95) 17/03/1995. Sales Agent : Oy Edita Ab Hakuninmaantie PL EDITA Helsinki Tel. : Fax: [email protected] Website: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvista tarvikkeista (400/96) 07/06/ /590/EEC (symbol) PLASTICS Monomers & additives 2002/72/EC (consolidation 90/128/EEC and its 7 amendments) PLASTICS Testing 82/711/EEC (basic rules) 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2nd. amend. 82/711/EEC) 85/572/EEC (simulants) Kauppa- ja teollisuusministeriön päätös tunnuksesta, joka voidaan liittää elintarvikkeen kanssa kosketukseen joutuviin tarvikkeisiin (259/92) 20/03/1992 Kauppa- ja teollisuusministeriön asetus elintarvikkeen kanssa kosketukseen joutuvista muovisista tarvikkeista (953/2002) Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvien muovisten tarvikkeiden sisältämien ainesosien siirtymisen testaamiseen tarvittavista perussäännöistä (487/1998) 23/06/1998 Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvien muovisten tarvikkeiden sisältämien aineosien migraation testaamiseen käytettävistä simulanteista (262/92) 20/03/1992 PLASTICS Vinyl chloride monomer 78/142/EEC Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvista vinyylikloridimonomeeria sisältävistä tarvikkeista (263/92) 20/03/ /766/EEC 81/432/EEC Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvien tarvikkeiden vinyylikloridipitoisuuden valvontaan käytettävästä analyysimenetelmästä (264/92) 20/03/1992 Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvista tarvikkeista elintarvikkeeseen siirtyvän vinyylikloridin valvontaan käytettävästä analyysimenetelmästä (265/92) 20/03/1992 REGENERATED CELLULOSE FILM 93/10/EEC Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvien 93/111/EEC (1st amend. 93/10/EEC) tarvikkeiden valmistuksessa käytettävästä regeneroidusta selluloosasta valmistetusta kalvosta (855/94) 30/09/1994

14 CERAMICS 84/500/EEC BADGE, BFDGE, NOGE 200/16/EC Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvista keraamisista tarvikkeista (267/92) 20/03/1992 Kauppa- ja teollisuusministeriön asetus tiettyjen epoksijohdannaisten käytöstä elintarvikkeiden kanssa kosketuksiin joutuvissa materiaaleissa ja tarvikkeissa (92/2003) 10/02/2003 ADDITIONAL (NON-EC) NATIONAL PROVISIONS METALS AND ALLOYS Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvista tarvikkeista liukenevista raskasmetalleista (268/92) 20/03/1992 PAPER AND BOARD Kauppa- ja teollisuusministeriön päätös elintarvikkeen kanssa kosketukseen joutuvasta paperista ja kartongista (143/93) 29/01/1993 Heavy metals migrating from food contact materials and articles Paper and board (food contact materials) 14

15 FRANCE SUMMARY All EC Directives implemented. Additional national provisions for many food contact materials and articles. Legislation published in the Journal Officiel (J.O.) [Official Journal]. A compendium of legislation for food contact materials and articles is available as Brochure nº 1227, published by Direction des JournauxOfficiels, 26 rue Desaix, Paris Cedex 15, tel: +33 (0) , fax: +33 (0) ou IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Décret Numéro du 08/07/1992 relatif aux matériaux et objets destinés à entrer en contact avec les denrées, produits et boissons pour l'alimentation de l'homme ou des animaux J.O. du 10/07/1992, p /590/EEC (symbol) PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) Arrêté ministériel du 28/01/1983 relatif à la détermination du symbole pouvant accompagner les matériaux et objets destinés à entrer en contact avec des denrées, produits et boissons alimentaires Numéro complémentaire du J.O. du 25/02/1983, p Arrêté ministériel du 14/09/1992 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 13/10/1992, p /39/EEC (1st amend. 90/128/EEC) 93/9/EEC (2nd amend. 90/128/EEC) 95/3/EC (3rd amend. 90/128/EEC) 96/11/EC (4th amend. 90/128/EEC) 99/91/EC (5 th amend.90/128/eec) 2002/72/EC (Consolidation 90/128/EEC and its 7 amendments) PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) Arrêté ministériel du 14/09/1992 modifiant et complétant l'arrêté du 19/12/1988 relatif aux règles de base nécessaires à la vérification de la migration des constituants de matériaux et objets en matière plastique au contact des denrées, produits et boissons alimentaires et fixant la liste des simulateurs à utiliser pour vérifier cette migration J.O. du 25/09/1992, p Arrêté ministériel du 14/09/1992 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 13/10/1992, p Arrêté du 20/01/1994 modifiant l'arrêté ministériel du 14/09/1992 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 16/02/1994, p Arrêté du 30/09/1997 modifiant l'arrêté ministériel du 14/09/1992 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 19/10/1997, p Arrêté du 3 janvier 2001 modifiant l arrêté du 14 septembre 1992 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 06/02/2001, p Arrêté du 2 janvier 2003 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 29/01/2003, p.1771 Arrêté du 19/12/1988 relatif aux règles de base nécessaires à la vérification de la migration des constituants de matériaux et objets en matière plastique au contact des denrées, produits et boissons alimentaires et fixant la liste des simulateurs à utiliser pour vérifier cette migration J.O. du 27/12/1988, p

16 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2nd. amend. 82/711/EEC) Arrêté du 16/05/1994 modifiant l'arrêté du 14/09/1992 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 26/05/1994, p Arrêté du 20/04/1998 modifiant l'arrêté du 14/09/1992 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 07/05/1998, p. PLASTICS Vinyl chloride monomer 78/142/EEC Arrêté du 30/01/1984 relatif aux matériaux et objets en matière et objets contenant du chlorure de vinyle monomère et destinées à être mis au contact des denrées, produits et boissons alimentaires Numéro complémentaire du J.O. du 12/02/1984, p. 80/766/EEC 81/432/EEC Arrêté du 30/01/1984 relatif aux méthodes officielles d analyse concernant la détermination de la teneur en chlorure de vinyle monomère des matériaux et objets destinées à entrer en contact avec les denrées, produits et boissons alimentaires et la détermination de la teneur du chlorure de vinyle cédé par les matériaux et objets aux denrées, produits et boissons alimentaires mis à leur contact Numéro complémentaire du J.O. du 12/02/1984, p. REGENERATED CELLULOSE FILM 93/10/EEC Arrêté ministériel du 04/11/1993 relatif aux matériaux et objets en pellicule de cellulose 93/111/EEC (1st amend. 93/10/EEC) régénérée mis ou destinés à être mis en contact des denrées, produits et boissons alimentaires J.O. du 02/12/1993, p CERAMICS 84/500/EEC Arrêté ministériel du 07/11/1985 relatif à la limitation des quantités de plomb et de cadmium extractibles des objets en céramique mis ou destinés à être mis au contact des denrées, produits et boissons alimentaires J.O. du 01/12/1985, p ADDITIONAL (NON-EC) NATIONAL PROVISIONS PLASTICS Arrêté du 30/09/1997 modifiant l arrêté du 14/09/1992 relatif aux matériaux et objets en matière plastique mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 13/10/1992, p Article 2 of this text clarifies the contents of the positive list of additives - harmonised additives and additives approved by CSHPF (cited in Brochure nº 1227). VARNISHES AND COATINGS Application de la réglementation sur les matières plastiques RUBBERS AND ELASTOMERS Arrêté du 25/11/1992 relatif aux matériaux et objets en élastomères de silicone ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 02/12/1993, p. Arrêté du 09/11/1994 relatif aux matériaux et objets en caoutchouc au contact des denrées, produits et boissons alimentaires mis ou destinées à être mis au contact des denrées, produits et boissons alimentaires J.O. du 02/12/94, p. PAPER AND BOARD Arrêté du 28/06/1912 (articles 7) relatif à la coloration, à la conservation et à l emballage des denrées alimentaires et boissons J.O. du 29/06/1912, p. Circulaires, instructions, lettres-circulaires réunies dans la brochure n 1227 dans lesquelles sont cités les additifs dont l utilisation a été admise silicone elastomers rubbers Additives for paper and board 16

17 GLASS, CRYSTAL, ENAMELLED WARE, VITREOUS CERAMICS Arrêté du 15/11/1945 fixant la liste des matériaux susceptibles d être utilisés sans inconvénient pour la santé publique dans la fabrication des instruments de mesure J.O. du18/11/1945, p. Application de l arrêté relatif aux céramiques METALS AND ALLOYS Arrêté du 28/06/1912 modifié (articles 2 à 5) relatif à la coloration, à la conservation et à l emballage des denrées alimentaires et boissons J.O. du 29/06/1912, p. Arrêté du 15/11/1945 fixant la liste des matériaux susceptibles d être utilisés sans inconvénient pour la santé publique dans la fabrication des instruments de mesure J.O. du18/11/1945, p. Arrêté du 13/01/1976 relatif aux matériaux et objets en acier inoxydable au contact des denrées alimentaires J.O. du 31/01/1976, p. Arrêté du 27/08/87 relatif aux matériaux et objets en aluminium ou en alliages d aluminium au contact des denrées, produits et boissons alimentaires J.O. du 18/09/1987, p. WOOD Arrêté du 15/11/1945 fixant la liste des matériaux susceptibles d être utilisés sans inconvénient pour la santé publique dans la fabrication des instruments de mesure J.O. du18/11/1945, p. Les substances de traitement du bois admises après avis favorable du Conseil supérieur d hygiène publique de France sont cités dans la brochure n 1227 Substances for treating wood IRRADIATION TREATMENT Arrêté du 12/08/1986 relatif au traitement par rayonnements ionisants des matériaux et objets mis au contact des denrées, produits et boissons alimentaires J.O. du 20/08/86, p. CONTENTS OF DOSSIERS FOR APPROVAL OF SUBSTANCES Arrêté du13/11/1986 relatif aux dossiers de demande d autorisation d emploi des constituants de matériaux et objets mis au destinés à être mis au contact des denrées, produits et boissons alimentaires J.O. du 04/12/86, p. 17

18 GERMANY SUMMARY All EC directives implemented. Additional national provisions and recommendations. Legislation published in the Bundesgesetzblatt Teil I (BGBl. I). Legislation is made under powers of the Lebensmittel- und Bedarfsgegenständegesetz [Food and Commodities Act] in der Fassung der Bekanntmachung vom 23. Dezember 1997 (BGBl I S. 5), zuletzt geändert durch Artikel 3a BiozidG vom (BGBl. I S. 2076). Sales Point: Bundesanzeiger Verlagsges.mbH. Köln Amsterdamer Str. 192, Köln Tel.: +49/ 221/ Fax: +49/ 221/ [email protected] WebSite: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Lebensmittel- und Bedarfsgegenständegesetz in der Fassung der Bekanntmachung vom 09. September 1997 (BGBl. I S. 2296), zuletzt geändert durch Artikel 5 des Gesetzes vom 25. Februar 1998 (BGBl. I S. 374) Bedarfsgegenständeverordnung vom 10. April 1992 (BGBl. I S. 866) 80/590/EEC (symbol) PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) Bedarfsgegenständeverordnung vom 10. April 1992 (BGBl. I S. 866) Bedarfsgegenständeverordnung vom 10. April 1992 (BGBl. I S. 866) 92/39/EEC (1st amend. 90/128/EEC) Verordnung zur Änderung der Bedarfsgegenständeverordnung vom 11. April 1994 (BGBl. I S. 775) 93/9/EEC (2nd amend. 90/128/EEC) Verordnung zur Änderung der Bedarfsgegenständeverordnung vom 11. April 1994 (BGBl. I S. 775) 95/3/EC (3rd amend. 90/128/EEC) Fünfte Verordnung zur Änderung der Bedarfsgegenständeverordnung vom 17. April 1997 (BGBl. I S. 796) Bekanntmachung des unvollständigen Verzeichnisses von Additiven, die bei der Herstellung von Lebensmittelbedarfsgegenständen aus Kunststoff verwendet werden dürfen vom 26. Mai 1997 (BAnz. S. 8673) 96/11/EC (4th amend. 90/128/EEC) Fünfte Verordnung zur Änderung der Bedarfsgegenständeverordnung vom 17. April 1997 (BGBl. I S. 796) Bekanntmachung des unvollständigen Verzeichnisses von Additiven, die bei der Herstellung von Lebensmittelbedarfsgegenständen aus Kunststoff verwendet werden dürfen vom 26. Mai 1997 (BAnz. S. 8673) 99/91/EC (5th amend. 90/128/EEC) Achte Verordnung zur Änderung der Bedarfsgegenständeverordnung vom 21. Dezember 2000 (BGBl. I S. 1886) 18

19 PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) Bedarfsgegenständeverordnung vom 10. April 1992 (BGBl. I S. 866) 93/8/EEC (1st amend. 82/711/EEC) Verordnung zur Änderung der Bedarfsgegenständeverordnung vom 11. April 1994 (BGBl. I S. 775) 97/48/EC (2nd. amend. 82/711/EEC) PLASTICS Vinyl chloride monomer 78/142/EEC 80/766/EEC 81/432/EEC Verordnung zur Änderung der Technische Hilfsstoff-Verordnung und zur Änderung der Bedarfsgegenständeverordnung vom 26. November 1998 (BGBl. I S. 3492) Bedarfsgegenständeverordnung vom 10. April 1992 (BGBl. I S. 866) REGENERATED CELLULOSE FILM 93/10/EEC Verordnung zur Änderung der Bedarfsgegenständeverordnung vom 11. April /111/EEC (1st amend. 93/10/EEC) (BGBl. I S. 775) CERAMICS 84/500/EEC Bedarfsgegenständeverordnung vom 10. April 1992 (BGBl. I S. 866) Revised version including all amendments until December 1997: Bedarfsgegenständeverordnung in der Fassung der Bekanntmachung vom 23. Dezember 1997 (BGBl. I 1998 S. 5) ADDITIONAL (NON-EC) NATIONAL PROVISIONS AND RECOMMENDATIONS Gesetz betreffend den Verkehr mit blei- und zinkhaltigen Gegenständen vom 25. Juni 1887 (RGBl. S. 273), zuletzt geändert durch Artikel 63 des Gesetzes vom 2. März 1974 (BGBl. I S. 469) Gesetz betreffend die Verwendung gesundheitsschädlicher Farben bei der Herstellung von Nahrungsmitteln, Genußmitteln und Gebrauchsgegenständen vom 5. Juli 1887 (RGBl. S. 277), zuletzt geändert gemäß 8 der Verordnung vom 13. Dezember 1977 (BGBl. I S. 2589) Empfehlungen für Kunststoffe und andere Polymere zur gesundheitlichen Beurteilung im Rahmen des Lebensmittel- und Bedarfsgegenständegesetzes (Bekanntmachungen im Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz ) 19

20 GREECE SUMMARY All EC Directives implemented. Additional national provisions for plastics colourants, coatings, paper and board, metals and cans. Legislation is made under powers of the Ανώτατο Χηµικό Συµβούλιο (ΑΧΣ) [Supreme Chemical Council (SCC)] and Published in the Επίσηµη Εφηµερίς της Κυβερνήσεως (ΦΕΚ) [Official Journal of the Governement]. The legislation has been consolidated in the Codex Alimentarius [Food Code]. Sales Agent : National Printery Kapodistriou 34, Athens Tel.: , Fax: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) ΑΧΣ decision nº 1787/90 ΦΕΚ 348/B/ Codex Alimentarius, Article 21 80/590/EEC (symbol) ΑΧΣ decision nº 87/79 ΦΕΚ 362/B/ Codex Alimentarius, Article 21 PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) ΑΧΣ decision nº 638/91 ΦΕΚ 775/B/ Codex Alimentarius, Article 26 92/39/EEC (1st amend. 90/128/EEC) ΑΧΣ decision nº 489/93 ΦΕΚ 676/B/ Codex Alimentarius, Article 26 93/9/EEC (2nd amend. 90/128/EEC) ΑΧΣ decision nº 196/95 ΦΕΚ 737/B/ Codex Alimentarius, Article 26 95/3/EC (3rd amend. 90/128/EEC) and 96/11/EC (4th amend. 90/128/EEC) ΑΧΣ decision nº 191/97 ΦΕΚ 558/B/ Codex Alimentarius, Article 26 99/91/EC (5 th amend. 90/128/EEC) ΑΧΣ decision nº 238/00 ΦΕΚ 1370/B/ Codex Alimentarius, Article /62/EC (6 th amend. 90/128/EEC) ΑΧΣ decision nº 37/02 ΦΕΚ 601/B/ Codex Alimentarius, Article /17/EC (7 th amend. 90/128/EEC) ΑΧΣ decision nº 273/2002 ΦΕΚ 1179/B/ Codex Alimentarius, Article /72/EC (Codification of 90/128/EEC + its 7 amend.) PLASTICS Testing 82/711/EEC (basic rules) and 85/572/EEC (simulants) ΑΧΣ decision nº 458/2002 ΦΕΚ 195/B/ Codex Alimentarius, Article 26 ΑΧΣ decision nº 636/91 ΦΕΚ 775/B/ Codex Alimentarius, Article 26 20

21 93/8/EEC (1st amend. 82/711/EEC) ΑΧΣ decision nº 196/95 ΦΕΚ 737/B/95 Codex Alimentarius, Article 26 97/48/EC (2nd. amend. 82/711/EEC) ΑΧΣ decision nº 76/98 ΦΕΚ 548/B/ Codex Alimentarius, Article 26 PLASTICS Vinyl chloride monomer 78/142/EEC and 81/432/EEC ΑΧΣ decision nº 1976/85 ΦΕΚ 49/B/86 Codex Alimentarius, Part B (Methods) 80/766/EEC ΑΧΣ decision nº 2432/85 ΦΕΚ 663/B/ Codex Alimentarius, Part B (Methods) REGENERATED CELLULOSE FILM 93/10/EEC and 93/111/EEC ΑΧΣ decision nº 240/95 ΦΕΚ 963/B/ Codex Alimentarius, Article 24a CERAMICS 84/500/EEC ΑΧΣ decision nº 1597/86 ΦΕΚ 41/ Codex Alimentarius, Article 25 RUBBERS : N-NITROSAMINES 93/11/EEC ΑΧΣ decision nº 598/94 ΦΕΚ 956/B/ Codex Alimentarius, Article 28a BADGE/BFDGE/NOGE 2002/16/EC (and 2001/61/EC) ΑΧΣ decision nº 274/2002 ΦΕΚ 1179/B/ Codex Alimentarius, Article 21a ADDITIONAL (NON-EC) NATIONAL PROVISIONS PLASTICS Dyes and pigments for food contact plastics ΑΧΣ decision nº 358/95,ΦΕΚ 714/B/96 ΑΧΣ decision nº 1028/96,ΦΕΚ 273/B/97 Codex Alimentarius, Article 26a COATINGS Coatings - under revision Codex Alimentarius, Article 28 METALS AND ALLOYS Metallic articles in contact with foodstuffs ΑΧΣ decision nº 232/98,ΦΕΚ 1023/B/ Codex Alimentarius, Article 22 PAPER AND BOARD Paper for food packaging Codex Alimentarius, Article 24 CANS It has been repealed by ΑΧΣ decision nº 232/98,ΦΕΚ 1023/B/ which established Article

22 IRELAND SUMMARY All EC Directives implemented. Additional national provisions for cellulose regenerated, plastics (the basic rules for testing migration) and rubber (the limits for nitrosamines). Legislation made under the European Communities (Materials and Articles intended to come into contact with food) Regulations, , which give effect in Ireland to EU Directives on food contact materials. Sales Point: Government Publications Sun Alliance House Molesworth St. - Dublin 2 Tel: Fax: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Official Journal nº L40, of , p38 Corrigendum The Official Journal of the European Communities nº L347 of , p37 (S.I. No. 307 of 1991) 80/590/EEC (symbol) PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) 92/39/EEC (1st amend. 90/128/EEC) 93/9/EEC (2nd amend. 90/128/EEC) 95/3/EC (3rd amend. 90/128/EEC) 96/11/EC (4th amend. 90/128/EEC) 99/91/EC (5 th amend. 90/128/EEC) 2001/62/EC (6 th amend 90/128/EEC) 2002/17/EC (7 th amend. 90/128/EEC) The Official Journal of the European Communities nº L151, of , p21 (S.I. No. 307 of 1991) The Official Journal of the European Communities nº L75, of , p19 Corrigendum Official Journal nº L349 of , p26 (S.I. No. 307 of 1991) The Official Journal of the European Communities nº L168, of , p21 amending directive 90/128/EEC Official Journal of the European Communities nºl75 of 21 (S.I. No. 295 of 1993) The Official Journal of the European Communities nº L90, of , P26 (S.I. No. 93 of 1994*) The Official Journal of the European Communities nº 41 of 23 Februrary 1995, p44 amending Commission Directive 90/128/EEC Official Journal of the European Communities nº 175, of , p19 Corrigendum The Official Journal of the European Communities no L349 of (S.I. No. 226 of 1996) The Official Journal of the European Communities nº L61 of 12 March 1996, p26 amending 90/128/EEC Official Journal nº L349 of , p26 (S.I. No. 335 of 1997) The Official Journal of the European Communities nº L310 of 4 December 1999, p41 amending 90/128/EEC Official Journal nº L349 of , p26 ( S.I. No. 475 of 2000) The Official Journal of the European Communities nº L221 of 17 August 2001, p18 amending 90/128/EEC Official Journal nº L349 of , p26 ( S.I. No. 542 of 2002) The Official Journal of the European Communities nº L58 of 28 February 2002, p19 amending 90/128/EEC Official Journal nº L349 of , p26 ( S.I. No. 542 of 2002) 22

23 PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2nd. amend. 82/711/EEC) The Official Journal of the European Communities nº L297, of , p26 (S.I. No. 307 of 1991) The Official Journal of the European Communities nº L372, of p14 (S.I. No. 307 of 1991) The Official Journal of the European Communities nº L93F, of p37 (S.I. No. 93 of 1994) The Official Journal of the European Communities nº L222, of , p10 amending 82/711/EEC Official Journal of the European Communities nº L297, of , p26 (S.I. No. 278 of 1998) PLASTICS Vinyl chloride monomer 78/142/EEC The Official Journal of the European Communities nº L44, of , p15 (S.I. No. 307 of 1991) 80/766/EEC The Official Journal of the European Communities nº L213, of , p42 (S.I. No. 307 of 1991) REGENERATED CELLULOSE FILM 93/111/EEC (1st amend. 93/10/EEC) The Official Journal of the European Communities nº L310 of , p41 (S.I. No. 93 of 1994*) 93/10/EEC 83/229/EEC 86/388/EEC 92/15/EEC CERAMICS 84/500/EEC The Official Journal of the European Communities nº L93, of , p27 (S.I. No. 93 of 1994*) The Official Journal of the European Communities nº L123, of , p.31 (S.I. No. 307 of 1991) The Official Journal of the European Communities nº L228, of , p.32 1 st Amendment Limits on MEG and DEG (S.I. No. 307 of 1991) The Official Journal of the European Communities nº L102, of , P.44 2 nd Amendment. (S.I. No. 93 of 1994*) The Official Journal of the European Communities nº L277, of , p12 (S.I. No. 307 of 1991) PLASTICS Basic rules for testing migration 93/8/EEC The Official Journal of the European Communities nº L90, of , p22 1 st Amendment (S.I. No. 93 of 1994*) RUBBER Limits for nitrosamines 93/11/EEC BADGE, BFDGE, NOGE 2002/16/EC The Official Journal of the European Communities nº L93, of , p37 (S.I. No. 93 of 1994*) The Official Journal of the European Communities nº L51, of , p27 (S.I. No. 76 of 2003) * These regulations revoked S.I No.7 of Directive 83/229/EEC and its amendments were repealed by Directive 93/10/EEC. The Regulations also give effect to Commission Directive 93/11/EEC concerning the release of the N-Nitrosamines and N- Nitrosatable substances from elastomer or rubber teats and soothers. 23

24 ITALY SUMMARY All EC Directives implemented. Additional national provisions. Legislation published in the Official Gazette (G.U.). Legislation is made under the powers of Law No. 283 of and the Ministerial Decree of 21 March Sales Agent: Istituto Poligrafico e Zecca dello Stato P.zza G. Verdi, 10 Tel Fax: Website: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Law No. 283 of : Disciplina igienica della produzione e della vendita delle sostanze alimentari e delle bevande (Modificata dalla legge 26 febbraio 1963, n. 441). G.U. n. 139 del Legislative Decree No. 108 of : Attuazione della Direttiva 89/109/CEE concernente i materiali e gli oggetti destinati a venire a contatto con i prodotti alimentari. Pubblicato nel supplemento ordinario n. 31 alla G.U. Serie Generale n. 39 del pag DPR No : Attuazione della direttiva (CEE) n. 76/893 relativa ai materiali e agli oggetti destinati a venire a contatto con i prodotti alimentari. G.U. n. 298 del 28/10/ /590/EEC (symbol) Decree of Ministry of Health No. 198 of Aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U.n. 198 del pag 4675 PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) Decree of the Ministry of Health No. 220 of Regolamento recante aggiornamento del decreto ministeriale 21marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento delle direttive 82/711/CEE, 85/572/CEE, 90/128/CEE e 92/39/CEE. G.U. N 162 del pag.5 92/39/EC (1st amend. 90/128/EEC) Decree of the Ministry of Health No. 220 of Regolamento recante aggiornamento del decreto ministeriale 21marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento delle direttive 82/711/CEE, 85/572/CEE, 90/128/CEE e 92/39/CEE. G.U. N 162 del pag.5 93/9/EEC (2 nd amend. 90/128/EEC) DCM No. 735 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Attuazione delle direttive 93/8/CEE e 93/9/CEE. G.U. n.1 del pag.3 95/3/EC (3 rd amend. 90/128/EEC) DCM No. 572 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento della direttiva 95/3/CE G.U. n. 264 del 11/11/1996

25 96/11/EEC (4 th amend. 90/128/EEC) DMH No. 91 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento della direttiva 96/11/CE. G.U. n. 77 del 3/4/ /91/EEC (5 th amend. 90/128/EEC) DMH No. 210 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento della direttiva n. 99/91/CE. G.U. n. 175 del pag. 8 PLASTICS Testing 82/711/EEC (basic rules) Decree of the Ministry of health No. 220 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento delle direttive 82/711/CEE, 85/572/CEE, 90/128/CEE e 92/39/CEE.\G.U. n. 162 del /572/EEC (simulants) Decree of the Ministry of Health No. 220 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento delle direttive 82/711/CEE, 85/572/CEE, 90/128/CEE e 92/39/CEE. G.U. n. 162 del /8/EEC DCM No. 735 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Attuazione delle direttive 93/8/CEE e 93/9/CEE. G.U. n. 1 del /48 EEC DMH n.338 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale, a seguito del recepimento della direttiva n. 97/48/CE. G.U. n. 228 del pag. 13 REGENERATED CELLULOSE FILM 93/10/EEC Decree of the Ministry of Health No. 556 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Attuazione delle direttive 93/10/CEE e 93/111/CE. G.U. n. 229 del pag. 5 93/111/EEC (1st amend. 93/10/EEC) Decree of the Ministry of Health No. 556 of Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Attuazione delle direttive 93/10/CEE e 93/111/CE. G.U. n. 229 del pag. 5 CERAMICS 84/500/EEC Decree of the Ministry of Health of (Off.Gaz ) Aggiornamento del decreto ministeriale 21 marzo 1973 concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 120 del pag

26 RUBBER Limits for nitrosamines 93/11/EEC Decree of the Ministry of Health of Recepimento della direttiva 93/11/CEE della Commissione del 15 marzo 1993 concernente la liberazione di N-nitrasammine e di sostanze N-nitrosabili da succhiotti e tettarelle di elastomero o di gomma naturale. G.U. n. 68 del pag. 17 ADDITIONAL (NON-EC) NATIONAL PROVISIONS Plastic, rubber, paper, glass, stainless steel, The Ministerial Decree of 21 March 1973 Disciplina igienica degli imballaggi, recipienti, utensili, destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 104 del 20 aprile 1973 amended by: Decree of the Ministry of Health (DMH) of Modificazione al decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili, destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 227 del pag DMH (Integration to positive lists) Aggiornamento del decreto ministeriale 21 marzo 1973 riguardante la disciplina igienica degli imballaggi, recipienti, utensili, destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 319 del pag DMH (modifications to paper and boards) Modificazione al decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 96 del pag DMH (Integration to positive lists) Modificazione al decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili, destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 272 del pag DMH (modifications to paper and boards) Aggiornamento del decreto ministeriale 21 marzo 1973 riguardante la disciplina igienica degli imballaggi, recipienti, utensili, destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 180 del pag 5516 DMH (integration to positive lists) Aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili, destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 347 del pag DMH Aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 198 del pag DMH (integration to positive lists) Aggiornamento del decreto ministeriale 21 marzo 1973 concernente la disciplina igienica degli imballaggi, recipienti, utensili, destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 200 del pag 5177 DMH (integration to positive lists) Aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 340 del pag DMH (Tinned Cans) Disciplina dei contenitori in banda stagnata saldati con lega stagno-piombo ed altri mezzi. G.U.n. 76 del pag DMH (off. Gaz n.120 of ) Disciplina degli oggetti di ceramica destinati ad entrare in contatto con i prodotti. G.U. n. 98 del pag DMH No. 395 of (integration to positive lists) Aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica 26

27 degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. G.U. n. 226 del pag. 10. DMH N.243 of (Tin free steel) Disciplina degli oggetti in banda cromata verniciata destinata a venire in contatto con gli alimenti. G.U. n. 153 del pag. 7. DMH No. 90 of : (integration to positive lists, amemdments to paper and boards) Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973 concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. G.U. n. 67 del pag.7 DMH No. 408 of ( integration to positive lists) Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 303 del pag. 7. DMH No. 220 of : Integration to positive lists Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento delle direttive 82/711/CEE, 85/572/CEE, 90/128/CEE,e 92/39/CEE. G.U. n. 162 del pag. 5. DMH No. 322 of : Integration to positive lists Regolamentorecante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, dei recipienti e degli utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. G.U. n. 199 del pag. 3 DMH No. 511 of Integration to positive lists Regolamentorecante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, dei recipienti e degli utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. G.U. n. 198 del pag. 4. DMH No. 156 of Integration to positive lists Regolamentorecante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, dei recipienti e degli utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. G.U. n. 103 del pag. 3 DMH No. 572 of Integration to positive lists Regolamentorecante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, dei recipienti e degli utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. Recepimento della direttiva 95/3/CE. G.U. n. 264 del DMH No. 322 of : Integration to positive lists Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1993 concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 218 del pag. 14 DMH No. 538 of Phthalates limits Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari e con sostanze d uso personale. G.U. n. 28 del pag.7 DMH No. 411 of : Integration to positive lists) Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n. 11 del pag. 3 DMH No. 267 of 30 maggio 2001(modifications to paper and boards) Regolamento recante aggiornamento del decreto ministeriale 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d uso personale. G.U. n.155 del pag

28 LUXEMBOURG SUMMARY EC Directives implemented as listed below. No additional national provisions. Legislation on Food Contacts Materials and Articles which comes into contact with foods as enacted by the government of Luxembourg is published by the Service Central de Legislation, which is located at 43, bd F-D Roosevelt L-2450 Luxembourg (Tel: , Fax: , [email protected]). The journal can also be found at the web site address: and Legislation on food contacts materials and articles were made under the powers of the Ministry of Health. Sales Agent: Imprimerie de la Cour Victor Buck 6, rue Fr. Hogenberg, L-1735 Luxembourg Tel: Fax: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Règlement grand-ducal du 14 mai 1991 (Mémorial A n 35 du , page 688) 80/590/EEC (symbole) Règlement ministériel du 24 octobre 1980 (Mémorial A n 77 du , page 1981) PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) 92/39/EEC (1st amend. 90/128/EEC) 93/9/EEC (2nd amend. 90/128/EEC) 95/3/EC (3rd amend. 90/128/EEC) 96/11/EC (4th amend. 90/128/EEC) 99/91/EC (5th amend. 90/128/EEC) PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2nd. amend. 82/711/EEC) PLASTICS Vinyl chloride monomer 78/142/EEC 80/766/EEC 81/432/EEC REGENERATED CELLULOSE FILM 93/10/EEC 93/111/EEC (1st amend. 93/10/EEC) CERAMICS Règlement grand-ducal du 11 juin 1991 (Mémorial A n 44 du , page 926) Règlement grand-ducal du 18 mars 1995 (Mémorial A n 55 du , page 1390) Règlement grand-ducal du 18 mars 1995 (Mémorial A n 55 du , page 1390) Règlement grand-ducal du 21 février 1997 (Mémorial A n 11 du , page 628) Règlement grand-ducal du 28 août 1997 (Mémorial A n 73 du , page 2338) Règlement grand-ducal du 27 janvier 2001 (Mémorial A n 23 du , page 746) Règlement grand-ducal du 11 juin 1991 (Mémorial A n 44 du , page 926) Règlement grand-ducal du 11 juin 1991 (Mémorial A n 44 du , page 926) Règlement grand-ducal du 18 mars 1995 (Mémorial A n 55 du , page 1390) Règlement grand-ducal du 5 février 1999 (Mémorial A n 10 du , page 158) Règlement grand-ducal du 24 octobre 1978 (Mémorial A n 70 du , page 1422) Règlement ministériel du 25 août 1982 (Mémorial A n 78 du , page 1715) Règlement ministériel du 25 août 1982 (Mémorial A n 78 du , page 1715) Règlement grand-ducal du 8 février 1995 (Mémorial A n 16 du , page 725) Règlement grand-ducal du 8 février 1995 (Mémorial A n 16 du , page 725) 84/500/EEC Règlement grand-ducal du 22 février 1985 (Mémorial A n 10 du , page 178)

29 THE NETHERLANDS SUMMARY All EC Directives implemented. Additional national provisions for various food contact materials and articles. EC Directives implemented by the Dutch Packaging and Food Utensils Regulations under the powers of the Ministry of Health, Welfare and Sport relate to the following materials: plastics, paper and board, rubber products, metals, glass and ceramics, ceramics materials and enamels, textile products, regenerated cellulose, wood and cork, coatings and BADGE/BFDGE/NOGE. Legislation is published in the Staatscourant which is published daily in the Netherlands. Sales Agent: Servicecentrum Uitgevers PO Box: EA Den Haag Tel.: Fax.: Website : IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Staatscourant nº 167 of 29/08/ /590/EEC (symbol) Staatscourant nº 82 of 01/05/1981 PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) Staatscourant nº 167 of 29/08/ /39/EEC (1st amend. 90/128/EEC) Staatscourant nº 74 of 19/04/ /9/EEC (2nd amend. 90/128/EEC) Staatscourant nº 21 of 31/01/ /3/EC (3rd amend. 90/128/EEC) Staatscourant nº 51 of 12/03/ /11/EC (4th amend. 90/128/EEC) Staatscourant nº 161 of 22/08/ /91/EC (5th amend. 90/128/EEC) Staatscourant nº 80 of 25/04/ /62/EC (6th amend. 90/128/EEC) Staatscourant nº 69 of 10/04/ /17/EC (7th amend. 90/128/EEC) Staatscourant nº 183 of 24/09/2002 PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) Staatscourant nº 167 of 29/08/ /8/EEC (1st amend. 82/711/EEC) Staatscourant nº 21 of 31/01/ /48/EC (2nd. amend. 82/711/EEC) Staatscourant nº 88 of 12/05/1998 PLASTICS Vinyl chloride monomer 78/142/EEC Staatscourant nº 58 of 25/03/ /766/EEC 81/432/EEC Staatscourant nº 135 of 13/07/1984 REGENERATED CELLULOSE FILM 93/10/EEC Staatscourant nº 21 of 31/01/ /111/EEC (1st amend. 93/10/EEC) CERAMICS 29

30 84/500/EEC Staatscourant nº 50 of 11/03/1988 BADGE/BFDGE/NOGE 2002/16/EC Staatscourant nº 183 of 24/09/2002 ADDITIONAL (NON-EC) NATIONAL PROVISIONS COATINGS Staatscourant nº 45 of 04/03/ of 17/07/ of 10/03/ of 28/04/ of 05/11/ of 24/10/2000 RUBBERS AND ELASTOMERS Staatscourant nº 18 of 25/01/ of 09/03/ of 17/04/ of 28/04/ of 05/11/ of 05/10/ of 24/10/2000 PAPER AND BOARD Staatscourant nº 18 of 25/01/ of 09/03/ of 13/07/ of 10/03/ of 10/03/ of 28/04/ of 05/11/ of 24/10/2000 CERAMICS Staatscourant nº 18 of 25/01/ of 04/03/ of 13/07/ of 11/03/ of 17/04/ of 05/11/ of 24/10/2000 GLASS Staatscourant nº 18 of 25/01/ of 04/03/ of 13/07/ of 11/03/ of 17/04/ of 05/11/1996 METALS AND ALLOYS Staatscourant nº 18 of 25/01/ of 04/03/ of 13/07/ of 11/03/ of 17/04/ of 28/04/ of 05/11/ of 24/10/2000 WOOD, INCLUDING CORK Staatscourant nº 18 of 25/01/ of 09/03/ of 11/03/ of 28/04/ of 24/10/2000 TEXTILES Staatscourant nº 18 of 25/01/ of 09/03/ of 11/03/ of 17/04/ of 05/11/ of 24/10/

31 NORWAY All EC Directives implemented. Additional national provisions on non-ceramic materials without a coating of enamel glass and metals. Legislation published in Norsk Lovtidend which can be found at the following Internet addresses: and at the Norwegian Food Control Authority s web site address: (Tel: Fax: [email protected]) Legislation was made under powers of the Food Control Act (19 May 1933 No 3). This Legislation is enforced under the general powers of the Act on Administration (Ref 10 February 1967) in addition to the powers under the Food Control Act (Ref 19 May 1933 No 3). The power of enforcement under the Food Control Act has been delegated from the Ministry of Health and Social Affairs to the Norwegian Food Control Authority. IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Regulations 21 December 1993 No 1381 on materials and articles intended to come into contact with foodstuffs Chapter I General regulations. 80/590/EEC (symbol) PLASTICS Monomers & additives 2002/72/EC (consolidated plastic directive) Regulations 21 December 1992 No 1381 on materials and articles intended to come into contact with foodstuffs Chapter I General regulations Article 3 nr. 2 Regulations 21 December 1993 No 1381 on materials and articles intended to come into contact with foodstuffs. Chapter II Plastic materials and -articles and Annex I - monomer and additives list. PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2nd amend. 82/711/EEC) PLASTICS Vinyl chloride monomer 78/142/EEC 80/766/EEC (testing product) 81/432/EEC (testing in foodsimulant) Regulations 21 December 1993 No 1381 on materials and articles intended to come into contact with foodstuffs Chapter II (Plastic materials and articles) Article 11. Regulations 21 December 1993 No 1381 on materials and articles intended to come into contact with foodstuffs. Chapter III Vinyl chloride monomer, Chapter II Plastic materials and -articles and Annex I - monomer and additives list. RCF positive lists 93/10/EEC 93/111/EEC (1st amend. 93/10/EEC) CERAMICS lead and cadmium 84/500/EEC RUBBER - nitrosamines 93/11/EEC Regulations 21 December 1993 No 1381 on materials and articles intended to come into contact with foodstuffs. Chapter IV Regenerated cellulose film and Annex II positive list. Regulations 21 December 1993 No 1381 on materials and articles intended to come into contact with foodstuffs. Chapter VI Ceramics and Annex IV. Regulations 21 December 1993 No 1381 on materials and articles intended to come into contact with foodstuffs. Chapter II Nitrosamines from elastomer or rubber teats and soothers. EPOXY DERIVATIVES - BADGE/BFDGE/NOGE 2002/16/EC Regulations 21 December 1993 No 1381 on materials and articles intended to come into contact with foodstuffs. Chapter VIb Certain epoxy derivatives in plastics, coatings and adhesives and Annex V.

32 ADDITIONAL (NON-EC) NATIONAL REGULATIONS AND RECOMMENDATIONS NON-CERAMIC MATERIALS WITHOUT A COATING OF ENAMEL Additional national provisions Chapter VIa (Articles made of other Materials than Ceramics) and Annex III. GLASS Additional national provisions METALS Additional national provisions Chapter VIa (Articles made of other Materials than Ceramics) and Annex III. Chapter VIa (Articles made of other Materials than Ceramics) and Annex III. 32

33 PORTUGAL SUMMARY All EC directives implemented, except Directive 2002/16/EC. No additional national provisions. Legislation published in the Diário da República [Official Journal], and associated standards. Sales Agent: IMPRENSA NACIONAL CASA DA MOEDA, S.A. Rua da Escola Politécnica, LISBOA Tel.: Fax: Web page address: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) 80/590/EEC (symbol) PLASTICS Monomers & additives 2002/72/EC (monomers/additives lists) Codification of 90/128/EEC and 7 amendments: 92/39/EEC (1 st amend. 90/128/EEC) 93/9/EEC (2 nd amend. 90/128/EEC) 95/3/EEC (3 rd amend. 90/128/EEC) 96/11/EC (4 th amend. 90/128/EEC) 99/91/EC (5 th amend. 90/128/EEC) 2001/62/EC (6 th amend. 90/128/EEC) 2002/17/EC (7 th amend. 90/128/EEC) PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2 nd amend. 82/711/EEC) PLASTICS Vinyl chloride monomer 78/142/EEC 80/766/EEC 81/432/EEC REGENERATED CELLULOSE FILM 93/ 10/EEC 93/111/EEC (1st amend. 93/10/EEC) Decreto-lei nº 193/88, of 30/05/1988 Diário da República, I series, nº 125 of 30/05/1988, p.2324 Decreto-Lei n 4/2003 of 10/01/2003 Diário da República, I serie A, nº 8 of 10/01/2003, p.62. Decreto-Lei n 4/2003 of 10/01/2003 Diário da República, I serie A, nº 8 of 10/01/2003, p.62. Normas/Pré-normas Europeias [European Pre/standards] EN/ENV Decreto-Lei n 4/2003 of 10/01/2003 Diário da República, I serie A, nº 8 of 10/01/2003, p.62. Portaria nº 294/94, of 17/05/1994 Diário da República, I series B, nº 114 of 17/05/1994, p CERAMICS 84/500/EEC Decreto-lei nº 193/88 of 30/05/1988 Diário da República I, nº 125 of 30/05/1988, p Norma Portuguesa NP-2098 de 1986: Louça cerâmica em contacto com alimentos. Determinação do chumbo e do cádmio. [Portuguese Standard NP-2098 of 1986: Cearamicware in contact with food. Determination of lead and cadmium ] Despacho (Official Communication) in the DR nº 163, III series, of 18/07/1986. Norma Portuguesa NP-2099, de 1988: Louça cerâmica em contacto com alimentos. Limites admissíveis para o chumbo e cádmio. [Portuguese Standard NP-2099 of 1988: Cearamicware in contact with food. Permissible limits for lead and cadmium release]. Decreto Regulamentar [Regulatory Decree] nº 92, III series, of 30/04/1988. RUBBER: N-NITROSAMINES 93/11/EEC Portaria nº 863/94, of 26/09/1994 Diário da República, I series B, nº 223 of 26/09/1994, p

34 SPAIN SUMMARY All EC Directives implemented. Additional national provisions for polymers and regenerated polymers. Legislation is made under the powers of the Ministerio de Sanidad y Consumo; and the Ministerio de Agricultura, Pesca y Alimentación ; Legislation published in the Boletn Oficial del Estado Sales Agent : BOLETIN OFICIAL DEL ESTADO Avenida Manoteras Madrid Tel.: Website: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Real Decreto número 1425/88 de 25/11/1988, por el que se aprueba la Reglamentación Técnico-Sanitaria para la elaboración, circulación y comercio de materiales plásticos destinados a estar en contacto con productos alimenticios y alimentarios, BOE número 288 de 01/12/1988 Página Real Decreto número 397/90 de 16/03/1990, por el que se aprueban las condiciones generales de los materiales para uso alimentario, distintos de los poliméricos, BOE número 74 de 27/03/1990 Página 8562 (Marginal 7739) Real Decreto número 668/90 de 25/03/1990, por el que se modifica la Reglamentación Técnico-Sanitaria para la elaboración, circulación y comercio de materiales poliméricos en relación con los productos alimentarios, aprobada por el Real Decreto 1125/82 de 30/04/1982 BOE número 130 de 31/05/1990 Página (Marginal 12152) 80/590/EEC (symbol) Real Decreto número 1425/88 de 25/11/1988, por el que se aprueba la Reglamentación Técnico-Sanitaria para la elaboración, circulación y comercio de materiales plásticos destinados a estar en contacto con productos alimenticios y alimentarios, BOE número 288 de 01/12/1988 Página Real Decreto número 397/90 de 16/03/1990, por el que se aprueban las condiciones generales de los materiales para uso alimentario, distintos de los poliméricos, BOE número 74 de 27/03/1990 Página 8562 (Marginal 7739) PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) 92/39/EEC (1st amend. 90/128/EEC) 93/9/EEC (2nd amend. 90/128/EEC) 95/3/EC (3rd amend. 90/128/EEC) 96/11/EC (4th amend. 90/128/EEC) 99/91/EC (5th amend. 90/128/EEC) 2001/62/EC (6 th amend. 90/128/EEC) Real Decreto número 2207/94 de 16/11/1994 por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo BOE número 15 de 18/01/1995 Página1590 (Marginal 1234) Real Decreto número 442/2001 de 27 de abril 2001, por el que se modifica el Real Decreto 2207/94, de 16/11/1994, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo BOE número 102 de 28/04/2001 Página Corrección de erratas del Real Decreto 442/2001 en BOE número 135 de 06/06/2001 Página Real Decreto número 118/2003 de 31 de enero 2003, por el que se modifica el Real Decreto 2207/94, de 16/11/1994, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo BOE número 36 de 11/02/2003 Página

35 PLASTICS Testing 82/711/EEC (basic rules) 93/8/EEC (1st amend. 82/711/EEC) Real Decreto número 1425/88 de 25/11/1988, por el que se aprueba la Reglamentación Técnico-Sanitaria para la elaboración, circulación y comercio de materiales plásticos destinados a estar en contacto con productos alimenticios y alimentarios, BOE número 288 de 01/12/1988 Página Real Decreto número 2207/94 de 16/11/1994 por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo BOE número 15 de 18/01/1995 Página1590 (Marginal 1234) 97/48/EC (2nd. amend. 82/711/EEC) 85/572/EEC (simulants) Real Decreto número 1752/98 de 31/7/1998 (BOE 06/08/1998) por el que se modifica el Real Decreto 2207/94, de 16/11/1994, por el que se aprueba la lista de sutancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo. Corrección de errores en BOE 03/10/1998 Real Decreto número 2207/94 de 16/11/1994 por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo BOE número 15 de 18/01/1995 Página1590 (Marginal 1234) PLASTICS Vinyl chloride monomer 80/766/EEC 81/432/EEC Orden de 31/01/1989, por la que se aprueban los métodos oficiales de análisis de cloruro de vinilo BOE número 36 de 11/02/1989 Página 4170 (Marginal 3418) REGENERATED CELLULOSE FILM 93/10/EEC Real Decreto número 1413/94 de 25/06/1994, por el que se aprueban las normas técnicosanitarias sobre los materiales y objetos de pelcula de celulosa regenerada para uso 93/111/EEC (1st amend. 93/10/EEC) alimenticio BOE número 190 de 10/08/1994 Página (Marginal 18669) CERAMICS 84/500/EEC Real Decreto número 1043/90 de 27/07/1990, por el que se aprueba la Instrucción Técnico- Sanitaria sobre objetos de cerámica para uso alimentario BOE número 191 de 10/08/1990 Página (Marginal 19683) (Correción de erratas del Real Decreto número 1043/90 de 27/07/ BOE número 256 de 25/10/1990 Página (Marginal 25807) Real Decreto número 397/90 de 16/03/1990, por el que se aprueban las condiciones generales de los materiales para uso alimentario, distintos de los poliméricos BOE número 74 de 27/03/1990 Página 8562 (Marginal 7739) RUBBER: N-NITROSAMINES 93/11/EEC BADGE, BFDGE, NOGE 2002/16/EC Real Decreto número 1184/94 de 03/06/1994, por el que se establecen las Normas básicas relativas a la determinación de N-nitrosaminas y de sustancias capaces de convertirse en N- nitrosaminas (sustancias n-nitrosables) que pueden ceder las tetinas y chupetes de caucho (BOE de 06/07/1994) Real Decreto número 293/2003 de 07/03/2003, relativo a la utilización de determinados derivados epoxídos en materiales y objetos destinados a entrar en contacto con alimentos (BOE núm. 60, de 11/02/2003) 35

36 ADDITIONAL (NON-EC) NATIONAL PROVISIONS POLYMERS Real Decreto número 1125/82 de 30/04/1982, por el que se aprueba la Reglamentación Técnico-Sanitaria para la elaboración, circulación y comercio de materiales poliméricos en relación con productos alimenticios y alimentarios BOE (04/06/1982) Resolución de 04/11/1982 de la Subsecretaria para la Sanidad, por la que se aprueba la lista positiva de sustancias destinadas a la fabricación de compuestos macromoleculares, la lista de migraciones máximas en pruebas de cesión de algunas de ellas, las condiciones de pureza para las materias colorantes empleadas en los mismos productos y la lista de los materiales poliméricos adecuados para la fabricación de envases y otros utensilios que puedan estar en contacto con los productos alimenticios y alimentarios (BOE número 282 de 24/11/82), modificada par Orden del Ministerio de Sanidad y Consumo de 03/07/1985 (BOE de 12/07/1985). REGENERATED POLYMERS Real Decreto número 2814/83 de 13/10/1983, por el que se prohibe la utilización de materiales poliméricos recuperados o regenerados que hayan de estar en contacto con los alimentos (BOE 11/11/83)

37 SWEDEN SUMMARY All EC Directives implemented. Additional national provisions for lead, cadmium, and choking hazards. Legislation published in the Livsmedelsverkets författningssamling (LIVFS) [Statute of the Swedish National Food Administration]. EC Directives implemented by Livsmedelsverkets föreskrifter och allmänna råd om material och produkter avsedda att komma i kontakt med livsmedel [Ordinance of the National Food Administration on materials and articles intended to come into contact with foodstuffs] SLVFS 1993:18, and its amendments. The Ordinance was reprinted as a consolidation in SLVFS1997:9. Legislation made under the powers of Livsmedelslagen (1971:511) [The Food Act (1971:511)] and Miljöbalken (1998:808; kap. 14) [The Environmental Act (1998:808); chapter 14]. Sales Agent : National Food Administration Sweden Box 622, S UPPSALA Tel.: Fax: [email protected] Web page: IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Statens livsmedelsverks kungörelse med föreskrifter och allmänna råd om material och 80/590/EEC (symbol) produkter avsedda att komma i kontakt med livsmedel SLVFS 1993:18 - reprinted SLVFS 1997:9 PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) 92/39/EEC (1st amend. 90/128/EEC) 93/9/EEC (2nd amend. 90/128/EEC) 95/3/EC (3rd amend. 90/128/EEC) 96/11/EC (4th amend. 90/128/EEC) 99/91/EC (5 th amend. 90/128/EEC) 2001/62/EC (6 th amend. 90/128/EEC) 2002/17/EC (7 th amend. 90/128/EEC) 2002/16/EC (BADGE,BFDGE, NOGE) PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2nd. amend. 82/711/EEC) Statens livsmedelsverks kungörelse med föreskrifter och allmänna råd om material och produkter avsedda att komma i kontakt med livsmedel SLVFS 1993:18 - reprinted SLVFS 1997:9 as amended by SLVFS 1994:23 SLVFS 1996:3 and SLVFS 1997:9 SLVFS 2000:42 LIVSFS 2002:42 LIVSFS 2003:2 (18 februari 2003) Statens livsmedelsverks kungörelse med föreskrifter och allmänna råd om material och produkter avsedda att komma i kontakt med livsmedel SLVFS 1993:18 - reprinted SLVFS 1997:9 as amended by SLVFS 1994:23 and SLVFS 1998:9 PLASTICS Vinyl chloride monomer 78/142/EEC 80/766/EEC 81/432/EEC Statens livsmedelsverks kungörelse med föreskrifter och allmänna råd om material och produkter avsedda att komma i kontakt med livsmedel SLVFS 1993:18 - reprinted SLVFS 1997:9 REGENERATED CELLULOSE FILM 93/10/EEC Statens livsmedelsverks kungörelse med föreskrifter och allmänna råd om material och 93/111/EEC (1st amend. 93/10/EEC) produkter avsedda att komma i kontakt med livsmedel SLVFS 1993:18 - reprinted SLVFS 1997:9 as amended by SLVFS 1994:23 CERAMICS 37

38 84/500/EEC Statens livsmedelsverks kungörelse med föreskrifter och allmänna råd om material och produkter avsedda att komma i kontakt med livsmedel SLVFS 1993:18 - reprinted SLVFS 1997:9 ADDITIONAL (NON-EC) NATIONAL PROVISIONS METALS AND ALLOYS Special Articles on lead and cadmium in equipment used when handling foodstuffs (other than ceramic articles) SLVFS 1996:5 ALL FOOD CONTACT MATERIALS Ordinance on foreign substances in foodstuffs (SLVFS 1993:36, reprinted SLVFS 1994:17) 38

39 SWITZERLAND SUMMARY EC Directives on plastics (monomers & additives and testing) and on regenerated cellulose film are implemented Additional national provisions for varnishes and coatings, and other materials. Legal texts are available in the Systematische Sammlung des Bundesrechts (Systematic register) [SR] in German, French and Italian at the following Internet address: The Schweizerische Lebensmittelbuch (Swiss Food Manual) [SLMB] can be ordered at: Legislation is enforced under the power of the Bundesgesetz vom 9. Oktober 1992 über Lebensmittel und Gebrauchsgegenstände (Lebensmittelgesetz, LMG) (Food Law) [SR 817.0]. IMPLEMENTATION OF EC DIRECTIVES PLASTICS Monomers & Additives 90/128/EEC 92/39/EEC (1 st amend. 90/128/EEC) 93/9/EEC(2 nd amend. 90/128/EEC) 95/3/EC(3 rd amend. 90/128/EEC) 96/11/EC(4 th amend. 90/128/EEC) PLASTICS Testing 82/711/EEC 85/572/EEC 93/8/EEC (1 st amend. 82/711/EEC) 97/48/EC (2nd amend. 82/711/EEC) REGENERATED CELLULOSE FILM 93/10/EEC 93/111/EEC Verordnung des EDI vom 26. Juni 1995 über Materialien und Gegenstände aus Kunststoff (Kunststoffverordnung, AS KsV) [SR ] Kunststoffverordnung, Änderung vom 31. Januar 1998 [SR ] Schweizerische Lebensmittelbuch (Swiss Food Manual), Kap. 48: Bedarfsgegenstände aus Kunststoff, Ausgabe 1998 Verordnung des EDI vom 26. Juni 1995 über Zellglasfolien (ZfV) [SR ] ADDITIONAL NATIONAL PROVISIONS VARNISHES AND COATINGS The legislation on plastics [SR ] is applied OTHER MATERIALS Verordnung vom 1. März 1995 über Gebrauchsgegenstände (GebrV) [SR ] Framework ordinance on plastics, paper & board, rubber, ceramics and metal & alloys.

40 UNITED KINGDOM SUMMARY All EC Directives implemented. No additional national provisions. Since devolution was introduced in 1999, England, Scotland and Wales have separate legislation. Northern Ireland has had separate legislation for many years. Legislation is published by the Stationery Office Limited under the authority of Her Majesty s Stationery Office (HMSO). Legislation issued since 1997 is also published, free-of-charge, on HMSO s website at Most legislation is made under powers of the Food Safety Act 1990, in Great Britain, and the Food Safety (Northern Ireland) Order 1991, in Northern Ireland. The ceramics regulations, which apply across the UK, are made under the Consumer Protection Act Sales Point: The Stationery Office Limited (HMSO) P O Box 29 Norwich NR3 IGN HMSO Publications Centre PO Box 276 London SW8 5DT Tel: Tel: Fax : Fax: [email protected] or [email protected] Website: or IMPLEMENTATION OF EC DIRECTIVES ALL FOOD CONTACT MATERIALS 89/109/EEC (framework) Materials and Articles in Contact with Food Regulations 1987 Statutory Instrument 1987 No amended by: Statutory Instrument 1990 No Statutory Instrument 1991 No Statutory Instrument 1994 No. 979 Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987 Statutory Rule 1987 No. 432 amended by: Statutory Rule 1991 No. 344 Statutory Rule 1994 No /590/EEC (symbol) Materials and Articles in Contact with Food Regulations 1987 Statutory Instrument 1987 No amended by: Statutory Instrument 1990 No Statutory Instrument 1991 No Statutory Instrument 1994 No. 979 Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987 Statutory Rule 1987 No. 432 amended by: Statutory Rule 1991 No. 344 Statutory Rule 1994 No. 174

41 PLASTICS Monomers & additives 90/128/EEC (monomer/additive lists) 92/39/EEC (1st amend. 90/128/EEC) 93/9/EEC (2nd amend. 90/128/EEC) 95/3/EC (3rd amend. 90/128/EEC) 96/11/EC (4th amend. 90/128/EEC) 99/91/EC (5 th amend. 90/128/EEC) 2001/62/EC (6 th amend. to 90/128/EEC) (includes provisions of Directive 2002/16/EC on certain epoxy derivatives and two definitions from 2002/17/EC (7 th amend. to 90/128/EEC)) PLASTICS Testing 82/711/EEC (basic rules) 85/572/EEC (simulants) 93/8/EEC (1st amend. 82/711/EEC) 97/48/EC (2nd. amend. 82/711/EEC) } } The Plastic Materials and Articles in Contact with Food Regulations 1998 } Statutory Instrument 1998 No } The Plastic Materials and Articles in Contact with Food Regulations (Northern } Ireland) 1998 } Statutory Rule 1998 No. 264 } }Plastic Materials and Articles in Contact with Food (Amendment) (England) }Regulations 2000 }Statutory Instrument 2000 No }The Plastic Materials and Articles in Contact with Food Regulations 2000 (Scotland) }Statutory Instrument 2000 No. 431 }The Plastic Materials and Articles in Contact with Food Regulations 2000 (Northern }Ireland) }Statutory Rule 2000 No. 402 }The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) }Regulations 2000 }Statutory Instrument 2001 No (W70) }The Plastic Materials and Articles in Contact with Food (Amendment) (England) }Regulations }Statutory Instrument Number 2002 No }The Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) }Regulations }Statutory Instrument Number 2002 No. 498 }The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) }Regulations }Statutory Instrument Number 2002 No (W272) }The Plastic Materials and Articles in Contact with Food (Amendment) (Northern Ireland) }Regulations }Statutory Rule Number 2002 No. 316 The Plastic Materials and Articles in Contact with Food (Amendment) (England) }Regulations }Statutory Instrument Number 2002 No }The Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) }Regulations }Statutory Instrument Number 2003 No. 9 }The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) }Regulations }Statutory Instrument Number 2003 No. 302 (W44) }The Plastic Materials and Articles in Contact with Food (Amendment) (Northern Ireland) }Regulations }Statutory Rule Number 2003 No. 2 Plastic Materials and Articles in Contact with Food Regulations 1998 Statutory Instrument 1998 No Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998 Statutory Rule 1998 No. 264 PLASTICS Vinyl chloride monomer 78/142/EEC 80/766/EEC 81/432/EEC Materials and Articles in Contact with Food Regulations 1987 Statutory Instrument 1987 No amended by: Statutory Instrument 1990 No Statutory Instrument 1991 No Statutory Instrument 1994 No. 979 Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987 Statutory Rule 1987 No. 432 amended by: 41

42 Statutory Rule 1991 No. 344 Statutory Rule 1994 No. 174 REGENERATED CELLULOSE FILM 93/10/EEC Materials and Articles in Contact with Food Regulations /111/EEC (1st amend. 93/10/EEC) Statutory Instrument 1987 No amended by: Statutory Instrument 1990 No Statutory Instrument 1991 No Statutory Instrument 1994 No. 979 Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987 Statutory Rule 1987 No. 432 amended by: Statutory Rule 1991 No. 344 Statutory Rule 1994 No. 174 CERAMICS 84/500/EEC Ceramic Ware (Safety) Regulations 1988 Statutory Instrument 1988 No COATINGS AND ADHESIVES 2002/16/EC Implemented within the regulations on plastic materials and articles within each of England, Scotland, Wales and Northern Ireland (see above). 42

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