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FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU

Resolutions of the Council of Europe and Belgian Legislation

Els HeyvaertRegulatory Expert Food Contact MaterialsFPS Health, Food Chain Safety and EnvironmentEurostation | Victor Horta Place, 40/10 | 1060 Brussels | Belgiumels.heyvaert@health.belgium.be

Resolutions of the Council of Europe and Belgian Legislation

• Council of Europe• short introduction• Resolutions and guidelines

• Belgian Legislation• RD 11 mai 1992• RD Varnishes• Future RD metals and alloys

The Council of Europe: short introduction

The Council of Europe, whose seat is with the “Palais de l’Europe” (Strasbourg), is the vastest and most senior of the European political organizations.

Created in 1949 by 10 States founders, it covers the near total of the European continent today, with its 47 Member States.

The Council of Europe thus became a privileged place where are expressed the concerns, the hopes and the aspirations of 800 million Europeans.

The Council of Europe is an intergovernmental organization which is devoted mainly to the protection of the human rights, the democracy and the State of right.

Candidate : Bélarus

47 Members states

Albanie, Allemagne, Andorre, Arménie, Autriche, Azerbaïdjan, Belgique, Bosnie- Herzégovine, Bulgarie, Chypre, Croatie, Danemark, Espagne, Estonie, « l’ex- République yougoslave de Macédoine », Fédération de Russie, Finlande, France, Géorgie, Grèce, Hongrie, Irlande, Islande, Italie, Lettonie, Liechtenstein, Lituanie, Luxembourg, Malte, Moldova, Monaco, Monténégro, Norvège, Pays-Bas, Pologne, Portugal, République tchèque, Roumanie, Royaume-Uni, Saint-Marin, Serbie, Slovaquie, Slovénie, Suède, Suisse, Turquie, Ukraine

ObserversCanada, Saint-Siège, Japon, Etats-Unis d’Amérique, Mexique, Maroc

•États fondateurs•Autres pays membres•États observateurs à l’Assemblée parlementaire•États observateurs au Comité des Ministres•États candidats officiels

Who takes part ?

Ctee for the Protection of Human Health (CD-P-SC)

Steering Ctee of Experts packaging

Food & pharma

Steering Ctee of Experts

cosmetics

Representatives of the membersstates parties to the Convention on the development of EUPharmacopeia with competencesin national programs for the protection of consumers’ health

Experts appointed by MS (also from Industry)

Ad Hoc WG

+ cooperation with European Commissionand EFSA

Texts of the Council of Europe• Resolutions (adopted by the Committee of the Ministers)

• Guidelines and/or Technical Documents (TD) adopted by “Steering Committee”

• All these documents require, if necessary, a total or partial transposition in the national law to become binding.

In the absence of EU or national Regulations, the documents of the Council of Europe can be used as reference documents to show the harmlessness and the inertia of a FCM (art. 3 of the EU Regulation)!

EC specific texts :84/500 ceramics

10/2011 plastics…

Transpositions in national texts

Resolutions and guidelines of CoE(Strasbourg)

Transposition in national law : in

the future ?

Interpretation of Article 3 for matters not covered by specific EU legislation “Complementarity of the four international bodies”

EFSA JRC

Harmonized legislation(s) : Gaps and approximation

Binding legislation

Soft law, recommandation

§ Resolution AP(89)1: Colorants for plastics§ Resolution AP(92)2: Polymerisation aids§ Resolution AP(2002)1: Paper and board§ Resolution AP(2004)1: Coatings§ Resolution AP(2004)2: Cork§ Resolution AP(2004)3: Ion exchange resins§ Resolution AP(2004)4: Rubber§ Resolution AP(2004)5: Silicons§ Resolution AP(2005)2: Inks§ Resolution(2013): Metals and alloys§ Guidelines (2004): Glass § Guidelines (2004): Napkins …

Resolutions and guidelines

Resolution on Food Contact Materials9

Resolution on Food Contact Materials

• The goal is to have a document with Common Criteria for materials and articles. • Defenitions, SML/SRL, QM• CMR substances…

• simplify next documents dedicated for specific materials.

1. Scope :FCM of Regulation 1935/2004 not covered by specific legalprovisions at european level

2. Definitions : SRL, SML, ORL, OML, Non-evaluated substances

3. General Requiements• Reference to art 3 of 1935/2004• Substances• Specific, generic and overall release• General treshold for non-evaluated substances

4. Risk assessmentCf EFSA guidelines5. LabellingSee art 15 of 1935/20046. Declaration of compliance7. TraceabilitySee art 8 of 1935/20048. Good Manufacturing PracticeSee 2023/2006

9. Compliance testingRespect of SRL, SML, ORL, OML,… in accordance with 882/2004

10. Technical guidelines

Will cover specific and detailed material requirements :General provisionsSpecific requirements for the material, includind labellingList of evaluated substances (national and european)Testing conditions

Revision of texts under the aegis of the EDQM (work by rapporteur country)

Rapporteur Resolutions

Austria Paper and board

Belgium Ion exchange resins

Belgium Metals and alloys

Netherland & Belgium Coatings *

Portugal Cork

Greece Inks

*not active at this moment

Belgian Legislation16

Ø RD 11 mai 1992Ø RD 25 september 2016Ø Future

17 Belgian FCM legislation

RD 11 Mai 1992 concerning materials and articles intendedto come into contact with food

RD 11 Mai 1992

• Regulation 1935/2004• Declaration of Compliance

• Who?• What?

• Tin• Paper and Board (greasy products – list)• Glass

21 RD 25 September 2016 Varnishes

Art. 1 ScopeArt. 2 Definitions

Art. 3 General provision

Art. 4 Composition of the monomers

Art. 5. Composition of the additives

Art. 6 Overall migrationArt. 7 Specific migration

Art. 8 Verification of the specific migration

Art. 9 Declaration of compliance

Art 10. Mutual recognition

Scope of the Royal Decree

The provisions of this Decree apply to varnishes which, in the finished state, are intended to come into with food and are designed for that purpose.

The following types of varnishes are covered:

• Varnish for metal materials and articles;

• Varnish for flexible materials and articles;

• High performance varnishes.

Substances authorized by Royal Decree

Additives, monomers and other starting substances can be used in the manufacture of varnishes, if they are:üIncluded in European Regulation No. 10/2011,

applying the same restrictions/specificationsexcept when the use in specific plastics is stated

üApproved by a EU Member State applying the more stringent restrictions/specifications

üPositively evaluated by EFSA, or scientific institutes with equivalent competences

Additives, monomers and other starting substances can be used in the manufacture of varnishes, if they have been subjected to:üAn evaluation carried out by the Belgian Superior Health Council in accordance with

Royal Decree of 30th of January 1979 laying down the procedure for inclusion on the lists of authorized

substances in articles and substances intended to into contact with food, as well as the amendments to these lists.

Additives, monomers and other starting substances can be used in the manufacture of varnishes, on the condition that:üThey comply with Art.3 of EU Reg. 1935/2004

üThey do not transfer their constituents to foodstuffs in quantities exceeding 10 µg/kg of food or simulant

üThey are not classified as CMR according to the criteria laid down EU Reg. 1272/2008 and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures (+ nano)

üThey are not genotoxic based on QSAR predictions, in case of absence of in vitro and in vivo toxicological data following EFSA’s criteria

üThe principle of non-migration (i.e. LOD < 10 µg/kg) is applied

Overview of the Royal Decree

Art. 1 ScopeArt. 2 Definitions

Art. 3 General provision

Art. 4 Composition of the monomers

Art. 5. Composition of the additives

Art. 6 Overall migrationArt. 7 Specific migration

Art. 8 Verification of the specific migration

Art. 9 Declaration of compliance

Art 10. Mutual recognition

ØProcedure is similar to the evaluation of the overallmigration described in EU Regulation 10/2011 (OM1-9)

ØCoatings on metal packaging are excluded

ØSpecific procedure for the overall migration with 3% acetic acid for High performance varnishes:

3% Acetic acid is used for the migration, but only the chloroform soluble organic material is weighed and compared to the overall migration limit.

Verification of the overall migration

Verification of the specific migration

Flexible FCM

Metal FCM

Procedure according to EU Reg. 10/2011

Procedure according to EU Reg 10/2011

Exception: the use of 5 g/L citric acid as simulant B instead of 3% Acetic acid

High capacity FCM Specific proceduredescribed in the Royal

Decree

Future?

RD on metals and alloys

• based on Resolution CM/Res(2013)9 on metals and alloys used in food contact materials and articles (Council of Europe)

• 2018?

Resolution Metals and Alloys- CM/Res(2013)9

The Council of Europe Committee of Ministers (restricted composition*) adopted the Resolution (2013)9 on metals and alloys used in food contact materials and articles

Specific Release Limits: MetalsSymbol Name SRL [mg/kg food] Maximum tolerable concentration

during transitional period (f: multiplication factor)

Ag Silver 0.08

Al Aluminium 5

Co Cobalt 0.02 0.1 (f=5)

Cr Chromium 0.250 1.0 (f=4)

Cu Copper 4

Fe Iron 40

Mg Magnesium -

Mn Manganese 1.8

Mo Molybdenum 0.12 0.6 (f=5)

Ni Nickel 0.14 0.7 (f=5)

Sn* Tin 100

Ti Titanium -

V Vanadium 0.01 0.05 (f=5)

Zn Zinc 5

Specific Release Limits: contaminantsSymbol Name SRL [mg/kg food] Maximum tolerable concentration

during transitional period (f: multiplication factor)

As Arsenic 0.002 0.01 (f=5)

Ba Barium 1.2

Be Beryllium 0.01 0.05 (f=5)

Cd Cadmium 0.005 0.02 (f=4)

Hg Mercury 0.003 0.015 (f=5)

Li Lithium 0.048

Pb Lead 0.010 0.04 (f=4)

Sb Antimony 0.04 0.2 (f=5)

Tl Thallium 0.0001 0.0005 (f=5)

Chapter 3 : Analytical methods

• citric acid, artificial tap water…• New methodology of measurment of utensils• Double limits for repeated use

Chapter 4 : Declaration of compliance

Technical Guide

Dank u voor uw aandacht

Els Heyvaertels.heyvaert@health.fgov.be

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