resolutions of the council of europe and belgian legislation · fod volksgezondheid, veiligheid van...
TRANSCRIPT
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
Resolutions of the Council of Europe and Belgian Legislation
1
Els HeyvaertRegulatory Expert Food Contact MaterialsFPS Health, Food Chain Safety and EnvironmentEurostation | Victor Horta Place, 40/10 | 1060 Brussels | [email protected]
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
2
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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.
3
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
Who takes part ?
5
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
Ad Hoc WG
Ad Hoc WG
+ cooperation with European Commissionand EFSA
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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)!
6
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
7
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
§ 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
8
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
Resolution on Food Contact Materials9
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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.
10
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
1. Scope :FCM of Regulation 1935/2004 not covered by specific legalprovisions at european level
2. Definitions : SRL, SML, ORL, OML, Non-evaluated substances
11
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
3. General Requiements• Reference to art 3 of 1935/2004• Substances• Specific, generic and overall release• General treshold for non-evaluated substances
12
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
13
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
14
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
Belgian Legislation16
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
Ø RD 11 mai 1992Ø RD 25 september 2016Ø Future
17 Belgian FCM legislation
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
RD 11 Mai 1992 concerning materials and articles intendedto come into contact with food
18
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
RD 11 Mai 1992
• Regulation 1935/2004• Declaration of Compliance
• Who?• What?
• Tin• Paper and Board (greasy products – list)• Glass
19
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
20
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
21 RD 25 September 2016 Varnishes
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
22
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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.
23
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
24
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
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
25
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.
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
26
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
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
27
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
28
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
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
29
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
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
30
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?
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
31
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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)
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
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
FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU
Dank u voor uw aandacht
35