+ANNESS V
---+1. Organic materials Organic materials shall only be made of: (a) the starting substances listed in …
---+2. Metallic materials Only metallic materials included in the European positive list of …
---+3. Cementitious materials Cementitious materials shall only be made of one or more of the …
---+4. Enamels and ceramic materials Enamels and ceramic materials shall only be made of starting …
---+5. Exceptions for assessment of materials used in minor and assembled components For assembled …

ANNESS V



ANNESS V

PRINĊIPJI GĦALL-ISTABBILIMENT TA’ METODOLOĠIJI KOMUNI MSEMMIJA fl-ARTIKOLU 11

Gruppi ta’ materjali

1. Materjal organiku

Il-materjali organiċi għandhom ikunu magħmulin biss minn:

(a) 

is-sustanzi inizjali elenkati fil-lista pożittiva Ewropea ta’ sustanzi inizjali li għandhom jiġu stabbiliti mill-Kummissjoni skont il-punt (b) tal-ewwel subparagrafu tal-Artikolu 11(2); u

(b) 

sustanzi li fir-rigward tagħhom ma jista’ jkun hemm l-ebda possibbiltà’ li s-sustanza u l-prodotti ta’ reazzjoni tagħha jkunu preżenti f’livelli li jaqbżu 0,1 μg/l fl-ilma maħsub għall-konsum mill-bniedem, sakemm għal sustanzi speċifiċi ma jkunx meħtieġ valur aktar strett b’kont meħud tat-tossiċità tagħhom.

Il-materjali organiċi għandhom jiġu ttestjati skont it-Tabella 1 f’konformità mal-metodi għall-ittestjar speċifikati fl-istandards Ewropej rilevanti jew, fin-nuqqas ta’ dawn, metodu rikonoxxut fil-livell internazzjonali jew nazzjonali u għandhom jissodisfaw ir-rekwiżiti stipulati hemmhekk. Għal dan l-għan, ir-riżultati tat-testijiet f’termini ta’ migrazzjoni tas-sustanzi għandhom jiġu kkonvertiti f’livelli stmati fil-vit.

2. Materjal metalliku

Għandhom jintużaw biss il-materjali metalliċi inklużi fil-lista pożittiva Ewropea ta’ kompożizzjonijiet li għandhom jiġu stabbiliti mill-Kummissjoni skont il-punt (b) tal-ewwel subparagrafu tal-Artikolu 11(2). Għandha tinżamm konformità mal-limitazzjonijiet stipulati fil-lista pożittiva Ewropea fir-rigward tal-kompożizzjoni ta’ dawn il-materjali, l-użu tagħhom għal ċerti prodotti u l-użu ta’ dawn il-prodotti.

Il-materjali metalliċi għandhom jiġu ttestjati skont it-Tabella 1 f’konformità mal-metodi għall-ittestjar speċifikati fl-istandards Ewropej rilevanti jew, fin-nuqqas ta’ dawn, metodu rikonoxxut fil-livell internazzjonali jew nazzjonali u għandhom jissodisfaw ir-rekwiżiti stipulati hemmhekk.

3. Materjal tas-siment

Materjali tas-siment għandhom ikunu magħmulin biss minn wieħed jew aktar minn dawn li ġejjin:

(a) 

il-kostitwenti organiċi elenkati fil-lista pożittiva Ewropea ta’ kostitwenti li għandhom jiġu stabbiliti mill-Kummissjoni skont il-punt (b) tal-ewwel subparagrafu tal-Artikolu 11(2);

(b) 

kostitwenti organiċi li fir-rigward tagħhom m’hemm l-ebda possibbiltà li l-kostitwenti u l-prodotti ta’ reazzjoni tagħhom huma preżenti f’livelli li jaqbżu 0,1 μg/l fl-ilma maħsub għall-konsum mill-bniedem; jew

(c) 

kostitwenti mhux organiċi.

Il-materjali marbuta mas-siment għandhom jiġu ttestjati skont it-Tabella 1 f’konformità mal-metodi għall-ittestjar speċifikati fl-istandards Ewropej rilevanti jew, fin-nuqqas ta’ dawn, metodu rikonoxxut fuq livell internazzjonali jew nazzjonali u għandhom jissodisfaw ir-rekwiżiti stipulati hemmhekk. Għal dan l-għan, ir-riżultati tat-testijiet f’termini ta’ migrazzjoni tas-sustanzi għandhom jiġu kkonvertiti f’livelli stmati fil-vit.

4. Enamel u materjal taċ-ċeramika

L-enamel u l-materjali taċ-ċeramika għandhom ikunu magħmula biss minn sustanzi inizjali mill-lista pożittiva Ewropea ta’ kompożizzjonijiet li jiġu stabbiliti mill-Kummissjoni skont il-punt (b) tal-ewwel subparagrafu tal-Artikolu 11(2), wara li titwettaq valutazzjoni tal-elementi użati fil-kompożizzjoni ta’ dawn il-materjali.

L-enamel u l-materjali taċ-ċeramika għandhom jiġu ttestjati skont it-Tabella 1 f’konformità mal-metodi għall-ttestjar speċifikati fl-istandards Ewropej rilevanti jew, fin-nuqqas ta’ dawn, metodu rikonoxxut fil-livell internazzjonali jew nazzjonali u għandhom jissodisfaw ir-rekwiżiti stipulati hemmhekk. Għal dan l-għan, ir-riżultati tat-testijiet f’termini ta’ migrazzjoni tas-sustanzi għandhom jiġu kkonvertiti f’livelli stmati fil-vit.

5. Eċċezzjonijiet għall-valutazzjoni tal-materjal li jintuża f’komponenti minuri u komponenti mmuntati

Għal prodotti mmuntati: komponenti, partijiet u materjali minuri għandhom jiġu deskritti fid-dettall u l-ittestjar għandu jitnaqqas skont dan. Għal dan l-iskop, “minuri” tirreferi għal livell ta’ influwenza fuq il-kwalità tal-ilma maħsub għall-konsum mill-bniedem li ma jeħtieġx l-ittestjar kollu.



Tabella 1. Ittestjar marbut ma’ tipi ta’ materjal

Kriterji

Organiku (Ara n-Nota 1)

Metalliku (Ara n-Nota 2)

Tas-siment

Enamel u materjal taċ-ċeramika

Listi pożittivi Ewropej

 

 

 

 

Lista pożittiva Ewropea ta’ sustanzi iniżjali għal materjal organiku

X

M.M.

X

M.M.

Lista pożittiva Ewropea ta’ kompożizzjonijiet metalliċi aċċettati

M.M.

X

M.M.

M.M.

Lista pożittiva Ewropea ta’ kostitwenti għal materjali tas-siment

M.M.

M.M.

X

M.M.

Lista pożittiva Ewropea ta’ kompożizzjonijiet għal enamel u materjali taċ-ċeramika

M.M.

M.M.

M.M.

X

Testijiet organolettiċi

 

 

 

 

Riħa u togħma

X

M.M.

X

M.M.

Kulur u Turbidità

X

M.M.

X

M.M.

Valutazzjonijiet ġenerali ta’ iġjene

 

 

 

 

Tnixxija tal-karbonju organiku totali

X

M.M.

X

M.M.

Residwi fil-wiċċ (metalli)

M.M.

X

M.M.

M.M.

Ittestjar tal-migrazzjoni

 

 

 

 

Parametri rilevanti ta’ din id-Direttiva

X

X

X

X

MTCtap tas-sustanzi PL

X

M.M.

X (ara n-Nota 3)

M.M.

Sustanzi mhux mistennija (GCMS)

X

M.M.

X (ara n-Nota 3)

M.M.

Konformità mal-listi ta’ kompożizzjoni

M.M.

X

M.M.

X

Żieda fit-tkabbir mikrobjali

X

M.M.

X (Ara n-Nota 3)

M.M.
(1)   

Ir-Regolament tal-Kummissjoni (UE) Nru 10/2011 tal-14 ta’ Jannar 2011 dwar il-materjali u oġġetti tal-plastik maħsuba li jiġu f’kuntatt mal-ikel (ĠU L 12, 15.1.2011, p. 1).

M.M.:  Mhux meħtieġ

MTCtap:  Konċentrazzjoni tollerabbli massima fil-vit (derivata jew mill-opinjoni tal-ECHA għall-finijiet ta’ inklużjoni tas-sustanza fil-lista pożittiva Ewropea, jew ibbażata fuq limitu ta’ migrazzjoni speċifika stabbilit fir-Regolament tal-Kummissjoni (UE) Nru 10/2011 (1) u b’kunsiderazzjoni ta’ fattur ta’ allokazzjoni ta’ 10 % u konsum ta’ ilma ta’ żewġ litri kuljum)

GCMS:  Kromatografija tal-Gass - Spettrometrija tal-Massa (metodu ta’ skrinjar)

Nota 1:  Għandhom jiġu determinati eċċezzjonijiet speċifiċi skont il-punt 5 ta’ dan l-Anness.

Nota 2:  Il-metalli ma għandhomx ikunu soġġetti għal ittestjar organolettiku peress li hu ġeneralment aċċettat li jekk jiġu ssodisfati l-valuri parametriċi stabbiliti fl-Anness I, mhux probabbli li jkun hemm problemi organolettiċi.

Nota 3:  Skont l-eżistenza ta’ sustanzi organiċi fil-kompożizzjoni.

1. Ħarsa ġenerali

,
1. Organic materials Organic materials shall only be made of: (a) the starting substances listed in …

1.

 Organic materials

Organic materials shall only be made of:

(a)

the starting substances listed in the European positive list of starting substances to be established by the Commission in accordance with point (b) of the first subparagraph of Article 11(2); and

(b)

substances in relation to which there is no possibility that the substance and its reaction products are present at levels exceeding 0,1 μg/l in water intended for human consumption, unless for specific substances a more stringent value is needed taking into account their toxicity.

Organic materials shall be tested in accordance with Table 1 in line with methods for testing specified in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein. For this purpose, the test results in terms of substance migration shall be converted into estimated levels at the tap.
2. Metallic materials Only metallic materials included in the European positive list of …

2.

 Metallic materials

Only metallic materials included in the European positive list of compositions to be established by the Commission in accordance with point (b) of the first subparagraph of Article 11(2) shall be used. The limitations stipulated in the European positive list in respect of the composition of these materials, their use for certain products and the use of these products shall be complied with.

Metallic materials shall be tested in accordance with Table 1 in line with methods for testing specified in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein.
3. Cementitious materials Cementitious materials shall only be made of one or more of the …

3.

 Cementitious materials

Cementitious materials shall only be made of one or more of the following:

(a)

organic constituents listed in the European positive list of constituents to be established by the Commission in accordance with point (b) of the first subparagraph of Article 11(2);

(b)

organic constituents in relation to which there is no possibility that the constituents and their reaction products are present at levels exceeding 0,1 μg/l in water intended for human consumption; or

(c)

inorganic constituents.

Cement-bound materials shall be tested in accordance with Table 1 in line with methods for testing specified in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein. For this purpose, the test results in terms of substance migration shall be converted into estimated levels at the tap.
4. Enamels and ceramic materials Enamels and ceramic materials shall only be made of starting …

4.

 Enamels and ceramic materials

Enamels and ceramic materials shall only be made of starting substances from the European positive list of compositions to be established by the Commission in accordance with point (b) of the first subparagraph of Article 11(2), after carrying out an assessment of the elements used in the composition of these materials.

Enamels and ceramic materials shall be tested in accordance with Table 1 in line with methods for testing specified in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein. For this purpose, the test results in terms of substance migration shall be converted into estimated levels at the tap.
5. Exceptions for assessment of materials used in minor and assembled components For assembled …

5.

 Exceptions for assessment of materials used in minor and assembled components

For assembled products: minor components, parts and materials shall be described in detail and testing shall be reduced accordingly. For this purpose, ‘minor’ refers to a level of influence on the quality of water intended for human consumption that does not require full testing.

Table 1. Testing related to material types

Criteria

Organic (See Note 1)

Metallic (See Note 2)

Cementitious

Enamels and ceramic materials

European positive lists

 

 

 

 

European positive list of starting substances for organic materials

X

N.N.

X

N.N.

European positive list of accepted metallic compositions

N.N.

X

N.N.

N.N.

European positive list of constituents for cementitious materials

N.N.

N.N.

X

N.N.

European positive list of compositions for enamels and ceramic materials

N.N.

N.N.

N.N.

X

Organoleptic tests

 

 

 

 

Odour and flavour

X

N.N.

X

N.N.

Colour and Turbidity

X

N.N.

X

N.N.

General hygiene assessments

 

 

 

 

Leaching of total organic carbon

X

N.N.

X

N.N.

Surface residues (metals)

N.N.

X

N.N.

N.N.

Migration testing

 

 

 

 

Relevant parameters of this Directive

X

X

X

X

MTCtap of PL substances

X

N.N.

X (See Note 3)

N.N.

Unexpected substances (GCMS)

X

N.N.

X (See Note 3)

N.N.

Compliance with compositions lists

N.N.

X

N.N.

X

Enhancement of microbial growth

X

N.N.

X (See Note 3)

N.N.

N.N.:

Not necessary

MTCtap:

Maximum tolerable concentration at the tap (either derived from the opinion of ECHA for the purposes of inclusion of the substance in the European positive list, or based on a specific migration limit set in Commission Regulation (EU) No 10/2011 () and considering a 10 % allocation factor and water consumption of 2 litres per day)

GCMS:

Gas Chromatography – Mass Spectrometry (screening method)

Note 1:

Specific exceptions to be determined in line with point 5 of this Annex.

Note 2:

Metals shall not be subject to organoleptic testing because it is generally accepted that if the parametric values set out in Annex I are met, organoleptic problems are unlikely to arise.

Note 3:

Depending on the existence of organic substances in the composition.

(1)  Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
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