Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2024/365 23.4.2024 COMMISSION IMPLEMENTING DECISION (EU) 2024/365 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards methodologies for testing and accepting starting substances, compositions and constituents to be included in the European positive...
Official Journal EN of the European Union L series 2024/365 23.4.2024 COMMISSION IMPLEMENTING DECISION (EU) 2024/365 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards methodologies for testing and accepting starting substances, compositions and constituents to be included in the European positive lists (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020on the quality of water intended for human consumption(1), and in particular Article 11(2), point (a), thereof,
Whereas:
(1) Testing and acceptance methodologies should be established for assessing the safe use of starting substances, compositions and constituents.
(2) Inclusion or removal of an entry in a European positive list should be based on the identification of the starting substance, composition or organic cementitious constituent and the identification of its intended use. The physico- chemical properties of the starting substance, composition or organic cementitious constituent necessary for carrying out migration testing should be established. The starting substance, composition or organic cementitious constituent should be tested for migration.
(3) Inclusion or removal of an entry in a European positive list should be based on the identification of chemical species that are relevant for the acceptance methodology, or risk assessment, because they may have an impact on the safe use of a material or product, such as an impurity, the constituent of a starting substance or a degradation product.
These relevant chemical species should be determined on the basis of the information on the identification of the starting substance, composition or constituent and on the basis of its intended use as well as the results of migration testing. The toxicological properties of these relevant chemical species should also be identified.
(4) For proportionality and efficiency reasons, testing for physico-chemical properties and toxicological properties as well as risk assessment should be more limited if a similar assessment has already been carried out at Union level within a reasonable period of time or if the substance has a stringent classification in Part 3 of Annex VI of Regulation (EC) No 1272/2008 of the European Parliament and of the Council(2)or the applicant proposes such classification. For proportionality reasons, the testing requirements for toxicological properties should be stricter where there is a high exposure to a certain substance through migration.
(5) In order to respect the precautionary principle and in order to cover the potential for significant exposure over a long period of time, the acceptance methodology should be based on a worst-case risk assessment of each relevant chemical species. The risk assessment should consider migration, including release, under the worst foreseeable conditions of use. In particular, the risk assessment should consider the expected long-term exposure to materials or products in contact with water intended for human consumption and, in the case of metallic compositions, the differences in the properties, such as composition and corrosivity, of all water in the Union intended for human consumption.
(1) OJ L 435, 23.12.2020, p. 1.
(2) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation
(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 1/33EN OJ L, 23.4.2024
(6) Economic operators and relevant authorities should be allowed sufficient time to adapt their national methodologies to the methodologies set out in this Decision. The application of this Decision should therefore be deferred.
(7) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 22(1) of Directive (EU) 2020/2184,
HAS ADOPTED THIS DECISION:
Article 1 Definitions For the purpose of this Decision, the following definitions apply:
(1) ‘non-intentionally added species’ means either one of the following:
(a) an impurity of a starting substance or organic cementitious constituent or composition;
(b) a reaction product or a degradation product of a starting substance or organic cementitious constituent that forms during the processing or use of the material;
(c) a reaction product or a degradation product of a starting substance or organic cementitious constituent that forms in contact with water during the use of the material;
(2) ‘nanoform’ means a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm–100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm. For the purpose of this
definition:
(a) ‘particle’ means a minute piece of matter with defined physical boundaries;
(b) ‘aggregate’ means a particle comprising strongly bound or fused particles;
(c) ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;
(3) ‘migration’ means transfer of substances from a material into water intended for human consumption.
Article 2 Testing and acceptance of starting substances, compositions and constituents
1. The methodologies referred to in Article 11(2), point (a), of Directive (EU) 2020/2184 shall apply to the following:
(a) starting substance for organic materials;
(b) organic constituent of cementitious materials;
(c) composition of metallic materials;
(d) composition of enamels, ceramic and other inorganic materials.
2. Where a polymer is intended for use in an organic material or a cementitious material, the testing and acceptance methodologies shall be applied to the monomer, pre-polymer or polymer in accordance with the rules set out in points v to viii of Annex I and points iii and iv of Annex III to Commission Implementing Decision (EU) 2024/367(3).
(3) Commission Implementing Decision (EU) 2024/367 of 23 January 2024 laying down rules for the application of Directive
(EU) 2020/2184 of the European Parliament and of the Council by establishing the European positive lists of starting substances, compositions and constituents authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption (OJ L, 2024/367, 23.04.2024, ELI: http://data.europa.eu/eli/dec_impl/2024/367/oj).
2/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojEN OJ L, 23.4.2024 Article 3 Testing methodology
1. Starting substances, compositions and organic cementitious constituents shall be identified in accordance with the requirements set out in Annex I.
2. The intended use of starting substances, compositions, constituents, as well as materials and products shall be specified in accordance with the requirements set out in Annex II.
3. The physico-chemical properties of the relevant chemical species shall be determined in accordance with the requirements set out in Annex III.
4. Migration into water intended for human consumption shall be determined in accordance with the requirements set out in Annex IV.
5. The relevant chemical species shall be identified in accordance with Section 3 of Annex IV.
6. The toxicological properties of the relevant chemical species referred to in paragraph 5 shall be determined in accordance with the requirements set out in Annex V.
Article 4 Acceptance methodology in the European positive lists
1. Starting substances, compositions and constituents shall be accepted in accordance with Annex VI on the basis of an assessment of the risks raised by the relevant chemical species identified for the corresponding starting substance, composition or organic cementitious constituent.
2. Starting substances and organic cementitious constituents which have a biocidal function and which are subject to Regulation (EU) No 528/2012 of the European Parliament and of the Council(4)shall only be accepted if they belong to product-type 6 (preservatives for products during storage) as set out in Annex V to that Regulation.
Article 5 Entry into force This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 31 December 2026.
Done at Brussels, 23 January 2024.
For the Commission The President Ursula VON DER LEYEN
(4) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 3/33I XENNA STNEUTITSNOC DNA SNOITISOPMOC ,SECNATSBUS GNITRATS FO NOITACIFITNEDI tes noitamrofni eht gnidulcni ,detareneg eb llahs smrofonan fo noitasiretcarahc dna stneutitsnoc dna snoitisopmoc ,secnatsbus gnitrats fo noitacifitnedi eht elbane ot noitamrofni tneiciffuS eb llahs snosaer eht ,elbat eht ni ot derrefer smeti eht fo erom ro eno no noitamrofni evig ot yrassecen yllacifitneics raeppa ton seod ti fi ro elbissop yllacinhcet ton si ti fI .elbaT eht ni tuo .detats ylraelc elbaT tneutitsnoc a ro noitisopmoc a ,ecnatsbus gnitrats a fo noitacifitnedi eht ot drager htiw gnitset dna noitamrofni dradnatS rehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro gnitset dna noitamrofni dradnatS :reifitnedi rehto yna ro emaN .1.1 eruP fo noinU lanoitanretnI eht ni emaN .1.1.1 nemon )CAPUI( yrtsimehC deilppA dna ehc lanoitanretni rehto ro/dna erutalc .elbaliava fi ,seman lacim .)elbaliava fi( )noitaiverbba ,eman edart ,eman lausu ,.g.e( seman rehtO .2.1.1 naeporuE ,)sceniE( secnatsbuS lacimehC laicremmoC gnitsixE fo yrotnevnI naeporuE moC gnitsixE fo yrotnevnI naeporuE .3.1.1 ycnegA eht yb dengissa rebmun eht ro )scnilE( secnatsbuS lacimehC deifitoN fo tsiL ,)sceniE( secnatsbuS lacimehC laicrem .elbaliava fi ,6002/7091 )CE( noitalugeR rednu buS lacimehC deifitoN fo tsiL naeporuE remyloP regnoL-oN ro )scnilE( secnats yb dengissa rebmun eht ro ,rebmun )PLN( )CE( noitalugeR rednu AHCE .elbaliava fi ,6002/7091 oN eman )SAC( ecivreS stcartsbA lacimehC .4.1.1 .elbaliava fi ,rebmun SAC dna fi ,rebmun tsiL evitisoP noinU naeporuE fi ,rebmun tsiL evitisoP noinU naeporuE fi ,rebmun tsiL evitisoP noinU naeporuE .5.1.1 .elbaliava .elbaliava .elbaliava EN OJ L, 23.4.2024 4/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojrehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro fo eman dna yrogetac lairetam fo emaN :noitangiseD .6.1.1 moc cinagroni rehto ro cimarec ,lemane .noitisop noitangised lairetam desidradnatS • dradnats naeporuE rednu rebmun ;elbaliava fi ,2141 NE noitangised lairetam desidradnatS • nats lanoitanretni rednu lobmys .elbaliava fi ,1-0911 OSI drad noitisopmoc cillatem gnitsixe fo ytitnedI .7.1.1 .ot sgnoleb noitisopmoc eht taht yrogetac cillatem wen fo noitangised dna ytitnedI .8.1.1 isopmoc eht taht yrogetac noitisopmoc .ot sgnoleb noit wen eht fo stneutitsnoc latem fo ytitnedI .9.1.1 roc dna yrogetac noitisopmoc cillatem inim( segnar noitartnecnoc gnidnopser .)w/w % mumixam dna mum wen eht fo seitirupmi latem fo ytitnedI .01.1.1 tneserp yrogetac noitisopmoc cillatem eht ni noitartnecnoc w/w % 20,0 evoba ixam gnidnopserroc dna noitisopmoc .)w/w %( ssam yb egatnecrep mum eht fo stneutitsnoc latem fo ytitnedI .11.1.1 cillatem wen eht rof lairetam ecnerefer gnidnopserroc dna yrogetac noitisopmoc dna muminim( segnar noitartnecnoc .)w/w % mumixam EN OJ L, 23.4.2024
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 5/33rehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro refer eht fo seitirupmi latem fo ytitnedI .21.1.1 moc cillatem wen eht rof lairetam ecne evoba tneserp era taht yrogetac noitisop moc eht ni noitartnecnoc w/w % 20,0 noc gnidnopserroc rieht dna noitisop ixam dna muminim( segnar noitartnec .)w/w % ,mum ralucelom ot detaler noitamrofnI .2.1 latsyrc ro alumrof larutcurts dna :erutcurts gnidulcni ,serutcurts latsyrc fo noitpircseD dulcni ,serutcurts latsyrc fo noitpircseD alumrof larutcurts dna alumrof raluceloM .1.2.1 ..elbaliava fi ,sesahp enillatsyrc ..elbaliava fi ,sesahp enillatsyrc gni lacimehC lanoitanretnI CAPUI gnidulcni( raluceloM deifilpmiS ,)IhCnI( reifitnedI aton )SELIMS( metsyS yrtnE eniL tupnI liava fi ,noitatneserper rehto dna noit .)elba ipyt dna ytivitca lacitpo no noitamrofnI .2.2.1 .elbaliava fi ,sremosi)oerets( fo oitar lac thgiew ralucelom ro thgiew raluceloM .3.2.1 .elbaliava fi ,egnar ti erehW .noitasiretcarahc lacimehC .3.1 mrofonan siht ,mrofonan a srevoc ot tnausrup desiretcarahc eb llahs :.4.1 tniop necnoc lacipyt ,.e.i ,)%( ytirup fo eergeD .1.3.1 rep ni( egnar noitartnecnoc dna noitart fo )mumixam dna muminim ,egatnec .stneutitsnoc ecnatsbus EN OJ L, 23.4.2024 6/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojrehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro SAC ,CE .g.e sreifitnedi rehto dna( semaN SAC ,CE .g.e sreifitnedi rehto dna( semaN rehto dna ,srebmun SAC ,CE( semaN .2.3.1 isopmoc eht fo stneutitsnoc fo )srebmun opmoc eht fo stneutitsnoc fo )srebmun noc ecnatsbus fo )elbaliava fi ,sreifitnedi ,.g.e( mrof yna ni stnemele eht ,.e.i ,noit ,.g.e( mrof yna ni stnemele eht ,.e.i ,noitis noc w/w % 20,0 evoba tneserp stneutits gnidnopserroc dna )dnuobnu ro dnuob gnidnopserroc dna )dnuobnu ro dnuob ta dna noitalumrof eht ni noitartnec xam dna muminim( segnar noitartnecnoc dna muminim( segnar noitartnecnoc bus eht ni w/w % 1,0 ≥ noitartnecnoc .)w/w % mumi .)w/w % mumixam noitamrofni tnuocca otni gnikat( ecnats
2.1.1 ,1.1.1 stniop rednu dettimbus
1.4.2 tniop ,1 elbaT dna evoba 3.1.1 dna lacipyt ,eseht fo hcae roF .)II xennA fo egnar noitartnecnoc dna noitartnecnoc .)w/w % mumixam dna muminim( ,CE .g.e sreifitnedi rehto dna( semaN • SAC ,CE .g.e sreifitnedi rehto dna( semaN SAC ,CE .g.e sreifitnedi rehto dna( semaN .3.3.1 rehto ,seitirupmi fo )srebmun SAC evoba tneserp seitirupmi fo )srebmun evoba tneserp seitirupmi fo )srebmun erp )bP( dael dna )dC( muimdac naht moc eht ni noitartnecnoc w/w % 20,0 umrof eht ni noitartnecnoc w/w % 20,0 noitartnecnoc w/w % 20,0 evoba tnes mumixam gnidnopserroc dna noitisop noc ta dna lairetam lanif eht fo noital gnidnopserroc dna noitisopmoc eht ni .)w/w %( thgiew yb egatnecrep ecnatsbus eht ni w/w % 1,0 ≥ noitartnec /w %( thgiew yb egatnecrep mumixam bus noitamrofni tnuocca otni gnikat( ;)w fo .2.4.2 dna .1.4.2 stniop rednu dettim .)II xennA fo 1 elbaT necrep mumixam eht no noitamrofnI • noitartnecnoc lacipyt ,eseht fo hcae roF muimdac rof )w/w %( thgiew yb egat dna muminim( egnar noitartnecnoc dna .)bP( dael dna )dC( .)w/w % mumixam noitacifitnedi eht rof cificeps atad lacitylana evitatitnauq dna evitatilauq yrassecen llA evitatitnauq dna evitatilauq yrassecen llA .4.3.1 ,sisylana latnemele sa hcus ,noitisopmoc eht fo stneutitsnoc dna noitisopmoc eht fo acifitnedi eht rof cificeps atad lacitylana noI ,ypocsortcepS noitprosbA cimotA ,yrtemortcepS ssaM amsalP delpuoC ylevitcudnI ,teloivartlu sa hcus ,ecnatsbus eht fo noit ro )FRX( ecnecseroulF yaR-X ,.g.e( atad noitcarffid ro/dna cirtemirtit ,yhpargotamorhC ,ecnanoser citengam raelcun ,der-arfni .)DRX( noitcarffiD redwoP yaR-X irtit ,cihpargotamorhc ,murtceps ssam carffid ro/dna sisylana latnemele ,cirtem .atad noit EN OJ L, 23.4.2024
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 7/33rehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro eht fo noitacifitnedi eht rof yrassecen era taht secnerefer lacihpargoilbib etairporppa eht ro sdohtem lacitylana eht fo noitpircseD .5.3.1 ecnatsbus dna seitirupmi fo noitacifitnauq dna noitacifitnedi eht gnidulcni( tneutitsnoc suoititnemec cinagro ,ecnatsbus gnitrats noitpircsed ehT .tneutitsnoc noitisopmoc cinagroni rehto ro ,cimarec ,lemane dna ,tneutitsnoc noitisopmoc cillatem ,)stneutitsnoc ot .1.3.1 stniop rednu detroper stluser eht fo noitaterpretni tnaveler eht dna dewollof slocotorp latnemirepxe eht fo tsisnoc llahs .decudorper eb ot sdohtem eht wolla ot tneiciffus eb llahs noitamrofni sihT .4.3.1 :mrofonan a fo noitasiretcarahC .4.1 onan eht fo sreifitnedi rehto ro semaN .1.4.1 cinagro ro ecnatsbus gnitrats eht fo mrof .elbacilppa fi ,tneutitsnoc suoititnemec noitubirtsid ezis elcitrap desab rebmuN .2.4.1 fo noitcarf rebmun eht fo noitacidni htiw mn 1 egnar ezis eht ni selcitrap mrofonan .mn 001 – noitasilanoitcnuf ecafrus fo noitpircseD .3.4.1 hcae fo noitacifitnedi dna tnemtaert ro ro SAC dna eman CAPUI gnidulcni tnega .rebmun CE olohprom rehto dna oitar tcepsa ,epahS .4.4.1 rofni ,ytinillatsyrc :noitasiretcarahc lacig gnidulcni ,erutcurts ylbmessa no noitam curts wolloh ro serutcurts ekil llehs ,.g.e .elbaliava fi ,serut yb aera ecafrus cificeps( aera ecafruS .5.4.1 ro ssam yb aera ecafrus cificeps ,emulov .)htob ro sdohtem lacitylana eht fo noitpircseD .6.4.1 refer lacihpargoilbib etairporppa eht ni stnemele noitamrofni eht rof secne fus eb llahs noitamrofni sihT .4.1 tniop orper eb ot sdohtem eht wolla ot tneicif .decud EN OJ L, 23.4.2024 8/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojrehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro rof deriuqer noitamrofni lanoitiddA .5.1 cinagro dna secnatsbus gnitrats era hcihw stneutitsnoc suoititnemec :sremylop-erp )b( ro sremylop )a( SAC ,CE .g.e sreifitnedi rehto dna( emaN .1.5.1 caer rehto dna sremonom fo )srebmun orp si ecnatsbus eht hcihw morf stnat .decud noitpircsed ssecorp gnirutcafunaM .2.5.1 fo esu eht no noitamrofni gnidulcni( rieht sa llew sa stnatcaer dna sremonom .)oitar .remylop)-erp( eht ot sevitiddA .3.5.1 ylop)-erp( eht fo noitamrofni erutcurtS .4.5.1 .rem troper tset ;noitubirtsid ssam raluceloM .5.5.1 si noitubirtsid ssam ralucelom eht fo .deriuqer .ssam ralucelom degareva rebmuN .6.5.1 dna muminim( egnar ssam raluceloM .7.5.1 .)mumixam stneutitsnoc ecnatsbus eht fo seititnedI .8.5.1 dna aD 0001 < thgiew ralucelom htiw .)w/w %( thgiew yb egatnecrep rieht artnecnoc rieht dna sremonom laudiseR .9.5.1 .)%( snoit ytisocsiV .01.5.1 xedni wolf tleM .11.5.1 EN OJ L, 23.4.2024
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 9/33II XENNA ESU DEDNETNI tuo tes noitamrofni eht gnidulcni ,detareneg eb llahs stcudorp dna slairetam lanif fo sa llew sa tneutitsnoc ,snoitisopmoc ,secnatsbus gnitrats fo esu dednetni eht no noitamrofni tneiciffuS .1 elbaT ni 1 elbaT esu dednetni ot drager htiw gnitset dna noitamrofni dradnatS rehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro gnitset dna noitamrofni dradnatS :esU .2 .yrogetac-bus lairetam dna yrogetac lairetam ,epyt lairetam eht fo noitacifitnedI etac-bus dna yrogetac ,epyt lairetaM .1.2 :yrog dna lairetam lanif fo esu dna ytitnedI .2.2 :tcudorp .tnenopmoc/tcudorp eht fo noitacificepS .1.2.2 .snoitallatsni citsemod-non .sv citsemod :sesu fo aera fo noitinifeD ,lemane rof spuorg tcudorp tnaveleR cillatem rof spuorg tcudorp tnaveleR cinagro rof spuorg tcudorp tnaveleR .2.2.2 refer( slairetam cinagroni rehto ro cimarec siht fo 2 elbaT ot refer( snoitisopmoc refer( slairetam suoititnemec ro slairetam noissimmoC ot VI xennA fo 5 elbaT ot .)xennA noissimmoC ot I xennA fo 5 elbaT ot .863/4202 )UE( noisiceD gnitnemelpmI noisiceD gnitnemelpmI .)1(863/4202 )UE( toh ro )C° 56 – 52( mraw/)C° 52 ≤( dloC toh ro )C° 56 – 52( mraw/)C° 52 ≤( dloC toh ro )C° 56 – 52( mraw/)C° 52 ≤( dloC .3.2.2 .esu retaw )C° 56 ≥( .esu retaw )C° 56 ≥( .esu retaw )C° 56 ≥( .noitcnuf lacinhcet eht fo noitacificepS :noitcnuf lacinhceT .3.2 bus gnitrats eht fo esu fo snoitidnoC .4.2 cinagro ro noitisopmoc ,ecnats lanif eht fo ;tneutitsnoc suoititnemec :tcudorp eht fo dna ;lairetam EN OJ L, 23.4.2024 10/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojrehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro etam cinagro rof secnatsbus gnitrats roF .1.4.2 gnitrats eht fo egasod mumixaM :slair ecudorp ot noitalumrof eht ni ecnatsbus .lairetam lanif eht suoititnemec fo stneutitsnoc cinagro roF .2.4.2 :slairetam eht fo egasoD :sremylop fo esac nI • ot stnatcaer rehto ro sremonom sremylop eht ecudorp tneutitsnoc eht fo egasod mumixaM • noc cireneg a ecudorp ot )remylop( .tneutits noc cireneg eht fo egasod mumixaM • ot noitalumrof eht ni desu tneutits .lairetam lanif eht ecudorp eht no tneutitsnoc ro noitisopmoc ,ecnatsbus gnitrats eht fo noisulcni eht rof esu fo snoitidnoc rehto ro snoitcirtser desoporP .3.4.2 .tsil evitisop naeporuE dna gnissecorp eht no noitamrofnI .5.2 lanif ,lairetam eht fo erutcurts lanretni :tcudorp dna lairetam orp ro lairetam lanif ,lairetam fo tnemtaert gnidulcni ,tcudorp dna lairetam lanif ,lairetam eht fo gnissecorp eht no noitamrofnI .1.5.2 .esu ot roirp tcud EN OJ L, 23.4.2024
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 11/33rehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro lanif eht fo serutarepmet gnissecorP gnirutcafunam eht fo noitpircseD • lanif eht fo serutarepmet gnissecorP .2.5.2 .lairetam orp ot desu spets gnissecorp dna .lairetam klub roF .lairetam lanif eht ecud noitpircsed sedulcni siht slairetam nahcem sa hcus gnissecorp yna fo taert taeh( lamreht ,)gnimrof( laci ,yhpargollatsyrc gnitceffa )tnem dna ezis( seigolohprom niarg seitirupmi ,erutcurts esahp ,)epahs laudiser ,noitubirtsid rieht dna ro/dna erutcurtsorcim ,sesserts yllacificeps roF .noitidnoc ecafrus ,sgnitalp ,sreyal ecafrus decudorp ,gnitalp eht fo ecafrus deilppa eht gnissecorp niam dna epyt ssecorp porp gnitalp sa llew sa snoitidnoc ;debircsed eb dluohs seitre dna gnirutcafunam etairporppA • gnitluser dna spets gnissecorp tnemtaert taeh‘ sa hcus ,seitreporp sid esahp‘ ro ’esahp-ateb ecuder ot .’lairetam lanif eht ni noitubirt .lairetam lanif eht fo erutcurts lanretni eht no noitamrofnI .3.5.2 stnemssessa level lanoitan dna noinU .6.2 :snoitasirohtua dna ni esu rof level lanoitan ro noinU naeporuE eht ta noitaluger tnaveler rehto dna tnemssessa ksir ,noitasirohtua yna fo sliateD .1.6.2 .noitpmusnoc namuh rof dednetni retaw htiw tcatnoc otni gnimoc slairetam ro slairetam lanif ni esu rof level lanoitan ro noinU naeporuE eht ta noitaluger tnaveler rehto dna tnemssessa ksir ,noitasirohtua yna fo sliateD .2.6.2 .doof htiw tcatnoc otni gnimoc slairetam ro slairetam lanif evitca ladicoib fo noitasirohtua UE .7.2 :secnatsbus EN OJ L, 23.4.2024 12/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojrehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro trats eht fo sutats tnemssessa/lavorppA .1.7.2 suoititnemec cinagro ro ecnatsbus gni )UE( noitalugeR rednu tneutitsnoc .2102/825 oN gnitrats eht ot tnaveler epyt-tcudorP .2.7.2 noc suoititnemec cinagro ro ecnatsbus )UE( noitalugeR rednu tneutits .2102/825 oN noitalugeR rednu etad trats lavorppA .3.7.2 .2102/825 oN )UE( )UE( noitalugeR rednu etad dne lavorppA .4.7.2 .2102/825 oN yllanoitnetni-non fo noitacifitnedI .3 :seitirupmi naht rehto seiceps dedda -non fo ecneserp eht no noitaulavE .1.3 naht rehto seiceps dedda yllanoitnetni stneutitsnoc ecnatsbus dna seitirupmi otni gnikat lairetam eht morf gnitargim :gniwollof eht tsael ta tnuocca ;seitreporp lacimehc-ocisyhp )a( ;snoitcnuf lacinhcet )b( ;xirtam eht htiw noitcaretni )c( ;scitsiretcarahc retaw )d( yb sretaw gnitset fo sisylana fo stluser )e( gnineercs etairporppa na gniylppa noissimmoC ni tuo tes sa dohtem noisiceD gnitnemelpmI 863/4202 )UE( EN OJ L, 23.4.2024
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 13/33rehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro ro ecnatsbus gnitrats eht fo snoitcaeR .2.3 rucco tneutitsnoc suoititnemec cinagro lairetam eht fo gnissecorp eht gnirud gnir arged ro noitcaer dna lairetam lanif dna otni gnikat osla( demrof stcudorp noitad nomed sa ytilibats lamreht eht tnuocca ytilibats lamreht yrotadnam a yb detarts )ecnatsbus eht fo ,tset ro ecnatsbus gnitrats eht fo snoitcaeR .3.3 rucco tneutitsnoc suoititnemec cinagro ni lairetam lanif eht fo esu eht gnirud gnir namuh rof dednetni retaw htiw tcatnoc noitadarged ro noitcaer dna noitpmusnoc otni gnikat osla( demrof stcudorp a yb detartsnomed sa sisylordyh tnuocca bus eht fo yduts sisylordyh yrotadnam .)ecnats taht secnatsbus rehto fo noitacifitnedI .4.3 retaw gniknird eht otni etargim yam dna secnatsbus gnitrats gnisu nehw stneutitsnoc suoititnemec cinagro caer rehto ro sremonom era
hcihw :stnat ylop yna fo ecneserp eht fo noitaulavE .1.4.3 eler si taht aD 0001 woleb trap desirem ro ecnatsbus gnitrats eht fo esu eht ot tnav .tneutitsnoc suoititnemec cinagro eht ot sdael taht ssecorp fo noitpircseD .2.4.3 woleb trap desiremylop eht fo noitamrof .aD 0001 EN OJ L, 23.4.2024 14/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojrehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro rof ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro ylop rof noitubirtsid thgiew raluceloM .3.4.3 troper tset ;aD 0001 woleb trap desirem si noitubirtsid thgiew ralucelom eht fo .deriuqer fo thgiew ralucelom degareva rebmuN .4.4.3 .aD 0001 woleb trap desiremylop fo )xam dna nim( egnar ssam raluceloM .5.4.3 .aD 0001 woleb trap desiremylop 0001 woleb trap desiremylop laudiseR .6.4.3 .)%( noitartnecnoc sti dna aD SAC ,CE .g.e sreifitnedi rehto dna( emaN .5.3 dedda yllanoitnetni-non fo )srebmun .4,3–.1.3 stniop rednu deifitnedi seiceps eht sdrager sa licnuoC eht fo dna tnemailraP naeporuE eht fo 4812/0202 )UE( evitceriD fo noitacilppa eht rof selur nwod gniyal4202 yraunaJ 32 fo 863/4202 )UE( noisiceD gnitnemelpmI noissimmoC )1( .atad//:ptth :ILE ,4202.40.32 ,863/4202 ,L JO( noitpmusnoc namuh rof dednetni retaw htiw tcatnoc otni emoc taht stcudorp ni desu sa slairetam lanif gnitpecca dna gnitset rof sdohtem dna serudecorp .)jo/863/4202/lpmi_ced/ile/ue.aporue EN OJ L, 23.4.2024
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 15/332 elbaT snoitisopmoc cillatem rof spuorg tcudorP ecafrus tcatnoc demussA stnenopmoc ro stcudorp cillatem fo selpmaxE tcudorP ’a‘ puorg % 001 .sepiP A % 01 .snoitallatsni sgnidliub ni seirallicna ,sgnittiF B % 1 fo noitpmusnoc namuh rof dednetni retaw htiw tcatnoc ni secafrus eht fo mus ehT .B puorG tcudorP fo stcudorp fo stnenopmoC .1 C .tcudorp eht fo ecafrus dettew latot eht fo % 01 naht ssel eb llahs stnenopmoc eseht lla .wolf tnenamrep htiw skrow tnemtaert retaw dna sniam retaw ni seirallicna ,sgnittiF .2 % 1,0 < 2 yrogetacbus C puorg tcudorp rof debircsed sa skrow tnemtaert retaw ni dna sniam retaw ni seirallicna dna sgnittif fo stnenopmoC D .)evoba EN OJ L, 23.4.2024 16/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojEN OJ L, 23.4.2024 ANNEX III PHYSICO-CHEMICAL PROPERTIES
Section 1. No standard information or testing requirement No standard information or testing shall be required for starting substances and organic cementitious constituents where
either of the following conditions are fulfilled:
(a) a parametric value for the starting substance or organic cementitious constituent is set under Annex I to Directive
(EU) 2020/2184;
(b) a Maximum Tolerable Concentration at the tap (MTC ) value for the starting substance or organic cementitious tap constituent is set in the corresponding Annex to Commission Implementing Decision (EU) 2024/367(1)following a decision by the Commission on an application for a starting substance, composition or organic cementitious constituent that has been submitted to ECHA under Article 3 of Commission Delegated Regulation (EU) 2024/369(2) and the applicant submits at least any new or updated information available as from the date of the Commission’s decision;
(c) a specific migration limit is set under Commission Regulation (EU) No 10/2011(3)for less than 15 years before the submission of an application under Article 3 of Delegated Regulation (EU) 2024/369.
Section 2. Standard information or testing required
2.1. Testing under this Section shall be carried out in compliance with the principles of good laboratory practice
provided for in Directive 2004/10/EC of the European Parliament and of the Council(4) or other international standards recognised as being equivalent to Directive 2004/10/EC by the Commission or ECHA.
2.2. Testing under this Section shall be carried out in compliance with the test method as determined and specified by ECHA and published on its website, taking into account in particular the requirements set out in point 2.5.
2.3. Column 1 of Table 1 establishes the required standard information and testing for a starting substance or organic cementitious constituent.
Column 1 of Table 1, points 4.7 and 4.8 establish the required standard information and testing for relevant chemical species other than a starting substance or organic cementitious constituent.
Column 1 of Table 1, points 4.1.3, 4.2 and 4.4 establish the required standard information and testing for a metallic, enamel, ceramic or other inorganic composition.
(1) Commission Implementing Decision (EU) 2024/367 of 23 January 2024 laying down rules for the application of Directive
(EU) 2020/2184 of the European Parliament and of the Council by establishing the European positive lists of starting substances, compositions and constituents authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption (OJ L, 2024/367, 23.04.2024, ELI: http://data.europa.eu/eli/dec_impl/2024/367/oj).
(2) Commission Delegated Regulation (EU) 2024/369 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down the procedure regarding inclusion in or removal from the European positive lists of starting substances, compositions and constituents (OJ L, 2024/369, 23.04.2024, ELI: http://data.europa.eu/eli/reg_del/2024/369/oj).
(3) 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).
(4) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 17/33EN OJ L, 23.4.2024 Column 2 of Table 1 establishes specific rules according to which the standard information and testing of column 1 may be omitted, replaced by other information, or adapted in another way.
2.4. Any other relevant physico-chemical information shall be identified and considered in addition.
2.5. Where a test method offers flexibility in the determination or choice of the study design, including by not prohibiting certain specifications, the chosen study design shall ensure that the data generated are adequate for migration testing and risk assessment.
2.6. The general rules for adaptations set out in Sections 1 and 2 of Annex XI to Regulation (EC) No 1907/2006(5)shall apply mutatis mutandis.
Table 1 Standard information and testing, and specific rules for the adaptation of such information and testing, with regard to physico-chemical properties Column 1 Column 2 Standard information and testing Specific rules for adaptation of the standard information and testing
4.1. Appearance at 20 °C and 101,3 kPa
4.1.1. Physical state
4.1.2. Aggregate state (e.g., viscous, crystalline, powder)
4.1.3. Colour
4.1.4. Odour
4.2. Melting/freezing point No need to provide information below a lower limit of – 20 °C.
4.3. Boiling point No need to provide information for the following:
(a) gases;
(b) solids which either melt above 300 °C or decompose before boiling, in which case the boiling point under reduced pressure may be estimated or measured;
(c) substances which decompose before boiling (e.g. auto-oxidation, rearrangement, degradation, decomposition, etc.).
4.4. Density The study for density does not need to be conducted in the following
cases:
(a) the substance is only stable in solution in a particular solvent and the solution density is similar to that of the solvent, in which case an indication of whether the solution density is higher or lower than the solvent density is sufficient;
(b) the substance is a gas, in which case an estimation based on calculation shall be made from its molecular weight and the Ideal Gas Laws.
(5) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396,
30.12.2006, p. 1-849).
18/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojEN OJ L, 23.4.2024 Column 1 Column 2 Standard information and testing Specific rules for adaptation of the standard information and testing
4.5. Vapour pressure No need to provide information if the melting point is above 300 °C.
If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recognised calculation method is sufficient.
4.5.1. Henry’s law constant must always be stated for solids and liquids if it can be calculated.
4.6. Surface tension of an aqueous The information need only be provided in the following cases: solution (a) based on structure, surface activity is expected or can be predicted;
(b) surface activity is a desired property of the material;
If the water solubility is below 1 mg/l at 20 °C, the test does not need to be conducted.
4.7. Water solubility No need to provide information in the following cases:
(a) the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours);
(b) the substance is readily oxidisable in water.
If the substance appears ‘insoluble’ in water, a limit test up to the detection limit of the analytical method shall be performed.
For metals and sparingly soluble metal compounds, information on transformation/dissolution in aqueous media shall be provided.
4.8. Partition coefficient (n-octanol/ No need to provide information if the substance is inorganic. water) and its pH dependency If the test cannot be performed (e.g., the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for the parti tion coefficient as well as details of the calculation method shall be
provided.
4.9. Granulometry The study does not need to be conducted if the substance is marketed or used in a non-solid or non-granular form.
4.10. Dissociation constant No need to provide information in the following cases:
(a) the substance is hydrolytically unstable (half-life less than 12 hours) or is readily oxidisable in water;
(b) it is scientifically not possible to perform the test, for instance if the analytical method is not sensitive enough;
(c) based on the structure, the substance does not have any chemical group that can dissociate.
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 19/33VI XENNA SEICEPS LACIMEHC TNAVELER FO NOITAMRIFNOC DNA NOITARGIM noitargim fo noitanimreted eht rof gnitset dna noitamrofni dradnats ,stnemeriuqer lareneG .1 noitceS lanoitanretni rehto ro 52071 CEI/OSI NE dradnats ni rof dedivorp ecitcarp yrotarobal doog fo selpicnirp eht htiw ecnailpmoc ni tuo deirrac eb llahs noitceS siht rednu gnitset ynA .1.1 .AHCE ro noissimmoC eht yb tnelaviuqe gnieb sa desingocer sdradnats wollof osla llahs gnilledom ro gnitset hcuS .woleb deifitnedi ro etisbew sti no dehsilbup dna AHCE yb denimreted dohtem tset etairporppa eht wollof llahs gnilledom ro gnitset ynA .2.1 noitargim rof tnemeriuqer eht tnuocca otni gnikat ,noitargim no noisulcnoc elbailer dna etauqeda erusne ot etisbew sti no dehsilbup dna AHCE yb denimreted snoitacificeps eht .esu fo snoitidnoc elbaeeserof tsrow no desab noitanimreted eb llahs eceip tset eht dna tneutitsnoc ro noitisopmoc ,ecnatsbus gnitrats eht rof esu dednetni eht fo sisab eht no tuo deirrac eb llahs noitceS siht rednu gnilledom ro gnitset ynA .3.1 .esu fo snoitidnoc elbaeeserof tsrow fo evitatneserper :detareneg eb llahs ,1 elbaT ni tuo tes noitamrofni eht gnidulcni tsael ta ,secnatsbus gniwollof eht lla fo noitargim eht fo noitanimreted eht no noitamrofni tneiciffuS .4.1 eht ni ,5.1 dna
3.1 stniop htiw ecnadrocca ni deifitnedi seiceps dedda yllanoitnetni-non hcae dna ,tneutitsnoc ecnatsbus ,tneutitsnoc suoititnemec cinagro ,ecnatsbus gnitrats eht )a( a fo tnatcaer rehto ro remonom a sa snoitcnuf hcihw tneutitsnoc suoititnemec cinagro na ro ecnatsbus gnitrats yna sa llew sa II xennA fo 1 elbaT ni 3 tniop dna I xennA fo elbat ;lairetam eht ni remylop niam :sselnu ,I xennA fo elbat eht ni
3.3.1 dna
2.3.1 stniop htiw ecnadrocca ni deifitnedi ytirupmi dna tneutitsnoc noitisopmoc cillatem hcae )b( ro ;nit ro ruflus ,nocilis ,surohpsohp si tneutitsnoc noitisopmoc cillatem eht )i( ;cniz ro nit ,nocilis ,surohpsohp ,esenagnam ,nori ,muinimula si ytirupmi noitisopmoc cillatem eht )ii( tneutitsnoc noitisopmoc cinagroni eht sselnu ,I xennA fo elbat eht ni
3.3.1 dna 2.3.1 stniop htiw ecnadrocca ni deifitnedi ytirupmi dna tneutitsnoc noitisopmoc cinagroni hcae )c( .cniz ro nit ,muidos ,nocilis ,muissatop ,surohpsohp ,negortin ,muisengam ,nori ,eniroulf ,muiclac ,nobrac si morf gnitluser sretaw noitargim eht ,slairetam cillatem sa snoitisopmoc fo tsil evitisop naeporuE eht ni dedulcni ton era taht syolla ro slatem era hcihw secnatsbus gnitrats fo esac nI .5.1 .)b(4.1 noitceS tniop ni tuo tes selur eht htiw ecnadrocca ni desylana eb llahs lairetam lanif eht fo eceip tset evitatneserper a fo gnitset .deredisnoc dna deifitnedi eb llahs elbaliava si taht noitamrofni noitargim tnaveler rehto ynA .6.1 EN OJ L, 23.4.2024 20/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj1 elbaT noitargim ot drager htiw gnitset dna noitamrofni dradnatS rehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro ro ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro :noitargiM .5 seceip tseT .1.5 eht neewteb seceip tset eht fo egarots eht dna seceip tset eht fo noitcudorp eht ,snoisnemid gnidulcni seceip tset eht fo noitpircsed deliateD .1.1.5 .seceip tset eht fo recudorp eht fo eman eht gnidulcni gnilpmas eht dna noitcudorp cinagro/ecnatsbus gnitrats eht fo egasoD .2.1.5 tset eht ecudorp ot tneutitsnoc suoititnemec .seceip /ecnatsbus gnitrats eht fo noitartnecnoC .3.1.5 tset eht ni tneutitsnoc suoititnemec cinagro .seceip .seceip tset eht fo noitisopmoC .seceip tset eht fo noitisopmoC .4.1.5 tset eht fo ecafrus renni eht fo ssenhguoR .5.1.5 .seceip ro morf edam stcudorp rof dohtem tseT dohtem tseT :snoitisopmoc cillatem llA )a( dna stcudorp edam-yrotcaf rof dohtem tseT aiv ytefas cineigyh rof gnitseT .2.5 suoertiv/nialecrop( yssalg gnitaroprocni nats ni dehsilbatse tset gir cimanyd rof rocni ro morf edam stcudorp deilppa etis cele ro sdohtem noitargim dradnats eht ot gnidrocca slairetam )lemane fo tnemssessa rof 1-46651 NE drad ot gnidrocca slairetam cinagro gnitarop eht fo sdohtem lacimehcort elpmI noissimmoC VI xennA ni debircsed .esaeler latem moC ot I xennA ni ot derrefer sdradnats ni deificeps sa secnatsbus .863/4202 )UE( noisiceD gnitnem tibihxe hcihw snoitisopmoc cillateM )b( noisiceD gnitnemelpmI noissim .4.1 noitceS VI xennA htiw tcatnoc ni ruoivaheb evissap .863/4202 )UE( pmusnoc namuh rof dednetni retaw nats ni dehsilbatse dohtem tseT :noit evissap eht etaulave ot 65061 NE drad rehto dna sleets sselniats fo ruoivaheb .snoitisopmoc
cillatem evissap :sgnitalP )c( tniop ni ot derrefer dohtem stseT • ro ;)a( EN OJ L, 23.4.2024
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 21/33rehto ro ,cimarec ,slemane fo noitisopmoC slairetam cillatem fo noitisopmoC /slairetam cinagro ro ecnatsbus gnitratS slairetam cinagroni stneutitsnoc suoititnemec cinagro nats ni dehsilbatse dohtem tset ehT • tnereffid 3 htiw ,85061 NE drad .seceip tset evissap rehto dna sleets sselniats fo ruoivaheb evissap eht etaulave ot dohtem tset eht gnidulcxe( .2.5 tniop htiw ecnadrocca ni gnitset roF hcet dna sdohtem lacitylanA .3.5 :)snoitisopmoc cillatem seuqin ele ro seiceps lacimehc tnaveler yllaitnetop fo snoitartnecnoc esylana ot desu seuqinhcet dna sdohtem lacitylana fo sliated dna noitpircseD tnaveler sedulcni siht )sgnitalp ,sgnitaoc( sreyal ecafrus roF .gnitset noitargim morf gnitluser retaw tcatnoc ro/dna noitargim morf stnem ylpmoc llahs dna detadilav eb llahs seuqinhcet dna sdohtem ehT .etartsbus eht morf dna reyal ecafrus eht morf stnemele ro seiceps lacimehc fo noitaterpretni tnaveler eht dna dewollof slocotorp latnemirepxe eht fo tsisnoc llahs noitpircsed ehT .airetirc ecnamrofrep muminim htiw .decudorper eb ot sdohtem eht wolla ot tneiciffus eb llahs noitamrofni sihT .stluser eht noitargim eht ot drager htiw gnitset dna noitamrofni fo noitatpada rof selur lareneG .2 noitceS gnitnemelpmI noissimmoC fo I xennA ni tuo tes dradnats gnitset noitargim eht htiw ecnadrocca ni gnilledom lacitamehtam gnisu slairetam cinagro ni noitargim fo noitciderp A .1.2 fo yna ,noitanalpxe cifitneics a fo sisab eht no ,erehw lairetam cinagro na ni desu
4.1 noitceS ,VI xennA ni deificeps sa secnatsbus a rof gnitset ecalper yam 863/4202 )UE( noisiceD :tem si snoitidnoc gniwollof eht ;elbissop yllacinhcet ton eb ot detartsnomed si gnitset )a( ;euqinhcet elbaliava tseb eht gnisu ,noitacifitnauq fo timil eht woleb retaw ni ecnatsbus eht fo noitartnecnoc a eriuqer dluow gnitset )b( .retaw ni sedarged yldipar ecnatsbus tset eht )c( noitisopmoc cillatem rehtona ot ,seitiralimis larutcurts dna lanoitisopmoc fo tluser a sa ,ralimis eb ot ylekil si noitargim sti fi deviaw eb yam noitisopmoc cillatem a fo gnitset lacisyhP .2.2 :tem era snoitidnoc gniwollof eht dna ,ralucitrap ni ,dna snoitisopmoc retaw tnuocca otni sekat noitanalpxe gnitroppus eht dna wolf retaw tnenamrep rednu desu era snoitisopmoc eht ,snoitisopmoc suorref roF )a( ;noitartnecnoc negyxo :syolla reppoc roF )b( ;ruoivaheb noisorroc ralimis evah syolla eht )i( ;yrogetac noitisopmoc cillatem emas eht ot sgnoleb eceip tset evitatneserper eht )ii( ;erutcurtsorcim dna seitirupmi ,stnemele gniyolla lacitnedi evah syolla eht )iii( .l/gμ 001 naht rehgih seulav CTM evah noitisopmoc cillatem ralimis eht fo seitirupmi dna stneutitsnoc eht )vi( pat :)b( dna )a( syolla reppoc dna snoitisopmoc suorref htob roF )c( ;tuo deirrac neeb sah noitisopmoc cillatem ralimis eht rof tset noitargim elbailer dna etauqeda na )i( EN OJ L, 23.4.2024 22/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj;detartsnomed neeb sah seiceps lacimehc tnaveler fo noitacifitnedi dna noitanimreted ) C( pat eht ta noitartnecnoc fo esoprup eht rof ycauqeda )ii( pat .desu neeb evah noitisopmoc cillatem ralimis taht fo seiceps lacimehc tnaveler fo noitacifitnedi dna C eht )iii( pat noitisopmoc cillatem eht fo noitargim eht yhw noitanalpxe na edulcni llahs noitatnemucod hcuS .dedivorp eb llahs dohtem deilppa eht fo noitatnemucod elbailer dna etauqeda ,sesac lla nI .noitanalpxe hcus yfitsuj yllacifitneics ot noitamrofni gnitroppus dna noitisopmoc cillatem ralimis eht no noitamrofni eht no desab denimreted eb yam seiceps lacimehc tnaveler fo noitacifitnedi eht rof airetirC.3 noitceS eht steem tneutitsnoc ro noitisopmoc ,ecnatsbus gnitrats eht taht etartsnomed ot redro ni V xennA ni tuo tes stnemeriuqer eht yb derevoc era taht esoht era seiceps lacimehc tnaveleR :gniwollof eht edulcni seiceps lacimehc tnaveleR .IV xennA ni tuo tes airetirc ecnatpecca ;lairetam eht ni remylop niam a fo tnatcaer rehto ro remonom a sa noitcnuf hcihw stneutitsnoc suoititnemec cinagro dna secnatsbus gnitrats )a( suoititnemec cinagro ro ecnatsbus gnitrats eht morf gnitanigiro seiceps dedda yllanoitnetni-non dna stneutitsnoc ecnatsbus ,stneutitsnoc suoititnemec cinagro ,secnatsbus gnitrats )b( ;noitargim fo slevel rieht fo evitcepserri IV xennA fo
1.1 noitceS ni ot derrefer sdrazah htlaeh namuh eht fo eno wohs hcihw tneutitsnoc suoititnemec cinagro ro ecnatsbus gnitrats a morf gnitanigiro seiceps dedda yllanoitnetni-non dna stneutitsnoc ecnatsbus ,stneutitsnoc suoititnemec cinagro ,secnatsbus gnitrats )c( namuh rof dednetni retaw otni etargim ot dnuof neeb evah dna 1 elbaT htiw ecnadrocca ni detset neeb evah hcihw dna )b( ro )a( tniop rednu llaf ton od hcihw tneutitsnoc ;l/gμ 1,0 gnideecxe ) C( pat eht ta noitartnecnoc a htiw noitpmusnoc pat ;1 elbaT htiw ecnadrocca ni detset neeb evah hcihw ,seitirupmi ro stneutitsnoc noitisopmoc cillatem )d( .1 elbaT htiw ecnadrocca ni detset neeb evah hcihw noitisopmoc cinagroni rehto ro cimarec ,lemane na fo seitirupmi ro stneutitsnoc noitisopmoc cinagroni rehto ro cimarec ,lemane )e( EN OJ L, 23.4.2024
ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj 23/33EN OJ L, 23.4.2024 ANNEX V TOXICOLOGICAL PROPERTIES
Section 1. No standard information or testing
1.1. No standard information or testing is required for a relevant chemical species where either of the following
conditions are fulfilled:
(a) a parametric value for the relevant chemical species is set under Annex I to Directive (EU) 2020/2184;
(b) a MTC value for the relevant chemical species in the applicable material type is set in the corresponding tap Annex to Implementing Decision (EU) 2024/367 following a decision by the Commission on an application for a starting substance, composition or constituent that has been submitted to ECHA under Article 4 of Delegated Regulation (EU) 2024/369 and the applicant submits at least any new or updated information available as from the date of the Commission’s decision;
(c) the relevant chemical species is classified in Regulation (EC) No 1272/2008 of the European Parliament and of the Council(1)as one of the following:
(i) Category 1A or 1B for carcinogenicity, mutagenicity or reproductive toxicity or Category 1 for endocrine disruption for human health;
(ii) persistent bioaccumulative and toxic;
(iii) very persistent and very bioaccumulative;
(iv) persistent mobile and toxic;
(v) very persistent and very mobile;
(d) the relevant chemical species is identified as a substance of very high concern in the Candidate List established under Article 59 of Regulation (EC) No 1907/2006, except those identified on the basis of Article 57(f) of Regulation (EC) No 1907/2006 only for the environment;
(e) the relevant chemical species is authorised as an active substance under Regulation (EU) No 528/2012 on the basis of an opinion of the Committee of the Risk Assessment of ECHA setting a defined safety threshold for the oral route and used as such in materials in contact with water under Product-type 6.
1.2. No standard information or testing is required for a relevant chemical species, to the extent that a specific migration limit is set under Commission Regulation (EU) No 10/2011 for less than 15 years from the date of submission of the application under Article 3 of Delegated Regulation (EU) 2024/369.
Section 2. Standard information or testing required Part 1. General and specific rules
1.1. Testing under this Section shall be carried out in compliance with the principles of good laboratory practice
provided for in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or ECHA and with the provisions of Directive 2010/63/EU of the European Parliament and of the Council(2), if applicable.
(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation
(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(2) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010. on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
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1.2. Any applicant shall ensure that testing on vertebrate animals is carried out only when no alternative methods, identified under this Section, is available. If testing on vertebrate animals is unavoidable, such testing shall be designed, where appropriate, by taking into account the possibility to explore several parameters within the framework of one study (e.g. kinetic data generation, micronucleus formation, neurotoxicity, immunotoxicity) or to combine two studies (e.g. long-term toxicity study and carcinogenicity study) to the extent permitted by the corresponding test method.
1.3. Testing under this Section shall be carried out in compliance with the appropriate test guideline determined and specified by ECHA and published on its website, taking into account in particular the requirements set out in
Section 1.6.
1.4. A stepwise approach for toxicological testing shall be applied based on the C of a relevant chemical species in tap water intended for human consumption. For the lowest migration concentration band, the standard information is set out in Table 1, and every time a new migration band is reached, the standard information set out in the corresponding Tables 2 and 3 shall be added.
Column 1 of Tables 1, 2 and 3 establishes the standard information for relevant chemical species.
Column 2 of Tables 1, 2 and 3 lists specific rules according to which the standard information and testing may be omitted.
Standard information and testing may be adapted according to the general rule set out in Part 2.
1.5. Any other relevant toxicological information that is available shall be identified and considered.
1.6. Where a test method offers flexibility in the determination or choice of the study design, including by not prohibiting certain study specifications, for example in relation to the choice of dose levels, the chosen study design shall ensure that the data generated are adequate for hazard identification and risk assessment. To this end, testing shall be performed at appropriately high dose levels. If dose (concentration) selection is limited by the physico- chemical properties or biological effects of the test substance, the applicant shall provide a scientifically robust justification.
Table 1 Standard information and testing – C below 2,5 μg/l tap Column 1 Column 2 Standard information and testing Specific rules for adaptation of the standard information and testing
6.1. Genotoxicity/Mutagenicity:
6.1.1. In vitro genetic toxicity
6.1.1.1. In vitro gene mutation study in bacteria The in vitro gene mutation study in bacteria does not need to be conducted if this test is not applicable for the relevant chemical species. In this case, the applicant shall provide a justification and perform an in vitro study referred to in point 6.1.1.3.
The study does not need to be conducted for nanoforms where it is not appropriate. In this case, other studies involving one or more in vitro mutagenicity studies in mammalian cells shall be provided.
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6.1.1.2. In vitro mammalian chromosomal The study does not need to be carried out if an adequate data from aberration study or in vitro mammalian an in vivo cytogenicity test is available. micronucleus study
6.1.1.3. In vitro gene mutation test in mamma The study shall be carried out in the following cases: lian cells (a) there are negative results in both in vitro studies referred to in points 6.1.1.1. and 6.1.1.2.;
(b) the in vitro study referred to in point 6.1.1.1. is inapplicable to the relevant chemical species.
The study does not need to be carried out if there are adequate data from a reliable in vivo mammalian gene mutation test.
6.1.2. In vivo genetic toxicity
6.1.2.1. An appropriate in vivo mammalian The study shall be carried out if there is a positive result in any of somatic cell genotoxicity study the in vitro genotoxicity study referred to in point 6.1.1. which gives rise to a concern.
The study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate.
6.1.2.2. An appropriate in vivo mammalian germ The study shall be carried out if there is a positive result in an cell genotoxicity study available in vivo mammalian somatic cell genotoxicity study, which gives rise to concern.
The study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate.
The study does not need to be conducted if there is clear evidence that neither the relevant chemical species nor its metabolites reach the germ cells.
6.2. Appropriate toxicokinetic and The study shall be carried out if there is any of the information metabolism studies in mammals, available, raises a concern for at least one of the following hazard appropriate repeated dose toxicity classes defined in Annex I to Regulation (EC) No 1272/2008:
study, appropriate reproductive Specific Target Organ Toxicity – Repeat Exposure (STOT RE), Car toxicity study, appropriate carcino cinogenicity, Mutagenicity or Reprotoxicity (CMR) or endocrine genicity study or appropriate addi disruption for human health.
tional studies referred to in Tables 2 The study shall address each of the concerns identified. and 3 26/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojEN OJ L, 23.4.2024 Table 2 Standard information and testing – C equal to or above 2,5 μg/L and below 250 μg/L tap Column 1 Column 2 Standard information and testing Specific rules for adaptation of the standard information and testing
7.1. Toxicokinetics and metabolism studies
in mammals:
7.1.1. Data to demonstrate the absence of poten tial for accumulation in human
7.2. Repeated dose toxicity:
7.2.1. Sub-chronic repeated dose toxicity study The study does not need to be conducted where any of the fol (90-days) in one animal species (rodents), lowing conditions are fulfilled: male and female, via oral route of admin (a) a reliable short-term toxicity study (28 days) or a repeated istration dose toxicity study with the reproduction/developmental toxicity screening test is available showing severe toxicity effects according to the criteria for classifying the relevant chemical species as STOT RE (Regulation (EC) No 1272/2008), for which the observed No Observed Adverse Effect Level (NOAEL)-28 days, with the application of an appropriate assessment factor allows the extrapola tion towards the NOAEL-90 days for the same route of exposure;
(b) a reliable chronic toxicity study is available, in which an appropriate animal species and route of administration were used;
(c) the relevant chemical species is unreactive, insoluble, not bioaccumulative and there is no evidence of absorption and no evidence of toxicity in a 28-day ‘limit test’.
7.3. Reproductive toxicity:
7.3.1. Reproduction/Developmental toxicity The study does not need to be conducted where any of the fol
screening study lowing conditions are fulfilled:
(a) a reliable extended one-generation reproductive toxicity study is available, in which an appropriate animal species and route of administration were used;
(b) the relevant chemical species is of low toxicological activity (no evidence of toxicity seen in any of the tests available
provided that the dataset is sufficiently comprehensive and informative), it can be proven from toxicokinetic data that no systemic absorption occurs via the oral route of expo sure, e.g., plasma/blood concentrations below detection limit using a sensitive method and the relevant chemical species and its metabolites are absent in urine or bile.
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7.4. Appropriate toxicokinetic and metabo The study shall be carried out if any information available raises lism studies, appropriate repeated dose a concern for at least one of the following hazard classes defined toxicity study, appropriate reproduc in Annex I to Regulation (EC) No 1272/2008: STOT RE or CMR tive toxicity study, appropriate carci or endocrine disruption for human health.
nogenicity study or appropriate addi The study shall address each of the concerns identified. tional studies referred to under Table 3 Table 3 Standard information and testing – C equal or above 250 μg/L tap Column 1 Column 2 Standard information and testing Specific rules for adaptation of the standard information and testing
8.1. Toxicokinetics and metabolism studies
in mammals:
8.1.1. Study on absorption, distribution, meta bolism and excretion
8.1.2. Considerations on the potential need for Additional information might be needed based on the outcome additional toxicokinetic information of the toxicokinetic and metabolism study conducted in rats or based on the evaluation of the toxicological and physicochem ical profile of the relevant chemical species.
8.2. Repeated dose toxicity:
8.2.1. Long-term repeated dose toxicity (≥ 12 This study does not need to be conducted if the combined months), oral route of administration chronic toxicity/carcinogenicity study referred to in point 8.4.1.
is provided.
8.3. Reproductive toxicity: The studies do not need to be conducted where the relevant chemical species is of low toxicological activity (no evidence of toxicity seen in any of the tests available, in which a sufficiently comprehensive and informative dataset has been used), it can be proven from toxicokinetic data that no systemic absorption occurs via the oral route of exposure, e.g., plasma/blood con centrations below detection limit using a sensitive method and the relevant chemical species and its metabolites are absent in urine or bile.
8.3.1. Extended one-generation reproductive An Extended One-Generation Reproductive Toxicity Study with toxicity study, oral route of administration the extension of cohort 1B to include the F2 generation where
any of the following conditions are met:
(a) the relevant chemical species displays genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to its classification as mutagen category 2;
(b) there are indications that the internal dose for the relevant chemical species and/or any of its metabolites will reach a steady state in the test animals only after an extended ex posure;
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(c) there are indications of one or more relevant modes of ac tion related to endocrine disruption from available in vivo studies or non-animal approaches.
An Extended One-Generation Reproductive Toxicity Study including cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) shall be included in case of particular concerns on (developmental) neurotoxicity or
(developmental) immunotoxicity justified by any of the fol
lowing:
(a) existing information on the relevant chemical species itself derived from relevant available in vivo or non-animal ap proaches (e.g., abnormalities of the central nervous system
(CNS), evidence of adverse effects on the nervous or im mune system in studies on adult animals or animals ex posed prenatally);
(b) specific mechanisms/modes of action of the relevant che mical species with an association to (developmental) neu rotoxicity and/or (developmental) immunotoxicity (e.g., cholinesterase inhibition or relevant changes in thyroidal hormone levels associated to adverse effects);
(c) existing information on effects caused by substances ana logous to the relevant chemical species being studied, sug gesting such effects or mechanisms/modes of action.
Two-generation reproductive toxicity studies that were initiated before 13 May 2015shall be considered appropriate to address this standard information requirement.
8.3.2. Prenatal developmental toxicity study, in rat, unless another animal species is justi fied to be more appropriate, oral route of administration
8.3.3. Further pre-natal developmental toxicity A decision on the need to perform additional studies on a sec study, in a second animal species, oral route ond animal species or mechanistic studies shall be based on the of administration or mechanistic study outcome of the first test (point 8.3.2.) and all other relevant available data (in particular rodent reproductive toxicity stu dies).
8.4. Carcinogenicity: The study does not need to be provided where all of the fol See 8.4.1 for new study requirements lowing conditions are fulfilled:
(a) no genotoxic potential is identified in genotoxicity tests; and
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(b) the sub-chronic and long-term (≥ 12 months) toxicity stu dies show no evidence of toxicity at the limit dose level.
8.4.1 Combined Chronic Toxicity/Carcinogeni The study does not need to be conducted if adequate data from a city study oral route of administration reliable carcinogenicity study, oral route of administration is
available: in such circumstances the long term repeated dose toxicity study referred to in point 8.2.1. must be provided.
8.5. Additional toxicity properties: If there is an indication for one or more mechanisms/modes of action of the relevant chemical species with an association to
(developmental) neurotoxicity and/or endocrine disruption and/or
(developmental) immunotoxicity, corresponding additional data shall be generated in accordance with this point, unless already fully covered by the information under point 8.3.1.
8.5.1. Appropriate neurotoxicity information or If anticholinesterase activity is detected, a test for response to study, including developmental neurotoxi reactivating agents shall be generated. city, in rat, unless another animal species is justified to be more appropriate (e.g. adult hen for delayed neurotoxicity study), oral route of exposure
8.5.2. Appropriate information or study on endo This standard information or study shall be generated if there is any crine disruption, oral route of exposure if evidence from in vitro studies or from repeated dose or reproduc relevant tion toxicity studies, that the relevant chemical species may have endocrine disrupting properties for human health, in order to elu cidate the mode/mechanism of action and provide sufficient evi dence for relevant adverse effects.
8.5.3. Appropriate immunotoxicity information or This standard information or study shall be generated if there is any study, including developmental immuno evidence, from skin sensitisation, repeated dose or reproductive toxicity toxicity studies, that the relevant chemical species may have immunotoxic properties, in order to elucidate the mode/mechan ism of action and provide sufficient evidence for relevant adverse effects.
8.5.4. Appropriate mechanistic data or studies This standard information or testing shall be generated if necessary to clarify any effects reported in toxicity studies.
Part 2. General rules for adaptation of Column 1 of Tables 1, 2 and 3
2.1. The general rules for adaptation set under Sections 1 and 2 of Annex XI to Regulation (EC) No 1907/2006 shall apply mutatis mutandis with the exception set out in Section 2.2.
2.2. The general rules for adaptation under Sections 1.3 (Qualitative or Quantitative structure-activity relationship ((Q)SAR)) and 1.5 (Grouping of substances and read-across approach) of Annex XI to Regulation (EC) No 1907/2006 shall apply to the standard information and testing referred to in Table 1, point 6.1.1., only in the case of a substance constituent or a non-intentionally added species for which experimental testing is not technically possible (e.g., it cannot be isolated and tested as such).
30/33 ELI: http://data.europa.eu/eli/dec_impl/2024/365/ojEN OJ L, 23.4.2024 ANNEX VI ACCEPTANCE METHODOLOGY
Section 1. Limited acceptance methodology
1.1. Section 2 shall not apply to a relevant chemical species which is a starting substance, or an organic cementitious constituent, or a substance constituent or a non-intentionally added species where such substance or constituent is:
(a) classified as (i) Category 1A or 1B for carcinogenicity, mutagenicity or reproductive toxicity; (ii) Category 1 for endocrine disruption for human health; (iii) persistent bioaccumulative and toxic; (iv) very persistent and very toxic;
(v) persistent mobile and toxic; or (vi) very persistent and very mobile under Regulation (EC) No 1272/2008; or
(b) identified as a substance of very high concern under the Candidate List established under Article 59 of Regulation (EC) No 1907/2006, except those identified on the basis of Article 57(f) of Regulation (EC) No 1907/2006 only for the environment.
In either case, the starting substances or organic cementitious constituents referred to in the first paragraph shall be
accepted in the European positive list under the following conditions of use:
(a) The relevant chemical species is:
(i) a non-intentionally added species, or
(ii) substance constituent, or
(iii) starting substance or organic cementitious constituent which is monomer of a main polymer of the contact material.
(b) C is lower than the generic limit of 0,1 μg/l or the relevant MTC calculated from a parametric value set under tap tap Annex I to Directive (EU) 2020/2184 by application of an appropriate allocation factor (ALF) to take into account multiple routes of exposure to the relevant chemical species, besides exposure via materials used in products in contact with water intended for human consumption;
(c) The concentration of the starting substance, organic cementitious constituent, substance constituent or non- intentionally added species in the final material is lower than 0,1 % (weight/weight), except if physical migration testing is uncertain in which case the concentration in the final material is lower than 0,02 % (weight/weight).
1.2. Part 2.4 of Section 2 shall not apply in the case of any concern that a relevant chemical species which is a starting substance, or an organic cementitious constituent, or a substance constituent, or a non-intentionally added species may have genotoxicity, carcinogenicity or endocrine disruption properties for human health with non-threshold mode of action.
In such case, the starting substances or organic cementitious constituents referred to in the first paragraph may be accepted in the European positive list if C is lower than a generic limit of 0,1 μg/l or the relevant MTC value calculated from a tap tap parametric value set under Annex I to Directive (EU) 2020/2184 by application of an appropriate ALF to take into account multiple routes of exposure to the relevant chemical species, besides exposure via material used in products in contact with water intended for human consumption.
1.3. Part 2 of Section 2 shall not apply to a relevant chemical species in any of the following cases:
(a) a parametric value for the relevant chemical species in the applicable material type is set under Annex I to Directive
(EU) 2020/2184, in which case the MTC value shall be calculated by application of an appropriate ALF to take into tap account multiple routes of exposure to the relevant chemical species, besides exposure via material used in products in contact with water intended for human consumption, in which case that MTC value shall be used for the tap purpose of Part 4 of Section 2;
(b) a MTC value for the relevant chemical species in the applicable material type is set under the corresponding Annex tap of Commission Implementing Decision (EU) 2024/367 following a decision by the Commission on an application for a starting substance, composition or organic cementitious constituent that has been submitted to ECHA under Article 4 of Commission Delegated Regulation (EU) 2024/369, in which case that MTC value may be used for the tap purpose of Part 4 of Section 2 provided that it may not be impacted by information not included in the previous application for the concerned starting substance, composition or organic cementitious constituent;
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(c) an authorisation for an active substance has been granted under Regulation (EU) No 528/2012 on the basis of an ECHA opinion setting a defined safety threshold for the oral route and used as such in material in contact with water under product-type 6, in which case that safety threshold shall be used for the purpose of Part 4 of Section 2;
(d) a specific migration limit has been set under Commission Regulation (EU) No 10/2011 in less than 15 years from the date of submission of the application under Article 4 of Commission Delegated Regulation (EU) 2024/369, in which case that specific migration limit divided by 20 l/kg shall be used for the purpose of Part 4 of Section 2.
1.4. Part 2.4 of Section 2 shall not apply in the following cases:
(a) the available information for the relevant chemical species is insufficient to exclude genotoxicity, in which case the generic limit MTC of 0,1 μg/l shall apply for the purpose of Part 4 of Section 2;
tap
(b) the available information set out in Tables 1, 2 and 3 of Annex V for the relevant chemical species is sufficient to exclude genotoxicity but does not allow to conclude on toxic effects listed under Part 2.1.2 of Section 2. In such case the generic limit MTC of 2,5 μg/l shall apply for the purpose of Part 4 of Section 2. Such generic limit cannot be tap applied for the toxic effects for human health with non-threshold mode of action referred to in the first paragraph of
Section 1.2.
Section 2. Comprehensive acceptance methodology Part 1. Introduction
1.1. The acceptance methodology for starting substances, compositions and constituents shall be based on a risk assessment.
Such risk assessment shall result in:
(a) determining the maximum tolerable concentration at tap water (MTC ) for each relevant chemical species; tap
(b) ensuring that C for each relevant chemical species is lower than its MTC . tap tap
1.2. In addition to the information required under Annexes I, II and III, a risk assessment shall take into account any other relevant technical or scientific information which is available addressing worst foreseeable conditions of use. Where appropriate, conditions of use shall be implemented.
1.3. The information provided in the risk assessment shall allow the Committee for Risk Assessment of ECHA to evaluate and reach an opinion on whether the starting substance, composition or constituent complies with the criteria set out under Article 11(1) of Directive (EU) 2020/2184.
Part 2. Hazard assessment
2.1. Principles
2.1.1. For accepting a starting substance, composition or constituent, the hazard assessment process, in relation to human health shall entail assessment of effects, comprising the following steps:
(a) hazard identification: identification of the adverse effects which the relevant chemical species have an inherent capacity to cause;
(b) hazard characterisation: dose (concentration) – response (effects) assessment: estimation of the relationship between dose, or level of exposure to the relevant chemical species, and the incidence and severity of an effect, where appropriate.
2.1.2. The hazard assessment for human health shall address the following potential toxic effects for the general human
population and exposure by the oral route:
(a) mutagenicity;
(b) systemic (target-organ) toxicity after repeated dose administration;
(c) toxicity for reproduction;
(d) carcinogenicity;
(e) neurotoxicity;
(f) immunotoxicity;
(g) endocrine disruption for human health.
2.1.3. The hazard identification shall address the properties and potential adverse effects of the relevant chemical species that migrate from the material.
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2.2. Dose-response assessment
2.2.1. The establishment of a quantitative dose (concentration)-response (effect) relationship is required and, where possible, a no observed adverse effect level (NOAEL) shall be identified. If it is not possible to identify a NOAEL, the lowest observed adverse effect level (LOAEL) shall be identified. Where appropriate, other dose-effect descriptors may be used as reference values.
2.2.2. When carrying out the hazard assessment, special consideration shall be given to toxicity data derived from observations of human exposure where such data are available, e.g. information gained from manufacture, from poison centres or epidemiology surveys.
2.3. Derived no effect level
2.3.1. The derivation of a derived no effect level (DNEL) shall be carried out in accordance with Section 1.4 of Annex I to Regulation (EC) No 1907/2006.
2.4. Maximum Tolerable Concentration at the tap (MTC ) tap
2.4.1. Subject to Part 2.4.2, the MTC is equal to a value calculated on the basis of the safe oral dose (DNEL), the body weight tap (60 kg), the drinking water ingestion rate of 2 l (litres) per day and an appropriate ALF (expressed as a percentage) to take into account multiple routes of exposure to the relevant chemical species, besides exposure via material used in products in contact with water intended for human consumption.
MTC (μg/l) = DNELðmg=kg=dÞ×60ðkgÞ×1 000ðμg=mgÞ ×ALF tap 2ðl=dÞ
2.4.2. By way of exception to Part 2.4.1:
(a) If the C < 2,5 μg/l and genotoxicity tests are negative: MTC shall (1) not be lower than 0,1 μg/l for an organic tap tap cementitious constituent; and (2) not be higher than 2,5 μg/l, unless duly justified and the application fulfils the requirements of Table 2 of Annex V, in which case point (b) below applies.
(b) If the C is equal or above 2,5 μg/l but below 250 μg/l, the MTC shall not be higher than 250 μg/l. tap tap Part 3. Migration assessment
3.1. The C to be compared against the MTC value shall be determined based on the worst foreseeable conditions of use, tap tap including in terms of representativeness of the concentration in the material matrix, water, surface area to water volume, and temperature, as determined by ECHA and published on its website for each test method taking into account, in particular, the requirements for determination based on the worst foreseeable conditions of use and the appropriate EN standard.
Part 4. Risk acceptance
4.1. Risk acceptance for starting substances for organic materials, organic cementitious constituents and compositions for enamels, ceramic and other inorganic materials The starting substance, composition or constituent shall be accepted if C < MTC for each relevant chemical species on tap tap the 10th day of testing according to point 5.2 in Table 1 of Annex IV.
4.2. Risk acceptance for metallic materials For the assessment of the test rig results (according to standard EN 15664-1) the arithmetic mean of the equivalent pipe concentrations MEP (T) analysed from relevant contact waters (see Annex IV, Section 1.1) shall be considered.
n The composition can be accepted for a product group with the assumed contact surface a (see Table 2 of Annex II), if the
following criteria are met for all required test waters:
(a) MTC values are met for all analysed elements starting week 16 of testing; tap
(b) Analysed metal concentrations are not showing increasing trend.
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