32024R2564

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Document 32024R2564

Regolament Delegat tal-Kummissjoni (UE) 2024/2564 tad-19 ta’ Ġunju 2024 li jemenda r-Regolament (KE) Nru 1272/2008 tal-Parlament Ewropew u tal-Kunsill fir-rigward tal-klassifikazzjoni u l-ittikkettar armonizzati ta’ ċerti sustanzi

C/2024/3992

ĠU L, 2024/2564, 30.9.2024, ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj

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Il-Ġurnal Uffiċjali
ta'l-Unjoni Ewropea

Is-serje L

2024/2564

30.9.2024

REGOLAMENT DELEGAT TAL-KUMMISSJONI (UE) 2024/2564

tad-19 ta’ Ġunju 2024

li jemenda r-Regolament (KE) Nru 1272/2008 tal-Parlament Ewropew u tal-Kunsill fir-rigward tal-klassifikazzjoni u l-ittikkettar armonizzati ta’ ċerti sustanzi

(Test b’rilevanza għaż-ŻEE)

IL-KUMMISSJONI EWROPEA,

Wara li kkunsidrat it-Trattat dwar il-Funzjonament tal-Unjoni Ewropea,

Wara li kkunsidrat ir-Regolament (KE) Nru 1272/2008 tal-Parlament Ewropew u tal-Kunsill tas-16 ta’ Diċembru 2008 dwar il-klassifikazzjoni, l-ittikkettar u l-imballaġġ tas-sustanzi u t-taħlitiet, li jemenda u jħassar id-Direttivi 67/548/KEE u 1999/45/KE, u li jemenda r-Regolament (KE) Nru 1907/2006 (1), u b’mod partikolari l-Artikolu 37(5) tiegħu,

Billi:

(1)	Il-Parti 3, it-Tabella 3, tal-Anness VI tar-Regolament (KE) Nru 1272/2008 fiha l-lista tal-klassifikazzjoni u tal-ittikkettar armonizzati tas-sustanzi perikolużi abbażi tal-kriterji stabbiliti fil-Partijiet 2 sa 5 tal-Anness I ta’ dak ir-Regolament.

(2)

Tressqu proposti għall-introduzzjoni tal-klassifikazzjoni u tal-ittikkettar armonizzati ta’ ċerti sustanzi u għall-aġġornament jew għat-tħassir tal-klassifikazzjoni u tal-ittikkettar armonizzati ta’ ċerti sustanzi oħra lill-Aġenzija Ewropea għas-Sustanzi Kimiċi (“l-Aġenzija”), skont l-Artikolu 37 tar-Regolament (KE) Nru 1272/2008. Il-Kumitat għall-Istima tar-Riskji (RAC) tal-Aġenzija adotta l-opinjonijiet (2) li ġejjin dwar dawk il-proposti, wara li qies il-kummenti li waslu mingħand il-partijiet ikkonċernati:

—	Opinion of 18 March 2022 concerning multi-walled carbon tubes (synthetic graphite in tubular shape) with a geometric tube diameter range ≥ 30 nm to < 3 μm and a length ≥ 5 μm and aspect ratio > 3:1, including multi-walled carbon nanotubes, MWC(N)T;

—	Opinion of 18 March 2022 concerning α-methyl-1,3-benzodioxole-5-propionaldehyde [1] (S)-α-methyl-1,3-benzodioxole-5-propionaldehyde; (2S)-3-(1,3-benzodioxol-5-yl)-2-methylpropanal [2] (R)-α-methyl-1,3-benzodioxole-5-propionaldehyde; (2R)-3-(1,3-benzodioxol-5-yl)-2-methylpropanal [3];

—	Opinion of 18 March 2022 concerning acetone oxime;

—	Opinion of 18 March 2022 concerning (3E)-dec-3-en-2-one;

—	Opinion of 18 March 2022 concerning 2,3-epoxypropyl neodecanoate;

—	Opinion of 18 March 2022 concerning propyl 3,4,5-trihydroxybenzoate;

—	Opinion of 18 March 2022 concerning benthiavalicarb-isopropyl (ISO); isopropyl [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate;

—	Opinion of 18 March 2022 concerning hexyl salicylate;

—	Opinion of 18 March 2022 concerning sulfur;

—

Opinion of 18 March 2022 concerning reaction mass of N,N’-ethane-1,2-diylbis(decanamide) and 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide and N,N’-ethane-1,2-diylbis(12-hydroxyoctadecanamide) [1] reaction mass of N,N’-ethane-1,2-diylbis(decanamide) and 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide [2];

—	Opinion of 18 March 2022 concerning 2-[ethyl[3-methyl-4-[(5-nitrothiazol-2-yl)azo]phenyl]amino]ethanol;

—	Opinion of 30 May 2022 concerning glyphosate (ISO); N-(phosphonomethyl)glycine;

—	Opinion of 2 June 2022 concerning silver massive: [particle diameter ≥ 1 mm];

—	Opinion of 2 June 2022 concerning silver powder: [particle diameter > 100 nm < 1 mm];

—	Opinion of 2 June 2022 concerning silver nano: [particle diameter > 1 nm ≤ 100 nm];

—

Opinion of 2 June 2022 concerning S-metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide; (R a S a)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl]acetamide [contains 80-100 % 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide and 0-20 % 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2R)-1-methoxypropan-2-yl]acetamide];

—	Opinion of 2 June 2022 concerning 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one;

—	Opinion of 2 June 2022 concerning formaldehyde … %;

—	Opinion of 2 June 2022 concerning formic acid ... %;

—	Opinion of 2 June 2022 concerning dicamba (ISO); 2,5-dichloro-6-methoxybenzoic acid; 3,6-dichloro-2-methoxybenzoic acid;

—	Opinion of 2 June 2022 concerning 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate;

—	Opinion of 2 June 2022 concerning peracetic acid … %;

—

Opinion of 2 June 2022 concerning tetrasodium 4-amino-5-hydroxy-3,6-bis[[4-[[2-(sulphonatooxy) ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate [1] Reaction products of 4-amino-5-hydroxynaphthalene-2,7-disulfonic acid, coupled twice with diazotized 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate, sodium salts [2] disodium 4-amino-5-hydroxy-3,6-bis{[4-(vinylsulfonyl) phenyl]diazenyl}naphthalene-2,7-disulfonate [3];

—	Opinion of 15 September 2022 concerning perboric acid, sodium salt [1] perboric acid, sodium salt, monohydrate [2] perboric acid (HBO(O2)), sodium salt, monohydrate [3] sodium peroxoborate [4] sodium perborate [5];

—	Opinion of 15 September 2022 concerning perboric acid (H3BO2(O2)), monosodium salt trihydrate [1] perboric acid, sodium salt, tetrahydrate [2] perboric acid (HBO(O2)), sodium salt, tetrahydrate [3] sodium peroxoborate, hexahydrate [4]

—	Opinion of 15 September 2022 concerning sodium peroxometaborate;

—	Opinion of 15 September 2022 concerning trimethyl borate;

—	Opinion of 15 September 2022 concerning ethanethiol; ethyl mercaptan;

—	Opinion of 15 September 2022 concerning 1H-benzotriazole;

—	Opinion of 15 September 2022 concerning methyl-1H-benzotriazole;

—	Opinion of 15 September 2022 concerning N,N’-methylenediacrylamide;

—	Opinion of 15 September 2022 concerning Sodium 3-(allyloxy)-2-hydroxypropanesulphonate;

—	Opinion of 1 December 2022 concerning tert-butyl 2-ethylperoxyhexanoate;

—	Opinion of 1 December 2022 concerning n-hexane;

—	Opinion of 1 December 2022 concerning biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl;

—	Opinion of 1 December 2022 concerning copper; [specific surface area > 0,67 mm2/mg];

—	Opinion of 1 December 2022 concerning reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol;

—	Opinion of 1 December 2022 concerning 1,4-dichloro-2-nitrobenzene;

—

Opinion of 1 December 2022 concerning 2,4-dimethylcyclohex-3-ene-1-carbaldehyde [1] (1α,2α,5α)-2,5-dimethylcyclohex-3-ene-1-carbaldehyde [2] 2,6-dimethylcyclohex-3-dene-1-carbaldehyde [3] 3,5-dimethylcyclohex-3-ene-1-carbaldehyde [4] 3,6-dimethylcyclohex-3-ene-1-carbaldehyde [5] 4,6-dimethylcyclohex-3-ene-1-carbaldehyde [6] reaction mass of 3,5-dimethylcyclohex-3-ene-1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde [7] dimethylcyclohex-3-ene-1-carbaldehyde [8] Dimethylcyclohex-3-ene-1-carbaldehyde [9] 1,2,4(or 1,3,5)-trimethylcyclohex-3-ene-1-carbaldehyde [10] 1,3,4-trimethylcyclohex-3-ene-1-carbaldehyde [11] 2,2,4-trimethylcyclohex-3-ene-1-carbaldehyde [12] 2,4,6-trimethylcyclohex-3-enecarbaldehyde [13] isocyclocitral [14] 3,5,6-trimethylcyclohex-3-ene-1-carbaldehyde [15] 4,6,6-trimethylcyclohex-3-ene-1-carbaldehyde [16];

—	Opinion of 1 December 2022 concerning pyraclostrobin (ISO); methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate;

—	Opinion of 1 December 2022 concerning dibenzoyl peroxide; benzoyl peroxide;

—	Opinion of 1 December 2022 concerning fenpropidin (ISO); (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]piperidine.

(3)

Il-Kummissjoni rċeviet informazzjoni addizzjonali mill-partijiet ikkonċernati li jikkontestaw il-valutazzjoni xjentifika stabbilita fl-opinjonijiet tar-RAC tat-18 ta’ Marzu 2022 dwar il-bentijavalikarb-isopropil, in-neodekanoat tat-2,3-epossipropil, it-tubi tal-karbonju b’diversi ħitan, is-saliċilat tal-eżil, fl-opinjonijiet tar-RAC tat-2 ta’ Ġunju 2022 dwar il-fidda f’forma massiva, il-fidda f’forma ta’ trab u l-fidda f’forma ta’ nanopartikoli u l-opinjonijiet tar-RAC tal-1 ta’ Diċembru 2022 dwar l-n-eżan u r-ram. L-informazzjoni addizzjonali ġiet ivvalutata mill-Kummissjoni u ma nstabitx li kienet biżżejjed biex tqajjem dubji dwar l-analiżi xjentifika li tinsab fl-opinjonijiet tal-RAC.

(4)

Fir-rigward tas-sustanza fjokki tar-ram (miksijin bl-aċidu alifatiku) (numru tal-indiċi 029-019-01-X (3)), l-entrata tagħha għall-klassifikazzjoni tagħha bħala perikoluża għall-ambjent akkwatiku jenħtieġ li tiġi emendata biex tkun f’konformità mal-entrata aktar ġenerika tar-ram [erja tas-superfiċje speċifika > 0,67 mm2/mg] (numru tal-indiċi 029-026-00-0), imdaħħla fl-Anness.

(5)	Fir-rigward tas-sustanza ram granulat (4) (numru tal-indiċi 029-024-00-X), l-entrata tagħha jenħtieġ li titħassar peress li hija koperta mill-entrata aktar ġenerika tar-ram [erja tas-superfiċje speċifika > 0,67 mm2/mg] (numru tal-indiċi 029-026-00-0), imdaħħla fl-Anness.

(6)

L-Istimi tat-Tossiċità Akuta (ATE) jintużaw prinċipalment biex tiġi ddeterminata l-klassifikazzjoni għat-tossiċità akuta għas-saħħa tal-bniedem tat-taħlitiet li fihom sustanzi kklassifikati għat-tossiċità akuta. L-inklużjoni ta’ valuri ATE armonizzati fl-entrati elenkati fl-Anness VI tar-Regolament (KE) Nru 1272/2008 tiffaċilita l-armonizzazzjoni tal-klassifikazzjoni tat-taħlitiet u tipprovdi appoġġ lill-awtoritajiet tal-infurzar. Wara valutazzjoni xjentifika ulterjuri, ġie derivat valur ATE għar-rotta tal-inalazzjoni għall-fenpropidin (numru tal-indiċi 612-299-00-0), flimkien ma’ dawk proposti fl-opinjonijiet tar-RAC għal sustanzi oħra. Dak il-valur ATE jenħtieġ li jiddaħħal fil-kolonna ta’ qabel tal-aħħar tat-Tabella 3 tal-Parti 3 tal-Anness VI tar-Regolament (KE) Nru 1272/2008.

(7)

L-entrati li jikkorrispondu għan-numri tal-indiċi 005-017-00-7, 005-017-01-4, 005-018-00-2, 005-018-01-X, 005-019-00-8, 005-019-01-5 ġew sostitwiti bl-entrati għall-aċidu perboriku, melħ tas-sodju [1] aċidu perboriku, melħ tas-sodju, monoidrat [2] aċidu perboriku (HBO(O2)), melħ tas-sodju, monoidrat [3] perossoborat tas-sodju [4] perborat tas-sodju [5] (numru tal-indiċi 005-022-00-4), għall-aċidu perboriku (H3BO2(O2)), melħ tal-monosodju, triidrat [1] aċidu perboriku, melħ tas-sodju, tetraidrat [2] aċidu perboriku (HBO(O2)), melħ tas-sodju, tetraidrat [3] eżaidrat tal-perossoborat tas-sodju [4] (numru tal-indiċi 005-023-00-X) u għall-perossometaborat tas-sodju (numru tal-indiċi 005-024-00-5) u għalhekk jenħtieġ li jitħassru.

(8)	Fid-dawl tal-opinjonijiet tar-RAC, huwa għalhekk xieraq li jiġu introdotti, jiġu aġġornati jew jitħassru l-klassifikazzjoni u l-ittikkettar armonizzati tas-sustanzi kkonċernati abbażi tal-valutazzjoni magħmula f’dawk l-opinjonijiet u wara l-valutazzjonijiet ulterjuri.

(9)	Għalhekk, jenħtieġ li r-Regolament (KE) Nru 1272/2008 jiġi emendat skont dan.

(10)

Jenħtieġ li l-konformità mal-klassifikazzjonijiet armonizzati ġodda jew aġġornati ma tkunx meħtieġa minnufih, peress li huwa neċessarju perjodu ta’ żmien sabiex il-fornituri jadattaw l-ittikkettar u l-imballaġġ tas-sustanzi u tat-taħlitiet għall-klassifikazzjonijiet il-ġodda jew aġġornati u sabiex ibigħu l-stokkijiet eżistenti soġġetti għar-rekwiżiti regolatorji preeżistenti. Dak il-perjodu ta’ żmien huwa neċessarju ukoll sabiex il-fornituri jkollhom żmien biżżejjed biex jieħdu l-azzjonijiet meħtieġa sabiex jiżguraw il-konformità kontinwa ma’ rekwiżiti legali oħra wara l-bidliet li jsiru skont dan ir-Regolament. Madankollu, jenħtieġ li l-fornituri jkollhom il-possibbiltà li japplikaw il-klassifikazzjonijiet armonizzati ġodda jew aġġornati, u li jadattaw l-ittikkettar u l-imballaġġ skont dan, fuq bażi volontarja qabel id-data tal-applikazzjoni ta’ dan ir-Regolament sabiex jiġi żgurat livell għoli ta’ protezzjoni tas-saħħa tal-bniedem u tal-ambjent u biex tingħata biżżejjed flessibbiltà lill-fornituri,

ADOTTAT DAN IR-REGOLAMENT:

Artikolu 1

L-Anness VI tar-Regolament (KE) Nru 1272/2008 huwa emendat kif stabbilit fl-Anness ta’ dan ir-Regolament.

Artikolu 2

Dan ir-Regolament għandu jidħol fis-seħħ fl-għoxrin jum wara dak tal-pubblikazzjoni tiegħu f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea.

Għandu japplika minn l-1 ta’ Mejju 2026. Madankollu, is-sustanzi u t-taħlitiet jistgħu jiġu kklassifikati, ittikkettati u ppakkjati f’konformità mar-Regolament (KE) Nru 1272/2008 kif emendat b’dan ir-Regolament mid-data tad-dħul fis-seħħ ta’ dan ir-Regolament.

Dan ir-Regolament għandu jorbot fl-intier tiegħu u japplika direttament fl-Istati Membri kollha.

Magħmul fi Brussell, id-19 ta’ Ġunju 2024.

Għall-Kummissjoni

Il-President

Ursula VON DER LEYEN

(1) ĠU L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj.

(2) L-opinjonijiet huma aċċessibbli fuq is-sit web li ġej: https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/name/-/ecNumber/-/casNumber/-/dte_receiptFrom/-/dte_receiptTo/-/prc_public_status/Opinion+Adopted/dte_withdrawnFrom/-/dte_withdrawnTo/-/sbm_expected_submissionFrom/-/sbm_expected_submissionTo/-/dte_finalise_deadlineFrom/-/dte_finalise_deadlineTo/-/haz_addional_hazard/-/lec_submitter/-/dte_assessmentFrom/-/dte_assessmentTo/-/prc_regulatory_programme/-/.

(3) Ara l-Opinjoni tar-RAC Opinion of 1 December 2022 concerning copper [specific surface area > 0,67 mm2/mg], elenkata hawn fuq;

(4) Ibidem.

ANNESS

Il-Parti 3, it-Tabella 3 tal-Anness VI għar-Regolament (KE) Nru 1272/2008 hija emendata kif ġej:

(1)

l-entrati li ġejjin jiddaħħlu skont l-ordni konsekuttiva tan-numri tal-indiċi li jikkorrispondu għal kull entrata:

Nru tal-Indiċi	Isem Kimiku	Nru KE	Nru CAS	Klassifikazzjoni		Tikkettar			Limiti ta’ Konċ. Speċifiċi, Fatturi-M u ATEs	Noti
Nru tal-Indiċi	Isem Kimiku	Nru KE	Nru CAS	Klassi tal-Periklu u Kodiċi(jiet) tal-Kategorija	Kodiċi(jiet) tad-Dikjarazzjoni tal-Periklu	Pittogramma, Kodiċi(jiet) tal-Kliem Sinjal	Kodiċi(jiet) tad-Dikjarazzjoni tal-Periklu	Kodiċi(jiet) Supplimentari tad-Dikjarazzjoni tal-Periklu	Limiti ta’ Konċ. Speċifiċi, Fatturi-M u ATEs	Noti
“005-022-00-4	aċidu perboriku, melħ tas-sodju [1] aċidu perboriku, melħ tas-sodju, monoidrat [2] aċidu perboriku (HBO(O2)), melħ tas-sodju, monoidrat [3] perossoborat tas-sodju [4] perborat tas-sodju [5]	234-390-0 [1] 234-390-0 [2] - [3] - [4] 239-172-9 [5]	11138-47-9 [1] 12040-72-1 [2] 10332-33-9 [3] - [4] 15120-21-5 [5]	Oss. Sol. 3 Ripr. 1B Toss. Akuta 3 Toss. Akuta 4 STOT SE 3 Ħsara lill-Għajn. 1	H272 H360FD H331 H302 H335 H318	GHS03 GHS08 GHS06 GHS05 Dgr	H272 H360FD H331 H302 H335 H318		inalazzjoni: ATE = 0,75 mg/L (trabijiet jew raxx) orali: ATE = 890 mg/kg bw Ħsara lill-Għajn. 1; H318: C ≥ 22 % Irrit. tal-Għajnejn 2; H319: 14 % ≤ C < 22 %	11”
“005-023-00-X	aċidu perboriku (H3BO2(O2)), triidrat tal-melħ tal-monosodju [1] aċidu perboriku, melħ tas-sodju, tetraidrat [2] aċidu perboriku (HBO(O2)), melħ tas-sodju, tetraidrat [3] perossoborat tas-sodju, eżaidrat [4]	239-172-9 [1] 234-390-0 [2] - [3] - [4]	13517-20-9 [1] 37244-98-7 [2] 10486-00-7 [3] - [4]	Ripr. 1B Toss. Akuta 4 STOT SE 3 Ħsara lill-Għajn. 1	H360FD H332 H335 H318	GHS08 GHS05 GHS07 Dgr	H360FD H332 H335 H318		inalazzjoni: ATE = 1,2 mg/L (trabijiet jew raxx) Ħsara lill-Għajn. 1; H318: C ≥ 36 % Irrit. tal-Għajnejn 2; H319: 22 % ≤ C < 36 %	11”
“005-024-00-5	perossometaborat tas-sodju	231-556-4	7632-04-4	Oss. Sol. 2 Ripr. 1B Toss. Akuta 3 Toss. Akuta 4 STOT SE 3 Ħsara lill-Għajn. 1	H272 H360FD H331 H302 H335 H318	GHS03 GHS08 GHS06 GHS05 Dgr	H272 H360FD H331 H302 H335 H318		inalazzjoni: ATE = 0,62 mg/L (trabijiet jew raxx) orali: ATE = 730 mg/kg bw Ħsara lill-Għajn. 1; H318: C ≥ 22 % Irrit. tal-Għajnejn 2; H319: 14 % ≤ C < 22 %	11”
“006-104-00-2	tubi tal-karbonju b’diversi ħitan (grafit sintetiku f’forma tubulari) b’dijametru tat-tubu ġeometriku fil-medda minn ≥ 30 nm sa < 3 μm u b’tul ta’ ≥ 5 u b’proporzjon tal-aspett ta’ > 3:1, inklużi n-nanotubi tal-karbonju b’diversi ħitan, MWC(N)T	—	—	Karċ. 1B STOT RE 1	H350i H372 (pulmuni)(inalazzjoni)	GHS08 Dgr	H350i H372 (pulmuni)(inalazzjoni)		STOT RE 1; H372: C ≥ 1 %; STOT RE 2; H373: 0,1 % ≤ C < 1 %”
“029-026-00-0	ram [erja tas-superfiċje speċifika > 0,67 mm2/mg]	231-159-6	7440-50-8	Akkwatiku Akut 1 Akkwatiku Kroniku 1	H400 H410	GHS09 Wng	H410		M = 10 M = 1”
“047-004-00-9	fidda f’forma massiva: [dijametru tal-partikoli ≥ 1 mm]	231-131-3	7440-22-4	Ripr. 2 STOT RE 2	H361f H373 (sistema nervuża)	GHS08 Wng	H361f H373 (sistema nervuża)”
“047-005-00-4	fidda f’forma ta’ trab: [dijametru tal-partikoli > 100 nm < 1 mm]	231-131-3	7440-22-4	Ripr. 2 STOT RE 2 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H361f H373 (sistema nervuża) H400 H410	GHS08 GHS09 Wng	H361f H373 (sistema nervuża) H410		M = 10 M = 10”
“047-006-00-X	fidda f’forma ta’ nanopartikoli: [dijametru tal-partikoli > 1 nm ≤ 100 nm]	231-131-3	7440-22-4	Ripr. 2 STOT RE 2 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H361f H373 (sistema nervuża) H400 H410	GHS08 GHS09 Wng	H361f H373 (sistema nervuża) H410		M = 1000 M = 1000”
“603-247-00-8	massa ta’ reazzjoni ta’ 1,3-diossan-5-ol u 1,3-diossolan-4-ilmetanol	—	—	Ripr. 1B	H360Df	GHS08 Dgr	H360Df”
“605-042-00-9	α-metil-1,3-benżodiossol-5-propjonaldeid [1] (S)-α-metil-1,3-benżodiossol-5-propjonaldeid; (2S)-3-(1,3-benżodiossol-5-il)-2-metilpropanal [2] (R)-α-metil-1,3-benżodiossol-5-propjonaldeid; (2R)-3-(1,3-benżodiossol-5-il)-2-metilpropanal [3]	214-881-6 [1] - [2] - [3]	1205-17-0 [1] 737776-68-0 [2] 737776-59-9 [3]	Sens. tal-Ġilda 1B	H317	GHS07 Wng	H317”
“605-043-00-4	2,4-dimetilċikloeż-3-en-1-karbaldeid [1] (1α,2α,5α)–2,5 -dimetilċikloeż-3-en-1-karbaldeid [2] 2,6-dimetilċikloeż-3-en-1-karbaldeid [3] 3,5-dimetilċikloeż-3-en-1-karbaldeid [4] 3,6-dimetilċikloeż-3-en-1-karbaldeid [5] 4,6-dimetilċikloeż-3-en-1-karbaldeid [6] massa ta’ reazzjoni ta’ 3,5-dimetilċikloeż-3-en-1-karbaldeid u 2,4-dimetilċikloeż-3-en-1-karbaldeid [7] dimetilċikloeż-3-en-1-karbaldeid [8] Dimetilċikloeż-3-en-1-karbaldeid [9] 1,2,4(jew 1,3,5)-trimetilċikloeż-3-en-1-karbaldeid [10] 1,3,4-trimetilċikloeż-3-en-1-karbaldeid [11] 2,2,4-trimetilċikloeż-3-en-1-karbaldeid [12] 2,4,6-trimetilċikloeż-3-enkarbaldeid [13] isoċikloċitral [14] 3,5,6-trimetilċikloeż-3-en-1-karbaldeid [15] 4,6,6-trimetilċikloeż-3-en-1-karbaldeid [16]	268-264-1 [1] 252-395-6 [2] - [3] 268-263-6 [4] 267-186-5 [5] 253-139-6 [6] - [7] 248-742-6 [8] 272-113-5 [9] 276-055-1 [10] - [11] - [12] 215-833-7 [13] 215-638-7 [14] 266-810-3 [15] - [16]	68039-49-6 [1] 35145-02-9 [2] 6975-94-6 [3] 68039-48-5 [4] 67801-65-4 [5] 36635-35-5 [6] - [7] 27939-60-2 [8] 68737-61-1 [9] 71832-78-5 [10] 40702-26-9 [11] 1726-47-2 [12] 1423-46-7 [13] 1335-66-6 [14] 67634-07-5 [15] 6754-27-4 [16]	Sens. tal-Ġilda 1	H317	GHS07 Wng	H317”
“606-156-00-1	ossim tal-aċeton	204-820-1	127-06-0	Karċ. 1B Toss. Akuta 4 STOT SE 3 STOT RE 2 Ħsara lill-Għajn. 1 Sens. tal-Ġilda 1	H350 H312 H336 H373 (sistema tad-demm) H318 H317	GHS08 GHS07 GHS05 Dgr	H350 H312 H336 H373 (sistema tad-demm) H318 H317		dermali: ATE = 1 100 mg/kg bw”
“606-157-00-7	(3E)-dek-3-en-2-on	—	18402-84-1	Toss. Akuta 4 Asp. Toss. 1 Irrit. tal-Ġilda 2 Akkwatiku Kroniku 2	H332 H304 H315 H411	GHS07 GHS08 GHS09 Dgr	H332 H304 H315 H411	EUH071	inalazzjoni: ATE = 1,5 mg/L (trabijiet jew raxx)”
“606-158-00-2	2-(dimetilammino)-2-[(4-metilfenil)metil]-1-[4-(morfolin-4-il)fenil]butan-1-on	438-340-0	119344-86-4	Ripr. 1B Akkwatiku Akut 1 Akkwatiku Kroniku 1	H360Df H400 H410	GHS08 GHS09 Dgr	H360Df H410		M = 1 M = 1”
“607-770-00-2	neodekanoat tat-2,3-epossipropil	247-979-2	26761-45-5	Muta. 2 Sens. tal-Ġilda 1 A	H341 H317	GHS08 GHS07 Wng	H341 H317		Sens. tal-Ġilda 1 A; H317: C ≥ 0,001 %”
“607-771-00-8	bentijavalikarb-isopropil (ISO); isopropil [(S)-1-{[(R)-1-(6-fluworo-1,3-benżotijażol-2-il)etil]karbamoil}-2-metilpropil]karbamat	—	177406-68-7	Karċ. 1B Repr. 2 Sens. tal-Ġilda 1 Akkwatiku Kroniku 2	H350 H361fd H317 H411	GHS08 GHS07 GHS09 Dgr	H350 H361fd H317 H411”
“607-772-00-3	saliċilat tal-eżil	228-408-6	6259-76-3	Ripr. 2 Sens. tal-Ġilda 1	H361d H317	GHS08 GHS07 Wng	H361d H317”
“607-773-00-9	7-ossabiċiklo[4.1.0]ett-3-ilmetil 7-ossabiċiklo[4.1.0]ettan-3-karbossilat	219-207-4	2386-87-0	Muta. 2 STOT RE 2 Sens. tal-Ġilda 1	H341 H373 (kavità nażali) H317	GHS08 GHS07 Wng	H341 H373 (kavità nażali) H317”
“607-774-00-4	4-ammino-5-idrossi-3,6-bis[[4-[[2-(sulfonatoossi) tat-tetrasodju etil]sulfonil]fenil]ażo]naftalen-2,7-disulfonat [1] Prodott tar-reazzjoni tal-aċidu 4-ammino-5-idrossinaftalen-2,7-disulfoniku, akkoppjat darbtejn mas-sulfat tal-idroġenu 2-[(4-amminofenil)sulfonil]etiliku diażotizzat, imlieħ tas-sodju [2] disodju 4-ammino-5-idrossi-3,6-bis{[4-(vinilsulfonil) fenil]diażenil}naftalen-2,7-disulfonat [3]	241-164-5 [1] - [2] - [3]	17095-24-8 [1] - [2] 100556-82-9 [3]	Sens. Resp. 1 A Sens. tal-Ġilda 1	H334 H317	GHS08 Dgr	H334 H317”
“607-775-00-X	3-(allilossi)-2-idrossipropansulfonat tas-sodju	258-004-5	52556-42-0	Ripr. 1B Ħsara lill-Għajn. 1	H360F H318	GHS08 GHS05 Dgr	H360F H318”
“609-074-00-4	1,4-dikloro-2-nitrobenżen	201-923-3	89-61-2	Karċ. 1B	H350	GHS08 Dgr	H350”
“611-182-00-1	2-[etil[3-metil-4-[(5-nitrotijażol-2-il)ażo]fenil]ammino]etanol	271-183-4	68516-81-4	Sens. tal-Ġilda 1 A	H317	GHS07 Wng	H317		Sens. tal-Ġilda 1 A; H317: C ≥ 0,001 %”
“612-299-00-0	fenpropidin (ISO); (R,S)-1-[3-(4-terz-butilfenil)-2-metilpropil]piperidina	—	67306-00-7	Ripr. 2 Toss. Akuta 4 Toss. Akuta 4 STOT SE 3 STOT SE 3 STOT RE 2 Irrit. tal-Ġilda 2 Ħsara lill-Għajn. 1 Sens. tal-Ġilda 1 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H361d H332 H302 H335 H336 H373 (sistema nervuża, għajejn, pulmuni) H315 H318 H317 H400 H410	GHS08 GHS07 GHS05 GHS09 Dgr	H361d H332 H302 H335 H336 H373 (sistema nervuża, għajnejn, pulmuni) H315 H318 H317 H410		Inalazzjoni: ATE = 1,2 mg/L (trabijiet jew raxx) orali: ATE = 1330 mg/kg bw M = 1 000 M = 10 000 ”
“613-350-00-X	1H-benżotriażol	202-394-1	95-14-7	Akkwatiku Kroniku 2	H411	GHS09 Wng	H411”
“613-351-00-5	metil-1H-benżotriażol	249-596-6	29385-43-1	Akkwatiku Kroniku 2	H411	GHS09 Wng	H411”
“616-243-00-6	N,N’-metilendiakrilammid	203-750-9	110-26-9	Muta. 1B	H340	GHS08 Dgr	H340”
“617-024-00-8	terz-butil 2-etilperossieżanoat	221-110-7	3006-82-4	Ripr. 1B Sens. tal-Ġilda 1	H360FD H317	GHS08 GHS07 Dgr	H360FD H317”

(2)

l-entrati li jikkorrispondu għan-numri tal-indiċi 005-005-00-1, 016-022-00-9, 016-094-00-1, 029-019-01-X, 601-037-00-0, 604-020-00-6, 605-001-00-5, 607-001-00-0, 607-043-00-X, 607-094-00-8, 607-198-00-3, 607-315-00-8, 607-432-00-4, 613-272-00-6, 616-127-00-5 u 617-008-00-0 huma sostitwiti bl-entrati li ġejjin rispettivament:

Nru tal-Indiċi	Isem Kimiku	Nru KE	Nru CAS	Klassifikazzjoni		Tikkettar			Limiti ta’ Konċ. Speċifiċi, Fatturi-M u ATEs	Noti
Nru tal-Indiċi	Isem Kimiku	Nru KE	Nru CAS	Klassi tal-Periklu u Kodiċi(jiet) tal-Kategorija	Kodiċi(jiet) tad-Dikjarazzjoni tal-Periklu	Pittogramma, Kodiċi(jiet) tal-Kliem Sinjal	Kodiċi(jiet) tad-Dikjarazzjoni tal-Periklu	Kodiċi(jiet) Supplimentari tad-Dikjarazzjoni tal-Periklu	Limiti ta’ Konċ. Speċifiċi, Fatturi-M u ATEs	Noti
“005-005-00-1	borat tat-trimetil	204-468-9	121-43-7	Fjam. Lik. 3 Ripr. 1B Toss. Akuta 4*	H226 H360FD H312	GHS02 GHS08 GHS07 Dgr	H226 H360FD H312			11”
“016-022-00-9	etanetjol; merkaptan tal-etil	200-837-3	75-08-1	Fjam. Lik. 1 Toss. Akuta 3 Toss. Akuta 4 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H224 H331 H302 H400 H410	GHS02 GHS06 GHS09 Dgr	H224 H331 H302 H410		inalazzjoni: ATE = 7,1 mg/L (fwar) orali: ATE = 680 mg/kg bw”
“016-094-00-1	kubrit	231-722-6	7704-34-9	Irrit. tal-Ġilda 2	H315	GHS07 Wng	H315”
“029-019-01-X	fjokki tar-ram (miksijin bl-aċidu alifatiku)			Toss. Akuta 3 Toss Akuta 4 Irrit. tal-Għajnejn 2 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H331 H302 H319 H400 H410	GHS06 GHS09 Dgr	H331 H302 H319 H410		inalazzjoni: ATE = 0,733 mg/l (trabijiet jew raxx) orali: ATE = 500 mg/kg bw M = 10 M = 1”
“601-037-00-0	n-eżan	203-777-6	110-54-3	Fjam. Lik. 2 Ripr. 2 Asp. Toss. 1 STOT SE 3 STOT RE 1 Irrit. tal-Ġilda 2 Akkwatiku Kroniku 2	H225 H361f*** H304 H336 H372 (sistema nervuża) H315 H411	GHS02 GHS08 GHS07 GHS09 Dgr	H225 H361f*** H304 H336 H372 (sistema nervuża) H315 H411”
“604-020-00-6	bifenil-2-ol; 2-fenilfenol; 2-idrossibifenil	201-993-5	90-43-7	Karċ. 2 Korr. tal-Ġilda 1 Ħsara lill-Għajn. 1 Sens. tal-Ġilda 1B Akkwatiku Akut 1 Akkwatiku Kroniku 1	H351 H314 H318 H317 H400 H410	GHS08 GHS05 GHS07 GHS09 Dgr	H351 H314 H317 H410		M = 1 M = 1”
“605-001-00-5	formaldeid … %	200-001-8	50-00-0	Karċ. 1B Muta. 2 Toss. Akuta 2 Toss. Akuta 4 Korr. tal-ġilda 1B Sens. tal-Ġilda 1 A	H350 H341 H330 H302 H314 H317	GHS08 GHS06 GHS05 Dgr	H350 H341 H330 H302 H314 H317	EUH071	inalazzjoni: ATE = 100 ppmV (gassijiet) orali: ATE = 500 mg/kg bw STOT SE 3; H335: C ≥ 5 % Korr. tal-Ġilda 1B; H314: C ≥ 25 % Irrit. tal-Ġilda 2; H315: 5 % ≤ C < 25 % Irrit. tal-Għajnejn 2; H319: 5 % ≤ C < 25 %	B, D, F”
“607-001-00-0	aċidu formiku ... %	200-579-1	64-18-6	Fjam. Lik. 3 Korr. Met. 1 Toss. Akuta 3 Toss. Akuta 4 Korr. tal-Ġilda 1 A Ħsara lill-Għajn. 1	H226 H290 H331 H302 H314 H318	GHS02 GHS05 GHS06 Dgr	H226 H290 H331 H302 H314	EUH071	inalazzjoni: ATE = 7,4 mg/L (fwar) orali: ATE = 500 mg/kg bw Fjam. Lik. 3; H226: C > 85 % Korr. tal-Ġilda 1 A; H314: C ≥ 90 % Korr. tal-Ġilda 1B; 314: 10 % ≤ C < 90 % Irrit. tal-Ġilda 2; H315: 2 % ≤ C < 10 % Ħsara lill-Għajn. 1; H318: C ≥ 10 % Irrit. tal-Għajnejn 2; H319: 2 % ≤ C < 10 %”	B”
“607-043-00-X	dikamba (ISO); aċidu 2,5-dikloro-6-metossibenżojku; aċidu 3,6-dikloro-2-metossibenżojku	217-635-6	1918-00-9	Toss. Akuta 4 Toss. Akuta 4 STOT SE 3 STOT SE 3 Ħsara lill-Għajn. 1 Akkwatiku Akut 1 Akkwatiku Kroniku 2	H332 H302 H335 H336 H318 H400 H411	GHS07 GHS05 GHS09 Dgr	H332 H302 H335 H336 H318 H410		inalazzjoni: ATE = 4,0 mg/L (trabijiet jew raxx) orali: ATE = 1 500 mg/kg bw M = 1”
“607-094-00-8	aċidu peraċetiku … %	201-186-8	79-21-0	Org. Peross. D Toss. Akuta 2 Toss. Akuta 2 Toss. Akuta 3 Korr. tal-Ġilda 1 A Akkwatiku Akut 1 Akkwatiku Kroniku 1	H242 H330 H310 H301 H314 H400 H410	GHS02 GHS06 GHS05 GHS09 Dgr	H242 H330 H310 H301 H314 H410	EUH071	inalazzjoni: ATE = 0,2 mg/L (trabijiet jew raxx) dermali: ATE = 60 mg/kg bw orali: ATE = 80 mg/kg bw STOT SE 3; H335: C ≥ 1 % M = 10 M = 100	B, D, T”
“607-198-00-3	3,4,5-triidrossibenżoat tal-propil	204-498-2	121-79-9	Toss. Akuta 4 Sens. tal-Ġilda 1 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H302 H317 H400 H410	GHS07 GHS09 Wng	H302 H317 H410		orali: ATE = 1 700 mg/kg bw M = 1 M = 1”
“607-315-00-8	glifosat (ISO); N- (fosfonometil)gliċina	213-997-4	1071-83-6	Ħsara lill-Għajn. 1 Akkwatiku Kroniku 2	H318 H411	GHS05 GHS09 Dgr	H318 H411”
“607-432-00-4	S-metolaklor (ISO); 2-kloro-N-(2-etil-6-metilfenil)-N-[(2S)-1-metossipropan-2-il]aċetammid; (R a S a)-2-kloro-N-(6-etil-o-tolil)-N-[(1S)-2-metossi-1-metiletil]aċetammid [fih 80-100 % 2-kloro-N-(2-etil-6-metilfenil)-N-[(2S)-1-metossipropan-2-il]aċetammid u 0-20 % 2-kloro-N-(2-etil-6-metilfenil)-N-[(2R)-1-metossipropan-2-yl]aċetammid]	—	87392-12-9	Karċ. 2 Sens. tal-Ġilda 1 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H351 H317 H400 H410	GHS08 GHS07 GHS09 Wng	H351 H317 H410	EUH066	M = 10 M = 10”
“613-272-00-6	piraklostrobin (ISO); N-(2-{[1-(4-klorofenil)-1H-pirażol-3-il]ossimetil}fenil) N-metossi karbamat tal-metil	—	175013-18-0	Ripr. 2 Toss. Akuta 3 Toss. Akuta 4 STOT SE 3 STOT RE 2 Irrit. tal-Ġilda 2 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H361d H331 H302 H335 H373 (fwied, passaġġ gastrointestinali, kavità nażali) H315 H400 H410	GHS08 GHS06 GHS09 Dgr	H361d H331 H302 H335 H373 (fwied, passaġġ gastrointestinali, kavità nażali) H315 H410		inalazzjoni: ATE = 0,58 mg/L (trabijiet jew raxx) orali: ATE = 450 mg/kg bw M = 100 M = 100”
“616-127-00-5	massa ta’ reazzjoni ta’ N,N’-etan-1,2-diilbis(dekanammid) u 12-idrossi-N-[2-[(1-ossodeċil)ammino]etil]oktadekanammid u N,N’-etan-1,2-diilbis(12-idrossioktadekanammid) [1] massa ta’ reazzjoni ta’ N,N’-etan-1,2-diilbis(dekanammid) u 12-idrossi-N-[2-[(1-ossodeċil)ammino]etil]oktadekanammid [2]	430-050-2 [1] - [2]	- [1] - [2]	Sens. tal-Ġilda 1 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H317 H400 H410	GHS07 GHS09 Wng	H317 H410		M = 100 M = 10”
“617-008-00-0	perossidu tad-dibenżojl; perossidu tal-benżojl	202-327-6	94-36-0	Org. Peross. B Irrit. tal-Għajnejn 2 Sens. tal-Ġilda 1 Akkwatiku Akut 1 Akkwatiku Kroniku 1	H241 H319 H317 H400 H410	GHS01 GHS02 GHS07 GHS09 Dgr	H241 H319 H317 H410		M = 10 M = 10”

(3)	l-entrati li jikkorrispondu għan-numri tal-indiċi 005-017-00-7, 005-017-01-4, 005-018-00-2, 005-018-01-X, 005-019-00-8, 005-019-01-5 u 029-024-00-X jitħassru.

ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj

ISSN 1977-074X (electronic edition)

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