(fra kommisjonsforodningen) 

(1) Part 3, Table 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation. 

(2) Proposals to introduce harmonised classification and labelling of certain substances and to update the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency (‘the Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment (RAC) of the Agency adopted, after having taken account of the comments received from the parties concerned, the following opinions on those proposals:

 – Opinion of 16 March 2023 concerning 2-ethylhexanoic acid, monoester with propane-1,2-diol;

 – Opinion of 16 March 2023 concerning Aqueous extract from the germinated seeds of sweet Lupinus albus; 

– Opinion of 16 March 2023 concerning N-1-naphthylaniline; Nphenylnaphthalen-1-amine; 

– Opinion of 16 March 2023 concerning propyl 4-hydroxybenzoate; 

– Opinion of 16 March 2023 concerning α,α'-propylenedinitrilodi-o-cresol; 

– Opinion of 16 March 2023 concerning ozone;

 – Opinion of 16 March 2023 concerning dinitrogen oxide; 

– Opinion of 16 March 2023 concerning tetrairon tris(pyrophosphate); ferric pyrophosphate; 

– Opinion of 16 March 2023 concerning 2-phenylpropene; α-methylstyrene; – Opinion of 16 March 2023 concerning tetraphosphorus trisulphide; phosphorus sesquisulphide; 

– Opinion of 16 March 2023 concerning pethoxamid (ISO); 2-chloro-N-(2- ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl)acetamide; 

– Opinion of 8 June 2023 concerning 1,1-dichloroethylene; vinylidene chloride;

– Opinion of 8 June 2023 concerning bixlozone (ISO); 2-(2,4-dichlorobenzyl)- 4,4-dimethyl-1,2-oxazolidin-3-one; 

– Opinion of 8 June 2023 concerning 9-octadecenoic acid (Z)-, sulfonated, potassium salts [1]; Reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts [2]; 9(or 10)-sulphooctadecanoic acid, potassium salt [3]; 

– Opinion of 8 June 2023 concerning barium bis[2-chloro-5-[(2-hydroxy-1- naphthyl)azo]toluene-4-sulphonate]; C.I. Pigment Red 53:1; 

– Opinion of 8 June 2023 concerning barium chromate; 

– Opinion of 8 June 2023 concerning chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents; 

– Opinion of 8 June 2023 concerning chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2; 

– Opinion of 8 June 2023 concerning fluoroethylene; 

– Opinion of 8 June 2023 concerning tetrahydrofurfuryl methacrylate;

– Opinion of 8 June 2023 concerning 2,3-epoxypropyl isopropyl ether; 

– Opinion of 8 June 2023 concerning trimethyl phosphate; 

– Opinion of 8 June 2023 concerning 3-isocyanatomethyl-3,5,5- trimethylcyclohexyl isocyanate; isophorone di-isocyanate; 

– Opinion of 8 June 2023 concerning 2-bromo-2-(bromomethyl)pentanedinitrile; [DBDCB]; 

– Opinion of 8 June 2023 concerning folpet (ISO); N- (trichloromethylthio)phthalimide; 

– Opinion of 14 September 2023 concerning 2-bromo-3,3,3-trifluoroprop-1-ene; 

– Opinion of 14 September 2023 concerning clopyralid (ISO); 3,6- dichloropyridine-2- carboxylic acid; – Opinion of 14 September 2023 concerning 3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate; 

– Opinion of 14 September 2023 concerning captan (ISO); 1,2,3,6-tetrahydro-N- (trichloromethylthio)phthalimide; 

– Opinion of 14 September 2023 concerning dinotefuran (ISO); (RS)-1-methyl-2- nitro-3-(tetrahydro-3-furylmethyl)guanidine; 

– Opinion of 14 September 2023 concerning methyl oct-2-ynoate; – Opinion of 14 September 2023 concerning proquinazid (ISO); 6-iodo-2- propoxy-3- propylquinazolin-4(3H)-one; 

– Opinion of 14 September 2023 concerning 2,3-epoxypropyl o-tolyl ether;

– Opinion of 14 September 2023 concerning 2-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride. 

(3) The Commission has received additional information from stakeholders contesting the scientific assessment set out in the RAC opinion of 16 March 2023 concerning dinitrogen oxide. The additional information has been assessed by the Commission and has not been found sufficient to cast doubts on the scientific analysis contained in the RAC opinions. 

(4) In light of the RAC opinions, it is appropriate to introduce or update the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions and following the further assessment by the Commission. 

(5) Regulation (EC) No 1272/2008 should therefore be amended accordingly. 

(6) Compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or updated classifications and to sell existing stocks subject to the pre-existing regulatory requirements. That period of time is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing compliance with other legal requirements following the changes made under this Regulation. Suppliers should, however, have the possibility to apply the new or updated harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis before the date of application of this Regulation, to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers,