CELEX: 
Language: en
Date: 2019-01-10
Title: COMMISSION REGULATION (EU) …/… amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting Commission Regulation (EU) 2018/669

COMMISSION REGULATION (EU) …/…
            
            
               of XXX
            
            
               amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting Commission Regulation (EU) 2018/669
            
            
               (Text with EEA relevance)
            
            
               THE EUROPEAN COMMISSION,
            
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to 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
                  1
               , and in particular Articles 37(5) and 53(1) thereof, 
            
            
               Whereas: 
            
            
               Table 3 of Part 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. 
            
            
               (1)Proposals to introduce harmonised classification and labelling of certain substances and to update or delete the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency pursuant to Article 37 of Regulation (EC) No 1272/2008. Based on the opinions on those proposals issued by the Committee for Risk Assessment of the Agency (RAC), as well as on the comments received from the parties concerned, it is appropriate to introduce, update, delete or leave unchanged harmonised classification and labelling of certain substances. 
            
            
               (2)It is appropriate and scientifically justified to follow RAC’s opinions regarding the hazard classes proposed for the harmonised classification and labelling of certain substances.
            
            
               (3)Acute Toxicity Estimates (ATE) are mainly used to determine the classification for human health acute toxicity of mixtures containing substances classified for acute toxicity. The inclusion of harmonised ATE values in the entries listed in Annex VI to Regulation (EC) No 1272/2008 facilitate the harmonisation of the classification of mixtures and provide support for enforcement authorities. Following further scientific assessments on some substances, ATE values have been calculated and should be inserted in the penultimate column of Table 3 of Part 3 of Annex VI to Regulation 1272/2008. The substances concerned are methylmercuric chloride, pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate, N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid), pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate, ethylene oxide; oxirane and metaldehyde (ISO); 2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane.
            
            
               (4)In its scientific opinion of 22 September 2017 on the substance cobalt, RAC proposed to classify that substance as carcinogen category 1A with a specific concentration limit of ≥ 0,01 %. However, the methodology used to determine a specific concentration limit required further assessment in particular of its applicability to metal compounds. It is therefore appropriate not to introduce, for the time being, any specific concentration limit in Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 for cobalt, in which case the general concentration limit of ≥ 0,1 % should apply, in accordance with Table 3.6.2 of Annex I to that Regulation.
            
            
               (5)In its scientific opinion of 14 September 2017 on the substance titanium dioxide, RAC proposed to classify that substance as carcinogen category 2 by inhalation. As titanium dioxide induced-lung carcinogenicity is associated with inhalation of respirable titanium dioxide particles, it is appropriate to define respirable titanium dioxide particles in the titanium dioxide entry. In addition, as some dangerous dust or droplets could be formed during the use of mixtures containing titanium dioxide, it is necessary to inform the users on the precautionary measures that need to be taken to minimise the hazard for human health. 
            
            
               (6)Regulation (EC) No 1272/2008 should therefore be amended accordingly. 
            
            
               (7)Commission Regulation (EU) 2018/669
                  2
                provides for the translation of chemical names into all official languages of the Union, except Irish. Regulation (EU) 2018/669 contains the harmonised classification, labelling and packaging for the substance pitch, coal tar, high temp. as applicable on 1 January 2016. However,  Commission Regulation (EU) No 944/2013
                  3
                amended the harmonised classification, labelling and packaging of that substance as from 1 April 2016. Due to an administrative oversight, Regulation (EU) 2018/669 did not take into account the amendments introduced with Regulation (EU) No 944/2013. As Regulation (EU) 2018/669 will become applicable as of 1 December 2019, it will erroneously re-introduce the original classification, labelling and packaging for the entry pitch, coal tar, high temp. Regulation (EU) 2018/669 should therefore be corrected accordingly.  
            
            
               (8)To ensure that suppliers of substances and mixtures have time to adapt to the new classification and labelling provisions, the application of this Regulation should be deferred. 
            
            
               (9)In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow the application of the new provisions at an earlier stage on a voluntary basis, suppliers should have the possibility of applying the new classification, labelling and packaging provisions on a voluntary basis before the date of application of this Regulation.
            
            
               (10)The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  4
               ,
            
         
         
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1
            
            
               Amendments to Regulation (EC) No 1272/2008
            
            
            
               Regulation (EC) No 1272/2008 is amended as follows:
            
            
               (1) Annex II is amended as set out in Annex I to this Regulation.
            
            
               (2) Annex III is amended as set out in Annex II to this Regulation. 
            
            
               (3) Annex VI is amended as set out in Annex III to this Regulation.
            
            
                Article 2 
            
            
               Correction to Regulation (EU) 2018/669
            
            
               The Annex to Commission Regulation (EU) 2018/669 is corrected as set out in Annex IV to this Regulation.
            
            
               Article 3
            
            
               Entry into force and application
            
            
               This Regulation 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 [OP: please insert date to be determined as follows: Date of entry into force plus 18 months – the date should be the 1st day of the following month.] 
            
            
               Article 2 shall apply from 1 December 2019. 
            
            
               By way of derogation from the second paragraph, substances and mixtures may, before [OP: please insert specific date of application determined under the second paragraph], be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
         
         
            
               
                     For the Commission
               
               
                     The President
                     […]
               
            
         
         
      
    ---documentbreak--- 
      
         
         
            
               EN
                  Annexes 1 to 4
            
            
               ANNEX I
            
            
            
               In Annex II to Regulation (EC) No 1272/2008, in Part 2, the following section 2.12 is inserted:
            
            
            
               ‘2.12. Mixtures containing titanium dioxide.
            
            
               The label on the packaging of liquid mixtures containing 1% or more of titanium dioxide particles with a diameter equal to or below 10 µm   shall bear the following statement:
            
            
               EUH211: 'Warning! Dangerous droplets may be formed when sprayed. See information supplied by the manufacturer. Comply with the safety instructions.'
            
            
               The label on the packaging of solid mixtures containing 1% or more of titanium dioxide shall bear the following statement:
            
            
               EUH212: 'Warning! Dangerous dust may be formed when used. See information supplied by the manufacturer. Comply with the safety instructions.'
            
            
               The label on the packaging of liquid and solid mixtures not intended for the general public and not classified as hazardous which are labelled with EUH211 or EUH212, shall bear statement EUH210 in addition. 
            
            
               
            
               ANNEX II
            
            
                
            
            
               In Part 3 of Annex III to Regulation (EC) No 1272/2008, in Table 2.1, the following rows EUH 211 and EUH 212 are inserted:
            
            
            
            
                     
                        ‘EUH211
                     
                  
                  
                     
                        Language
                     
                  
                  
                     
                        Warning! Dangerous droplets may be formed when sprayed. See information supplied by the manufacturer. Comply with the safety instructions.
                     
                  
               
                     
                        EUH212
                     
                  
                  
                     
                        Language
                     
                  
                  
                     
                        Warning! Dangerous dust may be formed when used. See information supplied by the manufacturer. Comply with the safety instructions.’
                     
                  
               
            
               
         
         
            
               ANNEX III
            
            
            
               Annex VI to Regulation (EC) No 1272/2008 is amended as follows: 
            
            
            
               (1)Part 1 is amended as follows:
            
            
            
               (a) in point 1.1.3.1, the following note V is added:
            
            
                  ‘Note V:
            
            
               If the substance is placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry their hazardous properties must be evaluated in accordance with Title II of Regulation (EC) No 1272/2008 to assess whether a higher category (Carc.  1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.’;
            
            
               (b) in point 1.1.3.2, the following note 10 is added:
            
            
                   ‘Note 10:
            
            
               The classification as a carcinogen by inhalation applies only to mixtures placed on the market in powder form containing 1% or more of titanium dioxide particles with diameter ≤ 10 µm.’;
            
            
            
               (2)in Part 3, Table 3 is amended as follows:
            
            
            
            
               (a) the rows corresponding to index numbers 604-083-00-X and 611-159-00-6 are deleted;
            
            
            
               (b) the rows corresponding to index numbers 015-189-00-5, 027-001-00-9, 028-018-00-4, 603-023-00-X, 605-005-00-7, 606-047-00-9, 607-232-00-7, 607-247-00-9, 608-039-00-0, 613-054-00-0, 616-018-00-2 and 648-055-00-5 are replaced by the following rows respectively:
            
            
         
         
            
            
            
            
                     
                        Index No
                     
                  
                  
                     
                        Chemical name
                     
                  
                  
                     
                        EC No
                     
                  
                  
                     
                        CAS No
                     
                  
                  
                     
                        Classification
                     
                  
                  
                     
                        Labelling
                     
                  
                  
                     
                        Specific Conc. Limits, M-factors and ATEs
                     
                  
                  
                     
                        Notes
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        Hazard Class and Category Code(s)
                     
                  
                  
                     
                        Hazard statement Code(s)
                     
                  
                  
                     
                        Pictogram, Signal Word  Code(s)
                     
                  
                  
                     
                        Hazard statement Code(s)
                     
                  
                  
                     
                        Suppl. Hazard statement Code(s)
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        ‘015-189-00-5
                     
                     
                  
                  
                     
                        phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
                     
                  
                  
                     
                        423-340-5
                     
                  
                  
                     
                        162881-26-7
                     
                  
                  
                     
                        Skin Sens. 1A
                     
                     
                        Aquatic Chronic 4
                     
                     
                  
                  
                     
                        H317
                     
                     
                        H413
                     
                     
                         
                     
                     
                  
                  
                     
                        GHS07
                     
                     
                        Wng
                     
                     
                  
                  
                     
                        H317
                     
                     
                        H413’
                     
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        ‘027-001-00-9
                     
                  
                  
                     
                        cobalt
                     
                  
                  
                     
                        231-158-0
                     
                  
                  
                     
                        7440-48-4
                     
                  
                  
                     
                        Carc. 1B
                     
                     
                        Muta. 2
                     
                     
                        Repr. 1B 
                     
                     
                        Resp. Sens. 1
                     
                     
                        Skin Sens. 1
                     
                     
                        Aquatic Chronic 4
                     
                     
                  
                  
                     
                        H350
                     
                     
                        H341
                     
                     
                        H360F 
                     
                     
                        H334
                     
                     
                        H317
                     
                     
                        H413
                     
                  
                  
                     
                        GHS08
                     
                     
                        Dgr
                     
                  
                  
                     
                        H350
                     
                     
                        H341
                     
                     
                        H360F 
                     
                     
                        H334
                     
                     
                        H317
                     
                     
                        H413’
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        ‘028-018-00-4
                     
                     
                  
                  
                     
                        nickel bis(sulfamidate);
                     
                     
                        nickel sulfamate
                     
                  
                  
                     
                        237-396-1
                     
                  
                  
                     
                        13770-89-3
                     
                  
                  
                     
                        Carc. 1A
                     
                     
                        Muta. 2
                     
                     
                        Repr. 1B
                     
                     
                        Acute Tox. 4
                     
                     
                        STOT RE 1
                     
                     
                        Resp. Sens. 1
                     
                     
                        Skin Sens. 1
                     
                     
                        Aquatic Acute 1
                     
                     
                        Aquatic Chronic 1
                     
                  
                  
                     
                        H350i
                     
                     
                        H341
                     
                     
                        H360D***
                     
                     
                        H302
                     
                     
                        H372**
                     
                     
                        H334
                     
                     
                        H317
                     
                     
                        H400
                     
                     
                        H410
                     
                  
                  
                     
                        GHS08
                     
                     
                        GHS07
                     
                     
                        GHS09
                     
                     
                        Dgr
                     
                  
                  
                     
                        H350i
                     
                     
                        H341
                     
                     
                        H360D***
                     
                     
                        H302
                     
                     
                        H372**
                     
                     
                        H334
                     
                     
                        H317
                     
                     
                        H410
                     
                  
                  
                     
                  
                  
                     
                        oral: ATE = 853 mg/kg bw (anhydrate)
                     
                     
                        oral: ATE = 1098 mg/kg bw (tetrahydrate)
                     
                     
                     
                        STOT RE 1; 
                     
                     
                        H372: C ≥ 1 %
                     
                     
                        STOT RE 2; 
                     
                     
                        H373: 0,1 % ≤ C < 1 %
                     
                     
                        Skin Sens. 1; 
                     
                     
                        H317: C ≥ 0,01 %
                     
                     
                     
                        M=1’
                     
                  
                  
                     
                        H
                     
                  
               
                     
                        ‘603-023-00-X
                     
                  
                  
                     
                        ethylene oxide; 
                     
                     
                        oxirane
                     
                  
                  
                     
                        200-849-9
                     
                  
                  
                     
                        75-21-8
                     
                  
                  
                     
                        Flam. Gas 1
                     
                     
                        Press. Gas
                     
                     
                        Carc. 1B
                     
                     
                        Muta. 1B
                     
                     
                        Repr. 1B
                     
                     
                        Acute Tox. 3
                     
                     
                        Acute Tox. 3
                     
                     
                        STOT SE 3
                     
                     
                        STOT SE 3
                     
                     
                        STOT RE 1
                     
                     
                        Skin Corr. 1
                     
                     
                        Eye Dam. 1
                     
                     
                  
                  
                     
                        H220
                     
                     
                        H350
                     
                     
                        H340
                     
                     
                        H360Fd
                     
                     
                        H331
                     
                     
                        H301
                     
                     
                        H335
                     
                     
                        H336
                     
                     
                        H372 (nervous system)
                     
                     
                        H314
                     
                     
                        H318
                     
                  
                  
                     
                        GHS02
                     
                     
                        GHS08
                     
                     
                        GHS06
                     
                     
                        GHS05
                     
                     
                        Dgr 
                     
                     
                     
                  
                  
                     
                        H220
                     
                     
                        H350
                     
                     
                        H340
                     
                     
                        H360Fd
                     
                     
                        H331
                     
                     
                        H301
                     
                     
                        H335
                     
                     
                        H336
                     
                     
                        H372 (nervous system)
                     
                     
                        H314
                     
                  
                  
                     
                  
                  
                     
                        inhalation: ATE = 700ppm (gases)
                     
                     
                        oral: ATE = 100 mg/kg bw’
                     
                  
                  
                     
                        U
                     
                  
               
                     
                        ‘605-005-00-7
                     
                  
                  
                     
                        metaldehyde (ISO); 
                     
                     
                        2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane
                     
                  
                  
                     
                        203-600-2
                     
                  
                  
                     
                        108-62-3
                     
                  
                  
                     
                        Flam. Sol. 2
                     
                     
                        Repr. 2
                     
                     
                        Acute Tox. 3
                     
                     
                        Aquatic Chronic 3
                     
                  
                  
                     
                        H228
                     
                     
                        H361f
                     
                     
                        H301
                     
                     
                        H412
                     
                     
                  
                  
                     
                        GHS02
                     
                     
                        GHS08
                     
                     
                        GHS06
                     
                     
                        Dgr
                     
                  
                  
                     
                        H228
                     
                     
                        H361f
                     
                     
                        H301
                     
                     
                        H412
                     
                  
                  
                     
                  
                  
                     
                        oral: ATE = 283 mg/kg bw’
                     
                  
                  
                     
                  
               
                     
                        ‘606-047-00-9
                     
                     
                  
                  
                     
                        2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
                     
                  
                  
                     
                        404-360-3
                     
                  
                  
                     
                        119313-12-1
                     
                  
                  
                     
                        Repr. 1B
                     
                     
                        Aquatic Acute 1
                     
                     
                        Aquatic Chronic 1
                     
                  
                  
                     
                        H360D
                     
                     
                        H400
                     
                     
                        H410
                     
                  
                  
                     
                        GHS08
                     
                     
                        GHS09
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360D
                     
                     
                        H410’
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        ‘607-232-00-7
                     
                  
                  
                     
                        pyridate (ISO); 
                     
                     
                        O-(6-chloro-3-phenylpyridazin-4-yl) S-octyl thiocarbonate
                     
                  
                  
                     
                        259-686-7
                     
                  
                  
                     
                        55512-33-9
                     
                  
                  
                     
                        Acute Tox. 4
                     
                     
                        Skin Irrit. 2
                     
                     
                        Skin Sens. 1
                     
                     
                        Aquatic Acute 1
                     
                     
                        Aquatic Chronic 1
                     
                     
                  
                  
                     
                        H302
                     
                     
                        H315
                     
                     
                        H317
                     
                     
                        H400
                     
                     
                        H410
                     
                     
                  
                  
                     
                        GSH07
                     
                     
                        GHS09
                     
                     
                        Wng
                     
                  
                  
                     
                        H302
                     
                     
                        H315
                     
                     
                        H317
                     
                     
                        H410
                     
                     
                  
                  
                     
                  
                  
                     
                        oral: ATE = 500 mg/kg bw
                     
                     
                     
                        M=1
                     
                     
                        M=10’
                     
                  
                  
                     
                  
               
                     
                        ‘607-247-00-9
                     
                     
                  
                  
                     
                        dodecyl methacrylate
                     
                  
                  
                     
                        205-570-6
                     
                  
                  
                     
                        142-90-5
                     
                  
                  
                     
                        STOT SE 3
                     
                     
                  
                  
                     
                        H335
                     
                  
                  
                     
                        GHS07
                     
                     
                        Wng
                     
                     
                  
                  
                     
                        H335
                     
                     
                  
                  
                     
                  
                  
                     
                        STOT SE 3; H335: C ≥ 10%’
                     
                  
                  
                     
                  
               
                     
                        ‘608-039-00-0
                     
                     
                  
                  
                     
                        2-phenylhexanenitrile
                     
                  
                  
                     
                        423-460-8
                     
                  
                  
                     
                        3508-98-3
                     
                  
                  
                     
                        Acute Tox. 4
                     
                     
                        Aquatic Chronic 2
                     
                  
                  
                     
                        H302
                     
                     
                        H411
                     
                  
                  
                     
                        GHS07
                     
                     
                        GHS09
                     
                     
                        Wng
                     
                  
                  
                     
                        H302
                     
                     
                        H411
                     
                  
                  
                     
                  
                  
                     
                        oral:
                     
                     
                        ATE = 500 mg/kg bw’
                     
                  
                  
                     
                  
               
                     
                        ‘613-054-00-0
                     
                     
                  
                  
                     
                        thiabendazole (ISO); 
                     
                     
                        2-(thiazol-4-yl)benzimidazole
                     
                  
                  
                     
                        205-725-8
                     
                  
                  
                     
                        148-79-8
                     
                  
                  
                     
                        Aquatic Acute 1 Aquatic Chronic 1
                     
                  
                  
                     
                        H400
                     
                     
                        H410
                     
                  
                  
                     
                        GHS09
                     
                     
                        Wng
                     
                  
                  
                     
                        H410
                     
                  
                  
                     
                  
                  
                     
                        M=1
                     
                     
                        M=1’
                     
                  
                  
                     
                  
               
                     
                        ‘616-018-00-2
                     
                     
                  
                  
                     
                        diethyltoluamide (ISO):                                    N,N-diethyl-m-toluamide;                                      [deet]
                     
                  
                  
                     
                        205-149-7
                     
                  
                  
                     
                        134-62-3
                     
                  
                  
                     
                        Acute Tox. 4
                     
                     
                        Skin Irrit. 2 
                     
                     
                        Eye Irrit. 2
                     
                     
                  
                  
                     
                        H302
                     
                     
                        H315
                     
                     
                        H319
                     
                     
                  
                  
                     
                        GHS07
                     
                     
                        Wng
                     
                     
                  
                  
                     
                        H302
                     
                     
                        H315
                     
                     
                        H319
                     
                     
                  
                  
                     
                  
                  
                     
                        oral:
                     
                     
                        ATE = 1892 mg/kg bw’
                     
                  
                  
                     
                  
               
            
            
               (c) the following rows are inserted:
            
            
            
                     
                        Index No
                     
                  
                  
                     
                        Chemical Name
                     
                  
                  
                     
                        EC No
                     
                  
                  
                     
                        CAS No
                     
                  
                  
                     
                        Classification
                     
                  
                  
                     
                        Labelling
                     
                  
                  
                     
                        Specific Conc. Limits, M-factors and ATEs
                     
                  
                  
                     
                        Notes 
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        Hazard Class and Category Code(s)
                     
                  
                  
                     
                        Hazard statement Code(s)
                     
                  
                  
                     
                        Pictogram, Signal Word  Code(s)
                     
                  
                  
                     
                        Hazard statement Code(s)
                     
                  
                  
                     
                        Suppl. Hazard statement Code(s)
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        ‘022-006-002
                     
                  
                  
                     
                        titanium dioxide; 
                     
                     
                        [in a powder form containing 1% or more of particles with diameter ≤ 10 µm]
                     
                  
                  
                     
                        236-675-5
                     
                  
                  
                     
                        13463-67-7
                     
                  
                  
                     
                        Carc. 2 
                     
                  
                  
                     
                        H351 (inhalation)
                     
                  
                  
                     
                        GHS08
                     
                     
                        Wng
                     
                  
                  
                     
                        H351 (inhalation)
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        V, 10
                     
                  
               
                     
                        080-004-00-7
                     
                  
                  
                     
                        methylmercuric chloride
                     
                  
                  
                     
                        204-064-2
                     
                  
                  
                     
                        115-09-3
                     
                  
                  
                     
                        Carc. 2
                     
                     
                        Repr. 1A
                     
                     
                        Lact.
                     
                     
                        Acute Tox. 2
                     
                     
                        Acute Tox. 2
                     
                     
                        Acute Tox. 2
                     
                     
                        STOT RE 1
                     
                     
                        Aquatic Acute 1
                     
                     
                        Aquatic Chronic 1 
                     
                  
                  
                     
                        H351
                     
                     
                        H360Df
                     
                     
                        H362
                     
                     
                        H330
                     
                     
                        H310
                     
                     
                        H300
                     
                     
                        H372 (nervous system, kidneys)
                     
                     
                        H400
                     
                     
                        H410
                     
                  
                  
                     
                        GHS08 
                     
                     
                        GHS06 
                     
                     
                        GHS09 
                     
                     
                        Dgr 
                     
                     
                  
                  
                     
                        H351
                     
                     
                        H360Df
                     
                     
                        H362
                     
                     
                        H330
                     
                     
                        H310
                     
                     
                        H300
                     
                     
                        H372 (nervous system, kidneys)
                     
                     
                        H410
                     
                  
                  
                     
                  
                  
                     
                        inhalation: ATE = 0,05 mg/l (dusts or mists)
                     
                     
                        dermal: ATE = 50 mg/kg bw
                     
                     
                        oral: ATE = 5 mg/kg bw
                     
                     
                  
                  
                     
                        1
                     
                  
               
                     
                        601-090-00-X
                     
                  
                  
                     
                        benzo[rst]pentaphene
                     
                  
                  
                     
                        205-877-5
                     
                  
                  
                     
                        189-55-9
                     
                  
                  
                     
                        Carc. 1B
                     
                     
                        Muta. 2
                     
                     
                  
                  
                     
                        H350
                     
                     
                        H341
                     
                     
                  
                  
                     
                        GHS08
                     
                     
                        Dgr
                     
                  
                  
                     
                        H350
                     
                     
                        H341
                     
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        601-091-00-5
                     
                  
                  
                     
                        dibenzo[b,def]chrysene;
                     
                     
                        dibenzo[a,h]pyrene
                     
                  
                  
                     
                        205-878-0
                     
                  
                  
                     
                        189-64-0
                     
                  
                  
                     
                        Carc. 1B
                     
                     
                        Muta. 2
                     
                     
                  
                  
                     
                        H350
                     
                     
                        H341
                     
                     
                  
                  
                     
                        GHS08
                     
                     
                        Dgr
                     
                  
                  
                     
                        H350
                     
                     
                        H341
                     
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        603-236-00-8
                     
                  
                  
                     
                        ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.
                     
                  
                  
                     
                        308-208-6
                     
                  
                  
                     
                        97925-95-6
                     
                  
                  
                     
                        Repr. 1B
                     
                  
                  
                     
                        H360D
                     
                  
                  
                     
                        GHS08
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360D
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        607-733-00-0
                     
                     
                  
                  
                     
                        cyflumetofen (ISO); 
                     
                     
                        2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate
                     
                  
                  
                     
                        -
                     
                  
                  
                     
                        400882-07-7
                     
                  
                  
                     
                        Carc. 2
                     
                     
                        Skin Sens. 1A
                     
                     
                  
                  
                     
                        H351
                     
                     
                        H317
                     
                  
                  
                     
                        GHS08
                     
                     
                        GHS07
                     
                     
                        Wng
                     
                  
                  
                     
                        H351
                     
                     
                        H317
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        607-734-00-6
                     
                  
                  
                     
                        pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate
                     
                  
                  
                     
                        404-290-3
                     
                  
                  
                     
                        7216-95-7
                     
                  
                  
                     
                        Repr. 1B
                     
                     
                        Acute Tox. 4 STOT RE 2
                        Eye Irrit. 2
                     
                  
                  
                     
                        H360D
                     
                     
                        H332
                     
                     
                        H373 (inhalation)
                           H319
                     
                  
                  
                     
                        GHS08
                           GHS07
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360D
                     
                     
                        H332
                     
                     
                        H373 (inhalation)
                           H319
                     
                  
                  
                     
                  
                  
                     
                        inhalation:
                     
                     
                        ATE = 1,5 mg/l (dusts or mists) 
                     
                  
                  
                     
                  
               
                     
                        607-735-00-1
                     
                  
                  
                     
                        N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid)
                     
                  
                  
                     
                        200-652-8
                     
                  
                  
                     
                        67-43-6
                     
                  
                  
                     
                        Repr. 1B
                     
                     
                        Acute Tox. 4 STOT RE 2
                        Eye Irrit. 2
                     
                  
                  
                     
                        H360D
                     
                     
                        H332
                     
                     
                        H373 (inhalation)
                           H319
                     
                  
                  
                     
                        GHS08
                           GHS07
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360D
                     
                     
                        H332
                     
                     
                        H373 (inhalation)
                           H319
                     
                  
                  
                     
                  
                  
                     
                        inhalation:
                     
                     
                        ATE = 1,5 mg/l (dusts or mists)
                     
                  
                  
                     
                  
               
                     
                        607-736-00-7
                     
                  
                  
                     
                        pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
                     
                  
                  
                     
                        205-391-3
                     
                  
                  
                     
                        140-01-2
                     
                  
                  
                     
                        Repr. 1B
                     
                     
                        Acute Tox. 4
                     
                     
                        STOT RE 2
                     
                     
                  
                  
                     
                        H360D
                     
                     
                        H332 
                     
                     
                        H373 (inhalation)
                     
                     
                  
                  
                     
                        GHS08
                     
                     
                        GHS07
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360D
                     
                     
                        H332
                     
                     
                        H373 (inhalation)
                     
                     
                  
                  
                     
                  
                  
                     
                        inhalation:
                     
                     
                        ATE = 1,5 mg/l (dusts or mists)
                     
                  
                  
                     
                  
               
                     
                        607-737-00-2
                     
                  
                  
                     
                        diisohexyl phthalate
                     
                  
                  
                     
                        276-090-2
                     
                  
                  
                     
                        71850-09-4
                     
                  
                  
                     
                        Repr. 1B
                     
                  
                  
                     
                        H360FD
                     
                  
                  
                     
                        GHS08
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360FD
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        608-069-00-4
                     
                  
                  
                     
                        fludioxonil (ISO); 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile
                     
                  
                  
                     
                        -
                     
                  
                  
                     
                        131341-86-1
                     
                  
                  
                     
                        Aquatic Acute 1
                     
                     
                        Aquatic Chronic 1
                     
                  
                  
                     
                        H400
                     
                     
                        H410
                     
                  
                  
                     
                        GHS09
                     
                     
                        Wng
                     
                  
                  
                     
                        H410
                     
                  
                  
                     
                  
                  
                     
                        M=1
                     
                     
                        M=10
                     
                  
                  
                     
                  
               
                     
                        613-329-00-5
                     
                  
                  
                     
                        halosulfuron-methyl (ISO); 
                     
                     
                        methyl 3-chloro-5-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-1-methyl-1H-pyrazole-4-carboxylate
                     
                  
                  
                     
                        -
                     
                  
                  
                     
                        100784-20-1
                     
                  
                  
                     
                        Repr. 1B
                     
                     
                        Aquatic Acute 1
                     
                     
                        Aquatic Chronic 1
                     
                  
                  
                     
                        H360D
                     
                     
                        H400
                     
                     
                        H410
                     
                  
                  
                     
                        GHS08
                     
                     
                        GHS09
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360D
                     
                     
                        H410
                     
                  
                  
                     
                  
                  
                     
                     
                        M=1000
                     
                     
                        M=1000
                     
                  
                  
                     
                  
               
                     
                        613-330-00-0
                     
                     
                  
                  
                     
                        2-methylimidazole
                     
                  
                  
                     
                        211-765-7
                     
                  
                  
                     
                        693-98-1
                     
                  
                  
                     
                        Repr. 1B 
                     
                  
                  
                     
                        H360Df
                     
                  
                  
                     
                        GHS08
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360Df
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        616-225-00-8
                     
                  
                  
                     
                        (RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide; mandestrobin
                     
                  
                  
                     
                        -
                     
                  
                  
                     
                        173662-97-0
                     
                  
                  
                     
                        Aquatic Acute 1 Aquatic Chronic 1
                     
                  
                  
                     
                        H400
                     
                     
                        H410
                     
                  
                  
                     
                        GHS09
                     
                     
                        Wng
                     
                  
                  
                     
                        H410
                     
                  
                  
                     
                  
                  
                     
                        M=1
                     
                     
                        M=10
                     
                  
                  
                     
                  
               
                     
                        616-226-00-3
                     
                  
                  
                     
                        carboxin (ISO); 
                     
                     
                        2-methyl-N-phenyl-5,6-dihydro-1,4-oxathiine-3-carboxamide; 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide
                     
                  
                  
                     
                        226-031-1
                     
                  
                  
                     
                        5234-68-4
                     
                  
                  
                     
                        STOT RE 2
                     
                     
                        Skin Sens. 1
                     
                     
                        Aquatic Acute 1
                     
                     
                        Aquatic Chronic 1
                     
                  
                  
                     
                        H373 (kidneys)
                     
                     
                        H317
                     
                     
                        H400
                     
                     
                        H410
                     
                  
                  
                     
                        GHS08
                     
                     
                        GHS07
                     
                     
                        GHS09
                     
                     
                        Wng
                     
                  
                  
                     
                        H373 (kidneys)
                     
                     
                        H317
                     
                     
                        H410
                     
                  
                  
                     
                  
                  
                     
                     
                     
                     
                        M=1
                     
                     
                        M=1
                     
                  
                  
                     
                  
               
                     
                        616-227-00-9
                     
                  
                  
                     
                        metaflumizone (ISO); 
                     
                     
                        (EZ)-2'-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [E-isomer > 90%, Z-isomer <10% relative content]; [1]
                     
                     
                        (E)-2'-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [2]
                     
                  
                  
                     
                        -
                     
                  
                  
                     
                        139968-49-3 [1]
                     
                     
                        852403-68-0 [2]
                     
                  
                  
                     
                        Repr. 2
                     
                     
                        Lact.
                     
                     
                        STOT RE 2
                     
                  
                  
                     
                        H361fd
                     
                     
                        H362
                     
                     
                        H373
                     
                  
                  
                     
                        GHS08
                     
                     
                        Wng
                     
                  
                  
                     
                        H361fd
                     
                     
                        H362
                     
                     
                        H373
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        650-056-00-0
                     
                  
                  
                     
                        dibutylbis(pentane-2,4-dionato-O,O')tin
                     
                  
                  
                     
                        245-152-0
                     
                  
                  
                     
                        22673-19-4
                     
                  
                  
                     
                        Repr. 1B
                     
                     
                        STOT RE 1 
                     
                  
                  
                     
                        H360FD
                     
                     
                        H372 (immune system)
                     
                  
                  
                     
                        GHS08
                     
                     
                        Dgr
                     
                  
                  
                     
                        H360FD
                     
                     
                        H372 (immune system)’
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
            
               
            
               ANNEX IV 
            
            
                
            
            
               In the Annex to Commission Regulation (EU) 2018/669, the row with Index No ‘648-055-00-5’ is replaced by the following:
            
            
            
            
                     
                        ‘648-055-00-5
                     
                  
                  
                     
                        pitch, coal tar, high-temp.; 
                           [The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.]
                     
                  
                  
                     
                        266-028-2
                     
                  
                  
                     
                        65996-93-2
                     
                  
                  
                     
                        Carc. 1A
                           Muta. 1B
                           Repr. 1B
                     
                  
                  
                     
                        H350
                           H340
                           H360FD
                     
                  
                  
                     
                        GHS08
                     
                     
                        Dgr
                     
                  
                  
                     
                        H350
                           H340
                           H360FD’