Corrigendum to Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Official Journal of the European Union L 307 of 28 November 2019)
Date: 2019-12-13
Institutions: European Commission
Subjects: approximation of laws, chemical product, consumer information, cosmetic product, health risk, product safety




L_2019324EN.01008001.xml










13.12.2019   


EN


Official Journal of the European Union


L 324/80







Corrigendum to Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

(Official Journal of the European Union L 307 of 28 November 2019)


On page 19, Annex I and Annex II are replaced as follows:



‘ANNEX I

(1)   
Annex II to Regulation (EC) No 1223/2009 is amended as follows:
The following entries are added:








Reference number


Substance identification




Chemical name/INN


CAS number


EC number




a


b


c


d




“1612


Phosmet (ISO); S-[(1,3-dioxo-1,3-dihydro-2H- isoindol-2-yl)methyl]-O,O-dimethyl phosphorodithioate;

O,O-dimethyl-S-phthalimidomethyl phosphorodithioate


732-11-6


211-987-4




1613


Potassium permanganate


7722-64-7


231-760-3




1614


2-Benzyl-2-dimethylamino-4′- morpholinobutyrophenone


119313-12-1


404-360-3




1615


Quizalofop-p-tefuryl (ISO);
(+/–) tetrahydrofurfuryl (R)-2-[4-(6- chloroquinoxalin-2-
yloxy)phenyloxy]propionate


200509-41-7


414-200-4




1616


Propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4- dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl}-1H- 1,2,4-triazole


60207-90-1


262-104-4




1617


Pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate


243973-20-8


635-361-9




1618


Tetramethrin (ISO);
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate


7696-12-0


231-711-6




1619


(1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2- methylprop-1-enyl)cyclopropanecarboxylate


1166-46-7


214-619-0




1620


Spirodiclofen (ISO);
3-(2,4-dichlorophenyl)-2-oxo- 1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate


148477-71-8


604-636-5




1621


Reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy) but-2-ylamine


897393-42-9


447-920-2




1622


1-Vinylimidazole


1072-63-5


214-012-0




1623


Amisulbrom (ISO)3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide


348635-87-0


672-776-4”






(2)   
Annex III to Regulation (EC) No 1223/2009 is amended as follows:
Entry 98 is replaced by the following:













“98


Benzoic acid, 2-hydroxy- (*1)



Salicylic acid


69-72-7


200-712-3








(a)


Rinse-off hair products












(a)


3,0 %






Not to be used in preparations for children under 3 years of age.


Not to be used for children under 3 years of age (*2)











(b)


Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant












(b)


2,0 %






Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.


 




Not to be used in oral products.




For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.






(3)   
Annex V to Regulation (EC) No 1223/2009 is amended as follows:
Entry 3 is replaced by the following:













Reference number


Substance Identification


Conditions


Wording of conditions of use and warnings




Chemical name/INN


Name of Common Ingredients Glossary


CAS number


EC number


Product type, Body parts


Maximum concentration in ready for use preparation


Other


 




a


b


c


d


e


f


g


h


i




“3


Salicylic acid (*3) and its salts


Salicylic acid


69-72-7


200-712-3


 


0,5 % (acid)


Not to be used in products for children under 3 years of age.


Not to be used for children under 3 years of age (*4)





Not to be used in oral products.




Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.




Calcium salicylate, magnesium salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA- salicylate


824-35-1, 18917-89-0, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5


212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3


 


0,5 % (acid)


Not to be used in products for children under 3 years of age, except for shampoos.


Not to be used for children under 3 years of age (*5)










‘ANNEX II

(1)   
Annex II to Regulation (EC) No 1223/2009 is corrected as follows:






(a)


entry 395 is replaced by the following:








Reference number


Substance identification




Chemical name/INN


CAS number


EC number




“395


Hydroxy-8-quinoline and its sulphate bis(8-hydroxyquinolinium) sulphate, except for the uses of the sulphate provided for in entry 51 of Annex III


148-24-3
134-31-6


205-711-1
205-137-1”














(b)


entry 1396 is replaced by the following:








Reference number


Substance identification




Chemical name/INN


CAS number


EC number




a


b


c


d




“1396


Borates, tetraborates, octaborates and boric acid salts and esters, including:


 


 




Disodium octaborate anhydrous [1]


12008-41-2 [1]


234-541-0 [1]




Disodium octaborate tetrahydrate [2]


12280-03-4 [2]


234-541-0 [2]




2-Aminoethanol, monoester with boric acid [3]


10377-81-8 [3]


233-829-3 [3]




2-Hydroxypropyl ammonium dihydrogen orthoborate [4]


68003-13-4 [4]


268-109-8 [4]




Potassium borate, boric acid potassium salt [5]


12712-38-8 [5]


603-184-6 [5]




Trioctyldodecyl borate [6]


- [6]


- [6]




Zinc borate [7]


1332-07-6 [7]


215-566-6 [7]




Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt [8]


1330-43-4 [8]


215-540-4 [8]




Tetraboron disodium heptaoxide, hydrate [9]


12267-73-1 [9]


235-541-3 [9]




Orthoboric acid, sodium salt [10]


13840-56-7 [10]


237-560-2 [10]




Disodium tetraborate decahydrate; borax decahydrate [11]


1303-96-4 [11]


215-540-4 [11]




Disodium tetraborate pentahydrate; borax pentahydrate [12]


12179-04-3 [12]


215-540-4 [12]”














(c)


entry 1507 is replaced by the following:








Reference number


Substance identification




Chemical name/INN


CAS number


EC number




“1507


Diaminotoluene, methyl-phenylenediamine, technical product-reaction mass of [4-methyl-m-phenylenediamine and 2-methyl-m-phenylenediamine]


–


–”














(d)


the following entries are added:








Reference number


Substance identification




Chemical name/INN


CAS number


EC number




a


b


c


d




“1624


Pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate


23103-98-2


245-430-1




1625


1,2-Dichloropropane; propylene dichloride


78-87-5


201-152-2




1626


Phenol, dodecyl-, branched [1]


121158-58-5 [1]


310-154-3 [1]




Phenol, 2-dodecyl-, branched [2]


1801269-80-6 [2]


- [2]




Phenol, 3-dodecyl-, branched [3]


1801269-77-1 [3]


- [3]




Phenol, 4-dodecyl-, branched [4]


210555-94-5 [4]


640-104-9 [4]




Phenol, (tetrapropenyl) derivatives [5]


74499-35-7 [5]


616-100-8 [5]




1627


Coumatetralyl (ISO); 4- hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl) coumarin


5836-29-3


227-424-0




1628


Difenacoum (ISO); 3-(3- biphenyl-4-yl-1,2,3,4- tetrahydro-1-naphthyl)- 4-hydroxycoumarin


56073-07-5


259-978-4




1629


Brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin


56073-10-0


259-980-5




1630


Flocoumafen (ISO); reaction mass of: cis-4- hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin and trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin


90035-08-8


421-960-0




1631


Acetochlor (ISO); 2- chloro-N-(ethoxymethyl)-N-(2-ethyl-6- methylphenyl)acetamide


34256-82-1


251-899-3




1632


e-Glass microfibres of representative composition


-


-




1633


Glass microfibres of representative composition


-


-




1634


Bromadiolone (ISO); 3- [3-(4′-bromobiphenyl- 4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy- 2H-chromen-2-one


28772-56-7


249-205-9




1635


Difethialone (ISO); 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]- 4-hydroxy-2H-1-benzothiopyran-2-one


104653-34-1


600-594-7




1636


Perfluorononan-1-oic acid [1]


375-95-1 [1]


206-801-3 [1]




and its sodium [2]


21049-39-8 [2]


- [2]




and ammonium [3] salts


4149-60-4 [3]


- [3]




1637


Dicyclohexyl phthalate


84-61-7


201-545-9




1638


3,7-Dimethylocta-2,6- dienenitrile


5146-66-7


225-918-0




1639


Bupirimate (ISO); 5-butyl-2-ethylamino-6- methylpyrimidin-4-yl dimethylsulfamate


41483-43-6


255-391-2




1640


Triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1- (1H-imidazol-1-yl)-2- propoxyethanimine


68694-11-1


604-708-8




1641



tert-Butyl hydroperoxide


75-91-2


200-915-7”










(2)   
Annex III to Regulation (EC) No 1223/2009 is corrected as follows:






(a)


entry 9 is replaced by the following:













Ref
No.


Substance identification


Restrictions


Wording of conditions of use and warnings




Chemical name/INN


Name of Common Ingredients Glossary


CAS number


EC number


Product type, body parts


Maximum concentration in ready for use preparation


Other


 




a


b


c


d


e


f


g


h


i




“9


Methylphenylenediamines, their N- substituted derivatives and their salts (1), with the exception of the substance listed under reference numbers 9 a and 9 b of this Annex and the substances listed under reference numbers 364, 413, 1144, 1310, 1313 and 1507 of Annex II


 


 


 


Hair dye substance in oxidative hair dye products


 








(a)


General use












(a)


To be printed on the label:
The mixing ratio.
“

Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary “black henna” tattoos may increase your risk of allergy.
Do not colour your hair if:






—


you have a rash on your face or sensitive, irritated and damaged scalp,










—


you have ever experienced any reaction after colouring your hair,










—


you have experienced a reaction to a temporary “black henna” tattoo in the past.




Contains phenylenediamines (toluenediamines).
Do not use to dye eyelashes or eyebrows.”














(b)


Professional use












(b)


To be printed on the label:








For (a) and (b):
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base


The mixing ratio.
“For professional use only. Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary “black henna” tattoos may increase your risk of allergy.
Do not colour your hair if:






—


you have a rash on your face or sensitive, irritated and damaged scalp,










—


you have ever experienced any reaction after colouring your hair,










—


you have experienced a reaction to a temporary “black henna” tattoo in the past.




Contains phenylenediamines (toluenediamines).
Wear suitable gloves.””














(b)


the following entry is added:













Reference number


Substance identification


Restrictions


Wording of conditions of use and warnings




Chemical name/INN


Name of Common Ingredients Glossary


CAS number


EC number


Product type, body parts


Maximum concentration in ready for use preparation


Other




a


b


c


d


e


f


g


h


i




“51


Bis(8-hydroxyquinolinium) sulphate


Oxyqui-noline sulphate


134-31-6


205-137-1


Stabilizer for hydrogen peroxide in rinse-off hair products


(0,3 % as base)


 


 




Stabilizer for hydrogen peroxide in leave-on hair products


(0,03 % as base)”











                  ’
               


(*1)  For use as a preservative see Annex V, No 3.

(*2)  Solely for products which might be used for children under 3 years of age.”
         

(*3)  For uses other than preservative, see Annex III, No 98.

(*4)  Solely for products which might be used for children under 3 years of age

(*5)  Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.”